Access to Medicines

L’esperienza concreta mostra come le imprese farmaceutiche, nel frammentato panorama europeo dei regimi di fissazione dei prezzi e di rimborso dei medicinali, riescano a praticare, per i farmaci orfani, dei prezzi molto piu` alti rispetto ai farmaci comuni. Il fatto che tali prezzi siano determinati in modo sostanzialmente indipendente dai criteri ordinari di fissazione dei prezzi dei medicinali ha indotto in dottrina a ritenere che possano sussistere gli estremi di un abuso di posizione dominante, sotto forma di applicazione di prezzi “eccessivi” ai sensi dell’art. 102, lett. a), TFUE.
Il presente lavoro si propone di sviluppare tale intuizione di partenza, assumendo l’ipotesi che la normativa antitrust europea possa contribuire a ridurre il livello dei prezzi dei medicinali considerati, nel tentativo di bilanciare l’interesse sociale a che le imprese farmaceutiche abbiano sufficienti incentivi a sviluppare farmaci anche per patologie rare con l’interesse, altrettanto generale, a che i prezzi di questi medicinali siano sostenibili per i SSN.

The trend of continued rejection of compulsory licence applications in India goes against the local generic drug manufacturers and public health safeguards incorporated in the Indian patent law. It raises serious questions about the intervening role of the state in patent monopoly to equalise the competing interests between patent holders and consumers of "public good." This trend indicates a policy shift of the government regarding compulsory licensing.

Rayleigh to Compton scattering ratio will takes a major and most significant role in the non-destructive nuclear radiation technique. This non destructive technique is feasible in the industry, particularly in the drug manufacturing field. The R/C ratio could be theoretically estimated by using the atomic form factor (F) and incoherent (Compton) scattering function (S) for some pharmaceutical ingredients at different scattering angle from 20 o to 180 o with defined photon energy from 8 keV to 32 keV X-rays. The opted samples are low Z compounds and are inspecting an interaction with x-rays and studied the variation of Z eff , R/C, and electron density of respective samples with the function of scattering angle.

El estudio aborda la arquitectura normativa e institucional de los diferentes procesos de adquisición de medicamentos ejecutados por los gobiernos que forman parte de la Unión de Naciones Suramericanas (UNASUR). Además, identifica una serie de parámetros que se consideran indispensables para llevar a cabo un proceso eficiente de compra pública de medicamentos e identifica experiencias exitosas desarrolladas en la región, constituyéndose en una herramienta de consulta indispensable para los formuladores de políticas pública e instancias gubernamentales encargadas de efectuar procesos de adquisición de medicamentos.

The purpose of this research is to discuss whether and to what extent the patent rights to be implemented in times of an emergency with the requirement of accessing essential medicine around the world. To discuss the above, the researcher uses Comparative Legal Methodology along with the critical review of literature as the research methodology. The researcher elaborates on the importance of using TRIPS flexibilities and Compulsory Licensing during COVID-19 to grant access on the essential medicines to least developing countries. Further, the researcher analyzes the use of compulsory licensing in relation to three different jurisdictions i.e., Canada, South Africa and India and how it impacts the balancing of prolonged discourse on private profits and public health. Also, this research basically focuses on the information collected in relation to the topic during the pandemic period starting from 2019 to the period ending at December 2021 as the researcher believes that the topic is still growing. In terms of originality, to the best of author's knowledge, this is the first time in Sri Lanka, research is carried out analyzing access to medicine during COVID-19 pandemic.

Individuals in low-income countries ("LICs") often lack access to appropriate medicines. The multidisciplinary nature of this problem requires a holistic approach. Whereas, other writings on the topic tend to focus on one or a small number of issues, often from the perspective of a single discipline, this paper seeks to consider the major issues from a multidisciplinary perspective. It first considers mechanisms for improving the availability of medicines in LICs, through grants, prizes, treaties, advance market commitments, priority review and product development partnerships to incentivize and fund R&D for neglected diseases. The paper then assesses mechanisms for improving affordability of medicines in LICs, such as differential pricing mechanisms, monopsonies, patent law flexibilities and human rights obligations. Next, the paper reviews mechanisms for improving the efficacy of medicines in LICs, including authentication, criminalization, international and national enforcement and communication and education. Finally, the paper examines mechanisms for improving the obtainability of medicines in LICs, through low-cost intervention, task-shifting, efficient regulation, grassroots service provision and education. The paper concludes by identifying areas warranting further research. The multidisciplinary nature of the problem of access to medicines in LICs requires a holistic approach, especially one that identifies and examines the areas where cross-disciplinary collaboration is valuable. The need for such a discussion was the primary reason for convening the Roundtable. The Roundtable proceedings included presentations on all participants' areas of expertize, reflections across

