Healthy Skepticism Library item: 16831

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Publication type: Journal Article

Lexchin J, O'Donovan O
Prohibiting or ‘managing’ conflict of interest? A review of policies and procedures in three European drug regulation agencies
Social Science & Medicine 2009 Sep 24;
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VBF-4X9G8VC-2&_user=8303832&_coverDate=09/24/2009&_alid=1114653813&_rdoc=1&_fmt=high&_orig=search&_cdi=5925&_sort=r&_docanchor=&view=c&_ct=1&_acct=C000000593&_version=1&_urlVersion=0&_userid=8303832&md5=55e3d0f54e165f8c4f2281a43b85dc33

Abstract:

In light of debates about the relationship between interests and scientific expert judgments, and the potential for declarations of conflict of interest (COI) to minimize corporate bias, we reviewed the approach to COI in 3 European drug regulatory bodies. These bodies were the Irish Medicines Board, the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency in the European Union. Official statements about COI laws and codes of practice in the 3 contexts suggest that COIs are prohibited. In practice, the approaches to COI in the 3 drug regulatory agencies presuppose and promote the ideas that COIs cannot and need not be eliminated as the risk of bias can be managed. Because the evidence about if and how COI affects micro-level decision-making in drug regulatory authorities is neither complete nor comprehensive, we advocate a precautionary principle model. Under this model COI would be prohibited on the grounds that it might influence the outcome of regulatory decisions.

Keywords:
Ireland; UK; European Union; Conflict of interest; Drug regulation; Risk management