Uganda: Activists demand access to potential Covid-19 drug

Health and LGBT-rights activists in Uganda have joined over 140 institutions and organisations worldwide to demand that U.S. pharmaceutical company Gilead stop claiming exclusive rights to  remdesivir, an antiviral developed to treat Ebola that may be useful as a treatment for the novel coronavirus.


From the African Human Rights Media Network


A patient being ferried to a health facility in a traditional makeshift carrier for the sick in Ntungamo, western Uganda. (UhspaUganda photo)

By Kikonyogo Kivumbi

Access to remdesivir might provide some relief for Uganda’s health care system, which is overwhelmed by the numbers of people seeking health care during the Covid-10 pandemic. Because of increased demand for medical care, Ugandan hospitals have started turning away patients.

Model of the new coronavirus that causes Covid-19. (Image courtesy of the U.S. CDC)

Uganda currently has 33 confirmed cases of coronavirus patients, which strains a health-care system with fewer than 55 intensive care beds, mostly in and around the capital, Kampala.

For every 1.3 million residents, Uganda has an average of only one functional intensive care bed, according to a February 2020 study published in the Journal of Critical Care.

The nation’s health-care system is already under stress because of the demands of HIV patients, LGBT-rights and health advocates note.

Strains on Ugandan hospitals are part of the reason why the nation on March 30 entered into a lockdown to prevent the spread of coronavirus infections.

In addition to that public-health strategy, activists are seeking access to potential Covid-19 medications such as remdesivir, which is currently being tested to see if it could be an effective treatment for  the disease.

“It’s very critical that any drug that can save life from Covid-19 should not be subjected to such Gilead-like patent,” Aisha Nalubega, an LGBT rights activist with the Uganda Health and Science Press Association, said today in Kampala.

Because of Uganda’s Industrial Property Act of 2016, which is now in force, Ugandan LGBT activists worry about accessibility to drugs that may not be deemed essential except to a small minority of people in the country.

At issue is the law’s acceptance of patent rights on new medications and medical equipment, as required under the World Trade Organization (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Those patents allow companies to charge high prices for newly developed medicines and diagnostic equipment unless the government exercises its right under TRIPS and the Industrial Property Act to override patent restrictions for public-health reasons as discussed earlier on Erasing 76 Crimes.

The activists from the  People’s Health Movement Uganda,Human Rights Research Documentation Centre- Uganda want Gilead to:

  • Declare that Gilead will not enforce and claim exclusive rights on patents, regulatory and trial data   and 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 ability of production and supply by generic manufacturers worldwide;
  • 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.

In a  statement issued March 30 by the Third World Network addressed to Daniel O’Day, the chief executive officer of Gilead Science Inc., the activists  noted:

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 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.

O’Day on March 28 published an open letter on the issue, stating that “if [remdesivir] is approved, we will work to ensure affordability and access so that remdesivir is available to patients with the greatest need.”

A sample of the drug remdesivir, which is undergoing tests. (Gilead Science photo)
A sample of the drug remdesivir, which is undergoing tests. (Gilead Science photo)

The letter followed intense criticism of Gilead for seeking designation of remdesivir as an “orphan drug” by the U.S. Food and Drug Authority, a designation that comes with tax incentives aimed at encouraging the development of drugs for rare diseases.

[The Los Angeles TImes reported on April 7: “One of the most promising treatments for COVID-19, an antiviral drug called remdesivir, which was originally developed to fight Ebola, is made by the U.S. pharmaceutical company Gilead Sciences. Last month, the FDA designated remdesivir an ‘orphan drug,’ potentially limiting its availability — a decision that sparked such a fierce backlash that it was rescinded two days later.”]

Gilead maintained it had filed for the orphan drug designation – which awards companies with patent exclusivity for seven years – at a time when the extent of the coronavirus outbreak was unknown.

Even so, critics accused the big pharma company of profiteering off of the global pandemic.

Their letter and the list of endorsing organisations and individuals is reproduced below verbatim:

To:

Mr Daniel O’Day
Chief Executive Officer
Gilead Science, Inc.
30 March 2020

Open Letter to Gilead concerning ensuring access to Remdesivir

Daniel O'Day, chief executive officer of Gilead Science Inc.
Daniel O’Day, chief executive officer of Gilead Science Inc.

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, nearly 700,000 people have been infected, causing more than 30,000 deaths. Making effective therapeutics available and accessible rapidly for all patients 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 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 health care 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 health care systems and their economies. Gilead has a poor track record for ensuring universal access to life-saving treatments and the company’s recent actions with remdisvir provide scant assurance that the company can be trusted to act in the public interest.

