China details implementation rules of human genetic resources management
Published: Jun 02, 2023 10:34 PM


China's Ministry of Science and Technology has announced detailed rules for the implementation of regulations on the management of human genetic resources, which will take effect from July 1. The rules stipulate that overseas institutions or individuals are prohibited from collecting or storing human genetic resources in China or transferring resources overseas.

The collection and preservation or the provision of China's human genetic resources abroad must be carried out by Chinese scientific research institutions, colleges and universities, medical institutions or enterprises, according to the rules, which were published on the ministry's website on Thursday.

Overseas organizations and individuals, and institutions established or controlled by foreign stakeholders, are not allowed to collect and preserve Chinese human genetic resources inside China or provide Chinese human genetic resources outside the country, the rules stipulate.

Overseas organizations and individuals, and institutions established or actually controlled by foreign stakeholders include those that directly or indirectly hold more than 50 percent of the shares, equity, voting rights, property shares or other similar rights and interests of the institution; those whose voting rights or other rights and interests are sufficient to dominate or exert a significant influence on the decision-making, management and other behaviors of the institution; or those able to dominate or exert a significant influence through investment relationships, agreements or other arrangements, according to the rules.

Institutions established in the Hong Kong and Macao special administrative regions and actually funded and controlled by domestic finance are regarded as Chinese entities, the rules clarified.

The rules came four years after China's regulations on the management of human genetic resources took effect on July 1, 2019. They are aimed at enhancing management over human genetic resources and promoting effective protection and rational utilization of the resources in the country, the ministry explained on its website.

They also optimized the requirements and process for applying for administrative licenses for activities involving human genetic resources. For example, it clarified that human genetic resources refer to the genetic materials, such as organs, tissues and cells that contain hereditary substances such as human genome and genes, excluding clinical data, imaging data, protein data, and metabolic data.

International cooperative clinical trials conducted in China for the purpose of obtaining China's marketing authorization of relevant drugs and medical devices, which would use China's human genetic resources but do not involve the export of the resource materials, do not need to apply for the relevant license, according to the rules.

Global Times