Jacob Puliyel vs Union Of India, Writ Petition (Civil) No. 607 of 2021

Introduction

We as humans have been dominating from time immemorial but a teensy-weensy virus showed us our place. Covid -19 was a deadly virus that affected the whole of the human race. Several countries had faced lockdown due to the outbreak of the Covid-19 virus. Every country was rigorously working for finding the solution to tackle this situation and as a result ,some countries launched their vaccines. After the approval of WHO, the governments started vaccinating  people. To ensure good health of the citizens & to protect them from the deadly virus ,the Government had made vaccines compulsory for all citizens. In line with our ‘’cost and benefit attitudes’’, the ‘’Covid -sponsored’’ vaccine enabled way of life’’ has been subjected to judicial scrutiny by way of public interest litigation in the case of Jacob Puliyel vs. Union of India.[i]

The Supreme Court was entrusted with the judicial review of the vaccination drive, restrictions and mandatory protocols imposed by government with a view to curtail the COVID-19 virus. Hailing the matter as being of public interest ,the writ was filed by Dr. Jacob Puliyel.

FACTS OF THE CASE

The petitioner Jacob Puliyel is a former member of the National Technical Advisory Group on Immunisation (NTAGI)  filed a writ petition that was presented before the Supreme court of India contending:

1. Adverse consequences of emergency approval of vaccines in India.
2. The need for transparency in publishing segregated clinical trial data of vaccines.
3. The need for disclosure of clinical data
4. Lack of transparency in regulatory approvals
5. Minutes and constitution of the expert bodies
6. Imperfect evaluation of Adverse Events Following Immunization (‘’AEFI’’): and
7. 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’.

ISSUES:

1. Is  the vaccines  mandates being violative of Article 21 [ii]of the Indian Constitution?
2. Was the collection and reporting of AEFIs improper?
3. Whether the segregated clinical trial data in the public domain is  disclosed or not?
4. Whether the vaccine for Covid-19 is safe for children?

PRELIMINARY ISSUES:

Before going into the  legal sanctity of the vaccination mechanism, the petition was challenged by the government  on two grounds:

• Maintainability

The Respondent ,The Union of India (UOI) , contended that the decisions regarding vaccinations and associated  procedures is a matter of domain  experts, and sameshould not be interfered with in judicial review . Further , the UOI also contended that the questions raised by the petitioners may result 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 object of maintainability was dismissed.

• Judicial review of executive decisions based on expert opinion
• The UOI contended that the courts 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 [iii]as well as those from the Supreme Courts of the United States [iv]and New Zealand [v].
• 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 Courts’s review. The Petitioner supplemented his argument with precedents [vi]from Supreme  Court, which establish that policy decisions taken by the executive are not beyond the scope of judicial review if they are manifest 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 writ petition, especially those related to Fundamental rights.

CONTENTIONS

1. Vaccine Mandates:

The petitioner contended that due to the vaccine mandates of the government (including certain state governments),specific prohibitions are placed against unvaccinated people. It makes them coercive and thus unconstitutional and violative of Article 21 of the Constitution. The petitioner also emphasized that natural immunity acquired post Covid-19 infection is more  robust and long -lasting than the immunity provided by vaccines . It further highlighted that the presently available vaccines are ineffective against variants ,and thus both vaccinated and unvaccinated persons can transmit the virus.

 However, the UOI contradicted this argument by saying that vaccine are proven to be safe and productive , and any deliberation on the same will increase the already pervasive vaccine hesitancy in the country . It also argued that the approval of emergency authorizations of vaccines, associated clinical trails, etc are all done within the country’s legal framework. The state governments of Tamil Nadu, Maharashtra , Madhya Pradesh, NCT of Delhi argued thatany 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 regularly revised basis the evolving situation of the pandemic.

• Non -disclosure of segregated clinical trial data in the public domain:

The petitioner contended that clinical trail data for COVAXIN and COVISHIELD had not been made public . He urged that the disclosure of segregated data of clinical trials is essential to determine the adverse effects 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 contention as mentioned earlier, by stating that the emergency use approvals were granted after following due procedure and required expert committees were constituted and consulted for the same.

• Improper collection and reporting of AEFIs:

It was contended by the petitioner that there have been several adverse events and deaths post injection of the vaccines and the government lacked an appropriate mechanism for reporting the same.

The UOI contended that the procedures and protocols for monitoring adverse events following immunization, as established under the National Adverse Event Following Immunisation Surveillance Guidelines , were followed carefully .Further ,the UOI stated that the COWIN portal has established mechanisms for reporting  all AEFI’s. All cases of severe AEFI’s , including reported deaths , are subjected to rapid reviews ,analysis and causality assessment by trained subject reports . It clarified that merely saying an AEFI case should not be attributed to the vaccine unless proven by the causality assessment analysis.

d)Vaccination of Children :

The petitioner contended that scientific evidence shows that risk of administering vaccines to children outweighs the vaccine’s benefits .He also stated that data shows that several 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 pediatric vaccination is advised by global agencies such as the WHO,UNICEF, AND THE CDC. Expert opinion in India is also in sync with such international organizations. The UOI supplemented its argument by showcasing vaccinations data, revealing the safety of vaccine use on children.

ANALYSIS

1. Regarding the first issue, the court noted the evolving nature of the virus and observed the global mandates regarding the same by international organizations such as WHO. Accordingly, the Court held that the Government of India’s vaccination drive is in the interest of public health and cannot be faulted .

It is pertinent to note that while determining personal autonomy , the court held that:

• Bodily integrity is protected under Article 21 , and no citizen can be forced to be vaccinated.
• Bodily integrity includes the right to life and the right to refuse  medical treatment within  its ambit.
• 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, then the government may take reasonable restrictive steps against the said people.

B)Regarding the second issue, the court  noted that there are stringent statutory requirements, which must be compiled with by the manufactures of vaccines and other participants during the different stages of clinical trails of vaccines. Furthermore, the court disagreed with the submission on behalf of the petitioner that emergency approvals to the vaccines were given in haste , without adequately reviewing the data from clinical trials. The Court also noted that vaccines had received consent from WHO.

C).Dealing with the third issue, the Court noted that as per the data presented by the UOI, a well -defined mechanism exists for collecting data relating to adverse events due to Covid-19 vaccines. Even medical practitioners at private hospitals are associated with reporting adverse events.

Thus, Court dismissed the petitioner’s challenge. However, the Court emphasized the need to report adverse and suspected 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.

 D)Pertaining to the fourth issue, the Court opined that it could not analyze and provide a judgement regarding the safety  and integrity of pediatric vaccination as the said aspect is beyond judicial review and a matter to be determined by concerned  subject matter experts. Further , the Court also noted that the decision of the UOI regarding pediatric vaccination meets global scientific consensus. Thus , the Court dismissed the challenge raised by the petitioner regarding the same.

JUDGEMENT

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 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 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 regards 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. 

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[i] Jacob Puliyel vs Union Of India Writ Petition (Civil) No. 607 of 2021.

[ii] Art. 21 Constitution of India,1949

[iii] Academy of Nutrition Improvement v. Union of India; G. Sundarrajan v. Union of India; and Shri Sitaram Sugar Company Ltd. v. Union of India.

[iv] Henning Jacobson v. Commonwealth of Massachusetts;  Zucht v. King; Docket No. 21A240 titled Joseph R. Biden v. Missouri.

[v] Kassam v. Hazzard; Henry v. Hazzard.

[vi] 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.

Written by: Devyani Setu, an intern under Legal Vidhiya