We request Gilead to fully recognize the scale and potential consequences of pursuing exclusive rights as opposed to enabling 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, regulatory and trial data and 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 ability of production and supply by generic manufacturers worldwide;

–          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 COVID-19 pandemic. Gilead must act in the public’s interests 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. 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. Asia Pacific Forum on Women, Law & Development (APWLD
  18. Asian Peoples Movement on Debt and Development (APMDD)
  19. Associação Brasileira Interdisciplinar de AIDS (ABIA)
  20. Bangladesh Krishok Federation
  21. Centre for Health Policy and Law, Northeastern University, School of Law, US
  22. Centre for Peace Education and Community Development, Taraba State, Nigeria
  23. Colombian Oversight and Cooperation Committee
  24. (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
  42. 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 Health Advocates France
  49. Global Humanitarian Progress Corporation GHP Corp. Colombia
  50. Global Justice Now
  51. Global South
  52. GNP+, Global Network of People living with HIV
  53. Groupe sida Genève
  54. Grupo de Apoio à Prevenção da AIDS – Rio Grande do Sul (GAPA – RS)
  55. Grupo de Resistência Asa Branca (GRAB)
  56. Grupo de Trabalho sobre Propriedade Intelectual (GTPI)
  57. Grupo Incentivo à Vida (GIV)
  58. Health Action International (HAI)
  59. Health and Development Foundation (Thailand)
  60. Health Equity Initiatives
  61. Health GAP (Global Access Project)
  62. Housing Works, USA
  63. Human Rights Research Documentation Centre, Uganda
  64. Human Touch Foundation Goa, India
  65. IDRIS Association, Kuala Lumpur
  66. I-MAK
  67. Indonesia AIDS Coalition
  68. International Women’s Rights Action Watch Asia Pacific (IWRAW Asia Pacific)
  69. IT for Change
  70. ITPC (International Treatment Preparedness Coalition)
  71. Kamayani Bali Mahabal , Convenor Jan Swasthya Abhitan Mumbai, India
  72. KEI (Knowledge Ecology International)
  73. Kolkata Rishta, India
  74. 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)
  75. Kripa Foundation Nagaland, India
  76. Labor Education and Research Network, Inc (LEARN), Philippines
  77. Lawyers Collective, India
  78. Lower Drug Prices Now, USA
  79. Madhyam (India)
  80. Malawi Health Equity Network
  81. Malaysian AIDS Council
  82. Médecins Sans Frontières Access Campaign
  83. Medical Mission Sisters
  84. Medical Mission Institute Würzburg
  85. Medico International, Germany
  86. MyWATCH (Malaysian Women’s Action on Tobacco Control and Health)
  87. Nelson Mandela TB HIV Community Information and Resource Centre CBO, Kisumu Kenya
  88. Nepal Development Initiative
  89. NETWORK Lobby for Catholic Social Justice, USA
  90. NGO Forum on Asian Development Bank
  91. NTFP EP Philippines (Non-Timber Forest Products Philippines)
  92. Oxfam
  93. Pacific Network on Globalisation (PANG)
  94. Pan African Positive Women’s Coalition-Zimbabwe
  95. Pan-African Treatment Access Movement (PATAM)
  96. People PLUS. Belarus
  97. People’s Health Institute (South Korea)
  98. People’s Action, USA
  99. People’s Health Movement, Uganda
  100. Pharmaceutical Accountability Foundation
  101. Pharmacists without Borders Germany
  102. PHM Germany (People’s Health Movement, Germany)
  103. Pink Triangle Foundation
  104. Project on Organising Development Education and Research- PODER
  105. Positive Malaysian Treatment Access & Advocacy Group (MTAAG+).
  106. Prescrire
  107. Public Citizen
  108. Public Eye, Switzerland
  109. Public Services International
  110. Red Latinoamericana por el Acceso a Medicamentos, Argentina
  111. Rede Nacional de Pessoas Vivendo com HIV – São Paulo (RNP + SP)
  112. Religious of the Sacred Heart of Mary NGO, USA
  113. Rural Area Development Programme (RADP), Nepal
  114. Sahayog Odisha, India
  115. Salud por Derecho
  116. Sankalp Rehabilitation Trust, India
  117. Sentro Ng Mag Nagkakaisa, Progresibong Manggagawa (SENTRO)
  118. Sisters of Charity Federation
  119. Social Security Works
  120. Society for International Development (SID)
  121. Solidaritas Perempuan (Women’s Solidarity for Human Rights), Indonesia
  122. STOPAIDS
  123. Swasthya Adhikar Manch, India
  124. T1International
  125. Test Aankoop/Test Achats (Belgian consumer organisation)
  126. Thai Network of People Living with HIV/AIDS (Thailand)
  127. Third World Network (TWN), Malaysia
  128. Transnational Institute (TNI), The Netherlands
  129. Transparency International Health Initiative
  130. TranspariMED
  131. Treatment Action Group (TAG)
  132. Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru)
  133. Trisuli Plus Communtiy action Group, Nepal
  134. Universities Allied for Essential Medicines (UAEM)
  135. Universities Allied for Essential Medicines Europe
  136. Viet Labor Movement, Vietnam
  137. Voice of Patient, India
  138. War on Want (UK)
  139. Woman Health Philippines
  140. Women, Law and Development, (MULEIDE), Mozambique
  141. World Vision Deutschland e.V.
  142. Yale Global Health Justice Partnership
  143. Yolse Switzerland
  144. Youth Engage, Zimbabwe

Individuals:

  1. Achal Prabhala, Shuttleworth Fellow and coordinator of the AccessIBSA project
  2. Arjun Kumar Bhattarai, Nepal Development Initiative
  3. med. Christiane Fischer
  4. Hafiz Aziz ur Rehman, International Islamic University, Islamabad Pakistan
  5. 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. Brook K. Baker, Northeastern University, School of Law, US
  12. Tracy Swan, ITPC Global

Kikonyogo Kivumbi, the author of this article, is the executive director of the Uganda Health and Science Press Association.

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Written by Kikonyogo Kivumbi

Kikonyogo Kivumbi is the executive director of the Uganda Health and Science Press Association. Contact him at [email protected]

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