中国个人基因组数据共享的规制失效及其完善路径

The Regulatory Failures and Improvement Methods for Sharing Personal Genomic Data in China

摘要:

基因测序技术的更新迭代催生消费型基因检测行业和个人基因组数据的大量生成，个人基因组数据的共享成为检测机构获取收益的重要方式，也是促进基因组学研究和医药产品研发的重要推动力。然而，当前我国对基因组数据的各类法律规制措施都缺乏对其特殊性的关注，检测机构能轻松取得消费者的知情同意，并采取无效的匿名化措施获取个人基因组数据的所有权或控制权。缺乏对检测机构共享基因组数据的有效规制会引发个人、群体和国家层面的多重风险，并导致利益分配不均和风险防控义务失衡。为促进个人基因组数据共享并控制多重风险，应引入利益平衡原则来完善知情同意原则，并将基因组数据共享的收益主要用于消除或降低个人基因组数据共享所带来的多重风险。以此为基础构建的基因组数据共享机制，能真正实现安全与利用并重的数据使用原则，保护数据主体的基本权益，发挥基因组数据共享对科技创新的促进作用，促进我国基因检测行业的良性发展。

Abstract:

The rapid advancements in genomic sequencing technology have led to the emergence of a commercial testing industry and the generation of vast amounts of personal genomic data . The sharing of personal genomic data has become a crucial means for testing companies to gain profits, and is also a fundamental element in advancing genomics research and pharmaceutical product development. However, in China, the current legal regulations governing genomic data often overlook its unique characteristics, leading to significant challenges. Specifically, genetic testing companies are able to frequently secure informed consent from consumers with relative ease, allowing them to gain ownership or control over personal genomic data through invalid anonymization measures. This regulatory gap poses serious risks at multiple levels—individual, group, and national—resulting in an unequal distribution of benefits and imbalances in the obligations for risk prevention and control. In order to facilitate the sharing of personal genomic data and mitigate multiple risks, the principle of balancing interests should be introduced. This principle would enhance the informed consent process, ensuring that the benefits derived from genomic data sharing are primarily employed to mitigate the multifaceted risks associated with such sharing. On this basis, improving the mechanism for genomic data sharing can help establish comprehensive lifecycle management for genomic data, promote its sharing, eliminate associated risks, and protect the rights of data subjects. This will further drive scientific and technological innovation and industry development in the field of genomics.