The counterfeit medicines discussion is an example of how the use of a turbid rationale for greater intellectual property protections serves sophisticated private interests while potentially harming the public interest. The risk of harm created by counterfeit medicines provides a compelling counter-narrative to the access to medicines critique of intellectual property rights. Intellectual property advocates and the pharmaceutical industry have portrayed poor global enforcement of intellectual property rights as contributing to the proliferation of dangerous counterfeit medications. Yet, the deliberate linkage in the literature between weak intellectual property rights and the harms caused by counterfeit medicines provides a justification for new international treaties, such as the recent Anti-Counterfeiting Trade Agreement, that require increased government enforcement of intellectual property rights, even where the public interest justifications are relatively weak. The counterfeit medicines narrative gives private industry a public interest rationale instead of a profit-oriented rationale for demanding government enforcement of private intellectual property rights. This Article advocates a public interest test to determine when, and to what extent, government monitoring and enforcement of intellectual property rights is warranted

In 2008 and 2009, customs officials in the European Union, alleging patent
infringement detained and seized generic medicines in transit from India to Brazil. The two countries requested consultations through the World Trade Organization’s Dispute Settlement Understanding based on alleged violations of the Agreement on Trade-Related Aspects of International Property Rights and other international agreements. These disputes are different from all prior ones—they are premised upon the claim that the EU violated the TRIPS agreement through the use of its border measures that went beyond the TRIPS minimum standards, rather than claiming that the other country did not meet those minimum obligations. They also show how developed countries seek to enact such intellectual property standards outside the WTO and limit global access to medicines. This note examines how developing countries can use the DSU to challenge these restrictions, and pursue policies that promote global access to medicines.

América Latina está incorporando regulaciones que incidan
en el costo y el gasto en medicamentos. Sus objetivos
centrales son cuatro: i) garantizar la competitividad en el
mercado, ii) asegurar precios asequibles a los consumidores
individuales (canal comercial), iii) contener el gasto público
en medicamentos (canal institucional) y iv) garantizar
la eficiencia del gasto en medicamentos. La experiencia
de América Latina difiere de la de los países de regiones
desarrolladas. En estas últimas los países tienden a
converger en sus políticas, tanto en la promoción de
medicamentos genéricos y estrategias de control de precios,
como en las medidas de racionalización y contención
del gasto farmacéutico. En contraste, en América Latina
ciertas debilidades institucionales impiden la consolidación
y aplicación de una política regulatoria efectiva. El presente
trabajo revisa la experiencia acumulada en la adopción
de regulaciones económicas dirigidas a reducir el gasto y
mejorar el acceso a los medicamentos, postula lecciones
aprendidas a nivel internacional y ofrece recomendaciones
para los países de América Latina. Su propósito es
aportar elementos clave para los decisores de política y las
autoridades de los países interesados en llevar adelante la
regulación económica de medicamentos

Sentencia Nº. 679-18-JP/20 Derecho a medicamentos de calidad, seguros y eficaces  CORTE CONSTITUCIONAL DEL ECUADOR. La Corte Constitucional, en casos de personas con enfermedades catastróficas y de alta complejidad (acciones de protección por falta de medicamentos), analiza y desarrolla el contenido del derecho a la disponibilidad y al acceso a medicamentos de calidad, seguros y eficaces, y los indicadores para garantizar este derecho en políticas públicas. Además, desarrolla el derecho a la tutela efectiva para el acceso a estos medicamentos.

