Covid Vaccine Makers and indemnity

Covid Vaccine Makers and indemnity

Subject : Science & tech

Context : In talks over supply of their vaccines in India, Pfizer and Moderna are seeking indemnity against costs of compensation for adverse events.

Concept :

• Globally, the two companies have supplied their Covid-19 vaccines only after indemnities were given against the costs of compensation for adverse effects due to vaccination.
• This means that they cannot be sued in those countries on account of such effects.
• Grant of indemnity does not always mean beneficiaries cannot seek compensation for adverse events, but the bar is very high.

In India

• The Indian drug regulator has not granted indemnity against the costs of compensation for severe side effects to the manufacturers of any of the three Covid-19 vaccines — Covishield, Covaxin and Sputnik V — to which it has given emergency use authorisation.
• For clinical trials, Indian law has laid out rules and a formula for grant of compensation in case of injury or death of any trial subject.
• But when a vaccine is approved for commercial use, there is no specific provision under the Drugs and Cosmetic Act for compensation.
• However, beneficiaries seeking compensation can file petitions before legal forums, such as consumer courts or a High Court.

International level

• The US, which began vaccinating its population in December, was the first country to provide such legal protection to Covid-19 vaccine manufacturer. The UK too has granted indemnity to vaccine manufacturers.
• And the World Health Organization (WHO) has a special compensation programme for low-income countries covered under its COVAX facility.
• The Public Readiness and Emergency Preparedness Act (PREP) Act authorises the US Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the administration of medical countermeasures such as vaccines.
• Immunity under the PREP Act covers “all claims for loss” — death; physical, mental, or emotional injury, illness, disability, or condition; fear of such injury, including medical monitoring costs; and loss of or damage to property, including business interruption loss.