Study On Legal Problems Of Tort Liability In Chinese Drug Clinical Trials

Human medical trials are highly risky,but human medical trials are the only way for new drugs to enter the market.They can not be omitted and can not be ignored.At present,China's drug clinical trial tort liability in the legislation,there is no drug clinical trial infringement of the special legislation,departmental regulations too administrative,substantive protection is insufficient.On the judiciary,judicial authorities have not enough understanding of the particularity of drug clinical trial infringement cases,the principle of imputation is not uniform,causality is found to be different,and the burden of proof is unknown.The lack of relevant laws makes the issue of infringement caused by clinical trials of drugs in our country unsolved and the rights and interests of the subjects can not be effectively protected.In view of the present situation of infringement of drug clinical trials in our country,taking the theory of drug clinical trials as the starting point,it is divided into two categories: therapeutic and non-therapeutic according to the subjects of each phase of drug clinical trials.Based on this,we can make a classification of the principle of imputation in our country's drug clinical trials.Through the discussion of the principle of fault,no-fault,fair responsibility and negligence presumption,different principle of imputation is applied to the classification according to the difference of non-therapeutic and therapeutic subjects of drug clinical trials.To study the constitutional elements and exemptions of drug clinical trial infringement,summarize the types of drug clinical trial infringement,identify the fact of infringement damage,ascertain the rules of causal relationship of therapeutic trial of infringement,and affirm the fault of tort liability of therapeutic clinical trial.The identification of tort liability in clinical trials should be divided into non-therapeutic and therapeutic clinical trials.Non-therapeutic clinical trial tort liability should be based on the principle of liability should be no fault liability,therapeutic clinical trial tort liability should be attributed to the principle of presumption of fault.Clarification of causation of causation in infringement of therapeutic trials should adopt causal causality rules,and the determination of the fault of tort liability in therapeutic trials should be based on objective criteria.