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CSR AT SANOFI
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EXPERTS' CORNER
INDICATORS GRI INDEX MATERIALITY
Acting ethically and responsibly for the patient

Sanofi acts ethically and responsibly to be a healthcare partner today and tomorrow. Our
Pharmacovigilance
Malaria Human Marketing
sustainability approach places the patient at the heart of the Groups business conduct. This approach is based on four key areas: Patient, People, Ethics and Planet.
Rights
Counterfeit drugs
Innovation Water
Climat change
Environment
management
PUBLICATIONS
Corporate Social Responsibility, 20112012 Brochure (PDF, 1247Kb) All our publications
OUR VISION Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships CSR performance
PATIENT Patient indicators Access to healthcare Supporting patients Patient-focused innovation Product risk management
ETHICS Ethics indicators Human rights Ethics in R&D Business ethics
PEOPLE People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and well-being Contributing to local economic development
PLANET Planet indicators CO2 emissions and energy Local environmental impact Pharmaceuticals in the environment Biodiversity
Contact | Sitemap | Glossary | Publications | Help | Legal Notice | Sanofi 2011-2012. All rights reserved | Update: 13 February 2012
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OUR VISION Message from Senior Management The Group's profile Our CSR approach
CSR governance A cross-functional approach Increasing awareness of CSR initiatives Outlook
PATIENT Patient indicators Access to healthcare

The Group's commitment Infectious diseases Non-infectious diseases Rare diseases Humanitarian emergencies
ETHICS Ethics indicators Human rights

Policy Actions
PEOPLE People indicators Diversity

Gender equity Work-life balance People with disabilities Preventing discrimination Age management
PLANET Planet indicators CO2 emissions and energy

Background Policy Goals Actions Indicators
Ethics in R&D
Ethics in clinical trials Bioethics Use of laboratory animals for research Nanotechnology Biopiracy
Supporting change
Actions
Local environmental impact

Green chemistry Water consumption Wastewater discharge Protection of the atmosphere Packaging Waste management Soil and groundwater protection
CSR reporting
Identifying CSR challenges Materiality test Business case approach
Supporting patients
Policy Actions Transparency
Business ethics
Corporate governance Institutional relations Fighting corruption Free competition policy Responsible marketing Personal data protection Responsible procurement
Employee career development

Actions
Our stakeholders Policies and management systems

Internal policies Management systems Risk management
Patient-focused innovation
Managing innovation Our innovations in 2010 Business case: Dengue fever
Relationships with schools and universities Compensation and employee benefits

Compensation Employee benefits
Pharmaceuticals in the environment

Policy Actions
Product risk management

Pharmacovigilance Global quality Continuity of activities and supplies The fight against counterfeit drugs
Standards and memberships

Complying with standards Memberships and partnerships
Employee representation and information

Actions
Biodiversity
Policy Actions Business case: Artemisinin
CSR performance
GRI Recognition and Awards How data are reported: Methodological note Statutory auditors review report Social indicators Environmental indicators Other indicators
Ensuring occupational health, safety and wellbeing

Safety in the workplace Occupational health Prevention and management of major occupational risks HSE compliance for subcontractors and suppliers
Contributing to local economic development
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OUR INDICATORS
Our vision
Acting ethically and responsibly for the patient.
OUR VISION INDICATORS

A network of 40 CSR correspondents, on all 5 continents 25 operating departments in the CSR Functional Network A budget allocation of 27.7 million over five years for the Sanofi Espoir Foundation 20 stakeholders surveyed for the 2010 CSR reporting 200 initiatives CSR initiatives published in 2010 on a new in-house CSR blog
Corporate Social Responsibility (CSR) lies at the core of sanofi-aventis business as a global healthcare leader. Being a healthcare partner involves promoting social progress, economic development and respect for the environment as well as acting ethically and responsibly. A model for sustainable growth requires a new approach to healthcare that focuses on the patient. Sanofi-aventis CSR approach concentrates on four key areas: Patient, People, Ethics and Planet.
Our CSR approach

In conjunction with the transformation process, the Groups CSR approach continued to progress in 2010. CSR supports the Groups strategy in many ways: stronger corporate governance, organization, awareness and commitments.
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CSR reporting
Sanofi-aventis continued its transformation process in 2010. External outreach helped spur development within the Group.
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Our stakeholders
Sanofi-aventis interacts with a wide variety of stakeholders each day. The primary ties with stakeholders are described in detail.
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Policies and management systems

Sanofi-aventis relies on internal policies and tailored management systems (HSE, Global Quality, Pharmacovigilance, etc.). Specific procedures are established to manage risk.
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MATERIALITY TEST 2010: A new materiality test to identify and prioritize CSR challenges
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Sanofi-aventis is committed to meeting CSR standards. The Group complies with the standards of key international organizations.
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OUR COMMITMENTS For 2011, sanofi-aventis plans to increase stakeholders involvement in implementing the Groups CSR strategy.
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2010 highlights
Sanofi Espoir Foundation created
The new Foundation, whose Board is chaired by Jean-Franois Dehecq, is tasked with supporting international actions of general interest in the healthcare field
BUSINESS CASE
Agefi 2010 Grand Prix

Sanofi-aventis recognized for CSR governance
BUSINESS CASE APPROACH While CSR initiatives represent a benefit for stakeholders, sanofiaventis is also convinced that these initiatives represent opportunities for the Group: Illustration through 7 Business Cases.
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Listed on the DJSI World Index

For the fourth consecutive year, sanofi-aventis was listed on the Dow Jones Sustainability World Index (DJSI World)
Creation of CSR Excellence

Within the CSR Direction, CSR Excellence was created to complement the initiatives of Access to Medicines, Diversity / Disability and specific initiatives designed to help employees and their families
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You are here: Home > Our vision > Message from Senior Management
Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships CSR performance Christopher A. Viehbacher Chief Executive Officer
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Message from Senior Management

Corporate Social Responsibility is part of the DNA of Sanofi
Gilles Lhernould Senior Vice President Corporate Social Responsibility
What were the highlights of 2010?

Christopher A. Viehbacher (CV): We continued the implementation of our strategy to be a patient-centric, global and diversified healthcare partner focused on delivering innovative solutions to meet public health needs across the world. This strategy enabled us to deliver good results in 2010, opened up the company to forge exciting new partnerships. We also saw excellent performance in our identified growth platforms. We are in good shape in our quest to build a company based on sustainable growth. Gilles Lhernould (GL): The Group also made important strides in the field of Corporate Social Responsibility in 2010, with valuable progress in all areas, particularly thanks to our CSR approach: stronger corporate governance, increased employee awareness and greater involvement from our stakeholders.
Why is CSR important for Sanofi?

CV: As a leading healthcare partner, we have a great responsibility to our patients of course, but also to the environment in which we operate. We have businesses in just about every region and country in the world. Acting ethically and with integrity are core to our success and a focus of all employees within the company. How we conduct our business, our approach to R&D, manufacturing and commericalization, and our commitment to promoting access to healthcare are as important as the products and services themselves. CSR is also a catalyst for innovation, inspiring us to reach further than our objectives. It also opens the door to new business models and new markets. GL: I would say that CSR is a springboard for the Groups performance because it gives us positive momentum. Corporate Social Responsibility benefits both Sanofi and our stakeholders helping us to better anticipate risks, attract and retain talented employees, and improve the Groups image.
Sanofi excels at meeting certain CSR challenges what are some examples?
CV: Throughout 2010, we continued to ensure the highest ethical standards throughout the company. I am pleased that we once again received recognition for our Groups CSR performance. There were many successful initiatives and activities, but one I am particularly proud of is our progress in promoting access to healthcare to all those in need - because this is the very essence of our work. This commitment and our focus on solidarity in response to humanitarian emergencies are elements that motivate me and all our employees. The Sanofi Espoir Foundation, created in late 2010, helps us fulfill this mission.
GL: I would also mention the fight against counterfeit drugs, which is absolutely essential to protecting patient safety. Another important area is ethics in R&D, without overlooking our initiatives to protect the environment by preserving biodiversity. We also excel at the challenge of promoting diversity within our workforce.
What are your CSR priorities?

CV: We will continue to build on our CSR strategy, putting it at the core of all our activities. It is our responsibility. This approach is also constructive for the company, as it ensures continued innovation as we strive to achieve our ambition to improve the lives of as many people as we can, respecting the people within our company, our patients and our environment around us. As part of the strategy identification, the Group established 12 key CSR challenges at the beginning of 2011 that will now become the immediate priorities' GL: We also have plans to expand our progress-based strategy. This requires, first, deciding on priority challenges and taking advantage of our CSR correspondent networks. We can also realize this ambition by pursuing the most innovative projects, and in particular by upholding the principles of human rights within the Group. Lastly, achieving this ambition is built on collaboration with our stakeholders so that we can better meet their expectations specifically in areas where we know we can improve our performance, such as the impact of pharmaceuticals in the environment. CV: I would also like to add that our approach and our accomplishments depend on the women and men of Sanofi. I would like to take this opportunity to thank them for their commitment and passion in making the world a healthier place.
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Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships CSR performance
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The Group's profile

A global healthcare leader A diversified product portfolio with prescription drugs, consumer health products (OTC) and generics A leader in human vaccines Balanced presence between traditional markets and emerging markets(1) Approximately 100,000 employees in 100 countries 2010 sales: 30.4 billion, with growth of 3.7% (2) Sanofi-aventis ambition is to become a diversified global healthcare company focused on the patients needs. To reach this objective and deliver sustainable growth, the Group is concentrating on three key themes: Increasing innovation in Research and Development Seizing external growth opportunities Adapting Group structures to meet future challenges Sanofi-aventis relies on its core strengths in the healthcare field, with six key platforms for growth: emerging markets, human vaccines, consumer health products, the diabetes drug portfolio, innovative products and animal health. (1) Worldwide excluding the United States, Canada, Western Europe, Japan, Australia and New Zealand. (2) Compared with 2009 published data .
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You are here: Home > Our vision > Our CSR approach
Message from Senior Management The Group's profile Our CSR approach CSR governance A cross-functional approach Increasing awareness of CSR initiatives Outlook CSR reporting Our stakeholders Policies and management systems Standards and memberships CSR performance Acces to healthcare Patient safety Innovation for patients Ethics in R&D Good governance Human rights Health and safety in the workplace Diversity Workforce development Water Pharmaceuticals in the environment Climate change and energy
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Our CSR approach

Corporate Social Responsibility is part of the DNA of sanofi-aventis, at the core of the Groups strategy and development. Being a healthcare partner involves promoting social progress, economic development and respect for the environment as well as acting ethically and responsibly. The CSR approach places the patient at the center of the Groups business activities. As an integral part of the Groups strategy and values, CSR also represents a vision for the future that fosters sustainable growth. Sanofi-aventis expresses its responsibility as a global healthcare company through its CSR approach. This approach, which enriches all the Groups activities today, focuses on four key areas: Patient : The patient at the center of the Groups business Ethics : Ethics in action People: Employees and local communities Planet: Environmental performance As part of the process to identify sanofi-aventis CSR challenges, the Group established the following 12 key CSR challenges at the beginning of 2011:
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OUR VISION Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and
PEOPLE People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and
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Message from Senior Management The Group's profile Our CSR approach CSR governance A cross-functional approach Increasing awareness of CSR initiatives Outlook CSR reporting Our stakeholders Policies and management systems Standards and memberships CSR performance
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CSR governance
Given the vast array of CSR issues, it is important to establish solid, tailored CSR governance practices to manage the CSR approach efficiently throughout the entire Group.
The Sanofi Espoir Foundation continues to support the companys values and will allow us to put into practice important measures focusing on health issues in our civilization today
Christopher A. Viehbacher CEO, Sanofi www.fondation-sanofiespoir.com
CSR governance is part of the corporate governance strategy implemented at all Group levels. For more information: Find out more about Corporate Governance at sanofi-aventis 2010 Document de Rfrence - 1.2 Gouvernement dentreprise (Excerpt) (PDF, 228Kb)
The CSR Direction: At the core of the Group strategy

The sanofi-aventis Corporate Social Responsibility Direction was created at the end of 2009, in response to Senior Managements decision to establish a structure at the highest level that is tasked with: Managing and integrating the Groups CSR approach throughout sanofi-aventis entities Bringing together all the Groups major initiatives in the field of economic, social and environmental responsibility The CSR Direction reports directly to sanofi-aventis Senior Management. The Senior Vice President of Corporate Social Responsibility, Gilles Lhernould, is a member of the Groups Management Committee. This is a clear illustration of the strategic importance of this role in ensuring consistency for all the Group's CSR initiatives. In 2010, the CSR Direction was expanded with the creation of CSR Excellence. Its addition complements the missions of the other departments already operating within the CSR organization, namely Access to Medicines, Diversity / Disability and Childhood Mission, which supports employees and their families.
A foundation to coordinate all the Groups solidarity initiatives

www.fondation-sanofiespoir.com
A recognized CSR approach

In September 2010, sanofi-aventis received first prize in the 7th Grands Prix du Gouvernement dEntreprise organized by the daily financial newspaper Agefi, in the category of Social Responsibility. These prizes are awarded to companies listed on the SBF 120 (stock market index that includes the 120 largest stock market capitalizations in France) that meet the level of excellence demanded by investors in terms of transparency and implementing good practices.
A Foundation focusing on access to healthcare

October 2, 2010, the date on which the Sanofi Espoir Foundation was officially founded, marked an important step for sanofi-aventis. The corporate foundation, which is chaired by Jean-Franois Dehecq, is tasked with supporting actions of general interest in the healthcare field on an international scale. The Foundations actions are in line with the United Nations Millennium Development Goals, particularly those relating to fighting diseases, improving maternal and child health and combating poverty. With a budget of 27.7 million over five year, the Foundation will be able to gain leverage from and pursue initiatives previously instituted by the Humanitarian Partnership Department, which was initially part of the CSR Department. With greater resources, the Foundation will be able to develop new programs. Gilles Lhernould is a member of the Foundations Board of Directors, strengthening the natural ties between the Groups CSR access to healthcare policy and the initiatives established by the Foundation.
GRANDS PRIX DU GOUVERNEMENT DENTREPRISE 2010 AGEFI Sanofi-aventis was awarded 1st prize for Social Responsibility 2010: creation of CSR Excellence
An organization to pilot the CSR approach across all entities
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Piloting a cross-functional approach

Creating the Excellence in CSR Department in 2010 has made it possible to strengthen the initiatives already put in place by the Group in order to integrate the CSR approach into all areas of the Group.
A network of approximately 40 correspondents
across all Group regions and functions, on all continents.
Greater
As sanofi-aventis center for CSR expertise, CSR Excellence is responsible for proposing the CSR strategy for the Group to the Management Committee. It also implements this strategy at every level of sanofiaventis organization locally, regionally and globally. In 2011, in order to implement the Groups CSR approach more effectively and offer operating units continuous support, CSR Excellence developed two internal CSR networks: The CSR Functional Network includes representatives from over 20 operating departments, thus representing all the Groups corporate functions. The purpose of this network is to better integrate the global CSR strategy into business activities. It also makes it possible to define action plans and related indicators, to better monitor and promote the CSR initiatives and projects conducted by operating departments. The CSR Regional Network is made up of CSR correspondents from the regions and countries where the Group operates. The purpose of this network is to adapt the Groups global CSR strategy locally and regionally, and identify the specific challenges for each region / country so that the Group can put the right projects in place for these challenges. Today, sanofi-aventis has a network of approximately 40 correspondents across all Group regions and functions, on all continents. In addition to these activities, CSR Excellence also seeks to report and share CSR initiatives and actions in order to promote them among employees and external stakeholders. Seeking to understand stakeholder expectations (society, patients, healthcare professionals, NGOs, employees, etc.), the Group works in close collaboration with operating units to define the commitments and related action plans to address sanofiaventis CSR challenges. In 2010, stakeholders were more extensively involved in the preparation of the 2010 CSR Report. For more information: Materiality test
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stakeholder
involvement
PEOPLE People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee
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Increasing awareness of CSR initiatives

Numerous initiatives were organized in 2010 to increase awareness of CSR challenges among all Group employees and to encourage them to participate in the Groups approach on a daily basis.
The CSR Direction is now regularly taking part in Human Resources and operating department training seminars in order to present the Groups CSR strategy and make employees aware that they play a crucial role in implementing the Groups CSR approach every day. In 2010, CSR Excellence also developed and rolled out an in-house collaborative communication platform a CSR blog that helps the Groups organizations promote CSR initiatives put in place worldwide. This platform, which serves as a tool to help employees emulate and share experiences, has made it possible to promote over 200 initiatives since the tool was created. The Groups CSR intranet and website were reorganized and enhanced. New communications tools (e.g., a Group CSR brochure) were also developed to promote the Groups achievements internally and externally.
2010: New tools for sharing best CSR practices and for CSR communications
A new collaborative platform An enhanced intranet site A new website A brochure
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Outlook
Sanofi-aventis has set several goals for 2011:
Increase stakeholder involvement in establishing the Groups CSR strategy and develop partnerships with stakeholders Continue to develop and communicate on key CSR issues for the Group Maintain the momentum generated by the two internal networks and establish a means to share best practices. The Group plans to organize an annual CSR convention to promote this type of exchange. The goal will be to bring together all the Groups CSR players working at local, regional and global levels to increase awareness about the CSR approach and develop action plans together.
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You are here: Home > Our vision > CSR reporting
Message from Senior Management The Group's profile Our CSR approach CSR reporting Identifying CSR challenges Materiality test Business case approach Our stakeholders Policies and management systems Standards and memberships CSR performance
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CSR reporting
Sanofi-aventis continued its transformation process in 2010. External outreach helped spur development within the Group.
For several years, sanofiaventis has been working with our stakeholders in an interactive process to better understand their expectations, so that we can be even more responsive. For the 2010 CSR Reporting process, sanofi-aventis consulted 20 stakeholders to identify and prioritize the CSR challenges the Group must meet.
Didier Terrolle Director, CSR Excellence, sanofiaventis
The transformation process also had an impact on the Groups CSR approach: In 2010, the Group gave greater weight to stakeholders expectations concerning CSR challenges. This approach, which was carried out with the assistance of Deloitte, made it possible to improve the CSR reporting methods for sanofiaventis*. Identifying CSR challenges Materiality test Business case approach
* The information in italics identified by an asterisk was reviewed by the Statutory Auditors, who expressed an assurance specifically concerning these data. Their assurance statement, describing the work they performed as well as their comments and conclusions, is available in the section: Vision / CSR performance / Statutory auditors review report
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OUR VISION Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships
PEOPLE People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits
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You are here: Home > Our vision > CSR reporting > Identifying CSR challenges
Message from Senior Management The Group's profile Our CSR approach CSR reporting Identifying CSR challenges Materiality test Business case approach Our stakeholders Policies and management systems Standards and memberships CSR performance This approach is consistent with: Compliance with strict standards
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Identifying CSR challenges to further limit risks

For many years now, analysts and investors have assessed company performance and opportunities taking into account the analysis of their results and financial prospects as well as their CSR performance. These factors have a substantial impact on the business performance of companies and help anticipate both tangible risks (e.g., health, social and environmental risks) and intangible risks (e.g., risks involving reputation, image and human capital).
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Economic regulatory reforms, which have gradually expanded the definition of significant risks to include CSR challenges (1) Expectations from shareholders. For more information: Protecting against risk 2010 Document de Rfrence - 2.2.11 Assurances et Couvertures des Risques (Excerpt) (in French, PDF, 58Kb)
Sanofi-aventis has implemented a methodical approach the materiality test that is designed to identify the many CSR challenges that the Group must address and prioritize. (1) See in particular the Sarbanes-Oxley Act in the United States, the NRE Law (Nouvelles Rgulations Economiques) in France, the Grenelle II Law in France and the 2004 debate on the Operating and Financial Review in the United Kingdom.
PEOPLE People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and well-being Contributing to local
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Message from Senior Management The Group's profile Our CSR approach CSR reporting Identifying CSR challenges Materiality test Process Results Business case approach Our stakeholders Policies and management systems Standards and memberships CSR performance
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Materiality test
To prepare for the 2010 CSR Report, sanofi-aventis updated the materiality test conducted by the Group over the last several years for its CSR reporting.
stakeholders surveyed for the 2010 materiality test
20
The materiality test is a key part of the Groups CSR reporting strategy. It makes it possible to prioritize the CSR challenges that are identified by the Group and its stakeholders. This twofold approach is very important for two reasons: It encourages communication of relevant information that is significant for stakeholders It assists the analysis of the Groups current and future performance. Analysis process Analysis results
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Materiality analysis process

Sanofi-aventis process for analyzing the materiality of CSR challenges is primarily based on the recommendations outlined in the GRI (Global Reporting Initiative) G3 Guidelines and the AA1000 (AccountAbility Principles) standard. Materiality analysis is carried out using a list of CSR challenges that was initially developed to help define the Groups CSR strategy. It utilizes extensive analyses of a variety of internal and external information sources. Today this list of challenges organized into four key areas (Patient, Ethics, People and Planet) is updated every year by the CSR Direction with the help of expert functions (operating departments, regions and countries) that are involved in managing relevant CSR challenges. Once the CSR challenges have been selected and categorized, they are assessed and prioritized using two types of parameters: The significance level for these challenges based on external information sources The Groups internal strategy
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Assessing CSR challenges based on significance for stakeholders and CSR practices in the pharmaceutical sector and beyond
The materiality test first takes into account parameters related to external pressure. The goal is to prioritize the significance for stakeholders of all the CSR challenges identified regardless of whether or not they are specific to the pharmaceutical sector. This assessment also includes benchmarking of a selection of companies.
Stakeholder consultation
Sanofi-aventis surveyed a sample of over 20 stakeholders at the end of 2010. A total of 15 stakeholders with six different nationalities (American, Belgian, Brazilian, Chinese, French and Hungarian) from various business sectors (patient organizations, healthcare professionals, NGOs, universities, investors, Group employees, etc.) agreed to take part in the materiality test and were surveyed on the following topics: General knowledge about corporate social responsibility within the pharmaceutical sector Key expectations and recommendations for the CSR approaches that pharmaceutical companies should put into practice Initiatives to be carried out and information expected to assess the relevance of these initiatives The degree of importance of the various CSR challenges In order to promote transparency and in agreement with stakeholders, certain quotations gathered during the consultation process have been included in the Groups 2010 CSR Report.
Benchmarking CSR practices of international groups

Benchmarking is used to identify the CSR challenges of various international groups, the commitments they have made, their good practices and how they communicate on CSR issues. Nine pharmaceutical and non-pharmaceutical companies were selected for this benchmarking.
Analyzing external questionnaires

External questionnaires from extra-financial rating agencies, non-profit CSR organizations and investors were analyzed in depth. This process helped identify the challenges they consider to be important and defined the level of information they require.
Media review
A media review was conducted to identify the main topics and CSR emerging issues for the year.
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Assessing CSR challenges relative to internal strategy

At the same time, sanofi-aventis CSR challenges were assessed by various functional representatives within the Group who are involved in the implementation of the Groups CSR approach. These representatives prioritized the challenges based on their relevance and how they influence sanofi-aventis strategy. The chart below illustrates the general approach used for the materiality test:
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Materiality analysis results

After all the CSR challenges are assessed, they are placed on a matrix in order to categorize them based on their level of importance for external stakeholders and how relevant they are to the Group's overall strategy.
Each challenge is positioned on the matrix. The chart below positions the challenges based on a color code that corresponds to each of the key areas of the Group's CSR strategy: Patient, People, Ethics and Planet.
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Finally, in addition to the raw results of the materiality analysis represented in the matrix above, the diagrams below provide a clear view of the four focus areas, the various Group CSR challenges, their relevance and degree of priority relative to one another.
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You are here: Home > Our vision > CSR reporting > Business case approach
Message from Senior Management The Group's profile Our CSR approach CSR reporting Identifying CSR challenges Materiality test Business case approach Our stakeholders Policies and management systems Standards and memberships CSR performance
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Business case approach

CSR: A benefit for stakeholders, an opportunity for sanofi-aventis.
While CSR initiatives represent a benefit for stakeholders, sanofi-aventis is also convinced that these initiatives represent real opportunities for the Group and its development. Carrying out CSR initiatives responsibly and ethically creates a positive dynamic and helps the Group's reputation. CSR initiatives offer many opportunities: Anticipating risks better Improved image and reputation Greater confidence in sanofi-aventis products Attracting, retaining and motivating talented employees Constructive approach with stakeholders New growth vectors (increased sales, new markets) Anticipating and participating in regulatory changes Reduced costs through optimized resource management In 2010, sanofi-aventis illustrated these opportunities through several concrete examples presented through business cases (see table below). They demonstrate that the Groups CSR approach is beneficial for stakeholders and represents an opportunity for sanofi-aventis.
CHALLENGE OUR RESPONSE
PATIENT
Fighting malaria
A global approach to the disease
Eradicating polio
Sanofi Pasteur, a longstanding partner for the Global Polio Eradication Initiative
Fighting dengue fever
Developing a safe, effective tetravalent vaccine that is accessible in countries where dengue fever is endemic Modifying behaviors to improve safety performance
PEOPLE
Health & safety
ETHICS
Responsible procurement
Introducing fair trade within Industrial Affairs
PLANET
Biodiversity
Producing semisynthetic artemisinin
Local environmental footprint
Limiting packaging waste
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PATIENT Patient indicators Access to healthcare Supporting patients Patient-focused
PEOPLE People indicators Diversity Supporting change Employee career
PLANET Planet indicators CO2 emissions and energy Local environmental
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Our stakeholders
Given its international scope, sanofi-aventis understands the importance of providing concrete responses to the needs and expectations of a wide variety of stakeholders, particularly healthcare stakeholders.
Stakeholders include all those interacting with sanofi-aventis, internally and externally, who are part of the day-to-day framework of the Groups activities: patients, employees, shareholders, suppliers, competitors, local communities, public authorities, healthcare professionals, etc. The type of day-to-day interaction with stakeholders varies depending on different needs. It can involve providing reliable factual information, establishing constructive dialogue, or forming partnerships. Responding within the scope of the consultation of stakeholders for the 2010 CSR reporting, Professor Gregory Katz, ESSEC-sanofi-aventis Chair Co-Director, ESSEC Institute of Health Economics & Management, stated: Stakeholders expect more dialogue on the issues and obstacles sanofi-aventis is confronted with . A process based on interaction Main types of stakeholder relationships
A process based on interaction

For several years now, sanofi-aventis has been promoting interaction with its stakeholders in order to better understand the issues that are significant to them and provide a better response. This proactive approach allows the Group to take on a major role as a healthcare player and take part in developing a model for sustainable economic growth. To support this approach, sanofi-aventis has implemented a formal consultation and exchange process with many categories of stakeholders that involves satisfaction surveys, working groups, etc. As part of the 2010 CSR Reporting process, 20 stakeholders were surveyed by sanofi-aventis to identify and prioritize the CSR challenges that the Group must address. For more information: Materiality analysis process Other resources are used to give stakeholders transparent information about the Groups activities and provide them with responses to questions they may have regarding the primary CSR challenges: annual reports, brochures and other communication tools (websites, etc.). For many years now, the Group has also formed many collaborations with NGOs and international organizations, particularly to develop medicines and vaccines, and access to treatments for patients. The Groups stakeholder building initiatives have been recognized in Hungary. In 2010, the Group was awarded the Pro Urbe prize by local authorities of Veresegyhaz, a city where sanofi-aventis operates.
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Main types of stakeholder relationships

The table below outlines the Group's major types of stakeholder relationships. The results of these interactions are described in the various sections covering the challenges related to the four key areas of the Groups CSR approach: Patient, Ethics, People and Planet.
STAKEHOLDERS COMMUNICATION DIALOGUE / CONSULTATION COLLABORATIONS
Employees
In-house communication tools (intranet, Internet, CSR blog, CSR events) Awareness-raising initiatives (training, CSR report, brochures)
Dialogue with employees, employee representatives and trade unions Direct expression forum Raising awareness about sustainable development Satisfaction surveys
Support for employees' individual projects (spin-offs, NGOs, etc.) Calls for CSR projects
Patients
Dedicated internet sites CSR brochures and reports Communication about product safety information Communication about proper use of products Communication about clinical trials
Dialogue / consultation panels with patients and patient organizations
Information (prevention, screening, education, treatments) and support for patients and their families Support for recycling programs for unused medicines where available
Citizens
CSR Internet site CSR brochures and reports Communication about product safety information Communication about clinical trials
Forums for dialogue and consultation
Information on healthcare prevention, screening and education Support for recycling unused medicines
Healthcare professionals
Dedicated Internet sites Scientific publications Communication about product safety and efficacy information Communication about clinical trials
Working groups Scientific meetings Development expertise Satisfaction surveys
Clinical trials Training
Regulatory authorities and agencies
Pharmacovigilance Communication about the Groups corporate strategy and policy
Compliance with standard practice (e.g., registration dossier assessment and inspections) Development expertise Prescription guidelines, negotiating prices and reimbursements
Research partnerships Providing medicines and vaccines at no cost / low cost for populations in developing countries Prevention and management of health crises
Other pharmaceutical groups
Representation on pharmaceutical industry organizations
Research partnerships Joint ventures
Suppliers
Suppliers Code of Conduct
Raising awareness about human rights, working conditions and respect for the environment Evaluation
Improvement plans
NGOs
Brochures, reports, Internet site Customized information sessions
Multi-stakeholder associations Answering questionnaires Participating in forums Satisfaction surveys
Providing medicines and vaccines at no cost / low cost or selling at differential prices Awareness-raising, prevention and training initiatives for NGOs
Rating agencies
Brochures, reports, Internet site
Answering questionnaires / occasional requests
Investors
Quarterly financial results Annual and half-year reports Internet site Group CSR performance
Financial events / meetings of analysts Special meetings Answering questionnaires / occasional requests Roadshows
Conferences for the financial community
Individual shareholders
Letter to shareholders Individual shareholder handbook
Individual shareholders advisory committees Specific meetings in France
Annual review Internet site Group CSR performance
General Meeting Individual shareholder fairs in France and the United States
Local communities
Brochures and reports Open houses Special events
Panels of local residents Dialogue with local authorities
Local development initiatives (humanitarian sponsorship, governments, NGOs, etc.)
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You are here: Home > Our vision > Policies and management system...
Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Internal policies Management systems Risk management Standards and memberships CSR performance Sanofi-aventis has established many documents to structure the Groups CSR approach.
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Policies and management systems

Sanofi-aventis CSR approach is based on internal policies and tailored management systems that make it possible to integrate the approach throughout the entire Group. Risk management is also a key part of the sanofi-aventis CSR approach.
Internal policies
Management systems
Standards and controls: A fully integrated CSR approach
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Risk management
The evaluation of opportunities and risks is affected by continual new developments.
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Internal policies
Sanofi-aventis has established many documents to structure the Groups CSR approach.
The Group has developed internal codes, charters, policies and other tools that are aligned with the Code of Ethics and the Social Charter. These internal policies apply to the entire Group. Code of Ethics Social Charter Other internal policies
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Code of Ethics
General principles Distributing and understanding the Code of Ethics
General principles
With operations in more than 100 countries, and as one of the leaders in the pharmaceutical industry, sanofi-aventis is firmly committed to the ethical principles that govern its activities. Ethical conduct is essential both within the Group and outside the Group. All sanofi-aventis employees, regardless of where they work or the job that they do, must uphold the principles and values in the Code of Ethics so that these principles and values serve the Group and all its partners: Sanofi-aventis aims to combine economic and social performance by reaffirming its commitment to the company values: Safety and health in the workplace, encouraging dialogue within the Group, training and employment, employee benefits and respect for privacy are key issues for the Group. Sanofi-aventis is careful to maintain a climate of mutual respect with its many partners in the field of medicine, science and commerce. The Group attaches great importance to providing information to the medical and scientific community, especially about clinical trial results conducted for drug development and the realization of post-marketing studies. Working to preserve life and health, sanofi-aventis pursues an ambitious policy to protect and ensure the safety of its industrial sites and to protect the environment. Sanofi-aventis applies principles of corporate governance and encourages transparency. In accordance with relevant regulations, the Group has a duty to supply its shareholders and the market with timely, regular, trustworthy and relevant information concerning its activities, its financial performance and its economic results. The work of the Group's Board of Directors is governed by a charter defining the rights and duties of the Directors and the Board's relations with its various specialized committees. Sanofi-aventis respects the cultural and legal environment of the countries in which it operates: By objecting to all forms of corruption By complying with the rules of free competition By adhering to the principles of the Universal Declaration of Human Rights By supporting the principles of the International Labor Organization (ILO) and the guidelines issued by the Organization for Economic Cooperation and Development (OECD) geared to multinational enterprises By promoting various international initiatives forging links between the business sector and society Sanofi-aventis is a member of the United Nations Global Compact and is committed to supporting and applying its key principles concerning human rights, labor, the environment and anti-corruption.
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Distributing and understanding the Code of Ethics

In November 2005, the Code of Ethics was posted on the sanofi-aventis intranet and the Groups corporate website. The Code of Ethics is under revision in 2011 and will be made available to all Group employees. For more information: Sanofi-aventis Code of Ethics (PDF, 1836Kb)
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PATIENT Patient indicators Access to healthcare Supporting patients
ETHICS Ethics indicators Human rights Ethics in R&D
PEOPLE People indicators Diversity Supporting change
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Social Charter
The Social Charter outlines the principles that form the common core for human relations within the Group.
READ MORE ABOUT SANOFI-AVENTIS SOCIAL CHARTER
Sanofi-aventis Social Charter (PDF, 1268Kb)
It has been distributed to all employees in some 20 languages. It contains important sections on human rights and the principles of the UN Global Compact, particularly in the field of labor relations: Freedom of association and recognition of the right to collective bargaining The abolition of child labor The elimination of discrimination in employment It also includes all the elements in International Labor Organization Conventions 138 and 182 with respect to childrens safety and physical and moral health.
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Other internal policies

In addition to the Code of Ethics and the Social Charter, sanofi-aventis has defined a set of CSR-related principles and policies.
The table below lists the corresponding documents (codes, charters, policies, etc.) that are applicable to the entire Group.
INTERNAL POLICIES PRINCIPLES
Code of Ethics
The Code of Ethics details the key principles for developing sanofi-aventis and forging the Groups future. It helps employees analyze the actions that they should adopt in situations inside and outside the Group. In 2010, sanofi-aventis established an anti-corruption policy, which was provided to all Group employees, via the Groups intranet. This policy describes sanofi-aventis commitment to fighting all forms of corruption by presenting anti-corruption laws and regulations to employees so that they can apply them within the scope of their work. Principles guaranteeing the exhaustive, accurate and objective nature of financial information published by the Group in compliance with regulations issued by the relevant administrative authorities or any other public or private body with regulatory powers regardless of where they are located in the world. Principles describing the responsibilities and goals of internal audit as well as the related professional and ethical rules intended to provide Senior Management with reasonable assurance concerning the level of control over Group operations. This code presents key principles in terms of governance and internal control. It forms a foundation for initiating monitoring at the local level of the effectiveness and the relevance of controls in place. This charter outlines the IT Audit Departments responsibilities and objectives within the sanofi-aventis Group. It establishes the professional and ethical rules that IT system auditors must follow. It also defines the methodological framework for IT audit and serves as a key communication tool. The Social Charter outlines the principles that form the core basis for human relations in terms of social dialogue, employee benefits, occupational health and safety, working conditions, professional training and non-discrimination within the Group. Sales representatives apply rules when dealing with prescribing physicians or patients to ensure that the Group provides them with all necessary information for the proper use of the medicine in question. These rules comply with the requirements of the World Health Organization (WHO) and the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations). Rules defining the actions and behaviors Group buyers adopt in matters of potential conflict of interest, accepting gifts from suppliers and confidentiality. Within the scope of the supplier selection process, they include the evaluation of their sustainability policy, hygiene, security, environment and citizenship. Compliance with this code of conduct is essential to the commercial relationship between the supplier and sanofi-aventis. The Code describes the conditions that Group suppliers must respect in terms of human rights, working conditions, the environment and the fight against corruption. This charter describes for all types of scientific publications on the Groups compounds, vaccines and techniques (concerning both pre-clinical and clinical trial results) the principles to be followed as regards quality, transparency, respect for
Anti-corruption Policy
Internal Audit Charter
Code of Internal Control Principles
IT Audit Charter
Social Charter
Good Promotional Practices
Ethical Charter for Procurement
Suppliers Code of Conduct
Charter on the Ethical Principles Governing Scientific / Medical Publications for the Groups Techniques / Compounds / Vaccines
copyright and good publishing practices. The principles set out in this charter also apply to all publication authors, i.e., regardless of whether or not they are sanofiaventis employees. Charter on the Humane Care and Use of Laboratory Animals Rules governing the conditions for using laboratory animals. They include seeking alternative methods as well as the routine implementation of the best standards by the Group, its partners and subcontractors. Internal rules concerning the collection, processing, utilization, distribution, transfer and storage of individual data in order to ensure an adequate level of protection. These principles ensure patient safety by implementing a Quality management system that is incorporated into all the Groups activities. Its principles of continuous improvement a key concept of this policy is shared with all employees. This policy establishes a high Quality standard worldwide to provide effective and safe products that are developed, manufactured, distributed and marketed in full compliance with regulatory requirements and the Groups corporate values. Guidelines outlining the Groups scope of action to safeguard the health and safety of employees and outside partners, and to protect natural resources and the environment. This document outlines the Foundations guiding principles, its five priorities, its missions, as well as its actions and governance.
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Data Protection Charter
Quality Policy
Health, Safety and Environment Policy (HSE)
Sanofi Espoir Foundation Brochure
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Management systems
Standards and controls: A fully integrated CSR approach
LEARN MORE ABOUT SANOFI-AVENTIS HSE POLICY

HSE Policy (PDF, 1208Kb)
The sanofi-aventis CSR approach is based on a cross-functional method designed to ensure full integration at every level in order to further minimize risk: The Group complies with widely recognized international CSR standards. Additionally, various external standards are used to develop internal guidelines such as codes, charters and procedures. Sanofi-aventis implements these guidelines and monitors their application across the entire Group. Sanofi-aventis adopts procedures that makes it possible to share and ensure proper application of policies that the Group has undertaken to follow. Various management systems establish a framework for monitoring the application of these procedures and implementation of action plans. The Groups management systems cover the following areas: HSE Global Quality Pharmacovigilance Compliance Internal Control and Audit
By the end of 2010: Nearly managers had received HSE culture training
5,000
An HSE network of over worldwide
600 people
occupational injury with lost-time frequency rate between 2010 and 2013
Safety: 30% decrease in the
direct and indirect CO2 emissions between 2005 and 2013
Environment: 15% decrease in
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HSE
Sanofi-aventis has implemented an HSE management system that encompasses all operational levels. This system is designed to protect the health and safety of each employee, develop and utilize safe industrial processes, and limit the environmental impact of the Group's activities.

By the end of 2010: Nearly managers had received HSE culture training
5,000
It is based on an integrated policy with 77 requirements. These HSE requirements focus, for example, on the health of employees at their workstations, fire safety and ozone-depleting gases. They are supported by a set of standards and guidelines that provide further guidance for implementation of the management system. For more information: HSE Policy (PDF, 1208Kb) Progress-based approach A new policy in 2010 Actions Commitments and goals
An HSE network of over worldwide
600 people
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Progress-based approach
Sanofi-aventis HSE management system covers all the Groups activities and seeks to continuously improve HSE performance.
One of the main responsibilities of the HSE Department is to ensure compliance with regulations and internal procedures. HSE performance is measured using reporting tools, self-inspections and audits that are part of a progress-based approach for all the concerned organizations.
Three audit categories

The HSE Department relies on audits to correct any failures to comply with the policy and minimize non-compliance. HSE audits are divided into three categories: Management audits aimed at ensuring compliance with the Groups HSE rules Specialized audits that target a specific area, for example Risk related to using nitrogen, Outside service providers, or Biosafety Technical visits focusing on protecting property that are carried out with insurance adjusters Sanofi-aventis carried out a total of 141 audits in 2010: 22 HSE management audits throughout the Groups sites or pharmaceutical operations headquarter offices 16 specialized audits 103 technical visits The primary goal of these audits in coordination with the various training programs performed by the HSE Department is to foster genuine behavioral change in line managers whose operations are being audited, as opposed to reacting to issues found after an audit. This illustrates greater maturity within the HSE system.
The HSE management system is also designed to improve feedback about experiences so that all employees can understand the risks better. Major incidents and injuries are analyzed by those involved at the local level. These analyses aim to correct risk situations and provide feedback on divergences, anomalies and shortfalls from technical, human and organizational standpoints. This forms the basis for learning from experience. The goal is then to share the acquired knowledge through Site HSE Coordinators.
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PEOPLE People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information
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A new HSE policy in 2010

The HSE management system is continuously being improved. In 2010, the focus was on improving performance and managing HSE risks while keeping pace with changes within the Group.

The revised HSE covers sanofi-aventis new and existing entities as well as its new directions and values. The HSE Policy was signed by Christopher A. Viehbacher, Chief Executive Officer, demonstrating the Groups strong commitment to addressing HSE issues. For more information: HSE Policy (PDF, 1208Kb)
HSE 2015 Plan

In order to solidly root this HSE policy within the Groups activities and sectors, the HSE Committee developed a five-year strategic plan HSE 2015 in 2010. This plan focuses on the following: A new HSE organization Developing and anticipating future HSE skills Training Support for new entities Feedback on experiences Better HSE communication In 2010, the HSE 2015 Plan was presented to over 250 HSE Managers from all the Groups functions and regions. It was then distributed to all Group affiliates. For more information: Commitments and goals
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Actions
Adapting the organization to incorporate changes within the Group Developing an HSE culture Improving feedback about experiences Providing support to new entities Broadening environmental and safety certification
Adapting the organization to incorporate changes within the Group

Over 600 people worldwide are dedicated to improving the Groups HSE processes. In 2010, the organization of the HSE Department was reviewed in order to take into account challenges that the Group will have to face in the future. Several positions were created to enable the Group to better meet these new challenges (e.g., Biosafety Manager, New Entity Support Manager and Regional HSE Managers) and address new regulatory constraints (REACH Manager).
Regardless of the site where employees work, we must ensure that all Group employees benefit from the same measures to safeguard their health and safety in the workplace.
Alain Lamaud Group HSE Director, sanofiaventis
Developing an HSE culture

Offering HSE culture training to managers is an important part of the HSE Departments role. When managers receive training, they acquire knowledge and skills in order to properly control the risks that employees are exposed to in their work environment. The HSE Culture training program instituted by sanofi-aventis was launched in 2005 at the Groups chemical sites in France and expanded to R&D sites as a pilot in 2007. The program was expanded outside France in 2010. Brazil, the Czech Republic, Germany, Hungary, Italy, South Africa and the United Kingdom initiated the program in 2010. The training program will be rolled out in Africa, Asia-Pacific, Eastern Europe and Latin American. Over 5,000 Group managers have already received HSE Culture training. The program covers over 80 sites located in 18 countries worldwide, and training modules have been adapted and translated into 12 different languages. By 2015, the Group will have trained a total of nearly 10,000 people worldwide in HSE Culture.
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Nearly of sanofi-aventis industrial sites are ISO 14001 certified
60%
141 audits in 2010: 22 HSE audits 16 specialized

audits visits
103 technical
Improving feedback about experiences

In 2010, the Group decided to strengthen its approach to further improve feedback about experiences. The goal is to improve knowledge-sharing about information acquired during the analysis of significant or recurring injuries and thereby attempt to prevent new incidents. Site HSE Coordinators report information in descriptive documents that are made available to the entire HSE network via the intranet. The most important and most instructive information is documented by the Corporate HSE Department in PRESS sheets (this acronym stands for Prevention by learning from sanofiaventis experience) for distribution worldwide. PRESS sheets include the event description, an analysis, immediate corrective actions, if any, as well as recommendations for improving safety. In 2010, knowledge sharing and feedback primarily addressed fire risk, electricity risk and thermal burns. Other specific examples were shared with the new entities, particularly regarding nitrogen and process safety.
In 2011, Knowledge Sharing and Feedback days will continue on topics related to the Groups accident / incident data analyses (e.g., lock out / tag out). This initiative is used to draft communication and training plans, as well as guidelines for the specific topics addressed.
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Providing support to new entities

The HSE 2015 Plan describes the HSE integration process for new entities acquired by the Group. This process entails the following steps: Implementing priority HSE processes (e.g., crisis management) Assessing the HSE situation and establishing action plans Providing support for and monitoring action plans Using a general HSE audit for final validation of the process New entities will receive this specific HSE support for approximately 30 months. After this time, they will be fully integrated into the Group's HSE management system. In 2010, assessment and information support phases were rolled out at Zentiva sites. The process was also launched or pursued at sites or operations for Bi-par, Chattem, Kendrick, Medley, Npentes and Shanta.
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Broadening environmental and safety certification

Sanofi-aventis seeks to highlight the progress the Group has made in health, safety and environmental management and promote its achievements with third parties by encouraging certification. Production sites are key priorities. ISO 14001 and OSHAS 18001 standards focus on the principle of continuous improvement of performance related to health, safety and the environment. Today, out of 81 industrial sites worldwide, 48 are ISO 14001 certified and 19 are OSHAS 18001 certified. A specific certification program has been implemented for sites in the intercontinental region.
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10,000
Commitments and goals

Sanofi-aventis HSE commitment is detailed in the HSE 2015 Plan.
managers will receive HSE culture training by 2015
This plan was developed in 2010. It responds to continual changes to the Groups product portfolio, the number of units to be produced, production and R&D sites, as well as changes in the Groups entities. The Groups main commitments in this plan involve: Reducing bodily injury and exposure to chemical, biological and physical agents Reducing the Groups environmental impact (waste management, consumption of natural resources, protecting soil and surface water, limiting greenhouse gas emissions)
Safety
Over the period 2006-2010, safety results showed an improvement of approximately 30% for all indicators: injury with lost time, severity rate, first-aid, motor vehicle accidents, etc. The target for the HSE 2015 plan is to improve safety by an additional 30% (occupational lost-time accident frequency rate) over the next three years (2010-2013).
Environment
Thanks to the initiatives put in place over the past several years, sanofi-aventis was able to reduce CO2 emissions by 17% (indirect emissions) and 8% (direct emissions) per unit produced between 2005 and 2010. Sanofi-aventis understands the importance of climate change and plans to dedicate additional means to further reduce emissions. The Group's overall goal is to reduce direct and indirect CO2 emissions by 15% between 2005 and 2013 (relative values).
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PEOPLE People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and well-being
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Quality
Sanofi-aventis approach consists of implementing guidelines for quality and continuous improvement to cover each phase of the products life cycle, as well as all related services.
Sanofi-aventis Senior Management is firmly committed to providing effective and safe products worldwide that are developed, manufactured, distributed and marketed in full compliance with regulatory requirements and the Groups corporate values. Quality Managers are appointed in each operating entity and each site or affiliate involved in activities that may impact product quality, patient safety or data integrity. They conduct and coordinate quality and compliance activities, and they contribute to compliance with regulatory requirements and continuous improvement of the Groups performance. Since 2009, a Global Quality organization has brought together existing Quality teams and ensured the consistent implementation of the Quality Policy throughout the products life cycle. For more information on the development of Quality Systems, Quality risk management, audits and inspections, see the section on Global Quality. For more information: Global Quality
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Pharmacovigilance
The Pharmacovigilance organization at all affiliates and at the Group level make it possible to collect, record, analyze and communicate information about the safety of the Groups products.
This pharmacovigilance information, which is reported by clinical trial investigators, healthcare professionals, pharmacovigilance centers, healthcare authorities and patients, is carefully analyzed to reduce and prevent the occurrence of adverse events, promote the safe and proper use of medicines. Pharmacovigilance seeks to continuously optimize the risk / benefit ratio for the Groups medicines and vaccines. This mission, which involves sanofi-aventis responsibility to patients, applies to products that are being developed as well as those already available on the market. For more information on the organization of local and global Pharmacovigilance, the regulatory framework, the reporting process for adverse events and data management, and Group employee pharmacovigilance training, see the Pharmacovigilance section: Product risk management / Pharmacovigilance
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Compliance
Since 2006, a warning system has been in place to ensure that internal practices comply with the Groups Code of Ethics. All Group employees may anonymously express their concern about potential illicit practices or practices that they feel contradict ethical principles.
Affiliates may sometimes manage warning reports directly. In these cases, the information is investigated locally by the Compliance Manager to determine whether the allegations are well-founded. The Compliance Manager then communicates the report and any sanctions to the Global Compliance team. For several years, an external compliance helpline has been available to employees in the United States in accordance with local regulations and practices. Employees can contact the hotline at any time. Furthermore, in accordance with the Sarbanes-Oxley Act in the United States, warnings involving the areas of financial or accounting audit are reported to the Internal Audit and Control Department to be investigated. A report may then be drafted by the companys Audit Committee. Interactions with affiliates and exchanges within the network of Compliance Managers allow the Group to accurately determine the areas that are considered the most sensitive. The Group uses topics addressed in the Code of Ethics as a foundation to organize with the support of the Compliance Managers presentations on specific topics so that employees can understand and be aware of all the areas and activities for which ethical considerations are important.
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Internal audit
The Internal Audit and Control Department uses a systematic and methodological approach to ensure effective internal control in all countries. It seeks to promote safety, reliability and ethics through the Groups various activities
It is also committed to ensuring compliance with regulations and new constraints related to financial transparency and corporate governance. In terms of internal control, the department is responsible for compliance with the U.S. Sarbanes-Oxley Act and French law (Section L. 225-37 of the French Commercial Code). The Internal Audit and Control department is responsible for providing Senior Management with assurance on the level of control of its operations and providing guidance to improve operations and help create added value. Internal audit helps the Group reach its goals by using a systematic and methodological approach to assess its risk management, control and corporate governance processes. It also makes recommendations to improve the effectiveness of these processes. Internal audit is responsible for identifying good practices and proposing areas for improvement or progress. Internal audit is responsible for oversight of compliance with anti-fraud and anti-corruption regulations, and verifies that the Groups activities are carried out within an ethical professional framework. Internal audit is also committed to implementing a quality approach to ensure compliance with standards that regulate its activity. In November 2006, Internal Audit received certification from IFACI (the French Institute of Internal Audit and Internal Control). Lastly, the department assesses the reliability, integrity and safety of the Groups IT applications, infrastructure and networks.
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Risk management
The evaluation of opportunities and risks is affected by continual new developments.
Regulations make it necessary to implement standardized procedures to enable risk monitoring. As such, sanofi-aventis carefully monitors all issues that affect the Group. Major risks identified are reviewed on a regular basis and presented to the Board of Directors Audit Committee. Over the last ten years, increasing attention has focused on topics relating to businesses corporate social responsibility. Analysts are beginning to assess the financial impact of corporate social responsibility and environmental performance in certain key areas. Businesses are also trying to measure the return on investment associated with their CSR policy. Processes for risk identification, assessment and management Risk factors identified by the Group Increasing importance of certain challenges Protecting against risks
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2010: A Risk
Processes for risk identification, assessment and management

At the end of 2010, within the scope of the Groups transformation, Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis, decided to create a Group Level Risk Committee.
created at the Group level
Committee was
This committee is chaired by the Senior Vice President, Corporate Social Responsibility and the Senior Vice President, Audit and Internal Control Assessment. The committee reports to the Executive Committee and will be responsible for overseeing and promoting strategic and operating risk assessment and management for all the Groups operations. As indicated in the French 2010 Document de Rfrence under Section 3.2.1, Chairmans report, and in accordance with Article 404 of the Sarbanes-Oxley Act as well as obligations pursuant to the application of French law, the Group has implemented an approach for risk identification, assessment and management to ensure internal control over financial reporting. Internal procedures established by sanofi-aventis for financial risk identification and monitoring, include conditional liabilities as well as significant risk evaluations. These are described in detail in Section 3.2.1 of the Chairmans Report concerning corporate governance and internal control. The important factors that could lead to significant differences between sanofi-aventis business, research, financial and operating results as well as forecasts are described in the 2010 Document de Rfrence , Chairmans report 2010, Section 3.1.10 Risk factors. In addition to these risks, sanofi-aventis may be exposed to other significant unknown risks or impacts from those that sanofi-aventis does not currently consider significant. For more information: Section 3.1.10 Facteurs de risques beginning on page 152 Section 3.2.1 Procdures de contrle interne et gestion des risques beginning on page 170 Section 3.2.1 Rapport du Prsident Identification, valuation et gestion des risques beginning on page 172 2010 Document de Rfrence (in French, PDF, 228Kb)
PEOPLE People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and
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Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Internal policies Management systems Risk management Processes Risk factors identified by the Group Increasing importance of certain challenges Protecting against risks Standards and memberships CSR performance Risks relating to legal matters Risks relating to sano-aventis business Industrial risks relating to the environment
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Risk factors identified by the Group

In addition to market-related risks, risks may concern corporate social responsibility and environmental issues such as certain legal risks, certain risks related to activities or environmental risks.
Risks relating to legal matters

Thanks to its patents and other intellectual property rights, sanofi-aventis has exclusive rights over various products created from the Groups research. Nonetheless, patent protection varies depending on the product and the country. Sanofi-aventis operations and results could be adversely affected if the Group is unable to defend its intellectual property rights. Therefore, the Groups success depends on effectively protecting our intellectual property rights and our patents. Product liability represents a risk for the pharmaceutical industrys activity insofar as product liability claims may be introduced, such as class action lawsuits in the United States. The pharmaceutical industry is under increasing scrutiny by United States and European authorities, which accentuates the Groups exposure to what may be significant risks. For example, the marketing of our products is heavily regulated, and alleged failures to comply with applicable regulations could incur fines, penalties and injunctive or administrative remedies, potentially leading to the imposition of additional regulatory controls or exclusion from government reimbursement programs. The relevant authorities may conduct inquiries or investigations, or private parties could initiate litigation concerning adherence to applicable rules for antitrust, particularly regarding competition, marketing practices and pricing.
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Risks relating to sano-aventis business

These risks include: The difficulty of renewing our product portfolio in order to replace products whose patents or regulatory exclusivity are due to expire The diversification of our business Our increasing presence in emerging markets In addition, the Group must anticipate risks concerning product manufacturing and distribution, those relating to counterfeit products, and risks related to reimbursement policies that are determined by governments or payers. Worldwide, the pharmaceutical industry faces changes in the regulatory framework and increasing wariness on the part of consumers who want more guarantees regarding the safety and efficacy of medicines and healthcare products. Moreover, incentives for research are limited. Healthcare authorities have imposed more stringent requirements, especially in terms of the quality and quantity of data required, in order to establish that a product is effective and safe. Marketed products are reassessed on a regular basis to evaluate the risk / benefit ratio after they have been approved. These reassessments can give rise to marketing restrictions, product suspensions / recalls and an increased risk of legal disputes. A pharmaceutical companys performance depends in part on the conditions for drug reimbursement. Governments and the public expect businesses to bring to market innovative products that meet major public health needs. They also depend on marketing medicines at reduced prices and generic products to help maintain the economic balance of healthcare systems. The pharmaceutical industry has been criticized for taking an incremental approach to innovation, producing neither major therapeutic improvements nor healthcare savings. In light of this situation, there is growing pressure concerning pricing and reimbursement due to the following: cost controls imposed in many countries, reduction of reimbursement for certain products and increasing difficulty in obtaining a satisfactory reimbursement rate. To meet these challenges and expectations today, the Group offers a broad portfolio of prescription, generic and over-the-counter (OTC) products, which help to control healthcare system costs. In addition, sanofi-aventis has a specific approach to production and commercialization for emerging markets.
For more information: Access to healthcare

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Industrial risks relating to the environment

This area focuses on the utilization of hazardous substances, site remediation and compliance costs. As a result of its chemicals activities, the Group may have risks related to accidental emissions or industrial incidents that could lead to damages, fines and operating losses. Unexpected soil contamination may be discovered at an industrial site, leading to environmental liability. This situation may concern sites that the Group has owned for many years or sites that were acquired or sold, for which the question of liability may lead to disputes. Lastly and more generally speaking, when it comes to monetary investments, it is important to be prepared to react in response to rapidly changing environmental regulations. For more information: Section 3.1.10 - Facteurs de risque beginning on page 152 2010 Document de Rfrence (in French, PDF, 228Kb)
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Increasing importance of certain challenges

As is true for any company, sanofi-aventis must maintain its right to operate among the local communities where Group sites are located. To this end, the Group must control its direct corporate social responsibility and environmental impact (making the most positive and the least negative impact), respect ethical rules and create employment opportunities.
The Group actively monitors new developments connected with its environmental and corporate social responsibilities, even in areas where financial analysts have not established a direct link to the Groups financial performance. The information below presents an example for each of the four key areas of the Groups CSR approach: Patient: Respecting human rights and the right to health Ethics: Marketing practices People: Employees health Planet: Combating climate change
Patient: Respecting human rights and the right to health

Respect for human rights forms the foundation upon which a corporate social responsibility policy is built. Both international regulations and voluntary initiatives alike have made human rights a key issue for companies. This is particularly true for international groups like sanofi-aventis that operate in countries where the risk of human rights violations can be significant. The Group has thus put in place an ambitious policy involving self-assessment of its practices as well as training to ensure that human rights are respected throughout the Group. One aspect of this challenge is the right to health, and specifically low-income populations right to healthcare and treatments. The World Health Organization (WHO) recommends promoting access to pharmaceutical products worldwide, under certain conditions, by demonstrating flexibility regarding intellectual property rights. This major issue offers an important opportunity for the sector to develop in new markets, yet it also poses the risk of criticism for not responding fast enough. In this field, the Group has established specific programs targeting major diseases that affect developing countries and in which the Group has therapeutic expertise. These programs include specific R&D investments to develop adapted and non-patented products, sales at differentiated prices and drug and vaccine donations. For more information: Ensuring respect for human rights Access to healthcare
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Ethics: Marketing practices

Healthcare professionals and other stakeholders expect pharmaceutical companies to provide reliable product information, while facilitating competition without promoting the overuse of medicines. Some observers and patient organizations denounce certain marketing practices utilized by pharmaceutical companies. Beyond risk to the sectors reputation, this pressure is increasing due to the current trend among governments to promote generics and discontinue reimbursements for certain medicines. In this context, the implementation of responsible marketing rules such as those established by sanofi-aventis provides an opportunity to maintain a climate of trust with the authorities, prescribing physicians and patients. For more information: Responsible marketing
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People: Employees health
Employees health risks represent a potential basis for legal action in the United States and Europe. The relationship between chronic disease and the occupational environment has become an important issue. In light of this situation, protecting and monitoring employees' health is not only a matter of preventing absenteeism and demonstrating concern for employees; it is also a way to prevent financial and legal risks. For more information: Ensuring occupational health, safety and well-being
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Planet: Combating climate change

Various risks related to evolving environmental regulations are analyzed in the 2010 Document de Rfrence . Greenhouse gas emissions are a primary concern. At the end of 2008, the European Council adopted the Climate and Energy Package, setting new quotas by sector, which will have a financial impact on businesses. In fact, this emerging issue goes beyond the European regulatory framework because other countries could adopt more restrictive regulations. The Groups sound performance with respect to greenhouse gas emissions gives it a quota surplus. For more information: Combating climate change
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Protecting against risks

The sanofi-aventis Insurance Department develops solutions to limit certain random risks and offset these risks either partially or completely over time through financial means.
The following risks are considered insurable: traditional risks, such as shipping by sea or land, liability for operations and delivered products, fire and related operating losses; as well as risks specific to the pharmaceutical industry, including those inherent to clinical trial management throughout the world, cold chain management for the transport of medicines and vaccines and production line management, and medicines and vaccines packaging developed in many different languages for use worldwide. Establishing insurance programs to cover these risks depends on actions taken at every level, from the early stages of research and development, through manufacturing and distribution: Protection of goods management, regardless of the amounts and types of protection, makes it possible to limit the impact of an incident by protecting investments made within a company. The direct financial consequences of such an incident are therefore reduced and the related operating loss is largely offset by insurance coverage. Risk prevention management, whether or not it can be insured, makes it possible to limit the risk impact and to integrate all actions coordinated within the company. Insurance plays a catalysts role to finding solutions by taking into account the portion of transferred risk that may or may not be borne by the company. When insurance policies are negotiated, the terms and conditions of coverage offered by insurers and the quality of protection and prevention are important and decisive factors. For more information: Assurances et couverture des risques section beginning on page 99 2010 Document de Rfrence (in French, PDF, 228Kb)
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Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships Complying with standards Memberships and partnerships CSR performance Complying with standards Memberships and partnerships
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Sanofi-aventis addresses issues identified as being important for the pharmaceutical sector through a series of policies, procedures and initiatives that respect cultural and legal environments in the countries where the Group operates.
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Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships Complying with standards Memberships and partnerships CSR performance
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Complying with standards

Sanofi-aventis addresses issues identified as being important for the pharmaceutical sector through a series of policies, procedures and initiatives that respect cultural and legal environments in the countries where the Group operates.
Respecting human rights

For human rights, the Group adheres to the Universal Declaration of Human Rights (UDHR) principles as well as other individual rights established by organizations in accordance with the United Nations system. The principles set forth in universal human rights documents apply to people and organizations, and consequently, to businesses. Sanofi-aventis plays an active role in the public debate on human rights. The Group is a founding member of the EDH initiative, among the eight CAC 40 companies that are members. EDH is inspired by the work carried out since 2003 by the Business Leaders Initiative on Human Rights (BLIHR) to promote human rights in companies and aims to complement its work with contributions from French-speaking countries. The Group adheres to several international codes, rules and principles such as principles of the International Labor Organization (ILO), the United Nations Global Compact, and the directives issued by the Organization for Economic Cooperation and Development (OECD).
Adhering to international rules regarding the Groups area of business

Sanofi-aventis respects the international rules specific to the pharmaceutical industry, in particular with regard to: Clinical trials and animal testing, in particular rules developed by professional associations (European, American and Japanese) concerning clinical trial transparency, as well as ILAR (Institute for Laboratory Animal Research) and UFAW (Universities Federations for Animal Welfare) guidelines on animal testing Promotional practices such as Organization for Economic Cooperation and Development (OECD) directives geared to multinational firms and particularly concerning good business practices, anti-corruption and preventing illegal payments, as well as "ethical criteria" of the World Health Organization (WHO) with regard to drug promotion and codes from the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) concerning good commercial practices WHO recommendations for drug donations In addition to these external codes and standards, a set of principles and policies that applies to the entire Group was defined. The most important of these are listed in the Internal Policies section.
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Memberships and partnerships

Sanofi-aventis is committed to complying with CSR standards, and the Group is a member of the following organizations.
Organizations working in the field of CSR Pharmaceutical industry associations Other professional organizations in France
Organizations working in the field of CSR

Global Compact www.unglobalcompact.org CSR Europe www.csreurope.org EDH - Entreprises pour les droits de lhomme EPE - Entreprises pour lEnvironnement www.epe-asso.org (In French) IMS - Entreprendre pour la Cit www.imsentreprendre.com (In French) ORSE - Observatoire sur la Responsabilit Sociale des Entreprises www.orse.org (In French and English) WEC - World Environmental Center www.wec.org
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Pharmaceutical industry associations

International
IFPMA - International Federation of Pharmaceutical Manufacturers and Associations www.ifpma.org IFPMA / IVS -Influenza Vaccine Supply International Task Force www.ifpma.org / Influenza Vaccines
Europe
EFPIA - European Federation of Pharmaceutical Industry Associations www.efpia.org EVM - European Vaccine Manufacturers www.evm-vaccines.org ABPI - Association British Pharmaceutical Industries, in United Kingdom www.abpi.org.uk LEEM - The French Pharmaceutical Companies Association www.leem.org VFA - Verband Forschender Arzneimittelhersteller, In Germany
www.vfa.de (In German)
United States
PhRMA - Pharmaceutical Research-based Manufacturers Association www.phrma.org BIO - Biotechnology Industry Organization www.bio.org
Japan
JPMA - Japan Pharmaceutical Manufacturers Association www.jpma.or.jp
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Other professional organizations in France

MEDEF - Mouvement des Entreprises de France www.medef.com (In French) AFEP - Association Franaise des Entreprises Prives
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Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships CSR performance GRI Recognition and Awards How data are reported: Methodological note Statutory auditors review report Social indicators Environmental indicators Other indicators GRI Awards Methodological note Statutory auditors review report Social indicators Environmental indicators Other indicators
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CSR performance
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Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships CSR performance GRI Recognition and Awards How data are reported: Methodological note Statutory auditors review report Social indicators Environmental indicators Other indicators
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Global Reporting Initiative

The Global Reporting Initiative (GRI) is an organization that aims to provide standardized performance indicators to be applied globally for corporate sustainability reporting of companies economic, environmental and social performance.
Covered Partially covered Not covered Begun in 1997, the GRI is a joint initiative by the American Non-Governmental Organization CERES (Coalition for Environmentally Responsible Economies) and UNEP (United Nations Environment Program) with the mission of improving the quality, rigor and utility of sustainable development reporting. Corporations, NGOs, consulting firms and academic institutions all participate in this international initiative. The GRI provides reporting guidelines to help interested companies to provide sustainability reporting of their economic, environmental and social initiatives. NRE : Not reported Externally
1. Strategy and Analysis

Element 1.1 Statement from the most senior decisionmaker of the organization (e.g., CEO, chair, or equivalent senior position) about the relevance of sustainability to the organization and its strategy. 1.2 Description of key impacts, risks, and opportunities. Links/Remarks csrreporting.sanofi.com / Our vision / Message from Senior Management State
Prsentation de lactivit du Groupe - 2.2.1 Stratgie, p54-55 Item 3, D. Risk Factors / Environmental Risks of Our Industrial Activities, p11 csrreporting.sanofi.com / Our vision / Message from Senior Management csrreporting.sanofi.com / Our vision / Our CSR approach csrreporting.sanofi.com / Our vision / Risk Management
2. Organizational Profile
Element 2.1 Name of the organization Links/Remarks 1.1. Principales informations relatives la Socit, p1 Item 3A Selected Financial Data, p1 2.2 Primary brands, products, and/or services 2.2. PRSENTATION DE LACTIVIT DU GROUPE - 1. Principaux produits pharmaceutiques, p55-56 2 ACTIVIT DU GROUPE Introduction, p51-52 Item 4. Information on the Company / Introduction, p14
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csrreporting.sanofi.com / Our vision / The Group's profile www.sanofi.com / Products and Vaccines 2.3 Operational structure of the organization, including main divisions, operating companies, subsidiaries, and joint ventures Item 4, C. Organizational Structure, p66 csrreporting.sanofi.com / Our vision / The Group's profile sanofi.com / Our presence throughout the world sanofi.com / Affiliates websites 2.4 Location of organizations headquarters 1.1. Principales informations relatives la Socit, p1 Item 4, D. Property, Plant and Equipment, p69 sanofi.com / Our presence throughout the world 2.5 Number of countries where the organization operates, and names of countries with either major operations or that are specifically relevant to the sustainability issues covered in the report 2.2. PRSENTATION DE LACTIVIT DU GROUPE - 2.3. Organisation du Groupe, p101 Item 4, D. Property, Plant and Equipment, p66-69 sanofi.com / Our presence throughout the world sanofi.com / Affiliates websites 2.6 Nature of ownership and legal form 1.1. Principales informations relatives la Socit, p1 Item 10, B. Memorandum and Articles of Association, p160 2.7 Markets served (including geographic breakdown, sectors served, and types of customers/beneficiaries) Annual Consolidated Financial Statements, D.35.3. Information by geographical region, p F-118 sanofi.com / Products and Vaccines sanofi.com / Our presence throughout the world sanofi.com / Affiliates websites 2.8 Scale of the reporting organization, including:Number of employees, Number of operations, Net sales or net revenues, Total capitalization broken down in terms of debt and equity (for private sector organizations) and Quantity of products or services provided sanofi.com / Products and Vaccines sanofi.com / Our presence throughout the world sanofi.com / Affiliates websites csrreporting.sanofi.com / Our vision / The Group's profile 2.9 Significant changes during the reporting period regarding size, structure, or ownership Item 5. Operating and Financial Review and Prospects/ Acquisitions, p79 csrreporting.sanofi.com / Our vision / Message from Senior Management csrreporting.sanofi.com / Our vision / How data are reported: Methodological note 2.10 Awards received in the reporting period csrreporting.sanofi.com / Our vision / Recognition and Awards
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3. Report Parameters
Report Profile Report Scope and Boundary GRI Content Index Assurance
Report Profile
Element 3.1 Reporting period
Links/Remarks 1.1. Principales informations relatives la Socit, p2 sanofi.com / Publications csrreporting.sanofi.com / Our vision / How data are reported: Methodological note
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State
3.2 Date of most recent previous report
sanofi.com / Publications csrreporting.sanofi.com / Our vision / How data are reported: Methodological note
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3.3 Reporting cycle
sanofi.com / Publications csrreporting.sanofi.com / Our vision / How data are reported: Methodological note
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3.4 Contact point for questions regarding the report or its contents
csrreporting.sanofi.com / Contact
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Report Scope and Boundary

Element 3.5 Process for defining report including determining materiality, prioritizing topics within the report and Identifying stakeholders the organization expects to use the report 3.6 Boundary of the report Links/Remarks csrreporting.sanofi.com / Our vision / Identifying CSR challenges csrreporting.sanofi.com / Our vision / Materialtiy test csrreporting.sanofi.com / Our vision / How data are reported: Methodological note csrreporting.sanofi.com / Our vision / How data are reported: Methodological note csrreporting.sanofi.com / Our vision / How data are reported: Methodological note
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3.7 State any specific limitations on the scope or boundary of the report 3.8 Basis for reporting on joint ventures, subsidiaries, leased facilities, outsourced operations, and other entities that can significantly affect comparability from period to period and/or between organizations 3.9 Data measurement techniques and the bases of calculations, including assumptions and techniques underlying estimations applied to the compilation of the Indicators and other information in the report 3.10 Explanation of the effect of any restatements of information provided in earlier reports, and the reasons for such re-statement (e.g., mergers/ acquisitions, change of base years/periods, nature of business, measurement methods) 3.11 Significant changes from previous reporting periods in the scope, boundary, or measurement methods applied in the report
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csrreporting.sanofi.com / Our vision / How data are reported: Methodological note
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GRI Content Index

Element 3.12 Table identifying the location of the Standard Disclosures in the report Links/Remarks csrreporting.sanofi.com / Our vision / Global Reporting Initiative
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Assurance
Element 3.13 Policy and current practice with regard to seeking external assurance for the report. If not included in the assurance report accompanying the sustainability report, explain the scope and basis of any external assurance provided. Also explain the relationship between the reporting organization and the Links/Remarks csrreporting.sanofi.com / Our vision / Statutory auditors review report
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assurance provider(s)
4. Governance, Commitments, and Engagement

Governance Commitments to External Initiatives Stakeholder Engagement
Governance
Element 4.1 Governance structure of the organization, including committees under the highest governance body responsible for specific tasks, such as setting strategy or organizational oversight. Links/Remarks 1.2.1. ORGANES DADMINISTRATION ET DE DIRECTION, p11-19 Item 6. Directors, Senior Management and Employees / C. Board Practices, p141 csrreporting.sanofi.com / Our vision / CSR Governance csrreporting.sanofi.com / Ethics / Complying with corporate governance standards 4.2 Indicate whether the Chair of the highest governance body is also an executive officer (and, if so, their function within the organizations management and the reasons for this arrangement) 1.2.1. ORGANES DADMINISTRATION ET DE DIRECTION, p11 Item 6. Directors, Senior Management and Employees / C. Board Practices, p141 csrreporting.sanofi.com / Our vision / Message from Senior Management csrreporting.sanofi.com / Ethics / Complying with corporate governance standards csrreporting.sanofi.com / Vision / CSR Governance 4.3 For organizations that have a unitary board structure, state the number of members of the highest governance body that are independent and/or nonexecutive members. State how the organization defines independent and non-executive. This element applies only for organizations that have unitary board structures. See the glossary for a defi nition of independent. 1.2.1. ORGANES DADMINISTRATION ET DE DIRECTION, p12, p16 Item 6. Directors, Senior Management and Employees / C. Board Practices, p141 csrreporting.sanofi.com / Ethics / Complying with corporate governance standards csrreporting.sanofi.com / Vision / CSR Governance 4.4 Mechanisms for shareholders and employees to provide recommendations or direction to the highest governance body. 1.2.1. ORGANES DADMINISTRATION ET DE DIRECTION, p12, p16 Item 10. Additional Information/ Shareholders Meetings, p163 4.5 Linkage between compensation for members of the highest governance body, senior managers, and executives (including departure arrangements), and the organizations performance (including social and environmental performance). 1.2.1. Organes dadministration et de direction - 5. Rmunrations, p36-43 Item 6. Directors, Senior Management and Employees/ B. Compensation, p130 csrreporting.sanofi.com / Ethics / Corporate governance in practice 4.6 Processes in place for the highest governance body to ensure conflicts of interest are avoided. 1.2.1. Organes dadministration et de direction - 5. Rmunrations, p36-43 csrreporting.sanofi.com / Ethics / Corporate governance in practice 4.7 Process for determining the composition, qualifications, and expertise of the members of the highest governance body and its committees,including any consideration of gender and other indicators of diversity. 1.2.1. Organes dadministration et de direction - 2.B. Rglement intrieur du conseil dadministration, p12-13 Item 6. Directors, Senior
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Management and Employees/ Appointments and Governance Committee, p143 4.8 Internally developed statements of mission or values, codes of conduct, and principles relevant to economic, environmental, and social performance and the status of their implementation. 4.9 Procedures of the highest governance body for overseeing the organizations identification and management of economic, environmental, and social performance, including relevant risks and opportunities, and adherence or compliance with internationally agreed standards, codes of conduct, and principles. 4.10 Processes for evaluating the highest governance bodys own performance, particularly with respect to economic, environmental, and social performance. Item 16B. Code of Ethics, p199 csrreporting.sanofi.com / Our vision / Internal policies 3.2.1. Rapport du Prsident, p173-177 Item 6. Directors, Senior Management and Employees/ Appointments and Governance Committee, p143 csrreporting.sanofi.com / Our vision / Materiality test 1.2.1. Organes dadministration et de direction - 2.A. Composition, mission du conseil, p12 Item 6. Directors, Senior Management and Employees/ Appointments and Governance Committee, p143 csrreporting.sanofi.com / Ethics / Governance
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Commitments to External Initiatives

Element 4.11 Explanation of whether and how the precautionary approach or principle is addressed by the organization. 4.12 Externally developed economic, environmental, and social charters, principles, or other initiatives to which the organization subscribes or endorses. 4.13 Memberships in associations (such as industry associations) and/or national/international advocacy organizations. Links/Remarks csrreporting.sanofi.com / Patient / Pharmacovigilance csrreporting.sanofi.com / Our vision / Complying with standards
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csrreporting.sanofi.com / Our vision / Memberships and partnerships
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Stakeholder Engagement
Element 4.14 List of stakeholder groups engaged by the organization. Examples of stakeholder groups are Civil society, Customers, Local Communities, Shareholders and providers of capital, Suppliers and Employees, other workers, and their trade unions. 4.15 Basis for identification and selection of stakeholders with whom to engage. Links/Remarks csrreporting.sanofi.com / Our vision / Our stakeholders
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csrreporting.sanofi.com / Our vision / Our stakeholders csrreporting.sanofi.com / Our vision / Materiality test
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4.16 Approaches to stakeholder engagement, including frequency of engagement by type and by stakeholder group. 4.17 Key topics and concerns that have been raised through stakeholder engagement, and how the organization has responded to those key topics and concerns, including through its reporting.
csrreporting.sanofi.com / Our vision / Our stakeholders csrreporting.sanofi.com / Our vision / Materiality test csrreporting.sanofi.com / Our vision / Our stakeholders csrreporting.sanofi.com / Our vision / Materiality test
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5. Management Approach and Performance Indicators

Economic Performance Indirect Economic Impacts Materials Energy Water
Biodiversity Emissions, Effluents, and Waste Products and Services Compliance Employment Labor / Management Relations Training and Education Diversity and Equal Opportunity Investment and Procurement Practices Non-discrimination Freedom of Association and Collective Bargaining Child Labor Forced and Compulsory Labor Assessment Remediation Local Community Corruption Public Policy Compliance Customer Health and Safety Product and Service Labeling Marketing Communications
Economic Performance
Element EC1 Direct economic value generated and distributed, including revenues, operating costs, employee compensation, donations and other community investments, retained earnings, and payments to capital providers and governments. Links/Remarks 3.1.2. CHIFFRES CLS 2010, p110-114 3.1.4. COMPTES CONSOLIDS DE LANNE 2010, p123 Item 5. Operating and Financial Review and Prospects, p70 EC2 Financial implications and other risks and opportunities for the organizations activities due to climate change. EC3 Coverage of the organizations defined benefit plan obligations csrreporting.sanofi.com / Planet / CO2 emissions and energy Item 6. Directors, Senior Management and Employees/D. Employees/Employee Savings Schemes and Collective Retirement Savings Plan, p147. csrreporting.sanofi.com / People / Compensation EC4 Significant financial assistance received from government NRE
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Indirect Economic Impacts

