13 January,2021 07:18 AM IST | Mumbai | Vinod Kumar Menon
Health workers during the first vaccination dry run at Rajawadi hospital
As the debate over informed consent for COVID-19 vaccine continues, mid-day, in its continuing reportage of the issue, has reached out to legal experts to weigh in on the matter. As the first phase of the vaccination drive on January 16 approaches, they, too, acknowledged the need for such consent and explained the legal aspects of keeping frontline warriors informed.
Medico-socio-legal activist Dr Dinesh B Thakare told mid-day that âinformed consent' is a basic human right. Article 3 of UNESCO Universal Declaration on Bioethics and Human Rights in clause 2 says, "The interests and welfare of the individual should have priority over the sole interest of science or society."
Dr Thakare said, "Similarly, Article 6 in clause 1 necessitates âprior, free and informed consent' for âany preventive, diagnostic and therapeutic medical intervention'. It also provides for the consent to be âwithdrawn at any time and for any reason'."
"Most healthcare professionals and workers across Maharashtra were âregistered' for vaccination by their employer or they registered due to peer pressure or repeated calls from local authorities. All come under âpassive consent'. Though the final nod for taking a vaccine is âvoluntary', it's human tendency to register and consent when something is provided free of cost and especially when he is confused regarding what's exactly happening," Dr Thakare said.
He added, "Everyone knows that the COVID vaccines have some known side effects that are getting manifested randomly and unpredictably. Is the âpermitting authority' sure that receivers won't be harmed by unknown side effects later? Have authorities informed receivers of probable unknown side effects? Will there be compensation in case of such outcomes? Informed consent is necessary to safeguard the right of the receiver and for the legal safety of authorities."
"Under the cover of âPandemic and National Disaster Management Acts', authorities should not suppress the human right of getting full and available information," Dr Thakare said.
According to solicitor Stuti Galiya, "Informed consent as a right is recognised under Article 21 of the Constitution, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002, the Consumer Protection Act 2019, the Drugs and Cosmetic Act 1940 and the Clinical Establishment Act 2010."
"On a practical basis, such consent is not taken while administering vaccines in India. India also has no official vaccine compensation programme. Hence, going to court is the only option and a time-consuming and cumbersome one," Galiya explained.
"It is important that India puts appropriate systems in place for taking informed consent. This will help achieve the target set under the immunisation programme for disease eradication, let health agencies fight COVID without the fear of litigation and increase transparency and faith in the healthcare industry. The compensation system should be easy to follow and implement and shouldn't leave affected parties with no option but to approach the legal system," Galiya concluded.
Supreme Court lawyer, Tishampati Sen, told mid-day, "The Government in its role as the Parens patriae (i.e., legal protector of citizens unable to protect themselves) must be careful before granting some sort of a carte blanche which could deny legal remedy or relief to aggrieved individuals, consumers or groups." He continued, "With no prescribed âdeadline' for manufacturers and them declaring readiness based on an internal assessment, it would be interesting to see the possible legal rationale for there to be an exclusion to product liability requirements as mandated in laws."
Advocate Sen added, "Consent by candidates for vaccination may not really be âconsent' in the classical sense, since the candidate doesn't really know what he is consenting to. There is no disclosure/literature regarding risks, or even a comparison between the various vaccines and technologies adopted."
He concluded stating, "Masses are getting ready for vaccination in the hope of a better future relying on assurances based on disclosures made by vaccine companies. If lives get affected, surely these individual consumers may value their right to have their case tried in court, where even the manufacturer has a fair chance to dispel any liability on the grounds of law."
