CAJ | 학술논문

合法的药品临床试验亦有可能对受试者造成损害,发生损害时申办者和研究者应承担何种侵权责任,这是不可回避的问题.《中华人民共和国侵权责任法》第五章规定了产品责任,第七章规定了医疗损害责任包括医疗产品侵权责任,但对于药品临床试验的侵权责任性质没有专门予以规定.笔者认为,药品临床试验与临床医疗行为虽然往往都是以患者为对象,但行为的法律性质不同.由于在药品临床试验过程中参与者的地位各异,所承担的法律责任必然存在区别.分析相关法律关系和法律规定,当对受试者造成损害需要承担侵权责任时,申办者应承担产品责任,研究者承担医疗损害责任.只有这样才能最大限度地保护受试者的利益,也维护药物临床试验各方参与者的合法权益.
합법적약품림상시험역유가능대수시자조성손해,발생손해시신판자화연구자응승담하충침권책임,저시불가회피적문제.《중화인민공화국침권책임법》제오장규정료산품책임,제칠장규정료의료손해책임포괄의료산품침권책임,단대우약품림상시험적침권책임성질몰유전문여이규정.필자인위,약품림상시험여림상의료행위수연왕왕도시이환자위대상,단행위적법률성질불동.유우재약품림상시험과정중삼여자적지위각이,소승담적법률책임필연존재구별.분석상관법률관계화법률규정,당대수시자조성손해수요승담침권책임시,신판자응승담산품책임,연구자승담의료손해책임.지유저양재능최대한도지보호수시자적이익,야유호약물림상시험각방삼여자적합법권익.
Legitimate clinical trials of drugs may cause injuries for participants as well. It is inevitable for drug sponsors and researchers to bear some particular tort liabilities when medical injuries occur. The PRC Tort Liability Law outlines in its fifth chapter the product liability, and prescribes in its seventh chapters the tort liability for medical injury compensation including product liability, but it does not specify the nature of the tort liability for clinical trial of drugs. The author of this paper argues that the legal nature for drug clinical trial is different from that of clinical treatment although both have patients as the object of their study or treatment. Legal liabilities should differ for different parties involved in drug clinical trials due to their different status. Drug sponsors should be subject to product liability while researchers are subject to medical injury liability. Only this can maximize the protection of the interests of the participants in the drug clinical trial.