Element EC6 Policy, practices, and proportion of spending on locally-based suppliers at significant locations of operation. EC7 Procedures for local hiring and proportion of senior management hired from the local community at locations of significant operation. EC8 Development and impact of infrastructure investments and services provided primarily for public benefit through commercial, in-kind, or pro bono engagement. Links/Remarks csrreporting.sanofi.com / People / Contributing to local economic development csrreporting.sanofi.com / People / Contributing to local economic development csrreporting.sanofi.com / Patient / Overview of investments and principal programs
XX
State
XX
XX
Materials
Element EN1 Materials used by weight or volume Links/Remarks 3.1.9. Donnes environnementales, p148 csrreporting.sanofi.com / Our Vision / Environmental indicators EN2 Percentage of materials used that are recycled input materials 3.1.9. Donnes environnementales, p148 csrreporting.sanofi.com / Our Vision / Environmental indicators
XX XX
State
Energy
Element EN3 Direct energy consumption by primary energy source Links/Remarks 3.1.9. Donnes environnementales, p147 csrreporting.sanofi.com / Our Vision / Environmental indicators EN4 Indirect energy consumption by primary source 3.1.9. Donnes environnementales, p147 csrreporting.sanofi.com / Our Vision / Environmental indicators
XX XX
State
Water
Element EN8 Total water withdrawal by source Links/Remarks 3.1.9. Donnes environnementales, p147 csrreporting.sanofi.com / Our Vision / Environmental indicators
XX
State
Biodiversity
Element EN11 Location and size of land owned, leased, managed in, or adjacent to, protected areas and areas of high biodiversity value outside protected areas Links/Remarks 3.1.9. Donnes environnementales, p150 csrreporting.sanofi.com / Planet / Biodiversity / Position paper csrreporting.sanofi.com / Planet / Biodiversity / Actions EN12 Description of significant impacts of activities, products, and services on biodiversity in protected areas and areas of high biodiversity value outside protected areas csrreporting.sanofi.com / Planet / Biodiversity csrreporting.sanofi.com / Planet / Biodiversity / Actions
XX XX
State
Emissions, Effluents, and Waste

Element EN16 Total direct and indirect greenhouse gas emissions by weight Links/Remarks 3.1.9. Donnes environnementales, p149 csrreporting.sanofi.com / Our Vision / Environmental indicators EN17 Other relevant indirect greenhouse gas emissions by weight 3.1.9. Donnes environnementales, p149 csrreporting.sanofi.com / Our Vision / Environmental indicators EN19 Emissions of ozone-depleting substances by weight EN20 NOx, SOx, and other significant air emissions by type and weight csrreporting.sanofi.com / Our Vision / Environmental indicators 3.1.9. Donnes environnementales, p149 csrreporting.sanofi.com / Our
XX XX XX
State
XX
Vision / Environmental indicators EN21 Total water discharge by quality and destination 3.1.9. Donnes environnementales, p149 csrreporting.sanofi.com / Our Vision / Environmental indicators EN22 Total weight of waste by type and disposal method 3.1.9. Donnes environnementales, p149-150 csrreporting.sanofi.com / Our Vision / Environmental indicators EN23 Total number and volume of significant spills
XX XX XX
Products and Services

Element EN26 Initiatives to mitigate environmental impacts of products and services, and extent of impact mitigation Links/Remarks Item 4. Information on the Company/ B. Business Overview/ Environment, p56 crsreporting.sanofi.com / Planet / Pharmaceuticals in the environment crsreporting.sanofi.com / Planet /Local environmental impact EN27 Percentage of products sold and their packaging materials that are reclaimed by category No significant changes NRE
XX
State
Employment
Element LA1 Total workforce by employment type, employment contract, and region, broken down by gender Links/Remarks 3.1.8. DONNES SOCIALES, p139-146 Item 6. Directors, Senior Management and Employees/ D. Employees, p145 csrreporting.sanofi.com / Our Vision / Environmental indicators LA2 Total number and rate of new employee hires and employee turnover by age group, gender, and region. LA15 Return to work and retention rates after parental leave, by gender. csrreporting.sanofi.com / Our Vision / Environmental indicators No significant changes.
XX XX XX
State
Labor / Management Relations

Element LA4 Percentage of employees covered by collective bargaining agreements Links/Remarks 3.1.8. DONNES SOCIALES, p139-146 csrreporting.sanofi.com / People / Employee representation and information LA5 Minimum notice period(s) regarding No significant changes. significant operational changes, including whether it is specified in collective agreements
XX XX
State
Training and Education

Element LA7 Rates of injury, occupational diseases, lost days, and absenteeism, and number of workrelated fatalities by region and by gender. LA8 Education, training, counseling, prevention, and risk-control programs in place to assist workforce members, their families, or community members regarding serious diseases. Links/Remarks 3.1.8. Donnes sociales, p144 csrreporting.sanofi.com / Our Vision / Environmental indicators csrreporting.sanofi.com / People / Ensuring occupational health, safety and well-being crsreporting.sanofi.com / People / Prevention and management of major occupational risks
XX XX
State
LA10 Average hours of training per year per employee by gender, and by employee category.
3.1.8. Donnes sociales, p144 csrreporting.sanofi.com / Our Vision / Environmental indicators
XX
Diversity and Equal Opportunity

Element LA13 Composition of governance bodies and breakdown of employees per employee category according to gender, age group, minority group membership, and other indicators of diversity. Links/Remarks 1.2.1. Organes dadministration et de direction, p19-28 3.1.8. DONNES SOCIALES, p139, p141 csrreporting.sanofi.com / Our vision / CSR performance / Social indicators csrreporting.sanofi.com / People / Diversity LA14 Ratio of basic salary and renumeration of women to men by employee category, by significant locations of operation. csrreporting.sanofi.com / People / Compensation No significant changes. NRE
XX
State
Investment and Procurement Practices

Element HR1 Percentage and total number of significant investment agreements and contracts that include clauses incorporating human rights concerns, or that have undergone human rights screening. HR2 Percentage of significant suppliers, contractors and other business partners that have undergone human rights screening, and actions taken. HR3 Total hours of employee training on policies and procedures concerning aspects of human rights that are relevant to operations, including the percentage of employees trained. Links/Remarks 2.4. Investissements Principaux tablissements, p102-104 csrreporting.sanofi.com / Ethics / Business ethics / Responsible procurement csrreporting.sanofi.com / Ethics / Business ethics / Responsible procurement 3.1.8. Donnes sociales, p141 csrreporting.sanofi.com / Ethics / Human rights / Actions
XX XX
State
XX
Non-discrimination
Element HR4 Total number of incidents of discrimination and corrective actions taken. Links/Remarks csrreporting.sanofi.com / People / Diversity / Preventing discrimination
XX
State
Freedom of Association and Collective Bargaining

Element HR5 Operations identified in which the right to exercise freedom of association and collective bargaining may be at significant risk, and actions taken to support these rights. Links/Remarks csrreporting.sanofi.com / Ethics / Human rights / Actions
XX
State
Child Labor
Element HR6 Operations and significant suppliers identified as having significant risk for incidents of child labor, and measures taken to contribute to the effective abolition of child labor. Links/Remarks csrreporting.sanofi.com / Ethics / Human rights / Actions
XX
State
Forced and Compulsory Labor

Element HR7 Operations and signifi cant suppliers identified as having significant risk for incidents of forced or compulsory labor, Links/Remarks csrreporting.sanofi.com / Ethics / Human rights / Actions
XX
State
and measures to contribute to the elimination of all forms of forced or compulsory labor.
Assessment
Element HR10 Percentage and total number of operations that have been subject to human rights reviews and/or impact assessments. Links/Remarks csrreporting.sanofi.com / Ethics / Human rights / Actions
XX
State
Remediation
Element HR11 Number of grievances related to human rights filed, addressed and resolved through formal grievance mechanisms. Links/Remarks No significant changes. State NRE
Local Community
Element SO1 Percentage of operations with implemented local community engagement, impact assessments, and development programs. SO9 Operations with significant potential or actual negative impacts on local communities. Links/Remarks 3.1.8. Donnes sociales, p146 csrreporting.sanofi.com / people / Contributing to local economic development 3.1.8. Donnes sociales, p146 csrreporting.sanofi.com / people / Contributing to local economic development SO10 Prevention and mitigation measures implemented in operations with significant potential or actual negative impacts on local communities. 3.1.8. Donnes sociales, p146 csrreporting.sanofi.com / people / Contributing to local economic development
XX XX XX
State
Corruption
Element SO2 Percentage and total number of business units analyzed for risks related to corruption. SO3 Percentage of employees trained in organizations anti-corruption policies and procedures. SO4 Actions taken in response to incidents of corruption. Links/Remarks csrreporting.sanofi.com / Ethics / Business Ethics / Fighting corruption / Actions csrreporting.sanofi.com / Ethics / Business Ethics / Fighting corruption / Actions csrreporting.sanofi.com / Ethics / Business Ethics / Fighting corruption / Actions
XX
State
XX
XX
Public Policy
Element SO5 Public policy positions and participation in public policy development and lobbying. Links/Remarks csrreporting.sanofi.com / Ethics / Business ethics / Institutional relations
XX
State
Compliance
Element SO8 Monetary value of significant fines and total number of non-monetary sanctions for non-compliance with laws and regulations. Links/Remarks 3.3.2. tats financiers consolids annuels - D.22. Litiges et arbitrages, p262-273 ANNUAL CONSOLIDATED FINANCIAL STATEMENTS/ D.22. Legal and Arbitral Proceedings, p F-9
XX
State
Customer Health and Safety
Element PR1 Life cycle stages in which health and safety impacts of products and services are assessed for improvement, and percentage of significant products and services categories subject to such procedures.
Links/Remarks Item 4. Information on the Company / B. Business Overview / Health, p55 csrreporting.sanofi.com / Patient / Product risk management
XX
State
Product and Service Labeling

Element PR3 Type of product and service information required by procedures, and percentage of significant products and services subject to such information requirements. Links/Remarks csrreporting.sanofi.com / Patient / Product risk management
XX
State
Marketing Communications
Element PR6 Programs for adherence to laws, standards, and voluntary codes related to marketing communications, including advertising, promotion, and sponsorship. Links/Remarks csrreporting.sanofi.com / Ethics / business Ethics / Responsible marketing
XX
State
Compliance
Element PR9 Monetary value of significant fines for non-compliance with laws and regulations concerning the provision and use of products and services. Links/Remarks 3.3.2. tats financiers consolids annuels - D.22. Litiges et arbitrages, p262-273 ANNUAL CONSOLIDATED FINANCIAL STATEMENTS/ D.22. Legal and Arbitral Proceedings, p F-9
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XX
State
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Recognition and Awards

In 2010, sanofi-aventis was once again recognized by inclusion on the most important global indices for CSR performance.
Many sanofi-aventis CSR initiatives were recognized in 2010 in various regions of the world. These awards are recognition of the Groups CSR approach, which is fully integrated throughout every level of the Groups operations.
One of the awards received in 2010 was the 2010 Agefi CSR governance award, for which the Group received first prize in the Social Responsibility category.
During 2010, Sanofi-aventis also received other awards in recognition of the Group's local CSR initiatives, for example: The China Pharmaceutical Enterprise CSR Contribution Award The Hong Kong Caring Company Award A prize awarded to sanofi-aventis Morocco by the World Intellectual Property Organization
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How data are reported: Methodological note

Scope of consolidation Changes in scope Reporting guidelines Additional information and methodological limits
Scope of consolidation
Social data are consolidated for all Group companies worldwide that are fully consolidated, regardless of their activity (industrial or research sites, commercial affiliates, administrative headquarters), with the exception of Merial (1). At the end of 2010, health and safety data (occupational accidents and injuries) covered the same scope. Environmental data (including spending and investments) are consolidated for all industrial and research sites. Environmental impact measured as CO2 emissions from all company vehicles includes all Pharmaceutical Operations affiliates. The environmental impact of administrative headquarters locations is not included within this scope. Social, health, safety and environmental data are wholly integrated into the scope of consolidation (full data integration). Because sanofi-aventis intends to integrate Merial into a joint venture in 2011 and consequently lose exclusive control (see Note D.8.1 to the consolidated financial statements, page 223 of the 2010 Document de Rfrence), Merials data are not reported notwithstanding the fact that on December 31, 2010, Merial was a wholly owned subsidiary of sanofi-aventis. Merial has 16 industrial sites, nine research and development sites and a number of administrative offices including its headquarters located in Lyon (France) and Duluth (Georgia, U.S.).
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Changes in scope
Within the Group, changes in scope (new sites, site closings, transfers of activity) between 2009 and 2010 were analyzed according to predefined rules in order to assess Group performance on a scope that is comparable from one period to the next.
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Reporting guidelines
In order to ensure the uniformity and reliability of indicators used for all entities, the Group implemented standard reporting guidelines covering social factors as well as safety and environmental factors. These documents specify the methodologies to be used for indicator reporting for the entire Group: definitions, methodological principles, calculation formulas and emission factors. In addition, sanofi-aventis adopted standard data collection tools: Social data: In 2008, a new application developed to gather information for the International Social Report made it possible to automate a portion of the reporting of the social data collected for all Group entities. Safety data: The MSRS system makes it possible to collect safety data for the entire scope. Environment: The GREEN tool enabled the consolidation of all data contained in the report. These tools and guidelines are updated and improved on a regular basis.
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Additional information and methodological limits

The methodological principles for certain HSE and social indicators may have limits due to: The absence of definitions recognized on a national and / or international level, in particular concerning the different types of employment contracts The necessary estimates and the representative nature of the measurements taken, or the limited availability of external data required for calculations The practical methods used for data collection and entry As a result, we make every effort to list the definitions and methodology used for the following indicators and, where appropriate, the confidence
limits involved.
Safety indicators
Occupational injury with lost time frequency rate (2) The frequency rate of occupational lost time injuries is defined as the number of accidents resulting in lost time of one day or more within a 12month period, per million hours worked. For non-mobile personnel, accidents occurring during the home-workplace commute are not included in this indicator. However, they are included for medical sales representatives, in accordance with the reporting rules defined by the Group. In the event that additional accidents have not yet been recorded at the close of the financial year, or if changes in the qualification of accidents are observed after the financial year has ended, the frequency rate is subsequently corrected. Motor vehicle accidents (2) Accidents are considered to be motor vehicle accidents if they occur when the driver is at the wheel of the vehicle (driving or parking the vehicle). This concerns all traffic accidents occurring with vehicles owned or leased by the Group or owned by the employee if the vehicle is driven on a regular basis for professional purposes (medical sales representatives).
Environmental Indicators
CO 2 emissions (2) Direct emissions are calculated on the basis of data from the Greenhouse Gas Protocol Initiative in relation to fuel emission factors. Indirect emissions resulting from other energy sources purchased off-premises and taken into account are the following: Emissions in connection with electricity production evaluated based on International Energy Agency (IEA) emission factors (available by country, and updated annually in the GREEN tool) Emissions in connection with the production of steam caused by site-specific factors. Those resulting from drug product transport are not included in this total. Other greenhouse gas emissions are not significant compared to those of CO2 . Emissions resulting from pharmaceutical sales fleet vehicles (medical representatives) were estimated on the basis of fuel consumption using a reporting system that distinguishes the emission factor specific to the type of fuel consumed (gasoline or diesel). Percentage of renewable electricity (2) The percentage of renewable electricity compared to total electricity purchased is calculated using data on the source of electricity in each country where the Group operates, based on U.S. Energy Information Administration data. Volatile Organic Compound emissions (VOCs) (2) VOCs are estimated either on the basis of mass balance or by direct measurement; the uncertainty resulting from these estimates is of the order of 10%. Wastewater discharge (2) Data corresponds to waste after internal or external treatment. In the event of a lack of information about external treatment, a purification rate of 50% is assumed. Waste (2) The distinction between hazardous and non-hazardous waste corresponds to that used in European regulations for European Union member countries (Decision 2000/532/EC of May 3, 2000) and that used in local regulations for other countries. It is noted that waste from remediation activities is not included in the published operational total.
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Consolidation and internal controls

The Corporate HR and HSE Departments are responsible for ensuring that all data are consolidated on the basis of information provided by the industrial and research sites and Group affiliates or administrative headquarters throughout the world. When sites include more than one function, either environmental impact is attributed to the one with the greatest impact, or impact is shared among the functions. HSE coordinators for each activity perform an initial validation of safety and environmental data prior to their consolidation. Corporate HR and HSE also verify data consistency during consolidation. These validations include data comparisons from previous years as well as careful analysis of any significant discrepancies. Social data regarding the workforce are compared with consolidated data in the management control database. To ensure that site representatives have properly understood the HSE indicators, and to ensure that the data reported correspond with those requested, HSE data verification is carried out during in-house audits conducted at Group sites.
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External controls
In order to obtain an external review of our datas reliability and the thoroughness of our reporting procedures, we asked our Statutory Auditors to perform specific verification of certain CSR information and data, identified by an asterisk and available on the Groups CSR website. Since 2009, the review performed by the Statutory Auditors encompasses information concerning the implementation of the Groups CSR approach, with particular focus on the following areas: stakeholder consultation, ethics in research, access to healthcare, pharmacovigilance, the fight against corruption, biopiracy, pharmaceuticals in the environment, diversity within the Group, and responsible marketing. The information covered by this work is also identified by an asterisk and may be found on the Groups CSR website. The Statutory Auditors assurance statement, describing the work they performed as well as their comments and conclusions, appears on this
website. For more information: Statutory auditors review report In addition, in accordance with the NRE Law, selected HSE and social data published in this CSR report were specifically reviewed by the Statutory Auditors in accordance with the relevant legislation and French professional standards to ensure that this information is consistent with the management report (environmental data and social data paragraph in the management report). For more information: Social data Environmental data
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(1) Because sanofi-aventis intends to integrate Merial into a joint venture in 2011 and consequently lose exclusive control (see Note D.8.1 to the consolidated financial statements, page 223 of the 2010 Document de Rfrence), Merials data are not reported notwithstanding the fact that on December 31, 2010, Merial was a wholly owned subsidiary of sanofi-aventis. Merial has 16 industrial sites, nine research and development sites and a number of administrative offices including its headquarters located in Lyon (France) and Duluth (Georgia, U.S.). 2010 Document de Rfrence (in French, PDF, 228Kb) (2) Data available on the sanofi-aventis Corporate Social Responsibility website.
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Statutory auditors review report

Download Statutory auditors' review report in French (PDF, 115Kb) This is a free translation into English of the Statutory Auditors report issued in the French language and is provided solely for the convenience of English-speaking readers. This report should be read in conjunction with, and construed in accordance with, French law and professional auditing standards applicable in France.
Statutory auditors review report on a selection of corporate social responsability (CSR) information and data
At sanofi-aventis request and in our capacity as Statutory Auditors for sanofi-aventis, we have performed a review designed to provide moderate assurance on a selection of information and data relating to fiscal year 2010 published on the sanofi-aventis Groups Corporate Social Responsibility website (CSR website) and identified by an asterisk (information and data). The sanofi-aventis Corporate Social Responsibility Excellence Division was responsible for preparing the information and data published on the CSR website in accordance with the Groups reporting procedures applicable during 2010. These procedures are available at the Groups headquarters and summarized in the section How data are reported: Methodological note of the CSR website. Our responsibility is to express a conclusion on the selection of information and data based on our review.
Nature and scope of our procedures

We conducted our work in accordance with applicable auditing standards established by the Compagnie Nationale des Commissaires aux Comptes. We planned and performed the procedures set out below to obtain moderate assurance that the information and data are free of material misstatements. A higher level of assurance would have required more extensive procedures. For the CSR information covered by our procedures: We reviewed the content described on the CSR website in order to identify information relative to the Groups accomplishments in the implementation of its CSR approach, in particular concerning the following areas: stakeholder consultation, ethics in research, respect for human rights, diversity, access to healthcare, pharmacovigilance, the fight against counterfeit drugs, pharmaceuticals in the environment and responsible marketing. We conducted interviews with: The CSR Excellence Division, which is in charge of elaborating and implementing the CSR approach Individuals in operational divisions such as Access to Medicines, Pharmacovigilance and R&D that are involved in implementing the approach Individuals involved in implementing the approach in cross-functional departments such as human resources The outside firm that assisted the Group with stakeholder consultation We obtained supporting documentation such as internal procedures, minutes of committee meetings and other meetings, training materials, studies, questionnaires (for suppliers and stakeholders) and the survey findings that made it possible to support the selected information. For the data covered by our procedures: We assessed Group reporting procedures with regard to their consistency, relevance, reliability, neutrality and understandability. At the Group level, we performed analytical procedures and verified, on a random basis, the calculations and data consolidation. This work was based specifically on interviews with the individuals responsible for the preparation and application of the reporting procedures as well as for data consolidation (HSE Department). We selected a sample of industrial and research sites (Vitry, Neuville, Marcy l'Etoile, Bridgewater and Zentiva in the Czech Republic) and Pharmaceutical Operations in four countries (United States, France, China and Germany). This selection was made on the basis of quantitative and qualitative criteria applied to the data (such as their relative contribution, geographic area and function) and on the basis of work conducted in prior years. Based on interviews with the individuals responsible for data preparation at the selected sites and units, we verified the understanding and application of procedures and carried out detailed tests to verify the calculations made and reconcile the data with the supporting documentation. The contribution of these entities to the Group consolidated total is:
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Message from Senior Management The Group's profile Our CSR approach CSR reporting Our stakeholders Policies and management systems Standards and memberships CSR performance GRI Recognition and Awards How data are reported: Methodological note Statutory auditors review report Social indicators Environmental indicators Other indicators FTC workforce Total workforce Workforce as of December 31 Group employees with a permanent contract (PC) Group employees with a fixed-term contract (FTC) Total number of PC and FTC employees Total number of PC employees 98,213 104,867
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Social indicators
Workforce data Workforce distribution Consolidated frequency rate for accidents by function Occupational illnesses declared in 2010 at the Group level
Workforce data
DEFINITION UNIT OF MEASURE 2008 2009 2010 VARIATION 2009 / 2010
101,575
-3.10%
PC workforce
94,448
97,736
94,385
-3.40%
Total number of FTC employees % of PC employees in total workforce
3,765
7,131
7,190
+0.80%
4.00%
7.30%
7.60%
+4.00%
Workforce by category
Group employees by job category
% of executives in total workforce % of temporary employees in total workforce % of others in total workforce
24.30%
23.70%
23.50%
-0.80%
32.70%
31.30%
29.90%
-4.40%
43.00% 45,856 52,357 46.70% 53.30% 5,090
45.00% 48,825 56,042 46.60% 53.40% 6,419
46.60% 46,988 54,578 46.30% 53.70% 5,653
+3.50% -3.80% -2.60% -0.60% +0.60% -11.90%
Workforce by gender
Male and female Group employees
Number of women Number of men
Gender equity
% of total workforce
% of women % of men
Use of temporary employees
Number of temporary employees (full-time equivalent) % compared with PC workforce
5.40%
6.60%
6.00%
-9.00%
Recruitment
Hired on permanent contracts Hired on fixed-term contracts
Number of employees hired on PC Number of employees hired on FTC
8,120
5,622
8,924
+58.70%
3,152
4,483
5,479
+22.20%
Departures
Group departures PC Group departures FTC
Number of PC terminations Number of FTC terminations Total number of dismissals
9,235 2,410 2,205
8,594 3,073 3,127
11,357 5,087 6,040
+32.10% +65.50% +93.20%
Dismissal
Dismissals for personal or economic reasons Average age of PC employees
Average age
Number of years
40 years 9 months
40 years 9 months
41 years
10 months Average seniority Average seniority of PC employees Number of years 10 years 0 month 10 years 10 months 11 years
11 months Working hours Mean theoretical number of hours worked per year in France Mean time spent in training for employees participating in at least one training course Days of absence due to sickness. occupational or commuting accidents, maternity and other Consolidated frequency rate within the Group, for all Group employees Number of hours 1,562 1,554 1,568
Hours of training (1)
Average number of hours spent in training
27 2
30 2
29 2
Absenteeism
Number of days absent in France
288,205
316,579
314,594
-0.60%
Occupational Injuries
Number of injuries resulting in lost time of one day or more within a 12-month period, per million hours
2.7
2.2
2.1*
(1) Includes all data for employees receiving training during the year, including those who were no longer with the Group as of December 31. (2) France .
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Workforce distribution
Distribution of workforce worldwide as of December 31, 2010
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Workforce by function and region (number of employees) as of December 31, 2010
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Gender distribution and job category as of December 31, 2010
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Consolidated frequency rate for accidents by function

FREQUENCY RATE OF INJURIES WITH LOST TIME (1, 2) 2008 2009 2010
Research and Development Industrial Affairs Global Operations Vaccines Central Services Sanofi-aventis total Temporary employees
1.6 3.1 2.9 2.0 1.6 2.7 2.6
1.9 2.0 2.6 1.1 1.4 2.2 1.4
1.6 2.1 2.1 2.3 1.8 2.1* 2.4
(1) Number of occupational injuries resulting in lost time of one day or more within a 12-month period, per million hours worked. These data are consolidated for all Group companies . (2) Frequency rates for previous years have been adjusted based on the following factors: eliminating injuries dismissed by regulatory authorities, including injuries reported late, and changes in the scope of reporting .
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Occupational illnesses declared in 2010 at the Group level
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* Indicators identified by an asterisk (*) were the focus of more in-depth analysis, enabling the Statutory Auditors to express an assurance specifically concerning these data. Their assurance statement, detailing the work they performed as well as their comments and conclusions, appears on this sanofiaventis CSR Report website, Statutory Auditors Review Report section: Vision / CSR performance / Statutory auditors review report
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Environmental indicators
Water consumption Energy consumption Solvent consumption VOC emissions CO2 emissions SOx emission NOx emission Wastewater discharge Waste Ozone-depleting substances Biodiversity Other environmental indicators
Water consumption
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Energy consumption
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Solvent consumption
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VOC emissions
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CO2 emissions
Other CO 2 emission indicators: 2005-2013 Variation in CO2 emissions per unit produced: -15% 2005-2013 Variation in CO2 emissions per km traveled (emissions generated by medical sales vehicles): -20% 2009-2010 Variation in CO2 emissions (per kg / pallet) generated by product transport between sites in Europe (road transport): -19% 2009-2010 Variation in CO2 emissions (per kg / pallet) generated by intercontinental product transport between sites (by air or by sea): -16%
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SOx emission
NOx emission
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Wastewater discharge
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Waste
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Ozone-depleting substances
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Biodiversity
Number of natural plant substances studied by the Group between 2003 and 2010: 647 Number of plants on which the Group conducted research between 2003 and 2010: 152 Percentage of plants held by the Group appearing on the IUCN (International Union for Conservation of Nature) Red List of Threatened Species: 1.3%
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Other environmental indicators

In 2010, percentage 2010 of hybrid vehicles in the Groups vehicle fleet: 7% 2009-2010 variation in weight of products transported by sea (intercontinental): +3%
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* Indicators identified by an asterisk (*) were the focus of more in-depth analysis, enabling the Statutory Auditors to express an assurance specifically concerning these data. Their assurance statement, detailing the work they performed as well as their comments and conclusions, appears on this sanofiaventis CSR Report website, Statutory Auditors Review Report section: Vision / CSR performance / Statutory auditors review report Top of page
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Other indicators
Patients indicators
Access to healthcare Supporting patients Product quality and safety The fight against counterfeit drugs
Ethics indicators
Ethics in clinical trials Use of laboratory animals for research Corporate governance Institutional relations Responsible marketing Fighting corruption Responsible procurement
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OUR INDICATORS
Patient
The patient at the center of the Groups business activities
As a global healthcare leader, sanofi-aventis places the patient at the center of the Groups concerns. Respect for patients involves being attentive to their needs. It means adapting to the expectations of local populations, including the most disadvantaged ones. It also means building a new business model based on access to healthcare and innovation to serve patients.
OUR PATIENT INDICATORS

List of our indicators
Access to healthcare
Access to healthcare is a major challenge. It aims to ensure that quality medicines and vaccines reach as many patients as possible.
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Supporting patients and their families

Sanofi-aventis believes that its mission goes beyond simply ensuring that treatments are available. The Group is committed to working with patient organizations all over the world.
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PATIENT MATERIALITY TEST

See the results
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Innovation
As one of the pillars of the Groups transformation, innovation makes it possible to identify solutions for patients unmet needs in terms of treatment and prevention.
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Pharmacovigilance, product quality, anti-counterfeiting measures, product and patient safety are Group priorities.
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A NEW DENGUE FEVER VACCINE With a high focus of innovation Taking up a scientific and an industrial challenge, sanofi-aventis aims to develop and market a tetravalent dengue fever vaccine that is safe, effective and accessible as quickly as possible.
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2010 highlights
Together for Haiti Operation
Donations of medicines and vaccines representing a commercial value of over 11.2 million
New patient support global policy

Guaranteeing that interactions with patient organizations are managed in an ethical and responsible manner
WHO Partnership
Renewing our partnership on neglected tropical diseases for an additional five years
Seasonal influenza epidemic

198 million doses of vaccines supplied in 2010
Transactions and acquisitions

37 transactions, including 9 acquisitions
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Patient indicators Access to healthcare Supporting patients Patient-focused innovation Product risk management
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Access to healthcare Supporting patients Product quality and safety The fight against counterfeit drugs
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Patient indicators Access to healthcare The Group's commitment Infectious diseases Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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Access to healthcare
Access to healthcare is one of the major challenges facing societies today. For a healthcare leader like sanofi-aventis, enabling individuals to assert their right to health consists of facilitating access to quality medicines and vaccines to benefit as many patients as possible.
Chronic diseases are a greater challenge to global development than infectious diseases. We need to improve the prevention and management of noninfectious diseases such as diabetes, cancer and respiratory disease.
Christopher A. Viehbacher CEO, Sanofi Germany - October 2010 World Health Summit
The Group's commitment

Access to healthcare has always been a priority in the sanofi-aventis strategy, yet the Groups response to this challenge has changed over time in line with stakeholders expectations.
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Infectious diseases
Sanofi-aventis has made a long-term investment in fighting the principal infectious diseases, from malaria to influenza. The Group is also committed to combating neglected tropical diseases and is an active member of the Global Polio Eradication Initiative (GPEI).
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Non-infectious diseases
Access to healthcare for non-infectious diseases, also known as chronic diseases, is a sanofi-aventis priority in both industrialized and developing countries.
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Rare diseases
Despite the economic pressure associated with developing orphan drugs, sanofi-aventis considers the fight against rare diseases an important component in the Groups growth strategy. The challenge is to respond to a public health need.
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Our approach is based on the quality of our partnerships to bring appropriate responses to those most in need and contribute to sustainably reducing healthcare inequalities.
Jean-Franois Dehecq President of the Sanofi Espoir Foundation www.fondation-sanofiespoir.com
Humanitarian emergencies
As a healthcare leader, sanofi-aventis believes that responding to humanitarian emergencies is one of the Groups missions.
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To implement its access to healthcare policy, sanofi-aventis relies on: Dedicated organizations: The Groups Access to Medicines Department and the Sanofi Espoir Foundation Local partners and structures in charge of setting up programs and implementing initiatives in the field
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You are here: Home > Patient > Access to healthcare > The Group's commitment
Patient indicators Access to healthcare The Group's commitment Background Challenges Policy Overview of investments and principal programs Infectious diseases Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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The Group's commitment

The Group's commitment - Background
Access to healthcare is a fundamental challenge facing societies today. This is a complex issue that the pharmaceutical industry cannot tackle alone.
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The Group's commitment - Policy

Access to healthcare has always been a priority in the sanofiaventis strategy, yet the Groups response to this challenge has evolved over time in line with stakeholders expectations.
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The Group's commitment - Challenges

Access to healthcare involves numerous and complex issues for the pharmaceutical industry. It concerns questions as diverse as the price of medicines to the protection of intellectual property.
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Overview of investments and principal programs

In 2010, all the access to healthcare programs combined represent a total investment of tens of millions of euros, in addition to donations of nearly one million boxes of medicines and over 500,000 doses of vaccines making it possible to treat patients in 43 countries.
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Patient indicators Access to healthcare The Group's commitment Background Challenges Policy Overview of investments and principal programs Infectious diseases Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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The Group's commitment - Background

A challenge for society Stakeholders expectations
A challenge for society

Access to healthcare is a fundamental challenge facing societies today. It is a complex issue that the pharmaceutical industry cannot tackle alone. Good health is in fact often a direct correlate of many different issues, including access to essential services such as clean water and access to education. More specifically, access to healthcare is not simply a matter of the patient having access to medicines and vaccines, even if they are affordable, but of being able to receive global therapeutic care from diagnosis to treatment. There are many different factors that explain why one-third of the global population does not have access to essential medicines and vaccines: In a majority of situations, the primary obstacles are insufficient distribution infrastructure, lack of healthcare personnel, insufficient diagnostics, and more generally a lack of public health infrastructure. In these areas, the role that the pharmaceutical industry can play is often limited to long-term development aid programs or awareness-raising and training for healthcare professionals. In certain cases, when the cost of treatment or the lack of appropriate treatments limit access to healthcare, pharmaceutical companies are more directly concerned.
Stakeholders expectations
In the debate over access to medicines and vaccines, the expectations that various stakeholders (governments, international institutions, nongovernmental organizations, the media) place on the pharmaceutical industry have changed considerably over the last 20 years: At the end of the 1980s, the mobilization to combat HIV / AIDS emphasized the rarity of therapeutic responses. The industry was accused both of not making sufficient research efforts, and of selling the rare medicines on the market at prices that were not affordable for the poorest populations. During the 1990s, non-governmental organizations (NGOs) made broad efforts to alert public opinion about the numerous parasitic, viral and infectious diseases, so-called neglected diseases, that affect poor and rural populations on a very large scale. Although medicines existed, most of them were very dated and no R&D effort had been made to update or improve existing therapeutic tools. Today, the implicit demands made on pharmaceutical companies by civil society are growing. A number of developing countries have become emerging markets: Life expectancy in these countries has grown longer, lifestyles have changed, and the profiles of diseases that have an impact are closer to those found in developed countries even though healthcare systems and coverage are not necessarily in line with those found in developed countries. Given this situation, the pharmaceutical industry must address new demands: Developing treatments and modes of administration that are less expensive and more closely adapted to the situations in developing and emerging markets Reducing the prices of medicines locally Supporting the commercialization of generics, including by having a company manufacture generic versions of its own products. For more information: WHO website Mdecins Sans Frontires (MSF) Campaign for access to essential medicines website CARE website
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Patient indicators Access to healthcare The Group's commitment Background Challenges Policy Overview of investments and principal programs Infectious diseases Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management Off-patent and inexpensive medicines and vaccines: Multiple factors contribute to problems of access Price plays a secondary role Infectious and parasitic diseases, diarrhea, ear, nose and throat (ENT) disorders, various kinds of pain, etc.
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The Group's commitment - Challenges

Access to healthcare involves numerous and complex issues for the pharmaceutical industry, ranging from questions as diverse as the price of products and the protection of intellectual property.
The principal initiatives to facilitate access to healthcare

The table below briefly summarizes access to treatment issues, examples of possible initiatives and expectations from stakeholders.
ACCESS TO TREATMENT ISSUES EXAMPLES OF DISEASES POSSIBLE INITIATIVES AND STAKEHOLDERS EXPECTATIONS
Support for training, distribution and treatment infrastructures Optimization of production costs by manufacturing in developing and emerging countries, technology transfer and the production of generics
Medicines and vaccines associated with diseases that specifically affect developing and emerging countries Main obstacles: The price of medicines and the lack of specific R&D programs It is difficult to contemplate a return on investment for diseases that are rarely or never found in developed countries
Malaria, tuberculosis, sleeping sickness, leishmaniasis, schistosomiasis, etc.
Fund R&D programs, including partnerships to improve and discover treatments Waiving specific patents Differentiated pricing policies including at cost and / or subsidies to make medicines and vaccines affordable Support for training, distribution and treatment
Patented medicines associated with serious diseases affecting developed and developing countries and emerging markets Main obstacles: The price of medicines Patents that prevent the commercialization of generics and limit differentiated pricing policies
Cardiovascular disease, cancer, diabetes, psychiatric diseases, HIV / AIDS, respiratory illness (asthma, allergies), etc.
Differentiated pricing policy Waiving specific patents Support for training, distribution and treatment
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PATIENT Patient indicators Access to healthcare Supporting patients Patient-focused innovation Product risk
PEOPLE People indicators Diversity Supporting change Employee career development Relationships with
PLANET Planet indicators CO2 emissions and energy Local environmental impact Pharmaceuticals in the
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Patient indicators Access to healthcare The Group's commitment Background Challenges Policy Solidarity programs Diversification Access to medicines Access to healthcare Overview of investments and principal programs Infectious diseases Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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The Group's commitment - Policy

A global approach to disease
Access to healthcare has always been a priority in the sanofi-aventis strategy, yet the Groups response to this challenge has changed over time in line with stakeholders expectations. Until the late 1990s, it focused on financial support for international organizations and associations working to develop healthcare infrastructure and distribution systems, as well as the donations of medicines. These programs gradually evolved toward more sophisticated relationships, including R&D programs in particular to develop products that correspond even more closely to peoples needs. Today the Groups access to healthcare policy has grown in response to a combination of several factors: Sanofi-aventis has become a diversified healthcare company. Vaccines and medicines alone are not sufficient to fight disease. New patient needs are appearing in developing countries, emerging markets and developed countries. The sanofi-aventis policy is based on a global approach to disease organized in cooperation with a wide range of stakeholders worldwide. This global approach is exemplified in many ways and in particular by: Unifying the Groups solidarity programs through the Sanofi Espoir Foundation Strengthening the Groups diversification Implementing a sustainable access to medicines and vaccines policy Making a strong commitment to promoting access to healthcare
STAKEHOLDERS PERSPECTIVES
We imperatively need improved access to medicines and improved access to quality healthcare. In order to achieve this, we need to reinvent healthcare from R&D through approval, prevention, management and pricing policies.
Christopher A. Viehbacher CEO, Sanofi Germany - October 2010 - World Health Summit
Pharmaceutical companies should show greater transparency when it comes to their lobbying activities and management of intellectual property.
Philippe Lvque Executive Director, CARE France

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BUSINESS CASE: POLIO Polio is a disease that has nearly disappeared from the collective consciousness, yet it continues to strike in certain regions of the globe.
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Patient indicators Access to healthcare The Group's commitment Background Challenges Policy Solidarity programs Diversification Access to medicines Access to healthcare Overview of investments and principal programs
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Unifying the Groups solidarity programs through the Sanofi Espoir Foundation
Created in 2010, the Sanofi Espoir Foundation is a corporate foundation whose mission is to contribute to reducing health inequalities, particularly among the most needy, by focusing on key issues in prevention, training and access to care.
Facilitating access to healthcare for victims of disasters and displaced populations Infectious diseases Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management Supporting development aid to sustainably reduce healthcare inequalities Improving primary healthcare: Reducing maternal and infant mortality In addition to responding to humanitarian emergencies, the Foundation aims to be a partner in projects whose impact on health and development will contribute to reducing the economic burden of disease and the disease/poverty cycle. The Sanofi Espoir Foundation coordinates 88 solidarity programs with 75 partners (NGOs, hospitals, health centers, etc.) in 56 countries. These programs include humanitarian emergencies in five countries (Chile, China, Guatemala, Haiti and Pakistan), support for projects proposed by Group employees (23 countries), as well as development aid programs (37 countries). In 2010, 5.3 million was allocated to responding to humanitarian emergencies and to developing long-term programs for access to healthcare. The Foundations initiatives are complementary to those carried out directly by Group affiliates.
Breakdown for solidarity programs

* 2010 figures do not take into account humanitarian emergencies

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Facilitating access to healthcare for victims of disasters and displaced populations

As a healthcare leader, sanofi-aventis believes that responding to humanitarian emergencies is one of the Groups missions. The challenge is to ensure access to healthcare for victims of disasters and displaced populations. For more information:
BUSINESS CASE: MALARIA To make progress in the fight against malaria, sanofi-aventis takes a comprehensive approach based on a combination of prevention, diagnosis and treatment.
The Sanofi Espoir Foundation website

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Supporting development aid to sustainably reduce healthcare inequalities

In addition to humanitarian emergencies, the Foundation invests in building more long-term relationships to sustainably reduce healthcare inequalities. Initiatives focus primarily on non-infectious diseases (such as cancer) and infectious diseases (such as tuberculosis) as well as neglected diseases (leishmaniasis, Buruli ulcer, mental illness, etc.). For more information: The Sanofi Espoir Foundation website
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Improving primary healthcare: Reducing maternal and infant mortality

Improving primary healthcare is one of the United Nations Millennium Development goals. Through the Foundation, sanofi-aventis takes part in a number of programs designed to reduce maternal and infant mortality around the world. One example: To improve the health and well-being of children in the Philippines, the Group supports the activities of the Virlanie Association, which helps the most needy children of Manila escape violence, drugs, prostitution and organ trafficking. For more information: The Sanofi Espoir Foundation website
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Strengthening the Groups diversification

Promoting access to healthcare also means offering patients a broader and more accessible product portfolio. This is precisely a purpose of the Groups diversification strategy, which was intensified in 2009 and 2010.
A number of acquisitions made it possible to expand the Groups product portfolio, which, in addition to prescription medicines and vaccines, includes consumer healthcare products and generics, with a balanced presence on traditional and emerging markets. Diversification will promote sustainable growth for the Group, which thanks to this strategy is better poised to meet the needs of healthcare systems worldwide and to remain a dependable long-term healthcare provider.
Generic medicines at the heart of sanofi-aventis access to healthcare strategy

Generic drugs are a vital part of establishing a balance in healthcare systems, from a financial standpoint and to ensure access to care. With this in mind, sanofi-aventis made three major acquisitions in 2009 and continued their integration in 2010: Medley, the number one generics company in Brazil Kendrick, one of the principal manufacturers of generic medicines in Mexico, with a portfolio containing more than 50 active ingredients Zentiva, based in Eastern Europe, which has a portfolio containing more than 400 products and is becoming the Groups generic platform in Europe These acquisitions enable sanofi-aventis to expand its offerings and become a leader in the generics market. For more information: See the Generics section of the Sanofi corporate website
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Implementing a sustainable access to medicines and vaccines policy

To promote access to healthcare for the neediest patients, sanofi-aventis has for many years been strongly committed to a specific access to medicines and vaccines approach overseen by a dedicated department created within the Group Access to Medicines, which works in collaboration with the Groups vaccines division. In addition, initiatives are launched by the functions, at Group level, and by regions and countries. This approach is designed to mobilize sanofi-aventis expertise and make a long-term impact by improving access to medicines and vaccines for as many patients as possible: In emerging markets and developing countries In areas where the Group has acquired expertise In projects that incorporate the complementary competencies of our partners (*) To reach this goal, the Access to Medicines Department and the sanofi-aventis vaccines division have developed a global approach that includes: A differentiated pricing policy for the Groups medicines and vaccines, which facilitates access to treatment and may include no profit no loss prices Training and information programs that are adapted to all the different stakeholders in the healthcare pyramid Developing adapted medicines and vaccines that meet patients needs by continuously conducting research Producing quality medicines and vaccines based on the Groups industrial expertise The Group makes a deliberate choice to contribute in disease areas where we have longstanding, recognized expertise: Infectious diseases, in particular malaria, tuberculosis and certain neglected tropical diseases, especially sleeping sickness and leishmaniasis Non-infectious diseases such as cancer, diabetes, epilepsy and mental illness Vaccine-preventable diseases
BUSINESS CASE * The information in italics identified by an asterisk was reviewed by the Statutory Auditors, who expressed an assurance specifically concerning these data. Their assurance statement, describing the work they performed as well as their comments and conclusions, is available in the section: Vision / CSR performance / Statutory auditors review report Top of page Christopher A. Viehbacher CEO, Sanofi Germany - October 2010 - World Health Summit
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A NEW DENGUE FEVER VACCINE
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Making a strong commitment to promoting access to healthcare

Choosing not to patent a drug Taking part in programs to reduce time to market for medicines Bringing production sites closer to the final consumer
Choosing not to patent a drug

Sanofi-aventis considers that defending intellectual property rights is not only one of the pillars of the healthcare industry, but essential for the Groups future. Without patents, it is impossible to ensure the sustainability of investments that are necessary for innovation the driving force in providing therapeutic solutions for patients needs. In particular, it is paramount for the international agreements of the World Trade Organization (WTO) to be upheld and applied. The Group believes that this principle must, however, be applied with a degree of flexibility, specifically as it concerns facilitating access to medicines and vaccines. Under certain circumstances, such as in the case of ASAQ to treat malaria, the Group deliberately chooses to waive its right to patent a product even an innovative one to make it more accessible. In addition, the Group makes every effort to facilitate access to its products for economically disadvantaged populations, in particular medicines for neglected tropical diseases, which primarily affect developing countries.
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Taking part in programs to reduce time to market for medicines

Improving access to healthcare also involves close cooperation with healthcare authorities in charge of marketing authorizations in order to reduce the time required to bring new products to market, so that patients may benefit from these medicines as rapidly as possible. In Japan, time to market is two to three times longer than in Europe, due to national regulatory constraints requiring that data submitted to the authorities come from clinical trials conducted in Japan. Since 2009, sanofi-aventis has taken part in a program called Minimize Drug Lag, to reduce time to market for nine of the Groups medicines. The program aims to respond to unmet patient needs by focusing on products that have already been approved in other countries.
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Bringing production sites closer to the final consumer

To promote access to healthcare, sanofi-aventis strives to bring production sites closer to the final consumer. Since 2007, ASAQ has been produced in Morocco at a sanofi-aventis manufacturing facility that complies with international quality standards. Several hundred millions of euros also were invested to increase production capacity for doses of the Groups vaccines, specifically in Mexico, France, the United States and China. Similarly, sanofi-aventis decided to relocate production of all its tuberculosis drugs at the same South African site. This generates several benefits, including a reduction in manufacturing costs of around 35%, which makes the treatment accessible for more patients, especially locally. For more information: Transferring production of all the Groups tuberculosis programs to South Africa

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Overview of investments and principal programs
In 2010, the total investment for all access to healthcare programs represented tens of Background Challenges millions of euros. In addition, nearly one million boxes of medicines and over 500,000 doses Policy of vaccines were donated to help people in 43 countries. Overview of investments and principal programs
The Groups investments in 2010 Infectious diseases Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management Over 4.7 million in programs carried out by a dedicated team of 27 people in the Access to Medicines Department and 6 people in sub-Saharan Africa Over 18.3 million invested in research and development, specifically to fight malaria, tuberculosis and leishmaniasis $5 million per year for the WHO partnership on neglected diseases ($50 million since 2001) 5.3 million in 2010 allocated to responding to humanitarian emergencies and to developing more long-term access to healthcare programs In addition: One million boxes of medicines and over 500,000 doses of vaccines were donated to help disadvantaged people in 43 countries 43.3 million units of ASAQ (artesunate-amodiaquine) were sold at differentiated prices (for a value of 20.6 million) In 2010, primarily in the United States, nearly 200,000 patients benefited from the Groups products through Patient Assistance Programs (PAP), which provide medicines at reduced prices and even free of charge for low-income individuals and their families.
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The Groups principal programs
The Groups investments in 2010
The major difficulty is to assess the effective impacts and outcomes of the actions and compare them with the results achieved by other companies. Indicators related to the means deployed (budget, number of employees involved, hours dedicated, etc.) should be disclosed in addition to indicators related to the results (number of tablets donated, etc.).
An SRI asset manager
Employee volunteering, in addition to financial donations, adds immeasurable value to Foundation projects.
Anne Marden JPMorgan Asset Management
The Groups principal programs

Malaria Sleeping sickness Tuberculosis Leishmaniasis Epilepsy Buruli ulcer Chagas disease Mental illness Polio Influenza Yellow fever Childhood cancers Malaria
NUMBER TYPE PARTNERS OF OF PEOPLE ACTION AFFECTED (DEATHS / YR) INVESTMENT IMPACT AND ACTIONS IN 2010*
million per year for the WHO partnership on neglected diseases ( 2001)
$5
$50 million since 43.3
In 2010, million doses of ASAQ (artesunateamodiaquine) were sold at differentiated prices for a value of
20.6 million 1
In 2010 million boxes of medicines and over doses of vaccines were donated to countries
500,000 43
300-500 million (1-2 million)
Pasteur Institute The Drugs for Neglected Diseases initiative (DND i) Foundation Medicines for Malaria Venture (MMV) Institute for One World Health (IOWH) French universities various NGOs including CARE in particular International Solidarity Actions JEREMI (Jumelage et Rencontre pour lEntraide Mdicale Internationale) PlaNetFinance Caritas, the French Institute of Tropical Medicine of the Army Health Service (IMTSSA), Secours Catholique / Caritas The Swiss Institute for Tropical Medicine National malaria programs
5 M$
In 24 countries of subSaharan Africa commercialization of a fixed-dose combination of artesunate and amodiaquine (ASAQ) developed in collaboration with the DND i Foundation Over 43 million doses of ASAQ supplied (80 million between 2007 and 2010) of which 95% were sold at no profit no less price Community projects to combat malaria in Burkina Faso and Congo microfinance / micro-health insurance projects in Benin and Madagascar Providing malaria information tools and training for community healthcare personnel (who earn a diploma) 200,000 children educated about malaria through the Schoolchildren Against Malaria program in Cte dIvoire, Burkina Faso and Ghana ASAQ pharmacovigilance program involving over 20,000 patients. This program is included in a Risk Management Plan the first to be submitted to the WHO 30 countries impacted by the Groups programs, mostly in Africa
18.3 million was

invested in research and development to combat malaria, tuberculosis and leishmaniasis
Sleeping sickness
20,000 to 30,000 (if left untreated, disease is always fatal)
WHO / Drug for neglected Diseases Initiative (DNDi)
$2 million
101,000 vials distributed in 2010 (over 1.5 million since 2001) 2 million people tested and 10,500 new cases detected and treated Treatment option with NECT (eflornithine + nifurtimox) introduced in 9 countries, covering 96% of T. Brucei gambiense cases Renewed partnership with DNDi to develop fexinidazole as the first potential oral treatment for sleeping sickness
Tuberculosis
PARTNERS NUMBER TYPE OF OF ACTION PEOPLE AFFECTED (DEATHS / YR) INVESTMENT IMPACT AND ACTIONS IN 2010*
18 million (2 million)
Nelson Mandela Foundation and Republic of South African government
$5 million
TB Free Program in South Africa:
9 centers for the training of volunteer-relays to monitor patients treatment
25,000 volunteers trained, making it possible to monitor over 375,000 patients since 2005
Samusocial
0.15 million
Program implemented in France: 150,000 allocated, including 65,000 contributed by Group employees in France Program to assist patients with tuberculosis in Mumbai, India: 49 centers opened for DOTS (Directly Observed Treatment Short-course) program
InterAide
Leishmaniasis
12 million people affected and 2 million new cases annually (200,000)
WHO, Federal University of Rio de Janeiro
$1.2 million
Over 2.9 million vials of Glucantime distributed Begin Arabic and Farsi translation of a work about leishmaniasis therapy by Professor Pierre Buffet in (already available in English, Spanish, French and Portuguese) 4,000 families monitored Affected regions: Central America, Central Asia, Brazil, Mexico, Middle East, Panama, Peru, Sudan, Ethiopia
Oswaldo Cruz Foundation
In Brazil, training program for healthcare professionals; awareness-building and screening of local population in the Pernambouc region
Epilepsy
50 million
Sant Sud: AMC / Action and Research in Epilepsy Network (RARE) in Mali, REM in Madagascar, University of Phnom Penh / INT in Cambodia, KAWE (Kenyan Association for Welfare of Epilepsy), Cameroon Ministry of Health, International League Against Epilepsy, Institut de la Francophonie pour les maladies tropicales (Laos), Ministry of Health in Benin, Ministry of Health in the province of Buenos Aires
NA
Training about epilepsy for physicians and healthcare professionals
Buruli ulcer
5,000 new cases each year
WHO
$0.2 million
Sponsoring antibiotic treatments in 9 countries Training healthcare professionals in 5 African countries Epidemiological
surveillance in 11 countries
Handicap International
In Togo, since initiative started in 2007, 176 people trained and 338 received treatment Expanded to Benin in 2011
Chagas disease
10 million
WHO
$0.18 million
Support for WHO initiatives in Latin American countries Development of systems of information and epidemiological surveillance
Mental illness
NUMBER OF TYPE PARTNERS PEOPLE OF AFFECTED ACTION (DEATHS / YR) INVESTMENT IMPACT AND ACTIONS IN 2010*
1% of the global population (schizophrenia))
Psychiatric Department of Nouakchott (Mauritania) and Casablanca (Morocco) World Association for Social Psychiatry (WASP) Sant Sud (Algeria, Tunisia, Lebanon)
0.2 million
Training about mental illness for physicians and healthcare professionals Pilot phase in Vietnam Approximately 260 patients included in the Groups program in Mauritania and 40 in Morocco Agreement signed for program in Benin Program for early diagnosis and integration of children with disability
Polio
1,600
Global Polio Eradication Initiative (GPEI), WHO, UNICEF, Rotary International
Donation of over 120 million doses between 1997 and 2005
Within the scope of the Global Polio Eradication Initiative (GPEI): Since 1988, over 5 billion doses of polio vaccine supplied Development of the first oral monovalent polio vaccine specifically for needs in Egypt, contributing to the eradication of polio in this country Specially adapted polio vaccine formulations in certain regions At the request of UNICEF, commitment to supply 400 million doses of polio vaccine in 2011-2012 for use in developing
countries
Influenza
3 to 5 million serious infections (250,000 to 500,000 deaths)
WHO, local health authorities
NA
Working with the WHO, within the scope of the influenza pandemic:
Production of over 250 million doses of monovalent A(H1N1) vaccine in 2009 and 2010, while at the same time maintaining production of seasonal flu vaccines (more than 198 million doses produced in 2010) Commitment to donate up to 100 million doses of pandemic influenza vaccine to be distributed by the WHO to eligible countries in need
Yellow fever
200,000 cases (30,000 deaths)
GAVI (Global Alliance for Vaccines and Immunization)
6 million doses of vaccines
Public / private partnership with the Global Alliance for Vaccines and Immunization (GAVI) to promote access to vaccines for children living in the poorest countries Since 2003, 6 million doses of vaccines supplied annually to combat African epidemics
EPIVAC Program, implemented by the Preventive Medicine Agency (AMP), developed in partnership with the governments of beneficiary countries, Universities of Cocody-Abidjan (Cte dIvoire) and Paris-Dauphine (France), in collaboration with the WHO, UNICEF and the GAVI Alliance, as well as other partners working in Africa Childhood cancers
NUMBER TYPE PARTNERS OF OF PEOPLE ACTION AFFECTED (DEATHS / YR)
1 million
Funding of program to train doctors involved in the implementation of vaccination programs in 11 Central and West African countries
INVESTMENT IMPACT AND ACTIONS IN 2010*
160,000 (90,000)
Union for International Cancer Control (UICC)
0.6 million
23 projects ongoing in 18 countries in 2010 20,000 children have benefited from this program since 2004 Nearly 3,500 healthcare professionals have been trained Over 4 million since 2004
Fun Centers
20 Fun Centers in Brazil benefiting 300,000 children since 1999
Symbols used in table:
Research Donations of medicines / vaccines, or sale at low cost Training of medical personnel x Screening / raising awareness Reduction in production costs * Excluding expenses related to dedicated teams and excluding R&D expenses Top of page
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Patient indicators Access to healthcare The Group's commitment Infectious diseases Malaria Neglected tropical diseases Tuberculosis Access to vaccines Polio Yellow fever Influenza Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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Infectious diseases
An infectious disease is any disease that can be spread from one person to another. As a global healthcare leader, sanofiaventis makes a long-term investment in the fight against the primary infectious diseases worldwide.
Malaria
To make progress in the fight against malaria, sanofi-aventis takes a comprehensive approach based on a combination of prevention, diagnosis and treatment.
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Neglected tropical diseases

Sanofi-aventis is an active participant in combating highlyprevalent neglected tropical diseases such as sleeping sickness, leishmaniasis, Buruli ulcer and Chagas disease.
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Tuberculosis
The aim of the tuberculosis program conducted by sanofi-aventis is to provide healthcare authorities with new, high-quality tuberculosis treatments to bolster the fight against this disease.
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Access to vaccines
The commitment to promote vaccination and access to vaccines is lived out each day at sanofi pasteur. The Group makes every effort to ensure that vaccines will be accessible to as many people as possible, everywhere in the world.
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Polio
Since 1988, sanofi-aventis has been active alongside the WHO in the Global Polio Eradication Initiative.
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Yellow fever
As the main provider of yellow fever vaccine, sanofi pasteur is committed to fighting the major epidemiological risk this disease represents.
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Influenza
As the worlds leading influenza vaccine manufacturer, sanofi pasteur innovates and provides new flu vaccines adapted to peoples needs.
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You are here: Home > Patient > Access to healthcare > Infectious diseases > Malaria
Patient indicators Access to healthcare The Group's commitment Infectious diseases Malaria Policy Actions Business case Neglected tropical diseases Tuberculosis Access to vaccines Polio Yellow fever Influenza Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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Malaria
Background
What is malaria?
Malaria is a parasitic disease transmitted from person to person through the bite of the Anopheles mosquito. The parasite, known as Plasmodium, colonizes and destroys red blood cells. The destruction of red blood cells leads to malaria attacks and the sudden appearance of fever, fatigue, headache, shivering and vomiting. Attacks may become severe, leading to acute anemia, convulsions, coma and even death. Young children and pregnant women are especially at risk of developing severe malaria.
Setting differentiated prices in different countries is important to facilitate treatment of people that need it.
Stephanie Dunn Senior Sustainability Analyst Dexia Asset Management
Epidemiology
According to the World Malaria Report published by the WHO in 2009, this disease was responsible for 780,000 deaths worldwide in 2009. This represents over 2,000 deaths daily, with nearly 90% of them occurring in Africa. Malaria is the leading cause of mortality among African children; it causes 16% of deaths among children under age five (compared to 9% worldwide). An African child dies of malaria every 45 seconds. It is also the leading cause for hospitalization in many countries in Africa.
Information, education and communication tools for all those involved in the fight against malaria.
www.impact-malaria.com
The economic and social impact of malaria

Malaria fuels poverty because of the expenses and losses that it entails and because of its impact on peoples ability to work and receive an education. In many sub-Saharan African countries, malaria is the largest single health expenditure item. In addition to causing death and disability, malaria leads to absenteeism and therefore impacts adults ability to work as well as childrens capacity to learn. The economic cost of malaria in sub-Saharan African countries is estimated to be around $12 billion per year.
ASAQ : More than

million units distributed between 2007 and 2010
80
Prevention and treatment of malaria

Effective means to prevent and treat malaria are available today. Treatment of non-complicated malaria is based on a combination of two drugs, one of which must be an artemisinin derivative. Treatment is taken for three days. Severe or complicated malaria must be treated with injectable drugs, quinine being the drug most commonly used today. The international community has mobilized considerable resources to fight malaria. To succeed, however, these efforts require coordinating a number of partners and strategies adapted to each country, that must be followed continuously for several years. Lastly, due to the problem of resistance both to treatments and existing insecticides it is essential to develop new solutions. For more information: The Pasteur Institute website, section on Malaria (in French) The WHO website, section on Malaria The CDC (Centers for Disease Control and Prevention) website, section on Malaria The Roll Back Malaria Partnership website
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healthcare professionals trained in 2010 in 8 African countries

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You are here: Patient > Access to healthcare > Infectious diseases > Malaria > Policy
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Malaria - Policy
Sanofi-aventis commitment to the fight against malaria is not only in line with the Groups corporate social responsibility but reflects its longstanding expertise in the field of antimalarials.
A global approach The Impact Malaria program Areas for progress, goals and indicators
A global approach
To make progress in the fight against malaria, sanofi-aventis takes a comprehensive approach based on combining prevention, diagnosis and treatment. To make a lasting impact, the Group decided to take advantage of its areas of expertise to develop a sustainable, global model and combat this disease on all fronts. This global approach requires building collaborations to work with many different stakeholders, each of whom brings complementary competencies. The idea is that ultimately each individual from the schoolchild to the scientist will be able to contribute to combating malaria. When it comes to treatment, the Groups portfolio contains several antimalarial drugs. These include certain medicines that helped lay the foundation for malaria treatments (quinine, chloroquine, amodiaquine) and, more recently, artesunate and artemether, as well as artesunate-amodiaquine (ASAQ), the combination used today. In response to the need for new treatments, in 2010 the Group created a dedicated unit within Research and Development to conduct research on infectious diseases, including malaria.
ASAQ : More than

80
The Impact Malaria program

In 2001, the sanofi-aventis Access to Medicines Department introduced Impact Malaria, a long-term program designed to provide a comprehensive response to malaria. The Impact Malaria program takes advantage of many facets of the Groups extensive expertise through: Innovative training and education tools adapted to all those working in the field Adapted medicines and ongoing Research and Development efforts to develop new medicines A differentiated pricing policy, making treatment affordable for as many people as possible Applying the Groups industrial know-how for the production of quality medicines For more information: The Impact Malaria program website

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Areas for progress, goals and indicators

AREAS FOR PROGRESS SPECIFIC GOALS INDICATORS
Research and develop new antimalarial medicines to anticipate the emergence of resistance to current treatments Improve existing medicines so they are better adapted to patients needs
Carry out research and develop external collaborations with organizations working in the field of malaria treatment and prevention
The Group created a Research and Development unit in 2010 for infectious diseases, including malaria
Increase the number of African countries where ASAQ is available Continue implementation of
In September 2008, ASAQ obtained WHO prequalification and has now been registered in 30 sub-Saharan African countries
program to monitor safety and efficacy of ASAQ (Risk Management Plan)
Several clinical studies incorporated in the Risk Management Plan were conducted in 2010; others are ongoing Initiatives for healthcare professionals: By the end of 2010, 180 trainers had been trained and were able to train 5,000 healthcare professionals in 8 African countries Initiatives for local populations and communities: 200,000 children in Cte dIvoire, Burkina Faso and Ghana learned about how to prevent malaria thanks to the Schoolchildren against Malaria initiative Monitor sales volumes on relevant public and private markets
Increase information, education and communication initiatives
Improve care provided by healthcare professionals for the treatment of malaria Improve local populations ability to protect themselves against the risk of contracting malaria
Continue to apply a differentiated pricing policy so that all patients will have access to our antimalarial medicines
Continue to apply differentiated pricing policy and increase the number of patients who have access to sanofi-aventis antimalarial drugs through appropriate public and private markets
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Malaria - Actions
The programs described below are just a few examples of the many initiatives sanofiaventis organizes all over the world in the fight against malaria.
ASAQ: An unpatented malaria drug developed through a public / private partnership Awareness and education for schoolchildren Research and development of new antimalarial compounds An innovative program of pharmacovigilance in Africa Education and communication: The example of Impact Malaria Differentiated pricing policy
ASAQ: An unpatented malaria drug developed through a public / private partnership

The antimalarial drug ASAQ Winthrop / Coarsucam is the first treatment for malaria to be developed thanks to a public / private partnership in this case, between sanofi-aventis and the DNDi (the Drugs for Neglected Diseases initiative) Foundation. ASAQ, a single tablet containing a fixed-dose combination of artesunate and amodiaquine, has been placed on the pre-approved drug list of the World Health Organization Prequalification of Medicines Program. In order to make ASAQ available to as many patients as possible, the Group waived its right to seek a patent. Introduced in 2007, ASAQ has to-date been registered in over 30 countries where malaria is endemic. More than 80 million doses were distributed between 2007 and 2010. For more information: Business case: ASAQ
ASAQ : More than

80
Awareness and education for schoolchildren

In 2008, sanofi-aventis introduced the Schoolchildren against Malaria project in collaboration with the national malaria program in Cte dIvoire, followed by several other African countries. This project consists of giving schoolchildren essential information about malaria and then asking them to write their own plays on this topic. Theater contests are then organized to designate the best play. Not only does this approach allow children to learn more about malaria and how to protect themselves from infection, but it helps communicate this knowledge to families and friends. Between 2008 and 2010, this program contributed to raising awareness among 200,000 children in Cte dIvoire, Ghana and Burkina Faso. The Schoolchildren against Malaria initiative will be expanded to other countries including Madagascar and the Democratic Republic of Congo.
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Research and development of new antimalarial compounds

Because sanofi-aventis anticipates the development of resistance to the malaria drugs currently in use, in 2010 it set up a Research and Development program on infectious diseases, including malaria. The goal of the program is to conduct research and develop relationships with outside organizations (including academic institutions and universities) working on malaria treatments or prevention. The most advanced projects are subsequently developed in our own research centers and wholly financed by the Group. Current projects are outlined below:
PROJECT PROGRESS
Collaborative research with the University of Montpellier II on a series of products called bicationic compounds that interfere with phospholipid biosynthesis in the parasite. This led to the selection of a candidate for development: SAR97276 Collaboration with Palumed in Toulouse, France on trioxaquins, compounds that potentially combine two active mechanisms against the parasite Ferroquine, or SAR97193, a new 4-aminoquinoline derivative, is the result of cooperation with USTL (Lille, France). Ferroquine is very effective against strains of Plasmodium falciparum, whether they are sensitive or resistant to chloroquine
Phase II of clinical development
Pre-clinical phase of development
Phase II of clinical development in combination with artesunate
These projects provide a response to one of the WHOs goals (Roll Back Malaria program) to curb malaria and reverse current trends by 2015.
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An innovative program of pharmacovigilance in Africa

In developed countries, national pharmacovigilance programs monitor the efficacy and safety of drugs after they have been brought to market. These types of programs do not exist in a number of sub-Saharan African countries. Sanofi-aventis and DNDi therefore decided to set up an innovative program of field monitoring to gather quality information about ASAQs safety and efficacy. The program consists of studies designed by sanofi-aventis, DNDi and university researchers in close collaboration with national malaria programs in participating countries(*). With the goal of enrolling more than 20,000 patients treated with ASAQ, this is the most ambitious drug monitoring program ever conducted in Africa. Through this initiative focusing on the fixed-dose combination of artesunate and amodiaquine, sanofi-aventis is contributing to the development of local pharmacovigilance expertise that is adapted to the needs and resources of these countries. This initiative has received financial backing from the DNDi Foundation and the Medicines for Malaria Venture (MMV). For more information: Pharmacovigilance
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Education and communication: The example of Impact Malaria

Because drugs alone are not enough, the Impact Malaria program includes initiatives to promote information, education and communication for all those affected by the disease and efforts to combat it. The program aims to improve healthcare professionals management of malaria while helping communities protect themselves more effectively against the risk of contracting the disease. Information and education initiatives are designed for medical personnel and for local populations and communities.
Initiatives for medical personnel

Programs aim to distribute information about the most recent recommendations concerning the diagnosis and treatment of malaria. They are adapted for each country and carried out in cooperation with national malaria programs, based on a training-the-trainers approach. At the end of 2010, 180 trainers had been trained and they subsequently trained nearly 5,000 healthcare agents in eight African countries.
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Initiatives for local populations and communities

Impact Malaria develops and supports information and education initiatives for people to learn about malaria prevention and the proper use of medicines. An information toolbox on malaria has been developed, composed of materials with messages adapted to meet the most pressing needs, essentially concerning measures local populations can take to prevent malaria. Different regions have different malaria transmission profiles. Impact Malaria also supports a number of pilot community projects that will make it possible to determine the scope of actions necessary to achieve a real and lasting impact in each region. The most advanced projects are: An initiative launched in 2007 concerning the Makoua region of Congo Brazzaville, in conjunction with the NGO International Solidarity Actions. It will be completed in 2011. Sanofi-aventis has supported the development of PlaNet Finance since 2001 by providing 400,000 in funding per year. This support has made it possible to finance: Increasing awareness about malaria for over 130,000 people, including 120,000 in Benin and nearly 10,000 in Madagascar The creation of an affiliate of PlaNet Finance called PlaNet Guarantee, which is devoted to micro-
insurance. This company made it possible to provide life / disability insurance coverage to 120,000 people through 13 micro-finance institutions The development of an innovative health insurance system in Benin, which covered 10,000 people in 2010 Sanofi-aventis also supports JEREMI (Jumelage et Rencontre pour lEntraide Mdicale Internationale), an NGO, and its program to combat malaria among pregnant women and young children in the Ouahigouya district of Burkina Faso. For more information: See the Impact Malaria website
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Differentiated pricing policy

To ensure that the Groups malaria drugs are accessible, sanofi-aventis strives to provide them to as many patients as possible at affordable prices by practicing differentiated pricing. Treatments are provided at preferential prices that may include no profit no loss prices for public agencies, NGOs and charity organizations. Sanofi-aventis has experienced a considerable increase in order volumes and has optimized the Groups production facilities while continuing to meet the strictest quality standards. As a result, our stakeholders in the effort to combat malaria have benefited from a steady price decrease. The no profit no loss price initially set for ASAQ less than one U.S. dollar for adults and less than 50 cents for children has become the reference price for all antimalarial drugs. This differentiated pricing policy is designed to promote the long-term success of access to medicines programs for specific diseases. In 2010, 43.5 million doses of ASAQ were sold at differentiated prices in 24 endemic countries.
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* The information in italics identified by an asterisk was reviewed by the Statutory Auditors, who expressed an assurance specifically concerning these data. Their assurance statement, describing the work they performed as well as their comments and conclusions, is available in the section: Vision / CSR performance / Statutory auditors review report Top of page
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Business case: Malaria

Making progress in the fight against malaria, a disease that continues to cause approximately one million deaths each year.
Impact Malaria, an innovative approach with various partners and complementary expertise: ASAQ Winthrop, an adapted treatment: Result of public-private partnership with DNDi, Unpatented Pre-qualified by the WHO Easy to take; adapted to children Differentiated pricing policy ensuring ASAQ Winthrop affordability even for the poorest patients. Training and information tools. Ongoing research with the creation of infectious diseases R&D unit.
For patients: Access to treatment: 80 million units of ASAQ distributed since 2007 in over 30 countries, essentially at preferential prices. Improved patient compliance. Greater awareness about malaria prevention. For other stakeholders (WHO, governments, NGOs): Response to a public health challenge. Mobilization of complementary expertise.
Develop an innovative model for access to healthcare. International partnerships. Image: 2010 Global Business Coalition Core Competence Award (partnership with DND i ).
3 new compounds in R&D. Increase our initiatives including for noninfectious diseases.
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The challenge
One-third of the world's population lives in malaria-endemic areas. Malaria continues to cause nearly one million deaths each year primarily children under the age of five living in sub-Saharan Africa despite the fact that today effective methods exist to prevent and treat the disease. The international community mobilizes considerable resources to combat this disease. Medicines have been developed and there are means of preventing malaria (insecticide-treated nets in particular), yet these efforts are not sufficient to contain the disease. The challenge is as daunting as the stakes are high ensuring that patients have long-term access to treatments and means of prevention.
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Our response
Medicines alone are not enough. To be effective, the fight against malaria requires a comprehensive and integrated approach based on prevention, diagnosis and treatment in addition to mobilizing many different stakeholders with complementary expertise. The Impact Malaria program takes this global, innovative approach as its model. Created by sanofi-aventis in 2001, the program is based on four pillars: Information and education tools for local field workers A differentiated pricing policy An R&D program to meet future challenges Coordination with stakeholders that provide complementary skills and resources When it comes to developing adapted medicines, sanofi-aventis has extensive expertise in the field of antimalarials. The most recent is the Groups drug ASAQ Winthrop / Coarsucam, the first malaria treatment to be developed thanks to a public / private partnership, in this case between sanofi-aventis and the DNDi (the Drugs for Neglected Diseases initiative) Foundation. ASAQ, a single tablet containing a fixed-dose combination of artesunate and amodiaquine is among drugs recommended by the WHO. The drug is easy to take and treatment is adapted to children. To ensure treatment is accessible to as many patients as possible, sanofi-aventis chose not to patent ASAQ. It is manufactured in Morocco in a sanofi-aventis production facility that meets international quality standards. To ensure ASAQ is accessible for as many patients as possible, sanofi-aventis established a differentiated pricing policy: the same medicine is distributed under two brand names and on two price scales applied to public and private organizations. For public entities such as governments and NGOs, the drug is sold at a preferential price, including a no profit no loss price of less than one dollar to treat an adult and 50 cents for a child. The same drug is sold under a different brand name to wholesalers who supply private pharmacies at prices that vary according to the country. As a complementary measure and in conjunction with stakeholders working in the field, the Group develops a number of malaria training and information tools. Their efforts aim to raise awareness, prevent malaria and support treatment for patients by using tools designed to meet the needs of all links in the healthcare chain. One very successful initiative is the Schoolchildren against Malaria program, which since 2008 has taught 200,000 children in Africa about malaria and how to prevent it. Lastly, the Group invests in research and development to find new antimalarial drugs, mindful that sooner or later resistance to current medicines will appear. In 2010, an R&D unit was created and dedicated to research on new drugs to fight infectious diseases, including research on malaria drugs. Research efforts are also focused on existing medicines. To overcome a lack of pharmacovigilance programs in a majority of sub-Saharan African countries, a vast field surveillance program was established in 2009 to monitor the safety and efficacy of ASAQ. It is the largest drug monitoring study ever organized in Africa.
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Benefits for stakeholders

For patients, sanofi-aventis global response has clearly made an impact. ASAQ was introduced in 2007 and is registered today in over 30 malariaendemic countries. Between 2007 and 2010, over 80 million units were distributed, essentially at preferential prices. For partners such as the WHO, governments and various NGOs involved in these efforts, the approach taken by sanofi-aventis represents an effective response to a public health challenge. It also strengthens the mobilization of complementary expertise.
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Opportunities for the Group

With ASAQ and Impact Malaria, sanofi-aventis has devised an innovative and sustainable model for access to healthcare programs. The Impact Malaria initiative also allows sanofi-aventis to collaborate with international organizations as well as researchers, NGOs and health authorities. These initiatives are highly enriching, leading to interaction among experts, shared resources, etc. Moreover, in recognition of the success of the innovative partnership with the DNDi Foundation for the development of ASAQ, the Group received the 2010 Global Business Coalition Core Competence Award.
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What about the future?

