Article(id=1324078239873892511, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1324078037817504735, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202507180, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1752422400000, receivedDateStr=2025-07-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793614452569, onlineDateStr=2026-11-02, pubDate=1770652800000, pubDateStr=2026-02-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793614452569, onlineIssueDateStr=2026-11-02, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793614452569, creator=13701087609, updateTime=1793614452569, updator=13701087609, issue=Issue{id=1324078037817504735, tenantId=1146029695717560320, journalId=1227665162245664772, year='2026', volume='53', issue='3', pageStart='385', pageEnd='576', issueExtLink='null', onlineDate='null', pubDate='1770652800000', pubDateStr='2026-02-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793614404396, creator='13701087609', updateTime=1793614474144, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1324078330420527919, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1324078037817504735, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1324078330420527920, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1324078037817504735, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=486, endPage=491, ext={EN=ArticleExt(id=1324078240603701408, articleId=1324078239873892511, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Implementation effect of China’s centralized drug procurement policy from the perspective of policy tools—based on fuzzy-set qualitative comparative analysis, columnId=1228016567846367388, journalTitle=Modern Preventive Medicine, columnName=Health Policy and Management, runingTitle=null, highlight=null, articleAbstract=
Objective

To evaluate the effects of China’s centralized drug procurement policy and provide references for the healthy development of the pharmaceutical industry and policy optimization.

Methods

A framework was constructed based on policy instrument theory. Content analysis was used to quantify 27 national-level policy documents from 2000 to 2024, and fuzzy-set qualitative comparative analysis (fsQCA) was applied to conduct configuration analysis of 21 typical cases.

Results

The structure of policy instruments was imbalanced, with environmental instruments accounting for 46.69%, while demand-type instruments constituted only 26.03%. Five core necessary conditions (consistency>0.9) were identified: drug procurement,procurement behavior regulation, drug price adjustment, industry standards, and drug regulation, with consistency scores of 0.966, 0.934, 1.000, 0.963, and 0.948, respectively. Two configuration paths were distilled: a regulation-core-driven path and a comprehensive safeguard path characterized by multi-instrument synergy.

Conclusion

An optimization framework of"institutional rigidity-dynamic adaptation" is proposed. Recommendations include optimizing the structure of policy instruments, promoting synergy between regulation and the market, and improving incentive mechanisms to advance the continuous refinement of centralized drug procurement policies.

, authors=Zhu JIN, Li-min DUAN, authorsList=Zhu JIN, Li-min DUAN, authorCompany=null, correspAuthors=Li-min DUAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1324078242344337578, articleId=1324078239873892511, tenantId=1146029695717560320, journalId=1227665162245664772, language=CN, title=政策工具视角下我国药品集中采购政策实施效果研究——基于模糊集定性比较分析, columnId=1228016568014139551, journalTitle=现代预防医学, columnName=卫生政策与管理, runingTitle=null, highlight=null, articleAbstract=
目的

评估我国药品集采政策效果,为医药行业健康发展与政策优化提供参考。

方法

基于政策工具理论构建框架,采用内容分析法对2000—2024年国家层面27份政策文件进行量化,并采用模糊集定性比较方法(fuzzy-set qualitative comparative analysis,fsQCA)对21个典型案例进行组态分析。

结果

政策工具结构失衡,环境型工具占比46.69%,需求型工具仅占26.03%。识别出五项核心必要条件(一致性>0.9),包括药品采购、采购行为规范、药品价格调整、行业标准、药品监管,一致性分别为0.966、0.934、1.000、0.963、0.948,并提炼出两类组态路径:以监管为核心的核心驱动型路径、多工具协同的全面保障型路径。

结论

提出“制度刚性-动态适配”优化框架,建议优化政策工具结构、促进监管与市场协同、完善激励机制,以推动药品集采政策持续完善。

, authors=金柱, 段莉敏, authorsList=金柱, 段莉敏, authorCompany=null, correspAuthors=段莉敏, authorNote=

金柱(1998—),男,硕士在读,研究方向:公共管理

, correspAuthorsNote=
段莉敏,E-mail:
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金柱(1998—),男,硕士在读,研究方向:公共管理

