Dr. Jacob Puliyel ("Petitioner"), a former member of the National Technical Advisory Group on Immunization ("NTAGI") had filed a public interest litigation challenging the constitutional validity of vaccine mandates imposed by States, particularly Delhi, Tamil Nadu, Madhya Pradesh, and Maharashtra.
The Petitioner had prayed for the Court to issue the following directions to the concerned Respondents:
- For release of segregated trial data for each of the phases of trials that have been undertaken with respect to the vaccines being administered in India;
- For disclosure of the detailed minutes of the meetings of the Subject Expert Committee and the NTAGI with regard to the vaccines as directed by the 59th Parliamentary Standing Committee Report and the members who constituted the committee for the purpose of each approval meeting;
- For disclosure of the reasoned decision of the Drugs Controller General of India ("DCGI") for granting approval or rejecting an application for emergency use authorization of vaccines and the documents and reports submitted to the DCGI in support of such applications;
- For disclosure of the post vaccination data regarding adverse events, vaccinees who got infected with Covid, those who needed hospitalization and those who died after such infection post vaccination
- Directions to widely publicize the data collection of such adverse event through the advertisement of toll free telephone numbers where such complaints can be registered; and
- For declaring that vaccine mandates, in any manner whatsoever, even by way of making it a precondition for accessing any benefits or services, is a violation of rights of citizens and unconstitutional
Contentions by the Petitioner:
- The Petitioner contended that coercive vaccination would result in the interference with the principle of informed self-determination of individuals, protected by Article 21 of the Constitution of India. The Petitioner cited examples of the following State Government Orders:
- Order passed by the Government of NCT of Delhi on 08.10.2021 by which government employees, including frontline workers and healthcare workers, as well as teachers and staff working in schools and colleges were not to be allowed to attend their respective offices and institutions without the first dose of vaccination with effect from 16.10.2021;
- A directive issued by the Government of Madhya Pradesh on 08.11.2021 stating that it was mandatory to be vaccinated with two doses of the vaccine to get food grains at fair price shops; (this order was later withdrawn as per the Counsel for the State of Madhya Pradesh)
- An order passed by the Government of Maharashtra dated 27.11.2021 requiring persons to be fully vaccinated if they are connected with any program, event, shop, establishment, mall and for utilising public transport;
- An order issued by the Government of Tamil Nadu dated 18.11.2021 permitting only vaccinated people into open, public places, schools, colleges, hostels, boarding houses, factories, and shops; and other instances where students in the age group of 15 to 18 years were not permitted to appear for their examinations without being vaccinated.
- In its additional affidavit the Petitioner averred that natural immunity is long-lasting and robust in comparison to vaccine immunity and that vaccines do not prevent infection or transmission of COVID-19. The Petitioner also relied upon news articles and research studies conducted to state that there had been breakthrough infections even amongst vaccinated people, urging further that vaccinated people also transmit the virus, thereby making vaccine mandates meaningless.
Placing reliance on the above, the Petitioner contended that mandating vaccination for access to resources, public places and means of earning livelihood would be in violation of the fundamental rights of unvaccinated persons, especially so, when scientific studies have shown that unvaccinated persons do not pose more danger of transmission of the virus when compared to vaccinated persons.
Contentions by the Respondent:
- The Union of India contended that the serious threat posed by the unprecedented pandemic which had devastating effects on the entire world called for emergency measures, stating that it is accepted world over that vaccination for COVID-19 is necessary to avoid infection.
- The Union of India also went on to highlight that the country started one of the largest inoculation programmes in the world in larger public interest, while tackling challenges of vaccine hesitancy, effect of the second wave of the pandemic and other such adverse circumstances. Any interference with the steps taken by the Union on the basis of the advice given by the NTAGI and other expert bodies would provide impetus to the already prevailing vaccine hesitancy in certain sections of the society
- It was also submitted by the Union of India that decisions of domain experts should not normally be interfered with in judicial review and that the Court should not sit in appeal over a scientific process undertaken by domain experts on a subject which is not the expertise of any judicial forum.
- With respect to clinical trials, it was contended by the Union of India that details pertaining to identity and records of the participants in the clinical trial data cannot be disclosed in the interest of maintaining the privacy and confidentiality of human participants 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.
