Viewpoint... A preliminary exploration of the framework system of the whole process of government procurement of goods-to the central budget unit procurement of medical devices as an example.

Government procurement is a comprehensive legal project with the Government Procurement Law as the core. The Government Procurement Law not only constitutes the whole process of China's government procurement activities with the Budget Law, the Civil Code, the Bidding Law, the Administrative Punishment Law, and the Administrative and Institutional State-owned Assets Management Regulations and other laws and regulations, it also forms my country's government procurement policy system with the "Small and Medium-sized Enterprise Promotion Law", "Energy Conservation Law", "Environmental Protection Law", "Science and Technology Progress Law" and other laws. It has an irreplaceable important position in the fiscal expenditure system. It plays an important role in realizing my country's macroeconomic regulation. Medical equipment as a more special goods in government procurement, with the general characteristics of government procurement goods at the same time, but also because of the direct relationship between human health and life safety and has its particularity, this paper takes the central budget unit procurement of medical equipment as an example, the whole process framework of government procurement goods to be analyzed, hoping to provide practical reference for government procurement.

According to the provisions of the Government Procurement Law, government procurement refers to the use of financial funds by state agencies, institutions and organizations at all levels to purchase goods, projects and services within the legally established centralized procurement catalog or above the procurement limit standard. Therefore, the constituent elements of government procurement are the procurement subject, the source of funds, the centralized procurement catalog and the procurement limit standard, the procurement target and other four elements.

Procurement subjects include state organs, institutions and organizations. The main body of government procurement of medical devices is mainly public hospitals, while public hospitals belong to public institutions.

The funds used in government procurement are financial funds, I .e. funds included in budget management. According to the provisions of the "Government Procurement Law", the supervision and management powers of government procurement activities are mainly exercised by the financial departments of the people's governments at all levels. In accordance with the provisions of the Budget Law, the State implements a budget at the level of government. The budget system includes the budgets of the central government, provinces, autonomous regions and municipalities directly under the Central Government, cities and autonomous prefectures divided into districts, counties, autonomous counties, cities without districts, municipal districts, townships, ethnic townships and towns. However, considering many factors such as the small scale of township government procurement, the relatively backward management level, the "township finance and county management", and the weak awareness of government procurement, most of my country's township-level government procurement is included in the county-level government procurement management, for example, Article 54 of the "Shandong Provincial Government Procurement Management Measures" (Shandong Provincial People's Government Order No. 262) makes this provision.

Subject matter of government procurement, including goods, works and services. According to the "Government Procurement Law" and its implementing regulations, goods refer to various forms and types of goods, including raw materials, fuels, equipment, products, etc. Engineering refers to construction projects, including the new construction, alteration, expansion, decoration, demolition and repair of buildings and structures. Services refer to other government procurement objects other than goods and projects, including the services needed by the government itself and the public services provided by the government to the public.

In addition, in order to further clarify the concept of "procurement", the "Government Procurement Law" also stipulates that procurement refers to the acquisition of goods, works and services by contract, including purchase, lease, entrustment, employment, etc. As an important part of public financial expenditure, government procurement should be the proper meaning of government procurement. According to the provisions of the Civil Code, the Civil Code Guarantee Interpretation and other laws and regulations, my country has many restrictions on the guarantees provided by entities such as government legal persons and non-profit medical institutions for public welfare purposes. Strict restrictions have been made. Therefore, as a financial leasing behavior with both financing and statutory atypical guarantee attributes, it should not be used as a form of government procurement of medical devices.

According to the Regulations on the Supervision and Administration of Medical Devices, medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles that are directly or indirectly used in the human body, including required computer software; their utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or although these methods are involved, they only play an auxiliary role; its purpose is: (1) the diagnosis, prevention, monitoring, treatment, treatment or alleviation of diseases; the diagnosis, monitoring, treatment, alleviation or functional compensation of (II) injuries; (III) physiological structures or physiological processes Inspection, replacement, adjustment or support; (IV) life support or maintenance; (V) pregnancy control; (VI) through the examination of samples from the human body, providing information for medical or diagnostic purposes.

