Interim Measures of Zhejiang Province for Centralized Purchase of Pharmaceutical and Medical Consumables

527　、，《（）》，。，202161（）、、。

 

：0571-81051028

 

：yyjghzbcgc.
ylbzj@zj.
gov.
cn

 

：（51-1，310005）

 

 

2021524

 

 

（）

 

、，《》（〔2021〕2），。

 

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、（）：

 

(1) Adhere to demand-oriented, quality first.
According to clinical needs, reasonably determine the scope of centralized procurement of varieties to ensure product quality and supply, and meet the basic medical needs of the people.

 

　　 (2) Adhere to market leadership and promote competition.
Establish an open and transparent market competition mechanism, guide enterprises to conduct fair competition on the basis of cost and quality, and improve the mechanism for market discovery of prices.

 

　　 (3) Adhere to the integration of recruitment and procurement, and link volume and price.
Clarify the purchase volume, exchange the price with the volume, ensure the use, smooth the links of purchase, use, and settlement, and effectively control the rebates of medicine and equipment.

 

　　 (4) Adhere to policy convergence and departmental coordination.
Improve supporting policies such as quality supervision, production and supply, circulation and distribution, medical services, and medical insurance payments, strengthen departmental linkage, focus on reforming system integration, coordination and efficiency, and support and promote each other with the centralized procurement system.

 

　　Two, the main form

 

　　Centralized procurement with volume adheres to provincial-level overall planning, provincial-city linkage, and city-level integration.
It is divided into two forms: provincial-level centralized procurement and municipal-level joint centralized procurement.
County-level centralized procurement is generally not allowed.
The policies, rules, and procedures for provincial-level centralized procurement and municipal-level joint centralized procurement remain relatively uniform.

 

　　Provincial-level centralized procurement with volume is organized by the provincial-level and carried out across the province.

 

　　The municipal-level joint centralized procurement is carried out by the provincial-level overall planning, leading the municipal organization, and other municipal and provincial-level public medical institutions are required to participate in principle.
The lead city is responsible for formulating procurement documents, organizing reviews, and publishing information.
In the selection of varieties, the varieties that have been carried out at the national and provincial levels shall not be duplicated in the joint centralized procurement at the municipal level; the varieties that have been developed by the city shall not be duplicated in other cities.

 

　　3.
Scope of implementation

 

　　 (1) The scope of medicines and medical consumables.

 

　　1.
The scope of medicines is mainly the varieties with large dosage, high price, sufficient competition, and mature clinical use.
It does not include negotiated medicines and centralized procurement of medicines by national organizations; chemical medicines are generally selected from the varieties that have never passed the consistency evaluation of quality and efficacy.
.
Explore the merger of different generic drugs with similar indications or functions and indications to carry out centralized procurement.

 

　　2.
The scope of medical consumables is mainly the varieties that are purchased in large quantities, are more mature in clinical use, and have a clear classification catalog, excluding those that are purchased by national organizations in a centralized manner.

 

　　3.
The same variety can be grouped.
Chemical drugs are generally divided into two groups: original research drugs (reference preparations) and other generic drugs; other drugs are grouped as appropriate, and in principle no more than two groups of drugs with the same generic name are grouped.
Medical consumables are grouped according to circumstances such as imported, domestic and online transactions.

 

　　 (2) The scope of the enterprise.
For the marketing authorization holders who have obtained the registration certificate of drugs (medical consumables) within the scope of centralized procurement (if the marketing authorization holder is an overseas company, it shall be designated by the relevant law to perform the duties of the marketing authorization holder in China) Legal persons), who meet the requirements of centralized procurement in terms of quality standards, production capacity, supply stability, etc.
, can participate in principle.
Enterprises participating in centralized procurement should make commitments to product quality and supply guarantee.

 

　　 (3) Scope of medical institutions.
All public medical institutions (including military medical institutions, the same below); medical insurance designated social medical institutions and designated pharmacies shall be implemented in accordance with the requirements of designated agreement management.

 

　　Four, review method

 

　　The centralized procurement with quantity is carried out by a combination of technical review and price review.

