基于政策工具的我国抗肿瘤创新药物政策文件分析  

Analysis of Anti-tumor Innovative Drug Policy Text Based on Policy Tools in China

作　　者：钟小芳 李雅 朱虹 孙致远 赵舒扬 ZHONG Xiaofang;LI Ya;ZHU Hong;SUN Zhiyuan;ZHAO Shuyang(School of Pharmacy,School of Humanities and Social Sciences,Harbin Medical University,Harbin 150081,China;Department of Pharmacy Administration,School of Humanities and Social Sciences,Harbin Medical University,Harbin 150081,China)

机构地区：[1]哈尔滨医科大学药学院,哈尔滨150081 [2]哈尔滨医科大学人文社会科学学院药事管理教研室,哈尔滨150081

出　　处：《医药导报》2024年第4期654-660,共7页Herald of Medicine

基　　金：黑龙江省自然科学基金优秀青年项目(YQ2019G003);四川医事卫生法治研究中心课题(YF21-Q02);黑龙江省哲学社会科学研究规划项目(22GLB125);哈尔滨医科大学人文学院科研项目(HMURW20210102)。

摘　　要：目的通过对我国抗肿瘤创新药物政策文件分析,探讨抗肿瘤创新药物相关政策的侧重点以及不足,为未来抗肿瘤创新药物领域政策制定及优化提供参考。方法通过访问中国共产党中央委员会及国务院、国家卫生健康委员会、国家药品监督管理局等相关部委官方网站,以“癌症”“肿瘤”“肿瘤药”“创新药”等为关键词,收集2015年1月—2022年12月国家层面发布的抗肿瘤创新药物相关政策文件;基于政策工具和利益相关者二维分析框架,对收集的政策文件进行分类、编码、统计。结果共纳入政策文件30份,政策工具视角下共产生政策编码90条,需求型政策工具、环境型政策工具、供给型政策工具分别为24、43、23条,占比26.67%、47.78%、25.56%;以政策工具为基础,利益相关者视角下共产生编码183条,政府部门、医药企业、医疗机构、患者分别为70、36、54、23条,占比38.25%、19.67%、29.51%、12.57%。结论我国抗肿瘤创新药物政策上环境型政策工具应用占比最多,供给型与需求型政策工具应用缺位,整体存在应用不平衡现象;利益相关者分布格局不协调,政府部门与医疗机构关注度高于医药企业与患者。应合理促进抗肿瘤创新药物政策工具协同应用,科学规划抗肿瘤创新药物政策子工具布局,均衡考量抗肿瘤创新药物政策各方利益主体,保障政策高效实施。Objective By analyzing the anti-tumor innovative drug policies text in China,this study aimed to explore the focus and shortcomings of policies related to anti-tumor innovative drugs,and provide the reference for future policy formulation and optimization in the field of anti-tumor innovative drug.Methods By accessing the official websites of relevant ministries and subordinate institutions such as the Central Committee of the Communist Party of China,the State Council of the People's Republic of China,the National Health Commission of the People's Republic of China,and National Medical Products Administration,and using the keywords"cancer","tumor","anti-tumor drug",and"innovative drug",etc,the national level policies related to the anti-tumor innovative drugs from January 1,2005,to December 31,2022,were collected.Based on a two-dimensional analysis framework of policy tools and stakeholders,the collected policy texts were classified,encoded,and statistically analyzed.Results A total of 30 policy texts were involved,and a total of 90 policy codes were generated.There were 24,43,and 23 codes for demand-based policy tools,environmental policy tools,and supply-based policy tools,accounting for 26.67%,47.78%,and 25.56%,respectively.Based on policy tools and stakeholders,a total of 183 codes were generated,with government departments,pharmaceutical enterprises,medical institutions,and patients having 70,36,54,and 23 codes respectively,accounting for 38.25%,19.67%,29.51%,and 12.57%.Conclusions China had the highest proportion of environmental policy tools in the application of innovative anti-tumor drug policies,while supply-oriented and demand-oriented policy tools were underutilized,resulting in an overall imbalance in application;The distribution pattern of stakeholders was not coordinated,with government departments and medical institutions having higher attention than pharmaceutical enterprises and patients..It was necessary to reasonably promote the collaborative application of anti-tumor innovative drug policy t

关 键 词：抗肿瘤药 创新药 政策工具 利益相关者 

分 类 号：R97[医药卫生—药品]