Page 14 - 《中国药房》2022年2期

·药事管理·

我国药品及医用耗材集中带量采购政策的实施现状及建议 Δ

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张秋玉 ，王 芸，胡元霞，禄晓龙（贵州医科大学医药卫生管理学院，贵阳 550025）
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中图分类号 R95 文献标志码 A 文章编号 1001-0408（2022）02-0136-06
DOI 10.6039/j.issn.1001-0408.2022.02.02
摘 要 目的 为完善我国药品及医用耗材（以下简称“耗材”）集中带量采购（以下简称“集采”）工作提供参考和建议。方法 检索
2018年11月－2021年11月我国出台的药品及耗材集采相关政策文件，运用政策分析法并参照相关研究文献，分析我国集采政策
的实施现状及问题。结果与结论 国家卫生健康部门和医疗保障部门通过激励和监督措施来保障医疗机构合理使用中选产品；医
疗保障部门通过优化医保支付方式，促进医疗机构自主控费，并做好招标采购信用评价；药品监督管理部门负责药品一致性评价
和中选产品质量监管工作。随着国家组织和省际跨区域联盟药品及耗材集采工作的常态化推进，纳入集采的药品品种和剂型日
益符合我国医药市场需求；大部分中标药品的价格降幅超过了50％，且耗材降幅明显高于药品；药品中选企业以国内仿制药企业
为主，国产耗材逐步成为了进口耗材的竞争和替代品。但目前仍存在各联盟和各省（自治区、直辖市）重复招标采购、医疗机构补
偿机制建设情况不明确、耗材招标采购规则和质量评价标准不统一、部分耗材国产化率低、药品及耗材生产企业创新水平和盈利
能力低等问题。应鼓励地方集采工作，逐步建立“一品一策”的招标采购规则和质量评价标准；注重医疗机构补偿机制建设，规范医疗
服务价格动态调整工作；促进药品和耗材生产企业加大研发投入，向自主创新、高技术含量型企业转型，从而提高国产药品及耗材的
市场竞争力。
关键词 集中带量采购；药品；医用耗材；现状；建议；政策分析法
Implementation status and suggestions of centralized volume-based procurement policy for drugs and
medical consumables in China
ZHANG Qiuyu，WANG Yun，HU Yuanxia，LU Xiaolong（School of Medical and Health Management，Guizhou
Medical University，Guiyang 550025，China）

ABSTRACT OBJECTIVE To provide reference and suggestions for improving the volume-based procurement of drugs and
medical consumables （hereinafter referred to as “consumables”） in China. METHODS The relevant policy documents of
centralized volume-based procurement of drugs and consumables published from November 2018 to November 2021 were retrieved；
the implementation status and problems of centralized volume-based procurement of drugs and consumables in China were analyzed
by using the policy analysis method and referring to relevant research literatures. RESULTS & CONCLUSIONS National health
department and healthcare security administration guaranted the rational use of selected products in medical institutions through
incentive and supervision measures；healthcare security administration should optimize the way of medical insurance payment，
promote the medical institutions to control the fees by themselves，and conduct the credit evaluation of bidding and procurement；
medical products administration should evaluate the consistency of drugs and supervise the quality of selected products. With the
normalization of centralized volume-based procurement of drugs and consumables organized by the state and trans-regional alliance，
the drug varieties and dosage forms included in centralized procurement were increasingly in line with the demand of Chinese
pharmaceutical market. The price of most selected drugs decreased by more than 50％ ，and the decrease of consumables was
significantly higher than that of drugs. The selected enterprises were mainly domestic generic drug enterprises，and domestic
consumables had gradually become the competitors and substitute of imported consumables. However，there were still some
problems such as repeated bidding and procurement in various alliances and provinces（autonomous regions and municipalities），
unclear construction of compensation mechanism in medical institutions，inconsistent bidding and procurement rules and quality
evaluation standards for consumables，low localization rate of some consumables，low innovation level and profitability of
pharmaceutical enterprises and consumables manufacturers. Local centralized volume-based procurement should be encouraged，and
the bidding and procurement rules and quality evaluation standards of“one product，one policy”should be gradually established.
Great importance should be paid to the construction of
Δ 基金项目：国家社会科学基金项目（No.19XGL005）
compensation mechanism of medical institutions，standardize
＊硕士研究生。研究方向：药事管理学、卫生经济学。E-mail：
zhangqiuyu739632@126.com the dynamic adjustment of medical service prices；pharma-
# 通信作者：副教授，硕士生导师。研究方向：卫生经济学、医疗 ceutical enterprises and consumables manufacturers should
保险。E-mail：xiaolong_lu2006@126.com increase research and development investment to transform

·136 · China Pharmacy 2022 Vol. 33 No. 2 中国药房 2022年第33卷第2期