Africa: Open Letter to Gilead - Global Civil Society Calls For No Patents or Exclusivities on Potential COVID-19 Treatment

document

Mr Daniel O’Day
Chief Executive Officer
Gilead Science, Inc.

30 March 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 needs.
An exclusivity and monopoly-based approach will fail the world in combating the COVID-19 pandemic.
Gilead must act in the public interest now.
1SIGNATORIES:
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. AIDS Access Foundation (Thailand)
8. AIDS Action Europe
9. AIDS and Rights Alliance for Southern Africa (ARASA)
10. AIDS Healthcare Foundation
11. All India Agricultural Workers Union
12. All India Drug Action Network (AIDAN)
13. Alliance of Filipino Workers (AFW)
14. Alliance of Women Human Right Defenders ( NAWHRD), Nepal
15. American Medical Student Association
16. ARAS - Romanian Association against AIDS
17. ARK Foundation , Nagaland, India
18. Asia Pacific Forum on Women, Law & Development (APWLD
19. Asian Peoples Movement on Debt and Development (APMDD)
20. Associação Brasileira Interdisciplinar de AIDS (ABIA)
21. Bangladesh Krishok Federation
22. Centre for Health Policy and Law, Northeastern University, School of Law, US
23. Centre for Peace Education and Community Development, Taraba State, Nigeria
24. Colombian Oversight and Cooperation Committee
(Comité de Veeduría y Cooperación en Salud - Colombia)
25. Comité des Volontaires Contre le Coronavirus Burkina Faso
26. Consumer Association of Penang
27. CurbingCorruption
28. DAWN (Development Alternatives with Women for a New Era)
29. Deutsche Aidshilfe
30. Digo Bikas Institute, Nepal
31. DNDi (Drugs for Neglected Diseases Initiative)
32. Doctors for America
33. Drug Study Group (Thailand)
34. Drug System Monitoring and Development Centre (Thailand)
35. Ecologistas en Acción (Spain)
36. Ecumenical Academy (Czech Republic)
37. Educating Girls and Young Women for Development-EGYD
38. Faith in Healthcare
39. Families USA
40. Focus on the Global South
41. Food Sovereignty Alliance, India
242. Fórum de ONGs AIDS do Estado de São Paulo (FOAESP)
43. Forum for Trade Justice, India
44. Foundations for Consumers (Thailand)
45. FTA Watch (Thailand)
46. Fundación Grupo Efecto Positivo, Argentina
47. FUNDACION IFARMA, Colombia
48. Global Coalition of TB Activists, New Delhi, India
49. Global Health Advocates France
50. Global Humanitarian Progress Corporation GHP Corp. Colombia
51. Global Justice Now
52. Global South
53. GNP+, Global Network of People living with HIV
54. Groupe sida Genève
55. Grupo de Apoio à Prevenção da AIDS - Rio Grande do Sul (GAPA - RS)
56. Grupo de Resistência Asa Branca (GRAB)
57. Grupo de Trabalho sobre Propriedade Intelectual (GTPI)
58. Grupo Incentivo à Vida (GIV)
59. Health Action International (HAI)
60. Health and Development Foundation (Thailand)
61. Health Equity Initiatives
62. Health GAP (Global Access Project)
63. 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. Kamayani Bali Mahabal , Convenor Jan Swasthya Abhitan Mumbai, India
73. KEI (Knowledge Ecology International)
74. Kolkata Rishta, India
75. 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)
76. Kripa Foundation Nagaland, India
77. Labor Education and Research Network, Inc (LEARN), Philippines
78. Lawyers Collective, India
79. Lower Drug Prices Now, USA
80. Madhyam (India)
81. Malawi Health Equity Network
82. Malaysian AIDS Council
83. Médecins Sans Frontières Access Campaign
84. Medical Mission Sisters
385. Medical Mission Institute Würzburg
86. Medico International, Germany
87. MyWATCH (Malaysian Women's Action on Tobacco Control and Health)
88. Nelson Mandela TB HIV Community Information and Resource Centre CBO, Kisumu Kenya
89. Nepal Development Initiative
90. NETWORK Lobby for Catholic Social Justice, USA
91. NGO Forum on Asian Development Bank
92. NTFP EP Philippines (Non-Timber Forest Products Philippines)
93. Oxfam
94. Pacific Network on Globalisation (PANG)
95. Pan African Positive Women's Coalition-Zimbabwe
96. Pan-African Treatment Access Movement (PATAM)
97. People PLUS. Belarus
98. People’s Health Institute (South Korea)
99. People's Action, USA
100. People's Health Movement, Uganda
101. Pharmaceutical Accountability Foundation
102. Pharmacists without Borders Germany
103. PHM Germany (People’s Health Movement, Germany)
104. Pink Triangle Foundation
105. Project on Organising Development Education and Research- PODER
106. Positive Malaysian Treatment Access & Advocacy Group (MTAAG+).
107. Prescrire
108. Public Citizen
109. Public Eye, Switzerland
110. Public Services International
111. Red Latinoamericana por el Acceso a Medicamentos, Argentina
112. Rede Nacional de Pessoas Vivendo com HIV - São Paulo (RNP + SP)
113. Religious of the Sacred Heart of Mary NGO, USA
114. Rural Area Development Programme (RADP), Nepal
115. Sahayog Odisha, India
116. Salud por Derecho
117. Sankalp Rehabilitation Trust, India
118. Sentro Ng Mag Nagkakaisa, Progresibong Manggagawa (SENTRO)
119. Sisters of Charity Federation
120. Social Security Works
121. Society for International Development (SID)
122. Solidaritas Perempuan (Women’s Solidarity for Human Rights), Indonesia
123. STOPAIDS
124. Swasthya Adhikar Manch, India
125. T1International
126. Test 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 e.V.
143.Yale 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. Prof. Brook K. Baker, Northeastern University, School of Law, US
12. Tracy Swan, ITPC Global

