BREAKING – US Swings Weight Behind Global IP Waiver On COVID Vaccines; WTO Inches Towards ‘Text-Based’ Negotiations Intellectual Property 05/05/2021 • 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 email this to a friend (Opens in new window)Click to print (Opens in new window) World Trade Organization Director General Ngozi Onkonjo-Iweala presides over a meeting of the General Council discussing a proposal to suspend IP rules on COVID health products for the duration of the pandemic The United States has swung its weight behind a hotly-debated proposal by India and South Africa to suspend intellectual property rights on COVID-19 vaccines for the duration of the pandemic. The dramatic turnabout in the US position, announced Wednesday evening by US Trade Representative Katherine Tai, signals a sea change in the balance of powers around the debate over the IP waiver – which until now had been supported primarily by low- and middle-income countries. These extraordinary times and circumstances of call for extraordinary measures. The US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and we’ll actively participate in @WTO negotiations to make that happen. pic.twitter.com/96ERlboZS8 — Ambassador Katherine Tai (@AmbassadorTai) May 5, 2021 The announcement came on the heels of a World Trade Organization (WTO) General Council meeting where members seemed to be inching towards more granular, text-based, negotiations over the proposal by South Africa and India to temporarily suspend intellectual property rights COVID-19 treatments, tests and vaccines. It also came just afrer the two co-sponsors had said that they would revise their original blanket waiver proposal – in a bid to reconcile positions between the LMIC bloc of supporters and the primarily high-income opponents. Now, with the US administration of President Joe Biden behind the waiver concept – albeit only for vaccines – the revisions required to eventually reach consensus may become less daunting. “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary meausres,” said Tai in her statement, published by the Office of the US Trade Representative. “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the wiaver of those prpotections for COVID-19 vaccines,” she said in the statement. “We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen.” The US shift brought a swift reaction from all sides in the polarized debate – which has seen the pharma industry and civil society go head-to-head over the highly-technical IP issue. A statement by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) warned that waiving IP is the wrong answer to a complex problem. “Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis,” the statement said. “On the contrary, it is likely to lead to disruption, while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally.” Move Hailed by Waiver Advocates – But Some Protest Limitations To ‘Vaccines’ On the other side of the divide, the heads of WHO and most other global health agencies hailed the move, as did medicines access advocates, who have waged a hard camapign for the measure. But some voices also criticized the fact that the US statement referred only to “COVID-19 vaccines” and not treatments or tests – signalling the long road that still remains to reach consensus. Among the first to express support was WHO Director General Dr Tedros Adhanom Ghebreyesus – who has not concealed his position on the controversial initiative. The WHO DG called it a reflection of the “wisdom and moral leadership” of the United States. The @WhiteHouse support for the temporary waiving IP on #COVID19 vaccines reflects the wisdom and moral leadership of 🇺🇸 to support #VaccinEquity and work to end this pandemic. #InThisTogether — Tedros Adhanom Ghebreyesus (@DrTedros) May 5, 2021 Jeremy Farrar, director of the Wellcome Trust, an insitution that has invested heavily in key aspects of pharma’s COVID vaccine R&D, called it a “hugely important decision from Ambassador Tai and the USA.” At the same time, Jamie Love, head of the advocacy group, Knowledge Ecology International, said that by only tagging “vaccines” and not COVID tests or treatments, the initiative still doesn’t go far enough. “One reason why Biden will back a waiver on vaccines but not therapeutics or diagnostics, is that vaccines in foreign markets protect us. Therapeutics, diagnostics in foreign markets, don’t,” tweeted Love which has lobbied hard in the US and globally for the waiver. “Yeah – I think this is the next step of the battle. Tons of money going into treatments now, no reason to leave them out,” tweeted back, Nick Dearden, director of the UK-based non-profit Global Justice Now. One reason why Biden will back a waiver on vaccines but not therapeutics or diagnostics, is that vaccines in foreign markets protect us. Therapeutics, diagnostics in foreign markets, don't. — James Love (@jamie_love) May 5, 2021 At Wednesday’s WTO General Council meeting, meanwhile, WTO Director General Ngozi Okonjo-Iweala welcomed news of South Africa’s and India’s plans to revise the original IP Waiver proposal, submitted in October 2020. She urged all WTO members to advance to more nuanced talks over ways to ensure trade enables the scale up of needed COVID health products, as well as ensuring their freer and more equitable flow between countries. “I am firmly convinced that once we can sit down with an actual text in front of us, we shall find a pragmatic way forward, acceptable to all sides that allow the kinds of answers that our developing country members are looking at with respect to vaccines, whilst at the same time looking at research and innovation and how to protect them,” DG Okonko-Iweala said. TRIPS IP Waiver – Proposal Seen Polarizing Debate African health officials have appealed for more COVID vaccines after current supplies run out in some countries. The TRIPS waiver, initially championed by South Africa and India. has since been co-sponsored by a total of 60 WTO members, including Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, and the Least Developed Countries (LDC) Group. The proposal would suspend trade rules on COVID vaccines and medicines IP, governed by the WTO “TRIPS” Agreement on Trade Related Agreement on Aspects of Intellectual Property. While current rules do allow for countries to produce their own versions of patented products during health emergencies, many lower and middle-income countries (LMICs) have said that the IP “flexibilities” are in fact too rigid, and don’t really allow for the rapid scale-up of vaccines and medicines required by the COVID-19 pandemic. At the same time, G-7 countries, including the US, UK, European Union, Switzerland, Japan and Australia, as well as pharma industry stakeholders, have been lined up against the waiver proposal since its inception. Opponents say that what is really missing is technical capacity in LMICs to produce their own health products. In