美国和欧盟的罕用药研发激励政策对比研究与启示

发布时间：2018-05-24 00:47

本文选题：罕用药 + 研发激励　；参考：《中国药房》2017年16期

【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。
[Abstract]:Objective: to provide references and suggestions for the construction and improvement of the incentive policy for the research and development of rare drugs in China. Methods: from the legislative evolution of rare drugs, the incentive measures and effects of the research and development of rare drugs, the incentive policies of the United States and the European Union were compared, and suggestions were provided for the improvement of the relevant policies in China. Results & conclusion: the incentive policies of the United States and the European Union began in 1983 and 1999 respectively, and formed a relatively complete system through continuous improvement. There are differences between the United States and the European Union in terms of the standards, procedures, specific incentives (R & D aid, tax credit, fee relief, additional incentives for micro and small enterprises, market monopoly, special approval procedures, etc.) for rare drugs. For example, in the case of fee reduction, the United States waives prescription application fees, production costs and drug recognition fees, while the European Union pays for agreement assistance costs, initial and follow-up requirements, The examination fee and the initial listing application fee shall be reduced by certain proportion according to the type. After the implementation of the incentive policy on rare drugs, the number of qualifications and the number of listed ones have increased substantially. Micro, small and medium-sized enterprises have become the new force in the research and development of rare drugs, and the investment in R & D covers all kinds of disease treatment fields. Research and development of rare drug use has become the main direction of drug innovation and biotechnology development. As soon as possible, our country should determine the relevant legislation on the incentive for the research and development of rare drugs, establish the qualifications for the research and development of the rare drugs, and improve the specific measures for encouraging the research and development of the rare drugs from many aspects. At the same time, strengthen the cooperation with other countries on qualification recognition and R & D incentives.
【作者单位】：沈阳药科大学工商管理学院;
【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
【分类号】：R95

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