美国罕用药市场的激励机制及其启示

摘要

Serious market failure, as a result of insufficient incentive, exists in the orphan drugs market. Through legislation, the United States designed and established its owns systematic and linked orphan drugs incentive mechanism, which direct sat research, definition, clinical trials and approval of orphan drugs, so as to change the supply and demand status of orphan drugs. Such incentive mechanism erables the United States possess the most ap-proved orphan drugs in the world, and effectively relieves the problem of market failure of the orphan drugs. The ex-perience of the United States provides beneficial reference for the establishment and positive development of orphan drugs incentive mechanism in China.%罕用药市场因为激励不足存在严重失灵的问题。美国通过立法，针对罕用药的研发、认定、临床试验直至上市等各个环节，设计和建立了自成体系。联动共进的罕用药激励机制，改变了罕用药的供给和需求状况，使美国成为世界上罕用药上市最多的国家，有效缓解了罕用药市场失灵的问题。美国的经验为我国罕用药市场激励机制的建立和良性发展提供了有益的借鉴。