The 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 agencies directly under the State Council:
Improving the centralized procurement of drugs in public hospitals is an important part and key link in deepening the reform of the medical and health system. It is of great significance for accelerating the reform of public hospitals, standardizing the circulation order of drugs, and establishing and improving a drug supply guarantee system based on the essential drug system. With the approval of the State Council, the following guidance is hereby provided on improving the centralized procurement of drugs in public hospitals.
1. Overall Idea
Comprehensively implement the spirit of the 18th National Congress of the Communist Party of China and the Second, Third, and Fourth Plenary Sessions of the 18th Central Committee, and follow the market's decisive role in resource allocation. and better play the role of the government, learn from common international drug procurement practices, fully absorb the experience of essential drug procurement, adhere to the direction of centralized online drug procurement based on provinces (autonomous regions and municipalities), and implement one platform, top-down linkage, openness and transparency , classified procurement, and adopt measures such as recruiting production enterprises, integrating recruitment and procurement, linking quantity and price, double envelope system, and full-process monitoring to strengthen comprehensive supervision of the entire process of drug procurement and effectively ensure drug quality and supply. Encourage local governments to explore innovation based on actual conditions and further increase hospitals’ participation in drug procurement.
Centralized drug procurement should be conducive to breaking the mechanism of using drugs to supplement medical treatment, accelerating the reform of public hospitals, especially county-level public hospitals; conducive to reducing the falsely high prices of drugs and reducing the people's drug burden; conducive to prevention and containment Corruption in the field of drug purchase and sales, resisting commercial bribery; it will help promote the integration and reorganization of drug production and distribution enterprises, fair competition, and promote the healthy development of the pharmaceutical industry.
2. Implement classified drug procurement
(1) For essential drugs and generic drugs that have large clinical dosages, high purchase amounts and are produced by multiple companies, use provincial centralized bulk procurement Advantages: The provincial drug procurement agency adopts a double-envelope system for public bidding and procurement. The hospital, as the procurement entity, purchases drugs at the winning bid price.
Implement volume-based procurement. The hospital shall formulate a procurement plan and budget based on no less than 80% of the actual usage of drugs in the previous year, and specify the varieties, dosage forms and specifications. In principle, the dosage forms purchased for each drug shall not exceed 3 types, and the corresponding specifications of each dosage form shall in principle be No more than 2 types, taking into account the medication needs of adults and children. Provincial drug procurement agencies should compile a list of drugs purchased through public bidding based on the summary of hospital drug needs, reasonably determine the drug procurement quantity for each bidding group, and announce it to the public.
Further improve the double-envelope evaluation method. Pharmaceutical manufacturers bidding must prepare economic and technical bids and commercial bids at the same time. The economic and technical bid mainly evaluates the company's Good Manufacturing Practice (GMP) qualification certification, random inspections of drug quality, production scale, distribution capabilities, sales, market reputation, electronic supervision capabilities and other indicators, and will pass the "Drug Production" Quality Management Standard (Revised in 2010)" certification status, marketing status in developed countries (regions) such as the European Union, the United States, and Japan, and standardized dosage forms, specifications, packaging, etc. as important indicators. Only enterprises that pass the economic and technical bid review can enter the commercial bid review. In the review of commercial bids, the same bidding group selects the winning bidder and candidate winning bidders in order from low to high. Drugs whose bidding prices are obviously low and may have quality and supply risks must be comprehensively evaluated to avoid vicious competition. Priority will be given to purchasing generic drugs that reach international standards.
In pilot cities for public hospital reform, municipalities are allowed to purchase drugs on their own on the provincial centralized drug procurement platform. The transaction price in pilot cities shall not be higher than the provincial winning bid price. If the transaction price in the pilot city is significantly lower than the provincial-level winning bid price, the provincial-level winning bid price shall be adjusted according to the transaction price in the pilot city. The specific measures shall be formulated by each province (region, city).
(2) For some patented drugs and exclusively produced drugs, establish an open, transparent and multi-party price negotiation mechanism. The results of the negotiation are announced on the National Comprehensive Management Information Platform for Drug Supply Guarantee, and the hospital purchases drugs based on the negotiation results.
(3) Generic drugs for women and children, emergency (rescue) drugs, basic infusions, drugs with small clinical dosage (the specific scope of the above drugs is determined by each province, region and city) and commonly used low-price drugs , implement centralized network connection and purchase directly from the hospital.
(4) Drugs that are clinically necessary, used in small quantities and in short supply in the market shall be produced at designated locations through national bidding and purchased at negotiated prices.
