Global Covid-19 Response: Trips to Consider Temporary Waiver of IPR Protection for Covid-19 Vaccines

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Global Covid-19 Response: Trips to Consider Temporary Waiver of IPR Protection for Covid-19 Vaccines

The United States  Wednesday announced support for waiving intellectual property protection for Covid-19 vaccines, saying extraordinary circumstances call for extraordinary measures. United States Trade Representative Katherine Tai said the US will pursue text-based negotiations” on the waiver at the World Trade Organization (WTO). These will be a long-drawn affair. All 164 WTO members must agree on the draft, and any one member can veto it. The European Union, which had earlier opposed the waiver, has now stated its intent to discuss the US-backed proposal.

A WTO statement said the participants of the General Council meeting agreed to allow the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) to continue consideration of the proposal.

India and South Africa had proposed a temporary waiver on all Covid interventions, including testing diagnostics and novel therapeutics, in the WTO last year. Since then, over 120 countries have supported it, and there have been several rounds of formal and informal meetings on this so far. While it will be an onerous task” to get all members on board and discuss it, the US’ backing to the proposal has certainly made the task to begin negotiations much easier.

The IP waiver, whenever it happens,  might open up space for production of Covid vaccines with emergency use authorisations (EUA) — such as those developed by Pfizer, Moderna, AstraZeneca, Novavax, Johnson & Johnson and Bharat Biotech — on a larger scale in middle-income countries. Most production is currently concentrated in high-income countries; production by middle-income countries has been happening through licensing or technology transfer agreements. Ramping up production capacities will be a lengthy process — a reason being cited by pharmaceutical companies against the move. Most analysts expect this to take at least a few months; it is likely the agreement will be targeted by the WTO’s next ministerial conference in end-November.

 

Opposition to the proposal

Pharma companies including Pfizer and AstraZeneca and Microsoft founder Bill Gates have opposed the proposed waiver — saying eliminating IP protections would undermine the global response to the pandemic”, including the ongoing efforts to tackle new variants. It could also create confusion that could potentially undermine public confidence in vaccine safety and create a barrier to information sharing, they had said. And, most importantly, eliminating protections would not speed up production.”

A huge opposition has come from Germany, which believes suspending IPR for Covid vaccines will have serious implications” on its production. The protection of the intellectual property is a source of innovation and it must remain so in the future,” German Chancellor Angela Merkel said Thursday.

Russia and  the European Union (EU) have said it is “ready to discuss” the matter.

 

TRIPS waiver, just beginning of a long process

According to many experts in the field, while the waiver solves the issue of obtaining the legal right to manufacture the vaccines of other companies, that of sharing the know-how of manufacturing the vaccine still remains unsolved.

They claim waiving patents and giving access to the recipe are two different things.

We are just halfway done. For instance, it completely depends on Pfizer, if they want to share how they manufacture the vaccine. But yes, they cannot sue you for infringing on their product. Let’s see which companies come forward in sharing the latter. Otherwise, globally we need to create pressure again on the big pharma to share technology,” said senior advocate Anand Grover, who specialises in drug patents.

 

Incredible opportunity for India

Many believe it will be an incredible opportunity for India to harness its manufacturing capacities to fulfil its own demand, followed by that of several countries across the world.

Despite exporting millions of Covid-19 vaccines, India’s manufacturing capacity has remained under-utilised, said Achal Prabhala, a vaccine supply expert who is a fellow at the Shuttleworth Foundation. India’s manufacturing capacity is severely underused. We already have 24 registered vaccine manufacturers out of which only three are being used to make Covid vaccines, presently. This includes Bharat Biotech, Serum Institute of India, and Biological E. Panacea might soon make Covaxin as well – but what about the other 20?”

Apart from this, Prabhala said, there are several drug makers and biologics manufacturers who can jump in and make more vaccines. Several drug makers including Dr. Reddy’s and Hetero will be manufacturing Sputnik V. We have several hundred pharmaceutical companies in India who can potentially produce vaccines for us and for the world around,” he said.

For instance: mRNA vaccines can be potentially produced by any pharma company that manufactures injectable drugs whereas other traditional biological vaccines can be produced by any pharmaceutical company that currently makes biologic drugs.”

Known as a powerhouse of vaccine manufacturing, India produces 60 per cent of the world’s vaccines and accounts for 60-80 per cent of the United Nations’ annual vaccine procurement. India has exported 66 million doses of Covid-19 vaccines across the world until May 6, mainly through the Pune-based Serum Institute of India (SII), which is the world’s largest vaccine maker.

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