基于制度移植视角对我国孤儿药管理制度构建研究

Study of Construction of Orphan Drug Management Systems Based on the Angle of System Transplantation

目的:构建符合我国国情的孤儿药管理制度,促进孤儿药的生产与供给。方法:基于制度移植理论,运用文献研究法对美国、欧盟、日本的孤儿药管理制度的主要内容和制度特色进行比较和分析。结果:在孤儿药的管理上,美国、欧盟和日本在制度设计中均涉及诸多激励措施,给孤儿药的研发和上市带来积极影响。结论:推动制度供给外生变量,制定孤儿药管理的法律法规,成立孤儿药认证和管理机构,完善医保制度等配套制度。

To build orphan drug management that is suited to our country, to promote product and supply of orphan drugs. Methods Based on the theory of system transplantation, the main content and characteristics of orphan drug management system of the United States, the European Union and Japan are compared and analyzed using the method of literature research. Result On the management of orphan drugs, the European Union and Japan have clear laws and regulations. The design of systems is in- volved in many incentives which have positive impacts on the R＆D and market launch of orphan drugs. Conclusion Related gov- ernment departments in China should promote the exogenous variable of system supplies. The laws and regulations of orphan drug management should be made and certification authority and administration agency of orphan drug management should be set up, at the same time, we should complete matched systems such as medical insurance system.