How Should the WHO Pandemic Treaty Negotiations Tackle Intellectual Property?
By Viviana Muñoz Tellez
The WHO pandemic instrument should commit the Parties to limit the exclusionary effects that government-granted patents and other IPRs may have during pandemics in support of rapid diffusion of new vaccines, diagnostics, medicines and other tools and facilitate collaboration and freedom to operate. The current draft text of Article 11 would not make any change to the status quo.
This Policy Brief discusses issues concerning trade, intellectual property, and technology transfer that are most relevant for consideration at the 13th World Trade Organization (WTO) Ministerial Conference (MC13) in February 2024 and inclusion in its outcomes.
The following recommendations are proposed:
TRIPS non-violation and situation complaints: MC13 Decision on the scope and modalities of non-violation and situation complaints under the Agreement on Trade related Aspects of Intellectual Property Rights (TRIPS). A second option is to extend the moratorium.
TRIPS, diagnostics and therapeutics for COVID-19: MC13 Decision that extends the MC12 TRIPS waiver Decision (only applicable to vaccines) to diagnostics and therapeutics
Relationship between TRIPS and the Convention on Biological Diversity: to be addressed in the MC13 Outcome Document
Follow up to the MC12 Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics: to be addressed in the MC13 Outcome Document
Relationship of trade and technology transfer: include in the MC13 Outcome Document to reinvigorate and give direction to the Working Group on Trade and Technology Transfer (WGTTT) and increase attention in all relevant bodies on how the WTO can promote technology transfer
TRIPS Waiver Decision for Equitable Access to Medical Countermeasures in the Pandemic: COVID-19 Diagnostics and Therapeutics
By Nirmalya Syam and Muhammad Zaheer Abbas, PhD
The Marrakesh Agreement Establishing the World Trade Organization (WTO) allows WTO Members to agree to temporarily waive obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, the TRIPS Decision adopted by the 12th WTO Ministerial Conference in June 2022, after lengthy and protracted negotiations lasting for 20 months in the middle of a pandemic, allowed only a fragment of the waiver proposal submitted by India and South Africa. Moreover, since the adoption of the Decision there has been an impasse in the WTO about extending the Decision to COVID-19 diagnostics and therapeutics even though the WTO Members were mandated by the Decision to decide on this matter within six months of the Decision. This research paper analyses the current state of play and concludes that there is a need to immediately and unconditionally extend the Decision to COVID-19 diagnostics and therapeutics. Moreover, the paper suggests options for how the TRIPS flexibilities can be optimally utilized in a pandemic situation without developing countries being resigned to the vagaries of negotiations on a waiver which is supposed to be an urgent emergency solution. In this regard, the paper also suggests options that could be considered for reforming the process of decision-making on a waiver proposal to ensure that decisions on waivers are taken in a timely and expedited manner without being negotiated for an extensive period of time in the midst of an emergency.
South Centre Statement to the High Level Meeting on Pandemic Prevention, Preparedness and Response
20 September 2023
The UN HLMs on health have helped drive the highest level of political commitment to key global health issues. The HLD on PPR today underplays the seriousness of the crisis the world experienced with the Covid-19 pandemic and fails to provide the level of political support and guidance to the critical negotiations taking place in Geneva for an international instrument and amendments to the International Health Regulations (2005).
The South Centre will continue to support developing countries in these processes and seek to promote constructive dialogue with other UN members and stakeholders.
A Response to COVID-19 and Beyond: Expanding African Capacity in Vaccine Production
By Carlos M. Correa
The unequal global distribution of vaccines against the deadly COVID-19 virus has cast a spotlight on the lack of access to vaccines on the African continent, and the vulnerability that such a lack places on both the economies of African nations and the health of their people. Various initiatives have been launched to overcome the dependence of African nations on vaccines produced elsewhere. If implemented in timely and effective ways, those initiatives will contribute to the diversification of African economies and strengthen the capacity of nations on the continent to address their public health needs during pandemics and at other times. While establishing a viable vaccine industry on the continent presents serious challenges, the African Continental Free Trade Area (AfCFTA) can provide the framework for leveraging economies of scale to stimulate the production of needed vaccines across the region.
