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中国基因治疗中人类遗传数据的法律地位和完善路径。

The Legal Status and Improvement Path of Human Genetic Data in Gene Therapy in China.

机构信息

School of Law, Renmin University of China, Beijing, China.

School of Law, Jinan University, Guangzhou, China.

出版信息

Hum Gene Ther. 2024 Aug;35(15-16):520-526. doi: 10.1089/hum.2024.097. Epub 2024 Jul 31.

Abstract

In the legal context of Chinese law, genetic data are an object of complex rights. At the level of private law, genetic data contain personal information, thus being protected by the Civil Code and the Personal Information Protection Law. At the level of public law, genetic data are important genetic resource that embody both public and national interests, which should also be regulated by public laws such as the Biosecurity Law and the Data Security Law. The recently issued have refined the approval and record procedure, in order to promote the utilization of genetic data in China. At present, China still lacks sufficient protection for genetic data privacy, and the "informed consent" and "anonymization" system cannot work effectively. On the path of improvement, we should break constraints of individualism and start from the following three levels to strengthen genetic data privacy protection: formulating specialized legislation and leveraging the functions of group organizations and public interest litigation systems.

摘要

在中国法律的法律语境中,遗传数据是一种复杂权利的对象。在私法层面,遗传数据包含个人信息,因此受到《民法典》和《个人信息保护法》的保护。在公法层面,遗传数据是重要的遗传资源,体现了公共利益和国家利益,也应该受到《生物安全法》和《数据安全法》等公法的规范。最近发布的法规细化了审批和记录程序,以促进遗传数据在中国的利用。目前,中国对遗传数据隐私的保护仍然不足,“知情同意”和“匿名化”制度也无法有效发挥作用。在改进的道路上,我们应该打破个人主义的限制,从以下三个层面出发,加强遗传数据隐私保护:制定专门立法,并发挥团体组织和公益诉讼制度的作用。

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