9 September, 2025
As negotiations on EU pharmaceutical legislation reforms continue, the Biomedical Alliance in Europe (BioMed Alliance) has released a statement calling for an agreement that improves access to medicines, responds to unmet medical needs and the needs of patient groups, whilst continuing to foster European innovation in biomedical research.
The key issues highlighted by the statement include:
- Clarification on the definition of unmet medical needs to include quality of life and patient-reported outcomes.
- The revisions will mark one of the most extensive reforms to this legislation in over two decades.
- Addressing medicine shortages through stronger prevention plans and notification requirements.
- Improve access to treatments and address unmet medical needs by supporting the repurpose of medicines.
- Funding transparency is key to ensure affordability and fair pricing of medicines.
- Expanding the role of the Health Emergency Preparedness and Response Authority (HERA).
- Safeguarding paediatric medicines by prioritising long-term patient outcomes.
- Improvements to overall access to medicines for European patients.
BioMed Alliance is a unique initiative of leading European medical societies, including the European Respiratory Society (ERS).