Supreme Court: In a landmark ruling on COVID-19 vaccination drive, the bench of L. Nageswara Rao* and BR Gavai, JJ has held that bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated.
The Court, however, cautioned that,
“This judgment is not to be construed as impeding, in any manner, the lawful exercise of power by the executive to take suitable measures for prevention of infection and transmission of the virus in public interest, which may also take the form of restrictions on unvaccinated people in the future, if the situation so warrants. Such restrictions will be subject to constitutional scrutiny to examine if they meet the threefold requirement for intrusion into rights of individuals.”
The ruling came in the writ petition wherein the Petitioner highlighted the adverse consequences of emergency approval of vaccines in India, the need for transparency in publishing segregated clinical trial data of vaccines, the need for disclosure of clinical data, lack of transparency in regulatory approvals, minutes and constitution of the expert bodies, imperfect evaluation of Adverse Events Following Immunisation (AEFIs) and vaccine mandates in the absence of informed consent being unconstitutional. The Petitioner further stated in the Writ Petition that coercive vaccination would result in interfering with the principle of informed self-determination of individuals, protected by Article 21 of the Constitution of India.
Is the Vaccination Drive Arbitrary?
On the basis of substantial material reflecting the near-unanimous views of experts on the 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, the Court was satisfied that the current vaccination policy of the Union of India is informed by relevant considerations and cannot be said to be unreasonable or manifestly arbitrary.
Personal autonomy and public health
- Bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated.
- Personal autonomy of an individual involves the right of an individual to determine how they should live their own life, which consequently encompasses the right to refuse to undergo any medical treatment in the sphere of individual health.
- Persons who are keen to not be vaccinated on account of personal beliefs or preferences, can avoid vaccination, without anyone physically compelling them to be vaccinated. However, if there is a likelihood of such individuals spreading the infection to other people or contributing to mutation of the virus or burdening of the public health infrastructure, thereby affecting communitarian health at large, protection of which is undoubtedly a legitimate State aim of paramount significance in this collective battle against the pandemic, the Government can regulate such public health concerns by imposing certain limitations on individual rights that are reasonable and proportionate to the object sought to be fulfilled.
Restrictions on unvaccinated persons and impeding their right to access public resources
Neither the Union of India nor the State Governments produced any material to justify the discriminatory treatment of unvaccinated individuals in public places by imposition of vaccine mandates.
“No doubt that when COVID-19 vaccines came into the picture, they were expected to address, and were indeed found to be successful in dealing with, the risk of infection from the variants in circulation at the time. However, with the virus mutating, we have seen more potent variants surface which have broken through the vaccination barrier to some extent.”
Hence, the restrictions on unvaccinated individuals imposed through vaccine mandates cannot be considered to be proportionate, especially since both vaccinated and unvaccinated individuals presently appear to be susceptible to transmission of the virus at similar levels.
It has, hence, been directed that till the infection rate and spread remains low, as it is currently, and any new development or research finding comes to light which provides the Government due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals in furtherance of the continuing efforts to combat this pandemic, all authorities in the country, including private organisations and educational institutions, should review the relevant orders and instructions imposing restrictions on unvaccinated individuals in terms of access to public places, services and resources.
Non-disclosure of segregated clinical trial data in public domain
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, the GCP guidelines and the WHO Statement on Clinical Trials. The material provided by the 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 the meetings of the SEC and the NTAGI are available in public domain and therefore, challenge to the procedures adopted by the 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 and to the extent permissible by the 2019 Rules, the relevant data which is required to be published under the statutory regime and the WHO Statement on Clinical Trials shall be made available to the public without undue delay, with respect to the ongoing post-marketing trials of COVAXIN and COVISHIELD as well as ongoing clinical trials or trials that may be conducted subsequently for approval of other COVID19 vaccines / vaccine candidates.
Monitoring of Adverse Events Following Immunisation (AEFIs)
The Court refused to accept the sweeping challenge to the monitoring system of AEFIs being faulty and not reflecting accurate figures of those with severe reactions or deaths from vaccines.
“The role of the Pharmacovigilance Programme of India and the CDSCO, as elaborated upon by the Union of India, collates and studies previously unknown reactions seen during monitoring of AEFIs at the time of vaccine administration and we trust the 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.”
Information relating to adverse effects following immunisation
Information relating to adverse effects following immunisation is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic.
Recognising the imperative need for collection of requisite data of adverse events and wider participation in terms of reporting, the Union of India has been 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.
The decision taken by the Union of India to vaccinate children in India is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC and it is beyond the scope of review for this 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, the Court directed the Union of India 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.
[Jacob Puliyel v. Union of India, 2022 SCC OnLine SC 533, decided on 02.05.2022]
*Judgment by: Justice L. Nageswara Rao
For Petitioner: Advocate Prashant Bhushan,
For UOI: Solicitor General Tushar Mehta
For Respondent No. 4: Senior Advocate S. Guru Krishnakumar
For Tamil Nadu: Additional Advocate General Amit Anand Tiwari
For Maharashtra: Advocate Rahul Chitnis
For Madhya Pradesh: Advocate Mrinal Gopal Elker,
For Respondent no. 5: Advocate Shyel Trehan