To further improve the treatment of malaria and anticipate the development of resistance to current treatments, the Groups R&D teams are working to develop new medicines, both oral and injectable. Within the Access to Medicines Department, the methods and ideas developed by the Impact Malaria program serve as a model for initiatives to combat other diseases as well.
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You are here: Home > Patient > Access to healthcare > Infectious diseases > Neglected tropical diseases
Patient indicators Access to healthcare The Group's commitment Infectious diseases Malaria Neglected tropical diseases Sleeping sickness Leishmaniasis Buruli ulcer Chagas disease Tuberculosis Access to vaccines Polio Yellow fever Influenza Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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Neglected tropical diseases

Background
One billion people are affected by or risk contracting tropical diseases that the international community considers neglected. Very often, these diseases strike communities in rural or remote areas, urban slums and conflict zones with poor living conditions and hygiene. Neglected tropical diseases are very low on the list of international public health priorities and health agendas. These diseases are referred to as neglected because they are not mentioned in the United Nations Millennium Development Goals. Funding for research and development to find new treatments is limited given that the potential return on investment is either very small or nonexistent. Consequently, most of the medicines available today were developed years ago and are not always adapted to the needs of patients and caregivers. There is also a real risk that resistance to these treatments will develop, making them ineffective.
Policy
Sanofi-aventis commitment to neglected tropical diseases corresponds to the Groups corporate social responsibility as well as its expertise, which it has developed since 1946 in the research and production of treatments for sleeping sickness and leishmaniasis. In addition, because the Group is convinced that drugs alone are not enough, sanofi-aventis has always insisted on the need for a global response to diseases. For bacterial and protozoan diseases like sleeping sickness, leishmaniasis, Chagas disease and Buruli ulcer, it is essential to provide screening and organize information, education and communication programs.
Through our collaboration with the WHO and our global approach to disease, we are at the forefront of the fight against neglected tropical diseases. Our ambition is to be involved in building longterm partnerships that will make it possible to achieve a lasting reduction in healthcare inequalities, in particular in the field of neglected tropical diseases.
Dr Robert Sebbag Vice President Access to Medicines, sanofiaventis
Ten years of collaboration with the WHO

Since 2001, sanofi-aventis has been working with the WHO in a decade-long partnership to combat sleeping sickness (Human African Trypanosomiasis). Since 2006, this partnership was expanded to include other neglected tropical diseases leishmaniasis, Buruli ulcer and Chagas disease. From 2001 to 2010, sanofi-aventis contributed a total of nearly $50 million to the collaboration. In 2010, the Group announced plans to renew its support in 2011 for another five years of this program with the WHO. The objectives of this long-term program, which is based on a public / private partnership, are: To eliminate sleeping sickness To control leishmaniasis, Buruli ulcer and Chagas disease, which consists of preventing mortality, reducing morbidity and preventing transmission.
Sleeping sickness
Thanks to efforts by sanofi-aventis and the WHO, over 150,000 lives have been saved since 2001. In addition, a new drug is currently in development.
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Leishmaniasis
In response to the challenges posed by this complex disease, sanofi-aventis is committed to a single treatment price and partnerships to improve information for local populations and to train healthcare personnel.
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Buruli ulcer
Sanofi-aventis makes an active contribution to
Chagas disease
Sanofi-aventis is actively involved in
fighting Buruli ulcer. In collaboration with Handicap International, the Sanofi Espoir Foundation is working to prevent disability caused by this disease in Togo and Benin.
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combating Chagas disease in regions of the world where it is endemic.v

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You are here: Patient > Access to healthcare > Infectious diseases > Neglected tropical diseases > Sleeping sickness
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Sleeping sickness
Sleeping sickness, or Human African Trypanosomiasis (HAT), is one of the most complex and one of the most neglected of all endemic tropical diseases.
Since 2001, sanofiaventis has provided over 2 million vials of treatment to the WHO
Transmitted by the bite of the tsetse fly, this disease is most devastating in impoverished rural areas. Gambian sleeping sickness mainly affects West and Central Africa, while the Rhodesian variety of the disease can be found in East Africa. Initial symptoms are generally mild and non-specific. In the advanced stage of the disease, the parasite invades the brain and causes neurological lesions. If left untreated, the disease is fatal. In the 1960s, sleeping sickness was nearly eliminated but reappeared in the 1990s. Today it is once again under control and eradication is within reach. The sooner patients are screened and diagnosed, the fewer the number of cases requiring intensive treatment. Improved screening and treatment by mobile medical teams has greatly contributed to reducing the number of cases, which fell from 28,000 in 1999 to around 10,000 in 2009. It is important to note that if sleeping sickness is not treated, it is always fatal, whereas if treatment is administered during the first stage of illness, the patients life can be saved
lives have been saved since 2001
150,000
Fexinidazole
A new and promising treatment for sleeping sickness is in Phase 1 of clinical research
Sanofi-aventis response
Produce medicines and provide them to the WHO at no cost Support training in the field Develop a new drug in collaboration with DNDi
Produce medicines and provide them to the WHO at no cost

Four medicines are available to treat sleeping sickness. Sanofi-aventis produces three of them, which the Group provides to the WHO at no cost: Pentamidine for stage 1 of T. b. gambiense Eflornithine for stage 2 of T. b. gambiense Melarsoprol for stage 2 of T. b. gambiens e and T. b. rhodesiense Since 2001, the beginning of the Groups collaboration with the WHO, which was renewed in 2006, sanofiaventis has provided over two million vials of medicines and over 150,000 patients have been treated for this disease which represents 150,000 saved lives. In collaboration with Doctors without Borders (known as MSF - Mdecins Sans Frontires), which coordinates the distribution of medicines to affected countries, the WHO provides kits containing drugs and the necessary materials (perfusion fluids and materials, needles, gauze, adhesive tape) for intravenous treatments to be administered safely. As a result of these initiatives and those of others, since 2001 the annual incidence of sleeping sickness has decreased by over 60%.
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Support training in the field

Because sleeping sickness affects patients living in remote areas, mobile medical teams have been organized and are specially trained and equipped to detect the disease and manage treatment. Their goal is to ensure screening and diagnosis of the disease at the earliest stage possible.
Within the scope of the Groups partnership with the WHO, sanofi-aventis supports training for these mobile teams, which are made up of paramedical and assistance personnel. Thanks to the Groups support, in several countries the WHO has provided training on the administration and utilization of Human African Trypanosomiasis (HAT) treatments for personnel from national sleeping sickness programs. Improved detection combined with medical care provided by the mobile teams has greatly contributed to decreasing the number of new cases, which dropped from nearly 28,000 in 1999 to around 10,000 in 2009*. *Source : International Journal of Health Geographics 2010
Develop a new drug in collaboration with DND i

In 2009, sanofi-aventis entered into a collaboration agreement with DNDi (Drugs for Neglected Diseases Initiative) for the development, manufacture and distribution of a promising new oral treatment for sleeping sickness in the advanced stage fexinidazole. This medicine may replace complex and often poorly-tolerated treatments with a simpler drug, and it can be taken orally. Sanofi-aventis is responsible for the industrial development of fexinidazole, which entered Phase 1 of clinical research in 2010. If this new drug is effective, it will greatly simplify treatment for patients.
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Objectives
AREAS FOR PROGRESS OBJECTIVES
Curb the number of cases and achieve elimination (WHO objective) Provide treatment as of the first stage of the disease Decrease the use of Arsobal
Increase screening, diagnosis and the number of people trained in performing these techniques
Provide kits containing eflornithine + nifurtimox (underway via the WHO and MSF for logistics) Continue the development of fexinidazole with DNDi After analysis of dossiers, participate in R&D programs through development agreements, public / private partnerships, etc.
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Develop new compounds and therapeutic approaches
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Leishmaniasis
A complex parasitic disease Sanofi-aventis response Commitments
Over vials distributed in
100,000 1.5
2010 (more than million since 2001)
10,500 new
A complex parasitic disease

Leishmaniasis is a parasitic disease transmitted by an insect bite: the phlebotomine sand fly. An estimated 1.6 million new cases occur each year, primarily in the Middle East, Southern Asia, Eastern Africa and Latin America (source: WHO). Different forms of this complex disease primarily affect rural communities: Visceral leishmaniasis (VL), which mainly affects the liver and spleen, is the most severe form. If left untreated it is fatal within two years. Certain cases may evolve with skin dissemination of the parasites (cutaneous leishmaniasis, or post-kala azar). Visceral leishmaniasis affects 500,000 people and causes 50,000 deaths each year. Cutaneous leishmaniasis is the most common form of the disease with 1.1 million new cases each year. It causes skin lesions on the face, arms and legs. Although certain forms of cutaneous leishmaniasis heal spontaneously, the disease may cause severe scarring and permanent disfiguration. The disease also causes social stigma due to the erroneous but widespread belief that it can be contagious. Among the forms of cutaneous leishmaniasis, mucocutaneous leishmaniasis affects less than 5% of patients in Latin America. If it is not treated, it can severely disfigure the patient.
cases detected and treated in 2010
2 million people tested
Develop and produce appropriate treatments Provide education and training
Develop and produce appropriate treatments

Sanofi-aventis produces two drugs used for first - and second-line treatment of leishmaniasis: meglumine antimoniate and pentamidine. The Suzano site in Brazil is a major production site for meglumine antimoniate. To facilitate access to treatment, the Group has committed to a single price of $1.20 per 5 ml vial of meglumine antimoniate (excluding customs and transportation costs) in all developing countries. In 2010, more than 100,000 vials were distributed (over 1.5 million since 2001) and two million people were tested. Some 10,500 new cases were detected and treated. The development of formulations that would allow existing products to be applied directly to skin lesions is currently under evaluation.
Provide education and training

Very few reference works about leishmaniasis are currently available. Given the Groups expertise, sanofiaventis lent its support for the publication of a work about leishmaniasis therapy written by Professor Pierre Buffet, a specialist of this disease, about leishmaniasis therapy. It is available in several languages including English, French, Spanish and Portuguese. The Arabic and Farsi translations are expected to be ready in 2011. In addition, since 2002, sanofi-aventis has been a supporter of the Oswaldo Cruz Foundation, a research center in Brazil devoted to combating leishmaniasis in the Pernambuco region. The Foundation supports training for healthcare personnel and promotes education and awareness-raising programs. With the support of the Sanofi Espoir Foundation, the program organizes various initiatives for example, training workshops for community care workers and healthcare professionals, treatment monitoring, and projects to increase awareness and prevention among concerned populations.
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Commitments
AREAS FOR PROGRESS OBJECTIVES
Continue to apply a differentiated pricing policy so that all patients will have access to the Groups medicines
Pursue programs to train healthcare personnel in screening and diagnostic techniques, thanks to the agreement signed with the WHO in October 2006
Increase information, education and communication initiatives designed to improve care provided by healthcare professionals and develop local populations ability to protect themselves
Continue publishing a brochure about leishmaniasis therapy, written by a specialist of the disease to help physicians working in the field
Complete transfer of Glucantime production to a single site in Brazil
Optimize production and labor costs
Participate in efforts to prevent the development of resistance to treatments
Participate in R&D efforts to develop new treatments, including through outside agreements
Work alongside national authorities to combat the disease
Take part in liaison groups with national authorities

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You are here: Patient > Access to healthcare > Infectious diseases > Neglected tropical diseases > Buruli ulcer
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Buruli ulcer
The disease
Buruli ulcer is a severe cutaneous bacterial infection that leads to extensive destruction of the skin and soft tissues, usually in the legs and arms. If patients are not treated early on, they may suffer long-term functional disability with restriction of joint movements and visible cosmetic problems. It is estimated that 25% of patients who recover are left with a form of permanent disability. Buruli ulcer has been reported in 33 countries, half of them in Africa, with small outbreaks of infection in Australia. Most African patients are children under the age of 14.
Information for improved detection
In collaboration with the WHO, information materials about the disease have been developed to target affected populations. This initiative contributes to early detection of the infection. The Groups funding and support are currently focused on an antibiotic treatment.
Support a program to combat Buruli ulcer in Togo

The Sanofi Espoir Foundation is a supporter of the NGO Handicap International in Togo that seeks to prevent disability caused by Buruli ulcer. The actions in the field in support of the countrys Ministry of Health and local stakeholders include raising awareness within communities, training healthcare professionals, promoting early detection and treatment, and rehabilitation for persons with disabilities. In 2011, this program will be extended to a second coastal region in Togo and Benin, with the transfer of skills in motor physical therapy and rehabilitation for people with disabilities.
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You are here: Patient > Access to healthcare > Infectious diseases > Neglected tropical diseases > Chagas disease
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Chagas disease
The disease
Chagas disease, also called American Trypanosomiasis, is a parasitic disease transmitted by the fecal matter of the triatome, a bug that lives in crevices in the mud walls and thatched roofs of dwellings, generally in rural areas and urban slums throughout Latin America. The transfusion of infected blood is a second significant mode of transmission. The disease affects 10 million people worldwide, with endemic areas in 21 Latin American countries. Chronic infection, which usually begins in childhood, can in about 30% of cases cause irreversible damage to the heart, esophagus, colon and peripheral nervous system later in life. Patients with severe chronic disease become progressively ill. They may die of heart failure in early adult life. Although vector control has dramatically reduced the incidence of new cases in Latin America, much remains to be done to improve the treatment of the many people who continue to become infected due to infected blood transfusions. Mass migration from Latin America to North America and Europe means that it has become a global disease. Consequently, surveillance to monitor Chagas disease is important.
Through its partnership with the WHO, sanofi-aventis contributes to controlling Chagas disease in endemic areas, in particular by developing information and epidemiological surveillance systems.
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You are here: Home > Patient > Access to healthcare > Infectious diseases > Tuberculosis
Patient indicators Access to healthcare The Group's commitment Infectious diseases Malaria Neglected tropical diseases Tuberculosis Policy Actions Access to vaccines Polio Yellow fever Influenza Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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TB FREE PROGRAM Over 375,000 patients monitored since 2005 in South Africa
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Tuberculosis
What is tuberculosis? Treatment Epidemiology
What is tuberculosis?
Koch's bacillus (Mycobacterium tuberculosis ), which causes tuberculosis, is an infectious agent transmitted by breathing in airborne droplets expectorated by infected patients. The inhalation of a few contaminated droplets is enough to infect a person. The bacteria usually cause infection of the lungs, but sometimes other organs are affected too (bones, the meninges, lymph nodes). A person with untreated tuberculosis can infect an average of ten to 15 people each year. The movement of populations (travelers, war refugees, the homeless in industrialized countries) and the HIV/AIDS pandemic have greatly contributed to the global spread of the disease over the last 40 years.
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Nearly 6,000 people screened and treated in India in 2010, in collaboration with Inter Aide.
Not all people infected with Koch's bacillus will develop tuberculosis. The bacillus can remain dormant in the body for years without symptoms. Only 5% to 10% of infected persons will develop the disease. Individuals with weakened immune systems, particularly people living with HIV/AIDS, have a greater risk of developing tuberculosis after being infected. Together, the HIV virus and Koch's bacillus form a deadly combination; each infectious agent promotes the progression of the other. Tuberculosis is in fact the primary cause of death in people living with HIV / AIDS; it is responsible for the deaths of one-third of people living with HIV / AIDS worldwide, and 40% in Africa.
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RIFAPENTINE
Rifapentine: A promising compound to simplify and shorten treatment for tuberculosis (PDF, 75Kb)
Treatment
The aim of curative treatment is to destroy the bacteria present in the infected organs. Treatment is based on a combination of four antibiotics: rifampicin, isoniazid, pyrazinamide and ethambutol. This combination is the standard treatment currently recommended by the WHO. It must be started as soon as possible after diagnosis, and must be followed for at least six months. The WHO considers that, from a public health standpoint, incomplete treatment or poor compliance is worse than no treatment at all. If the infection is not eliminated, antibiotic-resistant bacilli may develop in the patient. Treating these resistant bacilli when it is possible takes much longer and is more complex and more expensive. To ensure good patient compliance with first-line treatments, fixed-dose combinations of drugs have been developed. For the first two months of treatment, the active ingredients of the four principal drugs are combined in a single tablet, or the two principal active ingredients are rolled into a single tablet for the followup phase, which lasts at least four months. This solution considerably reduces the number of tablets a patient must take each day.
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Epidemiology
Tuberculosis is, along with HIV / AIDS and malaria, one of the most serious infectious diseases worldwide. One-third of the world's population is infected with Koch's bacillus today, and it is estimated that a new infection occurs each second. It is also estimated that around eight million people develop the disease and two million people die from it each year. Twenty-two countries account for 80% of tuberculosis cases worldwide.
Over two million of the annual cases of tuberculosis occur in sub-Saharan Africa, and this figure is rising steadily due to the HIV / AIDS epidemic, which especially affects this region of the globe. Nearly three million cases have been reported in Southeast Asia and over 250,000 in Eastern Europe. The HIV / AIDS epidemic and the emergence of bacilli that are multi-resistant to antibiotics contribute to exacerbating the impact of tuberculosis, which is considered by the WHO to be a global health emergency. The WHO estimates that between 2000 and 2020, nearly one billion new infections will occur and 200 million people will develop the disease, causing 35 million deaths if progress is not made in controlling the spread of this infection.
Prevalence of tuberculosis
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You are here: Patient > Access to healthcare > Infectious diseases > Tuberculosis > Policy
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Tuberculosis - Policy
Sanofi-aventis was the very first company to manufacture rifampicin and remains one of the key producers of this basic ingredient in all tuberculosis treatments. Several of the Group's manufacturing facilities have developed and currently produce a range of drugs to treat tuberculosis, which are distributed in many countries. Building on the strength of the Groups experience, sanofi-aventis recently redefined its contribution to the fight against tuberculosis. It launched a program of industrial optimization and development to expand the product range and offer products that are better adapted, at lower cost, in order to improve access to treatment for as many patients as possible. This program is based essentially on existing production capacities in South Africa. In terms of research, the development of rifapentine has created the prospect of simpler and shorter tuberculosis treatments, which should lead to better patient compliance and therefore improve treatment effectiveness. At the same time, the Sanofi Espoir Foundation is organizing programs to control the spread of the disease, particularly in the slums of Mumbai.
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RIFAPENTINE
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You are here: Patient > Access to healthcare > Infectious diseases > Tuberculosis > Actions
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Tuberculosis - Actions
Setting up partnerships with international organizations Taking part in the international TB Free Program Fighting tuberculosis in the slums of Mumbai, India Working with Samusocial in France and Russia
Setting up partnerships with international organizations

In collaboration with a number of international organizations, sanofi-aventis has devised a strategy for developing and improving tuberculosis treatments. Partners include the CDC (Centers for Diseases Control and Prevention) in the United States, the TB Alliance, the CREATE Consortium (Consortium to Respond Effectively to the AIDS / TB Epidemic) and St. Georges Hospital Medical School in London. The strategy is based on: Continuing the development of an existing drug, rifapentine, for the treatment of latent and active tuberculosis, both alone and in combination with other drugs. The aim is to shorten the course of treatment and reduce the number of times medicine must be taken, while maintaining optimum efficacy. Rifapentine has been granted orphan drug status in Europe Carefully analyzing the Groups antibiotic portfolio in order to identify new active ingredients that may be effective against tuberculosis bacilli, especially strains that have developed resistance to standard treatments Pursuing research to discover new drugs, including through external collaboration These initiatives support the United Nations Millennium Development Goals and the Stop TB global program, which is spearheaded by the WHO, to stop progression of the disease by 2015. For more information: Rifapentine: A promising compound to simplify and shorten treatment for tuberculosis (PDF, 75Kb)
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RIFAPENTINE
Taking part in the international TB Free Program

With nearly 400,000 new infections each year and an average of 175 deaths daily, South Africa is one of the countries most affected by tuberculosis. Sanofi-aventis took part in creating the TB Free project in collaboration with the Nelson Mandela Foundation and the South African Ministry of Health. Patient supervision and monitoring during treatment for TB leads to better treatment compliance. According to international recommendations, the most effective strategy is one known as DOTS Directly Observed Treatment Short-course. It is based on the help of DOTS supporters who monitor patients to ensure they take their daily dose of medicines. After tuberculosis has been diagnosed, healthcare personnel, community care workers and volunteers who have received the necessary training supervise the patient directly. They make sure that patients take their prescribed dose of TB drugs for the entire course of treatment. Sputum examinations are performed after two months and again at the end of the treatment cycle to monitor disease progression. Registration and notification systems make disease surveillance possible for the entire course of treatment; they also allow an assessment of the percentage of patients who are cured, which provides information about the quality of the program. Thanks to this program, nine centers have been opened (one per region). They ultimately aim to train over 20,000 DOTS supporters nationwide. Each DOTS supporter can monitor around ten patients for the entire treatment period. Since 2005 when the program was introduced, more than 375,000 patients have received support and monitoring. If applied correctly, this strategy could avoid millions of cases of tuberculosis and deaths over the next decade.
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Fighting tuberculosis in the slums of Mumbai, India

The Sanofi Espoir Foundation supports the program of the NGO Inter Aide to help health authorities and local stakeholders reduce the economic impact and risk of tuberculosis infection in the slums of Mumbai. In these poor, densely populated neighborhoods, TB is one of the leading causes of mortality but also disability and unemployment. Teams from Inter Aide provide support to public health centers to improve patient care and monitoring, which has a positive impact on cure rates. They visit private doctors working in the slums to encourage them to send their patients to public or association-based centers where treatment is given free of charge. The teams also set up centers to provide DOTS (Directly Observed Treatment Short-course) inside the slums; 49 centers are functioning with support from Indian authorities. In addition, they organize campaigns to raise awareness and warn people about the risks of tuberculosis. In 2010, nearly 6,000 people were screened and received treatment. In 2011, the program will be extended to the outlying towns of Virar, Ulashnagar and Mira Bhayander.
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Working with Samusocial in France and Russia

For the last ten years, sanofi-aventis and Group employees have supported the work of a Samusocial mobile team in Paris (France) in its efforts to combat tuberculosis. This special team, which was created by the Samusocial, seeks out groups living in extreme poverty. It screens individuals for tuberculosis and provides treatment to cure the disease. Support consists of the donation of medicines as well as financial aid from the Group and employees at all French sites. Since 2007, sanofi-aventis has also supported the work of the International Samusocial in Moscow (Russia).
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Access to vaccines
According to the World Health Organization, vaccination provides protection against more than 26 infectious diseases today. With its vaccines division, sanofi pasteur, the Group has the broadest available range of vaccines, protecting against 20 infectious diseases.
11 Central and 400
The EPIVAC program has been rolled out in
Western African countries Since 2002, nearly
Vaccines save more than three million lives each year, but more than three million people still die due to a lack of access to existing vaccines. In response to this major public health challenge, sanofi pasteurs commitment to promote and facilitate access to vaccination is lived out each day. The Group makes every effort to ensure that vaccines are accessible to as many people as possible, everywhere in the world. Forging partnerships to prevent disease Applying a policy of differentiated prices Investing in production capacity
physicians have attended the program and earned a diploma
Each year, sanofi pasteur provides nearly
UNICEF and other international organizations
doses of vaccines to
300 million
Forging partnerships to prevent disease

From 2000 to 2008,
Due to the cost of vaccine administration, weak health systems and, in some cases, conflict, many people living in the worlds poorest countries do not have access to vaccines. To supply vaccines where there is widespread need, sanofi pasteur has formed ongoing partnerships with a number of international organizations including the World Health Organization, the United Nations Childrens Fund (UNICEF), the World Bank, the Bill and Melinda Gates Foundation, the Red Cross and Rotary International. To respond to patients needs, the Group has developed flexible solutions and implemented differentiated pricing policies. Each year, sanofi pasteur supplies nearly 300 million doses of vaccine to UNICEF and other international organizations. In December 2009, the Group entered into an agreement with the WHO to supply up to 100 million doses of influenza A (H1N1) vaccines at no cost, to be distributed by the WHO. This donation was intended to protect the most vulnerable patients against the risk of an influenza pandemic.
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213 million children

were immunized thanks to the GAVI Alliance programs, which represents
3.4 million lives

saved
The Global Alliance for Vaccines and Immunization (GAVI)

The GAVI Alliance was founded in 2000 by the Bill & Melinda Gates Foundation, the World Bank, the WHO, UNICEF and vaccine manufacturers, including sanofi pasteur. Committed to saving childrens lives and protecting peoples health through the widespread use of vaccines, GAVIs driving objective is to make a critical contribution to global immunization goals by supporting immunization programs and health systems, and accelerating the introduction of new vaccines. Sanofi Pasteur shares GAVIs objectives to improve the infrastructures required for effective vaccine administration and to encourage research and development programs focused on diseases that predominantly affect developing countries. Between 2000 and 2008, programs within the GAVI Alliance made it possible to immunize 213 million children, which represents 3.4 million lives saved. Sanofi Pasteur and the GAVI Alliance members have organized a major initiative to contain the risk of yellow fever epidemics. Since 2003, the Group has provided more than six million doses per year of yellow fever vaccines funded by GAVI to go toward emergency stockpiles of vaccines, in order to prevent epidemics in Africa. For more information: Yellow fever
The Global Polio Eradication Initiative (GPEI)
The Global Polio Eradication Initiative, which is spearheaded by certain national governments, the WHO, Rotary International, the United States Centers for Disease Control and Prevention (CDC) and UNICEF, is the largest public health initiative the world has ever known. Since 1988, some two billion children around the world have been immunized against polio thanks to unprecedented cooperation by more than 200 countries and 20 million volunteers, backed by an international investment of $3 billion. Sanofi Pasteur is the principal corporate donor to the GPEI. Thanks to this initiative, an estimated five million people have avoided contracting polio-related paralysis. For more information: Polio Business case: Polio
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Applying a policy of differentiated prices

Sanofi Pasteur has always applied a differentiated pricing policy to facilitate access to vaccines for countries that are eligible for programs organized by GAVI. Sanofi Pasteur practices a differentiated pricing policy that meets countries needs according to different levels of development. The goal is to make vaccines affordable and accessible to people in all countries, regardless of their level of economic development.
Investing in production capacity

Sanofi Pasteur invests to meet local public health needs: Several hundred million euros have been invested to increase the Groups production capacity, particularly in Mexico, France, the United States and China. For more information: Influenza The acquisition of Shantha Biotechnics in India, which was finalized in July 2009, is a perfect illustration of the Groups ambition: Shantha Biotechnics develops, manufactures and sells several different pediatric vaccines, making it possible to produce vaccines that are adapted to meeting local needs at local market prices.
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Taking part in healthcare infrastructure development and improving the level of knowledge about immunization
In addition to producing vaccines, sanofi pasteur strives to promote vaccination in Africa through cooperation and education. Specifically, the Group aims to meet the needs of the most disadvantaged groups. Supported by sanofi pasteur, the EPIVAC and PREVAC Plus programs work toward this goal.
EPIVAC: Building healthcare infrastructure

The EPIVAC program is a sanofi pasteur contribution to the GAVI Alliance. Implemented by the Preventive Medicine Agency (AMP), the program was developed in conjunction with the national governments of eligible countries and participating universities (Cocody-Abidjan in Cte dIvoiret and Paris-Dauphine in France), in collaboration with the WHO, UNICEF, GAVI and others working in Africa. The objective of the EPIVAC program is to train doctors involved in the implementation of immunization programs in 11 Central and West African countries. The training teaches them about vaccine organization and management in some of the poorest regions of the globe, and includes basic programs on epidemiology, applied computing, vaccinology, and management of health programs. Doctors who participate receive a diploma at the end of their training. Since 2002, nearly 400 doctors have been trained and certified through the EPIVAC program.
PREVAC Plus: Training improves the quality of learning

Launched in 2009 in Cameroon, PREVAC Plus is a pilot program to provide practical training in vaccinology. Financed by sanofi-aventis, the program was implemented by the University of Buea with the support of the Ministry of Health. Originally designed for nurses, in 2010 it was expanded to include pediatricians and general practitioners. Training is currently provided by a group of experts who attended the first classes and are able to teach their peers, based on a pyramid system of training-the-trainers. In light of the success of courses in Cameroon, Cte dIvoire and Senegal, the program will be introduced in Gabon and Burkina Faso in 2011. For more information: The GAVI Alliance website The Global Polio Eradication Initiative website The EPIVAC website
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You are here: Home > Patient > Access to healthcare > Infectious diseases > Polio
Patient indicators Access to healthcare The Group's commitment Infectious diseases Malaria Neglected tropical diseases Tuberculosis Access to vaccines Polio Business case Yellow fever Influenza Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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Polio
Background Policy Actions
a longstanding partner in the
Sanofi Pasteur is Global Polio Eradication Initiative launched

by the WHO in 1988.
Background
Poliomyelitis, more commonly known as polio, is a contagious disease caused by three different serotypes of poliovirus (types 1, 2 and 3). Transmission is human-to-human (primarily fecal-oral), which means that polio eradication is possible. Most people who are infected present no symptoms and there is no specific treatment. However, in some cases, polio may cause incapacitating paralysis and death. Polio continues to trigger epidemic outbreaks in certain countries of sub-Saharan Africa, as well as in India and the Middle East. Although the number of cases has dropped by over 99% since 1988, polio remains a devastating disease for the people it strikes. While there is no cure for polio, it can be avoided through immunization. Over two billion children worldwide have been immunized since 1988, and it is estimated that five million people have avoided contracting paralysis a consequence of polio. Two vaccines are used to prevent polio: - The injectable polio vaccine, made from inactivated virus (IPV, discovered by Jonas Salk) - The oral polio vaccine, made from live attenuated virus (OPV, discovered by Albert Sabin) After smallpox, polio is the second infection projected for worldwide eradication. The Global Polio Eradication Initiative spearheaded by the WHO and based on a collaboration between the WHO, UNICEF, the CDC and Rotary International has been underway since 1988. For more information: www.polioeradication.org
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99% reduction in
the number of cases
Since 1988, polio vaccines have led to a
An estimated million people have avoided contracting polio-related paralysis
Supplier of more than
400 million doses

of vaccines for use in developing countries in 2011 and 2012
Since 1988, sanofi pasteur has provided billion doses over of polio vaccine
Policy
Sanofi Pasteur has been a partner in the Global Polio Eradication Initiative since it was launched by the WHO in 1988. A pioneer in the development of the polio vaccine, sanofi pasteur is today the worlds number one supplier of polio vaccines. The Group plays a leading role in the effort to eradicate the disease because it provides both the injectable and oral vaccines, IPV and OPV.
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Actions
Actively involved in the polio eradication effort
Since 1988, sanofi pasteur has supplied over five billion doses of polio vaccine. Between 1997 and 2005, sanofi pasteur donated more than 120 million doses for polio eradication to respond to emergency situations in war-torn African countries. When an epidemic broke out in Egypt, and at the request of the WHO, the Group developed the first monovalent oral polio vaccine, which contributed to eliminating the disease in this country: Egypt was certified polio-free in 2006. Sanofi Pasteur also developed a bivalent vaccine that is used increasingly for the global eradiation effort.
In response to a request from UNICEF, sanofi pasteur recently committed to supply 400 million doses of polio vaccine in 2011 and 2012 for developing countries. For more information: Business case: Polio eradication
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You are here: Patient > Access to healthcare > Infectious diseases > Polio > Business case
Patient indicators Access to healthcare The Group's commitment Infectious diseases Malaria Neglected tropical diseases Tuberculosis Access to vaccines Polio Business case Yellow fever Influenza Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
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Business case: Polio

Continuing to play a decisive role in efforts to eradicate polio, a disease that remains endemic in four countries with transmission and outbreaks in several others.
Sanofi Pasteur is an active partner in the Global Polio Eradication Initiative (GPEI) Sanofi Pasteur is the worlds leading supplier of polio vaccines both oral and injectable and a longstanding partner in the GPEI, launched in 1988 by the WHO. Number of vaccine doses supplied Over 5 billion doses since 1988. Between 1997 and 2005: Over 120 million doses donated during emergency situations in Africa. 2011-2012: A new commitment to supply 400 million doses (UNICEF) for use in developing countries. Development of specific vaccine formulations Oral vaccine (OPV) containing a single viral strain for specific situations, in addition to standard vaccine made from three viral strains. Injectable vaccine (IPV), made from inactivated virus, available alone or as part of combination pediatric vaccine. Formulations adapted to specific geographic regions.
For patients and targeted countries: 99% decrease in the number of cases worldwide between 1988 and 2010. An estimated 5 million people have been saved from polio-related paralysis. Eradication in Egypt in 2006 (1st oral monovalent vaccine developed by sanofi pasteur) and in Saudi Arabia in 2007. Significant drop in prevalence in the rest of the world For employees: Five decades of participation in efforts to eradicate a disease and ability to develop and produce adapted vaccines create a sense of pride. For others (WHO, NGOs, GPEI): Support from a global long-term partner that is able to adapt formulations to meet specific needs and provide substantial production capacity.
In line with the sanofi-aventis access to healthcare
strategy. Global recognition for sanofi pasteur: A global partner of choice (oral and injectable vaccines). An essential industrial partner (quality + production capacity). Committed to public health (NYSE Euronext event in February 2011). Developing unique expertise for injectable vaccines (IPV) that can be used in promising pediatric combinations. Expanded production capacity.
Eradication is within reach. Continue to uphold longstanding commitment to immunization. Use of injectable polio vaccines (IPV ) is expected to grow.
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The challenge
Polio is a disease that has nearly disappeared from the collective consciousness, yet it continues to strike in certain regions of the globe. The number of cases has dropped considerably since 1988, when the WHO launched the Global Polio Eradication Initiative (GPI). Such progress has been possible in large part because partners like sanofi pasteur, the Groups vaccines division, have provided a constant supply of quality vaccines in large quantities and at affordable prices. Declared cases of polio across the globe decreased from 350,000 in 1988 to 1,600 in 2009, which represents a 99% drop in the number of cases. Yet much remains to be done. Polio is still endemic in four countries (Nigeria, Afghanistan, Pakistan and India) and the infection has reappeared in several countries. In light of the current situation, the challenge for sanofi pasteur is to continue to play a decisive role in eradicating the disease.
Our response
Sanofi Pasteurs response upholds what the Group considers to be a public health mission. As a pioneer in the development of polio vaccines in the past, and as the worlds principal supplier of polio vaccines today, sanofi pasteur has been a longstanding partner to the WHO in the global effort to eradicate polio. One of the most visible outcomes of this collaboration may be seen in the number of vaccine doses supplied by the Group. Since 1988, sanofi pasteur has provided over five billion doses of polio vaccines. It donated over 120 million doses between 1997 and 2005 in response to humanitarian emergencies in war-torn African countries. More recently, following a request from UNICEF, the Group committed to supplying 400 million doses for use in developing countries in 2011 and 2012. At the same time, the Group shares its expertise with health authorities to develop specific vaccine formulations that are adapted for certain regions of the globe. While the standard OPV (oral polio vaccine) contains three strains of the virus, sanofi pasteur has also supplied vaccines containing a single viral strain for specific situations. Moreover, the Group is one of the leading suppliers of the inactivated polio vaccine. IPV is available alone to prevent one disease (polio), or in combination with other pediatric formulations to confer protection against several diseases.
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The results of the global polio eradication program, which is ongoing, have been remarkable for patients and for the countries targeted by this effort. Between 1988 and 2009, the number of cases worldwide has dropped by 99%. An estimated five million people have avoided polio-related disability and paralysis. Sanofi pasteur has played a significant part in these results. In Egypt, thanks to the first monovalent oral vaccine developed by sanofi pasteur, at the request of the WHO, polio was declared eradicated in 2006. In Saudi Arabia, declared polio-free in 2007, sanofi pasteur is recognized as one of the crucial leaders in achieving eradication. In other regions of the globe, the prevalence of polio is clearly declining. It remains endemic in four countries: Afghanistan, Nigeria, Pakistan and India. Considerable progress has been made in India, where only 45 cases of polio were reported in 2010, compared to over 600 in 2009. For sanofi pasteur employees, playing an active part in the global eradication of a disease is a source of pride. For other key partners the WHO, NGOs, the GPEI, sponsors working with a long-term, trusted healthcare leader is highly rewarding. With sanofi pasteur, they are able to count on a partner that is able to develop and produce new vaccine formulations quickly and reliably. Last but not least, sanofi pasteur shares the Groups industrial know-how and substantial production capacity with other GPEI members.
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Sanofi Pasteurs active participation in the Global Polio Eradication Initiatives is fully in line with the sanofi-aventis access to healthcare strategy. As one of the worlds leading developers and manufacturers of polio vaccines both oral and injectable sanofi pasteur is a key industrial stakeholder due to its production capacity and the quality of its vaccines. This role furthermore represents an opportunity for the Groups reputation: The GPEI launched by the WHO and UNICEF gives sanofi pasteur special status as a global leader and supplier of both IPV and OPV.
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What about tomorrow?

Sanofi Pasteur has developed unique expertise for IPV and promising pediatric combinations. In light of the strides that have been made toward polio eradication, sanofi pasteur expects that the utilization of IPV will gradually grow in the future. As a result, the Group is increasing production capacity. Sanofi Pasteur will continue to maintain its important historical role and commitment to vaccination. In the future, the Group is convinced that the use of injectable vaccines will increase. Sanofi Pasteur is able to offer an industrial solution that will enable the mass production of IPV on a global scale. Following the eradication of smallpox, polio is expected to be the second infection to be eradicated worldwide, thanks in part to the contributions of sanofi pasteur.
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BUSINESS CASE
Yellow fever
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Background
Disease and symptoms
Yellow fever is a viral hemorrhagic fever transmitted by infected mosquitoes. Following an incubation period of about one week, infection begins with fever, shivering, muscle pain and headache. The symptoms of yellow fever can be confused with influenza, dengue fever and malaria. In severe or toxic forms of yellow fever, after three days the patient experiences an initial remission followed by hemorrhagic syndrome with vomiting. Blood appears in vomit, jaundice occurs (giving the disease its name), and kidney functions deteriorate. People who have a curable form of the disease remain immune for life. There is no specific treatment for yellow fever.
A resurgent disease: Epidemiology and vaccination

The WHO estimates that there are 200,000 cases of yellow fever each year, causing 30,000 deaths. The disease also represents a significant risk for the more than three million travelers who visit yellow fever endemic areas each year. Although yellow fever immunization campaigns have proven their effectiveness over the last 60 years, this disease remains a major concern in tropical regions of both Africa and South America. In countries at risk for yellow fever, the vaccine is recommended to prevent and contain epidemics. In order to prevent an epidemic, at least 60% to 80% of the population must be immunized against yellow fever. The vaccine is also recommended for travelers who visit regions at risk for the disease.
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Policy
For 60 years, sanofi pasteur, the vaccines division of sanofi-aventis, has been active in combating yellow fever with more than 200 million doses of yellow fever vaccine supplied over the last 20 years. Sanofi Pasteur, which has significantly increased its production capacity, is the primary supplier of yellow fever vaccines in Africa.
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Containing epidemics
The Global Alliance for Vaccines and Immunization (GAVI) is a public / private partnership created to facilitate access to vaccines for children in the worlds poorest countries. Since 2003, sanofi pasteur has provided most of the annual six million doses of yellow fever vaccines to build emergency stockpiles of vaccines funded by GAVI to control epidemics in Africa. In addition, redesigned packaging of the yellow fever vaccine has facilitated the implementation of mass immunization campaigns.
Participating in the development of health infrastructure and teaching about immunization
To promote vaccination in Africa through cooperation and education, sanofi pasteur supports the EPIVAC and PREVAC Plus programs. EPIVAC trains doctors who help organize immunization programs including for yellow fever in 11 Central and West African countries. The training teaches them about the organization and management of vaccination initiatives to improve access to vaccines in the poorest regions of the world. Such training provides valuable support and facilitates the success of wide-scale immunization campaigns. Participants receive a diploma at the end of their training. For more information: Access to vaccines / EPIVAC-PREVAC Plus
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Influenza
Background Policy
in 2010 to protect against seasonal flu
Fluzone HighDose and Intanza / IDflu: 2 innovative vaccines introduced
Background
Seasonal influenza and pandemic influenza A (H1N1)
Influenza is a highly contagious, acute viral respiratory infection. The influenza virus is characterized by a high degree of variability. Depending on the degree of genetic mutation a virus undergoes compared to previous years, the population may be more or less protected, and the intensity of epidemics consequently varies from one year to the next. A pandemic may occur when a completely new influenza virus one that has never infected humans is introduced and starts spreading in a human population that has no preexisting immunity. Most often the virus is transmitted from an animal carrier. The new influenza A (H1N1), identified for the first time in March 2009, was caused by a new virus, A (H1N1), which had not previously infected people. This virus was the result of recombinant phenomena from influenza viruses found in porcine, human and bird populations. During the post-pandemic period, a new virus is transmitted from person to person. It is not related to past or present seasonal flu viruses (which are viruses of human origin typically found during the winter).
Non-infectious diseases Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
Epidemiology and vaccination

Each year, influenza causes three to five million severe infections and 250,000 to 500,000 deaths worldwide, according to the WHO. The flu virus represents a genuine public health challenge because it spreads so easily and mutates so quickly. The rapid speed at which influenza is transmitted worldwide has considerable economic repercussions: hospitalizations, healthcare costs, loss of productivity. The influenza vaccine remains the best way to prevent the disease today. There are several types of influenza vaccines. Each year, their composition changes in accordance with WHO recommendations and depending on which influenza strains are circulating. The influenza A(H1N1) pandemic increased public awareness and placed influenza vaccination at the center of public health concerns. It also gave rise to a good deal of debate, especially about the relationship between the pharmaceutical industry and health authorities.
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Policy
Combating influenza is one of sanofi pasteurs top priorities. As the worlds largest producer of seasonal influenza vaccine, with over 198 million doses produced in 2010, sanofi pasteur: Innovates and offers new flu vaccines that are adapted to peoples needs Steadily increases production capacity to help control influenza. Since 2003, production capacity has grown by more than 40%. Given its expertise and leadership in controlling the spread of influenza, sanofi pasteur is an essential player in managing an influenza pandemic.
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Influenza - Actions
Mobilization to overcome a public health crisis Stepping up production capacity Continually innovating to develop new vaccines designed to meet peoples needs
in 2010 to protect against seasonal flu
Fluzone HighDose and Intanza / IDflu: 2 innovative vaccines introduced
Mobilization to overcome a public health crisis

As a healthcare leader, sanofi pasteur greatly helped the health authorities combat the influenza A(H1N1) pandemic declared by the World Health Organization in 2009. Sanofi Pasteurs teams were fully mobilized for over six months to deal with the public health crisis brought on by the pandemic, producing over 250 million doses of monovalent A(H1N1) vaccine in 2009 and 2010. At the same time, they maintained production of over 180 million doses of seasonal flu vaccines in 2009, and achieved record production of over 198 million doses of seasonal flu vaccines in 2010. As a global leader on the influenza vaccine market, sanofi pasteur worked alongside the WHO and healthcare authorities for the duration of the public health crisis, in order to: Develop, produce and supply the monovalent vaccine for the A(H1N1) influenza pandemic Maintain production and ensure supplies of annual doses of seasonal flu vaccines in 2009 and 2010, for both the Southern and Northern Hemispheres, in line with the Groups commitments as well as recommendations from the WHO and health authorities. In December 2009, the Group entered into an agreement with the WHO according to which sanofi pasteur committed to donate up to 100 million doses of pandemic influenza vaccine to be distributed by the WHO to eligible countries in need. As part of the response to the 2009 influenza A(H1N1) pandemic, this donation is intended to help protect the most vulnerable groups against the risk of an influenza pandemic. Sanofi Pasteur also honored a prior commitment made by the Group in 2008 when there was a risk of an influenza A(H5N1) pandemic.
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Stepping up production capacity

Sanofi Pasteur inaugurated two new influenza vaccine production sites in 2010 in China and Mexico. The new sites help respond to growing demand for seasonal influenza vaccines. In addition, the facilities will be able to switch from production of seasonal influenza vaccines to pandemic vaccine manufacturing in the event that a new influenza pandemic is declared.
Shenzhen (China)
With the Shenzhen site, sanofi pasteur now has 11 sites worldwide. This high-tech facility for the production of pandemic influenza vaccines represents an investment of $94 million and reaffirms the Groups commitment to contribute to the prevention of seasonal as well as pandemic influenza in China. Following regulatory approvals, this new site will produce seasonal influenza vaccines for Chinese patients. It has an initial production capacity of 25 million doses and can easily be expanded to keep pace with demand.
Ocoyoacac (Mexico)
The new Ocoyoacac site is part of the same approach. The new facilities are dedicated to the production of vaccine antigens used to make seasonal and pandemic influenza in Mexico. The start of commercial production is expected in 2012, following validation of production and approval of the facility by Mexican authorities. The Ocoyoacac facility is the result of an agreement signed in March 2009 by the Mexican vaccine manufacturer Birmex and sanofi-aventis. According to the terms of the agreement, sanofi pasteur will produce the influenza antigen and Birmex will be responsible for the other stages of manufacturing as well
as the distribution of the influenza vaccines in Mexico. The Ocoyoacac site is the largest foreign investment ever made in the Mexican vaccine industry.
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Continually innovating to develop new vaccines designed to meet peoples needs

In response to the specific needs of patients and healthcare professionals, sanofi pasteur launched two new innovative seasonal influenza vaccines in 2010: Fluzone High-Dose and Intanza / IDflu. Both vaccines, the fruit of the Groups innovation policy, marked a global breakthrough. Intanza / IDflu is the worlds first influenza vaccine administered by means of a new intradermic microinjection system. It exploits the immune potential of human skin by targeting a subcutaneous layer where the immune system is especially active. It confers safe and effective protection against influenza and facilitates injection of the vaccine. The second vaccine, Fluozone High-Dose, is the first vaccine made especially for persons aged 65 and older. For more information: Innovation in 2010 / Innovative products : Intanza and IDflu At the same time, sanofi pasteur is working to develop a new quadravalent vaccine. By increasing the number of viral strains contained in the vaccine, the Group should be able to enhance protection against the most common seasonal influenza viral strains.
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STAKEHOLDERS' PERSPECTIVES
Non-infectious diseases
Access to healthcare for non-infectious diseases, also called chronic diseases, is an important priority for sanofi-aventis: Firstly because patients needs in this area are growing, and secondly because these diseases represent an even greater obstacle to global development than infectious diseases.
Chronic, non-infectious diseases pose a major risk for the global economy.
World Economic Forum 2009
Sanofi-aventis believes it is vital to strengthen efforts to prevent and treat chronic diseases, particularly in the fields of diabetes and cancer.
Oncology
A global leader in oncology, sanofi-aventis is committed to making treatments more accessible throughout the world, especially for children and disadvantaged populations.
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Diabetes
Diabetes, a new global epidemic, is at the center of sanofi-aventis access to healthcare strategy.
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Mental illness
Sanofi-aventis was the first pharmaceutical company to initiate effective field initiatives to facilitate access to healthcare for patients with mental disorders in developing countries.
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Epilepsy
Tapping into the Groups areas of expertise, sanofi-aventis introduced a program to promote access to healthcare for patients with epilepsy.
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Oncology
Background and Policy
In the oncology field, sanofi-aventis ambition is to fight cancer on all fronts by conducting research into many of the action mechanisms by which cancer cells develop, grow and proliferate. The sanofi-aventis oncology portfolio is made up of a broad spectrum of novel agents with a variety of mechanisms of action for treating cancer and / or cancer side effects, including cytotoxic, antimitotic, antiangiogenic agents, antivascular agents, monoclonal antibodies and cancer vaccines as well as palliative care therapies. Sanofi-aventis is currently a global leader in oncology with two main compounds: Taxotere and Eloxatine.
Childhood cancer: My Child Matters Support for projects between 2005 and 2011 in countries.
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Jevtana
review.
A new sanofi-aventis drug for the treatment of prostate cancer was approved by the U.S. Food and Drug Administration in 2010 following a priority
PATIENT ASSISTANCE PROGRAMS IN THE UNITED STATES assisted nearly 200,000 patients in receiving the Groups products
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Oncology - Actions
Access to healthcare for cancer patients is a priority focus for sanofi-aventis. The Group is working in several directions so that as many people as possible will be able to receive treatment adapted to their needs. Five programs are described here:
Strengthening patient assistance programs in the United States Improving cancer care for children in developing countries Priority review procedures for drugs in development A public / private collaboration in Cameroon Supporting patients with cancer
Childhood cancer: My Child Matters Support for projects between 2005 and 2011 in countries.
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Jevtana
Strengthening patient assistance programs in the United States

In the United States, the Patient Assistance Program (PAP) provides access to Group medicines at reduced 200,000 patients benefited from Group products through these programs, representing an estimated value of $374 million. Since 2009, more patients have become eligible for these programs following adjusted income requirements, and a simplified application process, so that it is now easier for patients to have access to Group products. A new website was created for patients who wish to find out more about these programs. In addition, sanofi-aventis U.S. has developed PACT+ (Providing Access to Cancer Therapy), a program to provide support services for patients who need help with reimbursement procedures and general assistance. The program helps eligible patients have access to the treatments prescribed by their doctors. Specifically, PACT+ facilitates access to: Three sanofi-aventis drugs for the treatment of breast, lung and prostate cancer Antiemetic drugs (to prevent vomiting and nausea), improving the comfort of patients receiving certain chemotherapy treatments. In 2010, the program provided assistance to over 5,000 U.S. patients. For more information: www.pactplusonline.com In conjunction with the Pharmaceutical Research and Manufacturers of America (PhRMA), sanofi-aventis also supports PPARx, a prescription assistance plan including more than 475 programs to provide products free of charge or at preferential prices. Since PPARx was created in 2005, it has brought assistance to more than six million people.
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review.
A new sanofi-aventis drug for the treatment of prostate cancer was approved by the U.S. Food and Drug Administration in 2010 following a priority
PATIENT ASSISTANCE PROGRAMS IN THE UNITED STATES assisted nearly 200,000 patients in receiving the Groups products
www.pactplusonline.com
Improving cancer care for children in developing countries

Sanofi-aventis is one of the rare healthcare companies involved in programs to improve the management of childhood cancer in low- and middle-income countries. The Groups initiatives in this field are coordinated by My Child Matters. This program is supervised by the Sanofi Espoir Foundation, which develops long-term support actions. My Child Matters is a unique initiative developed with the Union for International Cancer Control. Each year, more than 160,000 children are diagnosed with cancer and about 90,000 die from the disease. In industrialized countries, the cure rate is around 80%. In developing countries, however, where 80% of children with cancer live, this figure drops to 20% or even 10%. In these countries it is difficult to have access to early diagnosis, information, care and treatment.
My Child Matters aims to reduce this disparity between industrialized countries and countries with limited resources by supporting projects in hospitals or run by NGOs in countries where pediatric oncology is still in its infancy. Judging by the number of countries participating in the program today, My Child Matters has become one of the most important initiatives for combating childhood cancer in emerging markets and developing countries. It combines funding to support projects with a network of international specialists to improve local expertise through a commitment to progress and solidarity. As part of its corporate social responsibility agenda, sanofi-aventis has already devoted three million euros to this initiative. Since the program was introduced in 2005, My Child Matters has already provided support for 40 grassroots projects in 26 countries. Over 20,000 children have benefited from the program worldwide to date and nearly 3,500 healthcare professionals have received training. To date, 23 projects are ongoing in 18 countries in Latin America, Africa and Asia. In 2011, the most promising programs will be further developed with an emphasis on sharing experiences, and a collaborative website will be developed.
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Priority review procedures for drugs in development

In certain countries, priority regulatory review procedures are used in exceptional circumstances for instance, in the case of highly promising drugs to treat conditions for which no therapeutic alternative exists. In 2010, Jevtana, a new sanofi-aventis drug to treat prostate cancer, received priority review and approval by the U.S. Food and Drug Administration. It was available on the market just one month after this priority review and approval which is remarkably quickly. Jevtana in combination with prednisone is the first therapy that brings a significant survival benefit in the treatment of patients with metastatic hormone-refractory prostate cancer previously treated with docetaxelbased therapy. Following the approval of Jevtana, healthcare professionals now may consider utilizing a new treatment for patients with the most advanced form of prostate cancer, for which there are very few therapeutic options. For this patient population, Jevtana is the only drug that brings about significant improvement in global survival. After the United States, Brazil was the second country to approve registration of Jevtana through an Early Access Program procedure.
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A public / private collaboration in Cameroon

Epidemiological studies anticipate 800,000 to one million new cases of cancer and more than 500,000 deaths over the next ten years in Africa if steps are not taken. For women in Africa, the most common types of cancer are breast and cervical cancer; for men they include prostate and liver cancer as well as Kaposis sarcoma. One-third of cancers are linked to chronic infections (hepatitis B, Epstein-Barr virus, HIV, etc.). Because it is generally difficult to obtain a diagnosis, cancer is widely underestimated in Africa. What very often turns out to be a late diagnosis considerably reduces the patients chance of survival. Sanofi-aventis has created a public / private collaboration with the Cameroon Ministry of Health with the aim of improving information, education and communication to healthcare professionals. The program also addresses measures to enhance prevention and provide access to treatments at preferential prices. Another part of the program is devoted to combating childhood cancers within the scope of the Groups My Child Matters initiative, which has allocated 50,000 to the Chantal Biya Foundation for mothers and children.
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Supporting patients with cancer

Because information, education and prevention are essential to the fight against cancer, sanofi-aventis is involved in a number of programs worldwide to help patients and their families. For more information: Supporting patients with cancer and their families
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Diabetes
A global pandemic
Diabetes is a major public health challenge today in terms of both the number of people affected and the costs incurred. Long considered to be a disease found in industrialized countries, today diabetes has a major impact on people in developing countries as well. Some even speak of a global pandemic. There has been an exponential rise in the number of people with diabetes, which currently stands at 285 million worldwide and is expected to reach 380 million by 2025.
Dr. Riccardo Perfetti Vice President Medical Affairs, Diabetes Division, sanofi-aventis Read the full interview
The diabetes epidemic is a public health issue
Sanofi-aventis, a resource for patients

Combating diabetes is one of sanofi-aventis therapeutic priorities. With nearly a century of experience in this area, the Group is moving beyond its traditional role as a producer and distributor of insulin to become a true 360 partner for patients, with a complete range of integrated solutions. These are not only designed to make patients lives easier, but also to empower them to take control and manage their disease. With the SoloSTAR disposable insulin pen and the reusable ClikSTAR pen for the administration of Lantus and Aprida, the Group offers a choice of device options designed to simplify insulin use and respond more closely to patients needs and lifestyles. For blood glucose monitoring, sanofi-aventis and AgaMatrix have developed innovative solutions with the aim of simplifying diabetes management for both patients and healthcare professionals. Marketing authorization is underway for these new medical devices (BGStar and iBGStar). The range of devices is part of the Groups comprehensive approach to diabetes. Sanofi-aventis considers awareness and educating patients to be the most important tools in controlling diabetes. We would like to introduce a totally new concept into our pipeline diabetes management and innovation based on the knowledge we already have to improve insulins and oral medications. Beyond that, we want to innovate in entirely new directions, breaking with past models and concepts. Dr. Riccardo Perfetti Vice President Medical Affairs, Diabetes Division, sanofi-aventis
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million people in the world have diabetes in 2011 There will be an estimated million by 2025
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Diabetes - Actions
To respond more effectively to the exponential rise in the number of diabetic patients and facilitate access to healthcare, sanofi-aventis develops many different regional initiatives. All these initiatives focus on the patient and the global management of diabetes, from prevention to treatment. The Group also works on developing new product combinations and adapted formulations to facilitate access to healthcare.
Preventing and managing diabetes in developing countries with the Sanofi Espoir Foundation
THE E-DIABETE PROGRAM Training for 10,000 African healthcare professionals

www.e-diabete.org
Together against Diabetes 2010 Congress

diabetologists coming together to share good practices
Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
More initiatives in the regions Expanding coverage of the e-Diabete program in Africa Developing new product combinations and better adapted formulations Sharing good practices Supporting patients with diabetes
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Preventing and managing diabetes in developing countries with the Sanofi Espoir Foundation
One of the Sanofi Espoir Foundations focuses is supporting the prevention and management of diabetes in the most economically disadvantaged countries and helping improve patients health and quality of life. To this end, the Foundation has forged numerous collaborations all over the world, in particular with NGOs (Sant Diabte Mali, Handicap International and others) and with government authorities. Programs are developed to provide: Information and education for communities Training for healthcare professionals Early screening and treatment of patients with diabetes and disabilities A sound framework for organizations of persons with diabetes Stepped-up efforts to ensure diabetes is taken into account by public policy makers These programs, which have been operating since 2006, cover six countries in Africa, Asia and Latin America. To date they have helped 12,000 people.
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SANOFI ESPOIR FOUNDATION AND DIABETES MANAGEMENT AND PREVENTION Programs in 6 African, Asian and Latin American countries have helped 12,000 people.
More initiatives in the regions

Fully aware that in certain countries the cost of care for a diabetic patient cannot be borne by healthcare systems, sanofi-aventis develops pilot projects in conjunction with private insurance companies. This is the case particularly in the Gulf region and certain Latin American countries. In the Middle East, sanofi-aventis introduced My Diabetes Story, an awareness-raising program, in 2010. The program targets the media, patients and diabetologists to increase public awareness and understanding about a disease that affects 26 million people in the Middle East. My Diabetes Story is the first program of its kind to be truly patient-centered. It aims to alert people about the seriousness of diabetes while also conveying messages of hope through uplifting patient stories. These real-life stories show that it is possible to live a healthy and fulfilling life with diabetes when patients receive adequate treatment and support. The program is also designed to educate the public and encourage the media to look at diabetes from the patients perspective.
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Expanding coverage of the e-Diabete program in Africa

One year after being introduced in French-speaking African countries, the e-Diabete training program created by sanofi-aventis has been extended to English-speaking countries so that it now offers training for healthcare professionals across most of the continent. Developed by sanofi-aventis in collaboration with the World French-speaking E-University (UNFM) and the Francophone African Network for Telemedicine (RAFT), e-Diabete is a training program designed for African healthcare professionals to improve diabetes diagnosis and treatment. Thanks to e-Diabete, over 10,000 healthcare professionals have updated their knowledge of the disease and received training to provide care for diabetic patients. Twice a month, more than 1,000 healthcare professionals attend interactive courses taught by local and foreign diabetes specialists. The program has received very enthusiastic feedback because it encourages interaction among the participants and is adapted to their local reality. For more information: The e-Diabete website
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Developing new product combinations and better adapted formulations

The development of product combinations and improved formulations provides a means to facilitate access to healthcare by simplifying treatment for patients. Innovations of this type are a valuable tool for improving access to healthcare. International recommendations advocate the use of oral combination drugs in the first- and second-line treatment of diabetes. Because fixed-dose combinations lead to better patient compliance, they help improve glycemic control. Since 2009, sanofi-aventis has marketed a fixed-dose combination of Amaryl and metformin in Africa, the Middle East and Latin America at a price that generally corresponds to the price of Amaryl alone. At the same time, the Group continues to develop new formulations (for example, extended-release combinations) adapted to meeting all patients needs.
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Sharing good practices

For the fourth year, sanofi-aventis and the American Diabetes Association (ADA), a reference in the field, organized a congress held in July 2010 in Vietnam entitled Together against Diabetes. This conference, which brought together over 400 specialists from Asia and United States, provided an opportunity to share good practices. ADA specialists presented training-the-trainers techniques in Asian countries. The 2010 program, entitled For Quality Diabetes Care also focused on empowering patients to achieve better glycemic control. Through this initiative, sanofi-aventis confirms its ambition to be a global leader in diabetes by offering a comprehensive range of healthcare solutions including insulins, injection pens and glucose monitoring devices as well as providing information and education for patients and physicians.
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Supporting patients with diabetes

Because information, education and prevention are fundamental for the control of diabetes, sanofi-aventis is involved in a number of programs worldwide to assist patients. For more information: Supporting patients with diabetes and their families
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Mental illness
Mental illnesses represent the second leading cause of morbidity and mortality in low- and lower-middleincome countries
New England Journal of Medicine, January 18, 2007
Background
Mental health disorders are among the most prevalent chronic diseases. Most patients, however, do not receive treatment due to a lack of means to diagnose and care for mental illness. Patients with these diseases suffer not only from debilitating and potentially life-threatening symptoms; they are also victims of ignorance, discrimination and social stigma, which can lead to exclusion from society and unemployment. Yet effective treatments exist. These patients simply need someone to diagnose the symptoms affecting them and to help find an effective therapy. Providing a medical diagnosis for their symptoms and prescribing treatment can give patients the opportunity to regain their place in society. Mental illness includes a variety of conditions, such as mood disorders, anxiety, addictions, psychoses and schizophrenia, which are prevalent in industrialized countries, emerging markets and developing countries. It is estimated that 450 million (1) people worldwide are affected by a psychiatric disorder. Schizophrenia and related psychoses affect 1% of the global population. Mental illnesses represent the second leading cause of morbidity and mortality in low- and middle-income countries (2). Severe conditions such as schizophrenia take a heavy toll: Life expectancy for patients with schizophrenia is ten times below average, and 10% of patients with schizophrenia commit suicide. In developing countries the treatment gap reaches up to 90%.
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Mental Health Program

and families have been helped since 2007
24,000 children 1,400
Policy
As a pioneer in the mental health field, sanofi-aventis was the first pharmaceutical company to become actively involved in programs to promote global access to healthcare for patients with mental disorders in developing countries. The Groups commitment takes a long-term perspective. It aims to build a sustainable, global model to combat mental illness on all fronts, from prevention to rehabilitation. Coordinated by the Access to Medicines Department, these programs include: Innovative training and education tools adapted to all those working in the field Adapted medicines Ongoing Research and Development for new medicines Differentiated pricing policy to make medicines more accessible At the same time, the Sanofi Espoir Foundation is developing partnerships to reduce health inequalities and ensure that the most disadvantaged groups have access to healthcare. 1. Worldwide Program for Mental Health, WHO 2002 2. New England Journal of Medicine, January 18, 2007
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Patient indicators Access to healthcare The Group's commitment Infectious diseases Non-infectious diseases Oncology Diabetes Mental illness Actions Epilepsy Rare diseases Humanitarian emergencies Setting up the Mental Health Program Taking part in creating the Impact Mental Health congress Stepping up research
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Mental illness - Actions
Mental illnesses represent the second leading cause of morbidity and mortality in low- and lower-middleincome countries
New England Journal of Medicine, January 18, 2007
Developing treatments for patients with schizophrenia and psychosis in Morocco: The FOSSAM project Helping children with mental disability in Algeria, Lebanon and Tunisia
Setting up the Mental Health Program

The Mental Health Program was introduced in 2007 by the sanofi-aventis Access to Medicines Department.
Mental Health Program

and families have been helped since 2007
Supporting patients Patient-focused innovation Product risk management
In late 2010, two public / private partnerships were established with the Ministries of Health in Morocco and Mauritania, respectively, for a population pool of 200,000 people (100,000 in Morocco and 100,000 in Mauritania).
24,000 children 1,400
Taking part in creating the Impact Mental Health congress

In 2010, sanofi-aventis joined the Fight Against Stigma program with the World Association for Social Psychiatry. This program is dedicated to promoting access to healthcare for patients with mental disorders in developing countries. This collaboration led to the creation of Impact Mental Health, an annual congress to promote better access to care for neglected patients with mental disorders and to form a powerful network of partners. The first event was held in November 2010 in Morocco, bringing together 35 participants (representatives of public health authorities, specialists and NGOs) from 17 countries. The goal was to share experiences of ways to include mental health issues in public health programs and to make recommendations about initiatives.
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Stepping up research
Central nervous system diseases are one of the primary areas of research and development at sanofiaventis. They encompass programs focusing on schizophrenia, anxiety, depression, addictions, drug dependence, bipolar disorders and sleeping disorders.
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Developing treatments for patients with schizophrenia and psychosis in Morocco: The FOSSAM project
Fossam means schizophrenia in classical Arabic. It is also the name of the first public / private partnership between sanofi-aventis and the Moroccan Ministry of Health to develop treatments for schizophrenic and psychotic patients. This collaboration welcomes other stakeholders such as AMALI, the Moroccan Association of Patients Families, and psychiatrists from the Ibn Rochd University Psychiatric Center in Casablanca. The project has several objectives. It aims to increase awareness among families, local communities and health authorities; to train doctors in the diagnosis of psychiatric disorders; to provide first-line treatments for patients with the support of psychiatrists; and to ensure medicines that are affordable and appropriate will be available.
In this project, sanofi-aventis is committed to sharing the Groups expertise and adapted information and training tools. The Group has also agreed to provide appropriate medicines at affordable prices and to grant a subsidy for the project launch. The project agreement was signed for three years starting in October 2008, with a pilot program organized in the Benslimane area. Following the positive results obtained in the pilot area, the organizers decided to expand the project to the national level.
A differentiated pricing policy to ensure medicines are affordable

A pioneer in treatments for psychoses, sanofi-aventis has a broad portfolio of medicines including a longacting antipsychotic drug (pipotiazine palmitate), a sedative antipsychotic (levomepromazine) and a secondgeneration antipsychotic (amisulpride). For these products, sanofi-aventis strives to ensure that prices are within the reach of all patients. These medicines are provided at low prices to public institutions and NGOs in developing countries.
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Helping children with mental disability in Algeria, Lebanon and Tunisia

Since 2007 in collaboration with the NGO Sant Sud, the Sanofi Espoir Foundation has developed a program to improve physical and psychological autonomy for children and teenagers with mental disability in Mediterranean countries. A number of operational relationships have been formed as part of the program with organizations in Algeria, Lebanon and Tunisia. For those working in the field, the objective is to facilitate the early diagnosis of mental illness among children living with a mental disability a strategy designed to help avoid problems of social and economic exclusion. Since 2007, this program has helped 24,000 children and 1,400 families.
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You are here: Home > Patient > Access to healthcare > Non-infectious diseases > Epilepsy
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Epilepsy
Background
Epilepsy is a chronic disorder of the central nervous system characterized by recurrent seizures that can vary from brief lapses of attention or muscle jerks to severe and prolonged convulsions. Seizures are caused by sudden, usually brief, excessive electrical discharges in the neurons. Most of the time the disease can be successfully treated with anti-epileptic drugs. Epilepsy is the most common neurological disorder in the world after migraines. It especially affects children and older persons.
Rare diseases Humanitarian emergencies Supporting patients Patient-focused innovation Product risk management
Policy
In 2006, the sanofi-aventis Access to Medicines Department established the Impact Epilepsy program. Sanofi-aventis is the first pharmaceutical company to commit to long-term initiatives to facilitate access to healthcare for patients with epilepsy outside of developed countries. The Impact Epilepsy program, which is based on the Groups essential expertise, includes: Innovative training and education tools adapted to those working in the field Adapted medicines and ongoing Research and Development for new medicines A differentiated pricing policy to make medicines accessible to all
Sanofi-aventis was the first pharmaceutical group to make a commitment to facilitating access to healthcare for patients with epilepsy in developing countries
Robert Sebbag Vice President, Access to Medicines, sanofi-aventis
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Epilepsy - Actions
Develop training programs in Africa in partnership with the French NGO Sant Sud Developing public / private partnerships A differentiated pricing policy for affordable medicines
Develop training programs in Africa in partnership with the French NGO Sant Sud
Since 2001, sanofi-aventis and Sant Sud have contributed to the Groups Impact Epilepsy program, organizing a number of initiatives in Africa. The prevalence of epilepsy is higher in Africa than elsewhere in the world due, among other things, to a higher prevalence of infectious diseases, poor obstetrics care, trauma, hereditary factors, etc. The initiatives supported by sanofi-aventis essentially concern training for doctors. One example is a training program set up in Mali for general practitioners and members of a network called RARE (the French acronym for Epilepsy Research Action Network). Sanofi-aventis and Sant Sud have also initiated a training program in Madagascar for general practitioners who form the Madagascar Epilepsy Network (REM). These programs aim to develop the expertise of local physicians to improve diagnosis and treatment of patients with epilepsy and to help them receive better care.
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Sanofi-aventis was the first pharmaceutical group to make a commitment to facilitating access to healthcare for patients with epilepsy in developing countries
Robert Sebbag Vice President, Access to Medicines, sanofi-aventis
Developing public / private partnerships

In 2010, the sanofi-aventis Access to Medicines Department established a partnership with the Ministry of Health of the Republic of Benin to facilitate access to medicines for patients with epilepsy in a pilot region with one million inhabitants. In December 2010, sanofi-aventis and the Argentinean Ministry of Health of the Province of Buenos Aires also initiated a pilot program to develop access to healthcare for patients with epilepsy. This program, called PROEPI, will be launched in the province of Buenos Aires. In Argentina, the prevalence of epilepsy is estimated to be 0.5%
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A differentiated pricing policy for affordable medicines

Sanofi-aventis produces two of the worlds most widely used anti-epileptic drugs: Phenobarbital Sodium valproate, which revolutionized the treatment of epilepsy and has been produced for nearly 40 years These two medicines are included on the World Health Organizations list of essential medicines and are part of the basic therapeutic arsenal used for the care of patients with epilepsy. For both these drugs, sanofi-aventis strives to ensure affordable prices for all patients and a pricing policy that can enable these programs long-term survival. As part of a differentiated pricing policy, these drugs are provided at low prices to public institutions and NGOs in developing countries. For more information: Link to brochure about chronic diseases (available soon)
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You are here: Home > Patient > Access to healthcare > Rare diseases
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Rare diseases
Rare diseases are a meaningful growth platform.
Christopher A. Viehbacher CEO, Sanofi
Background
What is a rare disease?
A disease is recognized as rare when it affects a limited number of people in proportion to the general population. This number varies in different regions of the globe: In Europe: Fewer than 5 people out of 10,000 In the United States: Fewer than 200,000 people out of the entire U.S. population In Japan: Fewer than 50,000 out of the entire Japanese population
ACQUISITION OF GENZYME Sanofi-aventis strengthens its position in the field of rare diseases.
www.sanofi.com / Acquisition of Genzyme
Orphan Drugs
Health authorities recognize rare diseases as being serious, chronic and evolving. They may be life threatening. Nearly 7,000 rare diseases have been reported worldwide, yet new rare diseases are reported on a regular basis. Eighty percent of them are hereditary diseases. According to the definition from the European Medicines Agency, orphan drugs are those used for the diagnosis, prevention and treatment of diseases that are rare, very serious or life threatening. Despite the economic pressure associated with developing orphan drugs, sanofi-aventis considers the fight against rare diseases to be an important component in the Groups growth strategy.
Policy
For sanofi-aventis, it is crucial to develop medicines to treat rare and / or severe disorders for which there are currently no available treatments, or for which existing treatments are not satisfactory. With an eye on innovation and satisfying unmet medical needs part of the obligation to respond to public health challenges sanofi-aventis has established a program of external partnerships and alliances while also developing specialized entrepreneurial units in-house. The acquisition of Genzyme, one of the global leaders in biotechnology, enables sanofi-aventis to strengthen its position in the field of rare diseases. The Group plans to make Genzyme the sanofi-aventis global center of excellence in rare diseases. For more information: Sanofi-aventis to acquire Genzyme
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Rare diseases - Actions

Rare diseases are a meaningful growth platform.
Christopher A. Viehbacher CEO, Sanofi
Oncology
The Oncology division works on mechanisms involved in the potential treatment of certain rare forms of cancer, in particular: Anti-vascular agents that inhibit vascularization in soft tissue sarcomas. For this very rare type of cancer, results with existing treatments are variable. Multikinase inhibitors implicated in tumor angiogenesis for the treatment of acute myeloid leukemia, a cancer characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with hematopoiesis (blood cell production). Inhibitors of Janus kinase 2 (JAK-2), a protein tyrosine kinase involved in several signaling pathways that are primarily responsible for cellular survival and proliferation for the treatment of primary myelofibrosis, a disease in which the proliferation of an abnormal type of bone marrow stem cells results in fibrosis. Because the cause of this disease is unknown, it is designated as a rare disease.
ACQUISITION OF GENZYME Sanofi-aventis strengthens its position in the field of rare diseases.
www.sanofi.com / Acquisition of Genzyme
Ophthalmology
In collaboration with Fovea Pharmaceuticals, the Ophthalmology division works on the development of innovative compounds for the treatment of ophthalmological diseases, with a special focus on retinal diseases: Usher syndrome is a genetic disorder in which patients are born deaf and experience gradual vision loss due to retinitis pigmentosa, a degeneration of the retinal cells. It is the leading cause of deaf-blindness in adults. Stargardt disease is characterized by a combination of bilateral vision loss and specific retinal lesions. It is the most common form of inherited macular degeneration.
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You are here: Home > Patient > Access to healthcare > Humanitarian emergencies
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Humanitarian emergencies
Charter for donations of medicines

Healthcare is one of the most vital needs when a humanitarian disaster occurs. As a healthcare leader, sanofi-aventis believes that responding to humanitarian emergencies is one of the Groups missions. The response to humanitarian emergencies, one of the Sanofi Espoir Foundations three pillars, aims to help facilitate access to healthcare for victims of disasters and displaced persons. Depending on local requirements determined in the field, actions may include donations of medicines and vaccines in compliance with a charter based on the guiding principles of the World Health Organization, and by financial donations to field workers to carry out emergency and post-emergency operations.
Actions
In 2010, nearly one million boxes of medicines and over 500,000 doses of vaccines were donated to 43 countries for people in need. Five countries have benefited from the Groups assistance in emergency situations: Chile, China, Guatemala, Haiti and Pakistan.
The charter for the donations of medicines and vaccines aims to ensure the quality, coordination and consolidation of donations made within the priority scope of humanitarian emergencies, according to rules contained in the WHO guiding principles. It makes both the donor and the beneficiary accountable for the appropriate use of these donations. In 2010, nearly 1 million boxes of medicines and over of vaccines were donated to countries.
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Together for Haiti Operation

In January 2010, the day after the earthquake struck Port-au-Prince and the surrounding region, sanofi-aventis was mobilized to offer assistance to victims of disaster. The Groups support took the form of a comprehensive response and long-term commitment. A wave of solidarity In January 2010, immediately after the earthquake, sanofi-aventis and Group employees joined forces with various stakeholders (Aide Mdicale Internationale, Care, the Red Cross, Handicap International, Mdecins du Monde and UNICEF, MAP International, PAHO, Partners in Health) to provide emergency financial assistance as well as donations of medicines and vaccines. The Group sent hundreds of thousands of boxes of medicines and doses of vaccines worth over 11 million. Other donations included equipment to meet emergency needs such as 500,000 protective masks donated by the sanofi-aventis U.S. to AmeriCares, and nine large tents (for approximately 200 people), 400 cots, sleeping bags and blankets donated by the Italian affiliate to the Saint Damien Pediatric Hospital, managed by Nuestros Pequeos Hermanos and located in Tabarre, 24 kilometers north of the quakes epicenter. Mobilizing for the long term In addition to these immediate emergency responses, the Group decided to allocate a specific budget of 1 million to help the long-term efforts required to support Haitis reconstruction. Sanofi-aventis also appealed to the generosity of all employees worldwide, asking them to contribute to the spirit of solidarity for disaster victims. Some 450,000 was collected, and this sum was matched by the Group and certain affiliates, amounting to a total of 1 million. Six organizations supported by the Group that work in Haiti and specialize in healthcare programs were selected to set up post-emergency initiatives. These NGOs are Aide Mdicale Internationale, CARE, the Red Cross, Handicap International, Mdecins du Monde and UNICEF. They are all focused
medicines and vaccines representing a commercial value of over
Together for Haiti: Donations of
11 million.
on providing the necessary coordination to ensure that all the stakeholders can work together in the interest of the Haitian people. Combating the epidemic of cholera Nine months after the earthquake, a cholera epidemic broke out in Haiti. According to the most recent WHO data, this epidemic has caused 259 deaths with 3,342 people infected to date. It was especially severe in the center of the island, placing a heavy burden on hospitals in the Artibonite area and the central plateau, north of Port-au-Prince. In response to this very troubling situation, sanofi-aventis partners were mobilized thanks to the Groups financial support: The Red Cross provided teams and logistics support, building two water treatment units, providing health kits to centers containing oral rehydration salts, chlorine powder, intravenous infusion sets, and antibiotics to treat 1,000 patients. It also distributed 8,000 hygiene kits for 40,000 people and advocated preventive measures by promoting good personal hygiene and hand washing, hygiene teams and cleaning of latrines. Mdecins du Monde initiated a prevention campaign among people living in camps around Port-auPrince, with the help of 70 community care workers. In cooperation with the Ministry of Health, intensive training was provided to Haitian medical personnel on how to manage cholera and set up small treatment units.
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Supporting patients and their families

Background
To guide interactions between the Group and patient organizations:
6 global principles 300
The Group works with

As a diversified healthcare leader focused on patients needs, sanofi-aventis believes its mission goes beyond simply making medicines available. The Group is committed to working with patient associations all over the world to: Encourage dialogue to better understand patients expectations Identify the best solutions for patients Take into account and respond to the broader needs of patients and their families throughout the patients journey Establish initiatives to address prevention and disease awareness For sanofi-aventis, working with patient associations and taking into account the priorities they share with the Group is an effective way to translate this commitment into action. In 2010, sanofi-aventis strengthened the Groups policy, focusing attention on ethics, responsibility and transparency.
nearly patient organizations in Europe
TRANSPARENCY Download the 2010 list of Patient Associations based in Europe and USA with whom the Group interacted in 2010. (USA coverage: Medical Educational Grants).
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Working with patient associations

Patient associations have many roles: They help patients by providing information about diseases and raising awareness about screening and prevention. They also may facilitate communication among their members and provide support for patients, relatives and friends during illness. In addition, these associations ensure that the patients collective voice is expressed and heard when it comes to their health and needs. An aspect of helping patients is making public authorities aware of the importance of access to the most appropriate treatments. The relationship between a healthcare leader like sanofi-aventis and patient associations is guided by a spirit of collaboration. This type of alliance represents an opportunity for the Group, for the associations and, most of all, for patients by: Encouraging pooling of competencies Making it possible to provide effective and direct support to the patient and, on a larger scale, to the community, which may take different forms: support groups, hotlines, information centers, websites, educational programs, etc. Enabling patient associations to shape the current and future healthcare environment to improve healthcare. Sanofi-aventis supports patient associations devoted to a number of different diseases in over 35 countries. The Group also collaborates with international and regional associations operating in 160 countries. For more information: List of patient associations The Groups support primarily involves associations that are active in therapeutic areas in which the Group has expertise, or is in the process of developing it. At the same time, the Group supports associations that, rather than focusing on a specific therapeutic area, strive to respond to the broad needs of patients.
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CancerCare conferences in the United States

annual conferences Over participants
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Supporting patients - Policy

To ensure the integrity of relationships between sanofi-aventis and patient associations, in 2010 the Group enhanced its policy by establishing a standard operating procedure that includes global principles governing interactions with patient associations. Ever mindful of the importance of transparency, the Group also decided to disclose the amounts of support it provides to European patient associations for collaborative projects.(*)
The Group works with nearly patient organizations in Europe
Ethics, responsibility and transparency: Enhancing Group policy

Approved in late 2010, the worldwide policy adopted by sanofi-aventis is designed to: Ensure that interactions between the Group and patient associations take place in an ethical, responsible and transparent manner Establish the standards for the Group Confirm that all the Groups actions worldwide are undertaken with the ultimate aim of bringing benefit to patients
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Six global principles

