@misc{10481/107943,
year = {2025},
month = {10},
url = {https://hdl.handle.net/10481/107943},
abstract = {Introduction: Drug repurposing leverages existing medicines to reduce time and
costs for exploring new therapeutic indications. However, off-patent medicines
do not provide enough private incentives for investment, and prescribing by
active ingredient can be a major barrier. Academics and non-profit sponsors also
face regulatory barriers.
Methods: This study combined a structured literature review with a questionnaire
completed by 25 drug repurposing experts to identify key challenges and policy
solutions across the full lifecycle of off-patent drug repurposing.
Results: Public funding is generally available for the early-stage research, where
opportunities often arise from off-label uses and real-world evidence. However,
limited support for confirmatory clinical trials, combined with the predominance
of academics and non-profit sponsors lacking regulatory objectives, reduces the
likelihood of successful authorisation to below 30%. Policy solutions include
prioritising research into rare diseases and other conditions with unmet health
needs, and call for a more prominent role of governments in public investment
and in reinforcement of public–private partnerships. Substitution in community
pharmacies remains a major challenge, which may be addressed through
indication-based differentiation and enhanced dispensing controls. Some
innovative public intervention mechanisms, such as Social Impact Bonds and
the InterVentional PharmacoEconomics proposal, offer potential, although realworld experience is still limited.
Conclusion: Off-patent drug repurposing faces persistent financial and
regulatory barriers that require a central role from academics and non-profit
sponsors, supported by governmental engagement throughout the lifecycle.
Although steps have been taken in recent years, efforts remain insufficient,
and structural and political barriers continue to hinder broader implementation.},
organization = {European Union’s Horizon Europe (Grant agreement number 101095593 - project HI-PRIX)},
publisher = {Frontiers Media},
keywords = {Drug repurposing},
keywords = {off-patent medicines},
keywords = {Policy solutions},
title = {Overcoming barriers to off-patent drug repurposing: a lifecycle-based policy solutions},
doi = {10.3389/fphar.2025.1670845},
author = {García Díaz, Mario and Epstein, David Mark and Espín, Jaime},
}