Drug Repurposing of Generic Drugs: Challenges and the Potential Role for Government

Karel H. Pol, Mohamad Aljofan, Olivier Blin, Jan H. Cornel, Gerard A. Rongen (), Aurélie-Gaëlle Woestelandt and Michael Spedding
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Karel H. Pol: Radboud University Medical Center
Mohamad Aljofan: Nazarbayev University School of Medicine
Olivier Blin: Aix Marseille Université, Inserm UMR 1106
Jan H. Cornel: Radboud University Medical Center
Gerard A. Rongen: Radboud University Medical Center
Aurélie-Gaëlle Woestelandt: Spedding Research Solutions SAS
Michael Spedding: Spedding Research Solutions SAS

Applied Health Economics and Health Policy, 2023, vol. 21, issue 6, No 2, 840 pages

Abstract: Abstract Drug repurposing is the process of identifying a new use for an existing drug or active substance in an indication outside the scope of the original indication. Drug repurposing has important advantages including reduced development time and costs, and potentially large societal healthcare cost savings. However, current generic drug repurposing research faces a number of challenges in obtaining research funds. Furthermore, regardless of the success of a repurposing trial, commercial parties often lack interest in pursuing marketing authorisation for financial reasons, and academic researchers lack the knowledge, time and funding. Therefore, the new indication of a repurposed drug often does not make it ‘on label’. We propose a large increase in public funding for generic drug repurposing research, including funds for the marketing authorisation process when a trial is successful, and a reduction in the regulatory burden of the marketing authorisation process for repurposed generic drugs.

Date: 2023
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DOI: 10.1007/s40258-023-00816-6

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