Key Facts and Data Points
- Directive: Supreme Court ordered the Union Government to formulate a no‑fault liability compensation policy for COVID‑19 vaccine adverse effects.
- Principle invoked: No‑fault liability – victims need not prove negligence or intent.
- Constitutional basis: Article 21 (Right to Life & Health) and Article 14 (Equality).
- Incidence of serious adverse events: Approx. 0.001 per 1 lakh doses (e.g., rare clotting disorders).
- Existing mechanisms: Adverse Events Following Immunisation (AEFI) committees will continue surveillance; compensation to be added.
- Prior SC judgments:
- Gaurav Kumar Bansal vs Union of India (2021) – NDMA guidelines for ex‑gratia assistance (Rs 50,000 per COVID‑19 death).
- Jacob Puliyel vs Union of India (2022) – Upheld vaccine approval process and AEFI monitoring.
- International parallels: Vaccine injury schemes in Australia, United Kingdom, Japan.
Background and Context
- India launched the largest COVID‑19 vaccination drive, making it effectively mandatory through restrictions on the unvaccinated.
- While most side‑effects are mild (fever, fatigue, headache), rare serious events such as myocarditis/pericarditis (mRNA vaccines) and Thrombosis with Thrombocytopenia Syndrome (TTS) (viral‑vector vaccines) have been documented.
- Prior to the SC order, victims had to pursue civil/consumer litigation, leading to fragmented outcomes.
Significance for India / Governance / Policy
- Uniform redressal: A single, ex‑gratia compensation framework ensures equitable relief and reduces litigation burden.
- State’s positive obligation: Aligns with the view of the State as an active guardian of health, not a passive regulator.
- Policy integration: Bridges surveillance (AEFI) with compensation, strengthening public confidence in immunisation programmes.
- Fiscal implication: Compensation fund will need allocation, possibly through the State Disaster Response Fund or a dedicated Vaccine Injury Fund.
Constitutional / Legal Provisions
- Article 21: Guarantees the right to life and health; interpreted to impose a duty on the State to protect citizens during mass health interventions.
- Article 14: Equality before law – mandates a uniform compensation mechanism to avoid disparate outcomes.
- No‑fault liability principle: Already embedded in Indian motor‑vehicle accident law (Motor Vehicles Act, 1988) and now extended to vaccine injuries.
International Practice
- United Kingdom: Vaccine Damage Payment Scheme – lump‑sum payment without proof of negligence.
- Australia: National Vaccine Injury Compensation Program – administered by a statutory body.
- Japan: Vaccine Injury Compensation System – provides compensation based on a predefined schedule.
Related Judicial Precedents
- Gaurav Kumar Bansal vs Union of India (2021) – NDMA’s ex‑gratia guidelines for COVID‑19 deaths.
- Jacob Puliyel vs Union of India (2022) – Validated AEFI mechanisms and affirmed bodily integrity under Article 21.
Rare Serious Adverse Effects (Illustrative)
- Myocarditis / Pericarditis: Mostly in adolescent/young adult males after the second dose of mRNA vaccines (Pfizer‑BioNTech, Moderna).
- Thrombosis with Thrombocytopenia Syndrome (TTS): Linked to viral‑vector vaccines (AstraZeneca, Janssen).
FAQs (For Quick Revision)
- What is ‘no‑fault liability’ in the SC order?
- Victims receive compensation without proving negligence.
- Which constitutional articles underpin the judgment?
- Articles 21 and 14.
- Name two rare serious adverse events associated with COVID‑19 vaccines.
- Myocarditis/pericarditis and TTS.
UPSC Relevance
- Prelims: Facts on the SC order, constitutional provisions, incidence rates, and international compensation models.
- Mains: Analyse the policy’s impact on public health governance, fiscal implications, and the balance between individual rights and collective welfare.
- Essay/Answer‑Writing: Discuss the role of the State in mass vaccination drives and the need for a no‑fault compensation mechanism.