【摘要】 目的:从经济学角度对我国孤儿药的研发问题进行分析,为我国孤儿药的发展与政策制定提供建议。方法:利用外部性理论和交易费用理论,分析我国药品企业对孤儿药研发积极性不高的原因,并针对这些原因提出相应的解决办法。结果:孤儿药在我国尚缺乏认定标准,其外部经济性、众多的交易费用以及较大的研发风险都会加重药品企业的经济负担,打击企业研发和生产的积极性。结论:我国药品企业可以对孤儿药实行合作研发的策略,并发挥中医药治疗的传统优势,以减少研发成本。政府应建立并发展孤儿药的制度体系,发挥税收及医保的作用,加速审批,给予医药企业市场独占权,鼓励合作研发。更多还原

【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 external 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.更多还原