Research On Legal Regulation Of The Price Monopoly In Pharmaceutical Industry In China

Under the background of market economic system reform,the market-oriented reform of China's pharmaceutical industry is also developing in a deeper direction.In 2015,China's drug market was further liberalized.As a result,China has established a market-oriented drug price formation mechanism.Under this background,competition in the pharmaceutical industry will intensify and price monopoly will become more frequent,resulting in greater supervision pressure.Nowadays,although China has issued the Guidelines on Price Behavior of Drug Shortage and crude drug,the Guidelines do not cover the whole drug field and have not risen to the level of law,so they have certain limitations.As a kind of special commodity,medicine is related to the life and health of the broad masses of people.How to regulate the price monopoly in the pharmaceutical industry under the existing environment is of great significance.In view of the particularity of the pharmaceutical industry,this paper comprehensively applies the research methods of comparative analysis,historical analysis,case analysis,normative analysis and empirical analysis.From the perspective of the legal regulation system of the pharmaceutical industry,taking the manifestation of drug price monopoly as the core,and focusing on the current regulatory situation in China,it studies the problems existing in the current regulatory situation in China.Some suggestions are put forward in order to create a fair and orderly competition environment for China's pharmaceutical industry.First of all,this paper takes the general theory of the legal regulation of price and price monopoly behavior in the pharmaceutical industry as the main line,and analyzes the related concepts,monopolistic behavior,monopoly causes and the theoretical basis of regulation.For the relevant market,China mainly considers factors such as drug function and doctor's prescription from the perspective of demand substitution.;in the monopolistic behavior,from the field of raw materials and pharmaceuticals,the field of finished medicines,the field of bidding,and the field of drug procurement under the GPO model.The typical form of drug price monopoly behavior in the five fields of drug procurement in public medical institutions starts from the analysis of the main body,content and consequences of China's monopolistic behavior.In the cause,it analyzes the exclusivity,low demand elasticity,and diversified subjects.In the theoretical basis,from the three theories of effective competition theory,market failure theory and government failure theory,the deep reasons of regulation are analyzed.Secondly,This paper analyzes the American model and the EU model and brought some inspiration to China.In the US model,the legal regulation of price monopoly behavior in the US pharmaceutical industry has gone through the process from common law to special law.The United States defines the relevant market for drugs as a drug for treating certain symptoms,while pharmaceutical companies use reverse payment agreements and product hopping to conduct price monopoly.In the EU model,the EU legal regulation of price monopoly behavior in the pharmaceutical industry has also gone through the process from common law to special law.The EU has considered information economics and behavioral economics when defining relevant markets.Then use the delayed payment agreement and the patent long-term strategy to monopolize the drug price.Finally,this paper takes the status of the legal regulation of price monopoly behavior in China's pharmaceutical industry as the starting point,and analyzes the current legal regulation in China,then this paper put forward five questions including the unclear division of the functions of the drug regulatory market and anti-monopoly law enforcement agencies,the high barriers to entry of generic drugs into the market,and the GPO Group procurement model,the lack of anti-monopoly guidelines for drug patent monopolies,and the monopoly of public hospitals to promote drug price monopoly.based on the problems reflected in the previous article,combined with the specific situation of China,the paper proposes five suggestions including establish a coordination mechanism between the pharmaceutical industry regulatory authorities and the anti-monopoly law enforcement agencies,improve reimbursement catalogues and compulsory licenses to promote the development and reform of generic drugs.Bidding methods and fair competition review to standardize the GPO procurement model,formulate anti-monopoly guidelines for the pharmaceutical industry,and eliminate the price monopoly of public hospitals through three medical linkages.Based on the above ideas,this paper systematically studies the price monopoly behaviors of the pharmaceutical industry from four levels: theoretical overview,foreign experience,problems and suggestions.