In a transformative moment for pharmaceutical regulation within the European Union, the European Patients’ Forum (EPF) calls to redefine what we mean by “unmet medical need.” This critical definition goes beyond the realm of research and development, reaching deep into the core of regulatory data protection, conditional marketing authorisations, and scientific support.
Patient organisations represented by EPF are coming together to advocate for more extensive patient involvement in shaping this pivotal definition and improving the proposed Commission’s decision. The primary goal is to distinguish innovative medicines that truly enhance patients’ lives from other new pharmaceutical products.
EPF’s proposed framework recognises that the concept of “unmet medical need” should go beyond immediate therapeutic requirements and encompass the broader societal and patient-centric perspective. Chronic diseases, though not all life-threatening, represent a mjor burden on patients, caregivers, and healthcare systems. It’s not just about mortality or morbidity; it’s about the impact on patients’ daily lives and their overall quality of life.