国外罕用药创新激励制度及对我国的启示

罕用药由于具有经济性差、研发过程困难大、流通过程中对制药企业要求较高的特点，制药企业生产、研发这一类药品较少。为了解决这一困境，美国、欧盟、日本等国家和地区颁布实施了相应的罕用药创新激励制度。本文主要梳理了这3个国家和地区的罕用药制度，为我国罕用药制度的建立提供了参考和建议。

The inspiration of the foreign innovation incentive system for orphan drug and its implication for China

Orphan drug is rarely produced by pharmaceutical companies due to its poor economy and great dififculties in R＆D and distribution process. In order to solve this predicament, some developed countries and areas, such as the United States, European Union and Japan, have implemented corresponding innovation incentive systems for the orphan drug. The systems related to orphan drug in these three countries and areas were presented in this paper so as to provide references and suggestions for the establishment of orphan drug system in China.