The Human Factor: Globalizing Ethical Standards in Drug Trials through Market Exclusion

Abstract

This Article is part one of a two-part series that seeks to deter unethical clinical drug trials in developing nations by preventing products developed unethically from gaining market approval. In particular, this Article argues for a combination of soft-law techniques, including more robust and subaltern-centric surveillance of international drug trials, and hard-law rules within the regulatory agencies of the United States and European Union (EU) that require clinical drug research to adhere to international ethical standards. The intended result is to create a stiff economic penalty: exclusion from lucrative markets for unethical testing practices. This in turn will create a strong ex ante economic incentive for drug companies to ethically conduct drug trials.

First, this Article outlines how the international community's current medical ethics regime has emerged as a reaction to historical ethical abuses. Next, this Article addresses how globalization has transformed human drug testing trials and, in the process, has rendered inadequate the current ethics regime, which does not operate well across international borders into developing nations. Lastly, this Article describes how soft law, which can work effectively across international borders, can be used to effectuate hard-law sanctions, such as blocking market approval within the United States and the EU to deter unethical practices in clinical drug trials.

Keywords: Drug trials, Globalization, Bioethics

JEL Classification: I1, K23, K32