What’s the next step for a COVID-19 intellectual property waiver?
The United States has supported an intellectual property waiver related to COVID-19 vaccines. What happens next? John Zarocostas reports from Geneva.
The “monumental” change in the Biden administration, breaking with decades of bipartisan politics and declaring on May 5 that it would support negotiations at the World Trade Organization (WTO) on lifting intellectual property protection for COVID-19 vaccines, has been hailed as a step in the right direction to address massive shortages and inequalities in supply. However, experts say there is still a long way to go before a waiver is passed, and more needs to be done to improve manufacturing capacity.
In the face of glaring shortages and rapid transmission of SARS-CoV-2, on October 2, 2020, India and South Africa proposed a temporary waiver of the WTO Agreement on Aspects of Property Rights Intellectual Property Rights (TRIPS) that would allow countries to suspend intellectual property protections for COVID-19 medical products – including vaccines, drugs, diagnostics, personal protective equipment and ventilators – for the duration of the pandemic. The goal is to accelerate access to affordable medical products for the prevention, containment or treatment of COVID-19. It also includes a “peace clause” according to which measures taken will not be subject to a dispute settlement dispute at the WTO.
Such a measure had been considered by the WTO. A 2013 WTO publication on the history and future of the world trade body concluded with insight: “The logic of patents may be more difficult to defend in the face of a public health crisis, especially when there are few effective drugs and these remain within the scope of the patent. term, which can lead to calls for the breaking or relaxation of patents. WTO Director General Ngozi Okonjo-Iweala told WTO delegates on May 5: The issue of equitable access to vaccines, diagnostics and therapies is both a moral and an economic issue. From our era.”
However, the proposal was mired in disagreement. Until the surprise policy returns, the US, as well as the EU, Australia, Brazil, Canada, Japan, Norway, Singapore, Switzerland, Taiwan, and the UK, s ‘were opposed to the joint proposal, which now has 62 co-sponsors and is supported by more than 100 of the 164 WTO members. The WTO operates by consensus, but if this cannot be achieved, a decision to grant the exceptional waiver should be adopted by three quarters of the membership. With the change of course by the United States, there was hope that other opposing countries would follow suit. “In relations between nations, political commitments matter, especially when made by the world’s largest economy,” said Alan Wolff, distinguished visiting scholar at the Peterson Institute for International Economics, based in Washington DC, and until recently, the deputy director general of the WTO, said The Lancet.
Following the Biden administration’s backing for a waiver, China and Russia, both proactive in vaccine diplomacy, also publicly announced their support for waiver negotiations at the WTO, increasing pressure on the government. EU and others. But we do not know how the other opponents will proceed. Ellen ‘t Hoen, Director of Medicines Legislation and Policy, said The Lancet “We haven’t heard a consistent response from the EU – Angela Merkel (German Chancellor) has been a consistent ‘no’. But some EU countries want to support the waiver. On May 7, Merkel told EU leaders that she did not think patent waivers were the answer and stressed that questioning patents “is not the way that will lead us to more and better vaccines ”. The EU, which normally has a common position on WTO issues, has said it is ready to discuss how to increase the supply of vaccines and other medical products.
Besides Germany, top 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 limited to vaccines alone, and could try to drag out negotiations.
Arthur Appleton, assistant professor at Johns Hopkins University, said The Lancet “It may be difficult to reach consensus for a waiver among the 164 members of the WTO given the divergent views on the scope of the proposed waiver.” The waivers said they would come up with a revised proposal, which is expected to be tabled in May and considered before the TRIPS Council meeting scheduled for June 8. The Lancet the revised text will retain 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 United States supports discussions on waiving intellectual property protections only for COVID-19 vaccines, while the India-South Africa proposal included waivers for all COVID-19 health technologies. Germán Velásquez, special adviser on policy and health at the South Center of Geneva, is more skeptical and says The Lancet he thinks that “the United States will try to delay the issue and weaken the text.”
“It is important that these negotiations in the TRIPS Council move forward quickly and result in a text that countries can easily implement in their national legislation. WHO strongly recommends that the exemption also apply to diagnostics, therapies and other tools to prevent, diagnose and treat COVID-19, ”said Mariângela Simão, WHO Assistant Director-General for ‘access to health products. The Lancet.
Intellectual property industry consultants and health diplomats say waiver will not solve immediate problem of huge vaccine production deficit compounded 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 the production capacity, distribution and production of raw materials and equipment used to manufacture packaging and transport vaccines”, Appleton said. “Of course, the mere threat of a waiver can help reduce the cost of vaccines, therapeutics and diagnostic tools, and translate into increased access in developing countries. The threat can also lead to voluntary licensing agreements on terms favorable to developing countries. “
Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations, said The Lancet that “The waiver would also call into question the framework that gives companies the confidence to sign contracts with other manufacturers with whom they voluntarily collaborate. 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 establishment of more than 280 partnerships and collaborations among vaccine manufacturers around the world. “As a result, the production capacity of the COVID-19 vaccine was increased in a matter of months from zero to 1.7 billion in April, and it is expected that 11.6 billion doses of the COVID-19 vaccine will be produced by this time. the end of 2021. “
For technologies, such as drugs, ‘t Hoen noted, a waiver of intellectual property would be sufficient to allow the production of generics. However, for vaccines, in addition to intellectual property, “you need additional technology transfer or access to materials such as cell lines. Some of them may be in the public domain. But if not, the original company or research institute should provide it ”.
Velásquez says expanding spare capacity in some developing economies could take 6 to 9 months. A study by McKinsey, the management consulting firm, estimated that technology transfer times for injectable vaccines range from 18 to over 30 months.
A spokesperson for Gavi, the Vaccine Alliance, while welcoming the US decision, said The Lancet that “Gavi now urges that, in the interest of fair access globally, the United States support manufacturers to transfer not only intellectual property but also know-how in order to stimulate worldwide production. “
“Now that intellectual property issues are potentially 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 the relevant technologies and know-how are transferred to as many qualified manufacturers as possible. WHO urges current Member States and 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 center ”. C-TAP is a mechanism put in place by WHO last June that enables voluntary licensing of technologies in a transparent and non-exclusive manner by providing a platform for developers to share intellectual property and data, including trade secrets and know-how. However, to date, no pharmaceutical company has registered.
Marie-Paule Kieny, research director at Inserm in Paris, said The Lancet “WHO has tried to help build or leverage vaccine manufacturing capacity in developing countries, and there is certainly capacity in some developing countries like Bangladesh, Argentina and other countries. in development. But patents aren’t the only problem. Indeed, there are no patents in most developing countries that 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 wasted in expanding vaccine manufacturing capacity,” said ‘t Hoen. “I hope the waiver discussions and US support in this regard will give C-TAP a boost. Whatever the manufacturing initiative, it is obvious that we need a global mechanism for sharing vaccine technologies. “
James Love, director of Knowledge Ecology International, said he believes C-TAP needs to be restarted to remain relevant. “For C-TAP to be relevant, it needs to have a top-level leader whose only job is to make it work, and who can push industry and governments to engage. C-TAP should at least hold press conferences every two weeks and explain what is going well and why things are not going well. “
© 2021 Elsevier Ltd. All rights reserved.