No legal compulsion to get vaccinated; government cannot be held liable for deaths from COVID vaccine: Central government to Supreme Court

While vaccination for COVID-19 is encouraged by the government in public interest, there is no legal compulsion to get vaccinated, the Central government told told the Supreme Court. .In response to a plea filed by parents of two girls who had passed away owing to side effects of the COVID vaccine, the Union Health Ministry told the Supreme Court that the deaths were tragic but the government could not be held liable. " ... the concept of informed consent is inapplicable to the voluntary use of a drug such as a vaccine. While the Government of India strongly encourages all eligible persons to undertake vaccination in public interest, there is no legal compulsion for the same," an affidavit filed by the government on November 23 said. .The Supreme Court had on August 29 issued notice to the Central government on the plea. The plea has sought a probe by an independent committee into the deaths, along with the release of the autopsy and probe reports in a time-bound manner. The plea has also requested that the parents be monetarily compensated, and has sought directions to the government to come up with guidelines for early detection and treatment of persons suffering from adverse side effects of vaccines. .The Union government's affidavit stated that Adverse Events Following Immunization (AEFIs) are reported for every vaccine. "Just as a medicine has side effects, AEFIs are reported for every vaccine in the world. A vaccine beneficiary always has the option to access even more information about the vaccine and its possible adverse effects from health workers at the vaccination site or their doctor before making an informed choice of their own," the Union Health Ministry contended. On the compensation being sought, the affidavit said that the petitioners have other legal remedies including approaching a civil court for damages. It was also emphasised that a strict liability on Union or State governments for administering the vaccine is not legally tenable, since the vaccines are manufactured by third-parties. "There is no material to suggest how the State can fastened with strict liability for the tragic death of the respective children of the Petitioners which is the requirement in law to sustain a claim for compensation against the State under Article 32 of the Constitution," the affidavit stated. Pertinently, it was submitted that the concept of lack of informed consent is not applicable in a voluntary vaccination programme.Informed consent is a principle in medical ethics/law, which says that patients must have sufficient information and understanding before they are to make decisions about any treatment or medicine they will be receiving."All relevant information on COVID-19 vaccination is made freely available in public domain by both the vaccine manufacturer and Ministry of Health and Family Welfare....It is humbly submitted that once a vaccine beneficiary, who has access to all relevant information, chooses to voluntarily enter a vaccination center and receive vaccination, the question of lack of informed consent does not arise," the affidavit said.The regulatory mechanism for administering vaccines in India is a well-established one based on experts opinions at various levels, it was further highlighted..The Kerala High Court had recently directed the National Disaster Management Authority (NDMA) to formulate guidelines for identifying cases of deaths due to the after-effects of Covid-19 vaccination and for compensating the dependants of such victims