No indemnity for manufacturers in Govt’s vaccine purchase deals
The Government has refused to give in to the request of Indian companies, particularly the Serum Institute of India (SII) which had publicly sought protection against all lawsuits for vaccines in case of any report of health risk or complication following inoculation of jab against Covid-19.
The purchase order executed by the Government with the vaccine makers stipulates that the companies will have to inform the Government authorities immediately in case of reports of any health risks or complications arising from the vaccine. It reads “Company shall be liable for all adversities as per CDSCO/ Drugs and Cosmetics Act/DCGI policy/approval.”
Last month, Adar Poonawalla, CEO of SII whose Covishield vaccine has been given emergency use authorisation (EUA), had said that manufacturers needed protection against all lawsuits for vaccines, especially during the pandemic. Hyderabad-based Bharat Biotech also has been given EUA to supply Covaxin which initially the Government had said was being kept as a “backup plan”.
Vaccine makers need to be protected against liability for serious adverse reactions to their shots during a pandemic scenario, Poonawalla had said. The Pune-headquartered company head during a virtual panel discussion on the challenges to vaccine development last month had also shared that he planned to propose this to the Government.
This is because such issues could potentially increase fear of getting vaccinated and also works to “bankrupt” or “distract” the companies making them, according to him.
“We need to have the Government indemnify manufacturers, especially vaccine manufacturers, against all lawsuits. In fact, COVAX and other countries have already started talking about that,” he said during Carnegie India’s Global Technology Summit.
On Thursday too at an event, Poonawalla asserted that the lawsuit against the firms will hit the vaccine supply.
However, the Government seems to not be keen to take up their request. “Indian vaccine makers will be held liable for any complications or adverse effects that arise from the administration of their jabs. The Government has not accepted their demand that they be indemnified against mishaps,” said sources in the Union Health Ministry.
“The Government can act: the US, for example, has in fact invoked a law, to say that during a pandemic — and this is especially important only during a pandemic — to indemnify vaccine manufacturers against lawsuits for severe adverse effects or any other frivolous claims which may come about. Because, that adds to the fear and also will bankrupt vaccine manufacturers or distract them if they have to just all day just fight lawsuits and explain to the media what is happening,” Poonawalla had said.
According to Poonawalla, when “frivolous” claims crop up and are blown out of proportion, it affects the confidence of not just anti-vaxxers, but the general public too. “Anyone may have a thought and skepticism then sort of sets in (that) definitely something can happen due to the vaccine … to dispel that, the Government needs to step in (with) messaging with influencers to spread, also, the right information.” He added that this was a measure SII was “going to propose” to the Centre.
The statements had come days after an issue raised by one of the volunteers who had taken SII’s ‘Covishield’ as part of mid-to late-stage clinical trials to test the safety and immunogenicity of the Covid-19 vaccine in India. The volunteer had sent SII a notice seeking Rs 5 crore in compensation, alleging that the vaccine had caused a severe neurological issue.
SII, however, rejected these claims, adding that its reputation was being “unfairly maligned”. As a result, it had reportedly sent the volunteer a legal notice of its own.
However, experts say the liability the clause could remain the same in the case of other vaccination programmes i.e. liability for any adverse effects due to vaccine lies with the company concerned.
Notably, considering the pace with which vaccines were made in record time amid the Covid-19 pandemic, many countries have shifted liabilities to the Government. These are the US, the UK, Canada, Singapore, EU and WHO-led COVAX. They provide immunity to manufacturers from lawsuits and will bear the compensation burden, as per various reports.
Friday, 15 January 2021 | PNS | New Delhi
