国外人类遗传资源监管立法借鉴与启示  

Reference and Enlightenment on the Supervision of Human Genetic Resources from Foreign Legislation

作　　者：安雯婷[1] 谷硕[2] 程淼 郑金[3] 张笑微 冀晓鹏 薛涛[2] AN Wenting;GU Shuo;CHENG Miao;ZHENG Jin;ZHANG Xiaowei;JI Xiaopeng;XUE Tao(Office of Research,the Second Hospital of Hebei Medical University,Shijiazhuang 050004,China;Office of Science and Technology/Center for Humanistic Care and Health Management Innovation,Hebei Medical University,Shijiazhuang 050017,China;Office of Research,the Third Hospital of Hebei Medical University,Shijiazhuang 050051,China;Office of Humanities and Social Sciences,Hebei Medical University,Shijiazhuang 050017,China)

机构地区：[1]河北医科大学第二医院科研处,河北石家庄050004 [2]河北医科大学科技处/人文照护与卫生管理创新中心,河北石家庄050017 [3]河北医科大学第三医院科研处,河北石家庄050051 [4]河北医科大学社会科学部,河北石家庄050017

出　　处：《中国医学伦理学》2023年第7期777-786,共10页Chinese Medical Ethics

基　　金：河北省社会科学基金项目“中外人类遗传资源监管政策法律规制比较研究”(HB21FX004)。

摘　　要：人类遗传资源作为一个国家或地区重要的生物资源,日益受到国际上诸多国家的重视和关注,诸多国家甚至将其上升至国家主权的维度。作为一个拥有着丰富多样性人类遗传资源的大国,中国的相关监管工作相较国外起步较晚,但发展较快。放眼世界,中国的人类遗传资源监管仍然有进一步完善和发展的空间。通过对一些国家人类遗传资源监管立法的考察,详细梳理归纳其先进经验和亮点措施,总结其深层次的立法导向,从人类遗传资源立法位阶高级化和法律效力增强化、政策法规系统化和体系化、平台和相关标准统一化、突出伦理法治理念、强化反歧视保障、重大人遗家系资源和国家特殊保护地区人类遗传资源的特别保护以及设立国际局部地区的人类遗传资源原则性共识或协定七个方面进行了详细分析和评价,以期对中国人类遗传资源监管政策和法律体系的构建提供借鉴。As an important biological resource of a country or region,human genetic resources(HGR)are increasingly attracting attention and concern from many countries internationally,and even have been elevated to the dimension of national sovereignty by many countries.As a large country with rich and diverse HGR,relevant regulatory work in China started relatively late compared to foreign countries,but has developed rapidly.However,looking around the world,there is still room for further improvement and development of domestic HGR regulation.By reviewing the regulatory legislation of HGR in some countries abroad,this paper sorted out their advanced experience and highlighted measures in detail,and summarized their deep-seated legislative guidance.A detailed analysis and evaluation were conducted from seven aspects:the advanced level of HGR legislation and the enhancement of legal effectiveness,the systematization and systematization of policies and regulations,the unification of platforms and relevant standards,the highlight of the concept of ethics and the rule of law,the strengthening of anti-discrimination protection,the special protection of major human genetic family resources and national special protection areas of HGR,and the establishment of principled consensus or agreement on HGR in international and local regions,to provide reference for the construction of regulatory policies and legal systems for HGR in China.

关 键 词：生物资源 人类遗传资源 监管法规 先进经验 

分 类 号：R-01[医药卫生]