(Mar. 24, 2021) At a meeting on March 10-11, 2021, the Trade-Related Aspects of Intellectual Property Rights Council (TRIPS Council) of the World Trade Organization (WTO) continued its consideration of a waiver from the implementation, application, and enforcement of several sections of the TRIPS Agreement in relation to the prevention, containment, and treatment of COVID-19. South Africa and India formally requested the TRIPS Council to recommend the waiver to the WTO General Council in October 2020. The request was co-sponsored by Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group (negotiating for 43 WTO members), and the Least Developed Countries Group (negotiating for 35 members).
What Is the TRIPS Agreement?
The TRIPS Agreement is the multilateral trade agreement on intellectual property (IP) and one of the founding agreements of the WTO. The TRIPS Agreement is binding on all WTO members, due to the WTO’s approach to negotiations as a “single undertaking,” as provided by article II (2) of the Marrakesh Agreement establishing the WTO. The obligations in the TRIPS Agreement follow the general obligations of the General Agreement on Tariffs and Trade and the General Agreement on Trade in Services (national treatment and most-favored-nation treatment), and its scope refers to the main international agreements of the World Intellectual Property Organization, as well as creating new standards beyond these instruments. As such, the TRIPS Agreement provides the minimum standards of protection that WTO members must grant to copyrights, trademarks, geographical indications, industrial designs, and patents held by nationals of fellow WTO members, as well as exceptions to these minimum standards.
What Is the Proposed TRIPS Agreement Waiver?
The proposed TRIPS Agreement waiver would be in place for a to-be-determined length of time until widespread vaccination is in place globally, and would cover Section 1 on copyright and related rights, Section 4 on industrial designs, Section 5 on patents, and Section 7 on the protection of undisclosed information. The proponents of the waiver argue that “existing vaccine manufacturing capacities in the developing world remained unutilized because of IP barriers, and hence insufficient amounts of vaccines [are] being produced to end the pandemic.” The World Health Organization (WHO) and the United Nations General Assembly (UNGA) have also endorsed the spirit of the waiver. The WHO COVID-Response Resolution (WHA 73.1) proposes that any unjustified obstacles must be removed and that TRIPS flexibilities should be strengthened. The General Assembly also passed two resolutions (UNGA Resolution 74/270 and UNGA Resolution 74/274) emphasizing “the need to rapidly scale manufacturing and strengthen supply chains to ensure efficient, timely, fair, transparent, and equitable access to and distribution of diagnostics, drugs, and COVID-19 vaccines to all of those in need, particularly in developing and least developed countries.”
What Are the Alternatives to the Proposed TRIPS Agreement Waiver?
Those WTO members opposed to the TRIPS Agreement waiver argue that the agreement is sufficiently flexible to address public health emergencies, including the use of exceptions and limitations for research, security exceptions, and the grant of compulsory licenses or government use authorizations. In the past, compulsory licenses have been granted in the event of health emergencies under article 31 bis of the TRIPS Agreement. As an amendment to the TRIPS Agreement, article 31 bis sought to allow compulsory licenses for the export of patented pharmaceuticals when they are not available in a country that has no or insufficient manufacturing capacity. However, the South Centre, an intergovernmental organization of developing nations, argues that in the case of the COVID-19 pandemic, compulsory licensing schemes are problematic because the negotiations are complex, costly, and often inefficient.
Alternatively, prior to her start as the new WTO Director-General, Ngozi Okonjo-Iweala argued for a “third way”—not establishing a TRIPS Agreement waiver and not relying on article 31 bis compulsory licenses to increase access to vaccines, drugs, and diagnostics. She points to the possibility of increasing access to vaccines and other products through facilitating (1) technology transfer and (2) the licensing of manufacturing to other manufacturers to produce vaccines and other products, while still making sure that IP issues are taken care of (which has already occurred in the case of AstraZeneca licensing manufacturing to the Serum Institute of India). But these proposed solutions seem disappointing to some public health activists, as there is “nothing to stop companies from initiating technology transfers or voluntary licenses already.” Another critique of the “third way” and other alternatives (such as a proposal to impose a two-year moratorium on enforcing patents but removing the waiver on other IP rights) is that these alternatives to the waiver “disregard the ability of the countries facing the vaccine shortages to identify the best solution to their situation.”
The next regular meeting of the TRIPS Council to continue the TRIPS Agreement waiver will be June 8-9, 2021, but members agreed to consider additional meetings in April to assess potential progress on the issue.
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