According to the provisions of the Announcement of the State Food and Drug Administration on Issuing the Classification Catalogue of Medical Devices (China Food and Drug Administration Announcement No. 104 of 2017) and the Announcement of the State Food and Drug Administration on Issuing the Working Procedures for Dynamic Adjustment of the Classification Catalogue of Medical Devices (SDA Announcement No. 60 of 2021), medical devices can be divided into 22 sub-directories according to their technical specialties and clinical use characteristics. The subdirectory consists of primary product category, secondary product category, product description, intended use, product name example, management category, etc. The state shall manage the registration and filing of medical devices according to the catalogue. In addition, in accordance with the provisions of the Notice on the Disclosure of the Catalogue and Scope of Application of Chinese Medical Device Standards by the Medical Device Standards Management Center of the State Food and Drug Administration, according to the technical field of medical devices, the scope of application of the currently effective 1852 medical device standards and The information such as standard level, effectiveness, name, and centralized unit are sorted out one by one, which provides a guiding basis for the procurement and management of medical devices.

China's medical device industry market is large, and growth continues. According to the statistics of China Drug Administration and Research Association, in 2019, the market size of medical devices was 720 billion billion yuan, double that of 308 billion billion yuan in 2015. In 2020, due to the outbreak of the new crown epidemic, a large number of diagnostic reagents, medical masks, extracorporeal membrane oxygenation (ECMO) machines and a series of medical devices related to epidemic prevention and control of the rapid surge in demand, the medical device industry's main sales revenue of about 872.5 billion yuan, an increase of 21%. Since 2015, the average annual growth rate of medical device industry revenue has remained at about 20%.

According to the notice of the Ministry of Finance on printing and distributing the classified catalogue of government procurement items (caiku [2013] No. 189, hereinafter referred to as "caiku [2013] No. 189 document"), the goods items related to "medical devices" include "medical equipment (code: A0320)" and its 33 sub-items, including surgical instruments (code: A032001) and general diagnostic instruments (code: 032002)… Other medical equipment (code: A032099), etc.

Taking the procurement of medical equipment by central budget units as an example, according to the "Notice of the General Office of the State Council on Printing and Distributing the Catalogue and Standards of Centralized Government Procurement by Central Budget Units (2020 Edition)" (Guo Ban Fa [2019] No. 55, hereinafter referred to as "Guo Ban Fa [2019] No. 55") The aforementioned "medical equipment (code: A0320)" and its 33 sub-items are not included in the centralized government procurement catalogue of central budget units, at the same time, the quota standard for decentralized procurement of goods by central budget units is more than 1 million yuan. Therefore, if the purchase of medical devices of the same item or category within the budget year of the central budget unit reaches more than 1 million yuan, it belongs to the government procurement of medical devices.

According to the provisions of the "Government Procurement Law", when preparing the departmental budget for the next fiscal year, the department responsible for preparing the departmental budget shall list the government procurement projects and fund budgets for the fiscal year and report them to the financial department at the same level for summary. The approval of departmental budgets is carried out in accordance with budget management authority and procedures. According to the provisions of the Budget Law, the organizational procedures of the budget include the preparation of the draft budget, the summary and approval of the draft budget, the formal budget, the implementation of the budget, the adjustment of the budget, the final accounts, and the report on the implementation of the budget.

In practice, before the draft budget is prepared, summarized, and approved to form a formal budget, it involves multiple processes such as funding calculations, new asset allocation budgets, government procurement budgets, first budgets, and second budgets. Among them, in the procurement process of government procurement, the budget "two on the number" has important practical significance. According to the provisions of the Notice of the Ministry of Finance on Doing a Good Job in the Disclosure of Government Procurement Information (Caiku [2015] No. 135), the budget amount of procurement items shall be based on the government procurement budget in the departmental budget approved by the financial department; for the items purchased before the approval of the departmental budget, it shall be based on the government procurement budget in the "second number" of the budget.

In practice, the procurement of public hospitals using "own funds" has problems such as not preparing government procurement budget and not being included in the scope of government procurement. The reply of the Ministry of Finance to the recommendation No. 8584 of the fourth session of the 13th National people's Congress (2021 No. 6) clearly points out that according to the Budget Law and the Financial rules of Public institutions (decree No. 108 of the Ministry of Finance) and other laws and regulations, the financial subsidy income of public hospitals, as well as business income, operating income and other income, should be included in the budget management, all government procurement activities carried out by public hospitals using funds included in budget management shall implement government procurement regulations.

