Friday, 03 April 2020

Open letter to Gilead concerning ensuring access to remdesivir

Dear Mr O’Day, 

We write to request that Gilead take immediate actions to ensure rapid availability, affordability, and accessibility of its experimental therapy remdesivir for the treatment of COVID-19, pending the results of the clinical trials demonstrating its efficacy. 

The COVID-19 pandemic has spread across all continents and, to date, over 720,000 people have been infected, causing more than 30,000 deaths. Making effective therapeutics available and accessible rapidly for all people based on their medical needs is essential for all countries to combat the pandemic and may save many thousands of lives. 

We are seriously concerned with Gilead’s current approach to remdesivir, which may obscure access to this potentially critical treatment for COVID-19. Gilead holds primary patents of remdesivir in more than 70 countries that may block generic entry until 2031. Despite public health emergency declarations in multiple states and cities in the United States (US) since the end of February, Gilead still sought an orphan drug designation from the US Food and Drug Administration on remdesivir with the aim to obtain further exclusive rights in the US, and only applied to rescind this exclusivity after public criticism in late March. Recently, faced with an overwhelming demand for individual compassionate use of remdesivir, Gilead announced its inability to ensure timely supply and reduced the scale of the programme. 

The COVID-19 pandemic affects every person. It is unacceptable for Gilead’s remdesivir to be put under the company’s exclusive control taking into account that the drug was developed with considerable public funding for both early-stage research and clinical trials, the extraordinary efforts and personal risks that both healthcare workers and patients have faced in using the medicine in clinical trial settings, and the unprecedented disaster all countries are facing for their people, their healthcare systems, and their economies. Gilead has a poor track record for ensuring universal access to lifesaving treatments and the company’s recent actions with remdesivir provide scant assurance that the company can be trusted to act in the public interest. 

We request Gilead to fully recognise the scale and potential consequences of pursuing exclusive rights as opposed to enabling the scale-up of production and affordable supply of remdesivir during this pandemic. We therefore urge Gilead to take immediate actions to: 

Declare that Gilead will not enforce and claim exclusive rights on patents and regulatory and trial data, or any other types of exclusivity anywhere in the world; 

make publicly available all data, sample products, and know-how that are needed for generic development and for regulatory processes, to facilitate the production and supply by generic manufacturers worldwide;

and improve transparency by disclosing its manufacturing capacity and existing supply and allow independent and proper governance over the allocation of the treatment according to medical

 An exclusivity and monopoly-based approach will fail the world in combating the COVID-19 pandemic. Gilead must act in the public interest now.

SIGNATORIES: 

Organisations:

