A New WHO International Treaty on Pandemic Preparedness and Response: Can It Address the Needs of the Global South?
By Dr. Germán Velásquez and Nirmalya Syam
A recent joint communiqué by 25 Heads of Government and the WHO Director-General have called for the negotiation of a pandemic treaty to enable countries around the world to strengthen national, regional and global capacities and resilience to future pandemics. The COVID-19 pandemic has demonstrated the fragility of the mechanisms at the disposal of WHO for preparedness and response to pandemics. The use of binding instruments to promote and protect health in the context of pandemics is needed. If WHO Member States decide that an international treaty to prepare and respond to pandemics is the way forward, it would be important to have clarity from the outset on the elements and areas that will be the subject of negotiation. The first step should be to identify the aspects of pandemic preparedness and response that the current crisis has revealed are not working, and how to build up on the existing instruments, notably the International Health Regulations (IHR). This paper discusses some of the critical issues that should be addressed in such a treaty if negotiations are launched, in view of the needs of countries at different levels of development and with disparate capacities to implement treaty obligations.
The TRIPS waiver proposal: an urgent measure to expand access to the COVID-19 vaccines
by Henrique Zeferino de Menezes
Despite multilateral commitments and political statements of solidarity and cooperation to guarantee the availability and access to COVID-19 vaccines (and other relevant technologies for control and treatment), the scenario after the beginning of vaccination is marked by the deepening of vaccine nationalism, the concentration of inputs and vaccines production, and the uneven distribution of options of vaccine doses already approved for use. This pattern of production restrictions and unequal access will lead to an increase in international inequalities, leaving a large part of the world to have access to vaccines not until 2024. While advanced purchase agreements (APAs) among pharmaceutical companies and some developed countries are multiplying, the proposed mechanisms for voluntary licensing of technologies and the COVAX Facility do not achieve their goal of democratizing access to vaccines. In this sense, the current TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) waiver proposal seems to be the political and institutional response with the greatest potential to guarantee the scaling of the production of pharmaceutical inputs, allowing the adoption of a comprehensive strategy to ensure timely, sufficient, and affordable access to all technologies developed to fight COVID-19.
Les réformes de l’Organisation mondiale de la Santé a l’époque de COVID-19
Par Germán Velásquez
Tout au long de ses 70 ans d’histoire, l’OMS a connu plusieurs réformes dirigées par plusieurs Directeurs généraux, tels que Halfdan Mahler à la Conférence d’Almaty sur les soins de santé primaires, en 1978, Gro Harlem Brundtland avec son appel à « tendre la main au secteur privé », en 1998, et Margaret Chan avec son débat inachevé sur le rôle des «acteurs non étatiques », en 2012. Une fois de plus, la crise sanitaire de 2020 a mis en évidence la fragilité de l’organisation et a révélé que l’OMS ne dispose pas des instruments et mécanismes juridiques nécessaires pour mettre en œuvre ses normes et lignes directrices, et que son financement n’est pas durable et adéquat pour répondre au défi de la COVID-19. Ce document cherche à identifier les principaux problèmes rencontrés par l’OMS et les mesures nécessaires qu’une réforme de l’Organisation devrait prendre.
Repenser la R&D pour les produits pharmaceutiques après le choc du nouveau coronavirus COVID-19
Par Dr. Germán Velásquez
La crise sanitaire mondiale sans précédent provoquée par la pandémie de coronavirus –COVID-19–, au cours du premier trimestre 2020, ramène avec une urgence particulière la discussion sur le modèle de recherche et développement (R&D) pour les produits pharmaceutiques et autres technologies de la santé. La crise COVID-19 montre qu’il est urgent de repenser la gouvernance mondiale de la santé publique pour la R&D en matière de santé. L’adoption d’un instrument contraignant – comme le permet l’article 19 de la Constitution de l’OMS – sur cette question a été proposée il y a de nombreuses années. Ce document soutient qu’il est temps de relancer et de concrétiser cette initiative.
Reconsidérations sur la fabrication mondiale et locale de produits médicaux après le COVID-19
Par Germán Velásquez
La crise sanitaire mondiale sans précédent provoquée par la pandémie de coronavirus (COVID-19), au cours du premier semestre 2020, ramène avec une urgence particulière la discussion sur la production pharmaceutique locale. La crise du COVID-19 a mis en évidence l’interdépendance de la production mondiale de médicaments—aucun pays n’étant autosuffisant. De nombreux pays industrialisés prennent la décision de rapatrier ou de développer la production d’ingrédients pharmaceutiques actifs (IPA). De nombreux gouvernements commencent à parler de souveraineté pharmaceutique et/ou de sécurité sanitaire. Si cela devient une réalité, les pays en développement devront développer et/ou renforcer la production locale de médicaments et de vaccins. La guerre pour obtenir le futur vaccin pour COVID-19 ne semble pas facile avec ces nouveaux développements.