 

　　 (1) Technical review.
Refers to the clinical efficacy, quality reliability, safety of clinical use, brand recognition of each declared product (if the same product involves multiple product specifications or multiple sets, the company chooses a representative product) by the organization expert The packaging quality and convenience, service reputation, etc.
will be reviewed and scored.
Each product is ranked according to the scores of all products in the same group from high to low, and the number of products that enter the price review is determined according to the number of declared companies.
Generally, there are no more than 8 products.

 

　　 (2) Price review.
Refers to the quotation made by the applying enterprise based on the representative product.
In principle, the quotation shall not be higher than the actual lowest online transaction price for centralized procurement with the province as the unit and the selected price for centralized procurement with volume.

 

　　 (3) Winning rules.

 

　　1.
Through quality and price competition for centralized drug purchases, the selected companies and the selected prices are generated based on the effective quotation (the "unit declared price" after conversion according to the price difference rule), the decline in the quotation or the comprehensive score.
Generally, no more than 2 products are selected for each group of drugs with the same generic name; if there are multiple selected companies, the price difference should be fair and reasonable.

 

　　2.
The centralized procurement of medical consumables allows multiple products in the same group to be selected.
The number of products to be selected is based on the province's clinical use needs, and if necessary, it is determined after expert evaluation, and no more than 4 products.
Among them, the product with the lowest quotation in the price review is determined to be the product to be selected, and other products are determined as the product to be selected according to the number of places selected in order from low to high.

 

　　3.
In the price review, if there are 2 or more companies in the same group with the same quotation (decrease rate), it will be determined based on factors such as the level of technical review scores, the purchase volume on the Zhejiang Pharmaceutical procurement platform in the previous year, and the size of the company.

 

　　4.
The results of the proposed selection will be publicized to the society and subject to social supervision.
The publicity period is generally 7 days.
After the publicity period expires, the results of the selection will be announced.

 

　　Five, procurement rules

 

　　 (1) Agreed purchase quantity.

 

　　1.
The agreed purchase amount is determined according to the purchase amount base and the agreed purchase ratio, and is disclosed in the purchase documents.
The procurement base is determined based on the demand reported by medical institutions, combined with the previous year's use, clinical use status, and medical technology progress.
The agreed procurement ratio is reasonably determined according to clinical use characteristics, market competition pattern and the number of selected companies, etc.
, generally 50-70% for drugs and 60-80% for medical consumables, and as far as possible under the premise of ensuring quality and supply and preventing monopoly Increase; among them, the agreed procurement volume by grouping is generally distributed according to the procurement share of all public medical institutions in the province in the previous year.
Encourage public medical institutions to purchase the selected products first for the parts whose actual demand exceeds the agreed purchase amount, and they can also purchase other online products at appropriate prices through the provincial medicine and equipment centralized procurement platform.

 

　　2.
The results of the selection should reflect the principle of quantity-price linkage, and clarify the agreed procurement volume of each selected company.

 

　　3.
Grouped drug varieties, if any group of products is not selected, the agreed purchase amount of this group can be adjusted to other groups according to certain rules and proportions.

 

　　4.
Medical consumables are allocated to the agreed purchase amount according to the selected product price in a certain proportion.
Among them, the agreed purchase volume of mandatory products shall not be less than 50%.
The agreed procurement volume of mandatory products is distributed to all medical institutions in proportion; the agreed procurement volume of other selected products is selected by the medical institution and the applying company through the provincial medical consumables centralized procurement system.
After the mutual matching is successful, one selected product is determined.

 

　　5.
Medical institutions that have not participated in the joint centralized procurement at the municipal level can purchase the selected products on the provincial pharmaceutical equipment procurement platform, but they must purchase the selected products in accordance with the above procurement rules.
The selected drugs in groups are purchased according to their purchase shares.
Medical consumables The purchase ratio of mandatory products among the selected products shall not be less than 50%.

 

　　 (2) The purchase agreement period.
The purchase agreement period is 12 months or 24 months.
If the agreed purchase amount is completed in advance during the purchase agreement period, the excess part will still be supplied and purchased at the selected price.
All parties shall strictly abide by laws, regulations and agreements, implement the results of the selection, enjoy rights, perform obligations, and assume corresponding responsibilities in accordance with the law.

