《民法典》背景下药物临床试验中的侵权责任

Tort Liability in Drug Clinical Trials in the Context of the Civil Code

COVID-19疫情进一步推动了药物临床试验的开展,而此类侵权纠纷的裁判在司法实践中呈现出混乱的状态。在《民法典》出台的背景下,应明确临床试验行为并非诊疗行为,不能适用医疗损害责任规则,需要协调人格权编与侵权责任编的适用,做好受试者、发起人和研究机构之间的利益衡量,全面保障受试者的权益。《民法典》第1008条直接表明了规范对象,却没有规定法律后果,难以单独发挥损害救济作用。另外,不能直接借鉴比较法上适用特殊归责原则的做法,药物临床试验侵权责任的请求权基础仍应是《民法典》第1165条第1款,适用过错原则。在认定侵权责任时还应考量《赫尔辛基宣言》的价值取向,准确认定其中的过错与违法性,可利用盖然因果关系、善良管理人等特殊标准,以平衡当事人利益。

The COVID-19 epidemic continues to drive the development of drug clinical trials,and the adjudication of such tort disputes presents a confusing pattern in judicial practice.In the context of the Civil Code,it should be clarified that the act of clinical trial is not a medical treatment act,and the rules of medical damage liability cannot be applied.It is necessary to coordinate the application of the codification of personality rights and the codification of tort liability,to make a good weighing of interests among subjects,sponsors and research institutions,and to fully protect the rights and interests of subjects.Article 1008 of the Civil Code directly indicates the object of regulation without stipulating the legal consequences,and it is difficult to play the role of damage relief alone.It is not possible to directly apply the practice of special imputation principles in Rechtsvergleichung,and the basis of the claim of tort liability for drug clinical trials should still be Article 1165(1)of the Civil Code,which applies the principle of fault.The value orientation of the Declaration of Helsinki should also be considered in determining the tort liability,and the fault and illegality in it should be accurately determined,and special criteria such as covert causation and good administrator can be used to balance the interests of the parties.