First, the overall requirements
(1) Target tasks. Promote the solution of pilot drugs in 11 countries to organize centralized procurement and use of pilot cities (hereinafter referred to as pilot cities) and other relevant regions, the price gap, so that qualified medical institutions across the country can provide quality and cheap pilot drugs, Let the reform results benefit more people; promote the nationwide organization of centralized drug procurement and use of pilot centralized procurement models, accumulate experience for comprehensive drug concentration and procurement; optimize relevant policies and measures to ensure long-term stable supply of selected drugs, Guide the healthy and orderly development of the pharmaceutical industry and high quality.
(2) The overall idea. In accordance with the general idea of state organization, alliance procurement, and platform operation, the state formulates basic policies, scope, and requirements, organizes relevant regions outside the pilot cities to form alliances with provinces, entrusts joint procurement offices, and conducts cross-regional alliances to concentrate procurement. . At the same time, on the basis of summarizing and appraising the experience of the national organization of centralized drug procurement and use of pilot drugs, we will further improve the policy of procurement and use of drugs, and promote the orderly competition and healthy development of the pharmaceutical market.
Second, the scope and form of centralized procurement
(1) The scope of the drug. The state organizes 25 generic drugs selected in the pilot procurement and use of drugs.
(2) Participating in the enterprise. The pharmaceutical production enterprises (the holders of drug listing licenses and the national distributors of imported drugs), which are approved by the drug regulatory authority and listed in the mainland China, can participate.
(3) Quality finalists. In principle, based on the evaluation of the quality and efficacy consistency (including the consistency evaluation, the same below), including all original drugs, reference preparations, generic drugs that pass the consistency evaluation, the above drugs In principle, the certification is based on the China Listed Drug List. The specific indicators are prepared by the Joint Procurement Office.
(4) Capacity requirements. Relevant enterprises must explain the source of raw materials and supply guarantee measures, calculate the production capacity according to the production and supply capacity of raw materials and preparations, and report to the Joint Procurement Office in advance. The selected company must ensure that the required purchase volume of the selected drug in the selected region is met during the purchase agreement period.
(5) Proportion of agreed purchases. The medical institution accurately submits the historical purchase amount of the relevant drugs in the past two years as required. The Joint Procurement Office determines the agreed purchase amount based on the number of selected companies based on 50%-70% of the historical purchases of the previous year.
(6) Centralized procurement form. Explore and improve the market-based drug price formation mechanism and adopt the bidding procurement model. In order to ensure quality and stability, the centralized procurement can allow multiple elections, and the number of companies selected for each drug is generally no more than three. Allow different prices of different companies in the same drug to be selected, and guide enterprises to bid reasonably.
(7) Term of the agreement. According to the number of selected enterprises, the term of the centralized procurement agreement is 1 year to 3 years. In principle, when the number of selected enterprises is small, the term of the agreement is relatively short. When the number of selected enterprises is large, the term of the agreement is relatively long.
(8) Form of organization. National Unity Organization, all relevant provinces (excluding provinces such as Beijing, Tianjin, Shanghai, Chongqing, and the provinces that have followed the national organization for centralized drug procurement and use before the introduction of this opinion) and the Xinjiang Production and Construction Corps voluntarily participate in and form a procurement alliance. Entrust the Joint Procurement Office to carry out specific procurement work, and according to the arrangement of the Joint Procurement Office, statistically report the historical purchase amount of relevant drugs. The Joint Procurement Office formulates specific procurement rules based on the basic requirements determined by the Office of the National Organization for the Centralized Procurement and Use of Pharmaceuticals, and conducts centralized procurement operations on behalf of the Alliance Region to organize and supervise the implementation of centralized procurement results. The Shanghai Pharmaceutical Centralized Bidding and Purchasing Management Office will undertake the daily work of the Joint Procurement Office and be responsible for the specific implementation.
Third, the main policy measures
(1) Purchasing with quantity and price. All relevant provinces and Xinjiang Production and Construction Corps shall report strictly to all public medical institutions in the region (excluding pilot cities), military medical institutions participating in the pilot expansion of regional areas, and voluntary participation in the pilot extended regional medical insurance designated social medical institutions. , medical insurance designated retail pharmacies drug use. The Joint Procurement Office summarizes the drug consumption of each relevant province and the Xinjiang Production and Construction Corps, and calculates the agreed purchase amount according to the procurement rules, then conducts volume purchases and converts prices to determine the selected enterprises and the selected prices. The relevant medical institution or its representative shall sign a contract for the purchase and sale of the quantity with the selected enterprise according to the selected price. For the remaining amount other than the agreed purchase amount, all relevant medical institutions can still purchase other types of nets with suitable prices through the provincial drug centralized procurement platform. For the 25 generic drugs that have been included in the national organization for centralized procurement and use of drugs, the number of manufacturers that have passed the consistency evaluation of the same variety of drugs has reached more than three. In the case of ensuring supply, the centralized procurement of drugs is no longer used. Varieties that did not pass the consistency assessment.
