Measures for the Supervision and Administration of Centralized Procurement of Pharmaceutical Products

药品集中采购监督管理办法

Promulgating Institution: State Council Office for Rectifying Business Misconducts; Ministry of Health; National Development and Reform Commission; Ministry of Supervision; Ministry of Finance; State Administration of Industry and Commerce; State Food and Drug Administration

Document Number:Guo Jiu Ban Fa [2010] No. 6

Promulgating Date: 06/02/2010

Effective Date: 06/02/2010

颁布机关: 国务院纠正行业不正之风办公室; 卫生部; 国家发展和改革委员会; 监察部; 财政部;国家工商行政管理总局; 国家食品药品监督管理局

文      号: 国纠办发[2010]6号

颁布时间: 06/02/2010

实施时间: 06/02/2010

Chapter 1: General Provisions

第一章  总则

  Article 1   These Measures are formulated in accordance with relevant laws and regulations for the purposes of strengthening the supervision and administration of the government-led, and province (autonomous region, or municipality directly under the Central Government)- based centralized online procurement of pharmaceutical products, and regulating the acts of centralized procurement of pharmaceutical products.

       第一条  为加强对以政府为主导,以省、自治区、直辖市为单位的网上药品集中采购工作的监督管理,规范药品集中采购行为,依据有关法律法规,制定本办法。

  Article 2   The supervision and administration of centralized procurement of pharmaceutical products shall comply with the principles of "seeking truth from facts, abiding by the law, combining punishment with prevention, and focusing on prevention", and shall stick to a combination of strengthening supervision with regulating the administration.

       第二条  药品集中采购监督管理工作遵循实事求是、依法办事、惩防结合、预防为主的原则,坚持加强监督与规范管理相结合。

  Article 3   With regard to the supervision and administration of centralized procurement of pharmaceutical products, a leadership or work mechanism shall be adopted wherein different levels of authorities are responsible for different issues, the provincial authorities take the main responsibility, and relevant functional departments have different responsibility scope respectively according to their statutory powers and cooperate with each other closely.

       第三条  药品集中采购监督管理工作实行分级负责、以省级为主,相关职能部门按照法定权限各负其责、密切配合的领导体制和工作机制。

  Article 4   The supervision and administration authorities for centralized procurement of pharmaceutical products shall make known to the public the supervision and administration system, clarify the work procedures, and voluntarily accept the supervision of the public.

       第四条  药品集中采购监督管理机构应当公开监督管理制度，明确办事程序，自觉接受社会监督。

Chapter 2: Supervision and Administration Authorities and Their Duties and Responsibilities

第二章  监督管理机构及职责

  Article 5   The Joint Ministerial Meeting for Rectifying Misconducts in Medicine Purchase and Sale and Medical Services shall be responsible for the organization and coordination of the nationwide supervision and administration of centralized procurement of pharmaceutical products, and shall legally see to it that the member entities of the Joint Meeting of Centralized Procurement of Pharmaceutical Products correctly perform their duties and responsibilities. It shall supervise and urge the people's governments at lower levels and the relevant departments to carefully implement the decisions and policies of their superior authorities relating to centralized procurement of pharmaceutical products, and investigate and deal with breach of law and regulations in centralized procurement of pharmaceutical products. Each province, autonomous region, and municipality directly under the Central Government may, according to the actual situation of their local area, determine the organizational form and basic duties and responsibilities of the supervision and administration authorities for centralized procurement of pharmaceutical products.