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(In Chinese), articleTitle=Study on the path of improving the practical ability of master of public health based on qualitative comparative analysis of fuzzy sets, refAbstract=null), Reference(id=1324078254692368624, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, doi=null, pmid=null, pmcid=null, year=2024, volume=40, issue=3, pageStart=355, pageEnd=365, url=null, language=null, rfNumber=[13], rfOrder=24, authorNames=孙钰, 宋雪瑶, 马建辉, journalName=资源开发与市场, refType=null, unstructuredReference=孙钰,宋雪瑶,马建辉,等.组态视角下减污降碳政策工具对环境规制效率的驱动机制——基于中国30个省份的fsQCA实证分析[J].资源开发与市场,2024,40(3):355-365., articleTitle=组态视角下减污降碳政策工具对环境规制效率的驱动机制——基于中国30个省份的fsQCA实证分析, refAbstract=null), Reference(id=1324078254776254705, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, doi=null, pmid=null, pmcid=null, year=2024, volume=40, issue=3, pageStart=355, pageEnd=365, url=null, language=null, rfNumber=[13], rfOrder=25, authorNames=Sun Y, Song XY, Ma JH, journalName=Resource Development & Market, refType=null, unstructuredReference=Sun Y, Song XY, Ma JH, et al. The driving mechanism of pollution and Carbon reduction policy instruments on environmental regulation efficiency under the grouping perspective——Empirical analysis of fsQCA based on 30 provinces in China[J]. Resource Development & Market, 2024, 40(3):355-365. (In Chinese), articleTitle=The driving mechanism of pollution and Carbon reduction policy instruments on environmental regulation efficiency under the grouping perspective——Empirical analysis of fsQCA based on 30 provinces in China, refAbstract=null), Reference(id=1324078254860140786, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, doi=null, pmid=null, pmcid=null, year=2025, volume=65, issue=5, pageStart=123, pageEnd=138, 237, url=null, language=null, rfNumber=[14], rfOrder=26, authorNames=容志, 陈舒婷, journalName=吉林大学社会科学学报, refType=null, unstructuredReference=容志,陈舒婷.城市社区网格化管理效能的影响因素及其组态路径研究——基于15个案例的模糊集定性比较分析[J].吉林大学社会科学学报,2025,65(5):123-138, 237., articleTitle=城市社区网格化管理效能的影响因素及其组态路径研究——基于15个案例的模糊集定性比较分析, refAbstract=null), Reference(id=1324078254981775603, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, doi=null, pmid=null, pmcid=null, year=2025, volume=65, issue=5, pageStart=123, pageEnd=138, 237, url=null, language=null, rfNumber=[14], rfOrder=27, authorNames=Rong Z, Chen ST, journalName=Jilin University Journal Social Science Edition, refType=null, unstructuredReference=Rong Z, Chen ST. Research on the influencing factors and configuration path of grid management efficiency in urban communities: A fuzzy set qualitative comparative analysis based on 15 cases[J]. Jilin University Journal Social Science Edition, 2025, 65(5): 123-138, 237. (In Chinese), articleTitle=Research on the influencing factors and configuration path of grid management efficiency in urban communities: A fuzzy set qualitative comparative analysis based on 15 cases, refAbstract=null), Reference(id=1324078255048884468, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, doi=null, pmid=null, pmcid=null, year=2024, volume=51, issue=23, pageStart=4321, pageEnd=4326, url=null, language=null, rfNumber=[15], rfOrder=28, authorNames=陆瑞钊, 黄凌波, 吴雨洁, journalName=现代预防医学, refType=null, unstructuredReference=陆瑞钊,黄凌波,吴雨洁,等.基于模糊集定性比较分析的中国公共卫生人力资源配置公平性影响因素与提升路径研究[J].现代预防医学,2024,51(23):4321-4326., articleTitle=基于模糊集定性比较分析的中国公共卫生人力资源配置公平性影响因素与提升路径研究, refAbstract=null), Reference(id=1324078255115993333, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, doi=null, pmid=null, pmcid=null, year=2024, volume=51, issue=23, pageStart=4321, pageEnd=4326, url=null, language=null, rfNumber=[15], rfOrder=29, authorNames=Lu RZ, Huang LB, Wu YJ, journalName=Modern Preventive Medicine, refType=null, unstructuredReference=Lu RZ, Huang LB, Wu YJ, et al. Research on the influencing factors and improvement paths of Equity in the allocation of public health human resources in China based on fuzzy set qualitative comparative analysis[J].Modern Preventive Medicine, 2024, 51(23): 4321-4326. (In Chinese), articleTitle=Research on the influencing factors and improvement paths of Equity in the allocation of public health human resources in China based on fuzzy set qualitative comparative analysis, refAbstract=null)], funds=[Fund(id=1324078251248845015, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, awardId=2024ZZB066, language=CN, fundingSource=内蒙古开展国家区域医疗中心建设研究(2024ZZB066), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1324078244877697196, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, xref=null, ext=[AuthorCompanyExt(id=1324078245246795949, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, companyId=1324078244877697196, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=College of Health Management, Inner Mongolia Medical University, Hohhot, Inner Mongolia 010110, China), AuthorCompanyExt(id=1324078245255184558, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, companyId=1324078244877697196, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=内蒙古医科大学卫生管理学院,内蒙古 呼和浩特 010110)])], figs=[ArticleFig(id=1324078249210413249, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Figure 1, caption=Overall research framework diagram, figureFileSmall=H/VbqJFFNfcrH1ohv75Gtg==, figureFileBig=iY5eIOkLlQ6oj2BiEBHLCw==, tableContent=null), ArticleFig(id=1324078249285910722, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=图1, caption=总体研究思路框架图, figureFileSmall=H/VbqJFFNfcrH1ohv75Gtg==, figureFileBig=iY5eIOkLlQ6oj2BiEBHLCw==, tableContent=null), ArticleFig(id=1324078249487237315, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Figure 2, caption=Two-dimensional analytical framework diagram for the centralized drug procurement policy, figureFileSmall=8BZIAlkvZiTcDv1Bkcwang==, figureFileBig=JeO4xksCpMS3r9jLG6pIjQ==, tableContent=null), ArticleFig(id=1324078249566929092, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=图2, caption=药品集采政策二维分析框架图, figureFileSmall=8BZIAlkvZiTcDv1Bkcwang==, figureFileBig=JeO4xksCpMS3r9jLG6pIjQ==, tableContent=null), ArticleFig(id=1324078249646620869, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Figure 3, caption=Specific measures of drug centralized procurement policy classification, figureFileSmall=AUwbGyPla992Cscz62NbeA==, figureFileBig=ieeUCUQn2GXWpTsbW85ttA==, tableContent=null), ArticleFig(id=1324078249738895558, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=图3, caption=药品集采政策具体举措分类, figureFileSmall=AUwbGyPla992Cscz62NbeA==, figureFileBig=ieeUCUQn2GXWpTsbW85ttA==, tableContent=null), ArticleFig(id=1324078249810198727, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Figure 4, caption=Selection of conditional variables and outcome variables, figureFileSmall=tysQnrW9FAQ7TOr4z4XaAw==, figureFileBig=wT7xa2hKQ1J/xmTSURaK5w==, tableContent=null), ArticleFig(id=1324078249881501896, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=图4, caption=条件变量与结果变量选取, figureFileSmall=tysQnrW9FAQ7TOr4z4XaAw==, figureFileBig=wT7xa2hKQ1J/xmTSURaK5w==, tableContent=null), ArticleFig(id=1324078249969582281, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Table 1, caption=

