World Trade Organization Reaches Agreement on Temporary TRIPS Waiver Regarding COVID-19 Vaccines

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On June 17, 2022, the World Trade Organization (WTO) announced an agreement on a deal that temporarily removes intellectual property barriers for COVID-19 vaccines, and postpones the discussions on extending the waiver to treatments and tests by six months.[1] For a period of five years, low- and middle-income countries may temporarily waive protections on patents relating to production of vaccines, either for domestic use or export. Reexport is not permitted, however. In addition, language advocated by the United States appears to preclude China from taking advantage of the waiver. Provisions in the original proposal to temporarily waive protections for trade secrets, copyrights, and industrial designs were not included in the agreement. 

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The development of COVID-19 vaccines occurred at a record-breaking speed, and the negotiation of how certain IP protections of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) would address the pandemic and COVID-19 vaccines could also be considered to be record-breaking, at least relative to the speed of prior TRIPS negotiations.

The 12^th Ministerial Conference (MC12) of the WTO met in Geneva from June 12-16^th, 2022, and reached a final decision as to the scope of a TRIPS waiver related to COVID-19 vaccines. The Ministerial Conference is the topmost decision-making body for the WTO as it brings together all members of the WTO. While the Ministerial Conference usually meets every two years, it had not met since 2017. Thus, the MC12 decision came less than two years after an initial proposal from India and South Africa in October 2020 that caused significant debate, and within a few months of a reported compromise between the European Union, India, South Africa, and the United States that emerged in March 2022. 

While the original proposal from India and South Africa included a broad waiver of protections over copyrights, designs, trade secrets, and patents in relation to health products and technologies for the prevention and treatment of COVID-19, the ministerial decision from MC12 entails less than the broad waiver of essentially all IP rights that was originally proposed. In particular, the final decision allows developing countries to authorize the use of patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the patent holder and without the proposed user to even make efforts to obtain such consent.  The authorization by the eligible WTO member may be given by any legal instrument available to the eligible WTO member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not the WTO member has a compulsory licensing regime in effect at the time. Thus, in effect, the decision allows for expansive compulsory licensing by all developing countries, even if they have yet to enact such regime.  

The decision is limited to vaccines, but by no later than six months, the WTO members will decide whether to extend the waiver to COVID-19 therapeutics and diagnostics. Indeed, it is reported that such discussions began at the July 6, 2022, meeting of the TRIPS Council.

While the final decision does not have the breadth of the original proposal (thus avoiding the extreme destabilizing effect on the global IP system that was originally feared), there is still a concern as to the long-term effect that the WTO decision will have. The concern is especially significant in view of the fact that there is more than adequate supply of COVID-19 vaccines (in particular within the COVAX system) and that continued lags in vaccination rates are unrelated to any lack of vaccine supply. The original call for the waiver was to address the understandable lag in production of the vaccines; however, once supply caught up with demand, it seems that the political call for an IP waiver was just too strong.  In the next few months, it remains to be seen if the call is still present as the Members discuss whether to extend this waiver to therapeutics and diagnostics.