[Medicine heaven and earth] 4 response to 4 + 7 price linkage of centralized drug purchase; focus on the hottest topics of new local policies in 2018

Since 2018, the central government, local governments, pharmaceutical companies and ordinary people have paid high attention to the consistency evaluation Enterprises spend tens of millions of money, only hope that through consistency evaluation drugs can be increased as soon as possible, which is the "hard truth" What people want is to buy medicines with high quality and low price Based on this, in order to coordinate the "vested interests" of all parties, each province has made regulations on the links of online purchase, price declaration, clinical use, and incentive measures of drugs through consistency evaluation Purchase: the evaluated drugs become "fragrant cake", and the products without evaluation are "slaughtered by others" There are 23 provinces, 4 municipalities directly under the central government, and 5 autonomous regions in China, all of which have issued civilized and definite requirements for "priority procurement" of evaluated drugs, especially in Shanghai, Inner Mongolia, Ningxia, Shaanxi, Shanxi, Liaoning, Jilin, Guangxi, Zhejiang and other nine provinces, which require "direct procurement"; some other provinces have opened green channels for evaluated generic drugs, such as Jiangsu (record procurement), Beijing, Guangxi, Tianjin (for example The varieties with large clinical use and high proportion of money are preferred to be purchased; Shanxi, Jiangsu and Zhejiang provinces also included the special procurement policy scope of "deemed through consistency evaluation varieties" But on the other hand, the drugs without evaluation are "fish and meat under the table" Gansu, Hubei and 11 cities (the "4 + 7" urban drug collection mode) have opened up the Internet for them, and stipulate that when purchasing the generic drugs without evaluation, the price must be lower than the evaluated varieties 14 provinces, such as Guangdong, Liaoning, Hunan, Jiangxi, Zhejiang and Heilongjiang, directly kicked out the products that had not been evaluated (that is, they held the attitude of not purchasing), and Jiangsu province directly cancelled the approval documents for generic drugs that failed to pass the consistency evaluation, and intensified efforts to eliminate products with low quality, high repetition rate and failed to pass the consistency evaluation It's concise and comprehensive As long as it's through consistent generic drugs, it's like holding "fragrant cake" In addition, the former CFDA made a special mark on (deemed as) the evaluated drugs in August last year, so the market has long been "fish in the pool" Network price: low price is the main direction, but each has its own characteristics; 4 In response to the latest situation of low price linkage in 11 cities, it is stipulated that the general direction of the purchase price of evaluated drugs is "low price and lowest price", but the specific measures of each province are quite different Jiangsu, Zhejiang and Shanxi require that the purchase price should not be higher than that of other provinces, among which Zhejiang also requires that as long as the consistency evaluation has been carried out, one product and two regulations can be broken; Hubei and Qinghai require that all regions should treat the products through the consistency evaluation equally with the original drugs Shaanxi takes the average price of the lowest three provinces in China and the low value of the current network price in Shaanxi as the limit price; Guangxi takes the average value of the shortlisted price of the lowest five provinces as the reference price of the network; Hunan's varieties passing the consistency evaluation refer to the average provincial price of the lowest three provinces in China (excluding the provinces adopting the market price mode temporarily) Shanghai's sunshine platform provides purchasing price information of other provinces and cities, this city and the same varieties as a reference for price negotiation, and sets price negotiation reminders for the varieties with large increase or high price; the city's attitude towards the online price of over evaluated drugs is relatively "loose" Before that (November 30), Shanghai required 1295 drugs on the Internet to actively apply for reduction of the bidding price, and the price was referred to the "purchase price of 15 provinces and cities" However, the adjustment catalogue did not include the price negotiation measures such as consistency evaluation drugs and national negotiation drugs Ningxia will abolish the maximum drug price limit and its relevant regulations Enterprises can independently declare product prices according to reasonable market prices; Shandong's drugs included in the open bidding catalogue and passed the consistency evaluation of quality and efficacy of generic drugs are listed in the first bidding group, not limited by the number of winning products, and are independently quoted by the manufacturer within the range of no higher than the highest price of the