- within Consumer Protection, Coronavirus (COVID-19) and Privacy topic(s)
Introduction
Mass vaccination programmes represent one of the most effective public health interventions in modern history. They have dramatically reduced the incidence of infectious diseases and saved countless lives. However, like all medical interventions, vaccines carry a small but real risk of adverse events. In rare cases, these adverse events can be serious, leading to significant injury or even death. This creates a fundamental tension: while society as a whole, benefits enormously from high vaccination coverage, the burden of rare but serious adverse events falls on individual citizens.
Traditional tort-based liability systems are often ill-suited to address vaccine-related injuries. Proving causation between a vaccine and a specific adverse outcome can be scientifically complex and legally burdensome. Litigation is slow, expensive, and unpredictable. Moreover, holding vaccine manufacturers or administrators strictly liable can have a chilling effect on vaccine development, supply, and public health campaigns. In response to these challenges, many countries have established no-fault compensation programmes specifically designed to provide timely and fair redress to individuals who suffer serious adverse events following vaccination, without requiring proof of negligence or defect.
The Right to Health and State Obligation
The Supreme Court of India has consistently interpreted Article 21 of the Constitution to encompass the right to health as an integral component of the right to life. This includes not only protection against state-inflicted harm but also positive obligations on the state to take measures to protect and promote public health. During mass public health interventions such as nationwide vaccination drives, the state assumes a heightened responsibility for the well-being of citizens who participate in these programmes in the collective interest.
When the state actively promotes and, in some cases, mandates or strongly encourages vaccination as part of a public health strategy, it creates a relationship of trust and reliance. Citizens who suffer serious adverse consequences from complying with this public health directive have a strong moral and constitutional claim to support from the state. A no-fault compensation mechanism can be viewed as a necessary corollary of the state’s positive obligation under Article 21 to protect bodily integrity and health during mass public health interventions. It operationalises the principle that the burdens of public health measures should be shared by society as a whole, rather than borne exclusively by unfortunate individuals.
Design Considerations for a No-Fault Vaccine Compensation Scheme
An effective no-fault vaccine compensation programme must address several key design questions. First, the scope of covered vaccines and adverse events must be clearly defined, typically through a schedule or list of recognised injuries developed with expert medical input. Second, the standard of proof for establishing a causal link between vaccination and injury must balance accessibility with scientific integrity; many successful programmes use a presumption of causation for listed injuries occurring within specified timeframes. Third, the level and nature of compensation — including medical expenses, lost earnings, pain and suffering, and death benefits — must be adequate to provide meaningful relief without creating incentives for frivolous claims.
Funding mechanisms are also critical. Options include dedicated government budgets, levies on vaccine manufacturers or importers, or hybrid models. Administrative efficiency is essential to ensure that claims are processed fairly and expeditiously, without the delays characteristic of conventional litigation. Transparency in decision-making, publication of reasoned orders, and provision for appeals or reviews help maintain public trust in the system.
Challenges and the Way Forward
Establishing a robust no-fault vaccine compensation scheme in India presents several challenges. These include developing reliable systems for adverse event surveillance and causality assessment, building administrative capacity at national and state levels, ensuring sustainable funding, and managing public expectations. There is also the need to integrate such a scheme with existing mechanisms for reporting and investigating adverse events following immunisation (AEFI).
Nevertheless, the experience of numerous countries that have successfully operated vaccine injury compensation programmes for decades demonstrates that these challenges are surmountable. As India continues to rely on large-scale vaccination campaigns to address both routine and emergency public health threats, the establishment of a fair, efficient, and rights-respecting compensation mechanism is not only a constitutional imperative but also a practical necessity for maintaining public confidence in immunisation programmes.
Conclusion
The right to health under Article 21 of the Constitution imposes on the state a positive obligation to protect citizens during mass public health interventions. When serious adverse events occur following vaccination, the affected individuals should not be left to bear the consequences alone. A well-designed no-fault compensation scheme represents a practical and principled response to this challenge. It acknowledges the collective benefit derived from vaccination programmes, distributes the burden of rare but serious harms more equitably, and reinforces public trust in the state’s commitment to protecting health and bodily integrity. As India strengthens its public health infrastructure and prepares for future health emergencies, establishing such a mechanism should be treated as an essential component of a rights-based approach to public health governance.
References
- Rachana Gangu & Anr v. Union of India & Ors 2026 INSC 218 (SC) paras 14, 16–17.
- Rachana Gangu & Anr v. Union of India & Ors 2026 INSC 218 (SC) paras 20, 25–27.
- Rachana Gangu & Anr v. Union of India & Ors 2026 INSC 218 (SC) paras 31, 34–38.
- Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996) 4 SCC 37.
- State of Punjab v. Mohinder Singh Chawla (1997) 2 SCC 83.
- State of Punjab v. Ram Lubhaya Bagga (1998) 4 SCC 117.
- Jacob Puliyel v. Union of India 2022 SCC OnLine SC 533.
- Ministry of Health and Family Welfare, Government of India, Adverse Event Following Immunization: Surveillance and Response - Operational Guidelines 2024 (2024) https://www.mohfw.gov.in/sites/default/files/National%20AEFI%20Surveillance%20and%20Response%20Operational%20Guidelines%202024.pdf.
- World Health Organization, ‘Adverse Events following Immunization: Causality Assessment of Adverse Events Following Immunization’ https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/aefi/aefi.
- World Health Organization, Causality Assessment of an Adverse Event Following Immunization (AEFI): User Manual for the Revised WHO Classification (2021) https://www.who.int/publications/b/47379.
- World Health Organization, ‘Injury Compensation’ (Global Advisory Committee on Vaccine Safety, 25 January 2019) https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/pharmacovigilance/injury-compensation.
- R G Mungwira and others, ‘Global landscape analysis of no-fault compensation programmes for vaccine injuries: a review and survey of implementing countries’ (2020) https://doi.org/10.1371/journal.pone.0233334.
- US Health Resources and Services Administration, ‘About the National Vaccine Injury Compensation Program’ https://www.hrsa.gov/vaccine-compensation/about.
- Vaccine Damage Payments Act 1979, Section(s) 1-2 https://www.legislation.gov.uk/ukpga/1979/17/pdfs/ukpga_19790017_301114_en.pdf.
- World Health Organization, ‘No-fault compensation programme for COVID-19 vaccines is a world first’ (22 February 2021) https://www.who.int/news/item/22-02-2021-no-fault-compensation-programme-for-covid-19-vaccines-is-a-world-first.
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