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

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.