Coding scheme for the analysis of china’s centralized drug procurement policy texts

, figureFileSmall=null, figureFileBig=null, tableContent=
编号文献名称分析内容编码
1《国务院办公厅转发国务院体改办等部门关于城镇医药卫生体制改革指导意见的通知》国办发〔2000〕16号(七)解决当前存在的以药养医问题,必须切断医疗机构和药品营销之间的直接经济利益联系。
……
(十)按照国家产业政策和医药行业发展规划,严格药品生产企业准入条件,控制新增生产加工能力,制止低水平重复建设,不得增加供过于求的产品的布点。
1-7-1
1-10-1
2《关于进一步做好医疗机构药品集中招标采购工作的通知》卫规财发〔2001〕208号(一)要认真学习《指导意见》,把药品集中招标采购工作纳入医疗体制改革,总体安排、通盘考虑、协调实施。
……
(八)药品集中招标采购的监督,药品集中招标采购必须遵循公开、公平、公正和诚实信用的原则,接受政府有关部门、社会和舆论的监督。
2-1-1
2-8-1
……………………
27《国家医保局 国家卫生健康委员会关于完善医药集中带量采购和执行工作机制的通知》医保发〔2024〕31号(一)确保中选药品和耗材进院。进一步支持将紧密型医共体作为整体进行报量。
……
(十)加强政策解读和宣传培训。各级医保、卫生健康部门要提高政治站位,全面准确解读医药集中带量采购政策,引导医务人员、患者进一步认识集采改革的重大意义。
27-1-1
27-10-1
), ArticleFig(id=1324078250066051274, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=表1, caption=

