The original research drug generic reimbursement system will open the price reduction order of the original research drug of multinational pharmaceutical enterprises

The reporter of the economic reference recently learned from the source that the national development and Reform Commission and other relevant departments are investigating the reimbursement system of original research drugs and domestic generic drugs of multinational pharmaceutical enterprises, and choosing the right time to prepare for launch It is reported that the launch of the system and the generic evaluation policy of the State Food and Drug Administration will kick off the price reduction of original research drugs of multinational pharmaceutical enterprises   Equal reimbursement system   The so-called "equal reimbursement system" means that medical insurance pays the same proportion to the original research drugs or 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 " This leaves the options to the individual patient, which is more reasonable than pricing, the source said Moreover, it also gives the original research drug and domestic generic drug to the market for full competition   An expert in the industry told the economic reference newspaper that the industry association and the expert group had been calling for the implementation of the "equal reimbursement system" for a long time, but the relevant ministries and commissions had 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, the State Food and drug administration, has the final say."   She 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 the State Food and drug administration 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."   It is understood that 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 ten years, China has been pricing the original research drugs separately   According to the "drug government pricing method" issued by the national development and Reform Commission, compared with the generic drugs produced by GMP enterprises, the price difference rate of the original developed drugs that have passed the patent protection period of the invention country is no more than 35%, and that of other dosage forms is no more than 30% 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   According to the reporter of economic reference, in recent years, the price gap between the original research drug and the generic drug has become larger and larger, some even reaching about 50%, due to the "only low price is to take" drug bidding policies in various regions   There is a great controversy on the independent pricing of the original research drug   The debate on whether to protect the price of the original drugs has never stopped Domestic imitated pharmaceutical enterprises hope that the relevant government departments "a bowl of water will be level"; however, multinational pharmaceutical enterprises disagree and insist on 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 kinds of chemicals, and the approval number is 121000 Most of them 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, however, 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 the generic drugs is large, which to a certain extent affects the clinical efficacy of generic drugs, and even affects the public drug safety   The relevant personnel of the pharmaceutical research and development industry committee of the association of foreign invested enterprises (rdpac for short, many multinational pharmaceutical enterprises are members of the Committee) previously told the reporter of the economic reference newspaper that the cost of the original research drug in research and development, clinical verification, pharmacovigilance, import of raw materials and auxiliary materials, and management costs is huge, so the price must be higher than that of generic drugs If we adjust the price of the original research drug based on the price, it will inhibit the investment of the 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 with the economic reference that under the unified national standard for drug production, it is true that different manufacturers will produce different products, "but how big is the difference, and how much should it be reflected in the price? No one can make it clear "   Consistency evaluation to narrow the gap between generic drugs and original drugs   Coincidentally, a series of policies of the State Food and drug administration want to clarify these technical issues and narrow the gap between the original drugs and generic drugs   At the end of last year, the State Food and Drug Administration issued the work plan for quality consistency evaluation of generic drugs It is proposed that in 5-10 years, through the quality consistency evaluation of generic drugs, the varieties whose internal quality fails to meet the requirements should be eliminated, and the overall level of generic drugs in China should be promoted to reach or close to the international advanced level   On July 11, General Administration of food and drug of the people's Republic of China issued the notice on research tasks of 2013 quality consistency evaluation program for generic drugs The first 75 varieties of generic drugs in China will be compared with the original research drugs of multinational pharmaceutical companies Industry insiders pointed out that although this document aims to improve the quality level of China's generic drugs, the industry seems to try to narrow the gap between the quality and safety of foreign-funded original research drugs and domestic generic drugs, which paves the way for narrowing the price of 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 so easy to reduce the price of original research drugs for 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, on the one hand, because the product quality is relatively guaranteed and the market demand is guaranteed; on the other hand, the system of "medical care with drugs" in China has caused foreign pharmaceutical companies and hospitals to establish a certain chain of interests - the high price and high profit space of the original research drug, which is favored by doctors   However, the recent exposure of GlaxoSmithKline's "bribery door" shows 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 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.