According to the relevant provisions of the Budget Law, the opinions of the CPC Central Committee and the State Council on the comprehensive implementation of budget performance management, the opinions of the State Council on further deepening the reform of the budget management system (Guo Fa [2021] No. 5), and the notice of the Ministry of Finance on the implementation of the opinions of the CPC Central Committee and the State Council on the comprehensive implementation of budget performance management (Cai Yu [2018] No. 167), government revenue and expenditure budgets at all levels are fully integrated into performance management, and the whole process of government procurement projects is integrated into performance management.

Performance management of medical equipment procurement in public hospitals, it is necessary to follow the "Financial Rules for Public Institutions" (Ministry of Finance Order No. 108), "Notice of the Ministry of Finance and the Ministry of Health on Printing and Distributing the" Hospital Financial System "" (Caishe [2010] No. 306), "Ministry of Finance, National Health and Family Planning Commission, Guiding Opinions of the State Administration of Traditional Chinese Medicine on Strengthening the Financial and Budget Management of Public Hospitals" (Caishe [2015] No. 263), "the requirements of the relevant provisions of the Notice on the Implementation of the Comprehensive Budget Management System for Hospitals (Guowei Financial Fa [2020] No. 30), etc, distinguish between budgeting, approval, implementation, final accounts and evaluation, improve the performance management process, formulate and implement budget performance management systems and implementation rules, and in accordance with the" Opinions of the General Office of the State Council on Strengthening the Performance Appraisal of Tertiary Public Hospitals "(2019 No. 4)," The General Office of the National Health Commission on the issuance of the "National Tertiary Public Hospital Performance Appraisal Operation Manual (2022 Edition) Notice" (Guowei Medical Letter [2022] No. 92) for performance appraisal.

According to the "Government Procurement Law" and its implementation regulations, the "Administrative and Institutional State-owned Assets Management Regulations" and the "Notice of the Central Committee of the Communist Party of China and the State Council on Printing and Distributing the" Regulations for Party and Government Organs to Strictly Save and Oppose Waste "(Zhongfa [2013] No. 13) And other relevant regulations, government procurement should prepare a complete procurement budget in accordance with the law, strictly implement the budget and asset allocation standards, and asset allocation standards.

For the asset allocation of medical devices, according to the Regulations on the Supervision and Administration of Medical Devices and the Notice of the State Health Commission and the State Drug Administration on Printing and Distributing the Administrative Measures for the Allocation and Use of Large Medical Devices (Trial) (No. 12 of the State Health Planning 2018) and other laws and regulations, the allocation of large medical devices by medical device users shall be approved by the competent health department of the people's government at or above the provincial level, obtainment of a large medical device configuration license. Large medical equipment configuration management directory is divided into A, B two categories. The National Health Commission is responsible for the configuration management and issuance of configuration licenses for Class A large medical equipment; the provincial health administrative department is responsible for the configuration management and issuance of configuration licenses for Class B large medical equipment. At the same time, the health department has stipulated different medical equipment and other health resource allocation for hospitals with different public welfare purposes and levels. For example, the "Notice on Printing and Distributing Technical Guidelines for Fever Outpatient Building Equipment (Trial)" (National Health Office Planning Letter [2020] No. 683) sets up a reference catalog for the configuration of medical equipment in fever outpatient clinics.

According to the "Notice of the General Office of the State Council on Further Doing a Good Job in the Work of Invigorating Fiscal Stock Funds" (Guo Ban Fa [2014] No. 70), "Notice of the Ministry of Finance on Further Strengthening the Management of Local Fiscal Balance Carry-over Funds" (Caiyu [2013] No. 372), "Notice of the Ministry of Finance on Issuing and Promoting Local Invigorating Fiscal Stock Funds" (Caiyu [2015] No. 15) the normative document of the Notice on the Measures for the Management of Carry-forward and Balance Funds (Caiyu [2016] No. 18) stipulates that, budget units should refine the preparation of expenditure budgets, speed up the progress of budget implementation, establish a regular clean-up mechanism, reduce the scale of balance carry-over funds, deepen the reform of departmental budget management, and strengthen the management of departmental balance carry-over funds. Among them, the department budget balance funds and funds carried forward for more than two years, by the same level of financial recovery, overall use.

