4_Pharma as Political Player - Abraham

4_Pharma as Political Player - Abraham - MEDICINES,...

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For personal use. Only reproduce with permission from The Lancet Publishing Group. MEDICINES, SOCIETY, AND INDUSTRY II THE LANCET • Vol 360 • November 9, 2002 • www.thelancet.com 1501 The industry has achieved a similar situation in many countries, including Finland, France, Germany, and the Netherlands, where secrecy in drug regulation remains extensive; 55–58 even many individual regulators and industrial scientists accept that secrecy undermines public health and scientific understanding of drug safety. 59 In the EU, some advances have been made in provision of discretionary drug regulatory information by the CPMP, in the form of post-approval summary bases of approval, known as European public assessment reports. Since 2001, summaries of positive and negative CPMP opinions have been published at the Committee’s discretion. 60 However, public access to drug regulatory information beyond this level is prohibited if disclosure “could undermine the protection of commercial and industrial secrecy” or if “confidentiality [is] requested by the source of the information or required by legislation of the member state supplying that information”. 61 The much greater rights of public access to regulatory information in the USA suggest that the cloak of secrecy surrounding European drug regulatory processes could be lifted without disastrous effects on the pharmaceutical industry. For further discussion of the accountability of the pharmaceutical industry, see paper in this series by Dukes, to be published in The Lancet on Nov 23. Concluding remarks The present drug regulatory systems are insufficiently robust in their political relations with the pharmaceutical industry, because they prevent proper public accountability, are highly vulnerable to industrial capture, and permit the industry’s scientific experts to have extensive conflicts of interest while providing their expert advice. A regulatory system capable of delivery
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