Supreme Court clarifies the legality of vaccine mandates and the importance of data transparency in COVID-19 cases (2 May 2022)

Date of the Judgment: 2 May 2022

Citation: (2022) INSC 416

Judges: L. Nageswara Rao, J. and B.R. Gavai, J.

Can the government mandate vaccines, infringing on personal autonomy? The Supreme Court of India addressed this critical question in a recent judgment, balancing individual rights with public health concerns during the COVID-19 pandemic. The court examined the legality of vaccine mandates, the need for transparency in clinical trial data, and the procedures for reporting adverse events following immunization (AEFIs). This judgment clarifies the extent to which the government can impose restrictions on unvaccinated individuals and emphasizes the importance of informed consent and data accessibility.

Case Background

The petitioner, Dr. Jacob Puliyel, a former member of the National Technical Advisory Group on Immunization (NTAGI), filed a public interest litigation (PIL) challenging the government’s COVID-19 vaccine policies. The petition raised concerns about the emergency approval of vaccines, the lack of transparency in clinical trial data, and the imposition of vaccine mandates.

Dr. Puliyel argued that coercive vaccination violates the principle of informed self-determination, protected under Article 21 of the Constitution of India. He also highlighted the potential for natural immunity acquired from COVID-19 infection to be more robust than vaccine-induced immunity. The petitioner sought the release of segregated clinical trial data, disclosure of expert committee meeting minutes, and a declaration that vaccine mandates are unconstitutional.

The Union of India defended its vaccination program, emphasizing the need for emergency measures to combat the pandemic. The government argued that vaccination is essential to avoid infection and that India has successfully manufactured vaccines to protect its citizens. They also expressed concerns that the petition could fuel vaccine hesitancy. The Union of India asserted that all necessary procedures were followed in granting emergency licenses and that clinical trial data cannot be disclosed due to privacy concerns.

Several state governments also filed counter-affidavits, justifying the restrictions placed on unvaccinated individuals in public interest.

Timeline

Legal Framework

The Supreme Court considered several legal provisions and principles in its judgment:

• Article 21 of the Constitution of India: Guarantees the right to life and personal liberty, which includes the right to bodily autonomy and the right to refuse medical treatment.
• Drugs and Cosmetics Act, 1940: Governs the manufacture, sale, and distribution of drugs and vaccines in India.
• New Drugs and Clinical Trials Rules, 2019: Provides the regulatory framework for clinical trials and drug approvals.
• Disaster Management Act, 2005: Empowers the government to take measures for disaster management, including public health emergencies.
• Tamil Nadu Public Health Act, 1939: Empowers the State Government to make vaccinations compulsory in the event of a declaration by the Government of an outbreak of a notified disease.
• National Ethical Guidelines for Biomedical and Health Research involving Human Participants: Published by the ICMR, these guidelines emphasize the importance of privacy and confidentiality of human participants in research.
• Declaration of Helsinki: Ethical principles for medical research involving human subjects.
• WHO Statement on Clinical Trials: Guidelines on public disclosure of clinical trial results.

Arguments

Petitioner’s Arguments:

• ✓ Vaccine mandates are unconstitutional as they violate bodily autonomy and the right to access one’s livelihood.
• ✓ Natural immunity acquired from COVID-19 infection is more robust and long-lasting than vaccine immunity.
• ✓ Vaccines do not prevent infection or transmission of the virus, especially against new variants.
• ✓ There is a lack of transparency in clinical trial data, resulting in the absence of informed consent.
• ✓ Restrictions on unvaccinated individuals are unwarranted, as they pose no greater risk of transmission than vaccinated individuals.
• ✓ The adverse events reporting system in India is not transparent, with inadequate investigation and follow-up of deaths and serious adverse events after vaccination.
• ✓ Children are at minimal risk from COVID-19, and the risks of vaccination outweigh the benefits.

Union of India’s Arguments:

• ✓ Vaccination is necessary to avoid infection and protect public health.
• ✓ India has successfully manufactured vaccines to protect its citizens.
• ✓ The government has followed all necessary procedures in granting emergency licenses.
• ✓ Clinical trial data cannot be disclosed due to privacy concerns.
• ✓ There are established procedures and protocols for monitoring AEFIs.
• ✓ COVID-19 vaccination is voluntary and not linked to any benefits or services.
• ✓ The decisions of domain experts should not normally be interfered with in judicial review.

