Legal conundrum in vaccine race to fight coronavirus

Serum Institute of India CEO Adar Poonawalla on Friday made a pitch to indemnify vaccine makers in case people suffer adverse events. The statement follows a 5-crore legal notice sent by a trial participant to SII after he suffered a serious neurological dysfunction. Mint explores

Leroy Leo
Updated20 Dec 2020, 10:57 PM IST
Serum Institute of India CEO Adar Poonawalla on Friday made a pitch to indemnify vaccine makers in case people suffer adverse events.
Serum Institute of India CEO Adar Poonawalla on Friday made a pitch to indemnify vaccine makers in case people suffer adverse events.

Serum Institute of India CEO Adar Poonawalla on Friday made a pitch to indemnify vaccine makers in case people suffer adverse events. The statement follows a 5-crore legal notice sent by a trial participant to SII after he suffered a serious neurological dysfunction. Mint explores

What is an indemnity in case of vaccines?

Vaccines undergo rigorous trials to determine safety, but in rare cases, they may still cause unexpected serious adverse events (SAEs). Usually, vaccine-makers, and those involved in administration and distribution, get insurance to cover the risk. But, considering that the race for a covid jab is like no other, insurance may not be available. So, manufacturers are seeking indemnity, which is insurance for legal claims made for SAEs. Instead of companies paying for the claims, governments are liable to pay the damages from a special fund. The money would effectively go from public coffers or some fund which gets private donations.

What is World Health Organization’s view?

WHO in its draft note has included provisions to indemnify vaccines in its COVAX facility, which is aimed at equitable access to these shots. Under the provisions, each country receiving vaccines through COVAX will be required to indemnify manufacturers, donors, distributors and other stakeholders against any loss they incur from the use of the vaccines. As per the regulations, people with unexplained SAEs will not have to prove jab manufacturers’ fault post inoculations. However, the rules are only for unexplained SAEs and will not include wilful misconduct and gross negligence or failure to abide by regulations by entities.

Indemnity for vaccine makers

Are other nations providing indemnity to jab makers?

The UK and Australia have provided legal indemnity to Pfizer and AstraZeneca. The US has invoked a law that provides manufacturers immunity from lawsuits, and people with covid-19 vaccine-related SAE must file claims with a fund administered by the government. Among developing countries, Argentina has passed a similar law.

What has been the Centre’s position?

India has so far not clarified on whether it would indemnify jab makers and what would be the process of reimbursement in case there is an SAE. Health secretary Rajesh Bhushan had said, earlier this month, that it “will be guided by the law and the courts of the day”. Adding to complications in India is the absence of law to compensate people if they received substandard medical products. It is best shown by J&J’s hip implant controversy, where the firm questioned compensations’ legality in the Drugs and Cosmetics Act.

What challenges are related to indemnity?

Many countries signed purchase contracts with companies that include indemnity clauses, but have declined to provide details on the provisions. Some experts have questioned the need for such a provision, in the light of firms like Pfizer planning to profit from jabs. Low- and lower-middle income countries may not have the means to compensate those who sustain SAEs—a point also mentioned in WHO’s draft. WHO has proposed to create a special fund to aid such nations and is also looking at engaging with third parties.

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First Published:20 Dec 2020, 10:57 PM IST
HomeNewsIndiaLegal conundrum in vaccine race to fight coronavirus

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