The policy adopted by sanofi-aventis concerning interactions with patient associations is based on six global principles that guide all the Groups actions and are part of the operating procedure established at Group level: 1. The independence of patient associations with respect to their policies and activities (including political decisions) shall be assured. 2. Collaborations between patient associations and sanofi-aventis must be based on mutual respect and trust. 3. Sanofi-aventis shall not ask or encourage any patient association to promote any of its products. 4. Transparency of interactions must be ensured consistent with sanofi-aventis Group and affiliate policies and procedures, legal requirements and local standards (e.g., industry codes). 5. Sanofi-aventis supports broad funding from multiple sources, and may not seek to be the sole funder of any patient association or major program. 6. All interactions including funding should comply with sanofi-aventis Group and affiliate policies and procedures, patient association rules, legal requirements and local standards (e.g., industry codes). These global principles are consistent with sanofi-aventis commitment as a sustainable healthcare provider. They apply the highest standards of ethics and integrity to the Groups stakeholder relations.
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Implementing the policy

The standard operating procedure governing the Groups interactions with patient associations was widely distributed internally in early 2011. To guarantee it is successfully implemented within the affiliates, divisions and functions concerned, a training module has been specially designed and training sessions will be held during 2011. The procedure is intended to guide and support the relevant affiliates, divisions and functions in applying the policy, instituted at Group level, in all their interactions with patient associations.
Transparency A deliberate choice

Sanofi-aventis is committed to respecting the applicable regulations, rules and voluntary commitments made collectively by the pharmaceutical industry with the aim of continuously increasing transparency and
adopting an ethical, responsible approach to business. As part of this policy, we continue to update our approach by adding voluntary commitments. In 2010 sanofi-aventis decided to take a new step toward transparency. The Group recognizes the importance of transparency and its role in developing trust-based relationships with stakeholders, the public and, more importantly, patients the ultimate recipients of healthcare. We believe that transparency is a measure of all healthcare players credibility. In compliance with recommendations issued by the EFPIA (European Federation of Pharmaceutical Industries and Associations) and exceeding mandatory requirements, sanofi-aventis decided to disclose the amounts of funding provided by the Group in 2010 to support patient associations based in Europe. For more information: Patient associations Upholding the same goal of transparency, we publish a quarterly Educational Grant Transparency Report in the United States, listing all the associations that receive independent medical education grants (including funding for U.S. patient associations). In addition, a specific report concerning independent medical education grants for U.S. patient associations was published in 2010. For more information: Educational Grants
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Patient indicators Access to healthcare Supporting patients Policy Actions Supporting patients with cancer Supporting patients with diabetes Increasing awareness of meningococcal infections Healthy eating habits Transparency Patient-focused innovation Product risk management
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Supporting patients - Actions

Here are some examples of initiatives that the Group initiated or continued in 2010, either directly or in collaboration with stakeholders:
Supporting patients with cancer In the United States In France In Brazil In Korea in India Supporting patients with diabetes In the United States In Mexico In Egypt Increasing awareness of meningococcal infections In the United States Promoting healthy eating habits In Brazil

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Supporting patients with cancer

In the United States: Sponsoring telephone conferences In France: Meeting and Information Centers In Brazil: Helping hospitalized women tolerate their treatment In South Korea: A library for patients In India: Providing support to patients treated with Taxotere
In the United States: Sponsoring telephone conferences

CancerCare is an organization in the United States that provides free educational and counseling programs to help anyone affected by cancer understand and deal with their diagnosis, treatment options, quality-of-life concerns and other important topics. For several years, sanofi-aventis has supported an array of important initiatives with this organization, including sponsoring medical telephone conferences. The foundation of CancerCares Education program is their Telephone Education Workshops, free one-hour conference calls presented by cancer specialists from around the country. Key medical experts speak to patients via telephone conference during a one-hour session on different tumor types. Not only can patients learn more about cancer, but they are able to ask their questions directly to the experts. Over 50 telephone education workshops are organized each year and heard by more than 45,000 people. Past conferences can be accessed via podcast or replay, and each month 2,000 people listen to the archives. Sanofi-aventis long-term collaboration takes various forms, including: Support for organizing workshops about breast, prostate and colon cancer Financial assistance to help families who qualify to cover essential expenses such as transportation costs. This contribution is part of CancerCares financial assistance program. Since initiating the CancerCare project, sanofi-aventis has contributed more than $2.5 million to this program. For more information: www.cancercare.org
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Supporting specialized hotlines run by patient organizations

Sanofi-aventis supports several hotlines run by patient advocacy groups. For example, the Group supports the Y-ME National Breast Cancer Organization in the United States in particular its telephone hotline, YourShoes Breast Cancer Support Center. Available 24 hours a day, seven days a week, YourShoes is a free, confidential resource that provides information and support to patients with breast cancer. It is the only hotline staffed by specialized, trained peer counselors who are breast cancer survivors. Moreover, the hotline takes calls in over 150 languages. The peer counselors are experienced in handling all types of questions and concerns related to breast cancer. They provide emotional support to patients as well as their relatives and friends at critical moments during their illness. For the last six years, this hotline has received from 40,000 to 50,000 calls annually. For more information: www.y-me.org / Yourshoes
Participating in a popular television program about cancer

Since 2008, sanofi-aventis U.S. has been involved in a cancer awareness project originally called Frosted Pink. The project provides women with in-depth information about womens cancers delivered via
nationally televised programs how to manage, live with and beat cancer. In 2009, it was redesigned and its name was changed to Kaleidoscope, bringing a message of inspiration and education for all types of cancer by using a range of colors, like a kaleidoscope. This program aims to highlight the challenges facing patients with cancer such as medical follow-up, the long-term effects and psychological impact of cancer treatments, etc. For more information: www.womenandcancer.com / Kaleidoscope
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In France: Meeting and Information Centers
Meeting and Information Centers (ERI): A concept created in 2001 by the French National Anti-Cancer League, sanofi-aventis France and the Gustave Roussy Institute. The ERI center concept was developed in response to a request from people living with cancer (the 1998 Patients General Assembly). For patients, their families and friends, the ERI center offers a place where they feel welcome, are listened to, and can obtain information. Here they can talk to someone who may direct them to more specialized help. Located inside public and private hospitals, the centers are open to anyone and no appointment is required. Sanofi-aventis France and local committees of the French National Anti-Cancer League provide financial support for the first two years after a new ERI center opens. Following this initial two-year period, healthcare institutions commit to keeping the centers running, although the institutional stakeholders remain active and involved for as long as the center exists. In 2010, the ERI centers received 42,000 visits. Nearly one-third of visitors came back often, both during and after their illness, and continued to receive follow-up by support teams. Most of the time, visits to an ERI center coincided with medical appointments or hospitalizations. Since 2001, three out of four visitors are women, and breast cancer is the illness most commonly inquired about. Nine times out of ten, visits to the center take place where the patient is hospitalized, but 10% of the time patients come from a neighboring facility. The average amount of time devoted to each visitor is 20 minutes. ERI centers play a fundamental role in improving global care for those who are affected by cancer, whether directly or indirectly. They have been recognized by the French government as national and regional public health initiatives and are an important part of the French national agenda to fight cancer (the National Cancer Plan). Implementation plan: 2001: Opening of the first ERI 2010: 33 ERIs up and running, with an increase in ERIs in private institutions 2011: Opening of three new ERIs (in Nantes, Paris, Grenoble) For more information: www.ligue-cancer.net (In French) Brochure about ERI centers in French (PDF, 912Kb)
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In Brazil: Helping hospitalized women tolerate their treatment

The Conviver program was created in 1999 at the initiative of sanofi-aventis Brazil. In 2008, the program adopted a new format and was reintroduced with the support of Femana, a Brazilian organization specialized in providing support for women with breast cancer. Through specific activities organized by the hospital, the Conviver program aims to provide a friendly environment for women during their treatment. It provides a range of materials for healthcare personnel to use during meetings and to organize beauty sessions for patients. The program takes a multidisciplinary approach in order to support women patients, encouraging exchange and interaction and providing information to dispel doubts they may have about their treatment. This empowers patients to become actively involved in their own recovery. Since 2008, nearly 1,200 people have benefited from this program, which operates in three Brazilian hospitals.
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In South Korea: A library for patients

In 2010, the Oncology Division of sanofi-aventis Korea introduced a new initiative for hospitalized patients with cancer. The idea behind this project, called Reading Hospital, is to create a library within the hospital itself. The library provides books as a means of offering emotional support for patients and sharing medical information to facilitate communication with hospital staff. Healthcare specialists, journalists and public figures recommend the books that are loaned to patients. Thanks to this initiative, patients and their families have a better understanding of cancer and especially prevention of future risks.
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In India: Providing support to patients treated with Taxotere

Sanofi-aventis blockbuster drug Taxotere is a cancer drug that, while therapeutically effective, also causes certain side effects. A program in India by the name of Aashayein, which means hope in Hindi, was developed to provide support for patients being treated with Taxotere, focusing especially on dialogue to make the side effects easier to live with. The Oncology Division of sanofi-aventis India, working with attending physicians, initiated this project. Patients who wish to take part in the program receive support through home visits or telephone calls during chemotherapy treatment. Qualified counselors provide support and telephone assistance, guiding patients and their families and offering both specialized reading materials and psychological support. The program is currently operating in four Indian cities. The results are very encouraging. In less than one year, this initiative has helped over 300 patients. In addition, patients who are part of the support program have a very low treatment discontinuation rate (around 1%).
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Supporting patients with diabetes

Information, education and prevention are essential in efforts to combat diabetes. Sanofiaventis supports a number of programs worldwide to improve patient awareness. Here are some examples:
In the United States: Promoting patient-focused programs In Mexico: Bringing health care centers closer to patients In Egypt: A campaign to raise awareness
In the United States: Promoting patient-focused programs

A1C Champions Program
In the United States, the A1C Champions Program sponsored by sanofi-aventis U.S. gives people with diabetes a forum to share their personal experiences as well as their management and lifestyle strategies. Since it was established in 2003, over 185,000 people with diabetes have actively participated in this program. For more information: www.a1cchampions.com
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Why insulin? A new education program for patients

In 2010, sanofi-aventis U.S. launched a national campaign called Why insulin? in the United States to inform and educate patients about insulin and its use. Based on the observation that many patients have never had an in-depth discussion about insulin with their physicians, and that insulin could make a significant impact on their lives, the Group devised a campaign to stimulate discussion and counter preconceived notions. The campaign focused on training patients about the basics of insulin use and the importance of talking with their doctors about blood sugar levels. It made use of press advertisements, mailings, interactive communications and a dedicated website. During the second phase, a television campaign to raise awareness built on the other initiatives. By late 2010, the Why insulin? programs website had been visited 788,993 times, and over 250,000 people indicated they wanted to receive more information. For more information: www.whyinsulin.com
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In Mexico: Bringing health care centers closer to patients

Since 2007, sanofi-aventis has developed important programs in Mexico to improve awareness about diabetes. Very often, treatment is initiated only when diabetes is already well advanced. The challenge is to reverse this trend, which is due to poor patient information, inadequate awareness among healthcare professionals and a lack of appropriate infrastructure. Two important examples of diabetes awarness programs include Siempre a tu lado (Always at your side) and CASA, which sanofi-aventis Mexico has developed since 2007. CASA, which means house, provides personalized care and free services for patients. There are currently 11 centers in the country, including three located in Mexico City. On average, they see 30,000 people monthly, 70% of whom are diabetics. CASA offers a full range of services: education for people taking insulin, blood glucose testing, nutrition
workshops, personalized follow-up and awareness initiatives. This range of services represents a global response to patients needs in connection with diabetes. Staff members working at the centers come from many different medical and social specializations they include nutritionists, diabetologists and social workers. This healthcare policy developed by the Group is already making a very clear impact, since the treatment period for diabetic patients has gone from six months to nine months. This grass-roots initiative has met with great success in Mexico, and similar programs are being introduced in other countries, including Argentina, Venezuela and Brazil.
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In Egypt: A campaign to raise awareness

Egypt ranks among the top 10 countries in the world having the highest number of people living with diabetes. To counter this epidemic, in 2010 sanofi-aventis took part in a vast campaign to promote awareness and inform the public. The campaign targets patients of all ages and their families. It highlights healthy habits and everyday lifestyle choices that patients must make to reduce diabetes-related risks. By encouraging people to control diabetes and reduce risk factors, the campaign made it possible to extend the ongoing collaboration with the Egyptian Ministry of Health.
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Increasing awareness of meningococcal infections

In United States
The Group works with

The early stage of a meningococcal infection is difficult to identify because the symptoms are similar to those of more common viral illnesses (fever, headache, etc.). The disease progresses very quickly and leaves little time for diagnosis. It can cause death within 24 hours. From 11% to 19% of infections lead to serious consequences, in particular for the nervous system: hearing loss, brain damage, chronic convulsions and paralysis. If septicemia occurs, the consequences may include amputation, and the mortality rate may reach 40%. Given the lack of awareness about the disease and its severity, sanofi pasteur is pursuing an active policy of prevention by supporting initiatives to increase awareness among health officials and the public about the need for vaccination. In the United States, the National Association of School Nurses launched a campaign targeting adolescents a high-risk group in collaboration with sanofi pasteur U.S. Voices of Meningitis is a website presenting the stories of people whose lives were dramatically changed by a meningococcal infection. Families tell their stories in order to share their experience, increase public awareness of the disease and its devastating consequences, and promote vaccination. Sanofi Pasteur also supports an international group of specialists who are part of the Global Meningococcal Initiative. Created in 2010, this initiative brings together scientists and doctors for the purpose of education, research and cooperation to promote prevention. Via scientific publications, the Global Meningococcal Initiative targets physicians, scientists and public health officials. It provides recommendations about prevention policies, surveillance systems and meningococcal vaccination strategies. For more information: www.voicesofmeningitis.org
nearly patient organizations in Europe
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Promoting healthy eating habits

Brazil: Comida que cuida
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Since 2006, sanofi-aventis Brazilian affiliate has published a series of books about healthy eating habits. They were written in collaboration with a team of doctors, nutrition specialists and patients. These colorful books were designed for patients with cancer, diabetes or cardiovascular disease, as well as their families. They explain how to adopt good eating habits during treatment to help improve patients comfort and quality of life. Hospitalized patients may receive copies of the books free of charge. Since the series was launched in 2006, the books have been distributed to over 300,000 patients. A new edition of the first book in the series, written for patients undergoing cancer treatment, is currently being published. The revised edition will include additional recipes and new illustrations. It will also feature a new chapter that is devoted to good eating habits for children undergoing treatment and explains how food may help them recover more quickly. For more information: www.sanofi-aventis.com.br / Comida que Cuida (in Portuguese)
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Transparency
Sanofi-aventis recognizes the importance of transparency as a means to build trust with stakeholders including the public, and most importantly the patient as the ultimate recipient of care. Transparency with patient associations is an intrinsic part of the Group's Global Principles covering Interactions with Patient Associations. As part of an ongoing commitment, we continue to update our approach towards enhancement of transparency, which incorporates voluntary approaches.
This is why when disclosing our activities with patient associations during 2010 based in Europe, we include the financial amounts associated with these activities. This exceeds the requirements of EFPIA (European Federation of Pharmaceutical Industries and Associations) Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations. In addition, we also provide a list of Medical Education Grants to patient associations in the US provided by sanofi-aventis U.S.* or sanofi pasteur U.S. You can also find and download a list of activities in 2008 and 2009 to European-based patient groups, as previously provided. Our interactions with patient associations are viewable by selecting a country or as a consolidated list:

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Our Global Principles for Interacting with Patient Associations (PDF, 20Kb) Sanofi-aventis Support in 2009 to Patient Associations based in Europe (PDF, 146Kb) Sanofi-aventis Support in 2008 to Patient Associations based in Europe (PDF, 271Kb) * these activities are also reported on www.sagrants.com as part of the Educational Grant Transparency Report.
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Patient indicators Access to healthcare Supporting patients Patient-focused innovation Managing innovation Our innovations in 2010 Business case: Dengue fever Product risk management
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Innovation
Solidly rooted in the values of sanofi-aventis, innovation is one of the drivers of our transformation process. The Groups actions are guided by the goal of providing patients with solutions for unmet therapeutic needs. They rely on innovation as a mindset, and on continuously asking questions. From research to marketing, production to sales, and medicines to vaccines, all the functions are developing new approaches to reach this shared objective.
The core of our activity is and will always be innovation. Opportunities are everywhere inside and outside the Group and we must seize them. Christopher A. Viehbacher
Managing innovation
So that our structures will keep pace with our transformation process, the Group is organized to stimulate innovation at every level.
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Our innovations in 2010

Industrial innovation, new services for patients, new products, acquisitions and ground-breaking collaborative projects innovation brings results.
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By rethinking our research projects in light of the needs of patients, we have reversed the usual distinction between research and development. Translational medicine links laboratory discoveries directly to clinical applications and is key to this development. It should enable us to considerably speed our innovation process.
Dr Elias Zerhouni President, Global R&D, sanofi-aventis
Business case: Dengue fever

A new vaccine combined with a new approach to prepare for its launch well in advance: The dengue fever vaccine currently under development is innovative in more ways than one.
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Patient indicators Access to healthcare Supporting patients Patient-focused innovation Managing innovation Structures Tools Awards Our innovations in 2010 Business case: Dengue fever Product risk management
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Managing innovation
New innovation management processes and structures
In 2010, the sanofi-aventis organization was designed to stimulate innovation from top to bottom with a new Innovation Committee, the Industrial Development and Innovation Department, and the reorganization of Research and Development.
Read more Jean-Philippe Santoni Senior Vice President, Industrial Development and Innovation Department, sanofiaventis
Tools for sharing best practices

At every level, the Group is determined to enhance and accelerate ways to share best practices.
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In a constantly-changing environment, this new organization is now equipped to operate in close, sustained collaboration with internal and external partners.
Awards to inspire emulation and innovation

A number of awards were introduced or continued in 2010 to motivate in-house teams and reward the most innovative initiatives.
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A new Innovation Committee made up of international experts from outside the pharmaceutical industry
2010: Innovation Award organized for the nd time
KITE Innovation Day 2010 (sanofi pasteur):
49 applications and 7 winning teams
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New innovation management processes and structures

Services for patients: Structuring the innovation process and finding more efficient ways to share patient initiatives within the Group Industrial Affairs: A powerful network to optimize the product portfolio Research & Development: A new organization to stimulate innovation
Services for patients: Structuring the innovation process and finding more efficient ways to share patient initiatives within the Group
The sanofi-aventis Pharmaceutical Customer Solutions (PCS) team contributes to promoting a culture of innovation. One of its objectives is to design initiatives that encourage the development of services to improve patients daily lives as well as the care they receive. To speed up the development of such tailored services, in 2010, for the first time, PCS brought together a group of internationally renowned experts creating an Innovation Board. Members are recognized for their expertise in fields such as innovation, services, customer relations and new technologies. One feature they all have in common is that they come from business sectors outside the pharmaceutical industry. The Boards primary objective was to devise a new Innovation process for sanofi-aventis services that was introduced in 2010.(*). This original strategy, based on combining diverse competencies, made it possible to develop an innovation process in late 2010, which is scheduled to be rolled out among Group affiliates in 2011. Services that are already offered to patients either globally or at the country level are shared via the sanofi-aventis Intranet using the LINKS platform.
Jean-Philippe Santoni Senior Vice President, Industrial Development and Innovation Department, sanofiaventis
Interview with Bruno Leroy, Associate Vice President in charge of Market Access Strategy and Innovation within the Pharmaceutical Customer Solutions (PCS) Department, sanofi-aventis:
In early 2010, Global Marketing underwent substantial reorganization to enable faster implementation of the sanofi-aventis strategy focused on proposing innovative solutions to meet patients needs. From an innovation standpoint, what was the PCS teams contribution in 2010? There was very strong mobilization to assess and develop an in-depth understanding of patients needs. We devised innovative studies based on ethnography, observation and analyzing patients broad behavior patterns in real-life situations. New methodologies were proposed to sanofi-aventis teams to help identify innovative services. In particular, we created an innovation process with a committee of specialists offering a wide range of experience gained outside the pharmaceutical sector. Meetings were organized on a regular basis with a design specialist to focus on the needs of individuals (commonly known as Human Centered Design) to generate a process of innovation in the services available to sanofi-aventis employees. Networks of sanofi-aventis employees were organized to encourage the sharing of best practices. A network of general managers was created from all Group countries. In January 2011, the innovation approach will be enhanced, first with the creation of a new entity dedicated to innovation (Customer Solutions and Innovation), and secondly by concentrating the teams activities on strategic innovative projects whose purpose is to ensure that services and solutions with added value for patients become rapidly available.
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Industrial Affairs: A powerful network to optimize the product portfolio

The Industrial Development and Innovation Department was created in 2009. This department acts as an interface between Research & Development and the industrial process to improve the dynamics of product life cycle management thanks to process and technology innovations for medicines and medical devices. This department plays a key role in enabling sanofi-aventis to better respond to customers needs and patients expectations.
Three questions for Jean-Philippe Santoni, Senior Vice President, Industrial Development and Innovation Department, sanofi-aventis:
What is the role of this new department? In support of our strategy, which is focused on patients needs, our role is to develop innovative medicines and medical devices that can be manufactured on an industrial scale and will contribute to the Groups general performance. These medicines and devices must meet patients expectations and satisfy unmet medical needs in all regions worldwide. How is the Industrial Development and Innovation Department structured? The Industrial Development and Innovation Department is composed of three operational groups: A programs department, in charge of suggesting strategies for brands, industrial development and portfolio management, as well as identifying opportunities for information sharing and synergies among the different regions A development centers network organized by region. This network is also in charge of providing information about alternate technologies and developing scientific collaborations as part of a strategy of outreach based on internal and external connections A group in charge of medical device development, whose mission is to design convergent technologies while concentrating on areas that will best serve sanofi-aventis commercial interests These three operational groups rely on the Groups Support functions for controls, Human Resources and quality / compliance. What is the development centers network? The development centers are organized by region within the Industrial Development and Innovation Department. Regional managers represent Industrial Affairs for any issues concerning product development at the regional level. As far as the regional entities are concerned, they initiate proactive proposals to meet project demands and provide progress reports on projects under development. Because these centers are organized into networks, we are able to adapt our competencies and technologies to match our principal product lines as well as new lines, whether this is for new chemical entities or biological agents or to expand a product line, for consumer healthcare, medical devices, generics, developing new packaging, etc. Last but not least, the network is organized in such a way as to develop and maintain links with the rest of the world and external collaborations. This allows innovations to come to light, internally and externally, and encourages the formation of productive scientific alliances. In a constantly-changing environment, this new organization is now equipped to operate in close, sustained collaboration with internal and external stakeholders.
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Research & Development: A new organization to stimulate innovation

Sanofi-aventis: A new research organization
The growing number of chronic, long-term diseases and the costs they generate, from both an individual and public health standpoint, has led to new methods for managing treatments. Healthcare personnel as well as pharmaceutical companies find themselves entrusted with a new mission, one that goes beyond medicines. Today, they also have a role to play in teaching patients with chronic disease how to manage their treatment. In parallel, the sequencing of the human genome has opened up new prospects by improving scientists understanding of diseases and ultimately enabling the identification of individuals at risk. This new approach will make it possible to prevent and hinder disease, particularly in areas where unmet therapeutic needs remain. These recent developments challenge traditional models of research, which form the basis of R&D. They have required the advent of translational medicine, which is based on close collaboration between multidisciplinary basic research and clinical research teams. To meet this challenge, R&D has undergone extensive reorganization featuring: The creation of business units dedicated to chronic conditions such as diabetes, cancer, aging and autoimmune diseases. This brings the functions of R&D closer so that scientific discovery can benefit patients more quickly.
Outreach and external collaborations and alliances, making it possible to find fertile ground where new ideas and ways to apply them will flourish including the development of state-of-the-art tools to further our understanding of biomedicine. This new organization makes it possible to pilot a change in culture. In addition, it opens the doors to innovation through the improved management of medical knowledge.
Sanofi Pasteur: A new operational R&D model and resources in line with projects
The vaccines that sanofi pasteur develops today will be a source of growth tomorrow. Aware that many vaccines have already been invented, the company also knows that the vaccines still to be developed will very likely require the use of technologies that also need to be invented. Consequently, sanofi pasteur has stepped up exploratory research to develop its portfolio of new vaccines. This approach involves a renewed focus on two centers of excellence: Marcy LEtoile (France) and Cambridge (United States). Sanofi Pasteur is strongly committed to R&D within the scope of partnerships with major universities, research institutes, government bodies, biotechnology companies and contract research organizations. The number of such partnerships increased in 2010 to tap into external innovation and expand the Groups areas of expertise. For more information: Acquisitions / Agreements Also in 2010, sanofi pasteur worked on portfolio segmentation for new vaccines in order to define portfolio priority projects for the Group and adapt resources accordingly. The two leading priorities in the sanofi pasteur portfolio which correspond to currently unmet health needs are the dengue fever and Clostridium difficile vaccines.
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Patient indicators Access to healthcare Supporting patients Patient-focused innovation Managing innovation Structures Tools Awards Our innovations in 2010
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Tools for sharing best practices

Marketing Industrial Affairs
Marketing
The Pharmaceutical Customer Solutions unit launched a number of initiatives designed to foster a culture of innovation among teams, with an emphasis on sharing best practices and successful initiatives. The LINKS platform is an example of one such initiative. Open to all employees, it allows them to share
Business case: Dengue fever Product risk management
knowledge, internal best practices and innovative projects originating in different affiliates. A new version of the platform will be available in 2011 to improve interactivity among employees and enable a more efficient exchange of information. Innovation Process in Services is also available in-house via the LINKS platform for all sanofi-aventis employees. It will be rolled out to the affiliates in 2011. In 2010, Web 2.0 social networks were created by affiliate general managers in order to accelerate information sharing, especially about innovative projects, and identify solutions that promote access to healthcare and better treatments for more patients. An efficient means for sharing best practices on innovative topics consisted of creating regularly scheduled virtual exchanges (Business Innovation Impact Plus Web forum). These virtual monthly forums for innovation bring together sanofi-aventis employees from all over the world. Specialists from inside and outside the pharmaceutical industry are invited to interact with sanofi-aventis teams. Lastly, in 2010 strides were made to increase the routine use of digital technologies and remote communication tools, making it possible to speed up exchanges and reduce the need for travel (with an increase in webinars Digital Thursday, webforum and e-learning).
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Industrial Affairs
An innovation club was created in 2010 to add momentum to innovation within the Group. The purpose of this club is to accelerate the innovation process and further expand the scope of implementation within Industrial Affairs. In addition, since 2010, each site has been invited to create an Innovation Cart on the internal platform ShareYourInnov.com, which was developed to facilitate the application of innovations that were part of the Innovation Awards. The platform has a filter so users can go directly to selected innovations and create an Innovation Cart on-line. It also allows users to discover innovations being rolled out at other industrial sites.
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Awards to inspire emulation and innovation

Ideabox Awards Industrial Affairs Innovation Awards At sanofi pasteur: The KITE initiative
Ideabox Awards
With the support of regional platforms, in 2010 sanofi-aventis launched an initiative called Ideabox throughout affiliates worldwide. This interactive suggestion box allows employees to propose initiatives that will improve relationships with patients and healthcare professionals. Prizes for the best ideas were presented during an Ideabox awards ceremony attended by Group management.
Industrial Affairs Innovation Awards

Launched in 2009, these awards have become a much-anticipated event within Industrial Affairs to celebrate and share the most promising innovations. A multidisciplinary jury including representatives of sanofi pasteur selected the winning innovations. This dynamic initiative is now well-established within the organization and has become a key component in the Groups industrial culture. Beyond this annual event, innovation has become a daily mindset approached from a cross-disciplinary perspective by sanofi-aventis teams and, more broadly, by the industrial sites network as well as beyond the Group. This collaborative spirit makes it possible to expand the scope of innovation and helps stimulate the development of new ideas. It also contributes to strengthening the entrepreneurial dimension and teamwork that constitute the strength of the industrial sector.
Awards in 2010: Key figures:

333 applications submitted to the jury (280 in 2009) Over 1,000 participants in nearly 30 countries Three finalists and one prizewinner in each of three categories: Technology, Value Creation, Management & Organization Three Special Jury Prizes for projects featuring simplicity and intelligence in implementation
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At sanofi pasteur: The KITE initiative

Introduced in 2008, an initiative known as KITE (Knowledge & Innovation for Technology Excellence) aims to provide access to innovative technologies that support industrial performance and the development of new vaccines through technology monitoring, assessment and recommending new technologies while ensuring their development. Thanks to a matrix organization, KITE contributes to stimulating a culture of innovation and fostering creativity at sanofi pasteur. In 2010, a special innovation day was organized within the scope of sanofi pasteurs exploration strategy and the KITE initiative. In the presence of guest experts from outside the Group, prizes were distributed for the most technologically innovative projects. On September 30, 2010, during the KITE Innovation Day, seven teams were rewarded for their projects involving innovative techniques. The winning projects were selected from among 49 applications. Just one example: the prize for the Vaccine Life Cycle Breakthrough Innovation was awarded for a microbead technology, an innovative method of vaccine lyophilization (freeze-drying). Re-thinking the
formulation / filling phases and enhancing the vaccines stability made it possible to obtain a dry form that is better adapted to needs in endemic areas as well as to a changing vaccine market.
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You are here: Home > Patient > Patient-focused innovation > Our innovations in 2010
Patient indicators Access to healthcare Supporting patients Patient-focused innovation Managing innovation Our innovations in 2010 Industrial innovations New services for patients Innovative partnerships Innovative products Business case: Dengue fever Product risk management
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Our innovations in 2010

Innovations in industrial processes
The 2010 Industrial Innovation Awards rewarded the best innovations in three categories: Technology, Value Creation, Management & Organization.
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Industrial innovations receiving awards in 2010
New services for patients

Patient relations is a key area of innovation for sanofi-aventis. A number of projects are developed to improve services that bring a true benefit to patients.
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Development of a laser technology to improve security for vaccine vials Designing a new box for Doliprane Simplifying the intellectual property management process
major Nearly research partnerships
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Acquisitions and innovative partnerships

In 2010, sanofi-aventis entered into 20 major research partnerships.
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Innovative products
The Group has some particularly innovative new products, such as Jevtana and the Intanza / IDflu influenza vaccines.
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Innovations in industrial processes

In 2010, Industrial Innovation Awards were presented for the following projects:
In the Technology category: Developing innovative technology that improves the security of vaccine vials In the Value Creation category: A new box for Doliprane In the Management & Organization category: Simplifying the intellectual property management process
Technology Award: Developing innovative technology that improves the security of vaccine vials
Teams at Marcy LEtoile (a vaccines division site) won the Technology award for the implementation of an innovative improvement for controls of vials of 100% lyophilized (freeze-dried) vaccine, which increases the assurance of sterility with minimal impact on industrial performance. They developed a laser technology that is extremely reliable and relatively inexpensive. A device installed directly on the production line immediately detects any vials that are not properly sealed.

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Value Creation Award: A new box for Doliprane

When a new French law was introduced authorizing the over-the-counter sale of certain medicines in pharmacies, teams at sanofi-aventis Lisieux seized the opportunity to create a surprise benefit for customers. Focusing on a leading sanofi-aventis product in France, Doliprane, they developed a new box for the tablets, which remain unchanged. This box is more practical and much more solid than prior packaging. It also has a new safety feature: Thanks to a special tab, it is possible to remove tablets from one side of the box while keeping the product insert / drug information visible on the other, thereby increasing safety for patients each time they take Doliprane.
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Management & Organization Award: Simplifying the intellectual property management process
How does one transform a brilliant idea into a patent? For most people, the answer is far from simple, which is why it is essential to have an efficient intellectual property management process in place. Without it, there is a lack of consistency, applications may be filed more than once, and certain employees develop good ideas that could be patented but they do not realize it. To improve this process, a new interface was created for the Innovation team at the Frankfurt (Germany) site, providing a link between engineers and the Patent Department. It was designed to radically simplify intellectual property management. It has made a clear impact: In three years, the number of patent applications has multiplied by 20.
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New services for patients

For sanofi-aventis, patient relations is a key area for innovation. A number of projects were developed to improve services that bring a true benefit to patients. These new services concern the therapeutic areas covered by the Groups medicines as well as those covered by sanofi pasteurs vaccines.
The following innovations are described below: For patients with diabetes : GoMeals : A healthy eating program available on smartphones E-diabete: On-line training for healthcare personnel in French-speaking Africa A new community site for vaccines Customer service training in Indonesia (KISS project)

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For patients with diabetes: GoMeals and E-Diabete

GoMeals program available on smartphones
GoMeals is a program in the United States launched by sanofi-aventis U.S. to help people living with diabetes make healthy food choices. It has been available on smartphones since November 2009 and on tablet devices since June 2010. The designers of GoMeals set out to meet a specific challenge develop a simple, comprehensive and user-friendly tool for people living with diabetes, enabling them to measure the carbohydrate content of foods (while grocery shopping or dining at a restaurant) so they can determine the appropriate insulin dose. The GoMeals application, which can be downloaded free of charge, provides users with an analysis of foods, meals and dishes on restaurant menus. The database includes over 40,000 foods and more than 20,000 dishes served by over 200 restaurant chains. The application provides information about calorie intake and distribution of fat, protein and carbohydrates. The program also makes it possible to monitor nutritional intake over the course of the day, and to store this information for 30 days. GoMeals was created in collaboration with nutrition and diabetes specialists. It was also designed using input from patients, in particular members of the A1C Champion Initiative as well as parents of children affected by diabetes. It can be used for type 1 or type 2 diabetes. Since it was introduced in 2009, the GoMeals application has been downloaded more than 250,000 times. Nearly 75% of those who use the application access it at least once a week and 48% access it daily.
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E-Diabete: An innovative program for African healthcare professionals

Developed by sanofi-aventis in collaboration with the World French-speaking E-University (UNFM) and the Francophone African Network for Telemedicine (RAFT), e-Diabete is a training program designed for African healthcare professionals to improve diabetes diagnosis and treatment. The RAFT network, which covers 15 French-speaking African countries, enables healthcare professionals (hospitals and clinics) to have access to medical training on-line, via a low-bandwidth Internet connection. Thanks to e-Diabete, over 10,000 healthcare professionals have updated their knowledge of the disease and are now trained to provide care for diabetic patients. Twice a month, more than 1,000 healthcare professionals attend interactive courses taught by local and foreign diabetes specialists. The program has received very enthusiastic feedback because it encourages interaction among the participants and is adapted to their local reality.
For more information: www.e-diabete.org

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An innovative community focusing on vaccines

In 2010, sanofi-aventis Australia inaugurated Vaxiplace, a new community site about vaccines for healthcare professionals. The site contains information about immunization, epidemics, clinical data, and the various vaccines that are available. By helping to keep professionals informed, the site indirectly contributes to improving patients understanding of vaccines. The sites novelty is the community aspect: The purpose of the Vaxiplace site is not limited to providing information. It can also be used to organize discussion forums for healthcare professionals who can exchange with colleagues about clinical practices and participate in real-time discussions with their peers. Three weeks after the launch of the site, over 250 general practitioners had already signed up for the forum. For more information: www.vaxiplace.com.au
Indonesia KISS Project

In Indonesia, sanofi-aventis introduced a new training program in April 2009 for hospital personnel, which goes by the name Key Institute Strategic Support (KISS). The program aims to meet three objectives: Improve the quality of patient services by training hospital teams Enable sanofi-aventis to convey a different Group image Forge new types of collaborative projects The quality of patient services in hospitals generally needs to be improved due to insufficient training. Sanofi-aventis offers to train hospital staff about how to cope with change in a rapidly evolving environment; better take into account patients needs; and improve daily schedule management. To date, the training program has been implemented in 80 hospitals. Some 4,000 hospital employees have participated, including nurses, pharmacists, general practitioners and hospital management. In 2011, there are plans to extend the program to 60 more hospitals and to train 3,000 staff members.
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Acquisitions and innovative partnerships

Mobilizing teams dedicated to the selection and evaluation of external collaboration opportunities, sanofi-aventis has translated its strategy into action by looking beyond the Group for innovative projects (focusing on upstream research) and reinventing the sourcing model for early-stage innovations.
Throughout its history, sanofi aventis has created a unique mix of cultures that enables it to take on a large number of acquisitions while respecting their business models and maximizing value creation. This diversity has become a major asset in the Groups capacity to transform and adapt to a changing global environment.
Jrme Contamine, Executive Vice President, Chief Financial Officer, sanofi-aventis
In 2010, the Group entered into a number of agreements, making it possible to bring specific products and technologies into the R&D pipeline: Nearly 15 licensing agreements Over 40 major research partnerships, in particular with prestigious institutions such as Caltech, Scripps, MIT and Harvard in the United States (after the Salk Institute in 2009), Charit in Germany and Aviesan in France Sanofi-aventis participated in the Innovative Medicine Initiatives, the largest public / private initiative directed jointly by the European Union and EFPIA, with the aim of speeding up development of the most effective and safest medicines for patients. The Group also participated in a program run by the National Institutes of Health (NIH), the worlds largest biomedical research agency, whose role is to help the United States government meet access to healthcare challenges. Thanks to the quality and diversity of this outside innovation network, the Groups R&D was able to position itself in new innovation niches, where previously it had not been present. In addition, sanofi-aventis has become even more attractive to potential partners since it was once again listed among the Top 10 global pharmaceutical companies (BCG study). These external collaborations represent an opportunity for sanofi-aventis as well as for partners, both public and private, who are able to tap into the Groups expertise and resources as they develop new medicines. In April 2010, 60% of the Groups clinical portfolio consisted of products coming from external Research and Development.
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Focus: The most innovative acquisitions in 2010

Genzyme, a decisive step toward biotechnology
On February 16, 2011, sanofi-aventis officially announced the definitive agreement under which the Group is to acquire Genzyme for approximately $20.1 billion. Genzyme is a leader in efforts to develop and apply the most advanced technologies in life sciences, with products and services focused on treating rare inherited disorders, kidney disease, orthopedics, cancer, immune and transplant-related diseases. This acquisition strengthens sanofi-aventis sustainable growth strategy and expands the companys presence in biotechnology. The Group intends to make Genzyme its global center for excellence in rare diseases.

BUSINESS CASE
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VaxDesign: Biotechnology innovation to speed up the development of new vaccines

Acquired in 2010 by sanofi pasteur, VaxDesign is a U.S. biotechnology company based in Orlando, Florida, that develops, manufactures and markets in vitro models of the human immune system. VaxDesign developed a unique technology, unlike any other in the world that reproduces the human immune response in vitro and enables earlier selection of the best candidate products as opposed to using animal models before studies in human clinical trials. The Modular IMmune In vitro Construct (MIMIC) system developed by VaxDesign was designed to capture genetic and environmental diversity and predict human immune responses. The MIMIC platform should
A NEW DENGUE FEVER VACCINE With a high focus of innovation Taking up a scientific and an industrial challenge,
make it possible to accelerate vaccine development, reduce time to market and improve success rates in pre-clinical and clinical studies.
Vivalis: Innovative research on human monoclonal antibodies

In 2010 sanofi pasteur entered into a commercial license and collaboration agreement with Vivalis, a biopharmaceutical company for research and development on fully human monoclonal antibodies against several infectious diseases. This collaboration will pave the way for new medical solutions to benefit patients all over the world.
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sanofi-aventis aims to develop and market a tetravalent dengue fever vaccine that is safe, effective and accessible as quickly as possible.
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Innovative products
Below are a few examples that illustrate the Groups innovation strategy for both medicines and vaccines.
Multaq Jevtana: Innovation that responds to patients unmet needs Innovative seasonal flu vaccines Clostridium difficile: Sanofi Pasteurs candidate vaccine in Phase II clinical trials
Multaq
Multaq is the only anti-arrhythmic drug that offers comprehensive treatment for the symptoms of atrial fibrillation. In a large-scale clinical development program, Multaq demonstrated efficacy in improving symptoms by controlling both cardiac rhythm and frequency, with a reduction in cardiovascular events in addition to control of symptoms. The reduction in cardiovascular events led to fewer emergency cardiovascular hospitalizations, whether or not in conjunction with atrial fibrillation. Multaq represents one of the major therapeutic innovations of the last ten years for atrial fibrillation.
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Jevtana: Innovation that responds to patients unmet needs

In 2010, sanofi-aventis received marketing authorization for Jevtana (cabazitaxel injection). In combination with prednisone, this is the first therapy that brings a significant survival benefit in the treatment of patients with metastatic hormone-refractory prostate cancer treated previously with docetaxel-based therapy. This new drug fills an important therapeutic need. Following the approval of Jevtana, healthcare professionals may now consider utilizing a new treatment for patients with the most advanced form of prostate cancer, for which there are few therapeutic options. For this patient population, Jevtana is the only drug that brings about significant improvement in overall survival. Jevtana is the result of 14 years of sanofi-aventis research. Marketing authorization for this drug highlights the success of the Groups new R&D strategy within the Oncology Division. Nearly ten other oncology projects are under development in sanofi-aventis research laboratories.
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Innovative seasonal flu vaccines

Asserting our position as the world leader in the development of influenza vaccines, the Groups R&D efforts concentrate on innovative methods to assess new formulations and new means of administration with an eye to meeting specific patient needs. Intanza: The first influenza vaccine to be administered via intradermic micro-injection Since 2010, in Europe as well as countries in the international zone, sanofi pasteur has marketed the first influenza vaccine to be administered by means of a new intradermic micro-injection. The vaccine is called Intanza and IDflu. In light of the advantages it offers comfort and ease of administration this vaccine aims to improve immunization coverage rates in Europe. This innovation brings benefits to both patients and the Group. Patients welcome the minimal invasion of a small needle and the innovative means of administration (intradermally), while the Group differentiates itself from other vaccine producers in a highly competitive environment. In 2010, sanofi pasteur U.S. applied to the United States regulatory authorities to receive marketing
authorization for the intradermic flu vaccine Fluzone ID. Results of Phase III trials of the Fluzone ID vaccine have shown that intradermic immunization requires less antigen and a smaller amount of vaccine than when Fluzone is injected intramuscularly, while inducing a comparable immune response. The Fluzone High Dose vaccine (influenza virus vaccine) was designed specifically to induce a stronger immune response among persons aged 65 and older. It has been shown that this age group, which has a weaker immune response, responds better to Fluzone High Dose. This new vaccine was successfully launched in the United States in 2010.
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Clostridium difficile : Sanofi Pasteurs candidate vaccine in Phase II clinical trials

Clostridium difficile, an anaerobic spore-forming bacterium, is a major public health concern in North America and Europe. It is the leading cause of infectious diarrhea among adults, particularly the elderly, in hospital settings. Currently there is no vaccine available to prevent this hospital-acquired infection, and ACAM-Cdiff is the only candidate vaccine under development by sanofi-pasteur. After receiving approval from the Food and Drug Administration (FDA) for a fast-track evaluation, sanofi pasteur U.S.s candidate vaccine to prevent Clostridium difficile entered Phase II clinical trials in the United States in late 2010, marking a major step in its development. The clinical trial is designed to assess the vaccines efficacy in preventing the first episode of Clostridium difficile infection among at risk subjects, particularly adults who are planning to be hospitalized or will enter a rehabilitation center for an extended period of time.
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Patient indicators Access to healthcare Supporting patients Patient-focused innovation Managing innovation Our innovations in 2010 Business case: Dengue fever Product risk management
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Business case: Dengue fever

Responding to a public health need: the prevention of dengue fever, the second most widespread endemic tropical disease after malaria, for which no treatment exists.
Development of an innovative tetravalent vaccine by sanofi pasteur: The most advanced candidate vaccine under development worldwide The largest program of clinical studies underway Exceptionally high clinical and industrial investments Launch of dengue vaccine prepared well in advance, in-house and with stakeholders
For patients: A solution designed to prevent a disease that threatens nearly half the worlds population The worlds first dengue fever vaccine For employees: Project saves jobs; employees in 3-year training program transitioning from chemical to biotechnology production. For stakeholders: Anticipate future challenges regarding vaccination and access through collaborative projects. For affected countries: Reduce the epidemics economic and social impacts
Fully supports the Groups access to healthcare strategy. Drives growth. Strengthens cooperation with healthcare authorities. Builds team spirit by working on a high-priority program. Image and reputation (Best vaccine under development in Asia Award in 2010).
Vaccine expected to be available by 2015 at the earliest.
The challenge
Sanofi Pasteur decided to invest in building a plant to produce dengue fever vaccine in Neuville-sur-Saone, near Lyons (France) even before development of the vaccine has reached completion. The Group is breaking ground thanks to its scientific and industrial expertise with the aim of making the vaccine available as rapidly as possible in the regions of the globe where dengue fever is an urgent public health problem. The challenge is to: Complete development of a safe and effective tetravalent vaccine targeting the four viral serotypes to prevent dengue fever and its serious complications (hemorrhagic fever) through clinical studies conducted in all dengue-endemic regions of the globe Provide national regulatory authorities in dengue-endemic countries with the data necessary to register the vaccine Continue and complete construction and certification of facilities where the vaccine will be produced, with the goal of being able to provide it in the most exposed countries as soon as the vaccine is registered by national regulatory authorities Collaborate to anticipate future dengue vaccination challenges in order to facilitate the organization and implementation of immunization programs The access to healthcare challenge is substantial because it concerns a disease that threatens nearly half the worlds population and especially affects the most disadvantaged communities. More broadly, the challenge is also to participate in raising much-needed global awareness about dengue fever.
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Our response
Sanofi Pasteur organized a powerful response to the daunting challenge this disease represents: To date, the Group is working on the worlds most advanced candidate vaccine. The vaccine under development is in Phase III clinical trials a stage that no other potential dengue vaccine has reached. The level of the Groups investment in this project is exceptionally high: To speed up the process, all teams are synchronized and working in parallel (R&D, Medical Affairs, Regulatory Affairs, affiliate teams, etc.). To conduct clinical studies, a global program is expected to ultimately enroll approximately 40,000 participants in Asia, Latin America and the United States. Both children and adults will be included in the studies. From an industrial viewpoint, a 300 million investment has been allocated to finance a new production site for dengue fever vaccine, and construction is already underway. Thanks to this investment, a chemical production facility is being transformed into a biotechnology site. When it is completed and operational, the Neuville-sur-Saone (France) site will be the Groups third European production center devoted entirely to vaccines The launch of the new vaccine is being prepared well in advance, both in-house and with respect to the Groups stakeholders. Sanofi Pasteur collaborates actively with the WHO, national governments, payors, and NGOs (Dengue Vaccine Initiative, Bill and Melinda Gates Foundation, Sabin Institute, etc.). These efforts aim to reduce insofar as possible any delays that might stand in the way of introducing the vaccine quickly once it has received authorization from national authorities.
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Developing the worlds first dengue fever vaccine represents valuable progress first and foremost for patients. By 2015, sanofi-aventis anticipates that they will at last be offered a solution to prevent the second most widespread disease in the world after malaria. For Group employees, the dengue fever vaccine program saves jobs at the Neuville-sur-Saone site in France. To switch from chemical to biotechnology production, employees are taking part in a three-year training program. Worldwide, today more than 1,000 employees are involved in this high-priority program, which will contribute to the Groups future growth. For other stakeholders like the WHO, national governments, healthcare authorities, sponsors, NGOs and foundations all of whom collaborate with sanofi pasteur it is important to be able to anticipate the health challenges related to access to vaccines. Above all, for countries exposed to dengue fever, distribution of this vaccine will make it possible to limit the economic and social consequences of the epidemic by addressing the following issues identified to date: Optimizing time to market for the countries most severely affected by the epidemic Developing greater awareness of the disease / epidemiology through innovative initiatives: Dengue Vaccine Initiative (public / private partnership), Dengue v2V (vaccine to Vaccination Expert Advocacy Group), Dengue Matters (Newsletter), Dengue Watch (disease reporting website www.denguewatch.org), etc. Providing funding for the poorest countries Establishing differentiated pricing policies
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The dengue fever vaccine project fully supports the sanofi-aventis access to healthcare strategy. Meeting patients needs goes beyond developing
an appropriate vaccine. Above all, it involves proposing global solutions to meet a healthcare need. This requires working on areas such as the vaccines accessibility, improving awareness of the disease and supporting the patient. The development of the dengue fever vaccine is moreover a growth driver for sanofi-aventis. In addition, it provides an opportunity for the Group to strengthen cooperation with healthcare authorities around the world. Lastly, this project offers an opportunity for sanofi pasteur to build team spirit by working on a high-priority program and testing a new coordination model in which: All the companys functions work together: Production, R&D, Medical Affairs, Commercial Operations, Marketing, Regulatory Affairs, and affiliate teams Substantial resources are devoted to this program, which leads the list of priorities for the Group The new vaccine also represents an opportunity for the Groups reputation. The sanofi pasteur candidate dengue fever vaccine received an honor in June 2010 when it was designated Best vaccine under development in Asia. The prize was presented during the fourth World Vaccine Congress Asia.
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What about tomorrow?

The plant at Neuville-sur-Saone (France) will be a new showcase for the Groups public health mission, with state-of-the-art facilities to produce dengue fever vaccine in the quantities required to meet vaccination needs and combat this devastating epidemic. The first vaccine should be available in 2015 at the earliest. For more information: www.sanofipasteur.com / Dengue Fever
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One of sanofi-aventis principal missions is to ensure the safety and quality of the Groups products. We aim to provide the best possible risk management associated with the utilization of our products.
Over sanofiaventis employees work in pharmacovigilance
500
Pharmacovigilance
Pharmacovigilance seeks to constantly optimize the risk / benefit ratio for the Groups medicines and vaccines a commitment that requires implementing appropriate global and local organizations.
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Global quality
Sanofi-aventis adheres to Quality Guidelines and promotes continuous improvement at each phase of the products life cycle, as well as related services.
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VIDEO THE FIGHT AGAINST COUNTERFEITING A CHALLENGE FOR PUBLIC HEALTH

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The fight against counterfeit drugs

Counterfeit drugs are a public health issue and a major concern for sanofi-aventis.
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Continuity of activities and supplies

Sanofi-aventis considers that safeguarding the continuity of its activities is one of the Groups responsibilities. The Group makes every effort to ensure the supply chain will continue to deliver medicines and vaccines to the market without interruption.
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13,000 products
have been analyzed in the Tours (France) anti-counterfeit laboratory since it opened
audits In 2010: were performed on suppliers of Active Pharmaceutical Ingredients, including
288
126 in India and

China
2 challenges:
Safeguarding supplies on a daily basis Safeguarding supplies in the event of a pandemic
PLANET Planet indicators CO2 emissions and energy Local environmental impact
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Pharmacovigilance
Ensuring the safety and quality of the Groups products When does Pharmacovigilance come into the picture? A solid regulatory environment
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Ensuring the safety and quality of the Groups products

One of sanofi-aventis principal missions is to ensure the safety and quality of the Groups products. Pharmacovigilance seeks to constantly optimize the risk / benefit ratio for the Groups medicines and vaccines. This mission, which engages sanofi-aventis responsibility toward patients, concerns both products under development and those already on the market and being used by patients. The purpose of Pharmacovigilance is three-fold: To detect, evaluate and monitor risks related to the use of all sanofi-aventis medicines and vaccines To seek and implement measures to reduce such risks as well as to prevent adverse events To promote the proper and safe use of medicines Pharmacovigilance involves working on an ongoing basis with the relevant authorities and all healthcare professionals to improve the understanding of products effects and, as much as possible, mitigate risks under conditions of actual use. These efforts make it possible to: Optimize the risk / benefit ratio of a drug, device or vaccine Determine the best treatment for a specific patient Inform physicians about potential risks associated with a product Propose market conditions for a product
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patients monitored over 2 years
20,000
drug monitoring study ever launched in Africa
2010: Implementation and unification of AWARE , a pharmacovigilance / epidemiology database Signal detection:
A high-performance global quantitative detection and evaluation tool
When does Pharmacovigilance come into the picture?

The diagram below shows the different phases in a drugs life cycle, from research to marketing. Pharmacovigilance plays a role from the first time a compound is administered to human subjects (clinical trials) and continues throughout the entire development and product marketing cycle.
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A solid regulatory environment

Pharmacovigilance is highly regulated in the pharmaceutical industry. There are numerous regulations, general policies and recommendations in force in Europe and the United States as well as internationally. Compliance with these regulations guarantees that the highest standards of practice are maintained for patient safety.
In Europe
EMA (European Medicines Agency ) www.ema.europa.eu European Union Eur-lex.europa.eu / Regulation (eu) no 1235/2010 of the European Parliament and of the Council of 15 December 2010 Eur-lex.europa.eu / Regulation (ec) no 726/2004 of the European Parliament and of the Council of 31 March 2004 Eur-lex.europa.eu / Directive 2010/84/eu of the European Parliament and of the Council of 15 December 2010 Eur-lex.europa.eu / Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 Eur-lex.europa.eu / Directive 2001/20/ec of the European Parliament and of the Council of 4 April 2001 Ec.europa.eu / VOLUME 9A of the Rules governing medicinal products in the European Union
Ec.europa.eu / EudraLex - Detailed guidance on the collection, verification and presentation of adverse reaction reports Ec.europa.eu / EudraLex - Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions Ec.europa.eu / Volume 10 - Guidance documents applying to clinical trials Version 6.0 (June 2010) Ec.europa.eu / Volume 10 - Guidance documents applying to clinical trials Version 1.0 (Dec 2009) Ec.europa.eu / EudraLex - Volume 10 Clinical trials guidelines
Internationally
CIOMS (Council for International Organizations of Medical Science) www.cioms.ch / About Us www.cioms.ch / Benefit-Risk balance for marketed drugs: evaluating safety signals ICH (International Conference on Harmonisation ) http://www.ich.org/LOB/media/MEDIA2217.pdf
In the United States

FDA (Food and Drug Administration ) www.fda.gov www.accessdata.fda.gov / Code of Federal Regulations
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Pharmacovigilance - Policy
Sanofi-aventis commitment to product safety requires the implementation of the appropriate global and local organization. The Group Pharmacovigilance Department is in charge of monitoring all pharmaceutical products, from the first time a compound is administered to human subjects (Phase I clinical trials) to the end of the product's life cycle.
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A global and local organization

Centralized and local divisions
To ensure the safe use of products under development and those that are already on the market, sanofiaventis has instituted: Centralized pharmacovigilance divisions, one for vaccines and one for all other medecines. Each division collects all information reported worldwide, whether during clinical trials or through unsolicited notification; In the centralized pharmacovigilance divisions, specific teams of expert physicians, pharmacists, health care professionals and epidemiologists are in charge of adverse event evaluation. The strength of the Pharmacovigilance teams resides in the monitoring, analysis and integration of all potential sources of safety information (reports from health professionals and patients, clinical trials, observational studies or health record databases, as well as internal research findings and medical and scientific literature). Local pharmacovigilance divisions in each of our affiliates, whether or not there are regulatory pharmacovigilance obligations (i.e., concerning the reporting of adverse events to local health authorities) in these countries. The local structures collect, record and report information reported by patients, clinical trial investigators and healthcare professionals. In addition, these pharmacovigilance groups interface with local health authorities and various departments within the affiliate. An organized process for adverse events reporting
20,000
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Pharmacovigilance - Actions
Centralizing risk management AWARE: A new pharmacovigilance / epidemiology database Improve awareness and provide pharmacovigilance training Developing an innovative drug monitoring study in Africa
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Centralizing risk management

Centralized management for product pharmacovigilance and product safety information
In addition to inspections and audits conducted, respectively, by the health authorities and by the sanofiaventis Quality R&D Department, the Countries and Regions Interface created within the Pharmacovigilance and Epidemiology Department pays regular visits to the affiliates to ensure they have adequate means and resources. The affiliate Pharmacovigilance teams provide monthly activity reports to the central team. The corporate Pharmacovigilance Quality and Compliance Department makes regular checks to verify that health authorities reporting deadlines are respected. Thanks to its network, warning system and rigorous standards, the Pharmacovigilance Department is able to fulfill its mission and ensure that sanofi-aventis provides the best possible risk management associated with the use of medicines.
20,000
Risk management plan

In 2009, sanofi-aventis established a new risk management plan. Implemented at all relevant Group affiliates, the risk management plan is designed to formalize, in precise terms, the procedures to identify, evaluate and report a product or a devices adverse events from Phase I clinical trials to post-marketing and to mitigate them. These iterative processes are especially useful in improving product knowledge and related risks, and anticipating any action that may need to be taken after the product is marketed, such as organizing clinical or epidemiological safety trials and taking measures to minimize risks. This approach incorporates continually assessing a products risk / benefit ratio. This process makes it possible, first, to evaluate the incidence and prevalence of diseases, and second, to determine potential or identified risks in relation to medicines and vaccines.
A warning system: Signal detection

As part of the Groups risk management plan, sanofi-aventis has implemented a warning system called signal detection. Within Pharmacovigilance and Epidemiology, product safety officers are responsible for the analysis and assessment of any potential signal detection raised by each product and to document the findings appropriately, whatever the source of the signal. A dedicated team in charge of the coordination of post-marketing signal management activities has been formed within the Risk Management & Pharmaco-epidemiology group. They have implemented a new global quantitative signal detection and evaluation tool that uses sophisticated data mining techniques. At the local level, within affiliates, the affiliate pharmacovigilance managers are on the watch for any signal and are responsible to detect locally any unanticipated trends, clusters or pattern variances in product usage or safety data. Affiliate functions immediately notify the Group pharmacovigilance department of any potential signal identified at their level. For early signal detection in product development programs, multidisciplinary Safety Monitoring Teams (SMT) review clinical trial data throughout the course of development to identify risks, determine the safety profile of products, and implement appropriate action plans to optimize safe product use. The SMTs missions are to: Ensure an integrated and proactive approach for meeting regulatory authority expectations and new
industry standards Allow proper risk mitigation through modifying ongoing product development strategies Apply a consistent safety management strategy across all clinical studies and projects
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AWARE: A new pharmacovigilance / epidemiology database

Pharmacovigilance databases are vital tools because they collect information concerning any potential connection between a medicine and an adverse event. In 2009, sanofi-aventis launched a new global database called AWARE. This unique system, which replaced two previous databases, makes it possible to manage pharmacovigilance data generated by the affiliates and by the Group Pharmacovigilance Division. Designed to meet European regulatory requirements (EMA), U.S. requirements (FDA), and Japanese standards (PMDA), AWARE offers flexible functionalities that make it possible to adapt to new regulatory developments. One of the highlights of 2010 was the roll-out and unification of the new AWARE database in about 50 countries where the Group operates. Today the database is up and running. The goal for 2011 is to continue systems harmonization by including the vaccines division and the European generics platform.(*)
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Improve awareness and provide pharmacovigilance training

In 2010, the sanofi-aventis Pharmacovigilance and Epidemiology department set up a new training program to increase employee awareness about the importance of pharmacovigilance and related processes. The training program was rolled out internationally for the entire Group, including medical sales representatives. This awareness-building initiative reviews basic safety rules, presents the organization and describes available tools as well as procedures to follow. Specific training is also available for all employees working for the Groups pharmacovigilance teams to ensure they update their knowledge on a regular basis. Among other benefits, the training program will make it possible to respect the Groups commitment to comply with all mandatory declarations of adverse events within required time limits. Following a routine FDA inspection of the sanofi-aventis site in Bridgewater, New Jersey (U.S.) in April and May 2010, the FDA issued a warning letter to the Group. This warning letter referred to the declaration process and time limits; it did not concern the safety of a specific drug.
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Developing an innovative drug monitoring study in Africa

In October 2009, in conjunction with the Medicines for Malaria Venture (MMV) Foundation, sanofi-aventis initiated the largest drug monitoring study of an antimalarial drug ever organized in sub-Saharan Africa. The study is designed to monitor the efficacy and safety of ASAQ Winthrop / Coarsucam for the treatment of malaria. Since ASAQ is widely distributed, it is important to monitor the drugs safety and ensure its proper use. Thanks to the MMVs support, 15,000 patients in Cte dIvoire will be monitored for at least two years to assess the drugs effects under real life conditions. In 2010, monitoring continued as planned. Four health centers participated over the course of the year, and staff members at three new centers were trained to speed up recruitment. By late December 2010, over 2,800 patients had received treatment and monitoring within the scope of this study. The MMV scientific committee renewed its annual approval for the program to continue in 2011. This study is part of a field-monitoring program for ASAQ that will ultimately enroll approximately 20,000 patients. The World Health Organization expressed its interest in formalizing the program as a Risk Management Plan, which marked a first for this type of initiative. Through this program, which operates in conjunction with African experts, sanofi-aventis is contributing to the development of innovative methods to monitor the safety and efficacy of drugs adapted to the needs and resources of the countries where they are used.
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Global quality
Background and policy
Respecting pharmaceutical regulatory requirements A commitment for the patient How Global Quality is organized at sanofi-aventis Sanofi-aventis develops, manufactures and markets a broad range of prescription medicines, consumer healthcare products (OTC), vaccines and generics across the globe. The quality and safety of healthcare products is essential. For several decades, the pharmaceutical industry has been operating in a highly regulated environment.
Quality is a core value of the company that must be implemented at all levels. A consistently high standard of Quality, applied worldwide, allows us to ensure patient safety and meet customer expectations
Excerpt from the sanofi-aventis Quality Policy Quality Policy (PDF, 742Kb)
Respecting pharmaceutical regulatory requirements

Before products can be brought to market, numerous clinical trials and laboratory studies must be conducted to assess and improve their risk / benefit ratio. Such trials and studies must be carried out in compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). In addition, at each step of product development it is necessary to adhere to Good Manufacturing Practices (GMP), guaranteeing that marketed products will meet demanding quality standards. Compliance with Good Distribution Practices (GDP) is also essential to ensure quality and guarantee the traceability of products, from the distribution center to the final point of delivery: wholesaler, dispensing pharmacy, hospital pharmacy, etc. In addition to these good practices, a number of statutes and regulations define legal requirements in relation with pharmacovigilance, medical information and sales and promotional practices. Together, these requirements are continuously strengthened and updated in line with scientific and technological developments, taking into account market globalization as well as the needs of stakeholders: patients, healthcare professionals, health authorities, etc.
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A commitment for the patient

Patient safety is an absolute priority for sanofi-aventis. With this in mind, the Groups approach consists of implementing guidelines for quality and continuous improvement to cover each phase of the products life cycle, as well as related services. The sanofi-aventis senior management is committed to providing safe and effective products worldwide, which are developed, manufactured, distributed and marketed in full compliance with statutory and regulatory requirements and the Groups corporate values. The same high quality standard is applied worldwide to guarantee patient safety and to satisfy stakeholders expectations. This commitment appears in the sanofi-aventis Global Quality Policy, which is distributed to all employees in all countries (in 11 languages) and is upheld by the Groups senior management. For more information: Global Quality Policy (PDF, 742Kb)
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How Global Quality is organized at sanofi-aventis
At every operational unit, site or affiliate involved in activities having a potential effect on product quality, patient safety or data integrity, Quality Managers conduct and coordinate quality and compliance activities. They contribute to compliance with regulatory requirements and continuous improvement of the Groups performance. Since 2009, Global Quality has been working at Group level to coordinate the various Quality teams and to ensure the consistent implementation of the Quality Policy throughout the products life cycle. In 2010, the scope of Global Quality was extended to the commercial affiliates through the creation of a dedicated team.
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Global quality - Actions

The sanofi-aventis Quality Policy involves many different actions, including:
Quality systems covering the entire product cycle Ensuring the quality of vaccines Preparation for inspections Quality risk management Quality across the entire Supply Chain
In 2010: products recalled from the market for what the authorities considered to be a defect that could potentially threaten patients lives.
Quality systems covering the entire product cycle

The International Conference on Harmonization (ICH) Q8, Q9 and Q10 guidance established by regulatory authorities have been welcomed by sanofi-aventis as marking substantial progress to encourage innovation and process effectiveness in an industry that historically has been focused on regulatory compliance. Specifically, the Group uses ICH guideline Q10 (Pharmaceutical Quality System) to complement ISO quality management standards as a key reference to ensure the coherency of Quality Systems already in place. The sanofi-aventis Quality Systems are structured in such a way as to cover all processes in connection with product development, manufacturing and distribution, including early research phases through the application of the internal rules of Good Research Practices. They also cover cross-functional support processes such as personnel qualifications, documentation and management of third parties. Each sanofi-aventis division monitors Quality Systems effectiveness by setting objectives and performance indicators and by organizing periodic reviews involving senior management and internal partners.
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audits In 2010: audits performed for suppliers of Active Pharmaceutical Ingredients, including
288
126 in India and

China
Sanofi-aventis is a member of the Rx-360 consortium

www.rx-360.org
Ensuring the quality of vaccines

The production of vaccines is complex and requires very strict controls at every stage of the process. It can take up to 22 months to produce a vaccine. About 70% of the time is dedicated to quality controls. Meeting global demand, while conforming to very strict quality and regulatory controls, is an ongoing challenge. Our goal is for sanofi pasteur to be a reference with respect to quality. Therefore, we have developed a strong quality culture and take great care to see that this focus has been incorporated into the daily mindset of each employee. To reach this level of quality, sanofi pasteur implemented very specific measures: good industrial management as well as marketing practices, management principles and performance measurement. To constantly improve customer satisfaction and meet regulatory demands while keeping our business highly competitive, the quality teams work closely with the heads of industrial operations. Together they define quality policies and guidelines and guarantee that processes correspond to good manufacturing practices.
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Preparation for inspections

Over the years, sanofi-aventis has adopted an approach designed to ensure that the Group is optimally prepared, at all times, for inspections led by regulatory authorities, to verify compliance with Good Practices and all related processes.
In 2010, a total of 187 inspections were conducted at sanofi-aventis sites by health authorities (see table).
ACTIVITY NUMBER OF INSPECTIONS
Pharmacovigilance Clinical research (GCP) Pre-clinical research (GLP) Manufacturing and distribution sites (GMP / GDP) TOTAL
4 53 4 126 187
Regulatory inspections provide an independent assessment of the Quality system in place, the Groups standards and actual practices. Their outcome is systematically reviewed as an opportunity for sharing lessons learned and continuous improvement. Any observation made during a regulatory inspection gives rise to corrective and preventive action plans, and Quality standards are updated accordingly. Following a routine inspection at the sanofi-aventis U.S. Bridgewater, New Jersey, site in April and May 2010, the FDA sent the Group a warning letter concerning inadequate procedures for the surveillance, receipt, evaluation, and reporting of adverse events within the required time limits and failure to include all post-marketing studies in the Annual Report to the FDA as part of new product approval files. The warning letter concerns reporting requirements and deadlines, and does not concern the safety of a specific product. Sanofi-aventis has committed to adhering to all reporting obligations in the future. In February 2011, the Group received an FDA warning letter concerning the facility located in Frankfurt, Germany, which underwent a routine inspection in September 2010. The letter cited failures to comply with Good Manufacturing Practices (GMP) without mentioning a specific product. The Group has taken note of the warning and is making efforts to comply with the recommendations; nevertheless, the Group considers that the points mentioned in the letter do not compromise the quality of marketed products nor the Groups ability to supply all its marketed products. The health authorities regularly conduct inspections as part of the evaluation of product registration submissions. Sanofi-aventis has implemented a specific cross-functional process to prepare and manage these pre-approval inspections and ensure that these products are marketed in compliance with their registration file, with no administrative delay.
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Quality risk management

A formal Quality risk management approach facilitates better decision-making and may increase authorities confidence in the Groups ability to deal with potential issues. An integrated Quality risk management process is consequently implemented for all relevant activities. All sanofi-aventis operational units, sites and affiliates are in charge of evaluating and managing risks relating to Quality and compliance. This process aims to anticipate and control Quality risks that might generate one of the following consequences: Unexpected adverse reactions, including among patients enrolled in clinical trials Non-compliance with regulations or regulatory files that have been submitted Discontinuation of a study, for example, due to a product supply interruption Suspended or cancelled authorization to manufacture or market products Loss of customer confidence, or harm to the companys image By way of example, the Group has created a worldwide database to enable Group sites to record customer complaints related to the Quality of marketed products. The complaints are automatically classified based on their potential impact for patients. The use of this tool has led to a significant decrease in the average time required to investigate the complaint and determine the corrective actions that may be necessary. In 2010, no sanofi-aventis product was recalled from the market for what the authorities consider to be a defect that could potentially threaten patients lives.
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Quality across the entire Supply Chain

In a global economy, the quality of sanofi-aventis products is determined not only by the final link in the chain, but also by the quality of the raw materials manufactured by suppliers as well as services provided by subcontractors. All materials and equipment that may have an impact on product quality are purchased from approved sources according to predefined acceptance criteria, which include compliance with technical specifications and quality requirements. The quality of the subcontractors with whom the Group works is audited by a formal process that includes
an initial assessment, qualification and routine assessment of compliance with regulatory requirements as well as sanofi-aventis internal standards. The frequency with which audits are performed is determined following a risk analysis taking into account several factors, such as the criticality of the product or service and the history of Quality performance of the third party. For example, in 2010 sanofi-aventis conducted a total of 288 audits of Active Pharmaceutical Ingredients manufacturers, including 126 located in India and China. The table below shows the number of audits performed for suppliers of Active Pharmaceutical Ingredients in 2010.
REGIONS NUMBER OF AUDITS PERFORMED FOR SUPPLIERS OF ACTIVE PHARMACEUTICAL INGREDIENTS IN 2010
Europe North America South America Africa Middle East Asia Pacific China India Other
111 23 10 1 143
43 83 17
TOTAL
288
In addition, sanofi-aventis voluntarily elected to strengthen Quality controls of ingredients provided by suppliers located in countries where cases of fraudulent products were recently reported. Since its creation in 2009, sanofi-aventis has been a member of the Rx-360 consortium, a non-profit organization whose mission is to improve pharmaceutical supply chain security and ensure product quality and authenticity across the entire supply chain.
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2 challenges:
Continuity of activities and supplies

Background
As a global healthcare leader, sanofi-aventis is committed to safeguarding business continuity and considers this to be one of the Groups responsibilities. The Group makes every effort to ensure the supply chain will continue to deliver medicines and vaccines to the market without interruption, with the goal of protecting patients health, each day. Additionally, in the event of a pandemic, the Group is committed to: Reacting as quickly as possible to bring to market vaccines to prevent the pandemic Protecting Group employees Taking all necessary measures to safeguard the continuity of the Groups activities, ensuring that the production of medicines and vaccines will not be interrupted To reach these goals, the Group must be capable of evaluating and assuring preparedness for accidents or health-related risks that could have a negative impact on its activities in particular, the production of medicines and vaccines.
Safeguarding supplies on a daily basis Safeguarding supplies in the event of a pandemic
Policy
Sanofi-aventis has established a Supply Chain Division entrusted with the Group-wide management and coordination of all processes that are part of the Supply Chain. Its role is to guarantee the uninterrupted supply of medicines and vaccines to the market on a daily basis. Many different processes are connected to this mission. They come into play early on, starting with the delivery of raw materials and antigens to production sites, and extending to managing the availability of medicines and vaccines to pharmaceutical distribution channels (wholesalers, dispatchers, warehouses, dispensing pharmacies and hospital pharmacies, etc.). In the event of a pandemic, sanofi-aventis has designed specific processes and continuity plans for Group activities. In a pandemic situation, the Group must simultaneously: Maintain the capacity to continue development, production and distribution of the medicines and vaccines needed to prevent or cure pandemic-related infections as quickly as possible Safeguard the continuity of Group activities to supply all other Group medicines and vaccines for all patients Make every effort to protect all sanofi-aventis employees and, insofar as possible, their families
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Continuity of activities and supplies - Actions

Guaranteeing supply continuity on a daily basis Preparing for health-related risks: The example of the VIGIFLU program
Essential sanofiaventis medicines and vaccines determined for
40 countries
Guaranteeing supply continuity on a daily basis

In order to guarantee continuity for the entire supply chain, Supply Chain management has created dedicated teams in all locations where the Group operates to ensure controlled processes and a policy of continuous improvement.
99.5%
Average customer service rate worldwide:
VIGIFLU : A global
program to ensure preparedness for health-related risks
Identifying key activities

The processes involved in supply continuity include the following activities, for which the Supply Chain Division is directly responsible: Defining product inventory levels, taking into account the criticality, manufacturing times and volatility of products from the viewpoint of commercial forecasts Activating back-up solutions established for certain products Coordinating and supervising crisis situations when necessary
Identifying public health products

For several years, the Groups Global Quality Organization has worked alongside certain sanofi-aventis affiliates and the Supply Chain Division to identify public health products for each country. These are Group medicines and vaccines that have no therapeutic equivalent or for which substitutes would be difficult to find. On the basis of this list, it is possible to define production priorities in the event of a major accident at one of our production sites (fire, natural disaster, etc.) or a pandemic. Contingency plans can be drawn up based on these priorities. To date, this approach has been applied by about 40 countries and will be expanded in 2011 to include all countries where the Group operates. In addition, a management plan to anticipate potential risks in connection with certain products (involving complex manufacturing processes, difficulties obtaining active ingredient supplies, etc.) has been established to determine which medicines are concerned, in order to be able to offer solutions for different markets such as increasing inventories or seeking to identify back-up solutions for the production of active ingredients or finished products.
Proven results
Service Quality is the Supply Chains leading priority, measured by the average customer service rate indicator. For several years now, measurements of customer service rates have been nearly 100% in almost all countries (global average: 99.5%). This service rate is monitored monthly, as is the number of product references subject to inventory shortages, which is monitored twice a month. Thanks to this system, the Icelandic volcanic dust cloud that occurred in April 2010 did not cause any delays in shipments to the affiliates.
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Preparing for health-related risks: The example of the VIGIFLU program

To prepare for a possible influenza pandemic, in September 2005 the Group introduced a global program called VIGIFLU. A multidisciplinary committee with representatives from various departments was entrusted with piloting the
program: General Affairs, HSE, Human Resources, Preventive Medicine, Safety, Communications, Industrial Affairs, Pharmaceutical Operations and Medical Affairs, in addition to an external medical expert. This steering committee is responsible for: Promoting a prevention and employee protection plan that would also cover subcontractors and visitors in the event of an influenza pandemic Ensuring implementation of a business continuity plan for the development and production of the Groups medicines and vaccines to guarantee a regular supply of essential medicines (insulins, anti-thrombotic drugs, cancer drugs, antibiotics, etc.) and other vaccines From the outset, VIGIFLU was implemented at all Group sites, with the creation of dedicated local committees in charge of developing continuity and emergency plans designed for the activity of each site as well as the specificities of each function. In addition, each site organized simulation exercises. Thanks to these preparations, the entire Group was able to respond immediately in April 2009 when an H1N1 influenza pandemic was declared. This momentum was sustained through the vaccination of personnel, completed in early 2010. Following the declaration of the post-pandemic period by the WHO, the Groups strategy was revised. Business continuity plans have been maintained and the committee remains active, for example, by regularly monitoring possible health-related risks worldwide (for example, H5N1 influenza).
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The fight against counterfeit drugs

Background
What is a counterfeit medicinal product? A public health challenge Global mobilization
Since January 1, 2011, all sanofi-aventis products sold in France use the Data Matrix identification system.
What is a counterfeit medicinal product?

