Tackle The Other Hesitancy

Context: Insurance, not immunity, can propel vaccine makers without leaving potential victims in the lurch.

Issues related to vaccine production:

• Issues related to pricing, payment modalities: Along with logistics and bridging studies are common.
  • Vaccines are generally not considered very profitable, as their market usually exhausts after a dose or two being administered to a limited population.
  • So, pharma companies tend to prioritise medicines that must be taken repeatedly to generate revenue for years to come.
• Legal indemnity: Some suppliers have insisted on government protection from potential lawsuits relating to vaccine-related adverse events, resisting their entry in the vaccination program.
  • Thus, manufacturers routinely refuse to supply vaccines without immunity from liability, or indemnification from the state, or a combination of the two.
  • For e.g. In the US, the Public Readiness and Emergency Preparedness (PREP) Act, 2005, provides manufacturers immunity from lawsuits related to injuries caused by vaccines — with exceptions for cases like negligence.
  • However, India does not offer any such immunity, indemnification or vaccine compensation programme.

Arguments opposing indemnification of pharma companies

• Liability is unforeseeable: Given that adequate trials would take years, but pressing public health needs dictate that the vaccines be administered today.
• Disincentivises supply: Limitless liability will disincentivise pharma companies from supplying vaccines on an emergency basis, and it would, in general, discourage the development of new vaccines.
• Poses a moral hazard: A government is naturally incentivised to do away with laws that impose these significant sums or not recognise legitimate claims from victims of serious adverse events.

Arguments favouring indemnification of pharma companies

• Ensures full access to justice: Watering down of laws will leave people with limited or no access to justice.
• Reduced Risk: Of having a large number of injured people to whom government may be unable to offer compensation.
• Maintain public confidence: The public confidence is unlikely to be high in a vaccination programme that leaves them without recourse in case of an adverse event.

Way forward

• No-fault, vaccine-injury compensation system of WHO Covax: High-income countries to pay a small fee per dose of vaccine administered through Covax.
  • This fee will be used to fund premiums of liability insurance in mid-income and low-income countries and claims settled by the insurer.
  • Residents of these countries who suffer serious adverse events as a result of vaccination may file claims with the insurer and receive a quick settlement.
  • In India, the same solution can be found by enacting a law along the lines of Public Liability Insurance Act, 1991, for vaccines under emergency use authorisations.

Conclusion: Thus, immunity or indemnification from GoI may not be the most appropriate solution to the dilemma.