Research On Anti-Monopoly Legal Issues In The API Industry In China

Medicines guarantee the health of human life and are related to national economy and people’s livelihood.APIs are essential materials for the production of pharmaceuticals.The healthy operation and orderly competition of the API industry are the prerequisites for ensuring stable output in the downstream finished pharmaceutical market.In recent years,the monopoly behavior of the API industry has intensified,mainly manifested in price increases and supply interruption,etc.These phenomena not only seriously damage the economic interests of related companies in the API industry,but also cause economic pressure and hidden health risks to patients at the consumer terminal,and also pose challenges to China’s market economy system.Cracking down on monopoly behaviors in the API industry has become the focus of China’s antitrust enforcement in recent years.However,according to the current practice of anti-monopoly law enforcement in API industry,the legal regulation of monopoly behaviors in the API industry still needs to be further explored.Based on the topic selection background,research significance and current research status at home and abroad,this paper identifies the value of the research on antitrust issues in the API industry.Firstly,the paper introduces the basic situation of the API and the industry,and analyzes the causes of monopoly behaviors in the industry from the aspects of economics and law.Secondly,this paper makes a detailed analysis of the forms of monopoly behavior matching with the provisions of the anti-monopoly law in the API administrative enforcement cases in China,and finds that the forms of the API monopoly in China are mainly the traditional monopoly behavior,but also involve the blank areas beyond the legal provisions.Thirdly,through the analysis of the previous two chapters,it is judged that there are theoretical and practical difficulties in the three major aspects of the determination of the monopoly conduct constituents,the realization of sufficient evidence,and the determination of punishment standards in China’s API antitrust regulation.The cracking of many difficult problems in the process of antitrust regulation of the API industry should focus on the construction of a reasonable antitrust legal system.First,efforts should be made at the legislative level.It is necessary to constantly improve the anti-monopoly legal system,to achieve coordination between anti-monopoly laws and the laws and regulations of the pharmaceutical industry,and to make legislative responses to theoretical difficulties encountered in the process of law enforcement.Secondly,at the level of law enforcement,it is necessary to adhere to the leading position of the StateAdministration for Regulation,coordinate with industry regulatory agencies,and jointly strengthen the level of law enforcement.Thirdly,actively explore the construction of anti-monopoly judicial system and supporting systems for anti-monopoly civil litigation and anti-monopoly civil public interest litigation,and make up for the defects of anti-monopoly on API in the judicial level.Finally,it is necessary to strengthen anti-monopoly active compliance construction,actively guide to conduct compliance self-discipline,and industry associations to actively carry out supervision.