(5) Procurement of narcotic drugs, psychotropic drugs, free drugs for the prevention and treatment of infectious and parasitic diseases, national immunization program vaccines, family planning drugs and traditional Chinese medicine pieces shall be carried out in accordance with current national regulations to ensure openness and transparency.
All drugs (excluding traditional Chinese medicine pieces) used in hospitals should be purchased through the provincial drug centralized procurement platform. Provincial drug procurement agencies should summarize the procurement plans and budgets reported by hospitals, and based on the national essential drug catalog, medical insurance drug reimbursement catalog, essential drug clinical application guide and formulary, etc., and reasonably prepare a drug procurement catalog for hospitals in their administrative regions in accordance with the above principles. The categories list the drugs purchased through bidding, drugs purchased through negotiation, drugs purchased directly by hospitals, and drugs produced at designated locations. Encourage joint procurement between provinces, regions, and specialized hospitals. In principle, the procurement cycle is once a year. For drugs newly approved for marketing during the procurement cycle, various localities can organize separate centralized procurement on a provincial (regional, municipal) basis based on disease prevention and treatment needs and after pharmacoeconomics and evidence-based medicine evaluation.
3. Improve drug settlement methods
(1) Strengthen the management of drug purchase and sales contracts. When a hospital signs a drug purchase contract, it should specify the purchase variety, dosage form, specification, price, quantity, distribution batch and time limit, settlement method and settlement time, etc. The procurement quantity agreed in the contract shall be the entire procurement quantity for one procurement cycle declared in the procurement plan.
(2) Standardize drug payment. Hospitals should incorporate drug revenue and expenditure into budget management and pay for goods in strict accordance with the time stipulated in the contract. The period from delivery acceptance to payment must not exceed 30 days. Rely on and give full play to the advantages of centralized payment and settlement of provincial drug centralized procurement platforms, encourage hospitals and drug manufacturers to directly settle drug payments, and drug manufacturers and distribution companies to settle delivery fees.
4. Strengthen drug distribution management
(1) Drug manufacturers are the first person responsible for ensuring drug quality and supply. Drugs can be delivered directly to designated hospitals by the winning bidders or by entrusting drug operating companies with distribution capabilities. Drug operating enterprises entrusted by drug manufacturers should register on the provincial drug centralized procurement platform, and the registration information should be disclosed to the public. Provincial drug procurement agencies should promptly publish the list of distribution companies for each hospital and accept social supervision.
(2) For the distribution of medicines in remote and inaccessible areas, health and family planning departments at all levels must strengthen organization and coordination, follow the principles of combining near and far, and linking urban and rural areas, increase the concentration of procurement and distribution, and make overall plans for hospitals Drug supply and distribution management work with primary medical and health institutions. Encourage all localities to explore integrated county-rural distribution based on actual conditions. Give full play to the service network advantages of the postal and other logistics industries and support them in participating in drug distribution under certain conditions.
(3) Provincial drug procurement agencies should make timely corrections to enterprises that affect clinical use of drugs due to untimely delivery or refuse to provide distribution services in remote areas, and urge them to make rectifications within a time limit. If an enterprise that fails to change within the time limit is disqualified from winning the bid, and the hospital is forced to use drugs from other enterprises instead, the overrun costs will be borne by the original bid-winning enterprise. Specific measures will be formulated by each province (autonomous region, municipality).
V. Standardized Procurement Platform Construction
(1) The provincial drug procurement agency is responsible for the use, management and maintenance of the provincial centralized drug procurement platform. The provincial (regional, municipal) people's government Necessary human, financial and material support must be provided to ensure the normal operation of its work.
(2) Establish a drug procurement data sharing mechanism, unify the standardized construction standards of provincial drug centralized procurement platforms, promote the standardization of drug procurement coding, and realize the national drug supply assurance comprehensive management information platform, provincial drug Centralized procurement platforms, hospitals, medical insurance agencies, price authorities and other information data are interconnected and resources are shared.
(3) Provincial drug centralized procurement platforms should provide services to hospitals and drug production and operation enterprises at all levels, improve drug bidding and procurement, distribution management, evaluation, statistical analysis, dynamic supervision and other capabilities, and collect and analyze in a timely manner Hospital drug purchase prices, quantities, payment collection times, drug production and operation enterprises' delivery rates, bad records, etc. are regularly announced to the public. Encourage qualified places to carry out electronic transactions and adopt various methods such as signing electronic contracts and online payments through centralized drug procurement platforms to save transaction costs and improve transaction transparency.
