文章基本信息

标题：Making Sure That Orphan Incentives Tip the Right Way in Europe
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作者：Denis Horgan ; Jasmina Koeva-Balabanova ; Ettore Capoluongo 等
期刊名称：Healthcare
电子版ISSN：2227-9032
出版年度：2022
卷号：10
期号：9
DOI：10.3390/healthcare10091600
语种：English
出版社：MDPI Publishing
摘要：The delicate balance of funding research and development of treatments for rare disease is only imperfectly achieved in Europe, and even the current provisional equilibrium is under a new threat from well-intentioned policy changes now in prospect that could—in addition to the intrinsic complexities of research—reduce the incentives on which commercial activity in this area is dependent. The European Union review of its pharmaceutical legislation, for which proposals are scheduled to appear before the end of 2022, envisages adjusting the decade-old incentives to meet objectives that are more precisely targeted. However, researchers, physicians, patients and industry have expressed concerns that ill-considered modifications could have unintended consequences in disrupting the current balance and could reduce rather than increase the flow of innovative treatments for rare diseases.
关键词：enorphan medicinesdrug developmentpharmaceutical strategypolicy frameworkregulationrare diseasespatientsEU regulationincentives