HAI Europe members Dr. Orla O’Donovan and Dr. Joel Lexchin published the article ‘Prohibiting or ‘managing’ conflicts of interest (COI)? A review of policies and procedures in three European medicines regulation agencies’ in Social Science & Medicine (2010).
The authors conclude that drug regulatory agencies, including the European Medicine Agency,
“…presuppose and promote the ideas that COIs cannot and need not be eliminated as the risk of bias can be managed. …Given that much available evidence implies that commercial interests bias regulatory science, we advocate an alternative normative approach based on the precautionary principle.” Continue reading article…
Conflicts of interest among drug regulators could potentially have harmful health consequences. Under the precautionary principle, such conflicts should be prohibited as they might negatively influence the outcome of regulatory decisions.
This policy review, coupled with the recent discovery of misleading and/or incomplete Declaration of Interest statements made by corporate-sponsored patient organisations sitting on European Medicines Agency committees, highlights the immanent need for a rigorous review and exclusion of conflicts of interest within the Agency.