Concerning a petition on human rights violations in clinical trials the Indian Supreme Court has issued notice to the pharmaceutical companies GlaxoSmithKline (UK) und Merck (USA) and asked for specific details on the trials.
In the same hearing, the Court accepted an amicus curiae brief the ECCHR submitted in the case in February 2014. According to ECCHR, "a proper investigation should include the organizations conducting the trial as well as the pharmaceutical companies that benefit from the scientific results."
In 2009, the States of Andhra Pradesh and Gujarat launched a research project for the vaccination against the human papilloma virus (HPV) which can cause cervical cancer. Adolescent girls between the ages of 10-14 in the States of Andhra Pradesh and Gujarat were to be vaccinated. The vaccines were provided by GlaxoSmithKline and Merck.
The project was designed and executed by PATH (Program for Appropriate Technology in Health) and funding was received from the Bill & Melinda Gates Foundation. In April 2010, however, the Government of India suspended the program as several violations of ethical standards by PATH were widely reported by human rights organizations. However, by that time, 24,000 girls were already vaccinated. A governmental inquiry commission had especially questioned the fact that school head masters signed consent forms on behalf of the children. Women's health activists now seek accountability and brought a public interest petition to the Court.
This case gives the Indian Supreme Court the opportunity to address the obligations of trial sponsors and manufacturers. Therefore, ECCHR's brief offers a review of relevant standards for trial sponsors and manufactures that have been developed in international treaties, legislation, and jurisprudence. This comparative analysis can inform the standard of care that can be expected from "reasonable corporations."
The Affidavit is supported by legal experts from the Business and Human Rights Project at Essex University. In this case, special care was required by three separate human rights conventions. The trial subjects were young girls between 10-14 years old, and several of them were from tribal backgrounds. They were thus particularly vulnerable and entitled to special protection under the Convention on the Rights of the Child, the Convention on the Elimination of All Forms of Racial Discrimination and the Convention to Eliminate All Forms of Discrimination Against Women.
Q&A: The HPV proceedings before the Indian Supreme Court