National Medical Insurance Bureau: “4+7” jointly identified the purchase volum

Copyfrom： Release time：2018-12-13 The editor：

National Medical Insurance Bureau: “4+7” jointly identified the purchase volume and put an end to “selling with gold”
 
In accordance with the decision-making arrangements of the Party Central Committee and the State Council, the state-organized pilot project for centralized drug procurement has progressed smoothly. On December 7, the State Council convened a national organization to organize the centralized procurement and use of drugs to initiate the deployment meeting; on the same day, after legal compliance, open and transparent procedures, the results of the proposed election were confirmed by notarization, and a one-week public announcement was officially carried out, which marked This work entered the implementation phase. The person in charge of the pilot office and the joint procurement office was interviewed by reporters on relevant issues.
　　　
1.Why should we carry out pilot projects for centralized drug procurement in the state?
　　
Person in charge of the pilot office: The national organization of centralized drug procurement pilot is a major reform of the centralized drug procurement system. The purpose is to enable the people to use higher quality drugs at relatively low prices.
The national organization of centralized drug procurement pilots is a major reform of the centralized drug procurement system. In recent years, relevant departments have actively promoted the centralized procurement of drugs, which has played a certain role in promoting the return of drug prices to a reasonable level, but there are also some outstanding problems. First, the price is decoupled. In the current bidding procurement, it is generally only the price is not taken, the company lacks sales expectations, and it is difficult to achieve a significant drop in drug prices. Second, there is insufficient competition. The quality level of generic drugs is generally low, and it is difficult to compete fairly with the original research drugs at the same level. The price of some original research drugs has been significantly higher than that of neighboring countries and regions for a long time. The “patent cliff” has not happened in China. The third is the scattered procurement. The procurement level is low and the power is scattered, resulting in insufficient bargaining power. At the same time, regional policy differences have affected the formation of a unified market and weakened the market competition mechanism. Fourth, there is a lack of synergy in policies. The measures such as drug purchase, use, medical insurance payment, and payment settlement are insufficient, and it is difficult to play a synergistic role.
The purpose of the national organization of centralized drug procurement pilots is to enable the people to use higher quality drugs at relatively low prices. Medicines are an important weapon for the people to prevent and cure diseases. One of the important reasons why the current masses of the people reflect a strong medical treatment is that the price of medicines is artificially high. The Party Central Committee and the State Council attach great importance to alleviating the burden of medical expenses for the people. General Secretary Xi Jinping presided over the fifth meeting of the Central Committee for Reform of the Central Committee to finalize the "National Organizational Drug Centralized Procurement Pilot Program", emphasizing the national organization of centralized drug procurement pilots, with the aim of exploring and improving the centralized drug procurement mechanism and market-oriented drug price formation. The mechanism will reduce the burden on the masses of drugs, standardize the order of drug circulation, and improve the safety of drug use by the masses. Premier Li Keqiang presided over the State Council executive meeting and called for the pilot of centralized drug procurement in the country to achieve a significant reduction in drug prices.
The national organization of centralized drug procurement pilot is an important manifestation of the deepening development of medical reform in China. For a long time, due to the constraints of the institutional environment and management system, China's centralized drug procurement system has many problems, but it is difficult to achieve fundamental changes. In 2018, the institutional environment for centralized drug procurement has undergone positive changes. First, significant progress has been made in the evaluation of generic drug conformity, and some generic drugs have reached the same level as the quality of the original drug, providing a quality basis for fair competition. Second, in accordance with the party and state institutional reform plan, the management system of drug bidding procurement, price management and medical insurance fund payment was rationalized. Thirdly, the anti-cancer drug tax reduction was taken as an opportunity to implement the price reduction “combination boxing”, which formed a policy environment and public opinion atmosphere to lower the price of medicines. The society paid more attention to the use of high-quality generic drugs with appropriate prices. These changes have provided a good institutional environment and social atmosphere for the national organization of centralized drug procurement pilots.
　　　　
2. How does the national organization of centralized drug procurement pilots be carried out?