(2) Enlisting and ensuring use. All relevant medical institutions shall give priority to the use of the selected drugs, and according to the contract of purchase and sale of the quantity, complete the contract consumption and the agreed purchase ratio requirements within the agreement period.
(3) Quality priority and guarantee supply. The selected enterprise is the first responsible person to guarantee the quality and supply. It is necessary to strictly control the quality, independently select the enterprises with the distribution ability and good reputation, and select the drugs to be selected, and establish the emergency reserve, inventory and capacity reporting system of the production enterprises according to the purchase and sale contract. . Relevant departments should strengthen the supervision of the production, circulation and use of the entire chain of drugs, strengthen production and inventory monitoring, and ensure the quality and supply of drugs.
In addition to the force majeure factor, the selected companies with quality and supply problems shall bear the additional costs of drug replacement, otherwise they will be regarded as untrustworthy behavior. All products of the relevant untrustworthy enterprises shall not participate in the drugs and medical consumables of all public medical institutions nationwide within two years. Centralized purchasing.
(4) Guarantee the payment and reduce the transaction cost. As the first responsible person for the settlement of medicines, medical institutions shall settle accounts with enterprises in time according to the contract, and reduce the transaction costs of enterprises. Strictly check the medical institutions' failure to settle the payment of medicines on time. The medical insurance fund shall pay the settlement payment to the medical institution in a timely manner. On the basis of the total budget, the medical insurance fund shall prepay to the medical institution in advance at not less than 30% of the purchase amount. After completing the agreed purchase amount, it shall continue to pay in advance according to the actual purchase amount of the selected drug. The medical institution shall continue to guarantee timely payment. . Encourage qualified areas to be settled directly by the medical insurance fund and the enterprise.
(5) Exploring the synergy between the payment standard for medical insurance for centralized procurement and the purchase price. For centralized procurement of medicines, the centralized purchase price is used as the medical insurance payment standard within the scope of medical insurance. In principle, the original payment for the same generic name, the reference preparation, the generic drug that passed the consistency evaluation, and the medical insurance fund are paid the same. Standards are settled. Patients use drugs that are higher than the payment standard. The part that exceeds the payment standard is paid by the patient. If the price of the drug used by the patient differs greatly from the centralized purchase price of the selected drug, the payment standard can be gradually adjusted and adjusted in 2-3 years. Formulate supporting policies and measures; patients use drugs that are lower than the payment standard and pay at the actual price. On the basis of guaranteeing quality and supply, guide medical institutions and patients to form reasonable medication habits. If the medical insurance designated retail pharmacy participates in the purchase, it may be allowed to increase the price on the basis of the selected price. The part exceeding the payment standard shall be paid by the patient, and the following part of the payment standard shall be reimbursed by the medical insurance according to the regulations.
(6) Promoting the reform of medical institutions through the transformation of mechanisms. We will deepen the reform of the payment method for medical insurance, establish an incentive and risk-sharing mechanism between the medical insurance agency and the medical institution to “save balance and rational over-spending”, and promote the use of selected drugs at reasonable prices by medical institutions. For medical institutions that reduce the expenditure of medical insurance funds due to the use of selected drugs, the annual budget for total medical insurance will not be reduced. If the medical service revenues and expenditures of public medical institutions form a balance, they can be used according to the “two permissions” (allowing medical and health institutions to break through the current level of wage adjustment and control of medical institutions, allowing medical service income to be deducted from costs and withdrawing funds according to regulations, mainly used for personnel rewards. The requirements are co-ordinated for personnel compensation expenses.
(7) Mobilize the enthusiasm of medical institutions to ensure the dosage. Encourage the rational use of selected drugs in centralized procurement, and incorporate the use of selected drugs into the performance appraisal of medical institutions and medical personnel. All relevant departments and medical institutions shall not affect the reasonable use and supply guarantee of the selected drugs on the grounds of cost control, quantity requirements for medical institutions, and approval of the Pharmacy Committee. For medical institutions that do not purchase and use drugs according to regulations, they shall be punished in the total medical insurance index, the performance appraisal of medical institutions, the qualification of medical insurance, and the assessment of the target responsibility of medical institutions. Medical personnel who do not use the selected drugs according to the regulations shall be dealt with seriously according to the corresponding provisions of the Prescription Management Measures and the Hospital Prescription Review Management Regulations (Trial). Strengthen the role of pharmacists in the prescription adjustment review, and promote the selection of selected drugs. It is necessary to further improve the clinical application guidelines for drugs, strengthen the monitoring of drug use in medical institutions, strictly review prescriptions and prescriptions, strengthen the publicity and training of physicians and pharmacists, organize comprehensive clinical evaluation of drugs, promote scientific and rational drug use, and ensure the safety of patients.
