英国执行EUTCD的经验和启示--兼谈中国干细胞疗法监管科学框架

摘要

the United Kingdom's efforts made and success obtained in the legislations and enforcement of EUTCD, have important reference value for China in the establishment of legal system of human tissue and cells, the development of regulatory science, effective governance for the chaos of 'stem cell therapy' in China. Based on case studies, the paper introduces and analyzes the basis, the basic system and the mode of operation of British Human Tissue A ct, and conceives of the framework of regulatory science for stem cell therapy in China, which shall include scheduled regulatory objectives and long-term strategy, the science of legislation, institutional culture, regulatory regime and enforcement mechanisms, the industry governance, and ethical - legal issues for patients' advocacy as well.%英国为执行EUTCD在立法和执法上所作的努力及其所获得的成功，对我国建立人体组织细胞法律制度、发展监管科学、有效治理“干细胞治疗乱象”具有重要的借鉴价值。本文在实证的基础上，经过分析和介绍英国《人体组织法》的基础、基本制度和运作方式，设想中国干细胞疗法监管科学的框架应包括监管的目标和长远战略、科学立法、制度文化、监管体制与执法机制、行业治理、患者维权的伦理-法律问题等。