Growing Consensus Emerging At WTO – Strengthen Supply Chain & Tech Transfer To Expand Vaccine Access Analysis 15/04/2021 • Svĕt Lustig Vijay 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) WTO Headquarters in Geneva A growing consensus seems to be emerging out of this week’s high-level WTO meeting that glaring inequities in access to vaccines can be remedied by strengthening supply chains, avoiding export bans across borders, and ensuring that big pharma voluntarily transfers its vaccine technologies to poorer countries so they can produce their own vaccines. “The significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable,” said United States Trade Representative Katherine Tai, in a statement published out of her appearance Wednesday at the WTO’s closed-door discussion with high-level representatives from industry, government and civil society on Wednesday. “As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis”, she added. “The same needs to be demanded of industry.” Broader Technology Transfer in Poorer Countries is Possible, Says Iweala Ngozi Okonjo-Iweala, WTO’s newly elected Director-General While Tai’s comments at the WTO forum were deemed “unfair” by the US Chamber of Commerce, the WTO’s new director-general, Ngozi Okonjo-Iweala, seemed to agree that the vaccine industry should more aggressively expand technology transfer in low- and middle-income countries – noting that in one case, technology transfer took only six months. “One of the things that came out [of the discussions at the WTO] is that yes indeed, there is manufacturing capacity that exists now that can be turned around to produce more [vaccine],” she said. However, she did acknowledge that scaling-up vaccine production will also require the training of more skilled personnel, recruitment of raw materials, and stable supply chains. Going forward, “more active” matchmaking between companies with investment capacity and those with untapped production capacity could be fruitful to boost vaccine production in low-income countries, she added. Terrific conference yesterday on solving the problem of inequity in access to vaccines – so no one has to stand in line. Grateful to all the participants; governments, international orgs, vaccine manufacturers, and CSOs! Lots of learning, lot’s of concrete follow up action! https://t.co/YRW1Y1ESf0 — Ngozi Okonjo-Iweala (@NOIweala) April 15, 2021 Discussions On Intellectual Property Waiver Have “Advanced Knowledge” Okonjo-Iweala also said that the closed-door discussions had “advanced knowledge” about the issues surrounding the proposed waiver on WTO rules related to Trade Related Aspects of Intellectual Property (TRIPS). Since it was proposed last year by South Africa and India, the intellectual property waiver has been backed by almost a half of WTO members and discussed eight times at the WTO. However, it seems to have remained in limbo, mostly due to fierce opposition by industry leaders and high-income WTO countries, including key European Union members, the United Kingdom, United States, Switzerland, and Japan. Rather than a wholesale waiver, existing “flexibilities” in the TRIPS agreement could be used to fast-track solutions where needed, said the EU’s Executive Vice-President in a statement after Wednesday’s WTO meeting. “Should voluntary solutions fail, the TRIPS Agreement already provides a framework for sharing technology through the granting of compulsory licences,” said the EU’s Valdis Dombrovskis. “This includes fast-track compulsory licences for export to countries without manufacturing capacity.” Civil Society Call To Revise TRIPS agreement; No Mention Of IP Waiver At the same time, civil society advocates joining the discussions seemed to be steering away from a focus on the IP waiver proposal, instead calling on the WTO to make a series of meaningful technical amendments in the existing TRIPS Agreement – as well as helping low- and middle-income countries to make more effective use of the exceptions contained in the rules. Currently exceptions in the TRIPS agreement are difficult and cumbersome to implement, KEI’s James Love said. He called on WTO members to act on a seven point plan – some related to the easing of existing TRIPS legalities and others outside of its current scope, that he said would ramp up manufacturing capacity. Specifically, he called on WTO and its members for the following measures: Transparency of contracts: Encourage greater transparency of contracts made between by pharma and member states – in line with a recent International Monetary Fund proposal; also, he urged greater transparency from pharma and member states in reporting about drug and vaccine R&D costs, vaccine revenues and the number of doses distributed. Exports of products produced by compulsory licenses: Revise what he called a “flawed” Article 31f and 31bis of the TRIPS agreement, which allows generic producers to export products manufactured under a compulsory license to other low- and middle-income countries only under very restricted conditions; “during a pandemic, there should be no restrictions on the ability to export a useful product under a compulsory license,” added Love. Model Exceptions. The WTO should collaborate with WHO on the development of model patent exceptions for emergencies, Love said, citing Germany and Canada as examples of countries that have already created such legal frameworks – which are often lacking elsewhere. Sharing know-how. Love cited the “failure” of governments that invested heavily in vaccine R&D to include in their funding agreements “measures to require the sharing of manufacturing know-how and access to working cell lines and rights in data.” In the future, the WTO can work with the WHO to develop “initially soft norms” on how such know-how sharing provisions should be included in future R&D funding agreements. WTO Agreement on the Supply of Public Goods. “The pandemic is part of the larger challenge of supporting the global commons. The WTO has been asked to consider a new agreement, based in some ways on the GATS, to create voluntary offers of binding commitments to supply public goods.” Buyouts of know-how. While not the best option last year when governments were funding R&D, today it should be given consideration, he said. Remove sanctions on Cuba, with respect to health related products. “There should be no sanctions on Cuba that relate to the development and distribution of its two promising vaccine candidates.” “There has been an appalling lack of transparency, including regarding the agreements to subsidize and de-risk the research and development of vaccines, as well as procurement contracts and licensing agreements,” Love said. “WTO agreement patent flexibilities have been used in some cases, but many countries have laws poorly equipped to deal with pandemics, vaccines or biologic products, and the provisions in the agreement on exports are flawed.” “And while it is possible to issue a compulsory license on patented inventions, there are few national laws and no global agreements on providing access to manufacturing know-how, working cell lines and rights in test data.” As a further step to support public acquisition of critical know-how, Love has suggested that governments create a buyout fund to allow for “full technology transfer”, including rights to inventions, data, know-how, and biologic resources – similar to the deals reached by private pharma companies such as AstraZeneca when it purchased Oxford’s vaccine technology and/or Pfizer’s acquisition of BioNtech. He has emphasized that governments may not need to buy out the know-how for all vaccines – and suggested that as little as $20 million in funding, with an aim of an initial $1 billion, could help kick off negotiations with manufacturers. Image Credits: @WTO/Bryan Lehmann. 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. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.