罕见病防治药械研发激励法律保障机制研究  

On the Legal Protection Mechanism for Research and Development Incentive of Orphan Drugs and Medical Devices

作　　者：许迎玲 杨悦 Xu Yingling;Yang Yue(School of Medical Device,Shanghai University of Medicine&Health Sciences,Shanghai 201318,China;School of Pharmaceutical Sciences,Tsinghua University,Beijing 100084,China;National Medical Products Administration Key Laboratory for Research and Evaluation of Innovative Drug,Beijing 100084,China)

机构地区：[1]上海健康医学院医疗器械学院,上海201318 [2]清华大学药学院,北京100084 [3]国家药品监督管理局创新药物研究与评价重点实验室,北京100084

出　　处：《中国科技论坛》2024年第2期118-125,共8页Forum on Science and Technology in China

基　　金：中国药品监督管理研究会研究课题“医疗器械现代化治理体系构建研究”(2023-Y-Q-004)。

摘　　要：罕见病防治药械关涉人民生命健康,如何激励企业加大研发投入、确保产品安全有效可及,是全面推进健康中国建设面临的重要问题。中国积累了通过立法开展研发激励的有益经验,但存在激励措施单一、关键制度缺位、激励领域失衡、专门立法缺位、政策待法定化、规范之间存在冲突等问题。从保护患者权益、落实宪法条款、加强制度建设等角度出发,应当在法治轨道上以制度创新、制度合力提升产品可获得性。具体到研发激励法律保障机制建构上,应当遵循回应性立法与前瞻性立法并重、研发激励与全生命周期监管并重等理念;将研发激励立法融入一般法和专门法,聚焦监管环节布局下位法;以“上市前节约研发成本,上市中加快上市进程,上市后提高研发回报”为目标,明确各阶段制度建设重点、框定立法实质内容。Orphan drugs and medical devices are related to people's lives and health.How to incentivize enterprises to increase R&D investment and ensure the safety,effectiveness,and accessibility of the products is an important issue faced in comprehensively promoting the construction of a healthy China.China has accumulated beneficial experience in implementing R&D incentive through legislation,but there are problems such as single incentive measures,lack of key systems,imbalance in incentive fields,lack of specialized legislation,policies need to be legalized,conflicts between norms.From the perspectives of protecting the rights and interests of patients,implementing constitutional provisions,and strengthening institutional construction,we should improve the availability of the products through institutional innovation and synergy on the track of the rule of law.In terms of the construction of the legal protection mechanism for R&D incentive of orphan drugs and medical devices,the ideas of equal emphasis on responsive and forward-looking legislation,equal emphasis on R&D incentive and full lifecycle supervision and so on should be adhered to.The R&D incentive legislation should be integrated into general laws and special laws,and the lower-level laws should be enacted around regulatory processes.The focus of institutional construction which framed the substantive content of legislation should be clarified based on the goal of saving R&D costs before registration,accelerating the process during registration,and improving R&D returns after registration.

关 键 词：罕见病 罕见病防治药械 研发激励 法律保障机制 

分 类 号：R951[医药卫生—药学]