7 things that will happen after 4 + 7

Consistency evaluation, as a national key policy in the pharmaceutical industry, has a far-reaching significance Its tactical purpose is to confirm that the quality and efficacy of generic drugs are consistent with the original drugs by comparing with the in vivo bioequivalence test or in vitro dissolution test of the reference preparations There are four strategic objectives: first, we hope to replace the imported original research drugs with domestic generic drugs on the premise that the quality and efficacy are basically the same as the original research drugs; second, we hope that the original research drugs will be able to show the "cliff" of price drop under the impact of the low price of generic drugs after the patent period; Third, we hope to create conditions for the competition between original research drugs and generic drugs under fair rules; fourth, we hope to eliminate a number of backward drug production capacity through technical standards and economic means For this reason, the relevant departments have given some commitments correspondingly, including: if one drug of the same kind has passed the consistency evaluation, the evaluation application of other enterprises will not be accepted within three years; if three drugs of the same kind have passed the evaluation, the centralized procurement will not purchase the drugs of the same kind; each province will issue policies to give subsidies of 1-3 million yuan to each evaluated variety; after the centralized procurement, the same product will not be accepted The net price of the drugs without evaluation shall be lower than the middle price of the drugs without evaluation After purchasing ▍ 4 + 7, we should pay attention to the correct direction and thinking to support the consistency evaluation But before and after the 4 + 7 centralized purchase, there are some parts worth discussing Before purchasing: 1 The progress is restricted There are nearly 20000 drug varieties that need consistency evaluation As of December 22, 2018, 636 applications for conformity assessment (243 enterprises, 191 varieties) have been accepted and 132 varieties have been completed Among the 289 national essential drugs in the original plan, only 21 have been evaluated, only 7% In 2016, the State Office issued a document requiring 202 target drugs to be completed by the end of 2018, which is impossible to be completed, and will lead to a large number of drugs in production being deregistered; 2 Due to the conflict of interest, some of the original research drugs used for comparison and their data are difficult to obtain; 3 Due to the different batches of some of the original drugs, the dissolution curves are not the same, so it is difficult to get rigorous consistency evaluation results To this end, the drug examination center of the State Food and Drug Administration issued the notice on September 30, making four commitments: communicating with the applicant at the window of the applicant, organizing the expert team to communicate with the enterprise in various forms, including face-to-face discussion, organizing special training in October, and sending personnel to the site for investigation and communication In the middle of this month, an inspector of the National Bureau disclosed on the Internet that the consistency evaluation may relax the standards and postpone the deadline, but it has no result afterwards In December 2018, the results of centralized purchase of 4 + 7 drugs in the national pilot have been published and come into effect: 31 pilot generic drugs, 25 of which were selected, with a success rate of 81% Among them, 22 generic drugs passed the consistency evaluation, accounting for 88% Summary of pilot office and joint procurement of procurement: this centralized procurement gives the opportunity for fair competition between generic drugs and original research drugs through consistency evaluation, which shows three major effects: substitution effect of generic drugs, substantial price reduction effect and cliff effect of original research drug patents This centralized procurement accounted for 30-50% of the total demand for drugs in 11 pilot cities (not 60-70% as previously reported), and the scale of the pharmaceutical market in these 11 cities accounted for about 30% of the national total in 2017 In the future, the purchase price of drugs required beyond the centralized purchase volume will not be higher than the final purchase price Even for the original research drug, it is necessary to "realize the gradient price reduction according to the price difference before continuing to purchase and use" However, if the price of the original research drug is really close to that of the generic drug, it will bring new competitive pressure to the generic drug As the complete purchase process of this centralized purchase has not been completed yet, it is not known whether the relevant elements determined by the selected drugs, such as the actual purchase price, the actual purchase volume, and the actual drug payment, can be implemented Therefore, the conclusive opinions are not easy to come out However, through the consistency evaluation of drugs, there is no doubt that the marketing advantages of market access in centralized procurement have been revealed In this centralized procurement, Zhejiang pharmaceutical companies performed well: there were 121 drugs that had been evaluated for consistency in the nationwide centralized procurement, accounting for 33 in Zhejiang, including 15 in Huahai; 25 drugs selected in the procurement, 9 in Zhejiang, including 6 in Huahai The biggest bright spot of this centralized purchase is the drop in drug prices, which is beyond many people's expectation (generally expected to drop by 30-40%) In fact, the price cut should be unexpected and reasonable - in 2017, Shanghai carried out volume purchase of 26 drug specifications, with an average decrease of 54% I have mentioned in many articles that in the current final consumption price of drugs, the expenses of doctors, hospitals and medical representatives account for about 55% and the remaining 45%, which is the production cost, distribution expenses, taxes paid and return on investment In this centralized procurement, the state promises to purchase with volume The above expenditures, which account for more than half of the final consumption and are actually kickbacks and bribes, are no longer needed Is it unreasonable to reduce the price now? In addition, there is a "30% (originally planned to be 50%) advance payment" and "timely collection" discount Unfortunately, the advance payment to the hospital is only "to encourage the medical insurance funds to advance the drug payment directly to the enterprise" There are doubts about the hospital's ability to pay on time This centralized procurement, like the previous centralized procurement, still adopts the strategy of winning the bid at the lowest price, which makes consistency evaluation the bottom line of drug quality