General office of the state council about perfect public hospital drug centralized purchasing work guidance 
 
 

The 2015-02-28 national health and population and family planning commission of the People's Republic of China 

Countries do hair [2015] no. 7 

The provinces, autonomous regions and municipalities directly under the central government, ministries under the state council, directly affiliated institutions:
 
    Improve public hospital drug centralized purchasing is an important content of deepening the reform of medical health system and the key link, to speed up the reform of public hospitals, standardize the order of drug circulation, establish a sound system for basic drugs based drug supply security system is of great significance. Agreed to by the state council, now is perfect public hospital drug centralized purchasing work put forward the following guidance.
 
    First, general idea
 
    Comprehensively implement the party's 18 large and 18 fourth plenary session of 2, 3, spirit, according to the market plays a decisive role in the allocation of resources and better give play to the role of the government's general requirements, draw lessons from international drug procurement practice, fully absorb the essential medicines procurement experience, adhere to provinces (autonomous regions and municipalities) as the unit of the online drug centralized purchasing direction, implement a platform, the classification of the upper and lower linkage, open and transparent, procurement, production enterprises, move and oneness, pegged to the quantity and price, double envelope system, monitor the whole process, strengthen the regulation of drug purchase process comprehensive, ensure drug quality and supply. Encouraging local practical exploration innovation, further improve the hospital participation in the drug purchase.
 
    Drug centralized purchasing to help dispel to medicine medical mechanism, accelerate the reform of public hospitals especially public hospitals at the county level; Reducing drug prices artificially high, reduce the financial burden on the people use; Is beneficial to prevent and curb corruption, drug distribution areas, against commercial bribery; Will be conducive to the drug production integration of restructuring, the fair competition of enterprises and promote the healthy development of the pharmaceutical industry.
 
    Second, the implementation of drug classification procurement
 
    (a) for clinical use, the purchase amount is high, the enterprise production and a number of essential drugs and generic drugs, giving full play to the advantages of provincial focus on the batch purchase, by provincial drug procurement agencies to adopt double envelope system of public bidding procurement, hospital as the principal part of the procurement according to the bidding price for medicines.
 
    Implement with quantity purchase. Hospital according to not 80% below last year's actual usage of drug purchasing plan and budget, and specific to the varieties, types and specifications, dosage forms for each drug purchase, in principle, shall not exceed 3 kinds, each corresponding specifications in principle no more than two kinds of dosage forms, both adults and children need. Provincial drug procurement agencies should summary according to the requirements of hospital drug use situation, prepare the list of public bidding procurement, reasonable drug purchase quantity of each bidding grouping, and publish to the society.
 
    We will further improve the double envelope evaluation method. Pharmaceutical producing enterprises must at the same time of the bidding economic and commercial tender technical tender document. Economic technical tender document is mainly to the enterprise of pharmaceutical production quality management practices (GMP) certification, drug quality to sample random sampling, the scale of production, distribution, sales, market reputation, electronic regulation ability index for review, and will be sent to you by the pharmaceutical production quality management standard (revised in 2010) certification, the European Union, the United States, Japan and other developed countries (regions) appear on the market sales, standardization of dosage forms, specifications, packing and so on as an important indicator. Through economic and technical bid evaluation of enterprises in the commercial tender review. During the commercial bid evaluation, bid the same packet according to the quotation from low to high select the bid-winning enterprises and candidate won the bid. For a strikingly low bid price, quality and supply risk of possible drugs, must make a comprehensive assessment, and avoid vicious competition. Prior purchasing reached the international level of generic drugs.
 
    In the reform of public hospitals pilot cities, allowing for city unit in the provincial drug centralized purchasing platform to purchase. Pilot cities to clinch a deal price shall not be higher than the provincial level the bid price. Pilot city clinch a deal the price obviously lower than the bidding price at the provincial level, provincial bidding price should be according to the pilot city clinch a deal the price adjustment, the specific measures shall be formulated by the provinces (autonomous regions and municipalities).
 
    (2) on the part of the patent medicines, the sole drug production, establish a transparent, participating mechanism of price negotiation. Negotiation result on national drug supply security integrated management information platform, hospital drug procurement according to the negotiation result.
 
    (3) for children's specialized generic drugs, urgent (rob) deliver drugs, infusion, small clinical dosage of drugs (determined by provincial) for the specific scope of the drug and the commonly used drugs at a lower price, centralize and hanging nets, procurement directly by the hospital.
 