State Governments’ Arguments:

• ✓ Restrictions on unvaccinated individuals are in the larger public interest and are essential for curtailing the spread of COVID-19.
• ✓ Vaccination prevents severe disease and significantly reduces hospitalization and mortality.
• ✓ The restrictions are reasonable and are reviewed periodically.

Innovativeness of the argument: The petitioner innovatively argued that the scientific evidence of transmission is the same for both vaccinated and unvaccinated people and therefore, the vaccine mandates are discriminatory and violative of Article 21 of the Constitution.

Issues Framed by the Supreme Court

The Supreme Court framed the following issues for consideration:

1. Whether vaccine mandates are violative of Article 21 of the Constitution of India.
2. Whether non-disclosure of segregated clinical trial data in the public domain is justified.
3. Whether there is improper collection and reporting of AEFIs.
4. Whether vaccination of children is justified.

Treatment of the Issue by the Court

The following table demonstrates how the Court decided the issues:

Authorities

The Supreme Court relied on the following authorities:

Judgment

How each submission made by the Parties was treated by the Court?

How each authority was viewed by the Court?

• Indian Banks’ Association, Bombay v. Devkala Consultancy Service [CITATION]: Used to determine if the petitioner has sufficient knowledge in the subject matter to file a PIL.
• Academy of Nutrition Improvement v. Union of India [CITATION]: Used to emphasize the limited scope of judicial review in matters of policy framed on the basis of expert opinion.
• G. Sundarrajan v. Union of India [CITATION]: Used to emphasize the limited scope of judicial review in matters of policy framed on the basis of expert opinion.
• Shri Sitaram Sugar Company Ltd. v. Union of India [CITATION]: Used to emphasize the limited scope of judicial review in matters of policy framed on the basis of expert opinion.
• Henning Jacobson v. Commonwealth of Massachusetts [CITATION]: Used to discuss the scope of judicial review in matters relating to public health and vaccinations.
• Zucht v. King [CITATION]: Used to discuss the scope of judicial review in matters relating to public health and vaccinations.
• Joseph R. Biden v. Missouri [CITATION]: Used to discuss the scope of judicial review in matters relating to public health and vaccinations.
• Kassam v. Hazzard; Henry v. Hazzard [CITATION]: Used to discuss the scope of judicial review in matters relating to public health and vaccinations.
• Ryan Yardley v. Minister for Workplace Relations and Safety [CITATION]: Used to discuss the scope of judicial review in matters relating to public health and vaccinations and to analyze scientific data.
• Delhi Development Authority v. Joint Action Committee, Allottee of SFS Flats [CITATION]: Used to state that policy decisions taken by the executive are not beyond the scope of judicial review, if they are manifestly arbitrary or unreasonable.
• Directorate of Film Festivals v. Gaurav Ashwin Jain [CITATION]: Used to state that policy decisions taken by the executive are not beyond the scope of judicial review, if they are manifestly arbitrary or unreasonable.
• Distribution of Essential Supplies and Services During Pandemic, In re [CITATION]: Used to state that policy decisions taken by the executive are not beyond the scope of judicial review, if they are manifestly arbitrary or unreasonable.
• Roman Catholic Diocese v. Cuomo [CITATION]: Used to discuss the scope of judicial review in matters relating to public health and vaccinations.
• South Bay United Pentecostal Church v. Newsom [CITATION]: Used to discuss the scope of judicial review in matters relating to public health and vaccinations.
• Kassam v. Hazzard; Henry v. Hazzard [CITATION]: Used to discuss the scope of judicial review in matters relating to public health and vaccinations.
• Ministry of Health v. Atkinson [CITATION]: Used to determine that the Crown has the burden to demonstrate that a limitation of a fundamental right is demonstrably justified.
• Ugar Sugar Works Ltd. v. Delhi Administration [CITATION]: Used to state that arbitrariness, irrationality, perversity and mala fide will render the policy unconstitutional.
• Villianur Iyarkkai Padukappu Maiyam v. Union of India [CITATION]: Used to state that courts are not inclined to strike down a policy at the behest of a petitioner merely because it has been urged that a different policy would have been fairer or wiser or more scientific or more logical.
• Pyarali K. T ejani v. Mahadeo Ramchandra Dange [CITATION]: Used to state that the Court cannot re-weigh and substitute its notion of expedient solution.
• Union of India v. Dinesh Engineering Corporation [CITATION]: Used to state that courts will not ordinarily interfere since decisions on policy matters are taken based on expert knowledge of the persons concerned.
• Common Cause (A Registered Society) v. Union of India [CITATION]: Used to emphasize the right of an individual to choose how he should live his own life, without any control or interference by others.
• Aruna Ramachandra Shanbaug v. Union of India [CITATION]: Used to emphasize the right of an individual to choose how he should live his own life, without any control or interference by others.
• K. S. Puttaswamy v. Union of India [CITATION]: Used to state the requirements to be fulfilled by the State while placing restraints on the right to privacy to protect legitimate State interests.
• National Legal Services Authority v. Union of India [CITATION]: Used to emphasize the right of an individual to choose how he should live his own life, without any control or interference by others.
• X v. Hospital ‘Z’ [CITATION]: Used to state that non-disclosure of medical information of an individual can be traced to the right to privacy protected under Article 21, it is not absolute and is subject to action lawfully taken for protection of health.
• Kharak Singh v State of U.P. [CITATION]: Used to state that non-disclosure of medical information of an individual can be traced to the right to privacy protected under Article 21, it is not absolute and is subject to action lawfully taken for protection of health.
• Gobind v. State of M.P. [CITATION]: Used to state that non-disclosure of medical information of an individual can be traced to the right to privacy protected under Article 21, it is not absolute and is subject to action lawfully taken for protection of health.
• Jane Roe v. Henry Wade [CITATION]: Used to state that non-disclosure of medical information of an individual can be traced to the right to privacy protected under Article 21, it is not absolute and is subject to action lawfully taken for protection of health.
• Association of Medical Super Speciality Aspirants and Residents v. Union of India [CITATION]: Used to state that the scales must tilt in favour of communitarian dignity while balancing communitarian dignity vis-à-vis the dignity of private individuals.
• Four Aviation Security Service Employees v. Minister of COVID-19 Response [CITATION]: Used to state that even a modest vaccination protection on a modest number of personnel needs to be considered in the context of potential effects of a pandemic.
• Spencer v. Attorney General of Canada [CITATION]: Used to elaborate on the precautionary principle.
• Aruna Rodrigues (4) v. Union of India [CITATION]: Used to emphasize the importance of disclosure of relevant technical data and informed consent.
• Master Hridaan Kumar (minor) v. Union of India [CITATION]: Used to emphasize the importance of disclosure of relevant technical data and informed consent.
• Vincent Panikurlangara v. Union of India [CITATION]: Used to state that it is the obligation of the State to ensure the creation and the sustaining of conditions congenial to good health.
• Ashwani Kumar v. Union of India [CITATION]: Used to state that the Constitution mandates the State to make available to the elderly the right to live with dignity and to provide the elderly, ill and disabled with assistance, medical facilities and geriatric care.
• Laxmi Raj Shetty v. State of T amil Nadu [CITATION]: Used to state that courts cannot take judicial notice of facts stated in a news item published in a newspaper.

