2019.06.21 DONG, Xiao (Marissa)、GUO, Jinghe、DONG, Junjie
On May 28, 2019 the State Council published the Regulations for the Management of Human Genetic Resources (the “Regulations”), which will come into effect on July 1, 2019. Key elements of the Regulations are summarized as follows.
Article 2 of the Regulations defines human genetic resources (“HGR”) as including HGR materials and HGR information. “HGR materials” include genetic materials that contain human genomes and genes, such as organs, tissues and cells. “HGR information” refers to data derived from genetic resource materials.
Articles 11 and 12 of the Regulations provide for the conditions for the collection of HGR of important genetic genealogy or in specific regions, and include relevant requirements for the protection of privacy, reiterating that such collection is subject to approval by the Ministry of Science and Technology (MST).
Articles 13 to 16 address the conditions and security requirements for the storage of HGR and provisions of basic platforms for scientific research, including that they should be approved by the MST, and comply with various requirements including passing ethical review.
Article 7 of the Regulations stipulates that foreign organizations, individuals and institutions established or controlled by foreign organizations, individuals and institutions (“foreign parties”) are prohibited from collecting and storing China’s HGR within China or from exporting them overseas. Article 21 further provides that foreign parties that utilize Chinese HGR to conduct scientific research are required to do so in collaboration with a Chinese partner.
Article 22 further provides various conditions for international cooperation and that international cooperation involving Chinese HGR should be approved by the MST. International cooperation to obtain marketing approval for drugs and medical devices does not require approval, but should be filed with the MST.
Article 27 of the Regulations stipulates that the export of Chinese HGR for the purposes of international research cooperation or other special purposes requires an export certificate from the MST.
The Regulations provide new requirements for HGR information. Specifically, the provision of HGR information to Foreign Parties or making it available to the general public requires:
(a)A security review organized by the MST, if it may affect public health, national security or the public interest; and
(b)Record-filing with the MST (Article 28).
Since HGR information is included within the definition of HGR, it is unclear how the above requirements will coordinate with the approval requirements for HGR as referred to in Sections 3 above.
Other noteworthy provisions of the Regulations include:
(a)Article 3 provides for exceptions to the application of the Regulations, such as the collection and storage of HGR for purposes such as clinical treatment, blood collection and supply, and the investigation of crimes, which should be conducted in accordance with the relevant laws and regulations. However, it remains to be clarified whether the relevant international cooperation and export of HGR for the above listed purposes are also exempted from the Regulations.
(b)HGR are prohibited from being sold, although payment for or collection of reasonable costs for the provision and use of HGR for scientific research is not considered buying and selling (Article 10).
(c)Prior to the implementation of the Regulations, the legal liabilities provided for violations of the earlier HGR regulations remain general, and any punishment was imposed on the basis of other regulations. With the introduction of the Regulations, companies found to be in violation may now face fines of up to ten million RMB.
Compared with the previous Interim Measures for Management of Human Genetic Resources (1998) and the related implementation guidelines, the Regulations take a more systematic and comprehensive approach to regulating the collection, storage, usage and export of HGR. They specify the relevant legal liabilities and also provide clear provisions for the storage and export of HGR information. However, certain provisions remain to be clarified in practice, such as the exceptions to the provisions for approval for international cooperation, and the application of fines.