This paper links the main issues of the project “Contested World Order” (WZB, GIGA, HSFK) to the policy field of global health: the authority of the institutional setting, and the preferences and strategies of rising powers and non-state actors (NStAs) – the assumed protagonists of recent power shifts.
The first part discusses the loss of WHO authority since the rise of Global Health Governance, and WHO’s fight to reassert its position. The core of the paper deals with the conflict on intellectual property rights (IPRs) and access to medicines as a central issue in global health. Between 1995 and 2005, civil society organizations (CSOs) and some emerging powers fought successfully for improving access conditions under the TRIPS agreement (Doha Declaration). WHO’s activities to regain the initiative led to the adoption of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (2008) (GSPoA). Chapter 4 analyses the role of NStAs and rising powers (notably BRICS) during negotiations on implementing GSPoA. While CSOs insisted on a binding R&D treaty, BRICS countries finally agreed to more modest results. They support the welfare-orientation and the intergovernmental character of WHO but without seriously challenging basic rules in the global economy. Finally, consensus within WHO was restraint to issues which did not touch the basic IPR framework.

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional 'regulatory' protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their tra...

El propósito de este trabajo es presentar algunos de los aportes de la filosofía,
y en particular de la ética y la filosofía política, en un campo teórico
usualmente asociado a las disciplinas del derecho y de la economía.
Para esto, tomaré como caso de análisis el debate contemporáneo sobre
propiedad intelectual y acceso a medicamentos. En especial, focalizaré
en los límites que encuentra el discurso ético en el contexto
regulativo global de la propiedad intelectual y en los modos en que la ética
puede intervenir con más fuerza en la discusión sobre la protección
de los datos de prueba clínicos.

Since China launched its national HIV/AIDS treatment program in 2003, the issue of ARV access has become a major obstacle to expanding treatment and prolonging patients’ lives. Examining the efforts and limitations of multiple stakeholders in the process of attaining full access to ARVs in China, this paper presents and analyzes the problems surrounding ARV access in China from different standpoints, focusing on the epidemic situation, capacities and constraints on domestic production, legal and policy barriers hampering access to ARVs, and noteworthy civil society responses and advocacy for ARV access. This paper not only describes how national stakeholders play their respective roles in the process of reaching national objectives in terms of access to ARVs, but also offers a comparative view of international stakeholders and practices respectively.This comparison in turn assists us in exploring and testing out ways for China to overcome the obstacles blocking access to ARVs.

This paper examines access to new and innovative pharmaceuticals in a post-TRIPS era. The WTO's TRIPS Agreement (TRIPS) makes it obligatory for WTO members-except least-developed country members (LDCs)-to provide pharmaceutical product patents with a 20-year protection term. Developing country members, other than LDCs, were meant to be compliant with this provision of TRIPS by 2005. Access to medicines generally includes two distinct components, viz. availability and affordability.

Article 30 of the TRIPS agreement enshrined the general rule of exceptions on patent that formed one of the important flexibilities for WTO members. In the light of such provisions, research and experimental exceptions have been integrated in a number of national patent laws, with objective of balancing rights and obligations of patent system, and to encourage innovations. Yet, the promulgation and implementation of such exceptions present diverse effectiveness across countries in terms of the actual promotion of innovation. In the field of medical innovation, patent based model for research and development has been considered as insufficient especially in the context of meeting health needs of marginalized populations in developing countries. Thus, closer analysis on the extent to which integrating research and experimental exceptions could function in encouraging medical innovation is of the interest for research. The paper intends to discuss the effects and limitations of using research and experimental exceptions in the context of medical innovation from the perspective of developing countries.

The paper starts with discussing the origin, evolution and contemporary debates on the legislation on research and experimental exceptions, in combination with analysis of leading jurisprudence of case law. The major division of exception for research on and research of the patented subject matter will be discussions in the light of assessing the effectiveness and limitations in the actual medical research and development context. The future role of TRIPS and its conjunction with other international law instruments in this context will be discussion with the perspective of promoting optimal use of such flexibility by developing countries for medical innovation., with the focus on access to medicines and innovation. She worked as legal advocate for many years, and has published a number of articles on the issue of TRIPS flexibility and access to medicines.

