LNB News 11/10/2024
Document Information
Issue Date: 11 October 2024
Published Date: 11 October 2024
Jurisdiction(s): European Union
The European Medicines Agency (EMA) has opened a consultation on its draft revised policy regarding the handling of competing interests among scientific committee members and experts (Policy 0044). This revision follows recent Court of Justice rulings in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 and aims to eliminate doubts regarding the objective impartiality of EMA’s assessments. While the EMA has always prohibited individuals currently employed by or holding financial interests in a pharmaceutical company from participating in its activities, the revisions increase and align restrictions across roles and groups for experts with current interests in a product, as well as those with past employment in a pharmaceutical company. Additionally, the revision strengthens handling of competing interests in the medical device industry, introduce new rules to address certain interests in research organisations, and further clarify the use of expert witnesses. Comments on the draft revised policy can be submitted until 10 November 2024.
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