Law Commons^™

The Human Factor: Globalizing Ethical Standards In Drug Trials Through Market Exclusion, Fazal R. Khan

Fazal Khan

This paper proposes a framework of international soft law and domestic drug regulations to a priori remove incentives for unethical clinical drug research in developing nations. The globalization of drug testing is very problematic from a bioethics perspective. While stringent regulations in the U.S. or E.U. may pose an adequate check on unethical research practices, many multinational corporations are engaging in regulatory arbitrage by outsourcing ethically questionable research to countries with less restrictive regulations. Given the tremendous financial reward a blockbuster therapy might generate, there is a strong incentive to move more research and development to countries with even looser …