Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity
Authors
Liddicoat, Johnathon
Liddell, Kathleen
Aboy, Mateo
Wested, Jakob
Publication Date
2021-07-20Journal Title
IIC - International Review of Intellectual Property and Competition Law
ISSN
0018-9855
Publisher
Springer Berlin Heidelberg
Volume
52
Issue
7
Pages
825-851
Language
en
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
Liddicoat, J., Liddell, K., Aboy, M., & Wested, J. (2021). Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity. IIC - International Review of Intellectual Property and Competition Law, 52 (7), 825-851. https://doi.org/10.1007/s40319-021-01088-0
Description
Funder: University of Cambridge
Abstract
Abstract: EU law incentivises drug marketing authorisation holders (MAHs) to find new uses for their compounds (research known as “repositioning”) by offering them an extra year of market protection if the new use is authorised. This extra year, known as the “+1”, was enacted on limited evidence, and no study has examined its effect since it began. Yet, several leading commentators suggest lengthening the +1. This study assesses the effectiveness of the +1 by analysing all the relevant instances of MAHs repositioning their drugs before and after the +1 came into effect. The results show that: (i) 42.2% of MAHs repositioned their drugs before the +1 came into effect, and (ii) once the +1 did come into effect, it did not increase the percentage of MAHs that repositioned their drugs. This study finds that the +1 failed to increase repositioning and then proceeds to consider reform options, including repealing the law. In doing so, this study takes the first steps towards an evidence-based policy for the topic.
Keywords
Article, Drug repositioning, Regulatory exclusivities, Patents, Empirical study, Intellectual property
Identifiers
s40319-021-01088-0, 1088
External DOI: https://doi.org/10.1007/s40319-021-01088-0
This record's URL: https://www.repository.cam.ac.uk/handle/1810/326913
Rights
Licence:
http://creativecommons.org/licenses/by/4.0/
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