我国药品集采相关政策文本内容分析编码表

, figureFileSmall=null, figureFileBig=null, tableContent=
编号文献名称分析内容编码
1《国务院办公厅转发国务院体改办等部门关于城镇医药卫生体制改革指导意见的通知》国办发〔2000〕16号(七)解决当前存在的以药养医问题,必须切断医疗机构和药品营销之间的直接经济利益联系。
……
(十)按照国家产业政策和医药行业发展规划,严格药品生产企业准入条件,控制新增生产加工能力,制止低水平重复建设,不得增加供过于求的产品的布点。
1-7-1
1-10-1
2《关于进一步做好医疗机构药品集中招标采购工作的通知》卫规财发〔2001〕208号(一)要认真学习《指导意见》,把药品集中招标采购工作纳入医疗体制改革,总体安排、通盘考虑、协调实施。
……
(八)药品集中招标采购的监督,药品集中招标采购必须遵循公开、公平、公正和诚实信用的原则,接受政府有关部门、社会和舆论的监督。
2-1-1
2-8-1
……………………
27《国家医保局 国家卫生健康委员会关于完善医药集中带量采购和执行工作机制的通知》医保发〔2024〕31号(一)确保中选药品和耗材进院。进一步支持将紧密型医共体作为整体进行报量。
……
(十)加强政策解读和宣传培训。各级医保、卫生健康部门要提高政治站位,全面准确解读医药集中带量采购政策,引导医务人员、患者进一步认识集采改革的重大意义。
27-1-1
27-10-1
), ArticleFig(id=1324078250137354443, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Table 2, caption=

Distribution of use of policy tools in centralized drug procurement in China

, figureFileSmall=null, figureFileBig=null, tableContent=
政策工具具体名称频数(条)占比(%)
供给型自身建设1928.79
药品配送1421.21
药品采购1624.24
人才培养34.55
财政支持1421.21
合计66100.00
需求型采购行为规范4571.43
药品信息服务1117.46
药品价格调整711.11
合计63100.00
环境型行业标准1916.82
平台建设1412.39
药品监管3329.20
组织管理2421.24
资质认定2320.35
合计113100.00
), ArticleFig(id=1324078250242212044, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=表2, caption=

我国药品集采相关政策工具使用分布情况

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政策工具具体名称频数(条)占比(%)
供给型自身建设1928.79
药品配送1421.21
药品采购1624.24
人才培养34.55
财政支持1421.21
合计66100.00
需求型采购行为规范4571.43
药品信息服务1117.46
药品价格调整711.11
合计63100.00
环境型行业标准1916.82
平台建设1412.39
药品监管3329.20
组织管理2421.24
资质认定2320.35
合计113100.00
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Distribution of policy tools used in different categories of centralized drug procurement in China [n(%)]

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政策工具总体要求覆盖范围采购规则保障措施配套政策运行机制组织保障总计
供给型8(12.12)7(10.61)17(25.75)12(18.18)7(10.61)10(15.15)5(7.58)66(100)
需求型5(7.93)8(12.70)16(25.40)8(12.70)8(12.70)7(11.11)11(17.46)63(100)
环境型14(12.39)16(14.16)30(26.55)19(16.81)6(5.32)21(18.58)7(6.19)113(100)
), ArticleFig(id=1324078250456121550, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=表3, caption=

我国药品集采不同类别对政策工具的使用分布情况[n(%)]

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政策工具总体要求覆盖范围采购规则保障措施配套政策运行机制组织保障总计
供给型8(12.12)7(10.61)17(25.75)12(18.18)7(10.61)10(15.15)5(7.58)66(100)
需求型5(7.93)8(12.70)16(25.40)8(12.70)8(12.70)7(11.11)11(17.46)63(100)
环境型14(12.39)16(14.16)30(26.55)19(16.81)6(5.32)21(18.58)7(6.19)113(100)
), ArticleFig(id=1324078250531619023, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Table 4, caption=

Resultant variable and conditional variable calibration

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变量类型变量名称完全隶属交叉点完全不隶属
A自身建设704010
B药品配送60305
C药品采购85502
D人才培养452015
E财政支持552512
F采购行为规范75358
G药品信息服务301520
H药品价格调整90600
I行业标准80451
J平台建设653510
K药品监管78403
L组织管理502518
M资质认定70385
), ArticleFig(id=1324078250623893712, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=表4, caption=

结果变量与条件变量校准

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变量类型变量名称完全隶属交叉点完全不隶属
A自身建设704010
B药品配送60305
C药品采购85502
D人才培养452015
E财政支持552512
F采购行为规范75358
G药品信息服务301520
H药品价格调整90600
I行业标准80451
J平台建设653510
K药品监管78403
L组织管理502518
M资质认定70385
), ArticleFig(id=1324078250691002577, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Table 5, caption=

