Case Analysis: – Jacob Puliyel v. Union of India

Harsh Srivastava & Hitanshi Arora

2nd Year BA, LL. B Hons. Student, UPES, School of Law.

INTRODUCTION

The COVID-19 pandemic has wreaked havoc around the world, and India has not been immune. India has been one of the worst-affected countries by the pandemic, with over 18 million confirmed cases and over 200,000 deaths. Getting vaccinated against COVID-19 has become a vital necessity in the aftermath of this tragedy. As a preventive precaution against the disease, the government has made vaccination mandatory. To guarantee that a bigger portion of the population is protected against the virus, the government has made vaccination mandatory. This is especially significant in India, where healthcare infrastructure is not as developed as in other countries. With a population of over 1.3 billion people, mass vaccination is critical to keeping the healthcare system from being overburdened.

The Jacob Puliyel vs. Union of India[1]Supreme Court case was decided by the Supreme Court of India on May 2, 2022. The case focused on numerous facets of India’s vaccination policy, such as the transmission of clinical trial data, the authenticity of emergency vaccine approvals, and the reporting of adverse vaccination effects.  However, the issue of compelled vaccination of people was raised in a case before the Supreme Court in the form of a writ petition. It talks about the preservation of individual rights.

COURT: – The Honorable Supreme Court

CITATION: – WP(C) 607 OF 2021

TITILE: – Jacob Puliyel vs Union of India

DATE OF ORDER: – 2^ND May 2022

JUDGES: – L Nageswara Rao and Mr. Bhushan Ramkrishna Gava

PARTIES OF THE CASE

PETITIONER: – Jacob Puliyel

RESPONDENT: – Union of India & Ors

FACTS OF THE CASE

Dr. Jacob Puliyel, a former National Technical Advisory Group on Immunisation {NTAGI} member who filed the writ petition, asked the court to order the release of the detailed minutes of the Subject Expert Committee {SEC} and NTGAl meetings regarding the vaccines as well as the justification behind CGI’s decision to approve or reject an application for emergency use authorisation of vaccines. It was argued that the vaccines’ clinical testing were still ongoing and that they were now only approved for emergency usage. The clinical studies are anticipated to be finished in 2023.

The negative effects of urgent regulatory approvals for vaccines in India were highlighted, as were the need for transparency in publishing separate clinical trial data for vaccines, the need for clinical data disclosure, lack of transparency in regulatory approvals, minutes, and the composition of expert bodies, and mandates for vaccines in the absence of informed consent because no clinical data was made public.

ISSUE OF THE CASE

1 .Are vaccination mandates in violation of Article 21 of the Indian Constitution?

2 . Non – Disclosure of segregated clinical trial data in public domain ?

3 .Improper AEFI reporting and collection  ?

4 . Vaccination of the children ?

1. ARE VACCINATION MANDATES IN VIOLATION OF ARTICLE 21 OF THE INDIAN CONSTITUTION ?

The case involved a petitioner who argued that the vaccine mandates implemented by the Indian government and some state governments were unconstitutional and coercive. They claimed that natural immunity acquired after contracting COVID-19 was more effective than vaccines, and that vaccines were ineffective against certain variants and could still be transmitted by both vaccinated and unvaccinated individuals. The Union of India and state governments argued that vaccines were safe and effective and that vaccine hesitancy would increase if doubts were raised about their safety. They also argued that vaccine mandates were implemented for the public good and were regularly revised based on the evolving situation of the pandemic.

The court acknowledged the evolving nature of the virus and held that the vaccination drive undertaken by the government was justified in the interest of public health. However, it also held that citizens cannot be forced to be vaccinated as bodily integrity is protected under Article 21.[2] The court suggested that restrictive measures may be imposed on unvaccinated individuals if there is data to show that they may transmit the virus and affect public health. The court also recommended that all authorities review their vaccine mandates and ensure that any restrictions are proportional to the current COVID-19 situation. The court asked the Union of India to develop a “health pass” similar to the one used in France, but emphasized that its observations were limited to the prevailing circumstances and should not impede the lawful exercise of power by the executive.

2 NON- DISCLOSURE OF SEGREGATED CLINICAL TRIAL DATA IN PUBLIC DOMAIN

The petitioner argued that there were adverse events and deaths after people received Covid-19 vaccinations, and the government didn’t have a proper system for reporting them. However, the UOI argued that they followed established protocols formonitoring adverse events following immunisation, and the COWIN portal had mechanisms for reporting all such incidents. They also clarified that a reported AEFI case should not be attributed to the vaccine without being proven by the causality assessment analysis. The Court found that there was a well-defined mechanism for collecting data on adverse events, including reports from private medical practitioners.  Therefore, the Court rejected the petitioner’s claim but emphasized the importance of reporting such incidents and directed the UOI to establish a system for individuals and private doctors to report them and make the information accessible to the public.

