Nobody Can Be Forced To Get Vaccinated; Vaccine Mandates Not Proportionate : Supreme Court
Review vaccine mandates : Court's suggestion to all authorities, including private organisations and educational institutions.
The Supreme Court on Monday held that no individual can be forced to get vaccinated and the right to bodily integrity of a person under Article 21 of the Constitution includes the right to refuse vaccination.The Court also held that the vaccine mandates imposed by various state governments and other authorities in the context of COVID-19 pandemic are "not proportionate". The Court held so as...
The Supreme Court on Monday held that no individual can be forced to get vaccinated and the right to bodily integrity of a person under Article 21 of the Constitution includes the right to refuse vaccination.
The Court also held that the vaccine mandates imposed by various state governments and other authorities in the context of COVID-19 pandemic are "not proportionate". The Court held so as no substantial data has been produced on record to show that the risk of transmission of COVID-19 virus from the unvaccinated persons are higher than from vaccinated persons.
The Government is entitled to impose restrictions on individual rights in public health interests, but the restrictions should meet the 3-fold requirement legality, legitimate need and proportionality laid down by the Supreme Court in the Puttaswamy judgment.
"No data has been placed by the Union of India or the States appearing before us, 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", the Court stated.
Review vaccine mandates
Therefore, the Court suggested that all authorities, including private institutions and educational institutions, should review the restrictions on the unvaccinated. The Court however clarified that this direction is confined to the present context of the COVID pandemic situation. It further clarified that it does not extend to any other directions on COVID-19 appropriate behaviour issued by the authorities.
"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, we suggest 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 clarified that in the context of the rapidly-evolving situation presented by the COVID-19 pandemic, our 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".
Union's vaccine policy not unreasonable or arbitrary.
The Court also held that the policy of the Union Government on COVID-19 vaccination policy is reasonable. It also held that the clinical trial data of the vaccines have been published in accordance with the relevant norms. The material provided by the Union of India does not support the conclusion that emergency use approval has been granted in haste.
Publish reports on Adverse Events
The Court also directed the Union of India to publish reports on Adverse Events Following Immunisation(AEFI) from public and doctors on a publicly accessible system without compromising data of the individuals who are reporting the same.
Vaccination for children approved
Regarding vaccine for children, the Court said that it is not possible for us to second guess the opinion of experts and the vaccination indeed follows the global standards and practices.
"On paediatric vaccine, it is in tune with international standards. We direct the Union of India to make sure the key findings of the stages of trial already approved for children be made public at the earliest", the Court said.
A bench comprising Justices L Nageswara Rao and BR Gavai was pronouncing the judgment on a PIL filed by Dr.Jacob Puliyel, challenging the vaccine mandates and seeking publication of the clinical trial and adverse events of vaccination.
The Court rejected the arguments against the maintainability of the writ petition. Though executive has wide latitude in policy matters, it does not bar the Courts from scrutinising if the policy is beyond the pale of arbitrariness.
Relevant Quotes from the judgment
On bodily integrity - no individual can be forced to get vaccinated
"The upshot of the above discussion leads to the following conclusions:
a) Bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated.
b) 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.
c) 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" -Paragraph 49.
Personal autonomy encompasses right to refuse undergo any medical treatment
"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, encompasses the right to refuse to undergo any medical treatment in the sphere of individual health" - Para 89(iii)
Vaccine mandates are not proportionate
"While there is abundant data to show that getting vaccinated continues to be the dominant expert advice even in the face of new variants, no submission nor any data has been put forth to justify restrictions only on unvaccinated individuals when emerging scientific evidence appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons. To put it differently, 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. 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. While vaccination mandates in the era of prevalence of the variants prior to the Delta variant may have withstood constitutional scrutiny, in light of the data presented by the Petitioner, which has not beencontroverted by the Union of India as well as the State Governments, we are of the opinion that 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"- Para 58
Authorities asked to review vaccine mandates
"No data has been placed by the Union of India or the States appearing before us, 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, we suggest 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 clarified that in the context of the rapidly-evolving situation presented by the COVID-19 pandemic, our 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. Our suggestion also does not extend to any other directions requiring maintenance of COVID-appropriate behaviour issued by the Union or the State Governments" - Para 89(v)
Union's vaccination policy reasonable
"On the basis of substantial material filed before this Court 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, this Court is 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. Contrasting scientific opinion coming forth from certain quarters to the effect that natural immunity offers better protection against COVID-19 is not pertinent for determination of the issue before us" - Para 89(iii).
