Should seizure of COVID-19 vaccine manufacturers’ patents be the primary focus in tackling an urgent crisis?

By Peter Fabricius *

Can a TRIPS waiver save Africa from the COVID-19 pandemic? South African President Cyril Ramaphosa seems to think so. He 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 since last October for a TRIPS waiver on the manufacture of COVID-19 vaccines.

They say the mandatory suspension of vaccine patents is key to tackling the pandemic. Such a move would allow developing countries like South Africa and India to manufacture the same vaccines themselves, on a larger scale and at lower cost.

As third wave of pandemic hits Africa, World Health Organization (WHO) Director General Tedros Ghebreyesus mentionned the continent’s infection and death rate had climbed nearly 40% in the past week. This surge is fueled, among other things, by a great shortage of vaccines in Africa.

South Africa and India have gained support from over 100 countries for a TRIPS waiver. The developed countries where most vaccines are made have resisted their urges until US President Joe Biden endorsed the waiver. And during his visit to South Africa in May, French President Emmanuel Macron also caved in 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 has not changed its basic position, to reiterate that the best way to boost vaccine production was to obtain voluntary licenses. This involved the patent owners voluntarily signing contracts with other manufacturers to manufacture their vaccines.

The best example is the Serum Institute of India, which mass-produces the Oxford / AstraZeneca vaccine. And the South African company Aspen Pharmacare partially manufactured the Johnson & Johnson vaccine, also for export to Africa.

But Ramaphosa nonetheless welcomed “huge progress” at the top towards a TRIPS waiver. He said G7 leaders had agreed to open a debate on the matter and highlighted the European Union (EU) proposals that would be on the negotiating table alongside the South African and Indian proposals.

The EU is also essentially synonymous with voluntary licenses, but is more flexible than others. He accepts that if cooperation fails, compulsory licenses – without the consent of a patent holder – “are a legitimate tool in the context of a pandemic.”

Beyond a TRIPS waiver, Ramaphosa has secured support from France, Germany and possibly the United States and the World Bank to fund an increase in Johnson & Johnson’s vaccine manufacturing capacity. Aspen in South Africa.

And this week, Ghebreyesus and Ramaphosa ad that South Africa would host the WHO’s first COVID-19 messenger RNA (mRNA) vaccine technology transfer center. This means that pharmaceutical companies with sophisticated mRNA technology – the basis of Pfizer and Moderna vaccines – will provide licenses and know-how to enable a South African consortium to manufacture these vaccines.

But even though he welcomed this development, Ramaphosa insisted it was not a substitute for a TRIPS waiver. He lambasted northern countries for their “vaccine nationalism” in hoarding vaccines while Africa and the rest of the south suffered from severe shortages. He mentionned a TRIPS waiver was one of the best ways to beat COVID-19.

Its fervor raises suspicions that the quit campaign is an ideological problem for South Africa and others on the left – who have always been wary of big drug companies – rather than an objective solution to a crisis. This is because a TRIPS waiver cannot save Africa from the immediate grip of the pandemic.

Even the mRNA project in South Africa would take at least about 12 months before manufacturing could begin, WHO chief scientist Soumya Swaminathan said. And it would be with voluntary licenses and full technological cooperation and training from patent holders. Manufacturing vaccines from scratch and without this cooperation via a TRIPS waiver would take much longer.

Yogesh Pai, an assistant professor at National Law University in Delhi, said the TRIPS waiver proposal was “simplistic” on the assumption that allowing the copying of formulas from companies making vaccines would automatically allow other manufacturers to produce quickly. COVID-19 vaccines.

Pai said that more complex technologies, such as vaccines, don’t just include knowledge, which is patented to prevent copying. It also involved undisclosed information and know-how on quality control measures for production and clinical data required for regulatory approvals.

A waiver of intellectual property would not give another company access to this deeper level of know-how. Only a cooperative deal in which the owner of the technology helped the new manufacturer produce the vaccines could do that, Pai suggested.

Prashant Yadav, a medical supply chain expert at Harvard Medical School, said The ISS today that it would probably take two to three years to produce a vaccine through a TRIPS waiver. First, the waiver should be secure, and then the necessary processes worked out without the help of the original developer.

Can Africa wait that long? When launching the mRNA project this week, Michael Ryan, head of the WHO’s health emergency program, stressed that manufacturing COVID-19 vaccines in Africa, while laudable, would not solve the immediate crisis. The only solution was for rich countries to immediately stop hoarding vaccines. “It will be a catastrophic moral failure globally if we don’t do it,” Ryan warned.

Yadav says the urgent strategy should be to reallocate doses purchased by countries that don’t need them and expand vaccine production through voluntary licensing and technology transfer from the original companies.

Of course, Ramaphosa might be right to suspect that rich countries are not selfless enough to donate their “surplus” vaccines, and therefore Africa and the rest of the southern hemisphere must become more self-reliant.

But a TRIPS waiver is at best a medium-term solution. Industrialized African countries – like South Africa – need to step up voluntary licensing programs with drug companies to increase vaccine production as soon as possible.

Where companies refuse to cooperate, the TRIPS Agreement already allows compulsory licenses – but without depriving them of returns on their intellectual property, as a waiver would. This could remedy the COVID-19 vaccine shortage faster than a TRIPS waiver.

In the short term, the only apparent cure is a vigorous campaign to pressure rich countries to donate vaccines. Some European countries vaccinate 12-year-old children, while Africa’s most vulnerable populations remain at risk.

*About the Author: Pierre Fabrice, SSI Consultant

Source: This article was published by The ISS today





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