‘Liability protection to vaccine makers should be prospective not retrospective’

Even though providing protection against liability claims to the vaccine manufacturers as contemplated by the central government seems unconstitutional, if at all it is given then it should be prospective and not retrospective, said an advocate whose client has preferred a claim against Serum Institute of India Private Ltd.

The Cenre is mulling to provide protection from indemnity protection to Pfizer and Moderna in case of adverse effects on people administered with their Covid-19 vaccine.

Indian vaccine maker Serum Institute that makes the Covishield vaccine also said such protection should be applicable for all companies.

Incidentally Serum Institute is already facing a liability claim of Rs 5 crore from a city based business consultant who had volunteered for the Covishield’s clinical trial and suffered adverse side effects.

“There should be a liability claim option for the people. Can the central government underwrite the liability on behalf of the corporates,” N.G.R. Prasad, Advocate, Row & Reddy, told IANS.

Prasad is the advocate for the Chennai volunteer.

“Such a protection may result in drug companies not taking safety very seriously.AIndia is a populous country and no liability clause even for the central government is unconstitutional and will be tested in the court of law,” Prasad added.

He said if at all a protection against liability claims is to be given to the companies, then it should be prospective and not retrospective.

The drug supply contract is subject to the Contract Act which provides that the contracting parties should be on equal footing and there is also the Article 21 of the Indian Constitution that provides for Right to Life, Prasad said.

On the insurance protection for the companies, a top official of a general insurance company told IANS that the reinsurers should provide the back up support for the primary insurers to underwrite such covers.

Queried about the status of the case filed by his client Prasad said some of the opposite parties have to file their counters.

The volunteer, a city-based business consultant, had developed severe neurological complications after the first dose of Covishield vaccination which was under development at Serum Institute, the volunteer’s wife had told IANS.

On coming to know about the call for volunteers for the third phase of human trial at Sri Ramachandra Institute for testing the Covid-19 vaccine developed by the Oxford University, the public spirit in him wanted to volunteer.

The volunteer had signed the consent form on September 29, 2020. As the test for antibodies against Covid-19 was negative, the Covishield study vaccine was given to him on October 1, 2020.

For 10 days after vaccination, there was no adverse reaction, but on October 11, 2020 the volunteer woke up at 5.30 a.m. with a severe headache and went back to sleep and did not get up when his wife tried to wake him up at 9 a.m. At 2 p.m., he woke up and vomited and went back to sleep, saying he had a severe headache.

There was a total behavioural change in him – he was not aware of his surroundings, he showed irritation towards light and sound, and was resisting any effort to make him get up from bed, the legal notice issued to Serum Institute and others said.

“Our client developed severe neurological health complications after he was given the test dose. We had sent a legal notice to the Serum Institute; Indian Council for Medical Research (ICMR); AstraZeneca, UK; Drugs Controller General of India; Andrew Pollard, Chief Investigator, Oxford Vaccine Trial; The Jenner Institute Laboratories, University of Oxford; and the Vice Chancellor of Sri Ramachandra Higher Education and Research,” Prasad had told IANS.

The volunteer has claimed a compensation of Rs.5 crore for his neurological problems that cropped up after the vaccination.

On its part, the Serum Institute that it would file a case claiming damages over Rs 100 crore which the volunteer’s wife had termed as shocking, intimidating and also childish.

(Venkatachari Jagannathan can be contacted at v.jagannathan@ians.in)