The person in charge of the pilot office: The national organization of centralized drug procurement pilots adheres to the correct working principles, adopts a scientific and rational organization form and overall thinking, and pays attention to the top-level design.
The national organization of centralized drug procurement pilots adheres to the correct working principles. First, adhere to the people as the center, guarantee the demand for clinical drugs, effectively reduce the burden on patients, and ensure the quality and supply of drugs. Second, adhere to the law and compliance, strictly implement relevant policy provisions, ensure that the special procurement procedures are open and transparent, and accept the supervision of all parties. The third is to adhere to the combination of market mechanism and government role, not only respect the market-based drug price formation mechanism, but also better play the role of the government to build platforms, promote docking, guarantee supply, and strengthen supervision. The fourth is to adhere to a smooth transition and proper connection.
This pilot adopts the organizational form and overall thinking of “national organization, alliance procurement, and platform operation”. The first is the national organization. It is the National Health Insurance Bureau, the National Health and Health Commission, the State Food and Drug Administration and other relevant state departments to set up national pilot working groups and their offices, formulate basic policies, scope and requirements, play the role of organization and coordination, and promote the formation of alliances in pilot cities. The second is alliance procurement. Public hospitals in 11 cities including Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu, and Xi'an are the main buyers of centralized procurement, forming a procurement alliance, and representatives from each pilot city form a joint procurement office to gather demand. And strength, improve the negotiation bargaining power. The third is platform operation. It is the centralized drug procurement agencies and public medical institutions in the pilot areas that have entrusted the Shanghai Pharmaceutical Centralized Bidding and Purchasing Management Office and its sunshine procurement platform to undertake specific centralized procurement work and improve the professional competence and level of centralized procurement.
This pilot pays attention to the top design. In view of the outstanding problems in the centralized procurement system for pharmaceuticals, this pilot has highlighted the following aspects in the design of the program. First, adhere to quality standards. The quality qualification of the centralized procurement of drugs is based on the consistency evaluation as the quality of the bottoming requirements, to improve the quality of medication, and also to avoid the phenomenon of "bad money to drive out good money" in the competition. The second is to adhere to the "capacity procurement." This is the biggest highlight of this centralized procurement pilot. The Joint Acquisition Office has collected the quantity of drugs used in 11 pilot cities. The procurement volume of each variety has been clarified in the procurement announcement, which gives the pharmaceutical manufacturers clear expectations, which is conducive to their own quotation according to the purchase quantity, and eliminates the phenomenon of “selling with gold”. . The third is to insist on fair competition. This centralized procurement pilot gives opportunities for fair competition between generic drugs and original research drugs through consistency evaluation, which is conducive to strengthening competition, promoting the substitution of generic drugs, and promoting the realization of “patent cliffs”. The fourth is to adhere to the "alliance procurement." This pilot drug centralized procurement will concentrate the purchase of scattered drugs in public hospitals in 11 pilot cities, and form a large-scale group purchase effect, which is conducive to price conversion, significantly reduce drug prices, and effectively reduce the burden of patients' drug costs; Reduce the cost of cross-regional marketing for companies.
　　　　
3. What are the expected results of the national organization of centralized drug procurement pilots?

