Anhui Province, the province's net inspection reagents procurement

Pharmaceutical Network December 14 News December 12, Anhui Provincial Health Planning Commission, the Office of Human Services, Department of Finance, Development and Reform Commission, Price Bureau, Industry and Commerce Bureau, Food and Drug Administration and other departments jointly issued a document to jointly promote the province linked to diagnostic reagents Network procurement, and require lower prices.

In all the provinces, drug Provincial level Bidding Procurement has been basically completed, the province as a unit of centralized procurement of high-value supplies also made about the same, the current remaining low-value supplies and testing reagents provincial mining has not yet mobilized a large area.

As the first pilot province of medical reform in the province, Anhui Province, the test reagent provincial net purchase, will become the future of a mainstream way?

Anhui inspection reagents procurement methods, but also how? We can pick from the implementation plan 'point of view:

In order to strengthen the procurement management of clinical laboratory reagents in public medical institutions, standardize the purchase behavior and reduce the price of inflated prices.According to the "General Office of Anhui Provincial Government on Issuing Anhui Province in 2017 to Deepen medicine Notice on Key Tasks for Pilot Reform of Health System (Wanzheng Office Secret [2017] No.92) and Notice of Anhui Leading Group on Printing and Distributing the Implementation Plan of Intensive Medical Transaction of Medical Supplies by Medical Institutions in Anhui Province (for Trial Implementation) Anhui Medical Reform 〔2014〕 No. 1), combined with the actual situation in our province to develop the implementation of the program.

Main objectives: To establish a platform and regulatory platform for procurement of clinical laboratory reagents, standardize the purchase and sale of clinical laboratory reagents, and ensure the quality and supply of public medical institutions; gradually push forward the rationalization of purchase prices and reduce the price of clinical laboratory reagents.

(II) Basic Principles The government guides the market operation and unifies the platform, moves up and down, scientifically and reasonably, operates in a regulated manner, is open and transparent, and supervises throughout.

(C) the scope of implementation. People's governments at all levels throughout the province, state-owned enterprise (Including state-controlled enterprises) and other public medical institutions (including grass-roots medical institutions) to implement centralized online clinical testing reagents. Encourage other medical institutions voluntarily participate in online trading.

(D) procurement cycle. Temporarily not limited to the procurement cycle.

(5) Organizational Structure The Provincial Health and Family Planning Commission and the relevant departments are responsible for the organization and management of the online centralized examination of clinical laboratory reagents, and the provincial centralized medicine procurement center (hereinafter referred to as the Provincial Pharmaceutical and Drug Acquisition Center) is responsible for the implementation of the centralized online examination of clinical reagents. Provincial Medical Procurement Supervision and Management Office (hereinafter referred to as the Provincial Medical Supervision Office) is responsible for receiving complaints, the full supervision of clinical testing reagents online focus transactions.

(F) announcement method. All the announcements and information of centralized online transaction of clinical laboratory reagents in our province through the drug procurement sub-platform of Hefei public resource trading platform (hereinafter referred to as provincial pharmaceutical centralized procurement platform, http://www.ahyycg.cn/ ) Released.

(A) Scope of the Catalog In principle, according to the Notice of the State Health and Family Planning Commission on Issuing Catalogs of Clinical Laboratory Projects in Medical Institutions (2013 Edition) (Guo Wei Yi Fa [2013] No. 9), public medical institutions in our province commonly use clinical Test items all of the test reagents included in the scope of centralized procurement.

(B) directory classification.

1. Classification according to clinical test items Clinical test reagents are divided into 5 categories, including clinical blood and body fluid tests, clinical chemistry tests, clinical immunizations and serological tests, clinical microbiology tests, clinical molecular biology and cytogenetics tests.

2. Classification by reagent category Clinical testing reagents are divided into general (open) type test reagents and special plane (closed) type test reagents two types.

(C) the development of the directory Combined with the clinical needs and usage of public medical institutions in our province, after the experts argue, by the provincial pharmaceutical production center to organize production enterprises to declare, pooled analysis, social publicity to form a centralized inventory of clinical testing reagents, specific to the relevant Manufacturers and models specifications.

