传染病病毒样本及基因序列数据获取的国际法规制  

Regulation of International Law on Access of Infectious Disease Virus Samples and Genetic Sequence Data

作　　者：冯洁菡 赵思涵 FENG Jiehan;ZHAO Sihan

机构地区：[1]武汉大学国际法研究所

出　　处：《武大国际法评论》2022年第2期79-97,共19页Wuhan University International Law Review

基　　金：国家社科基金一般项目“后TRIPS时代知识产权全球治理体系变革与中国因应方略研究”(项目批准号:18BFX157)和国家社科基金重大项目“重大突发公共卫生事件中的国际法问题研究”(项目批准号:20&ZD201)的阶段性成果。

摘　　要：对传染病病毒样本及病毒基因序列数据的获取应当主张主权权利加以严格限制,抑或作为公共资源实现开放共享,发展中国家和发达国家对此存在较大争议。以承认主权权利为基础的《生物多样性公约》和《名古屋议定书》中的“遗传资源”定义适用于传染病病毒样本,并以事先知情同意和共同商定条款保证公平合理的惠益共享,可确保样本获取的可追溯性,维护国家生物安全,矫正发展中国家在全球医药开发与获益中的弱势地位,且符合当前各国立法实践趋势。病毒基因序列数据是一种抽象的虚拟排列信息,《生物多样性公约》中的“遗传资源”定义是否适用存在争议,目前各国对规范病毒基因序列数据的获取也尚无统一的立法模式。考虑到基因序列数据获取和流动的特点,更适宜通过公共数据库、签署数据库授权许可使用协议等开放形式确保获取的可控制性。There exist great conflicts between developing and developed countries on whether the access of infectious disease virus samples and genetic sequence data should be strictly restricted by claiming sovereign rights or be approached as open sharing public resources.Based on recognizing sovereign rights,the definition of genetic resources prescribed in Convention on Biological Diversity and Nagoya Protocol applies to infectious diseases virus sample,and assures equitable benefit sharing by prior informed consent and mutually agreed terms.The claim of sovereign rights could ensure the traceability of sample access,safeguard national biosafety and correct the vulnerable position of developing countries in the global medical development and benefit sharing,in accordance with current state practice.Virus genetic sequence data is an abstract and virtual arrangement information and it remains controversial whether Convention on Biological Diversity is applicable.Besides,there is no unified legislative model to regulate the access of virus genetic sequence data in state practice currently.Considering the characteristics of access and transferring of genetic sequence data,it is more suitable to ensure the controllability of access through open forms such as public domain database,signing database authorization and license agreements.

关 键 词：传染病病毒样本 基因序列数据 主权权利 生物多样性公约 名古屋议定书 

分 类 号：D99[政治法律—国际法学]