The bottom logic of centralized drug purchase: who will control the future direction of 4000 drug companies?

On January 1, 2019, the general office of the State Council issued the pilot program for centralized procurement and use of drugs organized by the state, which clarified the basic principles of volume procurement, volume for price, integration of bidding and procurement, and guaranteed use So far, the bidding results of the first batch of 4 + 7 pilot cities have been published, and the second batch of catalog is said to be in the pipeline It is worth noting that the biggest achievements of the 4 + 7 and some previous provincial pilot projects are first strategic and theoretical discrimination between right and wrong, and then concrete results First of all, the practice of centralized procurement with volume, at least in the following aspects, has changed the status quo, respected the law and complied with the law First, the quantity of public procurement; second, the real link between quantity and price; third, the actual performance of the contract; fourth, consciously abiding by the commitments; fifth, prepaying the drug payment; sixth, matching the rights and responsibilities and ensuring consistency; seventh, the independent quotation of the enterprise Volume purchase is the most important, necessary, simple and easy link in the centralized purchase of drugs But for a long time, purchasing with quantity is just a slogan, and the fundamental implementation is purchasing without quantity This centralized procurement with quantity has become an unavoidable key word in the procurement process It is clear that the quantity with quantity is "the procurement volume accounts for 30-50% of the drug demand of these 11 cities", and it is impossible to replace the quantity with the quantity with the quantity of hospitals As for the sharp price reduction of this centralized procurement, it is unexpected and reasonable According to analysis, the current final consumption price of drugs, including the cost of doctors, hospitals and medical representatives, accounts for about 55% The remaining 45% is the production cost, distribution cost, tax payment and return on investment In this centralized belt purchase, the state has promised to take more than half of the final price and no longer needs the marketing expenses and benefit transmission of kickback and bribery Is it unreasonable to reduce the price? Besides, there is a preferential policy of "30% advance payment" and "timely payment collection" However, the over evaluated drugs began to replace the imported original drugs to a large extent Now it is generally recognized that the vast majority of drugs with inflated prices are imported original research drugs, patent drugs and exclusive drugs Objectively speaking, the high price has certain reasons: for example, the original research drug has to digest huge R & D costs; the patent drug has patent protection; the exclusive drug has fewer competitors; these drugs have better curative effect; the side effects and adverse reactions are relatively small Therefore, it is generally difficult to force these drugs to reduce prices In this purchase, a large number of domestic evaluated generic drugs were purchased The quality and efficacy of imported original research drugs were directly forced In addition, the original "one product, two regulations" for the national treatment of imported original research drugs were cancelled, and the imported original research drugs began to be replaced by domestic evaluated generic drugs The sharp price reduction and fair competition of domestic generic drugs have also promoted the price reduction of original research drugs that continue to occupy the market The prices of the two original research drugs selected in this study were reduced by 76% and 68%, respectively, and compared with foreign countries, the prices were reduced by more than 25% This is also the practical support for the consistency evaluation Consistency evaluation is a national push measure It is intended to confirm that generic drugs are consistent with the original drugs in quality and efficacy by comparing with the trial of reference drugs Thus: (1) to replace imported original research drugs with domestic generic drugs; (2) to promote the price drop of original research drugs; (3) to promote fair competition between original research drugs and generic drugs; (4) to eliminate a number of backward drug production capacity The actual procurement achieved the above objectives The proportion of selected generic drugs was 88% The role of medical insurance is to reduce the arrears by increasing the prepayment of drug purchase The medical insurance fund prepays 30% of the total price to the hospital in advance, which is a good faith measure taken by the payer of the drug payment to take the initiative to "lose oneself and benefit others" in addition to his own legal responsibility, reflecting the noble sentiment However, to fully achieve the target of reducing arrears, we need to take corresponding measures Whether there is money is only hardware, whether it can really reduce arrears depends on whether there is mechanism software to reduce arrears The unsolved problem will be the focus of the reform in the previous centralized purchase of drugs, there are many problems A number of problems have been solved and eased in this centralized procurement, and the remaining problems will be the focus of reform in the future First, we have not yet established a scientific and reasonable mechanism for the formation of drug prices At present, the reality of drug price is the coexistence of virtual high and virtual low Most of the drugs with inflated prices are original research drugs, imported drugs and exclusive drugs; most of the drugs with inflated prices are those that have undergone multiple rounds of competition, some of which are below the cost, so they are forced to withdraw from the market, resulting in shortages The shortage of drugs will inevitably be replaced by the high price drugs of the same kind When unfair competition drives down the price of drugs and there is a false low price of drugs, it is not far from the appearance of false high price of drugs This is the law of the economy This time, the centralized procurement with volume only relies on competition and price reduction, and has not yet established a scientific and reasonable mechanism for drug price formation to accurately adjust the price: reduce the false high drug price, and increase the false low drug price No 2 document proposes to "explore and improve the mechanism of centralized drug purchase and market-oriented drug price formation", which should be aimed at all drugs, first of all, drugs with inflated high price and inflated low price It is hoped that it will be reflected in the centralized purchase of drugs in the future Second, it has not been able to prevent and eliminate the emergence of drug shortage The drop in drug prices will help to cut costs for patients and health care, and will certainly be welcomed However, a proper decline in drug prices should first have supply