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Public health – COVID-19 pandemic – Vaccines and other public health measures – Fundamental rights of individuals – Bodily integrity and personal autonomy of an individual – Held: Bodily integrity is protected under Art. 21 of the Constitution and no individual can be forced to be vaccinated – Further, personal autonomy of an individual, which is a recognised facet of the protections guaranteed under Art. 21, encompasses the right to refuse to undergo any medical treatment in the sphere of individual health – However, in the interest of protection of communitarian health, the Government is entitled to regulate issues of public health concern by imposing certain limitations on individual rights, which are open to scrutiny by constitutional courts to assess whether such invasion into an individual’s right to personal autonomy and right to access means of livelihood meets the threefold requirement as laid down in K.S. Puttaswamy case, i.e., (i) legality, which presupposes the existence of law; (ii) need, defined in terms of a legitimate State aim; and (iii) proportionality, which ensures a rational nexus between the objects and the means adopted to achieve them – Constitution of India, 1950 – Art. 21. Public health – COVID-19 pandemic – Vaccines and other public health measures – Vaccination policy – Restrictions on unvaccinated individuals –Challenge to – Held: Substantial material filed before the Court reflecting the near-unanimous views of experts on benefits of vaccination in addressing severe disease from the infection, reduction in oxygen requirement, hospital and ICU admissions, mortality and stopping new variants from emerging – Current vaccination policy of the Union of India is informed by relevant considerations and cannot be said to be unreasonable or manifestly arbitrary – However, no data placed by Union of India or the States, controverting the material placed by the Petitioner in the form of emerging scientific opinion which appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons – In light of this, restrictions on unvaccinated individuals imposed through various vaccine mandates by State Governments / Union Territories cannot be said to be proportionate – Till the infection rate remains low and any new development or research finding emerges which provides due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals, it is suggested that all authorities in this country, including private organisations and educational institutions, review the relevant orders and instructions imposing restrictions on unvaccinated individuals in terms of access to public places, services and resources, if not already recalled – It is however clarified that in the context of the rapidly-evolving situation presented by the COVID-19 pandemic, the suggestion to review the vaccine mandates imposed by States / Union Territories, is limited to the present situation alone and is not to be construed as interfering with the lawful exercise of power by the executive to take suitable measures for prevention of infection and transmission of the virus – The suggestion also does not extend to any other directions requiring maintenance of COVID-appropriate behaviour issued by the Union or the State Governments. Public health – COVID-19 pandemic – Clinical trials of vaccines – Non-disclosure of segregated clinical data – Held: The results of Phase III clinical trials of the vaccines in question have been published, in line with the requirement under the statutory regime in place, Good Clinical Practices (GCP) guidelines and the WHO Statement on Clinical Trials – Material provided by Union of India, comprising of minutes of the meetings of the SEC, do not warrant the conclusion that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data – Relevant information relating to meetings of Subject Expert Committee (SEC) [the body which sends recommendations to the Central Drugs Standard Control Organisation] and National Technical Advisory Group on Immunization (NTAGI) are available in public domain and therefore, challenge to the procedures adopted by the expert bodies while granting regulatory approval to the vaccines on the ground of lack of transparency cannot be entertained – However, subject to the protection of privacy of individual subjects, with respect to ongoing clinical trials and trials that may be conducted subsequently for COVID-19 vaccines, all relevant data required to be published under the extant statutory regime must be made available to the public without undue delay. Public health – Immunisation – Adverse Events Following Immunisation (AEFI) – Central Drugs Standard Control Organisation (CDSCO) – Sweeping challenge to the monitoring system of AEFIs being faulty and not reflecting accurate figures of those with severe reactions or deaths from vaccines, not acceptable – Role of the Pharmacovigilance Programme of India – CDSCO, as elaborated upon by Union of India, collates and studies previously unknown reactions seen during monitoring of AEFIs at the time of vaccine administration – Union of India to ensure that this leg of the AEFI surveillance system is not compromised with, while meeting the requirements of the rapid review and assessment system followed at the national level for AEFIs. Public health – Immunisation – Adverse effects following immunisation – Information relating to – Held: Such information is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic – Imperative need for collection of requisite data of adverse events and wider participation in terms of reporting – Union of India directed to facilitate reporting of suspected adverse events by individuals and private doctors on an accessible virtual platform – These reports shall be made publicly accessible, without compromising on protecting the confidentiality of the persons reporting, with all necessary steps to create awareness of the existence of such a platform and of the information required to navigate the platform to be undertaken by the Union of India at the earliest. Public health – Vaccination – Paediatric vaccination – Policy decision – Scope of review – Held: Decision taken by Union of India to vaccinate children in the country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC – It is beyond the scope of review for the Court to second-guess expert opinion, on the basis of which the Government has drawn up its policy – Keeping in line with the WHO Statement on Clinical Trials and the extant statutory regime, Union of India directed to ensure that key findings and results of the relevant phases of clinical trials of vaccines already approved by the regulatory authorities for administration to children, be made public at the earliest, if not already done. Public Health – Policy decisions based on expert opinion – Judicial review – Scope – Held: Court would be slow in interfering with matters of policy, especially those connected to public health – Wide latitude is provided to the executive in matters involving policy decisions based on expert opinion – Court does not have the expertise to appreciate and decide on merits of scientific issues on the basis of divergent medical opinion – However, this does not bar the Court from scrutinising whether the policy in question can be held to be beyond the pale of unreasonableness and manifest arbitrariness and to be in furtherance of the right to life of all persons, bearing in mind the material on record – Constitution of India, 1950 – Art. 14. Evidence – News item published in newspaper – Admissibility – Held: The courts cannot take judicial notice of facts stated in a news item published in a newspaper – A statement of fact contained in a newspaper is merely hearsay and therefore, inadmissible in evidence, unless proved by the maker of the statement appearing in court and deposing to have perceived the fact reported – Judicial Notice. Public interest litigation – Public interest litigation moved by a person having knowledge in the subject-matter of the lis and, thus, having an interest therein, as contradistinguished from a busybody, in the welfare of people – Maintainability of. |
