Three "Related" Raw Material Enterprises Receive 326 Million Days' Price Fines. The Industry Appeals For Heavy Penalties, Imprisonment And Promotion Of Filing System.

Recently, the State Administration of market supervision has investigated and dealt with a case of abuse of dominant position in the field of major raw material drugs, and imposed administrative penalties on monopolistic behavior of 3 calcium gluconate raw material distribution enterprises. The total amount of fines was 325 million 500 thousand yuan, and pointed out that the monopoly of three enterprises increased the national medical insurance expenditure and damaged the interests of patients.

The State Administration of market supervision confiscated the illegal gains of the related companies, Shandong Kang Hui Medicine Co., Ltd., Weifang Pu Yun Hui Medicine Co., Ltd. and Weifang sun god Medicine Co., Ltd., and at the same time imposed a fine of 10%, 9% and 7% of the three companies respectively in 2018. Previously, enterprises suspected of chlorpheniramine raw material monopoly were fined 8% or 4% of the above year's sales respectively.

In fact, the monopoly of raw material drugs has been for many years. In November 2017, the national development and Reform Commission issued the guide to the price behavior of the shortage of drugs and API operators, which formally defined the definition and contents of specific monopolistic behaviors, but the specific penalties were not clear.

In April 15th, Shi Lichen, head of Beijing Ding Chen medical management consulting center, told the reporter of twenty-first Century economic report that the above illegal income and penalty amount had a larger floating space and needed specific and specific basis. In addition to increasing economic penalties, criminal responsibility should also be added. "To solve the root cause, we still need to promote the development of the archival filing system for raw materials. Many companies can produce raw materials to form healthy competition. Otherwise, the price of raw materials will be transmitted to the preparations, and the national medical insurance and the interests of the patients will be damaged.

The highest drug monopoly ticket in history

From August 2015 to December 2017, Kang Hui, Pu Yun Hui and sun god company controlled the sales market of calcium gluconate raw materials for injection in China through underwriting, mass purchase or requiring production enterprises not to sell abroad. From 2015 to December, 2016 and 2017, three enterprises involved in the market share of China's calcium gluconate raw material sold in the market were 94%, 91% and 87% respectively, and sold injectable calcium gluconate raw materials at an unfair high price, and obtained a high monopoly profit. The three companies were sold in the market.

In 2017, three enterprises increased the purchase price of raw materials of calcium gluconate for injection of 80 yuan / kg to 760~2184 yuan / kg, and the price increased 9.5 times to 27.3 times. Compared with 2014, the sales price of injectable calcium gluconate raw materials increased by 19 times to 54.6 times in 2017.

? ? In addition, after controlling the sales market of calcium gluconate raw materials in China, Kang Hui, Pu Yun Hui and Helios also forced the manufacturers to repurchase the Calcium Gluconate Injection produced by the manufacturer to three enterprises, or to act as the foundry of three enterprises, and sell Calcium Gluconate Injection according to the instructions of three enterprises, otherwise they would not supply the injection of Portuguese. Calcium gluconate.

It is understood that the above three companies are very closely related. In June 2015, Lu Guohua, deputy general manager of Kang Hui company and Zhang Kun, manager of second business department, bought Weifang Hengchang Pharmaceutical Co., Ltd. and changed the name of the company to Weifang Pu Yun Hui Pharmaceutical Co., Ltd., after the establishment of Pu Yun Hui company, it has been controlled by Kang Hui company, and two employees have served each other, and their financial and business contacts are very close.

Sun god company is registered as an independent legal entity, but its injection products such as calcium gluconate raw material are actually controlled by Conway.

A pharmaceutical company responsible person told the twenty-first Century economic news reporter that the monopoly of injectable calcium gluconate raw material, with less production enterprises, coupled with several enterprises are linked, it is easy to control the upstream raw materials, large clinical demand, downstream manufacturers, so that these monopolistic enterprises have great operational space.

For the monopolistic behavior of the above-mentioned three "related" enterprises, the General Administration of market supervision decided to punish three enterprises severely: confiscation of 108 million 900 thousand yuan for illegal gains by Kanghui company, and a fine of 10% yuan for sales in 2018, which is 143 million 800 thousand yuan, plus 252 million 700 thousand yuan. The company confiscated the illegal income of 6 million 50 thousand yuan, and imposed a fine of 9% yuan on sales in 2018, accounting for 48 million 300 thousand yuan, totaling 54 million 350 thousand yuan. The sun god company confiscated the illegal income of 6 million 50 thousand yuan, and imposed a fine of 7% yuan in 2018, accounting for 12 million 400 thousand yuan; the total sum was 18 million 450 thousand yuan. The total number of fines in three enterprises amounted to 325 million 500 thousand. This is the monopolization case of raw materials monopoly, which is the highest amount of penalty since the establishment of the General Administration of market supervision.

