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药物临床试验,俗称人体试药,是新药研制并上市的必经过程。试药中的受试者,因缺少民事法律规范中专门性、系统性的规定,自身的合法权益常受损害,得不到充分有效的法律保护。司法实践中,法院处理受试者合法权益受损案件,一般适用过错归责原则,由原告即受试者承担举证责任这很难有效保护受试者的利益,因此本文认为应采取举证责任倒置,并区分不同性质的被告承担不同的举证责任。
Drug clinical trials, commonly known as human test drugs, are new drugs developed and listed the necessary process. Due to the lack of specialized and systematic regulations in the civil law norms, the subjects in the test medicine often suffer from the legal rights and interests of themselves and can not obtain full and effective legal protection. Judicial practice, the court dealt with subjects with legal rights and interests in cases of damage, the general application of the principle of fault liability, the burden of proof by the plaintiff that the subject is difficult to effectively protect the interests of the subjects, the paper believes that the burden of proof should be reversed , And to distinguish between different types of defendants bear different burden of proof.