In India, Covid-19 Vaccines Face A More Urgent Problem Than IPR

There is no shortage of voluntary licences for the latest Covid-19 vaccine technology, writes Prashant Reddy.

Coronavirus vaccine research done inside the Pasteur Institute laboratories in Lille, France, on March 9, 2020. (Photographer: Adrienne Surprenant/Bloomberg)
Coronavirus vaccine research done inside the Pasteur Institute laboratories in Lille, France, on March 9, 2020. (Photographer: Adrienne Surprenant/Bloomberg)

As the country faces the full force of a brutal second wave of the Covid-19 pandemic, there is an important international debate underway about the proposal put forth by India and South Africa before the World Trade Organization calling for a waiver of certain provisions of the Agreement on Trade-Related Intellectual Property Rights or TRIPS.

The hope is that by suspending intellectual property rights, especially for patents, countries would be able to freely manufacture any medicines or equipment required to combat Covid-19. The waiver is not limited to vaccines. In Washington D.C., a group of U.S. senators is pressuring the Biden administration to go along with the waiver, especially in the context of the global vaccine shortage and the Indian press is following the issue keenly.

Health and legal experts in the country have supported India’s position, even arguing for the government to issue compulsory licenses for the patents covering Covid-19 vaccines.

While it’s tough to argue against IPR relaxations during a pandemic it’s not clear why experts are making this problem number one.

The calls to suspend IPR are based on the assumption that Indian vaccine manufacturers can reverse engineer the patented vaccines by themselves, without any assistance from the corporations that developed those vaccines in the first place. That is a questionable assumption.

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Can Vaccines Be Reverse-Engineered Without Inventors Sharing ‘Know-How’?

While Indian pharmaceutical manufacturers have proven to be adept at reverse-engineering small molecule drugs, like the anti-retroviral drugs developed to treat human immunodeficiency virus, without any assistance from the corporations that invented these drugs, it is a whole different game to try and reverse engineer biologicals like vaccines.

Most of the Covid-19 vaccines involve an element of genetic manipulation and it is highly unlikely that any Indian vaccine manufacturer can reverse engineer these vaccines and even if they do, these new versions will certainly have to go through time-consuming and expensive clinical trials once again to validate the immunogenicity and efficacy of the reverse-engineered version. It is very likely that Indian vaccine manufacturers will require some element of co-operation from the original vaccine developer, in the form of biological samples that can be used for mass manufacture and other ‘know-how’ related to the manufacturing process.

Neither a TRIPS waiver that is agreed to by the American or European governments nor a compulsory licence under Indian law, can legally mandate vaccine developers like AstraZeneca or Johnson & Johnson to share know-how with others if they do not want to do so.

A waiver or a compulsory license only lifts the legal restraints imposed by patent law.

Much of the activism around the issue of the TRIPS waiver is ignoring this important technical issue because the inspiration for arguments about waivers and compulsory licenses comes from the Indian response to the HIV epidemic when Indian manufacturers like Cipla Ltd. and Ranbaxy Ltd. were able to reverse engineer antiretroviral drugs developed by Big Pharma, without receiving any ‘know-how’ or technical assistance from the latter.

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There Is No Shortage Of Voluntary Licences For Latest Covid-19 Vaccine Technology

One of the most interesting developments over the last decade in the world of pharmaceuticals has been the trend of Big Pharma companies like Gilead and Merck granting voluntary patent licences to Indian pharmaceutical companies for their newly patented drugs for diseases ranging from HIV to hepatitis to diabetes. The terms of these licences limit these companies from selling in specific territories outside India. This trend has not altered with the new Covid-19 vaccines. Already Covid vaccine producers AstraZeneca, Novax, Johnson & Johnson, and the Gamaleya Research Institute have offered voluntary licences to Indian companies like Serum Institute of India, Biological E, and Dr. Reddy's Laboratories.

Moderna made clear last year it would not enforce its Covid-19 related patents against vaccine producers and would also offer voluntary licenses.

If there is indeed so much cutting-edge vaccine technology available for the Indian market, why are we spending time and energy arguing for TRIPS waivers or compulsory licences? The entire logic of compulsory licensing is based on the assumption that voluntary licences are being denied by the inventor companies. The case for compulsory licences loses steam as soon as voluntary licences are being issued.

Given the number of voluntary licenses being offered to Indian vaccine manufacturers it is not clear which one of them is going to avail of a compulsory license.
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Why Not Just Depend On ICMR-Bharat Biotech’s Covaxin?

Unlike the AIDS epidemic, this time around India has its own vaccine, Covaxin, which was developed by Bharat Biotech and the Indian Council for Medical Research. If India has faith in this vaccine, as demonstrated by the fact of its quick approval, why does the country need to grant compulsory licences for foreign vaccines? Why not simply allow any vaccine manufacturer in India or the developing world to manufacture this new vaccine and actively share the know-how with them? Shouldn’t India lead by example if it wants the entire world to waive IP rights over all Covid-related inventions?

Turning Focus To Actual Issues Impeding Vaccine Access

That the debate on IP issues has consumed international debate is not surprising. A group of savvy public health activists would like to reform international IP laws and for them the present pandemic presents a golden opportunity to make their case, regardless of whether their proposed solutions will actually solve the shortage of vaccines in the world. The issue of IP has sucked up far too much political oxygen at a time when we should have been discussing the glacial pace of regulatory approvals and poorly-planned procurement of vaccines by the Indian government.

While most developed countries were ready to make upfront payments for the manufacture and stockpile of vaccines that were yet to clear clinical trials, the Indian government was doing almost nothing to purchase the required number of vaccines.

It appears to have been under the impression that the private vaccine industry in India would deliver the required dosages when required without quite understanding that the economics of the vaccine industry depends on bulk purchases by the government.

There is hardly any private market for vaccines and the Indian vaccine industry has always survived on government bulk orders. Without any clarity on regulatory approvals for new vaccines or solid government purchase commitments, the private industry simply did not manufacture the vaccines that could have been saving Indians from a brutal second wave. There’s a chance that may change now.

It would help if the public debate in India spent more time on holding its own government accountable for the shortage of vaccines rather than blame the delay on IP laws.

Prashant Reddy T. is a lawyer and a co-author of ‘Create, Copy, Disrupt: India’s Intellectual Property Dilemmas’, published by OUP in 2017.

The views expressed here are those of the author, and do not necessarily represent the views of BloombergQuint or its editorial team.