Is it true that the second quarter came? China's pharmaceutical enterprises are eliminated, and 3000 pharmaceutical enterprises are out

On February 19, Shanghai Municipal Medical Security Bureau, Shanghai Municipal Commission of health and health and Shanghai Drug Administration jointly issued the notice on how to do well in the pilot work of centralized purchase and use of drugs organized by the state As a supporting policy of "4 + 7" volume procurement, the notice clearly requires that the proportion of patients who are not selected drugs whose price is higher than the bid winning price should be increased by 10% or 20%, which also means that drug price reduction can obtain a larger market In addition to Shanghai, Beijing also revealed relevant supporting policies According to the time plan, the round of "4 + 7" pilot cities with volume procurement will be officially launched at the end of March Recently, some experts in the industry said that the second round of "4 + 7" does not need to wait until the second half of the year, and will start as soon as the second quarter And it is likely to further expand the scale, no longer 11 pilot cities, but at least 11 provinces In addition, multinational pharmaceutical companies will make substantial price cuts in the purchase of the second wheel belt to meet the target All parties in the industry are paying attention to the next trend of volume purchasing, and this topic is bound to be the hot topic of this year's two sessions With the approaching of the Symposium of "voice responsibility" medical people's Congress and CPPCC members in 2019, the topic of volume purchasing will surely be one of the "protagonists" of the day Up to now, a number of industry associations (Academic Associations) and enterprises, including China Pharmaceutical Enterprise Management Association, have submitted 89 proposals and suggestions, among which 10 proposals and suggestions involve centralized drug purchase mechanism Throughout these proposals and suggestions, it is mentioned that some policies and measures including procurement documents and their follow-up may have the effect of excluding and restricting the market competition of products purchased with volume in Chinese market (including pilot areas and even a wider range), how to optimize the drug quality supervision and procurement system more effectively, and how to "purchase with volume" How does the price game affect the sustainable development of Chinese pharmaceutical industry In fact, from the current regulatory direction, it is being managed from the two dimensions of drug increment and stock Increment means to speed up the review and approval of innovative drugs and the speed of entering medical insurance Stock means to reshape the domestic generic drug market pattern through consistency evaluation, and at the same time serve the demand side with volume procurement For the pharmaceutical industry, these two aspects are not only important trends in the past year but also in the next two years On the one hand, through volume procurement, the past generic drug market can be reversed by relying on the mode of sales with gold On the other hand, it is necessary to accelerate the speed of new drug marketing and access, and expand drug access 1 To reduce the number of pharmaceutical companies, experts from the above industries said that at present, the pharmaceutical industry is in a state of serious oversupply, so from the national level, it is necessary to carry out a substantial reduction, including through market means and supervision The former is such as "4 + 7" and the previous way of purchasing with volume, which is used to eliminate most enterprises Then by joining the international regulatory system such as ICH, we can improve the regulatory requirements for drug production and strengthen the reduction of the number of market participants "The ultimate goal of compression from two directions is to let the last 500 or so generic pharmaceutical manufacturers and a certain number of innovative enterprises of different scales remain in China's drug supply market, so that the total number of pharmaceutical manufacturers is about 1000." Industry experts said According to data statistics, up to now, 184 product specifications have passed the consistency evaluation In this round of "4 + 7" volume procurement, 31 products were purchased, and 25 products were finally concluded, involving 100 products At present, there are about 80 product specifications that have passed the consistency evaluation are concentrated in about 20 products, so the "4 + 7" of the second round has actually provided enough targets For the second round of "4 + 7", the above industry experts believe that because most of the multinational pharmaceutical companies in the tire volume procurement missed the standard and did not reduce the price, the second round is to consider expanding the scale to allow foreign original research drugs to reduce the price The corresponding products of the target are those that are used more by multinational pharmaceutical companies and have a higher amount of money According to the expert, a number of multinational pharmaceutical companies are ready to make substantial price cuts in the purchase of second wheel belt Although it is not sure whether the second wheel volume will be purchased in the second quarter Previously, Hengrui also said in the 2018 annual report conference call that the first wheel volume will not be purchased until March, and six months after the pilot, almost September and October, so the time left will be relatively tight But we can be sure that the logic of the national level for drugs that have passed the patent period is to let