China’s 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.
Key Updates to the HGR Regulations:
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.
Redefining Foreign Parties and Human Genetic Resources:
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’s 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.
International Collaborations and IP Ownership:
The Rules state that any patents resulting from international collaboration must be co-owned by a domestic entity, contrasting with an earlier draft that allowed for contractual mutual determination of IP ownership and profit sharing. Details regarding ownership or profit sharing related to other nonpatent IP are not specified.
Other Key Changes:
The Rules also include measures impacting the collection and storage of HGR, with a narrower scope of collection activities that require permission. Hypertension, diabetes, color blindness, and hemophilia are removed from the regulation of important genetic lineages, and specific collection requirements for rare diseases are adjusted. A security review must be conducted prior to handing HGR information to foreign parties in certain cases, including those involving important genetic families and large-scale genomic sequencing. The Rules also detail MOST’s authority to carry out inspections and enforce the HGR regulations.-Fineline Info & Tech
