The person in charge of the State Council Office of Healthcare Reform issued a Q&A on the establishment and standardization of the procurement mechanism for essential drugs
Recently, the General Office of the State Council issued the "Guiding Opinions on the Establishment and Standardization of the Procurement Mechanism for Essential Drugs in Government-run Primary Healthcare Institutions" (hereinafter referred to as the "Procurement Mechanism"). In this regard, the reporter interviewed the person in charge of the Office of the State Council Leading Group for Medical Reform.
Q: The national basic drug system has been implemented for more than a year, why the introduction of the Procurement Mechanism?
The establishment of the national essential drugs system is a major institutional innovation that benefits people's livelihoods and aims to protect the basic medicines for the masses. Since the launch of the implementation of this system last year, significant progress and initial results have been achieved, so far, more than 50% of government-run primary health care institutions have implemented the basic drug system and zero-differential rate sales. However, some new situations and problems have also emerged, highlighted by the fact that the centralized bidding and purchasing of essential medicines is not standardized, the problem of inflated drug prices has not been effectively and reasonably resolved, and the supply of some medicines has been cut off or out of stock in some areas, which has affected the effectiveness of the implementation of the essential medicines system and the extent to which the public has benefited from it. In accordance with the instructions of the State Council Leading Group on Medical Reform, the State Council Office of Medical Reform, together with the relevant departments, conducted an in-depth analysis of the key aspects of the bidding and purchasing of essential medicines and the salient problems that existed, and actively drew on the successful experience of centralized purchasing of medicines both at home and abroad, listened carefully to the opinions and suggestions of the relevant parties and experts both at home and abroad, and put forward targeted measures, resulting in the first draft of the Purchasing Mechanism. After extensive consultation with relevant departments and localities, and repeated revisions and improvements, the draft of the Procurement Mechanism was submitted for review and approval, discussed by the plenary of the State Council's Office of Healthcare Reform, and submitted to the plenary of the State Council's Leading Group of Healthcare Reform for deliberation and adoption, and the Procurement Mechanism was formally issued by the State Council's General Office on Nov. 19th.
The Procurement Mechanism is an important supporting document for the national essential drugs system, which will certainly promote the establishment of a standardized provincial centralized purchasing mechanism for essential drugs as soon as possible, and build up a better supply guarantee system for essential drugs at the grass-roots level to ensure the smooth implementation of the essential drugs system.
Q: What is the overall consideration for the introduction of the "procurement mechanism"? What are the innovative initiatives and highlights?
The general idea of the Procurement Mechanism is to implement centralized procurement and unified distribution on a provincial (regional and municipal) basis; to insist on the combination of government-led and market mechanisms, to give full play to the advantages of centralized bulk purchasing, the combination of bidding and purchasing, the volume-price linkage, the signing of the contract, and completing the whole process of purchasing in one go, so as to minimize the cost of purchasing, and to achieve the safety and efficacy of essential medicines, with good quality and at a reasonable price, Supply in a timely manner, to promote the production and supply of essential drugs, so that the masses can really benefit.
The Procurement Mechanism, in response to the outstanding problems in various places, has put forward a series of targeted and innovative measures focusing on the three core elements of quality, price and supply of essential medicines, which mainly include: Firstly, the main body of the procurement responsibility is clarified, and the purchasing agency determined by the provincial health administrative department is responsible for the procurement of essential medicines as the main body of the procurement, and the government-run primary health care institutions have signed the authorization or entrustment agreement, and the drug suppliers have signed the purchase agreement with the government-run primary health care institutions. It signs authorization or entrustment agreements with government-run primary medical and healthcare institutions, and signs purchase and sales contracts with drug suppliers and is responsible for the implementation of the contracts. Secondly, it adheres to the linkage between quantity and price, and realizes the whole process of procurement in one go through the preparation of a procurement plan, specifying the quantity to be procured (if the quantity cannot be determined for the time being, a single-source commitment is adopted), signing the purchase and sale contract, and strictly paying the payment time. Give full play to the advantages of bulk purchasing. Thirdly, quality is prioritized and prices are reasonable. Adhere to the quality in the first place, take the "double envelope" bidding method, to ensure that high reputation, good quality, strong supply capacity of enterprises to participate in the competition. At the same time, the actual purchase and sale prices of essential medicines in the market to conduct a comprehensive survey, in principle, the centralized purchasing price shall not be higher than the actual purchase and sale prices in the market, to ensure that the purchase price is reasonable. Fourth, strict integrity records and information disclosure system, the violation of the contract, the quality of substandard, not on time delivery and other violations of the enterprise are recorded, and announced to the community, the implementation of a strict market clearance system, overdue, within two years may not participate in the national bidding for the procurement of any drug. Through the online procurement platform, to improve the transparency of the transaction, the purchase price of basic drugs, the number and winning enterprises should be promptly announced to the community, to accept social supervision, from the system and mechanism to create an open, fair and just procurement environment.
