On 4 December 2023, the World Trade Organization (WTO) published a document (WT/GC/W/913, IP/C/W/694/Rev.1) entitled, “Decision text on extension of the 17 June 2022 Ministerial Decision to COVID-19 therapeutics and diagnostics”. This document is a communication from Bangaldesh, The Plurinational State of Bolivia, Egypt, India, Indonesia, Pakistan, South Africa, and the Bolivarian Republic of Venezuela on behalf of the Co-Sponsors of the IP/C/W 669/REV.1 Proposal (the TRIPS waiver proposal). The content of this proposal (IP/C/W/694) was originally published on 6 December 2022.
This updated decision text (WT/GC/W/913, IP/C/W/694/Rev.1) is on the agenda of the WTO General Council meeting scheduled for 14-15 December 2023 (Agenda item 3(III). The chapeau of this document states:
- On 17 June 2022, WTO Members adopted a Ministerial Decision on the TRIPS Agreement, document WT/MIN(22)/30 [WT/L/1141]. This Decision is far removed from the comprehensive TRIPS waiver proposal contained in documents IP/C/W/669 and IP/C/W/669/Rev.1 (“original TRIPS waiver proposal”) co sponsored by 65 WTO Members (co-sponsors).
- A more comprehensive waiver decision as envisaged in the original TRIPS waiver proposal would support the efforts to ensure timely, equitable and universal access to safe, affordable and effective therapeutics and diagnostics, ramping up of production and expanding supply options. The MC12 Ministerial Decision on the TRIPS Agreement (document WT/MIN(22)/30) is the result of over one and a half years of arduous and lengthy discussions on the original TRIPS waiver proposal and intense negotiations heading towards the 12th Ministerial Conference in the midst of a global crisis. It is of limited scope covering only vaccines.
- Diagnostics and therapeutics are essential tools for a comprehensive approach to fight the pandemic, that it is not over. Omitting these vital tools will deter the effectiveness of the decision that aims timely and affordable access to effective vaccines against the ongoing COVID-19 pandemic. Cosponsors have provided extensive facts and evidence, among others, in documents IP/C/W/670, IP/C/W/672, IP/C/W/673 IP/C/W/674, IP/C/W/684 and RD/IP/49 as well as submissions in the TRIPS Council. Much of which has been supported by distinguished health experts.
- At a minimum, the extension of the policy tools provided in document WT/MIN(22)/30 to therapeutics and diagnostics will result in a holistic approach to enable developing countries to address those IP barriers that prevent the expansion and diversification of production and increase accessibility to crucial life-saving COVID-19 tools. The current outcome represents a narrow-conditioned Decision due to demands of some WTO Members, requiring significant compromises on the part of the co-sponsors that had hoped for greater solidarity among WTO Members during a public health emergency and consequently a more comprehensive waiver decision as envisaged in the original TRIPS waiver proposal that would support ramping up of production and expanding supply options.
The proposed decision reads as follows:
General Council Decision on Extension of the 17 June 2022 Ministerial Decision to COVID-19 Therapeutics and Diagnostics (hereafter referred to as ‘Therapeutics and Diagnostics Decision’)
The General Council
Having regard to the 17 June 2022 Ministerial Decision on the TRIPS Agreement, document WT/MIN(22)/30
Decides as follows:
The MC12 Decision on the TRIPS agreement is extended mutatis mutandis for the production and supply of COVID-19 therapeutics and diagnostics.
An eligible Member may apply the provisions of this Therapeutics and Diagnostics Decision until 5 years from the date of this Decision. Any extension of the MC12 Decision on the TRIPS Agreement pursuant to paragraph 6 shall apply to this Decision as well.
However, based on positions expressed at the most recent TRIPS Council meeting in June 2023, it remains unlikely that the impasse on the extension of the MC12 Decision on the TRIPS agreement to Covid-19 therapeutics and diagnostics will be resolved by the end of 2023.
Here is a snapshot of WTO Members’ view from the June 2023 TRIPS Council not amenable to the proposed extension (Source: Minutes of the TRIPS Council, IP/C/M/108/Add.1).