Clinical testing reagents to implement the province's unified network limit, online transactions. By the medical institutions with the amount of procurement, volume and price linked to determine the actual transaction products and prices. Encourage medical institutions combined with the amount of procurement, to further reduce the clinical Inspection reagent purchase price.

(A) business registration.

Participate in the province of clinical testing reagents online transactions focused on the production and operation of enterprises in the provincial centralized pharmaceutical procurement platform to declare clinical testing reagents business information and products based on the request and submit or upload the appropriate information on the material integrity of the manufacturing enterprises and related products Information, distribution business list in the provincial pharmaceutical centralized procurement platform publicity.

(B) hanging net limit.

1. Limit basis. "Anhui Medical Leading Group on the issue of Anhui Province, public medical institutions medical consumables online transaction implementation plan (Trial) Notice" (Anhui Medical Reform [2014] No. 1)

2. The principle of setting price limit Before the release of this implementation plan, since 2014, the province-level bidding and price-limiting quotations of provinces under implementation in various provinces, municipalities and autonomous regions across the country have been suspended; hospital The most recent actual purchase price.

3. Limit method. Clinical testing reagents according to the packing unit (specific to the specification or model) limit.

(C) product network.

1. Confirmed by the manufacturer, agreed to limit the purchase price range of the centralized procurement catalog, the formation of online trading directory. Medical institutions shall not be higher than the price limit for online purchase online.

2. Enterprises do not agree with the net price limit or no provincial price (or net price limit) and the province's actual purchase price varieties, the formation of online filing transactions directory by the medical institutions based on clinical needs, bargaining their own online Sunshine online purchase.

3. After confirming the transaction between the medical institution and the manufacturing enterprise or the entrusted delivery enterprise, the relevant transaction information such as the transaction type, purchase volume (amount) and actual transaction price must be accurately and truthfully filled in online.

(D) the signing of the contract.

1. Medical institutions to determine the purchase of species must be with the manufacturing enterprises or their entrusted distribution companies signed a sales contract and the "medical and health institutions, the purchase and sale of pharmaceutical products, clean contracts."

2. Purchase and sales contracts to clear the species, specifications, price, quantity, delivery time, settlement and settlement time, liability for breach of contract, with the service, etc. The number of contract purchases based on the actual number of medical institutions last year, based on the actual adjustment to determine If the amount of procurement agreed in the contract can not meet the clinical needs, medical and health institutions can sign additional contracts with suppliers, the supplier shall not refuse.

3. Supply companies and medical institutions must fulfill the obligations and obligations stipulated in the contract for purchase and sale according to the provisions of the Law of Contract and other laws and regulations.The medical institutions should do a good job in procurement, acceptance, storage, storage and use according to the contract of purchase and sale, And within 15 working days from the date of settlement, it will be confirmed by the provincial purchasing platform for receiving goods.

(E) online purchase.

1. Online centralized trading directory and online filing transaction directory (hereinafter referred to as hanging catalog) announced the date of implementation, the medical institutions based on clinical needs, adhere to the principle of quality first, reasonable price, price appropriate principle, the online procurement of clinical tests required Reagents. In principle, medical institutions to complete inventory clean-up within two months.

2. The products and medical institutions in the online catalog must be purchased online through the central purchasing platform of provincial medicine, and the offline transaction is strictly forbidden. The medical institution should submit the purchase order online in special circumstances, purchase in special circumstances and complete the purchase order within 5 working days Information supplements.

Out-of-network products are purchased from the original channel, but must be declared online by the manufacturer within the time limit for the next new product purchase, and the medical institution can not purchase the products because the enterprise fails to successfully connect to the network.

3. Online centralized transaction catalog products, by the medical institutions and enterprises in the voluntary, fair and equitable, consensus, under the premise of price and price linked to determine the actual purchase price.

4. The online catalog of products in the transaction catalog shall be self-bargaining by the medical institutions according to their own needs, and shall be purchased centrally through online centralized control of the total amount for the record purchasing and purchasing, and the proportion of the total amount purchased for the record-buying in the medical institutions shall not exceed 10% of the total purchase amount of the testing reagents.

5. Enterprise distribution, accompanying services, VAT and other taxes and fees are included in the actual transaction purchase price within the actual purchase price of medical institutions shall not be higher than the provincial price limit and the original purchase price of medical institutions due to national and local policy Price adjustment, should be in accordance with the provisions of the actual transaction price adjustment.

