The Supreme Court directed the Union Government, through the Ministry of Health and Family Welfare, to frame a no-fault compensation policy for individuals who suffer serious adverse events following COVID-19 vaccination. The Court issued the direction while considering petitions concerning deaths allegedly caused by adverse effects from COVID-19 vaccines. The Court clarified that the formulation of such a compensation framework would not amount to an admission of liability or fault on the part of the Union Government or any other authority.
The direction was issued by a bench comprising Justices Vikram Nath and Sandeep Mehta. While directing the Union Government to formulate the compensation policy, the Court observed that the existing mechanism for monitoring adverse events following immunization would continue to operate. The Court indicated that the current surveillance and monitoring framework relating to vaccine safety should remain in place and continue to function as it presently does.
The Court further directed that relevant data concerning adverse events following immunization should be periodically placed in the public domain. This direction was issued in line with observations made in an earlier judgment delivered in 2021 in the case concerning Dr. Jacob Puliyel. The Court emphasized that making such information publicly available would be consistent with the earlier observations of the Court regarding transparency in relation to vaccine safety data.
At the same time, the Court clarified that there was no need to constitute a separate court-appointed expert body to examine adverse events related to COVID-19 vaccination. The bench noted that an existing system for surveillance and monitoring of adverse events already operates and that the same mechanism would continue to be relied upon for examining such incidents.
The Court also clarified that the creation of a no-fault compensation policy would not prevent affected individuals from pursuing other remedies available under law. The bench stated that the direction to frame such a policy should not be interpreted as restricting the rights of individuals to seek relief through other legal avenues if they believe they are entitled to compensation or other forms of remedy.
The judgment was delivered in a writ petition filed by Rachna Gangu and Venugopalan Govindan. The petitioners had approached the Court alleging that their daughters died as a result of adverse effects caused by the COVID-19 vaccine. In their petition, they sought compensation from the Union Government for the alleged deaths caused by the vaccine. They also requested the constitution of an expert committee to investigate the adverse effects associated with COVID-19 vaccination.
In addition to this petition, another matter was also before the Supreme Court in which the Union Government had challenged an interim order passed by the Kerala High Court. The interim order had been issued in a petition filed by Sayeeda K. A., who had alleged that her husband died due to vaccination. In that case, the High Court had directed the formulation of a compensation policy, and the Union Government had challenged that order before the Supreme Court.
During the proceedings, the Union Government had earlier filed a counter-affidavit in 2022 stating that it was not liable to provide compensation for alleged vaccine-related deaths or injuries. The government argued that vaccination was a voluntary act undertaken by individuals who made an informed decision based on the information provided about potential risks associated with vaccination.
The government had maintained that people who chose to receive the vaccine did so voluntarily after being informed of the possible risks involved. Therefore, according to the government’s earlier submissions, the act of vaccination could not automatically create liability on the part of the state for any adverse outcomes.
The Supreme Court heard extensive arguments in the matter, including submissions relating to the request for an independent inquiry into adverse events related to COVID-19 vaccines. The petitioners had also raised concerns alleging systemic suppression of data relating to adverse events during the vaccination drive.
During the course of the hearing held on November 13 of the previous year, the Court indicated that it would examine all the submissions made by the parties before arriving at a decision. The bench stated that it would consider whether a committee was required to be constituted and what directions, if any, should be issued in relation to the issues raised in the petitions.
The Court had also indicated that it would examine the amendment application filed in the matter seeking an independent inquiry into vaccine-related adverse events. The application had also raised allegations regarding the handling and reporting of data relating to adverse events during the vaccination campaign.
After considering the submissions made by the parties and examining the issues raised in the petitions, the Supreme Court delivered its judgment directing the Union Government to frame a no-fault compensation policy for serious adverse events following COVID-19 vaccination. The Court made it clear that the creation of such a policy should not be interpreted as an admission of fault or legal liability on the part of the government or any authority involved in the vaccination programme.
The Court reiterated that the existing framework for monitoring adverse events following immunization would continue to function and that there was no requirement to create a new expert body for examining such cases. The bench emphasized that the established surveillance mechanism would remain responsible for monitoring and evaluating adverse events related to vaccination.
The Court also reiterated that relevant data relating to adverse events should be periodically made available in the public domain in accordance with earlier judicial observations. This requirement was intended to ensure transparency regarding the monitoring and reporting of vaccine-related adverse events.
Through these directions, the Supreme Court addressed the issues raised in the petitions concerning alleged deaths and injuries following COVID-19 vaccination. The judgment directed the Union Government to formulate a policy framework for providing compensation without requiring proof of fault in cases involving serious adverse events following vaccination. At the same time, the Court clarified that such a policy would not constitute an admission of liability and would not prevent affected individuals from pursuing other legal remedies available under the law.
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