accessibility, quality assurance and production sustainability If we pursue price reduction to the extreme, we will be in short supply The defect of this pilot project is that there is no virtual low purchase price, including drugs that are already in short supply A large number of long-term drug shortages will cause great or even irreparable damage to peers, patients and enterprises themselves Third, we should study how to further support the consistency evaluation This procurement has achieved remarkable results in supporting the access of evaluated drugs to the procurement market At present, 99% of the drugs that need to be evaluated have not been evaluated for consistency Among them, the high cost of evaluation is an important factor If the cost of evaluation can not be reflected in the drug price, it will be very difficult to continue to push forward the consistency evaluation in the future Fourth, we should study how to realize the price balance of drugs in different places legally and reasonably After 4 + 7 centralized procurement, relevant departments have made it clear that "provinces are not encouraged to simply follow the price" The reason is also very clear, because "different procurement mode, no volume, different prepayment mode" In other words, it is not in favor of the "lowest price linkage" among provinces However, according to some websites, some provinces and cities have plans to link the lowest price At the same time, the price of the same drug varies greatly between provinces, cities and cities, depending on whether or not to enter the centralized procurement For example, the price difference between a drug in Shanghai and a city in Shandong is more than ten times, and the price difference between a drug in Sichuan is even dozens of times! It caused great social repercussions and uneasiness The unreasonable phenomenon that the price gap between neighboring cities is too large should be solved However, the solution is by no means "linkage at the lowest price", which has neither legitimacy nor rationality From a legal point of view, there is no legal and policy basis for the linkage of the lowest price in each province The legal constraints of any purchase contract can only be limited to the elements agreed in this contract From a reasonable point of view, the costs between provinces are not the same, and a certain price difference is normal The linkage of the lowest price violates the law of economy, which has not been done even in the period of planned economy The ideal way to solve this problem is to speed up the pace of reform, take the lead in the high price of drugs, implement centralized procurement with volume as soon as possible, and reduce the high price In the interim transitional approach, high price regions can also be entrusted with low price regions to purchase goods and share the existing low price achievements The entrusted region bears the cost of the entrusted purchase At present, six types of purchasing will become the next trend of volume purchasing First, centralized procurement The procurement entities will include multi City consortia and provincial centralized procurement As for the procurement of medical consortia, the medical insurance department is gradually promoting through the construction of medical insurance information platform (with an investment of 300 million, which has been launched) and participating in the centralized procurement of close county medical communities It has been disclosed on the Internet that Beijing, Shaanxi, Guangzhou and other places have started this work Zhejiang Province issued a notice in June last year that it will start the unified purchase and payment of drug consumables through 28 close county medical communities (30 county hospitals and 190 township hospitals in total) with independent legal personality The original hospital purchase interface and purchase platform authority will be suspended from January 1 this year Second, purchase with quantity Economic law and market credit will be respected No legal basis, no reason, no public support from any market body, and no volume procurement at the cost of damaging the government's credit will be gone forever Third, competitive procurement With the national laws and regulations, policy systems and technical standards as the measurement and open and fair competition as the means, the competition among drug manufacturers will be on the right track Although the operation of the dark box will be greatly reduced, the fierce competition will be launched in another field Fourth, purchase at a reduced price Price reduction is always the eternal theme of any purchase Although the State Council has made a special study on drug shortage after this pilot project, it is estimated that the virtual low price of some drugs in short supply is expected to be increased But most drugs, especially those with high profits, will continue to be underpriced Pharmaceutical enterprises must keep a low price with low profit Fifth, standardize procurement There will be no longer the phenomenon of publicly declaring that the drug procurement can not comply with the bidding law, the government procurement law and relevant laws and regulations for any reason According to the law and regulations, it will be strictly followed by all participants in the centralized procurement of drugs, and the centralized procurement of drugs will run on the track of the rule of law Sixth, expand procurement The reason why the 4 + 7 procurement pilot is only carried out among 31 products is that there are too few generic drugs that have been evaluated With the increase of the number of over evaluated generic drugs, the scale of centralized drug procurement will continue to expand In addition, with the expansion of the scale of drug procurement and the accumulation of experience, the centralized procurement of pharmaceutical accessories and medical devices will be gradually on the stage 03 prospect of the industrial pattern after the centralized procurement with quantity; the drug procurement in the future may be launched successively at the national and provincial levels First, centralized procurement with volume will be the largest market for drug manufacturers The number of domestic over rated generic drugs is gradually increasing On December 22, 2018, there are nearly 20000 drug varieties that need to be assessed for consistency nationwide, only 132 of which have been assessed By the end of March 2019, there were 240 reviews It is expected that in the next step, we will focus on purchasing with volume, and the variety will increase substantially The drug market, which remains outside the centralized procurement, will become smaller and smaller Second, the enterprise will strictly perform the signed volume purchase contract In this centralized procurement, the state, under the condition of clarifying and ensuring the implementation of the procurement volume, will sell the drugs at a low price This is the way for the market to allocate resources It is the responsibility of the enterprise to deliver the medicine according to the agreement after winning the election this time