winning products in the same bidding group Inner Mongolia requires consistent evaluation of generic drug price negotiation to take the historical transaction price or retail drugstore price of enterprises in autonomous regions and other provinces as reference, and implement zero margin sales In addition, the bargaining results of 11 cities' volume procurement led by the state have been published, and the reduction of the bid price of over evaluated drugs has reached more than 50% Then, will the bidding prices as low as "dust" be linked in all provinces of the country? It's also the focus of attention Let's talk about the latest situation that Xiaobian has learned Recently, the media revealed that Anhui will organize experts to carry out price negotiation for 4 + 7 related varieties It is said that it is necessary to reduce the price on the basis of the existing hospital purchase price in Anhui Province, and it will not fall as low as the price of 4 + 7; according to the observation of the online prices of a batch of evaluated drugs published successively by Hainan Province and Inner Mongolia Autonomous Region, there is no 4 + 7 linkage; Shanghai Pharmaceutical Institute said that these factors should be fully taken into account when collecting the price of 4 + 7 in non selected areas, and "mode" and "mode" should be encouraged“ Price "is linked together, that is to say, the price of over evaluated drugs has been reduced, and the corresponding market volume should also be given Incentive measures: provincial and municipal governments adopt cash subsidies, with a minimum of 500000 yuan and a maximum of 600000 yuan Most provinces encourage pharmaceutical enterprises to develop and produce generic drugs in the form of reward amount, so as to accelerate the consistency evaluation of generic drugs Other provinces help enterprises to open the way of retail drugstores, and require drugstores to do a good job in the supply of evaluated drugs Ningxia awarded 2 million yuan for each variety that passed the consistency evaluation, and 10% of the reward and subsidy funds can be allocated in advance for those that entered the work procedure of the consistency evaluation of generic drugs; Fujian awarded a one-time reward and subsidy according to the proportion of 20% of the evaluation cost and the maximum of no more than 1 million for varieties that completed the consistency evaluation by the end of 2018 for provincial production enterprises; In Anhui Province, for generic drugs that have completed the consistency evaluation of quality and efficacy, a one-time subsidy of 1 million yuan will be given to each variety, with a maximum of 3 million yuan for a single enterprise; in Beijing, 1-2 million yuan will be provided for varieties that have carried out in vitro consistency evaluation research, 2-3 million yuan will be provided for varieties that have carried out be test; in Shandong Province, 4 million yuan will be provided for a single variety that has been evaluated; Gansu Province grants 3 million yuan to each variety that has passed the national evaluation; Zhejiang Province grants 3 million yuan to the once evaluated drugs; Jiangxi Province grants 500000 yuan to 1 million yuan to the varieties that have passed the evaluation; Sichuan Province grants 1.5 million yuan to 2 million yuan to the top three varieties that have passed the consistency evaluation; Zhejiang Province will give a one-time reward of 3 million yuan to the top three pharmaceutical manufacturers that have passed the consistency evaluation of generic drugs in China; Henan Province will give a one-time reward to the top three pharmaceutical manufacturers that have passed the consistency evaluation in China and those that have passed the evaluation on schedule, One million yuan will be awarded in one time by the provincial finance; another two million yuan will be awarded in one time for each approval document of Chongqing city for those passing the consistency evaluation and ranking in the top three of the same varieties in China; the lowest 500000 yuan and the highest 4 million yuan will be awarded in Guangxi for those passing the consistency evaluation of generic drugs; Guizhou Province will provide more than 1 million yuan of project funds to each drug manufacturer that has passed the consistency evaluation In addition to the above-mentioned provincial million subsidies, the local and municipal governments have also put forward corresponding sincerity Bozhou will give a one-time subsidy of 6 million yuan as the scientific research fund for consistency evaluation; Fuyang City will give a one-time subsidy of up to 5 million yuan to each drug manufacturer that passes the consistency evaluation, and 100000 yuan to the legal representative of the enterprise Haikou will subsidize 500000 yuan for a single drug to carry out the consistency evaluation, and if it passes the national acceptance, it can get a reward of up to 3 million yuan; Harbin will give a one-time reward of 30% of the actual investment and up to 3 million yuan to Harbin after the drug varieties pass the national consistency