The global intellectual property (IP) regime is in the midst of a paradigm shift in favor of greater access to protected work. Current explanations of this paradigm shift emphasize the agency of transnational advocacy networks, but ignore the role of academics. Scholars interested by global IP politics have failed to engage in reflexive thinking. Building on the results from a survey of 1,679 IP experts, this article argues that a community of academics successfully broke the policy monopoly of practitioners over IP expertise. They instilled some skepticism concerning the social and economic impacts of IP among their students as well as in the broader community of IP experts. They also provided expert knowledge that was widely amplified by NGOs and some intergovernmental organizations, acting as echo chambers to reach national decision makers. By making these claims, this article illustrates how epistemic communities actively collaborate with other transnational networks rather than competing with them, and how they can promote a paradigm change by generating rather than reducing uncertainty.

Objective To describe access to antiepileptic drug therapy and estimate the prevalence of epilepsy in children in Camagüey Province, Cuba. Methods All the community pharmacies in the province were visited and information collected about the number of children receiving antiepileptic drugs in 2009. Availability and cost of each antiepileptic drug were determined. The prevalence of epilepsy was estimated by determining the number of children receiving anti-epileptic drugs. Results There were 923 children who received a total of 977 antiepileptic drugs in Camagüey Province. The estimated prevalence of epilepsy was 5.18 per thousand children which is lower than previously reported rates in other low and lower-middle income countries. Most of the children (871, 94%) received a single antiepi-leptic drug. Carbamazepine and valproate were the two most frequently prescribed antiepileptic drugs. Antiepileptic drugs were available from the local pharmacy on 76% of occasions. If the antiepileptic drug was not available from the local pharmacy , the parent had to travel to another pharmacy to obtain the medicine. Conclusions The estimated prevalence of epilepsy in children in Cuba is lower than that estimated in other lower-middle income countries. Access to drug therapy in children with epilepsy can be achieved in lower-middle income countries.

Background: WHO has a pivotal role to play as the leading international agency promoting good practices in health and human rights. In 2005, mifepristone and misoprostol were added to WHO's Model List of Essential Medicines for combined use to terminate unwanted pregnancies. However, these drugs were considered 'complementary' and qualified for use when in line with national legislation and where 'culturally acceptable'. Discussion: This article argues that these qualifications, while perhaps appropriate at the time, must now be removed. First, compelling medical evidence justifies their reclassification as a 'core' essential medicine. Second, continuing to subjugate essential medicines for medical abortion to domestic law and cultural practices is incoherent with today's human rights standards in which universal access to these medicines is an inextricable part of the right to sexual and reproductive health, which should be supported and realised through domestic legislation. Conclusion: This article shows that removing such limitations will align WHO's Model List of Essential Medicines with the mounting scientific evidence, human rights standards, and its own more recently developed policy guidance. This measure will send a strong normative message to governments that these medicines should be readily available in a functioning and human-rights-abiding health system.

Why and how do issues expire? This paper applies the concept of path dependency to issue-life cycle and argues that the manner in which an issue dies is closely associated with how it comes to life. This paper argues that, on the access to medicines issue, the first actors (1) to have called attention to a legal problem, (2) to have capitalised on the HIV/AIDs crisis, and (3) to have used the example of Africa, were also the first to have felt constrained by their own frame in their attempt to (1) look for economical rather than legal solutions, (2) expand the list of medicines covered beyond anti-AIDs drugs, and (3) allow large emerging economies to benefit from a scheme designed by countries without manufacturing capacities. In order to escape an issue in which they felt entrapped, issue-entrepreneurs worked strategically to close the debate in order to better reframe it in other forums.

Access to medicine is at the forefront of multilateral debates surrounding the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). This paper argues that bilateralism allows the United States to circumvent these debates and to set standards that serve and protect the pharmaceutical industry. In addition to the TRIPs requirements, recently-concluded US Free Trade Agreements (FTA) prescribe the patentability of new uses of known medicines, strengthen the protection of undisclosed data, extend the term of protection to compensate administrative procedures, prohibit some exceptions to the conferred rights, define circumstances for compulsory licensing, proscribe the doctrine of international exhaustion, and restrict the grounds for revocation. Although these “TRIPs-plus provisions” are not incompatible with the Doha Declaration on Public Health, they are additional barriers for the entry of generic medicines.

