Three takeaways from the revised TRIPS waiver proposal on May 21
On May 21, 62 WTO member states submitted a revised proposal on an exemption from certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This revised proposal follows the original proposal India and South Africa in October 2020. Earlier this month, U.S. Trade Representative Katherine Tai posted a declaration announcing the Biden-Harris administration’s willingness to “actively participate in textual negotiations at the World Trade Organization” regarding a waiver for COVID-19 vaccines (see customer alert).
As stakeholders contemplate the WTO negotiations on a possible TRIPS waiver, the revised proposal is important in at least three ways.
First, unlike the original proposal, the preamble text of the revised proposal underlines the uncertain nature of the ongoing global crisis which, among other things, includes the emergence of new variants of COVID-19 and the ‘urgent need to diversify and make things happen. until production ”. It also recognizes the need to “preserve incentives for research and innovation, and that these must be balanced against the interest of public health”. This preamble text appears to reflect a first move to balance interests, while also tying the waiver to broader discussions on scaling up production of COVID-19-related products, which may later inform how the scope negotiations derogation and its relevance to the response to a pandemic are approached.
Second, paragraph 1 of the revised proposal, unlike the same paragraph in the original proposal, provides further clarification on the scope of the proposed waiver. More specifically, the scope encompasses “health products and technologies, including diagnostics, therapeutic products, vaccines, medical devices, personal protective equipment, their materials or components, as well as their methods and means. for the prevention, treatment or containment of COVID-19 ”.
As in the original proposal, the scope of the revised waiver also applies to the implementation, application and enforcement of the copyright provisions of the TRIPS Agreement 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 list specified does not appear to be exhaustive. What is certain, however, is that the scope of the revised proposal remains wide, including, among others, COVID-19 vaccines and diagnostic tests, as well as the underlying manufacturing technologies, and covering various types of intellectual property. Whether, in subsequent negotiations, the scope of the waiver is reduced, for example by limiting health products and technologies or the applicable provisions of the TRIPS Agreement, will be crucial 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 for other health products or technologies.
The third, paragraph 2 of the revised proposal provides that the waiver would be in effect for three years and, on the basis of paragraph 5, would be continuously reviewed 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 about the trajectory of the pandemic, the unknowns regarding health products and the time needed to make manufacturing feasible and viable.
It will be increasingly important for stakeholders to follow developments in the WTO negotiations in the light of the revised proposal. Given the support of 63 of the 159 WTO member states, how others – including the US, EU and China – respond to the revised proposal will likely have an impact on the initial phase of the negotiations. text-based negotiations, especially as various member states continue to oppose a waiver. absolutely.
To date, there also remains the possibility of exploring alternative options that do not rely on a TRIPS waiver, such as licensing agreements between vaccine manufacturers and low- and middle-income countries, as well as easing restrictions. export restrictions and tariffs to encourage supply chain and efficient distribution.
For example, it was also reported that a draft document at the G20 World Health Summit in Rome showed support for a “patent pooling” approach, which would be a voluntary effort, as opposed to the pursuit of a TRIPS waiver. As another example, a recently released version plan several large industry organizations are calling for a renewed focus on, among other things, maximizing COVID-19 vaccine production and removing trade barriers, but does not mention a TRIPS waiver.
In the run-up to the next WTO TRIPS Council meeting, scheduled for June 8-9, the revised proposal is certain to be the subject of careful consideration, especially as member states and stakeholders are exploring various options for moving forward.