“It is critically important to have in place an appropriate mechanism for making sure the rights of the owners of the information are well protected,” says Colin Mackay, director of communication and partnerships at the European Federation of Pharmaceutical Industries and Associations. In the US, the Food and Drug Administration (FDA) is also moving to achieve even more extensive transparency goals (Box 1). In all, the FDA is considering 21 draft proposals for changes in policy related to the disclosure of information in its possession. FDA “currently has teams working to assess the merits of each proposal,” says Joshua Sharfstein, previous chair of the transparency task force at FDA and currently principal deputy commissioner. Like EMA, FDA will continue to “support the redaction of trade secrets and individually identifiable patient information from all documents proposed for disclosure.”
“The crucial issue is how EMA will interpret commercial-in-confidence information,” says Beate Wieseler, deputy head of the department of drug assessment at the Institute for Quality and Efficiency in Healthcare (IQWiG) in Cologne, Germany. IQWiG is an independent technology assessment agency established by the federal government in 2004 that provides evidence-based evaluations of medical services to the statutory healthcare system.
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