人类遗传资源数据共享管理研究及对中国的启示

人类遗传资源对推进生命科学研究和促进医药产业发展具有重要意义。随着精准医学战略的实施和基因编辑技术的不断成熟,各国对人类遗传资源的争夺及其相关科技发展和产业的竞争愈发激烈。经济合作与发展组织(OECD)作为最重要的国际经济组织,其指南的制定通常是围绕各国政府普遍关注的科学进步和科学效率问题,从国家和全球公共利益的角度出发,提出应对技术发展、科研范式变化的方案,近年来美国、日本和英国等发达国家也出台了相应的遗传资源数据共享政策和管理指南。本文旨在通过对OECD提出的人类遗传资源共享指南和以美国、英国、日本为代表的技术发达国家在实践中的管理要点进行分析,为提高中国人类遗传资源共享的监管效力,促进资源的合法共享和有效利用提供参考。

Management of Data Sharing of Human Genetic Resources and Its Enlightenment to China

Human genetic resources are valuable for life science research and pharmaceutical industry.Competitions for human genetic resources and the relevant techniques and industries have increasingly become intense among countries with the the implementation of precision medicine strategy and the maturity of gene editing technology.In the context of scientific progress and efficiency,the Organisation for Economic Co-operation and Development,the most important international economic organization,has proposed solutions to technological development and research paradigm changes from the perspective of national and global public interests.The United States,Japan,the United Kingdom,and some other developed countries have also released their policies and guidelines on the sharing of genetic resource data.In this article we analyzed these policies and guidelines,with an attempt to further improve the administration of human genetic resource sharing in China and promote the legal sharing and effective use of these resources.