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Notice by the General Office of the State Council of Issuing the Pilot Program of the Centralized Procurement and Use of Drugs Organized by the State [Effective]
国务院办公厅关于印发国家组织药品集中采购和使用试点方案的通知 [现行有效]
【法宝引证码】

Notice by the General Office of the State Council of Issuing the Pilot Program of the Centralized Procurement and Use of Drugs Organized by the State 

国务院办公厅关于印发国家组织药品集中采购和使用试点方案的通知

(No. 2 [2019] of the General Office of the State Council) (国办发〔2019〕2号)

People's governments of all provinces, autonomous regions and municipalities directly under the Central Government, all ministries and commissions of the State Council and all institutions directly under the State Council: 各省、自治区、直辖市人民政府,国务院各部委、各直属机构:
The Pilot Program of the Centralized Procurement and Use of Drugs Organized by the State (hereinafter referred to as the Program) has been approved by the State Council and is hereby issued to you for your conscientious compliance and implementation. 《国家组织药品集中采购和使用试点方案》(以下简称《方案》)已经国务院同意,现印发给你们,请认真贯彻执行。
All pilot cities shall, in accordance with the requirements of the Program and in light of the actual conditions, develop implementation plans and supporting policies, strengthen organization and leadership, fulfill responsibilities level by level and effectively carry out publicity, guidance and risk prevention to ensure the implementation of various tasks set forth in the pilot program. Relevant provinces shall closely follow up the implementation of the pilot program, actively create conditions, give support to pilot cities, and strengthen guidance, supervision and evaluation. 各试点城市要按照《方案》要求,结合实际制定实施方案和配套政策,加强组织领导,层层压实责任,做好宣传引导和风险防范,确保落实试点各项任务。相关省份要密切跟踪试点落实情况,积极创造条件,给予试点城市支持,并加强指导、监督和考核。
All relevant departments and entities shall, according to the requirements of the division of labor, further detail their work and loose no time in developing concrete measures and clarifying the schedule so that they may advance the implementation on an item-by-item basis. In the case of the work involving multiple departments, the leading authorities shall strengthen coordination, and relevant departments shall cooperate closely. It is important to enhance the overall concept and strengthen communication and cooperation. Specifically, the relevant work shall be arranged and supervised and the results shall be provided. The office of the pilot group for the centralized procurement and use of drugs organized by the state shall, together with other relevant departments, effectively conduct monitoring and analysis, regular notification, supervision and inspection and summary and evaluation, and carry out key inspections over the pilot regions featuring slow progress and less obvious results. And major problems shall be reported to the State Council in a timely manner. 各有关部门和单位要按照分工要求,进一步分解细化涉及本部门本单位的工作,抓紧制定具体措施,明确进度安排,逐项推进落实。涉及多个部门的工作,牵头部门要加强协调,相关部门要密切配合。要增强全局观念,加强沟通协作,做到有布置、有督查、有结果。国家组织药品集中采购和使用试点工作小组办公室要会同相关部门做好监测分析、定期通报、督促检查、总结评估等工作,对进度缓慢、成效不明显的试点地区要开展重点督查,重大问题及时向国务院报告。
General Office of the State Council 国务院办公厅
January 1, 2019 2019年1月1日
Pilot Program of the Centralized Procurement and Use of Drugs Organized by the State 国家组织药品集中采购和使用试点方案
This Program is developed in accordance with the arrangements of the CPC Central Committee and the State Council to deepen reform of the pharmaceutical and health care systems, improve the drug pricing mechanism, and carry out the pilot program of the centralized procurement and use of drugs organized by the State. 根据党中央、国务院部署,为深化医药卫生体制改革,完善药品价格形成机制,开展国家组织药品集中采购和使用试点,制定本方案。
I. Overall Requirements   一、总体要求