- On the subject of monitoring of Adverse Event Following Immunisation ("AEFI"), the Union of India brought to the Court's attention established procedures and protocols in place for surveillance of AEFIs established under the National Adverse Event Following Immunisation Surveillance Guideline.
- It was also submitted by the Union of India that COVID-19 vaccination is voluntary and that the Government of India encourages all individuals to take vaccination in the interest of public health, as the individual's ill health has a direct effect on the society. It was also made clear that COVID-19 vaccination is not linked to any benefits or services.
- The vaccine manufacturers, brought to the notice of this Court that approval to their vaccines was granted after strict compliance of the procedure prescribed. The States of Tamil Nadu, Maharashtra, Delhi and Madhya Pradesh also filed counter-affidavits, justifying that the restrictions were not only aimed for the safety of a particular individual but also served a greater purpose of ensuring safety of the community at large.
Mandatory Vaccination and the Right to Refuse Medical Treatment:
- The Court held that it is the choice of an individual in deciding whether they wish to be vaccinated or not. Nobody can be forcefully vaccinated as it would result in bodily intrusion and violation of the individual's right to privacy, protected under Article 21 of the Constitution of India.
- Additionally, the Court recognised the right of an individual to refuse unwanted medical treatment and to not be forced to take any medical treatment that is not desired.
- Considering that the Union of India had stated that vaccination of COVID-19 is voluntary, the Court noted that the question of any intrusion into bodily integrity does not arise, however, the limitations placed on access to public places and public resources for unvaccinated persons result in coercive vaccination, and therefore, limit the right of unvaccinated persons to refuse medical treatment.
- The Court relied on several international precedents that discussed issues like whether vaccination is effective in limiting infection and transmission and whether vaccination prevents persons from contracting and spreading COVID-19.
- The Court concluded that 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, the Government can regulate public health concerns by imposing certain limitations on individual rights that are reasonable and proportionate to the object sought to be fulfilled.
Union and State Policies:
- The Court held that the Union of India was justified in centering its vaccination policy around the health of the population at large, with emphasis on insulating the weaker and more vulnerable sections from the risk of severe infection and its consequences. The policy was stated to be formulated in the interest of public health and informed by relevant considerations and was therefore not unreasonable.
- Noting that neither the Union of India nor the State Governments have produced any material before this Court to justify the discriminatory treatment of unvaccinated individuals in public places by imposition of vaccine mandates, the Court found that the restrictions on unvaccinated individuals 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.
Guidance for Organisations: The Court suggested that till the infection rate and spread remain low, 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 to combat the pandemic, all authorities in this 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. Alternatively the Court gave the example of implementing the "health pass" as employed in France, which may take the form of results of a viral screening test not concluding that a person has been infected with COVID-19, or proof of vaccination status, or a certificate of recovery following an infection.
In light of the Supreme Court's judgement all authorities including private organisations, cannot mandate vaccinations for its employees given that the Apex Court has upheld that "Nobody can be forcefully vaccinated as it would result in bodily intrusion and violation of the individual's right to privacy, protected under Article 21 of the Constitution of India".
In view of the same, any policy imposing restrictions (in terms of access to public places, services and resources) on unvaccinated employees will have to be revised, which will likely include refusing access to unvaccinated employees in an office space. Accordingly, revisions to the company policy for the health and safety of the employees could include the following:
- Incentivising vaccination instead of mandating it: Private organisations may promote and incentivise vaccination, however, steps should be taken to ensure that no detrimental/discriminating action is taken against unvaccinated persons as a result of the same.
- Provide access to information resources: Private organisations can make Covid-19, AEFI and vaccination related resources released by the Government and reliable international bodies (World Health Organisatione etc.) available to individuals.
- Imposing a Mask Mandate: In order to fulfill its duty of care towards its employees and and ensure the well-being and safety of all employees in a workplace, private organisations may impose a mask mandate on their premises.
- Consider the Supreme Court's recommendation of implementing a health pass: Implementing a "health pass" may be considered, which factors in results of a viral screening test not concluding that a person has been infected with COVID-19, or proof of vaccination status, or a certificate of recovery following an infection.