Commercialized Medical Research and the Need for Regulatory Reform

U Toronto, Legal Studies Research Paper No. 967393

JUST MEDICARE: WHAT'S IN, WHAT'S OUT, HOW WE DECIDE, C. Flood, ed., University of Toronto Press, 2006

17 Pages Posted: 7 Mar 2007

See all articles by Trudo Lemmens

Trudo Lemmens

University of Toronto - Faculty of Law

Abstract

This chapter discusses the impact of commercial interests on medical research and health care practice and analyzes whether existing legal and regulatory tools are able to curb some of the problematic ways in which commercial interests affect the production of medical evidence. In light of the growing emphasis on evidence-based medicine, it is increasingly important to understand how commercial interests affect the quality of the evidence produced in medical research, and to evaluate to what extent existing regulatory tools allow us to deal with the challenges.

The chapter first sketches a picture of the commercialized research scene: the financial interests in drug development, the promotion by funding agencies of the commercialization of research, the growing inroads of commercial interests into the regulatory system surrounding research and drug development, the strategic use of consumer groups, and so on. It then analyzes various existing mechanisms that provide some safeguards and concludes by discussing new approaches to enhancing the reliability of medical evidence. Particular attention is paid to the limits of the current drug regulatory review system and to recent proposals to fundamentally alter the clinical trials scene.

Keywords: medical research, research regulation, drug regulation, pharmaceuticals, conflict of interest, research integrity, commercialization, research ethics, clinical trials

JEL Classification: K32, K23, I18, I1

Suggested Citation

Lemmens, Trudo, Commercialized Medical Research and the Need for Regulatory Reform. U Toronto, Legal Studies Research Paper No. 967393, JUST MEDICARE: WHAT'S IN, WHAT'S OUT, HOW WE DECIDE, C. Flood, ed., University of Toronto Press, 2006, Available at SSRN: https://ssrn.com/abstract=967393

Trudo Lemmens (Contact Author)

University of Toronto - Faculty of Law ( email )

78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada

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