In Writ Petition (Civil) No. 607 of 2021-SC- Bodily integrity is protected under Article 21 of Constitution and no individual can be forced to be vaccinated, says Top Court while declaring current COVID vaccination policy to be reasonable Justices L. Nageswara Rao & B.R. Gavai [02-05-2022]

Read Judgment: JACOB PULIYEL v. UNION OF INDIA & ORS 

Tulip Kanth

New Delhi, May 04, 2022: Considering the near-unanimous views of experts on the benefits of COVID vaccination in addressing severe disease from the infection, reduction in oxygen requirement, hospital admissions, and stopping new variants from emerging, the Supreme Court has held 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. 

The Division Bench of Justice L.Nageswara Rao and Justice B.R.Gavai affirmed, “With respect to the infringement of bodily integrity and personal autonomy of an individual considered in the light of vaccines and other public health measures introduced to deal with the COVID-19 pandemic, we are of the opinion that bodily integrity is protected under Article 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 Article 21.”

The petitioner, a member of the National Technical Advisory Group on Immunization (NTAGI), was advising the Government of India on vaccines. He had filed this Writ Petition in public interest to direct the respondents to release the entire segregated trial data for each of the phases of trials that have been undertaken with respect to the vaccines being administered in India, disclose the detailed minutes of the meetings of the Subject Expert Committee and the NTGAI with regard to the vaccines, disclose the post vaccination data. It was also prayed to declare that vaccine mandates are a violation of the rights of citizens and unconstitutional.

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.

The Union of India raised a preliminary objection regarding the maintainability of the Writ Petition and said that it is accepted world over that vaccination for COVID-19 is necessary to avoid infection. In so far as disclosure of clinical trial data was concerned, the Union of India referred to the National Ethical Guidelines for Biomedical and Health Research involving Human Participants published by the ICMR, which require privacy and confidentiality of human participants to be maintained. Accordingly, the Union of India contended that such details pertaining to identity and records of the participants in the clinical trial data cannot be disclosed to the public as per the prevailing statutory regime. It was asserted by the Union of India that the remaining data has already been made available in the public domain.

The Bench was of the opinion that as far as judicial review of policy decisions based on expert opinion is concerned, there is no doubt that wide latitude is provided to the executive in such matters and the 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.

In the context of the rapidly-evolving situation presented by the COVID-19 pandemic, the Bench suggested that 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. 

As regards non-disclosure of segregated clinical data, the Bench noticed that 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 Top Court noted that the material provided by the Union of India, comprising 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. 

Holding that the 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 expert bodies while granting regulatory approval to the vaccines on the ground of lack of transparency cannot be entertained, the Bench reiterated that 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.

Recognising the imperative need for collection of requisite data of adverse events and wider participation in terms of reporting, the Bench directed the Union of India to facilitate reporting of suspected adverse events by individuals and private doctors on an accessible virtual platform. These reports have to  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.

Lastly, the Bench also recognised that the decision taken by the Union of India to vaccinate children in this country is in tune with global scientific consensus and expert bodies 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 Apex Court also 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.