Anti monopoly of health care reform: the first sword finger of imported drugs

 Anti monopoly of health care reform: the first sword finger of imported drugs

Guarantee supply and price stability of short drugs

According to the task, we should strengthen the enforcement of the monopoly of API and ensure the supply and price stability of the shortage drugs. We will promote the construction of multi-source information collection platform and collaborative monitoring mechanism among departments. We will implement the reporting system and inventory management system for drug shortage. We will establish and improve the regular monitoring and early warning mechanism of drug consumables prices, and strengthen the dynamic monitoring of domestic purchase prices and the tracking of foreign prices.

The industry insiders interviewed by the reporter said that the supply guarantee of shortage drugs has always been the normal work of relevant competent departments. The measures to ensure the continuous supply of shortage drugs are to establish a list of drugs in short supply, make fixed-point production and unified procurement, list management system, and shutdown report system. This time, it is further emphasized to strengthen the monitoring and early warning of drug prices, and strengthen the law enforcement of monopoly behaviors such as API and imported drugs, so as to solve the problem of drug shortage from the perspective of price and API.

The State Health Commission and other departments previously released the response to the NPC deputys suggestions on accelerating the implementation of measures to guarantee the supply of cheap and life-saving drugs. In recent years, the State Administration of market supervision has continued to carry out price supervision and anti-monopoly law enforcement in the field of drugs and raw materials, investigated and dealt with a number of drug monopoly cases, and imposed economic sanctions of more than 40 million yuan, including chlorpheniramine and ice vinegar Acid, isonicotiana, estazolam and other varieties.

From the specific cases, in April this year, the State Administration of market supervision and administration fined 325.5 million yuan to three calcium gluconate raw material drug distributors, which attracted wide attention in the industry. According to the website of the State Administration of market supervision and administration, Shandong Kanghui Pharmaceutical Co., Ltd., Weifang puyunhui Pharmaceutical Co., Ltd. and Weifang taiyangshen Pharmaceutical Co., Ltd. abused their dominant position in the sales market of calcium gluconate for injection in China from August 2015 to December 2017 by means of underwriting, purchasing in large quantities or requiring manufacturers not to sell to the outside world The market of calcium gluconate for injection in China was controlled.

The National Health Commission said that in the future, it will strengthen anti-monopoly law enforcement and price supervision in the field of API, guide API operators to operate in accordance with the law, and maintain the market order of fair competition.

For the first time, antitrust is targeted at imported drugs

In addition, it is particularly noteworthy that for the work of ensuring the supply and price of the shortage of drugs, the task also puts forward that we should strengthen the law enforcement of monopoly illegal acts such as raw material drugs and imported drugs.

The reporter confirmed to the relevant ministries and commissions that this is the first time that the target of monopoly violations is imported drugs. This task will be assigned to the antimonopoly Bureau of the State Administration of market supervision.

According to the reporter, up to now, the national anti-monopoly agency has not imposed substantive punishment on the illegal monopoly of imported drugs. However, in the relatively close field of imported medical devices, in 2016, the national development and Reform Commission imposed administrative penalties on Medtronic and its trading counterparts for the price monopoly agreement on medical devices in the fields of cardiovascular, restorative therapy and diabetes, with a fine of up to 118.5 million yuan.

According to the public information, since 2014, Medtronic has reached a monopoly agreement with its trading counterpart through distribution agreement, email notice, oral negotiation, etc., limiting the resale price, bidding price and minimum sales price of relevant medical device products to the hospital, and through the formulation and distribution of product price list of each distribution link, internal assessment and cancellation of dealers The price monopoly agreement has been implemented.

At that time, the domestic level of medical devices was not high, and the market competition of high-value consumables and implantable medical equipment was not sufficient. Hou Lu, a scholar at the Law School of Jilin University, believes that some drugs have the specificity of use, the necessity of existence and the irreplaceable nature of supply and demand. In order to pursue high profits, operators in the field of drug production and circulation have the motivation to use the attributes of drugs as special commodities to form a drug price alliance and reach a monopoly agreement, thus raising the price of drugs.

Analysts said that according to the guide to price behavior of drug operators in short supply and API issued by the national development and Reform Commission in 2016, price monopoly is divided into horizontal price monopoly and vertical price monopoly. At present, there is no reliable evidence to show which imported drugs have price monopoly. However, in the fields of antibody preparation (monoclonal antibody, double antibody, immune checkpoint inhibitor, car-t), immunoantineoplastic drugs and drugs for rare diseases, which are at the pyramid point of biomedical technology and industry, there are also problems such as insufficient suppliers and high retail prices, which have the market soil of price monopoly.

Market order and industry compliance still need to be optimized

In this regard, fan Ke, a partner of global law firm, said that in recent years, the compliance degree of the pharmaceutical industry in terms of price monopoly and abuse of market dominance still needs to be further improved. For example, in the open case of law enforcement departments, although an enterprise only participated in the meeting organized by competitors, did not explicitly accept the proposal of not supplying drugs to the outside world and increasing the price, and there was no evidence to show that it had reached a written monopoly agreement or communicated with other participating enterprises on price increase behavior after the meeting, but the participating enterprises had tacit understanding in a short time after the meeting It is still considered that the monopoly agreement has been reached and implemented. In other industries, some industry associations organize member enterprises to reach price monopoly agreements, or divide the sales areas and objects of member enterprises, the categories of products to be sold, and market share, etc., which are also suspected to constitute monopoly behavior.

Source of this article: Yang Bin, editor in charge of economic reference newspaper_ NF4368