Skip to main content

Research Repository

Advanced Search

EU Marketing Authorisation of Orphan Medicinal Products and Its Impact on Related Research

Gerke, Sara; Pattinson, Shaun D.

EU Marketing Authorisation of Orphan Medicinal Products and Its Impact on Related Research Thumbnail


Authors

Sara Gerke



Abstract

Over the last 15 years, there has been a steady increase in the development of orphan medicinal products (OMPs). This raises an important question: What impact does the EU marketing authorisation of an OMP have on related research? This article establishes that the key orphan incentive, namely the 10-year market exclusivity provision laid down in Article 8 of the EU Regulation on OMPs (Regulation 141/2000), has a huge potential impact on related research. It is argued that this provision can make it too difficult for researchers/sponsors to attain marketing approval for closely related products. This article advances two proposals to address this problem. First, it argues for new principles for assessing similarity, so as to clarify and narrow the ambit of market exclusivity. Secondly, it argues for improved conditions for a demonstration of ‘clinical superiority’ for similar OMPs.

Citation

Gerke, S., & Pattinson, S. D. (2017). EU Marketing Authorisation of Orphan Medicinal Products and Its Impact on Related Research. European Journal of Health Law, 24(5), 541-564. https://doi.org/10.1163/15718093-12341439

Journal Article Type Article
Acceptance Date Jan 10, 2017
Online Publication Date Feb 9, 2017
Publication Date Feb 9, 2017
Deposit Date Jan 12, 2017
Publicly Available Date Feb 9, 2019
Journal European Journal of Health Law
Print ISSN 0929-0273
Electronic ISSN 1571-8093
Publisher Brill Academic Publishers
Peer Reviewed Peer Reviewed
Volume 24
Issue 5
Pages 541-564
DOI https://doi.org/10.1163/15718093-12341439

Files





You might also like



Downloadable Citations