Open Letter to TRIPS Council Members: Remove Barriers to Access for Critical COVID-19 Supplies

On November 12, 2020, members of the Global Development Policy Center’s Working Group on Trade Treaties and Access to Medicines called for World Trade Organization (WTO) TRIPS Council to adopt a waiver proposal that would remove barriers to adequate supply and affordable prices for life-saving COVID-19 health technologies:

Dear Members of the TRIPS Council,

We, the undersigned, a collective of researchers and academics working on the impact of trade treaties on access to medicines, call on WTO Members, and especially the members of the TRIPS Council, to vote in favor of the proposal put forward by South Africa, India, Kenya and Eswatini to waive certain provisions of the TRIPS agreement relating to the “prevention, containment and treatment of COVID-19.”

At the beginning of the pandemic, there was consensus at the United Nations and World Health Assembly that international collaboration would be necessary to face this international crisis and curb the spread of COVID-19. In particular, countries saw the importance of scaling up manufacturing and knowledge sharing so more people can have equitable access to life-saving medical technologies, treatments and (eventually) vaccines.

Nevertheless, eight months into the pandemic, there has been no effective agreed global solution to ensure such affordable access. Currently, domestic intellectual property barriers, such as patents, trade secrets, data rights, copyright, and industrial designs, prevent any meaningful knowledge-sharing and technology transfer. This has led to limited product development worldwide and an inability to expand supply to meet the demand for effective medical technologies. Low and middle-income countries including Least Developed Countries have experienced shortages of medical products, including diagnostics, and are likely to continue to face shortages of new treatments and vaccines as they become available.

A global pandemic is not the time to follow a “business as usual” approach by protecting intellectual property rights (IPRs) and granting monopoly rights to pharmaceutical companies. Instead, governments should take the chance to secure a People’s Vaccine as a global public good.

The TRIPS agreement has several provisions allowing action at the domestic level, namely use of Article 73 to invoke a security exception to the rules and declare a temporary suspension of IPRs during an emergency such as the COVID-19 pandemic, and the more familiar use of compulsory licenses under Articles 31 and 44.2 (judicial licenses). However, countries will need to make changes in their domestic laws and regulations which may take a long time To expand access to biologic medicines and vaccines, there would also have to be adoption and use of exceptions to trade secrets, data rights, and other IPRs that protect cell lines, sophisticated manufacturing know-how, industrial designs, and other aspects of these key health products.

These national-level exceptions, while important, do not go far enough to protect vulnerable countries and groups during a pandemic where time is of the essence, and when a truly global response is essential. The waiver, implemented internationally, would give WTO Members complete freedom to operate and to build their capacities quickly to produce medical and health products without the threat of state-to-state dispute settlement.

Industry and some countries have argued that a waiver is unnecessary because of the availability of voluntary measures. Thus far, however, the WHO’s COVID-19 Technology Access Pool, designed to facilitate the voluntary sharing of knowledge and to promote deep technology transfer has been rejected by the R&D pharmaceutical industry. They have spurned the option of voluntary measures, so the waiver is an appropriate and necessary response.

We have witnessed shortages of IP-protected diagnostic tests, medical equipment, and personal protective equipment in developing countries, and there will be similar or even greater shortages of promising IP-protected monoclonal antibodies, novel antivirals, and vaccines. Already, pharmaceutical companies have started filing patent infringement suits against COVID-19 treatments and technologies, which makes collaborative research and development and expanded supply even more challenging.

In addition to this public health crisis, the economic consequences of the pandemic are threatening lives and livelihoods. The World Bank has estimated 150 million more people will be pushed into extreme poverty by the end of this year. The International Labour Organisation found 500 million jobs have been put in jeopardy already. There is a debt crisis on the horizon with many developing countries forced to spend more on servicing existing debts than on their health budgets as supply chains collapse, remittances plummet, and capital outflows reach unprecedented levels.

These dire realities demand a swift and decisive response. We strongly urge the TRIPS Council to urgently report the waiver request to the WTO General Council, and for the General Council to adopt the waiver proposal as an important step in removing barriers to adequate supply and affordable prices for life-saving COVID-19 health technologies.    

