Legal experts felt the government was unlikely to budge on a demand to indemnify vaccine makers during the period of the pandemic
With India’s Covid vaccination
drive scheduled to start on January 16 — with priority given to an estimated 30 million health care workers and frontline workers — vaccine makers are divided on the issue of indemnity in case of any serious adverse event (SAE). The government, too, is unlikely to indemnify or exempt vaccine makers from any liability arising out of SAEs due to inoculation.
Ahmedabad-based Zydus Cadila, whose deoxyribonucleic acid plasmid technology-based vaccine ZyCoV-D is now in Phase 3 trials, said it was not looking at a legal indemnity angle. Pankaj Patel, chairman of Cadila Healthcare, said the vaccine would be ‘thoroughly’ tested before roll-out and did not see any reason to seek indemnity.
Reposing confidence in his vaccine, Patel said like other drugs and vaccines that the firm rolls out, known side-effects (like fever, pain, etc) would be displayed on the label. The regulator has said vaccine makers (who now have restricted emergency-use authorisation) will have to give fact sheets on their products during inoculation.
Earlier, Adar Poonawalla, chief executive officer of Serum Institute of India (SII), and president of the Indian Vaccine Manufacturers Association, had indicated he had written to the health ministry
In a recent interview with Business Standard, Poonawalla had reasoned that an indemnity clause during the period of the pandemic would ensure the vaccination
drive did not halt if there was an injunction. “If there is an injunction and the court says that no more vaccines will be given to anyone pending further enquiry, many lives would be impacted. It is not about the financial loss to the firm. The entire government programme, too, stops. Some very high-level constitutional powers would have to be invoked to overrule such a situation. This has never been tested in our history,” he had said.
Legal experts felt the government was unlikely to budge on a demand to indemnify vaccine makers during the period of the pandemic. “The vaccination
is voluntary, not mandatory. This means there is ‘implied consent’ when one agrees to take a vaccine,” said a legal expert. He further pointed out that having an informed consent form, too, will be key — someone receiving an under-trial vaccine or a candidate without full marketing authorisation implies he/she understands the risks.
“Bharat Biotech and the Indian Council of Medical Research’s (ICMR’s) Covaxin is being rolled out in clinical trial mode. I doubt ICMR will indemnify the firm from liability in case of any SAE. The government is unlikely to do so either. Consumers can seek compensation under consumer laws. There could be a lot of chaos and confusion after the roll-out,” felt a senior Mumbai-based lawyer.
The issue of indemnity gathered pace after a Chennai-based volunteer (who suffered from encephalopathy) sent a legal notice to SII, claiming his illness was vaccine-induced. Subsequent investigations, however, ruled out any causal link with the investigational vaccine product. Activists also raised a red flag over Bharat Biotech’s Covaxin trial arm in Bhopal, where a man died (of poisoning) after he was administered the jab.
Both the approved vaccines — Covishield from SII and Covaxin from Bharat Biotech — do not yet have marketing authorisation. This means sufficient data has not yet been submitted with the regulator to get full authorisation.