罕见病药品供应激励措施立法比较研究及其启示  

Comparative study on legislative measures for incentivizing supply of orphan drugs and its implications

作　　者：冯曦 严培 FENG Xi;YAN Pei(School of Health Management,Southern Medical University,Guangzhou 510515,China)

机构地区：[1]南方医科大学,广东广州510515

出　　处：《现代医院》2025年第1期8-14,共7页Modern Hospitals

基　　金：广东省高校哲学社科“公共卫生政策研究与评价”重点实验室(2015WSYS0010)。

摘　　要：罕见病药品因其投资大回报低而长期处于无药可用的困境。为此,美国和欧盟以及亚洲部分国家和地区针对罕见病药品供应制定诸多激励措施(包括财务激励和非财务激励)并取得了较为显著成效。我国针对罕见病药品的供应出台了相应的措施,但较之于欧美等国家和地区显得激励不足。我国应该进一步借鉴域外经验,明确罕见病药品认定标准,采取“二元”激励措施促进罕见病药品的供应,同时也应该在价格监管、风险控制等方面预防罕见病药品供应存在的负面效应。Orphan drugs face the challenge of being unavailable for a long time due to their high investment and low return.In response,the United States,European Union,and some countries and regions in Asia have implemented various incentive measures(including financial and non-financial incentives)for the supply of orphan drugs,achieving significant results.China has also introduced corresponding measures for the supply of orphan drugs,but compared to countries and regions such as Europe and the United States,the incentives are insufficient.China should further learn from international experiences,define criteria for identifying orphan drugs,adopt“dual-track”incentive measures to promote the supply of orphan drugs,and also take preventive measures in price regulation and risk control to mitigate any negative effects associated with the supply of orphan drugs.

关 键 词：罕见病药品 药品可及性 激励措施 比较研究 

分 类 号：D902.0[政治法律—法学理论] R197[政治法律—法学]