欧盟人类遗传资源生物库政策框架及现状

Analysis on policy framework of human genetic resources biobank in EU and its development

人类遗传资源科学管理和合理使用，对于政策决策者和科研人员尚属全球性新课题。为支持科研人员进行生物医学研究，部分国家建立了生物库，用来收集人类遗传资源、生物样本和相关数据，以系统方法进行组织和储存。欧盟及其成员国在建立和开发生物库资源平台方面领先全球，支持了大量科研项目并投入巨额资金支持相关计划和项目。其目标是将所有欧洲生物库进行网络联系，逐步形成泛欧洲的研究资源平台。目前，欧盟的生物库管理在法律、伦理、操作规程、公众接受和利益分享机制等方面还存在诸多挑战。汇总了欧洲整体生物资源管理和使用的政策建议和有益经验，以期对国内同行有所借鉴。

It is a new field for global policy makers and researchers to scientifically manage and rationally use the human genetic resources. In order to support biomedical researches some countries have set up biobanks by collecting and storing human genetic resources, samples and data systematically. European Union and its member states are forerunners in establishing and developing platforms of human genetic resources by huge investment to support a large amount of projects and initiatives, which aim at integrating the existing biobanks in Europe to form a uniform platform across the European continent. However, a number of challenges are faced by EU in terms of legal, ethical, operational aspects, as well as public acceptance and interest-sharing mechanism of such a platform. This article summarizes some policy suggestions and best practices in management and use of human genetic resources in Europe as a whole.