Legal gaps in the regulation of xenotransplantation using genetically engineered pigs: A case study of the South Korean legal framework
Jungbeen Lee1, Hyunji Jeon1, Ivo Kwon1.
1College of Medicine, Ewha Womans University, Seoul, Korea
This study identifies and analyzes regulatory shortcomings in South Korea's legal framework concerning xenotransplantation research utilizing genetically engineered pigs. Focusing on key statutes such as the Animal Protection Act, the Laboratory Animal Act, the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biological Products, and the 2024 Guidelines for the Quality, Non-Clinical, and Clinical Evaluation of Xenotransplantation Products issued by the Ministry of Food and Drug Safety, this study systematically reviews the legal and policy framework applicable to xenotransplantation research. The analysis reveals several critical structural issues, including legal ambiguities surrounding the classification and protection of source animals, the absence of clear criteria distinguishing laboratory animals from livestock, overlapping and vague standards for facility certification, and regulatory gaps concerning the transportation and handling of harvested organs. By highlighting these foundational issues, the study aims to contribute to future interdisciplinary discussions and policymaking efforts that will be necessary for the responsible governance of xenotransplantation and other biotechnology applications involving genetically modified animals.
This work was supported by a grant of the Xenotransplantation Research and Development Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (No. RS-2023-KH136898).