Thursday, 30 June, 2022
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Legal liability logjam is likely to delay India’s share in US vaccine distribution

US has reserved seven million from its first tranche of 25 million donated shots for South Asia and Southeast Asia, including India. Exact number for India is yet to be fixed.

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New Delhi: The Joe Biden administration in the US may have announced the distribution of 25 million surplus Covid shots to other countries, but their arrival in India could be delayed by a persisting logjam over indemnity for the American vaccine makers, ThePrint has learnt. 

The Biden administration declared Thursday how it will be allocating 25 million vaccine doses that it is donating to countries across the world. This is the first tranche of the 80 million surplus shots that the US promised last month it would donate by end of June. The first tranche includes shots made by three US-based companies, Pfizer, Moderna and Johnson & Johnson.

The US has reserved seven million of the 25 million shots for Asia, including India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Malaysia, Philippines, Vietnam, Indonesia, Thailand, Laos, Taiwan, Papua New Guinea, and the Pacific Islands.

However, both India and the US will now begin discussions on how much will be given to New Delhi, and this will depend on whether the Modi government is able to indemnify the US vaccine makers — Pfizer, Moderna and Johnson and Johnson — from legal liability in case of severe adverse reactions, top-level sources told ThePrint.

Hence, India will now have to hold negotiations with not just Biden administration officials, but also with the three pharma majors, the sources added. 

Several vaccine makers, including Pfizer and Moderna, have sought indemnity from countries where the vaccines are being released. The US and the UK are among the countries that have indemnified vaccine makers. 

Pfizer, Moderna and Johnson & Johnson are also among the firms with which India is in talks for sourcing of vaccines, and their possible manufacture in the country. The Modi government is currently in talks with Pfizer over indemnity.  

During a telephonic press briefing Friday, Gayle E. Smith, Coordinator for US Global Covid Response, US State Department, told a select group of reporters that the “refinement of actual numbers will be done with governments” and thus she would be “careful on putting a number out there”. “But they will be substantial numbers,” she added. 

The aforementioned sources said right now there is also “no clarity” on whether India will be considered for the next round of vaccine doses to be allocated by the Biden administration. After the first round of donations, the US will be left with 55 million doses that it plans to distribute by June end.

Also Read: How many doses of Covid vaccines will India get from US? We’ll know in a matter of days

US ‘concerned’ over Compulsory Licensing issues 

While vaccine distribution is one aspect of India and the US’ health cooperation, Washington is also keen on tying up with local vaccine producers in order to go for large-scale production of the shots. 

However, according to the sources quoted above, the US has sought an assurance from India that, in the process, New Delhi will “not invoke compulsory license (CL) provisions” as enumerated in the Indian Patents Act as well as under Article 31 of the TRIPS (Intellectual Property) Agreement of the World Trade Organisation.

Under the CL provisions, India can allow a local vaccine maker to produce the American vaccines without the consent of the patent owner.

According to the sources, the US has been “sceptical” that India might invoke the CL provisions after a certain number of years. 

The US, sources said, has also cited a 2012 incident that saw India grant CL to domestic drug producer Natco Pharma to manufacture and sell German Bayer Corporation’s cancer drug — Nexavar.  

“The US has said if India can invoke CL once, what stops them to do so again? So investments that have been planned by the US vaccine makers for joint collaboration are stuck on this aspect,” said an official involved in the talks, on condition of anonymity. 

The US, the sources said, is keen to produce its vaccines in India instead of anywhere else because of the country’s robust lab infrastructure as well as qualified and skilled manpower. 

The Modi government, the sources added, is keen to see collaborations between US vaccine makers and Indian players such as Bharat Biotech, Biological E, Biocon and Dr Reddy’s Laboratories, among others.

(Edited by Sunanda Ranjan)

Also Read: Hyderabad’s Biological E wants Rs 1,500 cr advance from Modi govt for 30 cr Covid vaccines


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