From Barriers to Solution Pathways: Drug Repurposing’s Path Forward for Off-Patent Drugs

Abstract

Background: Drug repurposing (DR) refers to the practice of identifying new uses for existing drugs. This practice has the potential to provide a faster and less costly alternative to traditional de novo drug development. Despite the advantages, the adoption of DR by product developers is limited.

Objective: The aim of this study was to identify the barriers and possible solution pathways for the repurposing of off-patent drugs, primarily within the context of the Dutch healthcare system.

Method: Qualitative semi-structured interviews were conducted with a diverse group of stakeholders (e.g., experts in the field of drug regulation, health technology assessment, the pharmaceutical industry, clinical practice, and academic research) in the Netherlands between July 2023 and October 2023. Thematic analysis was used, building on verbatim transcripts.

Results: Eleven stakeholders were interviewed. In general, interviewees emphasized the necessity for effective methods, strategies, and incentives to overcome overarching challenge that was identified: the lack of an adequate business case for product developers to invest in the repurposing of off-patent drugs. Significant barriers that were identified include costs and complexities of research, limited additional data exclusivity and market protection granted to marketing authorization holders, and limited outpatient reimbursement across various European member states for off-patent repurposed drugs. Identified potential solution pathways include facilitating partnerships between academia and industry, modifying fee structures for regulatory procedures, prolonging market and data exclusivity periods, intensifying the enforcement of second-medical use patents, and revising pricing and reimbursement models for off-patent repurposed drugs.

Conclusion: The overarching challenge is the lack of an adequate business case for product developers to invest in the repurposing of off-patent drugs, due to multiple barriers across the different themes. Addressing the barriers requires a holistic approach that includes regulatory adjustments, financial incentives, and collaboration among key stakeholders. Implementing the identified solution pathways could improve the business case for the repurposing of off-patent drugs