 

　　 (3) Renewal after expiry.
After the expiration of the purchase agreement, focus on stabilizing market expectations, stabilizing price levels, and stabilizing clinical use, comprehensively considering factors such as reliable quality, stable supply, good credit, and clinical demand, and determine the supply company, agreed purchase volume, and purchase agreement period in accordance with laws and regulations.
; Where there are major changes in the supply-demand relationship and the market structure, the selected enterprises, the selected prices, the agreed purchase quantity and the purchase agreement period will be generated through bidding, bargaining, negotiation, inquiry and other methods.

 

　　6.
Job Responsibilities

 

　　 (1) Medical insurance administrative department.
Undertake the overall coordination and supervision and guidance responsibilities for the normalized and institutionalized development of centralized and large-scale procurement, improve relevant policies and measures, and carry out monitoring and analysis, supervision and inspection, and summary evaluation in a timely manner.
Improve the coordination mechanism between drug and medical insurance payment standards and purchase prices.
The selected drugs in the medical insurance catalogue will use the selected price as the medical insurance payment standard, and gradually implement the same general list-one medical insurance payment standard; the selected products of medical consumables will use the selected price as the procurement price of medical institutions.
The highest price limit for the selected products is determined after expert evaluation; non-selected companies are encouraged to take the initiative to lower their prices.
Jointly carry out the dynamic adjustment and evaluation of medical service prices, and adjust the prices of medical services in a timely manner if the conditions are met.
In accordance with the requirements of government organizations, alliance procurement, and platform operations, guide the establishment of a centralized procurement office.

 

　　 (2) Health department.
The health department is responsible for guiding medical institutions to implement the management of the use of selected drugs, organizing training and publicity for medical institutions and clinicians, preventing and controlling the risks of rational use by patients, and incorporating the procurement and use of selected products by medical institutions into the performance evaluation of public medical institutions , Into the scope of the assessment of the responsibility of the person in charge of the medical institution.

 

　　 (3) Drug regulatory authorities.
Responsible for formulating supporting measures for the quality supervision of selected products, including selected products as key products under supervision, and strengthening production, circulation and use in accordance with the requirements of "the most rigorous standards, the most stringent supervision, the most severe penalties, and the most serious accountability" Quality supervision of the entire chain.
Promote the construction of a traceability system for the entire process of product production, circulation and use, and basically realize that the selected products can be queried and traceable throughout the process.
Strengthen the monitoring of the adverse reactions or events of the selected products, and deal with quality problems in accordance with laws and regulations.

 

　　 (4) Economic and information department.
Responsible for the government reserves of emergency medicines and medical consumables, urge the selected enterprises in the province to implement production and supply responsibilities in accordance with the agreed purchase volume of the selected products, support the enterprises to carry out production technology transformation, and improve the supply guarantee capacity of the selected drugs.

 

　　 (5) Relevant departments of the military.
Responsible for the supervision and guidance of military medical institutions' procurement, use of selected products, and payment settlement.

 

　　 (6) Centralized procurement office with quantity.
Entrusted by various public medical institutions, it is responsible for the selection of centralized procurement varieties and the formulation of procurement documents, making statistics on agreed procurement volume, organizing the selected enterprises to sign agreements with medical institutions, supervising the implementation of the results of the selection by medical institutions, coordinating processing and feedback implementation problem.

 

　　 (7) Centralized procurement agency for medical equipment.
Improve the functions of the pharmaceutical equipment centralized procurement platform, manage bidding, procurement, trading, and settlement, strengthen the standardized construction of the pharmaceutical equipment centralized procurement platform, unify the basic operating rules, work procedures, and network removal standards, and establish and improve the pharmaceutical price and recruitment credit evaluation system , Implement network-wide dynamic trustworthy incentives and untrustworthy punishments in accordance with laws and regulations.
Under the premise of fulfilling the main responsibility of medical institutions for procurement and settlement, explore ways to promote direct settlement between medical insurance funds and pharmaceutical companies through the establishment of electronic drug settlement centers .

 

　　 (8) Medical insurance agencies.
On the basis of the total budget of the medical insurance fund, a prepayment mechanism for centralized drug purchases shall be established.
The medical insurance fund shall be prepaid to medical institutions at a rate of no less than 30% of the agreed annual purchase amount.
After that, according to the procurement progress of the medical institutions, the medical institutions shall apply for payment The expenses are gradually offset against the advance payment.
The medical expenses applied for settlement by medical institutions shall be reviewed in a timely manner, and reasonable medical expenses shall be paid in full.
For the medical insurance funds saved due to centralized procurement, medical institutions will be given incentives to retain the balance in accordance with relevant regulations.