evaluation are put into production Guangzhou has provided financial support of 2 million to 3 million yuan for each category of preparations in the list of essential drugs that have passed the consistency evaluation of generic drugs and other chemical preparations that have first passed the consistency evaluation of generic drugs in the top three countries; Chengdu Tianfu International Biological urban management committee will give 20% financial subsidy and 500000-3000000 awards to each variety that passes the consistency evaluation (requiring the over evaluated variety to settle and industrialize in this area); Zibo will give a one-time reward of 2 million yuan to enterprises that enter into the top three production enterprises that pass the national consistency evaluation for the same variety of drugs; Yichang city will give a one-time reward of 2 million yuan to the top three domestic varieties that have passed the consistency evaluation; other varieties that have passed the consistency evaluation will receive a one-time reward of 1.5 million yuan; Quanzhou City will give a one-time reward and supplement to the varieties that have completed the consistency evaluation before the end of 2018 according to the proportion of 20% of the evaluation cost and the highest one million yuan If it is the first drug that has been evaluated in China, the municipal finance will give another reward of 10% of the evaluation cost and no more than 500000 yuan Xinxiang will give a one-off reward to the drug varieties that pass the consistency evaluation according to the proportion of 10% of the evaluation cost, and the maximum is no more than 1 million yuan Jinan will reward 1 million yuan for the top three domestic varieties that have passed the consistency evaluation Other varieties passing the consistency evaluation are deemed to have obtained the production approval documents of improved new drugs, with a one-time reward of 500000 yuan Weihai will reward 1 million yuan for the top three domestic varieties passing the consistency evaluation, and 500000 yuan for other varieties passing the consistency evaluation Shaoxing will give a reward of 1 million yuan for each variety that has passed the national consistency evaluation, and another reward of 1 million yuan after it is put into production In Fuzhou, RMB 1 million will be awarded for the varieties that have passed the consistency evaluation, have special circumstances and need to carry out clinical trials; RMB 1.5 million and RMB 1 million will be awarded for the first, second and third non essential drug generic varieties that have passed the consistency evaluation; RMB 50000 will be awarded for each imported reference preparation; In Deqing County, Huzhou City, a one-time reward of 1 million yuan will be given to each variety that has passed the consistency evaluation of generic drugs by local drug manufacturers, and another 300000 yuan will be given to the top three varieties that have passed the consistency evaluation in China; Taizhou city encourages enterprises to carry out generic drug consistency evaluation, and each drug variety passing the consistency evaluation will be rewarded with a maximum of 500000 yuan; Taizhou city will reward each drug variety passing the consistency evaluation with a maximum of 500000 yuan; For the generic drugs that have been listed and sold in Xiamen, if they have completed the consistency evaluation and obtained the relevant acceptance notice, each variety will be given a reward of 500000 yuan; Nanchang will give a reward of 500000 yuan or more for each variety that has passed the evaluation; Hangzhou will give 20% of the investment amount of enterprises in the city and 200000 yuan for each variety of clinical research institutions in the city On December 3, Hainan Medical Security Bureau issued a document on other dividend policies of the evaluated drugs, which can be transferred into the supplementary catalogue of medical insurance of Hainan Province for the pilot drugs that have obtained the national science and technology major special achievements of major new drug creation, and the drugs that have passed the consistency evaluation of quality and efficacy of generic drugs, that is, the evaluated drugs can enter the supplementary catalogue of medical insurance of Hainan Province On November 11, Guangdong provincial government issued a document allowing patients to freely choose to purchase drugs in medical institutions or designated retail pharmacies of medical insurance based on their prescriptions; and encouraging designated retail pharmacies of medical insurance to ensure the supply of generic drugs through consistency evaluation That is to say, patients can buy the evaluated drugs outside the hospital with the prescription Consistency evaluation has always been the highest word in the new local policies, which means it takes the "C" position Do you agree with it? In this paper, there are some omissions or deficiencies in the summary of conformity assessment policy I hope you can speak freely at the end of this paper Information source: yaozhi.com and yaozhi.com