2025-08-19
A new EU study reviews how hospital exemptions for ATMPs are applied across member states, highlighting variations, challenges, and opportunities for patients and developers.
The European Health and Digital Executive Agency (HaDEA) has released a comprehensive report on the use of hospital exemptions (HE) for Advanced Therapy Medicinal Products (ATMPs) across EU member states. Hospital exemption allows certain ATMPs to be used in patients without full EU marketing authorisation, provided they are prepared on a non-routine basis, follow quality standards, and are used under the responsibility of a medical practitioner.
The study highlights considerable differences in how hospital exemptions are regulated, implemented, and monitored across member states. Variations exist in:
Definitions and scope of hospital exemptions
Approval and oversight procedures
Data collection and transparency regarding patient outcomes
Interaction with marketing authorisation frameworks
These differences can affect both patient access and the ability to compare outcomes across countries.
For ATMP developers, the report notes that hospital exemptions can play a dual role. On one hand, they provide early patient access to promising therapies where no alternatives exist. On the other hand, inconsistent regulation and limited data-sharing may create uncertainty, especially when scaling products from hospital use to broader clinical development.
In Sweden, hospital exemption has been used to provide access to ATMPs under controlled conditions. The report identifies variation in practices across Nordic countries, underscoring the need for harmonised approaches to enable collaboration and patient access across borders. This is particularly relevant as Sweden aims to strengthen its position in the global ATMP field by 2030.
The study concludes that harmonisation of hospital exemption practices would benefit both patients and developers. Suggested steps include:
Improved transparency and data collection
Closer alignment with EU marketing authorisation processes
Strengthened oversight mechanisms
Encouragement of cross-border collaboration, especially in rare diseases where patient numbers are limited
Hospital exemptions remain a vital mechanism to deliver innovative therapies to patients who may not otherwise have access. However, clearer rules and more consistent implementation across Europe will be critical to ensuring safety, effectiveness, and equitable access.