Necessity analysis results

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条件变量结果变量
一致性覆盖度
自身建设A0.8730.940
~自身建设~A0.4330.814
药品配送B0.7910.962
~药品配送~B0.7910.962
药品采购C0.5170.811
~药品采购~C0.9660.900
人才培养D0.3170.820
~人才培养~D0.6240.984
财政支持E0.6450.781
~财政支持~E0.5860.971
采购行为规范F0.6840.799
~采购行为规范~F0.9340.924
药品信息服务G0.3700.822
~药品信息服务~G0.5190.987
药品价格调整H0.7190.769
~药品价格调整~H1.0000.844
行业标准I0.2270.824
~行业标准~I0.9630.906
平台建设J0.3210.808
~平台建设~J0.8400.956
药品监管K0.4670.803
~药品监管~K0.9490.932
组织管理L0.3520.796
~组织管理~L0.7090.973
资质认定M0.5930.810
~资质认定~M0.8940.931
), ArticleFig(id=1324078250825220306, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=表5, caption=

必要条件分析结果

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条件变量结果变量
一致性覆盖度
自身建设A0.8730.940
~自身建设~A0.4330.814
药品配送B0.7910.962
~药品配送~B0.7910.962
药品采购C0.5170.811
~药品采购~C0.9660.900
人才培养D0.3170.820
~人才培养~D0.6240.984
财政支持E0.6450.781
~财政支持~E0.5860.971
采购行为规范F0.6840.799
~采购行为规范~F0.9340.924
药品信息服务G0.3700.822
~药品信息服务~G0.5190.987
药品价格调整H0.7190.769
~药品价格调整~H1.0000.844
行业标准I0.2270.824
~行业标准~I0.9630.906
平台建设J0.3210.808
~平台建设~J0.8400.956
药品监管K0.4670.803
~药品监管~K0.9490.932
组织管理L0.3520.796
~组织管理~L0.7090.973
资质认定M0.5930.810
~资质认定~M0.8940.931
), ArticleFig(id=1324078250913300691, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Table 6, caption=

Intermediate resolution results

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组态原始覆盖度唯一覆盖度一致性
FA*FB*FC*~FD*~FE*FF*~FG*FH*FI*FJ*FK*FM0.5790.0580.979
FA*FB*FC*~FE*FF*~FG*FH*FI*FJ*FK*FL*FM0.5700.0240.990
FA*FB*FC*~FD*FF*~FG*FH*FI*FJ*FK*FL*FM0.5310.0090.990
FA*FB*FC*FD*FE*FF*FG*FH*FI*FJ*FK*FL*FM0.4250.0711.000
解的覆盖度0.707
解的一致性0.983
), ArticleFig(id=1324078250984603860, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=CN, label=表6, caption=

中间解结果

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组态原始覆盖度唯一覆盖度一致性
FA*FB*FC*~FD*~FE*FF*~FG*FH*FI*FJ*FK*FM0.5790.0580.979
FA*FB*FC*~FE*FF*~FG*FH*FI*FJ*FK*FL*FM0.5700.0240.990
FA*FB*FC*~FD*FF*~FG*FH*FI*FJ*FK*FL*FM0.5310.0090.990
FA*FB*FC*FD*FE*FF*FG*FH*FI*FJ*FK*FL*FM0.4250.0711.000
解的覆盖度0.707
解的一致性0.983
), ArticleFig(id=1324078251051712725, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1324078239873892511, language=EN, label=Table 7, caption=

Results of the configurational analysis of pathways to effective implementation

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前因条件核心驱动型全面保障型
组态1组态2组态3组态4
自身建设 A●●●●
药品配送 B●●●●
药品采购 C●●●●
人才培养 D□□●
财政支持 E□□●
采购行为规范 F●●●●
药品信息服务 G□□□●
药品价格调整 H●●●●
行业标准 I●●●●
平台建设 J●●●●
药品监管 K●●●●
组织管理 L●●●
资质认定 M●●●●
一致性0.9790.9900.9901.000
原始覆盖度0.5790.5700.5310.425
唯一覆盖度0.0580.0240.0090.071
总体解的覆盖度0.707
总体解的一致性0.983
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药品集采实施效果的实现路径组态分析结果

