COVID-19 vaccination drive: 'Cannot suppress human right of consent,' say experts

As the debate over informed consent for COVID19 vaccine continues midday 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 informedMedicosociolegal activist Dr Dinesh B Thakare told midday that lsquoinformed consentrsquo is a basic human right Article 3 of UNESCO Universal Declaration on Bioethics and Human Rights in clause 2 says ldquoThe interests and welfare of the individual should have priority over the sole interest of science or societyrdquoDr Thakare said ldquoSimilarly Article 6 in clause 1 necessitates lsquoprior free and informed consentrsquo for lsquoany preventive diagnostic and therapeutic medical interventionrsquo It also provides for the consent to be lsquowithdrawn at any time and for any reasonrsquordquoThe vaccination centre at R N Cooper Hospital PicSatej ShindeldquoMost healthcare professionals and workers across Maharashtra were lsquoregisteredrsquo for vaccination by their employer or they registered due to peer pressure or repeated calls from local authorities All come under lsquopassive consentrsquo Though the final nod for taking a vaccine is lsquovoluntaryrsquo itrsquos human tendency to register and consent when something is provided free of cost and especially when he is confused regarding whatrsquos exactly happeningrdquo Dr Thakare saidHe added ldquoEveryone knows that the COVID vaccines have some known side effects that are getting manifested randomly and unpredictably Is the lsquopermitting authorityrsquo sure that receivers wonrsquot 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 authoritiesrdquoldquoUnder the cover of lsquoPandemic and National Disaster Management Actsrsquo authorities should not suppress the human right of getting full and available informationrdquo Dr Thakare saidlsquoGet compensation systemrsquoAccording to solicitor Stuti Galiya ldquoInformed 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 2010rdquoldquoOn 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 timeconsuming and cumbersome onerdquo Galiya explainedldquoIt 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 shouldnrsquot leave affected parties with no option but to approach the legal systemrdquo Galiya concludedSupreme Court lawyer Tishampati Sen told midday ldquoThe Government in its role as the Parens patriae ie 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 groupsrdquo He continued ldquoWith no prescribed lsquodeadlinersquo 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 lawsrdquoAdvocate Sen added ldquoConsent by candidates for vaccination may not really be lsquoconsentrsquo in the classical sense since the candidate doesnrsquot really know what he is consenting to There is no disclosureliterature regarding risks or even a comparison between the various vaccines and technologies adoptedrdquoHe concluded stating ldquoMasses 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