How Civil Society Action can Contribute to Combating Antimicrobial Resistance
By Mirza Alas Portillo
One of the key groups of actors that must be recognized for their influential role in shaping health policy outcomes are civil society organizations (CSOs). The antimicrobial resistance (AMR) space is no exception. AMR is one of the most significant health threats of our time, and many CSOs have had a critical role in shaping the national, regional and global responses to this health threat. However, CSOs working in the AMR space have received little financial support. In the final report submitted to the UN Secretary-General, the United Nations Inter-Agency Coordination Group (IACG) on AMR recommended increasing collaboration, as doing so is necessary for effective action and is an essential part of tackling AMR. IACG also provided specific recommendations for strengthening the engagement of CSOs. While the need for this engagement is broadly recognized, there is limited literature documenting how CSOs have been involved in shaping AMR policies. Increased evidence can strengthen the case for expanding financial support to CSOs work on AMR. A critical look into how CSOs are spearheading campaigns to tackle AMR and promoting accountability through monitoring governments’, international organizations’ and other actors’ AMR-related commitments, particularly in developing countries, would be especially useful.
This paper aims to contribute to the analysis of CSOs involvement in the global AMR response. It begins by defining what constitutes a CSO and offers examples of how CSOs have contributed to addressing other critical health issues to draw lessons for handling AMR. It then undertakes a case analysis of a prominent CSO coalition, the Antibiotic Resistance Coalition (ARC), and describes that organization’s essential contributions in the AMR space. Finally, the paper offers reflections on why CSO participation in the AMR space needs to be further enhanced and supported.
Guía para la concesión de licencias obligatorias y uso gubernamental de patentes farmacéuticas
Por Carlos M. Correa
Al igual que otros derechos, los derechos de patente no son absolutos. Hay situaciones en las que su ejercicio puede limitarse para proteger los intereses públicos. Esas situaciones pueden surgir, por ejemplo, cuando debe garantizarse el acceso a los productos farmacéuticos necesarios. Las licencias obligatorias y el uso gubernamental con fines no comerciales son instrumentos, previstos en la mayoría de las leyes de todo el mundo, que pueden utilizarse específicamente para atender las necesidades de salud pública. El presente documento tiene por objeto proporcionar orientación jurídica para el uso eficaz de esos instrumentos, de conformidad con el derecho internacional.
Las reformas de la Organización Mundial de la Salud en la época de COVID-19
Por Germán Velásquez
A lo largo de sus 70 años de historia la OMS ha pasado por varias reformas lideradas por varios directores generales, como Halfdan Mahler en la Conferencia de Alma ata sobre la atención primaria de salud, 1978, Gro Harlem Brundtland con su « reach out to the private sector » 1998, Margaret Chan con su inconcluso debate sobre el rol de « los autores no estatales » 2012 . Una vez mas, y de forma contundente la crisis sanitaria del 2020 pone en evidencia la fragilidad de la Organización y nos revela que la OMS no tiene los instrumentos y mecanismos legales necesarios para aplicar sus normas y orientaciones y que su manera de financiamiento no es sostenible y adecuada para responder al desafío de la COVID-19. Este documento trata de identificar cuales son los problemas principales de que sufre la OMS y cuales serian las medidas necesarias que una reforma de la Organización tendría que abordar.
The COVID-19 pandemic has revealed that, despite the magnitude of the global health challenges it has to face, the WHO is currently unable to fully enforce its directives, norms and standards. It also shows that its funding is neither sustainable nor adequate to respond effectively to current and future global health crises. Overreliance on voluntary targeted funding puts at risk its capacity to operate as the global agency responsible for public health. These are some of the main challenges facing the WHO today.
The World Health Organization Reforms in the Time of COVID-19
By Germán Velásquez
During its 70-year history, the World Health Organization (WHO) has undergone various reforms led by several Directors-General, including Halfdan Mahler at the Almaty Conference on primary health care in 1978, Gro Harlem Brundtland with her “reach out to the private sector” in 1998, and Margaret Chan with her unfinished debate on the role of “non-state actors” in 2012. The organization’s fragility is once again being highlighted, as the COVID-19 pandemic has revealed that WHO does not have the legal instruments and mechanisms necessary to enforce its standards and guidelines, and that its funding is not sustainable and adequate to respond to the challenge. This paper seeks to identify the main problems faced by WHO and the necessary measures that a reform of the organization would have to take.
Patent Analysis for Medicines and Biotherapeutics in Trials to Treat COVID-19
By Srividya Ravi
This report provides an analysis of patents covering medicines in trials to treat 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 medicines considered for the patent analysis in this report are remdesivir, ruxolitinib and favipiravir, and the biotherapeutics tocilizumab, siltuximab and sarilumab.
PROPOSAL BY INDIA AND SOUTH AFRICA TO WAIVE CERTAIN PROVISIONS OF THE WTO TRIPS AGREEMENT TO SUPPORT THE GLOBAL COVID-19 PANDEMIC RESPONSE
The prolongation of the coronavirus COVID-19 pandemic threatens developing countries disproportionately, deepening the catastrophic social and economic crisis and reversing the gains made to date to eradicate extreme poverty and meet the Sustainable Development Goals (SDGs). In this situation, ensuring timely access to essential commodities by overcoming acute shortages faced by countries due to high demand and disruptions in the supply chain is critical. There is also an urgent need to speed up development of new vaccines, treatments and diagnostics, at scale, and make these widely available.
As reaffirmed by many delegations in the special session of the WHO Executive Board, transfer of technology and know-how is fundamental for scaling up manufacturing of medical products and equipment. In this regard, India and South Africa have made a joint proposal to the World Trade Organization (WTO) to temporarily waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to support the global Covid-19 pandemic response.