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前因条件核心驱动型全面保障型
组态1组态2组态3组态4
自身建设 A●●●●
药品配送 B●●●●
药品采购 C●●●●
人才培养 D□□●
财政支持 E□□●
采购行为规范 F●●●●
药品信息服务 G□□□●
药品价格调整 H●●●●
行业标准 I●●●●
平台建设 J●●●●
药品监管 K●●●●
组织管理 L●●●
资质认定 M●●●●
一致性0.9790.9900.9901.000
原始覆盖度0.5790.5700.5310.425
唯一覆盖度0.0580.0240.0090.071
总体解的覆盖度0.707
总体解的一致性0.983
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政策工具视角下我国药品集中采购政策实施效果研究——基于模糊集定性比较分析
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金柱 , 段莉敏
现代预防医学 | 卫生政策与管理 2026,53(3): 486-491
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现代预防医学 |卫生政策与管理 2026 , 53 (3) : 486 -491
政策工具视角下我国药品集中采购政策实施效果研究——基于模糊集定性比较分析
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金柱, 段莉敏
作者信息
  • 内蒙古医科大学卫生管理学院,内蒙古 呼和浩特 010110
通讯作者:
段莉敏,E-mail:
作者简介:

金柱(1998—),男,硕士在读,研究方向:公共管理

Implementation effect of China’s centralized drug procurement policy from the perspective of policy tools—based on fuzzy-set qualitative comparative analysis
Zhu JIN, Li-min DUAN
Affiliations
  • College of Health Management, Inner Mongolia Medical University, Hohhot, Inner Mongolia 010110, China
出版时间: 2026-02-10 doi: 10.20043/j.cnki.MPM.202507180
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目的

评估我国药品集采政策效果,为医药行业健康发展与政策优化提供参考。

方法

基于政策工具理论构建框架,采用内容分析法对2000—2024年国家层面27份政策文件进行量化,并采用模糊集定性比较方法(fuzzy-set qualitative comparative analysis,fsQCA)对21个典型案例进行组态分析。

结果

政策工具结构失衡,环境型工具占比46.69%,需求型工具仅占26.03%。识别出五项核心必要条件(一致性>0.9),包括药品采购、采购行为规范、药品价格调整、行业标准、药品监管,一致性分别为0.966、0.934、1.000、0.963、0.948,并提炼出两类组态路径:以监管为核心的核心驱动型路径、多工具协同的全面保障型路径。

结论

提出“制度刚性-动态适配”优化框架,建议优化政策工具结构、促进监管与市场协同、完善激励机制,以推动药品集采政策持续完善。

药品集中采购  /  政策工具  /  模糊集定性比较分析  /  组态路径
Objective

To evaluate the effects of China’s centralized drug procurement policy and provide references for the healthy development of the pharmaceutical industry and policy optimization.

Methods

A framework was constructed based on policy instrument theory. Content analysis was used to quantify 27 national-level policy documents from 2000 to 2024, and fuzzy-set qualitative comparative analysis (fsQCA) was applied to conduct configuration analysis of 21 typical cases.

Results

The structure of policy instruments was imbalanced, with environmental instruments accounting for 46.69%, while demand-type instruments constituted only 26.03%. Five core necessary conditions (consistency>0.9) were identified: drug procurement,procurement behavior regulation, drug price adjustment, industry standards, and drug regulation, with consistency scores of 0.966, 0.934, 1.000, 0.963, and 0.948, respectively. Two configuration paths were distilled: a regulation-core-driven path and a comprehensive safeguard path characterized by multi-instrument synergy.

Conclusion

An optimization framework of"institutional rigidity-dynamic adaptation" is proposed. Recommendations include optimizing the structure of policy instruments, promoting synergy between regulation and the market, and improving incentive mechanisms to advance the continuous refinement of centralized drug procurement policies.

