On May 02, 2022, the Hon’ble Supreme Court of India passed its judgement in a matter titled Jacob Puliyel v. Union of India & Ors[1], wherein it closely examined the details of the vaccination policy, the dissemination of clinical trials data, veracity of emergency approvals of vaccines and the reporting of adverse impacts of vaccination.
Background:
A public interest litigation petition was presented before the Supreme Court of India, contending:
(i) adverse consequences of emergency approval of vaccines in India.
(ii) the need for transparency in publishing segregated clinical trial data of vaccines.
(iii) the need for disclosure of clinical data.
(iv) lack of transparency in regulatory approvals.
(v) minutes and constitution of the expert bodies.
(vi) imperfect evaluation of Adverse Events Following Immunization (“AEFIs”); and,
(vii) vaccine mandates in the absence of informed consent being unconstitutional.
It was inter-alia contended that coercive vaccination would result in interfering with the principle of informed choice of individuals, protected by Article 21 of the Constitution of India.
It was also contended that natural immunity is more robust than immunity generated post vaccine inoculation and further that the vaccines available presently are not as effective against the newly mutating variants of Covid-19. Ergo the petitioner urged that vaccinated and unvaccinated people can both transmit and get infected by the virus – making the vaccine mandates (including state-wise mandates) ‘meaningless’.
Review of arguments made and Court’s analysis
i. Maintainability: The Respondent, Union of India (UOI), contended that the decisions regarding vaccinations and associated procedures is a matter of domain experts, and the same should not be interfered with in judicial review. Further, the UOI also contended that the questions raised by the Petitioner may result in increasing already existing vaccine hesitancy in the country.
The Court held that the issues raised by the petitioner had concerns related to public health and the fundamental rights granted under the Constitution – thus requiring due consideration by the Court. Thus, the objection to maintainability was dismissed.
ii. Judicial review of executive decisions based on expert opinion: The UOI contended that the Court should adhere to executive decisions – taken basis expert opinion and advise – in sensitive public health concerns such as the Covid-19 pandemic and associated vaccination. To supplement its argument, the UOI also submitted various precedents from the Supreme Court[2] as well as those from the Supreme Courts of the United States[3] and New Zealand[4].
The Petitioner countered the stand of the UOI and argued that the Court has a duty to safeguard the fundamental rights of individuals, which require the Court’s review. The Petitioner supplemented his argument with precedents[5] from the Supreme Court, which establish that policy decisions taken by the executive are not beyond the scope of judicial review, if they are manifestly arbitrary or unreasonable.
Specifically relying on the judgement of the Court in Distribution of Essential Supplies & Services during Pandemic, the Court re-emphasised that policy-making continues to be the sole domain of the executive and the judiciary does not possess the authority or competence to assume the role of the executive… However, it continues to exercise jurisdiction to determine if the chosen policy measure conforms to the standards of reasonableness, militates against manifest arbitrariness and protects the right to life of all persons. Accordingly, the Court held that nothing prevents it from examining the issues raised by the petitioner in the said Writ Petition, especially those related to fundamental rights.
Consequently, the Court identified the following issues to be analysed:
a. Vaccine mandates being violative of Article 21 of the Constitution of India.
b. Non-disclosure of segregated clinical trial data in public domain.
c. Improper collection and reporting of AEFIs.
d. Vaccination of children.
iii. Vaccine Mandates: The Petitioner contended that the vaccine mandates of the Government (including certain state governments), wherein certain prohibitions are placed against unvaccinated people – make them coercive in nature and thus unconstitutional. The petitioner also emphasised upon the fact that natural immunity acquired post Covid-19 infection is more robust and long-lasting than the immunity provided by vaccines. It was further highlighted that the presently available vaccines are ineffective against variants and thus both vaccinated as well as unvaccinated persons can transmit the virus. The arguments laid were supplemented by certain scientific articles and studies.
However, the UOI (as well as the various state governments) contradicted this argument by saying that the vaccines are proven to be safe and efficacious and any deliberation on the same will increase the already pervasive vaccine hesitancy in the country. It was also argued that the approval of emergency authorisations of vaccines, associated clinical trials, etc., are all done within the legal framework of the country. The state governments of Tamil Nadu, Maharashtra, Madhya Pradesh and NCT of Delhi argued that any vaccine mandate implemented in the said states (which had restrictive provisions against unvaccinated persons) was done keeping in mind the larger public interest and for the health and safety of the community as a whole and revised regularly basis the evolving situation of the pandemic.
The Court also noted the evolving nature of the virus and observed the global mandates regarding the same, by international organisations such as WHO. Accordingly, the Court held that, the vaccination drive that is being undertaken by the Government of India in the interest of public health cannot be faulted with.
It is pertinent to note that while determining personal autonomy, the Court held that:
a. Bodily integrity is protected under Article 21 and no citizen can be forced to be vaccinated.
b. Bodily integrity includes right to life, which also includes within its ambit the right to refuse medical treatment.
c. Citizens may choose not to get vaccinated. However, if there is data to show that such citizens may transmit the virus and affect public health as a whole, then the government may take suitable restrictive steps against said people.
