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Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity

Accepted version
Peer-reviewed

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Type

Article

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Authors

Liddell, K 
Aboy, M 
Wested, J 

Abstract

jats:titleAbstract</jats:title>jats:pEU 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 jats:italicnot</jats:italic> 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.</jats:p>

Description

Keywords

Drug repositioning, Regulatory exclusivities, Patents, Empirical study, Intellectual property

Journal Title

IIC International Review of Intellectual Property and Competition Law

Conference Name

Journal ISSN

0018-9855
2195-0237

Volume Title

52

Publisher

Springer Science and Business Media LLC

Rights

All rights reserved
Sponsorship
Novo Nordisk Foundation (via University of Copenhagen) (NNF17SA0027784)
This work was supported, in part, by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme in Biomedical Innovation Law (grant agreement number NNF17SA0027784).