Scientist in a COVID-19 test lab.
Policy Analysis

TRIPS Waiver Negotiations Go Down to the Wire in the Run-Up to MC12

The COVID-19 pandemic has raised concerns over the WTO’s rules on intellectual property rights and whether they are fit for purpose in the response to global health crises. Thiru Balasubramaniam from Knowledge Ecology International provides a summary of the progress made in negotiations about the existing agreement and the proposal for a waiver.
By Thiru Balasubramaniam on June 7, 2022

Most of the World Trade Organization’s (WTO’s) rules date back to the Uruguay Round. The COVID-19 pandemic exposed policy tensions in the rules-based multilateral trading system. In particular, WTO rules on intellectual property have led certain members to question whether these norms, established by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), are fit for purpose in the COVID-19 response.

The Background

In her address to the WTO’s Public Forum on September 28, 2021, Director-General Ngozi Okonjo-Iweala highlighted the pressing need for the WTO to address the problems of the global commons, including vaccine inequity and fisheries subsidies, stating that

"[e]ven as we fight to end the pandemic, making full use of trade’s power to tackle vaccine inequity, we must engage in serious thinking about what it will take to build back a better world economy. A world economy that is greener, more prosperous, and more inclusive. A world economy that is more responsive to problems of the global commons. A WTO that is more responsive to changing economic realities and the evolving needs of the people we serve."

On October 2, 2020, India and South Africa submitted a proposal to the TRIPS Council for a draft decision for a waiver from certain provisions of the TRIPS Agreement for the prevention, containment, and treatment of COVID-19. The proposal, IP/C/W/669, suggested the following:

"In these exceptional circumstances, we request that the Council for TRIPS recommends, as early as possible, to the General Council a waiver from the implementation, application, and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19."

Section 1 of Part II of the TRIPS Agreement deals with copyright and related rights, while Section 4 addresses industrial designs. Section 5 of Part II pertains to patents, and Section 7 involves the protection of undisclosed information.

The joint submission by India and South Africa for a waiver sought to recalibrate the architecture of the TRIPS Agreement to respond to the COVID-19 pandemic.

The joint submission by India and South Africa for a waiver sought to recalibrate the architecture of the TRIPS Agreement to respond to the COVID-19 pandemic. By May 2021, the TRIPS waiver proposal had 62 official co-sponsors, who issued a revised proposal on May 21.

In an earlier joint statement released on May 18, the co-sponsors noted the following:

"As the COVID-19 pandemic continues to rage on globally, there have been 162,177,376 confirmed cases of COVID-19, including 3,364,178 deaths, reported to WHO [the World Health Organization]. As of 12 May 2021, a total of 1,264,164,553 vaccine doses have been administered. However, the promise of international solidarity and of “global public goods” sounds hollow as staggering inequity in access persists and as Members of World Trade Organization continue to fail to work in solidarity and take action to remove intellectual property barriers."

In the revised proposal, the co-sponsors indicated that the operative paragraph (1) had been revised to address concerns that the original decision text was too broad. In particular, they noted that the revised text addressed this concern by

"focusing the text on “health products and technologies” as the prevention, treatment or containment of COVID-19 involves a range of products and technologies and intellectual property issues may arise with respect to the products and technologies, their materials or components, as well as their methods and means of manufacture."

On May 5, 2021, United States Trade Representative Katherine Tai expressed “the Biden-Harris Administration’s support for waiving intellectual property protections for COVID-19 vaccines” and a willingness to engage in text-based negotiations.

In response to the October 2020 submission by India and South Africa for a TRIPS waiver, the European Union issued the following riposte at the TRIPS Council in October 2020: “There is no indication that IPR issues have been a genuine barrier in relation to COVID-19-related medicines and technologies.” On June 4, 2021, the European Union released a counterproposal to the TRIPS waiver composed of these three elements: “1) trade facilitation and disciplines on export restrictions, 2) expansion of production, including through pledges by vaccine producers and developers, and 3) clarification and facilitation of TRIPS Agreement flexibilities relating to compulsory licences.”

With respect to providing a clarification of TRIPS Agreement flexibilities relating to compulsory licensing, it should be noted that paragraph 5(b) of the Doha Declaration on the TRIPS Agreement and Public Health states unequivocally that “Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.”

