줄기세포 치료제의 해외시술에 대한 형사적 책임성부 검토 : 실제 사례분석을 중심으로

Abstract

With the controversy over Dr. Hwang, Woo-suk’s study result on embryonic stem cell around 2005, Koreans’ interest in stem cell research and related treatment naturally increased. This overlapped with the massive interest in biomedical science technology regarding ‘regenerative medicine’, such as the development of cell therapeutics using stem cells, and the accessibility of Korea’s bio industry, especially in relation to mesenchymal stem cell treatment, to its people is getting closer day by day, so much that 4 out of 6 globally authorized stem cell treatments now (as of April 2015) are authorized by MFDS for manufactured goods. However, the mesenchymal stem cell medicine corresponds to drugs under the pharmaceutical law, so it would be applied by the pharmaceutical law and other relative regulations, such as business authorization from the director of MFDS for its production, approval from the director of MFDS for the clinical trial to prove its safety and effectiveness, and manufacture and sales authorization by the director of MFDS, but some stem cell-related companies are practicing illegal treatment procedures by avoiding above regulations. They are having overseas-based medical institutions, which the Korean pharmaceutical law can’t be applied and hence can’t be punished, to perform stem cell treatments that were not proven for its safety and effectiveness, without the authorization of the director of MFDS. There, this study is to examine the current regulation situation of health authorities on the overseas treatment of stem cell drugs by examining the outcome of criminal responsibility, such as violation of pharmaceutical law, through the analysis of the actual relevant cases, and suggest a methodological proposal to solve the problems of incomplete control. Follow-up studies should involve more in-depth discussion and researches.