Indemnity is not a new concept for vaccine manufacturers, especially Covid-19 vaccine manufacturers- Pfizer and Moderna. These two companies have been supplying vaccines to many nations only after they have received indemnities against the costs of compensation for adverse effects that might come post vaccination.
Indemnity is not a new concept for vaccine manufacturers, especially Covid-19 vaccine manufacturers- Pfizer and Moderna. These two companies have been supplying vaccines to many nations only after they have received indemnities against the costs of compensation for adverse effects that might come post vaccination. This means that in case of any adverse effects, legally, the companies cannot be sued.
However, provision of indemnity does not necessarily mean that people who have suffered the adverse effects cannot be compensated; albeit the bar is quite high. In all countries where Pfizer and Moderna are supplying their Covid-19 vaccine, the contract for indemnity has to be first signed.
Negotiations in India
In India, as the government holds multiple rounds of discussion with Pfizer and Moderna for Covid-19 vaccines supply in the country, indemnity is being discussed. While the discussions regarding indemnity have not been revealed, a report by The IE citing Dr VK Paul has noted that the government is examining Pfizer’s request of indemnity against the cost of compensation for severe side effects and also, there is a possibility that these vaccines come to India by July.
It is to note that Pfizer along with other vaccine manufacturers usually invoke a confidentiality clause during the final stages of commercial contracts with countries that is said to protect sensitive negotiations along with business-related information.
Dr Paul said that the vaccine manufacturer has requested indemnity from all nations, which is expressed in a legal language. As far as India is concerned, he said, the government is closely examining this request and will come up with a decision that is in the larger interest of people and on merits.
Other vaccines (Covishield, Covaxin, Sputnik-V) that have received emergency use authorisation in India were not granted any indemnity against the costs of compensation for severe side effects. However, for clinical trials, the Indian law has highlighted the provision of compensation in case of any injury or death of the trial subject. To put in perspective, the Drugs and Cosmetic Act does not have any provision for compensation once a vaccine is approved for commercial use.
Still, any beneficiary seeking compensation can file a petition before consumer courts or a High Court.
Indemnity in the US, UK and by WHO
Vaccine manufacturers Pfizer and Moderna, when they received approvals for vaccination in the US last year in December, the country provided such legal protection to the manufacturer. Similarly, the UK and the World Health Organization (WHO) has given indemnity to vaccine manufacturers.
It is to note that in both the countries and for vaccination under WHO’s Covax programme, there are certain compensations that can be provided under different acts, in cases where the adversity of conditions are extreme. In the US, the US Countermeasures Injury Compensation Program (CICP) can provide compensation to individuals who die or suffer serious injuries that are directly linked to the administration of vaccines, depending on the eligibility. For seeking compensation, the bar is quite high and compensations are usually rare, the IE report noted.
In the UK, a Vaccine Damage Payment can be provided in the form of one-off tax-free payment of £120,000. This is applied in cases where a person is severely disabled as a result of vaccination against certain diseases. The option is there for 19 vaccines, including Covid-19 vaccines.
The World Health Organisation, on the other hand, has a “No-Fault compensation programme” for 92 low- and middle-income countries. The programme can help with rare but serious adverse events that are related to COVAX-distributed vaccines and is applicable until June 2022.