News Brief
Pfizer vaccine.
To resolve concerns linked to the supply of foreign Covid-19 vaccines and accelerate their arrival, the Indian government has formed an inter-ministerial panel comprising top officials from the ministries of External Affairs, Health and Law, as well as V K Paul, who is the head of country’s coronavirus taskforce.
According to officials, the new panel of experts will examine issues like ‘indemnity clause’ — a contractual risk transfer between two contractual parties to prevent or compensate for a loss that may arise as a result of a certain event — and try to solve it. The clause has caused a squabble between global vaccine makers like American company Pfizer and the Indian government. However, as reported by The Economic Times, the expert panel will also look into other issues such as supply chain, logistics and pricing.
Within the government, there is a strong opinion that Pfizer's demand for indemnity against potential losses stemming from adverse effects should be accepted. This point of view is based on the logic that India should import as many Covid-19 vaccines as possible to strengthen its vaccination programme, thereby helping to prevent or reduce the impact of a possible third wave. But some officials have expressed concerns over the implications of such a strategy.
As per the report, an official said: “In the United States, for instance, there is a vaccine compensation fund and other mechanisms through which the United States government can compensate for adverse events following immunisation. How will we give compensation?”
America has a “National Vaccine Injury Compensation Program”. If a vaccine causes a serious problem, such as a severe allergic reaction, the VICP may provide financial compensation to individuals who file a petition and are found to have been affected by a VICP-covered vaccine. The Health Resource & Service Administration (HRSA) in the United States: “Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement.”
In India, there is no provision for compensation for recipients of the Covid-19 vaccine in the event of any side effects or medical complications (adverse events) as a result of inoculation — although following treatment is free in public health facilities.
However, apart from the US, compensation systems exist in the United Kingdom, Singapore and Canada for individuals who have a rare but major adverse effect after inoculation. While the US use a dedicated fund, other countries require businesses to pay compensation through an insurance policy. Even, Covax, a worldwide initiative aimed at equitable access to Covid-19 vaccines, offers a no-fault compensation policy that allows vaccine recipients to get compensation without having to prove that the jabs caused serious side effects.
As per The Times of India, earlier a senior official said that while the government's purchase order with vaccine manufacturers states that the pharmaceutical companies will be liable for all adversities and refuses to indemnify them against any casualty, individuals will have to go to court to seek damages if serious adverse events occur.
Additionally, he said: “Unlike for clinical trials conducted in India where there are specific rules defining compensation for participants, there is no mechanism under the Drugs and Cosmetics Act to provide compensation against any adverse event after receiving a vaccine approved for restricted emergency use. Such people can explore legal options. In such cases, the liability will be of the vaccine-maker.”
However, for months, the Indian government and Pfizer have been discussing how to bring the American pharmaceutical giant's vaccinations into the country. Paul, who is also a member of NITI Aayog's health committee earlier said that the mRNA vaccine, developed by Pfizer and its German partner BioNTech could be accessible in India in July.
In early June, an official told The Times of India, “We are trying to expedite the processes so that the vaccines which have shown promise globally are also available for citizens of our country… The decision will be taken keeping in view a larger public interest.”
A Pfizer spokesperson also stated that the company has been talking to the government to introduce the vaccine in the country. “[But] as these discussions are ongoing, we are unable to share any additional details at this time,” he added.