2022 (5) TMI 1668 - SC - Indian Laws

Maintainability of the Writ Petition in public interest - Release of entire segregated trial data for each of the phases of trials that have been undertaken with respect to the vaccines being administered in India - lack of transparency in the disclosure of segregated clinical trial data in the public domain. Maintainability of the Writ Petition in public interest - HELD THAT - A petition had been filed by the Petitioner earlier during his tenure as a member of the NTAGI with respect to the Rotavac vaccine claiming that adequate data from the clinical trials had not been provided to the NTAGI. The rejoinder affidavit further states that the petition was dismissed by this Court on the ground that the Petitioner could not have filed the said petition while being a member of the NTAGI. The enthusiasm of the Petitioner in approaching this Court has not gone unobserved. However as the issues raised by the Petitioner have a bearing on public health and pertain to the fundamental rights of the country s populace it is opined that they warrant due consideration by this Court. Therefore it is not required to entertain the challenge mounted by the Union of India to the maintainability of the Writ Petition. Judicial review of executive decisions based on expert opinion - HELD THAT - There can be no ambiguity in the principles of law relating to judicial review laid down by this Court. A perusal of the judgments referred to above would clearly show that this Court would be slow in interfering with matters of policy especially those connected to public health. There is also no doubt that wide latitude is given to executive opinion which is based on expert advice. However it does not mean that this Court will not look into cases where violation of fundamental rights is involved and the decision of the executive is manifestly arbitrary or unreasonable. It is true that this Court lacks the expertise to arrive at conclusions from divergent opinions of scientific issues but that does not prevent this Court from examining the issues raised in this Writ Petition especially those that concern violation of Article 21 of the Constitution of India. Vaccine mandates violate Article 21 of the Constitution of India which protects personal autonomy and bodily integrity - HELD THAT - On one hand the Union of India made it clear in the counter-affidavit that vaccination is voluntary and on the other a series of advisories and material had been filed by the Union of India supporting the claim of vaccination being mandatory - any restrictions placed on personal autonomy of individuals would be violative of Article 21 unless the criteria laid down in K.S. Puttaswamy 2017 (8) TMI 938 - SUPREME COURT is met. Evolution of COVID-19 and vaccines - HELD THAT - Vaccination of a majority of the population of this country has undoubtedly been instrumental in preventing severe disease hospitalisation and deaths and benefited the community at large especially those members with co-morbidities the elderly and sick persons. Even the Petitioner is not opposed to the vaccination programme and does not challenge the vaccination drive of the Government of India as has been reiterated by him during the course of his arguments. Exception to the vaccination programme taken by the Petitioner is only to coercive vaccination through vaccine mandates which place unjustifiable restrictions on those who wish to not be vaccinated. In light of the virulent mutations of the COVID-19 virus and advice of experts from the WHO as well as common findings of several studies on this subject the vaccination drive that is being undertaken by the Government of India in the interest of public health cannot be faulted with. Personal autonomy and public health - HELD THAT - i) Bodily integrity is protected Under Article 21 of the Constitution of India and no individual can be forced to be vaccinated. ii) 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. iii) 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. Assessment of the vaccine mandates imposed by State Governments - HELD THAT - 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 - 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 been controverted by the Union of India as well as the State Governments it is opined 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. Non-disclosure of segregated clinical trial data in public domain - HELD THAT - The information provided on behalf of the Union of India substantiates that the data provided by the vaccine manufacturers was considered by the SEC over a period of time and several conditions were imposed at the time of recommending approvals which have been modified or lifted subsequently on availability of further data arising from the clinical trials before the SEC as can be seen from the minutes of the meetings of the SEC available on the website of the MoHFW. We do not agree with the submission on behalf of the Petitioner that emergency approvals to the vaccines were given in haste without properly reviewing the data from clinical trials - As long as the relevant information relating to the minutes of the meetings of the regulatory bodies and the key outcomes and findings of the trials are available in public domain the Petitioner cannot contend that every minute detail relating to clinical trials be placed in public domain to enable an individual to take an informed conscious decision to be vaccinated or not. Given the widespread affliction caused by the virus there was an imminent need of manufacturing vaccines which would keep the infection at bay - A perusal of the material placed on record would show that there is material compliance with the procedure prescribed under the Drugs and Cosmetics Act 1940 and the 2019 Rules before grant of approval for the emergency use of the two vaccines. Improper collection and reporting of AEFIs - HELD THAT - The National AEFI Surveillance Secretariat has been functioning for 10 years and as has been pointed out there is a well-established protocol in place for identification and monitoring of AEFIs. The website of the MoHFW carries the results of causality assessment of AEFI cases from which the public can obtain relevant information pertaining to AEFIs. We have been informed that a thorough causality assessment analysis of AEFIs is carried out by experts and not every severe disease and death can be attributed to vaccination. Reactions are examined by experts specifically trained to undertake causality analysis before notifying such reactions as adverse events arising from vaccination. There is a well-defined mechanism for collection of data relating to adverse events that occur due to COVID-19 vaccines and the Government of India has taken steps to direct all concerned medical professionals at the ground level to report adverse events. There is an imminent need for collection of requisite data of adverse events and wider participation of people in reporting the adverse events is necessary for the purpose of gathering correct information. Thus the Union of India is directed to facilitate the reporting of suspected adverse events by individuals and private doctors on a virtual platform and the reports so made shall be publicly accessible after being given unique identification numbers without listing any personal or confidential data of the persons reporting. All necessary steps to create awareness of and to navigate this platform for self-reporting shall be effectuated by the Government roping in and training relevant participants right from the ground level of vaccine administration. Vaccination of Children - HELD THAT - The Union of India has stated that the results of clinical trials of COVAXIN for paediatric population have already been published. It is also noted that for the age group of 12 to 14 years Biological E s Corbevax is being administered. Keeping in line with the WHO Statement on Clinical Trials the Declaration of Helsinki and the GCP guidelines the Union of India is directed to ensure that key findings and results of the clinical trials of Corbevax be published at the earliest if not already done. Neither vaccine is an mRNA vaccine and to this extent the apprehensions of the Petitioner with respect to the associated risks of mRNA vaccines are unfounded in the present situation. Conclusion - (i) Vaccine mandates should be reviewed in light of current data. (ii) No need to disclose primary clinical trial data beyond existing requirements. (iii) AEFI reporting system is adequate but self-reporting should be enabled. (iv) Paediatric vaccination is justified and should continue. Petition disposed off.

