Liability issues surrounding the vaccination drive: a work in progress

Arjun Krishnamoorthy, Senior Associate with J Sagar Associates points out that if the State would prefer not to accept liability in case of any adverse effects in light of the COVID-19 vaccination drive, it should at the least resort to a no-fault compensation system, where the compensation is paid for by the State, given that, after all, it is for the greater good of society as a whole that the vaccination is provided

When India started its vaccination drive in January 2021, a WhatsApp forward that started doing the rounds summed up the issues surrounding the vaccination drive with the observation: “Covid times have been crazy – politicians and bureaucrats are assuring doctors of vaccine safety!”

As part of the vaccination drive, which is purely voluntary, persons receiving the vaccine are deemed to be part of the larger clinical trial of the vaccines, which had received an accelerated approval under the New Drugs and Clinical Trial Rules, 2009 (the “Rules”). Both the Serum Institute and Bharat Biotech released fact sheets specifying those persons who should not be taking the vaccine. Interestingly, the fact sheet in relation to Covaxin notes that persons suffering from any other serious health-related issues, as determined by the Vaccinator/Officer supervising the vacation, should not be given the vaccine.

Being a part of the larger clinical trial, a volunteer is required to provide informed consent prior to receiving the vaccine. The informed consent for Covaxin, for instance, requires the volunteer to confirm that s/he has read and understood the information pertaining to the vaccine, and having been satisfied with the responses to any questions asked, and having understood the benefits and risks of the vaccine, which have been duly explained to him/her, such volunteer has provided informed consent to being vaccinated. In the event of such consent not having been obtained, the manufacturer would be more likely to be held liable for any adverse effects under the Rules.

As informed consent is a minefield, I would like to state, before proceeding further, that, for the purposes of this article, the presumption is that the person providing informed consent is an adult (or, at the least, Gillick competent) and of sound mind.

In common law countries, the doctrine of informed consent, until 2004 at least, followed a doctor-centric approach, with the medical professional determining whether or not sufficient information had been provided to the patient (the volunteer in a clinical trial) to make an informed decision. In 2004, the House of Lords in Chester v Afshar moved towards a more ‘patient-centric’ approach, observing that the patient had every right to make a fully informed decision, and withholding information, however miniscule, would imply that informed consent had not been provided. This was further elaborated upon by the Supreme Court of the United Kingdom, in 2015, in Montgomery v Lanarkshire Health Board, when the Court observed that a medical professional was obligated to provide full disclosure to enable a patient to make an informed decision and provide consent.

In India, the Supreme Court of India observed in 2008 in Samira Kohli v Prabha Manchanda that, keeping in mind the prevailing health, literacy, and poverty conditions in India, as also the Indian psyche of rarely questioning or challenging medical advice, it is more important that the doctor-centric approach continue to be adopted.

On the same grounds, it is more likely for a volunteer to provide consent to being vaccinated on the advice of the doctor and, more than the doctor, look for guidance to the Government.

The Indian Constitution places a duty on the State to provide healthcare, to ensure that the right to health under Article 21 is guaranteed. This duty would then extend to ensuring that all its citizens (or at least those who volunteer, or through the system of nudges) receive the vaccine. The State would still have to be mindful of its obligations under Article 47, whilst taking an informed decision to issue an accelerated approval for the vaccines. In such instances, the State would then be liable in case of any adverse effects in light of the vaccination, given that but for the accelerated approval, any adverse effect may not have arisen. It makes no sense that the Rules are strictly followed solely for the purpose of liability, and not for the trial process itself.

If the State would prefer not to accept liability, it should at the least resort to a no-fault compensation system, where the compensation is paid for by the State, given that, after all, it is for the greater good of society as a whole that the vaccination is provided.

Failure to adopt either may be seen to be (as opined by Krishna Iyer in Municipal Council v Vardichan) the actions of a callous public body habituated to deleterious inaction.

(The views expressed in this publication are personal and are not the views of the firm.)