Large scale performance of withdrawal of pharmaceutical enterprise flow standard! How to avoid it?

Medical network, January 23, January 22, Ningxia and Sichuan released the news about the withdrawal of related drugs from the Internet Last year, Shanxi, Sichuan, Hubei, Gansu, Liaoning, Inner Mongolia and other provinces and regions have seen a large area of drug companies actively abandon the standard At the beginning of 2019, the notice of drug purchase of various provinces on the production enterprise's flow and withdrawal of standards appeared frequently, even imatinib, a product of "4 + 7" city's volume purchase catalogue, was also included On January 4, Shanghai Pharmaceutical centralized bidding and purchasing Affairs Management Office issued a notice saying that after receiving the application from Kangzhi pharmaceutical industry, it was unable to continue to supply at the original price due to the rising cost After research and decision, the drug procurement qualification was cancelled from January 7 On January 8, the central purchasing service center for pharmaceutical devices of Inner Mongolia Autonomous Region issued the notice on the announcement of Anhui golden sun Biochemical Pharmaceutical Co., Ltd and other enterprises applying for the disqualification of some drugs from the Internet According to the notice, from May 1 to December 31, 2018, due to the rise of raw materials, production line transformation, environmental pollution and other reasons, many drugs stopped production, 43 drug manufacturers (agents) including Anhui golden sun Biochemical Pharmaceutical Co., Ltd and Bayer medical and health care Co., Ltd Guangzhou Branch ）Apply for cancellation of 108 drugs' online listing qualification, and submit a letter of commitment for unified non supply nationwide, promising that "after the withdrawal result of the drugs applied for withdrawal is announced in Inner Mongolia, if the drugs are supplied in other provinces and cities, they will be included in the list of adverse records at that time, and will be handled in accordance with the measures for the management of adverse records of centralized procurement of drugs and equipment in Inner Mongolia Autonomous Region" On January 15, the office of the Joint Conference on centralized bidding and procurement of Henan Medicine issued the notice on standardizing the procurement and use of some anticancer drugs, pointing out that Novartis Pharma produktions Imatinib tablets (0.1g) produced by three enterprises, such as GmbH Germany, Jiangsu Haosen Pharmaceutical Group Co., Ltd and Sinopharm group Ouyi Pharmaceutical Co., Ltd., have not confirmed the price recommended by experts in the special centralized purchase and price negotiation of anticancer drugs, and the whole group flow standard In order to ensure clinical medication, the imatinib tablets (0.1g) produced by the above three enterprises can be purchased and used by medical institutions On January 22, Ningxia pharmaceutical centralized purchase network issued the notice on canceling the qualification of winning the bid (hanging the net) for 48 drugs with product specifications such as erdosetan capsule, among which 46 applied for canceling the hanging the net drugs and 2 applied for canceling the bidding drugs On the same day, Sichuan provincial centralized purchasing service center of pharmaceutical machinery issued the notice on canceling the network hanging of some drugs and giving bad records, saying that piracetam injection (specification: 20ml: 8G) and Yuanhu Zhitong oral liquid (specification: 10ml * 10 for each package) produced by Henan Fushen Pharmaceutical Co., Ltd applied for canceling the network hanging, and listed the company in the general bad records, which was announced by the decision of self-treatment From now on, the products involved will not be included in the scope of centralized classified procurement in Sichuan Province for one year In the face of the current application reasons for drug companies to transfer and withdraw their standards, most of them directly say that the prices of APIs rise frequently due to environmental protection, monopoly and other reasons, and the production costs of enterprises increase significantly So, is the flow standard of some varieties in the "4 + 7" urban volume procurement related to this? The procurement volume is less than 2% of the output After the establishment of the State Medical Security Bureau, the "national first standard" - the results of centralized procurement in "4 + 7" urban areas have been published, which has caused a great discussion in the industry In the end, 25 drugs were selected through centralized purchase, with a success rate of 81% Among them, 22 generic drugs passed the consistency evaluation, accounting for 88%, and 3 original drugs, accounting for 12% In addition, the six flow standard varieties were amoxicillin capsule (lithopone), azithromycin tablet (lithopone), tramadol tablet (lithopone), captopril tablet (Changzhou pharmaceutical factory), alfacalcitol tablet (Yaoyou) and azithromycin for injection (Hainan Puli) Taking amoxicillin capsule as an example, the author analyzed the cause of flow standard of these varieties Amoxicillin is a common antibiotic As a typical product of general medicine, there are many manufacturers, especially fierce competition Capsule is the main form of amoxicillin, which accounts for more than 80% of the market share At present, 144 domestic enterprises have amoxicillin capsule production number, 55 amoxicillin granules production number and 12 amoxicillin tablets production number According to the data of minenet, as of January 18, amoxicillin capsule was also the most popular product for consistency evaluation and declaration There were 126 registered reference preparations, 36 of which were accepted and 4 enterprises passed the consistency evaluation It can be seen from the procurement documents that the procurement volume of amoxicillin capsule is only 56.1466 million capsules According to the data of 2016 annual report of medical statistics, the national output of 0.25g amoxicillin capsule is 23894.07 million, and the output of SINOSURE is 3243 million This time, Amoxicillin Capsules accounted for less than 1% of the national output and only 2% of the total output The purpose of "4 + 7" urban volume purchasing is to achieve price reduction through volume Obviously, amoxicillin capsule procurement is too small, the enthusiasm of enterprises is not high Unable to meet the quotation requirements The procurement document indicates that: if the