WTO Chief Hopes for “Workable Compromise” on TRIPS Waiver by June; US Signs Deal to Share COVID Vaccine Know-How with WHO Medicines & Vaccines 12/05/2022 • Raisa Santos & 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 email this to a friend (Opens in new window)Click to print (Opens in new window) President Biden announces licenses between the NIH and the WHO Covid-19 Technology Access Pool (C-TAP) at the US Global COVID-19 Summit. The United States National Institute of Health (NIH) has finalized an agreement with WHO’s COVID-19 patent sharing facility (C-TAP) to share the patent rights on 11 government-funded coronavirus medicine and vaccine technologies – in what is perhaps the most significant agreement to date with WHO to share closely-guarded pharma know-how. The announcement was made today by US President Biden at the opening of the second Global COVID-19 Summit, co-hosted by the United States, Belize, Germany, Indonesia and Senegal which raised a total of $3 billion toward various forms of pandemic preparedness and response. That included a total of $960 million in commitments from the US and other developed countries toward the creation of a new Pandemic Preparedness and Health Security Fund to be housed by the World Bank. The new $200 million US contribution comes in addition to $250 million pledged last year, said US Secretary of Health and Human Services, Xavier Becerra, speaking at the Summit. Creation of a standing fund was recommended last year by The Independent Panel, whose critical review had noted that a standing pool of finance needs to be readily available to spur faster pandemic response. The pledges should provide the seed money needed to formally create the new Financial Intermediary Fund (FIF), said World Bank President David Malpass, speaking at the summit. “I’m hopeful that this will be enough to give us critical mass and we can work with the G-20 and get the steps done to take the FIF to our board in June,” he said. ‘Hope to be ready on TRIPS waiver’ by June World Trade Organization Director General Dr Ngozi Okonjo-Iweala speaking at the Second COVID-19 Summit But the World Trade Organization’s Director General Dr Ngozi Okonjo-Iweala said more would be needed to really operationalize the finance facility effectively. “Today’s commitments are good but they are just a down payment on the $10 billion a year needed to seed this fund,” she said “So we hope to see more commitments coming, while now the task remains to operationalize the FIF.” Meanwhile, Iweala expressed hopes that the WTO would finally be ready to present a compromise draft proposal for a “TRIPS” waiver on intellectual property for COVID vaccines to the Ministerial Council (MC-12) when it convenes in June. “We hope to have a workable compromise, that is being debated right now, and we hope it will be ready in June,” she told the Summit. Negotiations over the long-deadlocked initiative to waive the so-called TRIPS agreement on Trade Related Aspects of Intellectual Property Rights, was originally proposed by India and South Africa in 2020, but languished for months before a breakthrough just last week, when WTO published an “outcome document“, negotiated by the four-member “Quad” leading negotiations. Although unfinished, that text represented a significant bridging of once deeply-divided positions between developed countries led by the United States and the European Union, and developing countries, led by India and South Africa. The evolving agreement would allow countries that export less than 10% of the world’s total COVID vaccine supplies to apply the “waiver” to the generic production of vaccines for domestic use as well as for export, with minimal transaction costs. While China, a large COVID vaccine exporter, initially objected to explicit the 10% clause, China’s WTO Ambassador, Li Chenggang suggested to an informal meeting of the TRIPS Council this week that it could voluntarily abstain from taking advantage of the waiver if explicit mention of the 10% rule was dropped – clearing away another obstacle to final approval. Developed countries pledge $2 billion in immediate pandemic response Tanzania, once COVID vaccine hesitant, now aspires to 70% coverage. At the Summit, global leaders also pledged over $2 billion more in funding for immediate COVID response; much of it to be funneled into the WHO co-sponsored Act Accelerator (ACT-A), for procurement of vaccines, treatments, tests and health system capacity-building. That included a CAD 735 million donation from Canada and over $300 million from Spain, along with pledges by Australia, Austria, Sweden, Italy, South Africa and Thailand, to donate over 130 million more vaccine doses to low-income countries. And the African Union, as well as 16 low-and-middle income countries individually, also said they would invest more domestic resources in health systems, pandemic preparedness and COVID vaccine campaigns – along with new product R&D and manufacturing. The pledges included one by Africa’s most populous nation, Nigeria, to train 10,000 more frontline healthcare workers by December 2022 on basic infection prevention and control along with supporting more laboratory capacity for genomic sequencing, and a 70% COVID vaccination goal. Tanzania, once the most vaccine-hesitant country on the continent, pledged to vaccinate 70% of all eligible Tanzanians against COVID by fall 2022. Rwanda also pledged to reach the 70% goal by the year’s end as well as doubling booster coverage from 30-60% of those eligible. LMICs seeking know-how not donations However, it is vaccine know-how, not vaccine and medicines donations that low- and middle income countries stress that they are seeking now – and the NIH deal with C-TAP goes at least a step in that direction, long-sought by WHO. Significantly, the new US deal opens the way for generic manufacture of at least some components of patented mRNA vaccine technology. Those include technologies for producing the stabilized spike protein used in the leading COVID-19 mRNA vaccines produced by Pfizer and Moderna, as well as research tools for vaccine, therapeutic and diagnostic development as well as early-stage vaccine candidates and diagnostics. The US deal with WHO for sharing the 11 COVID-19 technologies also includes the Geneva-based non-profit Medicines Patent Pool (MPP), which has experience in the actual negotiation of licenses with generic manufacturers to supply WHO-approved treatments to low- and middle-income countries. Both WHO and the MPP welcomed the agreement, which would make these technologies more accessible to people in low- and middle-income countries and help to overcome the pandemic. “I welcome the generous contribution NIH has made to C-TAP and its example of solidarity and sharing,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. Sharing and empowering lower-income countries Lab technicians at work in Cape Town’s Afrigen Vaccines & Biologics, part of the WHO-supported mRNA Vaccine Technology Transfer hub created in Cape Town. “Whether it’s today’s pandemic or tomorrow’s health emergency, it’s through sharing and empowering lower-income countries to manufacture their own health tools that we can ensure a healthier future for everyone,” said Tedros, just before appearing at the Global COVID-19 Summit, hosted by The White House on Thursday. “We are honored to sign these public health-driven license agreements with NIH under the auspices of C-TAP with the goal of providing equitable access to life-saving health products for the most vulnerable in the world,” said Charles Gore, MPP Executive Director. The first major donation to the C-TAP, the WHO COVID-19 Technology Access Pool came from Spain in Nov. 2021 for a serological antibody test that checks for the presence of anti-SARS-CoV-2 antibodies. The longstanding WHO effort to build a repository of treatments, tests and vaccines available to any country on an open license had, until now, failed to gain much buy-in from either governments, researchers or industry. WHO has since refocused more of its efforts on building a series of technology transfer hubs that aimed to train researchers and jump-start manufacturing of vaccines and other innovations – including a hub for mRNA Technology Transfer, based in Cape Town and a Global BIomanufacturing Workforce Training Hub in the Republic of Korea. US pledges to ‘do its part’ with licensing agreement Word that the US would be sharing COVID technologies first came in March, announced by US Secretary of Health and Human Services Xavier Becerra at a virtual meeting with other ministers of health. “Sharing our scientific knowledge and health technologies with C-TAP to foster the development of crucial medical countermeasures is another step we are taking to assist our global partners in our shared fight against this devastating disease,” remarked Becerra. Said Biden in announcing the deal: “The United States will continue to do its part.” Image Credits: Luis Gil Abinader/Twitter , Rodger Bosch for MPP/WHO. 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