Should seizing the patents of COVID-19 vaccine manufacturers be the focus in dealing with an urgent crisis?
By Peter Fabricius*
Can a TRIPS waiver save Africa from the COVID-19 pandemic? South Africa’s President Cyril Ramaphosa seems to think so. He has invested considerable political and diplomatic capital in the project.
TRIPS – the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights – protects manufacturers’ patents against copying. South Africa and India have been campaigning hard since last October for a TRIPS waiver on the manufacture of COVID-19 vaccines.
They say the compulsory suspension of vaccine patents is critical to fighting the pandemic. Such a move would enable developing countries like South Africa and India to make the same vaccines themselves, on a larger scale and more cheaply.
As a third wave of the pandemic hits Africa, World Health Organization (WHO) Director-General Tedros Ghebreyesus said the rate of infections and deaths on the continent had rocketed by almost 40% over the past week. The surge is being fuelled by, among other things, a large shortage of vaccines in Africa.
South Africa and India have won the support of over 100 countries for a TRIPS waiver. Developed countries where most vaccines are made resisted their entreaties until US President Joe Biden backed the waiver. And when he visited South Africa in May, French President Emmanuel Macron also relented and offered France’s support.
Ramaphosa made lobbying for the TRIPS waiver the central mission of his guest participation at the G7 Summit in Cornwall, England, last week. The G7 didn’t shift its basic position, reiterating that the best way to boost vaccine production was through voluntary licensing. This entailed the owners of patents willingly signing contracts with other manufacturers to make their vaccines.
The best example of this is the Serum Institute of India, which mass-produces the Oxford/AstraZeneca vaccine. And South Africa’s Aspen Pharmacare has been part-manufacturing the Johnson & Johnson vaccine, also for export to Africa.
But Ramaphosa nonetheless welcomed ‘tremendous progress’ at the summit towards a TRIPS waiver. He said the G7 leaders agreed to open a debate on it and pointed to proposals from the European Union (EU) that would be on the negotiation table alongside the South African and Indian proposal.
The EU also essentially stands for voluntary licensing but is more flexible than others. It accepts that where cooperation fails, compulsory licences – without the consent of a patent holder – ‘are a legitimate tool in the context of a pandemic.’
Beyond a TRIPS waiver, Ramaphosa has elicited the support of France, Germany and probably the US and the World Bank to finance a boost in Aspen’s Johnson & Johnson vaccine manufacturing capacity in South Africa.
And this week, Ghebreyesus and Ramaphosa announced that South Africa would host the WHO’s first COVID-19 messenger RNA (mRNA) vaccine technology transfer hub. This means pharma companies with sophisticated mRNA technology – the basis of the Pfizer and Moderna vaccines – will provide licensing and know-how to enable a South African consortium to make these vaccines.
But even as he welcomed this development, Ramaphosa insisted it wasn’t a substitute for a TRIPS waiver. He blasted northern countries for their ‘vaccine nationalism’ in hoarding vaccines while Africa and the rest of the south were suffering a dire shortage. He said a TRIPS waiver was one of the best ways to defeat COVID-19.
His fervour is prompting some suspicion that the waiver campaign is an ideological issue for South Africa and others on the left – who have always been suspicious of big pharma – rather than an objective solution to a crisis. That’s because a TRIPS waiver cannot possibly rescue Africa from the immediate grips of the pandemic.
Even the mRNA project in South Africa would take at least around 12 months before manufacture can begin, WHO Chief Scientist Soumya Swaminathan said. And this would be with voluntary licensing and full technological cooperation and training from the patents’ owners. Manufacturing vaccines from scratch and without that cooperation through a TRIPS waiver would take much longer.
Yogesh Pai, Assistant Professor at the National Law University in Delhi, said the TRIPS waiver proposal was ‘simplistic’ in assuming that allowing the formulae of companies making vaccines to be copied would automatically enable other manufacturers to produce COVID-19 vaccines quickly.
Pai said most complex technologies, such as vaccines, comprised not only the knowledge, which is patented to prevent copying. It also involved undisclosed information and know-how about quality control measures for production and clinical data required for regulatory clearances.
An intellectual property waiver wouldn’t give another company access to this deeper level of know-how. Only a cooperative agreement in which the technology owner helped the new manufacturer produce the vaccines could do this, Pai suggested.
Prashant Yadav, an expert on medical supply chains at Harvard Medical School, told ISS Today that it would probably take two to three years to produce a vaccine via a TRIPS waiver. First, the waiver would need to be secured, and then the necessary processes worked out without the help of the original developer.
Can Africa wait that long? At the launch of the mRNA project this week, Michael Ryan, Head of the WHO’s Health Emergencies Programme, stressed that manufacturing COVID-19 vaccines in Africa, while commendable, wouldn’t address the immediate crisis. The only solution was for rich countries to stop hoarding vaccines immediately. ‘It will be a catastrophic moral failure at global level if we do not do that,’ Ryan warned.
Yadav says the urgent strategy should be reallocating doses purchased by countries that don’t need them and expanding vaccine production through voluntary licensing and tech transfer from the originator companies.
Of course, Ramaphosa could be right in suspecting that rich countries aren’t altruistic enough to donate their ‘surplus’ vaccines, and so Africa and the rest of the global south must become more self-reliant.
But a TRIPS waiver is a medium-term solution at best. Industrialised African countries – such as South Africa – need to intensify voluntary licensing programmes with pharmaceutical companies to step up vaccine production as soon as possible.
Where companies won’t cooperate, the TRIPS deal already permits compulsory licensing – but without depriving them of returns on their intellectual property, as a waiver would. That could address the COVID-19 vaccine shortfall faster than a TRIPS waiver would.
In the short term, the only apparent remedy is a vigorous campaign to put pressure on rich countries to donate vaccines. Some European countries are vaccinating 12-year-olds, while Africa’s most vulnerable populations remain exposed.
*About the author: Peter Fabricius, ISS Consultant
Source: This article was published by ISS Today