I am a law professor at Northeastern U. School of Law and Honorary Research Assistant at the University of KwaZulu Natal (Durban, S.A.). I am also a Senior Policy Analyst for Health GAP, a global HIV/AIDS advocacy NGO. My scholarship and activism focuses on access to comprehensive treatment, prevention, and support services for people living with HIV with a special focus on intellectual property, trade, and access to medicines and other health technologies. I consult broadly with civil society, UN and other international organizations, and low- and middle-income country governments.
As a result of global AIDS activism, governments' latent and exercised powers to bypass pharm... more As a result of global AIDS activism, governments' latent and exercised powers to bypass pharmaceutical monopolies, and halting pharmaceutical industry accommodation, a new form of voluntary licensing has emerged focused on first permitting and then facilitating generic production of certain pharmaceutical products for sale and use in many but not all low- and middle-income countries (LMICs). These so-called "access" licenses are pluralistic in detail and not free of commercial motivations for either originators or generic producers, but they do differ from arms-length, purely commercial licenses that have been broadly used in the industry for decades. Although the first of these access licenses were negotiated bilaterally by innovators at the receiving end of AIDS activism and threats of government action, including the issuance of compulsory or government-use licenses, the leading model of more public-health oriented voluntary licenses can be traced to the formation of the Medicines Patent Pool [MPP] under the financial sponsorship of Unitaid in 2010. The primary goals of this Article are: (a) to increase understanding of the history and evolution of access licenses and their key terms and conditions, including their impacts on access to medicines in territories included in and excluded from the licenses; (b) to identify and assess best-practice licensing terms for delivering meaningful access to medicines, including the impact of voluntary licensing practices on registration and uptake, and (c) to make policy recommendations on measures that can be taken to improve terms and conditions of access licenses, including those of the MPP. Despite the achievements of access licenses in increasing generic competition, accelerating access to newer HIV and HCV medicines in many LMICs, and reducing prices and saving money, the exclusion from coverage of significant populations in upper-middle income countries with significant disease burdens, restrained resources, and high levels of inequality, is deeply problematic. Offsetting the wholesale work that access licenses accomplish in creating aggregated markets for accelerated generic competition is concern about industry's power to bifurcate LMICs to maintain hegemony in the most commercially appealing markets and to weaken political will to oppose unworthy patents and to otherwise overcome monopoly control. As a consequence, the net plus value of voluntary licenses as an access strategy is contested. However, any fair assessment of voluntary licensing strategies must address the complementarity of this strategy with the strengths and weakness of other access strategies, including law reform, use of patent opposition procedures, and grant of compulsory and government use licenses. Although this complementarity is briefly addressed in the conclusion, more work and evidence is needed to identify optimal strategies.
Proponents of heightened intellectual property rights (IPRs) claim such rights are essential to f... more Proponents of heightened intellectual property rights (IPRs) claim such rights are essential to foreign direct investment (FDI), technology transfer, local innovation, and economic development. They claim that a secure domestic IPR regime encourages licensing to local manufacturers resulting in technology acquisition and product diffusion. They claim that heightened IPRs incentivize local inventors and creators and spur innovation responsive to local needs. Proponents make these claims regardless of differing levels of economic and technical development and underlying human capacity in Africa.These claims are fundamentally false according to historical antecedent and the preponderance of economic evidence. Despite a new global norm of enhanced IPRs, most low- and middle-income countries in Africa have little to show in terms of increased innovation, technology diffusion, or IP-related FDI. Instead, IPRs have primarily benefited rightholders from rich countries resulting in reduced access to affordable medicines, educational resources, agricultural inputs, and green technologies. African countries are anxious to increase their industrial, entrepreneurial, and innovative/creative capacities. However, their needs are better served by a more pluralistic set of development, IP, and innovation policies. Right now, African countries need to reform the proposed pro-IP Pan-African Intellectual Property Organization, support a WTO TRIPS pharmaceutical transition period extension for least developed countries, and adopt all relevant IP flexibilities and coordinate their use.
Key questions addressed in this chapter: How can real-life examples become a metaphor for learnin... more Key questions addressed in this chapter: How can real-life examples become a metaphor for learning? How do students evaluate their co-ops as learning experiences, and which variables impact on the quality of the learning experience? What theory or theories help ...
Legal Writing: The Journal of the Legal Writing Institute, Mar 1, 2003
... 2 Peggy Maisel & Lesley Greenbaum, Introduction to Law and Legal Skills (Butterwo... more ... 2 Peggy Maisel & Lesley Greenbaum, Introduction to Law and Legal Skills (Butterworths 2001); Peggy Maisel, Lesley Greenbaum & Brook K, Baker, Introduction to Law ... I will describe four cases that I worked on while I was in South Africa: two cases involving lobola, a maternity ...
