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[Of the 27 cases of monopoly agreements and abuse of market dominance investigated nationwide last year, a quarter (7 cases) occurred in the pharmaceutical industry.]

It took about 7 months for the anti-monopoly compliance guidelines in the pharmaceutical field to be publicly solicited for opinions from the public.

Recently, the State Administration for Market Regulation issued the Anti-monopoly Guidelines for the Pharmaceutical Sector (Draft for Comments) (hereinafter referred to as the "Guidelines"). The Guidelines consist of 7 chapters and 55 articles, covering the production and operation of the entire pharmaceutical sector, including traditional Chinese medicine, chemical medicine and biological products.

In recent years, monopoly behaviors in my country's pharmaceutical sector have occurred frequently, affecting the supply and price stability of drugs. The State Administration for Market Regulation has investigated and dealt with more than 20 cases of monopoly agreements and abuse of market dominance in the pharmaceutical sector, including the Grand Pharmaceutical Monopoly Case, Yangtze River Pharmaceutical Monopoly Case, and Shanghai Pharma Biochemical Monopoly Case, conditionally approved the acquisition of Beijing Tobixi Pharmaceuticals by Innovent Biologics and other cases of concentration of operators in the pharmaceutical sector, and stopped 11 cases of abuse of administrative power to exclude and restrict competition.

The Guidelines summarize the experience of several typical cases in the aforementioned regulatory enforcement practices, and systematically and comprehensively sort out the types, manifestations, and illegal characteristics of frequent pharmaceutical monopoly behaviors. For the first time, it puts forward regulatory requirements for the "abuse of market dominance through division of labor and cooperation" of upstream and downstream companies such as APIs and preparations, and clearly stipulates that monopoly behaviors such as "artificially causing shortages of drug supply and causing major losses to medical insurance funds" will be severely punished.

Protecting drug R&D innovation and promoting generic drug competition are the two major concerns of the Guidelines. To this end, the Guidelines incorporate new patent monopoly behaviors in the pharmaceutical field and respond to controversial issues in pharmaceutical BD transactions that may exclude or restrict competition, such as the termination of R&D by the seller and the "non-challenge regulations" agreed by both parties.