After Reading This Article You Can Solve This UPSC Mains Model Questions:
Mass vaccination programmes involve collective benefits but may impose rare risks on individuals. Evaluate how a vaccine injury compensation framework can strengthen public trust and vaccine acceptance. (10 Marks, GS-2 Social Justice)
Context
- Recently, the Supreme Court of India, in Rachana Gangu vs Union of India, directed the Ministry of Health and Family Welfare to formulate a “no-fault compensation scheme” for serious Adverse Events Following Immunisation (AEFI) arising from India’s COVID-19 vaccination campaign, marking a shift from a fault-based liability system to a no-fault framework in state-run public health programmes.
- Furthermore, the Supreme Court emphasised that in a welfare state, the government must assume a duty of care when it actively promotes public health interventions such as mass vaccination.
Background: Vaccine Injury Cases and Legal Context
A. Petitions Before the Supreme Court
- The issue of vaccine injury compensation came before the Supreme Court of India through petitions filed by families alleging that young individuals aged between 18 and 40 years had died or suffered serious complications after receiving COVID-19 vaccines such as the Covishield vaccine and Covaxin.
- A key petition was Rachana Gangu vs Union of India, which arose from the deaths in 2021 of two women aged 18 and 20 who were allegedly affected by Vaccine Induced Immune Thrombotic Thrombocytopenia (VITT), a rare complication associated with the Covishield vaccine.
- Key Issues Raised by Petitioners:
- Lack of Informed Consent: Petitioners argued that individuals were not adequately informed about possible rare side effects, including clotting disorders.
- Vaccination Practically Mandatory: Although vaccination was officially voluntary, administrative restrictions (travel, workplace entry, etc.) allegedly made vaccination de facto compulsory.
- Absence of Compensation Mechanism: India lacked a dedicated national vaccine injury compensation programme, leaving victims’ families without clear legal remedies.
B. Government’s Response to the Petitions
The Union Government presented the following arguments:
- Rigorous Safety Approval: Vaccines deployed in India had undergone scientific evaluation and regulatory approval, and the country maintains a robust AEFI monitoring system.
- Extremely Rare Adverse Events: Serious clotting disorders were reported at an extremely low rate (around 0.001 per lakh doses).
- Alternative Legal Remedies: Affected individuals could seek compensation through civil or consumer courts by proving negligence or liability.
A critical turning point occurred when AstraZeneca acknowledged in a U.K. court in 2024 that its vaccine (Covishield in India) could, in rare instances, cause VITT. This undermined the government’s earlier stance that such adverse events were purely coincidental.
Core Issues and Policy Challenges
The absence of a dedicated compensation framework created several systemic problems:
- Heavy Burden of Proof: In a fault-based system, victims must prove negligence by the State or manufacturer, which is difficult in complex medical cases like VITT.
- Legal Vacuum: Despite running one of the world’s largest immunisation programmes, India lacked a formal mechanism to compensate vaccine injuries.
- Voluntary vs Mandatory Paradox: While vaccination was declared voluntary, administrative mandates effectively made it compulsory, raising questions about state responsibility.
- Equality Concerns: Forcing families into lengthy individual litigation could produce unequal outcomes, violating Article 14 (Equality before Law).
Supreme Court’s Key Findings
- Rejection of Individual Litigation: The Supreme Court of India rejected the idea that affected families should file separate cases in lower courts, stating that this approach is not suitable for addressing vaccine injury cases arising from a large public health programme.
- Difficulty in Proving Negligence: The Court noted that proving negligence in vaccine injury cases requires complex scientific and medical evidence, which makes the legal process difficult and burdensome for ordinary families.
- Risk of Inequality and Inconsistent Judgments: The Court warned that forcing families to fight multiple individual cases could lead to different outcomes in different courts and unequal access to compensation, which may weaken the principle of equality before the law under Article 14 of the Constitution of India.
Judicial Reasoning: “No-Fault” Doctrine and State Accountability
The Supreme Court’s directive is a landmark shift in Indian law, moving from “proving guilt” to “ensuring welfare.” It anchors the state’s responsibility in a compassionate, constitutional framework.
1. The Principle of “No-Fault” Liability
Traditionally, getting compensation required proving that the manufacturer or the state was negligent (at fault). The Court has replaced this with No-Fault Liability.
- Direct Relief: Compensation is granted based on a plausible link between the vaccine and the injury. Families do not need to prove a mistake; the injury itself triggers the right to support.
