Advancing repurposing policy through multi-sectoral collaboration

<p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="first" dir="auto" id="d25383108e87">Drug repurposing holds immense potential for delivering timely and cost-effective therapies, particularly in areas of high unmet medical need. Yet, despite its promise, repurposing remains hindered by fragmented incentives, regulatory ambiguity, and underutilised collaborative potential across sectors. This presentation—grounded in the ongoing REMEDi4ALL initiative—will explore how a concerted, policy-driven, multi-stakeholder approach can unlock the full value of repurposing strategies. <p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" dir="auto" id="d25383108e89">Systemic barriers such as the on-label vs off-label dichotomy, the limitations of current marketing authorisation frameworks, and the challenges in intellectual property and data exclusivity are reviewed. The role of key stakeholders—including academic researchers, funders, regulators, EFPIA, patient organisations, clinicians, and payers—will be considered as part of a dynamic, interdependent ecosystem. Emerging opportunities including the critical role of emerging frameworks such as the EU Pharma Legislation revision, the STAMP repurposing framework, and the REMEDi4ALL Policy Board in shaping a more enabling environment will be highlighted. <p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" dir="auto" id="d25383108e91">The repurposing ecosystem requires new incentive models: publication metrics must give way to broader impact indicators such as regulatory milestones and translational readiness. The presentation will advocate for stronger public-private partnerships, innovative funding mechanisms, and smarter risk-sharing approaches that elevate both generic and originator-driven repurposing. <p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" dir="auto" id="d25383108e93">Ultimately, international alignment and knowledge exchange are essential to bridging the valley of death in translational research. This session aims to catalyse discussion on a sustainable, integrated approach to repurposing—one that is not theoretical, but already underway.