2015-09-14 3333
State Administration of Traditional Chinese Medicine [2015] No. 70
To the Health and Family Planning Commissions of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Health Bureau of Xinjiang Production and Construction Corps:
In order to implement the "Guiding Opinions of the General Office of the State Council on Improving the Centralized Drug Procurement in Public Hospitals" (State Council General Office [2015] No. 7, hereinafter referred to as the "Opinions"), the following requirements are hereby notified:
I. Comprehensive Construction of a New Mechanism for Centralized Drug Procurement
Adhere to the direction of centralized drug procurement, implement a single platform, top-down coordination, openness and transparency, and categorized procurement. Give full play to the role of the provincial-level leading group for centralized drug procurement, combine with local conditions, urgently formulate specific implementation measures, clarify division of responsibilities among departments, establish a timetable and technical roadmap, and promptly report to the State Council Leading Group for Health Care Reform to ensure the launch of a new round of centralized drug procurement work within 2015.
Provincial health and family planning administrative departments should actively communicate and coordinate with development and reform, finance, human resources and social security, commerce, food and drug regulatory departments, etc., and strive to effectively link quality and safety, price monitoring, distribution and use, medical insurance payment, and other policy measures in drug procurement, enhance and expand the people's benefits from centralized drug procurement.
II. Reasonably Determine the Scope of Drug Procurement
Hospitals should formulate procurement plans based on no less than 80% of the actual drug usage in the previous year, specifically for generic names, dosage forms, and specifications. In principle, the number of dosage forms for each drug procurement should not exceed 3, and the number of specifications for each dosage form should not exceed 2. The drug procurement budget should generally not exceed 25%-30% of the hospital's operating expenses. Provincial drug procurement agencies should promptly summarize and analyze hospital drug procurement plans and procurement budgets, reasonably determine the scope of drug procurement, implement quantity-based procurement, prioritize the selection of drugs that comply with clinical pathways, are included in major disease guarantees, major new drug development projects, and major public health projects, and take into account the medication needs of special populations such as women, the elderly, and children, and coordinate with medical insurance and new rural cooperative medical reimbursement policies.
Fully absorb effective methods from the national essential drug selection, based on the national essential drug list, medical insurance drug reimbursement list, basic drug clinical application guidelines, and prescription sets, follow the principles of common and essential clinical use, appropriate dosage forms and specifications, and convenient packaging and use, promote standardization of drug dosage forms, specifications, and packaging, and strive to improve the concentration of drug procurement and utilization.
III. Refine Measures for Categorized Drug Procurement
Provinces (regions, municipalities) should further refine the procurement of various categories of drugs based on the determined scope of drug procurement. All drugs used by hospitals (excluding traditional Chinese medicine decoctions) should be procured online.
(1) Tender procurement of drugs. For basic drugs and non-patented drugs that accounted for a cumulative percentage of no less than 80% of the total procurement amount of various types of drugs in the previous year, and were produced by three or more enterprises, they should be included in the scope of tender procurement.
(2) Negotiated procurement of drugs. Adhere to government-led, multi-party participation, openness and transparency, and pilot implementation at the national and provincial levels. Explore the implementation of the two-envelope bidding system for high-value drugs, and actively carry out pilot negotiations for other drugs that meet the negotiation conditions.
(3) Limited procurement of drugs. It is limited to drugs that have special needs for clinical use, have a small number of manufacturers, and have a high concentration of production, as well as traditional Chinese medicine decoctions.
(4) Pilot procurement of drugs. For innovative drugs that meet the pilot conditions, encourage pilot procurement through centralized procurement, negotiation procurement, or other methods.
Provincial drug procurement agencies should strengthen their capacity building, establish expert review committees for centralized drug procurement, formulate and improve evaluation methods, conduct comprehensive evaluations of drug quality, efficacy, and safety, and give priority to the selection of high-quality drugs. Strengthen drug procurement supervision, strictly implement the disclosure system for centralized drug procurement information, establish a joint punishment mechanism for dishonesty, and promote the formation of a standardized and orderly drug procurement market.
IV. Adhere to the Two-Envelope Bidding System
The two-envelope bidding system should be adhered to in the procurement of drugs. The financial envelope and the technical envelope should be opened separately and evaluated independently. The financial evaluation should be carried out only after the technical evaluation is qualified. Provincial drug procurement agencies should standardize the two-envelope bidding process, strictly control the proportion of price evaluation indicators, and improve the transparency and fairness of the bidding process.
V. Improve Hospital Drug Payment Management
Provincial health and family planning administrative departments should actively explore and innovate the payment methods for hospital drugs, implement drug payment in combination with medical service payment, strengthen drug procurement and distribution management, and improve the efficiency of drug use and the level of benefit-sharing. The payment method should be gradually changed from the current "drug price × quantity" to "drug payment by disease" or "case-based payment," gradually explore the establishment of a medical service fee and drug fee sharing mechanism, and promote the integration of drug payment and medical service payment.
VI. Improve the Drug Supply Guarantee System
Provincial drug procurement agencies should further improve the drug supply guarantee system, strengthen communication and coordination with drug production enterprises and distributors, ensure the quality and supply of drugs, and establish a drug supply monitoring and early warning system. Hospitals should actively participate in the drug shortage monitoring and early warning system, report drug shortage information in a timely manner, and promptly adopt measures to alleviate or solve drug shortages.
VII. Strengthen Supervision and Inspection
Provincial health and family planning administrative departments should strengthen the supervision and inspection of drug procurement in public hospitals, implement dynamic management of drug procurement, and promptly detect and rectify violations of laws and regulations and improper practices in drug procurement.
All provinces, autonomous regions, and municipalities directly under the Central Government should attach great importance to the implementation of this notification, refine the implementation measures according to local conditions, strengthen organizational leadership, and ensure that the new round of centralized drug procurement work is successfully launched.
National Health and Family Planning Commission, June 11, 2015