Article 1: Duty of care
Why in news: The Supreme Court of India directed the Ministry of Health and Family Welfare to design a no-fault compensation scheme for serious Adverse Events Following Immunisation (AEFI) during the COVID-19 vaccination programme.
Key Details
- Supreme Court Directive: The Supreme Court of India directed the Ministry of Health and Family Welfare to create a no-fault compensation scheme for serious Adverse Events Following Immunisation (AEFI) during the COVID-19 vaccination drive.
- Case Background: The ruling arose from the Rachana Gangu case, involving deaths of two young women allegedly linked to Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) after receiving the Covishield vaccine.
- Shift in Liability Approach: The judgement marks a shift from a fault-based liability system to a no-fault model, recognising that ordinary citizens cannot easily pursue complex civil litigation against vaccine manufacturers.
- Context and Evidence: In 2024, AstraZeneca acknowledged that Covishield could rarely cause VITT, reinforcing earlier scientific findings and weakening earlier claims that vaccine-related deaths were unproven.
- Significance: The ruling addresses the absence of a vaccine injury compensation mechanism in India, aligns with global practices, and sets a precedent for future public vaccination programmes while affirming the state’s duty of care in welfare policies.
Supreme Court Directive on Vaccine Injury Compensation
Background of the Case
- The Supreme Court of India directed the Ministry of Health and Family Welfare to design a no-fault compensation scheme for serious Adverse Events Following Immunisation (AEFI) during India’s COVID-19 vaccination campaign.
- This directive represents a shift from a fault-based liability system to a no-fault approach in state-run public health programmes.
- The case emerged from writ petitions filed by families who alleged that their relatives had died or suffered serious injuries after receiving COVID-19 vaccines.
Rachana Gangu Case
- The case specifically concerned the deaths of two women (aged 18 and 20) in 2021.
- Their deaths were allegedly linked to Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT), a rare complication associated with the Covishield vaccine.
- Families argued that India lacked a dedicated mechanism to compensate individuals harmed during a state-run vaccination programme.
Government’s Earlier Position
- The government had resisted creating a compensation framework for several years.
- It maintained that:
- COVID-19 vaccination was voluntary.
- Serious AEFI cases were extremely rare.
- Individuals could seek compensation by filing civil lawsuits against vaccine manufacturers.
- The Supreme Court rejected this reasoning, noting that litigation against pharmaceutical companies is impractical for ordinary citizens.
Connection with Earlier Supreme Court Judgement (Jacob Puliyel, 2022)
- In the Jacob Puliyel case (2022), the Court upheld emergency approval of COVID-19 vaccines.
- However, it also stressed the importance of transparency and public access to AEFI data.
- The current ruling builds upon that judgement by strengthening accountability in vaccination programmes.
New Scientific and Legal Developments
- In 2024, AstraZeneca acknowledged in a U.K. court document that Covishield could rarely cause VITT.
- This admission reinforced earlier medical literature identifying the risk.
- Since a majority of Indians received Covishield, the acknowledgement weakened earlier claims that such deaths were unrelated or coincidental.
Global Practices on Vaccine Injury Compensation
- Many countries already operate vaccine injury compensation programmes, including the United States and the United Kingdom.
- These systems follow a no-fault model, where claimants only need to show a plausible link between vaccination and injury, rather than proving negligence.
- The COVAX facility also established a no-fault compensation mechanism for 92 low- and middle-income countries.
India’s Situation and the Court’s Observations
- Despite conducting one of the largest vaccination drives globally, India did not have a dedicated national vaccine injury compensation programme.
- During the pandemic, the government reported over 1,100 deaths following vaccination out of approximately 219 crore doses administered.
- The Court emphasised that each case represents a human life, and the absence of a compensation policy left affected families in a legal vacuum.
Scope and Significance of the Ruling
- The Court clarified that the directive does not determine whether vaccines caused specific injuries or deaths.
- It also does not eliminate fault-based liability mechanisms in public health.
- Instead, it establishes a precedent for future vaccination programmes, such as the HPV vaccination drive.
- The ruling reinforces the principle that when the state promotes medical interventions for public welfare, it also has a duty of care towards citizens who may suffer rare adverse outcomes.
Conclusion
The judgment highlights the state’s duty of care in public health interventions. While vaccines remain essential for public welfare, the ruling emphasises that governments must also protect and compensate individuals who suffer rare adverse outcomes. By recommending a no-fault compensation mechanism, the Court strengthens public trust, accountability, and ethical responsibility in future vaccination programmes.
Descriptive Question:
Q. “When the state promotes vaccination for public welfare, it must also ensure accountability and compensation for rare adverse outcomes.” Discuss in the context of the Supreme Court’s directive on a vaccine injury compensation scheme in India.