China\u2019s Ministry of Science and Technology (MOST) has issued the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” [HGR Rules], effective from July 1, 2023. These new Rules update the earlier “Regulations on the Management of HGR” [HGR Regulations] released in 2019, impacting several key clauses and providing clarity on foreign collaborations in genetic research within China.<\/p>\n\n\n\n
Key Updates to the HGR Regulations:<\/strong> Redefining Foreign Parties and Human Genetic Resources:<\/strong>
The new Rules require foreign parties to cooperate with a Chinese partner when collecting or preserving Chinese HGR materials within China. This includes executing cooperation agreements that address ownership of intellectual property (IP) rights, benefit sharing, confidentiality, and other arrangements. Prior approval from MOST is also required for using Chinese HGR materials in international scientific research collaboration or transferring Chinese HGR materials or information abroad. Any patents resulting from international collaboration using HGR materials must be co-owned and jointly filed with the Chinese partner.<\/p>\n\n\n\n
The new Rules refine the definition of “Foreign Parties” to include entities established or under the “actual control” of a foreign entity or individual. “Actual control” is defined as an entity where a foreign party directly or indirectly owns 50% or more of the equity, voting rights, or other similar, or where the foreign party has significant control or influence over the entity\u2019s decision making, even if not holding a 50% or more stake. HGR information is now defined as “human genes, genome data, and other information generated using HGR materials,” excluding clinical data, imaging data, protein data, and metabolic data.<\/p>\n\n\n\n