What next for a COVID-19 intellectual property waiver?
Authors: John Zarocostas
Journal: The Lancet (2021)

The USA has backed a waiver for intellectual property related to COVID-19 vaccines. What happens next? John Zarocostas reports from Geneva. The “monumental” shift by the Biden administration, breaking with decades of bipartisan policy and declaring on May 5 it would support negotiations at the World Trade Organization (WTO) on waiving intellectual property protections for COVID-19 vaccines, has been welcomed as a step in the right direction to address the massive shortages and inequities in supplies. However, experts say that there is a long way to go before a waiver is adopted, and much work remains to improve manufacturing capacity. In the face of glaring shortages and rapid transmission of SARS-CoV-2, on Oct 2, 2020, India and South Africa proposed a temporary waiver of the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that would permit countries to suspend intellectual property protections for COVID-19 medical products—including vaccines, medicines, diagnostics, personal protective equipment, and ventilators—for the duration of the pandemic. The aim is to speed up access to affordable medical products for the prevention, containment, or treatment of COVID-19. It also includes a “peace clause” that the measures taken shall not be subject to a WTO dispute settlement challenge. Such a step had been envisaged by the WTO. A 2013 WTO publication on the history and future of the global trade body had insightfully concluded, “The logic of patents can be harder to defend in the face of a public health crisis, especially when there are few efficacious drugs and these remain within the patent term, that can lead to calls for the breaking or easing of patents.” Ngozi Okonjo-Iweala, WTO director-general, on May 5, told WTO delegates: “The issue of equitable access to vaccines, diagnostics, and therapeutics is both the moral and economic issue of our time.” However, the proposal has been mired in disagreement. Until the surprise policy U-turn, the USA, along with the EU, Australia, Brazil, Canada, Japan, Norway, Singapore, Switzerland, Taiwan, and the UK, had opposed the joint proposal, which now has 62 co-sponsors and is supported by more than 100 of the WTO's 164 members. The WTO works by consensus, but if this cannot be reached, a decision to grant the exceptional waiver would need to be adopted by three-quarters of members. With the USA changing tack, there has been hope that the other opposing countries would follow. “In the relations among nations, political commitments matter, especially when made by the world's largest economy”, Alan Wolff, distinguished visiting fellow at the Washington DC-based Peterson Institute for International Economics, and until recently, WTO deputy director-general, told The Lancet. Following the Biden administration's support for a waiver, China and Russia, both proactive in vaccine diplomacy, have also publicly announced they support talks on a waiver at the WTO, increasing the pressure on the EU and others. But it is unclear how other opponents will proceed. Ellen 't Hoen, director of Medicines Law and Policy, told The Lancet “We have not heard a coherent response from the EU—Angela Merkel (German Chancellor) has been a consistent ‘no’. But some of the EU countries want to support the waiver.” On May 7, Merkel told EU leaders that she does not believe that patent waivers are the solution and stressed that calling patents into question “is not the way that will lead us to more and better vaccines”. The EU, which normally has a joint position on WTO issues, has said it is ready to discuss how to ramp up supplies of vaccines and other medical products. Aside from Germany, senior WTO diplomats expect Switzerland, South Korea, and Japan—all countries with influential pharmaceutical industries—to try to resist a waiver, especially if the scope is not narrowed to just vaccines, and could try to drag talks out. Arthur Appleton, an adjunct professor at Johns Hopkins University, told The Lancet “it may be difficult to secure a consensus for a waiver among the 164 WTO members given divergent views on the breadth of the proposed waiver”. The proponents of the waiver have announced they will put forward a revised proposal, which is expected to be tabled in May and to be discussed in the lead-up to a TRIPS Council meeting slated for June 8. Geneva-based diplomats told The Lancet the revised text will keep “the broader perspective” and the scope will be the same, but clarified further, include flexible language, and address the period during which it will apply. The USA supports talks on waiving intellectual property protections only for COVID-19 vaccines, whereas the India–South Africa proposal included waivers for all COVID-19 health technologies. Germán Velásquez, special adviser on policy and health at the South Centre, Geneva, is more sceptical and told The Lancet he thinks “the US will try to