Anti-monopoly Regulation On Excessive Pricing Of API

In China,API is a type of medicine and regulated by relevant laws such as the Drug Administration Law.Since the drug price liberalization in 2015,the price of API in China has risen sharply.The sharp rise in the price of API has directly led to the soaring prices of finished drugs and the discontinuation of some important drugs,which affecting the health,safety and vital interests of drug consumers.The excessive-pricing of API may violate the anti-monopoly law and constitute an abuse of market ascendancy.Its regulation plays an important role in the development of China’s anti-monopoly law.The existing cases of anti-monopoly law enforcement of API focused on the identification of exclusive abuses such as refusal of transactions and additional unreasonable restrictions,but fail to curb the price increase of the API industry.Whether the anti-monopoly law should regulate the excessive-pricing behaviors,there are two distinct institutional choices of regulation and exception in theory.In practice,there are some difficult problems such as how to judge the price “too high” in the regulation of excessive-pricing behaviors,which need to be solved in this paper.The author proposes that the anti-monopoly law enforcement agency should use the“unfair and high price”clause of Article17(1)(1)of the anti-monopoly law of our country to directly identify the exploitative abuse of excessive-pricing as monopolistic behavior.Based on API law enforcement case as the breakthrough point,this paper analyzes the current status of the regulation of China’s API industry,points out the current problems of anti-monopoly law enforcement agencies regulating API excessive pricing,and draws on the theoretical and practical experience of developed countries in Europe and the United States on excessive pricing.It provides assistance and suggestions for the anti-monopoly law enforcement agencies in China to apply the “unfair and high price” clause to regulate the price increase in the field of API.