Three Takeaways From the May 21 Revised TRIPS Waiver Proposal

May 25, 2021

On May 21, 62 WTO member states[1] submitted a revised proposal on a waiver from certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. This revised proposal follows the original proposal from India and South Africa in October 2020. Earlier this month, U.S. Trade Representative Katherine Tai had issued a statement announcing the Biden-Harris Administration’s willingness to “actively participate in text-based negotiations at the World Trade Organization” regarding a waiver for COVID-19 vaccines (see prior client alert).

As stakeholders look ahead to WTO negotiations on a potential TRIPS waiver, the revised proposal is significant in at least three respects.

First, in contrast with the original proposal, the preambular text of the revised proposal underlines the uncertain nature of the ongoing global crisis which, among others things, includes the emergence of new variants of COVID-19 and the “urgent need to diversify and scale-up production”. It likewise recognizes the need to “preserve incentives for research and innovation, and that these should be balanced with the public health interest.” This preambular text appears to reflect an initial gesture to balance interests, while also linking the waiver to wider discussions on bolstering production of COVID-19 related products, which could subsequently inform how negotiations as to the scope of a waiver and its relevance to pandemic response are approached.  

Second, paragraph 1 of the revised proposal, in contrast to same paragraph in the original proposal, provides additional clarity as to the scope of the proposed waiver. Specifically, the scope encompasses “health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19.”

As in the original proposal, the scope of the revised waiver likewise applies to the implementation, application, and enforcement of TRIPS provisions regarding copyright and related rights (Part II, section 1), industrial designs (section 4), patents (section 5), and the protection of undisclosed information (section 7). 

The scope of potential “health products and technologies” remains unclear, not least because the specified list does not appear to be exhaustive. What is certain, however, is that the scope of the revised proposal remains broad including, among others, COVID-19 vaccines and diagnostic tests, as well as underlying manufacturing technologies, and covering various types of intellectual property. Whether, during subsequent negotiations, the scope of the waiver is reduced, such as limiting the health products and technologies or applicable TRIPS provisions, will be critical for stakeholders. Notably, Ambassador Tai’s statement earlier this month specifically reflects the Biden-Harris Administration’s support for a temporary waiver for COVID-19 vaccines only, not other health products or technologies.

Third, paragraph 2 of the revised proposal provides that the waiver would be in effect for three years and, based on paragraph 5, would be reviewed on an ongoing basis by the WTO General Council. The original proposal did not specify the duration of the proposed waiver. The three-year duration is justified in the communication, noting the uncertainty as to the trajectory of the pandemic, unknowns with respect to health products, and time required for making manufacturing feasible and viable.

Looking Ahead

It will be increasingly important for stakeholders to monitor how WTO negotiations evolve in light of the revised proposal. Given support from 63 of the 159 WTO member states, how others—including the U.S., EU, and China—respond to the revised proposal will likely impact the initial phase of text-based negotiations, particularly as various member states continue to oppose a waiver altogether.

As yet, there also remains the possibility of pursuing alternative options that would not rely on a TRIPS waiver, such as licensing agreements between vaccine manufacturers and low- and middle-income countries, as well as easing export restrictions and tariffs to encourage supply chain and distribution efficiencies.

For example, it was also reported that a draft document at the G20 Global Health Summit in Rome showed support for a “patent-pooling” approach, which would be a voluntary effort, unlike pursuit of a TRIPS waiver. As another example, a recently released plan from several major industry organizations calls for a renewed focus on, among other things, maximizing COVID-19 vaccine production and eliminating trade barriers, but does not mention a TRIPS waiver.

In the lead-up to the next WTO TRIPS Council meeting, scheduled for June 8-9, there is certain to be considerable scrutiny around the revised proposal, particularly as member states and stakeholders explore various options for moving forward.

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.