WTO battle over Covid-19 vaccine patents must not hold back world’s vaccination drive

Patents are not a critical barrier in the complex challenge of vaccine manufacture and roll-out, as seen in India
But arguing about patent waivers is distracting – people are dying in alarming numbers and our urgent priority must be to get shots into arms

David Dodwell

Published: 2:30pm, 7 May 2021

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As big pharmaceutical companies this week faced off in the World Trade Organization against the 100-strong People’s Vaccine alliance in a battle over whether to uphold or waive Covid-19-related intellectual property rights – and US President Joe Biden broke with decades of strident support of US companies’ IP rights by backing a waiver – one had to wonder if the guns are being pointed in the wrong direction.

Pharmaceutical giants can be hate figures because of their sometimes-extortionate drug pricing and profits. But as funeral pyres burn across India, thousands die daily in Brazil, and with the entire African continent still short of Covid-19 vaccines, the challenge is to get millions of jabs in arms as quickly as possible. If an IP waiver does not achieve this, it is a red herring.

Evidence is embarrassingly strong that the rich are hoarding the world’s vaccines. As a Nature magazine feature summarised in March, we need 11 billion vaccine doses – assuming two per person – to immunise 70 per cent of the world and achieve herd immunity.

So far, 8.6 billion doses have been ordered, 6 billion of these by rich countries. The US, European Union, Britain and several other affluent countries have bought at least four vaccine doses per adult in their populations.

With this hoarding, and a normal global production capacity of 3.5 billion doses, most people living in the poor parts of the world are unlikely to get vaccinated against Covid-19 until at least the end of 2022. Africa’s 1.2 billion people have so far received a bare 37 million doses.

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As US Senator Bernie Sanders complained: “There is something morally objectionable about rich countries being able to get that vaccine, and yet millions and billions of people in poor countries are unable to afford it.” There is also widespread recognition that none of us is safe until all of us are.

However, it is one thing to recognise the urgent moral and practical need to distribute vaccines more widely, and quite another to believe that restrictive IP laws – embodied in the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement – amount to a critical barrier.

Biden’s radical and controversial change of heart has aroused whelps of protest from pharmaceutical groups and brought their share prices tumbling. Yet, most experts argue that whatever we think about the way “big pharma” exploits IP laws to protect sales and boost profits, a waiver would be marginal in efforts to get more people vaccinated in the poor world, and that the vaccine distribution challenge is immensely complex.

“There are a lot of hurdles to a global Covid-19 vaccine roll-out that are totally unrelated to IP,” wrote Professor Gary Winslett at Middlebury College in Vermont. Besides, developing countries facing a health emergency already have the power to issue a compulsory licence to override TRIPs, he noted.

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At University College London, chair of IP law Robin Jacob added his endorsement that there is “no evidence” companies would be able to make the vaccines if patents were released.

At the International Vaccine Institute in Seoul, Jerome Kim adds his voice: “The thing about vaccines is that, unlike a drug, you can’t just [follow instructions] and assume that you’ve got a vaccine. This is a complex biological process that has multiple quality-control steps.”

It involves research and development, practical know-how, large numbers of highly trained people, complex procurement challenges, regulation, large-scale production capacity, supportive trade policy, and meticulous management of immensely complex, temperature-controlled supply chains.

Expect Biden to ramp up US vaccine production and distribution, export or donate its huge vaccine stockpile, and encourage international licensing and technology transfer.

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The reality of unprecedented cooperation between pharmaceutical groups to create Covid-19 vaccines illustrates the point well. Pfizer, which works with German group BioNTech, said it takes 280 components from 86 suppliers in 19 countries to produce their vaccine.

Johnson & Johnson said it examined more than 100 potential partners, and found only 10 capable of working with it in making the vaccines. It picked six. Merck & Co is working with Johnson & Johnson, Sanofi with Pfizer and BioNTech, and AstraZeneca with 25 manufacturing sites in 15 countries – prominently the Serum Institute of India.

Perhaps the Serum Institute, by far the world’s leading generic vaccine producer, illustrates best how IP protection is not an important barrier to developing and distributing the Covid-19 vaccine.

In collaborating with AstraZeneca, it has had complete access to all the necessary IP. Yet, in the midst of India’s appalling pandemic explosion, it has been unable to meet either local or international needs.

In India’s case, the warning is not that it has been blocked by IP protection but that it has been the victim of horrific governmental complacency, with even small details such as a lack of oxygen supplies crippling plans.

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So perhaps the IP battle on the shores of Lake Geneva, which Biden is now supporting, is more symbolic than substantive. But does that make it unimportant? That world leaders are engaging in a detailed multilateral discussion must surely be a good thing.

And if waiving IP rights – or a two-year moratorium on the enforcement of Covid-19 patents – can contribute even a little, then this must also be a good thing, even though a WTO-brokered agreement would be unlikely within 2021.

Why the world should support IP right waivers for Covid-19 vaccines

My one reservation echoes that of America’s Anthony Fauci: “Going back and forth, consuming time and lawyers in a legal argument about waivers – that is not the endgame.”

People are dying in alarming numbers around the world and our urgent priority must be to get vaccines into arms in the fastest and most efficient way possible. At all costs, Biden should ensure that Geneva’s lawyers in the WTO’s TRIPs Council do not get in the way of that.

David Dodwell researches and writes about global, regional and Hong Kong challenges from a Hong Kong point of view

This article appeared in the South China Morning Post print edition as: Getting the jabs done