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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
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| 篇名： | 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 |
| TITLE： | Implementation status and suggestions of centralized volume-based procurement policy for drugs and medical consumables in China |
| 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。 |
| ABSTRACT： | OBJECTIVE To provid e reference and sugge stions 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 compensation mechanism of medical institutions ，standardize zhangqiuyu739632@126.com the dynamic adjustment of medical serv ice prices ；pharma- ceutical enterprises and consumables manufacturers should increase research and development investment to transform into innovative and diversified enterprises ，so as to improve the competitiveness of domestic drugs and consumables. |
| 期刊： | 2022年第33卷第02期 |
| 作者： | 张秋玉，王芸，胡元霞，禄晓龙 |
| AUTHORS： | ZHANG Qiuyu，WANG Yun，HU Yuanxia ，LU Xiaolong |
| 关键字： | 集中带量采购；药品；医用耗材；现状；建议；政策分析法 |
| KEYWORDS： | centralized volume-based procurement ；drugs；medical consumables ；status；suggestions；policy analysis |
| 阅读数： | 1621 次 |
| 本月下载数： | 61 次 |
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