Article 43 of the Government Procurement Law stipulates that the Contract Law shall apply to government procurement contracts (the Contract Law has been repealed on January 1, 2021). At the same time, the Civil Code stipulates that the rights and obligations of the parties to the sale by tender and tender, as well as the procedures for tendering and bidding, shall be in accordance with the provisions of relevant laws and administrative regulations. Therefore, unless there are special provisions in government procurement laws and regulations, the provisions of the Civil Code shall apply to government procurement contracts.

In terms of contract types, according to the "Notice of the Ministry of Finance on Printing and Distributing the Measures for the Administration of Government Procurement Demand" (Caiku [2021] No. 22, hereinafter referred to as "Caiku [2021] No. 22"), government procurement contracts shall The contract type is determined in accordance with the typical contract categories stipulated in the Civil Code and the actual situation of the subject matter of procurement.

In the contract text, according to the provisions of Caiku [2021] No. 22, the government procurement contract text should contain all the statutory necessary terms and procurement requirements, including but not limited to the name of the subject matter, the quality, quantity (scale) of the subject matter of procurement, performance time (period), place and method, packaging method, price or remuneration, payment schedule, payment method, acceptance, delivery standards and methods, quality warranty scope and warranty period, liability for breach of contract and dispute resolution methods. The statutory provisions in this provision shall be determined in accordance with the legal provisions of the Civil Code.

In particular, it should be noted that since this article focuses on medical devices for government procurement of goods, it does not discuss the contents of government procurement contracts related to administrative agreements.

The contract section of the Civil Code provides for 19 typical contracts, of which the contract of sale has the status of "suzerain. According to the provisions of the Civil Code, if the law has provisions on other paid contracts, it shall be in accordance with its provisions. Buying and selling is the most common form of government procurement, the government procurement of goods as a paid acquisition of the subject matter of the carrier, most of its contract types are also expressed as sales contracts. Even if the type of government procurement contract constitutes other paid contracts because the form of procurement is leasing, employment, etc., according to the provisions of the Civil Code, if the law does not provide for other paid contracts, reference should be made to the relevant provisions of the applicable sales contract. Therefore, the contract of sale is also a typical representative of the government procurement contract.

The common legal problems of the contract of sale are the transfer of ownership of the subject matter, risk-taking and the attribution of interest, etc.

In practice, delivery can be divided into realistic delivery and conceptual delivery, with realistic delivery including door-to-door delivery, door-to-door pick-up and agency consignment; conceptual delivery including simple delivery, instructed delivery and possession modification. From the point of view of the lowest legal risk of the purchaser, the purchaser is best to choose the delivery method of home delivery.

The performance acceptance of government procurement contracts is a statutory matter. According to the "Guiding Opinions of the Ministry of Finance on Further Strengthening the Management of Government Procurement Demand and Performance Acceptance" (Caiku [2016] No. 205) and Caiku [2021] No. 22, the purchaser shall organize the performance acceptance work in accordance with the law, prepare the acceptance plan in a complete and detailed manner, improve the acceptance method, carry out the performance acceptance in strict accordance with the procurement contract, and strictly implement the requirements of the performance acceptance responsibility. Project acceptance is the last pass of procurement activities. The purchaser shall establish a scientific, reasonable and effective work mechanism for the performance acceptance of government procurement projects, formulate an internal management system, organize the performance acceptance of contracts, and perform the relevant duties of acceptance by setting up an acceptance team, making preparations before acceptance, clarifying the acceptance contents, determining the acceptance method, issuing the acceptance letter according to the acceptance results, and filing and filing the data of the whole acceptance process.