Resumen La falta de acceso a medicamentos afecta profundamente la salud de las personas. A su vez, el acceso a los medicamentos está vinculado a los mecanismos de protección de las innovaciones e invenciones farmacéuticas, como las patentes. Hace poco más de una década, la discusión estaba focalizada en el rol que las patentes jugaban en el acceso a los medicamentos esenciales, como los antirretrovirales para tratar el VIH/SIDA. En la actualidad, el eje está puesto en un conjunto específico de medicamentos que representan un porcentaje cada vez mayor del gasto en salud en todo el mundo, llamados Medicamentos de Alto Costo (MAC). El objetivo de este artículo es presentar críticamente los debates actuales en torno del acceso a los MAC, en especial los relacionados con el derecho de patentes, y esbozar algunos lineamientos que puedan conducir a un mejor acceso a ellos bajo el actual sistema internacional de propiedad intelectual. Palabras clave: propiedad intelectual, patentes farmacéuticas, medicamentos de alto costo (MAC), problemas éticos, acceso a medicamentos.

Abstract The lack of access to medicines deeply affects the health and life of people and it has been addressed by bioethics and others disciplines for decades. In turn, access to medicines is closely related to the mechanisms of protection of pharmaceutical innovation and inventions, such as patents. A decade ago, the discussion was mainly focused on the role that patents played in access to essential medicines, such as antiretrovirals to treat HIV/AIDS. At present, the attention is placed in a reduced and specific set of drugs that represent a growing health spending across the world, namely High Cost Medicines (HCM). The aim of this paper is to present critically the current debates around access to HCM, especially those that are related with the Patent Right, and to outline some ways that may lead to better access to HCM under the current intellectual property system.

Resumo A falta de acesso a medicamentos que afeta profundamente a saúde das pessoas é uma questão abordada pela bioética e outras disciplinas ao longo de décadas. Por sua vez, o acesso aos medicamentos está relacionado com os mecanismos de proteção das invenções e inovações farmacêuticas, tais como patentes. Há pouco mais de uma década, a discussão centrou-se no papel que as patentes têm no acesso aos medicamentos essenciais, incluindo anti-retrovirais para o tratamento de HIV/aids. No presente, o eixo está em um conjunto específico de medicamentos que representam uma parte crescente dos gastos com saúde em todo o mundo, chamado de Medicamentos de Alto Custo (MAC). O objetivo deste artigo é apresentar criticamente os debates atuais sobre o acesso a MAC, especialmente os relacionados com a lei de patentes, e delinear algumas diretrizes que podem levar ao melhor acesso a eles, no atual sistema internacional de propriedade intelectual. Palavras-chave: propriedade intelectual, patentes farmacéuticas, medicamentos de alto custo (MAC), questões éticas, acesso aos medicamentos.

Background: Developing countries, such as the Philippines, started implementing policies to improve access to medicines, which is a vital step toward universal healthcare coverage. This study aimed to evaluate the prices, availability and affordability of prescribed medicines for diabetes, hypercholesterolemia and hypertension with the exemption of 12% value-added tax in the Philippines. Methods: The prices and availability of 50 medicines were collected in August 2019 from 36 public and 42 private medicine outlets in six regions of the Philippines, following a modified methodology developed by the World Health Organization and Health Action International. Availability is reported as the percentage of outlets in which the surveyed medicine was found at the time of visit. Medicine prices are expressed as median unit prices (MUPs) in Philippine Peso. Affordability is calculated based on the number of days’ wages required for the lowest-paid unskilled government worker to purchase a mo...

How did I learn to understand that there can never ever be any acceptable alternative to immortality and living indefinitely forever young?

Is there any better way to learn and permanently remember the understanding that any possibly imaginable alternative to reverse all adverse effects of aging and happily live indefinitely forever young, healthy and energetic would have the same long-term negative consequences as intentionally committing suicide than I have described in this authentic experience report?