It is pertinent to note that the Court observed that the UOI did not have any justification for the restrictive provisions against unvaccinated people. The Court noted that during the pendency of the judgement in the matter, certain states (like Tamil Nadu and Maharashtra) had revised their vaccine mandates basis the evolving Covid-19 situation in their respective states. The Court suggested that all authorities (including the governmental, private institutions and educational institutions) must review their vaccine mandates and ensure that any restrictive provision therein is proportional to the existing Covid-19 situation in the country.
The Court also asked the UOI to come up with a ‘health pass’ as instituted in France. It is important to note that the Court emphasised that given the rapidly evolving nature of the Covid-19 virus, any observation made by the Court is restricted to the present prevailing circumstances and must not be considered impending on any matter on the lawful exercise of power by the executive.
iv. Non-disclosure of segregated clinical trial data in public domain: The petitioner contended that clinical trial data with respect to COVAXIN and COVISHIELD has not been made public. He urged that the disclosure of segregated data of clinical trials is essential to determine the adverse effects, if any, across various age groups and diverse populations and accordingly, enable individuals to make more informed decisions on whether to be vaccinated.
The UOI responded to the aforementioned contention by stating that the emergency use approvals were granted after following due procedure and required expert committees were constituted and consulted for the same.
The Court noted that there are stringent statutory requirements, which have to be complied with by the manufacturers of vaccines and other participants, during the different stages of clinical trials of vaccines. Furthermore, the Court did 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. The Court also noted that both the said vaccines have received approvals from WHO as well.
v. Improper collection and reporting of AEFIs
It was contended by the petitioner that there have been several adverse events and deaths post inoculation (of the vaccines) and that the government lacked an appropriate mechanism for reporting the same.
The UOI contended that the procedures and protocols for monitoring of adverse events following immunisation, as established under the National Adverse Event Following Immunisation Surveillance Guidelines, were followed scrupulously. Further, the UOI also stated that the COWIN portal also had established mechanisms for reporting of all AEFIs. All cases of serious and severe AEFIs, including reported deaths, are subjected to rapid reviews, analysis and causality assessment done by a team of trained subject experts. It was clarified that mere reporting of an AEFI case should not be attributed to the vaccine, unless proven by the causality assessment analysis.
The Court noted that as per the data presented by the UOI, there exists a well-defined mechanism for collection of data, relating to adverse events that occur due to Covid-19 vaccines. Even medical practitioners at private hospitals are associated with reporting of adverse events.
Thus, the Court dismissed the petitioner’s challenge. However, the Court emphasised upon the need to report adverse and suspected adverse events. It directed the UOI to facilitate the same and establish a mechanism for reporting by individuals and private doctors and making reports related to the same publicly accessible.
vi. Vaccination of Children
The petitioner contended that scientific evidence shows that the risk of administering vaccines to children outweigh the benefits offered by the vaccine in children. He also stated that data shows that a number of children have already developed Covid-19 antibodies. He also said that there is data to indicate the occurrence of adverse reactions in young persons upon inoculation.
The UOI responded to the same by stating that paediatric vaccination is advised by global agencies such as the WHO, the UNICEF and the CDC. Expert opinion in India is also in sync with such global organisations. The UOI supplemented its argument by showcasing vaccination data, revealing the safety of vaccine use on children.
The Court opined that it cannot analyse and provide a judgement regarding the safety and veracity of paediatric vaccination – the said aspect is beyond judicial review and a matter that is to be determined by concerned subject matter experts. Further, the Court also noted that the decision of the UOI regarding paediatric vaccination meets global scientific consensus. Thus, the Court dismissed the challenge raised by the petitioner regarding the same.
Conclusion:
The Court dismissed the said Writ Petition made by the petitioner.
It is important to note here that the Court did give a particularly detailed observation regarding personal autonomy and has re-established that personal autonomy should be respected, and any mandate to the contrary, must be reasoned and proportional. This case re-emphasises the prevailing judicial position that any arbitrary breach into personal autonomy will be deemed unconstitutional and to that extent executive decisions will be open to judicial review – even if the same is made with regard to matters of crucial public concern. That said, it must be noted that while making the observations, the court kept in mind the past and present situations. As for the future, the court gave suggestions to the government, rather than directives.
For further information, please contact:
Ashwin Sapra, Partner, Cyril Amarchand Mangaldas
ashwin.sapra@cyrilshroff.com
[1] Writ Petition (Civil) No. 607 of 2021.
[2] Academy of Nutrition Improvement v. Union of India; G. Sundarrajan v. Union of India; and Shri Sitaram Sugar Company Ltd. v. Union of India.
[3] Henning Jacobson v. Commonwealth of Massachusetts; Zucht v. King; Docket No. 21A240 titled Joseph R. Biden v. Missouri.
[4] Kassam v. Hazzard; Henry v. Hazzard.
[5] Delhi Development Authority v. Joint Action Committee, Allottee of SFS Flats; Directorate of Film Festivals v. Gaurav Ashwin Jain; and In Re, Distribution of Essential
Supplies and Services During Pandemic.