On June 18, 2021, the European Union submitted a Draft General Council Declaration on the TRIPS Agreement and Public Health in the Circumstances of a Pandemic. The first element of this declaration was the recognition that the pandemic is “a national emergency or other circumstances of extreme urgency” within the meaning of Article 31(b) of the TRIPS Agreement. Under this understanding, a WTO member “may waive the requirement of making efforts to obtain authorization from the right holder, provided for in Article 31(b).” The second element of the proposal was that the remuneration paid to the rights holder under a compulsory licence issued to address the COVID-19 response should reflect affordable prices. The third element said the exporting member “may provide in one single notification a list of all countries to which vaccines and medicines are to be supplied by the exporting member directly or through indirect means, including international joint initiatives that aim to ensure equitable access to the vaccines or medicines covered by the compulsory licence.”

A month after the postponement of the Twelfth Ministerial Conference (MC12) in November 2021, Okonjo-Iweala and WTO Deputy-Director General Anabel González held a series of informal negotiations with the European Union, India, South Africa, and the United States at the ministerial and technical level. This informal grouping of members became informally known as “the Quad.”

Watering Down the India–South Africa Proposal

On March 15, STAT published a leaked version of a document titled TRIPS COVID-19 Solution (the Outcome of the Quadrilateral Discussions at the End of Last Week, to be Presented to WTO Members). As noted by TRIPS expert James Love, the “original [TRIPS waiver] proposal tabled by India and South Africa in 2020 as IP/C/W/669 would have waived 40 articles of the WTO Trade-Related Agreement on intellectual property rights” while the “compromise only waives a single 20-word paragraph in one article: the one dealing with exports under a non-voluntary authorization.”

In short, the leaked document resembled the European Union proposal and looked quite different from the original proposal from India and South Africa. In addition, the text was limited to vaccines, at the insistence of the United States. Articles 39.1 and 39.2 of the TRIPS Agreement deal with trade secrets and manufacturing know-how; the leaked text does not address this.

On May 3, 2022, the WTO published a formal text, IP/C/W/688, Communication from the Chairperson. This formal text was identical to the leaked March text with two exceptions: 1) footnote 1 on the definition of eligible countries is now in brackets. As noted by the WTO Secretariat, China announced at the General Council meeting on May 10, 2022, that 

"it will not avail itself of the flexibilities under the Quad waiver text provided that language is used opening benefits of the waiver to all developing members while encouraging those with capacity to export vaccines to opt out. China and several other members rejected a second option in the text that would restrict waiver eligibility to those developing countries that exported more than 10% of the world’s vaccine doses in 2021."

In the run-up to MC12, it is expected that a flurry of informal meetings will be scheduled to negotiate the final outcome.

The second change from the leaked text is a new footnote 3, which indicates that the patent listing requirement in paragraph 3(a) of the text is now under brackets. In the run-up to MC12, it is expected that a flurry of informal meetings will be scheduled to negotiate the final outcome. However, Bloomberg reported on May 16 that the United States had rejected Beijing’s voluntary opt-out of document IP/C/W/688, even in return for dropping a provision that excludes China. The Biden Administration says any WTO deal on COVID-19 vaccines must explicitly exclude China from being able to benefit because “the second-largest economy in the world, which has COVID vaccines and mRNA technology, doesn’t need the waiver,” Deputy U.S. Trade Representative Maria Pagan was cited as saying.

The COVID-19 Technology Access Pool

On March 23, 2020, Carlos Alvarado Quesada, then president of Costa Rica, and Minister of Health Daniel Salas Peraza sent a letter to WHO Director-General Tedros Adhanom Ghebreyesus asking him to establish a program to “pool rights to technologies that are useful for the detection, prevention, control, and treatment of the COVID-19 pandemic.” In particular, Costa Rica suggested that

"(t)his pool, which will involve voluntary assignments, should include existing and future rights in patented inventions and designs, as well rights in regulatory test data, know-how, cell lines, copyrights and blueprints for manufacturing diagnostic tests, devices, drugs, or vaccines. It should provide for free access or licensing on reasonable and affordable terms, in every member country."

In May 2020, the WHO established the COVID-19 Technology Access Pool (C-TAP). On May 12, 2022, 2 years after the establishment of C-TAP, at the Global COVID-19 Pandemic Summit, U.S. President Joe Biden announced a licensing agreement between the United States National Institutes of Health and WHO C-TAP and the Medicines Patent Pool. These 11 technologies, provided under two licences, include the stabilized spike protein used in currently available COVID-19 vaccines.

Conclusion

MC12 is a test for the multilateral trading system and its ability to address the challenges posed by trade-related aspects of global public goods. A deficient WTO response to COVID-19, especially as it relates to the intersection of intellectual property rules and access to COVID-19 countermeasures, may lead members to question the relevance of the organization in addressing the exigent needs of its members. Up the hill at the WHO, member states have embarked on a process to negotiate a pandemic treaty; perhaps WHO can finish what might stall at the WTO.


Thiru Balasubramaniam is the Geneva Representative of Knowledge Ecology International.