Drug repurposing is attracting growing attention as a strategy to address unmet medical needs by identifying new uses for existing medicines. Against this backdrop, the Reagan-Udall Foundation for the FDA,…
Jake Fairnie12 August 2026
Reshapinginnovatingconnecting Drug repurposing
Strengthening Policy Frameworks to Support Medicines Repurposing
Why Drug Repurposing Matters for Policy-Makers
Drug repurposing has the potential to significantly improve patient access to effective treatments. Its wider applicability allows patients—especially those with rare and ultra‑rare diseases, where no approved therapies may exist—to benefit from existing medicines used in new ways. Repurposing can also offer faster and more cost‑effective development pathways compared with creating entirely new molecules, making it an important opportunity for health systems, regulators, and payers.
What REMEDi4ALL Found
Through a systematic literature review and extensive stakeholder engagement, REMEDi4ALL identified 33 key barriers affecting the successful implementation of drug repurposing. These barriers fall into nine major policy areas, including the perception of off‑patent medicines, the business case for both on‑patent and off‑patent repurposing, challenges for non‑industry‑funded projects, the ecosystem for non‑profit and SME‑driven initiatives, market authorisation pathways, exclusivity rights, and issues related to health technology assessment and pricing (Petykó et al., 2025).
To better understand which obstacles have the greatest real‑world impact, REMEDi4ALL conducted a multi‑stakeholder prioritisation exercise. Policy‑makers, regulators, clinicians, researchers, patient representatives, and industry stakeholders highlighted several high‑priority barriers, particularly those related to pricing and reimbursement, the lack of a viable business case for repurposed medicines, fragmented or insufficient funding, legal hurdles, and regulatory pathways that do not sufficiently support repurposing. These challenges are especially pronounced in rare and paediatric diseases, where existing incentives have not fully translated into sustainable repurposing practices (Gyöngyösi et al., 2026).
What Can Unlock Progress
To improve the drug repurposing ecosystem, REMEDi4ALL identified 19 facilitator mechanisms that can help overcome the major policy barriers limiting the development and uptake of repurposed medicines. These mechanisms fall into two main categories: Push incentives, which reduce the cost, time, and risk of R&D, and Pull incentives, which strengthen the financial and societal return for investors (Inotai et al., 2025).
Push incentives focus on enabling the development process and reducing barriers early in the journey. They include the creation of specific regulatory pathways for repurposed medicines, increased regulatory know‑how, accelerated timelines, and fee reductions or waivers. They also cover options to enable third‑party label extensions, explore complementary evidence‑generation strategies, strengthen education for supply‑side stakeholders, and expand both the types and sources of funding available for repurposing research.
Pull incentives target the later stages of development and market uptake by improving the rewards associated with successful repurposing. Key mechanisms include exclusivity‑type regulatory incentives for repurposed medicines, better monitoring of off‑label use and bringing it on‑label where possible, and appropriate health technology assessment frameworks that reflect the unique characteristics of repurposed medicines. They also include differentiated pricing approaches, reduced costs and timelines for post‑authorisation processes, targeted education for demand‑side stakeholders, compensation or rewards tied to successful R&D, and measures to increase overall demand for repurposed medicines.
REMEDi4ALL Resources for policy-makers
Policy barriers to drug repurposing in Europe: different stakeholder perspectives identified during survey-based shortlisting of key challenges (2026)
Authors: Kristóf Gyöngyösi, Zsuzsanna Ida Petykó, Dalma Hosszú, Pan Pantziarka, Heleen G. van der Meer, Donald C. Lo, Marcell Csanádi, George Dennis Obeng, Zoltán Kaló & András Inotai
Catalogue of Actions to Address Policy Barriers of Drug Repurposing (ISPOR 2025)
Authors: Andras Inotai, Dalma Hosszú, Kristóf Gyöngyösi,, Zsuzsa Reka Pozsar, Menke Winckers, Donald Lo, Pan Pantziarka, , Patricia Vandamme, Helene G. van der Meer, Dunja Huijbers, Raluca Radu, Maria Merkou & Zoltan Kalo
The eyes of the beholder: Perceived barriers to successful drug repurposing (2025)
Authors: Zsuzsanna Ida Petykó, Dalma Hosszú, Marcell Csanádi, Kristóf Gyöngyösi, George Dennis Obeng, David Ameyaw, Tamás István Dóczi, Zoltán Kaló, Donald C. Lo, Helene G. van der Meer, Pan Pantziarka & András Inotai
News & opportunities
REMEDi4ALL and iDR26 features in a RARE Revolution insider piece on “Drug repurposing: translating optimism into action for rare diseases” highlighting discussions at the conference and outlining ongoing hurdles related to realising the full potential of drug repurposing.
tools@teamitresearch.com29 July 2026
Prof. Zoltán Kaló, co-founder of REMEDi4ALL partner organisation Syreon Research Institute, has been appointed Director General of Hungary’s National Health Insurance Fund, taking up a senior leadership position within the newly formed Hungarian Government. Prof….
tools@teamitresearch.com10 July 2026
See more news and opportunities here
DRUG REPURPOSING OPPORTUNITIES
Patients are the driving force behind any repurposing project
If you are a patient representative looking to champion a new repurposing programme, we would like to talk to you. You can contact us here.
Sound scientific hypotheses are the seed to viable repurposing projects
If you have a drug repurposing idea you would like to share with us, please fill in this form. Our multidisciplinary scientific operations team will contact you back to explore onboarding opportunities to support your project no matter what stage of development it is in.
Advancing research policy is critical
Advancing research policy is critical to facilitate equitable access to repurposed medicines and contribute to make health systems more sustainable.
REMEDi4ALL offers a unique opportunity for funders
REMEDi4ALL offers a unique opportunity for funders to collaborate and support research with a high potential to translate into real solutions for patients and contribute to the sustainability of healthcare systems.
Repurposing
drugs as the
new normal
Developing a new medicine is a complex endeavour with uncertain outcomes. There is a growing interest among patients, clinicians and researchers to explore the potential use of existing medicines to address areas of unmet medical needs. REMEDi4ALL will bring together these entrepreneurs to create an ecosystem
where new connections can be established to test and validate existing medicines for a new purpose focusing attention on the critical steps of development. Ultimately, by involving the right experts at the right time, unlocking innovative tools to exploit existing data and generating a compliant incentivised process will allow for medicines repurposing to benefit those in need.
REMEDi4ALL Partners & Associated partners
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