Judicial review of policy decision
"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" - Para 89(ii).
Also Read :No Haste In Granting Emergency Use Authorization To Covaxin & Covishield: Supreme Court
Background
Dr. Jacob Puliyel, a former member of the National Technical Advisory Group of Immunization had approached the Apex Court assailing the constitutional validity of the vaccine mandates imposed by States, in particular, Delhi, Madhya Pradesh, Maharashtra and Tamil Nadu. He had sought the indulgence of the Court to issue directions to the concerned authorities to disclose the data pertaining to clinical trials of the COVID-19 vaccines administered to adults as well as children in India, as per the requirement of International Medical norms. The petitioner also impelled the Court to revamp the Adverse Events Following Immunization Reporting System which he alleged was opaque, flawed and unknown to the public at large.
Contentions raised by the petitioner
Vaccine Mandates
The sheet anchor of Advocate, Mr. Prashant Bhushan's argument against the vaccine mandates was that in the absence of clinical trial data people were restrained from providing informed consent and the same impinged on the right to self-determination protected under Article 21 of the Constitution of India, 1950. Relying on K Puttaswamy v. UOI (2017) 10 SCC 1 and Common Cause v. UOI (2018) 5 SCC1, he emphasised that informed consent is necessary for medical procedures and bodily integrity is an integral part of the right to privacy. The Court was apprised that though the Government of India had indicated that vaccines are to be administered voluntarily, the States have imposed mandated restricting movement, denying essential services and curbing the right to livelihood in derogation of Articles 19 and 21. Mr. Bhushan argued that when there exists scientific evidence to substantiate the claims that nature immunity is better than vaccine-immunity; vaccination does not prevent from getting infected or transmitting; vaccines are ineffective in preventing new variants; vaccines have serious adverse effects; long-effects of the vaccine are unknown, mandating vaccination is unconstitutional.
"For any vaccine to be mandated, the public health rationale underlying such a policy must be based essentially on efficacy and safety of vaccination and prevention of transmission of the disease", Mr. Bhushan submitted.
He referred to the decision of the UK Parliamentary Committee; judgement of the High Court of New Zealand in Yardley v. Minister for Workplace Relations and Safety [2022] NZHC 291 and orders of Gujarat High Court and Meghalaya High Court sticking down vaccine mandates.
Non-Disclosure of data
Mr. Bhushan submitted that the segregated data of clinical trials of vaccines must be disclosed through peer reviewed scientific journals. The disclosure would have a significant impact on determining the adverse effects of the vaccines. The significance of disclosure was asserted by placing reliance on the Nuremberg Code and Report Nos. 59 (2012) and 66 (2013) of the Parliamentary Standing Committee on Health and Family Welfare.
He informed the Court that an RTI Application was filed enquiring whether the Subject Expert Committee had looked at the raw days and/or discussed it. Responding to the same, the Central Drugs Control Standard Organisation stated that the brief of interim clinical trial results along with Subject Expert Committee's recommendations was publicly available on CDSCO website. Dissatisfied with the response, an appeal was filed and the First Appellate Authority refused to reveal any data stating that the manufacturers had refused to disclose data publicly.
Adverse Effect Following Immunization Reporting System
Mr. Bhushan submitted that besides it being an opaque and flawed system, there was a lack of public awareness about the same.
Children's Vaccine Mandate
Citing articles published in scientific journals, Mr. Bhushan argued that the overall risk from COVID-19 for children being remarkably low, it is not reasonable to vaccinate them, that too, without providing an opportunity to the parents to provide informed consent
Contentions raised by the respondents
Union Government
Solicitor General, Mr. Tushar Mehta at the outset, had questioned the bona fides of the petitioner. He contended that by way of a Public Interest Litigation, the petitioner cannot seek raw data of the clinical trial of the COVID-19 vaccines, merely to satisfy his curiosity, nor can he sit in judgment of the wisdom of domain experts. He refuted the claim of serious adverse effects. According to the official record till 13.03.2022, 1,80,13,23,547 doses had been administered and 77314 people or 0.004% of the vaccinated population had been adversely affected. Refuting the submissions made by Mr. Bhushan, alleging irregularities in the vaccine approval process, he took the Court through the statutory framework and submitted that the same had been adhered to while granting approval. Referring to the Epidemic Diseases Act, 1897 and Disaster Management Act, 2005, he demonstrated the wide ambit of power entrusted upon the Central Government to take measures during a pandemic.
