Revising EU pharmaceutical legislation: will it foster drug repurposing?

Area of Science:

• Pharmaceutical policy
• Drug discovery and development

Background:

• Off-patent drug repurposing presents a viable avenue for affordable treatments targeting unmet medical needs.
• The European Union (EU) has introduced new pharmaceutical legislation with provisions for drug repurposing.

Purpose of the Study:

• To analyze the proposed EU pharmaceutical legislation concerning drug repurposing.
• To identify barriers faced by academic and not-for-profit entities in utilizing these new repurposing incentives.
• To propose recommendations for strengthening drug repurposing initiatives within the EU.

Main Methods:

• Review of proposed European Union pharmaceutical legislation.
• Analysis of identified barriers for academic and not-for-profit stakeholders.
• Formulation of recommendations for policy enhancement.

Main Results:

• The proposed EU legislation presents challenges for academic and not-for-profit drug repurposing stakeholders.
• Key barriers include limited knowledge of regulatory processes, pharmacovigilance requirements, and data protection constraints.
• The legislation's potential is hindered by these obstacles.

Conclusions:

• The EU legislation requires strengthening to effectively support not-for-profit drug repurposers.
• Additional scientific, regulatory, and health technology assessment (HTA) support is crucial.
• Establishing fair data protection periods and pricing policies is essential for successful implementation.
• A comprehensive EU drug repurposing strategy is needed to foster the repurposing of various drug types.