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RSNN Expert Meeting Report: Addressing the framework of unmet medical need
The RSNN Expert Meeting "Addressing the framework of unmet medical need" took place on Tuesday 23 April 2024. A group of 19 experts from both private and public organisations, including regulators and HTA experts, representatives from pharmaceutical companies, researchers and practitioners from teaching hospitals met to discuss the proposed definition of unmet medical need (UMN) from different perspectives.
During the expert meeting several predefined questions were discussed regarding the definition of UMN in the European Commission's (EC) proposal for a new Directive and Regulation revising and replacing the existing pharmaceutical legislation.
The conclusion of the expert meeting was that the current EC’s proposed definition of UMN may not be fit for purpose for future therapies. The reasons for this potential shortfall are twofold: conceptual, as the proposed definition is disease-a specific, while operationalisation requires substantial disease-specific knowledge (that may sometimes be incomplete/lacking); and operational, as it proves to be challenging to produce evidence justifying UMN status and lack of expected future benefits.
The full meeting report is available for download here: link.
The report will be also be communicated to the Dutch Ministry of Health, Welfare and Sport as input towards the discussions currently taking place at the Council on (H)UMN.