6. Strengthen comprehensive supervision and management
(1) Strengthen the training and assessment of rational drug use for medical staff, give full play to the role of pharmacists in guiding drug use, standardize doctors’ prescribing behavior, and effectively reduce irrational drug use.
Establish a prescription review and physician interview system, focusing on tracking and monitoring auxiliary medications and drugs used in hospitals that are not commonly used. Establish and improve a comprehensive clinical drug evaluation system focusing on essential drugs, and promote the standardization of drug dosage forms, specifications, and packaging.
(2) Based on provinces (autonomous regions and municipalities), select a number of hospitals and grassroots medical and health institutions as monitoring points for drug shortages, collect and analyze drug supply and demand information in a timely manner, and strengthen monitoring and early warning of drug shortages.
(3) Make the centralized procurement of drugs an important assessment content for hospitals and their responsible persons, and incorporate it into target management and hospital review and evaluation. Hospitals that violate regulations for offline purchases and delay payment will be notified and criticized, given rectification within a time limit, ordered to pay liquidated damages, and downgraded, depending on the severity of the case. Corrupt behaviors such as commercial bribery will be severely investigated and dealt with in accordance with the law.
(4) Strengthen supervision and inspection of the implementation of drug prices, strengthen drug cost surveys and market purchase and sales price monitoring, standardize price behavior, and protect the legitimate rights and interests of patients. We will seriously investigate and deal with price violations and monopolistic behaviors in accordance with the law, as well as illegal activities such as counterfeiting or false invoicing, affiliated operations, and "voucher fraud." Strengthen the quality tracking and full-process quality supervision of key drugs, and severely crack down on the production and sale of counterfeit and shoddy drugs.
(5) Strictly implement the integrity record and market clearance system. All provinces (autonomous regions and municipalities) must establish and improve inspection and supervision systems, establish integrity records of pharmaceutical production and operation enterprises, and publish them to the public in a timely manner. For companies listed on the list of bad records, hospitals are not allowed to purchase their drugs for two years. Strengthen the supervision of hospitals and pharmaceutical production and operation enterprises in fulfilling the "Integrity Purchase and Sales Contract for Medical Products in Medical and Health Institutions".
(6) Comprehensively promote information disclosure and ensure that all aspects of drug procurement operate in the sun. Establish a reward reporting system and consciously accept supervision from the National People's Congress, the Chinese People's Political Consultative Conference and all sectors of society. Adhere to a unified national market, maintain a fair competitive environment, and oppose various forms of local protection.
7. Effectively strengthen organizational leadership
(1) Fulfill the responsibilities of all parties. The people's governments of all provinces (autonomous regions and municipalities) must strengthen organizational leadership, supervision and evaluation, and promptly study and solve major problems in centralized drug procurement. Relevant departments such as health and family planning, development and reform, human resources and social security, finance, commerce, industry and information technology, industry and commerce, food and drug supervision, and insurance supervision must perform their respective duties and cooperate closely to form a joint force. Medical insurance agencies and commercial insurance institutions must settle medical expenses with medical institutions in a timely and full amount in accordance with regulations.
(2) Carefully organize and implement. All provinces (autonomous regions and municipalities) should follow the spirit of this opinion, promptly study and formulate implementation plans for centralized drug procurement in local public hospitals, and launch a new round of drug procurement in 2015. Provincial drug procurement agencies must effectively organize, manage and implement local centralized drug procurement. Local governments can explore various forms of cross-regional joint procurement based on actual conditions and in accordance with the "four benefits" principles clarified in the overall approach of this opinion. The centralized procurement methods for drugs in military hospitals shall be studied and formulated by the military health authorities.
(3) Strengthen the prevention of integrity risks. Strengthen the supervision of provincial drug procurement agencies, improve the internal controls and external supervision mechanisms of provincial drug procurement agencies, adhere to the use of systems to manage power and manage people, strengthen education on integrity, and continuously improve business capabilities and awareness of integrity. Establish a power operation monitoring mechanism to realize mutual constraints and coordination of power, and implement a regular rotation system for personnel in important positions.
(4) Do a good job in publicity and guidance of public opinion. Centralized drug procurement involves the adjustment of interests of many parties. All regions and relevant departments must adhere to the correct orientation, strengthen policy interpretation and public opinion guidance, fully publicize the policy direction, significance, measures and results of centralized drug procurement, properly respond to social concerns, and create a good social atmosphere.
General Office of the State Council
February 9, 2015