declared price meets the reduction requirements and an agreement is reached, the candidate will be qualified for the proposed selection If they do not participate in or accept the negotiation, the product will be processed as flow standard, and will affect the centralized purchase of drugs involved in the pilot area The decrease is based on the lowest purchase price at the end of 2017 in the pilot area Although the document does not specify how much reduction must be achieved, it can be judged from the final bid results of other products According to the media, compared with the lowest purchase price of the same kind of drugs in the pilot cities in 2017, the average price of the winning products decreased by 52%, and the highest drop reached 96% In addition, according to the Internet, the joint procurement office requires drug companies to reduce the price by a minimum of 10% when negotiating Amoxicillin capsule used to be the base drug catalog product before, experienced the era of "double envelope" exclusive bidding in the base drug period, in which various pharmaceutical companies fought a price war, even at a price lower than the cost price to win the market share, it can be said that amoxicillin capsule's bidding price is quite low In 2014, the national catalogue of low-cost drugs was released by the national development and Reform Commission, which was included in the management of low-cost drugs After the implementation of low-cost drug online purchase, the product price picked up According to the statistics, Amoxicillin Capsules (0.25g * 24 capsules) of Zhongnuo, a stone medicine, have the lowest bid price of 2.48 yuan / box in Shanghai If the minimum reduction is 10% according to the negotiation requirements, it will be 2.23 yuan / box, i.e 0.093 yuan / capsule In recent years, the price of API has increased by 60% Environmental protection is the focus of the state and provinces and cities The "environmental protection war" has moved seriously Since 2017, especially after the implementation of the environmental protection tax law on January 1, 2018, the environmental protection supervision at the national, provincial and municipal levels has been the largest in history and the most severe in punishment Looking back on the environmental protection supervision, people in the pharmaceutical industry are more worried about "whether there will be another wave of production suspension and price rise" With the increase of environmental protection cost and strict environmental protection, many small and medium-sized API enterprises with weak strength withdraw beyond expectation, some enterprises stop production and move one after another, the shutdown time is extended, and the production capacity is reduced, resulting in many small varieties of API out of stock and out of stock, and many API prices rise frequently The cost pressure brought by environmental protection, the consistency evaluation of generic drugs, the "two vote system" and other policies all make the API market more centralized The increase of industry concentration will also aggravate the monopoly of API, which is another black hand to push up the drug price Combined with the current market quotation, the price of amoxicillin API increased by nearly 60% compared with 2016 Amoxicillin, as a broad-spectrum antibiotic, has formed a fixed medication habit in clinic After long-term market sales, consumers have known the product, without advertising, consumers can also accept Especially in the current domestic "serious illness into the hospital, minor illness into the drugstore" under the guidance of pharmaceutical consumption habits, consumers often go directly to the drugstore or clinic to buy Amoxicillin capsule's main market is the medical institutions below the county level and OTC retail channels, and the sales volume of these markets exceeds half of the total According to minenet, in 2017, the total sales of amoxicillin in China's urban public hospitals, county-level public hospitals, urban community health service centers, township health center terminals and China's urban retail drugstore terminals were 2.634 billion yuan Among them, the sales of amoxicillin capsule in the terminals of public medical institutions in China is 978 million yuan; the sales of amoxicillin capsule in the terminals of retail pharmacies in China is 1081 million yuan, and the sales proportion of primary medical institutions and retail pharmacies is as high as 78% To sum up, the author thinks that amoxicillin capsule of Zhongnuo may give up the "4 + 7" urban volume Procurement Based on the consideration of too small purchase volume, too low negotiation price, rising raw material cost and different sales channels How to avoid "one size fits all" in procurement and avoid the next "national standard" to appear again? In my opinion, we can start from two aspects: the national policy making and the responsibility of production enterprises The relevant departments of the state should be more practical in formulating the centralized procurement plan with volume, analyze and treat the procurement catalogue differently, and not simply "one size fits all" and stipulate the minimum price reduction range In particular, in the context of rising prices in various industries, the rise of drug production costs and other issues should be taken into consideration to avoid the re flow of bid after winning the bid It is expected that when carrying out the next round of "national standard", relevant departments can do enough market research, and start with drugs with high clinical use rate, high product unit price and high gross profit to effectively reduce the economic pressure of patients Production enterprises should take the initiative to actively participate in, correctly understand the determination and strength of the country to implement volume procurement to solve the problem of high drug prices, and the future development trend of enterprises needs to carry out product structure transformation and upgrading However, at present, the production enterprises need to undertake certain social responsibility For the products with small profit and low purchase volume in the purchase catalogue, from another perspective, there is no need to bring gold sales into the hospital channel Why not make a living signboard for the enterprise? Let doctors realize the advantages of the product, is not it free to cultivate the brand awareness of doctors? What is a blessing in disguise? The decision-maker of the production enterprise can weigh the steelyard in his mind.