일본「재생의료안전법」이 한국 생명윤리 관련 규제에 주는 시사점

Abstract

There is a rising interest on Japanese regenerative medicine act while preparing for legislation on cell therapy in Korea. Regenerative medicine means medical practice to regenerate structure or function of human body and tissue through cell therapy. The purpose of legislation in Japan is not industrialization and deregulation but ensuring safety and reinforcement of regulation. Japanese “Act for Ensuring Regenerative Medicines Safety” is stricter in verification of safety than Korean “Bioethics and Safety Act”. Treatment and Research proposal review procedure is three different types depending on risk of cell. Risky cell such as embryonic stem cell is required high standard. Japanese act is characterized accrediting system, strict constitution and establishment requirement, strong exclusion of conflicts of interest for review board. The act applies to using cell irrespective of purpose such as treatment or research. All case is reported to Ministry of Health, Labour and Welfare. The ministry regulates even minimally manipulated somatic cell injection because it is close to experimental procedure or study. It is mandatory for cell culture-processing establishments to be authorized. In Korea, legislation on cell therapy is needed urgently. Because cell therapy is not legalized and regulated. For ensuring safety, customized regulation defending on risk of cell has to be established. In addition to Ethicality, regulation on efficacy should be considered.