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Central Government’s Stance and Existing Policy (or Lack Thereof)

Rashmi NSH by Rashmi NSH
2 years ago
in Science News
0
covid-19

The Central government’s stance, as presented to the Court and in prior affidavits, has been that no scheme for compensation exists for vaccine-related injuries under current law. The government has pointed out that it did declare the COVID-19 pandemic a “notified disaster” under the Disaster Management Act (DMA), 2005, which allowed ex-gratia payments for COVID-19 deaths – but that designation did not extend to adverse outcomes of vaccination. According to ASG Aishwarya Bhati, the Disaster Management Act has no provision to cover AEFIs from the vaccination drive: “The COVID-19 was declared a disaster, but the vaccination program followed medical protocol… The AEFI mechanism assesses whether a death is directly linked to the vaccine.” In essence, the government’s position is that the law and policy frameworks for disaster relief were targeted at the disease (the pandemic), and vaccine side effects were handled separately through medical monitoring and case-by-case evaluation, rather than through a financial compensation scheme.

In its responses to both the Kerala case and the earlier Rachana Gangu case, the Union government has consistently argued that COVID-19 vaccination in India was entirely voluntary and that people took the vaccine out of choice (albeit encouraged by the State). The concept of “informed consent” in a formal sense was said to be inapplicable because vaccines were not forcibly administered – an individual consented by their voluntary decision to be inoculated. Therefore, the government contends, it cannot be held strictly liable for extremely rare adverse outcomes. In a 2022 affidavit, the Ministry of Health and Family Welfare explicitly stated that holding the State responsible to pay compensation for “extremely rare” deaths from vaccines “may not be legally sustainable”, given the voluntary nature of the vaccine rollout. The only remedy for those aggrieved, the affidavit noted, would be to pursue a claim for damages in a civil court if they believe negligence or a defect was involved. “If a person suffers physical injury or death from AEFI, appropriate remedies in law are open… including approaching the civil courts for a claim of damages/compensation,” the government’s affidavit explained, emphasizing that any such claim would have to be decided on a case-by-case basis and proof of causation.

Furthermore, the government has highlighted that an elaborate AEFI surveillance system is in place to investigate serious adverse events and determine whether a causal link to the vaccine exists. The underlying implication of the Centre’s stand is that, because causality in many post-vaccination deaths can be uncertain or coincidental, it prefers to handle claims individually (through courts or existing health mechanisms) rather than presume all temporal associations are due to vaccines. In support of its position, the government cited data showing that adverse events were extremely low relative to the number of vaccine doses administered. By late 2022, out of 219.86 crore (2.19 billion) COVID-19 vaccine doses given in India, about 92,114 AEFI cases were reported (roughly 0.0042%), of which only 2,782 (0.00013% of doses) were serious/severe cases, including deaths. Even among those severe cases, the National AEFI Committee’s causality assessments were still ongoing, and not all had been confirmed as vaccine-related. The government noted, for example, that a very rare clotting disorder known as Thrombosis with Thrombocytopenia Syndrome (TTS) was identified in some instances (26 cases in India, 12 of them fatal, after Covishield shots). These numbers were presented to underscore that while adverse outcomes exist, they are exceedingly infrequent — a point seemingly used to argue against a broad compensation mandate.

Crucially, India does not currently have any dedicated statute or scheme that guarantees no-fault compensation for vaccine injuries. Unlike some countries that preemptively provide for vaccine injury claims, India’s public health policy has so far not included an official compensation program for any vaccine-related harm. This gap was acknowledged by experts and even in Parliament. In July 2021, the government told Parliament that there was “no provision of compensation for any side-effects or medical complications due to inoculation (under emergency use)” of COVID-19 vaccines. The only support mechanism specific to COVID-19 was the ex-gratia payment of ₹50,000 for COVID-19 disease deaths, a relief mandated by the Supreme Court under NDMA guidelines. However, that ex-gratia scheme explicitly did not cover vaccine-related deaths, since those were not classified as a disaster. The Centre’s view has been that any expansion of liability or compensation must be carefully evaluated in policy terms, rather than imposed by courts via writ mandates.

Indeed, during the Supreme Court hearing, the ASG cautioned that “there cannot be a mandamus [judicial command] for us to frame a policy in a particular manner when [a] policy has already been framed and it has not covered [vaccine side effects]”. This was a reference to the fact that the government’s pandemic relief policy (through NDMA) was a conscious policy choice that excluded vaccine injuries, and the executive believes courts should not rewrite policy by directive.

In summary, the Central government’s stance is that no compensation policy currently exists for vaccine side-effect cases, and any decision to create one involves governance considerations (like defining eligibility and funding) which the government is now reluctantly examining at the Supreme Court’s behest. Until now, affected individuals have had to resort to general legal avenues for any relief, as India’s public health framework does not provide a built-in safety net for vaccine injuries.

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Rashmi NSH

Rashmi NSH

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