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 needs.
An exclusivity and monopoly-based approach will fail the world in combating the COVID-19 pandemic.
Gilead must act in the public interest now.
1SIGNATORIES:
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. AIDS Access Foundation (Thailand)
8. AIDS Action Europe
9. AIDS and Rights Alliance for Southern Africa (ARASA)
10. AIDS Healthcare Foundation
11. All India Agricultural Workers Union
12. All India Drug Action Network (AIDAN)
13. Alliance of Filipino Workers (AFW)
14. Alliance of Women Human Right Defenders ( NAWHRD), Nepal
15. American Medical Student Association
16. ARAS - Romanian Association against AIDS
17. ARK Foundation , Nagaland, India
18. Asia Pacific Forum on Women, Law & Development (APWLD
19. Asian Peoples Movement on Debt and Development (APMDD)
20. Associação Brasileira Interdisciplinar de AIDS (ABIA)
21. Bangladesh Krishok Federation
22. Centre for Health Policy and Law, Northeastern University, School of Law, US
23. Centre for Peace Education and Community Development, Taraba State, Nigeria
24. Colombian Oversight and Cooperation Committee
(Comité de Veeduría y Cooperación en Salud - Colombia)
25. Comité des Volontaires Contre le Coronavirus Burkina Faso
26. Consumer Association of Penang
27. CurbingCorruption
28. DAWN (Development Alternatives with Women for a New Era)
29. Deutsche Aidshilfe
30. Digo Bikas Institute, Nepal
31. DNDi (Drugs for Neglected Diseases Initiative)
32. Doctors for America
33. Drug Study Group (Thailand)
34. Drug System Monitoring and Development Centre (Thailand)
35. Ecologistas en Acción (Spain)
36. Ecumenical Academy (Czech Republic)
37. Educating Girls and Young Women for Development-EGYD
38. Faith in Healthcare
39. Families USA
40. Focus on the Global South
41. Food Sovereignty Alliance, India
242. Fórum de ONGs AIDS do Estado de São Paulo (FOAESP)
43. Forum for Trade Justice, India
44. Foundations for Consumers (Thailand)
45. FTA Watch (Thailand)
46. Fundación Grupo Efecto Positivo, Argentina
47. FUNDACION IFARMA, Colombia
48. Global Coalition of TB Activists, New Delhi, India
49. Global Health Advocates France
50. Global Humanitarian Progress Corporation GHP Corp. Colombia
51. Global Justice Now
52. Global South
53. GNP+, Global Network of People living with HIV
54. Groupe sida Genève
55. Grupo de Apoio à Prevenção da AIDS - Rio Grande do Sul (GAPA - RS)
56. Grupo de Resistência Asa Branca (GRAB)
57. Grupo de Trabalho sobre Propriedade Intelectual (GTPI)
58. Grupo Incentivo à Vida (GIV)
59. Health Action International (HAI)
60. Health and Development Foundation (Thailand)
61. Health Equity Initiatives
62. Health GAP (Global Access Project)
63. 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. Kamayani Bali Mahabal , Convenor Jan Swasthya Abhitan Mumbai, India
73. KEI (Knowledge Ecology International)
74. Kolkata Rishta, India
75. 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)
76. Kripa Foundation Nagaland, India
