New regulations on drug bidding in Guangdong cause strong doubts

May 30, 2013 source: economic reference report may 17 On April 9, the office of the leading group for centralized drug purchase of Guangdong Province issued the notice on Soliciting Opinions on the revision of relevant rules of drug trade of Guangdong Province, and put five relevant documents such as drug trade rules of Guangdong Province, basic drug trade rules of Guangdong Province and drug trade purchase and distribution rules of Guangdong Province on the Internet for opinions According to the notice, Guangdong Province will make full use of modern electronic information technology, create a third-party drug electronic trading platform, create a new drug trading mode of "online bidding, online trading, online payment, online financing, online supervision", and effectively reduce the virtual high price of drugs through online bidding, volume price linkage and other measures After the announcement of the notice and related documents, it immediately triggered a strong shock in the pharmaceutical industry On May 20, the pharmaceutical sector as a whole fell by 2.25%, "bear" topped the Shanghai and Shenzhen stock markets On May 23, the joint venture of China Association for the promotion of scientific research and development of pharmaceutical industry issued a public attack on the Guangdong plan Among the five documents in which only low-cost bid winning in Guangdong scheme is open for comments, drug trading rules of Guangdong Province and basic drug trading rules of Guangdong Province are undoubtedly the most concerned by the industry The former corresponds to the traditional big bidding in the industry, while the latter corresponds to the bidding for basic drugs It is not difficult to see from the documents that the trading rules are basically similar whether it is a large-scale bidding or a basic drug bidding The most important thing in online bidding is the formulation of ceiling price, which is called "market price" in the document According to the documents, the working organization collects the bid winning prices of different pharmaceutical manufacturers, the ex factory prices recorded in the price department and the current purchase prices of Guangdong Province, and other data as the basis for the establishment of market entry prices, and publicizes the price collection information However, the average bid winning price of the same manufacturer and the same product specification in all provinces of China and the bid winning price of drug centralized procurement in Guangdong Province in 2009, the low value between them is taken as the market price It is worth noting that low price varieties are favored in both types of bidding According to the drug trading rules of Guangdong Province, if low-priced drugs and clinically necessary and difficult varieties are priced by the government, the price after deducting the latest plus difference rate from the highest retail price of the government shall be taken as the market price; the market price is the transaction price, without bidding or bargaining, and the medical institutions shall directly select manufacturers and products, and carry out online trading The same is true for the products listed in the list of basic drugs with low price in 2013 of Guangdong Province It is emphasized in the document that the manufacturer conducts online bidding according to the purchase volume summarized by the trading platform, and the lowest quotation is the trading variety The quotation is divided into three times, which are completed within one day Those who do not quote for the first time cannot participate in the subsequent quotation When modifying the quotation, it is required that the last quotation is lower than the previous one "According to the regulations, after each quotation, the trading platform will automatically prompt each manufacturer's quotation ranking, but the manufacturer can only see the manufacturer's ranking, plus" the lowest quotation is the trading variety ", which forces the manufacturer to voluntarily reduce the price in order to win the bid." Niu Zhengqian, vice president of China Pharmaceutical Enterprise Management Association, said it is clear that in online transactions aimed at reducing drug prices, "only low price is to take" is still the core practice "Guangdong's drug trade rules may overturn the current pattern of drug purchase and sale," the China Council for the promotion of drugs publicly criticized Jiang Guangce, chairman of Tibet Dechuan Investment Management Co., Ltd., said that Guangdong is the largest province of drug use in the country, with benchmarking significance, and the industry reshuffle is about to begin As soon as the Guangdong plan came out, the whole pharmaceutical industry became a sensation On May 23, the China Association for the promotion of scientific research and development of the pharmaceutical industry issued a public document attacking the drug trade rules of Guangdong Province The China Council for the promotion of drugs raised three objections First, according to the relevant laws and regulations on drug price management, the leading group of drug trade in Guangdong Province has no right to set the market price of drugs In recent years, enterprises have invested a lot of financial and material resources to pass the new GMP certification, resulting in the increase of production costs It is neither reasonable nor fair to calculate the market entry price based on the previous bidding price Second, the Guangdong plan does not reflect the requirements of relevant documents of the state on encouraging enterprises to improve their production level, which violates the incentive policies put forward by the four ministries and commissions to promote industrial upgrading and provide excellent enterprises This has seriously weakened the development motivation and development willingness of domestic excellent enterprises with reliable