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An Analysis On Dispute Between Ran,Li And George Company Etc Over Liability Of Clinical Trial For Drug

Posted on:2021-03-26Degree:MasterType:Thesis
Country:ChinaCandidate:Y Q LiFull Text:PDF
GTID:2506306122972279Subject:Master of law
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With the rising demand for drugs and the development of medical care,more and more new drugs and treatments are coming out.As a necessary link in the process of biomedical science and technology,drug clinical trials are different from the general medical behaviors and have inevitable high risks.At present,there is no specific legal standard for drug testing,and there are many urgent problems to be solved in legal liability.The dispute between Ran,Li and George Company is a typical case caused by the damage of subject in clinical trail for drug.There are three core points of dispute in this case: whether there is a contractual relationship between the subject and George Company;whether George Company should be liable for damages for breach of contract;the scope of compensation.First of all,the legal relationship between the three parties in drug clinica l trials must be clarified.The essence of the relationship between the sponsor and the researcher is entrustment.In therapeutic clinical trials and non-therapeutic clinical trials,the legal relationship between the researcher and the subject is differen t depending on subject’s physical condition.There is a contractual relationship between the sponsor and the subject.Secondly,The imputation principle of drug clinical trial contract is Strict Liability principle.In the informed consent,George Company promises to insure the subjects.This insurance can be construed as an accident insurance with the subject as the insured intended to compensate the subject.But George Company actually failed to fulfill this obligation,which constituted a breach of contract and caused damage to the subject’s property.So its behavior conforms to the constitutive requirements of the liability for breach of contract.Finally,Compensation for breach of contract should be limited while following the principle of full compens ation.The failure of George Company to comply with its obligations prevented the subject from receiving the insurance benefits,and the loss is within the range foreseen by George Company.Therefore,the subject’s loss should be compensated.In addition,in order to solve the clinical disputes in practice and protect the legitimate interests of the subjects,we should improve the protection system of subjects’ rights and interests by perfecting the subject compensation mechanism and strengthening the perfo rmance of the obligation of informed notification in the future.
Keywords/Search Tags:clinical trial for drug, informed consent, liability for breach of contract
PDF Full Text Request
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