Carolijn Terwindt1. 1. Legal advisor at the European Center for Constitutional and Human Rights, Berlin, Germany.
Abstract
In 2009, around 24,000 girls in India were enrolled in a human papilloma virus (HPV) vaccination program that was later reviewed to investigate allegations of informed consent irregularities and inadequate monitoring. If the allegations are found to be correct, the clinical trial will have violated core human rights, including the right to health. Unfortunately, such irregularities are not unheard of in trials that are outsourced and off-shored. Those in charge of such clinical trials are, however, rarely held accountable before a court of law. As an example of health rights litigation, this article highlights proceedings before the Indian Supreme Court ("the Court"), which addresses the lack of protection of trial subjects. The Court already urged the Indian Government to advance the regulatory framework on clinical trials. However, full enforcement of relevant standards should not only address the role of state agencies, but also include private organizations conducting clinical trials and pharmaceutical companies that benefit from the results. An amicus curiae intervention in the ongoing Indian proceedings calls on the Supreme Court to clarify these standards and order European and American companies to comply.
In 2009, around 24,000 girls in India were enrolled in a human papilloma virus (HPV) vaccination program that was later reviewed to investigate allegations of informed consent irregularities and inadequate monitoring. If the allegations are found to be correct, the clinical trial will have violated core human rights, including the right to health. Unfortunately, such irregularities are not unheard of in trials that are outsourced and off-shored. Those in charge of such clinical trials are, however, rarely held accountable before a court of law. As an example of health rights litigation, this article highlights proceedings before the Indian Supreme Court ("the Court"), which addresses the lack of protection of trial subjects. The Court already urged the Indian Government to advance the regulatory framework on clinical trials. However, full enforcement of relevant standards should not only address the role of state agencies, but also include private organizations conducting clinical trials and pharmaceutical companies that benefit from the results. An amicus curiae intervention in the ongoing Indian proceedings calls on the Supreme Court to clarify these standards and order European and American companies to comply.