摘要
目的:以血液制品为例,探讨特殊类别药品集采规则的差异化设计逻辑,为完善我国药品集中带量采购制度提供实证参考。方法:采用案头研究、实地考察、数据分析与专家调研相结合的方法。结果:血液制品具有原料稀缺、成本结构刚性及生产周期长等特征,集采面临刚性报量与临床动态需求不匹配、降价压力与高成本结构错位、临床支付限制影响可及性等挑战。面对这些挑战,各地在集采规则设计上进行了差异化探索,形成了不同的政策路径。其中,广东联盟实施的差异化集采规则在降价幅度上较为温和,保障了市场格局稳定与供应韧性。结论:血液制品集采应坚持临床价值导向,建立兼顾费用管理目标与供应韧性的精细化治理体系,包括构建弹性报量机制、优化价格形成机制、完善“保质稳供”风险防控体系、同步优化医保支付与临床使用的协同机制,从而系统提升血液制品的供应安全与可及性。
Abstract
Objective:The paper explores the differentiated design logic of centralized procurement rules for special categories of pharmaceuticals using blood products as an example, providing empirical references for improving China’s centralized volume-based procurement system. Methods:The study employed a combination of desk research, field visits, data analysis, and expert interviews. Results:Blood products are characterized by scarce raw materials, inflexible cost structures, and long production cycles. Centralized procurement faces challenges such as mismatches between rigid volume commitments and dynamic clinical demand, conflicts between price reduction pressure and high cost structures, and limitations on clinical payment affecting accessibility. In response to these challenges, various regions have adopted differentiated approaches in the design of centralized procurement rules, forming distinct policy approaches. Among them, the differentiated centralized procurement rules implemented by the Guangdong Alliance have achieved moderate price reductions, effectively ensuring market stability and supply resilience. Conclusion:Centralized procurement of blood products should adhere to a clinical value-oriented approach and establish a refined governance system that balances cost management goals with supply resilience. This includes developing a flexible volume commitment mechanism, optimizing price formation mechanisms, improving a risk prevention and control system centered on “quality assurance and stable supply”, and simultaneously enhancing the coordination between medical insurance payment and clinical use, thereby systematically improving the supply security and accessibility of blood products.
关键词
血液制品 /
集采规则 /
差异化设计 /
弹性报量机制
Key words
blood products /
rules of volume-based drug procurement /
differentiated design /
flexible volume commitment mechanism
江依帆, 陈子礼, 姚童, 孙巧, 王钾鑫, 宣建伟.
血液制品集采规则现状分析与政策优化[J]. 中国医疗保险. 2026, 0(4): 42-51 https://doi.org/10.19546/j.issn.1674-3830.2026.4.004
Centralized Volume-Based Procurement Rules for Blood Products: Current Situation Analysis and Policy Optimization[J]. China Health Insurance. 2026, 0(4): 42-51 https://doi.org/10.19546/j.issn.1674-3830.2026.4.004
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参考文献
[1] 中华人民共和国国务院办公厅.推动药品集中带量采购常态化制度化——进一步减轻群众用药负担[EB/OL].(2021-01-30)[2026-02-11].https://www.gov.cn/zhengce/2021-01/30/content_5583681.htm.
[2] 郭中平. 生物药和生物类似药研究的现状与发展[J].临床药物治疗杂志,2020,18(5):1-6.
[3] 王芳旭,陶立波.生物药集采的特点、难点与政策进展[J].中国医疗保险,2022(4):18-21.
[4] 闫硕.生物类似药集采即将开启300亿元市场迎变[N].21世纪经济报道,2025-08-06(012).
[5] 中华人民共和国卫生部.单采血浆站管理办法[EB/OL].(2008-01-04)[2026-03-03].https://www.gov.cn/zhengce/2008-01/04/content_5713781.htm.
[6] 徐培红,王英姿,干荣富.中国血液制品生产,使用现状及发展趋势分析[J].世界临床药物,2020,41(8):655-663.
[7] 陈淑銮,郑壮荣.基于作业成本法的血液产品成本核算的研究[J].临床输血与检验,2024,26(5):690.
