Research On The Related Legal Liability System Of Drug Safety In China

In recent years,the illegal and criminal activities in the field of drug safety in China have been difficult to prohibit,and safety incidents have occurred frequently,which has seriously endangered the life and health of the people and the harmony and stability of the society.In order to solve the drug safety problem,the government has adopted a number of measures such as amending laws and regulations,increasing supervision and inspection,and administrative accountability.However,due to the fact that some fundamental problems still remain in the legal liability system of drug safety,which lead to the lack of motivation for honesty and law-abiding among various market subjects represented by enterprise entity,the problem of drug safety is still not effectively solved.At present,China is in the critical period of drug safety legislation.The purpose of the thesis is to start from analyzing the legal liability system of the drug safety market subjects and combine the specific case analysis to find out the problems existing in China’s drug safety legal liability system,and put forward specific solutions to these problems which can be used for drug legislation departments and professionals in decision-making.The thesis mainly studies the following contents:Firstly,the thesis reveals the particularity of drug safety which is different from other safety systems based on the relevant theories of law and economics.Starting from the definition of drug safety liability system,the thesis expounds the basic theories of structure,characteristics and functions of drug safety liability system.Secondly,the thesis analyzes the problems in the legislation and practice of drug safety liability in China through the semantic analytical method,comparative research method and case analysis method.It is believed that the root cause of the market failure of drug safety in China lies in the imperfect legal liability system from the perspective of legal system.The specific performance is as follows:First,in general,China has long been focused on administrative liability in drug safety management,but lacks adequate attention to criminal liability and tort liability,and lacks effective incentives and constraints on market subjects,which has greatly weakened the effectiveness of drug safety supervision.Second,from the perspective of the specific legal liability setting,the main problems in administrative liability are:The division of liability for fake and inferior drugs is unreasonable,the punishment for illegal acts is insufficient,the key responsible persons’ liability is not carried out,and the incentive mechanism is not reasonable.The main problems in criminal liability are:There is a deficiency in the role of drug safety in criminal liability,the regulation of criminal liability for drug safety in the Criminal Law is not perfect,and the connection mechanism of execution between administrative law and criminal law is not perfect.The main problems in drug safety tort liability are:The definition of drug defects is not reasonable,the system of compensation for damages is not effective to protect the victims.These problems have weakened the effectiveness of the legal system in combating and curbing illegal acts,resulting in the lack of motivation for enterprises to abide by the law,and the problem of drug safety in China has not been effectively solved.Thirdly,the thesis conducts a relatively systematic study on the drug safety legal liability system of developed countries represented by the United States,Germany and Japan through the literature research method,and summarizes the characteristics of drug regulatory legal liability and tort liability in developed countries and their enlightenments to China.Finally,by learning from the successful experience at home and abroad and combining with the reality of our country,the thesis puts forward the suggestions for perfecting China’s drug safety legal liability system:to further improve administrative liability,to strengthen criminal liability,and to further improve drug tort liability.The main innovations of the thesis are as follows:Firstly,the thesis is system-oriented,and regards the drug safety legal liability system as a comprehensive system consisting of administrative liability,criminal liability and tort liability.It comprehensively applied relevant theories of law,economics,etc.,and takes the legal liability of market subjects in drug safety management as the main line,and systematically expounds the basic theories of the structure,function and characteristics of the drug safety legal liability system.It fills the theoretical gap in the research on the legal liability system of drug safety.Secondly,the thesis analyzes the experience of foreign drug safety liability system construction and the problems of drug safety liability system in China comprehensively and systematically.It also puts forward the thought and concrete measures of perfecting the legal liability system of drug safety in our country,which overcomes the lack of systematic and comprehensive research on the legal liability for drug safety in the current academic circles.Thirdly,in view of the shortcomings of qualification penalty system in the field of drug safety in China and drawing lessons from the ban system in the United States,the thesis proposes to expand the scope of qualification penalty,and further perfect he subject of law enforcement,subject of responsibility,scope of punishment,scope of punishment,discretion,information disclosure,termination of qualification penalty and sanction measures for violation of qualification penalty.Fourthly,the thesis analyzes the deficiencies of the incentive mechanism in the design of drug regulatory legal liability in China by comparing the heavier punishment and exemption circumstances on the legal liability of drug administration between China and developed countries,and proposes specific suggestions for improving the current incentive mechanism for administrative legal liability.Fifthly,the thesis analyzes the shortcomings of criminal liability for drug safety in China by comparing the differences in the establishment of criminal liability for drug safety between China and developed countries,and put forwards the way to reconstruct the criminal liability system.From the perspective of the liability subject,the legal liability of drug safety includes two aspects:the legal liability of market subject and the legal liability of government supervision.Both are essential for drug safety.However,due to limited time and energy,the thesis only discusses the legal liability of the market subject,and the legal liability of government supervision needs to be compensated in the follow-up study.