[CTC] Hours to Deadline, Countries Remain Divided at WTO on Extending Temporary Easing of IP rules for COVID-19 Tests & Treatments

Fri Dec 16 10:00:43 PST 2022

> From: Geneva Health Files
> 
> Hours to Deadline, Countries Remain Divided at WTO on Extending Temporary Easing of IP rules for COVID-19 Tests & Treatments <https://substack.com/app-link/post?publication_id=79396&post_id=90601911&utm_source=post-email-title&isFreemail=false&token=eyJ1c2VyX2lkIjo3NjExMDQ2NywicG9zdF9pZCI6OTA2MDE5MTEsImlhdCI6MTY3MTE4MzY2MSwiZXhwIjoxNjczNzc1NjYxLCJpc3MiOiJwdWItNzkzOTYiLCJzdWIiOiJwb3N0LXJlYWN0aW9uIn0.1mKDLnhCPwm5kDOqwmtJ6l5Kt6V0fb70c3voihUSXb0>
> Newsletter Edition #168 [The Curated Primer] 
> PRITI PATNAIK <https://substack.com/redirect/bdee6bdd-1b38-4438-ba4e-071505e4bffb?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI>
> DEC 16
> 
> Hi,
> 
> Today we bring you an update on the anti-climax of the TRIPS Council discussions on easing IP rules for COVID-19 tests and treatments, beyond vaccines.
> 
> This week, countries continue to be sharply divided not only on the crux of the extension decision, but also on how to proceed in 2023. When this story went to print, WTO members were making a last ditch effort to reach consensus on a draft report to be submitted to the General Council meeting. 
> 
> We will update the story on this webpage as the situation evolves. 
> 
> Like our work? Consider supporting our journalism that ensures nuance, detail, and accuracy. Readers paying for our work <https://substack.com/redirect/48023a7b-aa33-4f22-b73e-43b4da560912?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI> helps us meet our costs. Thank you for reading.
> 
> Until later!
> 
> Best,
> 
> Priti
> 
> Feel free to write to us: patnaik.reporting at gmail.com <mailto:patnaik.reporting at gmail.com> or genevahealthfiles at protonmail.com <mailto:genevahealthfiles at protonmail.com>; Follow us on Twitter: @filesgeneva
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> I. STORY OF THE WEEK
> 
> Hours to Deadline, Countries Remain Divided at WTO on Extending Temporary Easing of IP rules for COVID-19 Tests & Treatments
> 
> Uncertainty hung, hours before the deadline for deciding on the extension of temporary relaxation of certain IP rules <https://substack.com/redirect/7f35e674-134d-4127-a2f2-2e1cd261c20d?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI> for COVID-19 tests and treatments. WTO members were divided on the way forward at the end of the six month process that was capped by a deadline of December 17, 2022. Not only was there no agreement to the decision, members also seem to disagree on the next steps ahead to resolve the impasse, according to Geneva based sources.
> 
> Last week, the Chair of the TRIPS Council, Ambassador Lansana Gberie of Sierra Leone, put forward a proposal under his responsibility [WTO Doc JOB/IP/65], suggesting the extension of the deadline for these discussions until June 30, 2023. The proposal is a draft status report, meant for submission to the General Council meeting next week [19-20 December, 2022] at the WTO. Some observers construed this suggestion for an additional six months, as unusual, given the urgency in addressing the burden of the pandemic in many developing countries.
> 
> Last week, the US effectively threw in a spanner in these discussions <https://substack.com/redirect/49432a31-ed64-433d-b054-56c1cfb98330?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI> seeking more time by deciding to launch an investigation <https://substack.com/redirect/5c92c416-caf2-49bc-adf3-95c8a60e37fa?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI> to gather more evidence in order to decide on the extension decision.