[8] 国家药品监督管理局.关于发布药品生产质量管理规范(2010年修订)血液制品附录修订稿的公告[EB/OL].(2024-06-11)[2026-03-03].https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20240611171530189.html.
[9] 余鼎.中国血液制品现状和挑战——供给侧思考[EB/OL].(2025-07-05)[2026-03-16].https://mp.weixin.qq.com/s?__biz=MjM5NTI3MDE0NQ==&mid=2653774663&idx=1&sn=76b65f90da06000c5cd609ba759c0156.
[10] 广东省药品交易中心.关于发布《广东联盟双氯芬酸等药品集中带量采购文件》的通知[EB/OL].(2025-07-23)[2026-03-03].https://www.gdmede.com.cn/announcement/collect/detail?id=1947954711453765632.
[11] 十九省(区、兵团)联盟采购领导小组办公室.十九省(区、兵团)药品联盟采购公告(三)[EB/OL].(2023-08-16)[2026-03-03].https://ylbz.henan.gov.cn/2023/08-16/2798012.html.
[12] 天津市医药采购中心.关于开展京津冀“3+N”联盟部分西药和中成药带量联动采购有关工作的通知[EB/OL].(2023-09-06)[2026-04-11].https://www.tjmpc.cn/website/home/infoPage?NEWSCOLUMNID=aece0662d48f49b4b178a149c464e4ba&NEWSID=233866e780b04d6794d29c837d1ab4a1.
[13] 江苏省公立医疗机构药品(医用耗材)阳光采购联盟办公室.江苏省第五轮药品集中带量采购公告(一)[EB/OL].(2024-11-08)[2026-03-03].https://ybj.jiangsu.gov.cn/art/2024/11/8/art_73935_11414467.html.
[14] 薛天祺,葛靖,路云,等.全国胰岛素专项集中带量采购规则和中选成效分析[J].健康发展与政策研究,2022,25(1):44-48.
[15] 全国中成药联合采购办公室.关于发布《全国中成药采购联盟集中采购文件》和《全国中成药采购联盟集中采购文件(首批扩围接续)》的公告[EB/OL].(2024-12-01)[2026-03-04].https://ybj.hubei.gov.cn/zfxxgk/zc/qtzdgkwj/202412/t20241201_5432835.shtml.
[16] 渝豫桂琼滇青宁新新疆兵团药品联盟采购办公室.关于发布《渝豫桂琼滇青宁新新疆兵团短缺药品联盟保供稳价带量采购文件》的公告[EB/OL].(2021-05-21)[2026-03-04].https://ylbzj.cq.gov.cn/zwgk_535/gstz/202105/t20210521_9314932.html.
[17] Global Tenders. UK pharmaceutical government procurement analysis2024 [EB/OL].(2025-02-24)[2026-03-04].https://globaltenders.com/blogs/uk-pharmaceutical-government-procurement/.
[18] National Blood Authority (Australia). Managing Blood Supply[EB/OL].(2024-03-27)[2026-03-04].https://www.blood.gov.au/supply-system/managing-blood-supply.
[19] U.S. Department of Veterans Affairs Office of Procurement. PPV Frequently Asked Questions[EB/OL].(2026-01-23)[2026-03-04].https://www.va.gov/opal/nac/ncs/faqPpv.asp.
[20] ANDERSON A, HORSLEY W. Access for All: Ensuring all patients in the UK have access to the best treatments for haemophilia A[EB/OL]. (2022-04-20)[2025-09-02] https://www.england.nhs.uk/blog/access-for-all-ensuring-all-patients-in-the-uk-have-access-to-the-best-treatments-for-haemophilia-a/.
[21] 广东省医疗保障局.请问“人血白蛋白”可以报销吗?[EB/OL].(2025-12-18)[2026-03-04].https://hsa.gd.gov.cn/dawenku/ybypml/content/post_4831383.html.
[22] 国家医疗保障局.第十一批国家组织药品集采开标——中选产品满足临床和患者多元需求[EB/OL].(2025-10-28)[2026-03-04].https://www.nhsa.gov.cn/art/2025/10/28/art_14_18369.html.