WHO DG's Marked Shift on Intellectual Property: Cautions Against Undermining IP on Access to COVID-19 Tests & Treatments at WTO. Implications for "Equity" in Current Negotiations
Newsletter Edition #61 [Treaty Talks]
Hi,
One question can change the conversation.
Last week, WHO DG Tedros had an exclusive press briefing for Geneva-based journalists. A senior journalist asked his opinion on the moribund discussions at the WTO on extending certain clarifications existing rules in the TRIPS agreement to boost access to COVID-19 tests and treatments. (These rules currently only apply to COVID-19 vaccines.)
The DG’s views on IP were surprising, for it was the first time that he not only did not support the decision to extend these rules to COVID-19 tests and treatments, he went further and underscored the importance of IP, essentially echoing the position of some developed countries and the industry.
You do not have to go back very many months, to see that Tedros has been one of the more vocal champions of loosening IP rules in a time-bound manner during the pandemic of COVID-19. So his change in position is telling and hard to understand.
The DG speaks his mind, on all matters and is seen as an astute leader fluent with navigating global health politics. So what he says has significance. More so, when countries are wrangling over equity and access matters in a new Pandemic Agreement.
Read our report on this important and somewhat revealing update that will have implications on how the narrative on access to medicines during health emergencies will take shape in the coming months. (We also have an update from last week’s General Council Meeting at the WTO where the extension decision was discussed.)
The year is almost over, but never a dull moment in even in the twilight weeks of 2023.
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This is our final reported edition for this year. We will be back early to mid-January, after the Christmas break.
Watch out for the round up of our stories over the last few months, and more.
Until later.
Best,
Priti
Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva
I. STORY OF THE WEEK
WHO DG's Marked Shift on Intellectual Property: Cautions Against Undermining IP on Access to COVID-19 Tests & Treatments at WTO. Implications for "Equity" in Current Negotiations
Nishant Sirohi contributed to this story
In a distinct shift from his position on using existing flexibilities in the intellectual property system to respond effectively to COVID-19, WHO DG Tedros Adhanom Ghebreyesus last week rung a note of caution against undermining IP, and being measured while dealing with such rules, when asked about extending certain agreed rules at the WTO to boost access to tests and treatments.
These rules already apply to the production of COVID-19 vaccines. WTO members have failed to agree on the extension of these rules to therapeutics and diagnostics.
This was the first time since COVID-19 first appeared in 2020, that the DG of the WHO has taken such a position. He has been known for his position of being an unequivocal supporter during the TRIPS Waiver discussions at the WTO – that resulted in streamlining rules on compulsory licensing in the TRIPS Agreement, at the ministerial conference in June 2022.
His remarks come at a time when WHO member states are deeply divided on how and to what extent should access to medical products be made available during health emergencies and pandemics. Countries are negotiating a new Pandemic Agreement and also amending the International Health Regulations in light of COVID-19.
Largely developed countries have reiterated their known positions on preserving IP for innovation, and many developing countries see IP as a barrier in the access to medicines, particularly illustrated not only, but most visibly during COVID-19. The question on IP is central to a range of critical issues from tech transfer, to access and benefits sharing mechanism, to production and local manufacturing.
THE WHO DG ON IP
At an exclusive briefing organized for Geneva-based journalists by the Association of Accredited Correspondents at the United Nations, on December 15th, a senior journalist D Ravikanth, asked Tedros on whether he was disappointed that the World Trade Organisation is unable to extend the TRIPS Agreement to cover COVID-19 diagnostics and therapeutics? “You used to talk about vaccine inequity. Doesn't failure on this issue increase the inequity of access to diagnostics and therapeutics all over the world?,” he asked the DG.
In his response, Tedros said: “I think the IP issues, they are part of the negotiations now in the pandemic accord. And I hope the Member States will have a common ground. If you take IP, you know, we have to be careful because they should not be undermined…should not be undermined because it helps innovation. And if we're going to use it, we should also use it responsibly and in a very measured way. So, we need to strike a balance and I hope during the current negotiations, Member States will do that, to refrain from undermining it, but at the same time also find the common ground to use it in a measured [way]. And, you know, in a responsible way, and that's what I expect.”
This statement effectively mirrors the positions taken by not only developed countries that house the biggest pharmaceutical companies in the world, but also of the industry itself.
