Leading and Coordinating Global Health: Strengthening the World Health Organization
By Nirmalya Syam
The World Health Organization (WHO) should act as the directing and coordinating authority in global health but it has been steadily marginalized over time by design, through criticism as an inefficient organization, the reduction of assessed contributions and consequent impoverishment, and the proliferation of “new” international health agencies to which WHO has been compelled to cede operational space. This paper discusses how such marginalization of the WHO is in the interest of the dominant actors in global health, and leads to the neglect of health as a development issue. Today the global health system is more fragmented than it was when the WHO was established in 1948. Rich donor countries and corporations dominate multistakeholder governance structures in health partnerships, marginalizing most of the WHO membership and, notably, the Global South, in their decision-making. A consequence of this fragmentation in global health governance is that the space of the only multilateral organization where developing countries have an equal presence in terms of participation and decision-making as sovereign States –WHO– has been marginalized. Consequently, the development dimension of health is also marginalized and only the development assistance aspects of it receive major attention through vertical programmes and agencies addressing limited health needs without effectively addressing the basic need of strengthening health systems. Therefore, for developing countries it is imperative that WHO is effectively retooled to act as the leading and coordinating authority on global health with adequate legal powers, as well as institutional and financial capacities to do so without undue influence from donor countries and entities that have interests in the private sector. This would enable WHO to ensure that the interests of all countries are fairly addressed in its normative and operational activities. Such a transformation of WHO would require action both within and outside the organization. The paper proposes some suggestions in this regard.
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.
Directives pour l’examen des demandes de brevet relatives aux produits pharmaceutiques
Par Carlos M Correa
Ce document fait suite à un document antérieur, Directives applicables à l’examen des brevets pharmaceutiques: examen des brevets pharmaceutiques du point de vue de la santé publique, publié en 2007 comme document de travail par le Centre international pour le commerce et le développement durable (CICDD), la Conférence des Nations Unies sur le commerce et le développement (CNUCED) et l’Organisation mondiale de la santé (OMS).
Le présent document tient compte des évolutions survenues depuis la publication du document de travail CICDD-CNUCED-OMS en 2007. Il comprend de nouveaux exemples de demandes et/ou de délivrance de brevets, ainsi qu’une analyse et des références aux initiatives d’un certain nombre de pays qui ont adopté des lois et/ou des politiques visant à prendre en compte les considérations de santé publique dans l’examen des demandes de brevets.
Avec ce document, l’objectif est de fournir des orientations pour l’élaboration ou la révision de directives sur les processus d’examen des brevets dans les pays en développement, en réponse aux préoccupations concernant l’augmentation du nombre de brevets dans le secteur pharmaceutique. À cette fin, un certain nombre de recommandations sont formulées en ce qui concerne l’examen des demandes de brevetabilité relatives aux produits et procédés pharmaceutiques.
Ce document est une traduction de la version originale des “Directives pour l’examen des demandes de brevet relatives aux produits pharmaceutiques” publiées en anglais par le Programme des Nations Unies pour le Développement (PNUD). Le South Centre remercie le PNUD pour l’aimable autorisation de publier cette version non officielle. Traduit pour le South Centre par M. Natanael França.
Illicit Financial Flows and Stolen Asset Recovery: The Global North Must Act
by Abdul Muheet Chowdhary and Sebastien Babou Diasso
Domestic resource mobilization is essential for developing countries to achieve the Sustainable Development Goals by the deadline of 2030. Concomitantly, Illicit Financial Flows (IFFs), which also lead to asset theft, are major means through which these countries are losing resources. This research paper analyzes the World Bank’s Stolen Asset Recovery (STAR) database and shows that countries from where assets have been stolen are mostly developing countries, and countries where the stolen assets have been hidden are developed countries. The paper also shows that regarding the pending or ongoing asset recovery cases, there is a clear pattern where the majority of countries waiting to have their assets returned are developing countries, and those who must return them are developed countries. There is an unexplained and unjustified delay by developed countries in the process of returning the frozen assets to developing countries which needs to be addressed as soon as possible. There is also an evaluation of international legal reforms which can be implemented to accelerate the asset recovery process. However, all these will need the full commitment of Global North countries where most of the stolen assets are hidden and which bear the brunt of responsibility for returning them to the developing countries.
El mecanismo multilateral permanente propuesto y su posible relación con el universo existente de solución de controversias entre inversionistas y estados
por Danish y Daniel Uribe
La opción de reforma del Mecanismo Multilateral Permanente (SMM) que se está debatiendo actualmente en el Grupo de Trabajo III (GTIII) de la Comisión de las Naciones Unidas para el Derecho Mercantil Internacional (CNUDMI) ha planteado una serie de importantes preocupaciones sistémicas para las reformas procesales de la solución de controversias entre inversionistas y Estados. El presente documento trata en primer lugar de situar los debates sobre la SaaaMM en su contexto histórico y contemporáneo. A continuación, examina el Documento de Trabajo 213 de la CNUDMI y las disposiciones legales que contiene, que constituyen la base de los debates actuales sobre esta opción de reforma en el GTIII. Además, explora la posible relación de esta propuesta de SMM con diferentes aspectos del régimen jurídico internacional vigente en materia de inversiones. El documento concluye proporcionando algunos elementos que requieren una mayor consideración en este proceso, especialmente para proteger los intereses de los países en desarrollo.
