Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries

Author(s):
Coppens, D.G.M.; Gardarsdottir, H.; Bruin, M.L. de; Meij, P.; Leufkens, H.G.M.; Hoekman, J.
Published
2020
Publication type
Article / Letter to editor

Abstract

Aim: To study regulatory approaches for the implementation and utilization of the Hospital Exemption (HE) in nine EU countries. Materials & methods: Using public regulatory documentation and interviews with authorities we characterized the national implementation process of the HE, including national implementation characteristics and two outcomes: national licensing provisions and the amount of license holders. Results: National licensing provisions vary substantially among selected countries as a result of different regulatory considerations that relate to unmet medical needs, benefit/risk balance, and innovation. The amount of license holders per country is moderate (0-11). Conclusion: The HE facilitates HE utilization in clinical practice in some countries, yet safeguarding of public health and incentivizing commercial development is challenging.

advanced therapy medicinal productclinical practicecommercial developmentdrug regulatory sciencehospital exemptionimplementation processlicense holdersnational licensing provisions
Date issued
2020-11-05
Language
English
Publisher
FUTURE MEDICINE LTD
Is part of
Regenerative Medicine
hdl
1887/3182146
doi
10.2217/rme-2020-0008