Behind the cut-off of 61 life-saving drugs: the soaring cost of drug raw materials

Source: Daily Economic News May 8, 2017 medical network tetanus antitoxin, glucose injection These well-known drugs were marked as "emergency (rescue) drugs" on a list issued by Guangdong Drug Trade Center (hereinafter referred to as Guangdong Drug Delivery Center) on May 2 However, the reason why they are listed on this list is because the enterprises "cut off the supply" The reporter noted that 61 drug specifications (drug specifications, such as dosage size, dosage form, etc.) were listed on the "cut off" list, while the whole list showed that as many as 1004 drug specifications were cut off Why is the "life-saving medicine" cut off? "Guangdong is a big province of medicine Who wants to lose business after winning the bid?"? Enterprises are not unwilling to do it, but dare not do it " In the face of the reporter's interview, Li Yun (pseudonym), who used to be the chairman of a well-known pharmaceutical company in Guangdong, said straightly that it is not that the company does not want to do business, but that the hanging back of the production cost and the bid price makes the company have no production power "Daily economic news" reporter found that drug companies are reluctant to pay the bill and do not supply after winning the bid In May 2016, Guangdong drug delivery center publicized 806 drugs that were not supplied according to the contract, and clearly pointed out that if the drugs were not supplied on time after the end of the publicity period, it would be disqualified from entering the market within two years In addition, there have been many cases in China where pharmaceutical companies won the bidding and were not named publicly Huang Xiuxiang, secretary-general of Hunan Pharmaceutical Circulation Association, told reporters earlier that Guangdong, as a province with large drug consumption, has a large number of medical institutions to purchase If pharmaceutical enterprises can take this market and survive, their ability to make money in other provinces of the country will not be too poor Hard work in the standard, but now has become a "hot potato", so many pharmaceutical companies "cut off" what is the secret? The reporter contacted nearly ten enterprises on the "cut-off" list Except for two enterprises that thought that the "cut-off" was due to the distribution enterprises, the rest of the interviewees focused on the production cost Li Yun told reporters that there are two main reasons why pharmaceutical companies do not supply drugs in time or not: first, the production cost, especially the cost of raw materials, has increased too much; second, the monopoly of APIs is serious He said that the bid winning price of drug procurement is very scientific in theory The reference standards include the average price, market entry price and negotiation price of surrounding key provinces and cities However, due to the lag of economic activities of drugs, the bid winning price often refers to the data of the past four or five years, but the production cost, especially the cost of raw materials, has increased or even doubled year by year In addition, the new GMP standard certification, consistency evaluation and other policy impacts, the upgrading and transformation of the workshop and products, also promote the rise of drug costs Li Yunshen has experience in the rising cost of raw materials For example, he gave reporters that manufacturers of Ganmaoqing need to use morpholine guanidine as auxiliary materials, but there are only one or two enterprises in the country to produce this kind of API, and the price has skyrocketed from 12000 yuan per ton to about one million yuan, "very outrageous" Not only that, the stricter drug management standards also lead to the steep increase in the production costs of pharmaceutical enterprises Li Yun said that in the past, the regulatory authorities only tested the composition of Compound Danshen tablets, about 5000 pieces could be produced with 1 ton of 37 Since 2012, the test standard has been changed to a strict content test, requiring each tablet to contain 1 gram of 37 As a result, only 1000 pieces could be produced with 1 ton of 37 In addition, 37 raw materials have been fried badly in the past few years, which greatly increased the production cost There are also some drugs due to the cost increase caused by the improvement of the process The Ganmaoling, which can be bought for 1 yuan in the past, is just because of the process adjustment, the production cost and the price hanging upside down, and the enterprises who are unwilling to do the loss business simply give up production The chairman of a pharmaceutical company in Zhanjiang, Guangdong, told the daily economic news that it was helpless to stop supply In recent years, the price of traditional Chinese medicine has risen sharply, which has greatly pushed up production costs At present, the bid price of some drugs is not enough to buy raw materials If we supply according to the contract, we will not only lose profits, but also lose money The monopoly of APIs is a deep-seated reason Several heads of pharmaceutical manufacturers interviewed by reporters of the daily economic news mentioned that the monopoly of APIs has become an important factor in the rise of the price of pharmaceutical raw materials "When DOPA is required to be produced on a designated basis, there are fewer manufacturers, distributors have monopolized the raw materials, and vitamin B1 also has this situation." Zhang, head of the bidding Department of a pharmaceutical company in Guangdong, told reporters that the monopoly of distributors led to the rising cost of APIs However, due to the relevant regulations of the government, the price of low-cost drugs could not be increased, and the enterprises could not produce normally at all During the national "two sessions" this year, Geng Funeng, vice president of China Pharmaceutical Materials Association and chairman of gooddoctor Pharmaceutical Group, stated in the proposal on requiring relevant departments of the state to break monopoly of raw materials and stabilize drug prices submitted by Geng Funeng that some raw material drug production enterprises and business enterprises make use of drug management law and relevant laws and regulations "For the API under the management of approval number, the API with approval number must be used in the production of its preparation" By using the approval number resources in hand, the price of the API can be increased, or the raw materials can not be taken out (only for self production), resulting in the high price of the market preparation drugs or the people can not buy some life-saving drugs He also pointed out that some pharmaceutical operating companies and some exclusive raw material manufacturers jointly increased their prices, which led to the rise of nearly 840% in Apis; some pharmaceutical operating companies talked with foreign enterprises about the total agency at a higher price, which led to the rise of 677% in APIs, and some APIs increased 1566% in three years In fact, the national development and Reform Commission has also taken measures to rectify the monopoly of APIs In 2016, the national development and Reform Commission punished three companies, including Huazhong Pharmaceutical Co., Ltd., Shandong Xinyi Pharmaceutical Co., Ltd and Changzhou No.4 Pharmaceutical Co., Ltd., for reaching and implementing the monopoly agreement on eszolam API and tablet, with a total fine of more than 2.6 million yuan Although the state has shown a strong attitude towards anti-monopoly law enforcement in the pharmaceutical industry, the price rise of some APIs is still relatively strong, and the soaring prices of APIs have led to increasing supply and demand tension among upstream enterprises According to the public data, from October 2011 to may 2013, the price of thymol, the main raw material of "Xinlong to Xiehui water", increased from 275 yuan / kg to 8808 yuan / kg, 32 times higher; the price of digoxin tablet API increased from 75000 yuan / kg in September 2014 to 400000 yuan / kg in January 2015, 5 times higher in half a year In the case of domperidone APIs produced by Indian enterprises, there are only two exclusive distributors in China, and the price has risen from 900 yuan / kg to 7000 yuan / kg in two years The "double squeeze" of drug manufacturers caused by the rise in the price of APIs and the reduction in the price through bidding has hurt the enterprises, which can only lead to the disconnection of some drugs According to the list statistics released by Guangdong drug delivery center this time, 711 drugs of 1004 specifications are emergency (emergency) drugs, clinically necessary drugs and cheap drugs, including 61 emergency (emergency) drugs, 32 clinically necessary and difficult to purchase, 335 cheap drugs and 283 other basic drugs On May 3 and 4, the reporter of "daily economic news" called the public phone of Guangdong Drug Delivery Center for many times, hoping to know the quantity of drugs not supplied in time and not supplied and the reasons explained by the manufacturer, but as of the time of publishing, he had not been contacted Guangdong health and Family Planning Commission said that the situation of the drug delivery center needs to consult the relevant departments before replying to the reporter As of the time of publication, the reporter had not received a response.