Drugmaker Moderna is said to have secured an offer of legal indemnity regarding its COVID-19 vaccine from the Government, albeit with certain provisions.
Individuals familiar with the matter said an offer has been sent to the drugmaker, which is based in the United States, reports The Economic Times. The company’s board of directors are expected to deliberate the offer. Once accepted, this would allow for seven million doses of the Moderna vaccine to be imported into India immediately.
Moderna, alongside Johnson & Johnson and Pfizer, sought legal indemnity in India before making their vaccines available against legal costs arising from potential adverse effects. “Similarly, they have requested indemnity from all nations,” said Dr Vinod K. Paul, a member of government think tank Niti Aayog. “That is their expectation, that liability should be indemnified. They have expressed this in legal language. We are examining this request and we will make a decision in the larger interest of people and on merits. This is under discussion but there is no decision as of now.”
As The Indian Express explains, legal indemnity “means that they [the drugmakers] cannot be sued in those countries on account of such effects. Grant of indemnity does not always mean beneficiaries cannot seek compensation for adverse events, but the bar is very high.”
As Health Issues India reported last week, “Cipla, a pharmaceutical firm based in Mumbai, received the nod to import doses of the Moderna vaccine from the Drug Controller General of India (DCGI) last month. It became the fourth COVID-19 vaccine to receive emergency use authorisation from the Centre in India, following Covaxin (manufactured by Bharat Biotech); Covishield (the AstraZeneca vaccine, manufactured in India by the Serum Institute of India); and the Russian-manufactured Sputnik-V. Approval for the Pfizer/BioNTech vaccine is also on the cards, with arrangements said to be in the “final stages.””
Indemnity is ostensibly a sticking point for the company, however, but it is a concession made hitherto to no other manufacturer. However, with certain provisos, an offer is on the table. “The Indian government has agreed to the indemnity clause in the best way we could. There were certain country-specific changes we wanted and we have gone ahead with such a proposal,” a government official told The Economic Times.
The decision to grant indemnity to Moderna sets a precedent going forward. As a source told Reuters last month, “if one company gets it then all of them get it.”