Ratio Decidendi

The core legal principles established by the Supreme Court in this judgment are:

• Bodily Autonomy: The right to bodily autonomy is a fundamental aspect of Article 21 of the Constitution of India. No individual can be forced to be vaccinated against their will.
• Proportionality: Any restrictions imposed by the state on individual rights must be proportionate to the objective sought to be achieved. Restrictions on unvaccinated individuals are not proportionate given the similar transmission risks with vaccinated individuals.
• Transparency: While the court cannot mandate disclosure of primary clinical trial data when results and key findings have been published, the state must ensure transparency in its actions and facilitate reporting of suspected adverse events.
• Expert Opinion: Courts should generally defer to expert opinions on matters of public health. The decision to vaccinate children is in line with global scientific consensus and expert bodies.

Obiter Dicta

The Supreme Court also made several observations that are not binding as legal precedent but provide guidance:

• The court emphasized the importance of informed consent in medical interventions.
• The court highlighted the need for a robust and transparent system for reporting and investigating adverse events following immunization (AEFIs).
• The court acknowledged the potential for natural immunity acquired from COVID-19 infection to be more robust than vaccine-induced immunity.
• The court stated that the restrictions on unvaccinated individuals were not proportionate given the similar transmission risks with vaccinated individuals.

Flowchart of the Decision-Making Process

Conclusion

The Supreme Court’s judgment in Jacob Puliyel vs. Union of India & Ors. is a landmark decision that balances individual rights with public health concerns during a pandemic. The court upheld the right to bodily autonomy and emphasized the need for transparency in clinical trial data and adverse event reporting. While the court recognized the importance of vaccination in combating COVID-19, it also cautioned against coercive measures and highlighted the need for informed consent. This judgment has far-reaching implications for future public health policies and the protection of individual liberties.