Research On The Composition Of Civil Liability For Adverse Drug Reaction

Adverse drug reactions have special characteristics that are different from drug damage.It is difficult to apply the existing legal system of drug harm to the determination of their civil liability.In judicial practice,the lack of corresponding legal norms often leads to different judicial Chaos.This article aims to point out the problems of civil liability for adverse drug reactions under the regulatory system of drug marketing license holders,clarify the corresponding legal relationship,and try to reshape the theory of civil liability for adverse drug reactions.The first chapter mainly defines the adverse drug reactions,and puts forward the problems of the civil relief under the drug marketing authorization holder system and the justification of the relief.First of all,according to the legal definition of adverse drug reactions,they should be distinguished legally by type.Secondly,by comparing the differences between the civil liability for adverse drug reactions under the original regulatory system and the drug marketing authorization holder system,the civil liability for adverse drug reactions in China shows that the subject of liability is more unclear and the principle of imputation is more chaotic.The second chapter analyzes the legal relationship of adverse drug reactions under the drug marketing authorization holder system,and concludes that the nature of its civil liability involves contract liability and tort liability.Contract liability is specifically manifested as actual breach of contract liability,injurious payment liability and post-contract liability,while tort liability is specifically represented as product liability,medical damage liability and general personal damage liability,however,the above nature of the liability is identified or there is a theoretical flaw,There are difficulties in practice.First,the actual liability for breach of contract,liability for damages,and post-contract liability are difficult to apply to different types of adverse drug reactions.Secondly,according to the definition of adverse drug reactions,there are no defects in the drugs that have adverse reactions,and there is a sequential double standard theory,a non-sequential double standard theory,and a single standard of unreasonable danger.This view makes its applicable product liability controversial.Thirdly,in terms of medical damage liability,adverse drug reactions do not constitute medical technology damage liability,and in most cases do not involve medical ethical damage liability,and the dispute over its applicable medical product liability is similar to the analysis of product liability.Finally,if general liability for personal damages is applied,it is difficult for victims' civil compensation rights to be effectively protected due to the principle of imputation that is not conducive to the victims and the rules of the burden of proof.The third chapter mainly discusses who should bear civil liability and what kind of civil liability to bear in the case of adverse drug reactions under the drug marketing authorization holder system.In the event of adverse drug reactions,the holder of the marketing authorization should be in the legal position of the subject of the first civil liability,bear the liability for drug infringement of drug adverse reactions,and follow the principle of presumption of fault,which is not only consistent with the theory of civil liability,but also convenient for practical operating.The fourth chapter introduces the main components of the liability for infringement of adverse drug reactions.First of all,in the case where the holder of the marketing authorization bears infringement of adverse drug reactions,a typed distinction is made on its corresponding reasonable attention obligations,which mainly include the obligation to explain and supplement,the obligation to follow up and observe the drug after it is marketed,and the obligation to recall.Secondly,for the proof of causality,the market share should be used to determine the theory of causality and the theory of presumed causality in Germany.Finally,the waiver of drug marketing license holders was reshaped,that is,the qualification of drugs does not indicate that they are not defective,the time cut-off of the development risk defense is extended,and the marketing license holders are required to assume fair responsibility for no adverse adverse reactions.