Constitution of India – Art.21 – Right to Life – Directions by Supreme Court – For formulation of no-fault compensation framework to address serious adverse events following immunisation arising in the context of COVID-19 vaccination: Held: Constitution does not view the right to life solely through the lens of fault – Art.21 embodies a positive obligation of the State to ensure that where grave harm is alleged to have occurred in the course of a State led public health intervention, affected families are not left without any accessible mechanism of redress – The Union of India shall, through the Ministry of Health and Family Welfare, frame a no-fault compensation policy for serious adverse events following COVID-19 vaccination – The existing mechanisms for monitoring adverse events following immunisation shall continue, and relevant data shall be periodically placed in the public domain in accordance with the observations in Jacob Puliyel – No separate court-appointed expert body is necessary in view of the existing mechanisms for scientific assessment of adverse events following immunisation – Clarified, this judgment shall not preclude any person from pursuing such other remedies as may be available in law – Equally, the formulation of the no-fault framework is not to be construed as an admission of liability or fault on the part of the Union of India or any authority. [Paras 20, 38] Constitution of India – Art.21 – Right to Life – Deaths allegedly after administration of COVID-19 vaccination – Writ petitions filed seeking inter alia, the constitution of an independent expert medical board to inquire into such deaths, the formulation of protocols for early detection and treatment of adverse events following immunization (AEFI), and the grant of compensation – In one of the writ petitions filed before the High Court of Kerala raising similar grievances, High Court passed interim directions to the Ministry of Health and Family Welfare and the National Disaster Management Authority to formulate a policy for identification of AEFI cases and for compensating the families of such deceased persons – Challenge to: Held: Present petitions raise serious questions of violation of fundamental rights, more particularly that of right to life – Constitution does not view the right to life solely through the lens of fault – Art.21 embodies a positive obligation of the State to ensure that where grave harm is alleged to have occurred in the course of a State led public health intervention, affected families are not left without any accessible mechanism of redress – The absence of such an institutional framework raises constitutional concerns which warrant a calibrated response – Government data itself suggests that the vaccines also led to loss of life – Thus, State cannot shrug its responsibility in coming to aid to those affected families who have lost their near and dear ones – In Jacob Puliyel, this Court underscored the responsibility of the State in monitoring adverse events following immunisation – That responsibility cannot end at surveillance alone, but must extend to providing fair compensation to those who suffered vaccine-related injury – Union of India shall continue to ensure that surveillance of adverse events following immunisation (AEFI) is carried out through efficient monitoring mechanisms, and that relevant data is placed in the public domain in a transparent and timely manner – Directions issued for formulation of no-fault compensation framework to address serious adverse events following immunisation arising in the context of COVID-19 vaccination – Public Health. [Paras 12, 20, 25, 34, 35, 38] Public Health – Constitution of India – Arts.21, 14 – Right to health u/Art.21 – Obligation of State – Vaccine injury claims – Plea of the Union that individuals aggrieved by adverse outcomes may seek remedies before civil courts or consumer fora on the grounds of negligence-based principles. Held: While such remedies do exist, they are ill-suited as the only pathway of redress in the context of a mass immunization program – Vaccine injury claims raise questions where scientific attribution is often complex – To insist upon proof of negligence and fault in each case would impose an onerous burden upon affected families and would not be the best solution to those left affected – Further, a multiplicity of individual proceedings risks inconsistent outcomes and unequal access to relief, thereby undermining the guarantee of equality u/Art.14 – The relationship between the individual and the State cannot be viewed through the prism of fault-based liability – Where the State undertakes an intervention of this scale in discharging of its duty to protect public health, the right to health u/Art.21 would automatically extend to a corresponding obligation of institutional support in cases of grave outcomes, no matter how rare they are. [Para 26] Constitution of India – Art.21 – Right to Life includes right to health – Positive obligation on the State to safeguard health of its people:
Held: Art.21 is not limited to protection against unlawful deprivation; of life, but also includes within its ambit a wide range of other rights that facilitate the smooth operation of right to life – Right to health and bodily integrity, is one such right – The jurisprudence of this Court has progressively evolved from recognising the right to health as a facet of the right to life u/Art.21 to emphasising the positive duty of the State to act as provider, facilitator, and regulator in all aspects of healthcare – Present proceedings approached with the limited objective of examining, whether in the exceptional context of a pandemic response, the absence of any structured framework to address serious adverse events raise constitutional concerns warranting an institutional response – In doing so, neither the vaccine efficacy is adjudicated upon nor the Court is sitting in scientific review over the regulatory approval process – The question is confined to whether the State’s welfare obligations require the exploration of an equitable mechanism of redressal for harm arisen in the course of a national public health intervention. [Paras 14, 16, 17] No-Fault Compensation – Principle of No-fault liability in Indian Law – No-fault vaccine injury compensation scheme across various jurisdictions in the world, discussed:
Held: India does not have any uniform or structured policy mechanism to provide redress to individuals who suffer adverse effects following vaccination – This gap cannot be lightly overlooked, particularly when vaccination programmes are undertaken as public health measures under the aegis and authority of the State itself concern becomes all the more pressing in the context of the COVID-19 pandemic, where immunisation was carried out on an unprecedented scale as a collective societal necessity – In such a situation, the State cannot be heard to say that those who experience serious adverse consequences must fend for themselves, without any clear or accessible avenue of relief – The absence of a coherent framework, therefore, calls for timely intervention, lest the rights of such persons remain only theoretical and without meaningful enforcement. [Paras 28-31]
As published in the Supreme Court Reports, Supreme Court of India. Headnotes prepared by: Divya Pandey. Text from the Indian Supreme Court Judgments open data set (Dattam Labs), CC BY 4.0.
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