An assessment of the Commission’s criteria to define unmet medical need and high unmet medical need

In April 2023, the European Commission (EC) proposed definitions for unmet medical need (UMN) and high unmet medical need (HUMN) as part of the revised pharmaceutical legislation. In order to understand the potential impact of such new definitions on the European research & development landscape, Exon Consultancy assessed the criteria of the proposed definitions.

We investigated the methodology applied to the analysis of UMN and HUMN definitions, highlighted product examples that likely fail to meet the criteria of the EC and explored how the Commission’s criteria might impact hypothetical products from several disease areas. We identified several challenges, documented in a report for EFPIA stakeholders, which calls for the creation of policies that better achieve their intended objectives and effectively address patient needs.

More information about the project can be found here.

Client:
EFPIA

Date of completion:
2023