Q: The high price of the winning bid is the past centralized bidding and procurement of drugs has not been a good solution to the problem, this time the introduction of the "procurement mechanism" how to ensure that the procurement of drugs at a reasonable price?
The centralized bidding and procurement of drugs has a high price phenomenon, the main reason is that the bidding and procurement is disjointed, the provincial bidding only to determine the list of enterprises, the medical institutions generally have a second bargaining. This "procurement mechanism" puts forward targeted measures, mainly:
One is the quantity and price linkage, through the preparation of procurement plans clear procurement of specific dosage forms, specifications and quality requirements, clear procurement of quantities (or the implementation of a single-source commitment); so that the drug supply enterprises in the bidding before the number of supplies can be more accurately calculated and the market share, to facilitate the calculation of the cost and rationalize the offer.
The second is to strengthen the market price survey of essential medicines, requiring a detailed investigation and mastery of essential medicines in the last three years, the retail price of social retail pharmacies, as well as the implementation of the essential medicines system before the actual purchase price of primary health care institutions, in principle, the centralized purchasing price shall not be higher than the market price of the actual purchase and sale. In this way, the centralized purchasing price is guaranteed to be within a reasonable range.
Third, the adoption of a categorized procurement approach targeted at rationally determining prices. Higher prices and the existence of price inflation of essential medicines for public bidding, through the double envelope bidding system and other ways to make full use of market competition to form a reasonable procurement price. At the same time, for exclusive varieties as well as essential medicines whose prices have been stabilized by multiple purchases and are in sufficient supply, prices are rationally determined by exploring the government's unified pricing approach. And for the small amount of special drugs, emergency drugs and clinically used cheap drugs by inviting tenders, inquiry procurement or fixed-point production, reasonable determination of the procurement price, in order to ensure supply.
Fourth, the end of the bidding that is the signing of the purchase and sale contracts to ensure that the winning price of the grass-roots purchasing price, to maximize the compression of the circulation link, reduce the layers of price increases in the space.
Fifth, strict payment system for the procurement of essential medicines, requiring payment within 30 days from the delivery and acceptance of qualified payment, while the current drug payback time is usually about 6 months or even longer, taking up a large amount of liquidity, and the new measures to implement a unified payment, will greatly reduce the cost of liquidity occupied by the enterprise, which further reduces the price of medicines.
Q: While lowering drug prices, how does the Purchasing Mechanism guarantee the quality of drugs?
Quality first is a principle that the Procurement Mechanism has always adhered to, and centralized purchasing is a way to reasonably determine the price of essential medicines on the premise of ensuring that they are safe, effective and of good quality.
In the procurement process, the implementation of the "double-envelope" bidding system, economic and technical bids should not only be GMP (GSP) qualification certification, the history of drug quality sampling and testing, electronic monitoring capabilities and other indicators reflecting the quality of medicines, but also to assess the production scale of the enterprise, distribution capacity, sales, industry rankings, market reputation and other comprehensive strength indicators. Ranking, market reputation and other comprehensive strength indicators, only economic and technical bid evaluation qualified enterprises to enter the business bid evaluation, eliminating the quality and reputation does not meet the requirements of the enterprise.
In the regulatory process, the procurement of essential drugs to implement the whole process of quality control, supply enterprises to supply drug samples sent to the provincial food and drug regulatory departments for the record, the provincial food and drug regulatory departments to strengthen the quality of essential drugs sampling, if necessary, will be sampling samples and the filing of samples for comparison, to ensure the quality of essential drugs.
In the penalty measures, the establishment of a "blacklist system", once there is maliciously low prices, the supply of substandard quality of drugs and other behaviors of the enterprise, to take out of the national drug bidding and purchasing market to take punitive measures, through strict regulatory measures to ensure the quality and safety of drugs.
