Non-Disclosure Of Vaccine Trial Data Preventing Independent Evaluation : Prashant Bhushan Tells Supreme Court

The Supreme Court, on Tuesday, heard the rebuttal arguments of Advocate, Mr. Prashant Bhushan, appearing for the petitioner in a plea, inter alia, seeking directions to the Union Government to publicize the data pertaining to the clinical trials of the COVID-19 vaccines administered in India as per the requirement of the International medical norms. Apart from this, the petition also challenges the vaccine mandates imposed by the States of Madhya Pradesh, Maharashtra, Delhi and Tamil Nadu as unconstitutional. It further seeks revamping of the Adverse Events Following Immunization (AEFI) reporting system, which it claims, to be opaque and flawed. Another issue raised in the petition is the non-disclosure of the clinical trial data of the vaccines administered to children in India.The Court was hearing a writ petition filed by Dr.Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, seeking the data of clinical trial and adverse effects of COVID vaccines and challenging the vaccine mandates imposed by some States. On Tuesday, appearing before a Bench comprising Justices L. Nageswara Rao and B.R. Gavai, Mr. Bhushan refuted the arguments of transparency made by the Solicitor General. He stressed upon the petitioner's plea to disclose the clinical trial data as it would permit the independent experts to look into the veracity of the claims of the manufacturers. In this regard, he referred to a United States District Court judgment, wherein the regulatory body was directed to disclose all the information pertaining to the Pfizer vaccine. He also argued to demonstrate the vaccine mandates imposed by the above-mentioned States were irrational and disproportionate. Further, he put forth the flaws in the adverse event reporting mechanism, which he claimed, was alien to many, as its existence has not been adequately advertised by the Union Government. Previously, Mr. Bhushan had elaborately argued the issues raised in the petition. Countering his arguments the Solicitor General had submitted that adequate statutory provisions and robust mechanisms were in place to ensure that protocol is followed while granting approval to vaccines and while reporting adverse events. The Solicitor had emphasised that all the information sought by the petitioner are already in the public domain. However, it was made abundantly clear that neither was it open to a Public Interest petitioner to seek raw data of the clinical trial of the COVID-19 vaccines, merely to satisfy his curiosity, nor can he sit in judgment of the wisdom of the statutory bodies comprising domain experts. The Solicitor General had vehemently argued that an individual's personal liberty is not absolute and therefore, the court should reconcile competing interests by balancing the interests so involved. Non-disclosure of Data -Non disclosure is preventing independent experts from making their own determination Mr. Bhushan contended that the Union Government is preventing independent experts from making their independent determination by not providing data. The reason being cited by the Union Government is that with a multi-layered system in place, Government experts are sufficiently capable of making such determinations. "We are told that the Subject Expert Committee (SEC) and the National Technical Advisory Group on Immunisation(NTAGI) are good multi-layered systems which take care of everything. So much so, that independent experts are not to be given access. They say why independent experts arrive at their independent conclusion when such a body is already doing the same." United States District Court had directed FDA to provide all data pertaining to Pfizer vaccine Reliance was placed on In Public Health and Medical Professionals for Transparency v. Food and Drug Administration, wherein the plaintiff under the Freedom of Information Act (FOIA) sought all data and information for the Pfizer Vaccine with the exception of publicly available reports on the Vaccine Adverse Events Reporting System from the Food and Drug Administration. The United States District Court for the Northern District of Texas, Fort Worth Division had allowed the plea. Bhushan read out the following excerpts from the order : "Echoing these sentiments, "[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society." NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). "FOIA was [therefore] enacted to 'pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.'" Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep't of the Air Force v. Rose, 425 U.S. 352, 361 (1976)). And "Congress has long recognized that 'information is often useful only if it is timely' and that, therefore 'excessive delay by the agency in its response is often tantamount to denial.'"...

Non-Disclosure Of Vaccine Trial Data Preventing Independent Evaluation : Prashant Bhushan Tells Supreme Court

Sohini Chowdhury

Mr.Bhushan argued that disclosure of clinical trial data was an established practice across the world.

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