Three key points in the draft for opinions on centralized drug purchase in Guangdong Province

Source: on March 1, 2016, the pharmaceutical economic news recently published five drafts for public comments, including the measures for drug transactions in medical institutions of Guangdong Province (Revised Version) It has been nearly two and a half years since the issuance of the opinion draft, which is officially issued and being implemented by Guangdong Province on September 17, 2013, the trading measures for essential drugs of medical institutions in Guangdong Province (Trial Implementation) and the trading measures for non essential drugs of medical institutions in Guangdong Province (Trial Implementation) Although it is not a national pilot city of medical reform, Guangdong, as the forefront of reform and opening up, has always been in the first camp to try first and dare to taste fresh, from the first "sunshine purchase" to the radical version of "drug exchange mode" The release of this opinion is no accident First, the original pilot period of the program currently being implemented was only one year Second, in November 2014, Guangdong has issued a draft for comments on relevant plans Third, in 2015, the guiding opinions of the general office of the State Council on improving the centralized drug procurement in public hospitals (GBF [2015] No 7) was issued, which has a unified direction from the guidance of policy-making Fourth, in December 2015, Guangdong Provincial Health and family planning work conference deployed the centralized drug procurement in 2016, required to revise and improve the drug transaction management measures of Guangdong Province, and steadily promote the transaction of medical consumables and Chinese herbal pieces through the platform In the context of the above-mentioned comprehensive factors, Guangdong bidding strives to make progress in strategy, grasp the pace and strength, and grasp the key point of "saving medical insurance funds, not forming a price highland" in tactics Instead of flooding, it aims at a specific goal and adjusts in a targeted way The opinion draft behind the selection of transaction mode requires that "basic drugs are not divided into different levels There are four levels of drugs in the non essential drugs medical insurance catalogue The first level, the second level and the third level of essential drugs that meet the medical insurance catalogue of non essential drugs can choose to participate in the trade of essential drugs or non essential drugs, which shall not be changed within one year after selection " To some extent, this allows the drugs in the first, second and third layers of the base drug to have certain leeway But why do you say that? At present, it has not been the market pattern that the basic medicine decides the country and the world In 2014, the national opinion on Further Strengthening the management of drug allocation and use in primary medical and health institutions (hereinafter referred to as the opinion) stressed that in the future, primary medical and health institutions, in addition to basic drugs, can also be equipped with a certain number or proportion of non basic drugs, which should be selected from the medical insurance or new rural cooperative medical reimbursement catalogue This rule breaks the limitation of "only basic drugs can be used" in basic medical institutions, and to some extent neutralizes the practical impact of stopping the supplement of basic drugs Shortly after that, the official website of Guangdong health and Family Planning Commission issued the notice on Forwarding the opinions of the national health and Family Planning Commission on Further Strengthening the management of drug allocation and use in primary medical and health institutions Primary medical and health institutions can allocate and use a certain number and proportion of non essential drugs (including low-cost drugs) from the catalogue of drugs for basic medical insurance of Guangdong Province (2010 version) Among them, the quantity of quality regulations shall not exceed 40% of the total amount of the national essential drugs catalogue used by the agency and the basic drugs catalogue supplemented by the province, and the proportion of purchase amount shall not exceed 40% of the total amount of drugs purchased by the agency in the whole year What a big 40%! If the operation is proper and the tactical application is reasonable, the first, second and third level drugs can avoid the fierce low-cost fight of domestic generic drugs, and calmly face the relatively loose market in the status of "non basic medicine medical insurance" In terms of the current transaction mode, the drug use structure of Guangdong medical and health institutions has become "basic medicine + non-basic medicine medical insurance + low-cost medicine + non-basic medicine non-medical insurance", allowing flowers to bloom, which is also a relatively good situation There are some worries about the transaction in the pilot city of medical reform The bidding trading rules in this opinion draft clearly indicate that the pilot city of public hospital reform can be purchased by the city itself on the trading platform According to the requirements of No 7 document, the pilot cities of public hospital reform are allowed to purchase drugs by themselves on the provincial drug centralized procurement platform with the city as the unit If the transaction price of the pilot cities is significantly lower than the provincial bid price, the provincial bid price shall be adjusted according to the transaction price of the pilot cities In 2015, the "Supplementary Notice on several issues in the centralized procurement of drugs in public hospitals (Draft for comments)" was circulated, which required that the pilot cities and the provincial level procurement should be synchronized in time and price linkage, and the second price negotiation was prohibited In this context, some provinces have defined the way of "pilot cities carry out centralized procurement" into the