As India preps for COVID-19 vaccine rollout, Centre says 'no proposal' to indemnify vaccine manufacturers

On 3 January, the Government of India gave its final approval for the AstraZeneca-Oxford COVISHIELD vaccine, manufactured by the Serum Institute of India (SII) and for COVAXIN developed by Bharat Biotech and Indian Council for Medical Research (ICMR). Both have been provided green signal for restricted emergency use.

The news garnered a variety of reactions. Experts questioned how such an approval can be provided, especially for COVAXIN, which is yet to provide data on its efficacy from Phase 3 trials. Amidst all this, the Government of India in response to an RTI filed by this reporter said that it currently has no proposal to indemnify or exempt vaccine manufacturers from any liability in case of serious side-effects/adverse reactions due to inoculation of their vaccines.

Recently, SII’s CEO Adar Poonawala , at a virtual panel discussion on the challenges to vaccine development, had floated this idea as he believed that frivolous lawsuits may “add to the fear about vaccines”. He had also said that it will “bankrupt vaccine manufacturers or distract them if they have to, just all day, fight lawsuits and explain to the media what is happening”.

In the United States last year, the Health and Human Resources Secretary had invoked the Public Readiness and Emergency Preparedness Act, which empowers him to provide legal protection to companies making or distributing critical medical supplies, such as vaccines and treatments, unless there is “willful misconduct” by the company. In other words, unless willful misconduct is proven, vaccine manufacturers will be immune from any lawsuits suing them for any unintentional harm from their vaccines.

Poonawala seeks a similar immunity from the Indian government.

A source from the SII, who requested anonymity, told the reporter that “so far there has been no development as such. This (immunity) is an industry demand and since the vaccine manufacturing was required to be expedited, this is a reasonable demand, especially during the pandemic.” However, the source was not aware if any such request has been sent already. “Maybe on industry’s behalf, the proposal may be sent”.

Companies fear that despite their best efforts and highest care taken in making the vaccine, they may face frivolous lawsuits, draining company’s resources and reputation. Bharat Biotech refused to comment and share its views on the matter.

Lawyers, specialising in pharmaceutical laws, refused to come on record with their views stating that the current situation is as too “sensitive and controversial”. They, however, on condition of anonymity said that the demand for indemnity is reasonable.

“Of course, blanket immunity as such cannot be given but a reasonable indemnity is a completely legitimate demand. Manufacturing companies cannot be absolutely immune from litigations because they will eventually make profits. Also, they should have some insurance protection as well. Companies will probably export their vaccines in the future and they can't expect all jurisdictions around the world to give them the same protection”, a lawyer from a top leading law firm said while also suggesting that the companies “should invest in pharmacovigilance arrangements for adverse event monitoring.”

The reporter reached out to the Union Ministry of Health and Family Welfare for their comments but despite several reminders, no response was forthcoming. The story will be updated if and when a response is received.

Not everybody is in favour of providing such an indemnity to vaccine manufacturers. Dr Amar Jesani, senior physician and editor of Indian Journal for Medical Ethics has the same view.

"On one hand, they will make profits and on the other, they want no liability? The way the companies succeeded in getting emergency approval from Govt clearly shows that they have colluded," Dr Jesani said.

On being asked about companies’ concern over frivolous litigations, he said that people are not willing to get into a fight against such big and powerful companies, if the claims are not genuine. Litigations take years and drain one of their resources. “If I am harmed, I have a right to be compensated. What is the harm in this? Why should it affect company’s credibility and reputation? It is the companies that file frivolous litigations against other companies and the government. A common man does not.”

On immunity provided by the US government to vaccine manufacturers, Jesani said that the US has tighter regulations for health sector whereas in India it is a “jungle raj”. “If you want the US model, then bring in the entire model first, including their regulations. Cherry picking one thing (blanket immunity) is not acceptable”. He also recalled that these companies have not got any immunity for other vaccination drives and there is no reason to get it now.

The author is an independent investigative journalist.