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16 Health & Hum. Rts. J. 84 (2014)
Health Rights Litigation Pushes for Accountability in Clinical Trials in India

handle is hein.journals/harhrj16 and id is 282 raw text is: Health and Human Rights Journal Health Rights Litigation Pushes for Accountability in Clinical Trials in India CAROLIJN TERWINDT 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 clin- ical 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 In- dian 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. CAROLIJN TERWINDT, MSc, LLM, JSD, is a legal advisor at the European Center for Constitutional and Human Rights, Berlin, Germany. Please address correspondence to Carolijn Terwindt. Email: terwindt@ecchr.eu. Competing interests: None declared. Copyright K 2014 Terwindt. This is an open access article distributed under the terms of Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licences/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medi- um, provided the original author and source are credited. 84

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