中国药房2017，Vol.28Issue(16)：2161-2166,6.DOI:10.6039/j.issn.1001-0408.2017.16.01
美国和欧盟的罕用药研发激励政策对比研究与启示
Comparative Study and Enlightenment of the R&D Incentive Policies for Orphan Drugs in USA and the EU
摘要
Abstract
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 biotechnol-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.关键词
罕用药/研发激励/美国/欧盟/对比/研究Key words
Orphan drug/Research and development incentive/USA/EU/Comparative/Research分类
医药卫生引用本文复制引用
杨莉,田丽娟,林琳..美国和欧盟的罕用药研发激励政策对比研究与启示[J].中国药房,2017,28(16):2161-2166,6.基金项目
国家社会科学基金项目(No.13CFX086) （No.13CFX086）
辽宁省教育厅科学研究一般项目(No.W2014119) （No.W2014119）
沈阳药科大学中青年教师事业发展支持计划 （）
