Research On The Rights And Interests Protection Of Drug-testees

Clinical trial of drugs is the essential process before the new drug is available. There are more than800kinds of new drugs being tested clinically in China, which involves more than500,000people, who are so-called drug-testees. However, due to the relevant laws and regulations are deficient, it is very difficult for testees to claim for compensation once they are hurt by the test. So the protection of testees’rights and interests is increasingly focused by the media and the public.I have two aims to write this article. One is to appeal to legislate on relevant laws and to improve relevant regulations by certain departments. The other is to provide some workable ways to protect testees’rights and interests.The following are analyzed based on three drug-test claim cases in law, using theoretical analysis, empirical analysis and comparative analysis. Firstly, relevant knowledge of clinical trials of drugs is introduced. Secondly, primary rights and interests of drug-testees in clinical trials of drugs are analyzed. Thirdly, informed consent,, liability for breach of contract caused by the test, and the shortcomings of legislation in the liability for breach of contract caused in clinical trials of drugs are analyzed. Fourthly, tort liability caused by the test and the shortcomings of legislation in the tort liability caused in clinical trials of drugs are analyzed. Fifthly, we’d like to compare and analyze how to apply liability of contract and tort liability to protect the rights and interests of drug-testees from five aspects such as constituent elements of responsibility, the scope of compensation for damages, the burden of proof, the limitation of action and jurisdiction limits.The above analyses suggests as following:Firstly, research and test units should sign clinical trials protocols with the subjects. Secondly, we should set up the Oversight Committee that is independent of research and test units. Thirdly, liability without fault must be put into effect to drug-test damage compensation. Fourthly, drug-testees must be granted compulsory insurance, and we should establish drug-test insurance mandatory filing system. Only in this way, can drug-testees’rights and interests be effectively guaranteed; at the same time, can the research and development of new drugs be carried on smoothly. There are two innovation points in this article. The first is that this article breaks through the traditional understanding of informed consent in theory, and point out that the right to know exist through the whole process of clinical trials of drugs,, and the certain period time after drug-test is included. The second is that research on legal system has been combined with concrete application, workable proposals have been put forwarded.