摘要
目的:为构建和完善我国的罕用药研发激励政策提供参考和建议。方法:从罕用药的立法沿革、研发罕用药的激励措施与效果方面对美国和欧盟的罕用药研发激励政策进行对比,并为我国完善相关政策提供建议。结果与结论:美国与欧盟的罕用药激励政策分别始于1983年美国《罕用药法案》与1999年欧盟《罕用药管理规范》,之后通过不断完善,形成了较为完备的体系。美国与欧盟在罕用药的认定标准、认定程序、具体激励措施(研发资助、税收减免、费用减免、微型与中小企业额外激励、市场独占、特殊审批程序)等方面有所差异,如在费用减免方面,美国对处方申请费用、生产费用和药物确认费用进行减免,而欧盟对协议帮助费用、初始和后续要求费用,审批前的检查费用和首次上市申请费用依类型按一定比例进行减免。罕用药激励政策推行后,其资格认定数量及上市数量大幅增加、微型与中小型企业成为罕用药研发的生力军、研发投资涵盖各类疾病治疗领域、罕用药研发成为药物创新和生物技术发展的主要方向。我国应该尽快确定罕用药研发激励的相关立法、设立罕用药的资格认定、从多方面入手完善罕用药研发激励具体措施,同时加强与其他国家在罕用药资格认定和研发激励方面的合作。
OBJECTIVE： To provide references and suggestions for building and improving the R＆D incentive policies for or- phan drugs in China. METHODS： The R＆D incentive policies for orphan drugs in USA and the EU were compared in aspects of its legislative history, incentive measures and effects. And suggestions for improving related policies in China were put forward. RE- SULTS ＆ CONCLUSIONS： The R＆D incentive policies for orphan drugs in USA and the EU respectively started from Orphan Drug Act in USA （1983） and Orphan Drug Management Specification in the EU （1999）, then formed relatively complete system by continuous improvement. The USA and the EU showed differences in its certification standard, procedure and specific incentives [R＆D funding, tax deduction, fee reduction, additional incentives for micro and small and medium enterprises （SMEs）, market exclusivity and special approval procedure], etc. In terms of fee reduction, for example, prescription application fee, production cost and drug confirmation fee were exempted in USA, while arrangement assist fee, initial and follow-up fee, checking fee before approval, initial listing type were reduced to a certain percentage in the EU. After developing incentive policies for orphan drugs, there is great increase in numbers of recognized qualifications and listing, SMEs have become new force in orphan drug R＆D, R＆D investment covers all types of diseases, orphan drug R＆D are becoming the main direction of drug innovation and biotectmol- ogy development. China should determine the relevant legislation of R＆D incentives for orphan drugs as soon as possible, set certi- fication and improve specific measures of R＆D incentives for orphan drugs from multiple aspects, while strengthen the cooperation with other countries in qualification and R＆D incentives.
出处
《中国药房》
CAS
北大核心
2017年第16期2161-2166,共6页
China Pharmacy
基金
国家社会科学基金项目(No.13CFX086)
辽宁省教育厅科学研究一般项目(No.W2014119)
沈阳药科大学中青年教师事业发展支持计划
关键词
罕用药
研发激励
美国
欧盟
对比
研究
Orphan drug
Research and development incentive
USA
EU
Comparative
Research
