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Unpublished Paper
The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion
ExpressO (2007)
  • Fazal R Khan, University of Georgia School of Law
Abstract
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 regulations and less transparency. The danger in this “race for the prize” is the exploitation of vulnerable populations that have little recourse to hold anyone accountable given their low-power status in a globalized society. In particular, this article argues for a combination of “soft-law” techniques including more robust and subaltern-centric surveillance of international drug trials to enforce existing “hard law” rules within the regulatory agencies of the United States and European Union 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 conduct drug trials ethically.
Keywords
  • medicine,
  • Africa,
  • AIDS,
  • bioethics,
  • medical ethics,
  • international law,
  • health care law,
  • soft law,
  • hard law,
  • economics,
  • pharmaceutical,
  • drug industry,
  • clinical trials,
  • human rights,
  • globalization
Disciplines
Publication Date
September 26, 2007
Citation Information
Fazal R Khan. "The Human Factor: Globalizing Ethical Standards in Drug Trials Through Market Exclusion" ExpressO (2007)
Available at: http://works.bepress.com/fazal_khan/1/