　　The person in charge of the pilot office: The expected results of the national pilot, the overall summary is to explore the "two mechanisms" and achieve the "four effects."
Explore two mechanisms. First, give full play to the role of the market, strengthen government guidance, and improve the mechanism for drug price formation. Second, through the procurement of quantity and the linkage of quantity and price, the original research drug and generic drug will be fully competitive, and the centralized drug procurement mechanism will be improved.
Achieve four effects. First, the price of medicines has been improved. By promoting competition, promoting drug price reduction and generic substitution, and reducing the sales expenses and financial costs of pharmaceutical companies through price-price linkage and timely payment, the price of medicines will be further reduced. By setting the quality threshold, taking quantity purchases, expanding market share and improving the overall level of drug use by the masses. The combination of the two enables the people to use quality and efficient drugs at a lower price. The second is the transformation and upgrading of the pharmaceutical industry. Promote the upgrading of the structure and product structure of pharmaceutical enterprises by setting quality standards and quantity procurement; standardize the circulation order and purify the industry ecology through mass-price linkage, guarantee use, and timely payment; promote the scale of drug distribution enterprises through regional linkage Intensification, intensification and modernization; allowing generic drugs that pass the consistency evaluation to compete fairly with the original drug and promote consistency evaluation. The third is the deepening of reforms in public hospitals. By squeezing out the sales expenses of drugs, changing the "selling with gold" model, purifying the medical staff's medical practice environment and promoting rational drug use; reducing the cost of drugs and reducing the cost space through price reduction and substitution effects, creating conditions for deepening the reform of public hospitals. Fourth, medical insurance will reduce burdens and increase efficiency. Through the above effects, the burden of medical expenses for the masses is alleviated, the efficiency of the use of medical insurance funds is improved, and conditions are also created for expanding the scope of medical insurance and raising the level of protection for ordinary people.

4. How to treat the results of the national organization of centralized drug procurement?

The person in charge of the Joint Acquisition Office: The pharmaceutical enterprises attach great importance to the centralized procurement. All eligible enterprises participate in the declaration, reflecting the enthusiasm of the enterprises participating in the national organization of centralized drug procurement pilot work. In the end, there were 25 centralized procurement of 31 pilot generic drugs, with a success rate of 81%. Among them: 22 generic drugs passed the consistency evaluation, accounting for 88%, and 3 original drugs, accounting for 12%, and the substitution effect of generic drugs appeared. Compared with the minimum purchase price of the same drug in the pilot city in 2017, the average price of the proposed price fell by 52%, with the highest drop of 96%. The original research drug gefitinib was reduced by 76%, and fosinopril tablets were reduced by 68%, which was 25% lower than that of neighboring countries and regions. The “patent cliff” appeared. At present, the results of the proposed election are still in the publicity period. After the end of the publicity period, the company will determine and publish the results of the election. The pilot office will guide and promote the pilot programs and supporting policies of the pilot cities, fulfill the results of the bidding, and realize the benefits of the masses.

5. How do you view the sharp decline in the price of the drug to be selected? Is this a negative factor for pharmaceutical manufacturers?

　The person in charge of the Joint Acquisition Office: The average price of the drug selected for the centralized procurement of medicines in the country reached 52%, demonstrating the strength of alliance procurement and quantity procurement. After the announcement of the results of the proposed election, public opinion is heated. Generally speaking, public opinion believes that this is a long-awaited good thing for the benefit of the country and the people. The masses can get high quality and low price drugs. The production enterprises can save transaction costs and focus on Research and development to grasp the quality. There are also some aspects that have different views on this and even some overreactions. I want to explain a few points.
First, the results are in line with expectations. Centralized procurement itself has the effect of reducing the purchase price. Specific to enterprises, due to their different cost structure and different market structure, the decline is high or low. In 2017, Shanghai launched a volume purchase of 26 drug products, with an average decline of 54%. With reference to the Shanghai effect, the overall decline in centralized procurement was in line with expectations.
Second, winning the bid does not affect development. The seriousness of drug prices is a serious problem in the field of medicine in China. According to the survey data of the authoritative department, in the sales price of the drug, the production cost and reasonable profit of the production enterprise only account for a small part. Therefore, after the prices of these proposed drugs have dropped drastically, the main reason for the squeeze is the “moisture” such as sales expenses, and the pharmaceutical manufacturers “can still make money”. In fact, the national organization of centralized drug procurement adheres to the principle of combining the market mechanism with the role of the government. Through the consistency evaluation of pharmaceutical manufacturers, whether to participate in the “4+7 centralized procurement” and the purchase quotation are all produced by the enterprise. The business situation is determined by itself. It is understood that the companies to be selected are willing to reduce the price by price.
Third, the price cut does not degrade. This centralized procurement will pass the consistency evaluation as the short-listed standard. After the election, the drug regulatory department will strengthen the supervision and inspection and product sampling inspection, strengthen the quality supervision of the whole life cycle, and ensure that the consistency evaluation is not a “one-off” evaluation, so the masses do not have to worry about the drug. Quality and efficacy.
Fourth, the current period is not good, and the long-term is good. The fundamental reason for the sharp drop in the price of the drug to be selected is that under the state-organized centralized drug procurement model, there is no need for “moisture” such as sales expenses and marketing costs included in the sales price. First, the volume of purchases has greatly reduced the cost of drugs entering the hospital. Second, the promise of timely repayments reduces corporate spending and financing costs. Third, alliance procurement significantly reduces its marketing costs. Fourth, to change the price of the market, the unit production cost of the drug is reduced by the scale effect. These factors can hedge the impact of drug price cuts and bring tangible benefits to selected companies. It can be said that the mode of procurement driven by the centralized procurement of drugs by the state liberates the pharmaceutical manufacturers from the disorderly competition of “selling with gold”, which is conducive to guiding them to shift their efforts to improve the quality of drugs and promote the correctness of drug research and development. The track comes up and has great and far-reaching significance for the healthy development of China's pharmaceutical industry.