3. IMPROPER AEFI REPORTING AND COLLECTION ?

The petitioner claimed that administering vaccines to children may cause more harm than benefits as per scientific evidence, and that adverse reactions have been reported in young individuals. However, the UOI argued that global agencies such as WHO, UNICEF, and CDC recommend pediatric vaccination, and expert opinion in India supports this. The UOI presented data that demonstrated the safety of vaccine use on children. The Court acknowledged that it is not within its jurisdiction to determine the safety and veracity of pediatric vaccination and that it is a matter for subject matter experts. The Court also noted that the UOI’s decision on pediatric vaccination aligns with global scientific consensus. Therefore, the Court dismissed the petitioner’s challenge on this matter.[3]

4. VACCINATION OF THE CHILDREN

The petitioner argued that administering vaccines to children poses more risks than benefits, citing scientific evidence and adverse reactions reported in young individuals.

Additionally, he claimed that many children have already developed immunity to Covid-19. In response, the UOI presented evidence to support the safety of pediatricvaccination, citing recommendations from global organizations such as the WHO, UNICEF, and CDC, and emphasizing the consensus among Indian experts. The Court held that it is not within its jurisdiction to determine the safety and efficacy of pediatric vaccination and deferred to subject matter experts. The Court acknowledged the UOI’s reliance on global scientific consensus and dismissed the petitioner’s challenge regarding pediatric vaccination.

MAINTAINABILITY

The Union of India argued that the decision-making process regarding vaccinations and related procedures should be left to the domain experts and not interfered with by the judiciary. The UOI also expressed concerns that the petitioner’s arguments could fuel vaccine hesitancy in the country. However, the Court deemed the petitioner’s concerns to be related to public health and fundamental rights granted under the Constitution, and therefore, required proper consideration. Consequently, the Court rejected the UOI’s objection to maintainability.

JUDICIAL REVIEW OF EXECUTIVE DECISIONS BASED ON EXPERT OPINIONS

The Union of India argued that in public health matters such as Covid-19 vaccination, the Court should not interfere with the decisions made by domain experts. They cited various precedents from the Supreme Court, as well as those from the United States and New Zealand. However, the petitioner argued that it is the Court’s responsibility to protect fundamental rights. The Court agreed with the petitioner and stated that it has the authority to review policy decisions if they are manifestly arbitrary or unreasonable. The Court identified four issues to be analysed, including vaccine mandates, non-disclosure of clinical trial data, improper reporting of adverse events, and vaccination of children. The Court emphasized that policy-making is the responsibility of the executive, but the Court has the jurisdiction to ensure that policy measures meet the standards of reasonableness and protect the right to life.

JUDGMENTS

The Indian Constitution’s Article 21 protects bodily freedom, and the court ruled that no one can be forced to get immunised. Individuals have the freedom to choose whether or not they wish to get vaccinated, as well as the choice to live their lives whatever they choose and the right to refuse medical care. Nobody can force someone to get vaccinated if they do not want to. Additionally, it was determined that the government’s limits are appropriate given how challenging it will be to manage events in such unrestricted locations. It was decided that clinical trial results should be disclosed and made publicly available within a year of the research’s conclusion. It need to be openly accessible and free of charge. The public will have access to allmeeting details connected to the public domain, and they will be well-informed and aware when determining whether or not to get vaccinated.

Regarding the third concern, the Court has described in detail how to track, assess, and report the prevalence of AEF is to the relevant authorities. The Court made sure that the rapid review and assessment mechanism used at the national level was not compromised by the AFI system. The Union of India is mandated to simplify the online reporting of alleged harmful effects by patients and private physicians.

These reports must not contain any personal or confidential information about the individuals who made them and must be made public after getting unique identification numbers. From the beginning of vaccination administration, the government shall take all necessary steps to make this self-reporting platform known and understandable, recruiting and teaching relevant parties. It was determined that the Court cannot render a ruling regarding the safety of vaccines and associated services. The paediatric vaccine was found to be in conformity with the other organisations, such as WHO and UNICEF, as well as the global scientific consensus.

RATIO DECENDI

The safety and effectiveness of vaccines are a subject of scientific debate, the government has the authority to take reasonable measures to protect the public’s health, including mandating immunisation in some situations, the court stated.

The government’s decision to make COVID-19 vaccination mandatory for some groups, including healthcare professionals and frontline workers, was upheld by the court as being within its rights and not infringing upon any fundamental rights.

However, the court also emphasized the importance of ensuring that individuals are adequately informed about the risks and benefits of vaccination and that their consent is obtained before administering the vaccine.

The court directed the government to take steps to ensure that individuals are provided with accurate and complete information about the vaccines and their potential risks and benefits, and that their consent is obtained in a meaningful and informed manner.

CONCLUSION

No one can be forced to have a vaccination, and the limitations placed on persons were not arbitrary, the court ruled in dismissing the writ petitioner. The limits were put in place primarily for the benefit of public health. In consideration of each person’s right to privacy, the results of the trials should be made available to the general public. The vaccination complies with the general consensus of science; hence the court had no authority over the vaccines’ safety.

REFERENCES

1 . LiveLaw .

2 . Bar and Bench

3 . Manupatra

4 . Casemine
5 . SCC Online

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[1] Jacob Puliyel v. Union of India, WP(C) 607 OF 2021 (Del HC 2021).

[2] Indian Const. art. 21 (19th ed. 2017).

[3] Conventus Law. “India: Coercive Vaccination? Explaining The Jacob Puliyel v. Union Of India Case.” (June 15, 2021), https://conventuslaw.com/report/india-coercive-vaccination-explaining-the-jacob-puliyel-v-union-of-india-case/.