- Recognition in Indian and Global Legal Framework: The principle of no-fault compensation is already recognised in certain areas of Indian law. Examples
- Motor Vehicles Act compensation framework, where victims of road accidents may receive compensation without proving fault.
- Industrial accident compensation regimes, which provide relief to workers injured during employment.
- Global Practice: Similar no-fault vaccine injury compensation systems operate in several countries, including Australia, the United Kingdom, and Japan, where claimants are not required to prove negligence but only establish a reasonable connection between vaccination and injury.
- Article 14 (Right to Equality): Forcing families to fight expensive, scientific legal battles against powerful entities violates Article 14. This doctrine ensures that even the most vulnerable have an equal path to justice.
2. Right to Health and Life (Article 21)
The Court expanded the scope of Article 21, stating that the “Right to Life” inherently includes the “Right to Health.”
- The State as a “Parens Patriae” (Guardian): In a state-led public health drive, the government does not act merely as a service provider but as a Guardian of Welfare. Its role is to protect the life and dignity of every citizen.
- Duty of Care: When the state endorses a medical intervention for the “public good” (like herd immunity), it assumes a Duty of Care. It cannot abandon the few individuals who suffer rare, severe side effects while serving a collective social goal.
3. The Welfare State and Constitutional Mandates
This judgment reinforces India’s identity as a Welfare State, governed by the Directive Principles of State Policy (DPSP).
- Article 38: Mandates the state to secure a social order that promotes the welfare of the people.
- Article 39(e) & Article 47: These articles specifically task the state with protecting the health of its citizens and regard the improvement of public health as a primary duty.
- Core Logic: In a welfare state, the “Duty of Care” means that the protection of the majority cannot come at the uncompensated cost of a few.
4. Reference to Earlier Judicial Precedents (Jacob Puliyel Case)
The Court referred to Jacob Puliyel vs Union of India, which:
- Upheld the legality of the emergency vaccine approval process.
- Recognised the AEFI (Adverse Events Following Immunisation) monitoring system as an important safety mechanism.
- Reaffirmed that bodily autonomy and personal integrity under Article 21 mean that vaccination cannot be forcibly imposed on individuals.
5. Precedent of Ex Gratia (Gaurav Kumar Bansal Case)
- The Court’s present approach also reflects its earlier intervention during the pandemic in Gaurav Kumar Bansal vs Union of India, which addressed financial relief for families of COVID-19 victims.
- In that case, the Court directed the National Disaster Management Authority to frame guidelines for providing ex-gratia compensation to families of those who died due to COVID-19.
- NDMA Compensation Framework: Following this judgment:
- The National Disaster Management Authority issued September 2021 guidelines.
- ₹50,000 ex-gratia compensation was provided for each COVID-19 death.
- Payments were made by States through the State Disaster Response Fund (SDRF).
- District grievance committees were created to resolve disputes regarding death certification and compensation claims.
- Definition of COVID-19 Death: Deaths occurring within 30 days of a positive COVID-19 test were treated as COVID-19 deaths for compensation purposes.
Global Best Practices: The International Landscape
India’s move aligns with established global norms where vaccine injury is treated as a collective social responsibility rather than an individual legal burden.
- United States: Operates the National Vaccine Injury Compensation Program (VICP), funded by a small tax on vaccine doses.
- United Kingdom: Utilizes the Vaccine Damage Payment Scheme (VDPS) to provide lump-sum payments for severe disabilities.
- COVAX Facility: Established a no-fault mechanism specifically for 92 low- and middle-income countries to ensure equity during the pandemic.
Way Forward: Framework for a Robust Policy
To bridge the gap between public health goals and individual rights, the following steps are required:
- Creation of a Dedicated Fund: The government should establish a permanent Vaccine Injury Compensation Fund, possibly through a public-private partnership or manufacturer levies.
- Simplified Claim Procedure: Following the NDMA model, the process must be administrative and time-bound, avoiding the complexities of traditional courtrooms.
- Enhanced AEFI Transparency: Data regarding side effects must be made publicly available to ensure informed consent for future drives, such as the upcoming HPV vaccination for cervical cancer.
- Independent Medical Boards: While existing AEFI committees monitor data, independent boards could be utilized to adjudicate complex compensation claims fairly.
Conclusion
The Supreme Court’s directive effectively bridges the gap between public health goals and individual rights by establishing that the State cannot endorse medical risks without providing a safety net. This transition to a no-fault framework ensures that India’s identity as a Welfare State is upheld through a compassionate “Duty of Care” that prioritizes human dignity over statistical insignificance.
