Burst! Northeast Pharmaceutical notice: receiving the notice of case investigation

November 5), Northeast Pharmaceutical Group Co., Ltd (hereinafter referred to as Northeast Pharmaceutical) received the notice on investigation of anti monopoly cases from Liaoning market supervision administration (liaoshijian anti monopoly [2019] No 8) from Liaoning market supervision administration on November 4, 2019 In the specific announcement, Northeast Pharmaceutical did not disclose more details of the investigation, but the public information shows that at the end of last year, there was a public report about the monopoly of APIs in Northeast Pharmaceutical It was reported by the public network that the monopoly of APIs was around November last year, and a public report letter was circulated on the Internet The letter said that in order to increase the factory price of its own preparations, Northeast Pharmaceutical increased the price of levocarnitine, a raw material drug, by dozens of times, or even cut off its supply According to the public data, levocarnitine injection is suitable for a series of concurrent symptoms caused by secondary carnitine deficiency in patients with chronic renal failure undergoing long-term hemodialysis Its clinical manifestations include cardiomyopathy, skeletal myopathy, arrhythmia, hyperlipidemia, hypotension and muscle spasm during dialysis, etc In June 2018, the national health and Health Commission and other five departments jointly issued the catalogue of the first batch of rare diseases, which includes 121 diseases Levocarnitine injection is a key drug for the treatment of several diseases According to the official website of the State Food and drug administration, at present only Northeast Pharmaceutical and Changzhou Lanling Pharmaceutical Co., Ltd have the approval documents for the production of domestic levocarnitine APIs However, according to the report letter, Northeast Pharmaceutical is currently the only manufacturer of levocarnitine APIs in China, and the price of the raw materials has increased from 700 yuan / kg to 8000 yuan / kg, or even out of stock The manufacturer of zuokanitin injection communicated and coordinated with Northeast Pharmaceutical for many times, but the other side was still unwilling to supply, resulting in no rice in the pot for the preparation manufacturer, drug supply interruption, and long-term unstable supply for clinical use and patients According to the report letter, the reason for the cut-off of supply of Northeast Pharmaceutical is to make other pharmaceutical manufacturers unable to produce levocarnitine injection, while only Northeast Pharmaceutical can produce levocarnitine injection, and then significantly increase the price of the preparation, which will eventually lead to an increase in patients' expenditure, as well as an increase in the cost of national medical insurance The letter also lists the affected manufacturers, including more than 10 enterprises such as Harbin Yuheng pharmaceutical, Jiangxi Dongfu pharmaceutical, and Zhejiang Beisheng pharmaceutical Hansheng pharmaceutical According to the head of Purchasing Department of a manufacturer interviewed by China business daily, the company's latest purchase of zuokanitin APIs from Northeast Pharmaceutical was about a month or two ago, and the purchase price of zuokanitin this time skyrocketed to about 8000 yuan / kg, compared with about 3000 yuan / kg at the beginning of this year When the reporter of China Business News called the sales director of zuokanitin API of Northeast Pharmaceutical in the name of the purchaser, the other side said that the external sales of zuokanitin API of Northeast Pharmaceutical had been suspended recently and was only reserved for self use As for why to stop supply, the other party said that due to environmental protection and other reasons, the production of the product is relatively tight, so it does not supply to the outside world Many pharmaceutical companies have been punished for monopolizing APIs after being publicly reported Northeast Pharmaceutical responded that the content of the article was inconsistent with the actual situation, and zuokaniding API of the company did not suspend its external supply The person in charge acknowledged that the price of drugs did rise, mainly due to environmental protection, relocation and staff costs However, Northeast Pharmaceutical did not disclose whether the anti-monopoly investigation was related to the above report In the announcement, Northeast Pharmaceutical disclosed that the full text of the investigation letter received was as follows: Liaoning provincial market supervision and Administration Bureau began to carry out anti-monopoly investigation on you (unit) on November 4, 2019 Please cooperate with the investigation and provide the information required by this organ according to the anti monopoly law of the people's Republic of China and other relevant laws and regulations If you (unit) refuse to provide, do not fully provide relevant materials and information, or provide false materials and information, or hide, destroy Transfer of evidence, or any other act of refusing or obstructing the investigation, shall bear legal responsibility according