Finding “efficiencies” in global HIV programs is the buzzword of the hour. This term has peppered... more Finding “efficiencies” in global HIV programs is the buzzword of the hour. This term has peppered speeches of everyone from Global AIDS Ambassador Eric Goosby 1 to President Clinton 2 and Bill Gates. 3 Even UNAIDS is utilizing new frameworks for costing HIV ...
Investor-state dispute settlement (ISDS) provisions in bilateral investment treaties and other tr... more Investor-state dispute settlement (ISDS) provisions in bilateral investment treaties and other trade or investment treaties allow foreign investors to challenge, in a secretive tribunal of highly paid lawyers, any government action that interferes with investors’ ‘legitimate’ expectations of profit. The ISDS process, despite lacking the safeguards and transparency of domestic legal systems, has the potential to drastically affect the lives of millions of people, particularly when it affects national intellectual property policies or decisions concerning public health.
Background: The potentially destructive polarisation between 'vertical' financing (aiming... more Background: The potentially destructive polarisation between 'vertical' financing (aiming for disease-specific results) and 'horizontal' financing (aiming for improved health systems) of health services in developing countries has found its way to the pages of Foreign Affairs and the Financial Times. The opportunity offered by 'diagonal' financing (aiming for disease-specific results through improved health systems) seems to be obscured in this polarisation. In April 2007, the board of the Global Fund to fight AIDS, Tuberculosis and Malaria agreed to consider comprehensive country health programmes for financing. The new International Health Partnership Plus, launched in September 2007, will help low-income countries to develop such programmes. The combination could lead the Global Fund to fight AIDS, Tuberculosis and Malaria to a much broader financing scope. Discussion: This evolution might be critical for the future of AIDS treatment in low-income countrie...
Key questions addressed in this chapter: How can real-life examples become a metaphor for learnin... more Key questions addressed in this chapter: How can real-life examples become a metaphor for learning? How do students evaluate their co-ops as learning experiences, and which variables impact on the quality of the learning experience? What theory or theories help ...
Nationalism has trumped solidarity, resulting in unnecessary loss of life and inequitable access ... more Nationalism has trumped solidarity, resulting in unnecessary loss of life and inequitable access to vaccines and therapeutics. Existing intellectual property (IP) regimens, trade secrets and data rights, under which pharmaceutical firms operate, have also posed obstacles to increasing manufacturing capacity, and ensuring adequate supply, affordable pricing, and equitable access to COVID-19 vaccines and other health products in low-income and middle- income countries. We propose: (1) Implementing alternative incentive and funding mechanisms to develop new scientific innovations to address infectious diseases with pandemic potential; (2) Voluntary and involuntary initiatives to overcome IP barriers including pooling IP, sharing data and vesting licences for resulting products in a globally agreed entity; (3) Transparent and accountable collective procurement to enable equitable distribution; (4) Investments in regionally distributed research and development (R&D) capacity and manufact...
IRPN: Innovation & Patent Law & Policy (Sub-Topic), 2016
This amicus brief was submitted to the North American Free Trade Agreement (NAFTA) arbitral tribu... more This amicus brief was submitted to the North American Free Trade Agreement (NAFTA) arbitral tribunal in Eli Lilly v. Canada (ICSID Case No. UNCT/14/2) by Amici. Amici are scholars whose research and teaching focus is intellectual property law (Dr. Burcu Kilic, Professor Brook Baker, HU Yuanqiong, Professor Cynthia Ho, Dr Luke McDonagh, Pratyush Upreti and Yaniv Heled, J.S.D.). The brief was accepted by the Tribunal with respect to Dr. Burcu Kilic (Washington DC, United States), Professor Brook K. Baker (Boston, United States), Professor Cynthia Ho (Chicago, United States), and Mr. Yaniv Heled J.S.D. (Atlanta, United States), denied with respect to the other academics for lack of standing. In September 2013, the Claimant Eli Lilly and Company (Lilly) launched a CDN $ 500 million claim against the Government of Canada under the North American Free Trade Agreement’s (NAFTA) investment chapter. The Claimant is challenging Canada’s invalidation of secondary patents related to the previou...
Northeastern University School of Law Public Law & Legal Theory Research Paper Series, 2016
In 2000, my colleague Yousuf Vawda and I became active in the global campaign to address intellec... more In 2000, my colleague Yousuf Vawda and I became active in the global campaign to address intellectual property rights (IPRs), human rights, and barriers to access to affordable medicines for treating HIV and AIDS in South Africa. This paper details their academic collaboration, their activist-oriented “clinical” offering, and the vibrant campaign that it helped to spawn. It also situates the Fix the Patent Laws Campaign (the “Campaign”) within the global framework of pro-Pharma legal rules and diplomatic pressures, showing the connections between the global political economy and local reform efforts grounded in the right to health enshrined in the South African Constitution. In Part II, I discuss the beginning of my involvement in IP and access-to-medicines work. Part III describes law reform efforts that address upstream barriers to the right to health and the collaboration between academics, practitioners, funders, and social movements that help energize needed reforms. Part IV ex...
