Research On The Legislation Of Protecting Health Right Of Drug Testing People In China

Medical clinical human trials are closely related to the health rights and interests of drug testers.Legitimate medical human trials are in line with utilitarian morality and allowed danger theory,and should not be completely prohibited.However,no matter what type of new drug human trials are,we must effectively protect the health rights of drug testers,and safeguard the closely related right to know,the right to make decisions,and the right to claim damages,etc.The relevant legal system must be reasonable,feasible and effective to protect the right to health of the drug testing person."Nuremberg Code" and "Helsinki Declaration" are the two most representative legal documents to protect the health rights and interests of the subjects in the international rules."ICH" and "WHO guidelines for the management of clinical trials of drugs" are the current international common standards for clinical trials of new drugs,On this basis,many developed countries have improved their domestic laws on the protection of subjects’ rights and interests,Among them,the subject protection mode of medical human trial,the standard of right damage identification,the certification system of institutional ethics review committee and the subject relief system adopted by the United States have formed a perfect system,Germany is the first country to formulate the regulations on human body experiments.France has written the responsibility of illegal medical human body experiments into the criminal code.The Netherlands implements the principle of fault liability in the field of human body experiments and improves the third party compulsory liability insurance system.Lithuania implements the principle of no fault liability in the field of compensation for human body experiments.In contrast,the current laws on the protection of the right to health of drug testing people in China are mainly low-level departmental rules.There are many loopholes in the criminal responsibility,administrative responsibility and civil relief of drug testing infringement,which need to be improved through legislation as soon as possible.However,there are many legislative difficulties in the protection of the right to health of drug testing people in our country.The applicable standards of the principle of liability fixation of drug testing infringement are different.There are also theoretical disputes in the academic circles on the recovery of civil legal liability.The unpredictability of medical clinical trials,the numerous links of drug testing,and the complicated regulatory procedures all bring great challenges to the current legislation.In view of these legislative difficulties,it is necessary to establish the negative list of drug human trial under specific circumstances through legislation,such as establishing the prohibition clause of human trial under the condition that the drug toxicity is determined but the curative effect is unknown,and the restriction clause of human trial under the condition that the drug toxicity and curative effect are uncertain;At the same time,it is also necessary to implement the principle of presumption of fault in the field of clinical trial drug infringement,broaden the civil relief path of trial drug infringement,and realize the independence of the claim for compensation for mental damage,so as to improve the realization degree of the choice of the tester;On this basis,it is necessary to realize the independence of medical human test liability as soon as possible,and clarify the criminal liability and administrative liability clauses of drug test infringers;In addition,it is necessary to improve the social relief of the right to health,increase publicity,cultivate a good environment for drug testing,and improve the insurance and relief fund system,so as to relieve the worries of drug testing people participating in medical human trials.