Study On The Legal Regulation Of API Industry Monopoly

With the stability of drug prices affects the livelihood of the people,and the stability of drug prices plays a crucial role in the stabilization of drug prices.But in recent years,the monopolistic behavior of API enterprises is becoming more and more intense.API enterprises often drive up API prices by restricting production,refusing to trade,bundling and attaching unreasonable trading conditions,and then grab monopoly profits.The disorderly rise of API prices leads to a sharp rise in pharmaceutical costs of downstream pharmaceutical manufacturers,which not only destroys orderly competition in the API industry and brings serious economic losses to downstream enterprises,but also threatens the lives and health of citizens.Frequent API enterprise monopoly and market structure,sales model,the antitrust legislation,law enforcement has the close relation,only through the enterprise’s own adjustment is not enough to solve the problem of frequent monopoly,therefore,in the aspect of law further regulation is an enterprise which API API enterprise monopoly behavior of the optimal solution.This paper will explain the value of studying the monopoly behavior of API enterprises from the setting,significance and research situation at inland and abroad.The first part of this paper introduces the implementation of the Anti-monopoly Law by API companies,followed by an explanation of the characteristics,forms,causes and hazards of monopolistic behavior by API companies.The second part,from the perspective of different department laws,explains the current situation and deficiencies of Chinese laws on the monopoly behavior of API enterprises.There are conflicts between department laws when anti-monopoly law enforcement agencies determine monopoly behavior of API enterprises.Although China’s laws have made corresponding regulations on the monopoly behavior of API enterprises,There is still a lag in legislation and a low level of related laws,which restricts the execution of antitrust enforcement agencies.The third part will introduce the relevant anti-monopoly law enforcement based on the introduction.the difficulties in identifying the monopoly behavior of API enterprises are analyzed.It is mainly manifested in the following aspects: the determination of rejection of transaction is not accurate enough,the determination of common abuse of dominant market position conflicts,the determination of exclusive transaction and other behaviors cannot be accurately distinguished,the provisions of hub-spoke agreement is not perfect,the reverse payment is not introduced,and the legal liability fails to make up for all losses.In the forth part,the author proposes the relevant supervision measures from the aspects of entity and procedure,in order to offer some practical advice for the regulation of Chinese API companies.