Originally, consistency evaluation has technical characteristics that do not consider the process, side effects, adverse reactions and impurities This technical characteristic is combined with the economic characteristic that only low price is taken, which will inevitably encourage enterprises to produce qualified low-quality products Consistency evaluation has become the so-called "one-time evaluation", which will damage the economic interests and physical health of patients Kang In response, the head of the joint procurement said: "after the selection, the drug regulatory department will strengthen supervision and inspection and product sampling, strengthen the quality supervision of the whole life cycle, and ensure that the consistency evaluation is not a" one-time evaluation " We certainly believe in the words of the person in charge of joint procurement and the work of the drug regulatory department However, in the economic accounting without reasonable price, the actual effect remains to be tested Is it really profitable to reduce the price of entecavir by 96% on a sunny day? According to the provincial pharmaceutical industry association, it really makes money The enterprise adopts the "cost plus method" - that is, to add a little profit to the cost as the lowest selling price However, cost can be divided into total cost and variable cost If the R & D cost, construction capacity cost and management cost are not shared, these costs are shared by other products of the same enterprise, and only variable cost is calculated for the selected products After such accounting, the gross profit of entecavir is positive, and it can make money indeed If such accounting is true, it is the marketing strategy of the enterprise, and it is the market dumping of the enterprise The drop in drug prices will benefit 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 Failing to do so will cause great, possibly even irreparable damage to peers, patients and enterprises themselves For the former centralized procurement, drug companies are passive victims in the administrative forced price reduction, the only low price that takes precedence over quality, and the secondary price negotiation of hospitals But there is one thing that drug bidding enterprises are responsible for - that is, bidding at ultra-low prices, bidding at lower cost Because bidding is to win the bid at a low price and lose the bid at a high price, it is impossible to make the price and sales volume complement each other After losing the standard, the price and quantity are both zero Therefore, some enterprises, under the guidance of the idea of "giving profits but not letting the market", unilaterally cater to winning the bid at a low price, and even have the phenomenon that the bidding price is lower than the enterprise cost After winning the bid at ultra-low price, the supply of low-cost drugs could not be maintained due to various reasons, resulting in the disappearance of low-cost drugs This is evidenced by the continuous phenomenon of drug delisting, supply interruption and shortage after winning the bid From an economic point of view, the production of any product will always produce costs, and the consistency evaluation will always increase the total cost, and the sales price cannot be lower than the cost This is a necessary condition for enterprises to maintain simple reproduction If there is a false low quotation, it is either forced by the outside non market forces, against their will; or it is their own business strategy problems, using the wrong countermeasures Both are unsustainable In the field of medicine, the phenomenon of false low drug price is not only guided by the bidding that only takes low price, but also led by the enterprise's own wrong strategy of "giving profits but not letting the market", which is a typical way to stop boiling water and thirst In fact, no one can compete for and lose the market gained by transferring the profits to the cost Therefore, the virtual low price of drugs will inevitably lead to the cut-off of supply, and the feeling of the society is that low-cost drugs disappear Through the above analysis, in the past, we may have some understanding and sympathy when criticizing the ultra-low price bidding Then, for the centralized procurement after the country has made clear the quantity procurement, especially the consistency and over evaluation drugs, the enterprise should make scientific calculation and rational quotation, return a fair market, a fair peer, and a fair own Now 99% of the drugs that need to be evaluated have not passed the consistency evaluation, among which the evaluation cost is an important factor If the cost of evaluation cannot be reflected in the drug price, it will be very difficult to continue to push forward the consistency evaluation in the future If the expansion effect of this centralized procurement can not offset the effect of price reduction, the procurement will still fall into the original "price reduction - expansion - loss - supply interruption - shortage" cycle, coupled with the cost increase caused by the consistency evaluation while the sales price is greatly reduced Then, in the new line of deficit and shortage, over evaluation medicine will probably bear the brunt Therefore, after the announcement of the pre selection results, the stock price of the pharmaceutical sector in the secondary market dropped 128 billion yuan on the same day and 838.7 billion yuan in 12 trading days I'm afraid that's why it's not overreacting ▍ consistency assessment, what happens next? Today, consistency evaluation has come to the next big probability: 1 Centralized procurement is very powerful for promoting consistency evaluation This time, there are only 25 drugs selected, obviously because the number of over evaluated products is too small It is estimated that in the spring and summer of next year, after the increase of the evaluated products, the state will soon organize the second centralized procurement 2 Generic drugs that have not yet been evaluated and want to take a share in the drug market, especially those that have already been evaluated, will speed up their pace and participate in the evaluation with all their strength 3 There are three generic drugs that have been evaluated for the same kind of drugs, which can no longer be selected by centralized purchase In addition to other sales strategies, the enthusiasm of enterprises to participate in the evaluation of such drugs will be affected 4、 After the cost increase formed by the comprehensive consistency evaluation and the cost reduction brought by the implementation of the quantity purchase, it is reflected in the centralized purchase that it is possible to reduce the price by a large margin This is conducive to the interests of drug companies, patients, medical insurance and social atmosphere, but the response of hospitals and doctors is still unknown Because of the number of hospital procurement arranged and the number of hospital procurement that can be implemented