At the same time, the Procurement Mechanism also proposes to gradually improve the quality standards of essential medicines, improve the electronic monitoring information system of essential medicines, not only to effectively guarantee the quality of medicines in the current centralized purchasing of essential medicines, but also based on the establishment of a more scientific and reasonable system of evaluation and supervision of the quality of medicines in the long run.
Q: How to realize the timely distribution of essential drugs to each primary medical and health institutions, non-stop, not out of stock, what are the considerations of the Procurement Mechanism?
Relative to large medical institutions, primary health care institutions are scattered, the amount of drugs used is small, distribution profits are thin, in the drug supply chain is in a disadvantaged position, especially some remote, small-scale primary health care institutions drug supply is difficult to effectively guarantee. The Procurement Mechanism proposes that the enterprises identified as suppliers of essential medicines should commission their own operators to carry out distribution or direct distribution, and that the supplier enterprises should be responsible for the quality and supply of medicines. It is an innovation of the Procurement Mechanism to transfer the distribution of medicines to the market and to give full play to the market's allocation of resources and division of labor to achieve timely distribution of medicines. This design does not mean that the government will not do anything about the distribution process, on the contrary, the government will mainly through supervision and services to ensure that the timely delivery of essential drugs in place, convenient and accessible.
In terms of regulation, the main body responsible for drug distribution is clearly defined and bound by contract. Procurement agencies in the purchase and sales contracts signed with the supplier enterprises, in the contract to clarify the supply mode, time, location and requirements, clear supply enterprises are the first responsible for the distribution. Whether the supplying enterprise is distributing on its own or entrusting the distribution to the drug business enterprise, the supplying enterprise chooses on its own. Basic drugs once the supply is not timely and other issues, the supplier enterprises to assume responsibility for breach of contract. This initiative to solve the current drug distribution chain in the production and distribution of enterprise responsibility is difficult to divide the knot, provides a legal basis.
In terms of services, the establishment of a non-profit online centralized purchasing platform for primary medical and health care institutions, drug production and business enterprises to provide drug procurement, distribution and settlement services. Primary medical and health care institutions send orders on the platform, enterprises supply within a specified time, primary medical and health care institutions confirm online, and purchasing organizations pay on time. At the same time, the relevant departments use the centralized purchasing platform to implement dynamic supervision of drug transactions and supply, analyze drug procurement, use and payback, and in the event of untimely supply, quickly coordinate and deal with the situation, to avoid the emergence of the basic drugs out of supply, out of stock.
Through the new system design, primary healthcare organizations only need to send orders online, and the supplying companies will deliver the needed medicines to their doorsteps in a timely manner, guaranteeing the convenient accessibility of essential medicines. At the same time, the Purchasing Mechanism also encourages localities to further expand the functions of the centralized purchasing platform for essential medicines, introduce the concept of modern logistics into the drug supply guarantee system on the basis of centralized purchasing, establish an information system for real-time updating of essential medicines throughout the entire process, from factory to use, and further improve the efficiency of distribution.
Q: After the implementation of the Procurement Mechanism, what impact will it have on drug manufacturers and operators?
The establishment of a standardized centralized purchasing mechanism for essential drugs is not only to guarantee the quality, price and supply of essential drugs, but also to promote the production of essential drugs. Only if the production enterprises are willing to produce and the distribution enterprises are willing to distribute, the basic drugs can fundamentally guarantee the quality and supply. At present, China's production and distribution of drugs are many, small, scattered, chaotic problems, as many as 5,257 drug manufacturers, drug wholesalers 13,000, has appeared in the industry's overcapacity, structural supply exceeds demand situation. In the long run, the centralized purchasing mechanism has a positive significance in regulating the order of drug production and circulation, establishing a benign competition mechanism, and guiding drug production and operation enterprises to optimize their structure and resource integration.
Currently, the new procurement mechanism also has many favorable measures to protect the reasonable profits of drug production and management enterprises. The Purchasing Mechanism proposes clear quantities and supply areas for purchasing, and bulk purchasing, which increases the sales volume of enterprises, effectively reduces the costs of advertising and marketing, and is conducive to reducing costs and improving efficiency and effectiveness. Through the unified payment system, the purchasing organization will make unified payments for medicines and shorten the payment cycle to 30 days, so that enterprises do not have to call for payment from individual primary health care institutions, reducing circulation costs and increasing the rate of capital flow. In particular, it should be emphasized that the centralized procurement of essential drugs is not simply a price reduction, but on the basis of protecting the reasonable profits of enterprises, compression of unreasonable costs of the distribution chain, so as to achieve reasonable prices.