When I was only 6 years old, I went through an emotional trauma, from which I am still suffering today and that has led me to come here and be the only one working in the EIT building during Christmas break. On October 2nd, 1980, only one day before my daddy’s birthday, my aunt Frieda, who I liked a lot because she paid lots of attention to my long stories and actually took them serious, suffered from a sudden heart attack. My daddy succeeded to bring her back to life with CPR and my mom called the emergency doctor in the mean time. The doctor was a quiet man from Romania. He had short back hear and looked like being around 30 years old. His voice was very quiet and emotionally detached when he asked my grandma about the age of my aunt. My grandma replied: "She is 83 years old." And then something happened, which I never expected, i.e. the doctor went on in his empathy-lacking quiet voice to say the few German words, which I still remember as if my aunt had died yesterday. He said “Ich denke, wir hoeren auf.” In English this means, “I think, we are going to quit.” He meant going to quit any efforts and even medical interventions at our disposal to bring my aunt Frieda back to live and to make sure she’ll stay alive. When the doctor said this, it was spooky quiet, as if a ghost would kill my aunt. I felt like screaming into the face of the doctor, YOU MUST DO YOUR JOB AS EMERGENCY DOCTOR, TO DO EVERYTHING IN YOUR POWER TO MINIMIZE MY AUNT’S RISK TO DIE FROM THIS PARTIAL HEART ATTACK REGARDLESS OF HER AGE!!!! But I was only six. I was scared and confused. It was my first real encounter with death. I helplessly looked at my parents and looked at my grandma. I wanted them to demand from the doctor not to use my aunt Frieda’s advanced age against her. Although I was only six years old I strongly felt that no medical provider has the moral right and should be punished harshly when using his patient’s age as a shallow absolutely unjustified excuse for refusing to save their lives. But it was so quiet this time, which I recall must have been around 7.30 p.m. on October the 2nd, 1980, when my aunt laid diagonally across the carpet on the floor of the children’s room. Neither my mom nor my daddy nor my grandma nor my 2 younger siblings opened their mouth.

Although I was furious beyond anyone’s imagination, the fact that my otherwise very confident parents and even my grandma, who was best friends with my dying aunt, i.e. all three adults in the room, who’d I expect to fight for my life if I ever needed urgent medical care, and who’d otherwise readily expressed their opposition to anything they did not agree with or considered unfair, did not even attempt to pressure the doctor on a mental, emotional emphatic, moral, medical or legal level, to take his job seriously regardless how he personally felt about my aunt’s advanced age. When something totally unexpected like this happens, i.e. in case of such kind of second degree murder due to medical neglect and intentionally withholding readily available medical interventions without any apparent rational reason for not even trying to save my aunts life, when we still had a chance, I became speechless. I felt like screaming to my parents to not allow the doctor to let my aunt die, after my daddy had brought her back to life already. My daddy is very good in CPR. He’ll fight for everyone’s life as if it was his own. My daddy waited for the doctor’s instructions on how to proceed after restoring my aunts consciousness to the point where she had her eyes opened and could hear every single word, which was spoken by anyone in the children’s room. When all this happened I stood about 4 feet away from my aunt. I was afraid to move any closer because I was worried of accidentally bump into something I could not see but which would kill here. Now something happened that I can never forget. My daddy got up from the carpet and stopped CPR! I felt like screaming “NOOOOOOOOOOOOO!!!!!!!!!” “WHYYYYYYYYYY???” “DON’T!!!!!!” “KEEP BREATHING MORE AIR IN HER MOUTH!!!!! Don’t listen to this evil doctor. He has no respect for life! He does not deserve to be an emergency doctor!!! What if she were his aunt???? She is conscious and will most likely fully come back to life if you’ll just give her enough time to get over this medical crisis!!!! Actually, she was already over the hump because apparently her heart was beeping already independently and all my daddy was still doing, was breathing air in my aunt’s mouth. I wanted my mom to call another doctor. I wanted him to be a German doctor, who treats our aunt as if she was his aunt. I felt that this Rumanian doctor had no empathy for Germans because when my entire family looked up to him for help, he indirectly killed by neglect.