delay the issue and try to weaken the text”. “It is important these negotiations at the TRIPS Council move fast and result in a text that countries can easily implement in their national legislation. WHO strongly recommends that the waiver also apply to diagnostics, therapeutics, and other tools to prevent, diagnose, and treat COVID-19”, Mariângela Simão, WHO Assistant-Director General for Access to Health Products, told The Lancet. Intellectual property industry consultants and health diplomats say the waiver will not solve the immediate problem of the huge shortfall in vaccine production aggravated by vaccine nationalism, hoarding of supplies, and poor sharing or donation of COVID-19 vaccines. “Even if a waiver is approved, there may still be bottlenecks related to production capacity, distribution, and the production of raw materials and equipment used to manufacture package and transport vaccines”, said Appleton. “Of course, just the threat of a waiver may help drive down the cost of vaccines, therapeutics, and diagnostic tools, and result in increased access in the developing world. The threat may also lead to voluntary licensing agreements on terms favourable to developing countries.” Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, told The Lancet that “The waiver would also put into question the framework that gives companies the trust to sign contracts with other manufacturers they voluntarily collaborate with. The waiver is at best a distraction, at worst it will disrupt the supply chain and divert scarce resources.” No coercion was needed, Cueni noted, to encourage the setting up of more than 280 partnerships and collaborations among vaccine manufacturers worldwide. “As a result COVID-19 vaccine production capacity has been scaled up in a matter of months from zero to 1·7 billion in April, and it is anticipated that 11·6 billion COVID-19 vaccine doses will be produced by the end of 2021.” For technologies, such as medicines, 't Hoen has noted, an intellectual property waiver would be sufficient to allow generic production. However, for vaccines, in addition to the intellectual property “you need additional technology transfer or access to materials such as cell lines. Some of those may be in the public domain. But if not the original company or research institute would have to provide this”. Velásquez says that expanding idle capacity in some developing economies could take 6–9 months. A study by McKinsey, the management consultancy, estimated that technology transfer times for injectable vaccines range from 18 to more than 30 months. A spokesperson for Gavi, the Vaccine Alliance, while welcoming the decision by the USA, told The Lancet that “Gavi urges now that in the interest of global equitable access, the US supports manufacturers to transfer not only intellectual property but also know-how in a bid to boost global production.” “Now that intellectual property issues are potentially being addressed, it is even more important that we engage in knowledge sharing and technology transfer”, said Simão. “The complex process of vaccine production can be accelerated if relevant technologies and know-how are transferred to as many qualified manufacturers as possible. WHO urges the member states and current manufacturers to actively collaborate with WHO to share their know-how, data, and technologies through the WHO COVID-19 Technology Access Pool (C-TAP) and the mRNA technology transfer hub”. C-TAP is a mechanism established by WHO last June that enables the voluntary licensing of technologies in a transparent and non-exclusive way by providing a platform for developers to share intellectual property and data including trade secrets and know-how. However, to date no pharmaceutical companies have signed up. Marie-Paule Kieny, research director at Inserm in Paris, told The Lancet “WHO has been trying to help build or leverage vaccine manufacturing capacity in developing countries, and there is certainly capacity in some developing countries such as Bangladesh, Argentina, and other developing nations. But patents are not the only issue. Indeed, there are no patents in most developing countries which would hinder the production of mRNA vaccines”. “Companies have so far not been willing to collaborate with C-TAP and as a result a year is lost in expanding vaccine manufacturing capacity”, said 't Hoen. “I hope that the waiver discussions and the US's support for it will give a boost to C-TAP. Whatever the manufacturing initiative, it is obvious that we need a global mechanism for sharing of vaccine technologies.” James Love, Director of Knowledge Ecology International, said that he thinks C-TAP needs to be rebooted if it is to remain relevant. “For C-TAP to become relevant, it needs to have a high profile leader whose only job is to make it work, and who can push industry and governments to engage. C-TAP needs to hold at least biweekly press conferences, and explain what is going right, and why things are not going right.”