There is currently no internationally recognized definition of counterfeit medicines. A medicinal product is considered to be counterfeit when it is deliberately mislabeled with respect to its identity (packaging, labeling information, name and composition) and / or its source (manufacturer, country of production, country of origin, marketing authorization holder) and / or its background (dossiers and documentation related to its distribution network). For more information: www.who.int / Impact / Conference presentations and documents
VIDEO THE FIGHT AGAINST COUNTERFEITING A CHALLENGE FOR PUBLIC HEALTH

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A public health challenge

The figures most commonly cited by international organizations indicate that counterfeiting involves, on average, 10% of the global pharmaceutical market, although this figure may reach up to 70% in certain African and Eastern European countries. The WHO estimates that 50% of illegal medicinal product sales over the Internet are counterfeit. Trafficking in counterfeit medicines is estimated to generate a total of several hundred million euros in sales each year. Counterfeit medicines give rise to multiple risks because they: Endanger patients health (according to the WHO, counterfeit medicines may be responsible for a large number of deaths worldwide) Feed a parallel and freeloading economy, which is contrary to sustainable development and may present risks to safety, hygiene, the environment, ethics, human rights, etc.
2010: Creation of the independent non-profit International Institute against Counterfeit Medicines.
Global mobilization
The fight against counterfeit drugs mobilizes an increasing number of stakeholders, governments and healthcare authorities as well as police organizations and customs officials. In 2010, empowered by this mobilization, sanofi-aventis teams contributed to several investigations that led to the confiscation of 6.4 million counterfeit tablets, compared to 1.2 million seized in 2009. Since 2008, the European Commission has been working on a draft directive to prevent counterfeit medicines from being introduced into the distribution chain. This project advocates, in particular, protecting boxes of medicines by including specific safety features on packaging. The directive was finalized in December 2010.
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Patient indicators Access to healthcare Supporting patients Patient-focused innovation Product risk management Pharmacovigilance Global quality Counterfeit drugs are a major concern for the Group. Continuity of activities and supplies The fight against counterfeit drugs Policy Actions
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The fight against counterfeit drugs - Policy

Counterfeit medicines and access to health The Cotonou Declaration Sanofi-aventis supports the distribution of quality medicines Counterfeit products and intellectual property
The Central AntiCounterfeit Laboratory has analyzed
13,000 products
since it opened In 2010: people received training organized by sanofi-aventis in combating counterfeit drugs, including Group
Counterfeit medicines and access to health
3,140
Nevertheless, sanofi-aventis considers that any action designed to legitimately combat counterfeit drugs must not result in limiting access to medicines for the most disadvantaged patients. Aware of the Groups responsibility on this issue, sanofi-aventis coordinates international efforts to combat counterfeit copies of its products and has established a number of programs to promote access to medicines. Concerning medical products in transit between third countries, the Group has made a commitment not to assert its intellectual property rights when it can be established that the detained products are legal in the country of destination and the country of origin. The Groups policy on the issue of counterfeit drugs has been defined in a position paper.
2,050 outside the

In 2010: arrests in connection with counterfeiting of sanofi-aventis products
154
The fight against counterfeit drugs: the Group's position

While actively engaged in the fight against counterfeit medicines, sanofi-aventis nonetheless believes that, in the interest of patients, this fight should not hinder trade in legal generic products. Furthermore, sanofi-aventis is aware of the fact that generic medicines also enable governments to control their health spending. In its fight against counterfeit medicines, sanofi-aventis in no way equates legal generic products with counterfeit medication. Sanofi-aventis would also like to point out that it operates a wide-ranging policy of access to medicines including generics and vaccines. Because the majority of the worlds population has little or no access to even the most basic medicines, sanofi-aventis has for many years engaged in concrete initiatives to make access to medicines a cornerstone of its strategy towards the poorest and most vulnerable in both developing and developed countries. For sanofi-aventis any action in the legitimate fight against counterfeit drugs must not result in limiting access to medicines for the poor. However, this does not mean that uncontrolled distribution should be allowed to unleash a growing flood of counterfeit products on the developing world. Sanofi-aventis believes that counterfeit or illegal medicines carry many risks including patient health risks as well as supporting a black and sometimes criminal economy. Another risk is the infringement of intellectual property rights that harms innovation, given that these rights are part of a fair and necessary balance to encourage research and reward those companies willing to take the risk of developing new medicines. In order to combat the destructive risks of counterfeit medicines, which are directly opposed to the objectives of sustainable development, EU rules allow for the temporary seizure of a product to enable sanofi-aventis to carry out the tests and inspections needed to ensure that the products in question are not illegal or counterfeit and/or transiting via criminal channels and therefore harmful to the health and safety of patients. Sanofi-aventis bases its actions on considerations of public health arising from the risks associated with the distribution of counterfeit medicines, and in a spirit of cooperation with local authorities. Sanofi-aventis therefore supports the position of the European Commission that Customs inspections may be carried out on goods in transit between third
6.4 million products

were seized in 2010 compared with million in 2009
1.2
countries, particularly by means of the confiscation procedure provided for in Council Regulation EC 1383/2003 of 22 July 2003. However, sanofi-aventis will not avail itself of this procedure, which is designed to enable a rights-holder to assert his rights in the event of an infringement of intellectual property rights, when it can be established that the detained products are legal in the country of destination and the country of origin.
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The Cotonou Declaration Sanofi-aventis supports the distribution of quality medicines

In late 2009, at the request of the Chirac Foundation, the Cotonou Declaration against counterfeit drugs marked the launch of a campaign to instigate unprecedented international mobilization to halt the trade in counterfeit medicines. In collaboration with the Chirac Foundation, sanofi-aventis played a large role in the preparatory work leading up to the declaration. The sanofi-aventis Corporate Economic Security Department continues to work in very tangible ways to support the Foundations objectives. For more information: The Chirac Foundation - The Cotonou Declaration, October 12, 2009
Counterfeit products and intellectual property

Although a specific international definition of counterfeit medicines has not yet been established, sanofiaventis makes a clear distinction between false medicines, which represent a potential threat to health, and patent violations. Sanofi-aventis considers respect for intellectual property to be a critical part of stimulating research and encouraging the risk-taking it involves. The Group believes it is essential for the international agreements of the World Trade Organization (WTO) to be applied and upheld. However, with respect to medical products in transit between third countries, the Group has made a commitment not to assert its intellectual property rights when it can be established that the detained products are legal in the country of destination and the country of origin.
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Patient indicators Access to healthcare Supporting patients Patient-focused innovation Product risk management Pharmacovigilance Global quality Continuity of activities and supplies The fight against counterfeit drugs Policy Actions Organizing the approach Focus on the Central Anti-Counterfeit Laboratory (CLCA) Better protection of the product for better protection of the patient Taking part in national and international organizations Investigations and legal actions Combating networks responsible for illicit sales of medicines on-line Awareness and education
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The fight against counterfeit drugs - Actions

The sanofi-aventis center for the global analysis of counterfeit drugs is a particularly powerful tool in the fight against trafficking in counterfeit medicines. Christian Estrosi, French Minister of Industry, during a visit to the Groups Central AntiCounterfeit Laboratory in Tours, August 2010
The sanofi-aventis center for the global analysis of counterfeit drugs is a particularly powerful tool in the fight against trafficking in counterfeit medicines.
Christian Estrosi French Minister of Industry, during a visit to the Groups Central AntiCounterfeit Laboratory in Tours, August 2010
Creation of the International Institute against Counterfeit Medicines in 2010 International coordination system
The Central AntiCounterfeit Laboratory has analyzed
Organizing the approach

The fight against counterfeit drugs has gradually grown more structured within the Group: 2005: Creation of an anti-counterfeit organization 2007: Creation of a Central Operational Coordination Team supported by an international network of teams within affiliates. Under the direction of the coordinator, all impacted departments are represented and work together to define a strategy and organize the means to combat these occurrences 2008 : Expansion of the correspondent network in over 70 countries and appointment of specialized regional correspondents 2008: Inauguration of the Central Anti-Counterfeit Laboratory (CLCA) devoted to the analysis of suspected products and the development of a database to identify similarities among different suspected products and locate counterfeit networks 2009: In-house initiatives to increase awareness of the counterfeit drug incidents by organizing a number of information meetings for employees at various industrial sites 2010: Expansion of awareness-raising initiatives for employees, mobilization with national and international public authorities in the fight against counterfeit drugs, assistance in dismantling counterfeit networks and organized efforts to combat sales of fake medicines on Internet.
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13,000 products
since it opened In 2010: people received training organized by sanofi-aventis in combating counterfeit drugs, including Group
3,140
2,050 outside the

In 2010: arrests in connection with counterfeiting of sanofi-aventis products
154
Focus on the Central Anti-Counterfeit Laboratory (CLCA)

The sanofi-aventis Central Anti-Counterfeit Laboratory (CLCA), which opened in 2008, is located at the Groups pharmaceutical site in Tours (Indre-et-Loire, France).
6.4 million products

were seized in 2010 compared with million in 2009
1.2
The laboratory is an integral part of the program set up by the Group to combat counterfeit drugs. With a dedicated team of specialists and state-of-the-art technologies, the CLCA pursues a three-fold mission: Perform direct technical examinations of packaging and product inserts as well as the most sophisticated chemical analyses on suspected samples Design new analytical methods, in part with the aim of sharing them globally to allow each industrial site worldwide to apply the same criteria when examining and performing analyses on all suspected products
that correspond to products manufactured by sanofi-aventis Centralize so-called identity cards containing information about counterfeit products in a single, centralized database the only database that enables Group-wide cross-referencing of different counterfeit drugs (*) The CLCA has become an essential tool used by the health authorities, police organizations and customs officials as well as the courts in France, in addition to any country concerned with this issue. Since 2008, CLCA teams have analyzed over 13,000 products.
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Better protection of the product for better protection of the patient

In addition to using safety features on packaging to prevent tampering and ensure seal integrity (tamperevident boxes) as well as safety labels containing both visible and invisible verification systems, sanofiaventis is working on high-tech solutions using codes and identification systems to make product traceability more reliable. Sanofi-aventis is participating in the implementation of a harmonized medicine codification and verification system based on the use of Data Matrix codes and mass serialization combined with routine controls at the time of dispensing. The Group actively supports the EFPIA European project, which is based on the serialization of prescription medicines and the use of the Data Matrix system of 2D bar codes printed on each box. The codes contain information to allow traceability (product code, batch code, expiration date) as well as the serial number (serialized Data Matrix codes). Following the positive preliminary findings of a pilot test initiated in 2009 in Sweden by the EFPIA, in which sanofi-aventis took an active part, the objective is for all European countries to adopt this system. The Data Matrix system offers several advantages because it enables: Harmonization of codes and product identification in Europe to allow improved controls and increased protection at borders (to address the risk of counterfeit medicines entering the logistics chain) Easier batch recalls and automatic detection of expired products Better traceability of medicines in dispensing pharmacies and hospitals, limiting the risk of error during dispensing (in particular when combined with electronic prescription systems) thereby ensuring that the right product is delivered to the right patient Prevention of counterfeit medicines and reimbursement fraud In 2010, sanofi-aventis extended the use of safety labels on the Groups new products and certain sensitive products (Plavix, Taxotere, Jevtana, Multaq, etc.) that are sold worldwide. Since January 1, 2011, all sanofi-aventis products sold in France use the Data Matrix identification system. It is also used in Turkey, where all products sold on this market have a serialized Data Matrix code in compliance with the countrys legal requirements. In 2011, sanofi-aventis will advance its policy of identifying each package of medicines using the Data Matrix system and international standards recommended by the profession, in compliance with legislation in force in various countries.
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Taking part in national and international organizations

Convinced that public / private cooperation is essential to effectively fight counterfeit drugs, sanofi-aventis participates actively in international and local organizations. Internationally, the Group collaborates with: The WHO and the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) International federations (IFPMA) and European federations (EFPIA) in the pharmaceutical industry and the Pharmaceutical Security Institute (PSI) At the local level, the Group is very active with: The National Anti-Counterfeit Committee (CNAC) and LEEM (the French Pharmaceutical Companies Association) in France The Quality Brands Protection Committee (QBPC) in China The Pharmaceutical Research and Manufacturers of America (PhRMA) in the United States These collaborative ties have made it possible for sanofi-aventis to: Take part in drafting a Council of Europe convention to make counterfeiting of medicinal products a criminal offense Sign the Internet Charter to fight counterfeit drugs in France Concurrently, the Group cooperates in joint operations with Interpol (International Criminal Police Organization), the World Customs Organization (WCO) and all customs and police authorities to dismantle counterfeiting networks.
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Investigations and legal actions
The Central Coordination Teams day-to-day mission is to: Investigate every suspicious counterfeit product, whether it is reported by patients, healthcare professionals or the authorities Cooperate with customs officials after submission of our patents (by the Legal Department in charge of trademarks and patents) Ensure tracking and routine intelligence on the Internet Test market surveillance operations in various countries throughout the world Although each case of counterfeiting must lead to legal action, it should be noted that sanofi-aventis seeks punishment rather than compensation. The Groups overriding interest is to seek criminal prosecution, without overlooking civil procedures that will result in the destruction of counterfeit products.
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Combating networks responsible for illicit sales of medicines online

A new international operation targeting the on-line illicit sale of medicines was completed in late 2010. Sanofi-aventis took an active part in this high-impact operation, which was coordinated by Interpol and the WHO. Conducted in 24 participating countries, it resulted in the identification of 125 websites that are engaged in illegal activities for the sale of prescription-only medicines or products suspected of being counterfeit. There were several arraignments, and individuals were taken into police custody. The operation is a reminder to the public that if consumers buy medicines on-line they run a risk of receiving products whose quality, origin and risk / benefit ratio are either unknown or not guaranteed. According to the WHO, approximately 50% of drugs sold on the Internet may be counterfeit. This operation also demonstrated that cooperation between public authorities and private companies is essential to effectively identify and dismantle these networks. In France, sanofi-aventis, LEEM (the French Pharmaceutical Companies Association) and key stakeholders in the pharmaceutical industry signed a charter in late 2009 to combat the sale of counterfeit medicines on the Internet.
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Awareness and education

Raising awareness among employees, healthcare professionals and the healthcare authorities is an important part of sanofi-aventis approach. The Group pursues a policy to actively promote information and education across the globe, based on: Distributing a tool kit for in-house training Creating a press kit about fighting counterfeit drugs, intended specifically for journalists Organizing information meetings regularly at various sites in France and throughout the world Offering training specifically for professionals in charge of efforts to combat counterfeit drugs, as well as healthcare authorities In 2009, nearly 1,000 police officers, customs officials and public health agents received training in 17 countries in Africa, Asia, Europe and the Middle East. In 2010, over 3,000 people were trained (1,090 employees and 2,050 police officers, customs officials and public health agents especially in Russia, Indonesia, Taiwan, India, Vietnam, Bolivia, and the United Arab Emirates). In addition, in 2010 sanofi-aventis took part in the creation of a new training institute: the International Institute against Counterfeit Medicines.
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Creation of the International Institute against Counterfeit Medicines in 2010

The creation of this institute, whose purpose is to provide training in the fight against counterfeit drugs, was driven by sanofi-aventis determination to make a valuable contribution in the fight against counterfeit medicines. Counterfeit drugs are first and foremost a public health issue. The institute was founded in compliance with French law governing non-profit organizations and its articles of association were filed on October 6, 2010 with the appropriate government authority. The institute is located in the Paris region and is fully independent. It has been designed to provide a center of excellence in the fight against counterfeit health products by offering: High-level training that can be applied in the field A unique resource center in addition to an Internet site Research activities to improve knowledge about this issue and develop appropriate responses
In pursuit of these objectives, the institute forges ties with organizations and entities involved in fighting counterfeit drugs and defending patients rights worldwide. The Institute has been designed to accommodate trainees from all over the world. It has two training rooms equipped with interpretation booths, an auditorium with a seating capacity of over 300, a documentation center and a room equipped for Internet use.
International coordination system

To ensure that all cases of counterfeit sanofi-aventis products are detected and managed effectively, sanofi-aventis has organized an international coordination system: The affiliate in question develops a report for the Central Coordination Team and sends suspected product samples to the Central Anti-Counterfeit Laboratory for visual examination and physico-chemical analysis. If the product is confirmed to be a counterfeit, the Central Coordination Team informs all concerned departments and initiates three types of action: public health actions; investigative actions; and legal actions.
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OUR INDICATORS
Ethics
Respecting the rules of ethics
OUR ETHICS INDICATORS

Sanofi-aventis is committed to acting ethically and responsibly at all levels of its activities (R&D, production and marketing). Respecting the rules of ethics in relation to Group employees, patients, customers, suppliers and other stakeholders is one of the pillars of the Groups CSR approach.
Ensuring respect for Human Rights

Sanofi-aventis seeks to ensure respect for human rights at all levels of the Group.
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Ethics in R&D
Sanofi-aventis is committed to respecting the fundamental principles of ethics in its research activities.
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MATERIALITY TEST ETHICS

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Business ethics
Ethics are a core part of the Group's business. Sanofi-aventis focuses on fighting corruption, ensuring compliance with good promotional practices, developing responsible procurement, protecting personal data and promoting free competition.
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BUSINESS CASE
2010 highlights
Human rights
A new human rights training tool was created in conjunction with EDH (Entreprises pour les Droits de lHomme)
BUSINESS CASE: FAIR TRADE Incorporate CSR into the Responsible Procurement approach
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Clinical trials
148 clinical trials conducted in 2010, with 15% of patients coming from BRIC countries (Brazil, Russia, India, China)
Fighting corruption
New anti-corruption procedure established
Responsible marketing
New training program launched for good promotional practices
Risk scale introduced into the Group supplier database
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Ethics indicators
Ethics in clinical trials Use of laboratory animals for research Corporate governance Institutional relations Responsible marketing Fighting corruption Responsible procurement
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Ensuring respect for Human Rights

Background
A key challenge for companies
The issue of ensuring respect for human rights in companies has become a key corporate social responsibility topic as a result of two main factors: international standards have become more stringent, and stakeholders are putting more pressure on companies to provide information on human rights. Beyond legal ramifications, human rights issues may pose a risk for a companys image or reputation, especially when violations are committed by others within its sphere of influence (e.g., suppliers). For this reason, non-financial rating agencies and ethical investors now take human rights issues into account for their evaluations and ratings.
A key challenge for the pharmaceutical industry

When it comes to human rights, pharmaceutical companies must address: The challenges facing all business sectors including social issues (fair compensation, working conditions, occupational health and safety, the abolition of forced labor and child labor, etc.) and environmental issues (protecting the planet, reducing CO2 emissions, etc.). These issues are covered in the PEOPLE and PLANET sections of sanofi-aventis CSR reporting. Issues that are specific to the pharmaceutical industry, particularly those related to the right to health, such as access to healthcare, preventing biopiracy and respecting ethics rules during clinical trials. These issues are covered in the PATIENT and ETHICS sections of sanofi-aventis CSR reporting. For more information: Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines: United Nations Report: The right to health (PDF, 111Kb)
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For several years, sanofi-aventis has developed a set of policies to ensure respect for human rights.
Making a commitment to human rights in companies

Since 2007, sanofi-aventis has been committed to human rights as a founding member of EDH (Entreprises pour les Droits de lHomme) alongside seven other French international groups: AREVA, BNP Paribas, Casino, EDF, Lafarge, STMicroelectronics and GDF SUEZ. EDHs goal is to help make the principles of the Universal Declaration of Human Rights an integral part of company operations through the following initiatives: Discussing and sharing best practices with other players, particularly other companies Working together, and with the main stakeholders in human rights, to develop solutions to improve these practices Participating in discussions and debates in France and other countries on how to incorporate the issue of human rights into company management systems and tools Helping respect human rights within companies For more information: Overview of EDH (in French) (in French, PDF, 20Kb) EDH is inspired by the work carried out by the Business Leaders Initiative on Human Rights (BLIHR). BLIHR is an initiative created in 2003 to provide companies with practical solutions to implement the Universal Declaration of Human Rights. For more information: www.blihr.org
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Human rights - Policy

By complying with international human rights standards and principles, sanofi-aventis has made a formal commitment to incorporate human rights principles in the Groups operating activities.
The Groups Code of Ethics takes as its references the Universal Declaration of Human Rights, the United Nations Global Compact, the Organization for Economic Cooperation and Development directives and the International Labor Organization principles, as well as national laws and regulations. The Group is also committed to the right to health for all, as defined in the International Covenant on Economic, Social and Cultural Rights. Furthermore, sanofi-aventis has complied with the 10 Principles of the United Nations Global Compact since 2003. Within the scope of this commitment, each year the Group issues a Communication On Progress (COP), which is signed by Christopher A. Viehbacher, to report on the Groups progress in human rights to the Secretary-General of the United Nations. For more information: www.unglobalcompact.org Sanofi-aventis Communication on Progress to the United Nations Sanofi-aventis Code of Ethics (PDF, 1836Kb)
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Human rights - Actions

Sanofi-aventis human rights policy is manifested in its actions and commitments, which take into account interactions with stakeholders as well as their expectations, and it is based on compliance with various guidelines.
A new human rights training tool in collaboration with EDH
2010: Self-
assessment at the global level
The codes, principles, charters and initiatives adopted are a clear expression of the Groups resolve to meet an ambitious objective: International standards must be complied with, and it is important to implement a progress-based approach and develop the tools necessary for stakeholder interaction. Identifying and responding to the challenges facing the Group Implementing a progress-based monitoring approach Raising awareness and training employees Contributing to work on ensuring respect for human rights
2011: Introducing self-assessment at certain local entities

2010: Identifying
human rights challenges:

By stakeholder By CSR area
Identifying and responding to the challenges facing the Group

The principles set forth in universal human rights treatises apply to people, nations and by extension, to businesses. In 2010, sanofi-aventis began analyzing for each of its various stakeholders (e.g., employees, patients, suppliers and local communities) the relevant areas of human rights as well as the codes and policies that exist in-house. The following table outlines the human rights issues that sanofi-aventis must address for different Group stakeholders. It illustrates both the diversity of our stakeholders and the range of human rights issues related to them, with particular attention paid to each one. These issues must fall in line with the rules described in various internal reference documents, in particular the Groups Code of Ethics and Social Charter.
STAKEHOLDERS HUMAN RIGHTS ISSUES
Employees
Fair compensation and working conditions Occupational health and safety Non-discrimination and respect for diversity Respect for privacy Freedom of association Abolition of forced labor Abolition of child labor Fighting corruption
Suppliers
Abolition of forced labor Abolition of child labor Fair compensation and working conditions Respect for privacy Freedom of association Non-discrimination
Health, safety and protecting the environment
Patients
The right to health: Access to healthcare Respecting ethics rules specific to the pharmaceutical industry
Local communities
Safety and protecting the environment Contributing to local economic development Respect for hics rules for research and in business
For sanofi-aventis CSR reporting, most of the challenges related to human rights are covered in the following sections: People: Work practices, occupational health and safety practices, non-discrimination, respect for diversity, etc. Ethics : Human rights related to suppliers, fighting corruption, good practices for clinical trials, preventing biopiracy, etc. Planet: Environmental safety and protection, contributing to local economic development, etc. Patient : Regarding specific questions related to the right to health, the Patient section of the CSR Reporting covers several challenges specific to the pharmaceutical industry, such as improving access to health, pharmacovigilance, the fight against counterfeit drugs etc.
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Implementing a progress-based monitoring approach

In 2010, sanofi-aventis introduced an approach to ensure that its human rights policies are implemented, and to identify any areas for improvement.
Analyzing the situation today at the Group level

Sanofi-aventis monitoring approach includes a self-assessment phase for existing practices involving all the relevant functions, as well as a training session. This corporate-level self-assessment, which is based on the Business and Human Rights Matrix of the BLIHR (Business Leaders Initiative for Human Rights), allowed the Group to establish an inventory of its practices at the global and regional levels in 2010.
The Business and Human Rights Matrix is a tool used to: Learn about human rights issues in companies Analyze the situation today Identify all the policies, practices and initiatives aimed at ensuring respect for human rights and provide a basis for developing an action plan For more information: www.blihr.org
Local-level self-assessment
The Group initiated a local-level self-assessment in 2011 for a pilot entity selected based on internal criteria (type of Group activities in the country, number of employees, etc.) and external criteria (risks of human rights violations, etc.)(*). The self-assessment is based on the Danish Institute for Human Rights Quick Check tool. It will be adapted to each country and will include additional questions specific to the pharmaceutical industry. After the local pilot self-assessment is conducted, feedback about experiences will be obtained, and the self-assessment tool will be adapted for other entities. Action plans will subsequently be put in place.
What is Quick Check? Quick check is an evaluation tool provided by the Danish Institute for Human Rights to detect human rights risks. This diagnostic tool is designed to assist firms in the detection of potential human rights violations by looking at the impact of their operations for employees, local communities and other stakeholders. The Human Rights Compliance Assessment Quick Check contains questions tailored specifically to companies. Answers are used to update information contained in the database comprised of the 240 human rights indicators found in the primary international treaties and conventions. For more information: Danish Institute for Human Rights
Monitoring respect for human rights

To monitor respect for human rights, the Group uses an alert system and a targeted audit program for suppliers. The Compliance Department ensures that the Code of Ethics principles are applied throughout the entire Group. The implementation of these codes is coordinated by a Compliance Officer Network and, at
the central level, by the Global Compliance function.

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Raising awareness and training employees

In 2010, sanofi-aventis took part in developing a new inter-company training tool for senior executives of the various companies that are members of EDH (Entreprises pour les Droits de lHomme). The goal for 2011 is to introduce this tool, which uses materials developed with EDH that are tailored specifically to the pharmaceutical industry. Sanofi-aventis plans to use this training to raise awareness about human rights among Group employees. It will improve their understanding of the issues and the risks related to human rights, making it an integral part of business conduct.
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The Groups contribution to work on ensuring respect for human rights

Participating in developing the Guiding Principles
As a member of EDH, in 2010 sanofi-aventis wrote a position paper to contribute to the first draft of the Guiding Principles presented by John Ruggie (Special Representative of the Secretary-General on the issue of human rights and transnational corporations and other business enterprises). For more information: Business & Human Rights Resource Centre Guiding Principles - John Ruggie (PDF, 744Kb) EDHs contribution regarding the Guiding Principles by John Ruggie (PDF, 81Kb)
Participating in drafting official human rights guidance

Within the scope of the United Nations Global Compact, in 2010, sanofi-aventis took part in revising the first draft of Reporting Guidance: 1st and 2nd Principles on Human Rights, which is being developed to help companies comply with the human rights principles of the UN Global Compact.
Analyzing the issue of human rights in due diligence

Sanofi-aventis is part of an EDH working group focusing on due diligence. The purpose of this working group is to review the various resources that deal with human rights due diligence, such as ISO 26000, the Guiding Principles by John Ruggie and other documents and to establish guidelines on this issue.
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Ethics in R&D
Scientific and medical research is an essential part of preventing and combating disease. It demands transparency toward stakeholders, respect for individuals and compliance with regulations. It therefore involves far-reaching ethical considerations.
Ethics in clinical trials

All clinical trials worldwide must be conducted in accordance with the most stringent ethics and quality rules to protect patient safety.
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Bioethics
Sanofi-aventis Bioethics Committee is drafting a Bioethics Charter emphasizing that research must not be conducted to the detriment of basic individual rights.
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Use of laboratory animals for research

Sanofi-aventis is firmly committed to going beyond regulatory requirements to protect the welfare of laboratory animals.
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Nanotechnology
Sanofi-aventis explores new paths of research and uses nanotechnology to bring new benefits to patients.
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Biopiracy
Each time the Group investigates a new product isolated from natural sources, a contract is established, stipulating our adherence to the Convention on Biodiversity. This commitment safeguards against biopiracy.
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No.1 priority:
Patient safety
Ethics in clinical trials

Ensuring patient safety
Before new treatments can be offered to patients, it is crucial to ensure that they are effective and safe. This is why clinical trials are a mandatory part of the marketing approval process, both for the registration of new drugs and for the introduction of new indications concerning marketed products.
What is a clinical trial?

A clinical trial is a research study in human volunteers carried out to answer specific health-related
Biopiracy Business ethics
questions. It may focus on a drug, a vaccine, a medical device or a surgical procedure. A majority of clinical trials are carried out on drugs and are conducted by pharmaceutical companies. Such trials are organized all over the world and must adhere to the most stringent ethical and methodological standards, as well as complying with all applicable national and international regulations. Clinical trials represent one of the essential components in drug development. They are necessary to identify those patients who will best be able to benefit from therapeutic innovations, depending upon their disease or condition. They also make it possible to identify potential adverse events and determine dosage and conditions of use. For more information: What is a clinical trial? Why are clinical trials necessary? What are the criteria for the decision to launch a clinical study? How is a clinical trial organized? What are the risks for patients?
Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation.
Excerpt from the Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects)
TO LEARN MORE ABOUT CLINICAL TRIALS:

www.sanofi.com / R&D / Clinical trial
A major ethical challenge

For pharmaceutical companies, clinical trials represent a major ethical issue, since drugs are not conventional products and patients are vulnerable in view of their disease or risk factors. Vaccines are administered to healthy individuals to prevent disease, and as such, it is crucial for vaccines to be well tolerated and involve minimal risk. Whether a trial focuses on products designed to cure or treat a disease or condition, or prophylactic products that act on risk factors and make it possible to prevent or delay the onset of disease, the trial must be designed to protect the safety of participating patients and ensure their consent is based on clear, complete information.
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PLANET Planet indicators CO2 emissions and energy Local environmental impact Pharmaceuticals in the environment
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No.1 priority:
Patient safety
Ethics in clinical trials - Policy

Respecting the ethics rules that apply to all types of human clinical trials Transparency of information about clinical trials
Respecting the ethics rules that apply to all types of human clinical trials
All clinical trials worldwide must be conducted in complicance with the most stringent ethics and quality rules. Applying internal directives throughout the Group, sanofi-aventis seeks to design and conduct clinical trials that can provide solid and reliable data, focusing first and foremost on the rights, safety and welfare of clinical trial participants. Before a clinical trial may begin, it is routinely subject to multidisciplinary review by sanofi-aventis R&D teams. Information about the studies is then submitted to the health authorities and to independent ethics committees in accordance with applicable local and international regulations.
Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation.
Excerpt from the Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects)
Stringent rules
Clinical trials must follow the rules contained in the Declaration of Helsinki and the recommendations of the International Conference on Harmonization (ICH), particularly Good Clinical Practices (GCP). In addition to these rules, for clinical trials conducted by the Group, sanofi-aventis complies with all applicable national and international rules and laws including: European Directive 2001/20/EC CFR21 regulations issued by the FDA Regulations issued by the Japanese Ministry of Health, Labor and Welfare (MHLW) For more information: The Declaration of Helsinki: www.wma.net / Declaration of Helsinki ICH's recommendations: www.ich.org
TO LEARN MORE ABOUT CLINICAL TRIALS:

www.sanofi.com / R&D / Clinical trial
Ensuring free and informed consent

All documents related to clinical trials particularly written information provided to potential participants must comply with current legislation and regulations. Sanofi-aventis makes sure that all participants (or their legal representatives) enrolled in clinical trials conducted by the Group give free and informed consent to participate in the trial. Consent must be given prior to any procedure provided for by the study protocol and before any data is collected. The principle of free and informed consent applies to all types of clinical trials. To learn more about the different types of clinical trials, see: How is a clinical trial organized? Before a clinical trial is conducted, it is the duty of the physician or medical personnel to ensure that: 1. The participant has completely understood all the information contained in the consent form to be signed by both parties; this information is related to risks, benefits, protection of personal data and study procedures. 2. That he or she is not subject to outside pressure to participate in the trial.
Personal data protection

The collection of personal data within the scope of a clinical trial must be clearly defined prior to any clinical trial, and must be mentioned in the information submitted to relevant authorities.
All participants whose personal data is collected must be fully informed of the purpose of collecting this information and how it will be used. Health-related data, which are considered sensitive data according to regulations, can only be collected once participants have provided their consent. Specific consent may be required to collect genetic data, depending on local legislation. Participants must be clearly informed of their right to access and amend their personal data. Personal Data Protection Charter To protect every individual's right to privacy, sanofi-aventis has outlined its positions in a charter designed to ensure that the use of personal data has a legitimate purpose under local laws and has been clearly defined before it is collected. The goal is to ensure the transparent, fair, secure and confidential processing and transfer of personal data. A Personal Data Protection Committee ensures compliance with the charter at the Group level. Audits carried out by the teams in charge of quality are used to monitor the process. For more information: Personal data protection
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Transparency of information about clinical trials

Responding within the scope of the consultation of stakeholders for the 2010 CSR reporting, Stephanie Dunn, Senior Sustainability Analyst, Dexia Asset Management, stated: Sanofi-aventis should be more transparent in communicating its results of clinical trials, on both the positive and negative outcomes. Sanofi-aventis is committed to being transparent about the clinical trials conducted by the Group. Information on ongoing trials and on clinical trial results is available to the public on the clinical trials registry www.clinicaltrials.gov and the database of results is available at www.clinicalstudyresults.org. For more information on the transparency of clinical trials, see: Disclosure of information on ongoing clinical trials and on trial results Clinical Trial Registry Clinical Trials Results Database
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Ethics in clinical trials - Actions

Monitoring risks and assessing the risk / benefit ratio Conducting clinical trials worldwide Ensuring quality and compliance with ethics rules (3) Training employees Conducting pediatric clinical trials
clinical trials conducted in 2010, of with patients from BRIC countries (Brazil, Russia, India and China)
148
15%
Monitoring risks and assessing the risk / benefit ratio

In order to develop drugs that meet patients needs while protecting their safety, sanofi-aventis has implemented at every stage of the drug development cycle an approach to monitor risks and routinely assess the risk / benefit ratio.. Patient safety risk monitoring is addressed in particular using Signal Detection processes, under the responsibility of the Pharmacovigilance Department. see Pharmacovigilance. Risk / benefit ratio assessment is carried out in coordination with the BRAC Committee (Benefit Risk Assessment Committee). The benefit corresponds to the medical service rendered, and the risk refers to the patients health. The results of this monitoring and the risk / benefit assessment are sent to healthcare authorities, according to a timetable established based on the product's development phases. In order to ensure that this risk monitoring process is transparent, within the scope of certain trials, data is monitored by external independent expert committees (Data Monitoring Committees, DMC) in charge of monitoring a given products safety data. Moreover, the Group ensures there is no financial, regulatory or scientific conflict of interest for any members of the DMC.
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Since 2007, sanofi-aventis has voluntarily submitted clinical trial protocols of malaria drugs to a French independent review board.
176 clinical trial
audits performed in 2010
Conducting clinical trials worldwide

Sanofi-aventis clinical trials are conducted worldwide, including in developing countries and emerging markets. The goal is to be able to: Study global and local diseases Meet the expectations of local scientists Gain access to cutting-edge research Fulfill the requirements to obtain marketing authorization in certain countries Geographic breakdown of patients involved in clinical trials in 2010 (1)
Conducting clinical trials in emerging markets and developing countries

Applying the same ethical standards Clinical trials conducted by sanofi-aventis in emerging markets and developing countries are subject to the same ethical standards as any other clinical trial conducted by the Group, and the same quality
requirements also apply. Sanofi-aventis does, however, ensure that clinical trials are only conducted in countries that comply with current international regulations (ICH, GCP and Declaration of Helsinki) and in countries where regulations guarantee a sufficient level of protection for those participating in clinical trials. Sanofi-aventis has established a global Good Clinical Practices directive based on the U.S. Code of Federal Regulations Title 21 (Food and Drug Administration) and Rules Governing Medicinal Products in the European Union. This directive applies to all Group entities, Medical Affairs, R&D, Vaccines and all affiliates. This directive also ensures compliance with existing national laws, if any. (*) Sharing common interests Organizing clinical trials in emerging markets and developing countries is beneficial for local communities and the Group. For local communities, clinical trials offer several benefits: Providing appropriate medical care for highly prevalent diseases that represent an important public health challenge Development of medical services and strengthening of local skills in connection with training about regulations and international standards Infrastructures developed within the framework of the trials subsequently serving all patients and healthcare professionals, whether or not they participated in the clinical trials For sanofi-aventis, conducting clinical trials in emerging markets and developing countries also offers significant advantages. It makes it possible to: Benefit from good quality infrastructures and equipment, at competitive prices Work with highly-trained medical personnel Benefit from high potential to recruit patients who have not received multiple treatments Valuable participation from emerging markets (1) Sanofi-aventis is determined to expand the Groups role in the emerging markets of the BRIC countries (Brazil, Russia, India and China). The number of clinical trials conducted in these countries and the number of enrolled patients reflects this strategy: Among the 148 clinical trials organized worldwide by sanofi-aventis in 2010, 40% were conducted in these emerging markets. In 2010, 15% of patients enrolled in sanofi-aventis clinical trials were from BRIC countries emerging markets (Brazil, Russia, India and China). Involving developing countries (1) Sanofi-aventis estimates that in 2010, 11% of patients enrolled in clinical trials conducted by the Group live in developing countries (according to the World Bank country classification of low-income and lowermiddle-income economies, as of December 1, 2010). Over 30% of the clinical trials organized by the Group worldwide in 2010 were conducted in a developing country.
Conducting clinical trials in the least developed countries (2)

Clinical trials organized in the least developed countries are limited to those that cannot be conducted elsewhere due to the disease being treated (e.g., malaria). In 2010, five trials were carried out in one of the least developed countries, as defined by the United Nations. These studies were conducted on malaria treatments in Benin, Burkina Faso, Cte dIvoire and Uganda. In these countries, sanofi-aventis continues to pay strict attention to compliance with the highest ethics and quality standards. To strengthen this commitment, since 2007, sanofi-aventis has voluntarily submitted its clinical trial protocols for malaria studies to a French independent ethics committee (CPP Comit franais de Protection des Personnes). In an advisory capacity, this committee reviews projects to be carried out in the least developed countries. (*) A number of international recommendations stipulate that projects carried out in developing countries by sponsors from industrialized nations should be reviewed by two ethics committees: a local committee (in the country where the study is being organized) and a committee in the industrialized country where the sponsoring entity is located. Despite the positions taken by the French National Ethics Advisory Committee, French legislation has no provisions for independent ethics committees to review trials being organized outside of France. The sanofi-aventis Access to Medicines Department considers that it would be a positive step to modify French legislation in order to authorize or require a double review that would align Frances processes with those of most other industrialized countries. This proactive approach has been initiated by sanofi-aventis. In addition, sanofi-aventis supports clinical trials on the efficacy of the malaria drug ASAQ. These studies are sponsored directly by the investigators (Investigator-Sponsored Trials, ISTs). Sanofi-aventis provides the malaria drug ASAQ, and in exchange the Group has access to additional efficacy and safety data. In 2010, two ISTs received support from sanofi-aventis in Burkina Faso. In September 2010, sanofi-aventis was invited to meet with the working group of the EMA in London as a member of the EFPIA. The purpose of this working group is to discuss and provide remarks on ethical issues and good practices regarding clinical trials organized in third-party countries that are part of
submissions for marketing authorization in Europe. EFPIA favors developing a European framework to make clinical trials clearer and more transparent.
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Ensuring quality and compliance with ethics rules (3)

Clinical trials, as well as all the systems and processes involved in these studies, are audited by a specialized internal independent Quality department. A very stringent policy is applied to compliance with Good Clinical Practices (GCP) with the aim of rapidly notifying the relevant managers, regulatory authorities and ethics committees, as appropriate, in the event of non-compliance with these practices. In 2010, 42% of clinical trial audits were carried out in Europe, 27% in the United States / Canada, and 12% in the emerging markets of the BRIC countries. The geographical distribution of the audit program corresponds to the breakdown of subjects enrolled in clinical trials. In addition, 53 inspections were peformed in 2010 by national healthcare authorities with respect to GCP (49 covering pharmaceuticals, and four covering vaccines). Four pharmacovigilance inspections were performed in 2010 (three covering pharmaceuticals, and one covering vaccines). Fifteen percent of these inspections took place in Europe, 46% in the United States / Canada, and 4% in emerging markets (BRIC). For more information on inspections: Global Quality Inspection details
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Training employees
All sanofi-aventis employees who are involved in activities in connection with clinical trials receive continuing education over the course of the year. Training covers ethics, procedures and all quality requirements.
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Conducting pediatric clinical trials

Various regulations were put into effect worldwide to support research in this area and to encourage pediatric trials: The Best Pharmaceuticals for Children Act (United States) The European Directive on medicinal products for pediatric use (1986/609/CE), which went into effect on January 26, 2006 ICH E11 (United States, Europe and Japan). Since 2006, sanofi-aventis has established an international pediatric clinical development network for the purpose of meeting the increasing demand for safe and effective medicines for children. To offer the best quality of healthcare for children, sanofi-aventis takes a number of child-specific factors into consideration when conducting trials -- such as age and psychological and psychosocial situations -- in addition to safety. The informed consent of parents or legal guardians is required for all trials involving children; this may sometimes include a relevant authority within the concerned community. Sanofi-aventis makes its expertise readily available for pediatric drug development in order to meet the highest ethical standards and comply with applicable statutes and regulations in effect.
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(1) Phase I, II, and III trials to develop pharmaceuticals, not including vaccines (2) Phase II and IV trials organized by the Groups R&D and Access to Medicines entities (3) Phase I, II, III and IV trials to develop pharmaceuticals, not including vaccines
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STAKEHOLDERS' PERSPECTIVES:
Bioethics
Scientific research has paved the way for major advances, and today researchers are able to work directly with living organisms, in particular human beings. Although national and international ethics regulations exist, they are not all harmonized. In order for the Groups research to be carried out properly across all sanofi-aventis sites worldwide, it appeared essential to take a stance regarding the main topics in bioethics.
Sanofi-aventis should take a clear position on bioethics, disclosing the current practices, the interactions with stakeholders, including potential different regional approaches.
Stephanie Dunn, Senior Sustainability Analyst, Dexia Asset Management
The Groups position

The Bioethics Charter, which will soon be available, presents an overview of the work of sanofi-aventis Bioethics Committee. In light of todays changing legal context, this charter is designed to provide guidance for all employees and remind them that research on human subjects and biospecimens should never, for any reason, be conducted to the detriment of basic individual rights such as integrity, dignity and privacy. Sanofi-aventis is committed to adhering to these principles in its research programs, particularly in sensitive areas such as: Embryonic stem cell research (within the scope of regenerative medicine) Oncogenetics (genetics of tumors) The study of genetic characteristics of individuals, combined with their response to treatment Gathering collections of samples (within the scope of personalized medicine) Information for individuals participating in research (modifying consent, reusing samples, disclosing information to participants) Protecting privacy (using personal data vs. using anonymous samples, protecting privacy vs. withdrawing consent) Sanofi-aventis will not elect to conduct research in a particular country simply because legislation there is more permissive. The Bioethics Charter will refer to more detailed internal guidelines and procedures that apply to specific situations. Each issue is addressed by an expert working group that sends its proposals to the Bioethics Committee, which in turn endorses the proposals in position papers. Sanofi-aventis is also committed to complying with current local regulations and legislation in each country.
Stem cells
In its position paper, which will be legally validated and finalized after all information pertaining to the use of embryonic stem cells in China has been obtained, the sanofi-aventis Bioethics Committee issued a favorable opinion concerning the use of human embryonic stem cells and their derived cells for scientific research applications and therapeutic applications.(*) This position paper is intended for all sanofi-aventis collaborators. Academic and private collaborators involved in human embryonic stem cell programs must commit to complying with sanofi-aventis Binding Corporate Rules. The committees favorable opinion is restricted to the use or creation of non-totipotent cell lines derived from blastocyst stage in-vitro fertilization surplus embryos. However, it is important to provide the necessary guarantees to the Bioethics Committee. These concern:
Security of access to stem cells (badge, safety area) Data privacy protection using a validated data-processing system that complies with quality and regulatory requirements, making it possible to track embryonic stem cells at all times Providing to the sanofi-aventis Bioethics Committee any documents describing the processes used to create new human embryonic stem cell lines The strict observance by the Group of applicable local law, in particular as concerns declarations and requisite submissions to health authorities The absence of residual embryonic stem cells in the event of the importation of differentiated cells derived from embryonic stem cells
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Use of laboratory animals for research

Policy
Animal experiments are subject to strict regulations to which sanofi-aventis complies both nationally and internationally: Each country or region has its own animal welfare laws that must be followed (e.g., European Directive 86/609/EC, European convention ETS/123 and the Animal Welfare Act in the United States). In addition to regulations, sanofi-aventis adheres to rules and standards developed by:
The Group adheres to the 3Rs principle (replacement, reduction and refinement) and has introduced many related initiatives. Sanofi-aventis focuses particular attention on animals welfare by applying the best standards for care and using all means to minimize pain and distress. Each experimental protocol involving laboratory animals must be approved by an ethics committee that is responsible internally for ensuring the scientific justification of the experiment, verifies that there is no validated alternative method for the research question, and assesses the level of pain that the animal may experience, taking into account all the appropriate measures to prevent pain. All concerned employees also receive regular training.
Focus on the new European Directive on the protection of animals used for scientific purposes (2010/63/EC)
In 2010, sanofi-aventis took an active role in revising the European Directive and provided input to create a balanced regulation that provides greater protection for animals used in scientific research. Sanofi-aventis also took part in revising the ILARs Guide, which is the basis for AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accreditation in all countries. Furthermore, between 2010 and 2013, sanofi-aventis would like to play a key role in transposing the new European Directive into national legislation in various countries by offering the Groups expertise in order to conduct this initiative in collaboration with national authorities and stakeholder representatives.
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Internal policies
In addition to regulatory compliance, the Group proactively implements policies that apply worldwide: Postion paper: Sanofi-aventis commitment goes beyond regulations, for example the Group establishes ethics committees that monitor all aspects of animal welfare. Charter on the Humane Care and Use of Laboratory Animals External studies conducted by third parties on behalf of sanofi-aventis are carried out in accordance with the abovementioned principles. When studies are contracted out, the Procurement Department assesses the service provider using a questionnaire, and on-site assessments are conducted by external experts. Companies must meet the Groups standards in order to be selected.
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Use of laboratory animals for research - Actions

Ethics committees for animal experimentation Groups of experts Accreditation of research laboratories Compliance of new sites
Ethics committees for animal experimentation
Animals are used only where there is a firm expectation that the results will contribute to the protection and / or improvement of human health and safety or the quality of medicines or vaccines Animals are used with the consideration that they deserve and when no suitable alternative exists Absolutely all research protocols are validated by the Ethics committees, whose position is decisive. ethics committees are made up of senior animal researchers, personnel in charge of caring for the animals including at least one veterinarian and an independent member. The presence of a biostatistician on ethics committees is designed to ensure that the lowest number of animals of each species required to generate statistically significant results is used.
Groups of experts
Within the scope of the Groups Transforming initiatives, and in order to strengthen compliance with standards and ensure that they are applied worldwide, special teams have been created, including one specialized in the use of animals in research. These teams, which are made up of internal experts, serve as advisory committees. Four specific groups were created to address topics on an ad hoc basis related to the use of animals in research and share best practices: Public Policy on Animal Research Animal Care and Use Standards Animal Models and Veterinary Clinical Health Refinement, Reduction, Replacement of Animals Used in Research (3Rs)
Accreditation of research laboratories

In addition to national monitoring and in order to guarantee that the Group's laboratories comply with the highest quality standards, sanofi-aventis uses the services of an independent accreditation agency, the Association for Assessment and Accreditation of Laboratory Animal Care. This association is responsible for assessing and certifying laboratory animal health programs. Assessment is based on the animals environment, housing conditions and veterinary care, as well as policies and procedures for animal welfare.
Compliance of new sites

All new sites acquired by sanofi-aventis or sanofi pasteur undergo an animal welfare audit to ensure that the sites comply with the Groups standards. When necessary, an action plan is put in place to meet these standards. The Cambridge, Massachusetts site (formerly Acambis Inc.), which was acquired by sanofi pasteur in 2008, is one of the Groups sites undergoing accreditation.
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Use of laboratory animals for research - Indicators

3Rs principle
Sanofi-aventis adheres to the 3Rs principle and implements the appropriate related measures. The goal is to ensure the research animals optimal health and welfare before, during and after the trial by applying the 3Rs principle (replacement, reduction and refinement):
Replacement
Measures consist of obtaining the same information using lower-order species and alternative methods (without the need to use animals).
Reduction
Measures consist of obtaining the same information while decreasing the number of animals used. Example: The example of sanofi pasteur shows that the number of animals used for vaccines was inversely proportional to the increase in the number of vaccines produced. The number of animals used has decreased since 2004. 3Rs principle - Reduction
Refinement
Measures address animal welfare and aim to minimize pain before, during and after research and improve housing conditions. Two examples of refinement measures are presented below: Using medical imaging Sanofi-aventis seeks to limit unnecessary experiments as much as possible, for example, by using non-invasive methods. In 2006, the Group inaugurated a new building for animal imaging. Non-invasive imaging techniques used in oncology research make it possible to monitor various parameters over time by repeating imaging procedures on the same animals. Imaging techniques have been perfected and can now be used on small animals such as mice, as they are used for clinical diagnostics in humans. Finally, given the sensitivity of these techniques, it is possible to obtain statistically reliable parameters with smaller groups of animals. Medical imaging has thus helped reduce and refine the use of animals in research. Using the dried blood spot (DBS) technique In 2010, dried blood spot (DBS) technology received the sanofi-aventis Global 3Rs Award. The method consists of using serial blood sampling in small quantities (15-50 L), thus allowing one animal to provide multiple samples over the course of the study. In addition to taking smaller blood samples per animal (refinement), fewer animals are needed for pharmacokinetic studies (two to three times fewer animals). Once the technique is fully rolled out, DBS will help significantly reduce the number of animals used for these studies without impacting data quality.
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Protocols reviewed by an internal ethics committee

100% of protocols (for regulatory or non-regulatory studies) are reviewed, debated and approved prior to animal use.
Types of animals used
95% of animals used are rodents. Sanofi-aventis is committed to reducing where possible the use of non-human primates (e.g., sanofi pasteur significantly reduced by approximately 75% the use of primates over the past five years).
Percentage of breeders audited

100% of the breeders are audited internally on a three- or four-year cycle (sanofi-aventis or sanofi pasteur). Breeders are also audited externally by AAALAC and/or national authorities. In cases of non-compliance, measures are taken depending upon the infringement (e.g., a warning or suspension of the agreement until the issue is resolved).
Contract Research Organizations (CRO) audited

100% of CROs used in toxicology studies are audited at least every three years to ensure that they comply with sanofi-aventis quality principles. Moreover, animal welfare audits are conducted when establishing a contract with a CRO.
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Nanotechnology
Nanotechnology refers to the techniques that make it possible to design and produce objects that vary in size by several nanometers (10 -9 m) to dozens of nanometers, depending on the number of molecules combined in the object. Sanofi-aventis works on applications of nanotechnology in biomedical sciences. The scientific challenges, expected technological advances and risks are different depending on the method of administration oral, intravenous or topical.
Research is being conducted in collaboration with an external partner to improve bioavailability and accelerate solubilization of oral medicines. Business ethics Sanofi-aventis also works on intravenous administration to produce objects that are smaller than the smallest capillaries. This type of nanotechnology makes it possible to significantly improve the biodistribution and toxicity profile of injectable medicines. Sanofi-aventis works in partnerhsip with the University of Toulouse on PLA-PEG copolymers. The Group has also started collaborating with the University of Paris-Sud on squalene derivatives and exploring the grafting of targeting agents onto nano-objects. When the active ingredient can be delivered to the target tissue with precision, it becomes possible to customize the patients treatment according to the stage of the disease (e.g., size and / or vascularization of the tumor).
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Biopiracy
Biopiracy refers to the commercial utilization of endemic resources and local know-how without sharing the profits with the communities or countries that are the source. The Convention on Biological Diversity (CBD) describes the principles governing such utilization, although local laws may vary to a great extent.
Each time NPS (Natural Product Science), the research department of sanofi-aventis which performs a majority of the investigations on natural products, purchases new natural sources for its research, a contract is established. The contract has to follow the recommendations of the Convention on Biological Diversity. It is only after the establishment of this contract that the research department receives the samples from its partner and may proceed with its research. In particular, the contract states pre-existing knowledge and industrial property, the conditions for the use of results, the modalities of the transfer of knowledge and if it leads to development and market authorization, any consequential royalties and financial profits. Each new natural source studied (for example, a plant) is registered in a database internal to NPS. Once the natural compounds have been extracted (for example, from a plant), the structures of the pure natural compounds are registered in a Group chemical database. Moreover, when a biological activity is demonstrated for one of these compounds it is also recorded in another Group database, called biological database. Links between the biological and chemical databases make it possible to determine, for each new chemical compound created, whether or not there is a connection with a naturally derived compound.(*)
Depending on the original contract, it may be possible to file a patent when a new biological activity is demonstrated; compound development is then carried out in compliance with the terms of the original contract, and may lead to royalty payments if the compound is brought to market or key clinical steps are taken. Raw material supplied for production may be provided either by extraction from the original source, or by chemical synthesis (semi-synthesis or total synthesis), which is sometimes competitive from an economic standpoint. In the case of extraction, a feasibility discussion will be carried out with partners depending on the quantities required. For more information: Convention on Biological Diversity
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Business ethics
Ethical business conduct is a key issue for sanofi-aventis, which establishes codes and charters to manage its business activity. The Group believes that economic performance cannot be dissociated from responsibility.
Corporate governance
Good governance is the foundation upon which the Group's ethical conduct is built. It is a priority objective for sanofi-aventis and an ongoing approach based on a specially adapted organization that relies on concrete and specific guidelines.
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Institutional relations
Observers expect pharmaceutical companies to be transparent about their lobbying activities and the positions they take on specific issues.
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In all activities that serve to promote or advertise our products, we are committed to applying the highest ethical standards to the materials used providing upto-date, accurate, objective and not misleading materials that are sufficiently comprehensive to allow for a proper assessment of the quality of the product and for its proper use.
Excerpt from the sanofi-aventis Code of Ethics Code of Ethics of the Group (PDF, 896Kb)
Fighting corruption
Fighting corruption is one of the major areas covered by the Code of Ethics, which reaffirms the Groups commitment to fighting all forms of corruption.
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Free competition policy

Sanofi-aventis adheres to the principle that the proper functioning of the economy is based on fair exchange within the framework of open competition.
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2010: New anticorruption
procedure established
E-learning on data protection in 2010: Some 1,200
Complying with the rules of good promotional practices is an imperative for sanofi-aventis.
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Sanofi-aventis adheres to legislation on processing personal data for individuals in order to protect the privacy of patients, employees and partners.
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Binding Corporate Rules (BCRs) and protection of personal data.
employees received training on the
For several years, sanofi-aventis has been committed to developing a proactive approach for responsible procurement with its suppliers.
of Over Group buyers have received responsible procurement awareness training
80%
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Corporate governance
Good governance is the foundation upon which the Group's ethical conduct is built. It is a priority objective for sanofi-aventis and an ongoing approach based on a specially adapted organization that relies on concrete and specific guidelines.
The Groups goal is to be in line with the highest standards for good corporate governance. Thus, practices at sanofi-aventis comply with recommendations contained in the NRE (Nouvelles Rgulations Economiques) and in the AFEP-MEDEF Code de gouvernement dentreprise (Corporate Governance Code of the Association Franaise des Entreprises Prives and the Mouvement des Entreprises de France). The Group has also organized its internal control system through the distribution of Group codes and charters; their degree of implementation is monitored on a regular basis through audits and self-assessments. For more information: Item 6. Directors, Senior Management and Employees, Form 20F 2010, beginning on page 118 Annual Report on Form F-20 2010 (PDF, 1170Kb) Section 1.2. Gouvernement dentreprise of the 2010 Document de rfrence, beginning on page 11 Section 3.2. Rapport du Prsident du Conseil dadministration , beginning on page 170 2010 Document de Rfrence (in French, PDF, 228Kb) Corporate governance organization
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Complying with corporate governance standards

The corporate governance standards used by sanofi-aventis primarily come from the AFEP-MEDEF Corporate Governance Code.
(*) Annual Report on Form F-20 2010 (PDF, 1170Kb)
For more information: www.sanofi-aventis.com / Corporate Governance

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Sanofi-aventis does
Corporate governance in practice

Several examples illustrate the Groups corporate governance practices:
Directors Code Gender balance within management bodies Compensation of senior executives Preventing conflicts of interest No anti-takeover statutes
its major shareholders
not have any cross-holdings in
Directors Code
The Directors Code establishes the responsibilities of the directors, the composition, duties and working procedures of the Board and its Committees, and the roles and powers of the Chairman and the Chief Executive Officer. In February 2011, the Directors Code was updated, in particular to take into account the recommendations of the AFEP-MEDEF Corporate Governance Code. For more information: See Item 6. Directors, Senior Management and Employees, Form 20F 2010, beginning on page 118 Annual Report on Form F-20 2010 (PDF, 1170Kb) Complete text of the Directors Code: 1.2 Gouvernement dentreprise - section 2B : page 12 2010 Document de Rfrence (in French, PDF, 228Kb)
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Gender balance within management bodies

Sanofi-aventis believes that gender balance within management boards helps improve corporate governance. Since 2008, the Group has also been involved in the Boardwomen Partners program that includes CAC 40 companies that want to promote greater gender balance on their boards of directors. Under new legislation in France, within the next three years, 20% of board members must be women, and within the next six years, the percentage must be 40% (French Law No. 2011-103 of January 27, 2011 on the balanced representation of women and men on boards of directors and supervisory boards, and on professional equality). In 2010, the percentage of women on the Board of Directors increased with the appointment of Carole Piwnica, bringing the percentage of women to 14%. On the Groups Executive Committee, one out eight members is a woman. The Management Committee is made up of 24 members, including four women. Responding within the scope of the consultation of stakeholders for the 2010 CSR reporting, Anne Marden, JP Morgan Asset Management, stated: Sanofi-aventis should leverage the international structure to bring out the best of its managerial talent, and encourage more women to seek governance roles ).
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Compensation of senior executives

Compensation and retirement commitments for corporate officers, directors and members of the Executive Committee are detailed in the Document de reference and Form 20F 2010, p. 130.
Compensation is disclosed individually for the Chief Executive Officer and the Chairman of the Board of Directors, whereas the total compensation of all Executive Committee members is presented collectively. For more information: See Item 6.B Compensation, p130 ff, Form 20F 2010 Annual Report on Form F-20 2010 (PDF, 1170Kb) Section 1.2.1 Organes dadministration et de direction - Part 5 Rmunrations, page 36 2010 Document de Rfrence (in French, PDF, 228Kb)
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Preventing conflicts of interest

Sanofi-aventis has introduced measures to prevent risks pertaining to conflicts of interest. Shareholdings: The Group does not have any shareholdings in its major shareholders. As such, there are no cross-holdings. Related-party agreements: In order to protect shareholders and ensure that senior executives and directors do not take advantage of their duties by entering into, for their benefit, agreements that are unfavorable for sanofi-aventis, the commitments made by the Group in favor of a senior executive or a major shareholder are subject to authorization by the Board of Directors and approved by the shareholders at a general meeting. Agreements with corporate officers, directors and the Groups main shareholders are thus presented to shareholders transparently. Related-party agreements are addressed in a Special Report of the Statutory Auditors that is presented in the Document de rfrence. For more information: Section 1.2.2 Conventions et engagements rglements page 49 2010 Document de Rfrence (in French, PDF, 228Kb)
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No anti-takeover statutes
Sanofi-aventis has not established any anti-takeover statutes. The Groups Document de rfrence specifies that the Groups bylaws do not contain any provisions to delay, postpone or prevent a change in control for the Group. Furthermore, the bylaws stipulate that any measures to be adopted to counter a takeover bid must be voted on by the Group's shareholders. For more information: Complying with corporate governance standards
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Institutional relations
The pharmaceutical business model is highly dependent on regulatory frameworks and decisions by administrative and legal authorities. This is especially true of the rules governing research, the procedures to obtain marketing authorization, intellectual property protection and reimbursement policies, which have a decisive influence.
In this field, changes to the regulatory landscape clearly have substantial consequences for a number of social and environmental issues: ethics in research, therapeutic advances, access to treatment, etc. For this reason, observers expect pharmaceutical companies to be transparent about their lobbying activities and the positions they take on specific issues. Through its regional and affiliate public affairs networks, sanofi-aventis develops and maintains relationships with the institutions that draft and enforce the various industry regulations. The goal is to provide information they need and enable them to become familiar with the Groups positions for the sake of clarity and transparency. This mission is carried out in a context of transparency and in accordance with strict ethical rules (respect for individuals and the mandate they fulfill, refusal of practices that run counter to business ethics) and, in particular, the rules specified in the Groups Code of Ethics. For more information: Sanofi-aventis Code of Ethics (PDF, 1836Kb) Included in the Groups objectives are the pursuit of general interests and the development of mutually beneficial solutions, for example, within the scope of public-private partnerships. This direct presence is supported by a strong commitment to participate in key professional federations representing the pharmaceutical industry at national, European and international levels. Committed to the principle of transparency, the Group publishes its primary contributions and in 2009 joined the European Commissions register of interest representatives. For more information: European Commission / Register of interest representatives website
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Major Group contributions

ORGANIZATION GROUP CONTRIBUTION IN 2010 DECISION CENTER
Institutional Relations in the United States* PhRMA (1) LEEM (2) IFPMA (3) Estimated costs related to direct interest representation activities with European institutions Including EFPIA (4) Including EBE (5) Including AESGP (6)
$4,780,000 $10,841,372 3,769,000 $234,000 500,000
Washington Washington Paris Paris Brussels
193,640 22,000 35,000
Brussels Brussels Brussels
* In accordance with the Lobbying Disclosure Act of 1995, the Group reported $4.78 million in general lobbying expenditures to the U.S. Congress
in 2010. This covers the cost of remuneration for all employees engaged in lobbying activities, the use of lobbying consultants, costs related to planning and research activities, operating costs for the sanofi-aventis U.S. government affairs office in Washington, D.C., support staff and the fees paid to professional federations. (1) Pharmaceutical Research and Manufacturers of America (2) The French Pharmaceutical Companies Association (3) International Federation of Pharmaceutical Manufacturers and Associations (4) European Federation of Pharmaceutical Industries and Associations (5) European Biopharmaceutical Enterprises (6) Association of the European Self-Medication Industry
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H1N1 pandemic
Responding within the scope of stakeholder consultation for the 2010 CSR Reporting, Julien Coll of Transparency International France stated: For the 2010 reporting, it is important to provide answers regarding suspected conflicts of interest for the entire industry with respect to healthcare policies adopted in response to influenza A. Given the importance of this issue, sanofi-aventis must present its position.
The Groups position

As a longstanding public health leader, sanofi pasteur the vaccines division of sanofi-aventis greatly contributed to responding to the A(H1N1) influenza pandemic declared by the World Health Organization in 2009. Sanofi Pasteurs teams were fully mobilized for over six months to deal with the public health crisis brought on by the pandemic, producing over 250 million doses of monovalent A(H1N1) vaccine in 2009 and 2010. At the same time, they maintained production of over 180 million doses of seasonal flu vaccines in 2009, and achieved record production of over 198 million doses of seasonal flu vaccines in 2010. As a global leader on the influenza vaccine market, sanofi pasteur worked alongside the WHO and healthcare authorities for the duration of the public health crisis, in order to: Develop, produce and supply the monovalent vaccine for the A(H1N1) influenza pandemic Maintain production and ensure supplies of annual doses of seasonal flu vaccines in 2009 and 2010, for both the Southern and Northern Hemispheres, in line with the Groups commitments as well as recommendations from the WHO and health authorities In December 2009, the Group entered into an agreement with the WHO, in line with sanofi pasteurs commitment in June 2009 to donate up to 100 million doses of influenza A(H5N1) vaccine to be distributed by the WHO to eligible countries in need. As part of the response to the 2009 influenza A(H1N1) pandemic, this donation is intended to help protect the most vulnerable groups against the risk of an influenza pandemic. Sanofi Pasteur also honored a prior commitment made by the Group in 2008 when there was a risk of an A(H5N1) influenza pandemic.
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Sanofi-aventis' key positions

ISSUES SANOFI-AVENTIS POSITION
Human rights
Sanofi-aventis complies with the principles of the Universal Declaration of Human Rights and with the individual rights established by the United Nations organizations.
Human Rights
Sanofi-aventis believes that innovation is the most effective answer to unresolved public health problems (unmet medical needs, technically or economically unadapted treatments, etc.). For this reason, the Group supports public policies and initiatives designed to encourage innovation worldwide.
Patient-focused innovation
Sanofi-aventis considers respect for intellectual property an essential part of stimulating research and ingencouraging the risk-taking it involves. The Group believes it is important for the international agreements of the World Trade Organization (WTO) to be applied and upheld. In a health emergency situation, in compliance with procedures, or in the event of a serious public health crisis, sanofi-aventis position is that intellectual property rights must not stand in the way of access to medicines and vaccines. According to WTO (World Trade Organization) agreements, products manufactured under a compulsory license must be used primarily for crisis management in accordance with TRIPS (Trade-Related Aspects of Intellectual Property Rights) rules. Through its access to medicines policy, the Group also facilitates, as much as possible, access to its products for economically disadvantaged populations, especially for tropical diseases that primarily affect developing countries. Sanofi-aventis ensures product quality for patients and medical personnel in all countries throughout the world. The Group actively supports public authorities efforts, wherever they may be, to guarantee the highest standards of drug quality and safety and fight counterfeit drugs. In accordance with this position, it alerts health authorities of the risks involved in parallel trade and pharmaceutical sales over the Internet. Sanofi-aventis position on products in transit: The Group has made a commitment not to assert its intellectual property rights for products in transit when it can be established that the detained products are legal in the country of destination and the country of origin.
Compulsory licenses
Ensuring the quality of medicines and fighting counterfeit drugs
Fight against counterfeit drugs
Clinical trials
Sanofi-aventis supports efforts to improve clinical trial transparency so that patients and / or healthy volunteers will be well informed about the trials in which they participate and their rights will be protected. It publishes information about its own clinical trials via specialized Internet sites. Regardless of the country where the Group carries out clinical trials, it ensures compliance with ethical standards for the protection of those enrolled in the trials.
Clinical trials
Patients rights
Sanofi-aventis considers that meeting patient needs must be the first criterion to assess the validity and relevance of health policies. Patients should be able to benefit from innovations that can improve their health as quickly as possible without obstruction by unjustified administrative barriers.
Patient
Access to medicine in developing countries
Sanofi-aventis promotes international solidarity efforts making it possible to finance better access to healthcare for populations in need. The Group has numerous partnerships with national and international public health organizations (WHO, Global Alliance for Vaccines and Immunization, Nelson Mandela Foundation, etc.).
Access to Medicines
Good commercial practices
The Group adheres to good commercial practices adopted by professional associations to which it belongs (IFPMA, EFPIA and the main national codes in the United States, France, United Kingdom, Germany, Japan, etc.). Sanofi-aventis refutes any coerced prescription practices or those that could be considered corruption.
Pediatric drugs
Sanofi-aventis routinely studies the opportunity to develop new pediatric medicines, and meets registration agencies requirements. The Group also applies this approach to drugs for the treatment of diseases in developing countries: for example, it produces a pediatric version of the drug combination artesunate + amodiaquine (ASAQ), launched recently by the Group for the treatment of malaria, a disease that especially affects children.
Access to Medicines
Price setting
The Groups preference is to let the market determine the "fair" price of a medicine, for all drugs that are not reimbursed by a public health insurance system. In countries where price setting is practiced by administrative authorities, the Group would like prices to take into account the need to pursue todays research efforts for the sake of tomorrows health. In Europe, where prices are set by authorities in the different countries but products circulate freely, the Group has stated its preference for pharmaceutical companies freedom to set a single "factory exit" price for Europe with variable national compensation (from one country to another) applied to locally consumed products. Experience has clearly shown that parallel trade brings very little benefit to patients. In addition, increasing the number of commercial intermediaries makes it more difficult, and sometimes impossible, to ensure product traceability. This may create patient risk, especially in connection with counterfeit products introduced into commercial channels. For all these reasons, sanofi-aventis has always expressed very strong reservations about the parallel trade of medicine. In accordance with international standards, sanofi-aventis has established principles aimed at preserving the biodiversity of natural plant and wild animal species for use in research projects to discover new drugs, and ensuring fair distribution and sharing of benefits resulting from the use of this type of resource with the countries where these species are found. These principles also emphasize that the Group preserves biodiversity surrounding its sites, particularly those located in sensitive natural areas.
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Parallel trade
Biodiversity
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Fighting corruption
Background
The economic, social and political cost of corruption weighs heavily on development and growth in many countries, and its impact on essential sectors such as the healthcare sector is substantial. As economic players, all companies are faced with this issue. Organizations that are responsible for fighting corruption focus attention on the pharmaceutical industry, particularly in the United States, looking specifically at research (clinical trial transparency), administrative authorization procedures (marketing authorization and reimbursements) and drug promotion practices. In light of this situation, for several years sanofi-aventis has been strengthening its approach to fighting corruption in all countries where the Group operates.
Sano-aventis is fully committed to ghting all forms of corruption in every country in which we operate.
Excerpt from the Group Code of Ethics
23% of alerts
reported in 2010 led to sanctions
Policy
Fighting corruption is one of the central themes of the sanofi-aventis Code of Ethics. The Code reaffirms the Groups commitment to fighting all forms of corruption (active, passive, direct as well as indirect corruption). Under the Code, the Group must comply with anti-corruption laws and focus particular attention on its relationships with third parties. Service providers must adhere to the Suppliers Code of Conduct, which is distributed by the Groups buyers. Link to Responsible procurement. For more information: Responsible procurement Sanofi-aventis Code of Ethics (PDF, 1836Kb)
3,200
Anti-corruption elearning:
participants in 2010
Solid guidelines
To ensure ethical conduct, sanofi-aventis adheres to: 1. The external reference principles of the United Nations Global Compact (principle 10) 2. The principles of the Organization for Economic Cooperation and Development (OECD) 3. The pharmaceutical sector codes included in the Groups Code of Ethics 4. Measures adopted in application of the U.S. Sarbanes-Oxley Act (Section 301)
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Fighting corruption - Actions

Raising awareness about the fight against fraud and corruption Implementing an effective alert system
Sano-aventis is fully committed to ghting all forms of corruption in every country in which we operate.
Excerpt from the Group Code of Ethics
Raising awareness about the fight against fraud and corruption

In order to increase awareness among Group directors, managers and employees, sanofi-aventis communicates information about fraud detection and prevention to all affiliate general managers worldwide. The Chief Executive Officer and Executive Vice President Finance of sanofi-aventis evaluate the adequacy and effectiveness of the Groups control over published financial information and fraud. Local chief financial officers sign an attestation letter twice a year to demonstrate their commitment to the process and to report fraudulent cases, if any, that occurred during that time period. There is no minimum value included in the definition of fraud and appropriate sanctions are levied in all cases.
23% of alerts
reported in 2010 led to sanctions
Anti-Corruption Policy
In 2010, sanofi-aventis established an anti-corruption policy and made it available to all employees via the Groups and Corporate Compliances intranets. The policy was also distributed by Compliance Officers based in all countries. For more information : Anti-bribery policy (PDF, 1190Kb) Implementing training tools Ever mindful of the need to expand initiatives to prevent and combat corruption, the Group provided presentations in 2010 for management committees, regional operational managers and business sector operational managers. Special presentations were also organized in countries such as Ukraine, Greece, Mexico, Brazil, India, the Czech Republic, etc. The Group made special presentations on the Foreign Corrupt Practices Act (FCPA) to the support functions, the vaccines division and employees in the United States. These presentations were then made available to all employees on the Corporate Compliance intranet. In 2010, the Group introduced special e-learning training for all Affiliate Managers, their employees and Compliance Officers. This e-learning tool is also available on the Corporate Compliance intranet. Some 3,200 employees have already taken part in this training. Other tools, such as short videos covering issues including fighting corruption, conflicts of interest and antitrust or competition law, can also be found on the Corporate Compliance intranet. ll the messages contained in these training tools are communicated by the Corporate Compliance team and a network of some 80 Compliance Officers working in affiliates around the world.
3,200
Anti-corruption elearning:
participants in 2010
Implementing an effective alert system

The Group has an alert system to facilitate reporting any failure to comply with laws, regulations or any of the principles established in the Code of Ethics, particularly in terms of financial and accounting standards, internal control, antitrust or competition regulations and fighting corruption. In 2010, the total number of calls received on the alert hotlines from sanofi-aventis affiliates worldwide was 836. Out of these calls, 293 met the Groups definition of a potential violation and were investigated; 23% of these alerts led to sanctions.
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Free competition policy

Sanofi-aventis adheres to the principle that the proper functioning of the economy is based on fair exchange within the framework of open competition.
Competition and antitrust issues may arise from contacts between sanoaventis and its competitors, or between sano-aventis and its suppliers and customers.
Excerpt from sanofiaventis Code of Ethics
Violation of anti-trust and competition laws is punishable by fines imposed on the company and on the implicated individuals and may result in damage claims. In certain countries, serious violations such as illegal agreements on price-fixing or on allocating markets with competitors could be punishable by prison sentences for those involved . Problems associated with competition and with anti-trust activities may arise both from contacts that sanofi-aventis maintains with its competitors and from its relationships with suppliers and customers. In the Groups contacts with competitors, or horizontal agreements , sanofi-aventis employees may never address the following: Price-fixing: tariffs, standards, discounts, conditions for promotions and invoicing, margins, reductions, rebates Product information : marketing projects and strategies Production : industrial capacity, logistics, product quality Allocation of markets: by geographical zones, by customer, or by therapeutic area Financial information : costs of goods and services purchased or products, profits, margins Intention to submit (or not) a bid in a call for tender Existing agreements or contracts with a supplier or customer Within the scope of relationships with suppliers as well as customers, or so-called vertical agreements , any practice of a discriminatory nature as well as boycotting are violations of competition rules and antitrust laws in most countries. In practical terms, this is what sanofi-aventis requires of Group employees: To respect legal and regulatory measures, both national and international, concerning the right to free competition When attending forums, seminars or any other types of meetings, to avoid informal contact with competitors in order to avoid discussing subjects that could be likely to violate antitrust laws. If one or more competitors were to raise such a topic, employees are asked to express their reluctance to continue the discussion. They must not hesitate to state their unwillingness to address a specific topic, and bring an end to the conversation. To contact their supervisor or the Legal Department if they have questions or doubts The sanofi-aventis Code of Ethics contains a chapter on respect for the principle of free competition. For more information: Sanofi-aventis Code of Ethics (PDF, 1836Kb)
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Sano-aventis is obligated to promote products in a manner that is ethical, objective, balanced and reliable when communicating information about our medicines and vaccines. Marketing practices are the focus of growing attention from stakeholders today.
GOOD PROMOTIONAL PRACTICES: SECTION OF THE NEW CODE OF ETHICS

Sanofi-aventis Code of Ethics (PDF, 1836Kb)
General policy
Sanofi-aventis applies the highest ethical standards and is dedicated to providing all necessary information about the proper use of a medicine so that the prescribing physician and patient can make an informed decision.
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Pharmaceutical marketing practices

Sanofi-aventis strives to comply with good promotional practices by monitoring documents, assessing oral presentations, introducing training and implementing warning procedures.
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oral medical sales presentations evaluated in France in 2010 A Green Meeting Charter for an ecoresponsible attitude
582
Training for medical sales representatives

The quality of the information provided by sanofi-aventis medical sales representatives is a constant concern for the Group.
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Promotional samples
Distributing samples is an integral part of promoting medicines, and this activity must be carried out in strict compliance with international rules and local laws.
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Conferences and physicians' meetings

As a leader in the pharmaceutical industry, sanofi-aventis is committed to complying with the industry rules concerning the organization of conferences and physicians' meetings.
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General policy
Complying with the rules of good promotional practices is an imperative for sanofi-aventis.
Over sanofiaventis websites reviewed in 2010 by the Groups Internet Committee
700
The Groups responsibility is engaged when communicating information about our medicines and vaccines. Stakeholders expect a clear commitment from pharmaceutical companies to greater transparency, ethics and standards in marketing practices. Regardless of the promotional materials used, the Group must provide all necessary information to prescribing physicians about the proper use of a medicine so they can make an informed decision about the products risk / benefit ratio. Similarly, the patient must receive all useful information to ensure the proper use of a non-prescription drug. Stakeholders expectations Guidelines and procedures External and internal codes to which the Group adheres
In all activities that serve to promote or advertise our products, we are committed to applying the highest ethical standards to the materials used.
Excerpt from sanofiaventis Code of Ethics Code of Ethics of the Group (PDF, 896Kb)
Stakeholders expectations
Marketing practices in the healthcare industry are the focus of growing attention from stakeholders today, especially patient organizations and consumer advocacy groups, which have called for concerted action by pharmaceutical companies, government, institutions and consumer advocacy groups to: Develop guidelines and common indicators for CSR reporting on responsible pharmaceutical promotion Ensure that industry complies with existing CSR codes, standards and regulations Strengthen existing codes to provide a stricter framework for the promotion of medicines via the Internet, interactions with pharmaceutical companies and patient organizations, and disease awareness campaigns Suggest alternatives to self-regulation alone Promote greater transparency in relationships between pharmaceutical companies and healthcare professionals
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Guidelines and procedures

In order to market medicines internationally, information must be standardized, and the messages conveyed must comply with strict rules. As a global company, sanofi-aventis adheres to the codes governing our industry in Europe (EFPIA), the United States (PhRMA) and worldwide (IFPMA). The internal codes drawn up by the Group to oversee its promotional activities are based on these guidelines and refer to them explicitly. In some cases, however, it is important to take into account specific cultural environments as well as medical care standards and regulations that may vary from one country to another. Procedures and directives that comply with international standards have been established by the sanofiaventis Global Medical Affairs Department: For promotional materials: the principles of Good Promotional Practices, guidelines concerning gifts and promotional items of medical use, procedures for the review of promotional materials, a guide to authorized promotional materials, etc. For websites: the validation procedure used by the Internet Committee for all websites developed by the Group The Group Internet Committee, which is made up of representatives from a wide range of functions (Medical Affairs, Legal Affairs, Pharmaceutical Customer Solutions, IT, etc.) monitors Group websites to ensure they are free of any hidden product promotions. This committee may immediately interrupt access to a website
if it does not meet the Groups criteria for ethical conduct. In late 2010, the Group Internet Committee reviewed and validated over 700 websites, including 145 new websites. A total of 26 Web 2.0 projects were validated in 2010.
Breakdown of websites by target audience
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External and internal codes to which the Group adheres

Pharmaceutical product promotion is governed by national regulations and by codes developed collectively by pharmaceutical companies.
For more information: Sanofi-aventis Code of Ethics (PDF, 1836Kb) Principles of Good Promotional Practices at sanofi-aventis (PDF, 2367Kb) The IFPMA website: www.ifpma.org Directive 2001/83/EC of the European Parliament: www.europa.eu / Community code relating to medicinal products for human use
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Pharmaceutical marketing practices

