On May 5, 2021, the US Government announced that it was in favour of waiving intellectual property protections for the COVID-19 vaccines. “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures”, stated US Trade Representative, Katherine Tai. “The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.” Tai added that the USA would pursue such a waiver at the World Trade Organisation (WTO).

WHO Director-General, Tedros Adhanom Ghebreyesus, described the announcement as a “monumental moment in the fight against COVID-19”. Yuan Qiong Hu, Senior Legal and Policy Advisor at Médecins Sans Frontières' Access Campaign, told The Lancet Respiratory Medicine that it was a “significant step in the right direction”. Others were less keen. “The limiting factors in the production of vaccines are the production capacities and the high-quality standards and not patents”, said a spokesperson for the German Government. “The protection of intellectual property is a source of innovation and must remain so in the future.”

Discussions over waiving intellectual property protections for a range of COVID-19 tools and technologies have been ongoing at WTO for several months. The waiver was initially proposed by India and South Africa in October, 2020. It has since been endorsed by more than 100 governments around the world. Opponents include Australia, Brazil, the European Union, and the UK. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement establishes minimum international standards for protecting and enforcing patents. It includes provisions for waivers, but nation states still have to agree on the scope of the measures. The new announcement by the USA is a powerful boost for supporters of a waiver.

The statement by Tai only mentioned vaccines, which implies that the USA would not back a more broadly applied waiver. Hu thinks this is regrettable. “The original proposal was trying to cover all of the essential tools needed for treatment, prevention, and diagnostics”, she said. “There are ongoing supply shortages and many are related to intellectual property. Until we can start vaccinating people in serious numbers, we should make sure that the medical profession has everything it needs to save lives.”

As of May 6, 2021, 19 million doses of the COVID-19 vaccines had been administered in the whole of Africa. In the UK alone, 55 million doses have been administered. Only 10% of Indians have received a single dose of the COVID-19 vaccine compared with over half of Americans. India has been averaging 400 000 new daily cases of COVID-19 since the beginning of May, 2021. The vaccines remain in short supply. AstraZeneca and Johnson & Johnson have experienced serious production problems. As The Lancet Respiratory Medicine went to press, Novavax stated that their vaccine candidate will not be authorised in the USA or UK any earlier than July.

“There is no doubt that richer countries are surging ahead with their vaccination drives, while many poorer nations are barely getting started”, said Olivier Wouters, Assistant Professor of Health Policy at the London School of Economics and Political Science. He welcomed the proposal to waive patents for the COVID-19 vaccines, citing the large sums of public money that went into developing several of the vaccines, but warned that it may not be effective without a comprehensive strategy to boost production in low-income and middle-income countries.

“For this to work, the companies that developed the COVID-19 vaccines will need to share the technical know-how around their vaccines, either directly with other manufacturers or with co-ordinating bodies”, explained Wouters. Substantial funding will be also needed to scale up manufacturing in poorer nations. Hu stressed the importance of ensuring that all relevant intellectual property is shared. “There are hundreds, if not thousands, of background intellectual property attached to the mRNA vaccine technology, for example”, she said. “You would have to open up that whole space to transfer vaccine development.”

Tai's statement cautioned that the WTO negotiations “will take time given the consensus-based nature of the institution and the complexity of the issues involved”. Even if the waiver is granted, it will not address the shortages of raw materials that are impeding production of the COVID-19 vaccines. Indeed, as more vaccines obtain authorisation and put further pressures on supply lines, these shortages could worsen. Nor would a waiver do anything to fix the problem of richer nations hoarding the limited supplies of the available vaccines. Wouters called on countries where new cases are declining and vaccination drives have covered key populations to donate vaccines to the COVAX facility. “We should reflect on whether it is reasonable for richer nations to vaccinate healthy people in their twenties and thirties before other nations have covered those most vulnerable to this virus”, he said.

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DOI: https://doi.org/10.1016/S2213-2600(21)00241-1

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