Three measures to eradicate the monopoly of raw material drugs

Practice has proved that the monopoly of raw materials directly increases the cost of pharmaceutical enterprises, and the transmission to the terminal has damaged the interests of pharmaceutical companies, medical insurance and patients.

Shi Lichen told the twenty-first Century economic analysis reporter that under the background of state gathering, API is the key, which has an important impact on the pharmaceutical enterprises. Some pharmaceutical companies have already done some good products, and the winning bid can also be profitable. But after the monopoly of raw materials, they can only choose to stop production, otherwise the losses will be serious. At the same time, enterprises will also be blacklisted, affecting subsequent bidding matters.

The chairman of a pharmaceutical company in Sichuan told the economic news reporters in twenty-first Century that the company had reported the raw materials monopoly to the downstream pharmaceutical companies, but failed to achieve the expected effect. The suspected monopolized enterprises were punished. After paying the fine, they continued to monopolize, and the price of raw material drugs remained high. The cost of the enterprises continued to push up. "Profit one hundred million or two hundred million, a fine of hundreds of thousands or even millions of dollars, is still cost-effective for the bulk drug monopoly enterprises."

The monopoly of raw material drugs has been a serious problem for many years, and the relevant departments of the state have also dealt a blow. However, driven by interests, there is still a growing trend.

In November 2017, the national development and Reform Commission issued the "guide for the price behavior of the shortage of drugs and API operators" in the form of announcements, and clarified the manifestations, illegality identification, and exemption conditions of price monopoly agreements in the fields of shortage of drugs and API, and reminded relevant operators not to fabricate the price information and string on the shortage of drugs and API. Manipulation of market prices and other violations of the price act.

However, penalties for the monopoly of raw materials are not specified. Shi Lichen said that at that time, the national development and Reform Commission, the State Administration for Industry and commerce, and the departments under the Ministry of commerce all involved in the enforcement of anti monopoly law. However, because of the multisectoral supervision, the situation of water control in Kowloon was formed, and the penalties and regulations were not clear.

In February 10, 2017, Wuhan Xinxing Medicine Co., Ltd., monopolized Methylis salicylas raw material medicine, was fined more than 220; in February 13, 2017, Shandong Weifang long Shun and medicine, hinder investigation and evidence collection, fined 120 thousand; in July 3, 2017, Zhejiang Xinke pharmaceutical and Tianjin Hanwei pharmaceutical industry abuse of market dominant position, high price selling isoniazid raw material medicine, altogether fined more than 44.

In December 2018 and January 2019, the General Administration of Market Supervision announced two cases of monopoly of raw materials. Among them, three production companies of glacial acetic acid raw material were punished by 12 million 833 thousand and 800 yuan according to law, and 6 million 582 thousand and 200 yuan of illegal income was confiscated, and three enterprises were fined 4% yuan for sales in the same year, accounting for 6 million 251 thousand and 600 yuan. The total penalty for three enterprises involved was 12 million 833 thousand and 800 yuan.

According to the "anti monopoly law", a business operator who has reached a monopoly agreement or abuses the dominant market position will be ordered to stop illegal activities, confiscate illegal gains and impose a fine of more than 1% or less of the sales in the previous year. The cost of illegal activities is quite high.

In Shi Lichen's view, at present, the anti monopoly duty is managed by the State Administration of market supervision, and it can be managed more systematically. In addition to the clear handling of the strength and rules, the most important thing is to be assigned to a specialized department for docking and feedback on enterprise reporting.

At the same time, Shi Lichen thought that in addition to economic penalties, criminal penalties should also be strengthened. "Some monopolistic behaviors abroad need to be punished, and there are other jurisprudence in other industries in China, but not in the pharmaceutical industry."

There are also manufacturers who have pointed out that the current control measures for drug prices are mostly focused on pharmaceutical companies, and the case of raw material drugs is launched on the basis of anonymous reporting. It is hoped that in the future, multi sector comprehensive law enforcement will be conducted to investigate the monopolistic behavior of raw drugs that are not up to normal prices, and consider increasing the crackdown on monopoly enterprises with huge profits.

Shi Lichen believes that the fundamental way to eradicate monopoly in the industry is to carry out the archival filing system for raw materials.

Xiong Weizheng, chairman of Ling Rui pharmaceutical, suggested that the access threshold for API manufacturers should be relaxed, while price departments should tighten up the price regulation. Du Zhenxin, chairman of Shandong Chen Xin Pharmaceutical Limited by Share Ltd, suggested that DMF should be used as a raw material for the registration and filing of medicinal raw materials.

?