Position Paper

EBE and EFPIA call on the EU Commission and Member States to improve transparency on Hospital Exemptions for Advanced Therapies

10 Oct 2017

“Therapies for the future – Exploring solutions for innovative treatments in Europe” will take place at the European Parliament [1] on 11 October 2017. In advance of this significant discussion, – and in a joint position on Hospital Exemptions for Advanced Therapy Medicinal Products (ATMPs) released today – the European Biopharmaceutical Enterprises (EBE), and the European Federation of Pharmaceutical Industries and Associations (EFPIA), call for greater transparency to boost patient safety and increase access to much needed therapies.

Generally, advanced therapies require a centralised EU marketing authorisation, unless they fall under the exemption – also called hospital exemption (HE) – provided for in Article 28 (2) of the Advanced Therapy Medicinal Product RegulationRegulation[2]. Here, under certain specified conditions, EU Member States may issue national authorisations. It is then left to the Member States to refine HE requirements within their national legal frameworks and the approach has led to divergence in the way the HE has been interpreted and implemented across the EU.

This divergence has created parallel paths to market access for ATMPs, resulting in uncertainty, barriers to patient access, lack of transparency on available therapies, and reduced incentives for developing ATMPs in the EU.

EBE and EFPIA call on the European Commission to improve patient safety and access to these effective ATMPs via two actions:
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 ten 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 intransparency has evolved 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.”

About EBE
The European Biopharmaceutical Enterprises (EBE) represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA). Established in 2000, EBE is recognised as the leading biopharmaceutical association in Europe. To learn more about EBE, visit www.ebe-biopharma.org

About EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. To learn more about EFPIA, visit: www.efpia.eu/

Media Contact
Barbara Freischem, Executive Director
European Biopharmaceutical Enterprises – EBE
Tel: +32 2 626 25 64
email: barbara@ebe-biopharma.org

[1] http://www.europarl.europa.eu/stoa/cms/cache/offonce/home/workshops/therapies;jsessionid=99414B45AE03514755445ACEA2CE4DB6
[2] Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products