Centralized drug procurement  /  Policy tools  /  Fuzzy-set qualitative comparative analysis  /  Configurational pathways
金柱, 段莉敏. 政策工具视角下我国药品集中采购政策实施效果研究——基于模糊集定性比较分析. 现代预防医学, 2026 , 53 (3) : 486 -491 . DOI: 10.20043/j.cnki.MPM.202507180
Zhu JIN, Li-min DUAN. Implementation effect of China’s centralized drug procurement policy from the perspective of policy tools—based on fuzzy-set qualitative comparative analysis[J]. Modern Preventive Medicine, 2026 , 53 (3) : 486 -491 . DOI: 10.20043/j.cnki.MPM.202507180
我国药品集中采购(简称药品集采)自20世纪90年代起,历经地方试点(1990—2004年)、制度建立(2005—2014年)、改革深化(2015—2019年)及战略升级(2019—2025年)四个阶段,逐步实现了从分散招标到统一组织、从以量换价到质量与价格并重。政策覆盖范围也从化学药扩展至生物药、中成药及高值耗材,并推动行业由营销驱动转向研发与成本控制并重。
药品集采旨在通过规模化采购降低药价、规范流通秩序、减轻患者负担[1]。尽管政策已实施二十余年,现有研究多聚焦政策文本[2]与采购模式[3],对实际效果的量化评估仍显不足。在相关研究中,模糊集定性比较分析(fuzzy-set qualitative comparative analysis,fsQCA)方法被广泛应用于分析政策工具与实施效果间的复杂关系。有研究基于76份政策文本,揭示政策工具组合对数字政府建设成效的影响[4];另一项基于31组数据的研究,识别出多维度条件协同驱动科技成果转化的政策路径[5];还有研究通过“亩均论英雄”改革案例,指出政府能力、改革成本与动力的联动作用对政策适应性的影响[6]。这些成果为分析药品集采政策的地方实践差异提供了方法借鉴,提示应结合地区医疗资源、政府能力等情境因素进行差异化评估。
基于此,本研究引入fsQCA方法,结合政策工具理论[7]构建三维分析模型:从供给型、环境型和需求型三个维度提炼一级指标,并进一步细化二级指标以反映药品集采政策动态发展特征[8]。该方法适于处理多重因素的复杂因果与组合路径,可弥补传统定量或定性研究的不足。全文研究框架见图1。
政策文本来自国务院政策文件库、国家卫健委、国家药监局官网、“北大法宝”及中国知网政策数据库。检索关键词包括药品管理、药品安全、药品政策、药品采购等。纳入标准:(1)2000年2月—2024年12月;(2)仅保留国家层面文件,去除地方性文本;(3)聚焦于药品集采主题;(4)文件类别限于法律法规、规划、通知、意见等具有规范效力的公文。最终获得27份有效政策文本。
案例及指标数据来源于2024年公开的21份药品集采谈判案例,数据源自国家及省级医保局官网、医药数据库及《中国卫生健康统计年鉴》,涵盖政策文本、药价降幅、采购量及区域经济指标。
对27份政策文本中的242条具体条目进行量化编码,格式为“政策序号-章节/条款”。从政策工具类型与采购分类两个维度进行频数统计,遵循“不可再细分”原则逐条标注,并编制《政策文本编码表》。见表1。
本文以药品集采政策为切入点,采用内容分析法进行系统剖析。从政策工具维度与药品集采系统化分类维度两大视角对政策进行系统剖析。
X维度,即政策工具维度。采用Rothwell与Zegveld的三分法:供给型工具通过政府直接投入快速提升服务能力,优势在于直接有效;需求型工具通过调节市场激发活力与创新,具有灵活性与时效性;环境型工具则通过政府创建有利环境为政策实施创造条件。
Y维度,即药品集采系统化分类维度。根据国务院办公厅《关于推动药品集中带量采购工作常态化制度化开展的意见》,为推动药品集采工作常态化制度化开展,将药品集采分为总体要求、覆盖范围、采购规则、保障措施、配套政策、运行机制和组织保障七种系统化维度[9]。具体政策分析框架见图2。
fsQCA适用于中小样本与多重配置问题,已广泛应用于管理与卫生政策领域的因果复杂性研究,相关文献为其提供了理论与方法支持[10-12]。
基于政策文本量化分析结果,按fsQCA方法的分析步骤剖析政策工具经由多重路径影响药品集采绩效:首先借助组态分析识别推动政策落地的核心条件;随后揭示不同条件组合之间的替代逻辑;最后对每条组态解所覆盖的典型个案进行深度剖析,以阐明其成功经验与适用情境[13]。见图3。
本研究将药品价格降低、供应稳定性与医疗机构积极性作为结果变量,因其直接对应政策核心目标,且均可观测和量化校准,符合fsQCA要求;条件变量为13类政策工具出现频次,作为政府政策注意力的代理指标,用以表征政策干预力度。基于既定框架完成文本编码与量化后,运用fsQCA方法分析不同政策工具组合对采购成效的影响路径,见图4。
在Excel 2021中整理原始数据并计算药品集采效果值;通过直接校准法处理变量;使用fsQCA4.1软件进行必要条件检验、组态分析与稳健性测试。