As a result of global AIDS activism, governments' latent and exercised powers to bypass pharm... more As a result of global AIDS activism, governments' latent and exercised powers to bypass pharmaceutical monopolies, and halting pharmaceutical industry accommodation, a new form of voluntary licensing has emerged focused on first permitting and then facilitating generic production of certain pharmaceutical products for sale and use in many but not all low- and middle-income countries (LMICs). These so-called "access" licenses are pluralistic in detail and not free of commercial motivations for either originators or generic producers, but they do differ from arms-length, purely commercial licenses that have been broadly used in the industry for decades. Although the first of these access licenses were negotiated bilaterally by innovators at the receiving end of AIDS activism and threats of government action, including the issuance of compulsory or government-use licenses, the leading model of more public-health oriented voluntary licenses can be traced to the formation of the Medicines Patent Pool [MPP] under the financial sponsorship of Unitaid in 2010. The primary goals of this Article are: (a) to increase understanding of the history and evolution of access licenses and their key terms and conditions, including their impacts on access to medicines in territories included in and excluded from the licenses; (b) to identify and assess best-practice licensing terms for delivering meaningful access to medicines, including the impact of voluntary licensing practices on registration and uptake, and (c) to make policy recommendations on measures that can be taken to improve terms and conditions of access licenses, including those of the MPP. Despite the achievements of access licenses in increasing generic competition, accelerating access to newer HIV and HCV medicines in many LMICs, and reducing prices and saving money, the exclusion from coverage of significant populations in upper-middle income countries with significant disease burdens, restrained resources, and high levels of inequality, is deeply problematic. Offsetting the wholesale work that access licenses accomplish in creating aggregated markets for accelerated generic competition is concern about industry's power to bifurcate LMICs to maintain hegemony in the most commercially appealing markets and to weaken political will to oppose unworthy patents and to otherwise overcome monopoly control. As a consequence, the net plus value of voluntary licenses as an access strategy is contested. However, any fair assessment of voluntary licensing strategies must address the complementarity of this strategy with the strengths and weakness of other access strategies, including law reform, use of patent opposition procedures, and grant of compulsory and government use licenses. Although this complementarity is briefly addressed in the conclusion, more work and evidence is needed to identify optimal strategies.
Proponents of heightened intellectual property rights (IPRs) claim such rights are essential to f... more Proponents of heightened intellectual property rights (IPRs) claim such rights are essential to foreign direct investment (FDI), technology transfer, local innovation, and economic development. They claim that a secure domestic IPR regime encourages licensing to local manufacturers resulting in technology acquisition and product diffusion. They claim that heightened IPRs incentivize local inventors and creators and spur innovation responsive to local needs. Proponents make these claims regardless of differing levels of economic and technical development and underlying human capacity in Africa.These claims are fundamentally false according to historical antecedent and the preponderance of economic evidence. Despite a new global norm of enhanced IPRs, most low- and middle-income countries in Africa have little to show in terms of increased innovation, technology diffusion, or IP-related FDI. Instead, IPRs have primarily benefited rightholders from rich countries resulting in reduced access to affordable medicines, educational resources, agricultural inputs, and green technologies. African countries are anxious to increase their industrial, entrepreneurial, and innovative/creative capacities. However, their needs are better served by a more pluralistic set of development, IP, and innovation policies. Right now, African countries need to reform the proposed pro-IP Pan-African Intellectual Property Organization, support a WTO TRIPS pharmaceutical transition period extension for least developed countries, and adopt all relevant IP flexibilities and coordinate their use.
Key questions addressed in this chapter: How can real-life examples become a metaphor for learnin... more Key questions addressed in this chapter: How can real-life examples become a metaphor for learning? How do students evaluate their co-ops as learning experiences, and which variables impact on the quality of the learning experience? What theory or theories help ...
Legal Writing: The Journal of the Legal Writing Institute, Mar 1, 2003
... 2 Peggy Maisel & Lesley Greenbaum, Introduction to Law and Legal Skills (Butterwo... more ... 2 Peggy Maisel & Lesley Greenbaum, Introduction to Law and Legal Skills (Butterworths 2001); Peggy Maisel, Lesley Greenbaum & Brook K, Baker, Introduction to Law ... I will describe four cases that I worked on while I was in South Africa: two cases involving lobola, a maternity ...
Finding “efficiencies” in global HIV programs is the buzzword of the hour. This term has peppered... more Finding “efficiencies” in global HIV programs is the buzzword of the hour. This term has peppered speeches of everyone from Global AIDS Ambassador Eric Goosby 1 to President Clinton 2 and Bill Gates. 3 Even UNAIDS is utilizing new frameworks for costing HIV ...