The Group is responsible for ensuring that the message conveyed by medical sales representatives is fair, balanced, accurate, and not misleading in any way. The information provided by representatives must be fair and ethical, and it must comply with regulatory requirements and in-house conduct standards concerning the promotion of medicines. Practices during pharmaceutical sales visits and the approach taken by medical sales representatives are monitored and evaluated on a regular basis.
2010: a new process for items and gifts given to healthcare professionals
promotional materials reviewed by Global Medical Affairs in 2010 prior to utilization
685
For more information: Sanofi-aventis Code of Ethics (PDF, 1836Kb) Principles of Good Promotional Practices at sanofi-aventis (PDF, 2367Kb) The IFPMA website: www.ifpma.org Directive 2001/83/EC of the European Parliament: www.europa.eu / Community code relating to medicinal products for human use
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Pharmaceutical marketing practices - Policy

Sanofi-aventis adheres to the codes of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The Group explicitly refers to these codes in its internal codes.(*)
Items and gifts given to healthcare professionals

In 2010, sanofi-aventis reviewed the process governing all giving of items and gifts to healthcare professionals in order to ensure Group compliance with relevant local and international regulations. Local regulations have become more stringent, and sanofi-aventis seeks to comply with the highest professional ethical standards by offering items: That help healthcare professionals in their day-to-day work and their interactions with patients, without any direct personal benefit for practitioners That come from suppliers where working conditions are acceptable for workers who manufacture the product That are of satisfactory quality Whose value corresponds to both international and local regulations
685
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You are here: Ethics > Business ethics > Responsible marketing > Pharmaceutical marketing pract... > Actions
Ethics indicators Human rights Ethics in R&D Business ethics Corporate governance Institutional relations Fighting corruption Free competition policy Responsible marketing General policy Pharmaceutical marketing practices Policy Actions Training for medical sales representatives Promotional samples Conferences and physicians' meetings Personal data protection Responsible procurement For more information: Sanofi-aventis Code of Ethics (PDF, 1836Kb)
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Pharmaceutical marketing practices - Actions

The Groups Code of Ethics contains a good promotional practices section in order to ensure compliance with the highest ethical standards throughout the Group.
Principles of Good Promotional Practices at sanofi-aventis (PDF, 2367Kb)
685
Furthermore, sanofi-aventis implements a range of actions to ensure compliance with good promotional practices: Monitoring promotional documents Auditing affiliates Training on good promotional practices Using an internal warning system
Monitoring promotional documents

When they concern the Groups strategic products, all promotional materials developed by the global Marketing teams are reviewed by Global Medical Affairs prior to distribution. Materials developed by the affiliates for local campaigns to promote the Groups strategic products must undergo a similar review by Global Medical Affairs prior to publication or distribution if they are substantially different from the documents developed by the global Marketing teams. Otherwise, affiliate promotional materials are reviewed locally prior to utilization by affiliate marketing teams, and occasionally by Global Medical Affairs. In 2010, Global Medical Affairs reviewed 685 promotional materials prior to utilization. The affiliates are required to send Global Medical Affairs all promotional materials used in the field. In 2010, 25,585 materials were submitted by the affiliates (23,559 in 2009). Global Medical Affairs reviews a sample of promotional materials developed locally. The purpose of this review is to: Assess the quality and volume of promotional materials produced by affiliates Make recommendations for materials to be developed in the future Request corrective measures to be taken, if necessary Collaborate with the Quality Department for audits of affiliates In 2010, the promotional material review process developed by affiliates was enhanced to incorporate a selective approach using a risk analysis method. A letter of non-compliance is sent by Global Medical Affairs when monitoring reveals a minor violation. More significant cases would lead to withdrawal of the promotional material and could result in affiliate audits. In 2010, 22 non-compliance letters were sent concerning one or more promotional materials. No requests to withdraw materials were made.
Auditing affiliates
Within the scope of audits, the Group conducts a targeted audit of the affiliates compliance with the approval procedures for promotional materials, as well as its adherence to sanofi-aventis codes and national regulations concerning authorized promotional material content. This type of audit may cover visual presentations and displays, brochures, the affiliates websites, promotional items for medical use, etc.
In addition, the Internal Audit Department reviews processes in connection with promotional activities as part of its general scope in all countries where the Group operates. If any deficiencies are observed, it recommends corrective and/or preventive measures, and implementation is monitored. Each year, sanofi-aventis draws up an affiliate audit plan.
Training on good promotional practices

The quality and ethics of medical presentations are key challenges. As such, sanofi-aventis focuses on ensuring that medical sales presentations will be fair, accurate and comprehensive, and not misleading in any way. This is accomplished by providing training for medical sales representatives with respect to products, diseases, marketing tools and pharmacovigilance. To a greater extent, affiliates are increasingly testing the knowledge level of their medical sales representatives on a regular basis. The Group offers training on good promotional practices to provide support to medical sales representatives. Training sessions are organized: In response to a request from countries, regions or the Group, or When a need has been identified to improve understanding and compliance with standards established by the Group These training sessions are organized either at the Groups sites or using Internet-based training tools. Training helps ensure that the Groups standards are understood and followed. It also makes it possible keep the regions informed about new issues in the field that they need to take into account for compliance.
Using an internal warning system

Sanofi-aventis has implemented an internal warning system so that employees may report any potential inconsistencies between practices in the field and the Groups Code of Ethics. Employees may also contact the Human Resources department directly. The Compliance Officer at the affected affiliate investigates to determine whether allegations are wellfounded, and then communicates this information to the Group Compliance Department. Confirmed violations give rise to disciplinary measures.
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Training for medical sales representatives

Background
Medical sales representatives must have a sound understanding of the characteristics of the products they promote, as well as their environment, in the broad sense. New employee training is provided to medical sales representatives when they first join the Group. In addition, they receive ongoing training and undergo reviews to test their knowledge. In France, the Public Health Code regulates promotional practices during pharmaceutical sales visits to physicians. In 2004, within the framework of the reform of the national health insurance scheme, the French Pharmaceutical Companies Association (LEEM) and the Economics Committee for Health Products (CEPS) signed the Charter of Ethics for Medical Sales Visits. This Charter sets out and strengthens the role of pharmaceutical sales visits in the proper use of drugs and the quality of information provided to prescribing physicians. In 2006, the French National Authority for Health published guidelines concerning the certification of visits by medical sales representatives. These guidelines reflect the Charter of Ethics for Medical Sales Visits requirements and criteria, which can be audited. The scope of this document, which originally only covered the activity of pharmaceutical sales calls to physicians and specialists whose fees are reimbursed by the French healthcare system, was expanded in July 2009 to cover, the pharmaceutical sales calls to hospitals. The guidelines concern all pharmaceutical sales call activities, whether it involves face-to-face visits or contact by other means; it is applicable to all operating pharmaceutical companies that are signatories to a CEPS agreement. The quality approach undertaken by sanofi-aventis in France is currently being adapted in accordance with these expanded regulations. Thanks to widespread mobilization, in February 2007, sanofi-aventis was one of the first pharmaceutical companies to receive certification from AFNOR, the French Standards Association. AFNOR certification was extended to the Groups hospital pharmaceutical sales calls in January 2010. Certification indicates official recognition for the quality of the information provided during medical sales representatives visits, which comply with standards of ethics and professional conduct. This level of quality provides an additional basis for our customers trust. For more information: Charter of Ethics for Medical Sales Calls (in French) AFNORs website
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2010: AFNOR certification received for hospital pharmaceutical sales calls in France
oral medical sales presentations evaluated in France in 2010,
582
61% compliant
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Training for medical sales representatives - Policy

Compliance with all applicable rules concerning the marketing of pharmaceutical products is a constant concern at sanofi-aventis.
Particular attention is paid to regulations governing the promotion of the Group products, especially regulations concerning side effects and related communication initiatives. Training for medical sales representatives, and the resources devoted to such training, are clear evidence of sanofi-aventis' commitment.
582
61% compliant
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Training for medical sales representatives - Actions

Sanofi-aventis implements a wide range of actions to ensure the quality of the information provided by the Groups medical sales representatives.
582
61% compliant
Product training for newly hired medical sales representatives

When new medical sales representatives join the Group, they are trained in science and in the products that they need to be familiar with for their professional activity. This training has three goals: To enable new medical sales representatives to acquire knowledge about our products To adapt medical sales representatives' knowledge to their product portfolio (e.g., for new products or changes in their workload) To teach medical sales representatives about new developments concerning the products they promote. Training materials are adapted to participants' needs. Specific training is offered about traditional products, as well as consumer healthcare and generic products. Training methods vary and may involve face-to-face sessions, printed documents and remote learning.
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Individual knowledge assessment

The goal is to assess knowledge about basic product information. This evaluation consists of a questionnaire, made available one to two months after the end of training, to be completed on-line at any point during a three-week period of time. The questionnaire includes randomly selected questions about important basic product information covered during each product training session. Participants must answer at least 70% of questions correctly. If their score is below 70%, the questionnaire is made available again two weeks after the first evaluation, to be completed at any time during a two-week period of time. If the minimum score is not obtained the second time, personalized support is provided.
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Improving continuous training

The goal is to enable all members of the sales force to remain up-to-date on essential medical, scientific and product information. Continuous training is essential for medical sales representatives and must: Give them the necessary knowledge about basic product information, which will be the basis of evaluation Ensure that promotional activity complies fully with all applicable rules Maintain quality and high standards Various types of training are offered to reach these goals: printed documents, continuing education, classroom training and other high tech means. Many projects are underway to help further enhance training: Training using printed documents, already widely used, will continue to be developed Continuous training may be offered via remote training methods, for example through virtual classes. Presentations by leaders and / or experts can be used to provide up-to-date information on a given disease or other aspects of their area of specialization
The Group also plans to continue classroom training Lastly, new means of information, such as podcasts, will be offered
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Evaluating pharmaceutical sales visit presentations

Presentations of medical sales representatives are evaluated on a regular basis to guarantee their quality. Meetings for medical sales representatives are organized approximately twice a year in France to present the promotional materials for use during sales visits to healthcare professionals. At each of these meetings, evaluations are carried out to guarantee the scientific and regulatory quality of information and review the presentations delivered by medical sales representatives. The following ratings may be assigned: compliant as is, compliant with revisions, or non-compliant. Sales representatives presentations are corrected as needed during the meeting. Adjustments may be made to ensure compliance with the information contained in the Summary of Product Characteristics (SPCs), with recommendations established by official organizations (such as the Transparency Committee and the French National Health Authority), and to verify the fairness and objectivity of the presentation. Good practices for medical sales representatives are also reviewed (for example, when providing prescribing information and recommendations from the Transparency Committee concerning products presented during the visit). Additional corrective actions, both individual and collective, may also be taken with respect to specific training for medical sales representatives, clarifications and new information for promotional materials, the creation of new documents, etc. In 2010, these evaluations were performed during seminars for medical sales representatives and during dedicated training sessions when they were assigned new products.
In France during 2010, 582 oral medical sales presentations were evaluated. The results of the evaluation are as follows: Compliant as is: 353, representing 61% of the presentations evaluated Compliant with revisions: 229, representing 39% of the presentations evaluated Since the Group began validating presentations in 2006, no presentations have received a "noncompliant" rating.
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Promotional samples
Background and policy Actions

The distribution of free samples is part of pharmaceutical product promotion. Samples must always be distributed in compliance with local regulations and the rules defined by the International Federation of Pharmaceutical Industries and Associations (IFPMA). Sanofi-aventis adheres strictly to the IFPMA Code concerning the promotion of pharmaceutical products and complies with local regulations. These documents define the rules that apply to the distribution of samples. The Group's Principles of Good Promotional Practices outlines these rules. Sanofi-aventis also applies the EFPIA Leadership Statement on Ethical Practices, which recommends that pharmaceutical companies in Europe limit the number of samples distributed to healthcare professionals in accordance with the European Directive.
Actions
Subsidiaries are audited on a regular basis to ensure compliance with rules governing sample distribution. The Quality and Compliance Department of Regulatory Affairs is responsible for these audits. The outcome of audits is contained in a report that may be consulted by Group departments in charge of ensuring compliance with rules concerning promotional practices and training for teams in the field. By performing these checks, sanofi-aventis wishes to ensure no samples are distributed without a prior request from physicians.
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Conferences and physicians' meetings

Background Policy
A Green Meeting Charter for an ecoresponsible attitude
Background
Conferences and physicians' meetings are privileged forums where pharmaceutical companies can communicate the latest scientific data about their products. These events must comply with a number of regulations to which sanofi-aventis adheres. As a leader in the pharmaceutical industry, sanofi-aventis has a constant supply of new information about cutting-edge pharmaceutical products. Consequently, the Group is especially well suited to act as a partner for learned societies that organize international congresses. Conferences and physicians' meetings must comply with the general principles of the pharmaceutical industry and the legislation and regulations in force where they are held. The obligation to take into account local requirements is recent for international congresses. As a result, measures must be taken to ensure that local regulations are applied. This means having sound knowledge, in advance, of specific aspects of local regulations and having close ties with the senior management of the affiliate where the congress is being held. For more information: Code of Pharmaceutical Marketing Practices on the IFPMA website
hospitality guidelines
2010: Sanofi-aventis updated its
Personal data protection Responsible procurement
Policy
Sanofi-aventis is committed to ensuring that all the Groups affiliates respect the rules of good conduct when it comes to the organization of physicians' meetings. All organized events medical conferences, international conventions, targeted meetings and medical training must comply with numerous external rules that govern the relationship between the pharmaceutical industry and healthcare professionals: IFPMA, EFPIA and PhRMA codes, as well as local legislation in the countries where the events are held. The comprehensive regulatory framework defines the conditions that determine, for example, whether a pharmaceutical company may cover travel expenses for healthcare professionals (travel conditions and type of hospitality, hotels, etc.) as well as congress registration fees. The Medical Information and Promotional Material Excellence Department ensures that all documents used during congresses and satellite symposia comply with local regulations. Affiliates are also consistently consulted when congresses take place in their country.
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Conferences and physicians' meetings - Actions

Participating in scientific events Developing the Groups Green Attitude Updating hospitality guidelines
A Green Meeting Charter for an ecoresponsible attitude
Participating in scientific events

Scientific events organized or sponsored by sanofi-aventis during 2010 fall into three categories: Conferences and international conventions that may bring together healthcare professionals, competitors in the pharmaceutical industry and a wide range of organizations. The overall objective is to promote knowledge-sharing and exchange. Targeted meetings organized entirely by sanofi-aventis that are specifically designed to take stock of the Groups scientific projects both current and future. They may also focus on new developments in a given therapeutic area. Participants at this type of meeting may include sanofi-aventis employees, recognized scientific experts from outside the Group and healthcare professionals. Training seminars targeting healthcare professionals, organized with the support of sanofi-aventis at the request of professional groups, universities, foundations, etc. The Groups support may include providing expertise and / or financial support (i.e., grants) that are necessary to make this type of training possible. The Group has created a grant approval system for the formal review of grant applications. It is selective in the grants it approves and only provides support for training that is designed to enhance healthcare professionals expertise, thereby contributing to improving medical care for patients. Certain meetings may be accredited by ad hoc organizations, such as the American Academy of Continuing Medical Education (AACME) in the United States and the European Accreditation Council for Continuing Medical Education (EACCME) in Europe. In this case, training is officially recognized as continuing medical education for healthcare professionals who attend the meetings.
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hospitality guidelines
2010: Sanofi-aventis updated its
Developing the Groups Green Attitude

Sanofi-aventis is dedicated to fostering eco-responsible behavior for the conferences and events at which the Group participates. The Group established a Green Meeting Charter in 2010. The charter lists ten key points to be used whenever the Group organizes events, in a variety of areas including: transportation, using environmentallyfriendly materials, communication tools, accommodations, etc. For more information: Sanofi-aventis Green Meeting Charter (PDF, 93Kb) PLANET CO2 emissions Green Meeting
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Updating hospitality guidelines

In 2010, the Group revised the sanofi-aventis hospitality guidelines with respect to healthcare professionals. Various employees who deal with hospitality issues within the Group worked in close collaboration to revise these guidelines. In 2011, an awareness campaign about the hospitality guidelines will be organized using an e-learning tool. For more information: Hospitality Rules for Healthcare Professionals (PDF, 485Kb)
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Personal data include all information that makes it possible to identify an individual, a company or an organization. Due to the widespread use of information technology today, protecting personal data is a CSR issue.
Given the rise in the international transfer of personal data, it has become essential to protect these data in order to guarantee fundamental liberties, especially the right to privacy, which is an integral part of Human Rights. Background and policy Actions
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You are here: Home > Ethics > Business ethics > Personal data protection > Background and policy
Ethics indicators Human rights Ethics in R&D Business ethics Corporate governance Institutional relations Fighting corruption Free competition policy Responsible marketing Personal data protection Background and policy Actions Responsible procurement Respecting the regulatory framework What types of data are concerned?
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Personal data protection - Background and policy

Respecting the regulatory framework

In the countries where sanofi-aventis operates, the Group respects local legislation and laws governing the processing of personal data. Such legislation is designed to protect the right to privacy. For more information: World map of countries that have adopted personal data protection laws: www.privacyinternational.org / Data Protection Laws Around the World European Directive of October 24, 1995: Eur-lex.europa.eu / Directive 95/46/EC of the European Parliament and of the Council French National Data Protection Authority (CNIL), which is in charge of ensuring respect for the French law on information technology & civil liberties: www.cnil.fr / English
What types of data are concerned?

Three main types of information are included within the scope of personal data protection:
Data for patients involved in clinical and pharmacovigilance trials

These data consist of information about individuals who receive our treatments (during clinical trials, genetic studies, epidemiological and pharmacovigilance studies, etc.). Patients personal data include information that is necessary to conduct the studies (for example: age, gender, genotype, phenotype, etc.). For processing, a distinction is made between two types of information: data used for clinical development research and data used for other types of research (biobanking data, for example). In Research and Development, informed consent is required each time a patient participates in a clinical trial. Informed consent ensures both respect for the right to privacy and data protection.
About informed consent

Informed consent makes it possible to: Protect each individuals right to privacy by making sure that personal data are used for legitimate purposes consistent with local legislation and that such utilization is clearly pre-defined Support the protection of personal data by ensuring transparency and fairness as well as security and confidentiality during personal data processing (making sure that measures are taken to prevent fortuitous or illicit destruction, accidental loss, modification, disclosure and unauthorized access) Ethics in clinical trials
Data regarding employees

These data may be found, in the Human Resources systems or in files that ensure the traceability of our activities (audit trails and logs), as well as occupational medical records, employee directories and even Intranet access.
Data regarding the Groups partners
Data about commercial partners may concern physicians, investigators and subcontractors, for whom sanofi-aventis must guarantee compliance with the same rules (respect for privacy and data protection).
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Ethics indicators Human rights Ethics in R&D Business ethics Corporate governance Institutional relations Fighting corruption Free competition policy Responsible marketing Personal data protection Background and policy Actions Responsible procurement Defining rules at Group level Developing training modules Organizing the approach
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Personal data protection - Actions

To ensure the personal data protection within the Group, sanofi-aventis implements various actions:
All our employees, and third parties with whom sanoaventis has dealings (patients enrolled in clinical trials, medical practitioners, contractors, representatives of the scientic community, etc.), are entitled to their privacy. Sano-aventis is committed to protecting their personal data.
Excerpt from sanofiaventis Code of Ethics Code of Ethics of the Group (PDF, 896Kb)
Defining rules at Group level

The sanofi-aventis approach is based on the Code of Ethics, the Groups Personal Data Protection Charter and the Binding Corporate Rules (BCR).
The Code of Ethics

The sanofi-aventis Code of Ethics contains a chapter that addresses personal data protection. In the Code of Ethics, which is available to all employees, sanofi-aventis confirms its commitment to protecting personal data by guaranteeing a persons right to exercise control over the collection, processing, use, dissemination and storage of his / her personal data. For more information: Sanofi-aventis Code of Ethics (PDF, 1836Kb)
2010 : dploiement des BCR (Binding Corporate Rules) dans lensemble du Groupe.
The Groups Charter

Based on the European Directive of October 24, 1995, sanofi-aventis also established the Groups Personal Data Protection Charter. Available on the Groups web site, this charter ensures that the same policy will be applied in all countries. It also ensures compliance with local legislation where laws have been enacted. For more information: The Groups Personal Data Protection Charter (PDF, 66Kb)
employees received training about BCR

and personal data protection.
In 2010, e-learning about data protection: Approximately 1,200
BCR (Personal Data Protection)

The transfer of personal data is authorized among member states of the European Union because each country has transposed the Directive of October 24, 1995, which in particular sets out the standards to guarantee the protection of personal data during their transfer. For countries outside the EU that are not bound by this European Directive, the transfer of data to one of these countries may only take place if th e individual whose data are transferred gives explicit consent, and if a specific contract has been established between the country that exports and the country that imports these data. To harmonize data transfers outside the European Economic Space, sanofi-aventis has adopted internal rules known as Binding Corporate Rules. These have also been validated by the French National Data Protection Authority (CNIL) and by the authorities in charge of personal data for the European Economic Area. Each sanofi-aventis affiliate concerned by these data transfer rules (BCR) has signed a contract, which has also been validated by the CNIL, making explicit their commitment to respect these rules. The Binding Corporate Rules, which were approved in late 2009, started to be applied within the Group in 2010.
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Developing training modules
Sanofi-aventis has developed training modules concerning personal data and BCR so that all employees will be aware of their importance. The training modules, available on the Groups Intranet site and through the Compliance Officers Network, will be updated on a regular basis. There are two types of training modules: General training about personal data protection, designed for all employees Specialized training focusing primarily on BCR, intended especially for Group employees in charge of databases containing personal information Initially provided in French and English, the training modules come with a translation kit so that affiliates may develop adapted versions in their local language.
The purpose of these remote modules is to train as many employees as possible. By late 2010, they were distributed to all the Groups support functions. They will be rolled out in all countries in 2011.
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Sanofi-aventis has taken several measures to ensure compliance with procedures, including: A dedicated Intranet site A Compliance Officers Network whose task it is to ensure that all Group employees have access to the sanofi-aventis Code of Ethics and Personal Data Protection Charter A Personal Data Protection Committee
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Ethics indicators Human rights Ethics in R&D Business ethics Corporate governance Institutional relations Fighting corruption Free competition policy Responsible marketing Personal data protection Responsible procurement Actions Indicators Business case
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When it comes to procurement, Corporate Social Responsibility matters. CSR in this sector aims to select goods and services that are provided in compliance with the highest social, ethical and environmental standards. Procurement and responsibility Sanofi-aventis commitment
Average value of goods and services purchased annually by sanofiaventis:
11 billion
Over of Group buyers have received responsible procurement awareness training
80%
Procurement and responsibility

Until recently, the role of the Procurement Function within a business was to guarantee that suppliers deliver goods and services of the highest quality, on time and at the best price. But this role has changed: in an ever more global world, which evolves at an ever more rapid pace, with disparate social and environmental regulations at the local level, buyers can no longer ignore the ecological impact of the goods and services they purchase. Similarly, they must take into account the social, ethical and environmental context in which goods and services were produced or provided.
READ MORE ABOUT SANOFI-AVENTIS SOCIAL CHARTER

Sanofi-aventis commitment
Each year, sanofi-aventis purchases goods and services for an average value of 11 billion. Several years ago, the Group implemented a clearly-defined program with suppliers. As part of the program, the Group made the following commitments: Share with all suppliers the fundamental principles of the United Nations Global Compact as well as the Group's values. For more information, see the United Nations Global Compact website: www.unglobalcompact.org Require compliance with these principles and values in the production of goods and provision of services to sanofi-aventis Incorporate respect for the environment in the general conditions of goods and services purchased by the Group In 2010, the Group set certain goals to help its suppliers become even more involved in this approach. These goals are summarized in the following table:
Areas for progress: Involve suppliers in the Responsible Procurement approach

GOALS 2010 RESULTS 2010
Support Procurement colleagues as they pursue operational implementation of the program through targeted training sessions. Gradually incorporate the Responsible Procurement approach into the missions and individual goals of each buyer. Improve awareness about the Group's Sustainability approach among suppliers. Expand the program to more countries.
Over 80% of sanofi-aventis buyers have received awareness training about Responsible Procurement.
Improved supplier awareness continued in 2010.
By late 2009, 48 Procurement organizations in 29
countries had introduced the Responsible Procurement program. Improve targeting of procurement categories involving environmental and social risk. Targeting suppliers in procurement categories involving environmental and social risk was improved by introducing a risk scale into the Group supplier database in early 2010; by late 2010, 50% of suppliers belonging to what are considered high-risk categories had been or were being evaluated (for a total of 1,883 suppliers). By late 2010, 1,883 suppliers had been or were being evaluated, including 1,156 for Industrial Operations; 100% of chemical product suppliers in India and China had been evaluated.
Sustain the programs momentum; over 2,000 suppliers were evaluated by the Procurement organizations within the various functions, with improved targeting of procurement categories considered to involve environmental and social risk (chemical products, management of chemical, biological and electronic waste, suppliers using lowskilled workers).
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Responsible procurement - Actions

When it comes to training, evaluation, awareness and selecting products and services, sanofi-aventis translates the Groups commitment into actions:
Train procurement employees and roll out the approach among suppliers Risk evaluation Create awareness among suppliers Supplier evaluations Selecting goods and services that are environmentally friendly
By late 2010, procurement
48 29
organizations in countries had rolled out the Responsible Procurement program.
By late 2010,
1,883 suppliers
had been or were being evaluated

BUSINESS CASE
Train procurement employees and roll out the approach among suppliers
To ensure that Group buyers have a sound grasp of the issues and of the Responsible Procurement approach, sanofi-aventis has implemented a training program worldwide. This training program helps integrate a sound understanding of the principles contained in the United Nations Global Compact, Conventions of the ILO (International Labor Organization) and other specific standards (in particular, SA 8000 and ISO 14000). The training program has greatly enriched the Procurement Function. It contributes to implementing the Responsible Procurement approach throughout the Groups affiliates. In addition to the training sessions, this topic is routinely addressed at all regional Procurement conferences.
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Risk evaluation
A social and environmental risk scale has been incorporated into the Groups global supplier database. The purpose of the risk assessment methodology is to identify suppliers that should receive priority attention in terms of evaluation and monitoring. Two criteria are considered: First, the risk of social and environmental controversy in connection with the procurement category of that supplier Second, the risk that such a controversy could harm sanofi-aventis reputation The following diagram presents the criteria for analysis and the questions asked at each step:
By late 2010, 50% of suppliers belonging to what are considered high-risk categories had been or were being evaluated (a total of 1,883). In certain countries such as China or India, where risks are considered to be more significant, the Group decided to routinely evaluate all chemical product suppliers.
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Create awareness among suppliers

The sanofi-aventis Code of Conduct, which is distributed to all suppliers, was developed to ensure that all suppliers are aware of the Groups CSR principles. This code of conduct is part and parcel of the Groups CSR approach. Suppliers compliance with the code determines their commercial relationship with sanofi-aventis. The Group thereby intends to require its suppliers to comply with fundamental social, ethical and environmental principles.
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Supplier evaluations
To ensure they comply with the Groups fundamental principles, suppliers are evaluated during two- to three-hour interviews. A general questionnaire containing 30 questions about social, ethical and environmental issues provides a basis for discussion. Depending on the type of supplier, more specific additional questionnaires are used, in particular for suppliers using low-skilled workers, IT purchases and the purchase of animals used for research, etc. In addition to these evaluations, site audits may also take place. Following the evaluations and audits, an improvement plan may be developed and discussed with the aim of improving supplier compliance with the fundamental principles.
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Selecting goods and services that are environmentally friendly

Sanofi-aventis is committed to respecting the environment on a day-to-day basis. Through its procurement policy, it can contribute to the Groups goal of reducing our carbon footprint. It has adopted the use of a certified electronic product registration system (i.e., the Electronic Product Environmental Assessment Tool, or EPEAT) to ensure that the electronic products we purchase adhere to environmental standards (energy consumption reduction). The Group also wants to promote fair trade by using work garments manufactured with fair-trade cotton. And when Procurement acquires office equipment and supplies, it seeks products that take into account sustainability, i.e., products that can be recycled or are made of recyclable or environmentally-certified materials. For more information about fair-trade work garments: Business case
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155 new suppliers

evaluated in 2010
Responsible procurement - Indicators

In 2010, sanofi-aventis continued to implement the Responsible Procurement approach initiated by the Group several years ago and made use of dedicated collaboration-based tools.
100% of chemical
product suppliers in India and China have been evaluated
As a result, by late 2010, more than 80% of Procurement employees worldwide had participated in awareness-raising initiatives as part of the Responsible Procurement approach. This educational program is essential to successfully incorporate the approach in the day-to-day practices of sourcing and monitoring suppliers. The Group also continued supplier evaluations. In 2010, 155 new suppliers were evaluated to reach a total of 1,883 suppliers who have been or are being evaluated in 29 countries (including 19 on-site audits and 5 re-audits). The evaluations may be broken down as follows::
APPROVED (1) ACTION PLAN (2) REFUSED (3) ONGOING (4) TOTAL
BUSINESS CASE
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Industrial Affairs R&D Commercial Operations Vaccines TOTAL
953 198 289
37 5 43
11 14
155 47
1,156 203 393
112 1,552
2 87
1 26
16 218
131 1,881
(1) The evaluation shows that the supplier complies with sanofi-aventis values and principles. (2) Improvement is needed on one or more major points and the supplier agrees to implement an improvement plan. (3) Improvement is needed on one or more major points but the supplier refuses to implement an improvement plan. (4) The evaluation process is ongoing. In line with the Groups commitment, it should be noted that 100% of chemical product suppliers in India and China were evaluated.
AFRICA / MIDDLE EAST AMERICA ASIA / OCEANIA EUROPE
Countries
Algeria Egypt Morocco South Africa Tunisia
Argentina Brazil Canada Colombia Mexico United States Venezuela
Australia Bangladesh China India Indonesia Japan Pakistan Turkey Vietnam
France Germany Greece Hungary Italy Poland Spain United Kingdom
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Business case: Fair trade

Fair trade makes its entry into Industrial Affairs Standardize work garments used at the Groups industrial sites > Incorporate CSR into the Responsible Procurement approach.
FAIR TRADE project launched in 2008: Cross-functional project involving Procurement, Industrial Affairs, HSE, HR, Quality and service providers Decision to design only 3 types of fair-trade cotton work garments (one collection each for chemical manufacturing, pharmaceuticals and distribution)
For cotton-producing countries and local populations: Positive socio-economic impact: stable income, development benefits, job creation Agricultural practices that do more to protect the environment
In France, 100% of the Groups chemical manufacturing sites and distribution sites and 83% of pharmaceutical sites use work garments made from fair-trade cotton. Standardization: Facilitates traceability, supplies, cleaning and upkeep of work garments Contributes to enhanced safety for employees Ensures cost control and conveys a positive image of fair trade both internally and externally
Potential to replicate this approach at other sites, especially in the UK, Morocco, Brazil and Spain
The challenge
The challenge consisted of incorporating CSR into the Groups Procurement policy. This story began in 2008 when supplier contracts for work garments expired at certain sites in France. An idea took shape: why not harmonize these contracts through Group Procurement? As meetings were organized, the garment manufacturers asked about using fair-trade cotton, providing the perfect opportunity to embark on a CSR project. It required the backing of Group management, which was easily obtained. With managements support, a comprehensive approach was established and managed by the Industrial Affairs Procurement Department, covering each step from harvesting the cotton to delivering the work garments at the sites.
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Our response
Using fair-trade cotton to create work clothing required re-thinking the design of the uniforms themselves, thus creating a new opportunity: the standardization of work garments for all Industrial Affairs employees at French sites, by activity (chemical manufacturing, pharmaceuticals and distribution). The project, which involved many different stakeholders, was initiated in 2008. It involved teams at the participating sites including HR, HSE, Quality, Procurement and service providers to manufacture and clean the garments. The teams involved in the project faced a major challenge: each garment had to meet specific standards, requirements and characteristics in connection with each plants workstations and safety concerns. As a result, several different collections of garments had to be redesigned. Taking into account that each site is free to select the service provider of its choice to manage its garments was an additional factor making this a complex project. In response to this challenge, the Group adopted a very clear methodology: Convince the sites that this is a worthwhile project Standardize the garment collections Remove intermediaries in the choice of collection Take control of the garment production chain Garments are made from fair-trade cotton grown in Mali or Senegal by producers whose identification, certification and traceability are established. Spinning and weaving take place in France and the garments are made in Tunisia and Morocco.
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The Responsible Procurement approach implemented by sanofi-aventis has a positive impact at many levels for cotton-producing countries and local populations: First, from a socio-economic viewpoint. The people who produce and process the cotton can count on a stable income because the cotton is sold at a guaranteed minimum price. There is also a development benefit: because the selling price is slightly above market price, cotton-producing countries commit to investing in local development projects. Fair trade also contributes to creating agricultural jobs. From an environmental viewpoint, fair-trade agricultural practices respect of the planet. They support traditional growing by family farms and village cooperatives, rather than large landowners. They give priority to rain-fed farming (bearing in mind that irrigation-based farming requires 29,000 liters of water per kilogram of fiber produced), manual harvesting and limited chemical inputs. Growers can continue mixed-crop farming and crop rotation, alternating cotton and cereal crops.
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Nearly three years after sanofi-aventis launched this project, 100% of chemical manufacturing sites, 100% of distribution sites and 83% of pharmaceutical sites in France use work garments made from fair-trade cotton. Moreover, the choice of work uniforms has been standardized, with a total of three collections today in France: one each for chemical manufacturing, pharmaceuticals and distribution sites. As a result of standardization, it is now easier to manage supplies at the sites; cleaning and upkeep of garments has been simplified. Thanks to close cooperation with HSE teams, the most recent garments offer improved safety for employees (for example, flame-retardant fabric). Contrary to expectations, using fair-trade cotton to make these work garments has not turned out to be more expensive than using traditional cotton. In fact, the opposite is true; by reducing the number of models, standardization has made it possible to increase procurement volumes, which controls costs. Fair-trade work garments also convey a positive image for the Group both in-house and externally. Each garment carries a sustainability label in recognition of the project. Sanofi-aventis received a Procurement Award for this initiative. Conferred by the French Buyers Association (CDAF), the award in the sustainability category was presented on June 14, 2010 at a ceremony attended by the French Secretary of State for Small- and Medium-sized Enterprises. Last but not least, this project provides the perfect illustration of how it is not only possible but actually advantageous to incorporate CSR into procurement practices.
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The fair-trade cotton project, initiated and piloted by the Industrial Affairs Procurement Department, should gradually be expanded to the primary pharmaceutical production sites worldwide, especially in the United kingdom, Morocco, Brazil and Spain.
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OUR INDICATORS
People
Employees and communities
As a global healthcare leader, we believe that the men and women of sanofi-aventis are key assets for the Groups development, and we are committed to meeting the challenge of supporting them during the Groups transformation process.
OUR PEOPLE INDICATORS

Diversity
Sanofi-aventis is committed to preventing discrimination and considers diversity to be a resource to optimize performance.
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Supporting change
The Group is committed to supporting employees as they change functions and organizations by offering solutions adapted to the needs of each individual.
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MATERIALITY TEST PEOPLE

See the results

Developing skills at all levels and in all countries, because each employee has talent and potential.
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Ensuring occupational health, safety and well-being

The Group applies risk prevention strategies to protect the safety and health of employees.
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Relationships with schools and universities

To attract new talent, sanofi-aventis has forged numerous ties with schools and universities to give students the opportunity to learn about or join the Group.
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Compensation and employee benefits

Committed to fair recognition for performance, sanofi-aventis institutes appropriate policies for compensation and employee benefits in all countries.
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Respect for country cultures and their diversity is a source of wealth for sanofi aventis. We try to combine the best of these models to create a single identity and ensure the success of the Company and its employees.
Robert Pucci, Senior Vice President, Human Resources, sanofi-aventis

Sanofi-aventis places an emphasis on social dialogue as a means to inform, anticipate and adapt.
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As a global player, sanofi-aventis is committed to participating in the local development of the communities where the Group operates.
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2010 Highlights
Diversity
In 2010, 46.3% of the Group's employees were women
Above and beyond carrying out best practices, it is crucial for sanofi-aventis to retain and attract good scientists in its core activity of drug development.
Anne Marden JPMorgan Asset Management London
Supporting change
Double the workforce in China by 2015
Occupational accidents
Nearly 30% decrease in the frequency of occupational injuries with time lost between 2006 and 2010
Economic development
Moving all the Group's tuberculosis treatment production to a single site in South Africa
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People indicators Diversity Gender equity Work-life balance People with disabilities Preventing discrimination Age management Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Contributing to local economic development
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Diversity
As a multinational company that strives to respect different cultures, sanofi-aventis depends on the diversity and wide-ranging talents of its employees to make the Group more innovative, effective and competitive.
Employee diversity reflects the first level of an organizations openness to the world.
Professor Gregory Katz Chaired Professor, ESSEC-sanofi-aventis Chair Co-Director, ESSEC Institute of Health Economics & Management
Diversity: A commitment
The Group focuses on promoting equal opportunity and reasonable working conditions for all, regardless of gender, ethnic origin, sexual orientation, religion, age or disability. Managing diversity means: Taking into account individual differences that are unseen as well as those that can be observed in the Group Preventing all forms of discrimination Promoting balance between professional and private life The Group's Diversity policy is part of a forward-looking approach and aims to promote diversity in the broadest possible sense. The Group carries out proactive initiatives that address diversity-related issues in all countries.
Gender equity
In 2010, 46% of Group employees were women.
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People with disabilities

Hiring, retaining, training, outsourcing: Disability is an essential part of the sanofiaventis Diversity policy.
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CODE OF ETHICS: DIVERSITY, NONDISCRIMINATION AND EQUAL OPPORTUNITY Sanofi-aventis is committed to promoting diversity, which is an integral component of its Code of Ethics: Sanofiaventis is dedicated to promoting diversity, convinced that the distinctive identities of our employees and commercial partners are a source of strength and a key ingredient in the success of a global business
Age management
Sanofi-aventis, well aware that age diversity is a valuable resource that drives performance, organizes specific initiatives for both young and senior employees.
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Work-life balance
Sanofi-aventis considers a healthy balance between private and professional life to be essential to the well-being of Group employees.
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Preventing discrimination
Sanofi-aventis prohibits all forms of discrimination for whatever cause or reason, as well as all behavior that may compromise another person's personal dignity.
World Diversity Tour : 40 countries

participated in 2010
45% of the Groups

Groups employees are women
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46.3% of the
managers are women
Promoting diversity
Promoting diversity and employee awareness are integral components of the sanofi-aventis Diversity policy.
WORLD WOMENS WORDS @ SANOFIAVENTIS More than 500 women in nearly 50 countries / sites are coming forward to discuss the role of women in the workplace and how they contribute to the performance of the company. .
The WISE program
World Diversity Tour

Launched at the end of 2009, the World Diversity Tour is an awareness-building and informational program with the following objectives: Highlight the Groups commitments to diversity Establish local initiatives Communicate about these initiatives Overseen by Senior Management, the project was launched in late 2009. It reflects the Groups commitment to these subjects. Forty countries participated in this initiative in 2010.
Training employees
In order to strengthen the spirit of non-discrimination among all employees, training modules were developed to provide information on diversity and all forms of discrimination. In France, the Group has launched two types of programs: A one-day program designed for Human Resources managers. More than 20 managers were trained in 2010. Since the program was launched in 2007, more than 150 managers have been trained. A half-day program for managers at industrial sites. Thirty-four sessions have taken place since 2009, with 210 managers trained in 2010.
MANAGING DISABILITY FRANCE: 2010 call for projects

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Effective communication
Communicating openly about diversity is an important part of the sanofi-aventis Diversity policy. The Group relies on Diversity representatives in its countries of operation to drive change and ensure that the policy is implemented locally. The initiatives carried out are showcased on the Groups intranet, on its CSR blog and in the in-house newsletter.
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People indicators Diversity Gender equity Policy Actions Indicators Work-life balance People with disabilities Preventing discrimination Age management Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Contributing to local economic development
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Gender equity
Gender equity is a priority issue in the sanofi-aventis Diversity policy.
of the Groups employees are women
46.3%
In 2010, the number of women employees in the Group remained stable at 46.3% (46.6% in 2009). At 45%, the percentage of women managers is also stable relative to 2009. Throughout the Group, the percentage of women holding key positions with operational responsibility has reached 37%.
WORLD WOMENS WORDS @ SANOFIAVENTIS More than 500 women rallied in 2010
The WISE program
Women in the workplace

Women account for half of the world's population. To meet the challenges of tomorrows economy, businesses cannot afford to ignore the talents offered by this half of the population. Women have made significant strides on the labor market throughout the world. The employment rate for women is increasing faster than that of men, especially in countries where they have traditionally had a lower rate of employment. Out of three billion salaried workers in the world in 2008, 1.2 billion were women (40.4%). However, the gap in compensation and responsibility between men and women remains high (estimated to be 15% in the European Union and nearly 20% in the United States), despite the marked rise in women's education levels. Even more so than other sectors, the pharmaceutical industry must take advantage of the enormous pool of talent women represent, in particular women with medical and pharmacy degrees across the globe. Among the companies surveyed for the report Women Matter 2010 by McKinsey and Co., women represent 13% of corporate boards (9 companies surveyed) and 8% of executive committees (8 companies surveyed). Efforts to promote equal employment opportunities for all people must be continued, by combating both direct and indirect discrimination that may affect them and by helping all employees to achieve balance between their professional and private lives. For more information: Women Matter 2010 The Global Gender Gap Report 2010, World Economic Forum
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The WISE program in the U.S. won the ACE Award in 2010
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Gender equity indicators
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People indicators Diversity Gender equity Policy Actions Indicators Work-life balance People with disabilities To foster gender equity, the Group has defined two areas for action: Preventing discrimination Age management Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Contributing to local economic development
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Gender equity - Policy

Eager to make the most of employee talent, sanofi-aventis has made gender equity one of its priorities. In the Group today there is nearly equal gender composition worldwide in terms of the workforce, recruitment and management.
46.3%
The WISE program
In the countries where equal gender composition in the workforce has been achieved, it should be developed at all levels of the organization and across all functions. Although the proportion of women at the managerial level is quite encouraging (45%), the primary area in need of improvement today is promoting women to key positions of operational responsibility, where they remain a minority (37%). In all other countries, encourage gender diversity and ensure equal opportunity.
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People indicators Diversity Gender equity Policy Actions Indicators Work-life balance People with disabilities Preventing discrimination Age management Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Contributing to local economic development These include: Professional gender equity agreements Increasing awareness among management Examples of initiatives promoting women around the world Award-winning programs Group women win awards
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Gender equity - Actions

Sanofi-aventis carries out gender equity initiatives promoting equal employment opportunities around the world.
46.3%
The WISE program
Professional gender equity agreements

In France, the Group is carrying out gender equity negotiations within the various functions. After the agreement concerning R&D in 2006, the sanofi-aventis Group entered into a three-year agreement in March 2007. This agreement covers French employees from corporate functions. The agreement reflects the determination to promote gender equity within the company, in particular with respect to access to jobs and training, and career development (mobility, promotions, and compensation). The objective monitoring of the agreement is based on 30 or so specific indicators for jobs, training, mobility, absenteeism, compensation and work scheduling. Finally, in 2010, for the fourth consecutive year, sanofi-aventis has continued to narrow the gender wage gap among men and women Group employees in France.
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Increasing awareness among management

Awareness-building initiatives are regularly organized for management. Here are some examples:
Internationally
Awareness-building initiatives target new managers when they join the Group, during the annual international management Discover seminar (around 100 managers each year from across the globe). Since 2008, each Group succession plan for key positions has included a gender indicator. Awareness training modules, including e-Learning options, have been implemented in the United States (8,000 people trained) and in several other countries (Canada, Australia and others).
In France
School Women Excelling in their Career) in 2010. This prize was created to highlight the growing role of women as a factor of enrichment and success in corporations, and to raise awareness among leaders about the glass ceiling phenomenon, in which certain categories of employees may not have access to positions of greater responsibility in a hierarchical structure. Since 2008, sanofi-aventis has also been involved in the BoardWomen Partners Program, which includes half of the companies on the CAC 40 among its members. This program brings together directors who are interested in increasing the number of women on corporate boards with a view to improving governance. The program uses cross-mentoring initiatives to help train women who will eventually become board members. In 2010, the sanofi-aventis Board of Directors co-opted a new independent director, Carole Piwnica. This co-optation will be submitted for approval at the General Meeting of Shareholders that will take place in May
2011. Furthermore, at its meeting of March 9, 2011, the sanofi-aventis Board of Directors proposed that a new independent director, Ms. Suet-Fern Lee, be appointed at the General Meeting that will take place on May 6, 2011. As a result of these appointments, the new Board of Directors will be made up of 15 members, including three women.
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Examples of initiatives promoting women around the world

In 2010 there were many initiatives that focused specifically on women. These activities demonstrate the Group's commitment to gender equity among its teams.
International Women's Day

For International Women's Day, the Chief Executive Officer sent a letter to the Group's 100,000 employees reminding them of his commitment to gender equity, a source of success and open-mindedness. Many events were organized for International Women's Day in Group affiliates in 2010, especially in India and Japan.
World Womens Words @ sanofi-aventis

In March 2010, the sanofi-aventis Diversity Management team launched an initiative targeting women in the Group. The project aimed to provide a means of expression to all women employees worldwide, via a questionnaire. It enabled women to organize into groups, regardless of age, origin, family status, and level of responsibility in the company, in order to: First, discuss issues related to women and work Second, share the results of their exchanges with one or more members of management at the site or country level All the responses, ideas and suggestions were compiled and featured in a document that was officially presented to the Group's Senior Management in September 2010 and subsequently to the Management Committee, the Human Resources department and all participants. Ultimately, the World Womens Words @ sanofi-aventis project rallied more than 500 women in 50 different countries and sites. This initiative is in line with the sanofi-aventis Transforming program and its talent development objectives.
The Womens Forum, Deauville (France)

For the first time, sanofi-aventis was a premium sponsor of the Womens Forum, which took place in October 2010 in Deauville, France. Thirty sanofi-aventis employees attended from all over the world. They were able to exchange ideas with each other and with women from other countries and companies. Christopher Viehbacher, Chief Executive Officer, who also attended the conference, clearly expressed his gender equity ambitions for the Group. In addition, during the CEO Champions session, he made specific commitments regarding women employees at sanofi-aventis. For more information: www.womens-forum.com
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Award-winning programs
United States: The WISE program wins an award
In the United States, the WISE program (Women Inspiring sanofi-aventis Excellence) won the prestigious ACE Award in 2010 (Advancement, Commitment, Engagement) from the Healthcare Businesswomen's Association (HBA). Since 2007, the ACE Award has been awarded to companies committed to womens recruitment, advancement and talent management. WISE is an internal women's network composed of over 1,000 members that fosters the personal and professional leadership development of women working for the company. For more information: www.hbanet.org / Sanofi-aventis U.S. receive ACE Award www.hbanet.org - Healthcare Businesswomen's Association
Slovakia: Sanofi-aventis Slovakia receives the Family, Gender Equity and Equal Opportunity award
In May 2010, the senior management team of the sanofi-aventis Slovakian affiliate received the prestigious Family, Gender Equity and Equal Opportunity award from the Ministry of Labor, Social Affairs and Family. This prize, which has been given out since 2000, rewards employers who create a work environment that is compatible with employees family responsibilities, and who actively work toward gender equity and equal opportunity within their organizations.
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Group women win awards

Prix Trajectoire HEC au fminin
In 2010, the Trajectoires HEC au fminin prize (HEC Business School Women Excelling in their Career) was
awarded to Laurence Debroux, then Chief Strategic Officer of sanofi-aventis, in recognition of her diverse and exemplary career.
Stevie Awards for Women in Business given to sanofi-aventis Medical Director in Turkey
The Stevie Awards for Women in Business are among the most prestigious awards in the world for women executives. In 2010, Dr. Edibe Taylan, Medical Director of sanofi-aventis Turkey, won a Stevie Award in recognition of the many initiatives she has carried out for the Group, and in particular for her involvement in Diabetes 2020, the first collaborative training program on diabetes, which is now serving as a pilot for other countries. For more information: www.stevieawards.com / Women in Business
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Gender equity - Indicators

In 2010, 46.3% of Group employees were women. At 45%, the percentage of women managers is stable compared with 2009. As of March 12, 2010, four women were members of the Group Management Committee, which has 21 members. Of these four women, one is a member of the Executive Committee, which has eight members. There is one woman on the Board of Directors. Two new women directors will be joining the Board of Directors after approval by shareholders at the General Meeting on May 6, 2011. Throughout the Group, the percentage of women holding key positions with operational responsibility has reached 37% .
46.3%
The WISE program
Percentage of women at various levels of the organization

LEVEL OF THE ORGANIZATION % WOMEN IN 2010
Total executives Total sales force Total others Group Management Committee Executive Committee TOTAL WORKFORCE
45%
FIND ALL INDICATORS

44.2% 48.2% 19% (4 women out of 21) 12.5% (1 woman out of 8) 46.3%
Proportion of women by geographic area (in %) in 2010

REGION % WOMEN % WOMEN MANAGERS
Europe North America Latin America Africa Middle East Asia, Pacific Japan* WORLD
49.1% 51.5% 44.5% 37.6% 55.1% 38.3% 22.6% 46.3%
46.8% 46.3% 41.2% 42% 46.9% 43.2% 15.2% 45%
* The percentage of women working at sanofi-aventis Japan is twice the national average for companies .
Proportion of women: Career development and training programs
International career development programs (Discover, Explore, Evolve, Pilot, Perspectives) 38% women (422 participants in the four programs in 2010) For more information: Developing talent and careers / Training
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You are here: Home > People > Diversity > Work-life balance
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Work-life balance
The balance between private and professional life figures prominently in the sanofi-aventis Diversity policy. This issue is taking on growing importance for the Group because it corresponds to employees expectations.
SOCIAL CHARTER SANOFI-AVENTIS Sanofi-aventis undertakes to respect its employees' private lives (Social Charter, Article 7) and, as much as possible, to provide conditions that allow employees to reconcile their professional and private lives Excerpt from the Group Social Charter, Article 7
Background
Today, more and more employees seek to establish a balance between their private and professional lives. This balance is important for individuals personal development, while for businesses it represents a strategic challenge. When company policies and corporate culture respect the need to reconcile personal and professional life, they are in a better position to attract, motivate and retain employees.
Policy
Sanofi-aventis is committed to respecting its employees' private lives (Social Charter, Article 7) and, as much as possible, to providing conditions that allow employees to reconcile their professional and private lives, in accordance with local practices and circumstances. Sanofi-aventis encourages local initiatives on this issue at the country, and even the site level, in order to better respond to employees' expectations.
Commitments
AREAS FOR PROGRESS GOALS
Our Children Matter Association

families received support in countries 2010 in (not including the United States)
180
Increase workplace flexibility
Focus on respect for schedules, flexibility concerning hours worked per day, part-time work
35
Increase services to help families
Offer daycare solutions Optimize maternity leave and parental leave Manage unexpected events children participated in the Holiday Exchange in 2010
230
Develop activities outside the workplace For more information:
Offer activities to build stronger ties among employees

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Work-life balance - Actions

Workplace flexibility Facilitating family life Supporting employees facing unexpected events Activities outside the workplace
SOCIAL CHARTER SANOFI-AVENTIS Sanofi-aventis undertakes to respect its employees' private lives (Social Charter, Article 7) and, as much as possible, to provide conditions that allow employees to reconcile their professional and private lives Excerpt from the Group Social Charter, Article 7
Workplace flexibility
Striking a balance between private and professional life promotes higher productivity and employee motivation. With this principle in mind, sanofi-aventis has implemented various programs around the world: In Germany, the Work-life Balance program has received the Total E-Quality prize four times. Options for part-time work and flexible scheduling have increased for several years on the Frankfurt site. These measures are generally used by employees to organize their careers and family life. In Belgium, in December, 2008, sanofi-aventis received the E-working Award in the private sector category for the implementation of an experimental telecommuting project. In Spain, our affiliate obtained the Responsible Family Firm Certificate in May 2007 (Certificado empresa familiarmente responsable) for three years, for its results and its improvement plan, Armoniza, which addresses the issues of reconciling private and professional life (meetings, working hours, vacation dates, etc.). In France, the Group Professional Gender Equity agreement recommends best practices concerning meeting schedules.
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Our Children Matter Association

families received support in countries 2010 in (not including the United States)
180
35
Facilitating family life

Throughout the world, the Group supports creation of on-site daycare centers. The Frankfurt site (Germany) was the first to implement such a program. Today, four countries have on-site daycare centers: France, Canada, Germany and Brazil. In other countries employees have a variety of childcare options. In Germany, a program was designed specifically for men and women employees on parental leave. Working part time and flexible scheduling are also strongly encouraged. In Spain, the Armoniza project addresses the best practices for scheduling meetings and greater flexibility in arranging working hours and vacation dates. In France, the Group Professional Gender Equity agreement provides for a childcare allowance for parents who must attend training classes outside their regular working hours. In Canada, an early childhood center was opened for the children of employees working at the headquarters.
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children participated in the Holiday Exchange in 2010
230
Supporting employees facing unexpected events

Sanofi-aventis provides moral and material support to the children of employees faced with difficulties that could have an impact on their future. That is precisely the role of the association Our Children Matter, which was created in 1993. This association, which provides assistance when no other source of help is available, is funded by employee donations and an annual endowment from sanofi-aventis. In addition, the Group provides the funds necessary for its operating expenses. Across the globe, the association Our Children Matter works in three ways:
By responding to requests for individual assistance (medical expenses, hospitalization, help for children with disability, school expenses, housing, etc.). By organizing collective initiatives for all children of employees in a given country (immunization campaigns, eye exams, dental care, distributing information about HIV/AIDS, medical care, etc.). By organizing special operations when a major event occurs, such as a natural disaster that affects a specific site or country. Since 1994, the association has helped more than 1,800 families in 43 countries. More than 20,000 children of employees have participated in the collective initiatives funded by the Group. In 2010, the association provided individual assistance to 180 families in 35 countries (not including the United States). Its collective efforts in ten different countries reached nearly 2,000 children.
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Activities outside the workplace

Athletic and cultural associations for employees have been organized in a number of Group affiliates. In addition, the Holiday Exchange program reflects the Groups international dimension and the cultural diversity of employees. Intended exclusively for the children of employees, these holiday exchanges provide a unique opportunity for children to spend part of their holidays abroad with a sanofi-aventis host family. In 2010, 230 children participated in the Holiday Exchange program in more than 20 countries. Beyond the benefit for the participants, such programs allow sanofi-aventis to strengthen ties among employees.
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People with disabilities

Background
The sanofi-aventis Group policy on disability is based on four key commitments: Retaining employees who have become disabled Integrating disabled employees Encouraging sub-contracting activities to specialized centers Offering training and raising employee awareness about disability in the workplace Employment remains the best means of social integration, yet a person with disability encounters more difficulties in finding a job than do other people. It is essential to change the way people look at disability, disabled individuals and the work they can potentially do. As a company working in the healthcare field, sanofi-aventis must be even more concerned than other businesses about health issues and have an even better understanding of the difficulties created by a health problem or disability.

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Sanofi-aventis is an active member of handiEM, the new LEEM entity focusing on disability
www.handiem.org
Worldwide
According to the ILO (International Labor Organization), 386 million people of working age are disabled. At least 10% of the global population, or 600 million people, have some limitation of ability according to the WHO. The UN has adopted a convention on the rights of persons with disabilities. For more information: UN Convention on the rights of persons with disabilities European Commission website on Disability issues
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+21% increase in
the number of disabled employees in the Group between 2006 and 2010.

According to the National Council on Disability, 13% of the working age population is disabled. In addition, there is a rising trend in the number of disabled individuals. For more information: www.ncd.gov / National Disability Status and Program Performance Indicators
In France
Disabled individuals represent approximately 15% of the population, and this percentage is set to increase with the aging of the population. Equal opportunity, a concept that is fully accepted today, also applies to the disabled. Since the February 2005 law went into effect, more and more organizations have improved their compliance with the requirement to hire the disabled. The unemployment rate among the disabled in France is 20% higher than the rate for the general population. According to the AGEFIPH (a French organization to promote the employment of the disabled), one person out of two will be affected by a health problem during his or her working years. For more information: DARES study on access to employment for disabled persons in France www.agefiph.fr
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People with disabilities - Policy

As with any other employee, disabled individuals contribute to the Group's performance. The Group is committed to ensuring equal opportunity and promoting diversity as a source of talent and a means to optimize performance.
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In every country where sanofi-aventis operates, the Groups policy on disability is guided and overseen by a dedicated team, the Managing Disability team. They focus on four commitments: Retaining employees, regardless of the cause of their disability. Job retention applies to any situation where an employees aptitude for his or her job is altered due to disability issues. This entails preventing job exclusion and finding the best possible compromise between an employee's abilities and skills and the requirements of a specific job. Integrating disabled employees into the company (with a permanent contract, fixed-term contract, internship, temporary employment, etc.). As with all employees, the hiring of a disabled individual is based on that persons skills, aptitude for the position to be filled and motivation. There are no positions that are necessarily unsuited to the employment of a disabled individual. However, adjustments are sometimes necessary. Working with specialized centers employing more severely disabled individuals who cannot be present on sanofi-aventis sites. Outsourcing is a means to indirectly contribute to the employment of individuals who cannot be integrated into an ordinary working environment. Specialized centers can be found in numerous countries. The choice to outsource may consist of the temporary assignment of individuals from specialized centers to a site, or contracting out all or part of an activity.
www.handiem.org
+21% increase in
Increasing employee awareness about disability and work

Disability is like a foreign language: One must learn it in order to understand. A program to raise awareness about disability has been developed for all employees. Information and education are provided through brochures, posters, films and a dedicated intranet site. Special activities, such as role-playing games, lectures and testimonials, are organized for all employees to help change perceptions of disability in society. More specific training is designed for different functions: for HR teams and recruiters, social-medical teams, managers, HSE, communication, etc. Thanks to a network of Diversity-Disability delegates in various countries where sanofi-aventis operates, the policy is put into action where consistent with applicable local law, and experiences are shared in coordination with the Managing Disability team. The Group is gradually implementing this policy and these initiatives worldwide where consistent with applicable local law.
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People with disabilities - Actions

In keeping with its commitments, sanofi-aventis organizes many different disability-related initiatives in the countries where it operates. The Group is also actively making efforts to implement its Disability policy worldwide where consistent with applicable local law.
Company-wide initiatives Local examples

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Company-wide initiatives
Disabled workers across the globe
The definition of a disabled worker varies according to local laws and when legislation does not address the question, the Group takes into account visible disability (bearing in mind the World Health Organization definition). In 2010, for the entire Group, 30 countries (excluding U.S.) reported that there were 1,779 disabled individuals in their workforce (compared to 1,772 in 2009, 1,631 in 2008, 1,575 in 2007 and 1,472 in 2006), primarily in Europe and in the industrial sector. Since 2006, a communication network coordinated by the Groups Managing Disability team has been in place to ensure that efforts are combined and company initiatives are monitored.
www.handiem.org
+21% increase in
Workplace accessibility
Using tools developed by Managing Disability and the HSE Department, studies to investigate and assess workplace accessibility have been undertaken. The new Massy site Grand Massy was renovated to offer full access to its facilities for persons with disability. In addition, the Croissy Beaubourg industrial site completed the accessibility assessment of all of its facilities.
Access to information
Improving access to information for our employees and our professional contacts is a major focus for sanofiaventis efforts. This calls for a global approach that includes translating information into sign language, ensuring accessibility of websites, providing computer versions of printed documents, etc. The Group continues to improve the compatibility of its websites and received the W3C AA rating for the new corporate websites www.sanofi-aventis.com and www.sanofipasteur.com, as well as selected country sites, such as those for France, Turkey and Morocco. The Group CSR site also obtained this rating. The Access to Information Charter, drawn up by the Senior Vice President of Corporate Social Responsibility and the Senior Vice President of Information Systems, was widely distributed throughout the company and demonstrates the Group's interest in and commitment to this issue.
Raising awareness
Increasing employee awareness is one of the pillars of our Disability policy. A number of countries have responded by organizing their own initiatives. In France, during the annual national week devoted to the employment of the disabled, activities were organized at different sites. The French Pharmaceutical Companies Association (LEEM) has a new entity devoted to disability, HandiEM; sanofi-aventis is a member of its Board of Directors. Created in May 2010, HandiEM aims to provide disabled workers in the pharmaceutical sector, and others who would like to join them, with training, integration and job retention solutions specifically adapted to this sector.
For more information: www.handiem.org In 2010, awareness-raising campaigns were also organized in Mexico, Brazil, Japan and Egypt.
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Local examples
In China
In response to the Group call for projects, China implemented 17 collaborative projects with local NGOs to improve the living conditions of people living with disability. The association Caring for Disabled in Shanghai receives support and funding from the Group. This association assists severely disabled people by providing them with outings that allow them to explore their city. Example: During the World Expo 2010 in Shanghai, more than 120 disabled people visited the French Pavillon and the sanofi-aventis area, thanks to the assistance and support of over ten employees.
In Brazil
Various partnerships were formed between Group entities and different organizations, in particular with organizations for the deaf and hearing-impaired, to facilitate the integration of disabled individuals. In addition, sanofi-aventis was a sponsor of the Brazilian paralympic volleyball team.
In Egypt
In Cairo, sanofi-aventis has pursued a policy of employing individuals with disability for many years. For example, there are deaf and hearing-impaired employees working in the packaging division. In 2010, a special day was devoted to recognizing these workers and increasing awareness among all employees. Each of these employees received a diploma after the World Diversity Tour activities.
In France
Company-wide agreement Sanofi-aventis entered into a company-wide agreement to promote integration and job retention of disabled persons covering the years 2009 to 2012. This follows the agreement for 2006 to 2008, for which period the Group exceeded its objectives, having recruited 165 disabled employees and increased its investments in working with specialized firms. As a result of regular awareness-raising efforts, numerous disabled employees (300 over the three years) have made their disabilities known to the Group, thus making it possible to take specific measures in order to accommodate their needs. Managing Disability: Call for projects In accordance with the new agreement, sanofi-aventis presented awards to ten project originators for the second consecutive year. Designed to benefit communities, these projects received funding from sanofiaventis. In addition to financial support, the sanofi-aventis Group wishes to highlight employee commitment to disability issues, raise awareness among all employees and pursue an active Disability policy. For more information: Vido Managing Disability: call for project 2010
In Hungary
The Mozaik program, launched in 2006, continues to thrive. Based on the Groups commitment to disability issues, the program has even been extended to other companies in Hungary. In 2010, on-site events were organized with paralympic athletes and HR teams to raise employee awareness about disability.
In Japan
One aspect of the La Maison project, launched in 2006, is a focus on disability and improving conditions for the integration of disabled individuals. In addition, a consulting company provides sanofi-aventis teams with recommendations regarding work that can be done by disabled individuals.
In Mexico
Implementation of the Disability policy included integration and job retention initiatives as well as two days of events organized to improve employee awareness. Sanofi-aventis was an active participant in the International Disabled Persons Day on December 3. The theater company Sea y Verbo , made up of hearing-impaired actors, performed for all employees and their families.
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People indicators Diversity Gender equity Work-life balance People with disabilities Preventing discrimination Policy Actions
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Preventing discrimination
Promoting equal opportunity and reasonable working conditions for all, regardless of gender, ethnic origin, religion, disability, age and sexual orientation (or other characteristics protected by applicable local law) is a means to develop the global economy and to guarantee personal dignity and opportunity for all.
We must all be vigilant in our actions and decisionmaking to avoid discrimination and act in favor of diversity, with a view to performance and inclusion of all.
Delphine Valtier Group Diversity Director, sanofiaventis
Sanofi-aventis' objective is for all Group employees to embrace this principle and apply it on a daily basis. Age management Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Contributing to local economic development
Background
Discrimination in employment is universally condemned. Workplace discrimination is on the rise (according to the ILO) and may manifest itself in different ways: from more traditional forms based on sex, race and religion to newer forms of discrimination based on age, sexual orientation, health and disability. In 2007, nine out of ten ILO member states ratified the conventions concerning equal remuneration and discrimination. Certain countries recently made changes to their labor codes to include new measures. Because sanofi-aventis operates in more than 100 countries, the Group is determined to make the fight against all forms of discrimination a major focus. This social commitment necessarily includes respect for local cultures and regulations.
There is no discrimination in the Group based on family status.

Sanofi-aventis France 2010 study
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Preventing discrimination - Policy

Sanofi-aventis prohibits all forms of discrimination for whatever cause or reason, as well as any behavior that infringes on personal dignity. In addition to offering equal opportunities to employees based on their aptitudes and skills, the Group sees that these principles are respected by its partners and suppliers.
True open-mindedness and the absence of prejudices concerning other people's views or attitudes are vital prerequisites for performing our work effectively.

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Preventing discrimination - Actions

Communicating to all employees about the Group's commitment to prevent discrimination Partnerships to promote employment for young people from disadvantaged backgrounds
Communicating to all employees about the Group's commitment to prevent discrimination

Developing non-discriminatory management practices
To ensure more effective implementation of applicable local anti-discrimination regulations, the Group:
Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Contributing to local economic development
Undertook a survey in 2007 of local anti-discrimination laws in 38 countries where sanofi-aventis operates. This survey was updated primarily through a questionnaire sent to national HR correspondents in 2010 Distributed a brochure in 2007 about anti-discrimination laws to 5,000 HR employees and managers in France Organized awareness-raising initiatives among international managers during Discover integration seminars (approximately 100 managers representing 40 or so nationalities annually) Provided support and advice to managers thanks to the expertise of the Diversity-Disability Group ( * ) In 2010, a study of discrimination based on family status was undertaken. By analyzing days off and special leave in the context of specific family situations, the study showed that there was no discrimination in Group processes based on family status.

Direct communications with employees

For all employees, sanofi-aventis has set up forums for information and action through: The Diversity-Disability team, with the creation of a Diversity section on the Groups intranet site and Diversity and Managing Disability e-mail addresses The Compliance Direction, which can be reached by a dedicated e-mail address and telephone number
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Partnerships to promote employment for young people from disadvantaged backgrounds

Partnerships were created in several countries to improve awareness and encourage access to employment for these populations. In France, following the signing of the Diversity Charter, several projects are underway: Since 2007, the Group has been sponsoring young university graduates from sensitive urban areas through a program developed by an association called Our Neighborhoods Have Talent. Over 20 mentors from the various functions help graduates in their job search by fine-tuning their CVs and coaching them on interview techniques. Since September 2007, together with the French Ministry of National Education and the HEC Business School Foundation, the Group has been part of a project to create and support preparatory classes for prestigious business schools (grandes coles de commerce). This program targets young technology graduates from high schools in priority education zones. The sanofi pasteur recruitment team takes part on a regular basis in the Jobs and Cit Stadium organized by Nes&Cit in Lyon. The idea is to invite companies and job seekers from so-called sensitive neighborhoods to meet inside the Gerland Stadium for job dating opportunities. Sanofi pasteur also participates in professional orientation initiatives for young people from disadvantaged neighborhoods and supports the Sports in the City association in the Rhne-Alpes area. In Brazil, the Group is associated with the government-run program Jovem cidado , which aims to help young people find their first job. It targets job-seekers aged 16 to 21 coming from public schools. For six
months, four hours a day, sanofi-aventis teaches them office skills, how to write a CV, job interview techniques and other basic skills to facilitate and improve their contact with the business world. In South Africa, a complete anti-discrimination program was introduced in 2000 and continued in 2010. It has included defining objectives and indicators, implementing a procedure, organizing awareness-raising initiatives and training, working with recruitment agencies and universities and launching an internal development program. Sanofi-aventis South Africa is ranked among the best employers in the country. The Group has entered into supplier agreements that comply with Black Economic Empowerment legislation.
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Age management
Well aware that age diversity is both a valuable resource and a factor in performance, sanofi-aventis organizes specific activities for young as well as senior employees.
Supporting young people through apprenticeships Sponsoring the best junior scientists Supporting seniors Multiple generations in the workplace
Supporting young people through apprenticeships

Sanofi-aventis focuses on three areas: Helping junior people complement their initial training by acquiring knowledge, know-how and experience, with an emphasis on employability Helping junior people land their first job, with an emphasis on entry into the workforce Giving junior people the tools they need to find a job, with an emphasis on equal opportunity In accordance with a project initiated by the President of France in late 2009, sanofi-aventis employed 500 trainees at its French sites in 2010. The Group also has trainees in Spain, Brazil and Germany, amounting to a total of approximately 400 per year.
Sponsoring the best junior scientists

Within the scope of a research partnership with AVIESAN (the French Life Sciences and Healthcare Alliance), sanofi-aventis supports the CNRS ATIP program and the Inserm AVENIR program, which help to identify and support the best junior scientists who wish to set up their research laboratories in France. Sanofi-aventis support takes the following forms: Making additional contributions based on grants allocated through the research program Designating mentors in Group R&D centers The Group is providing support to five young scientists from the ATIP and AVENIR programs for a period of three years. These junior researchers are working in the fields of infectious diseases and neuroscience. Since they were initiated, these two programs have made it possible for 406 scientists (234 CNRS and 172 Inserm researchers) to form their own research teams to work in the fields of healthcare and the life sciences. In 2010, sanofi-aventis committed a five-year budget of up to 50 million euros for these partnerships. For more information: Press Release: Sanofi-aventis Strengthens Commitment to Research in France through Partnership with AVIESAN (PDF, 66Kb)
Supporting seniors
In France, a Seniors action plan was implemented in 2010 across all Group entities. The Human Resources Department offers a second half career interview to interested employees over age 45. The interview is meant to touch base with employees on the subject of their career path, skills and ambitions regarding professional development and career orientation. More than 10,000 employees are eligible for such interviews. Specific initiatives are also being carried out in Germany.
Multiple generations in the workplace

In 2010, in France, two presentations at the Grand Massy and Croix de Berny sites addressed the topic of managing multiple generations in the workplace. The purpose of the presentations was to raise awareness among different age groups about working together.
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Supporting change
Background and commitment
In 2009, sanofi-aventis began a wide-ranging transformation program to become a diversified global healthcare company focused on patient needs. All Group entities (Research & Development, Industrial Affairs, Commercial Operations, Vaccines and support functions) are involved in this transformation process. These developments reflect the adaptations needed for the Group to remain competitive internationally, to migrate research and industrial facilities toward biotechnologies, and to adjust sales forces in response to increasing regulatory constraints (such as exclusion from reimbursement or price regulation) and to generic competition for some of the Groups flagship products. In other some countries and particularly in emerging markets sanofi-aventis must strengthen the Groups presence in response to countries development and their populations access to care. The transformation program has gradually been implemented in all affected countries, and the Group is committed to supporting impacted employees as they change functions or organizations. The challenge facing the Group is to offer each employee a solution adapted to his or her needs. This requires anticipating change (training needs, site conversions, investments, etc.) and negotiating with employee representative bodies about support measures, keeping employees informed and taking the time required to fine-tune these adjustments. Supporting change includes two types of actions: Assisting employees during the Groups transformation Strengthening and integrating teams in areas with high growth potential
Karen Linehan Senior Vice President, Legal Affairs and General Counsel, sanofiaventis
The integrity and passion with which all our employees carry out their objectives is something that is unique to our company. We have undergone a deep transformation, yet at every stage, everyone continued to work together to ensure that we deliver what the patient needs: safe and effective vaccines and medicines.
Sanofi-aventis Social Charter

Sanofi-aventis' socially responsible approach entails anticipation and the ability to react quickly including being able to adapt to technological developments and broader change." Sanofi-aventis aims to combine economic and social performance and recognizes these are inseparable. Excerpt from the sanofi-aventis Social Charter
For more information: Sanofi-aventis Social Charter (PDF, 1268Kb)
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Supporting change - Actions

In each country affected by organizational changes, sanofi-aventis implements the optimal means for providing support to employees while respecting local regulations. In particular, the Groups actions involve negotiating with employee representative bodies and providing internal and external training as well as career development assistance for employees.
Assisting employees during the Groups transformation Strengthening and integrating teams in areas with high growth potential
Assisting employees during the Groups transformation

For all the reorganization projects, sanofi-aventis is making every effort to provide career support to Group employees, particularly when it comes to internal and external mobility. Support measures vary from one country to the next.
The integrity and passion with which all our employees carry out their objectives is something that is unique to our company. We have undergone a deep transformation, yet at every stage, everyone continued to work together to ensure that we deliver what the patient needs: safe and effective vaccines and medicines.
Karen Linehan Senior Vice President, Legal Affairs and General Counsel, sanofiaventis
In France
With its history of social engagement in this country, sanofi-aventis is committed to maintaining an active economic role in France. An essential part of accomplishing this goal involves providing training for Group employees. This means helping them acquire new skills in line with the Groups strategic needs in order to remain competitive on the market, particularly with a view to migrating toward biotechnology. Supporting internal career mobility This type of support includes: Providing a training program for employees whose jobs are impacted by the transformation from chemical industrial activities to new biotechnology activities Supporting mobility within the various sanofi-aventis sites In 2009 and 2010, a 17 million training fund was created to support internal career mobility for employees. Some of the changes within sanofi-aventis involve converting certain chemical industrial sites into biotechnology sites. Once this began, a major training program was developed in 2010 to help affected employees acquire the new skills they need.
In France, businesses created or acquired in 2010 with the support of the start-up unit.
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87
CAMPUS BIOTECH 10 million for biotechnology training
Biotech Campus: Facilitating the conversion to biotechnology Biotech Campus, a training program designed specifically for biotechnology, was implemented in 2010 to promote career mobility for sanofi-aventis employees in France. This training program, through which employees can earn certificates or diplomas, is operating in partnership with French schools and universities. Ultimately, nearly 700 employees will participate in the program, which demonstrates the Group's determination to remain proactive and develop the necessary skills in-house so it can meet the challenges of biotechnology. A budget of nearly 10 million has been earmarked for this training program.
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China: integrating 3,500 new employees by 2015
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Voluntary departure program In 2010, the Groups transformation in France involved: Implementing the new R&D model based on an outreach strategy that includes establishing partnerships with major public research institutions, bringing scientists closer to centers of expertise (in oncology, diabetes, etc.) and selling the Porcheville site to an international company, thus allowing the site to continue to develop its activity in the region
Finalizing the conversion of support functions to simplify the organization and ensure greater responsiveness Presenting investment and conversion plans for chemical and biotechnology facilities over the next four years Outlining an organizational plan for sanofi-aventis commercial activities in France The objective is to adapt the workforce in order to avoid redundancy by encouraging voluntary departures based on age-related factors (retirement age, anticipated retirement date) and by providing support for professional projects outside the Group such as starting or acquiring a business. Prior to implementation, all these support measures, which are entirely paid for by the company, are presented to and negotiated with employee representative bodies. In 2010, approximately 1,300 employees, particularly in R&D and the support functions, took advantage of these measures in France.
Assisting employees who wish to start or acquire a business For over 20 years, sanofi-aventis has had a dedicated entrepreneurial unit devoted to assisting employees who would like to start a business or purchase an existing business. This start-up entrepreneurial unit assists employees in the different phases of project development by calling on the necessary expertise inside and outside the Group and providing financial support. In 2010, this program was offered to employees starting their own businesses as well as those who opted for a voluntary departure within the scope of the GPEC (1) provisional workforce planning agreement for sanofi-aventis medical sales representatives in France, and voluntary departures within the scope of sanofi-aventis Group and sanofi-aventis R&D adaptation plans. Through the program, 87 businesses were created or acquired in 2010, primarily in services (28), health and well-being (20), hotel and restaurants (11) and animal health (7).
PROJECTS COMPLETED IN 2010
PART OF PROVISIONAL WORKFORCE PLANNING(1)
START-UP FOR AN INDIVIDUAL PROJECT
Number of projects finalized Number of projects led by women Number of projects led by men
40 (2)
47 (2)
30 10
25 22
Number of businesses created Number of businesses acquired Number of jobs potentially created(3)
36 4 46
37 10 69
(1) The provisional workforce planning agreement (GPEC) was implemented to offer prospects for certain functions (e.g., medical sales representatives, industrial affairs, etc.) and allow employees to acquire new skills to meet the technical and economic requirements of the ever-changing pharmaceutical sector. (2) Business sectors in which the 87 businesses were created or acquired: services (28), commerce (8), agriculture (4), health and well-being (20), construction (2), teaching (1), hotel and restaurant (11), decorating (6) and animal health (7). (3) Including entrepreneurs
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In Europe
The changes that took place in Europe in 2010 essentially applied to: Commercial operations in Germany, Spain and Italy The sale of the Alnwick (UK) R&D site, which was taken over by the same international company that acquired the Porcheville (France) site, allowing it to continue to develop activities in the region.
In every impacted European country, discussions with employee representative bodies took place throughout the year to communicate about the changes and define the most appropriate ways to support employees while taking into account local regulations. The objective is to inform social partners as early as possible in order to take into account their opinions and suggestions. The support provided can take many forms: internal retraining, outplacement, voluntary departures, early retirement, etc.

