Study On Protection Of Subjects’ Rights And Interests In Drug Clinical Trials

Over the past century,modern medicine has developed rapidly all over the world.Clinical trials of drugs play an important role in the process of new drug research and development.For some European and American countries with developed pharmaceutical industry,they often have a relatively sound system to protect the legitimate rights and interests of drug clinical trial subjects.As a developing country,China’s modern medicine started late and its development is relatively backward,which also determines that the issues related to the protection of subjects’ rights and interests in drug clinical trials in China are often ignored.However,in recent years,thanks to the continuous innovation-driven development strategy,China’s pharmaceutical industry has been developing rapidly,and the capacity of new drug research and development has been greatly improved.At the same time,the number of drug clinical trials is gradually increasing,and the number of subjects is also increasing sharply.Therefore,in view of the current situation,how to standardize drug clinical trials by law with higher standards and protect the legitimate rights and interests of subjects has become an urgent problem to be solved.However,since drug clinical trials started late in our country,the legal formulation is not perfect,and there are often various problems of legal application in judicial practice.First of all,in terms of legislation,there is no special legislation on drug clinical trials in our country.The protection of the subjects is mostly seen in some departmental regulations.The related provisions are also mostly principled provisions which are not strong operability.Secondly,in terms of judicial practice,due to the lack of clear provisions in laws and regulations,the court will handle most cases related to drug clinical trials according to the general medical act tort.Although drug clinical trials and medical behaviors have similarities,they are different in nature.In reality,if medical damage compensation is applied to the infringement of drug clinical trials,it is difficult to effectively protect the rights and interests of the subjects.At the same time,there are also some problems in judicial practice,such as confusion in the application of the principle of attribution,difficulty in determining causality,insufficient protection of subjects’ informed consent right,and timely and effective relief when subjects’ rights and interests are damaged.In view of the above problems,on the basis of balancing the interests of various parties,combining relevant cases,referring to the practices of some advanced countries in the field of drug clinical trials,and based on our national conditions,the following suggestions are put forward: Firstly,it is necessary to establish clear and standardized principles of accountability.We need to improve relevant legislation to ensure that courts have legal basis when handling relevant cases.At the same time,attention should also be paid to distinguishing different types of drug trials in order to apply different attribution principles;Secondly,it is necessary to classify and simplify the identification of causal relationships.Drug clinical trial infringement cases often have the characteristics of complexity,complexity,and strong professionalism.Reducing the difficulty of identifying causal relationships can to some extent reduce the burden of proof on the subjects,which is more conducive to protecting their legitimate rights and interests;Thirdly,it is necessary to strengthen the protection of the subject’s right to informed consent.Improve laws and regulations on the protection of subjects’ right to informed consent,add more actionable relief clauses,and strengthen the review and supervision functions of the ethics committee;Fourthly,establish a mandatory insurance system for drug clinical trials.Providing timely and effective compensation to subjects in the event of damage,to a certain extent,reduces the occurrence of litigation,reduces time and financial losses,and also reduces the risk of compensation for applicants and researchers.