ABSTRACT

In 2000, the European Union introduced orphan medicine legislation to support individuals with serious, rare diseases that currently lack effective treatments. As a result of the European Commission designating numerous medications as orphans based on favourable recommendations, several orphan medications have since been licensed for the European market. This study examined whether the market exclusivity incentive under the European Orphan Drug Regulation creates a monopoly or if other factors, such as market size or time, influence the difficulty of finding treatments for the same rare ailment. Further investigation is needed to understand the influence of market exclusivity on the development of follow-on OMPs, benefiting patients with rare diseases. The research indicates that factors like time and market size are more significant in explaining the lack of additional OMPs than the market exclusivity incentive's potential to create a monopoly. With public funding, the current system should be restructured to find more effective ways of encouraging the development of durable and effective medicines for those with orphan diseases. Keywords: European Orphan Drug Regulation, European Orphan Drug Regulation, Licensed medications, Serious, rare diseases, Market exclusivity incentive, Orphan medicine legislation
Publication date: 01/10/2025

https://ijbpas.com/pdf/2025/October/MS_IJBPAS_2025_9541.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.10.9541