The European Commission’s long-awaited study on the Hospital Exemption (HE) is finally out. It’s the first in-depth, EU-wide look at how this pathway is applied across Member States and what this means in practice.
The Hospital Exemption is a unique regulatory pathway that allows certain ATMPs to be prepared on a non-routine basis and used within the same Member State in a hospital setting. Its purpose: to give patients access to innovative therapies when no authorised alternative exists, while safeguarding quality, safety, and traceability.
General takeaways from this study:
- Transparency: Until now, there has been little publicly available data on how the HE is applied across Europe. This study offers a clear overview of national frameworks, numbers of HE products, and therapeutic areas.
- Harmonisation needs: The findings highlight major differences in interpretation and application of the HE between countries, which can lead to unequal patient access.
- Policy relevance: With the revision of the EU pharmaceutical legislation underway, this study provides critical evidence for discussions on the future role of the HE in Europe’s ATMP landscape.
- Impact on innovation: The report also examines the role of the HE in supporting early clinical use and development of ATMPs, and its relationship to the centralised marketing authorisation pathway.
