Published on: May, 4, 2022 at 20:00 IST
The Two Judge Bench of Justice L Nageswara Rao and Justice BR Gavai of the Supreme Court adjudicated the PIL filed challenging the vaccine mandates and seeking publication of the clinical trial and adverse events of vaccination.
The Supreme Court recently ruled that the vaccine Mandates are not proportionate and no one should be forced to get vaccinated.
The petitioner had contented how the forcing of vaccination is wrong, the mandates are illegal and non-disclosure of data decreases the credibility of the vaccine. The Contentions made by the petitioner are:
1. That 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.
2. that informed consent is necessary for medical procedures and bodily integrity is an integral part of the right to privacy.
3. That vaccination does not prevent from getting infected or transmitting, is ineffective in preventing new variants and has serious immediate and might also have adverse effects in the future, mandating vaccination is unconstitutional.
4. 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.
5. That even filing of an RTI application by a third party person didn’t result in disclosure of the data answering “how much reliance can be made on the vaccine?”
6. That besides the Immunization Reporting System being opaque and flawed, there was a lack of public awareness about the same.
7. That the overall risk from COVID-19 for children is remarkably low, it is not reasonable to vaccinate them, too, without providing an opportunity to the parents to provide informed consent.
The respondents included representation by the states, medical doctors, and vaccine manufacturers. The Contentions made by them were:
- 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.
- That the approval process of the vaccination was based on the statutory framework decided by the reliable authorities.
- That the clinical trial data is a confidential piece of data and according to Helsinki Declaration and the WHO, raw clinical trial data only refers to the obligation to disclose final results, findings and outcomes which have already been disclosed.
- That for pediatric vaccines there is a statutory regime in place, which is being strictly followed.
- 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.
- That Tamil Nadu’s mandate was justified, broadly on three grounds: It prevents mutation Unvaccinated people cause health risks and economic impact.
- That According to Maharashtra, 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.
- That According to Madhya Pradesh, 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.
- That the manufacturer denied the disclosure of clinical raw data, relying 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 petitioner after hearing the contentions of the respondent, rebutted with these contentions:
1. That disclosure would permit the independent experts to look into the veracity of the claims of the manufacturers.
2. That the assertion, vaccines significantly reduce the risk of transmitting the disease, had to be established by the Government by adducing evidence.
3. That by merely stating there exists a robust system for approving, it cannot be taken outside the ambit of judicial scrutiny
4. That only the vaccinator can report such effects; the public at large does not know the reporting system and only known adverse effects can be reported.
The Apex Court after going through all the facts and statements of both sides rejected the arguments against the maintainability of the writ petition.
That the government neither at the state nor central level has provided any information that would state a significant difference between the risk of transmission of covid amongst vaccinated and non-vaccinated citizens.
That since the infection rates have been low, the mandates put up by the state cannot be considered proportionate.
That the authorities and the institutions who have applied these mandates should review their decision of doing the same.
“No data has been provided by the Union of India or States before us controverting the material placed by petitioner which indicates that the risk of transmission by unvaccinated is at par with vaccinated. In light of this, the vaccine mandates cannot be said to be proportionate till the infection rate remains low and new development of research emergence which justifies the mandate”, the court said.
The Apex Court stated that a reasonable vaccination policy for COVID-19 was also found to be constitutional by the Court.
That furthermore, the court found that the clinical trial data of the vaccines had been published according to the applicable standards.
That we do not believe that emergency approval has been granted in haste based on the information provided by the Union of India.
The Apex Court of the Union of India was instructed to publish adverse events following vaccination (AEFI) reports from the general public and doctors on publicly accessible platforms without compromising the privacy of individuals.
The Apex Court further stated that no matter what the opinion of experts is, we cannot second guess them, and the vaccination follows global standards.
That Paediatric vaccines are in accordance with international standards.
That the Union of India must ensure that the key findings of the stages of trials already approved for children are made public as quickly as possible.
“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.
As a result, the Apex Court allowed the petition the PIL filed challenging the vaccine mandates and seeking publication of the clinical trial and adverse events of vaccination.