Nearly 18 months of tortuous negotiations on the extension of the June 17, 2022 Ministerial Decision on the TRIPS Agreement to COVID-19 diagnostics and therapeutics, in February 2024, the TRIPS Council threw in the towel after consensus could not be reached. As described in document IP/C/100, (Report to the General Council, Paragraph 8 of the Ministerial Decision on the TRIPS Agreement, IP/C/100, 13 February 2024)
4. While delegations remain committed to the common goal of providing timely, equitable and secure access to high-quality, safe, efficacious and affordable medical technologies for all, disagreement persists on whether an extension of the Decision to cover the production and supply
of COVID-19 diagnostics and therapeutics is necessary or appropriate to address any inequitable distribution of such COVID-19 related products.
10. The Council recognizes the considerable efforts Members have made to support a fact- and evidence-based discussion on paragraph 8 of the MC12 Decision on the TRIPS Agreement. Despite these efforts, consensus could not be reached.
An earlier version of the draft report of the TRIPS Council (JOB/IP/73, 26 January 2024) circulated by the Chair of the TRIPS Council, Ambassador Pimchanok Pitfield (Thailand) cast a more dismal outlook on the state-of-play of WTO negotiations on the extension of the June 2022 Ministerial Decision on the TRIPS Agreement to COVID-19 diagnostics and therapeutics.
The draft report stated:
10. The Council acknowledges that discussions are exhausted and that there is no consensus on an extension of the Decision to COVID-19 diagnostics and therapeutics. It therefore recommends the conclusion of the discussion under paragraph 8 of the Decision.
After opposition from some WTO Members, references to “exhausted” and “conclusion” were deleted. The wording in the final report (IP/C/100) reads as follows:
10. The Council recognizes the considerable efforts Members have made to support a fact- and evidence-based discussion on paragraph 8 of the MC12 Decision on the TRIPS Agreement. Despite these efforts, consensus could not be reached.
The report traced the arc of negotiations from Paragraph 8 of the June 2022 Ministerial Decision on the TRIPS Agreement.
1. Paragraph 8 of the Ministerial Decision on the TRIPS Agreement1 adopted on 17 June 2022 (the “Decision”) provides that [n]o later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics
2. Since the adoption of the Decision in 2022, Members have held extensive discussions in this regard in informal consultations in various formats, as well as at all formal and informal meetings of the Council for TRIPS in 2022 and 2023
.
Although the endgame of the 18 month WTO negotiations on the extension of the Ministerial Decision on the TRIPS Agreement to COVID-19 diagnostics and therapeutics resulted with a damp squib, progress was made in relation to the TRIPS Council’s work program on the role of IP in addressing future pandemics. In the report of the TRIPS Council to the WTO General Council on Paragraphs 23-24 of the WTO Ministerial Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics (IP/C/99, 13 February 2024), the report stated:
5. The Council for TRIPS will continue its work as directed by the Declaration, to review and build on all the lessons learned and the challenges experienced during the COVID-19 pandemic, to build effective solutions in case of future pandemics, in an expeditious manner.
Perhaps of greater significance is that the TRIPS Council report (IP/C/99) flagged the following concerns raised by many countries: “many Members expressed interest in deepening the discussion on this matter, including on voluntary licensing, technology transfer, the operation of the Medicines Patent Pool (MPP), geographical limitations of voluntary licences, and the operation of Article 31(f) of the TRIPS Agreement.” In terms of the WTO’s future engagement on the role played by intellectual property in addressing future pandemics, the TRIPS Council’s examination of the geographical limitations of voluntary licences and the operation of the MPP will be key. However, the TRIPS Council should also explore non-Article 31(f) solutions including (but not limited to): Article 30, Article 31(k), Article 44, and Article 73.
Ellen ‘t Hoen, (Director, Medicines Law & Policy) provided the following response:
“The failure of the WTO to extend the Covid decision to include the very products the decision would have been most useful for, will increase the the pressure on the negotiations of the Pandemic Accord which enters its last round of talks next week at the WHO to ensure strong provisions on technology transfer and IP sharing.”
Luis Villarroel, (Director, Innovarte) stated:
“Non-article 31(f) flexibilities, such as Article 30, Article 31(k) and Article 44 are widely under-exploited by developing countries vis-à-vis countries like the United States, putting them in a a position that undermines their capacity to respond to public health needs. The Council for Trips should ask themselves why this is happening and what can be done to overcome it.