Procurement requirements are the basis and basis for determining the procurement budget, preparing procurement documents and implementing procurement activities. Treasury [2021] No. 22 provisions, procurement needs refers to the purchaser to achieve the objectives of the project, the subject matter to be purchased and the technical and commercial requirements to be met. Technical requirements refer to the functional and quality requirements of the subject matter of the procurement, including performance, materials, structure, appearance, safety, or service content and standards. Taking government procurement of medical devices as an example, the purchaser shall pay attention to the following matters in the organization to determine the procurement requirements, prepare the procurement implementation plan and implement the relevant risk control management:

1. In the demonstration of medical equipment plan and the establishment of management institutions, according to the "Notice of the Ministry of Health on Printing and Distributing the" Measures for the Management of Medical Equipment in Medical and Health Institutions "(Wei Gui Cai Fa [2011] No. 24), medical and health institutions have a unit price The medical equipment plan of 500000 yuan and above shall conduct feasibility demonstration. Medical institutions at or above the second level and other health institutions at or above the county level shall set up special medical equipment management departments, which shall be directly responsible by the competent leaders, and shall be equipped with appropriate professional and technical personnel according to the scale of the institutions and management tasks. Institutions that are small in scale and should not set up special medical equipment management departments shall be managed by special personnel. Medical institutions at or above the second level and other health institutions with conditions shall establish a medical equipment management committee. Responsible for the evaluation, demonstration and consultation of major issues such as the medical equipment development plan, annual equipment plan, procurement activities, etc., to ensure scientific and democratic decision-making.

2. In determining the procurement needs, according to the provisions of Caiku [2021] No. 22, the procurement of medical equipment projects of more than 10 million yuan; the procurement of medical equipment projects involving public interests and high social concern; technical complexity and professionalism Strong projects, including the procurement of imported medical equipment projects, should be investigated in accordance with the law. The methods of investigation include consultation, demonstration, questionnaire survey, etc. When conducting demand surveys for market entities, the selected survey objects are generally not less than 3 and should be representative.

3. In terms of risk control, according to the provisions of Caiku [2021] No. 22 and the "Notice of the National Health Commission on Further Regulating and Strengthening the Management of Government Procurement" (Guowei Financial Letter [2020] No. 250), medical and health institutions shall organize experts to review and demonstrate the bidding documents for government procurement of medical devices. The expert group shall be composed of an odd number of more than 5 (inclusive), including one legal expert, and the personnel of the unit shall not serve as review and argumentation experts.

Government procurement policies include energy conservation, environmental protection, support for underdeveloped areas and ethnic minority areas, and promotion of the development of small and medium-sized enterprises. In the implementation of the government procurement policy of medical device procurement, the following matters should be paid attention:

1. Government procurement of imported products shall comply with the provisions of the law. According to the provisions of the Government Procurement Law, government procurement shall procure domestic goods, projects and services; except in one of the following circumstances: the goods, projects or services that need to be procured cannot be obtained within the territory of China or cannot be obtained on reasonable commercial conditions; Procurement for use outside China; other laws and administrative regulations provide otherwise. The definition of domestic goods, construction and services referred to in the preceding paragraph shall be implemented in accordance with the relevant provisions of the State Council. The Circular of the Ministry of Finance on Issuing the Measures for the Administration of Government Procurement of Imported Products (No. 119 [2007] of the Ministry of Finance) stipulates that government procurement shall purchase domestic products, and if it is really necessary to purchase imported products, audit management shall be implemented. If it is really necessary to purchase imported products, government procurement activities shall be carried out in accordance with the law after obtaining the approval of the financial department.

As far as government procurement of medical devices is concerned, the Ministry of Finance and the Ministry of Industry and Information Technology jointly issued the "Notice on Printing and Distributing the Guiding Standards for the Audit of Imported Products for Government Procurement" (2021 Edition), which regulates the guiding standards for the import audit of medical devices of different items, and specifies that 100 of 137 medical devices are required to be purchased domestically.