addition, broken supply chains for just one input into a vaccine, can create a bottleneck for manufacturing scale up. With the new US position, It can be expected that a revised proposal, might seek to expand existing TRIPS flexibilities on vaccines, per se, while still stopping short of the blanket waiver that was proposed in October on all COVID tests, treatments and equipments. A revised proposal might also address some of the deeper structural problems that exist in current trade rules – particularly the barriers that countries face when producing vital COVID health products under a “compulsory license” – to exporting those products to third country partners. And at least rhetorically, a revised proposal may try to tackle some of the broader supply chain, tech transfer and capacity building issues that everyone agrees are obstacles. In her statement Wednesday, Tai warned that negotiations on the waiver proposal “will take time, given the consensus nature of the institution [WTO] and the complexity of the issues involved.” However, the debate is likely to resume soon. South Africa and India have already proposed that the TRIPS Council hold a special meeting open to all WTO members in the second half of May. That would be followed by a formal TRIPS Council meeting in early June. WTO Needs “Sense of Urgency” Keith Rockwell, WTO spokesperson at Wednesday briefing. Iweala has constantly called for WTO members to etch a “third way” in the debate over the waiver issue. In her comments Wednesday, she urged WTO members to act quickly to ensure that the Agency can do its part to expand access to COVID treatments and vaccines more equitably. “The way the WTO handles this matter is critical,” DG Okonjo-Iweala told members. “We need to have a sense of urgency on how we approach this issue of response to COVID-19 because the world is watching.” “Vaccine policy is economic policy because the global economic recovery cannot be sustained unless we find a way to get equitable access to vaccines, therapeutics, and diagnostics,” she added. WTO spokesperson Keith Rockwell said that Wednesday’s WTO discussion was “far more constructive, pragmatic” and less “emotive” and contentious than previous debates – with some 42 delegations taking the floor. “We’ve learned in the last few weeks, that there is unutilized capacity in the developing world that can be tapped into in order to help to meet the demand,” said Rockwell. But what’s also clear is that there are “many other things” driving shortages – even if the “TRIPS waiver …were to be approved in its in its revised form. “There are many, many other factors that need to come into play. Among them, and perhaps the foremost among them is the importance of transferring know how to new production sites. It’s not enough to have the recipe for making these vaccines, you need to have the know how, as well that means, trained, skilled workers. It means having the right equipment. It also means having a regulatory infrastructure that is both strict and transparent.” In line with that, he said that member states were now also focusing on these and other key barriers to scale-up: “Many members have also said he calls for much greater transparency in terms of dealings between, between innovators and producers and governments, so that the terms of the of the transfers of technology for example, are more clear to everyone involved. Those are important elements to this. “In addition to that, we’ve seen a quite a lot of discussion about how it would be that we could tap into the unused capacity that’s been identified in recent weeks in the developing world,” he said, referring to Iweala’s estimates that the world may need to go from 5 billion doses [of all vaccines] produced last year to 10.8 billion – or even 15 billion doses – if there is a need to produce COVID booster doses. Moving Ahead – Iweala’s Four Points Ngozi Okonjo-Iweala, Director-General of the WTO, at a press conference held shortly after taking office. She pledged to bring countries together over access to COVID vaccines. In her closed-door comments at the WTO, Iweala stressed to members that countries need to step up the sharing of vaccines immediately – while negotiations over the waiver proceed. “Those who have ordered more than they need, need to share them with others, either through the COVAX facility or other mechanisms,” she was quoted as saying, by WTO spokesperson Keith Rockwell. “Secondly, it’s important that we look closely at export restrictions and prohibitions, and bureaucratic procedures customs procedures, red tape that has slowed the trade in vaccines diagnostics and therapeutics,” Rockwell said. Referring back to a high-level meeting with pharma companies last month, he noted that they had stressed that one of the biggest obstacles to ramping up production was access to raw inputs and materials: “We heard from one company… they said that because of a lack of filters, they had to shut down the entire production process. “So, even relatively simple or even mundane things like that vitals tubes, filters, if they’re not available, this can have an impact. Trading these products as well as in the ingredients for vaccines must continue. Thirdly, Iweala stressed the importance of WTO member countries to work with manufacturers to enable them to mobilize the existing capacity that’s idle: “She mentioned countries that we’ve heard from – Pakistan, Bangladesh, India, South Africa, Indonesia and Senegal. All said, there is more capacity that has gone underutilized….because of the need for technology and the need for the raw materials. Meanwhile, Iweala also urged Russia, China, Cuba and Brazil, which have vaccines under development, to “be in touch with the, with the World Health Organization to get emergency use authorization to enable universal access to these vaccines.” So far, China and Russia have focused on bilateral deals for vaccine distribution to LMICs – rather than working through WHO and the global COVAX vaccine facility. While China’s vaccines are currently in late stages of WHO quality and efficacy review – although the Russian Sputnik V vaccine remains further behind. Stocks In Vaccine Producers Plummet Along with any statements, the industry reaction was also evident in the stock market. Shares of Moderna, Pfizer and BioNTech dropped upon the US news – including a decline of 9.7% in Moderna stocks, which Bloomberg reported as the biggest intraday drop in two months. Pfizer dropped as much as 2.6% and American depositary receipts of Germany’s BioNTech retreated as much as 8.9%. Novavax Inc., which is also developing a Covid-19 vaccine, declined as much as 11%, Bloomberg reported. By Thursday morning, however, some of the same stocks had rebounded. This story was updated on 6 May. Image Credits: @WTO, WHO African Region , BBC. 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) 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.