       第五条  纠正医药购销和医疗服务中不正之风部际联席会议负责全国药品集中采购监督管理的组织协调,依法监督药品集中采购工作联席会议成员单位正确履行职责,督促下级人民政府及相关部门认真落实上级关于药品集中采购的决策部署,检查药品集中采购政策和规章制度的贯彻落实情况,调查处理药品集中采购中的违法违规问题。各省、自治区、直辖市可根据本地区实际,确定药品集中采购监督管理机构的组织形式和基本职责。

  Article 6   The supervision authorities and misconduct rectification offices shall be responsible for supervising and monitoring the performance of duties and responsibilities by the departments participating in the centralized procurement of pharmaceutical products, and supervising the acts of public servants of administrative organs, and other persons appointed or employed by State administrative organs that are involved in centralized procurement of pharmaceutical products, and investigating and punishing acts violating administrative disciplines.

       第六条  监察机关和纠风办负责对药品集中采购工作参与部门履行职责的情况进行监察,对药品集中采购工作中的行政机关公务员以及由国家行政机关任命或选聘的其他人员的行为进行监督,对违反行政纪律的行为进行查处。

  Article 7   The health administrative departments shall be responsible for supervising and administering the medical institutions in the procurement of medicine from the shortlisted products, and their performance of contract, etc.

       第七条  卫生行政部门负责监督管理医疗机构执行入围结果、采购用药及履行合同等行为。

  Article 8   The pricing departments shall be responsible for supervising and administering the pricing and charging acts during the centralized procurement of pharmaceutical products.

       第八条  价格管理部门负责监督管理药品集中采购过程中的价格、收费行为。

  Article 9   The finance departments shall be responsible for organizing the implementation of corresponding finance supervision.

       第九条  财政部门负责组织实施相应的财政监督。

  Article 10   The administrative departments in charge of industry and commerce shall be responsible for investigating and punishing unfair competition acts such as commercial bribery, illegal sales promotions, and fraudulent publicity during the centralized procurement of pharmaceutical products.

       第十条  工商行政管理部门负责查处药品集中采购中的商业贿赂、非法促销、虚假宣传等不正当竞争行为。

  Article 11   The food and drug supervision and administration departments shall be responsible for examining the qualifications of the medicine production and operation enterprises participating in the centralized procurement of pharmaceutical products, and supervising and administering the quality of the pharmaceutical products that are purchased in a centralized manner.

       第十一条  食品药品监督管理部门负责审查参与药品集中采购的药品生产经营企业资质，依法对集中采购的药品质量进行监督管理。

Chapter 3: Target, Content, and Way of Supervision and Administration

第三章  监督管理的对象、内容和方式

  Article 12   The targets of supervision and administration in centralized procurement of pharmaceutical products shall be:

(1) Governmental departments and public servants that organize the centralized procurement of pharmaceutical products;

(2) The entities, their staff and employees that implement the centralized procurement of pharmaceutical products; and

(3) Medical institutions, medicine production and operation enterprises, and their staff, participating in centralized procurement of pharmaceutical products.

       第十二条  药品集中采购监督管理的对象是:

    (一)组织药品集中采购的政府部门和公务员;

    (二)实施药品集中采购的单位及其工作人员和选聘人员;

    (三)参与药品集中采购的医疗机构、药品生产经营企业及其工作人员。

  Article 13   The main contents of the supervision and administration of centralized procurement of pharmaceutical products shall be:

(1) The relevant departments' lawful performance of duties and responsibilities, implementation of superior authorities' deployment, and their cooperation and coordination with each other, etc.;

(2) Implementing the relevant provisions on centralized procurement of pharmaceutical products by medical institutions;

(3) Compliance with the principles of openness, fairness, impartiality, and "quality-first and reasonable price ";

(4) The relevant entities and individuals' compliance with the laws and regulations and their honesty and cleanliness in work;

(5) Medical institutions' participation in centralized procurement of pharmaceutical products and their use of shortlisted pharmaceutical products according to the contract; and

(6) Medicine production and operation enterprises' lawful participation in bidding and performance of procurement and distribution contract.

