세포기반 인공혈액 개발연구와 보건의료법체계

Abstract

Research on the development of cell-based artificial blood involves technology for creating transfusion products by differentiating human stem cells into red blood cells and platelets. Cell-based artificial blood could overcome the limitations of the current blood supply system, such as the difficulties in sourcing rare blood types. However, since the research includes various ethical, legal, and social issues, it is necessary to clarify which laws within the health care legal framework apply to artificial blood. Cell-based artificial blood, not being blood cells or plasma collected from humans, does not fall under the definition of ‘blood’ or ‘blood products’ as defined by the “Blood Management Law.” The manipulation and processing beyond a minimal range of living cells categorize it under ‘advanced regenerative medicine’ and specifically as ‘cell therapy’ within the law governing “Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products.” Additionally, if cell-based artificial blood undergoes procedures to ensure safety after physical, chemical, or biological manipulation or production from living human cells cultured or proliferated ex vivo, it can be considered an ‘advanced biopharmaceutical.’ Therefore, under the current legal framework, the development of cell-based artificial blood is subject to different laws at each stage of research and development. At the preclinical research stage, it falls under ‘human materials research’ and is regulated by the “Bioethics and Safety Act.” During the clinical research phase, it is subject to laws related to ‘clinical research of advanced regenerative medicine’ and ‘advanced biopharmaceutical’ clinical trials under the “Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products.” To ensure the safe and efficient progress of cell-based artificial blood development research, it is necessary to clearly define its normative concept and develop specific guidelines reflecting its unique- ness, as well as conduct research on the ethical, social, and legal issues that arise at each stage of research.