ABSTRACT
OBJECTIVE:To analyze the research and development (R&D) of orphan drug in China from the respect of economics,and to provide suggestions for the development and policy formulation of orphan drug in China.METHODS:The theories of external economy and transaction costs were adopted to analyze the reasons about no enthusiasm in orphan drug R&D,and find some appropriate solutions for them.RESULTS:Orphan drug was still lack of identification standard in China.The extemal economy,much of transaction costs in orphan drug and R&D risk aggravated the economic burden on pharmaceutical enterprises,combated R&D and production enthusiasm of pharmaceutical enterprises.CONCLUSIONS:Chinese pharmaceutical enterprises can take part in orphan drug cooperative R&D,and play the advantage of TCM treatment so as to reduce R&D cost.The government should establish and develop orphan drug system,play the role of taxation and health insurance,accelerate approval,give market exclusivity for pharmaceutical enterprises and encourage cooperative R&D.