2. Government procurement shall implement policies to promote the development of small and medium-sized enterprises. Pursuant to the Convention on the Issuance<政府采购促进中小企业发展管理办法>According to the provisions of the notice (caiku [2020] No. 46, hereinafter referred to as "caiku [2020] No. 46"), if the procurement quota standard is above, the procurement of goods and services below 2 million yuan, and the procurement of engineering projects below 4 million yuan are suitable for small and medium-sized enterprises, the purchaser shall specifically purchase for small and medium-sized enterprises. For goods and services procurement projects exceeding 2 million yuan and engineering procurement projects exceeding 4 million yuan that are suitable for small and medium-sized enterprises, more than 30% of the total budget of this part of the procurement project is reserved for small and medium-sized enterprises, of which the proportion reserved for small and micro enterprises is not less than 60%. The reserved share is carried out through the following measures: the procurement project as a whole or the procurement package is specially set up for small and medium-sized enterprises; Suppliers are required to participate in procurement activities in the form of a consortium, and the small and medium-sized enterprises in the consortium bear a certain proportion; Suppliers who have obtained procurement contracts are required to subcontract a certain proportion of procurement projects to one or more small and medium-sized enterprises. There shall be no direct holding or management relationship between the small and medium-sized enterprises that form a consortium or accept subcontracts and other enterprises or subcontracting enterprises in the consortium.

As far as government procurement of medical devices is concerned, according to the provisions of Caiku [2020] No. 46, suppliers who enjoy the support policy for small and medium-sized enterprises are provided medical devices manufactured by small and medium-sized enterprises, that is, the medical devices provided are produced by small and medium-sized enterprises and use The SME trade name or registered trademark.

According to the provisions of the Government Procurement Law, government procurement methods include public bidding, invitation bidding, competitive negotiation, single-source procurement, inquiry and other procurement methods recognized by the Ministry of Finance. Among them, other procurement methods identified by the Ministry of Finance include competitive negotiation procurement and framework agreement procurement. The choice of government procurement methods shall conform to the statutory applicable circumstances and the characteristics of procurement requirements, and meet the standard of the amount of public bidding. If a procurement method other than public bidding is required due to special circumstances, it shall be approved in accordance with the law.

Taking the government procurement of medical devices by the central budget unit as an example, if the single purchase amount reaches more than 2 million yuan, the public bidding method must be adopted. If the procurement method other than public bidding is required due to special circumstances, the approval of the Ministry of Finance shall be obtained according to law. According to the Notice of the Ministry of Finance on the Issuance of the Interim Measures for the Administration of Competitive Consultation Procurement Methods in Government Procurement (Treasury [2014] No. 214), the items that can be procured through competitive consultation include: government procurement of service items; technical complexity or special nature, and the detailed specifications or specific requirements cannot be determined; the total price cannot be calculated in advance due to reasons such as the time and quantity of art procurement, patents, proprietary technology or services cannot be determined in advance; scientific research projects with insufficient market competition, and scientific and technological achievements transformation projects that need support; in accordance with the bidding law And its implementation regulations must carry out bidding for construction projects other than construction projects. The state has carried out a more detailed catalog management of medical devices, and has also made clearer regulations on the corresponding standards. Therefore, medical devices generally do not belong to situations such as complex technology or special nature, that is, government procurement of medical devices should not adopt competitive consultation procurement. Way to carry out procurement activities.

According to the provisions of the Government Procurement Law, if a supplier believes that its rights and interests have been damaged by the procurement documents, the procurement process, the winning bid and the result of the transaction, it may, within seven working days from the date when it knows or should know that its rights and interests have been damaged, challenge the purchaser in writing. If the supplier is not satisfied with the reply of the purchaser or procurement agency, or the purchaser or procurement agency fails to make a reply within the specified time, it may complain to the government procurement supervision and management department at the same level within 15 working days after the reply period expires. If the complainant is not satisfied with the complaint handling decision of the government procurement supervision and administration department or the government procurement supervision and administration department fails to deal with it within the time limit, he may apply for administrative reconsideration or bring an administrative lawsuit to the people's court according to law.

For example, if the technical and service requirements in the procurement requirements point to a specific supplier or a specific product, for example, if only a specific product can meet the individual technical requirements required in the procurement documents, or if only a specific product can meet the multiple technical requirements required in the procurement documents, it is an illegal situation as mentioned above. Other suppliers participating in the project may raise questions to the purchaser or procurement agency in accordance with the law, and may file a complaint with the financial department at the same level of the purchaser if they are not satisfied with the reply to the question or fail to reply within the statutory time limit, and may file a lawsuit or reconsideration in accordance with the law if they are not satisfied with the handling of the complaint by the financial department or if the financial department does not act passively.