Even if is negative medical intuition should turn out to be true and all of our medical interventions were doomed to fail this evening, I felt he should at least try anyways or else there would have been no point in the doctor making the trip to our home. Then he could have stayed in his killer-hospital. At least that way he would not have had the opportunity to encourage my daddy from reviving my aunt with CPR. When I was six, my daddy was still very powerful. He would have kept performing CPR for hours to save my aunt’s life, if this disguised killer-doctor, would not have instructed him to stop and let her die, just because he felt no old people deserve resources intensive medical care, unless they are his own relatives. Would he let his aunt or grandmother dies like that if he had good chances to prevent or at least postpone death? This I felt would have certainly give my aunt enough time to get over the fear, which is an inherent feature of anyone surviving a heart attack, especially when the doctor is instructing my daddy to stop keeping her alive. I felt like being in a madhouse. I could not speak. My otherwise very attentive parents and grandmother did not seem to be aware that I felt so much emotional pain with such a mental intensity that I almost felt as if I was the one dying instead of my aunt. This god dam Rumanian doctor! Why did he have to be on duty when my aunt needed dedicated professional medical help to get over her heart attack? Why did the hospital not send a German doctor with a strong voice, who’d be much more assertive in his speech and actions to instruct my parents to do everything in their power to save my aunt’s life? Why did my aunt deserve such an indecisive foreign doctor, who lacks the kind of strong loud confidence inducing voice, patients and their relatives need in their struggle of succeeding in overcoming any medical crisis? Why did this stupid hospital send us this absolutely useless and even counterproductive foreign physician, who refused to even say a single word when my parents and grandma looked up to him and expected rational life-saving medical advice? What was he thinking when he condemned my aunt with the only very ambiguous sentence, I still remember verbatim from this cursed Rumanian doctor, “I think we are going to quit.”? Was he asking my parents, whether they’d approve his proposal to quit saving my aunt’s life? Did he order my daddy to quit CPR and let my aunt die? This doctor showed lack of leadership when everyone is expecting him to take charge of the medical crisis at hand and to maximize the odds for the best possible medical outcome.

I remember not being able to feel anything that evening. My aunt laid dead diagonally across the carpet in the children’s room when I started to understand that everyone expects me to go to sleep as usual. I hid under my blanket and wanted to die. I cried so hard. What if I had a heart attack? Would my parents and grandma follow the medical advice of the doctor, if he told them that he thinks, we should quit saving my life? Luckily, I only was 6 and no doctor would even dream about using my age as an excuse for letting me die. But, what about 80 years from now? From then onward, I wanted to become strong, innovative, energetic and knowledge to defeat death before it would inevitably kill me only about 80 years later. That is why I came to America.

Mechanisms to increase access to health products are varied and controversial. Two innovative mechanisms have been used to accelerate the development of low-price supply lines for conjugate vaccines. The Meningitis Vaccine Project is a so-called push mechanism that facilitated technology transfer to an Indian company to establish capacity to manufacture a vaccine. The Advanced Market Commitment for pneumococcal vaccines is a so-called pull mechanism that guarantees companies a supplement paid in addition to the purchase price for vaccines for a specific period. We compare these approaches, identifying key dimensions of each and considering their potential for replication. We also discuss issues that the Global Alliance for Vaccines and Immunisation (GAVI) face now that these new vaccines are available. Progress towards GAVI's strategic aims is needed and funding is crucial. Approaches that decrease the financial pressure on GAVI and greatly increase political and financial engagement by low-income countries should also be considered.

To the Editor — Since 2015, the US Food and Drug Administration (FDA) has approved four products (Table 1) that fall under its definition of gene therapy1. More than 900 investigational gene therapies are in various stages of research and development, and some researchers estimate that 40 will be on the market by 20222. Because gene therapies are likely to have complex manufacturing and supply chain processes—which have implications for where and when they may be available— as well as high pricing, patients’ ability to access marketed gene therapies is a considerable moral concern. Here we focus on the challenges posed by ‘compassionate use’ of investigational gene therapies. Although compassionate use requests raise difficult questions for all types of investigational products, several characteristics of gene therapies make analysis even harder in this setting. One complexity arises because many of these products target diseases that affect pediatric patients. We also consider the one-dose and potentially curative aspects of these therapies; the desire and need to collect data, especially for rare disorders; the regulatory, technical, financial and logistical hurdles associated with the clinical development of these products; and issues affecting access.