    (4) to the clinical need, small dosage, the market supply shortages of medicines, bidding fixed-point production, bargaining procurement by the state.
 
    (5) of narcotic drugs, psychotropic drugs, free drug prevention and control of infectious diseases and parasitic diseases, national immunization programmes vaccines, drugs and Chinese medicine yinpian, family planning according to the existing provisions of the state procurement, to ensure open and transparent.
 
    Hospitals use all of the drugs (not including Chinese medicine yinpian) shall be through the provincial drug centralized purchasing platform. Drug procurement agencies at the provincial level shall collect hospital reported purchasing plan and budget, based on the national list of essential medicines list, medical insurance drugs, basic drugs clinical practice guidelines and prescription sets, etc., in accordance with the principle of the reasonable formulation of the administration of hospital drug procurement directory, classification specified in the tender purchase drugs, negotiation purchasing drugs, hospital directly purchase drugs, fixed-point production of drugs, etc. Encourage the provinces across regions, such as specialized subject hospital joint procurement. Last year a procurement cycle principle. Newly approved drugs for purchasing cycle, according to the need for disease control and prevention, around after drug economics and evidence-based medicine evaluation, further organization units of provinces, autonomous regions and municipalities directly under the centralized purchasing.
 
    Three, improve YaoKuan settlement way
 
    (a) in order to strengthen the management of drug purchase and sale contract. Hospital drug procurement contracts shall specify when purchasing varieties, dosage form, specification, price, quantity, delivery batch and time limit, the method of payment and settlement time, etc. The number of procurement contract should be the purchasing plan to declare all the purchases a procurement cycles.
 
    (2) regulate drug payment. Hospital drug revenues and expenditures shall be included in the budget management, in strict accordance with the contract, the time of payment from the delivery of the goods to the acceptance of payment shall not exceed 30 days. Relying on and play the provincial drug centralized purchasing platform the advantage of centralized payment and settlement, encourage hospital and pharmaceutical production enterprise direct settlement drugs and drug production and distribution enterprise settlement distribution costs.
 
    Fourth, strengthen the management of drug delivery
 
    (a) pharmaceutical production enterprise is the first responsible person to ensure drug quality and supply. Medicines can be delivered by the manufacturer directly or entrust a drug-handling enterprise distribution ability distribution to the designated hospital. Pharmaceutical trading enterprises entrusted by the pharmaceutical producing enterprises shall, in the provincial drug centralized purchasing platform for the record, the record to the public. Drug procurement agencies at the provincial level shall timely announce each hospital distribution enterprise list, accept social supervision.
 
    (2) of remote and inaccessible areas of drug delivery, the health to family planning departments at various levels shall strengthen organization and coordination, according to the principle of distance, linkage between urban and rural areas, improve the purchasing, distribution, concentration, make overall hospital with the drug supply and distribution management of grassroots medical institutions. Encourage various practical exploration county country integration and distribution. Giving full play to the advantages of postal logistics services such as network, support their participation in conformity with the conditions stipulated in the drug delivery.
 
    (3) distribution influence not in time for clinical medication or refused to provide distribution services enterprises in remote areas, drug procurement agencies at the provincial level shall be correct in time, and urge the rectification within a time limit. To exceed the time limit not to cancel its bid qualification of the enterprise, thus forced to use other hospital pharmaceutical enterprise substitution, the original bid enterprises should bear the cost overruns, the specific measures shall be formulated by the provinces (autonomous regions and municipalities).
 
    Five, standardize procurement platform construction
 
    (a) provincial drug procurement agencies in charge of provincial drug centralized purchasing platform, management and maintenance, the use of people's governments of provinces, autonomous regions and municipalities to give the necessary manpower, financial and material support, ensure the normal operation of the work.
 
    (2) set up the mechanism of drug purchase data sharing, unified provincial drug centralized purchasing platform standardization construction standards, promote the standardization of drug purchase code, to achieve national drug supply security integrated management information platform, the provincial drug centralized purchasing platform, hospitals, insurance agency orgnaization, the competent department of price information such as data connectivity, the sharing of resources.
 
    (3) the provincial drug centralized purchasing platform for all levels of hospitals and pharmaceutical production enterprises to provide services, improve the drug bidding procurement, distribution management, evaluation, statistical analysis, dynamic regulation ability, collect analysis of hospital drug purchase price, quantity, lead times and pharmaceutical production enterprise distribution, record, and so on and so forth, must be regularly publish to the society. Encourage conditional place to carry out the electronic trading, introduce by drug centralized purchasing platform electronic contracts, online payment, such as a variety of ways, saving transaction costs, improve transparency.
 