> 
> THE TRIPS COUNCIL INFORMAL MEETING [DECEMBER 15, 2022]
> 
> Ahead of the discussions this week, the Chair had circulated a draft report on December 9. The text had reflected the lack of consensus to reach a decision on the extension. The Chair suggested continuing discussions in the TRIPS Council and report back to the General Council by 30 June 2023.
> 
> At the TRIPS Council Informal meeting this week, some developing country members suggested changes to the draft, and did not agree with the version suggested by the Chair.
> 
> The current draft version [JOB/IP/65/Rev.1] reads as following (this is a restricted document not available publicly yet):
> 
> The Chair of the Council for TRIPS proposes the attached amended draft to be adopted as the Council's report to the General Council scheduled for 19-20 December 2022.
> 
> Amendments have been made in paragraphs 5 and 7.
> 
> PARAGRAPH 8 OF THE MINISTERIAL DECISION ON THE TRIPS AGREEMENT ADOPTED ON 17 JUNE 2022 REPORT TO THE GENERAL COUNCIL
> 
> 1. Paragraph 8 of the Ministerial Decision on the TRIPS Agreement 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, Members have held discussions in this regard in formal and informal meetings of the TRIPS Council on 6 July, on 19 September, on 3 and 12-13 October, on 2 and 22 November, and on 6 [and 15] December 2022.
> 
> 3. Delegations have exchanged views, asked questions, and provided responses, clarifications, and information, including through new submissions circulated as documents RD/IP/49, IP/C/W/693, RD/IP/51 and IP/C/W/694. Delegations engaged actively and their detailed substantive exchanges helped clarify various aspects and nuances of positions.
> 
> 4. While delegations remain committed to the common goal of providing timely 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.
> 
> 5. On 6 December 2022 a group of 65 Members tabled a proposal for the General Council to extend the Decision mutatis mutandis to COVID-19 therapeutics and diagnostics. Other Members preferred to continue fact- and evidence-based discussions on whether there are IP- and TRIPS-related barriers to accessing COVID-19 therapeutics and diagnostics, and on the exact scope of a potential extension of the Decision.
> 
> 6. This means that there is currently no consensus among Members to take a decision under paragraph 8 of the Decision.
> 
> 7. In light of the above, discussions in the TRIPS Council will continue and will be reported to the General Council no later than 30 June 2023.
> 
> RESERVATIONS BY DEVELOPING COUNTRIES
> 
> As the above current draft text shows, members disagree on the fundamental question on whether the extension is necessary and appropriate to address access to COVID-19 medical products. While the proponents asked to extend the Decision mutatis mutandis to tests and treatments, other countries, mostly developed ones, have sought time to furnish more facts and evidence to understand if IP is indeed a barrier in the access to COVID-19 medical products.  
> 
> (See our earlier story from last week: WTO could defer decision on COVID-19 tests & treatments, fueled by American resistance to ease IP rules <https://substack.com/redirect/49432a31-ed64-433d-b054-56c1cfb98330?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI>)
> 
> Sources said that countries including Switzerland, the European Union, the United Kingdom and the United States were in favor of adopting the text as suggested by the Chair.
> 
> Members including South Africa, India, Sri Lanka, Pakistan, Egypt and Tanzania on behalf of the African Group, suggested changes to the text of the draft report.  
> 
> They wanted a decision on the extension to be taken at the first General Council Meeting in 2023. They reportedly suggested : "discussions in the TRIPS Council will continue to decide on the extension to cover therapeutics and diagnostics by the first General Council in 2023."
> 
> This group of developing countries also wanted “acknowledge the leading role of WHO in coordinating the global response in the fight against COVID-19 and therefore the WTO will benefit from the WHO's expertise and advice with regard to the global state of therapeutics of diagnostics", according to Geneva-based trade sources.
> 
> According to sources, rich countries did not want a reference to WHO. They reportedly said that the discussion at the WTO has an intellectual property dimension, that goes beyond the remit of WHO. (See our earlier story: WHO Pushes for Better Access to COVID-19 Tests & Treatments at the WTO <https://substack.com/redirect/9ea7458a-3fcc-46b5-80af-00378383e7fe?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI>)
> 
> At WHO, member states seem to be in principle agreeable to have the WHO as the leader in coordinating health emergencies, in the context of the Pandemic Accord discussions. Although, several developed countries made clear that WHO is not the forum to discuss intellectual property matters. (See our earlier story: Emerging Fault Lines Suggest Tough Negotiations Ahead, As Countries Reveal Interests: WHO Pandemic Accord <https://substack.com/redirect/377b3829-f507-465c-ab30-1037695daf61?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI>)
> 
> WHAT’S NEXT
> 
> The chair reportedly regretted the lack of consensus on adopting the draft text. He suggested that a TRIPS Council meeting can be reconvened today, at short notice, on December 16, if differences are ironed out. Failing consensus, the Chair is said to have suggested that he would submit a report on his own responsibility, to the General Council meeting next week.
> 
> Developing countries who sought to introduce changes to the draft are keen on using the final hours of ahead of the December 17 deadline to shape the outcome in order to reflect the urgency of the pandemic.
> 
>  <https://substack.com/redirect/4505af08-78f6-4793-897a-fe29b6a217c3?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI>	
> Image credit: Monstera, Pexels
> NO EXTENSION AT ALL?
> 
> Some sources familiar with the discussions have not ruled out that buying more time, as demanded by developed countries could ultimately result in no extension at all.
> 
> WHO Director General Tedros Adhanom Ghebreyesus indicated this week that he is hopeful that in 2023 COVID-19 would no longer be a global health emergency.
> 
> “At this time a year ago, COVID-19 was killing 50,000 people a week.  Last week, less than 10,000 people lost their lives…There is still a lot that all countries can do to save lives. But we have come a long way.  We are hopeful that at some point next year we will be happy to say that COVID 19 is no longer a global health emergency,” Tedros said in Geneva this week. The WHO Emergency Committee is expected to meet in January 2023 to discuss among other issues, the criteria that will determine the end to the pandemic, he added.
> 
> CALLS TO SUPPORT THE EXTENSION GROW LOUDER
> 
> This week, more than 160 charities, NGOs, campaigners, academics, and health and trade experts from 50 countries called on <https://substack.com/redirect/1eb44c39-a9f5-4d68-bcfe-12a71bd54b55?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI> the WTO to ease patents for COVID-19 tests and treatments before the end of 2022.
> 
> In a letter <https://substack.com/redirect/eb1bc0d5-d2c9-44ce-a9e8-c732b36c5b92?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI>, they warn that the WTO “failed the world” in June with an agreement on vaccines that waived few intellectual property rules and did nothing to mandate the transfer of vaccine technology to lower-income countries. “Despite warm words from many Western leaders,” signatories say, “there was no evidence of solidarity at the WTO.”
> 
> Valentina Montanaro, Global Campaign Head of the People’s Vaccine Alliance, said: “Countries in the Global South should not have to wait for the United States to conduct a lengthy internal review before they can protect their populations. Another delay would be an insult to all those who have died from COVID-19 without access to effective medical tools. The WTO Director-General must step in and insist on a resolution this year. “
> 
> In a statement, the People’s Vaccine Alliance has said:
> 
> “We are very concerned about the lack of Decision at the TRIPS Council meeting on the 6th of December and the proposed delay on this urgent matter until June 2023….
> 
> The WTO has the power and opportunity to help developing countries control the virus by expanding the June 2022 Decision on vaccine intellectual property to cover tests and therapeutics by the 17th December 2022 deadline agreed by WTO member countries.
> 
> The WTO played an important role in the global response to the HIV crisis through the Doha declaration; a landmark WTO agreement that established that public health supersedes commercial interest. This step forward was made possible by WTO members coming together to negotiate in good faith to reach such a compromise.
> 
> We, the People’s Vaccine Alliance, believe that despite its significant limitations, the Decision could still help to diversify manufacturing and improve affordable access if extended to tests and treatments. This is the case because, in contrast to COVID-19 vaccines, technology transfer and a full waiver of intellectual property barriers are not necessary for generic medicine producers to make and export ample supplies of affordable treatments and tests.
> 
> Put simply, after failing the world in June of this year, the WTO is getting a second chance to make a meaningful impact in the fight against COVID-19 before the end of 2022. It has been almost three years since COVID-19 was declared a pandemic. Hundreds of millions of people remain unvaccinated in developing countries, facing the disease without treatment or protection.
> 
> …Hundreds of new treatments are in the pipeline with scores in final trials, but they will remain out of reach without action from the WTO.
> 
> We urge you to publicly resist the deliberate attempts from rich nations to delay negotiations beyond 2022. Any delay would be a damaging blow to the WTO’s credibility.”
> 
> PRESSURE FROM MEMBERS OF THE EUROPEAN PARLIAMENT:
> 
> Scores of MEPs this week, sent a letter of support <https://substack.com/redirect/cbe4551a-6aff-455e-9c4e-b789a72380a3?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI> for a wide TRIPS Waiver calling on Valdis Dombrovskis, Vice-President of the European Commission, and the members of the Council of the European Union.  
> 
> On the June Ministerial decision, the letter said, “The Decision not only fell short of the ambition of the waiver proposed by South Africa and India, and the EP Resolution in November 2021 calling on the EC to support a wide TRIPS waiver, for vaccines, therapeutics and diagnostics, it also restricts its scope to only vaccines, with a six- month deadline to decide whether to extend the decision to therapeutics and diagnostics.”
> 
> Excerpts from the letter:
> 
> “Access to COVID-19 therapeutics and diagnostics remains unequal, with a number of low and middle income countries (LMIC) facing a lack of necessary tools for accurate diagnosis and treatments despite voluntary licenses granted by pharmaceutical companies.
> 
> On 14 September 2022, the World Health Organization (WHO) reminded that widespread testing remains key to reduce deaths, reduce onward transmission and track the evolution of the pandemic globally. Yet testing in Low and Middle Income Countries (LMICs) is significantly lower than in high income countries due in part to limited supply of diagnostic tests to low and middle income countries and lack of equipment adapted and affordable for low-resource settings.
> 
> Patent protection on Covid-19 diagnostic (e.g. CIRSPR and PCR) have inhibited expansion of production to LMICs. Limited manufacturing capacities, linked to patent-based market exclusivity, hindered the necessary scale up of production of vaccines. This could happen again, especially with therapeutics and last-generation diagnostics.
> 
> As members of the European Parliament we would like to emphasize that EU Institutions have already repeatedly signaled support for a product scope covering at least vaccines and therapeutics.
> 
> The European Commission emphasized the use of compulsory licensing for equitable global access to COVID-19 therapeutics and vaccines in its June 2021 Communication to WTO. The Council of the European Union published a draft decision in November 2021 explicitly referring to the use of the TRIPS flexibilities for COVID-19 diagnostics and therapeutics. The European Parliament also called on the European Commission to support a wide TRIPS waiver, at MC12 for vaccines, therapeutics and diagnostics.
> 
> We therefore would like to urge you to maintain the past positions with support of a broader product scope of the TRIPS decision.”
> 
> Also see a recent analysis <https://substack.com/redirect/3244b87c-e83a-4286-a2a6-e3d597b76ee2?j=eyJ1IjoiMTliYjduIn0.bk8Qlm3y2GXta1zMwpMY8y23dzGOnypGAQRqFX1IMeI> from the Center for Global Development: Tough Pills to Swallow: Challenges and Priority Actions for the Rollout of COVID-19 Treatments and Future Access to Medical Countermeasures.
> 
> 
> 

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