The WTO will conclude negotiations over TRIPS and COVID 19 without extending the June 17, 2022 decision to therapeutics or diagnostics
The World Trade Organization (WTO) will soon be announcing that it will conclude negotiations over TRIPS Agreement exceptions for COVID-19. There is no consensus among countries over any extension of the June 17, 2022 decision on vaccines to include therapeutic or diagnostic tests.
A decision was supposed to have been reached by December 17, 2022, and the deadline has been extended and extended without much progress. The Biden Administration sent out some hope it would eventually support the extension, by asking for a US International Trade Commission (ITC) report. The US ITC report, nearly 500 pages long (see: https://www.keionline.org/39155), made no recommendations, and the Biden White House (lobbied extensively by drug companies and even some universities) was never willing to embrace the extension.
The June 17, 2022 decision was itself widely criticized by both drug companies and NGOs. My blog on the issue at the time (https://www.keionline.org/37830) pointed out the several shortcomings and a few silver linings.
I noted that:
“It is hard to imagine anything with fewer benefits than this, as a response to a global health emergency (other than the earlier negotiating texts for this Decision). The fact that the exception is limited to vaccines, has a five year duration and does not address WTO rules on trade secrets makes it particularly unlikely to provide expanded access to COVID 19 countermeasures,”
A simple (mutatis mutandis) extension of the June 17, 2022 decision was generally supported on the grounds that it would have been more useful for therapeutics or diagnostics, particularly those with less challenging regulatory pathways than vaccines, and because it was basically crazy to have any export bans (the main issue in the negotiations) on therapeutics or diagnostics during a pandemic.
At some point, the enormous amount of time, attention and political capital invested in what is a narrow and temporary WTO decision was seen as a distraction from more consequential matters, and the members of the WTO have decided to move on.
There is a sense that the global trade system is broken if the WTO cannot agree to appropriate exceptions to patent or other intellectual property rights during a global pandemic.
Several high income countries adopted emergency procedures in the beginning of the pandemic to overcome patent monopolies, including most notably Canada and Germany in the spring of 2020, and the United States throughout all of 2020 and 2021.
The U.S. actions were the most consequential, issuing dozens of FAR 52.227–1 authorization and consent clauses for the research and development and acquisition of COVID-19 countermeasures and also using the Defense Production Act.
The European Unions is in the process of adopting far-reaching measures to provide for EU-wide compulsory licensing, exceptions to rights in regulatory data and measures to compel sharing of manufacturing know-how.
The WTO’s June 17, 2022 decision was a very weak measure compared to what the USA did or the EU proposes.
The tragedy is not so much that the narrow June 27, 2022 decision is not extended, bur rather that the June 17, 2022 decision came more than two years after the beginning of the pandemic and through 2024 the power of the drug companies was able to completely block any future progress.
One lesson to be learned is that it is difficult to regulate drug monopolies in the public interest, even during global emergencies and even then the proposed nuanced exceptions are small.
I hope that going forward, health advocates and policy makers will begin to take seriously the proposals for new approaches to funding R&D that include (1) the de-linking of investment incentives from the grant of the almost-impossible-to-regulate legal monopolies, and (2) a serious discussion of how to share the costs of R&D globally, without relying solely on global intellectual property rules.