We remind Member States that countries that prefer not to implement the waiver domestically will not be obliged to do so. We also remind Member States that a three-quarters vote will be sufficient for passage of the waiver request and that they should not allow the call for “consensus” to permit upper-income Member States that have secured preferential and disproportionate access to promising diagnostics, therapeutics, and vaccines, to veto their collective right to safeguard their populations as well. Global solidarity and the imperative of truly equitable access require passage of the proposed waiver. 

Signed,

Members of the Working Group on Trade Treaties and Access to Medicines

Brook Baker, Professor of Law, Northeastern University School of Law; Senior Policy Analyst, Health GAP (Global Access Project)

Kevin P. Gallagher, Professor, Frederick S. Pardee School of Global Studies, Boston University; Director, Global Development Policy Center

Deborah Gleeson, Senior Lecturer, School of Psychology and Public Health at La Trobe University

Han Bing, Institute of World Economics and Politics (IWEP) of the Chinese Academy of Social Sciences

Warren Kaplan, Clinical Assistant Professor, Department of Global Health, Boston University School of Public Health; Member of the World Health Organization Collaborating Center in Pharmaceutical Policy

Priti Krishtel, Co-Founder and Director of Treatment Access, I-MAK

Elize Massard da Fonseca, Professor, Sao Paulo Business School (EAESP/FGV)

Rachel Thrasher, Researcher, Global Development Policy Center, Boston University

Yousuf Vawda, Associate Professor at the UKZN School of Law, Howard College Campus, Durban

Veronika Wirtz, Associate Professor, Department of Global Health, Boston University School of Public Health; Director, World Health Organization Collaborating Center in Pharmaceutical Policy; Director, Certificate in Pharmaceutical Development, Delivery and Access.

Signed,

Sharan Burrow, General Secretary, International Trade Union Confederation

Fred Siyoi, Chief Executive Officer, Pharmacy and Poisons Board

Jayati Ghosh, Professor, University of Massachusetts at Amherst

Balkrishna Khakurel, former Director General, Drug Regulatory Authority, Nepal

MD Sayedur Rahmen, Professor and Chairman, Department of Pharmacology Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Sonia Uema, Directora del CIME Centro de Información de Medicamentos, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba (Argentina)

Tom Kucharz, Researcher, Ecologistas en Acción

Chiara Piovani, Associate Professor, University of Denver

Naoko Otobe, Senior Expert on Gender, Work and Development

P. Sai-wing Ho, Professor in Economics, University of Denver

Joel Lexchin, Professor Emeritus, York University

Richard Elliott, Executive Director, HIV Legal Network (Canada)

Abhishek Sharma, Research Fellow, World Heart Federation, Geneva, Switzerland and Adjunct Researcher, Boston University School of Public Health, Boston, MA, United States

Christopher Noble, Research Associate, Harvard Medical School Program in Global NCDs and Planned Social Change

Yumiko Yamamoto, Associate Professor, Okayama University

Jordan Jarvis, PhD candidate, London School of Hygiene & Tropical Medicine

Mohd Salman, Professor, Hind Institute of Medical Sciences

Yavuz Yasar, Associate Professor, University of Denver

Ruth Lopert, Adjunct Professor, Dept. of Health Policy & Management, George Washington University

Dr Sham Moodley, Owner/Pharmacist, Independent Community Pharmacy Association South Africa

Lutz Heide, Professor, Tuebingen University, Germany

Mauricio Aragno, PSM specialist, UNDP/MSF

Celine Caillet, Research Scientist, Oxford University

Paul Ogendi, Lecturer, University of Nairobi

Fabrizio Botti, Senior Fellow, Istituto Affari Internazionali

Nicholas Wilkinson, Member of Parliament, Norway

Erlend Grønningen, Medical Doctor/PhD student, University of Bergen – Center for International Health

Johnbosco Nwogbo, Campaigns Officer, We Own It

Farida Khan, Professor of Economics, University of Colorado, Colorado Springs

Kirsten Myhr, MScPharm, MPH, Board Member of Health Action International Europe

Kate Enright, Humanitarian Pharmacist & DPhil Student, University of Oxford

Perla Mordujovich Buschiazzo, University Center of Pharmacology (CUFAR), WHO/PAHO Collaborating Center in rational use of medicines, National University of La Plata Argentina

Martín Cañás, Associate Professor in Pharmacology, National University Jauretche, Argentine Group for the Rational Use of Medicines (GAPURMED)