Le mécanisme multilatéral permanent proposé et sa relation potentielle avec l’univers existant du règlement des différends entre investisseurs et États
par Danish et Daniel Uribe
L’option de réforme du Mécanisme permanent de règlement des différends internationaux en matière d’investissements actuellement en discussion au sein du Groupe de travail III de la CNUDCI a soulevé un certain nombre de préoccupations importantes concernant la réforme du système de règlement des différends entre investisseurs et États. Le présent document s’attache, dans un premier temps, à situer les discussions sur le mécanisme de règlement des différends dans leurs contextes historique et actuel. Il examine ensuite le document de travail 213 de la CNUDCI et les dispositions juridiques qu’il contient, qui constituent la base des discussions en cours sur cette option de réforme au sein du Groupe de travail. Enfin, il explore les liens potentiels entre le projet de mécanisme de règlement des différends et les différentes facettes du régime des accords internationaux d’investissement. Il se conclut sur les différents points qui nécessitent un examen plus approfondi en vue notamment de préserver les intérêts des pays en développement.
Pautas para el Examen de Solicitudes de Patentes Relacionadas con Productos Farmacéuticos
Por Carlos M Correa
Este documento representa un seguimiento de un documento anterior, Pautas para el examen de patentes farmacéuticas – Una perspectiva desde la Salud Pública, que se publicó en 2007 como documento de trabajo por el Centro Internacional de Comercio y Desarrollo Sostenible (ICTSD), Estados Unidos, Conferencia de las Naciones Unidas sobre Comercio y Desarrollo (UNCTAD) y la Organización Mundial de la Salud (OMS).
El presente documento toma en cuenta los desarrollos desde la publicación del documento de trabajo ICTSD-UNCTAD-OMS en 2007. Incluye nuevos ejemplos de solicitudes y/o subvenciones de patentes, además analiza y hace referencia a las iniciativas de varios países que han adoptado leyes y/o políticas dirigidas a considerar temas de salud pública en el examen de solicitudes de patentes.
El objetivo de este documento es proporcionar orientación para el desarrollo o la revisión de directrices sobre los procesos de examen de patentes en países en desarrollo en respuesta a las preocupaciones sobre el aumento del número de patentes en el sector farmacéutico. A tal fin, se formulan varias recomendaciones con respecto al examen de la patentabilidad de las solicitudes relativas a productos y procesos farmacéuticos.
Este documento es una traducción de la versión original de las “Directrices para el examen de solicitudes de patentes relacionadas con productos farmacéuticos” publicadas en inglés por la Programa de las Naciones Unidas para el Desarrollo (PNUD). El South Centre agradece al PNUD por la amable autorización para publicar esta versión no oficial. Traducido para el South Centre por el Sr. Natanael França.
Left on Our Own: COVID-19, TRIPS-Plus Free Trade Agreements, and the Doha Declaration on TRIPS and Public Health
By Melissa Omino and Joanna Kahumbu
The cusp of the twentieth anniversary of the WTO Doha Declaration on the TRIPS Agreement and Public Health (hereafter “the Declaration”) was marked by a global pandemic. The Declaration and its iteration in the Agreement on Trade Related Aspects of Intellectual Property Rights (hereafter “TRIPS”) Article 31 bis, should have helped to contain the devastation in least developed and developing countries. The reality is that the pandemic is still ongoing, and the Global South led by South Africa and India are seeking a waiver of provisions to the TRIPS Agreement to ensure that COVID-19 therapeutics, diagnostics, and vaccines reach their citizens in order to contain the spread of the COVID-19 virus (“the TRIPS waiver”). These citizens are especially vulnerable because of their inability to access vaccines due to their prices and supply shortages caused by the refusal to share manufacturing technology. The Doha Declaration aimed at reaffirming the interpretation and implementation of the TRIPS Agreement to support WTO members’ right to protect public health and promote access to medicines. However, the operationalization of the Declaration via Article 31bis of TRIPS has been cumbersome and procedurally difficult to navigate. This paper argues that the current iteration of the Doha Declaration within TRIPS fails to meet the objectives of the Declaration as demonstrated by the need for a further waiver of the TRIPS agreement. It also attempts to “reimagine” Article 31 bis in light of the TRIPS waiver from the position of the Global South to make it more equitable and practicable and maintain the spirit of the Declaration.
The WTO TRIPS Decision on COVID-19 Vaccines: What is Needed to Implement it?
