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.
27th CONFERENCE OF THE PARTIES (COP27) OF THE UNFCCC
STATEMENT OF DR. CARLOS CORREA, EXECUTIVE DIRECTOR OF THE SOUTH CENTRE
We all are aware of the magnitude of the climate crisis the world is facing. We are also aware that its impact is not the same for all countries and populations. The disasters we are witnessing affect most severely developing countries which historically have not been responsible for the emissions that put at risk the life in the planet. Those countries, the most affected, have the lowest capacity to address the devastating effects of climate change events and to adapt to and mitigate them.
Climate change is a cross-cutting issue. However, the international system operates in silos and has been incapable of ensuring the adoption of the multiple and coordinated policies necessary to address it. The South Centre, as an intergovernmental organization of developing countries, attaches particular importance to and focuses its work on the intersection of climate change policies with other policy frameworks.
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.
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).
Webinar: The Future of the TRIPS Agreement (Part 2)
11 October 2022
Time: 10:00 – 11:30 CET
Sustainable recovery from the COVID-19 pandemic requires availability of medical technologies in all countries. To date, inequity in access continues. The interface of intellectual property and promotion of public health is central to this question. This session is a follow-up to the South Centre’s 2021 WTO Public Forum working session, which kick-started a discussion on the future of the TRIPS Agreement after the Covid-19 pandemic.
This session will bring together various stakeholders to discuss whether a reform of the TRIPS Agreement and/or authoritative interpretations of some its key provisions are needed, having in view the proposals made in response to a request for a waiver for the Covid-19 pandemic and other possible public-health oriented solutions. What are the existing limitations and opportunities within the current framework? What further actions could be taken under the WTO rules in order to promote access to medical technologies for a sustainable and equitable future?
Statement by the South Centre to the 2022 Assemblies of the Member States of WIPO
The South Centre is the intergovernmental organization of developing countries based in Geneva that supports developing countries’ efforts to build up a fair and inclusive multilateral system conducive to the achievement of the Sustainable Development Goals (SDGs). We are of the view that a central objective of World Intellectual Property Organization (WIPO) as part of the United Nations (UN) UN system should be to support the achievement of such goals through the promotion of a balanced international intellectual property (IP) system that reflects the interests of countries at different levels of economic and technological development, and in line with the WIPO Development Agenda.
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.
Twenty Years After Doha: An Analysis of the Use of the TRIPS Agreement’s Public Health Flexibilities in India
By Muhammad Zaheer Abbas, PhD
The World Trade Organization (WTO) linked intellectual property protection with trade. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), however, included a number of public health flexibilities in order to provide latitude to the Member States to tailor their national patent laws to fit their individual needs. In 2001, the Doha Declaration further clarified and reaffirmed the existing TRIPS flexibilities. This paper argues that India has taken the lead role in enacting the TRIPS Agreement’s substantive and procedural patent flexibilities by introducing unique legislative measures to deal with the problem of access to medicines. This article evaluates India’s use of section 3(d) as a subject matter exclusivity provision. It examines constitutional validity and TRIPS compliance of section 3(d). It also evaluates India’s use of the flexibility to define the term “inventive step”. Moreover, this article evaluates India’s use of compulsory licensing, the most notable exception to patent rights provided under the TRIPS Agreement. This empirical study is important in the context of the COVID-19 pandemic, which has once again highlighted the same public health issues that the Doha Declaration sought to address twenty years ago.
STATEMENT BY CARLOS M. CORREA, EXECUTIVE DIRECTOR OF THE SOUTH CENTRE, TO THE MEETING OF THE NAM HEALTH MINISTERSON THE OCCASION OF THE 75TH WORLD HEALTH ASSEMBLY, MAY 20, 2022
The South Centre has closely followed issues concerning access to medicines and the work of the WHO over the years. In the last couple of years, it has provided analyses and advice in connection with the COVID-19 crisis that has so severely affected the members of NAM.