从政策工具视角分析,环境型工具使用最为频繁(46.69%),供给型(27.28%)与需求型工具(26.03%)次之。在具体工具应用上,供给型工具侧重于自身建设(28.79%)与药品采购(24.24%);需求型工具以采购行为规范为主(71.43%);环境型工具则集中在药品监管(29.20%)与组织管理(21.24%)。见表2。
进一步从系统维度看,三类政策工具均将“采购规则”作为核心发力领域(占比25%~27%),其中环境型工具还关注“运行机制”(18.58%),供给型与需求型则分别侧重“保障措施”(18.18%)和“组织保障”(17.46%)。见表3。
整体而言,当前政策体系注重运用环境型工具构建制度框架,同时结合供给型与需求型工具细化规则设计与执行保障。
通过直接校准法,校准锚点设定:完全非隶属(10%)、交叉点(50%)、完全隶属(90%),具体数值见表4。此外,为避免案例隶属度恰好为0.50而导致计算过程中的数据丢失,本文将得到的隶属度统一加上0.001常数。
当一致性超过0.9,则该条件被视为必要条件。必要条件分析结果显示,药品采购、采购行为规范、药品价格调整、行业标准、药品监管的一致性分别为0.966、0.934、1.000、0.963、0.948,确认为必要条件。见表5。
为探究药品集采实施效果的多元实现路径,先将样本频数阈值设为1.00,再将一致性阈值设为0.80;若某条件变量一致性大于0.90,则强制设为“必须存在”。借助fsQCA生成复杂解、中间解与简单解,并以中间解为主、简单解为辅进行组态解读[14]:仅在中间解出现的前因条件视为边缘条件,同时在两解中出现则为核心条件。中间解结果见表6。
结果表明,存在多条差异化路径均呈现高实施效果,总体解的一致性为0.983,覆盖度为0.707,说明这些前因构型充分解释了样本中超过70%的成功案例,且结果可靠性较强。见表7。
研究发现,实现高水平药品集采效果可分为两类路径:一类为“核心驱动型”(组态1~3),均具备自身建设、采购规范及资质认定等核心制度要素;即使在人才培养、财政支持、药品信息服务等辅助条件缺失时,仍能实现高效果(一致性>0.979)。这表明制度因素在政策执行中占主导,资源缺失可通过强化核心机制弥补。其中,组态1覆盖度最高,为0.579,最具普适性;组态2和3引入组织管理,进一步强化解释力。
另一类为“全面保障型”(组态4),要求全部13项条件均存在,一致性达1.000,属理论上充分完美的配置,但原始覆盖度仅0.425,说明实践适用范围有限,更宜作为理想参照,而非普遍推行方案。
fsQCA属于集合论方法,运算中的微小调整不会改变实质性结论[15],本研究将一致性阈值从0.80微调至0.85(其余参数不变),所得组态与原有解释完全一致,表明结果稳健可靠。
当前政策工具结构存在失衡。环境型工具占比最高,供给型与需求型工具相对不足,尤其在人才培养和药品信息服务方面存在短板。建议优化工具结构,加强供给型工具与需求型工具投入,改善“重监管、轻服务”倾向。
fsQCA表明,药品采购、采购行为规范、价格调整、行业标准及药品监管是政策有效实施的必要条件,体现了“机制优先于资源”原则。建议在资源有限地区优先夯实制度基础,强化药品监管与人才培养;在资源较充足地区,则可整合财政、人才与信息服务,形成多维协同。
为提升集采效能,建议推动采购平台向“综合服务中心”转型、完善药品全生命周期质量追溯、建立科学透明的价格形成机制以及统一行业标准与采购规范的同时,着力解决当前政策中行政依赖强、市场调节不足、数据共享不畅及医疗机构激励不完善等问题。未来应重点从三方面推进改革:完善市场机制并优化配套资源、构建数据驱动的协同管理平台、设计激励相容的考核与补偿制度,以统筹控费与创新、效率与公平。
需要指出,本研究仍存在一定局限,如样本仅涵盖国家层面政策,未来可纳入地方实践以增强普适性;政策效果的长期影响也需进一步追踪。总体而言,本研究为政策优化提供了依据,未来政策应在保持框架稳定性的同时增强执行弹性,以实现多元目标。
  • 内蒙古开展国家区域医疗中心建设研究(2024ZZB066)
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2026年第53卷第3期
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doi: 10.20043/j.cnki.MPM.202507180
  • 接收时间:2025-07-14
  • 首发时间:2026-11-02
  • 出版时间:2026-02-10
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  • 收稿日期:2025-07-14
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内蒙古开展国家区域医疗中心建设研究(2024ZZB066)
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    内蒙古医科大学卫生管理学院,内蒙古 呼和浩特 010110

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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
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