The government is considering indemnity for covid-19 vaccine manufacturers such as Serum Institute of India (SII) and Pfizer, which would absolve them of liabilities in case of adverse effects, two people aware of the matter said.
Discussions on indemnity have so far centred around foreign vaccine manufacturers but the current thinking in government is in favour of giving similar treatment to domestic manufacturers as well if foreign vaccine makers are given the protection for legal liability.
Most developed as well as some developing nations have offered such indemnity so that they can quickly immunize millions of citizens without companies having to unduly worry about the adverse effects of a vaccine rapidly developed in the middle of the pandemic. But, not so in India, where Serum Institute’s plea has gone unanswered so far. Apart from Serum, US vaccine makers Pfizer, too, has requested similar legal protection. Absence of indemnity is one of the reasons why foreign vaccine makers are reluctant to bring their vaccines to India.
According to the people cited above, who spoke on condition of anonymity, the second wave of covid-19 that began in March has changed the thinking in the government. It is, however, not yet clear if the government would offer blanket indemnity to all vaccine makers, or consider them individually.
Significantly, Bharat Biotech, which manufactures the Covaxin vaccine, has not applied for indemnity, the company said on Tuesday.
“It is only logical that indemnity be given to Indian vaccine makers if foreign vaccine manufacturers get it. It wouldn’t make sense otherwise,” said the first person cited above.
Serum Institute has since last year demanded indemnity for the duration of the pandemic, and only for these particular vaccines. “Serum’s argument is that if foreign companies are given indemnity, then they should be given as well,” the second person said.
An indemnity is a form of insurance for legal claims made by vaccine beneficiaries if they face so-called serious adverse events (SAEs) after receiving a dose. If indemnity is granted, the government, instead of the vaccine maker, will compensate the affected people.
Indemnity has been a thorny issue, considering India does not have a compensation mechanism for adverse event following immunization (AEFI) in mass vaccination programmes. “For covid vaccines, the indemnity is likely to come along with a compensation mechanism, which is also to be discussed,” said the second person cited above.
Critics of indemnity have called for greater transparency.
“Other than sharing that there is an ongoing negotiation with Pfizer, the government has not provided any rationale for considering grant of indemnity to the company, which stands to make tens of billions of dollars in sales of the vaccine this year alone,” said Malini Aisola, co-convenor or All India Drug Action Network. “The public is entitled to know what terms are being discussed. Yet, absolutely no details are known. For example, what is the nature and extent of indemnity being proposed? Would it extend to wilful acts, fraud or negligence? How would the liability be shifted from the company on to the government?,” she said.
“The government should most definitely be on its guard and should take the public into confidence because of the risk of striking an uneven bargain for 50 million doses,” Aisola said. Livemint