To address changes in the U.S. market, the anticipated expiration of the patents for certain major drugs, and the increasing competition created by generics, sanofi-aventis continued to make adjustments to its workforce in 2010.
Therefore, the Group announced in October 2010 that it would reorganize its operational entities with the objective of resizing and repositioning pharmaceutical activities in order to keep up with the changes in the product portfolio. Nearly 25% of employees approximately 1,700 people were affected, primarily in sales. In keeping with Group values, sanofi-aventis implemented support measures for these employees, in particular concerning the financial conditions of their departures and follow-up with regard to outplacement.
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Strengthening and integrating teams in areas with high growth potential

Supporting change also entails: Integrating the teams of recently acquired companies Managing workforce growth in certain geographic areas, particularly China
Integrating recently acquired companies

Over 1,600 people joined the Group from the eight entities acquired in 2010, most of them in manufacturing and research. These eight acquisitions serve to strengthen sanofi-aventis presence in the area of therapeutics and developing markets, which is consistent with the Group's broader strategic orientation: Diabetes: Bioton Vostok in Russia Vaccines: VaxDesign in the United States Consumer health: Chattem in the United States, Ming Shen in China, Nepentes in Poland, Romania and Bulgaria Dermatology: Canderm in Canada Inhalation equipment: Siegfried in Germany Production site in Argentina
Managing workforce growth: The challenge of China

In China, sanofi-aventis must adapt its structures to deal with very strong market growth and increased international and local competition. Between 2004 and 2009, there was a fivefold increase in the Group's workforce. At the end of 2010, the workforce comprised more than 4,700 individuals, nearly 1,300 of whom were new employees recruited during the year. The Group estimates that by 2015, the workforce will exceed 8,000 people. To manage this substantial growth in the Chinese workforce, the Human Resources Department defined three key focus areas: Anticipating recruitment needs in line with organizational changes Supporting managers through talent management, which will make it possible to identify employees who are leaders or future leaders and develop their skills in keeping with the Group's strategic directions Organizing career development opportunities for employees through the creation of sanofi-aventis University, which designs and implements all employee training programs
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Policy
The Human Resources career development policy is based on developing professional skills and cultivating
Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Contributing to local economic development
SANOFI-AVENTIS SOCIAL CHARTER Professional training is an essential part of development for both the employees and sanofiaventis. Everyone has a duty and a right to undergo appropriate training, and to this end the Group provides the necessary resources and commitment. Excerpt from the sanofiaventis Social Charter
each employees potential, at all levels and in every country, recognizing that the diversity of the Groups workforce drives both performance and innovation. By taking into account a changing environment when devising career development plans, each employee gains a better understanding of the Groups strategy and culture, which enables employees to contribute to meeting challenges now and in the future. With regard to skills development, all employees are entitled to an interview with a manager at least once a year, during which they can discuss their strengths and the areas in which they want to grow. These interviews are also an opportunity for employees to talk to managers about their ambitions and growth opportunities, in their current positions as well as potential different positions and functions.
Making training a major factor in professional development

Training is one of the pillars of the sanofi-aventis Human Resources policy. Thanks to training, it is possible to: Anticipate and support changes in the organization Ensure the necessary resources to respond to the Groups economic imperatives Prepare and support career changes and talent development within the Group Provide for skill transfer and knowledge sharing In order to meet these challenges in the field and as closely as possible to where they occur, the various operational entities provide training at the most appropriate level. Group-wide training is also provided, specifically to promote corporate culture and support the Group's strategy by offering managers opportunities for reflection, exchange and personal development. Training activities are provided in a variety of formats: Group training: in a classroom setting Remote learning: e-learning Blended training, a combination of classroom and online training modules
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Talent management:
key positions identified for structured succession plans.
2,000
of employees in France participated in training programs in 2010
84.7%
The total number of hours of training received in France in 2010 is equivalent to an average of hours of training per employee.
29
managers participated in the various international career development programs: Discover, Explore, Evolve, Pilot, Perspectives
422
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Employee career development - Actions

Talent management Corporate development programs Examples of local initiatives
SANOFI-AVENTIS SOCIAL CHARTER Professional training is an essential part of development for both the employees and sanofiaventis. Everyone has a duty and a right to undergo appropriate training, and to this end the Group provides the necessary resources and commitment. Excerpt from the sanofiaventis Social Charter
Talent management
In 2010, the Group developed a single approach to talent management based on a One Group, one process, one tool principle. This approach means: Improved ability to anticipate and plan for the Groups future needs in the areas of professional skills and employee profiles Improved cross-functional collaboration thanks to the "talent reviews" conducted jointly by the functions, as well as planned and shared development initiatives Ensuring consistency of the "talent review" process by implementing common methods within the various Group entities Acknowledging the significant role of managers as drivers of talent development and sharing within the Group One important aspect of this new talent management approach is fostering diversity in those employees who could be candidates for succession in Group management. The goal is also to develop talent in emerging markets.
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Talent management:
key positions identified for structured succession plans.
2,000
Corporate development programs

For a number of years, sanofi-aventis has organized a series of Group-wide, international programs: Discover, Evolve, Explore, Pilot and Perspectives. Each of these programs brings together managers from diverse geographic horizons and from all Group functions to allow them to adopt common managerial practices that are based on accompanying both individuals and teams. In 2010, 422 managers benefited from one of these programs.
Discover, an international integration program

The Discover program aims to accelerate integration, strengthen the sense of belonging to the Group and increase motivation. During the program, each participant has the opportunity to gain better understanding of the Group organization and to embrace its culture and values. Participants also get a better grasp of the objectives and issues of their function or region, and can begin to create an international network. Discover is intended for managers who recently joined the Group or its affiliates, and who hold responsibilities with international scope.
of employees in France participated in training programs in 2010
84.7%
The total number of hours of training received in France in 2010 is equivalent to an average of hours of training per employee.
29
Evolve, a career development program for junior managers

The Evolve program is intended for junior managers with little or no experience managing teams. The program is offered to participants who have displayed the skills considered to be essential in a future leader. Evolve allows participants to accelerate their individual growth and implement an action plan. The goal of the program is for these managers to better grasp the Groups international and multicultural outlook.
Explore, an individual development program

The Explore program is designed for team managers, project managers and team coordinators, from all functions and countries, with seven to 15 years of professional experience. Explore provides managers with a broader vision that goes beyond their function or region and allows them to develop international, Group-wide networks.
managers participated in the various international career development programs: Discover, Explore, Evolve, Pilot, Perspectives
422
Pilot, a development program for managing managers

Pilot is intended for managers from all functions in the French-speaking countries where the Group operates who are in charge of managing other managers. The program helps them work on developing strategies and nurturing relationships while fostering a managerial culture grounded in the Group's values.
Perspectives, a development program for Senior Leadership

The Perspectives program is intended for sanofi-aventis senior management. Its goal is to provide the opportunity for exchange about the challenges faced by the Group and their roles as leaders.
2010 DISCOVER EVOLVE EXPLORE PILOT PERSPECTIVES TOTAL
Number of participants Number of nationalities % women Length of training (days)
75 33
71 26
136 32
66 4
74 21
422 N/A
35% 2.5
51% 2.5
38% 3.5
38% 9
27% 6
N/A N/A
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Examples of local initiatives

A wide-ranging professional development program in the intercontinental region
In 2009, the Group conducted a major study, surveying employees about the internal environment of sanofiaventis in their regions. The study covered the intercontinental region (Africa, Middle East, Central Asia and Latin America). The objective was to listen to what employees had to say, identify their perception of the Group's transformation, and find ways to help managers handle the changes in the Group and optimize their teams performance. Following this study, a number of initiatives were implemented in 2010: Training and career development programs A review of existing job descriptions and drafting of new job descriptions, particularly in marketin, Expanding the Connect Outside, Evolve Inside prize to include the intercontinental region. Patient / Innovation
Sanofi-aventis Vietnam
Sanofi-aventis Vietnam received second prize for Corporate Social Responsibility (in the category Working Conditions) the first time it participated in this competition. The CSR prizes were created in 2005 by the Chamber of Commerce and Industry in Vietnam in collaboration with several ministries and international organizations (UNDP, BIT, Global Compact Network). They reward companies that contribute to development of human resources and human capital, social progress and environmental protection. The CSR prizes concern two categories: working conditions and the environment. During the January 16, 2010 ceremony in Hanoi, Mr. Vu Tien Loc who is President of the Chamber of Commerce and Industry, Vietnam and Chairman of the CSR awards committee pointed out that these prizes "should motivate companies to continue to strengthen their reputations and competitiveness while sustainably improving the working conditions and well-being of their employees and protecting the environment. This should make them more competitive, and these actions should make it easier for companies to penetrate the international market. The sanofi-aventis initiatives that were recognized by the prize include: The implementation of policies to attract and retain employees and the roll-out of career development programs Fostering a balance between private and professional life: organizing workshops on current topics of interest, such as influenza A(H1N1), dengue fever, diabetes, cardiology, etc.; team-building activities and sports competitions; family days; drawing contests for children of employees; Children's Day; and the full moon festival Health: all affiliate employees have mandatory medical insurance and additional health and accident insurance. The affiliate offers annual medical check-ups and vaccination clinics Additional retirement benefits: from 2005 to 2009, a month of paid leave before retiring Creation of a training / internship program to guide young university graduates in their career choices (by participating in job fairs, orientation days and factory tours)
Sanofi-aventis Hong Kong

Sanofi-aventis Hong Kong was designated as Manpower Developer 1st by the Employee Retaining Board for its Manpower Developer Program. The jury evaluates the quality and effectiveness of companies' employee training and development programs. This designation recognizes the affiliate's commitment to employee training and development.
Sanofi-aventis Pakistan
In, 2010, implemented an employee development initiative. This is the first program to offer accreditation in business administration for the pharmaceutical industry in Pakistan. The program is the result of a partnership with the Institute of Business Administration in Karachi. The goal is to provide participants
coming from a sales background with the knowledge and skills they need to be more effective and become leaders at the local or international level. Upon completion of these two years of training, participants receive a certificate in business administration. This program gives members of the sales force a unique opportunity to develop their talents and hone their management skills without having to take time out from their careers.
Sanofi-aventis Asia-Pacific
In 2010, the sanofi-aventis Asia-Pacific university was created for the professional development of employees.
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Attracting future talent is a vital challenge for sanofi-aventis. The Group continues to strengthen its reputation and become a preferred employer. In this context, the Groups relationships with a growing number of schools and universities and the VIE (International Corporate Volunteer) Program provide students with numerous opportunities to learn about and join the Group.
Actions
Sanofi-aventis fosters lasting relationships and collaborations with a selection of international schools and universities, offering students the opportunity to discover the wide range of job possibilities within the Group while benefiting from the expertise of sanofi-aventis employees. The teams contributions to developing talent and furthering students knowledge, along with training programs and one-on-one mentoring, help young people grow and facilitates their entry into the professional world. For more information: www.sanofi-aventis.com / Careers
International Corporate Volunteer (VIE)

The purpose of the International Corporate Volunteer Program is to identify and attract young talent. The program offers genuine operational assignments in fields as varied as Marketing, Finance and Procurement. Thanks to the Groups global presence, young graduates have the opportunity to work in one of sanofi-aventis affiliates in Africa, Asia, Australia, Europe, the Middle East, North America and Latin America. For 12 to 24 months, VIE participants are entrusted with real responsibilities in a competitive, complex environment that provides them with genuine opportunities to learn, grow and acquire new skills. The VIE program is an excellent way for sanofi-aventis to discover and recruit the talented young people who will be the Groups future leaders. For more information: www.sanofi-aventis.com / Student Portal
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Compensation and employee benefits

Sanofi-aventis strives to ensure fair recognition for both individual and collective performance. Regardless of an individuals country, position or function, the Group seeks to offer fair, high-quality benefits for all employees.
Group compensation and employee benefits policies are implemented in each country in accordance with local practices and regulations. Find out more about: Compensation Employee benefits
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Compensation
Policy Actions
20 bonus shares allocated 105,000

to more than eligible employees In 2010, more than 250 million in variable collective compensation distributed by the Group in France
Policy
Sanofi-aventis compensation policy is designed to reconcile recognition for individual performance and internal equity, while taking into account the Groups position in the local economic environment. Beyond reaching individual objectives, variable individual compensation recognizes an employees personal commitment and contribution to the Groups success. In addition, the Group also wishes to highlight employee contributions to performance through a variety of systems of variable collective compensation according to each country and activity. The Group also pays particular attention to ensuring equal compensation between women and men in like roles and preventing all forms of discrimination. Lastly, in France, the Group strongly encourages investment in the employee savings plan in order to supplement future retirement pensions.
Actions
Worldwide plan to issue bonus shares
In October 2010, for the first time, the sanofi-aventis Board of Directors decided to implement a worldwide plan to issue 20 sanofi-aventis bonus shares to each eligible employee. More than 105,000 Group employees benefited from this plan, which serves to make each employee more invested in the Groups future. The issuing of bonus shares gives employees the opportunity to become sanofi-aventis shareholders. It is also a gesture in recognition of the impact that employees commitment and efforts have made on the Groups performance and transformation.
In France: Variable collective compensation

The goal of variable collective compensation, which brings together voluntary and statutory profit-sharing, is to give all employees an interest in the companys performance by favoring lower-paid employees. The company enhances this collective program by topping up employee contributions to the employee savings plan (PEG) and / or the collective pension savings plan (PERCO). The amounts distributed or allocated in 2010 for financial year 2009 came to 250.9 million (top-up of employee contributions into PEG and / or PERCO included), which represents 15.8% of the total payroll. In June 2010, 78.4% of eligible employees chose to invest in the PERCO plan. The Group also made an amendment to the PEG agreement to provide employees with access to an Ethics and Solidarity employee mutual fund as of January 1, 2010.
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Employee benefits
Policy Actions
Policy
Sanofi-aventis strives to ensure that all employees worldwide have high-quality benefits and income for retirement. Each plan must aspire to fairness, solidarity, respect for others and compliance with local regulations and cultures. It must also encourage social and individual accountability. The Group is careful to ensure such employee benefit plans are designed for the long term: The guarantees provided must not be excessive, but must cover all local needs and complement any state-run plans that may already exist. Financial commitments must be contained over the years and not create future debt that will burden tomorrows generations and hinder growth. Insofar as possible, the management and implementation of coverage must be carried out by strong local partners.
Actions
In 2010, sanofi-aventis continued the implementation of its global employee benefits policy, which was introduced in 2004. To address changes in the world economy, the Group decided to focus more specifically on initiatives related to healthcare and retirement. A number of contracts were entered into in 2010:
In the Middle East:

Jordan, Palestine (52 employees): Improved life insurance and disability coverage by offering full coverage, improved health insurance by adding coverage for serious illness, dental care and medical devices Israel (116 employees): Introduction of life insurance benefits
In Asia:
South Korea (420 employees): Finalized health coverage and extended health coverage to children of employees Uzbekistan (36 employees): Introduction of life insurance benefits
In Europe:
Germany (448 employees): Employees of a business acquired by Aventis now have the same employee benefit plan as other sanofi-aventis employees in Germany Italy: Introduction of the same life insurance benefits for all employee categories France: Employee benefit plans are managed in close collaboration with employee representatives. Changes in the accounts are subject to indepth analysis by working groups and joint oversight committees. The year 2010 was devoted to maintaining and ensuring balance for the healthcare coverage plans implemented in 2007. Now that this has been accomplished, certain services can be improved without increasing costs, which was finalized by an amendment to existing agreements.
In the United States (9,700 employees):

Harmonization of healthcare coverage for medical, vision, and dental care, using a sliding scale based on income, across business units.
In sub-Saharan Africa and Kenya:

The Group's Employee Benefits Department assisted local teams in issuing a request for proposals to health insurance providers in order to make the best choice among different proposed contracts on the basis of quality of service, cost optimization and compliance with the Group's ethics rules.
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With the health sector undergoing far-reaching transformation, sanofi-aventis is developing in new strategic directions and adapting the Groups organizations to promote sustainable growth. The transformation process is addressed on a regular basis with the various employee representative bodies, and the Group updates all employees about new developments.
European Works Committee: Training of 80

employee representatives from European the Union countries where the Group operates
27
Social dialogue: A priority

The Group seeks to develop high-quality social dialogue with all employees and their representatives while taking into account local laws and practices in each country. Industrial relations within the Group are founded on mutual respect and dialogue. In addition to compliance with legal obligations, dialogue with employee representative bodies is important in order to: Provide transparent information on a regular basis by communicating about changes within the Group (strategy, results, organizational changes, etc.). Address ways to support employees and anticipate all the necessary changes to enable the success of the sanofi-aventis transformation. This interaction with employee representatives may cover topics ranging from compensation to training to organizational changes. Discussions are subsequently made official through business agreements, which are necessary to the Group's development. In this spirit, employee representatives and management meet on a regular basis to exchange views, negotiate and enter into and ensure these agreements are being implemented.
SANOFI-AVENTIS SOCIAL CHARTER Workplace relations within the Group are based on mutual respect and dialogue. Excerpt from the sanofiaventis Social Charter
A solid foundation
When it comes to social dialogue, the Group applies the principles of the UN Global Compact, to which sanofi-aventis has subscribed. Sanofi-aventis supports freedom of association and recognizes the right to collective bargaining. The Group's social policy is detailed in the Social Charter, which is distributed to all employees so they can apply its principles in their work. For more information: Sanofi-aventis Social Charter (PDF, 1268Kb)
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Employee representation and information - Actions

At the Group level In Europe In France In other countries
European Works Committee: Training of 80

employee representatives from European the Union countries where the Group operates
27
At the Group level

Social dialogue is based on transparency and employee access to information. Various means of communication are available in all countries to keep employees informed, at the Group level as well as the affiliate level. Communication tools are adapted to the local environment (language, available communication methods: intranet, billboards, etc.) and the different types of job functions (non-mobile, itinerant, etc.). The Group strives to achieve a balance between communications originating from on-site management and communications that use new technologies. The goal of communications is to promote employees buy-in of the Group's strategy at all sites worldwide. Communication efforts are organized depending on available distribution channels, which can be varied yet complementary: Informational meetings organized for managers and employees Intranet sites providing access to a great deal of information, videos of senior management or members of the Executive Committee, "60 minutes with..." interviews during which employees can ask questions More traditional information tools, such as local newsletters and billboards
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SANOFI-AVENTIS SOCIAL CHARTER Workplace relations within the Group are based on mutual respect and dialogue. Excerpt from the sanofiaventis Social Charter
In Europe
Employee representative bodies engage in social dialogue in countries where the Group operates. In 2010, these bodies were kept regularly informed about the Groups progress and about the transformation program.
Communicating with the European Works Council

The sanofi-aventis European Works Council is composed of 40 permanent members and 40 alternates, representing employees from the 27 countries in the European Union member states where the Group operates. During 2010, members received training about the Councils role and prerogatives in light of changes in the legislative framework. The Council met four times in 2010 to give the employee representatives regular updates about developments within the Groups various entities (R&D, Industrial Affairs, Commercial Operations, Vaccines and support functions). These developments reflect the adaptations needed for the Group to remain competitive internationally, to migrate research and industrial facilities toward biotechnologies, and to adjust sales forces in response to increasing regulatory constraints (such as exclusion from reimbursement or price regulation) and to generic competition for some of the Groups flagship products. Moreover, additional meetings with the European Works Council office made it possible to share information at regularly scheduled meetings as well as on a spontaneous basis according to the latest developments in the Group.
Negotiating with employee representative bodies in every country

In each European country affected by the changes, negotiations with employee representative bodies were conducted throughout 2010 in order to: Inform them of changes that occurred within the Group (Commercial Operations in Germany, Spain, Italy,
France; sale of sites in England and France; site closures, etc.) Establish the employee support measures best suited to local circumstances (internal retraining, outplacement, voluntary departures, early retirement, etc.) The objective is to inform employee representatives at the earliest possible stage to take into account their viewpoints and proposals.
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In France
In France, the sanofi-aventis Works Council, composed of 25 permanent members and 25 alternates, as well as trade union representatives, met five times in 2010 (February, April, July, October and December). During these meetings, the Council was updated about the Groups activities and financial position, employment trends in France, and the status of the Group's transformation program (reorganization of R&D, Chemical Manufacturing, Commercial Operations in France, sale of an R&D site, etc.) and ongoing projects (such as integration of French acquisitions, etc.). In 2010, five amendments to the agreements on the cost of healthcare, disability and life insurance coverage were signed by employee representatives, as well as an agreement on a 3% increase in the minimum guaranteed annual salary. In addition, with a view to integrating employees of the companies Oenobiol and Fovea, acquired in 2009, into the Group's variable collective compensation system, five amendments to the agreements on this issue were signed. Specific agreements were entered into with certain Group companies (Sanofi-aventis Research and Development, Sanofi Winthrop Industrie, Sanofi Chimie, Sanofi-aventis France, Sanofi Pasteur and sanofiaventis Group), such as, for example, on the adoption of chemical industry classification at entity level. Finally, negotiations were initiated in 2010 on topics such as training, the provisional workforce planning agreement (GPEC), and measures concerning difficult working conditions. These negotiations are continuing in 2011.
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In other countries
Employee representative bodies exist in most countries where the Group operates. In 2010, these bodies were regularly informed about the Groups market and transformation program. In 2009, numerous affiliates conducted social climate surveys with an excellent employee response rate (over 90%). Sanofi-aventis affiliates in Taiwan and Japan carried out such surveys in 2010, after which action plans designed to respond to local challenges were implemented. Another survey, in which 11,000 employees participated worldwide, was conducted in 2010. This survey was intended to gauge employees' perception and understanding of the transformation program implemented within R&D. The satisfaction rate was 62% in October 2010, significantly higher than that reported in May (45%).
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Ensuring occupational health, safety and wellbeing

Protecting the health and safety of our employees is a key priority for sanofi-aventis. Regardless of the nature and type of collaboration (involving Group employees, temporary employees or external service providers), the Group has adopted a policy to assess and control risks.
Sanofi-aventis aims to ensure its partners carry out their work in accordance with the Groups HSE principles.
It is crucial to be able to assess potential occupational injury and health risks in the workplace. This also requires ensuring prevention and protection by providing employees with information and training so they can play an active role in their own health and safety.
Safety in the workplace

The goal is to reduce accident risks in the workplace by implementing and maintaining a prevention and protection system subject to ongoing monitoring.
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Occupational health
The Group is committed to safeguarding the health of each employee by protecting employees from any harmful exposure to chemical, biological, physical or psychosocial risk factors. Sanofi-aventis also provides medical surveillance for employees as needed, according to their work area.
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Nearly decrease in the Groups occupational injury with lost-time frequency rate between 2006 and 2010
30%
Prevention and management of major occupational risks

As sanofi-aventis business activity requires the use of hazardous substances such as solvents, flammable substances, combustible dust, etc., the Group strives to prevent major accidents (fires, explosions, etc.).
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HSE compliance for subcontractors and suppliers

In accordance with the Group's HSE policy, sanofi-aventis adopts a constructive attitude of transparency and dialogue toward external partners with respect to health, safety and environmental protection.
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managers received training about psychosocial risks in 2010 in France.

BUSINESS CASE
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BUSINESS CASE: SAFETY GAME To improve safety performance, in 2010 the Suzano site in Brazil worked on promoting awareness and modifying behaviors through a roleplaying activity: the Safety Game.
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BUSINESS CASE
Safety in the workplace

Background Policy
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Background
When it comes to occupational safety, sanofi-aventis' goal is to reduce the occurrence of workplace accidents to the lowest possible level. This involves implementing prevention and protection systems that are subject to ongoing monitoring and continuous training. Prevention and safety are major issues for all employees, irrespective of their role within the Group: full-time employees, temporary employees or subcontractors working at our sites. This process involves: Assessing current risks Anticipating new risks Developing expertise Offering support through training and feedback about experiences The HSE Departments goal is to make improvements in these areas. For more information: HSE management systems
Results that speak for themselves:

Nearly decrease in the occupational injury with lost-time frequency rate between 2006 and 2010. Nearly decrease in the occupational lost-time accident frequency rate involving motor vehicles between 2006 and 2010.
30%
40%
Policy
Sanofi-aventis operates management systems covering safety, occupational health and environmental protection. These systems are adapted to each of the Groups functions. They are assessed periodically. This process involves measuring the results obtained, defining objectives for progress, implementing actions plans called PASS and organizing associated control systems. The entire process depends on information, learning from experience, dialogue and training. Our occupational safety principles aim to reduce accident risks in the workplace by implementing and maintaining a prevention and protection system subject to ongoing monitoring. The Group sets qualitative goals for programs and training within the different Group functions, and it also establishes a quantitative objective for the occupational injury frequency rate. Training has been developed over the last three years to strengthen the Groups safety culture. This training is aimed at HSE professionals and operational managers. The goal for HSE professionals is to enhance their expertise. For operational managers, the goal is to strengthen a safety culture based on a sound understanding of the fundamentals of risk management and the recognition of safe behavior. For more information: HSE management systems
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2010: Industrial Affairs Health & Safety Awards organized for the
first time
OUR VISION Message from Senior Management
PLANET Planet indicators CO2 emissions and
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People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Safety in the workplace Actions Indicators Business case Occupational health Prevention and management of major occupational risks HSE compliance for subcontractors and suppliers Contributing to local economic development Improving safety for medical sales representatives Rewarding best practices
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BUSINESS CASE
Safety in the workplace - Actions

To reduce the occurrence of workplace accidents, sanofi-aventis has taken various initiatives, in particular with a view to:
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Improving safety during operations entrusted to external service providers
Improving safety for medical sales representatives

Due to the disturbing number of motor vehicle accidents involving medical sales representatives, the Group instituted a long-term program to reverse this trend starting in 2006. This approach is based on decisive involvement from management, a dedicated communication campaign, adapted training and a recognition program the Motor Vehicle Safety Awards. Since 2006, the motor vehicle safety campaign has led to a nearly 40% decrease in the occupational losttime accident frequency rate involving motor vehicles, as well as accidents involving damage to motor vehicles. New initiatives will be implemented in 2011. In 2010, the Group continued to focus on motor vehicle safety. Affiliate General Managers in attendance at the Second Motor Vehicle Safety Awards ceremony emphasized in front of over 300 of the Groups best medical sales representatives their commitment to further improving motor vehicle safety results. Countries participating in the Second Motor Vehicle Safety Awards accounted for nearly 70% of the Groups automobile fleet. Lebanon received first prize, followed by Brazil and Italy. 2010 results
OCCUPATIONAL ACCIDENTS (MEDICAL SALES REPRESENTATIVES) 2006 2007 2008 2009 2010 VARIATION 2006-2010

30%
40%
Total motor vehicle accidents Occupational lost-time accident frequency rate involving medical sales representatives (1) Fatalities
11,062 4.7
8,837 4.4
7,760 3.7
6,829 3.4
6,648 2.8
-40% -39%
first time
(1) Number of accidents resulting in lost time of one day or more within a 12-month period, per million hours worked. For more information: European Road Safety Charter of the European Commission
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Rewarding best practices

The Groups vaccines division has organized Health & Safety Awards for several years now. In 2010 the awards were organized for the first time in Industrial Affairs to recognize and reward best practices at production sites throughout the Group. Over 80 applications were submitted for this inaugural event.
The 2010 Industrial Affairs HSE Awards recognize the best results and initiatives to improve occupational health and safety on the sites. The awards ceremony took place during the Industrial Affairs HSE seminar. The winners for the best HSE performance were the Aramon site in France, the Anagni site in Italy, the Fawdon site in the United Kingdom, the Kawagoe site in Japan, the Harbor Park site in Hungary, and the Algiers site in Algeria. The winners for the best HSE initiative were the Frankfurt Chemical site in Germany for its initiative concerning the use of hazardous substances; the Frankfurt Injectables site in Germany for an initiative designed to prevent slip, trip and fall accidents; the Tours site in France for its initiative to improve dayto-day safety; the Suzano site in Brazil for its Safety Game; and the Amilly site in France for its Vigilance training program. For more information on the HSE initiative implemented at the Suzano site: Business case: Safety Game
Improving safety during operations entrusted to external service providers

Sanofi-aventis has developed a special program for the safety of external service providers. The Group continued to roll out this program in 2010 at its various sites. It is based on five points: Consideration of the safety factor when choosing a contractor Contractor accommodations at the sites Analysis of intrinsic risks specific to the subcontractors work and related protective measures Contractor work site audits and inspections Review of annual results For more information: Subcontractors and suppliers
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FREQUENCY RATE OF INJURIES WITH LOST TIME (1)(2) 2008
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BUSINESS CASE
Safety in the workplace - Indicators

The main indicator for safety in the workplace is the frequency rate of accidents. It is detailed below based on function and geographic area. Over the last five years, safety results have shown steady improvement in occupational accidents for all people working for the Group (non-mobile personnel, temporary employees and external service providers).
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Additional methodological information

For non-mobile personnel, accidents occurring during the home-workplace commute are not included in this indicator. However, they are included for medical sales representatives, in accordance with the reporting rules defined by the Group. In the event that additional accidents have not yet been recorded at the close of the financial year, or if changes in the qualification of accidents are observed after the financial year has ended, the frequency rate is subsequently corrected.

30%
Consolidated frequency rate for accidents by function

2009 2010
40%
Research and Development Industrial Affairs Commercial Pharmaceutical Operations Vaccines Support Functions Sanofi-aventis total Temporary employees
1.6 3.1 2.9 2.0 1.6 2.7 2.6
1.9 2.0 2.6 1.1 1.4 2.2 1.4
1.6 2.1 2.1 2.3 1.8 2.1 (*) 2.4
first time
(1) Number of accidents resulting in lost time of one day or more within a 12-month period, per million hours worked. These data are consolidated for all Group companies. (2) Frequency rates for previous years have been adjusted based on the following factors: eliminating injuries dismissed by regulatory authorities, including injuries reported late, and changes in the scope of reporting .
* Indicators identified by an asterisk (*) were the focus of more in-depth analysis, enabling the Statutory Auditors to express an assurance specifically concerning these data. Their assurance statement, detailing the work they performed as well as their comments and conclusions, appears on this sanofi-aventis CSR Report website, Statutory Auditors Review Report section: Vision / CSR performance / Statutory auditors review report
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Business case: Safety Game

Modifying behaviors to improve safety performance
Three types of initiatives can be effective in improving safety performance: technical, organizational and behavioral initiatives. In recent years, sanofi-aventis has made significant progress in its technical and organizational initiatives. In 2010, the Group focused on behavior, so that each individual will be actively involved in ensuring his or her own safety. The 2010 Health & Safety Awards recognized many of the best practices from the Group's sites, including the Safety Game an initiative developed at the Group's Suzano site in Brazil.
Modifying behaviors to improve safety performance at the Suzano site in Brazil
The Safety Game at a glance The goal is to use a game to promote awareness about the impact on safety of certain behaviors (being distracted, not following procedures, not being careful) and to implement day-to-day measures 891 participants (90% of the workforce) 200 safety initiatives proposed
Improved safety for employees After 5 months of the Safety Game at the site: 50% decrease in the number of injuries Reduced frequency rate - from 3.8 to 0.6
Developing a culture of safety among employees Encouraging innovative initiatives Cost reduction as a result of fewer injuries
Promoting innovative, enjoyable and effective Health & Safety initiatives by organizing the 2011 Awards
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Challenge
In early 2009, sanofi-aventis noted a decline in safety performance at the Suzano industrial site in Brazil. The frequency rate (3.8) was the highest it had been in six years, and 61 individual accidents had happened in 12 months. An analysis of these accidents and their causes revealed that most of them were not related to equipment safety or procedures, but rather to behavior: being distracted, not adhering to standard procedures or simply not being careful. It thus became necessary to find ways to help modify behaviors and improve the sites safety record.
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Our response
The idea was to work on promoting awareness and improving behaviors at the Suzano site through a role-playing actvitiy the Safety Game. Developed and coordinated by the Accident Prevention Committee, the Safety Game is an entertaining way to foster employee involvement, promote awareness and provide employee training. The Safety Game focuses on making safety a day-to-day concern for employees in all departments in order to improve the site's overall safety performance. The game is simple. Teams of volunteers sign up to play, and each team can have up to 20 participants. To win points, each team must imagine, suggest or present new HSE initiatives or new safety-promoting behaviors. A certain number of points is given for each type of initiative. The team with the most points wins. The Safety Game was launched in 2010 and continued for five months. A total of 891 people participated (90% of the sites workforce) and proposed 200 safety initiatives. Their suggestions covered many different areas, for example: Developing a safer way to handle boxes of injectable products by using a container that limits risks related to slip, trip and fall accidents A Whats wrong with this picture? game to identify hazardous situations
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The Safety Games results speak for themselves. After just five months, the number of accidents at the Suzano site had fallen by 50%, and the frequency rate went from 3.8 to 0.6. Simply by modifying behaviors, employee safety was ultimately improved. In recognition of this initiatives effectiveness, the Safety Game received the Industrial Affairs "Health & Safety" Innovation Award in 2010. This award provides further incentive for employees to apply their creativity to improving performance.
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The Safety Game is an effective tool to promote a culture of safety among employees. It is moreover an example of an innovative initiative devised by employees, for employees. This initiative also led to a reduction in accident-related costs for the Group.
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For the future, sanofi-aventis is committed to pursuing efforts to encourage initiatives that promote improved occupational health and safety, and to recognizing and rewarding innovative ideas with the greatest impact.
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Occupational health
Background Policy
Over HSE specialists were trained in 2010 in risks related to noise, vibrations and lighting
200
Background
The Group is committed to safeguarding the health of each employee by protecting employees from any harmful exposure to chemical, biological, physical or psychosocial risk factors. Sanofi-aventis also provides medical surveillance for employees as needed, according to their work area. The health in the workplace approach is based on the following three steps:
In France managers received training about psychosocial risks in 2010
180
Psychosocial risks are part of occupational risks. As such, they are considered to be on the same level of importance as chemical, biological and /or physical risks.
Fabienne Perekrestow Group Health & Safety Director, sanofi-aventis
One of the Groups major challenges is to safeguard and protect the health of each employee by limiting exposure to physical, chemical, biological and psychosocial risk factors in the workplace.
Policy
Sanofi-aventis operates management systems relating to safety, occupational health and protection of the environment adapted to each of its activities. These systems are assessed periodically by measuring the results obtained, defining objectives for progress and implementing action plans called PASS with associated control systems. The process depends on information, learning from experience, dialogue and training. The Group's policy is designed to continually assess occupational injury and health risks faced by our employees in the workplace, to take the appropriate preventive and protective measures, and to inform our employees and train them so they can ensure their own health and safety. For more information: HSE management systems
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In 2010, sanofi pasteur Canada received the Whos Who in Workplace Health Award for its
Phoenix Wellness Program
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Occupational health - Actions

Providing information and training about the risks of substances handled Optimizing the role of the corporate industrial hygiene laboratory Assessing exposure to biological agents: The TRIBIO Committee Implementing prevention programs Promoting well-being in the workplace worldwide
200
Providing information and training about the risks of substances handled

The COVALIS committee established by sanofi-aventis is a multidisciplinary team of specialists (physicians, toxicologists, chemists and product managers) who are in charge of characterizing the risk associated with specific substances by evaluating their pharmacological and toxicological properties. Active pharmaceutical ingredients are assigned to one of five categories, corresponding to five occupational exposure levels. Each site HSE team informs and trains employees about how to make the best use of these data via instructions, procedures and labeling created specifically for each work area. In 2010, training was rolled out for the HSE teams at various sites worldwide about chemical risks and wearing personal protective equipment.
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180
Optimizing the role of the corporate industrial hygiene laboratory

The Group has had an internal corporate industrial hygiene laboratory since 2006. This laboratory further strengthens the system for substances handled by employees, making it possible to confirm or validate upstream that exposure is in compliance with internal reference values or the values defined by national or international regulations. The laboratorys responsibilities for production and research sites were redefined in 2010. The goal is to enhance the quality of service and meet the Groups sites growing needs.
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Assessing exposure to biological agents: The TRIBIO Committee

The TRIBIO committee assesses and classifies all biological agents to which Group employees may be exposed according to several criteria pathogenicity, biological stability, means of transmission, infection routes, and the existence of preventive measures or an effective treatment. Employees receive information and training about the type of risks and means of prevention, personal protective equipment and personal hygiene. In order to continually decrease the occupational exposure level, each site implements industrial hygiene programs on the basis of these standards and local regulations, while emphasizing collective protection measures, as opposed to relying exclusively on personal protective equipment. The Group has developed a prevention policy for the risks of allergies from contact with laboratory rodents. This policy primarily involves training employees about best practices and recognizing rodent allergies. At the same time, allergen levels are quantified to identify premises that may pose a risk so that additional measures may be taken to limit exposure.
In 2010, handbooks were distributed to all relevant sites worldwide to help the entities establish risk prevention and employee protection measures. Specialized biological risk audits were conducted at several Group sites in 2010. For more detailed information on HSE audits. For more information: HSE management system audits
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Implementing prevention programs

Sanofi-aventis focuses on identifying and assessing risks, ensuring monitoring, promoting feedback about experience and developing a culture of prevention. Whether in terms of managing occupational illnesses or preventing psychosocial risks, the Group strives to ensure that all its employees have a satisfactory working environment. The Groups primary prevention programs cover: Ergonomics Biomonitoring of occupational exposure Asbestos-related risks Psychosocial risks
Ergonomics
Standards, guides and training modules that focus on how to assess ergonomic factors have been developed by the corporate industrial hygiene team. To complement these efforts, a large-scale training and information program has been organized to improve ergonomic conditions and prevent musculoskeletal disorders and other ergonomics-related problems. In addition to conducting studies on workstations and analyzing organizational approaches, it should be noted that entities have hired ergonomists and offered certain employees university training in ergonomics. Many of the Groups industrial sites also provide programs to help employees improve awareness about posture, muscle warm-ups, etc. Within the distribution function, a new program was rolled out in 2010 at the Marly-la-Ville site in France for musculoskeletal disorders. This initiative made it possible to eliminate postural stress for all employees affected at the site (33 people). This program is being reviewed to assess the possibility of expanding the program to other Group sites. In 2010, a training program was offered to HSE teams at all sites worldwide about risks related to noise, vibrations and lighting. This program organized using web conferencing involved over 200 people at 27 sites.
Biomonitoring of occupational exposure

Responding within the scope of the consultation of stakeholders for the 2010 CSR reporting, Claire Tutenuit, Delegate General of Entreprises pour l'Environnement, stated: We hope that sanofi-aventis will continue to develop the efforts undertaken within the scope of the Groups biomonitoring approach. They may want to draw on research conducted collectively by members of Entreprises pour l'Environnement in discussions about monitoring employees health. Biomonitoring of occupational exposure helps improve knowledge about chemical agents and their effects. Biomonitoring is a medical act: By targeting groups that are actually exposed to agents, it is possible to improve medical surveillance. Although the results may be difficult to interpret, biomonitoring makes it possible to obtain information in addition to atmospheric information, by including all types of exposure and factoring in actual conditions of exposure. It can also take into account previous chronic exposure. Lastly, biomonitoring makes it possible to assess the effectiveness of personal protection measures. Sanofi-aventis uses this kind of surveillance as a tool to improve risk control at Group sites. It is also used during the transfer of active ingredient production.
Asbestos-related risks
Measures taken to control asbestos-related risks take into account the most stringent regulations and are applied across the board at all Group sites. No activities were found to be exposed to asbestos-related risks at the sites that were specifically audited for this risk by an external organization. The sites of new entities will be systematically monitored for their management of this risk.
Psychosocial risks
Within the Group psychosocial risks are considered to be on the same level of importance as chemical, biological and / or physical risks. Many initiatives were launched in France to promote psychosocial risk prevention following a Group-wide occupational health agreement signed in December 2009 that addresses psychosocial risks. Here are some examples of these initiatives:
A multidisciplinary steering committee were created in 2010. This committee is made up of HR managers, site directors, occupational physicians and the Group's Occupational Health & Safety Department. Its responsibilities include coordinating Group risk management initiatives. Six psychosocial risk awareness training sessions were organized between November 2009 and January 2010. A total of 180 managers received awareness training. A dedicated Medical Observatory for Stress, Anxiety and Depression (OMSAD) was also set up at the end of 2010. Many other initiatives involving representative bodies and Committees for Health, Safety and Working Conditions were also implemented or maintained at the Group's various sites throughout France in 2010. These initiatives include steering committees, awareness / training projects, specialized support and mediation services, and projects aimed at offering management support. Specific questionnaires (Hospital Anxiety and Depression (HAD) and Cohen scales) are now being used in conjunction with occupational medicine. Employees can volunteer to answer a questionnaire during their occupational health check-up. Results are used to assess individual stress levels.
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Promoting well-being in the workplace worldwide

Sanofi-aventis occupational health policy includes many initiatives implemented regionally in all countries where the Group operates. For example: In India, prevention awareness campaigns launched in 2008 were maintained through 2010, and comprehensive healthcare check-ups were offered to teams. Thanks to the campaign, 1,650 check-ups were given to members of sales teams, representing 95% of the workforce. In North America, in 2009, sanofi-aventis U.S. launched cancer-screening campaigns, for which the Group was awarded CEO Gold Cancer Employer accreditation. Information campaigns on nutrition have also been organized. In Brazil , a program called Mais Vida focusing on nutrition, mental health and physical exercise has been in place since 2007. Over the last few years, the results of medical check-ups for Group employees have shown substantial improvement (cholesterol, triglycerides and blood pressure). In the Philippines and Thailand, Move for Health a program that promotes physical exercise, developed by the HSE team to improve posture at work has been available since 2010. The video training includes 3 to 5 minutes of daily exercises. For National Diabetes Month in Guatemala , a conference was organized for all employees about a balanced diet and health. In Colombia , an influenza vaccination campaign took place in 2010 for all employees and their family members (1,434 people vaccinated). A health campaign was also launched including brochures with fitness and posture tips. In France , a major awareness campaign for musculoskeletal disorders was launched in March 2010 at the Toulouse / Labege site. The campaign includes an entertaining guide that explains how to do stretching exercises, as well as a self-evaluation sheet that employees can use to analyze the ergonomics of their workstations. The goal is for employees to understand that they play a primary role in preventing musculoskeletal disorders. In Mexico , the Ser Saludable program launched in 2010 was designed to promote a healthy, balanced lifestyle for employees. The program is based on well-being, nutrition and physical exercise. Some 91% of employees have taken part in the evaluation so far. Over 900 employees have received personal fitness and nutrition programs. A photo exhibit was also organized for all employees to promote awareness about the damaging effects of smoking. Since the program was introduced, registration for the fitness center has increased by 20%, and the consumption of vegetables at lunchtime has increased by 55%. In Canada , sanofi pasteur received an award in 2010 for Phoenix Wellness an integrated health and wellness program for Group employees.
Sanofi Pasteur Canada: When employee wellness and health are beneficial for all Sanofi Pasteur Canada received the Whos Who in Workplace Health Award for Employee Communication for its Phoenix Wellness program. The program includes a workplace wellness newsletter and participation in several public events. The Whos Who in Workplace Health Awards are presented every year by Working Well magazine to recognize individuals and organizations that have displayed leadership and spurred innovation in occupational health. The program also received the Eat Smart! Award from Toronto Public Health. Phoenix Wellness is good for employees and companies alike: In 2009, the rate of occupational injury at sanofi pasteur Canada (0.23) was much lower than that of the average for the pharmaceutical industry (1.0). The average length of short-term disability absences was 30 days in 2009, compared with 36 days in 2008 (representing a 16.67% decrease). The percentage of sanofi pasteur employees who have submitted long-term disability requests in the last three years is almost zero. Furthermore, average recovery time was 4.7 months at sanofi pasteur Canada, which is less than half the time reported for the pharmaceutical industry as a whole.
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Occupational health - Indicators

The main indicator for occupational health is the number of occupational illnesses declared throughout the year.
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Most of the occupational illnesses declared in 2010 were musculoskeletal disorders related to various movements associated with repetition, posture or strain. A specific action program has been designed to cover issues relating to workstation ergonomics.
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Methodology
Occupational illnesses and their causes have been divided into categories according to the CEFIC (European Chemical Industry Council) classification system. More than one occupational illness may be reported for a single individual. It should be noted that a new reporting system was established in 2010 for the entire Group.
Occupational illnesses declared in 2010 at the Group level
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Prevention and management of major occupational risks

Background Policy
Background
Sanofi-aventis business activity requires the use of hazardous substances (solvents, flammable substances, combustible dust, etc.). Consequently, it is essential to prevent major accidents such as fires and explosions. Defining risk Risk is the result of exposure to a hazard. Hazards inherent properties of an object, substance or physical situation that could lead to damage to human health and / or the environment do not necessarily lead to risks if exposure can be prevented or controlled. A natural or technological phenomenon is only a risk if it applies to an area where human, economic or environmental issues are at stake. Risk is not material; it is the possibility that a dreaded event of a certain seriousness may happen. For example, an earthquake in the middle of a desert is not a risk for people. However, it is a major risk in San Francisco. Risk is therefore the result of the interaction between the probability of an event and one or more factors: Probability: the possibility that an event may occur and may have an impact on the system being studied (natural or technological) Factors: people, facilities or environments threatened by a hazard and vulnerable to related damage or injury For more information: INERIS website: Conduct research or contract studies and research on risk prevention (In French) Information portal on major risks: Prevention of Major Risks (PRIM) (In French) Cartorisque website: Maps of major technological and natural risks (In French) Sanofi-aventis and risk management For sanofi-aventis, the prevention of major risks consists of: Conducting risk assessments of the Group's processes as early as the stage of fundamental research Taking into account methods to prevent major risks at all Group sites, and in all situations, processes and projects Using the Hazard Vetting method each time manufacturing or equipment is scaled up or down
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The strength of sanofi aventis industrial community comes from a shared global idiom and a strong sense of solidarity, as revealed by the collective reaction to the plight of the Companys site in Scoppito (Italy) after the Aquila earthquake.
Philippe Luscan Senior Vice President, Industrial Affairs, sanofiaventis
people have received process safety training to date
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Policy
Sanofi-aventis has management systems relating to safety, occupational health and protection of the environment, adapted to each of the Groups functions. These systems are assessed periodically by measuring them against results, defining objectives for progress, implementing actions plans (called PASS) and organizing the necessary control systems. The entire process depends on information, learning from experience, dialogue and training. For more information: HSE management systems
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People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Safety in the workplace Occupational health Prevention and management of major occupational risks Actions HSE compliance for subcontractors and suppliers Contributing to local economic development
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Prevention and management of major occupational risks - Actions

To reach its objectives, sanofi-aventis has implemented process safety training.
people have received process safety training to date
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WHAT IS THE RISK?
By improving technical knowledge and on-site expertise, process safety training allows for a decentralized approach to process safety risks at each of the Groups sites. Technical training is provided to chemical development laboratory managers and workshop supervisors as well as chemical and pharmaceutical production engineers. To date, over 100 people have received process safety training. In 2010, the Group emphasized training employees of new entities. The case studies used for training are primarily based on learning from sanofi-aventis experience using past events to underscore the need to systematically assess the prevention and protection measures implemented for Group facilities.
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People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Safety in the workplace Occupational health Prevention and management of major occupational risks HSE compliance for subcontractors and suppliers Actions Indicators Contributing to local economic development
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HSE compliance for subcontractors and suppliers

Background Policy
Background
Issues concerning supplier health, safety, and the environment have been the focus of growing attention in recent years. As a result, the number of actions implemented by industry has also risen considerably. Working in the pharmaceutical industry, several thousand suppliers and subcontractors are responsible for manufacturing chemical substances that will be used as raw materials or synthesis intermediates. Most companies have set up programs to ensure that these external partners are able to carry out their work in strict compliance with rules concerning health, safety and protection of the environment.
Policy
In accordance with the Group's HSE policy, sanofi-aventis adopts a constructive attitude of transparency and dialogue toward external partners with respect to health, safety and environmental protection. Each entity takes into account these issues during operations involving purchasing and outsourcing. The selection of a contractor or supplier includes criteria relating to health, safety and the environment, measured in proportion to the risk incurred based on information exchanged regarding products and processes. This commitment makes it possible to ensure compliance of the operations performed by our partners. It is one of the key principles of the Groups HSE policy. Sanofi-aventis ensures that its partners carry out their work responsibly and in keeping with the Groups HSE principles.
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Outside service providers: 60% decrease in the occupational injury frequency rate between 2007 and 2010
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HSE compliance for subcontractors and suppliers Actions

HSE evaluation of sanofi-aventis external partners Improving contractor safety
HSE evaluation of sanofi-aventis external partners

HSE issues are taken into account in the relationships that sanofi-aventis maintains with manufacturers and strategic suppliers by: Identifying all the Groups manufacturers and strategic suppliers Always including an HSE clause in contracts for subcontract work, setting out the Groups HSE requirements Providing manufacturers, when contracts are established, with all the HSE information relating to the products and processes concerned Conducting HSE validation assessments for strategic manufacturers before finalizing the contracts Conducting follow-up HSE assessments of all manufacturers based on their strategic importance and the level of risk for the products and processes implemented GLOSSARY
Manufacturers
For sanofi-aventis, a manufacturer is any enterprise that manufactures a synthesis intermediate, an active ingredient from one of Groups processes, or a pharmaceutical product for the Group. Pharmaceutical manufacturers and chemical manufacturers of active ingredients or synthesis intermediates are mainly concerned. This definition also applies to any enterprise that carries out operations for the Group involving transformation, packaging, packing, storage, transport and distribution of chemicals or pharmaceutical products. This also includes any enterprise from which the Group buys a service, which will be carried out in general outside the Group, and which applies to products that belong to the Group, for example storage, transport, waste treatment, record-keeping, etc.
Strategic manufacturers
Strategic manufacturers include any subcontractors that manufacture or provide synthesis intermediates, active ingredients or strategic pharmaceutical products for the Group. This refers to any contractor whose sales turnover and / or activity with the Group are significant and whose loss would harm the Groups businesses.
Strategic suppliers
A strategic supplier is any supplier from which the Group buys synthesis intermediates or active ingredients that are needed for the manufacture of its strategic products and specialties. This refers to any supplier whose sales turnover and / or activity with the Group are significant and whose failure to provide products and specialties would harm the Groups businesses.
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Improving contractor safety

Thanks to the occupational accident prevention programs instituted over the last several years, the Group has been able to significantly reduce the occupational accident frequency rate and gravity rate for external service providers. Over the last five years, the frequency rate has decreased by nearly 60%. Despite these very encouraging results, tragically there were two fatal accidents in 2010 involving employees of external service providers (one in France and one in Italy). Action plans addressing the
causes of these two accidents have been put in place throughout all our sites. The Groups special safety program for outside service providers will continue to be implemented in 2011 at sites where sanofi-aventis functions are active. The program is based on five points: Consideration of the safety factor when choosing a contractor Contractor accommodations at the sites Analysis of intrinsic risks specific to the subcontractors work, work areas and related protective measures Contractor work site and work area audits and inspections Review of annual results This program extends beyond local regulations in this area. It highlights the Groups commitment to ensure the ongoing safety of all people working at its sites, whether they are Group employees, temporary employees or persons working for an outside service provider.
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HSE compliance for subcontractors and suppliers Indicators

One of the indicators that allows the Group to assess its partners compliance with HSE rules is the frequency rate of injuries with lost time for outside service providers.
FREQUENCY RATE OF INJURIES WITH LOST TIME / OUTSIDE SERVICE PROVIDERS (1)(2) 2008 2009 2010
Outside service providers
4.1
3.4
2.5
(1) Number of accidents resulting in lost time of one day or more within a 12-month period, per million hours worked. These data are consolidated for all Group companies. (2) Frequency rates for previous years have been adjusted based on the following: eliminating injuries dismissed by regulatory authorities, including injuries reported late, and changes in the scope of reporting .
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People indicators Diversity Supporting change Employee career development Relationships with schools and universities Compensation and employee benefits Employee representation and information Ensuring occupational health, safety and wellbeing Contributing to local economic development
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Sanofi-aventis considers that participating in the local economic development of communities where the Group operates is one of its responsibilities. In the principal areas where sanofi-aventis is present, the Group contributes to local development through: Support for those impacted by the Groups decisions Investment choices Decisions concerning production sites and, when necessary, transferring production
Actions
The following four examples provide a clear illustration of how the Group contributes to local development in France, South Africa, Venezuela and the United States. Participating in local economic development in France Concentrating the production of all the Groups tuberculosis treatments at a single site: Waltloo (South Africa) An active force in the local community: The Groups Venezuelan industrial site Supporting the local community: The example of the sanofi pasteur site in Monroe County, Pennsylvania (United States)
Participating in local economic development in France

With a strong French presence, sanofi-aventis decided to continue to invest in France, making investments in both industrial facilities and R&D. The goal is to remain competitive and maintain jobs in the French regions. In addition to a strong local presence, sanofi-aventis also contributes to regional economic development by providing support for the creation and development of very small enterprises as well as small- and medium-sized enterprises and industries. Through the work of a sanofi-aventis affiliate SOPRAN (Society for the Promotion of New Activities) the Group carries out local economic development initiatives and maintains an active presence in communities around our sites. SOPRAN helps start-ups as well as small- and mediumsized firms develop and create jobs within the scope of the ALDEE program (local actions for business development and exchange). The Group has also tasked SOPRAN with carrying out revitalization initiatives in accordance with legal obligations when reorganization may have a negative impact on employment. Consequently, within the framework of a revitalization agreement between sanofi-aventis France and the French government in July 2009, seven areas that have been especially impacted by job cuts for medical sales representatives have benefited from this agreement, or will benefit from it in 2011. They are located in the greater Paris area, Provence-Alpes-Cote dAzur, Aquitaine and Rhone-Alpes. The agreement provides for loans to new businesses that create new jobs, mentoring and skill-sharing programs, and subsidies to local economic players.
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Concentrating the production of all the Groups tuberculosis treatments at a single site: Waltloo (South Africa)
Each day, 47 people die of tuberculosis in South Africa. In this country, sanofi-aventis has undertaken to build a global industrial center to combat tuberculosis. Sanofi-aventis produces rifampicin-based drugs to treat tuberculosis. In the past, the two primary manufacturing sites for these drugs were located in Waltloo, South Africa, and Anagni, Italy. In 2006, the Group decided to transfer all production from Anagni to Waltloo over the following years. This transfer offered four advantages: Reducing production costs for one treatment by about 35%, making it affordable for a greater number of patients Enhancing the sites expertise in tuberculosis products Safeguarding the sites activity Bringing production closer to where treatments are used
Completing the transfer required the standardization and harmonization of various formulations, which differed by country. It also included overseeing the industrial development of these formulations, submitting registration dossiers and obtaining the corresponding authorizations before starting to manufacture the transferred products. This operation required a substantial investment over 23 million rand financed by the Group, which served in particular to expand the existing site. Since 2008, 87 jobs have been created at Waltloo, which represents an increase of 47%. An employee training program has also been introduced. This transfer program responds to a public health challenge: the production and distribution of tuberculosis treatments from South Africa to meet needs in South Africa as well as in southern African countries, and ultimately in the main global markets.
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An active force in the local community: The Groups Venezuelan industrial site
For ten years, sanofi-aventis has had a production site in Venezuela, where it employs over 500 people. The Group is a dynamic force in this area, at many levels: Schools: For the second year in a row, the Group established a partnership with a nearby business school to provide training for students while at the same time organizing actions to promote neighborhood prevention programs. Regional businesses: Through a program called Neighbor sanofi-aventis, the Group cooperates with 20 regional businesses in an effort to improve security in the area where they operate. Governments: Working with government representatives, sanofi pasteur has developed a program to donate hepatitis A and varicella vaccines in addition to organizing an information campaign. The surrounding community: Sanofi-aventis has initiated several operations involving donations, primarily of computers to be used in schools. Healthcare partners: In conjunction with the Venezuelan medicines agency, the Group has implemented agreements for the sale of medicines at cost to the Fundafarmacia pharmacy network.
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Supporting the local community: The example of the sanofi pasteur site in Monroe County, Pennsylvania (United States)
With a workforce of over 2,350 people in addition to several hundred subcontractors and suppliers, this sanofi pasteur U.S. site is the regions leading employer. The Group takes an active part in improving the quality of life for citizens and contributes to the areas vitality: In 2009, sanofi pasteur U.S. purchased the equivalent of $304 million in local services and paid $234 million in wages and salaries to employees who are Pennsylvania residents. The site continues to grow and thus contributes to local and regional economic development. Sanofi Pasteur U.S. is highly active in the areas economic life and is a member of several local committees as well as a catalyst for local economic development operations. Sanofi Pasteur U.S. supports a dozen or so local initiatives, especially in the fields of education and assistance for disadvantaged families.
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OUR INDICATORS
Planet
Preserving the planet: A vital responsibility
OUR PLANET INDICATORS

Environmental indicators
Sanofi-aventis continuously seeks ways to minimize the environmental impact of its business activities, protect public health and combat climate changes.
CO2 emissions and energy

Sanofi-aventis continuously strives to minimize greenhouse gas emissions and reduce energy consumption in order to limit the Groups carbon footprint.
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To limit its environmental impact, sanofi-aventis promotes green chemistry and reduces water consumption. The Group also focuses on handling wastewater discharge and air emissions from its sites, and better managing packaging and waste.
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PLANET MATERIALITY TEST

See the results
BUSINESS CASE

Sanofi-aventis seeks to analyze the environmental fate of pharmaceuticals, their potential impact on the environment and the possible consequences for human health.
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Biodiversity
The Group faces three main challenges: controlling the use of natural species, avoiding biopiracy and ensuring the preservation of biodiversity surrounding the Groups sites.
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Responding within the scope of the consultation of stakeholders for the 2010 CSR Reporting, JP Morgan Asset Management explained: Communication on planet-related issues should be totally transparent. Issues and areas for improvement should be disclosed as well.
BUSINESS CASE: ARTEMISININ Producing semisynthetic artemisinin Ensuring the preservation of biodiversity in areas where wormwood is grown.
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2010 highlights
Biodiversity
The Group issued a new position paper that describes the Groups guidelines, establishes principles and provides a clear stance on combating all forms of biopiracy

Eight new environmental assessments were carried out in 2010 in Europe and the United States
Objective for 2005-2013

Goal of a 15% reduction in direct and indirect CO2 emissions based on units produced
Solar energy
Watch the Solar Hot Water for sanofi-aventis video
Supply Chain
Less air freight and more transport by boat; fewer trucks, more barges and trains
Green Attitude
Establishing a Green Meeting Charter: Ten key points for eco-responsible behavior whenever the Group organizes events
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Planet indicators CO2 emissions and energy Background Policy Goals Actions Indicators Local environmental impact Pharmaceuticals in the environment Biodiversity
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CO2 emissions and energy

As a major economic player, sanofi-aventis has adopted an ambitious policy to address climate change. The Group seeks to limit its carbon footprint by minimizing greenhouse gas emissions and limiting energy consumption. The Groups initiatives focus on three main areas: Optimizing energy consumption and CO2 emissions from industrial and R&D sites Improving energy performance related to transporting medicines Optimizing day-to-day energy consumption at all sites (including administrative sites)
Responding within the scope of the consultation of stakeholders for the 2010 CSR reporting, Ms. Jos Cambou, who is the National Secretary of the France Nature Environnement federation and also oversees its Environmental Health network, explained: Environmental impact should be assessed and reduction programs should include all parameters along the supply chain, as well as the impact of employee transportation.
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CO2 emissions and energy - Background

CO2 and fossil fuel sources: Two key issues Definitions
issues: Anthropogenic greenhouse gas emissions Short supply of fossil fuel sources
CO2 and fossil fuel sources: Two key issues

Climate change covers two issues of growing importance: Anthropogenic greenhouse gas emissions and the short supply of fossil fuel sources. Like any business sector, the pharmaceutical industry which is a major economic player worldwide must concentrate on the impact that it has on these two key issues for the planet, even if it may consume relatively less fossil fuel and generate fewer related greenhouse gas emissions than other industries. The pharmaceutical industry uses energy at every stage while producing medicines, storing medicines, promoting products and distributing them. In the manufacturing stage, energy is consumed to produce steam, hot water, cold water and other resources to be used for: Synthesis processes for active ingredients Heating and air conditioning for pharmaceutical preparation buildings Production of special gases used in manufacturing Effluent and waste treatment at every stage of production For product distribution and promotional activities, energy is consumed as a result of the transport of goods and people.
Definitions
The Group differentiates between three different types of CO2 emissions: direct, indirect and third-party emissions. Direct CO2 emissions are generated by the combustion of fossil fuel sources by the Groups entities, for example during manufacturing processes, or while producing steam or hot water, for example, or incinerating waste. Indirect CO2 emissions are generated by those who produce energy sources purchased by the Group (electricity, brine, steam, etc.). Third-party emissions are generated as a result of the Groups purchases (raw materials, packaging supplies, services to organize international congresses and seminars) as well as the transport of goods (raw materials, pharmaceutical intermediates, medicines, etc.), business travel and employee commuting.
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CO2 emissions and energy - Policy

Limiting the Groups carbon footprint Implementing appropriate actions Organizing the approach
The Group strives to economize natural resources and to minimize the residual impact of atmospheric emissions, effluents and waste in all industrial activities.
Juergen Fink Environment Director, sanofiaventis
Limiting the Groups carbon footprint

Sanofi-aventis has adopted requirements and an ambitious action plan to fight climate change. All of the initiatives taken, both within the Group and outside the Group, meet specific environmental criteria. The Groups HSE policy sets out the need to economize natural resources and to minimize the residual impact of atmospheric emissions, effluents and waste in all industrial activities. The goal identified is to preserve the natural environment. Applying this principle, several years ago sanofi-aventis decided to reduce its energy consumption and carbon dioxide emissions. As a result, today, Group entities use natural gas in its boilers whenever possible. They also recover and reuse energy generated at numerous facilities. Greenhouse gas emissions generated by the Groups activities come from: Purchased fuel Purchased secondary energy (electricity or steam) The Groups purchases (raw materials, packaging supplies, services to organize international congresses and seminars) as well as the transport of goods, business travel and employee commuting
2011: Carbon Assessment rolled out within the Group
Implementing appropriate actions

Sanofi-aventis has put in place many initiatives to decrease consumption of fossil fuel at Group sites (and thereby reduce CO2 emissions), decrease the proportion of energy costs in total operating costs, and increase employee awareness. The main initiatives are: Systematic evaluation of the various technologies to recover energy and use cleaner forms of energy Installation of energy recovery systems in existing buildings Energy audits at Group level for each sector of activity Creation of Energy task forces within each sector of activity Sharing good practices among the Groups various entities Employee training and information campaigns on climate change and energy

2008 Pilot project to calculate greenhouse gases / Carbon Assessment initiated 2009 Energy task forces deployed throughout the Group Published new objectives for reducing direct and indirect CO2 emissions CO2 emissions assessment project rolled out at pilot sites Energy Director position created within Industrial Affairs 2010
Installation of systems that use renewable energies initiated in three sites in France: Quetigny - Thermal solar, Maisons-Alfort - Geothermal and Ambares - Photovoltaic Energy savings plan for air handling equipment rolled out 2011 Carbon Assessment rolled out throughout the Group Multi-site project to install solar panels put in place in partnership with EDF Energies Nouvelles (France)
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Goals for 2005-2013 reduction in direct and indirect CO2 emissions based on units produced
CO2 emissions and energy - Goals

Reducing direct and indirect CO2 emissions Evaluating third-party emissions
15%
20% reduction in
Reducing direct and indirect CO2 emissions

AREAS FOR PROGRESS GOALS
direct and indirect CO2 emissions based on units produced
Reduce emissions and routinely use the cleanest available energy from a technical and economic viewpoint
Direct emissions: 15% reduction in CO2 emissions per unit produced (1) by the end of 2013 compared with 2005 Indirect emissions: 15% reduction in CO2 emissions per unit produced (1) by the end of 2013 compared with 2005 - 20% less CO2 per kilometer traveled (2013 vs. 2005) Evaluate the Scope 3 Carbon Assessment at the end of 2011
Carbon Assessment
Goal for 2011 Carry out a Scope
Reduce sites energy consumption
Reduce energy consumption related to promoting medicines Assess the Groups global carbon impact based on purchases of goods and services, and the transport of merchandise and people
(1) It should be noted that changes in CO2 emissions per unit produced are calculated by sector of activity and added proportionally to the total. Each sector defines a representative business indicator, for example direct hours worked for vaccines, the number of boxes produced for pharmacies, etc.
Regarding emissions generated via product transport, the Group has established the following goals for 2011-2012: Upcoming commercial road-transport request for proposal will comply with the Euro 5 emission standards (reducing emissions of particulates). An inventory of suppliers fleets will be carried out to assess the percentage of trucks that comply with EURO 5, 4 or 3 standards. With current carriers, a method for evaluating CO2 emissions from transporting products to end customers in France will be studied to establish monitoring indicators through 2012. In 2011, the Group will continue to add lower carbon-intensity vans (electric, Compressed Natural Gas / CNG vehicles, etc.) to the fleet used in the Greater Paris Area to make pharmacy and hospital deliveries. Ever-closer collaboration between Pharmaceutical Products, Vaccines and R&D will enable each of these three activities to take advantage of knowledge, initiatives and projects, and thus build on experience to help reduce CO2 emissions.
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Evaluating third-party emissions

By 2011, the Group has also established a goal to conduct a comprehensive evaluation of emissions generated by purchasing goods and services. Since 2007, sanofi-aventis has focused on qualifying and quantifying emissions that are generated as a result of the Groups purchases. Six internal entities representative of the Group activities assessed their
carbon emissions in 2008 and 2009. This pilot strategy will be rolled out during 2011 to obtain an overview of the third-party emissions generated by sanofi-aventis activities. An action plan will be put in place to: Reduce the Groups dependence on fossil fuel sources Encourage the Groups service providers to take similar steps The Statutory Auditors carried out in 2009 a pre-audit to review the action plan methodology, the tools it uses and its scope. The relevance of the approach and processes followed by sanofi-aventis was confirmed by the Statutory Auditors.
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Planet indicators CO2 emissions and energy Background Policy Goals Actions Industrial and R&D sites Transporting medicines Group-wide programs Indicators Local environmental impact Pharmaceuticals in the environment Biodiversity
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CO2 emissions and energy - Actions

Sanofi-aventis focuses on three areas to reduce the Groups carbon footprint and optimize its energy consumption:
Reducing energy consumption at industrial and R&D sites

The Industrial Affairs Department the department that consumes the most energy in the Group has set a goal to reduce its energy consumption by 11% between 2009 and 2013.
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Improving energy performance related to transporting medicines

Whenever possible, sanofi-aventis implements alternative transport methods that optimize energy consumption and limit CO2 emissions.
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Optimizing day-to-day energy consumption throughout the Group

Eco-responsible behavior: Each employee is encouraged to reduce energy consumption.
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Planet indicators CO2 emissions and energy Background Policy Goals
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Goal for 2005-2013 reduction in direct and indirect CO2 emissions based on units produced
Reducing energy consumption at industrial and R&D sites
15%
Actions
Energy costs represent one of the highest items of expenditure for sanofi-aventis industrial and R&D operations. The Groups budget for energy purchases (electricity, gas, heating, Industrial and R&D sites etc.) is over 200 million per year.
Transporting medicines Group-wide programs Industrial and R&D sites generate direct and indirect carbon emissions of 1,041,000 tons of CO2 per year. The Group has set a goal to reduce its direct and indirect CO2 emissions by 15% per unit produced between 2005 and 2013. The Industrial Affairs Department, which accounts for 65% of the Groups industrial and R&D emissions, has established a comprehensive program for all of its sites in order to: Optimize air conditioning systems Improve industrial cooling techniques Develop cogeneration Use high-performance electric engines Use solar energy Use renewable energy sources instead of traditional energy sources Recover energy and treat liquid waste Recover heat
Cogeneration at the Ankleshwar site in India Decrease in CO2 emissions of nearly
Indicators Local environmental impact Pharmaceuticals in the environment Biodiversity
4,500 tons per

year
VIDEO SOLAR HOT WATER FOR SANOFI-AVENTIS Partnership with EDF Energies Nouvelles to install solar
Optimize air conditioning systems

Air conditioning systems, or HVAC systems, account for approximately 70% of energy consumption for a pharmaceutical production site and from 10% to 30% of consumption for a chemical or biotechnology site. Sanofi-aventis strives to make these systems more efficient in several ways by: Highlighting best practices that help reduce air conditioning energy consumption during activity (optimizing settings) and at other times (switching systems off or putting them on stand-by) Designing a self-evaluation tool to identify areas for improvement at each production site.
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panels at industrial sites in France
Improve industrial cooling techniques

Industrial cooling encompasses all the systems used to reach and maintain a temperature for facilities or products that is below that of the surroundings. At the Aramon site in France, during 2008-2010, cooling was centralized and optimized for several workshops to generate synergies among various users, improve the performance of cooling systems and significantly reduce water consumption for cooling. With these measures, the site used 27% less electricity (saving 2,000 MWh per year) and significantly reduced water consumption for cooling. A similar project is underway in Jurong in Singapore that will save 3,600 MWh per year and reduce CO2 emissions by 2,000 tons per year.
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Develop cogeneration
Cogeneration involves producing in the same facility and at the same time thermal energy (heat) and mechanical energy that will be converted into electricity. Cogeneration requires considerable investment to
install gas turbines and gas engines with boilers that recover waste heat in the form of steam or hot water. Depending on the needs, trigeneration can be used. This involves using steam or hot water for cooling. Cogeneration helps reduce energy costs and CO2 emissions. It generates energy savings of approximately 40%. The Group already has several cogeneration projects up and running in Europe, Asia and North America. In India, for example, sanofi-aventis Ankleshwar site launched a cogeneration project in 2009 in order to use one system to produce electricity, steam from heat recovery, and 7C cold water from excess steam. The cogeneration equipment has a gas-piston engine, with an alternator that produces electricity. Heat from exhaust is used to produce steam in a heat recovery boiler. The system generates 1 MWh of electric power, with 82% overall efficiency, which makes it possible to reduce CO2 emissions by nearly 4,500 tons per year.
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Use high-performance electric engines

Electricity accounts for an average of 40% of site energy consumption. Most of the energy consumed is used for electric engines. New technology is now available to improve the efficiency of engines and related systems. International regulations have also imposed new rules regarding engine performance. In 2010 an engine performance evaluation program was started at the Group level involving engine audits at four industrial sites: Elbeuf in France, Madrid in Spain, Rzeszow in Poland and Veresegyhaz in Hungary. The goal of the program is to establish the initiatives to be put in place to reduce the electricity consumption of engines used at these sites. The program will subsequently be implemented at all the Groups sites.
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Use solar energy

Producing hot water
At the end of 2009, the Quetigny site in France inaugurated a new industrial hot water system that uses solar collectors. The system is made up of 150m 2 of solar collectors that satisfy 50% of the sites hot water production needs. By using these collectors, the site consumes 66% less gas and cuts its CO2 emissions by 24 tons per year. For more information: Watch the "Solar Hot Water for sanofi-aventis" video
Installing solar panels

In 2010, sanofi-aventis signed a partnership agreement with EDF Energies Nouvelles to install solar panels on the premises of four of the Groups industrial sites in France.
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Use renewable energy sources instead of traditional energy sources

Using geothermal energy
Geothermal energy involves using hot water from deep underground. Hot water is collected from deep within the Earth and is converted into heat, thereby making it possible to limit the use of fossil fuels. Using renewable energy sources instead of traditional energy sources generates savings and reduces CO2 emissions. Switching to geothermal energy at the end of 2009 at the Maisons-Alfort industrial site in France made it possible to reduce the sites natural gas consumption by 45%, by using hot water pumped from some 2,000 meters below the Earths surface, instead of steam produced for heat. This new energy also helps reduce greenhouse gas emissions by approximately 350 tons of CO2 per year.
Using biomass energy

Biomass can produce energy through combustion in a boiler or by methanization of biogas. Two projects are being analyzed within the Industrial Affairs Department in order to begin using biomass energy: At the Aramon site in France, sanofi-aventis is currently analyzing whether it can use vegetation which is used to extract active ingredients as fuel for a boiler in order to produce steam. At the Elbeuf site in France, fermentation substrates are used to produce methane, which replaces part of the natural gas used for the boilers. In addition to the steam energy produced, the methanization unit will help reduce the treatment plants pollutant load by: Eliminating 1,000 trucks per year on the roads Saving 13,000 MWh per year in natural gas, representing a decrease of 3,000 tons of CO2 emissions per year No longer disposing of 15,000 tons of waste per year at off-site facilities
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Recover energy and treat liquid waste
In 2008, the Aramon site in France developed an innovative project that provides several benefits: Thermal oxidation of VOCs (volatile organic compounds), along with incineration of used solvents and liquid waste Oxidized heat recovery in the form of steam Total hydrochloric acid recovery that is then recycled to regulate pH in the wastewater treatment plant
The environmental impact of this new unit is very satisfactory and has made it possible to: Eliminate 10,000 tons of solvent waste Eliminate 400 trucks on the roads Use 50% less natural gas to produce steam on site Reduce VOC emissions by 60% Eliminate the supply of hydrochloric acid used to neutralize effluents on site
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Recover heat
Sanofi-aventis plans to standardize the use of heat recovery at its sites as one of several energy-efficient processes. Since 2003, the Frankfurt site in Germany has implemented a heat recovery system from the HVAC system (heating, ventilation and air conditioning). The recovery rate, between new air and extracted air, can reach 60% to 80%. Residual heat is also recovered. The Compiegne site in France also started using a heat exchanger to recover heat from the outbound airflow of the buildings air treatment system. This is the first time such a large system has been used in France. It can process 322,000 cubic meters of air per hour. This investment will save an estimated 5 GWh per year, or the equivalent of 13% of the sites annual consumption. This will reduce greenhouse gas emissions by nearly 1,000 tons of CO2 equivalents.
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You are here: Home > Planet > CO2 emissions and energy > Actions > Transporting medicines
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Improving energy performance related to transporting medicines

Sanofi-aventis is aware of the impact that its activities have on the environment and encourages developing alternative modes of transport for its goods.
Since 2006, CO2 emissions have decreased by tons for the entire Medicine Supply Chain (international transport)
32,400
The goals of the Groups Supply Chain initiatives are: Less air freight and more transport by boat Fewer trucks, and more barges and trains Since 2006, the various initiatives presented below have helped save 32,400 tons of CO2 for the entire Medicine Supply Chain (international transport): Reducing air freight and increasing shipment by boat between major distribution platforms Decreasing road transportation and increasing the shipment of goods by barge or train Using alternative modes of transport for deliveries to pharmacies and hospital facilities
Bernard Amoury Supply Chain Director, sanofiaventis
Using trains and barges instead of road transportation to reach ports allowed us to reduce our CO2 emissions by 56% between 2007 and 2010.
Reducing air freight and increasing shipment by boat between major distribution platforms
For both intercontinental and domestic transport of goods, sanofi-aventis encourages a reduction in air freight from European shipping platforms to limit the impact of CO2 emissions. This policy which previously only applied to sanofi-aventis pharmaceutical activities has been adopted by the Vaccines division since the end of 2010 and now covers all the Groups activities. Several initiatives have been implemented since 2002: Using sea shipping instead of air shipping Optimizing forecasts and inventories in destination countries Mobilizing teams working on the distribution platforms and in the Supply Chain Department This policy has generated significant gains for the environment:
FUEL CONSUMED (IN LITERS / PALLET) FOR INTERCONTINENTAL TRANSPORTATION (EUROPE -> UNITED STATES) CO2 EMISSIONS IN KG / LITER OF
In Bangladesh
100% of the
delivery vehicle fleet uses natural gas
DIESEL OR KEROSENE (SOURCE: CALCULATING EMISSION FACTORS, VERSION 4.0, JUNE 2006, ADEME)
By plane By boat
443
443 x 2.662 = 1,179 kg CO2 14 x 2.662 = 37 kg CO2
14
These environmental gains go hand in hand with significant economic gains. Using sea freight instead of air freight reduces costs by 75% for non-temperature-controlled shipments and 90% for refrigerated shipments.
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Decreasing road transportation and increasing the shipment of goods by barge or train
Sanofi-aventis carried out a study recently that showed that using barges and trains to transport goods to the ports of Marseille and Le Havre which are both located in France and are transit areas to Asia, Africa and North America is a reliable, environmentally-friendly means of transport. Compared with road
transportation, by using barges and trains, it is possible to reduce CO2 emissions from transporting products between sites, safeguard inventory levels, and combine quality, security and safety of transport.
Comparison of CO 2 efficiency for one ton of medicines based on transportation mode

For one ton of merchandise transported between sanofi-aventis Croissy Beaubourg site in France and the ports of Marseille and Le Havre in France, CO2 emitted per kilometer is: 89 g for a truck 26 g for a barge 7 g for a train (in France) Using barges or trains instead of road transportation to transport products to ports reduces CO2 emissions by 56% per year, representing a decrease of 140 tons of CO2 per year. Based on these positive results, several initiatives have been put in place: Decreasing the frequency of road shipping by loading trucks more efficiently Increasing use of barges and trains to reach ports instead of road shipping Optimizing forecasts and inventories in destination countries Using railway transportation instead of road shipping whenever possible: In 2010, 100% of merchandise transported from Germany to Hungary (430 tons of merchandise) and 72% to Italy (800 tons) was shipped by train. Hungary also shipped 268 tons of merchandise to Germany by rail.
Implementation plan for barges and trains

2002: Program initiated by the Saint-Loubes site and the Supply Chain team 2005: Program implemented for shipments from Europe (France and Frankfurt) to the United States 2007 / 2008: Barge and rail transportation extended to 100% of shipments in France, whenever possible Barge transportation initiated from Frankfurt to Rotterdam 2010: Program broadened to all containers, including refrigerated containers 2011: Program extended to Vaccines.
Results of the policy

For all the pharmaceutical sites served by the Supply Chain, the percent of weight shipped by sea (transported to ports by barge or train) rose from 0% in 2006 to 18.6% in 2009, and was approximately 16% in 2010. The total percentage for 2011 and 2012 is forecasted to be approximately 16%. It is important to note that this system is limited, in that it depends upon the number of containers that railway and waterway transport carriers can manage.
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Using alternative modes of transport for deliveries to pharmacies and hospital facilities
A pilot project has been implemented for transporting the Groups medicines in Paris using bicycles as the main means of transport for deliveries to pharmacies, instead of vans in central city areas. The Group plans to extend the project to other major cities. An environmentally-friendly compressed natural gas (CNG) van has also been operating in the Greater Paris Area since 2009, and a second CNG van will be used as of mid-2011. In Bangladesh, sanofi-aventis entire delivery fleet uses natural gas.
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Hybrid vehicles
Optimizing day-to-day energy consumption throughout the Group

Promoting more eco-responsible behavior Promoting eco-responsible means of transportation for employees Optimizing company vehicle fleets Encouraging virtual meetings
account for of sanofi-aventis vehicle fleet
7%
Promoting more eco-responsible behavior

In addition to reducing the consumption of energy required to produce medicines and vaccines, sanofiaventis has also identified areas where the Group can make a difference every day to improve its energy performance. Employees can make a fundamental contribution by adopting environmentally-responsible behavior to reduce energy consumption. Some areas identified include energy cost savings from installing high-efficiency devices as well as utilizing settings for lighting, heating and air conditioning that are adapted based on occupancy.
Lighting
Using low consumption lamps and LEDs Installing presence detectors (in bathrooms, etc.) Automatically shutting down devices and lights not in use
Ventilation
Using eco-responsible behavior to adjust the ventilation (high and low temperatures in summer and winter) Adjusting air flow The Group has published a practical guide for the Groups site managers to help promote eco-responsible behavior. This guide sets out rules for eco-responsible management to help foster real change in practices and behavior.
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Promoting eco-responsible means of transportation for employees

Sanofi-aventis encourages environmentally-friendly means of transportation. In the Paris region for example, the Group encourages carpooling, using shuttles available for employees to reach certain public transportation stations, or biking to work. In Canada, a Bike-Workplace program has been launched in Laval to encourage this practice that does not produce any CO2.
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Optimizing company vehicle fleets

Sanofi-aventis works with many automakers and leasing companies to select those vehicles that have lowest CO2 emissions.
Vehicle catalogues proposed to employees have been modified to eliminate SUVs and large minivans that consume more energy. They include a new selection of diesel vehicles equipped with particle filters as well as hybrids. For example, in Japan, sanofi-aventis Japan finished replacing its 1,400-vehicle fleet with hybrid vehicles in 2010. Switching to hybrid vehicles made it possible to cut CO2 emissions nearly in half from 3,226 tons to 1,648 tons per year. Worldwide, hybrids account for 7% of sanofi-aventis vehicle fleet.
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Encouraging virtual meetings

Virtual meetings are also being used to allow more participants to take part in conferences, discussions and informational meetings from remote locations. New videoconferencing technologies which are used at a significant number of Group sites worldwide allow participants to avoid traveling to event locations, thus significantly reducing travel-related CO2 emissions. Telepresence videoconferencing equipment has also been installed at five Group sites. Participants appear on the screens used for this technology in life-size. The system offers superior image quality and HD sound. The set-up and interior design of the rooms are the same at the various sites equipped with the system, making participants feel like they are in the same room.
Supporting Green Meetings

Sanofi-aventis is dedicated to fostering eco-responsible behavior for the conferences and events at which the Group participates. In 2009, sanofi-aventis created a Green Meeting Taskforce whose first initiative was to draft a guide to support decision-making and improved practices. The guide includes a carbon calculator and a selfdiagnostic tool for those organizing professional events. The Group established a Green Meeting Charter in 2010. The charter sets out ten key points to be used whenever the Group organizes events, for example analyzing all possible solutions to avoid travel and encouraging employees to reuse materials.
2010: New Green Meeting Charter

Systematically analyze all possible solutions to avoid travel by those participating in meetings: e.g., videoconferences, conference calls, webcasts, telepresence conferencing, etc. Promote local meetings Limit the use of paper Print as few copies as possible of documents and use recycled paper Promote reducing, reusing, and recycling materials for meetings (furniture, stands, etc.) Reduce energy consumption Select hotels and convention centers that are widely recognized as being environmentally friendly Select eco-responsible suppliers (transport carriers, food and beverage suppliers, etc.) Reduce waste for all aspects of meetings The Group has also developed an electronic tool in conjunction with the charter to help all Group employees who are responsible for preparing meetings, events and conferences. The tool is designed to guide employees so that they can implement the most environmentally-friendly solutions. This tool is also used to calculate the carbon footprint for the various solutions proposed. All of these initiatives are part of the Groups Green Attitude.
Implementation plan for the Groups Green Attitude

2009: Pilot project organized for major international conferences: American Society for Clinical Oncology (ASCO), European Society of Cardiology (ESC), American Diabetes Association (ADA), etc. Groups Green Attitude rolled out among suppliers, customers and employees Groups eco-responsible initiatives promoted 2010: Green Meeting Charter developed in conjunction with a decision-making tool Tool tested for pilot events and conferences 2011 2011: Charter and tool rolled out for the entire Group
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You are here: Home > Planet > CO2 emissions and energy > Indicators
Planet indicators CO2 emissions and energy Background Policy Goals Actions Indicators Local environmental impact Pharmaceuticals in the environment Biodiversity Group CO2 emissions Energy consumption CO2 emissions from transport
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CO2 - Indicators
The HSE Department compiles information on the sites CO2 emissions that are directly related to energy consumption (fossil fuel at industrial sites, electrical power, and fuel for the vehicle fleet for medical sales representatives).
The Groups energy consumption for 2010:
+3.7%
tons of CO2 emitted in 2010 from international transport of goods (vs. 63,000 tons in 2009).
55,000
Group CO2 emissions
Modifications in energy consumption (fossil fuel and electricity) resulted in increases of both direct and indirect CO2 emissions by 5.7% and 2.2% respectively from 2009 to 2010. The increase in direct CO2 emissions is mainly due to two factors: a cogeneration unit implemented at a site, and two new R&D buildings that were brought into service. The overall increase in CO2 emissions can also be explained by the fact that activities were transferred between sites. For example, new production was re-deployed to certain sites while the same production processes continued at the original sites from where it was being transferred.
Since 2005, specific CO2 emissions have decreased 8% per unit produced for direct emissions and 17% per unit produced for indirect CO2 emissions generated by the Groups activities.
It should be noted that changes in CO2 emissions per unit produced are calculated by sector of activity and added proportionally to the total. Each sector defines a representative business indicator, for example direct hours worked for vaccines, the number of boxes produced for pharmacies, etc.
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Energy consumption
Even though the manufacturing activities of the pharmaceutical industry do not necessarily require a significant amount of energy consumption, the Group strives to control the amount of energy needed.
In 2010, energy consumption increased by 3.7%. The reasons for this increase are the following: Certain active ingredient synthesis activities have been converted. This means new production was redeployed to certain sites while the same production processes continued at the original sites from where it was being transferred. New R&D and vaccine building were put into operation.
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CO2 emissions from transport

In 2010, international transport activities for the Groups products from production sites to their various destinations (distribution centers, third-party customers, etc.) generated 55,000 tons of CO2 emissions (vs. 63,000 in 2009). These emissions represent approximately 95% of the CO2 emissions generated by international transport for the Groups products. Initiatives put in place to reduce CO2 emissions from transport will be continued in 2011. One of the indicators for CO2 emissions from transport is the weight of CO2 emitted for each pallet transported. Sanofi-aventis goal is to continue to optimize CO2 emissions per pallet.
(KG CO2 / PALLET) 2009 2010 VARIATION 2009-2010
Transport in Europe between sites (road transport) Intercontinental transport (by air or boat) % weight transported by sea / total intercontinental weight
22.9
18.4
-19%
384.6 82.2%
323.1 79.9%
-16% +3%
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You are here: Home > Planet > Local environmental impact
Planet indicators CO2 emissions and energy Local environmental impact Green chemistry Water consumption Wastewater discharge Protection of the atmosphere Packaging Waste management Soil and groundwater protection Pharmaceuticals in the environment Biodiversity
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69% of the solvents

used are solvents that have been recycled at the Groups sites.

