DePaul Law Review, Vol. 57, No. 4 (Summer 2008), pp. 877-915. Originally uploaded at SSRN

Abstract

Given the tremendous financial reward that a blockbuster therapy might generate, there are strong incentives to move drug research and development to developing countries, which have minimal ethical guidelines and little transparency. The danger in this race for the prize--or for the bottom--is the exploitation of subaltern populations that have little legal recourse to hold drug companies accountable for the harm that those populations suffer as a result of unethical clinical trials. In other words, the drug industry is acutely aware that there is a minimal threat of costly civil suits and criminal sanctions for their ethical violations in impoverished countries. The result is that it has become an industry practice to relax international ethical norms for drug trials in developing countries. This does not mean that drug companies are inherently unethical institutions-- these corporations are composed of persons who are simply being human and responding to structural incentives. Additionally, the statistics derived from these clinical trials represent actual human individuals, who are also responding to the structural incentives that exist for them: a promise of healthcare only if they submit to risky experiments.

This Article is part one of a two-part series that seeks to deter unethical clinical drug trials in developing nations by preventing unethically developed products 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 the European Union (EU) that require clinical drug research to adhere to international ethical standards. The intended result would be a stiff economic penalty: exclusion from lucrative markets. This in turn would 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, it 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. Finally, 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.