Scholte Mirre, Grimm Sabine E, Pauly Bianca, Verbeeck Frank, Pasmooij Anna M G, Bouma Barend, van Duijn-Wiersma Jorika, Guney Emre, Kesselheim Aaron S, Schmidt Harald H H W, Joore Manuela A
Department of Clinical Epidemiology & Medical Technology Assessment (KEMTA), Maastricht University Medical Centre, Maastricht, the Netherlands; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; Departments of IQ Health and Radiology, Radboudumc, Nijmegen, the Netherlands; REPO4EU consortium.
Department of Clinical Epidemiology & Medical Technology Assessment (KEMTA), Maastricht University Medical Centre, Maastricht, the Netherlands; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; REPO4EU consortium.
Drug Discov Today. 2025 Jan;30(1):104286. doi: 10.1016/j.drudis.2024.104286. Epub 2025 Jan 3.
Repurposing off-patent drugs can be a potential source of low-cost treatments for patients with unmet medical needs. Here, we review the proposed new European Union (EU) pharmaceutical legislation in which two articles address drug repurposing. We find certain barriers hindering the adoption of these new incentives by academic and not-for-profit stakeholders, including lack of knowledge on regulatory aspects, pharmacovigilance, and restrictions in data protection. To further empower the intended stakeholders of the legislation, these initiatives can be strengthened by creating additional scientific, regulatory, and health technology assessment (HTA) support for not-for-profit repurposers, and by determining fair data protection periods and pricing policies. To support drug repurposing, Europe should work toward a comprehensive drug-repurposing strategy that fosters the repurposing of generic, shelved, and protected drugs.
重新利用已过专利保护期的药物可能是满足未得到满足的医疗需求患者的低成本治疗方法的潜在来源。在此，我们回顾了欧盟拟议的新药品立法，其中有两条条款涉及药物重新利用。我们发现一些障碍阻碍了学术和非营利利益相关者采用这些新激励措施，包括对监管方面、药物警戒以及数据保护限制缺乏了解。为了进一步增强该立法目标利益相关者的能力，可以通过为非营利性重新利用者提供更多科学、监管和卫生技术评估（HTA）支持，以及确定公平的数据保护期和定价政策来加强这些举措。为支持药物重新利用，欧洲应朝着全面的药物重新利用战略努力，该战略促进通用药物、搁置药物和受保护药物的重新利用。
