Informed consent: Enforcing pharmaceutical companies' obligations abroad

Area of Science:

• Pharmaceutical Law
• International Human Rights Law
• Clinical Trial Ethics

Background:

• Pharmaceutical companies conducting clinical trials internationally have faced increasing scrutiny regarding their obligations.
• International human rights organizations, governments, and media have influenced the development of these obligations.
• Past and present recommendations for informed consent protections have been insufficient without robust enforcement.

Purpose of the Study:

• To examine the evolution of obligations for pharmaceutical companies in international clinical trials.
• To analyze the effectiveness of current protections for informed consent.
• To propose a viable enforcement mechanism for accountability.

Main Methods:

• Analysis of past, present, and future recommendations for informed consent.
• Examination of legal precedents, particularly concerning the Alien Torts Statute (ATS).
• Discussion of challenges posed by national sovereignty to international enforcement.

Main Results:

• Existing obligations for pharmaceutical companies in clinical trials abroad lack meaningful enforcement mechanisms.
• International enforcement is hindered by issues of national sovereignty.
• Recent federal appellate court interpretations of the ATS provide a pathway for redress for victims of informed consent misconduct.

Conclusions:

• The Alien Torts Statute (ATS) presents a viable enforcement mechanism for US-based pharmaceutical companies, enabling foreign trial participants to seek redress in US courts.
• Enforcement through the ATS can hold sponsors accountable for informed consent violations and human rights abuses.
• Leveraging ATS analysis can enforce substantive informed consent and human rights protections, ensuring the "right to health".