“Switzerland’s view on a possible extension of the MC12 TRIPS Decision to COVID-19 therapeutics and diagnostics is well-known. Switzerland does not support an extension. We are convinced that an extension is unnecessary and would be counterproductive to our common goal of ensuring timely, affordable and equitable access and to pandemic preparedness.”
“The discussions are difficult and the situation is complex. Views vary, as we can also see in the present discussion. One important element that, in our view, adds to the complexity is the lack of a clear definition of these products, contrary to the situation of COVID-19 vaccines.
In addition there are multiple factors that affect their accessibility and affordability, such as available financing, licensing, procurement mechanisms or regulatory procedures, to name just a few. Following the discussions in the TRIPS Council in the last year and this one, it is clear that for a number of delegations open questions remain, especially as regards to the adequacy of the supply of COVID-19 therapeutics and diagnostics, the effect of mechanisms that are run by Medicines Patent Pool, UNICEF or the Global Fund on access to these products and, more generally, the assessment of various factors that contribute to the accessibility and affordability of COVID-19 therapeutics and diagnostics in low and medium-income countries.”
“In order to prepare for future pandemics, it is necessary to have mechanisms that provide strong incentives for the research and development of vaccines, diagnostics and therapeutics. From this perspective, intellectual property rights and the TRIPS Agreement play a crucial role in the research and development of vaccines, diagnostics and therapeutics.
With regard to paragraph 8 of the Ministerial Decision, Japan continues to believe that consideration and discussion about its extension for diagnostics and therapeutics should be based on facts and evidence regarding the multifaceted impact of IPRs and the TRIPS Agreement upon the production and supply thereof, within the context of COVID-19. In this regard, we understand that facts and evidence regarding various points of view from many stakeholders are included within the documents submitted and the ongoing investigation by USITC, and we appreciate these efforts.
Japan has shared various types of facts and evidence during past meetings for the purpose of holding a constructive discussion in order to reach a consensus-based decision among Members, and we are ready to continue contributing to this discussion in a constructive manner.”
“The MC12 Decision on COVID-19 vaccines was brokered in a particular context of the pandemic and was clear in its scope and applicability. The landscape for COVID-19 vaccines is very different to that for therapeutics and diagnostics, both in terms of supply and demand dynamics, and the scope of products covered. At present, the United Kingdom has not formed a conclusion on an extension and we are still considering our position. The United Kingdom supports discussions, led by evidence and facts, as a necessary step to determine whether an extension is required, taking into account other factors, including unintended consequences that a broader scope may bring.
We welcomed the discussion papers circulated last year, by Mexico and Switzerland, and Chinese Taipei, as important contributions to the discussion. We understand that pertinent questions raised by these submissions are yet to be addressed. These relate to, among other things, identifying if any barriers to accessing COVID-19 therapeutics and diagnostics are caused by IP, how product scope could be defined, the current supply and demand dynamics for these products, as well as concerns over the broad scope of a possible extension.
Chinese Taipei’s paper raised two fundamental questions: whether IP rights are the cause of insufficient accessibility, and whether an extension of the Decision will help? Their paper also notes the role of patents in incentivizing innovation and how weakening patent protection could adversely affect collective efforts to fight the pandemic.”
More recently, on 17 October 2023, the United State Trade Representative (USTR) released the following statement upon publication of the United States International Trade Commission’s report, “COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities.”
“Our office will carefully review the USITC’s findings alongside our colleagues throughout the Biden-Harris Administration. We look forward to having Congress and all stakeholders review this report too.
I would like to thank Chairman Johanson and the USITC for conducting this important investigation. We hope that the facts in this report and the record the USITC has meticulously gathered will help inform a thoughtful and constructive policy discussion and deliberative process here at home, around the world, and at the World Trade Organization on matters so critically important to global public health and economic resilience.”
With no clear timeline in sight for USTR, Congress, and all stakeholders to review the USITC’s 497 page report, the prospects for the extension of the 17 June 2022 Ministerial Decsion (on vaccines) to diagnostics and theraeutics appear grim.