Informed Consent: Enforcing Pharmaceutical Companies' Obligations Abroad

Health and Human Rights Journal, Vol. 12, No. 1, 2010

14 Pages Posted: 8 Jul 2011 Last revised: 6 Feb 2014

See all articles by Stacey B. Lee

Stacey B. Lee

Johns Hopkins University - Carey Business School; Johns Hopkins University - Bloomberg School of Public Health

Date Written: January 1, 2010

Abstract

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, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, 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 by an international tribunal or through one universally adopted code of ethics.

This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the “right to health.” 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 US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

Keywords: Alien Torts Statute, Human Rights, Clinical Trials, Informed Consent, Pharmaceutical Drug

Suggested Citation

Lee, Stacey B., Informed Consent: Enforcing Pharmaceutical Companies' Obligations Abroad (January 1, 2010). Health and Human Rights Journal, Vol. 12, No. 1, 2010, Available at SSRN: https://ssrn.com/abstract=1881024

Stacey B. Lee (Contact Author)

Johns Hopkins University - Carey Business School ( email )

100 International Drive
Baltimore, MD 21202
United States

Johns Hopkins University - Bloomberg School of Public Health ( email )

615 North Wolfe Street
Baltimore, MD 21205
United States

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