The BioMed Alliance recently responded to a public consultation regarding conflict of interest within the European Medicines Agency (EMA). The consultation published by the EMA follows a recent court of justice ruling due to which EMA along with other EU institutions are now revising their conflict of interest policy. The members of BioMed Alliance recognize the importance of well established rules for managing conflict of interest, but have concerns regarding the revised guidance particularly in the involvement of experts in regulatory processes.
Our specific concerns for the revised draft conflict of interest policy:
- Proportionality: While clear conflicts of interest must be avoided, it’s essential to prioritize involving top scientific experts.
- Managing conflict on interest in research organisations: the definition of research organisation remains board in the revised guidance and needs further clarifying. Additionally, the revised guidance suggests that certain research organization units involved in developing or manufacturing medicinal products or medical devices could be treated like pharmaceutical or medical device companies. Given the essential role of in-house devices, especially in rare diseases where experts often develop ATMPs or devices due to limited alternatives, a flexible approach with clear guidelines is needed. While managing conflicts of interest, these special circumstances should be considered to avoid excluding key expertise.
- Role of learned societies: learned societies can be valuable partners in identifying experts with specific knowledge. These societies generally have well-established conflict of interest policies, allowing them to account for potential conflicts when recommending experts.
Check out the full consultation response in the attachments below.