industry

Indemnity demand holding up Pfizer jab’s India approval


Pfizer’s insistence that the government should indemnify it against lawsuits in case of adverse affects linked to its jab has become a major hurdle for its Covid-19 vaccine obtaining approval in India. The discussions are essentially stalled over the indemnity issue, people in the know told ET.
has signed an indemnity clause with many countries that are using its vaccine, absolving the company from paying any legal cost in case of an adverse event.

On Monday, Pfizer’s CEO Albert Bourla said the company was in discussions with the Indian government seeking an “expedited approval pathway” for its Covid-19 vaccine, while announcing the US drugmaker’s donation of medicines worth more than $70 million (Rs 517 crore) to the country.

However, officials in the government said the demand for indemnity is the major roadblock.

Unlike many other countries, India does not offer any protection against adverse effects such as serious illness or death caused by the vaccine.

“This cannot be given to one company. If it is given to Pfizer then the domestic companies will ask for the same too,” one of the officials said.

The Indian government, while granting emergency licences to Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin, did not accept the vaccine-makers’ demand that they be indemnified against mishaps. The purchase order executed by the government with both Serum and Bharat Biotech stipulated that the companies would have to inform the authorities immediately in case of reports of any health risks or complications arising from the vaccine.

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Steps Taken by Nations

Considering the extraordinary situation and the need to develop vaccines in a short time span amid the pandemic, several nations have shifted at least a part of the potential liabilities to the government. These include the US, the UK, Canada and Singapore, as well as the EU. WHO’s Covax initiative has also taken similar steps. The UK government has granted Pfizer legal indemnity, protecting it from being sued, for its coronavirus vaccine. The US, too, has granted companies like Pfizer and Moderna immunity from liability if something unintentionally goes wrong with their vaccines.

Vaccine-makers in India have been pushing the government to include an indemnity clause in purchase agreement. Serum earlier said the government should indemnify vaccine makers against all lawsuits. “Company shall be liable for all adversities as per CDSCO/Drugs and Cosmetics Act/DCGI policy/approval. The liability clause remains the same as for other vaccination programmes,” said the official cited above.

The US government had invoked the Public Readiness and Emergency Preparedness Act (PREP Act), which limits the legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. This was done to “encourage the expeditious development and deployment of medical countermeasures during a public health emergency”.

In South Africa, Pfizer had sought indemnity protection against civil claims. It had also asked the government to put up sovereign assets as collateral. South Africa did not agree to these terms. However, it agreed to other terms of indemnity. In Latin America, health activists had accessed the contract between Pfizer and the Dominican Republic which said that since the vaccines were developed within a short span of time, there could be long-term side effects. According to the document, the liability in such a case will not rest with the company. Pfizer will also not be held legally responsible for reneging on its supply commitments.



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