drug centralized procurement scheme, and set a threshold for "significantly lower than" The 2016 work plan for centralized procurement of public hospital drugs in Hubei Province clearly points out that if the transaction price of the pilot city of medical reform is lower than 5% of the provincial bidding price, the provincial bidding price shall be adjusted according to the transaction price of the pilot city Guizhou and other provinces have also made clear provisions on the transaction price adjustment of pilot cities At present, 5% - 10% is a threshold, below which adjustment is necessary Come to Guangdong According to the data of all parties, in 2015, the cumulative turnover of drugs in Guangzhou, Shenzhen and Foshan accounted for half of the total turnover in Guangdong Province, but don't forget that Shenzhen (the first batch), Zhuhai (the second batch) and Dongguan (the third batch) are the members of 100 national health reform pilot cities On the eve of the Spring Festival this year, Zhuhai and Sanming, the "Star City of medical reform", will form a joint limited price purchasing committee to concentrate drugs, exchange quantity for price, link quantity with price, exchange usage and price information, and give priority to purchasing products of the same quality and low price This is a problem for pharmaceutical companies: if Sanming is given up because of its low price (Sanming's ability to bargain substantially and the speed of price disclosure are well known), it basically means giving up Zhuhai If you want to be a market in Zhuhai, you should basically be prepared to reduce the price of Guangdong Province affected by the actual purchase price of Zhuhai At present, Sanming's friendly forces are still growing, such as Wuhai, Ningbo In addition, according to relevant reports, in 2016, the national health and Family Planning Commission expanded the pilot cities of comprehensive reform of urban public hospitals to 200, and expanded the provincial pilot cities of comprehensive reform of medical reform When the medical reform cities expand to 200, a prefecture level city in Guangdong Province will surely be included It is inevitable that the price will go down How to postpone the trend of price reduction is worth thinking about by the bidding colleagues of pharmaceutical enterprises There is still a chance for the expired patent drugs to turn over According to the opinion draft, the basic drugs still follow the current trial scheme of bloody competition at all levels The categories in the medical insurance catalog give some degree of protection to the expired patent drugs Although the medical insurance catalog is divided into four bidding levels, in order to avoid that expired patent drugs are killed at low price when bidding varieties enter the bidding stage, the scheme carefully designs a reference - bidding adjustment coefficient for expired patent drugs If in the bidding stage, expired patent drugs can successfully break through according to relevant conditions, then everything is easy to talk about If you are unfortunately surrounded by competing products, you can negotiate along the "retreat route" guided by the plan as long as you can accept the conditions of "no more than the quotation of this transaction and the market price of expired patent drugs x bargaining adjustment coefficient" On the whole, the scheme not only allows the expired patent drugs to survive in the market and avoid being countered by low price, but also makes the price gap between expired patent drugs and export drugs or generic drugs not too large through the formulation of coefficient It is worth mentioning that the opinion draft classifies the generic drugs passing the quality consistency evaluation as the same level as the expired patent drugs, which does not mean the abandonment of the first generic drugs The opinion draft clearly stipulates in the economic and technical bid evaluation form that for the domestic drugs that obtain the preparation approval number of the national food and Drug Administration for the first time, the treatment of the first generic drug shall be given, and the score is 10 points, which transmits two important messages: 1 Generic drugs and expired patent drugs are classified into the same level, which is in line with the document spirit of "those passing the quality consistency evaluation are allowed to be marked on the instructions and labels, and support in clinical application, bidding procurement, medical insurance reimbursement and other aspects" in the opinions of the State Council on reforming the evaluation and approval system of pharmaceutical and medical devices (GF [2015] No 44) 2 The treatment of giving 10 technical points to the first generic medicine was in response to the decision of the executive meeting of the State Council on February 14 this year to promote the innovation and upgrading of the pharmaceutical industry, such as“ Aiming at the urgent needs of the masses, we should strengthen the R & D and innovation of the original research drugs, the first generic drugs, traditional Chinese medicine, new preparations, high-end medical devices, etc., and accelerate the industrialization of major drugs for frequently occurring and rare diseases such as tumors, diabetes, cardiovascular and cerebrovascular diseases Support domestic original research drugs and brand generic drugs that have obtained patents to carry out international registration and certification " To what extent will other important contents in the draft, such as the change of exclusive varieties from original bidding to bargaining, test the first-line market development ability? The management rules for the adjustment of the market price of drugs shall be formulated separately What will be the content of the rules and the trend of determination? It is suggested that the bidding colleagues of pharmaceutical enterprises should study carefully, form suggestions, submit them to the strategic decision-making level of enterprises in time, respond quickly and strive to achieve better results.