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Reshapinginnovatingconnecting Drug repurposing

Enabling Access to Repurposed Medicines Through Better Policies

Successful drug repurposing relies on a regulatory environment that enables and supports the complete repurposing journey. The aim of REMEDi4ALL is to bring repurposed drugs into use as standard of care medicines accessible to all patients. Therefore, the Consortium is working on policy issues that can help shape the regulatory environment in a way that benefits patients, developers, regulators, and payers together.

Drug repurposing as the new normal | Remedi4all

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.

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.

 

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.
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

The eyes of the beholder: Perceived barriers to successful drug repurposing

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

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

Drug repurposing as the new normal | Remedi4all

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.

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