The European Biopharmaceutical Enterprises (EBE) and European Federation of Pharmaceutical Industries and Associations (EFPIA) have issued a statement calling on the European Commission (EC) to improve transparency on hospital exemptions for advanced therapies.
Call to action
In general, advanced therapies are required to have a centralised EU marketing authorisation unless they fall under hospital exemption — when under special circumstances EU member states may issue national authorisations. As it is left to each separate member state to refine the exemption requirements within their own legal frameworks there has been a divergence as to how exemptions have been interpreted and implemented across Europe.
These variances have created parallel paths to market access for certain advanced therapies, which has resulted in uncertainty and barriers to patient access as well as a lack of transparency on what advanced therapies are available. This, in turn, has led to a reduced incentive for companies to develop advanced therapies in the EU.
In their joint position, the EBE and EFPIA have outlined two action points for the EC to improve patient safety and access to advanced therapies:
1. Developing a ‘best practice guide’ on the national implementation of hospital exemptions for ATMPs.
2. With the support of national competent authorities, develop a register of all ATMPs made available under HE.
“Nearly 10 years after the publication of the legal framework for advanced therapies that has provided much needed regulatory certainty the time has come to consider effective tweaks to those areas in which transparency has reduced and led to barriers to patient access and safety,” said Barbara Freischem, executive director of EBE. “We look forward to working with the Commission and member states to improve transparency on advanced therapies, including hospital exempted products.”