Informed Consent: Enforcing Pharmaceutical Companies' Obligations Abroad

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Carey Business School, Johns Hopkins University
The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, the United States government and courts, and the media have played a significant role in defining those obligations. This article examines the evolution of those obligations through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust these obligations become on their face, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement from an international tribunal or from one universally adopted code of ethics. Rather than continuing to pursue an untenable international approach, this article argues that a viable enforcement mechanism lies in application of the Alien Torts Statute (ATS). Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victim redress and enforcing sponsor accountability for informed consent misconduct. A vital component in ensuring the world population’s “right to health” includes substantive human rights protections. This article concludes that by building on the federal appellate court’s ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in the United States, a mechanism for enforcing not only substantive informed consent, but also human rights protections can be created.
K33 - International Law, K32 - Environmental, Health, and Safety Law