2015-09-14 3059
State Council Document No. [2015] 7
To the People's Governments of Provinces, Autonomous Regions, and Municipalities directly under the Central Government; Ministries and Commissions of the State Council and directly affiliated institutions:
Improving the centralized procurement of drugs in public hospitals is an important aspect and a key link in deepening the reform of the medical and health system. It is of significant importance for accelerating the reform of public hospitals, standardizing the circulation of drugs, and establishing a sound drug supply guarantee system based on the essential drug system. With the approval of the State Council, the following guiding opinions are put forward on improving the centralized procurement of drugs in public hospitals.
I. General Ideas
Fully 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, adhere to the general requirement that the market plays a decisive role in resource allocation and the government better fulfills its functions, draw on international practices in drug procurement, fully absorb the experience of centralized procurement of essential drugs, adhere to the direction of online centralized procurement of drugs at the provincial level, adopt measures such as inviting production enterprises to bid, integrating bidding and procurement, linking quantity and price, using double-envelope system, and comprehensive monitoring throughout the procurement process to strengthen comprehensive supervision of drug procurement and effectively guarantee drug quality and supply. Encourage local exploration and innovation based on local conditions and further enhance the participation of hospitals in drug procurement. Drug centralized procurement should be conducive to eliminating the mechanism of hospitals relying on drug sales to compensate for medical expenses, accelerating the reform of public hospitals, especially county-level public hospitals; it should be conducive to reducing inflated drug prices and alleviating the burden of drug expenses on the general public; it should be conducive to preventing and curbing corruption in drug purchase and sales, and resisting commercial bribery; and it should be conducive to promoting the integration and reorganization of drug production and distribution enterprises, fair competition, and the healthy development of the pharmaceutical industry.
II. Implementing Categorized Procurement of Pharmaceuticals
(1) For essential drugs and non-patent medicines with high clinical usage, high procurement value, and multiple manufacturers, the provincial-level centralized procurement advantages shall be utilized. The provincial drug procurement agency shall adopt a two-envelope bidding system for public bidding and procurement, with hospitals as the purchasing entities, procuring the drugs at the winning bid price.
Implement volume-based procurement. Hospitals shall formulate procurement plans and budgets based on no less than 80% of the actual drug usage in the previous year, specifying the varieties, dosage forms, and specifications. Each drug should be procured in principle in no more than three dosage forms, and each dosage form should correspond to no more than two specifications, taking into account the needs of adult and pediatric medication. The provincial drug procurement agency should compile a drug list for public bidding procurement based on the summary of hospital medication requirements, reasonably determine the quantity of drugs to be procured in each bidding group, and publish it to the public.
Further improve the two-envelope evaluation method. Bidding pharmaceutical manufacturers must simultaneously prepare both economic and technical proposals and commercial proposals. The economic and technical proposals mainly assess the enterprise's qualifications for Good Manufacturing Practice (GMP) certification, drug quality inspection and sampling, production scale, distribution capacity, sales revenue, market reputation, electronic supervision capabilities, and other indicators. The revised edition of the "Good Manufacturing Practice for Drugs (2010)" certification status, sales in developed countries (regions) such as the European Union, the United States, and Japan, and standardized dosage forms, specifications, packaging, etc., are considered important indicators. Only enterprises that pass the economic and technical proposal review can proceed to the commercial proposal review. In the commercial proposal review, the winning and candidate winning enterprises are selected within the same bidding group based on the quotation from lowest to highest. Drugs with significantly low bidding prices that may pose quality and supply risks must undergo comprehensive evaluation to avoid vicious competition. Priority should be given to the procurement of generic drugs that meet international standards.
In pilot cities for public hospital reforms, they are allowed to procure independently on the provincial-level centralized drug procurement platform at the municipal level. The transaction price in pilot cities shall not exceed the provincial winning bid price. If the transaction price in pilot cities is significantly lower than the provincial winning bid price, the provincial winning bid price should be adjusted according to the transaction price in pilot cities. Specific measures shall be formulated by each province (autonomous region, municipality).
(2) For some patented drugs and exclusive production drugs, an open and transparent price negotiation mechanism involving multiple parties shall be established. The negotiation results shall be published on the national comprehensive management information platform for drug supply and guarantee, and hospitals shall procure drugs based on the negotiation results.
(3) For non-patented drugs in the field of obstetrics and pediatrics, emergency drugs, basic infusion solutions, and drugs with small clinical usage (the specific scope of the above drugs shall be determined by each province, autonomous region, and municipality) and commonly used low-priced drugs, centralized online procurement shall be implemented, and hospitals shall procure directly
(4) For drugs that are clinically necessary, have low usage, and face market supply shortages, designated production and negotiated procurement shall be conducted by the state.
(5) For anesthesia drugs, psychiatric drugs, drugs for preventing and treating infectious and parasitic diseases, free drugs, national immunization program vaccines, family planning drugs, and traditional Chinese medicine pieces, procurement shall be carried out in accordance with existing national regulations to ensure transparency.
All drugs used in hospitals (excluding traditional Chinese medicine pieces) shall be procured through the provincial-level centralized drug procurement platform. The provincial drug procurement agency shall compile the procurement plans and budgets reported by hospitals and, based on the National Essential Medicines List, the medical insurance drug reimbursement list, the clinical application guidelines for essential medicines, and prescription collections, reasonably compile the hospital drug procurement catalog for the respective administrative regions, categorizing the drugs into bidding procurement drugs, negotiated procurement drugs, hospital direct procurement drugs, designated production drugs, etc. Inter-provincial cross-regional procurement and joint procurement by specialized hospitals are encouraged. The procurement cycle is generally once a year. For drugs newly approved and marketed within the procurement cycle, each region may, based on disease prevention and treatment needs, organize separate centralized procurement by province (autonomous region, municipality), after conducting pharmacoeconomic and evidence-based medicine evaluations.
