Public interest groups, which moved the Supreme Court over the unethical trial of HPV vaccine by PATH, have sought re-examination of the current ethical and legal framework to conduct drugs/vaccine trials in India to secure stronger protections for human subject participants.
The groups-- SAMA, a resource group for women and health, Locost, Drug Action Forum, Karnataka and Delhi Science Forum – also claimed that the existing laws proved to be inadequate to protect the subject participants.
The NGOs, armed with the report of the Parliamentary Standing Committee on the matter, alleged that violation of the right to health of thousands of young girls happened during the unethical conduct of HPV vaccine in Andhra Pradesh and Gujarat, between 2009 and 2010 by PATH in collaboration with the ICMR.
The bench consisting Chief Justice P Sathasivam and Justice Ranjan Gogoi on Monday had issued the notice to the Centre and others on the petition. The matter had been tagged along with another pending case on the topic and would now come up for hearing on December 6.
The spokespersons for the NGOs said they approached the court on behalf of thousands of young girls who were made to participate in vaccinate trials done without strong ethical or legal safeguards to protect their rights.
Apart from addressing the doubtful claims about the safety and efficacy of the vaccines involved, the NGOs have also sought to hold PATH and others liable for their illegal actions under the current ethical, penal and regulatory framework to protect subject of biomedical research provided under Schedule Y of the Drugs and Cosmetics Rules, 1945 and the Good Clinical Practice Guidelines and ICMR Guidelines, which has led to the violation of the right to health of thousands of young girls involved in the vaccine trials.
All material on record sufficiently refutes the claims of the ICMR and PATH that the trial was a study. In fact, the permission to import the vaccines had been granted by the DCGI on the condition that data on adverse events generated from the clinical trials would be submitted to him, according to the affidavit filed by the petitioners.
Even though the study protocols of the PATH had several flaws that could result in the violation of the rights of the participants to these trials they were given ethical approval by the Ethics Committees. They were not questioned on their choice to conduct the study with young girls who belong to socio-economically backward families, many of whose parents could not read or write nor did they ensure that the required standard of medical care would be available to the trial participants as a result of which many girls who possibly suffered serious adverse events related to the trial, died, it said.
“Violations in obtaining informed consent from the young girls were recorded by independent fact-finding teams as well as the recently released 72nd Report of the Parliamentary Standing Committee. The respondents abused their position of authority by authorizing hostel wardens and headmasters to provide informed consent on behalf of the girls. Many other discrepancies were found including insufficiency of information on the risks and alternatives to the vaccines in the consent forms as well as inconsistencies between signatures and names of the persons signing on behalf of the minors. Many of the girls and their parents had no knowledge about what the vaccine was for and some even considered it to be part of the Universal Immunization programme since the National Rural Health Mission (NRHM) logo was printed on the vaccination cards,” the affidavit said.