News

Legislation under the Nagoya Protocol in China

by Bin OU (NTD Intellectual Property Attorneys, China)

Recently, the Ministry of Environmental Protection of the Peoples’ Republic of China (“MEP”) released the Administrative Regulations for the Acquisition and Benefit Sharing of Biological Genetic Resources (Draft for Comment) for public comment.

The Draft is made to fulfill the requirements of the Nagoya Protocol and may have substantive effects on various aspects of biological research and development in China.

Specifically, the Draft provides four key systems for the acquisition and benefit sharing of biological genetic resources of China, the key elements of which are summarized below.

i) Differentiated management system. The Draft provides different regulatory measures for Chinese and foreign entities and individuals. Specifically, a foreign entity or individual who wishes to acquire and utilize biological genetic resources of China must undertake a substantive collaboration with a Chinese institution and the collaborative research and development activities must be carried out within China, with substantial participation of Chinese researchers. In addition, the acquisition and utilization by the foreign entity or individual must be approved by the competent authority under the State Council. For Chinese entities and individuals, the acquisition and utilization of biological genetic resources for commercial purposes must be approved by the competent authority under the provincial government, while the acquisition and utilization for academic study purposes only needs to be registered before the competent authority under the county-level government.

ii) Benefit sharing system. According to the Draft, an important point in this system is that China will set up a Biological Genetic Resources Conservation and Benefit-sharing Fund, and 0.5%-10% of the profits from the acquisition and utilization of biological genetic resources must be paid annually to the fund by the entities or individuals who acquire and utilize the biological genetic resources.

iii) International certificate system. As proposed by the Draft, an international certificate may be issued by the MEP upon request on the basis of the approval information from the competent authority of biological genetic resources.

iv) Export control system. The export of the biological genetic resources will be strictly controlled according to the Draft. Specifically, the export of the biological genetic resources must be approved by the competent authority of biological genetic resources under the State Council of China, and the copies of the biological genetic resources to be exported must be deposited in a designated deposit center prior to the export. In addition, a catalogue of export-controlled biological genetic resources will be set up for those important biological genetic resources.

The time window for public comments has closed. We are now expecting the final version of the Administrative Regulations for the Acquisition and Benefit Sharing of Biological Genetic Resources. In addition, other legislation in China regarding genetic resources, such as Administrative Regulations for Human Genetic Resources, is also ongoing, and close attention is needed to these developments.