His choice of words in the response above is significant. His statement went beyond the immediate, narrow question on the extension decision at the WTO. But he also raised the larger issue of how IP should be addressed in the on-going negotiations, effectively taking a position on the matter.
While this is not unusual, particularly for a DG like Tedros, who has taken several independent and strong positions, whether formerly supporting the TRIPS waiver allegedly at the disappointment of some WHO donor states who opposed the waiver talks at the WTO; or more recently on Palestine and calling for a ceasefire for example.
(This statement has to be also viewed in the context of a new Medical Countermeasures Platform discussed at WHO, outside of on-going negotiations.)
THE DG ON PANDEMIC ACCORD NEGOTIATIONS
Geneva Health Files also asked the DG about the current rate of progress in the negotiations. “Are you disappointed with the state of the negotiations towards a pandemic treaty? There continues to be a lot of divergence between the positions of developed and developing countries, and May 2024 is not far enough. Do you think that countries should focus their energies instead on strengthening and amending the IHR?”
Tedros said:
“On the Pandemic Accord you right, there are different interests, of course. And the process is a bit slow, but at the same time, we believe that it's going in the right direction. Of course, like any negotiation there are different interests….So far, we have identified four, I think, the four sticky issues. The Member States have identified, the Bureau has identified, and they have already established four Working Groups based on those issues. For instance, local production and technology transfer is one, and benefit sharing is another one, financing. So that I think going forward, since they have identified the priority areas. They can have the negotiations through these working groups that represent the different interests. And I hope that Member States will move forward and we believe that the Pandemic Accord can be finalised by May 2024. That's what I believe.
Of course, there is a bit of a speed issue. But our Member States are working hard, and there will be, as a solution, a middle ground that will bring all 194 countries into an agreement.
INB, the pandemic accord we need that, the IHR cannot replace it. And the amendment of the IHR is also important, in that it supplements to the Pandemic Accord and both the INB and IHR are progressing and we hope we will have it by May 2024.”
STATUS OF THE TRIPS EXTENSION DECISION AT THE WTO
GENERAL COUNCIL MEETING: DECEMBER 13-15
At the General Council Meeting at the WTO last week, the extension of the TRIPS decision to COVID-19 tests and treatments came up yet again without any resolution. Geneva-based trade sources told us that it is not clear yet whether the extension decision will feature on the agenda of the 13th Ministerial Conference in February 2024. So far there is no TRIPS council meeting scheduled ahead of the conference.
Co-sponsors of the TRIPS Waiver proposal published a new document dated 1, December 2023 (WT/GC/W/913) earlier this month for consideration at the GC meeting.
Decision Text On Extension Of The 17 June 2022 Ministerial Decision To COVID-19 Therapeutics And Diagnostics (Communication From The Delegations Of Bangladesh, 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)
Stating here in full:
“The following communication, dated 1 December 2023, is being circulated at the request of the delegations of Bangladesh, 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.
1. 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).
2. 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.
3. 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.
4. 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.
5. In view of this context and paragraph 8 of the Ministerial Decision, the co-sponsors call on the General Council to immediately extend the 17 June TRIPS Decision adopted by the Ministers by consensus after long protracted negotiations, mutatis mutandis to therapeutics and diagnostics. WTO Members have an opportunity to show they can act promptly to respond to the ongoing COVID-19 pandemic and the challenge of inequitable access to therapeutics and diagnostics and respond to the criticism that the Decision on vaccines came too little too late.
6. We call on the General Council to immediately adopt the annexed decision
ANNEX DECISION TEXT
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.
Also see from KEI: WTO: Prospects to adopt proposed decision text on the extension of the 17 June 2022 Ministerial Decision to Covid-19 therapeutics and diagnostics appear grim. KEI has published minutes of a prior TRIPS council meeting that present the statements of developed countries on the extension decision”
(Source: Minutes of the TRIPS Council, IP/C/M/108/Add.1).
Other references:
See our recent analysis: A Wait In Vain? The USITC Report on the WTO TRIPS Extension Decision For COVID-19 Tests & Treatments
Also, an update from TWN on the GC meeting on the extension decision: Members push mandated issues to trade ministers at MC13
From HPW: EU Hoarding Then Dumping COVID Vaccines Highlights Pandemic Accord Equity Challenge
Politico reported: “EU countries destroy €4B worth of COVID vaccines”
Also see this podcast from us for more context on the failings during COVID-19: The Geneva Health Files Interview with Fatima Hassan)
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