       第十三条  药品集中采购监督管理的主要内容是:

    (一)相关部门依法履行职责、执行上级部署、相互协作配合的情况;

    (二)执行医疗机构药品集中采购有关规定的情况;

    (三)坚持公开、公平、公正和“质量优先、价格合理”原则的情况;

    (四)相关单位和个人遵纪守法和廉洁从政从业的情况;

    (五)医疗机构参与药品集中采购并按照合同约定使用入围药品的情况;

    (六)药品生产经营企业依法参与竞标和履行采购配送合同的情况。

  Article 14   The main methods for supervising and administering centralized procurement of pharmaceutical products shall be:

(1) Organizing online supervision and administration, special-purpose examination, and focused supervision and examination;

(2) Accepting complaints, appeals, and reports;

(3) Rectifying, investigating, and punishing illegal or rule-breaking acts and issues, and circulating a notice on typical cases; or

(4) Pushing the relevant departments to establish and improve relevant rules and systems relating to the supervision and administration.

The supervision and administration authorities for centralized procurement of pharmaceutical products may, when performing the supervision and administration duties and responsibilities, access or reproduce the relevant documents, materials, accounts, electronic information data, etc., in accordance with the law, require the relevant entities or persons to make explanations on certain issues, and request the relevant functional departments or professional institutions to render assistance.

       第十四条  药品集中采购监督管理的主要方式是:

    （一）组织网上监管、专项检查和重点督查;

    （二）受理投诉、申诉和举报;

    （三）纠正、查处违法违规行为和问题，通报典型案件;

    （四）推动有关部门建立健全监督管理有关规章制度;

    药品集中采购监督管理机构在履行监督管理职责时，可以依法查阅、复制相关文件、资料、账目、电子信息数据等，要求有关单位或人员就相关问题作出解释说明，商请有关职能部门或者专业机构给予协助。

Chapter 4: Dealing with Illegal or Rule-Breaking Issues

第四章  违法违规问题的处理

  Article 15   If the governmental departments, public servants, or staff that are responsible for organizing the centralized procurement of pharmaceutical products have committed any of the following acts, the relevant supervision authority and misconduct rectification office shall impose punishment in collaboration with other relevant departments in accordance with the law:

(1) Refusing to implement the decisions and deployment legally made by the superior authorities;

(2) Violating the provisions on government-led and province (autonomous region, or municipality directly under the Central Government)-based centralized procurement of pharmaceutical products;

(3) Deciding on any major matters relating to the centralized procurement of pharmaceutical products, in violation of the decision making procedures and provisions;

(4) Carrying out administrative entrustment, or setting discriminating provisions or clauses, in violation of laws and rules;

(5) Violating the provisions on recusal, or manipulating or interfering with the centralized procurement of pharmaceutical products;

(6) Divulging the secrets of the centralized procurement of pharmaceutical products, or misleading or deceiving the leaders and the public;

(7) Setting charging items, charging standards, or apportionment fees, in violation of the relevant provisions;

(8) Extorting or accepting property, seeking unjustified benefits for the entities or for individuals; or

(9) Other illegal or rule-breaking acts.

       第十五条  负责组织药品集中采购的政府部门、公务员及工作人员,有下列行为之一的,由监察机关和纠风办会同有关部门依法给予处理:

    (一)拒不执行上级机关依法作出的决策部署的;

    (二)违反以政府为主导,以省、自治区、直辖市为单位规定组织开展药品集中采购的;

    (三)违反决策程序和规定,决定药品集中采购重大事项的;

    (四)违法违规进行行政委托,或者设置歧视性规定、条款的;

    (五)违反回避规定,或者操纵、干预药品集中采购的;

    (六)泄露药品集中采购工作秘密,或者误导、欺骗领导和公众的;

    (七)违规设定收费项目、收费标准或者摊派的;

    (八)索取或收受钱物,谋取单位或个人不正当利益的;

    (九)其他违法违规行为。

  Article 16   If the governmental departments, relevant entities or their staff or employees that are responsible for implementing the centralized procurement of pharmaceutical products have committed any of the following acts, the relevant supervision authority and misconduct rectification office shall urge the relevant department to impose punishment in accordance with the law:

(1) Carrying out the centralized procurement of pharmaceutical products in violation of the relevant provisions on the way, procedure, time limit requirement, and information release, etc., relating to centralized procurement;

(2) Being negligent in supervision and administration, or setting discriminating conditions in reviewing documentary materials or evaluating and selecting pharmaceutical products;

(3) Building, managing, and using the expert tank in violation of the relevant provisions;

(4) Violating the relevant provisions on information maintenance or security guarantee, or making false report on, concealing facts related to, or unauthorizedly altering, the medicine procurement data information;

(5) Failing to investigate and punish the defaults by medical institutions or medicine production and operation enterprises in a timely manner;

(6) Accepting the invitations for visits, tours of investigation, seminars, etc., which are likely to affect impartiality, or extorting or accepting property, or seeking unjustified benefits for the entities or for individuals; or

(7) Other illegal or rule-breaking acts.

       第十六条  负责实施药品集中采购的政府部门、单位及其工作人员和选聘人员,有下列行为之一的,由监察机关和纠风办督促有关部门依法给予处理:

    (一)违反药品集中采购方式、程序、时限要求和信息发布等有关规定实施药品集中采购的;

    (二)在文件材料审核、药品评审遴选等方面疏于监管或设置歧视性条件的;

    (三)违反规定建设、管理和使用专家库的;

    (四)违反有关信息维护和安全保障规定,或者谎报、瞒报、擅自更改药品采购数据信息的;

    (五)对医疗机构和药品生产经营企业的违约情况调查处理不及时的;

    (六)接受可能有碍公正的参观、考察、学术研讨交流等,索取或收受钱物,谋取单位或个人不正当利益的;

    (七)其他违法违规行为。

  Article 17   If the medical institutions or their staff participating in the centralized procurement of pharmaceutical products have committed any of the following acts, the relevant health administrative department, the administrative department in charge of industry and commerce, or other relevant department shall impose punishment in accordance with the law:

(1) Evading the provisions on the centralized procurement of pharmaceutical products, unauthorizedly purchasing no-shortlisted pharmaceutical products, or failing to organize the selection or procurement of pharmaceutical products in accordance with the prescribed procedures;

(2) Providing false pharmaceutical product procurement information;

(3) Failing to sign procurement contracts in accordance with the relevant provisions, or failing to make the payment according to the schedule;

(4) Failing to implement the price of centralized procurement of pharmaceutical products, re-negotiating price, forcing prices down in a disguised form, or signing supplementary clauses or agreements with the enterprises contravening with the substantial content of the contract;

(5) Accepting kickbacks or seeking unjustified benefits during the procurement, sales, or use of, or payment for pharmaceutical products; or

(6) Other illegal or rule-breaking acts.

       第十七条  参与药品集中采购的医疗机构及其工作人员有下列行为之一的,由卫生行政、工商行政管理等部门依法给予处理:

    (一)规避药品集中采购,擅自采购非入围药品,或者不按规定程序组织选购药品的;

    (二)提供虚假药品采购信息的;

    (三)不按规定签订采购合同,或者不按时回款的;

    (四)不执行集中采购药品价格,二次议价、变相压价,或者与企业再签订背离合同实质性内容的补充性条款和协议的;

    (五)在药品采购、销售、使用和回款等过程中收受回扣或者谋取不正当利益的;

    (六)其他违法违规行为。

  Article 18   If the medicine production or operation enterprises or their staff participating in the centralized procurement of pharmaceutical products have committed any of the following acts, the relevant pricing department, the administrative department in charge of industry and commerce, the food and drug supervision and administration department, or other relevant department shall impose punishment in accordance with the law:

(1) Providing fraudulent certification documents or committing frauds by other means;

(2) Interfering with fair competition through quotation of prices or manipulation of prices in collusion with each other, or conducting unfair competition through illegal sales promotions, commercial bribery, or fraudulent publicity, etc.;