Summary

1. ISSUES PRESENTED and CONSIDERED

The core legal questions considered in this judgment include:

(i) Whether vaccine mandates violate Article 21 of the Constitution of India, which protects personal autonomy and bodily integrity.

(ii) Whether there is a lack of transparency in the disclosure of segregated clinical trial data in the public domain.

(iii) Whether the collection and reporting of Adverse Events Following Immunisation (AEFIs) are improper.

(iv) Whether the vaccination of children is justified in the context of public health and safety.

2. ISSUE-WISE DETAILED ANALYSIS

I. Vaccine Mandates

Relevant Legal Framework and Precedents: Article 21 of the Constitution of India protects personal autonomy and bodily integrity. The Court referred to precedents such as K.S. Puttaswamy v. Union of India to establish the threefold requirement for intrusion into personal rights: legality, legitimate state aim, and proportionality.

Court's Interpretation and Reasoning: The Court acknowledged that personal autonomy includes the right to refuse medical treatment. However, in the interest of public health, the government can impose reasonable restrictions if they meet the threefold requirement.

Key Evidence and Findings: The Court noted the lack of data from the Union of India or States to counter the emerging scientific opinion that the risk of transmission from unvaccinated individuals is similar to that from vaccinated individuals.

Application of Law to Facts: The Court suggested that vaccine mandates should be reviewed, given the current low infection rates and lack of data justifying discrimination against unvaccinated individuals.

Treatment of Competing Arguments: The Court balanced personal autonomy against public health needs, emphasizing that restrictions must be reasonable and proportionate.

Conclusions: The Court suggested reviewing vaccine mandates, emphasizing that any future restrictions must meet the threefold requirement.

II. Non-disclosure of Segregated Clinical Trial Data

Relevant Legal Framework and Precedents: The Court referred to the Good Clinical Practices (GCP) guidelines and the WHO Statement on Clinical Trials, which require key findings to be published.

Court's Interpretation and Reasoning: The Court found that the results of Phase III clinical trials had been published, and there was no evidence of hasty approvals.

Key Evidence and Findings: The Court noted the publication of trial results in peer-reviewed journals and the transparency of expert body meetings.

Application of Law to Facts: The Court concluded that the existing statutory regime was followed, and there was no need to mandate the disclosure of primary clinical trial data.

Treatment of Competing Arguments: The Court dismissed the Petitioner's claims of opaqueness, citing compliance with the statutory regime.

Conclusions: The Court held that the procedures adopted were transparent and in line with statutory requirements.

III. Improper Collection and Reporting of AEFIs

Relevant Legal Framework and Precedents: The Court examined the National Adverse Event Following Immunisation Surveillance Guideline and the role of the Pharmacovigilance Programme of India.

Court's Interpretation and Reasoning: The Court found that there was a well-established protocol for monitoring AEFIs, and the system was not faulty.

Key Evidence and Findings: The Court noted the continuous monitoring and examination of AEFIs and the role of expert committees.

Application of Law to Facts: The Court directed the Union of India to facilitate reporting of suspected adverse events by individuals and private doctors on a virtual platform.

Treatment of Competing Arguments: The Court acknowledged the Petitioner's concerns but found that the existing system adequately addressed them.

Conclusions: The Court directed the creation of a platform for self-reporting of adverse events.

IV. Vaccination of Children

Relevant Legal Framework and Precedents: The Court referred to global consensus and expert opinions from organizations like the WHO, UNICEF, and CDC.

Court's Interpretation and Reasoning: The Court emphasized that it cannot second-guess expert opinion and that the decision to vaccinate children aligns with global scientific consensus.

Key Evidence and Findings: The Court noted the data on AEFIs in children and the phased approach to paediatric vaccination.

Application of Law to Facts: The Court directed the Union of India to publish key findings of clinical trials for paediatric vaccines.

Treatment of Competing Arguments: The Court dismissed the Petitioner's concerns about paediatric vaccination, citing expert consensus.

Conclusions: The Court upheld the decision to vaccinate children, directing the publication of trial results.

3. SIGNIFICANT HOLDINGS

Core Principles Established:

(i) Bodily integrity is protected under Article 21, and no individual can be forced to be vaccinated.

(ii) The government's vaccination policy is informed by relevant considerations and is not unreasonable or arbitrary.

(iii) Restrictions on unvaccinated individuals must be proportionate and justified by data.

(iv) Transparency in clinical trial data is required, but the existing statutory regime is sufficient.

(v) The AEFI surveillance system is adequate, but self-reporting should be facilitated.

(vi) Paediatric vaccination aligns with global consensus and expert opinion.

Final Determinations on Each Issue:

(i) Vaccine mandates should be reviewed in light of current data.

(ii) No need to disclose primary clinical trial data beyond existing requirements.

(iii) AEFI reporting system is adequate, but self-reporting should be enabled.

(iv) Paediatric vaccination is justified and should continue.