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).
The South Centre invites applications from the members of the Antibiotic Resistance Coalition (ARC) and other civil society organizations or research institutions from developing countries for limited financial funding (maximum 2000 USD per campaign) to design and launch campaigns or support continuing advocacy efforts at the sides of the World Antimicrobial Awareness Week 2022.
Brazilian Competition Law and Access to Health in Brazil: Exploitative Pricing in the Pharmaceutical Sector
By Bruno Braz de Castro
This paper aims to analyze the interfaces between Brazilian Competition Law and the issue of access to medicines, with a special focus on abuse of industrial property rights and related exclusionary and exploitative effects. The paper analyzes the case law of Brazilian Administrative Council for Economic Defense (CADE) in the pharmaceutical sector and discusses abusive practices such as illegitimately imposing non-existent or invalid intellectual property rights with anticompetitive purposes. It then addresses abusive strategies in the exercise of industrial property rights which are, in essence, valid: i.e., exclusionary practices, aimed at artificially raising barriers to entry; and exploitative practices, directly translated as the exercise of market power to the detriment of the consumer. The latter ultimately result in exploitative excessive prices; contractual, quality or privacy degradation; and restrictions on supply, such as by hoarding/preventing the exploitation of industrial property rights. The paper concludes that the prohibition of exploitative pricing under the current competition law is legally valid and effective, with certain methodological concerns towards reducing the risk of wrongful convictions (for instance, by applying screening tests to determine the markets that are candidates for intervention). In view of such guidelines, the pharmaceutical industry appears to be an important candidate for antitrust attention, given the magnitude of the harm potentially derived from non-intervention against the practice. Remedies in this area, importantly, should focus on identifying and solving the sector’s structural competitive problems. In the case of medicines subject to price regulation by the Drug Market Regulation Chamber (CMED), the technical expertise of the competition authority may be of great value in terms of competition advocacy, a fact that is demonstrated in light of recent discussions on extraordinary price adjustments because of competitive problems in certain markets.
La incorporación de la equidad en el Reglamento Sanitario Internacional y en futuros instrumentos jurídicos de la OMS sobre preparación y respuesta frente a pandemias
Por Nirmalya Syam
Los Estados miembros de la OMS están a punto de iniciar las negociaciones más importantes que podrían establecer el paradigma de las obligaciones jurídicas internacionales en materia de preparación y respuesta a futuras pandemias. Estas negociaciones se centran en las enmiendas al Reglamento Sanitario Internacional (2005) (RSI), así como en la negociación de un tratado u otro instrumento jurídico en el marco de la Constitución de la OMS que complemente el RSI para garantizar una mejor preparación y respuesta ante futuras pandemias, basándose en las experiencias de la actual pandemia de COVID-19. La consideración más crítica para los países en desarrollo en estas negociaciones será la integración de las preocupaciones de equidad, actualmente ausentes de las normas y mecanismos existentes a nivel mundial para permitir a los países en desarrollo prevenir y responder eficazmente a un brote pandémico. En este contexto, este informe sugiere algunos elementos de equidad que deberían perseguirse a través de propuestas textuales específicas de los países en desarrollo mediante enmiendas al RSI.
L’intégration de l’équité dans le Règlement sanitaire international et les futurs instruments juridiques de l’OMS sur la préparation et la riposte aux pandémies
Par Nirmalya Syam
Les États membres de l’OMS sont sur le point d’entamer les négociations les plus importantes qui pourraient définir le paradigme des obligations juridiques internationales en matière de préparation et de riposte aux futures pandémies. Ces négociations portent sur les amendements au Règlement sanitaire international (2005) (RSI) ainsi que sur la négociation d’un traité ou d’un autre instrument juridique dans le cadre de la Constitution de l’OMS qui complétera le RSI afin d’assurer une meilleure préparation et une meilleure riposte aux futures pandémies, en tirant parti de l’expérience de la pandémie actuelle de COVID-19. La considération la plus critique pour les pays en développement dans ces négociations sera l’intégration des préoccupations d’équité, actuellement absentes des règles et des instruments existants disponibles au niveau mondial pour permettre aux pays en développement de prévenir et de répondre efficacement à une pandémie. Dans ce contexte, ce document suggère quelques éléments d’équité qui devraient être poursuivis par des propositions textuelles spécifiques des pays en développement par le biais des amendements au RSI.
South Centre Comments on the Draft Annotated Outline of a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response
24 June 2022
The South Centre welcomes the opportunity to provide comments on the draft annotated outline of a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response. Comments are provided with respect to the process and the content.
TRIPS WAIVER: AN INSUFFICIENT MULTILATERAL RESPONSE. TRIPS-CONSISTENT NATIONAL ACTIONS ARE CALLED FOR
After almost 20 months from the submission of a “TRIPS waiver” request by India and South Africa, co-sponsored by 65 WTO member States (and supported by more than 100 WTO Members), a “Ministerial Decision on the TRIPS Agreement” (WT/MIN(22)/W/15/Rev.2) (‘the Decision’) was belatedly adopted by the 12th Ministerial Conference of the World Trade Organization on 17 June 2022.
This Decision does recognize that, as argued by developing countries and a large number of organizations and academics, intellectual property (IP) poses obstacles for the expansion of manufacturing capacity and timely access to health products and technologies to respond to COVID-19. The response to the pandemic required a rapid increase in the supply of countermeasures, while technology holders refused to share their technologies.
Not only developed countries successfully deviated the negotiations towards an outcome different from what was pursued by developing countries’ diplomats; the process for its adoption did not allow for the full and informed participation of the latter. The process leading to the Decision confirms the need to fully use the TRIPS flexibilities to address emergency and other situations where public health and other public interests are at stake, and to review the current international IP regime (including article 31bis of the TRIPS Agreement) to accelerate the sharing of technology, including know-how.
Doha Twenty Years On – Has The Promise Been Betrayed?
By Yousuf Vawda and Bonginkosi Shozi
The Doha Declaration’s twentieth anniversary in November 2021 has taken place in the midst of the COVID-19 pandemic. The experience of the past two years has demonstrated that the very factors that necessitated the Declaration—the problems of inequitable access to medicines and other health technologies for the world’s poor—continue to plague us.
Has the promise of the Doha Declaration been betrayed? In this contribution, we critically engage with this question, focusing our appraisal on whether the Doha Declaration has been successful in fulfilling its commitments to: (a) advancing access to health; (b) equity and fairness in the relations between WTO Members States; and (c) recognising perspectives from the developing world in formulating IP policy. Ultimately, we conclude that the promise of the Doha Declaration has failed to materialise.
There are many reasons for this. For instance, developed country governments have intentionally undermined the Declaration by their insistence on inserting more onerous TRIPS-plus provisions in free trade agreements and economic partnership agreements, which decimate the limited flexibilities permitted by the TRIPS Agreement. And where countries have sought to use such flexibilities, they have been assailed by an over-litigious pharmaceutical industry, and threats by governments such as the US 301 Watch List. For these reasons, we argue for the need for alternative paradigms to challenge Western hegemony and norms regarding IP and other trade-related issues, and for effectively challenging this through the application of a “decoloniality” approach.