(3) After the varieties of medicine procurement are announced, cancelling the tender or rejecting to sign procurement contracts with the medical institutions for any reason other than force majeure;

(4) Failing to conduct the transactions through the pharmaceutical product centralized procurement platform;

(5) During the procurement cycle, unauthorizedly raising the price or raising the price in a disguised form;

(6) Unauthorizedly distributing non-shortlisted pharmaceutical products, failing to distribute pharmaceutical products in accordance with the contract, or distributing the pharmaceutical products in violation of other provisions; or

(7) Other illegal or rule-breaking acts.

       第十八条  参与药品集中采购的药品生产经营企业及其工作人员有下列行为之一的,由价格管理、工商行政管理、食品药品监督管理等部门依法给予处理:

    (一)提供虚假证明文件或者以其他方式弄虚作假的;

    (二)采取串通报价、操纵价格等手段妨碍公平竞争,或者以非法促销、商业贿赂、虚假宣传等手段进行不正当竞争的;

    (三)公布药品采购品种后,非因不可抗力撤标或拒绝与医疗机构签订采购合同的;

    (四)不通过药品集中采购平台交易的;

    (五)在采购周期内,擅自涨价或者变相涨价的;

    (六)擅自配送非入围药品,不按合同约定配送药品,或者违反有关规定配送的;

    (七)其他违法违规行为。

  Article 19   Where the governmental departments, relevant entities, or medical institutions violate these Measures, they shall be ordered to rectify their wrongdoing and be subject to circulation of a notice of criticism. If the case is of a grave nature, the relevant leaders and responsible persons shall be subject to liabilities in accordance with the disciplines and laws. If the public servants of the administrative organs, or relevant personnel appointed or employed by the State administrative organs, or medical staff violate these Measures, they shall be subject to criticism or education, organizational punishment, or Party disciplinary or politically disciplinary sanctions. If their acts are suspected to have constituted a crime, the case shall be transferred to the judicial authority for handling.

If the medicine production or operation enterprises or their staff violate these Measures, they shall be subject to administrative sanctions in accordance with the relevant provisions. If their acts are suspected to have constituted a crime, the case shall be transferred to the judicial authority for handling.

       第十九条  政府部门、单位和医疗机构违反本办法的，应当责令其纠正错误并通报批评，情节严重的依纪依法对有关领导和责任人进行责任追究。

    行政机关公务员、由国家行政机关任命或选聘的相关人员、医务人员违反本办法的，依照有关规定给予批评教育、组织处理、党纪政纪处分，涉嫌犯罪的，移送司法机关处理。

    药品生产经营企业及其工作人员违反本办法的，依照有关规定给予行政处罚，涉嫌犯罪的，移送司法机关处理。

Chapter 5: Supplementary Provisions

第五章  附则

  Article 20   The supervision and administration authority for centralized procurement of pharmaceutical products of each province, autonomous region, or municipality directly under the Central Government may formulate detailed implementing rules in accordance with these Measures and by taking into account the actual situation of their respective local areas.

       第二十条  各省、自治区、直辖市药品集中采购监督管理机构可以依据本办法,结合本地区实际,制定实施细则。

  Article 21   The State Council Office for Rectifying Business Misconducts shall be responsible for the interpretation of these Measures in collaboration with other relevant departments.

       第二十一条  本办法由国务院纠正行业不正之风办公室会同有关部门负责解释。

  Article 22   These Measures shall become effective on the date of promulgation. The Interim Measures for the Supervision and Administration of Centralized Tendering and Procurement of Pharmaceutical Products by Medical Institutions (Guo Jiu Ban Fa [2001] No. 17) shall be simultaneously repealed.

       第二十二条  本办法自发布之日起施行。《医疗机构药品集中招标采购监督管理暂行办法》（国纠办发〔2001〕17号）同时废止。