How many drugs are repositioned each year in Europe?

Abstract

For two decades, commentators have argued for law and policy reform to incentivise organisations to develop new indications for (already) authorised drugs, an area of drug development known as ‘repositioning’. In short, they argue that hurdles in patent and pharmaceutical law hinder repositioning and, therefore, reform is required to increase its use. Yet, these arguments are made primarily on anecdotes; the empirical evidence is scant. One foundational question is how many drugs are repositioned each year in Europe. This study develops a method to examine the number authorised each year. The results show a marked increase in repositioning over the last 3 years, and that the number per year is comparable, though slightly fewer than, the number of new compounds, indicating modest to higher‐than‐expected activity. This study considers what the results mean for four suggested reform options, including the EU Commission's recent proposal. We conclude that the reforms may not achieve their goals or that further evidence is required before we can know whether they will be effective. Lastly, this paper explains how the method and data in this study could serve as a benchmark for evaluating the success of future reforms.