Context: India lacks a formal mechanism to compensate individuals suffering serious adverse events following immunisation (AEFI), raising concerns about state responsibility and public trust.
The Ethical and Public Health Dilemma
- Vaccination represents a social contract, where individuals accept small risks for collective immunity.
- While vaccines have eradicated diseases like smallpox and reduced mortality, rare but serious adverse effects do occur.
- Over 92,000 AEFI cases, including severe outcomes and deaths, highlight that risks, though limited, are real.
- When harm arises from a collective policy, the burden should not fall solely on the affected individual.
Constitutional and Legal Foundations
- Article 21 obligation: The right to health imposes a duty on the State to both promote and safeguard public health outcomes.
- Legitimate expectation: Citizens complying with State-led vaccination drives expect protection and redress in case of harm.
- Equity concern: Absence of compensation disproportionately affects economically vulnerable groups.
Limitations of Existing Legal Remedies
- Tort law constraints: Requires proof of fault, which is often absent in biological or immune-response cases.
- Consumer law ambiguity: Free vaccination complicates the definition of a consumer relationship.
- PIL limitations: Public interest litigation can guide policy but cannot ensure individual compensation delivery.
- The current system leaves victims in a legal vacuum without effective remedy.
Global Best Practices
- No-fault compensation model: Countries like the U.S., U.K., Japan, and Germany provide compensation without requiring proof of negligence.
- Dedicated tribunals: Specialised bodies ensure faster and expert-based adjudication.
- Compensation funds: Financed through public resources and industry levies, ensuring shared responsibility.
- These systems demonstrate that transparency enhances public trust rather than undermining vaccination efforts.
Framework for India
- Statutory backing: Establish a dedicated law to provide legal certainty and enforceable rights.
- No-fault principle: Compensation should not depend on proving negligence but on causal linkage within defined parameters.
- Vaccine Injury Table: A predefined list of conditions with timeframes can simplify causation assessment and claims processing.
- Independent tribunal: A specialised body with medical and legal expertise can ensure accessible and efficient adjudication.
- Dedicated fund mechanism: Shared funding by government and manufacturers can promote accountability and sustainability.
- Robust surveillance system: Transparent and disaggregated AEFI reporting is essential for credibility and evidence-based decisions.
Conclusion
- Vaccination is not merely a medical intervention but a collective societal bargain requiring mutual responsibility. A robust compensation mechanism is essential to uphold trust, justice, and the ethical foundation of public health governance.
