Antitrust reform: the first "sword finger" imported drugs.

Pharma Network August 12 - The General Office of the State Council has issued the "Deepening the reform of the medical and health system in the second half of 2020 key tasks" (hereinafter referred to as the "Mission"), proposed to "improve the normal monitoring and early warning mechanism of drug supplies prices, increase the law enforcement of monopoly violations such as raw materials, imported drugs."
" interview with reporters said the new expression sends a strong signal, the first time to punish monopoly violations of the target of imported drugs.
in the biopharmaceutical technology and industry "pyramid tip" anti-institutional agents, as well as immuno-anti-tumor drugs, rare disease drugs and other fields, there are few suppliers, high retail prices and other issues, with a price monopoly of the market soil.
, however, there is no reliable evidence of price monopolies in the imported drug sector.
shortage of drugs to ensure stable prices is still the focus of the "mission" proposed to increase the monopoly of raw materials and drugs law enforcement efforts, requiring a good job in the shortage of drugs to ensure stable prices.
promote the construction of multi-source information collection platforms and departmental coordination monitoring mechanisms for drugs in short supply.
implement a reporting system and a list management system for drug discontinuation in short supply.
establish and improve the normal monitoring and early warning mechanism of drug supplies prices, strengthen the dynamic monitoring of domestic procurement prices and foreign price tracking.
interview with reporters in the industry said that the shortage of drugs has been the normal work of the relevant authorities, the establishment of a shortage of drugs catalog, fixed-point production, unified procurement, inventory management system, stop-production reporting system, etc. are to ensure the continuous supply of drugs in short supply initiatives.
this time to further emphasize the monitoring and early warning of drug prices, increase the enforcement of monopoly behavior such as raw materials, imported drugs, from the price side and raw materials, to solve the shortage of drugs.
National Health And Safety Commission and other departments previously published on the NPC representatives "on speeding up the implementation of low-cost life-saving drugs supply safeguard measures" response shows that in recent years, the State Administration of Market Supervision continued to carry out price supervision and anti-monopoly enforcement in the field of drugs and raw materials, investigated and dealt with a number of monopoly cases of raw materials, the implementation of economic sanctions more than 40 million yuan, the raw materials involved in the drug including paracetaem, ice acetic acid, smoke umbilical cord, espene and other varieties.
from the specific case, in April this year, the State Administration of Market Supervision and Administration of the three calcium glucosate API distribution enterprises fined a total of 325.5 million yuan, by the industry's wide attention.
The website of the State Administration of Market Supervision and Administration shows that Shandong Kanghui Pharmaceutical Co., Ltd., Weifang Puyunhui Pharmaceutical Co., Ltd., Weifang Sun God Pharmaceutical Co., Ltd. and other three companies abused their dominant position in china's market for the sale of calcium gluconate for injection from August 2015 to December 2017, and controlled the sale of chinese injectable calcium gluconate raw materials by underwriting, buying in large quantities or requiring manufacturers not to sell them to the outside world.
health care commission said that in the future, it will strengthen anti-monopoly enforcement and price supervision in the field of API, guide API operators to operate in accordance with the law, and maintain a fair competition in the market order.
For the first time, the anti-monopoly targeting of "imported drugs" is particularly noteworthy, in order to do a good job in the shortage of drugs to maintain stable prices, the Task also proposed, "to increase the raw materials, imported drugs and other monopoly violations of the law enforcement efforts."
" reporter confirmed to the relevant ministries, this is the first time the monopoly violations of the target of "imported drugs", this task will fall to the State Administration of Market Supervision anti-monopoly.
, so far, the state-level anti-monopoly agencies have not yet imposed substantial penalties for monopoly violations of imported drugs.
But in the area of imported medical devices, the National Development and Reform Commission (NDRC) in 2016 imposed administrative penalties of up to 118.5 million yuan for the agreement reached and implemented by Medtron and its trading relatives on the price monopoly of medical device products in the field of cardiovascular, restorative therapy and diabetes business.
Public information shows that, since at least 2014, Medtron has reached a monopoly agreement with its trading relatives through distribution agreements, e-mail notifications, oral consultations, etc., limiting the resale price of relevant medical device products, bidding prices and minimum sales prices to hospitals, and implementing price monopoly agreements through the formulation of product price lists, internal assessments, and the withdrawal of low-cost winning products from dealers.
, the level of localization of medical devices is not high, high-value consumables and implantable medical equipment market competition as a whole is not sufficient.
Hou Wei, a scholar at Jilin University Law School, believes that some drugs are precisely because they have the specificity of use, the necessity of existence and the irreplaceability of supply and demand, and operators in the field of drug production and circulation, in order to chase high profits, have the motivation to use drugs as a special commodity attribute, forming a drug price alliance to reach monopoly agreements, thereby raising drug prices.
analysts say price monopolies are divided into "horizontal price monopolies" and "vertical price monopolies", according to the National Development and Reform Commission's 2016 Guidelines on Price Conduct for Operators of Shortage Drugs and API.
, there is no reliable evidence of price monopolies in the imported drug sector.
But in the biopharmaceutical technology and industry "pyramid tip" of anti-institutional agents (single resistance, double resistance, immuno-checkpoint inhibitors, CAR-T), as well as immuno-anti-tumor drugs, rare disease drugs and other fields, there are also few suppliers, high retail prices and other issues, with a price monopoly of the market soil.
liang Jialin, executive director of the China Value Medical Research Center, said that the current anti-monopoly investigation points to imported drugs, which show that drugs with the same efficacy and common name still have price differences at home and abroad.
" spread exists for several reasons: first, it may come from higher tax costs.
, in 2018, the State Council has reduced import duties and value-added tax on cancer drugs.
is likely to come from higher production costs.
to solve this problem, a large number of multinational pharmaceutical companies have moved their production bases to developing countries where production costs are lower, after some drugs were collected in bands and slashed prices.
is the attraction of excess profits that can come from monopoly violations, which law enforcement needs to significantly reduce.
"If multinational pharmaceutical companies impose a price monopoly on imported drugs in China, they are suspected not only of violating the Anti-monopoly Law, but also of violating the Bidding Law when participating in the bidding and procurement of drugs," he said.
, a partner at Global Law Firm, said that in recent years, the pharmaceutical industry has yet to further improve its compliance in terms of price monopoly and abuse of market dominance.
For example, in a public case of law enforcement, although an enterprise participated only in a meeting organized by competitors, did not explicitly accept the proposal for non-external supply of drugs and price increases, and there was no evidence that it reached a written monopoly agreement or communicated with other participating enterprises on price increases after the meeting, but because after the meeting, the participating enterprises in a short period of time to raise the factory price of a drug, is still recognized as a monopoly agreement reached and implemented.
in other industries, some trade associations organize member enterprises to reach price monopoly agreements, or divide the sales areas and objects of member enterprises, the types of products sold, market share, etc., are also suspected of constited as monopoly behavior.
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