them generally reduce prices, and then drive domestic enterprises to reduce prices at the same time Because most of the pricing of domestic enterprises is based on multinational pharmaceutical enterprises, the former will not reduce the price and the latter will not change, so as to promote the whole generic pharmaceutical market from the original "sales with gold" mode to the competition of cost and scale In addition, through volume purchase, the treatment cost of a certain kind of disease is reduced, which makes the price ceiling of this kind of disease appear What it really restricts is that there are more similar drugs behind it, which makes it difficult for other drugs to maintain high prices In the proposal on optimizing the drug quality supervision and purchasing system and cautiously implementing the "volume purchasing" of drugs, it is mentioned that the "volume purchasing" of drugs bidding should be cautiously implemented, and the effect and feasibility of implementing the "volume purchasing" in provinces, regions and cities should be fully studied and demonstrated and further extended to the whole country In addition, the proposal on improving the pilot policy and implementation of 4 + 7 belt procurement also proposes to reasonably determine the specific procurement quantity or the number of bid winning enterprises involved in the centralized belt procurement, respect the opinions of hospitals, doctors and patients, improve the decision-making mechanism of procurement quantity, guarantee the opportunity for other products to participate in the market competition, cancel the lowest price as the only evaluation principle, and implement the comprehensive evaluation We will prudently treat the linkage between non pilot areas and suspend the promotion of the model 2 call for innovative drugs to enter the medical insurance at the regular briefing of the State Council's policy held on February 19, Xiong Xianjun, director of the medical service management department of the State Medical Insurance Bureau, said that in 2019, a new round of adjustment of the medical insurance drug catalog will be carried out, and the good drugs for emergency rescue will be included in the medical insurance through expert review and drug access negotiation In this process, the prices of anticancer drugs, especially some new ones, are very expensive The National Health Insurance Bureau will bring them into the medical insurance through negotiation, and reduce the prices of anticancer drugs by the way of quantity for price Since the first edition of the national medical insurance drug catalog was formulated in 2000, it has been revised in 2004, 2009 and 2017, and the drug coverage has been increasing The 2017 edition of the national medical insurance catalog was published with a total of 2535 drugs In the process of revision, four types of clinical drugs, including children's medicine, innovative medicine, major disease treatment medicine and ethnic medicine, were mainly supported In addition, with the continuous promotion of drug trial reform in recent years, the accessibility of innovative drugs has been significantly improved, but some innovative drugs with high clinical value have not been included in the national and local medical insurance catalog The proposal on accelerating the entry of innovative drugs into the medical insurance catalogue and improving the clinical use policy mentioned that innovative drugs should first be included in the medical insurance catalogue and used in medical institutions for clinical treatment in the shortest time On the one hand, it will benefit patients as soon as possible, on the other hand, it will bring innovation returns to researchers and attract more global new varieties to be launched in China In addition, it is necessary to establish medical insurance access opportunities for innovative drugs submitted by innovative drug holders, and improve clinical supporting use policies for innovative drugs In addition, for rare disease drugs, the executive meeting of the State Council on February 11 has decided to give value-added tax preference to rare disease drugs In response to the representative's proposal, the national health and Health Commission said that the national health insurance department would improve the dynamic adjustment mechanism of the medical insurance drug catalog, establish a patent and exclusive drug negotiation and access mechanism, and gradually include the rare disease drugs with accurate effect and the medical insurance fund can undertake into the scope of medical insurance payment through expert review In the proposal on the inclusion of drugs for rare diseases with definite diagnosis and specific treatment in the scope of medical insurance reimbursement, it is suggested that, based on the management of anti-cancer drugs, drugs for rare diseases with definite diagnosis and specific treatment should be included in the scope of medical insurance reimbursement, so as to effectively alleviate the difficult and expensive use of drugs for patients with rare diseases In fact, whether it is anticancer drugs or drugs for rare diseases, this round of medical insurance catalog adjustment will take the effective protection of the basic medical rights and interests of the insured as the goal, with the improvement of the use efficiency of medical insurance fund as the core, do a good job in balancing the clinical demand and the bearing capacity of medical insurance fund, and bring more qualified good drugs for emergency and life-saving into the medical insurance catalog in accordance with the prescribed procedures, constantly To improve the level of basic medical security Source: e drug manager Author: tedy