production quality Third, some clauses are unscientific and unreasonable, for example, the drugs and essential drugs in the medical insurance catalog are required to be priced once a month This provision is totally inconsistent with the provisions of the original national standard for centralized procurement of drugs in medical institutions that the bidding period for drugs should not be less than one year Moreover, the enterprise has a huge burden and cannot cope with it It also makes it possible for medical personnel to change drugs produced by different manufacturers for patients every month, which is not conducive to the operation of medical institutions and the normal use of drugs by patients "We must not go back to the old way of winning the bid at a low price." According to the China Council for the promotion of drugs, Guangdong's draft for comment deviates from the strategic deployment of the major national science and technology projects for new drug creation, the quality consistency evaluation of generic drugs, and the improvement of drug quality and pharmaceutical production and operation level If the draft does not make major adjustments in the guiding ideology, it will cause a heavy blow to the pharmaceutical industry in China It will be a total denial to those high-quality enterprises that strive to improve production level and drug quality, and ultimately damage the interests of patients and the public At the beginning of this year, the four ministries and commissions jointly issued the notice on accelerating the implementation of the newly revised drug production quality management standards and promoting the upgrading of the pharmaceutical industry, giving preferential bidding policies to excellent enterprises Many enterprises reported to reporters that these policies had not been implemented at all at the local level According to the policy of four ministries and commissions, GMP certification of the corresponding varieties or dosage forms of the manufacturing enterprises is taken as an important indicator of the quality evaluation standard in the drug bidding and purchase, and the scoring weight is significantly increased, and the preferential policy of drug bidding and purchase is implemented "Every year, we spend a lot of human and financial resources to participate in provincial bidding." "It's too troublesome I thought about giving up the hospital market before, but the profit is the highest, and I'm reluctant to give up," the head of a listed company told reporters "The biggest headache is that even if we win the bid, we have to abandon it The price is too low, which destroys our unified price bottom line in the whole country If this is done in this province, agents in other provinces will not agree " The manager of a Chinese medicine listed company told reporters It's not good not to participate in drug bidding After participating in drug bidding, we can only abandon the bidding A nearly unsolved problem arises What kind of way should drug bidding take? The core of Anhui model, which has been questioned for many times, is "two envelope bidding, quantity price linkage, single source commitment, and the responsibility of production enterprises for distribution", which was once hailed as the highlight of medical reform Results in practice, the majority of pharmaceutical companies found that the Anhui model was almost equal to "only low price is to lift", at the same time, the enthusiasm of medical institutions was also affected What's more, the original intention of Anhui model is to eradicate the persistent disease of "medicine for medical treatment", but the effect is not obvious At this year's two sessions, many acting members of the pharmaceutical industry pointed out that the system of centralized bidding and purchase of drugs has many disadvantages and should be reformed "Bidding is a better way of market-oriented purchase in the world, but at present, the drug bidding policy arranged by the Chinese government is seriously alienated, which has become the second administrative control of drugs entering the market." Guan Yanbin, chairman of sunflower Pharmaceutical Group, pointed out that the essence of the current drug bidding is to turn the normal market behavior of drugs used in medical institutions into administrative approval, and different regions of the same product are approved annually, and the competent bidding Department has become the largest approval authority in the field of drugs "A large number of ordinary drugs have been eliminated by drug bidding, which has led to a serious decline in the quality of ordinary drugs, especially Chinese patent medicines." Liu Qun, chairman of Chongqing Tiansheng Pharmaceutical Group Co., Ltd., pointed out that there are thousands of medical institutions in a province, which have huge differences in drug purchase scale, distribution distance and payment collection conditions, and the purchase price should be different However, the provincial drug centralized bidding procurement ignored the normal influence of these objective factors on the purchase price, forced thousands of medical institutions to purchase the same winning product according to the same price, and destroyed the normal market trading rules with administrative power However, the government's health administration department has never made any statement about the appeal and opinions on the reform of drug bidding, and the drug bidding policy still goes its own way Experts from the health and Family Planning Commission said that at present, the bidding and purchase methods of drugs are too extensive, and one-time bidding work needs to cover too many varieties and dosage forms In the future, it should be further refined to reduce the number of varieties in each batch of bidding, which is also conducive to truly and reasonably reflect the level of drug quality In addition, after the refinement, the bidding period of drugs can be extended to about three years