Investor-state dispute settlement (ISDS) provisions in bilateral investment treaties and other tr... more Investor-state dispute settlement (ISDS) provisions in bilateral investment treaties and other trade or investment treaties allow foreign investors to challenge, in a secretive tribunal of highly paid lawyers, any government action that interferes with investors’ ‘legitimate’ expectations of profit. The ISDS process, despite lacking the safeguards and transparency of domestic legal systems, has the potential to drastically affect the lives of millions of people, particularly when it affects national intellectual property policies or decisions concerning public health.
Background: The potentially destructive polarisation between 'vertical' financing (aiming... more Background: The potentially destructive polarisation between 'vertical' financing (aiming for disease-specific results) and 'horizontal' financing (aiming for improved health systems) of health services in developing countries has found its way to the pages of Foreign Affairs and the Financial Times. The opportunity offered by 'diagonal' financing (aiming for disease-specific results through improved health systems) seems to be obscured in this polarisation. In April 2007, the board of the Global Fund to fight AIDS, Tuberculosis and Malaria agreed to consider comprehensive country health programmes for financing. The new International Health Partnership Plus, launched in September 2007, will help low-income countries to develop such programmes. The combination could lead the Global Fund to fight AIDS, Tuberculosis and Malaria to a much broader financing scope. Discussion: This evolution might be critical for the future of AIDS treatment in low-income countrie...
Key questions addressed in this chapter: How can real-life examples become a metaphor for learnin... more Key questions addressed in this chapter: How can real-life examples become a metaphor for learning? How do students evaluate their co-ops as learning experiences, and which variables impact on the quality of the learning experience? What theory or theories help ...
Nationalism has trumped solidarity, resulting in unnecessary loss of life and inequitable access ... more Nationalism has trumped solidarity, resulting in unnecessary loss of life and inequitable access to vaccines and therapeutics. Existing intellectual property (IP) regimens, trade secrets and data rights, under which pharmaceutical firms operate, have also posed obstacles to increasing manufacturing capacity, and ensuring adequate supply, affordable pricing, and equitable access to COVID-19 vaccines and other health products in low-income and middle- income countries. We propose: (1) Implementing alternative incentive and funding mechanisms to develop new scientific innovations to address infectious diseases with pandemic potential; (2) Voluntary and involuntary initiatives to overcome IP barriers including pooling IP, sharing data and vesting licences for resulting products in a globally agreed entity; (3) Transparent and accountable collective procurement to enable equitable distribution; (4) Investments in regionally distributed research and development (R&D) capacity and manufact...
IRPN: Innovation & Patent Law & Policy (Sub-Topic), 2016
This amicus brief was submitted to the North American Free Trade Agreement (NAFTA) arbitral tribu... more This amicus brief was submitted to the North American Free Trade Agreement (NAFTA) arbitral tribunal in Eli Lilly v. Canada (ICSID Case No. UNCT/14/2) by Amici. Amici are scholars whose research and teaching focus is intellectual property law (Dr. Burcu Kilic, Professor Brook Baker, HU Yuanqiong, Professor Cynthia Ho, Dr Luke McDonagh, Pratyush Upreti and Yaniv Heled, J.S.D.). The brief was accepted by the Tribunal with respect to Dr. Burcu Kilic (Washington DC, United States), Professor Brook K. Baker (Boston, United States), Professor Cynthia Ho (Chicago, United States), and Mr. Yaniv Heled J.S.D. (Atlanta, United States), denied with respect to the other academics for lack of standing. In September 2013, the Claimant Eli Lilly and Company (Lilly) launched a CDN $ 500 million claim against the Government of Canada under the North American Free Trade Agreement’s (NAFTA) investment chapter. The Claimant is challenging Canada’s invalidation of secondary patents related to the previou...
Northeastern University School of Law Public Law & Legal Theory Research Paper Series, 2016
In 2000, my colleague Yousuf Vawda and I became active in the global campaign to address intellec... more In 2000, my colleague Yousuf Vawda and I became active in the global campaign to address intellectual property rights (IPRs), human rights, and barriers to access to affordable medicines for treating HIV and AIDS in South Africa. This paper details their academic collaboration, their activist-oriented “clinical” offering, and the vibrant campaign that it helped to spawn. It also situates the Fix the Patent Laws Campaign (the “Campaign”) within the global framework of pro-Pharma legal rules and diplomatic pressures, showing the connections between the global political economy and local reform efforts grounded in the right to health enshrined in the South African Constitution. In Part II, I discuss the beginning of my involvement in IP and access-to-medicines work. Part III describes law reform efforts that address upstream barriers to the right to health and the collaboration between academics, practitioners, funders, and social movements that help energize needed reforms. Part IV ex...
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