  1. Access to Medicines Ireland
  2. Access to Medicines Research Group (China)
  3. Action against AIDS Germany
  4. ADIN (Africa Development Interchange Network)
  5. AFT (American Federation of Teachers)
  6. AHF India
  7. AIDES France
  8. AIDS Access Foundation (Thailand)
  9. AIDS Action Europe
  10. AIDS and Rights Alliance for Southern Africa (ARASA)
  11. AIDS Healthcare Foundation
  12. All India Agricultural Workers Union
  13. All India Drug Action Network (AIDAN)
  14. Alliance of Filipino Workers (AFW)
  15. Alliance of Women Human Right Defenders ( NAWHRD), Nepal
  16. American Medical Student Association
  17. ARAS - Romanian Association against AIDS
  18. ARK Foundation , Nagaland, India
  19. Asia Pacific Forum on Women, Law & Development (APWLD)
  20. Asian Peoples Movement on Debt and Development (APMDD)
  21. Associação Brasileira Interdisciplinar de AIDS (ABIA)
  22. Bangladesh Krishok Federation
  23. Centre for Health Policy and Law, Northeastern University, School of Law, US
  24. Centre for Peace Education and Community Development, Taraba State, Nigeria
  25. Colombian Oversight and Cooperation Committee (Comité de Veeduría y Cooperación en Salud - Colombia)
  26. Comité des Volontaires Contre le Coronavirus Burkina Faso
  27. Consumer Association of Penang
  28. CurbingCorruption
  29. DAWN (Development Alternatives with Women for a New Era)
  30. Deutsche Aidshilfe
  31. Digo Bikas Institute, Nepal
  32. DNDi (Drugs for Neglected Diseases Initiative)
  33. Doctors for America
  34. Drug Study Group (Thailand)
  35. Drug System Monitoring and Development Centre (Thailand)
  36. Ecologistas en Acción (Spain)
  37. Ecumenical Academy (Czech Republic)
  38. Educating Girls and Young Women for Development-EGYD
  39. Faith in Healthcare
  40. Families USA
  41. Focus on the Global South
  42. Food Sovereignty Alliance, India
  43. Fórum de ONGs AIDS do Estado de São Paulo (FOAESP)
  44. Forum for Trade Justice, India
  45. Foundations for Consumers (Thailand)
  46. FTA Watch (Thailand)
  47. Fundación Grupo Efecto Positivo, Argentina
  48. FUNDACION IFARMA, Colombia
  49. Global Coalition of TB Activists, New Delhi, India
  50. Global Health Advocates France
  51. Global Humanitarian Progress Corporation GHP Corp. Colombia
  52. Global Justice Now
  53. Global South
  54. GNP+, Global Network of People living with HIV
  55. Groupe sida Genève
  56. Grupo de Apoio à Prevenção da AIDS - Rio Grande do Sul (GAPA - RS)
  57. Grupo de Resistência Asa Branca (GRAB)
  58. Grupo de Trabalho sobre Propriedade Intelectual (GTPI)
  59. Grupo Incentivo à Vida (GIV)
  60. Health Action International (HAI)
  61. Health and Development Foundation (Thailand)
  62. Health Equity Initiatives
  63. Health GAP (Global Access Project)Housing Works, USA
  64. Human Rights Research Documentation Centre, Uganda
  65. Human Touch Foundation Goa, India
  66. IDRIS Association, Kuala Lumpur
  67. I-MAK
  68. Indonesia AIDS Coalition
  69. International Women's Rights Action Watch Asia Pacific (IWRAW Asia Pacific)
  70. IT for Change
  71. ITPC (International Treatment Preparedness Coalition)
  72. ITPC-LATCA (International Treatment Preparedness Coalition Latin American and Caribbean)
  73. Kamayani Bali Mahabal , Convenor Jan Swasthya Abhitan Mumbai, India
  74. KEI (Knowledge Ecology International)
  75. Kolkata Rishta, India
  76. Korean Federation Medical Activist Groups for Health Rights (Association of Korea Doctors for health rights, Association of Physicians for Humanism, Korean Dentist's Association for Healthy Society, Korean Pharmacists for Democratic Society, Solidarity for worker's health)
  77. Kripa Foundation Nagaland, India
  78. Labor Education and Research Network, Inc (LEARN), Philippines
  79. Lawyers Collective, India
  80. Lower Drug Prices Now, USA
  81. Madhyam (India)
  82. Malawi Health Equity Network
  83. Malaysian AIDS Council
  84. Médecins Sans Frontières Access Campaign
  85. Medical Mission Sisters
  86. Medical Mission Institute Würzburg
  87. Medico International, Germany
  88. MyWATCH (Malaysian Women's Action on Tobacco Control and Health)
  89. Nelson Mandela TB HIV Community Information and Resource Centre CBO, Kisumu Kenya
  90. Nepal Development Initiative
  91. NETWORK Lobby for Catholic Social Justice,
  92. USANGO Forum on Asian Development Bank
  93. NTFP EP Philippines (Non-Timber Forest Products Philippines)
  94. Oxfam
  95. Pacific Network on Globalisation (PANG)
  96. Pan African Positive Women's Coalition-Zimbabwe
  97. Pan-African Treatment Access Movement (PATAM)
  98. People PLUS. Belarus
  99. People’s Health Institute (South Korea)
  100. People's Action, USA
  101. People's Health Movement, Uganda
  102. Pharmaceutical Accountability Foundation
  103. Pharmacists without Borders Germany
  104. PHM Germany (People’s Health Movement, Germany)
  105. Pink Triangle Foundation
  106. Project on Organising Development Education and Research- PODER
  107. Positive Malaysian Treatment Access & Advocacy Group (MTAAG+).
  108. Prescrire
  109. Public Citizen
  110. Public Eye, Switzerland
  111. Public Services International
  112. Red Latinoamericana por el Acceso a Medicamentos, Argentina
  113. Rede Nacional de Pessoas Vivendo com HIV - São Paulo (RNP + SP)
  114. Religious of the Sacred Heart of Mary NGO, USA
  115. Rural Area Development Programme (RADP), Nepal
  116. Sahayog Odisha, India
  117. Salud por Derecho
  118. Sankalp Rehabilitation Trust, India
  119. Sentro Ng Mag Nagkakaisa, Progresibong Manggagawa (SENTRO)
  120. Sisters of Charity Federation
  121. Social Security Works
  122. Society for International Development (SID)
  123. Solidaritas Perempuan (Women’s Solidarity for Human Rights), Indonesia
  124. STOPAIDS
  125. Swasthya Adhikar Manch, India
  126. T1InternationalTest Aankoop/Test Achats (Belgian consumer organisation)
  127. Thai Network of People Living with HIV/AIDS (Thailand)
  128. Third World Network (TWN), Malaysia
  129. Transnational Institute (TNI), The Netherlands
  130. Transparency International Health Initiative
  131. TranspariMED
  132. Treatment Action Group (TAG)
  133. Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
  134. Trisuli Plus Communtiy action Group, Nepal
  135. Universities Allied for Essential Medicines (UAEM)
  136. Universities Allied for Essential Medicines Europe
  137. Viet Labor Movement, Vietnam
  138. Voice of Patient, India
  139. War on Want (UK)
  140. Woman Health Philippines
  141. Women, Law and Development, (MULEIDE), Mozambique
  142. World Vision Deutschland V.Yale
  143. Global Health Justice Partnership
  144. Yolse Switzerland
  145. Youth Engage, Zimbabwe 

Individuals:

  1. Achal Prabhala, Shuttleworth Fellow and coordinator of the AccessIBSA project
  2. Arjun Kumar Bhattarai, Nepal Development Initiative
  3. Dr med. Christiane Fischer
  4. Dr Hafiz Aziz ur Rehman, International Islamic University, Islamabad Pakistan
  5. Dr Mohga Kamal-Yanni MPhil. MBE. Global Health and Access to Medicines Consultant
  6. Dr Prabir Chatterjee MD, State Health Resource Centre, Chhattisgarh (India)
  7. Jordan Jarvis, London School of Hygiene & Tropical Medicine, UK
  8. Kamayani Bali Mahabal , Convenor Jan Swasthya Abhitan Mumbai, India
  9. Katrina Perehudoff PhD, Dalla Lana School of Public Health, University of Toronto, Canada
  10. Marcela Vieira, Researcher, Global Health Centre, Graduate Institute of Geneva
  11. Professor Brook K. Baker, Northeastern University, School of Law, US
  12. Tracy Swan, ITPC Global
Published in Health and Medicine