Julian Lopez, Associated professor, Universidad Nacional de Colombia

Fernando Tortosa, Medico, Comite asesor en biotecnologías de Rio Negro

Eugenio Cecchetto, Physician, Universidad Nacional de Córdoba – Argentina

Claudia Vargas, Director, Fundación IFARMA

Susan Craddock, Professor, University of Minnesota

Alessandra Mezzadri, Senior Lecturer in Development Studies, SOAS London

Ayshi Banerjee, Consultant, Action Aid India

Isabel Ortiz, Director, Global Social Justice Program IPD

Kavaljit Singh, Director, Madhyam, India

Biswajit Dhar, Professor, Jawaharlal Nehru University

Anis Chowdhury, Adjunct Professor, Western Sydney University and University of New South Wales, Australia

Neil Coleman, Co-Director, Institute for Economic Justice, South Africa

Ellen t Hoen, Global Health Law Fellow, Law Faculty, University of Groningen

Yogeshwar Gupta, Researcher   

Gabriele Köhler, Researcher and publicist

Sandra Polaski, Senior Research Scholar, Boston University Global Development Policy Center

Shoko Uchida, Co-director, Pacific Asia Resource Center

Lehlohonolo Chefa, Executive Director, Policy Analysis and Research Institute of Lesotho

Gita Sen, Professor, Public Health Foundation of India

Nicolas Pons-Vignon, Professor, SUPSI

Asad Rehman, Executive Director, War on Want

Fatima Suleman, Professor, University of KwaZulu-Natal

Alicia Puyana, Economics Professor, Facultad Latinoamericana de Ciencias Sociales

Hans V Hogerzeil, former WHO Director of Essential Medicines Policies, Professor Global Health, University of Groningen, Netherlands

Sign the Letter

For more information on the trade and the Working Group on Trade and Access to Medicines, contact Rachel Thrasher: rthrash@bu.edu.


Working Group Member Biographies

Brook Baker is a Professor Law at Northeastern University School of Law where he teaches disability discrimination law, negotiations, and a new course focused on human rights, intellectual property, and access to medicines. He is also a senior policy analyst for Health GAP (Global Access Project) and is actively engaged in campaigns for universal access to medicines. He has written and consulted extensively on intellectual property rights, trade, investor-state dispute settlement, access to medicines, and medicines regulatory policy, including with the African Union, South Africa, Uganda, ASEAN, Thailand, Indonesia, the World Health Organization, and many others. He serves as a key advisor to NGO delegation to Unitaid, which acts to improve market dynamics and early market entry of medicines and diagnostics needed to address HIV/AIDS, TB, Hepatitis C and malaria.

Deborah Gleeson is a Senior Lecturer in the School of Psychology and Public Health at La Trobe University on health systems, health policy and public health focus. Deborah holds the honorary role of Deputy Convenor of the Political Economy of Health Special Interest Group of the Public Health Association of Australia (PHAA). In this capacity, she plays a key role in PHAA’s advocacy for healthy trade agreements. She is also active in the People’s Health Movement, a global network of health activists and organizations that advocates for health equity at the global level. Her research interests include: the impact of international trade agreements on public health and access to medicines; public health policy (particularly nutrition, alcohol and tobacco policy); and policy making capacity in the health sector.

Kevin P. Gallagher is a professor of global development policy at Boston University’s Frederick S. Pardee School of Global Studies, where he directs the Global Development Policy Center. Kevin is the author or co-author of six books including The China Triangle: Latin America’s China Boom and the Fate of the Washington Consensus and Ruling Capital: Emerging Markets and the Reregulation of Cross-Border Finance. Kevin serves on the United Nations’ Committee for Development Policy and co-chairs the T-20 Task Force on An International Financial Architecture for Stability and Development at the G-20. He previously served on the investment sub-committee of the Advisory Committee on International Economic Policy at the US Department of State and on the National Advisory Committee at the Environmental Protection Agency.

Han Bing is a senior research fellow at the Institute of World Economics and Politics (IWEP) of the Chinese Academy of Social Sciences (CASS), which was described by Foreign Policy magazine as the top think tank in Asia. Her background is in human rights law with degrees from China and the UK. Before joining IWEP in CASS, Dr Han Bing lectured at the Institute of Human Rights and Humanitarian Law, China University of Political Science and Law.