(1) Objectives and tasks. The State will organize the centralized procurement and use of drugs on a trial basis by selecting pilot varieties from the generic names corresponding to generic drugs passing consistency evaluation of quality and efficacy (hereinafter referred to consistency evaluation, including those approved and marketed according to the registration and classification of chemical drugs) in 11 Chinese cities: Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu, and Xi'an, so as to significantly lower drug prices and reduce the patients' burden of drug costs. The centralized procurement and use of drugs reduces enterprise transaction cost, purify circulation environment, and improve industry ecology; moreover, it encourages medical institutions to regulate drug use and supports the reform of public hospitals. It helps explore ways to improve the centralized drug procurement mechanism and the market-based drug pricing mechanism. (一)目标任务。选择北京、天津、上海、重庆和沈阳、大连、厦门、广州、深圳、成都、西安11个城市,从通过质量和疗效一致性评价(含按化学药品新注册分类批准上市,简称一致性评价,下同)的仿制药对应的通用名药品中遴选试点品种,国家组织药品集中采购和使用试点,实现药价明显降低,减轻患者药费负担;降低企业交易成本,净化流通环境,改善行业生态;引导医疗机构规范用药,支持公立医院改革;探索完善药品集中采购机制和以市场为主导的药品价格形成机制。
(2) General thought. The general thought of “organization by the State, procurement by alliances and operation by platforms” shall be followed. That is, the State formulates basic policies, scope and requirements, organizes pilot regions to form alliances, and explores the centralized quantity-specific procurement among trans-regional alliances by taking public medical institutions in the regions that have the alliances as centralized procurement entities. On the basis of the summarization and evaluation of the pilot work, the coverage of centralized procurement shall be gradually expanded to guide society to form long-term and stable expectations. (二)总体思路。按照国家组织、联盟采购、平台操作的总体思路,即国家拟定基本政策、范围和要求,组织试点地区形成联盟,以联盟地区公立医疗机构为集中采购主体,探索跨区域联盟集中带量采购。在总结评估试点工作的基础上,逐步扩大集中采购的覆盖范围,引导社会形成长期稳定预期。
(3) Basic principles First, the “People First” approach shall be adopted to satisfy the demand for clinical medication, effectively lessen the burden of patients and ensure the quality and supply of drugs. Second, relevant policies and regulations shall be strictly implemented in accordance with laws and regulations to ensure that special procurement procedures are performed in a standardized, open and transparent manner. In doing so, they can accept the whole-process supervision of all parties. Third, the market mechanism shall be combined with the role of the government. The market-based drug pricing mechanism shall be respected, and at the same time the role of the government shall also be maximized in setting up platforms, promoting connectivity, ensuring supply and strengthening supervision. Fourth, a smooth and proper transition shall be ensured to effectively deal with the relationship between the pilot work and existing procurement policies. (三)基本原则。一是坚持以人民为中心,保障临床用药需求,切实减轻患者负担,确保药品质量及供应。二是坚持依法合规,严格执行相关政策规定,确保专项采购工作程序规范、公开透明,全程接受各方监督。三是坚持市场机制和政府作用相结合,既尊重以市场为主导的药品价格形成机制,又更好发挥政府搭平台、促对接、保供应、强监管作用。四是坚持平稳过渡、妥当衔接,处理好试点工作与现有采购政策关系。
II. Scope and form of centralized procurement   二、集中采购范围及形式
(1) Participants. Any manufacturer of the drugs (The national general agency of an imported drug shall be deemed as the manufacturer) covered by centralized procurement that are marketed in mainland China after the approval of the national drug supervision may participate. (一)参加企业。经国家药品监督管理部门批准、在中国大陆地区上市的集中采购范围内药品的生产企业(进口药品全国总代理视为生产企业),均可参加。
(2) Scope of drugs. Pilot varieties shall be selected from the generic drugs passing the consistency evaluation. (二)药品范围。从通过一致性评价的仿制药对应的通用名药品中遴选试点品种。
(3) Selection criteria. It includes quality criteria and supply criteria. The quality criteria mainly focuses on the clinical efficacy, adverse reactions, batch stability of drugs. In principle, it is based on the consistency evaluation. The supply criteria mainly places emphasis on enterprises' production capacity, supply stability and so forth. Those that ensure the supply of procurement in pilot areas may be selected. The specific indicators for selection criteria shall be developed by the joint procurement office. (三)入围标准。包括质量入围标准和供应入围标准。质量入围标准主要考虑药品临床疗效、不良反应、批次稳定性等,原则上以通过一致性评价为依据。供应入围标准主要考虑企业的生产能力、供应稳定性等,能够确保供应试点地区采购量的企业可以入围。入围标准的具体指标由联合采购办公室负责拟定。
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