Mr. Mehta vehemently opposed the claim of the petitioner that there was a lack of mechanism for addressing adverse effects from immunization. On the issue of disclosure of clinical trial data, it was asserted that the same was in the teeth of confidentiality provisions. It was highlighted that the Helsinki Declaration and the WHO statement relied upon by the petitioner to seek raw clinical trial data only refers to the obligation to disclose final results, findings and outcomes which have already been disclosed. Addressing the issue of children's vaccine mandate, it was argued that evidence provided by the petitioner is based on mRNA vaccine, whereas the vaccine being administered in India was inactivated virus vaccines. It was further pointed out that for pediatric vaccines there is a statutory regime in place, which is being strictly followed.
Mr. Mehta referred to a catena of foreign judgments with respect to vaccination in general, and the vaccination during the COVID-19 pandemic in particular to indicate that individual liberty is not absolute and is subject to other factors, like legitimate aim; and the necessity to achieve that aim. Moreover he argued that the vaccine mandate is a matter of policy; a matter of scientific adjudication and the scope of judicial review in policy matters, especially when the executive decision is based on expert opinion, is limited.
Tamil Nadu
Appearing for the State of Tamil Nadu, its Additional Advocate General, Mr. Amit Anand Tiwari submitted that the State Government has exercised power under Tamil Nadu Public Health Act, 1939 and the Disaster Management Act, 2005 to mandate vaccination for accessing public spaces. The mandate was justified, broadly on three grounds :
- It prevents mutation
- Unvaccinated people causes health risk and
- Economic impact.
Maharashtra
Advocate, Mr. Rahul Chitnis, appearing for the State of Maharashtra, submitted that the Government has mandated vaccination to enter shops, malls etc., and also to avail public transportation, but the same would pass the test of proportionality as expounded by the Apex Court in Modern Dental College And Research Centre And Ors. v. State of Madhya Pradesh.
Madhya Pradesh
The Counsel adopted the submissions made by the Solicitor General about the need to balance rights. It was also clarified that the Government did not intend to make vaccines mandatory to avail ration. On the contrary, the purpose of the notification was to encourage individuals to get vaccinated.
Senior Advocate, Mr. Guru Krishnakumar, appearing for Bharat Biotech, controverted Mr. Bhushan's argument that Phase III Trial of the vaccine has not been published. Moreover, it was emphasised that WHO guidelines referred to by the petitioner do not mandate the disclosure of the primary data and only the analysis of the data. Reliance was placed on Section 8(1)(d) of the Right to Information Act which exempts the disclosure of information including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party. The Counsel appearing for SII also opposed the petitioner's plea for disclosure.
Rebuttal Arguments of the petitioner
Mr. Bhushan contended that the non-disclosure of trial data is preventing independent experts from making their own determinations. He stressed upon the petitioner's plea that disclosure would permit the independent experts to look into the veracity of the claims of the manufacturers. In this regard, he referred to a United States District Court judgment, wherein the regulatory body was directed to disclose all the information pertaining to the Pfizer vaccine.
He submitted that even considering the Government's submission on privacy of the patients who participated in the trials, it ought to have made available segregated data. He emphasised that the assertion, vaccines significantly reduce the risk of transmitting the disease, had to be established by the Government by adducing evidence. Mr. Bhushan argued that by merely stating there exists a robust system for granting approval, it cannot be taken outside the ambit of judicial scrutiny. Mr. Bhushan asserted that the information available on the website pertains only to recommendations made by the expert bodies, but does not indicate the material on the basis of which such recommendations were made. With respect to the adverse reporting system, he pointed out that only the vaccinator can report such effects; the public at large have no knowledge about the reporting system and only known adverse effects can be reported.
Case Details : Jacob Puliyel vs Union Of India | 2022 LiveLaw (SC) 439 | WP(C) 607 of 2021 | 2 May 2022
Coram: Justices L Nageswara Rao and BR Gavai