Study On Tort Liability For Drug Clinical Trials

The introduction of new drugs is accompanied by huge economic and scientific value,while drug clinical trials are highly risky and essential.Subjects in drug clinical trials,with their limited knowledge and financial resources,must confront the risks of such trials,and their rights and interests are in dire need of protection.Subject protection,as a wide dimension research topic,requires the joint investment of scientific research in all fields.How to construct a reasonable tort liability system for drug clinical trials through legal theory research.This paper tries to seek answers from the field of tort liability in civil law and provide ideas for the protection of subjects’ private legal rights and interests.The first part of this paper discusses the scope of tort liability subjects in drug clinical trials.The intricate legal bond between the various participants in drug clinical trials necessitates the identification of them,which is the basis for the study of tort liability.It clarifies the legal relationship and rights and obligations between the subjects,divides the scope of subjects,and sorts out the ideas for subsequent research.The core of tort liability law,the imputation principle,is discussed in the second part.This principle reflects the basic idea and legislative policy orientation of civil law,and establishes the constitution of tort liability,the burden of proof,the condition of exemption,the principle of damage compensation,and the application of it to drug clinical trials.other aspects.Drug clinical trials are characterized by high risk,unknown,etc.The author compared the different influences of various imputation principles,combined with it is proposed that the concept of tort liability for drug clinical trial infringement be established,no-fault liability should be applied to non-therapeutic trials,and presumptive fault liability should be utilized to identify the characteristics of such infringement,the rapeutic clinical trials.The third part focuses on the constitutive elements of drug clinical trials,a special type of infringement.The theories involved are complicated,and it needs to be matched with the characteristics of drug clinical trials infringement through a large number of comparison and analysis.In this paper,the infringement of drug clinical trials is divided into several types,and it is believed that objective criteria should be used to judge whether the doer is at fault in principle,and the probability theory should be applied to determine the causality of drug clinical trials infringement cases.The fourth part involves the final issue,namely the liability assumption.This paper analyzes and concludes that there are four kinds of exemption causes in the tort,namely Subject recognition,irresistible,others’ fault,own fault.All kinds of liability bearing methods of tort liability are discussed.It is difficult to absolutely apply any method to protect the rights and interests of subjects.In order to ensure substantial fairness,rules such as break-even and equity principles should be reasonably applied.