6. How to ensure the quality and supply of selected drugs?

　　The person in charge of the pilot office: In order to ensure that the pilot achieves the goal of promoting reform, achieving effectiveness, and benefiting the people's livelihood, the State Food and Drug Administration and the Ministry of Industry and Information Technology will take effective measures to ensure the quality and supply of the selected drugs. The first is to ensure the quality of drugs. Strengthen the quality supervision of the production, circulation and use of the selected varieties throughout the period, increase the frequency of random inspections, and increase the responsibility of enterprises violating laws and regulations. The second is to ensure timely supply. Consolidate the responsibility of the production enterprises in accordance with the purchase agreement, establish a system of enterprise inventory and production suspension, and regulate the distribution behavior through agreements to ensure supply stability. The third is to ensure timely payment. The medical institution shall pay the enterprise's payment in time according to the purchase agreement. The medical insurance fund shall prepay the medical institution at a rate of not less than 30% of the purchase amount, and encourage the medical insurance fund to directly pay the drug to the enterprise to mobilize the enthusiasm of the enterprise.

7. How to ensure that the selected drugs are used in hospitals?

　  The person in charge of the pilot office: to ensure that the selected drugs enter the hospital and get priority use, this is the key to the success of the national organization of centralized drug procurement pilot. The medical security department will work with the health and health department to improve the incentive and restraint mechanism of public hospitals and escort the results of the election.
From the perspective of the medical security department, the measures to be taken include: First, the use of drugs in the management of medical insurance agreements, clear liability for breach of contract and treatment. The second is to introduce a payment standard policy. To clarify the medical insurance for the drugs with the same common name and different commodity names, the operating rules and transitional policies paid according to the same payment standard, and guide the insured to rational use of drugs. The third is to strengthen the monitoring and control of the procurement of selected and unselected drugs, and find measures to solve the abnormal situation in a timely manner. Fourth, the hospitals that reduce the expenditure of medical insurance funds due to the use of selected varieties in the standard. When the total amount of medical insurance budget is not reduced, the balance is reserved to the hospital in proportion to promote the reform of the hospital's salary distribution system and mobilize the enthusiasm of medical personnel. The fifth is to establish and improve the medical insurance assessment and evaluation index system of medical institutions, and to incorporate the use of selected drugs into the medical insurance assessment and evaluation index system, and establish corresponding reward and punishment systems.
From the perspective of the health and health sector, the measures to be taken include: First, the policy channel for the preferential procurement and rational use of the selected drugs. The second is to incorporate the selected drugs into the clinical pathway management, formulate guidelines for drug use, and promote the scientific and rational use of drugs by medical institutions. The third is to prioritize the use of selected drugs into the performance appraisal system of public medical institutions, and establish incentive and restraint mechanisms for medical institutions and medical personnel.