Position Paper on Unmet Medical Needs: A Call for a Patient-Centric Definition
Publication format: Position Paper
Year: 2025
Topic: Advocacy, Health Systems & Care Delivery, Policy & Regulation
Language: English
This Position Paper, published by Cancer Patients Europe in September 2025 and co-endorsed by eleven European health and patient organisations, responds to the ongoing EU pharmaceutical legislation trilogue. It critically analyses the European Commission, Council, and Parliament’s proposed definitions of Unmet Medical Need (UMN), arguing that all current proposals risk being too narrow or restrictive for cancer patients. CPE proposes its own patient-centric, flexible UMN definition that captures both breakthrough and incremental innovation, incorporating morbidity, quality of life, and patient experience as qualifying criteria.