论医学人体试验中的侵权责任——以比较法为视角

On the Clinical Trial Liability——In a Comparative Law Aspect

当前我国立法与司法未对医学人体试验侵权责任与医疗损害责任加以区分,对其归责原则和因果关系也有不同认识。在美国,法院渐趋认可人体试验侵权责任为独立诉因,在过错和因果关系的认定上,则分别有主观说和客观说等不同的观点。大陆法系国家中,法国将人体试验侵权责任作为一种特殊侵权,并区分治疗性试验和非治疗性试验分别适用过错责任原则和无过错责任原则。德国将人体试验作为一般过错侵权,并在涉及药品的案件中适用产品责任。荷兰将人体试验侵权责任作为一种独立的侵权责任,并适用过错责任原则。晚近的立陶宛《生物医学试验法》规定了人体试验侵权的无过错责任。我国应当构建独立于医疗侵权责任的人体试验侵权责任,其归责原则为过错责任原则。在因果关系问题上,应当采取相当因果关系、疫学原理因果关系以及因果关系推定理论来进行综合判断。

In the legal practice in China presently, the courts do not to distinguish clinical trial liability from medical malpractice. They also have different opinion on the causation and nature of the liability. In the United State, courts tend to treat the clinical trial liability as a distinct cause of action. In some case, the cause of action can also be battery or lack of informed - consent. A- mong civil law countries, loi Huriet - S6rusclat of France considers experimentation liability as a special tort; meanwhile the Ger- man law treats it as negligent malpractice. The Dutch Biomedical Research Involving Human Subjects Act takes experimentation liability as a special tort of negligence. The Law on Ethics of Biomedical Research of Lithuania sets up a strict liability model. An clinical trial liability as distinct from medical malpractice should be established in China. It shall be a type of negligence tort. Nonetheless, the burden of proving the investigator＇ s breach of duty shall be shifted to the defendant. The causation of the dama- ges may be found as consitio sine qua non, or by theory of epidemic causation.