Summary of the intervention by Carlos Correa, Executive Director of the South Centre,at the UN General Assembly – Pandemic Prevention, Preparedness and Response Multi-Stakeholder Hearing, New York, May 9th, 2023
The response to COVID-19 revealed serious shortcomings in the multilateral system. Despite solemn declarations, it was unable to ensure equity in addressing its health, economic and social impacts. See a summary of the South Centre’s intervention at the UN General Assembly – Pandemic Prevention, Preparedness and Response Multi-Stakeholder Hearing below.
Submission by the South Centre to the USITC hearing on Covid-19 diagnostics and therapeutics
India, South Africa and co-sponsors made a proposal for a waiver to certain provisions of the provisions of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in March 2020. In June 2022, the WTO Ministerial Decision on the TRIPS Agreement provided a partial waiver to obligations in Article 31, namely an exception to the 31.f export restrictions, in relation to patents for Covid-19 vaccines. No decision has yet been made with respect to diagnostics and therapeutics for Covid-19.
In this context, the U.S. Trade Representative (USTR) requested the U.S. International Trade Commission (USITC) to prepare a report on Covid-19 diagnostics and therapeutics.
Read below the submission by the South Centre to the USITC investigation: COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596).
El debate sobre la exención de los derechos de propiedad intelectual en tiempos de pandemia
Descripción:
El 11 de marzo de 2020 la Organización Mundial de la Salud (OMS) comunicó que la enfermedad por coronavirus de 2019 (COVID-19), podía ser considerada una pandemia. A medida que el contagio de la enfermedad aumentaba se hizo evidente la insuficiencia de los recursos sanitarios, vacunas y métodos de diagnóstico y tratamiento para enfrentar con éxito la pandemia. En este contexto, en la Organización Mundial del Comercio (OMC) se reavivó la tensión entre las reglas de propiedad intelectual y la salud pública.
Como consecuencia de ello, el 2 de octubre de 2020, Sudáfrica e India, presentaron ante la OMC una propuesta para que ciertas disposiciones del Acuerdo sobre los ADPIC no resultaran de aplicación para cualquier producto o procedimiento destinado a la prevención, contención y tratamiento de la COVID-19. Esta propuesta de exención (waiver), contó con la férrea oposición de la Unión Europea que presentó una propuesta alternativa. Para intentar llegar a un acuerdo se formó una comisión cuadrilateral conformada por Sudáfrica, India, la Unión Europea y EEUU. Finalmente, luego de dos años de negociaciones y en el marco de la 12ª Conferencia Ministerial (MC12) celebrada en Ginebra el 17 de junio de 2022, se aprobó un proyecto de exención de los derechos de propiedad intelectual que dista mucho de la propuesta original de 2020.
El presente trabajo, analiza detalladamente el proceso de discusión – en torno al tema del “waiver” – dado en el Consejo de los ADPIC de la OMC: estudia los antecedentes de la propuesta de exención, analiza los documentos presentados por las partes en pugna, revisa los argumentos esgrimidos a favor y en contra del waiver, los instrumentos propuestos y, asimismo, muestra cómo se desenvolvieron las distintas posiciones hasta alcanzar el acuerdo final.
Autores: Alejandra Aoun, Juan Correa, Martín A. Cortese, Vanesa Lowenstein, Sandra C. Negro, Guillermo E. Vidaurreta
Analysis of COVID-Related Patents for Antibodies and Vaccines
By Kausalya Santhanam
This paper provides an analysis of patents covering selected antibodies and vaccines used in the treatment or prevention of COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications. The antibody combination considered for the patent analysis in this paper are Casirivimab and Imdevimab. The vaccines considered for the patent analysis are mRNA-1273, Sputnik, ChAdOx1 nCoV-19 vaccine (AZD1222). The analysis was completed in May 2022.
South Centre Statement on the extension of the TRIPS waiver for diagnostics and therapeutics for COVID-19
Developing countries should consider options that can be implemented now to deal with IP barriers to expand production and access to COVID-19 therapeutics and diagnostics, while the so far elusive decision on whether to extend a TRIPS waiver to cover these products is taken by WTO.
Descripción: