COVID IP Waiver: Latest EU Proposal Sidesteps Key IP Barriers like Trade Secrets and Data Sharing, Charges MSF Analysis 15/10/2021 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Accra, Ghana health worker displays used vial of COVID-19 vaccine in March 2021, at start of the African rollout of vaccines by the COVAX global facility first began. Distribution stalled only a month later as COVAX suppliers dried up. Despite what some observes called an encouraging “change of tone”, this week’s round of World Trade Organization (WTO) debates over a proposed waiver on IP restrictions for COVID vaccines, treatments and other health products have concluded with no signs of substantive progress. Meanwhile, Médecins Sans Frontières lashed out again at the European Union on Friday, for what it described as “another misleading attempt” to undermine the waiver proposal – by focusing only on a narrow band of technical fixes to the current set of global agreements around IP. The waiver initiative has mustered strong support from over 100 low- and middle-income countries (LMICs) that see it as a way to jump-start more local medicines and vaccines production in countries that have only managed to immunise a small fraction of their population against SARS CoV2 – as compared to the 50%-70% coverage seen in rich nations. It is just as sharply opposed by an EU-led bloc of high-income countries that maintain there are more powerful factors driving vaccine scarcity – including a sheer dearth of technical capacity in LMICs to quickly establish vetted vaccine manufacturing facilities. The WTO TRIPS Council, which manages the set of WTO agreements on the Trade-Related Aspecs of Intellectual Propery (TRIPS) now has just six weeks now to reach an agreement on the charged IP issue ahead of the WTO’s climactic 12th Ministerial Council (MC12) meeting that begins 30 November. Said one Geneva-based trade official observing this week’s rounds of negotiations: “Despite the change of language and tone shown by the delegations, … members’ positions on substance do not deviate dramatically from what he heard in previous TRIPS Council meetings. MSF says EU proposal for limited waiver, side-steps ‘trade secret’ barriers to LMIC production Germany has been one of the main opponents of the WTO IP waiver. Portrayed here, Health Minister Jens Spahn at WHO briefing in Geneva in July. The latest EU proposal, leaked to the Huffington Post, remains focused only on a very limited waiver of some of the technical restrictions that currently limit countries’ ability to issue so-called “compulsory licenses” for the generic production of patented health products. In fact the EU position has changed little since its last formal proposal in June, which MSF described then as “weak and distracting’’. The EU arguments, spelled out in another document, reportedly leaked from the EU’s Directorate General of Trade (DG Trade), thus fail to address other critical IP areas that constrain access, such as “regulatory data and trade secrets”, MSF said. A broader waiver, mandating the release of such proprietary technologies, is needed “particularly in view of originator companies refusing to share their technologies,” asserted MSF in its briefing published on Friday. ”As per MSF analysis, the new leaked EU document again focuses only on compulsory licensing on patents…” said the MSF statement. “It focuses on products, but completely excludes mention of underlying technologies, components, raw materials, process and methods that are also protected under intellectual property (IP) and are equally important to initiate production by other companies. The document would still require each country to individually file and apply compulsory licenses on each component, product, etc. making required international collaboration difficult and exposing governments to the risk of being sued by IP-holding companies India describes EU proposals as “redundant” Speaking at the closed TRIPS Council meetings on Wednesday and Thursday, India also stressed that EU proposals for relaxing the restrictions around countries’ right to issue “compulsory licenses” for patented products are anyway “redundant” because the “requirement to negotiate with the right holder of the vaccine patent does not apply in urgent situations such as a pandemic,” in any case. The EU retorted that its proposals are intended to provide more “legal certainty” about steps that can be taken in the context of the pandemic. “ The EU also cited “many points of convergence” on the more technical reforms that it has proposed to simplify existing compulsory license rules and restrictions, with respect to obligations vis a vis: notification, marking, labelling, remuneration, the coverage of multiple countries in one single compulsory license notification, and the issuance of a single compulsory license for multiple patents. One EU official was quoted as saying that it was: “difficult to understand how, on the one hand, some members underline problems with the use of the compulsory licensing because it is too cumbersome. “And on the other hand, whenever the EU tries to have a discussion about how to address these issues it is told that it is only repeating or reiterating what is already absolutely clear. “It is either one or the other, either everything is absolutely clear and can be used, or there are some issues that we can work on,” the EU official was reported as saying. Access groups say high income countries failed to deliver Vaccine-sharing commitments by rich countries have not been fulfilled, leading to massive frustration. The dispute over the IP waiver also has become a lighting rod for the wider controversy around how high-income countries have failed to deliver on vaccines and medicines access to less affluent nations, observers say. After the massive buy-up of vaccines in late 2020 and early 2021 by a group of high and middle-income countries, the WHO Co-sponsored COVAX global vaccine facility was forced to rely almost exclusively on vaccines procured from the Serum Institute of India, for its massive vaccine distribution plan to LMICs. Those supplies dried up in April, when India faced its own COVID crisis. Developed countries have since failed to deliver on big commitments made since to share their own excess doses – despite the risks that rich countries’ vaccine hoarding will simply lead to the wastage of hundreds of millions of doses by the end of this year. The net result has been that currently, less than 3% of Africans have been fully vaccinated – making it unlikely that Africa will reach the 40% global goal set by WHO for vaccine coverage by the end of this year. And while pharma manufacturers, notably Moderna and Pfizer, have both announced new initiatives to manufacture more vaccine products in Africa – they remain only in initial stages of development – with actual production by Pfizer of 100 million doses in South Africa scheduled to start only next year – and Moderna’s more ambitious plan, even later. US administration – growing frustrations Greenpeace activists project messages outside Geneva’s WTO building in June, calling for approval an IP waiver on COVID-19 health products. Amidst the fraught European-LMIC dispute over the trade waiver, the US has still remained on the fence – saying earlier this year that it would support a waiver on vaccines – but not making concrete moves yet in the WTO council to advance that position. However, in domestic fora, the US Administration of Joe Biden has hinted at the possibility that it could invoke the US Defense Production Act to provoke pharma companies to produce more doses, more rapidly – pointing the finger at Moderna in particular. “The government played a very substantial role in making it that company, and that does up the ante on Moderna,” Biden’s Chief Science Officer, David Kessler said on Wednesday, referring to the US$ 10 billion invested in the company for its mRNA vaccine development. “They understand what we expect to happen. This government hasn’t made a decision yet on what it will do. But we are waiting.” Kessler was speaking at an online session, moderated by Yale law professor Amy Amy Kapczynski. According to a recent New York times investigation, only about 1 milion Moderna mRNA doses have reached low-income countries, as compared to 8.4 million for Pfizer’s vaccine – even though Moderna’s formulation is more temperature stable and thus more suited for LMIC conditions. Moderna’s slow expansion is viewed as particularly problematic in light of the fact that it is a clear vaccine front-runner – viewed as equal to, or possibly even better, than the Pfizer vaccine in terms of longevity of the protection that it offers to the SARS-CoV2 virus. Kessel linked Moderan’s slow expansion to the fact that its proprietory mRNA technology secrets are an asset that “they are reluctant to give up.” Even so, “there is a way to build, with Moderna and Lonza, significant capacity on continents like Africa and we expect them to do so,” he said. TRIPS Council members reconvening 26 October in small group sessions There remains however, “some reason for optimism”, insofar as members are “engaging with each other bilaterally”, the official added. After an inconclusive end to this week’s meetings, TRIPS Council members are set to resume a series of small group consultations on 26 October, in an effort to break the impasse. The aim is to reconvene the TRIPS Council once again to sign off on a hoped-for agreement in time for the next WTO General Council meeting 22-23 November, and from there, an agreement at MC12. Image Credits: @WTO , WHO, @Airfinity/BBC , Maxime Gautier/ Greenpeace. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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