The reimbursement system of original research drugs and generic drugs is in the process of preparation

Recently, the reporter learned from the sources that the national development and Reform Commission and other relevant departments are investigating the reimbursement system for the original research drugs and domestic generic drugs of multinational pharmaceutical enterprises, and choosing the right time to prepare for the launch It is reported that the launch of the policy combination of the system and the generic conformity assessment policy of the State Food and Drug Administration (CFDA) will kick off the price reduction of original research drugs of multinational pharmaceutical enterprises The so-called "equal reimbursement system" of equal reimbursement system means that the medical insurance pays the same proportion to the original research drugs and domestic generic drugs, while the expenses beyond the scope of medical insurance are borne by individuals "For example, for a drug of the same variety, Pfizer's price is 50 yuan, and the price of domestic generic drugs is 20 yuan, while the medical insurance only pays 10 yuan for this kind of drug If you choose Pfizer, you need to pay 40 yuan by yourself; if you choose domestic generic drugs, you only need to pay 10 yuan " Some experts pointed out that this is equivalent to giving the option to the individual patient, which is more reasonable than pricing Moreover, it also gives the original research drug and domestic generic drug to the market for full competition It is understood that the voice of "equal reimbursement system" proposed by industry associations and expert groups has been issued for a long time, but relevant ministries and commissions have not adopted it "Because of the adjustment of this policy, it involves many departments such as the national development and Reform Commission, the Health Planning Commission, the Ministry of personnel and social affairs, the Ministry of industry and information, and the CFDA has the final say." Experts pointed out that the national development and Reform Commission and the Ministry of industry and information technology, on the one hand, need to calculate the cost and price of drugs, on the other hand, need to give enterprises reasonable profits to promote industrial development The health and Family Planning Commission and CFDA should ensure that the quality of generic products is consistent with the original drugs, and provide detailed data such as the use of doctors and patients The Ministry of human resources and social security shall consider the payment ability of medical insurance and give a reasonable proportion of reimbursement "When these conditions are mature, the equal amount reimbursement system will come into effect." In foreign countries, drugs are generally divided into patent drugs and non patent drugs, there is no original research drug China is divided into patent drugs (drugs within the patent protection period), original research drugs (imported drugs beyond the patent protection period), and generic drugs (drugs of domestic pharmaceutical enterprises imitating patent drug enterprises) The price of patent medicine is relatively expensive, and it is almost the same in the world However, after the patent period, due to the large number of generic drugs on the market, the price of patent drugs dropped significantly, about 40% But for more than 10 years, China has been pricing the original research drug separately According to the "drug government pricing method" issued by the former State Planning Commission in 2000, compared with the imitated drugs produced by the enterprises that have passed the GMP certification, the difference rate between the injection and other dosage forms is not more than 35% and 30% respectively At the same time, it is stipulated that the government pricing of drugs shall take into account the reasonable production and operation costs, profits, prices of similar drugs or alternative drugs, and, if necessary, prices of the same kind of drugs in the international market The reporter learned that in recent years, drug bidding policies around the country often implement "only low price is to take", resulting in a growing price gap between the original research drugs and generic drugs, some even reaching about 50% In fact, there is a big dispute about the price of the original research drug alone The debate on whether to protect the price of the original research drug has never stopped Domestic generic pharmaceutical manufacturers hope that the relevant government departments "a bowl of water level"; but multinational pharmaceutical companies do not agree, adhere to high quality and high price By the end of 2012, 16000 drugs and 187000 drug approval numbers had been approved for marketing in China Among them, there are 7000 chemicals and 121000 approval numbers, most of which are generic drugs "On the whole, the development of generic drugs in China has made great progress, effectively solved the problem of people's lack of medicine, and played an important role in maintaining public health." A personage in the industry pointed out that with the deepening of medical reform and the gradual improvement of public living standards, the requirements for drug quality from all walks of life are also increasing, and some potential problems of generic drugs in China are becoming more and more prominent The gap between the quality of some generic drugs and those being generic drugs is large, which to a certain extent affects the clinical efficacy of generic drugs, and even affects the public drug safety Relevant personnel of the pharmaceutical research and development industry committee of China Association of foreign funded enterprises have previously told reporters that the cost of the original research drug is huge in research and development, clinical verification, drug vigilance, imported raw materials and auxiliary materials, and management costs, so the price is certainly higher than that of generic drugs If we adjust the price of original research drugs based on the price of generic drugs, it will inhibit the investment of industry quality system, which is not conducive to the healthy development of China's pharmaceutical market and pharmaceutical industry However, this theory of high quality, high price is not really tenable in the eyes of many domestic experts Yu Mingde, President of China Pharmaceutical Enterprise Management Association, pointed out in an interview that under the unified national standard for drug production, there will be differences in the quality of drugs produced by different manufacturers, "but how big is the difference, and how much should it be reflected in the price? No one can make it clear In fact, CFDA has launched a series of measures to clarify these technical issues and narrow the gap between the original research drug and the generic drug At the end of last year, the former State Food and Drug Administration issued the work plan for quality consistency evaluation of generic drugs, which proposed to use 5-10 years to eliminate varieties whose internal quality could not meet the requirements through quality consistency evaluation of generic drugs, so as to promote the overall level of generic drugs in China to reach or close to the international advanced level On July 11, CFDA issued the notice on the research task of 2013 quality consistency evaluation program for generic drugs, which proposed that the first 75 generic drugs in China would be compared with the original research drugs of multinational pharmaceutical enterprises in terms of quality Industry insiders pointed out that this document aims to improve the quality level of China's generic drugs, and also tries to narrow the gap between foreign-funded original research drugs and domestic generic drugs in terms of quality and safety, which paves the way for narrowing the price gap between foreign-funded original research drugs and domestic generic drugs "Although the evaluation is very difficult, if the evaluation of safety and effectiveness proves that the gap between the original research drug and the domestic generic drugs is not large, there is no doubt that the position of the original research drug of foreign enterprises will be shaken and the price will be in line with the domestic generic drugs." One industry source pointed out "However, it is not easy to reduce the price of the original research drugs of foreign enterprises There are still many interest barriers to break through." According to Guo Fanli, manager of the Industrial Research Department of CIC, the price of the original research drug is difficult to fall, one reason is that the product quality is relatively guaranteed, and the market demand is guaranteed; the other reason is that the system of "medicine for medical care" in China has led to the establishment of a certain benefit chain between foreign pharmaceutical enterprises and hospitals - the high price and high profit space of the original research drug have been favored by hospitals However, with the recent exposure of GlaxoSmithKline's "bribery door", it is difficult to hide the "felicity" of the original research drug price From the statement of the company's executives, we can see that there is still room for foreign companies to reduce the price of original research drugs The head of the relevant department of the Ministry of public security pointed out on July 22 that some senior executives of GlaxoSmithKline China seriously infringed the vital interests of the vast number of patients in China in order to push up the drug price and expand the sales "We plan to reduce the operating cost in the drug price by adjusting the operation mode so that more Chinese patients can get high-quality GSK drugs," GSK said in a statement Yu Mingde believes that if the Ministry of public security continues to publish the results of the investigation into other problem drug companies, the drug prices of these enterprises will also be reduced.