III. Improving the Settlement of Drug Payments
(1) Strengthening the Management of Drug Procurement Contracts: Hospitals should clearly specify the procurement varieties, dosage forms, specifications, prices, quantities, delivery batches and deadlines, settlement methods, and settlement time in drug procurement contracts. The agreed procurement quantity should encompass the total procurement volume for one procurement cycle as declared in the procurement plan.
(2) Standardizing Drug Payment: Hospitals should include drug income and expenses in budget management and strictly adhere to the agreed payment schedule, ensuring that payment is made within 30 days from the acceptance of the delivered goods. Leveraging the advantages of provincial-level centralized drug procurement platforms for payment settlement, hospitals are encouraged to directly settle drug payments with pharmaceutical manufacturers, and pharmaceutical manufacturers are encouraged to settle distribution fees with distribution companies.
IV. Strengthening Drug Distribution Management
(1) Pharmaceutical manufacturers are responsible for ensuring drug quality and supply. Drugs can be directly distributed by the winning manufacturers or entrusted to drug distribution companies with distribution capabilities for delivery to designated hospitals. Drug distribution companies authorized by pharmaceutical manufacturers should be registered on the provincial-level centralized drug procurement platform, and this information should be made public. Provincial drug procurement agencies should promptly publish the list of distribution companies for each hospital, allowing for public oversight.
(2) For drug distribution in remote and inaccessible areas, health departments at all levels should enhance organization and coordination. Following the principles of combining proximity and linking urban and rural areas, efforts should be made to improve the concentration of procurement and distribution, and effectively manage drug supply and distribution to hospitals and primary healthcare institutions. Encouragement should be given to explore integrated distribution in counties and villages based on local conditions. Leveraging the advantages of logistics networks such as postal services, support should be provided for their participation in drug distribution under specified conditions.
(3) Pharmaceutical manufacturers or distribution companies that fail to provide timely delivery services to remote areas, resulting in an impact on clinical drug use or refusal to provide distribution services, should be promptly corrected by provincial drug procurement agencies and urged to make necessary improvements within a specified period. If the companies fail to rectify the situation within the given time, their qualification for bidding should be canceled. If hospitals are forced to use alternative drugs from other companies as a result, the additional costs incurred should be borne by the original winning company, and specific measures should be developed by each province (region, city).
V. Standardizing Procurement Platform Construction
(1) Provincial drug procurement agencies are responsible for the use, management, and maintenance of the provincial-level centralized drug procurement platform. The provincial (regional, municipal) governments should provide necessary support in terms of manpower, financial resources, and physical resources to ensure the normal operation of the platform.
(2) Establishing a data sharing mechanism for drug procurement, standardizing the construction of provincial-level centralized drug procurement platforms, promoting the standardization of drug procurement coding, and achieving interconnection and resource sharing of information data between the National Drug Supply Guarantee Comprehensive Management Information Platform, provincial-level centralized drug procurement platforms, hospitals, healthcare insurance agencies, and price regulatory authorities.
(3) Provincial-level centralized drug procurement platforms should provide services to hospitals and pharmaceutical manufacturers and distributors at all levels, enhancing capabilities in drug tender procurement, distribution management, evaluation, statistical analysis, dynamic supervision, etc. They should promptly collect and analyze information on hospitals' drug procurement prices, quantities, payment collection time, as well as drug manufacturers' delivery rates and adverse records, and regularly make this information public. Encouragement should be given to conduct electronic transactions where feasible, adopting various methods such as signing electronic contracts and online payments through the drug centralized procurement platform to save transaction costs and enhance transparency.
VI. Strengthening Comprehensive Supervision and Management
(1) Drug regulatory authorities should strengthen the supervision and management of pharmaceutical manufacturers and distributors, actively implement relevant laws and regulations, and carry out inspections and supervision on their drug production, operation, and distribution activities.
(2) Provincial-level centralized drug procurement platforms should strengthen the dynamic supervision of hospitals' drug procurement, payment settlement, and drug distribution, monitor and analyze hospitals' drug procurement data and pharmaceutical manufacturers' delivery data, and promptly detect and handle any irregularities or violations.
(3) Hospitals should strengthen internal supervision and management, establish and improve rules and regulations for drug procurement, payment settlement, and drug distribution, clarify the responsibilities of relevant personnel, and implement strict assessment measures. Supervision departments should conduct regular inspections on hospitals' drug procurement, payment settlement, and drug distribution, and promptly address any issues discovered.
(4) Establishing a credit management system for pharmaceutical manufacturers and distributors, and implementing credit evaluation. A credit record system should be established for manufacturers and distributors based on their compliance with drug quality management, timely delivery, and fulfillment of contractual obligations. Pharmaceutical manufacturers and distributors with significant violations or breaches of contract should be included in the list of dishonesty and be subject to corresponding restrictions and penalties.
(5) Actively conducting public oversight. Provincial drug procurement agencies should establish a public oversight mechanism, regularly publish information on drug procurement, payment settlement, and drug distribution, and accept public supervision and reports of irregularities. Complaint channels should be provided to address public concerns and reports of violations promptly.
National Health and Family Planning Commission