Warren Kaplan is a Clinical Assistant Professor in the Department of Global Health at the Boston University School of Public Health, where he is a member of the World Health Organization Collaborating Center in Pharmaceutical Policy. His research focuses on pharmaceutical and legal policies related to health system strengthening and evaluations of medicines access and utilization. His current interests and expertise include intellectual property policy, antimicrobial resistance, medicines price analysis, generic medicines policies, quality use of medicines, access to medicines for non-communicable diseases and the role of the private sector to promote equitable access and efficient use of medicines in low and middle income countries. Dr. Kaplan served as Technical Officer at the World Health Organization Geneva, Switzerland in two different projects. He has worked as a technical adviser for various international organizations, such as Doctors Without Borders, the Clinton Foundation, the Alliance for Health Systems and Policy Research, Health Action International.

Priti (Radhakrishnan) Krishtel is the Co-Founder and Director of Treatment Access of I-MAK. She has worked as a health attorney in the U.S., Switzerland and India. Prior to founding I-MAK, she served as the Senior Project Officer of the Lawyers Collective HIV/AIDS Unit in India. In 2008, Priti was awarded the Echoing Green Fellowship for social entrepreneurs, the Pop!Tech Social Innovation Fellowship and was selected as one of 160 dynamic young leaders for the 2008 Asia 21 Young Leaders Summit in Tokyo. She was also selected by the King Baudouin Foundation as one of a group of young visionaries making change for its Spotlight On The Millennials series. In 2011, Priti was named an Associate Fellow by the Asia Society.

 Elize Massard da Fonseca is an assistant professor at the Sao Paulo Business School (EAESP/FGV), a leading public administration school in Brazil. She studies policy change and stability, interest groups and pharmaceutical regulation and conducts interdisciplinary research in political science and public health, and am also involved in studies aiming to inform decision makers. Since 2007, she has been a technical consultant for several United Nations agencies (PAHO, UNODC, UNFPA) on issues related to the monitoring and evaluation of public health and social protection projects. Other consultancy experiences include work with pharmaceutical companies and non-governmental organizations on institutional analysis.

Rachel Thrasher is a researcher at Boston University’s Global Development Policy Center and author of the forthcoming book, Constraining Development: The Shrinking of Policy Space in the International Trade Regime (May 2021). Her research focuses on the role of trade and investment treaties in constraining domestic policy space for developing countries in a wide range of areas – from land reform to capital flow management, sovereign debt to access to medicines. Her current interests and expertise are in investment treaties, investor-state dispute settlement, global intellectual property protection, and policies for renewable energy transitions. She also teaches International Trade Law at Boston University’s School of Law.

 Yousuf Vawda is an was an Associate Professor at the UKZN School of Law, Howard College Campus, Durban and holds, among other qualifications, a Doctorate in Law (LLD) which he obtained at UKZN with his doctoral thesis entitled “Access to Life-saving Medication in South Africa: The Case for Legislative Reform”. Yousuf was admitted in the High Court, South Africa and practiced as such from 1978 – 1994. In 2003, he joined the faculty at the UKZN School of Law where he has lectured since. Yousuf holds positions on various boards such as the Board of Directors – Legal Aid South Africa, Council Member of the Medicines Control Council, and Chairperson of its Legal Committee and is a founding trustee of AULAI Trust. He is also a Member of the Board of the School for Legal Practice, Durban. Yousuf’s research interests lie in Clinical law & Legal Aid Service delivery as well as Public Health issues, specifically HIV / AIDS & Access to medicines. Yousuf has also provided professional advice in several initiatives to reform medicines regulatory systems as well as intellectual property legislation in South Africa, various African countries and the African Union.

Veronika Wirtz is an Associate Professor in the Department of Global Health at the Boston University School of Public Health, where she is also Director of the World Health Organization Collaborating Center in Pharmaceutical Policy and Director of the Certificate in Pharmaceutical Development, Delivery and Access. Her research focuses on health system strengthening and policy and program evaluations of medicines access and utilization. Her interest and expertise include medicines price analysis, generic medicines policies, quality use of medicines, access to medicines for non-communicable diseases and the role of the private sector to promote equitable access and efficient use of medicines in low and middle income countries. Between 2014 and 2016 she was the Co-Chair of The Lancet Commission on Essential Medicine Policies. She has also worked as a technical adviser for various international organizations, among them the World Health Organization, the Pan American Health Organization, and the World Bank. She has further worked with the Ministry of Health in Mexico on various program evaluations and capacity building initiatives.

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