Meanwhile, the new procurement mechanism is a profound adjustment to the existing pattern of interests, drug production and management enterprises also need to focus on the new mechanism, active adaptation, timely adjustment, and to expand new development space. Under the new procurement model, the center of gravity of the drug business enterprise service will be gradually transferred to the distribution function. At present, some business enterprises have begun to transform or expand their services, actively improve the service network below the county level, provide distribution services for the characteristics of primary health care institutions, and explore comprehensive services such as drug inventory management.
Q: The Purchasing Mechanism proposes that the purchasing organization is the main body responsible for the centralized purchasing of basic medicines, what kind of consideration is this design based on? What is the relationship between the purchasing organization and the primary health care institutions?
The Procurement Mechanism proposes that the purchasing organization is the main body responsible for the procurement of basic drugs. The purchasing agency purchases medicines on behalf of primary healthcare institutions and is responsible for contract execution, which is conducive to realizing the link between quantity and price, changing decentralized purchasing to centralized purchasing and decentralized payment to centralized payment, maximizing the compression of intermediary links, improving the efficiency of purchasing, and lowering the cost of purchasing; it is conducive to the elimination of the mechanism of compensating for the cost of medicines at the root of primary healthcare institutions; and it is helpful for the responsible departments to clearly define the rights and responsibilities of the purchasing agency. Supervision and management of the drug procurement process.
The Purchasing Mechanism specifies the conditions and nature of the purchasing organization, which is determined by the provincial health administrative department and has the qualification of independent legal person and purchasing. In order to ensure the public welfare of the procurement of essential drugs, it also stipulates that the procurement agency shall not charge any fees to enterprises and primary health care institutions in the process of providing services, and the necessary working funds required are included in the government budget.
The procurement of essential drugs by procurement organizations as the responsible body requires close cooperation between procurement organizations and primary health care institutions. The Procurement Mechanism further specifies that the health administrative departments of each province (autonomous region and city) are the competent authorities for centralized procurement of essential drugs in their respective regions, and are responsible for setting up provincial centralized procurement platforms, as well as managing and supervising purchasing agencies and primary healthcare institutions in the process of centralized procurement of essential drugs, and coordinating and resolving problems arising from such procurement, so as to ensure that procurement work is carried out smoothly.
Basic medical and health institutions sign authorization or commissioning agreements with purchasing agencies, which regularly summarize the region's basic drug procurement needs, prepare drug procurement plans, implement basic drug purchases, and sign purchase and sales contracts with drug supply enterprises, and are responsible for payment and other contract implementation. At the same time, primary healthcare organizations are also required to regularly submit their demand for basic medicines to the purchasing agencies in accordance with the requirements of the agreements, and make timely payments.
Q: How can the initiatives proposed by the Procurement Mechanism be effectively implemented?
The new procurement mechanism is highly policy-oriented and operationally demanding, and for this reason, the Procurement Mechanism has put forward clear working requirements for localities and relevant departments to implement. First, a clear time schedule, requiring the provinces (autonomous regions and municipalities) and the Xinjiang Production and Construction Corps Medical Reform Leading Group in accordance with the spirit of the "Procurement Mechanism", and urgently study and develop the province (autonomous regions and municipalities) government-run primary health care institutions of basic medicines procurement of specific measures, in principle, within 30 working days to introduce. And as soon as possible in accordance with the new procurement methods to complete the procurement of basic drugs in a procurement cycle. Second, strengthening training and guidance, the State Council Office of Healthcare Reform will make a special deployment on the implementation of the Procurement Mechanism, and carry out centralized training, prepared a centralized procurement of essential medicines operation manual, to guide and help localities to carry out the work as soon as possible, to ensure that the system does not go out of shape and deform. Third, the establishment of incentive mechanisms, the State Council Office of Health Care Reform, in conjunction with the relevant departments of the procurement progress and effect of summary analysis of the localities, and the procurement of basic drugs as one of the core indicators of the health care reform assessment of the localities of the basic drug procurement assessment, and linked to the financial subsidies.
Previously, Anhui Province has carried out a procurement of basic drugs in accordance with the requirements of the Procurement Mechanism, and basically realized the expected goal of basic drug procurement, which played a demonstration role for the whole country.