    Sixth, strengthening comprehensive supervision and management
 
    (a) to strengthen the medical staff training and examination for the rational use of drugs, pharmacists should play the role of medication guide, regulate the behavior of doctors' prescriptions, effectively reduce the unreasonable drug use. Build system of prescription reviews and doctors questioning, focus tracking monitoring auxiliary medication, hospital extraordinary use of drugs. To establish and perfect, with emphasis on the basic drugs, the synthetic evaluation system of clinical medicine, we will promote standardization of drug dosage forms, specifications and packaging.
 
    (2) in provinces, autonomous regions and municipalities directly under the unit, select a number of hospitals and shortage of grassroots medical institutions as drug monitoring, timely analysis of drug supply and demand information collection, shortage of strengthen the drug monitoring and early warning.
 
    (3) the drug centralized purchasing situation as an important examination, head of the hospital and its content, into the target management and the evaluation of the hospital evaluation work. For illegal offline purchase, delay payment of the hospital, depending on the seriousness give notification criticism, rectification within a time limit, shall be ordered to pay liquidated damages, such as lower level processing. Relating to the commercial bribery and other corruption, serious punishment in accordance with the law.
 
    (4) strengthen the supervision and inspection of drug price implementation, strengthen the investigation and market sales price monitoring drug cost, standard price behavior, protecting the legal rights and interests of patients. Investigate illegal pricing and monopoly behavior in accordance with the law, as well as forge or falsely making out invoice, the affiliated business, such as "tickets" illegal behaviors. Strengthen the focus on drug quality tracking and quality regulation, crack down on producing fake medicines.
 
    (5) the strict integrity records and repel the market system. The provinces (autonomous regions and municipalities) to establish and perfect the system of inspection supervision, establishing pharmaceutical production enterprise credit record and publish to the society in a timely manner. To record list of the enterprises, the hospital two years may not buy their medicines. To strengthen hospital, pharmaceutical production enterprises to fulfill the medical and health institutions pharmaceutical products clean procurement contract situation of supervision.
 
    (6) the all-round information disclosure, ensure that every link of drug purchase to run in the sun. Build system of prize report, consciously accept the oversight of National People's Congress, the Chinese people's political consultative conference (CPPCC) and the social from all walks of life. Adhere to the unified national market, maintaining the fair competition environment, against all forms of protectionism.
 
    Seven, strengthen the organization and leadership
 
    (a) and implement the responsibilities for all parties. The provinces (autonomous regions and municipalities) people's government to strengthen organizational leadership and supervision assessment, in a timely manner on the major problems in drug centralized purchasing work. Health planning, development and reform, human resources, social security, finance, commerce, industry and information technology, industry and commerce, food and drug supervision, insurance supervision and other relevant departments to do their job, close cooperation, form the joint effort. To orgnaization of agency of insurance, business insurance institutions in accordance with the provisions, and medical institutions in a timely manner and in full settlement of medical expenses.
 
    (2) carefully organize their implementation. The provinces (autonomous regions and municipalities) to in accordance with the spirit of this opinion, to formulate local public hospital drug centralized purchasing plan, in 2015 a new round of comprehensive drug purchase. Provincial drug procurement agencies to conscientiously do a good job in the local drug centralized purchasing organization management and the concrete implementation. Place can be combined with the actual, according to this opinion clearly in the general idea of the "four benefits" principle, to explore the cross-regional joint procurement of a variety of forms. Military hospital drug centralized purchasing measures shall be formulated by the competent department of health research.
 
    (3) strengthen the integrity risk prevention. To strengthen the regulation of drug procurement agencies at the provincial level, and improve the drug procurement agencies at the provincial level supervision and external supervision mechanism, insist on a system of right of tube charge pipe, strengthen the integrity education practitioners, continuously improve business ability and sense of integrity. Power monitoring mechanism, realize the mutual restriction and coordination of power, the important positions and personnel regular job rotation system.
 
    (4) completes the propaganda of public opinion guide. Drug centralized purchasing work involving multiple interests adjustment, all localities and departments must adhere to the correct guidance, strengthening the policy interpretation and public opinion guide, fully promote drug centralized procurement policy direction, significance, measures and results, appropriate response to social concern, create a good social atmosphere. 

The state council general office
 
On February 9, 2015