(F) product distribution.

1. Production enterprises are the first responsible for the supply and distribution, can be directly delivered, but also commissioned delivery. Production enterprises should ensure that the quality of clinical testing reagents, timely and adequate supply of non-compliant supply distribution companies, manufacturing enterprises and medical Institutions can change distribution companies after consensus.

2. Production and operation of clinical test reagents should have the qualifications accredited by the food and drug supervision and administration department. The reagents and the production and operation enterprises that need cold-chain transport need to have cold chain transportation and storage conditions.

3. Production enterprises and their entrusted delivery companies according to the situation of online purchase orders in a timely manner online purchase order confirmation, delivery, service and other work, urged the purchasing unit truthfully fill in the online acceptance of storage information to ensure that the actual purchase and delivery storage and Online delivery warehousing information consistent.

4. Urgent use of products delivered within 8 hours, the general product delivered within 24 hours, up to 48 hours; normal delivery holidays .If the medical institutions have special distribution needs, should seek to meet.

5. Before the expiration of the enterprise license, the latest effective proof of change shall be submitted to the Provincial Drug Purchase Center, and if the validity period has not changed, stop the online transaction of the relevant product of the enterprise.

According to the actual needs of medical institutions in our province, the Provincial Pharmaceutical and Drug Procurement Center regularly announces, confirms and publishes the procedures to regularly adjust the catalogs, products and prices, and establish new and eliminated products. In principle, Adjust once

(A) dynamic product adjustment Clinical reagents for the new listing of clinical reagents and medical institutions to carry out the new test items required for clinical testing reagents, according to the application and after the public announcement on a regular basis to add nets, online transactions recorded in the directory.

(B) directory dynamic adjustment. For online filing transaction catalog products, businesses agreed to limit the net included online trading directory; on the online trading directory products, if the business does not agree to limit the price of the network, it will be adjusted to the Internet Record transaction directory.

(III) Adjusting the price limit According to the national bidding price, the limit price of netting and the latest actual purchasing price of public hospitals in our province and municipal level, the price limit of net-hanging products shall be dynamically adjusted.

(A) to strengthen supervision and management. All relevant departments to perform their duties, each with its own responsibility, in accordance with relevant laws and regulations of the clinical testing reagents online centralized trading activities supervision and management. Provincial Drug Supervision Office to strengthen clinical testing reagents online centralized supervision and inspection Timely discover and deal with the problems existing in the online centralized trading work, accept the related complaints and punish the non-compliant behaviors in strict accordance with relevant regulations.

All cities and counties should establish an online centralized transaction supervision and management mechanism for clinical laboratory reagents, be responsible for organizing, supervising and directing centralized centralized procurement of clinical laboratory reagents by medical institutions within the jurisdiction and assisting superiors and relevant departments to jointly strengthen supervision and administration.

(B) the serious non-compliance treatment. Clinical reagents suppliers are included in the commercial bad bribery records, in strict accordance with the "National Health and Family Planning Commission on the establishment of the pharmaceutical buying and selling bad business bribery records" (National Guard Law issued [2013] 50 No.) and "Anhui Province, the purchase and sale of medical malpractice commercial bad faith record system implementation of the relevant provisions of" the relevant provisions.

Violation of the relevant provisions of suppliers and medical institutions, with reference to "Anhui Province medical institutions to deal with bad behavior in the purchase and sale of drugs (Trial)" (Anhui Wei medicine 〔2011〕 26) included in the bad record, and in accordance with the "government departments involving enterprises Information unified collection publicity implementation plan "," Anhui Province Pharmaceutical Procurement Supervision and Management Measures (Trial Processing) "(Wei Yao Mi [2016] No. 315) and other provisions.

(C) strengthen the building of a clean and honest government, firmly establish the 'four awareness' and further reduce the two responsibilities of a comprehensive and strict party governance, intensify the centralized purchasing of clinical trial reagents, clean education and improve the internal control and external supervision of clinical testing reagent purchasing agencies Mechanism to improve the online centralized procurement system for clinical laboratory reagents, strengthen the supervision of key departments and key positions, prevent the risks of honest practitioners and promote the centralized online transaction of clinical laboratory reagents in a steady and orderly manner.