임상시험과 환자를 위한 구체적 의료행위의 구분기준에 관한 고찰 ‐ 대법원 2010. 10. 14. 선고 2007다3162 판결에 대한 비판적 검토를 중심으로 ‐

Abstract

Decision No. 2007Da3162 held by the Korean Supreme Court on Oct. 14, 2010established its own criteria for separating clinical trials from individual medical practices by legally defining “clinical trials” as “any human subject research whose safety and efficacy have not been sufficiently verified by knowledge and experiences at the time of commencement of the research.” According to this criteria, Off-Label Use of marketed pharmaceutical products could be considered as “clinical trial” if relevant safety and efficacy have not been sufficiently verified. However, current medical society has broadly taken advantage of Off-Label Use of marketed pharmaceutical products for the health of their patients. Furthermore such drug use cannot be interpreted as legally prohibited under any current regulations and even can be legally required considering physicians’ responsibility to provide their best medical treatment to patients. Nevertheless, the Korean Supreme Court’s “sufficient verification of safety and efficacy” standard would impose on physicians not only excessive procedural burden such as preparation of clinical trial protocol and collection of relevant materials required under the KGCP for the Korean Food and Drug Administration’s clinical trial approval but also potential criminal punishment arising from not performing such procedural requirements under the Pharmaceutical Affairs Act, in case of Off-Label Use. Considering relevant regulations and preexisting case laws,advanced country’s practices, physicians’ legal responsibility to provide their best medical treatment to patients, nature of medicine and appropriate scope of clinical trials, the Korean Supreme Court’s “sufficient verification of safety and efficacy” standard hardly seems to be proper construction of laws. In this context, the primary criteria for separating clinical trials from individual medical practices should be “the main purpose of provided medical activities.” And “the main purpose of provided medical services” can be determined based on review of various circumstantial aspects of such medical services’ performances. The potential problems caused by reckless use of drugs whose safety and efficacy are not properly verified could be resolved by imposing strict professional duty of care on physicians, denying claims of relevant medical service fees and punishing drug manufactures who produce and distribute pharmaceutical products without relevant product licenses, not by unreasonably broadening definition of clinical trials to concrete medical practices for individual patients.