Key issues Sanofi-aventis commitment
Between 2009 and decrease 2010: in VOC emissions and decrease in a SOx emissions
BUSINESS CASE
Key issues
Many issues affect the local environmental footprint of a pharmaceutical group such as sanofi-aventis: Various types of water usage Consumption of resources (raw materials and ingredients used to produce active ingredients and in the formulation of medicines and vaccines) Use of solvents for drug and vaccine synthesis and production phases Use of different materials to protect and package products Different types of emissions generated by the sites: These emissions include air emissions, wastewater effluents and waste of all kinds, and concern all types of sites R&D sites, production sites for active ingredients, medicine and vaccine manufacturing sites, as well as logistics and administrative sites.
10%
15%
BUSINESS CASE: PACKAGING In accordance with the Groups environmental policy, sanofi-aventis has decided to reduce the packaging materials needed to transport temperature-sensitive medicines from distribution centers to dispensing and hospital pharmacies.
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Sanofi-aventis commitment
Protecting the environment is a long-standing commitment at sanofi-aventis. With numerous sites operating throughout the world, the Group strives to reduce the potential impact on the environment of manufacturing medicines and vaccines in order to reduce the local environmental footprint of its activities. The HSE Department is responsible for overseeing initiatives to minimize environmental impact. All the Groups sites receive information about these issues, and various initiatives are carried out to limit water consumption and wastewater discharge, preserve air quality, manage waste responsibly and remediate contaminated soil.
4% decrease in the
amount of hazardous waste in 2010, compared with 2009
decrease 2010: in water consumption compared with 2009
3%
The Groups initiatives focus on seven main areas:

Green chemistry
Sanofi-aventis seeks to reduce consumption of raw materials and to select the most environmentally-friendly substances and
Water consumption
Responsibly managing water is a key issue for sanofi-aventis. The goal is to systematically assess the areas where water may potentially
materials, particularly with regard to solvents.

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be saved and institute initiatives to reduce consumption.

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The Group is committed to reducing its wastewater discharge and improving the quality of its effluents.
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Protection of the atmosphere

In addition to seeking to lower CO2 emissions, sanofi-aventis policy also focuses on gradually reducing emissions of volatile organic compounds as well as sulfur and nitrogen oxides released into the atmosphere.
Read more
Soil and groundwater protection

As part of its policy to preserve the environment, sanofi-aventis assesses the risks of contamination and invests in soil remediation initiatives.
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Waste management
The Group systematically prefers waste conversion, either through recycling or waste to energy conversion.
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Packaging
Sanofi-aventis is pursuing its efforts to reduce packaging for medicines and vaccines, while taking into account current regulatory constraints.
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69% of the solvents

used are solvents that have been recycled at the Groups sites.
Green chemistry
Background
Most pharmaceutical companies produce the active ingredients used to make their medicines. The principles and techniques associated with green chemistry a rapidly-developing field must be assessed and continue to be factored into production processes for active ingredients. They also may be applied in the earlier stages of R&D programs for new compounds and formulations.
Policy
Sanofi-aventis seeks to promote green chemistry in order to find innovative and more eco-friendly solutions for producing active ingredients and to reduce as early as the development phases of procedures and processes discharges of chemical substances during the production phases of active ingredients. The Group also strives to reduce the environmental impact of its activities by favoring the selection of substances and materials that have the least impact on the environment. As such, the Group has established a process designed to: Select solvents that are the least toxic for operators and the environment Reduce the quantity of solvents used in industrial processes Recycle solvents used as much as possible and regenerate them when possible
Actions
Using safer and more environmentally-friendly processes
Sanofi-aventis is committed to making its processes safer and more environmentally friendly. Using a fully integrated approach, the Group takes into account factors related to the health and safety of employees while seeking to protect the environment throughout the chemical and biochemical product development stages. At the earliest stages of product development, sanofi-aventis teams are encouraged to use reagents and solvents that pose the least possible hazard. In order to do this, compounds are categorized on a scale of one to five that evaluates their potential impact on the health and safety of operators (explosiveness, inflammability, etc.) and on the environment. An operating guide that includes environmental issues has been developed to help teams select which solvents to use. Throughout the development process, teams make decisions about the processes used based on economic and health / safety / environmental criteria in order to reduce the impact of syntheses and biosyntheses to be used for production. Even once an active ingredient is in production phase, industrial development teams continue to optimize the synthesis and biosynthesis processes as much as possible. Seeking greater yields can also make it possible to combine economic and environmental benefits, as oftentimes it goes hand in hand with a decrease in the amount of waste produced. However, choosing among processes can be complex, as obtaining greater yields often means using highly-reactive compounds that may be hazardous for health or the environment.
Optimizing solvent consumption

Solvents used in the production processes are either purchased (consumed quantities) or recycled at sanofi-aventis sites. To decrease the quantity of non-renewable raw materials consumed, the Group focuses on three areas:
Process optimization Recovery (when possible) Thermal conversion Several solvent recycling projects have been put in place to reduce the quantities consumed annually. The Clean and Safe Design working group has drafted recommendations concerning the use of solvents: Reduce quantities of new solvents purchased Select solvents that are not toxic or hazardous for the environment whenever possible Reduce emissions of volatile organic compounds Reduce liquid waste produced Implementation plan for the recommendations from the Clean and Safe Design working group 2004: Recommendations for using and substituting solvents drafted 2005: Recycling projects identified 2006: Budget requests submitted 2007: Studies carried out and specific issues and orders addressed 2008: First initiatives carried out 2009: Initiatives completed, and projects and industrial applications put into place 2010-2011: Facilities in operation optimized Solvent consumption Solvents used in the production process are either purchased (consumed quantities) or recycled at the Groups sites. In 2010, nearly 69% of solvents used were recycled.
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You are here: Home > Planet > Local environmental impact > Water consumption
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55.8 million cubic

meters of water consumed in 2010
Water consumption
2010: decrease in water consumption compared with 2009 2011: The Global Water Tool, a new assessment and management tool implemented for water-related risks.
3%
Background
The sustainable management of clean water has become one of the most important issues of the 21st century. This is because water is a fundamental resource for life and the worlds ecosystems. Communities use clean water for a wide range of human activities farming, domestic needs (through potable water supply), industrial applications, etc. and clean water must therefore be saved and preserved. Decisions regarding water management and the preservation of water quality must take into account changes in demand as well as differences related to conditions of water supply so that the resources available can adequately meet the needs of communities. While there are large quantities of water worldwide, only 1% of it is potentially potable.
Breakdown of the Earths Water In order to identify the risks that the Group faces related to water management, sanofi-aventis could use the auto-assessment tool developed by the WBCSD the Global Water Tool
Claire Tutenuit Delegate General of Entreprises pour l'Environnement
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Policy
Water is needed for many of the steps required to make medicines and vaccines. Responsibly managing this resource is a key issue for sanofi-aventis. Water utilized during the various stages of the industrial processes (i.e., fermentation and vaccine manufacturing), cleaning processes and for cooling systems during manufacturing account for most of the Groups water consumption. The Group systematically assesses the potential areas where water can be saved, makes investments and puts projects in place to reduce consumption.
Actions
Reducing water consumption
Sanofi-aventis has modernized its water management processes, particularly for closed-loop cooling facilities. Specific initiatives were carried out in 2010 to continue to reduce the use of water. Furthermore, sites that consume more than 100,000 cubic meters of water per year must develop a five-year plan to reduce consumption. Water consumption decreased by nearly 3% in 2010 (compared with a 2% decrease in 2009). Water consumption
Taking management of water consumption further (CDP Water)

The Group took part to another water consumption initiative in 2010 by responding to the CDP Water questionnaire (for 2009). Sanofi-aventis is considered moderately exposed to water-related risks. This is mainly associated with the Groups strategy to spread production and logistics sites over many countries. Overall, the Group carries out efforts to reduce consumption and discharge at all sites. However, at certain plants located in areas that have a risk of drought (Algeria, Morocco, Tunisia, Egypt, Turkey, etc.), the Group has established more advanced strategies to reduce water consumption using recycling technology and continuous water flow management initiatives. The CDP Water questionnaire also covers the issues of flooding and managing rainwater from storms. Both of these issues are addressed by sanofi-aventis risk management policy. In addition to focusing on the regulatory compliance of its sites, the Group has also set up a system to monitor regulatory and technological changes in order to anticipate emerging restrictions and to be able to identify the best technology for the future.
Using the WBSCD Global Water Tool

In 2011, sanofi-aventis decided to implement a new tool to improve how the Group manages water: the Global Water Tool. This tool, developed by the World Business Council for Sustainable Development, allows companies to assess and manage water-related risks. The Global Water Tool is used to analyze water use and make forecasts to define an action plan. For more information: World Business Council for Sustainable Development (WBCSD)
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The issue of wastewater discharge is a constant concern for the Group.

Alain Lamaud, VP HSE, sanofi-aventis
Background
Industrial wastewater discharges and those resulting from use of medicines by patients (see Pharmaceuticals in the environment) are key issues for society and the Group as a whole. Industrial wastewater discharge comes from effluents: From sites that manufacture active ingredients From sites that produce medicines and vaccines From R&D laboratories and pilot plants Effluents primarily fall into two categories: Effluents generated by cleaning processes Water from refrigeration and condensation systems
Policy
Sanofi-aventis policy primarily involves improving discharge treatment systems and implementing systematic quality controls for effluents. This policy falls under one of 77 HSE requirements developed by the Group to address the treatment of industrial effluents from production sites. Industrial effluent waste is either treated in sanofi-aventis wastewater treatment plants or at various local treatment plants, based on agreements with operators.
Actions
Assessing the quality of effluents
Compliance with maximum emission levels is one of the elements verified during internal audits of the Groups production sites. Certain levels that are monitored increased in 2010, in particular chemical oxygen demand (COD, which indicates that organic matter is present), total suspended solids (TSS) and nitrogen. These increases are mainly due to: Increased production at fermentation sites A problem with an effluent treatment plant at one of the Groups sites, and a deterioration in the treatment efficiency of a municipal treatment plant for effluents that one the Groups sites uses.
Implementing the best treatment techniques

At all the Groups sites, sanofi-aventis strives to identify and put in place the best techniques available to treat wastewater effluents based on their physicochemical characteristics. Various improvement projects for wastewater discharge were carried out at several Group sites in 2010. For example, at the Megrine site in Tunisia, the Ain Benian site in Algeria or the Prague site in the Czech Republic, improvements made it possible to reduce the level of discharge and improve the quality of effluents. Special studies were carried out at other sites in 2010 to determine what kind of investments should be made, particularly in India and Vietnam. At the Swiftwater site in the United States, which is located in a protected nature reserve with a stream that feeds into fish breeding areas, analysis was carried out on the various strategies for managing and treating future effluents from the plant based on recent increases in vaccine production. The site decided to combine an array of innovative treatment technology (UV, ozone) using membrane separation and filtering (activated carbon, sand, etc.). Water is treated and tested, and when it leaves the plant, it is capable of being discharged into the environment.
Creating a dedicated working group

A working group will be created in 2011 that focuses on technical and regulatory water-related issues. This working group, which brings together different internal experts, is responsible for strengthening the Groups various initiatives concerning these issues.
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Between 2009 and 2010: decrease in VOC emissions and decrease in a SOx emissions
Protection of the atmosphere

10%
15%
Background
Emissions addressed in this section are all air emissions, except for CO2. The primary substances that are responsible for local impacts on air quality are sulfur oxides (SO2), nitrogen oxides (NOx), carbon monoxide (CO), volatile organic compounds (VOCs) and fine particles and dust. Fuel oils used in boilers at sanofi-aventis sites for heating and steam production may be a source of SOx and NOx. The use of heavy fuel oil and coal could be a source of fine dust emissions.
Policy
Sanofi-aventis goal is to gradually reduce emissions of organic solvents, sulfur oxides and nitrogen oxides released into the atmosphere. This involves a number of initiatives including optimizing the industrial processes that generate the most emissions and investing in improvements to limit emissions. In addition, when natural gas is an option for sites, most sites decide to use this primary energy source to replace heavy fuel oil or coal so that they can limit fine dust and CO2 emissions. Sanofi-aventis CO2 emissions policy is described in the CO2 emissions and energy section of the website.
Actions
Local air quality is primarily affected by volatile organic compounds (VOCs), while nitrogen oxides (NOx) and sulfur oxides (SOx) impact air quality to a lesser degree.
Reducing emissions at production sites

For several years now, sanofi-aventis has taken significant steps within its production sites to develop new formulas for aqueous solutions, and to improve recycling facilities and steam-solvent vapor processing. These programs made it possible to reduce VOC emissions by 10% in 2010, and SOx emissions also fell 15%. VOC emissions
SOx emissions
NOx emissions
Taking steps to preserve air quality

Sanofi-aventis has taken steps to collect emissions resulting from various processes and to implement appropriate processing solutions (condensation, scrubbers, thermal oxidizers, etc.). The Groups objectives are: To focus on reducing emissions of specific volatile organic compounds To eliminate or reduce the development of peaks in ozone levels near the Groups sites Implementation plan for an improvement program in order to limit atmospheric emissions (excluding CO2) Multi-year program Investments made in 2005, 2006 and 2007 Program launched and fine-tuned from 2006 to 2008 Program enhanced in 2009, 2010 and 2011 Progress 2009: Improvements optimized 2010: Biofilter to replace thermal oxidation optimized and tested
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You are here: Home > Planet > Local environmental impact > Packaging
Planet indicators CO2 emissions and energy Local environmental impact Green chemistry Water consumption Wastewater discharge Protection of the atmosphere Packaging Business case: Packaging Waste management Soil and groundwater protection Pharmaceuticals in the environment Biodiversity
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Packaging
Background and Policy Actions

Pharmaceutical companies use many types of packaging for the medicines and vaccines that they sell. Packaging is crucial to ensure the quality and integrity of these products throughout the distribution chain. Specific regulations apply to packaging and impose significant restrictions. As a significant amount of raw materials is used for packaging, initiatives have been put in place to reduce the impact on the environment. Sanofi-aventis is committed to pursuing its efforts to limit the environmental impact of packaging, while taking into account current regulatory constraints.
Actions
Reducing the weight of packaging
In 2010, a project involving cardboard packaging was carried out in France to reduce the weight of the Groups medicine packaging. The goal of the project was to work with all the Groups French pharmaceutical sites and packaging suppliers to try to reduce the thickness of cardboard used, without affecting machine handling and thus the productivity of production lines. This process made it possible to save 220 tons of cardboard in 2010, representing a 2.6% decrease compared with 2009 (Total consumption for 2010 = 8,417 tons).
Limiting packaging waste

A key project was carried out in 2010 in France to reduce packaging for products that use the cold chain. Until recently, these products were shipped to hospital facilities in special insulated boxes with ice packs to keep products cold. The packaging was difficult to recycle because it requires a revalidation process for recovered materials. Starting in March 2011, all pharmaceutical products that use the cold chain will be delivered in refrigerated trucks. For more information: Business case: Reducing product packaging used to maintain the cold chain in France
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You are here: Home > Planet > Local environmental impact > Packaging > Business case: Packaging
Planet indicators CO2 emissions and energy Local environmental impact Green chemistry Water consumption Wastewater discharge Protection of the atmosphere Packaging Business case: Packaging Waste management Soil and groundwater protection Pharmaceuticals in the environment Biodiversity
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Business case: Packaging

A key project was carried out in 2010 in France to limit waste from packaging for products that use the cold chain.
Limiting packaging waste generated by transporting temperature-sensitive medicines from distribution centers to wholesalers / dispatchers and dispensing and hospital pharmacies
A SUPPLY CHAIN process Delivery using refrigerated trucks, eliminating the need for exterior boxes and ice packs Implemented in France as of March 2011
For the distribution centers: special packing is eliminated (no storage of packaging, less handling, less time in cold rooms for operators) For dispensing pharmacies and hospitals: easier logistics (no need to undo packaging, no storage, saves space), temperature can be traced throughout the entire supply chain For carriers: easier logistics, less weight transported, transport method with enhanced efficiency
Cost Neutral: extra cost of using refrigerated transport is offset by the decrease in weight transported (on average 5kg less per package) and the savings on exterior boxes (approximately 20 / package) Environment : 15 tons of insulated exterior packaging saved per month (deliveries to hospital pharmacies)
Sharing good practices that can be implemented outside France
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Challenge
In accordance with the Groups environmental policy, sanofi-aventis has decided to reduce the packaging materials needed to transport temperature-sensitive medicines from distribution centers to dispensing and hospital pharmacies. These medicines must be stored at all times at temperatures between +4C and +8C, including while they are being transported. Until recently in France, these medicines were transported in packages made up of an exterior insulated box and ice packs. This packaging is designed so that medicines can be transported safely while maintaining the cold chain. In 2010, the company decided to optimize transport conditions for these medicines in order to: Reduce the weight of packaging used to maintain the cold chain and thereby reduce greenhouse gas emissions from transporting medicines Find a solution for stakeholders, in particular hospital pharmacists, who want to reduce transport packaging (Packaging used to generate an average of five kilograms of waste per kilo of medicines transported, and generally this waste was not recycled.)
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Our response
The work initiated by the Supply Chain Department focused on changes in how products are transported. In metropolitan France, the proposed solution centered on delivering products using temperature-controlled vehicles that can maintain the cold chain and do not require special packaging for products. The Supply Chain Department then worked in close collaboration with specialized carriers that can transport and deliver medicines while maintaining the cold chain. Since the middle of 2010, this new system has been used to deliver vaccines to dispensing pharmacies. As of March 2011, all deliveries in France for temperature-sensitive medicines from the Groups distribution centers to hospitals pharmacies will be made using refrigerated trucks. This will make it possible to transport vaccines and medicines safely while eliminating exterior boxes and ice packs.
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For the distribution centers, the new system has several benefits: new empty packaging no longer has to be stored; the freezing process is eliminated for ice packs; special packing is eliminated (saving time and improving conditions for operators as less time is spent in cold rooms); the volume of products loaded onto trucks is reduced; and products do not have to be destroyed if there is a delivery delay. For dispensing pharmacies and hospitals, switching to refrigerated trucks has simplified logistics considerably. They no longer have to undo packaging (boxes and ice packs). And they do not have to store used packaging, which saves space and cuts costs related to destroying packaging. Lastly, from a pharmaceutical standpoint, using refrigerated trucks to deliver products makes it possible to trace the temperature throughout the entire supply chain. For carriers , logistics are also easier. Eliminating packaging supplies significantly reduces the weight and volume transported (5kg less per kilo transported), thereby making it possible to optimize delivery methods and enhance transport efficiency. For the environment , the new system, which divides the weight transported by six, also makes it possible to reduce fuel consumption and thus limit CO2 emissions from transporting products.
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Switching to refrigerated truck delivery does not cost more for sanofi-aventis. The extra cost of using temperature-controlled transport is offset by the decrease in weight transported (on average 5kg less per package) and the savings on exterior boxes (approximately 20 per package). In France, this Supply Chain program helps the environment by saving 15 tons of insulated exterior boxes per month for deliveries to hospital pharmacies and three more tons every month for vaccine deliveries to other pharmacies.
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The goal is to share good practices and implement identical solutions for the Group internationally.
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Waste management
2010 : of nonhazardous waste is converted (recycled or incinerated with energy recovery).
76%
Background
Waste is divided into two categories: non-hazardous and hazardous. Waste includes: Solid and liquid residue from chemical production and vaccine and drug manufacturing sites, R&D sites and process development sites Residue from cleaning processes Material that does not fall within specifications
Between 2009 and 2010, the amount of hazardous waste decreased by
4%
In 2010, waste conversion of nonhazardous waste increased by
Policy
Reducing the quantity of waste and managing waste are important objectives for sanofi-aventis. The Group systematically prefers waste sorting and conversion, which are key areas of the Groups policy. Waste conversion either involves recycling or waste to energy conversion.
10%
Actions
Reducing hazardous waste amounts and increasing non-hazardous waste recycling
In 2010, the amount of hazardous waste decreased by 4% compared with 2009. This decrease is primarily due to the conversion of a chemical site to biotechnology activities. At the same time, the amount of non-hazardous waste increased 10%, and the proportion of waste converted (recycling or incineration with energy recovery) increased from 75% to 76%. For the same period, recycling of non-hazardous waste increased by 12.5%. Waste
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You are here: Home > Planet > Local environmental impact > Soil and groundwater protectio...
Planet indicators CO2 emissions and energy Local environmental impact Green chemistry Water consumption Wastewater discharge Protection of the atmosphere Packaging Waste management Soil and groundwater protection Pharmaceuticals in the environment Biodiversity Soil and groundwater protection involves two issues:
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Soil and groundwater protection

million dedicated to soil remediation in 2010
45
Background
The sites currently operated by the Group can have an impact on soil and groundwater. Soil and groundwater contamination may exist at certain sites as a result of past industrial activities. It is important to remember that certain sites have very often been operating for many decades, at times when environmental standards were less stringent than today and when knowledge about the environmental impact of industrial contamination was more limited. Where past contamination exists, it may represent an environmental liability that the current site owner must manage.
Policy
Sanofi-aventis policy addresses the issue of remediation of historical soil and groundwater contamination. The objective is to take appropriate steps to ensure that the sites concerned do not pose undue risk for employees working at them, for neighboring communities or for the environment. Remediation work is carried out in accordance with applicable current legislation and regulation and local authorities. Once work is completed, the remediated property can generally be authorized for industrial or office use. Some remediation projects can be allocated for possible future residential use in concert with the relevant authorities.
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Actions
Setting up a process for remediation of contaminated sites
Today, industrial engineering standards and modern technical monitoring make it possible to prevent and avoid most risks related to sub-soil and groundwater contamination. Nevertheless, industrial practices used in the past at certain sites at times when environmental standards were not as they are today sometimes led to soil or even groundwater contamination when facilities were located near aquifers. Environmental laws and regulations today require sanofi-aventis to implement a remediation process for contaminated sites. These regulatory requirements concern sites where: The Group operates The Group (or legal predecessors) operated in the past The Group (or legal predecessors) may have stored waste For this reason, financial provisions are established and adjusted every year to take into account events that may occur as well as updates to environmental assessments. For more information: 2010 Document de Rfrence - 3.1.9 Donnes Environnementales - Pages 147-152 (Excerpt) ((in French), PDF, 71Kb)
Assessing the risks and investing in soil remediation

Sanofi-aventis adopts a responsible approach to managing the sites where the Group (or legal
predecessors) operates or operated in the past. The company systematically applies a multi-year soil and sub-soil preventive monitoring and evaluation program for the Groups properties, both for those that are currently and formerly owned and operated. Sanofi-aventis relies on detailed risk evaluations of soil and sub-soil contamination. These evaluations are carried out, when necessary, at the Groups sites or former sites. Remediation projects are launched either by local authorities or by the Group. Remediation is currently underway at over 20 sanofi-aventis sites worldwide as well as several other sites that have been sold to third parties with guarantees from the Group with respect to environmental liabilities. In total, remediation costs amounted to 45 million in 2010 (vs. 38 million 2009).
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You are here: Home > Planet > Pharmaceuticals in the environ...
Planet indicators CO2 emissions and energy Local environmental impact Pharmaceuticals in the environment Policy Actions Biodiversity
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Background
Chemical substances such as pesticides, plasticizers and many others are discharged into the environment as a result of human activities. Medicines can also be discharged into the environment. Medicines are a focus of attention due to their biological activity and because of their environmental presence even in small amounts. In certain countries, public debate focuses on reducing the size of medicine packaging for medicines sold as well as the criteria for establishing expiration dates for products.
3 areas of investigation:
The fate of pharmaceuticals in the environment Possible environmental effects Possible impact on human health
Finding pharmaceuticals in the environment

After pharmaceuticals are absorbed or administered, they are excreted by patients into the environment either in the same form or as substances called metabolites. There are also other less significant sources of discharge effluent from drug production plants and discharge resulting from the inappropriate disposal of unused medicines (e.g., direct discharge into sewage systems). Finding pharmaceuticals in the environment is not a new phenomenon. The improvement in analytical methods since the mid-1970s has made it possible to confirm the presence of an increasing number of pharmaceuticals in the environment. Depending on the substances and the environment in which they are found, these substances can be found in very low concentrations measured in nanograms or micrograms per liter. While risk for human health seems minimal at low levels of concentration, environmental risks are a concern, particularly for certain classes of pharmaceutical products such as hormonal substances, cytotoxins and antibiotics. Further research on this topic has contributed to public awareness and regulatory changes. Currently an environmental risk assessment must be carried out for each new drug marketed in Europe and the United States. Additional research still needs to be carried out to gain more knowledge about: The fate of pharmaceuticals in the environment Possible environmental effects Possible impact on human health
Packaging and expiration dates

The number of units packaged in each box of medicine and the expiration date of products are controversial issues in the public debate on the impact of drugs on the environment. Some stakeholders (e.g. environmental NGOs and patient organizations) mistakenly believe that pharmaceutical laboratories alone decide on the number of units for boxes of medicine. Thus, they believe that pharmaceutical laboratories tend to manufacture boxes with as many units as possible, contributing to an increase in medicine consumption or waste when patients do not use all the drugs. Yet, pharmaceutical laboratories do not decide on the number of units per package. Health authorities in each region are responsible for establishing the conditions for dispensing drugs and the number of units for boxes sold. Expiration dates, which are linked to the issue of packaging, are also the subject of debate. Many stakeholders think that pharmaceutical laboratories decide on the expiration period for their medicines on their own and that they try to make this period as short as possible to sell more products. Again, as with packaging, the pharmaceutical laboratories do not simply select product expiration dates. Rather, they are established after stability testing is conducted based on regulatory criteria.
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Pharmaceuticals in the environment - Policy

Sanofi-aventis is aware of the growing concern about the issue of pharmaceuticals in the environment and is now focusing on four key areas: Improving the Groups knowledge about the environmental impact of its products Developing general knowledge about the issue of pharmaceuticals in the environment, by working in close collaboration with stakeholders Analyzing discharge from the Groups production sites and assessing impacts on the environment, if any Supporting take-back programs for unused medicines The Group is working on establishing a Group-wide policy to coordinate, monitor and consolidate its commitments as part of a comprehensive program. The Group is also committed to rigorously complying with expiration dates and local regulations on product packaging, and working with all the players involved (e.g., health authorities, healthcare professionals, patient organizations and NGOs) in order to define the methods for establishing packaging sizes and expiration periods for medicines that respond to both public health and environmental issues. Responding within the scope of the consultation of stakeholders for the 2010 CSR Reporting, Ms. Jos Cambou, who is the National Secretary of the France Nature Environnement federation and also oversees its Environmental Health network, explained: Packaging should be better suited to necessary dosage to avoid excessive waste just like what is done in the animal medicines industry." Expiration date criteria should be publicly disclosed.
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Measuring the impact of the Groups products on the environment Developing knowledge about the issue Identifying the impact on the environment of discharge from sites Supporting takeback programs for unused medicines Complying with
5 areas of concentration for sanofiaventis:
regulations
regarding product packaging and expiration dates
Packaging should be better suited to necessary dosage to avoid excessive waste just like what is done in the animal medicines industry. Expiration date criteria should be publicly disclosed.
Ms. Jos Cambou, National Secretary of the France Nature Environnement federation, responding within the scope of the consultation of stakeholders for the 2010 CSR reporting.
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You are here: Home > Planet > Pharmaceuticals in the environ... > Actions
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2009: A special
Pharmaceuticals in the environment - Actions

Assessing the Groups products Helping develop knowledge Studying site discharge Supporting collection programs for unused medicines Complying with local regulations regarding product packaging and expiration periods
working group
was created to monitor the impact of discharge from sanofi-aventis sites on the environment
Assessing the Groups products

An environmental risk assessment must be carried out on any new drug marketed in Europe or the United States following specific guidelines. These assessments are a relatively new practice that has evolved over the last few years based on new knowledge acquired. While new drugs today are assessed for environmental risks, older drugs that are already marketed may be studied less as regulatory requirements were less stringent when they were launched. Thus since 2005, independent of any regulatory requirement, through its group of internal experts, the ECOVAL committee, sanofi-aventis has carried out environmental risk assessments of some of the Groups marketed drugs .* The environmental risk assessment is carried out for each drug, taking into account: Predicted environmental concentration (calculated based on consumption) Environmental fate Environmental effects, including impact on micro-organisms, plants and animals A minimum amount of environmental data is required to carry out an environmental risk assessment. Additional studies may also need to be carried out when data available is insufficient. Twenty-six major products have been analyzed. Additional studies were carried out for six of these products. These evaluations did not show any significant environmental risk. During this time, new products were also evaluated within the scope of their drug marketing approval, particularly in Europe and the United States. A total of eight new regulatory environmental assessments were carried out in 2010. Sanofi-aventis is committed to continuously improving the Groups environmental risk process. It plans to revise the process for establishing priorities and the internal assessment of marketed drugs in order to incorporate technological advancements and practices.
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new environmental regulatory assessments were carried out on medicines in 2010 in Europe and the United States as part of drug approvals for new sanofi-aventis products
Sanofi-aventis, No. contributor to Cyclamed, the French collection and energy recovery program for unused medicines: dues paid in 2010
778,000 in
Athens Green 360: 190,000 financed by sanofi-aventis for

the program to collect unused medicines.
WHAT TO DO WITH YOUR UNUSED MEDICINES? Sanofi-aventis recommendations:

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Helping develop knowledge

Sanofi-aventis understands that when patients use medicines, substances may be discharged into the environment in very low concentrations. As such, the Group is working with stakeholders in the pharmaceutical sector and the academic world to expand scientific knowledge in this area. The Group is also acquiring essential information through collaborations within the pharmaceutical industry in Europe and the United States. The aim of these projects is to assess the potential impact of pharmaceuticals in the environment, including on human health. In addition, the Group is building partnerships with universities in areas that it believes have not been studied sufficiently, e.g., the efficacy of wastewater treatment with respect to pharmaceuticals, or what happens to pharmaceuticals in the marine environment.
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BUSINESS CASE
In accordance with the Groups environmental policy, sanofi-aventis has decided to reduce the packaging materials needed to transport temperature-sensitive medicines from distribution centers to dispensing and hospital pharmacies.
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Studying site discharge

Discharge of active ingredients can be estimated at the site production level using two different approaches: By calculating discharge using material balance By using analytical measurements for wastewater effluents Both approaches are used at several Group sites. At the end of 2009, a working group was established to coordinate actions in this area and instituted more widespread data collection. This working group brings together internal expertise needed for this assessment. In 2010, the Group carried out studies to research and quantify active ingredients and their degradation products within effluents at production sites. Four sites were studied. In addition to these comprehensive studies, a more specific study was also carried out at one site to estimate discharge during the various stages of a manufacturing process. Other studies were carried out in 2011 at these sites and other sites to consolidate this information and collect new data. In addition to these measures, the Group is also working on a simplified assessment tools for environmental impacts involving discharge from production sites. After it is validated, this tool will gradually be rolled out at the Groups various sites. These initiatives are carried out in addition to environmental impact assessments regularly performed at Groups sites.
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Supporting collection programs for unused medicines

Sanofi-aventis actively supports local collection programs for unused medicines. These programs are designed to support proper disposal of unused and expired medicines through consumer take-back programs in many countries and through returned goods programs from hospitals, clinics, and pharmacies. These simple, but effective steps may contribute to protecting our environment. The Group set out its position in a document entitled "What to do with your unused medicines." An excerpt is provided here:
What to do with your unused medicines (excerpt) Sanofi-aventis is committed to encouraging proper disposal of unused medicines. Actions to reduce improper disposal of expired or unwanted prescription and non-prescription medicines would contribute to protection of our waterways. Although studies have indicated that only a small portion of medicines enter the environment through waste disposal, it is important to reduce our impact from all sources. Simple steps taken by the consumer will significantly reduce emissions contributing to environmental exposure. For certain types of medicines, for example anticancer drugs, special disposal methods are indicated. The general guidance provided below is for disposal of all medicines in a safe manner and applies to unused household medicines as well as those from long-term healthcare facilities. Most importantly, do not dispose of unused medicines down the drain. That is, medicines should be neither flushed down the toilet nor poured down the drain. Follow local disposal practices including community pharmaceutical take-back programs where available. Disposal practices vary by region. In most European nations, unused medicines can be returned to the pharmacy for safe collection and disposal by incineration. In the U.S. and many other nations, local take-back programs may exist through pharmacies or government or community waste treatment programs. Contact your pharmacy or local waste disposal agencies for more information if needed. Collection of unused medicines for reuse is an acceptable alternative in some communities if authorized programs exist. In the absence of local take-back programs, dispose of unused medicines in household trash taking precautions to avoid accidental misuse or possible diversion for drug abuse. Render unused medicine undesirable and unrecognizable (e.g., mix with household waste in non-descript packaging). Mark out or remove any labeling identifying personal prescription information. Dont forget that a simple preventive measure to reduce waste, when possible, is to get only the quantity of medicine you need. This will minimize having to dispose of expired unused medicines later. The situation is very different depending on the country. For example in Greece, sanofi-aventis is funding a new initiative, Athens Green 360 to promote the collection and destruction of unused medicines. In France, the Group has supported the Cyclamed program for many years.
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Athens Green 360 to promote the destruction of unused medicines: Raising awareness in Greece about the importance of collecting unused medicines
Greece has been developing a special process for collecting and destroying paper, glass, batteries, etc. for many years now; however, until recently there was no system in place to collect and destroy
unused medicines. Every year over an estimated 50 million boxes of medicine are thrown away by individuals into household trash in Greece (Source: Macedonia newspaper, July 14, 2010). To counter this trend, a new initiative was launched in 2010: Athens Green 360. This program, which was developed under the aegis of the PostBank Green Institute, implements an awareness campaign to teach people about the importance of collecting unused medicines (both expired and non-expired) so that they can be destroyed appropriately using incineration. The campaign consists of information brochures, a special website and TV / radio ads. The campaign brings together all the healthcare players particularly the pharmaceutical industry and health authorities to collaborate on this topic. The information brochures will be available in public and private hospitals, as well as doctors offices and pharmacies, which will offer operational support by collecting medicines. In addition to promoting the campaign and raising awareness, the program also plans to place collection containers for unused medicines in major supermarket chains. A specialized company will be responsible for collecting and transporting the returned medicines to incineration plants that are certified for handling this type of process. Sanofi-aventis in Greece donated 190,000 to the Athens Green 360 program as the exclusive official sponsor of the program for handling unused medicines.
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Cyclamed: Collecting and converting unused medicines in France

Cyclamed is a French environmental non-profit organization that brings together all professions within the pharmaceutical sector: dispensing pharmacies, wholesalers / dispatchers and pharmaceutical companies. The purpose of the organization is to make it safer to eliminate unused medicines in order to preserve the environment and protect public health. The organization, which is approved by French public authorities, is responsible for collecting and converting all unused medicines for human use, regardless of whether they are expired or nonexpired. Cyclamed is used for all galenical formulations tablets, capsules, syrups and ointments that consumers return to pharmacies. The program is only for waste from households, not waste from public hospitals, private hospitals or healthcare professionals. The organization oversees awareness and communications initiatives for the general public, healthcare professionals and environmental players. "Thinking Cyclamed" should become a reflex for everyone. Cyclamed is financed entirely by drug makers through: Dues that they pay the organization based on the number of boxes marketed A portion of the dues paid to Adelphe for packaging that is transferred to Cyclamed As the largest pharmaceutical company in the French market, sanofi-aventis makes the largest financial contribution to the Cyclamed program. In 2010, the Group paid a total of 778,000 in dues to the organization. What is the role of each player in Cyclamed? When patients have finished their treatment, they must return their unused medicines in their packages, even if only one pill or capsule is left. Pharmacies are required to take back unused medicines (in accordance with French Law 2007-248, published in the Journal Officiel on February 27, 2007). The pharmacists then check the expired or non-expired unused medicines returned by consumers and put them in a special box. When making their daily deliveries, wholesalers / dispatchers collect full boxes, place them in their vans and contact the service provider so that the unused medicines can be destroyed. Incineration using special facilities is the solution that has been chosen to safely destroy unused medicines. Transport service providers are in charge of transporting containers between the dispatchers and the incineration units. The 52 energy incineration units selected by Cyclamed all comply with stringent environmental standards. All the units process smoke in accordance with regulations, which are designed to eliminate risk of atmospheric pollution.
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Complying with local regulations regarding product packaging and expiration periods
In all the countries where the Group operates, sanofi-aventis is committed to complying with regulations on the size of packaging for medicines and expiration dates that have been established.
Size of packaging
The regulatory authorities in each country set out the rules for the size of packaging for medicines. The
proper use of medicines, public health issues and economic concerns are all important factors for public authorities when establishing the proper size of packaging for indications, proposed dosages and lengths of treatment. In France: Article L.162-17-1-1 of the French Social Security Code stipulates that pharmaceutical products are presented in appropriate packaging based on therapeutic indications warranting coverage by the public healthcare system, the dosage and the length of treatment. For more information: www.legifrance.gouv.fr / Textes lgislatifs et rglementaires - Mdicaments (in French) The Transparency Commission evaluates the medicines on the list of reimbursable pharmaceutical products, by including an assessment regarding the appropriateness of packaging based on therapeutic indications that the Commission considers founded based on the registration, dosage and length of treatment. (Article R 163-18 7 of the French Social Security Code). For more information: www.legifrance.gouv.fr / Commission de la transparence - Mdicaments remboursables (in French) As for OTC medicines, French Decree No. 2008-641 of June 30, 2008 stipulates that medicines should be on the list of medicines dispensed in pharmacies when packaging weight, volume or number of doses is adapted to the dosage and the length of treatment recommended on the patient information leaflet. For more information: www.afssaps.fr / Mdicaments en accs direct (in French) In Germany The Medicinal Products Act of the Federal Republic of Germany establishes that medicinal products can only be marketed using a specific packaging size and that the packaging sizes should be established for specific active pharmaceuticals and should take into account the therapeutic indications, the length of treatment and the pharmaceutical formulations. (Medicinal Products Act of the Federal Republic of Germany - Chapter 2 - Section 12) For more information: www.bmg.bund.de / Medicinal Products Act
Establishing the expiration period of medicines

The stability of medicines depends on intrinsic factors (e.g., raw materials, pharmaceutical formulations and packaging), and extrinsic factors (e.g., temperature, humidity and light). Deterioration of a drug can reduce its therapeutic efficacy and lead to products that create adverse or toxic effects. Stability testing is used to provide data on how the quality of a drug varies based on the amount of exposure to different factors. Stability testing is regulated by international guidelines. Shelf life and storage conditions of a drug are defined entirely based on the results of stability studies and in particular real-time data. The expiration period of newly-marketed medicines is generally limited to two years, based on an extrapolation or real-time data. Beyond two years, only real-time data can be used to extend shelf life. Based on the results of these studies, pharmaceutical companies propose expiration dates. Healthcare authorities then evaluate and establish expiration dates. Stability testing is a key step for obtaining drug marketing approval. It helps ensure the quality of the drug and its safety for use. The ICH (International Conference on Harmonization) Q1A guideline provides recommendations to be followed for stability testing to be carried out on active pharmaceuticals and drugs (finished products). These studies are used to determine the shelf life of a drug. For more information: www.ema.europa.eu / Stability Testing of new Drug Substances and Products The conditions for these studies vary depending on the climatic zone where a medicine is sold. The length of these studies varies from six months (accelerated studies) to 24-36 months in general (long-term realtime studies).
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You are here: Home > Planet > Biodiversity
Planet indicators CO2 emissions and energy Local environmental impact Pharmaceuticals in the environment Biodiversity Policy Actions Business case: Artemisinin
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2010:
Biodiversity
Biodiversity refers to the variety of species and their genetic diversity, as well as the various natural environments in which they grow.
International Year of Biodiversity

(United Nations)
POSITION PAPER
The preservation of biodiversity is essential given the key role it plays in maintaining the balance of our planet. Preserving biodiversity means maintaining and developing ecosystems, as well as carefully assessing how to manage plants and animals.
Biodiversity: A key commitment for sanofiaventis

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Biodiversity: A key issue worldwide

The world's natural ecosystems are deteriorating at a rate unprecedented in human history, with more and more natural species disappearing. Preserving biodiversity and ensuring the sustainable and fair use of natural resources stands out as a key issue worldwide and has become an essential part of any Corporate Social Responsibility policy. Two important events in 2010 had an impact worldwide: The United Nations declared 2010 to be the "International Year of Biodiversity" The Biodiversity Summit, held in Nagoya, Japan, in October 2010, made it possible for the first time to reach an international agreement to promote the protection of biodiversity, with an action plan for 20102020.
BUSINESS CASE
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Biodiversity and the pharmaceutical industry

The pharmaceutical industry places a great deal of importance on biodiversity. Natural resources are critical for the discovery and development of new drugs. Natural resources are also important because they offer valuable potential as sources for new chemical substances and active ingredients. It is therefore vital to preserve them. Today biologists consider that they may very well represent the treasure troves of pharmacopoeia in the 21st century, given the remarkable natural diversity of their substances and active ingredients.
Origin of compounds
Over the past 25 years, nearly half of the 1,184 new chemical entities that have been marketed worldwide have come from substances found in nature. These 1,184 new compounds can be broken down as follows:
Source: David J. Newman and Gordon M. Cragg, Natural Products as Sources of New Drugs over the Last 25 Years, Journal of Natural Products , 2007, Vol.70, p 461-477
B : Biological N: Natural product ND : Derived from a natural product and is usually a semisynthetic modification S: Totally synthetic drug, often found by random screening, modification of an existing agent S* : Made by total synthesis, but the pharmacophore is / was from a natural product V : Vaccine NM : Natural product mimic For more information: Natural Products as Sources of New Drugs over the Last 25 Years Natural Products as Sources of New Drugs over the Period 1981-2002
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You are here: Home > Planet > Biodiversity > Policy
Planet indicators CO2 emissions and energy Local environmental impact Pharmaceuticals in the environment Biodiversity Policy Position Paper Actions Business case: Artemisinin
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POSITION PAPER
Biodiversity - Policy
Adhering to the Convention on Biological Diversity Complying with the Groups own guidelines Taking action to preserve biodiversity Biodiversity represents three key issues for sanofi-aventis: The controlled use of natural plant and wild animal species for use in research projects to discover new drugs Determining fair distribution and sharing of benefits resulting from the use of this type of resource Ensuring the preservation of biodiversity surrounding the Groups sites, particularly those located in sensitive natural areas In these three areas, the Groups policy is based on: Adhering to the Convention on Biodiversity Complying with the Groups own guidelines , summarized in our 2010 position paper Sanofi-aventis understands how important preserving biodiversity is for the planet, and in 2010, the Group established a series of commitments focusing on protected species and streamlining research programs for natural substances.
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Biodiversity: A key commitment for sanofiaventis

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3 biodiversity issues:
The use of natural species for drugs Sharing benefits with communities Preserving biodiversity surrounding Group sites
MONITORING PROGRESS As part of the French national Corporate Social Responsibility / Sustainable Development program referred to in French as the Grenelle de lenvironnement program, LEEM the French Pharmaceutical Companies Association signed a "Drug Industry Progress Agreement" in 2009 with the French Ministry of Ecology and Sustainable Development. The purpose of the agreement is to monitor CSR commitments within the industry. As part of this progress agreement, sanofi-aventis now reports biodiversity indicators to LEEM each year.
www.leem.org / Convention de Progrs du Secteur Mdicament
Adhering to the Convention on Biological Diversity

Adhering to the Convention on Biological Diversity is the keystone of the Groups biodiversity policy. This international convention sets out the principles for obtaining and using natural resources. Contracts established by the Group with suppliers of natural products stipulate that suppliers must comply with the Convention on Biological Diversity. These contracts set conditions for sharing the benefits arising from the use of these resources. For more information: www.cbd.int
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Complying with the Groups own guidelines

Sanofi-aventis biodiversity policy is summarized in the Groups 2010 Position Paper. This paper presents an overview of all the principles that the Group has implemented over many years to preserve biodiversity. It also demonstrates that biodiversity is a key issue for sanofi-aventis, and establishes a clear stance on fighting all forms of biopiracy. Position Paper Biopiracy These guidelines are consistent with the Group's principles with regard to Human Rights, particularly as regards the fair and equitable sharing of the benefits arising from the use of communities natural resources. Human rights
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Taking action to preserve biodiversity

In 2011 and 2012, the Group is committed to: Verifying, before any order is placed, that the plants ordered are not on the IUCN (International Union for
Conservation of Nature) Red List of Threatened Species Ensuring that all new contracts are in line with the Convention on Biological Diversity and take into account the Red List criteria Ensuring that suppliers produce, if necessary, the official authorizations that allow them to collect the plants that have been ordered Continuing to reduce the weight of powdered plant samples used in research Sanofi-aventis will ensure compliance with local regulations regarding the preservation of diverse areas surrounding Group sites, and, if necessary, will carry out environmental impact assessments.
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Sanofi-aventis Position Paper on Biodiversity & Biopiracy

Sanofi-aventis continuously seeks ways to limit and lower the environmental impacts of its business activities in accordance with the Group CSR and HSE policies. In addition, as a Global leader in Healthcare, sanofi-aventis is aware that natural resources (plant, animal, etc.) from ecosystems are sources of potential innovative new medicines that could prevent and cure diseases. Thus, the Group recognizes the necessity to protect and sustain all natural resources that make up biodiversity. The Group is also aware that unapproved or significant removal of natural resources, as well as polluting production activities, may jeopardize the ecology and economy of the affected countries. Because sanofi-aventis acknowledges that each country has sovereignty over its natural resources and traditional knowledge for their use, the Group is committed to supporting internal and / or external initiatives against biopiracy. Sanofi-aventis focuses on preventing and managing any of its activities that may have an impact on biodiversity and is implementing processes against biopiracy. This includes: Controlling the collection and use of natural resources in research projects to discover new commercial drugs Understanding the effects of Group activities and medicines on natural resources Implementing a fair process for benefit sharing, with conventional knowledge holders, resulting from the marketing of medicines derived from natural resources Conserving habitats and species around Group sites throughout the world Sourcing biological materials and related services from suppliers who have appropriate environmental and biodiversity preservation standards (including compliance with international standards on biodiversity) The Group adheres to several external initiatives that define biodiversity preservation principles: The Convention on Biological Diversity, included in the United Nations Environment Programme (UNEP), and agreed to at the Earth Summit in Rio de Janeiro in 1992. It defines commitments for maintaining the world's ecological systems including the following three main goals: The preservation of biological diversity The sustainable use of its components Principles with respect to the acquisition and utilization of natural resources, and the fair and equitable sharing of the benefits from their use The Human Rights principles regarding the respect of rights for indigenous people to maintain, control, protect and develop their intellectual property over cultural heritage, traditional knowledge and traditional cultural expressions The United Nations Global Compact and Millennium Development Goals In addition, sanofi-aventis is committed to communicating in a transparent manner about the Groups actions and achievements to preserve biodiversity. The Group is also committed to following the G3 Global Reporting Initiative (GRI) guidelines concerning biodiversity to enhance the relevance and transparency of our reporting to local stakeholders.
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Biodiversity - Actions
Sanofi-aventis actions to preserve biodiversity are primarily related to the use of natural substances in R&D projects and respecting the biodiversity surrounding our sites.
The use of natural substances

Sanofi-aventis benefits from a natural substances center, which seeks to ensure that all the Groups R&D initiatives involving natural substances comply with the Convention on Biological Diversity.
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Respecting the biodiversity surrounding our sites

Various local initiatives have been implemented to preserve water, air quality, and plant and animal species at the Groups sites worldwide.
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Planet indicators CO2 emissions and energy Local environmental impact Pharmaceuticals in the environment Biodiversity Policy Actions Natural substances Biodiversity surrounding Group sites Business case: Artemisinin A center specialized in natural substances Limiting the amount of natural substances used Assessing the species used
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The use of natural substances

The actions implemented to adhere to the Convention on Biological Diversity and to comply with the Groups position on biodiversity involve both R&D programs that use natural substances and the use of these substances to manufacture drugs.
Between 2000 and 2010: Amount of natural substances needed to study components:
10 times less 647
Between 2003 and 2010, sanofi-aventis natural studied substances derived from
Establishing contracts that comply with the Convention on Biological Diversity
152 plants.
The actions implemented to adhere to the Convention on Biological Diversity and to comply with the Groups position on biodiversity involve both R&D programs that use natural substances and the use of these substances to manufacture drugs. These actions entail: Limiting the amount of substances used for research Identifying protected natural substances (IUCN Red List) and finding alternative solutions whenever possible Establishing contracts with suppliers stipulating that they must comply with international conventions and national legislation on preserving biodiversity Auditing suppliers to ensure that they comply with these obligations Putting into practice the principle of sharing benefits generated by the Group with countries and local populations that have specialized know-how, when products made from natural substances are commercialized. For more information: Biopiracy Implementing actions designed to avoid impinging on the needs of local populations that may be adversely affected (e.g., harvesting food crops) when harvesting natural substances to be used for the production of drugs and, where appropriate, developing alternative solutions.
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1.3% of the natural

species held by sanofiaventis since the creation of the sample bank appear on the current IUCN Red List of Threatened Species
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A center specialized in natural substances

For several decades now, sanofi-aventis has had a center located in Frankfurt, Germany, specializing in natural substances. This center of expertise brings together numerous experts and focuses primarily on investigating natural substances that may provide a source to develop new drugs. The center also shares knowledge with all the Groups R&D operating units that carry out studies on natural substances for sanofiaventis various treatment areas. This center currently has a collection of some 9,000 plants. Between 2003 and 2010, 647 natural substances from 152 plants were studied by the Groups experts.
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Limiting the amount of natural substances used

In an effort to preserve the species used, sanofi-aventis continuously seeks to streamline its R&D programs involving natural substances. Screening operations use much smaller quantities of plants today than in the past. In 2000 it took a few hundred grams of a plant to study its components, whereas today it only takes a few dozen grams.
Assessing the species used

With an eye to respecting protected species, sanofi-aventis carried out an evaluation in 2010 of all the species held by the Group. The evaluation focused on assessing these substances based on the criteria found on the IUCN Red List of Threatened Species. The evaluation was carried out based on the IUCN list as published in 2010. The list is updated each year. Therefore, natural species used by sanofi-aventis that were not protected when preliminary research was carried out could have become listed after this research was initiated. It is also important to note that the IUCN Red List is a recent initiative. Sanofi-aventis has been compiling its database of natural substances for several decades before the IUCN list was developed and at a time when the scientific community could not predict the extinction of certain plants. The results of this retrospective evaluation show that only 1.3% of the plants held by sanofi-aventis in 2010 appeared on the 2010 IUCN Red List of Threatened Species. For more information: www.iucnredlist.org / About
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Establishing contracts that comply with the Convention on Biological Diversity

All contracts between sanofi-aventis and its suppliers of natural species (currently based primarily in China and Madagascar) include clauses on preserving biodiversity. These contracts require suppliers to comply with the Convention on Biological Diversity and obtain local authorization, if necessary, to collect specimens. Some contracts go above and beyond respecting these obligations. For example, collaboration between sanofi-aventis and the Chinese firm Chengdu Diao specializing in extraction was set out in a contract that includes: A clause for sharing potential benefits if the natural substances studied are used for new drugs A clause for transferring technology related to extracting, purifying and splitting compounds derived from these substances A commitment to train Chinese employees at the Frankfurt site on extraction and purification techniques Similarly, the contract between sanofi-aventis and IMRA the Malagasy Institute of Applied Research includes a clause for sharing benefits if drug compounds are extracted from the supplied plants.
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Respecting the biodiversity surrounding our sites

In order to evaluate and preserve biodiversity in the areas where Group sites are located, sanofi-aventis carries out environmental impact assessments. These assessments cover sanofi-aventis current sites as well as plans to expand existing sites and build new sites. Environmental impact assessments are based on local regulations. The goal is for all sites to comply with these local regulations as well as the Groups biodiversity policy. Three of the Groups industrial sites are located in environmentally protected zones, in other words, areas where environmental regulations are more stringent in order to preserve the natural resources surrounding these sites. They are under particular scrutiny as a result of their location. The following examples illustrate how the biodiversity strategy is implemented locally at various sites: Implementing an appropriate water treatment strategy for the Swiftwater site in the United States Biodiversity initiatives that go beyond regulatory compliance: Focus on the Bridgewater site in the United States Maintaining green space around the Swiftwater site in the United States Preserving biodiversity in urban areas: Focus on the Croix de Berny site in France Protecting birds at the Quetigny site in France Identifying and describing the trees at the Frankfurt site in Germany
Implementing an appropriate water treatment strategy for the Swiftwater site in the United States
A stream that feeds into fish breeding areas runs through the Swiftwater vaccine production site. Sanofi-aventis has put in place a vast array of measures to protect the environment at the site. The sites water treatment strategy has been developed combining various water treatment stages and technologies. The Group has invested over $40 million to install a wastewater treatment plant and a special irrigation system, allowing water to be discharged safely into the stream, or used to water nearby forest areas after it has been monitored. Regular assessments carried out at the site for more than 18 years show that water quality has been consistent, and neither the flora nor the fauna have been harmed.
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Biodiversity initiatives that go beyond regulatory compliance: Focus on the Bridgewater site in the United States
In 2009 and 2010, sanofi-aventis commercial and R&D operations based in Bridgewater, New Jersey (USA), in collaboration with the New Jersey Water Supply Authorities, obtained River-Friendly Business Certification. This certification is awarded to companies that protect the natural environment where they operate. The first part of the certification process involved an evaluation, which was used to draw up recommendations to help protect the environment. These recommendations were then implemented by the Group. Examples include the development of natural green areas, planted areas, a butterfly garden and bird nest boxes. These initiatives to protect biodiversity were recognized by the New Jersey Department of Environmental Protection (NJDEP) as part of its Environmental Stewardship Initiative. This program was created in 2006 to recognize businesses that implement initiatives that exceed local regulations. For more information: www.njwsa.org
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Maintaining green space around the Swiftwater site in the United States
At the Swiftwater site, sanofi-aventis implemented a policy to develop green space to cover the equivalent of the area occupied by the plant as it
expands. This approach offers a way of offsetting environmental impact and contributes to maintaining environmental balance: Green space helps rainwater infiltration. The areas developed help stabilize the banks and supply groundwater. They help reduce the number of mosquitoes and improve the habitat for plants and animals. Twenty percent of the Swiftwater sites surface area (547 acres / 221 hectares) consists of green space.
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Preserving biodiversity in urban areas: Focus on the Croix de Berny site in France
Croix de Berny is an administrative site located near a large public park in a relatively open urban area. The site is made up of various buildings spread out over 6.5 hectares of grounds. The preservation, renewal and diversification of the parks plant and animal species are very important to the Group. Biodiversity inventories taken since 2004 have identified all the plant and animal species found on the site. These inventories have also made it possible to determine in conjunction with the LPO, the French Bird Protection League that ornithological diversity at the site is satisfactory. From there, increases were established for various animal species, based in particular on the improvements in specific environments and habitats. Following the last study, carried out in 2009 in conjunction with the service provider responsible for maintaining the sites green areas, an action plan was devised to promote biodiversity. This plan includes new natural fertilization, or mulching, techniques and reducing the use of plant-care products. Initiatives have also been developed at the site to manage and maintain bird nest boxes, manage lawn mowing and limit invasive species. Studies are also being carried out for rain water management and leaf composting.
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Protecting birds at the Quetigny site in France

Over the last several years, the Quetigny production site has made a special effort to protect birds. Since 2004, this commitment has been exemplified by its partnership with the French Bird Protection League (LPO), which offers advice on good practices to be implemented to protect birds. For example: Waiting longer to trim hedges and bushes so that birds can build nests Prohibiting chemical weeding Installing bird feeders for the winter, etc. The Quetigny site was one of the first industrial sites in France to become involved in protecting fauna. Thanks to initiatives at the site, the bird population has grown.
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Identifying and describing the trees at the Frankfurt site in Germany

In accordance with strict local regulations to preserve the environment, the site where sanofi-aventis operates in Frankfurt compiled a list of all the trees located throughout the site. This process made it possible to identify and describe over 4,600 trees. The description gives the exact location of each tree, the type of tree, its size and its age. Additional information is also included regarding the condition of the crown, trunk and roots. Each tree is given a number and a bar code, which are displayed on the tree. Every year an assessment is made to monitor changes in the site's trees and determine what type of new trees to plant. Pathways surrounded by trees and grass have recently been included in the plans for new buildings and infrastructure constructed to create a favorable habitat for amphibians.
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Planet indicators CO2 emissions and energy Local environmental impact Pharmaceuticals in the environment Biodiversity Policy Actions Business case: Artemisinin
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Business case: Artemisinin

Producing semisynthetic artemisinin: Ensuring the preservation of biodiversity in areas where wormwood is grown. Ensuring the supply of artemisinin, a natural substance that comes from wormwood. Artemisinin derivatives are used in first-line malaria treatments
Developing a method to produce semisynthetic artemisinin on an industrial scale Collaboration with the iOWH - Institute for OneWorld Health Offering sanofi-aventis' expertise: increased yields, chemical development and industrial processes
For patients: Ensuring a supply of consistent, high-quality raw material, shorter production times and affordable prices For local communities: Avoiding wormwood speculation to ensure that growers are compensated fairly and consistently, and that food crops are maintained For third parties (the WHO, governments, NGOs, other firms, etc.): Ensuring a constant supply of raw material for reliable production of medicines, thus helping slow the possible emergence of resistance to antimalarial drugs
In line with the Access to Medicines strategy Acquiring new skills and developing partnerships Developing activity at industrial sites Image : Good practice for biodiversity / cutting-edge biological process / public health challenge
Industrial roll-out of process in 2011 so that growing patient demand may be met by mid2012
The challenge
The challenge involves ensuring the supply of artemisinin, a natural substance that comes from wormwood and whose derivatives artesunate, artemether, dihydroartemisinin are used in first-line malaria treatments. It all started in 2001. In order to counter the rapid rise in resistance to antimalarial drugs, the WHO recommended using a combination of two compounds one of which is an artemisinin derivative for the treatment of uncomplicated malaria. Since 2008 sanofi-aventis has marketed a combination of this type (ACT, artemisinin-based combination therapies) under the brand names Coarsucam / Artesunate Amodiaquine Winthrop. Artemisinin is extracted from the leaves of the sweet wormwood plant. Extractors who extract artemisinin buy the leaves from growers. Sweet wormwoods grow in the wild in China and Vietnam. To meet the increasing need for artemisinin, other countries such as Kenya and Madagascar have started growing wormwood sometimes to the detriment of food crops. As the production cycle is long and yields are low, more surface area is devoted to growing the plant to meet rising demand. Production is insufficient, and the increasing amounts of artemisinin needed has led to significant tensions. Speculation has given rise to campaigns to plant more and more wormwood, followed by a drop in prices. Sanofi-aventis currently estimates that maximum wormwood production cannot exceed 80 metric tons per year, whereas an estimated 120 metric tons per year will be needed through 2015.
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Our response
Given what is at stake for public health, it is crucial to find a method for the industrial production of artemisinin in order to supplement agricultural production. The solution is a method that produces semisynthetic artemisinin. This method was developed through collaboration between sanofi-aventis and iOWH the Institute for OneWorld Health. The idea was to develop an industrial-scale manufacturing process for semisynthetic artemisinin, using yeast discovered by Professor Jay Keasling of the University of California, Berkeley and Amyris Biotechnologies. A $42.6 million grant was awarded to iOWH by the Bill and Melinda Gates Foundation in support of the project. Sanofi-aventis joined the program to provide expertise in fermentation and chemical development techniques as well as industrial process optimization. Collaboration of stakeholders and sanofi-aventis expertise, have lead to positive results. The project made it possible to increase the yield of yeast strains producing artemisinin and develop a new chemical process. The process improvements underwent technical validation in 2009 / 2010.
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For patients, semisynthetic artemisinin first of all means that they will benefit from consistent, high-quality raw material. The patient also benefits from shorter production times and affordable prices. In line with its entire access to healthcare policy, Sanofi-aventis strives to produce artemisinin for its own needs and for third parties without making a sales profit. For local communities, semisynthetic artemisinin helps fight wormwood speculation and stabilize price levels. This in turn ensures that producing countries receive appropriate compensation. It is also important to avoid expanding the use of crop land to the detriment of food crops. The program is conducted in complete transparency in conjunction with natural artemisinin growers and extractors. Over the course of the project, sanofi-aventis has taken part in many meetings with farmers and extractors from various producing countries to present the project and show them how they can benefit from it. For third parties such as the WHO, governments, NGOs and other pharmaceutical companies, the advantage of this approach is that they can be sure to have a constant supply of raw material for reliable production of quality medicines, thus helping to slow the possible emergence of resistance to antimalarial drugs.
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The policy of producing semisynthetic artemisinin is fully in line with sanofi-aventis' Access to Medicines strategy. This policy enables the Group to make a difference in one of its areas of expertise malaria. The products offered meet the needs of people and are affordable. With consistent, high-quality raw material and shorter production times, the Group is better equipped to respond to growing demand. This approach also helps the Group acquire new skills, particularly thanks to international partnerships. It also enables the Group to develop activity at our industrial sites. Finally, this approach strengthens the Groups image bringing together a good practice for biodiversity, the development of a cutting-edge biological process and the response to a public health challenge.
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The production of semisynthetic artemisinin will be rolled out on an industrial scale in 2011, making it possible to meet growing patient demand by mid-2012.
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Glossary
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AA1000
Accountability series and standards
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American Academy of Continuing Medical Education
ADA
American Diabetes Association
AFEP
French Association of Private Companies
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Actions Locales de Dveloppement conomique et dchanges (local actions for business development and exchange)
AMM
Marketing authorization
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American Society of Clinical Oncology
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Binding Corporate Rules
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Business Leaders Initiative on Human Rights
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Brevet de Technicien Suprieur (French postsecondary technical certificate)
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CDP
Carbon Disclosure Project
CEFIC
European Chemical Industry Council
CFR21
Code of Federal Regulations, title 21, Food and Drugs
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Chief Medical Officer
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National Anti-Counterfeit Committee
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Compressed Natural Gas
CNIL
French national data protection authority
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Carbon dioxide
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Chemical Oxygen Demand
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Comit de Protection des Personnes (French independent ethics review board)
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Corporate Social Responsibility
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Drugs for Neglected Diseases initiative
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European Accreditation Council for Continuing Medical Education
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European Economic Area
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European Federation of Pharmaceutical Industries and Associations
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European Medicines Agency
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Electronic Product Environmental Assessment Tool
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European Society of Cardiology
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Food and Drugs Administration
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Global Alliance for Vaccines and Immunisation
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Good Clinical Practices
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Workforce Planning Agreement
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Global Polio Eradication Initiative
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Global Reporting Initiative
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Group Sustainability Committee
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Human Immunodeficiency Virus
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Human Resources
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ICH
International Conference on Harmonization
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LInstitut Franais des Auditeurs et Contrleurs Internes
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International Federation of Pharmaceutical Manufacturers & Associations
ILAR
Institute for Laboratory Animal Research
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International Labor Organization
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INTERnational POLice
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Institute for OneWorld Health
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International Organization for Standardization
IUCN
International Union for Conservation of Nature
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LEEM
The French Pharmaceutical Companies Association
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MEDEF
Mouvement des Entreprises de France (French employers association)
MHLW
Ministry of Health, Labor and Welfare
MMV
Medicines for Malaria Venture
MSR
Medical Sales Representatives
MSRS
Monthly Safety Reporting System
MWh
Megawatt hour
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Non-governmental organization
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New Jersey Department of Environmental Protection
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Nitrogen oxides
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Organization for Economic Cooperation and Development
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Operating and Financial Review
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Provence-Alpes-Ctes dAzur (Southern Alps region of France)
PACT Plus
Providing Access to Cancer Therapy
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Patient Assistance Programs
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PPA
Prescription Assistance Program
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Quality Brands Protection Committee
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Psychosocial Risks
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SOX
Sarbanes-Oxley Act
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SO 2
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SPC
Summary of Product Characteristics
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Sustainability Report
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Sport Utility Vehicule
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TSS
Total Suspended Solids
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UFAW
Universities Federations for Animal Welfare
UICC
Union for International Cancer Control
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Corporate volunteer program
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Volatile Organic Compounds
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World Business Council for Sustainable Development
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World Health Organization
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5. Limitations of liability
Sanofi-aventis Groupe makes every effort to ensure to the best of its abilities the accuracy and updating of the information broadcast on the Site, whose content the company reserves the right to change at any time and without prior notice. Nonetheless, sanofi-aventis Groupe cannot fully guarantee the accuracy, precision, updating or exhaustiveness of the information made available on the Site. As a result, and with the exception of direct damage resulting from wilful misconduct or gross negligence by sanofi-aventis Groupe, the latter cannot be held liable for: any imprecision, inaccuracy or omission relative to the information provided on the Site; any damage resulting from fraudulent intrusion by a third party leading to the modification of the information or materials provided on the Site; in a more general way, any damage, direct or indirect, regardless of its cause, origin, nature or consequences, even whilst sanofi-aventis Groupe has been aware of the possibility of such damage, whether it be the result of (i) access or inability to access the Site, (ii) the use of the Site, including any damage or virus which may infect your computer system or any other product, and/or (iii) credit given to any information provided directly or indirectly by the Site. The materials in the Site and all other sites are provided as is, without any kind of warranty, whether express or implied. Sanofi-aventis Groupe does not offer any express or implied warranty relative without limitation to their merchantability and fitness for a particular purpose.
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6. Availability of the web site

You acknowledge that (i) it is technically impossible that the Site will be provided free of defaults and that sanofi-aventis Groupe cannot take any responsibility for this, (ii) that defaults may lead to the temporary unavailability of the Site, and that (iii) the operation of the Site may be adversely affected by conditions and performances outside sanofi-aventis Groupes control, such as, for example, transmission and telecommunication links between sanofi-aventis Groupe and you and between sanofi-aventis Groupe and other systems and networks. Sanofi-aventis Groupe and/or its suppliers may, at any time, temporarily or in permanently modify or interrupt, all or part of the Site in order to perform maintenance work and/or make improvements and/or changes to the Site. Sanofi-aventis Groupe is not liable for any modification to or suspension or interruption of the Site.
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7. Information on the products

The information contained and broadcast on the Site may contain direct or indirect references to products, programs and services of the Sanofi Group which are not proposed or available in certain countries or regions, or which may be offered under a different trademark, and which may be subject to different regulations and conditions of use according to the country. Such references do not imply any intention on the part of the Sanofi Group to sell these products, programs or services in your country. Please consult the local Sanofi Group subsidiary or your Sanofi Group commercial partner for any information concerning the products, programs and services which are available in your region / country.
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8. Legal framework
The Site and its content are governed by the Laws of France. Any possible litigation refering to the Site and its content will come under the competence of French Courts.
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9. Legal notice
9.1 Site Editor
Sanofi-aventis Groupe 54, rue La Botie FR - 75008 Paris Tel.: +33 (0)1 53 77 40 00 Sanofi-aventis Groupe, a corporation (socit anonyme) with a capital of 76,493,456 Euros, registered in the Paris Trade and Company Register under Number 403 335 938.
9.2 Publishing Director and Managing Editor

Laure Thibaud, Senior Vice President, Communications
9.3 Site Hosting

BT France Immeuble Jean Monnet 11 place des Vosges FR - 92061 Paris La Dfense Cedex Tel.: +33 (0)1 44 97 70 00
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10. Photo credits

Bertrand Celce Denis Felix - Interlinks Image Franck Fouquet Image Source - Getty Images Lim Jerry - Fotolia Eric Larrayadieu - Interlinks Image Ryan McVay - Photodisc - Getty Images Albert Montanier Hubert Mouillade Franck Parisot Daniel Rousselot - Interlinks Image Grard Ufras - Rapho
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The Group's profile

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The CSR Direction: At the core of the Group strategy

A foundation to coordinate all the Groups solidarity initiatives

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A Foundation focusing on access to healthcare

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Piloting a cross-functional approach

A network of approximately 40 correspondents

across all Group regions and functions, on all continents.

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Increasing awareness of CSR initiatives

A new collaborative platform An enhanced intranet site A new website A brochure

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ETHICS Ethics indicators Human rights Ethics in R&D Business ethics

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stakeholders surveyed for the 2010 materiality test

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Materiality analysis process

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