基于三维分析框架的基因治疗药物政策量化分析  

A quantitative analysis of gene therapy drug policy based on a three-dimensional analytical framework

作　　者：严越 牛佳苗 张宗久 YAN yue;NIU Jia-miao;ZHANG Zong-jiu(School of Medicine of Tsinghua University,Beijing 100084,China;Institute for Hospital Management of Tsinghua University,Shenzhen Guangdong 518055,China)

机构地区：[1]清华大学医学院,北京100084 [2]清华大学医院管理研究院,广东深圳518055

出　　处：《中国卫生政策研究》2024年第10期68-75,共8页Chinese Journal of Health Policy

基　　金：北京市功能区医疗卫生规划研究项目(北京市卫生健康委员会)委托项目。

摘　　要：目的:分析基因治疗药物政策文本的特征与现状,优化我国基因治疗药物政策体系。方法:采用内容分析法和词频分析法,构建“政策工具—互动主体—政策环节”的三维分析框架,对2009年3月—2024年3月发布的相关政策文件开展多维分类与交叉比较。结果:在纳入的37份国家级政策文本中,政策工具维度共筛选出246个文本条目,供给型(45.9%)、环境型(41.5%)政策工具占比较多,需求型(12.6%)政策工具占比较少,政策工具分布偏倚、内部结构存在差异;互动主体维度共筛选出195个文本条目,药品生产研发企业(36.9%)、药品监管评审机构(22.1%)、患者与受试者(19.0%)、医疗机构与医务人员(11.8%)、其他政府部门(10.2%)等各主体作用发挥不均;政策环节维度方面分为药物研发、生产和使用等三个阶段,部分政策涵盖多环节。结论和建议:组合政策工具,强化需求型政策,优化内部使用;考虑不同互动主体的需求来综合施策,合作促进共赢;环节联动增效,促进产业链协同发展,构建全链条生态。Objective:This study aims to analyze the characteristics and current status of gene therapy drug policy documents and to provide recommendations for optimizing China's gene therapy drug policy system.Methods:A three-dimensional analytical framework of“policy instruments-interactive subjects-policy phases”was constructed using content analysis and word frequency analysis.This framework was applied to the relevant policy documents issued from March 2009 to March 2024,enabling multidimensional classification and cross-comparison.Results:Among the 37 national-level policy documents included,246 text items were identified under the dimension of policy instruments,with supply-based instruments(45.9%)and environmental instruments(41.5%)being more prevalent,while demand-based instruments(12.6%)were less represented.The distribution of policy instruments was skewed,and internal structural differences were observed.In the dimension of interactive subjects,195 text items were identified,with drug manufacturing and R&D enterprises(36.9%),drug regulatory and accreditation agencies(22.1%),patients and subjects(19.0%),medical institutions and healthcare professionals(11.8%),and other government departments(10.2%)playing uneven roles.In the dimension of policy phases,the policies were categorized into three stages:drug R&D,production,and usage,with some policies covering multiple phases.Conclusions and suggestions:The study suggests combining and optimizing policy instruments for balanced application,strengthening demand-oriented policies,considering the needs of different interacting entities to formulate comprehensive policies,promoting cross-subject collaboration for win-win outcomes,and enhancing phase-linkage efficiency to build a comprehensive chain ecosystem for gene therapy drug development.

关 键 词：基因治疗药物 政策工具 三维交叉分析法 

分 类 号：R197[医药卫生—卫生事业管理]