77. Labor Education and Research Network, Inc (LEARN), Philippines
78. Lawyers Collective, India
79. Lower Drug Prices Now, USA
80. Madhyam (India)
81. Malawi Health Equity Network
82. Malaysian AIDS Council
83. Médecins Sans Frontières Access Campaign
84. Medical Mission Sisters
385. Medical Mission Institute Würzburg
86. Medico International, Germany
87. MyWATCH (Malaysian Women's Action on Tobacco Control and Health)
88. Nelson Mandela TB HIV Community Information and Resource Centre CBO, Kisumu Kenya
89. Nepal Development Initiative
90. NETWORK Lobby for Catholic Social Justice, USA
91. NGO Forum on Asian Development Bank
92. NTFP EP Philippines (Non-Timber Forest Products Philippines)
93. Oxfam
94. Pacific Network on Globalisation (PANG)
95. Pan African Positive Women's Coalition-Zimbabwe
96. Pan-African Treatment Access Movement (PATAM)
97. People PLUS. Belarus
98. People’s Health Institute (South Korea)
99. People's Action, USA
100. People's Health Movement, Uganda
101. Pharmaceutical Accountability Foundation
102. Pharmacists without Borders Germany
103. PHM Germany (People’s Health Movement, Germany)
104. Pink Triangle Foundation
105. Project on Organising Development Education and Research- PODER
106. Positive Malaysian Treatment Access & Advocacy Group (MTAAG+).
107. Prescrire
108. Public Citizen
109. Public Eye, Switzerland
110. Public Services International
111. Red Latinoamericana por el Acceso a Medicamentos, Argentina
112. Rede Nacional de Pessoas Vivendo com HIV - São Paulo (RNP + SP)
113. Religious of the Sacred Heart of Mary NGO, USA
114. Rural Area Development Programme (RADP), Nepal
115. Sahayog Odisha, India
116. Salud por Derecho
117. Sankalp Rehabilitation Trust, India
118. Sentro Ng Mag Nagkakaisa, Progresibong Manggagawa (SENTRO)
119. Sisters of Charity Federation
120. Social Security Works
121. Society for International Development (SID)
122. Solidaritas Perempuan (Women’s Solidarity for Human Rights), Indonesia
123. STOPAIDS
124. Swasthya Adhikar Manch, India
125. T1International
126. Test Aankoop/Test Achats (Belgian consumer organisation)
127. Thai Network of People Living with HIV/AIDS (Thailand)
128. Third World Network (TWN), Malaysia
4129.
130.
131.
132.
133.
134.
135.
136.
137.
138.
139.
140.
141.
142.
143.
144.
145.
Transnational Institute (TNI), The Netherlands
Transparency International Health Initiative
TranspariMED
Treatment Action Group (TAG)
Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
Trisuli Plus Communtiy action Group, Nepal
Universities Allied for Essential Medicines (UAEM)
Universities Allied for Essential Medicines Europe
Viet Labor Movement, Vietnam
Voice of Patient, India
War on Want (UK)
Woman Health Philippines
Women, Law and Development, (MULEIDE), Mozambique
World Vision Deutschland e.V.
Yale Global Health Justice Partnership
Yolse Switzerland
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. Prof. Brook K. Baker, Northeastern University, School of Law, US
12. Tracy Swan, ITPC Global

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