 

　　 (9) Medical institutions.
Public medical institutions shall purchase on the provincial centralized procurement platform for pharmaceutical equipment in accordance with regulations.
Sign a purchase and sale agreement with the selected company in accordance with the selected price and agreed purchase quantity to determine the rights and responsibilities of both parties.
Improve the internal assessment methods and salary mechanism, set a procedure for preferentially recommending the selection of centralized and high-volume purchases in the doctor’s prescription information system, encourage the preferential use of selected products, and complete the agreed purchases in accordance with the procurement contract; use non-selected products reasonably to meet different requirements Clinical needs.
Undertake the main responsibility of the purchase settlement, settle the payment in time with the company according to the purchase contract, the drug settlement time shall not exceed the end of the next month after the delivery and acceptance, and the settlement time of medical consumables shall not exceed 90 days.
Strengthen the monitoring of adverse reactions (adverse events) of selected products, and report suspected adverse reactions (adverse events) in a timely manner according to procedures.

 

　　 (10) The selected enterprise.
Undertake the main responsibility for product production, supply and quality, do a good job of predicting and preventing market risks, organize production in accordance with the purchase contract, report production capacity, inventory and supply as required, and ensure that the selected products of medical institutions are met in a timely manner during the purchase agreement period Procurement requirements.
Provide samples of selected products to the drug regulatory authorities as reference materials for supervision, management and inspection.
The selected products shall be distributed by the selected company independently or by the distribution company, and the distribution costs shall be borne by the selected company.
The distributor shall have the corresponding qualifications for the distribution of medicines or medical consumables and a complete circulation traceability system, have the ability to cover the contracted supply areas, and respond to the purchase orders of medical institutions in a timely manner and deliver them in place.
Strengthen the distribution guarantee in remote areas.
In the event of failure to supply in time, the selected enterprise shall bear the corresponding responsibilities and all expenses incurred, except for the force majeure factor, otherwise it will be regarded as a breach of trust and breach of contract.

 

　　Seven, safeguard measures

 

　　 (1) Establish a linkage mechanism.
Departments such as medical security, health, drug supervision, and economic and information management have established monthly monitoring, notification, and departmental information sharing linkage mechanisms to strengthen the supervision and management of the supply, procurement and use of selected products.

 

　　 (2) Strengthen supervision and assessment.
Medical institutions shall not restrict the selected products from entering the hospital on the grounds of cost control, drug regulatory requirements for medical institutions, and review by the Pharmaceutical Committee.
It is strictly forbidden for medical institutions and selected companies to re-negotiate the selected products in any form.
For medical institutions that do not purchase and use selected products as required, and fail to settle payment on time, strengthen management by means of interviews, notifications, etc.
, and include indicators of total medical insurance, rewards and supplementary funds for public hospital reforms, medical institution rating reviews, and medical insurance designated points Qualifications and medical institution leaders will be punished in the assessment of target responsibilities.

 

　　 (3) Strengthen publicity and guidance.
Comprehensive and accurate interpretation of the centralized procurement policy, and vigorously publicize the results, typical cases, and innovative practices of centralized procurement.
Give full play to the role of medical staff in clinical medication, and do a good job of explaining and guiding.
Improve the monitoring and response mechanism of major public opinion, actively respond to social concerns, build social consensus, and create a good public opinion atmosphere.

 

　　8.
Other

 

　　 (1) During the procurement cycle, if the national organization organizes drugs and medical consumables to purchase the same catalog with the same quantity, corresponding adjustments will be made in accordance with the requirements of the national policy.

 

　　 (2) During the procurement cycle, if other province-based centralized procurement prices and volume procurement prices are lower than the selected prices in our province, the enterprise should proactively declare and adjust the selected prices.

 

　　 （），、，。

 

　　 （）。。

 

　　 （）2021 。

　　527　、，《（）》，。，202161（）、、。

 

　　：0571-81051028

 

　　：yyjghzbcgc.
ylbzj@zj.
gov.
cn

 

　　：（51-1，310005）

 

　　

 

　　2021524

 

　　

 

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