to law If you (the unit) think that the law enforcement officer has a direct interest in you (the unit), you can apply to this organ for his withdrawal In recent years, it is not uncommon to be punished for the monopoly of APIs: in July 2017, the national development and Reform Commission imposed a fine of 443900 yuan on two pharmaceutical enterprises with price monopoly of isoniazid APIs; in December 2018, three glacial acetic acid API manufacturers were punished by 12.83 million yuan according to law for the monopoly; in January 2019, the basis investigated by the State Administration of market supervision in the periphery Based on the investigation of the relevant chlorpheniramine API enterprises, the two enterprises involved were ordered to stop the illegal activities, the illegal income of RMB 2.3947 million was confiscated from Erkang, Hunan, the fine of 8% of the sales in the previous year was RMB 8.4794 million, the fine of 4% of the sales in the previous year was RMB 1.5573 million, and the total fine of the two enterprises involved was RMB 12.4314 million After Erkang pharmaceutical, will Northeast Pharmaceutical become the second enterprise to be punished for monopolizing API? Attachment: full text of the letter of complaint circulated in November 2018 (source: Beijing Forum) zuokanitin injection API was maliciously controlled by Northeast Pharmaceutical Levocarnitine injection preparation (function indications: it is applicable to a series of concurrent symptoms of chronic renal failure patients with long-term hemodialysis due to secondary carnitine deficiency, such as cardiomyopathy, skeletal myopathy, arrhythmia, hyperlipidemia, hypotension and muscle spasm during dialysis, etc.) The drug has definite curative effect and good safety It has a wide coverage in domestic hospitals and plays an important role in the rehabilitation of patients However, at present, the raw materials used to produce the drug are monopolized by the malicious market, and the price is also out of stock from 10 times of growth to the current high price, resulting in the production unit without rice, the supply of drugs is interrupted, and the clinical and patient use of the hospital are not stable for a long time Supply Communicate and coordinate with raw material manufacturer (Northeast Pharmaceutical Group Co., Ltd.) for many times, and the other party is unwilling to supply Due to the particularity of drug policy, other API manufacturers can not supply API in a short time, and pharmaceutical manufacturers can not change API suppliers at will Northeast Pharmaceutical is out of stock maliciously, trying to make other pharmaceutical manufacturers unable to produce, only they can monopolize the production, and then greatly increase the price of preparations, which will eventually lead to the increase of patients' expenditure, as well as the increase of national medical insurance costs and social contradictions It has been reported many times in the early stage that the monopoly of APIs will directly produce the "throat locking" effect on downstream pharmaceutical enterprises ? as for the monopoly of raw materials of Northeast Pharmaceutical Group Co., Ltd., it is directly against the "guide to price behavior of short drugs and API operators" (Draft for comments) posted on the official website of the national development and Reform Commission The purpose of the document is to curb illegal price hikes and malicious marketing control, regulate the market price behavior of drugs in short supply and APIs, maintain the market price order, establish a fair market environment for drug purchase and sale, and protect the interests of consumers Many injured enterprises are waiting to see if a guide can end the era of API monopoly As a state-owned enterprise, Northeast Pharmaceutical Group Co., Ltd maliciously monopolizes raw materials, regardless of the rights and interests of the state and the general public, and constantly raises the price of raw materials, resulting in the price of levocarnitine raw materials rising from 700 yuan / kg to 8000 yuan / kg at present, which is still maliciously not supplied to the preparation production enterprises, greatly affecting the normal production of preparations in the production enterprises, so that the majority of patients have no Drug use Its intention is to raise the price of drugs, regardless of the safety of the patients, with the help of national resources, crazy for private profits As a part of the victims, we must stand up and speak out, hoping to attract the attention of relevant departments Please check thoroughly! At present, the monopolized pharmaceutical companies in the market include Harbin Yuheng Pharmaceutical Co., Ltd., Jiangxi Dongfu Pharmaceutical Co., Ltd., Zhejiang Beisheng pharmaceutical Hansheng Pharmaceutical Co., Ltd., Changchun Xiangtong Pharmaceutical Co., Ltd., Guangzhou Baiyunshan Mingxing Pharmaceutical Co., Ltd., Yunnan Longhai natural plant Pharmaceutical Co., Ltd., Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., Jiangsu Sihuan Biological Pharmaceutical Co., Ltd, Changzhou Lanling Pharmaceutical Co., Ltd., Shanghai Shangyao Xinya Pharmaceutical Co., Ltd., Changchun Haiyue Pharmaceutical Co., Ltd Thank you