英国执行欧盟细胞指令的经验和启示简

英国为执行欧盟人体组织和细胞三个指令在立法和执法上所作的努力及其获得的成功,对于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,具有重要借鉴价值.在实证的基础上,分析、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,应当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.

British Experience in Implementing EUTCD and Its Implication

The United Kingdom＇s efforts made and success obtained in the legislations and en- forcement of EUTCD, have important reference value for China in the establishment and develop- ment of regulatory science of human tissue and cells, which will provide 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 the Human Tissue Act of 2004, further con-ceives that the Chinese framework of regulatory science for stem cell therapy, shall include sched-uled regulatory objectives and long-term strategy, the science of legislation, institutional culture, regulatory regime and enforcement mechanisms, the industry governance, as well as ethical-legal is-sues for patients＇ advocacy.