By Carlos M. Correa and Nirmalya Syam
The 12th WTO Ministerial Conference adopted a Ministerial Decision on the TRIPS Agreement on 17 June 2022. This partially concluded almost two years of protracted discussions in response to a proposal by India and South Africa for a waiver from certain obligations under the TRIPS Agreement for health products and technologies for the prevention, treatment and containment of COVID-19. The adopted Decision only waives the obligation under article 31 (f) of the TRIPS Agreement. Developing country WTO members are now allowed to export any proportion of vaccines, including ingredients and processes, necessary for the COVID-19 pandemic that are manufactured under a compulsory license or government use authorization to other developing countries. It also contains some clarifications of relevant TRIPS provisions, while introducing a number of conditionalities that are not present in the TRIPS Agreement. This paper examines the object and scope of the Decision, the requirements established for its use, and the required actions to be taken by WTO members to implement it.
TRIPS Flexibilities and Access to Medicines: An Evaluation of Barriers to Employing Compulsory Licenses for Patented Pharmaceuticals at the WTO
By Anna S.Y. Wong, Clarke B. Cole, Jillian C. Kohler
Under Articles 31 and 31bis of the TRIPS Agreement, WTO members may validly sanction the use of a patented invention without the patent owner’s authorization by issuing a compulsory license (CL). In the pharmaceuticals space, governments have historically employed compulsory licenses to compel originator manufacturers to license their patents to generic manufacturers before patent expiry, increasing the supply and reducing the price of patented pharmaceuticals domestically.
This paper evaluates the three primary barriers to employing compulsory licenses for pharmaceuticals underscored by members during TRIPS waiver discussions at the WTO: (1) a lack of enabling domestic legislation, (2) a lack of domestic manufacturing capacity coupled with an unworkable Article 31bis importation system, and (3) consistent political pressure from other members to refrain from issuing compulsory licenses. A survey of members’ domestic compulsory license legislation finds that virtually all members have enacted enabling legislation under Article 31 for the issuance of compulsory licenses to supply their local markets. However, implementation of Article 31bis is limited by a lack of enabling compulsory license export legislation, streamlined administrative processes, or both across all members, preventing members lacking domestic manufacturing capacity from importing pharmaceuticals. An analysis of USTR Special 301 Reports from 1994-2021 further reveals that countries have consistently been placed on the Special 301 Report Priority Watch List for issuing pharmaceutical compulsory licenses, with instances as recent as 2020. As such, general reluctance by members to issue compulsory licenses due to overt political pressure through the Special 301 Report is likely warranted. These results highlight a range of barriers preventing the full use of compulsory licenses for pharmaceuticals under the current Article 31 and 31bis framework, with the effects disproportionately borne by member states lacking domestic manufacturing capacity.
Analysing Intersections between Climate Change and Human Rights
By Daniel Uribe Teran and Luis Fernando Rosales
The effects of climate change on people’s daily lives threaten the full enjoyment of human rights. The Human Rights Council adopted two landmark resolutions recognising the human right to a clean, healthy and sustainable environment (Resolution 48/13), and establishing the mandate for a Special Rapporteur on the promotion and protection of human rights in the context of climate change (Resolution 48/14). Nevertheless, a broader dialogue between the UNFCCC and the UN human rights architecture seems necessary to establish a coordinated and coherent response to climate change and its effects on human rights.
This research paper analyses the intersections of these two legal systems. It does so by identifying how the climate change negotiations and the human rights architecture can contribute to strengthening international cooperation. It also recognises the need for a more profound international debate on the linkages between human rights and climate change consistent with the principles of equity and common but differentiated responsibilities included in the UNFCCC.
Lessons From India’s Implementation of Doha Declaration on TRIPS and Public Health
By Nanditta Batra
The major bone of contention between the developed and developing countries in the TRIPS negotiations was patents for pharmaceuticals. The US-led developed countries bloc argued in favour of patents for pharmaceuticals amidst opposition from Brazil, India and other countries. Ample evidence, including patented AZT for HIV/AIDS treatment, showed that patents could make life saving drugs prohibitively expensive. Notwithstanding the effect of patents on access to medicines, Article 27 of the TRIPS Agreement ordained patents for inventions “in all fields of technology”. While the genie was out of the bottle in the form of patents for pharmaceuticals, the developing countries were able to extract some procedural and substantive flexibilities like transition period, parallel importation and compulsory licensing to leverage the IP system to further public health. However, there was uncertainty with respect to the interpretation of TRIPS agreement, scope of the flexibilities and Member States’ rights to use them. It is in this background that the historic Doha Declaration on the TRIPS Agreement and Public Health assumed importance as it reaffirmed the rights of the Member States to take measures to protect public health, reconciled the interpretative tensions in the text of TRIPS Agreement and clarified the scope of some of the flexibilities and attempts to find solutions to the problems faced by countries that do not have sufficient manufacturing facilities. The Declaration which was initially dismissed by some scholars as “non-binding,” “soft law” has been held by WTO Dispute Settlement Body (DSB) to constitute a “subsequent agreement” which must be followed in interpreting the provisions of TRIPS Agreement (Australia-Tobacco Plain Packaging Case).
