On June 1, 2023, China’s Ministry of Science and Technology issued the Implementation Rules for the Regulations on the Management of Human Genetic Resources. The rules took effect July 1, 2023.
The Implementation Rules for the Regulations on the Management of Human Genetic Resources clarify that human genetic resource information does not include clinical data, image data, protein data, and metabolic data.
On June 1, 2023, China’s Ministry of Science and Technology (“MOST”) issued the Implementation Rules for the Regulations on the Management of Human Genetic Resources (“Implementation Rules”), which came into effect on July 1, 2023. Before the Implementation Rules were issued, the Biosecurity Law, the Regulations on the Management of Human Genetic Resources (“Regulations”) and relevant guidelines issued by the MOST have jointly constructed the overall regulatory framework for supervision and management of human genetic resources in China. The Implementation Rules further clarify the overall framework and specific requirements for supervision and management of human genetic resources in China and provide more detailed compliance guidance to entities seeking to utilize China's human genetic resources to carry out research and other activities.
Highlights of the Implementation Rules
1. Clarification of the scope of human genetic resources information
According to the Regulations, human genetic resources (“HGR”) include HGR materials and HGR information. HGR materials refers to genetic materials such as organs, tissues and cells which contain human genomes, genes and other genetic substances, while HGR information refers to information materials such as data generated from the utilization of materials of human genetic resources. The guidelines issued by the MOST on July 14, 2023 include examples of HGR materials and HGR information, as follows:
HGR materials includes all types of cells, whole blood, tissue/tissue sections, semen, cerebrospinal fluid, pleural/peritoneal effusion, blood/bone marrow smear, hair (with hair follicles), but excludes human secretions, bodily fluids, and swabs that do not contain cells.
HGR information includes gene, genome, Transcriptome, epigenome, ctDNA and other nucleic acid biomarkers and other data information, as well as disease, race and other related information related to this data, but excludes gene information data that do not contain human genetic resources.
The Implementation Rules define the HGR information as human genes, genome data, and other information and materials generated from the utilization of human genetic resource materials. Meanwhile, they clarify that HGR information does not include clinical data, image data, protein data, and metabolic data. MOST previously clarified, in its April 2023 guideline, that collecting, providing or publicizing the following data does not require approval: (1) clinical image data (such as B-ultrasound, CT, PET-CT, nuclear magnetic resonance, X-ray and other video data, intervention, fundoscopy, endoscopy, dermoscopy, pathological diagnosis and other image data) or (2) clinical data that is not involved in population genetic research (such as blood routine, urine routine, liver and kidney function, blood biochemistry, height, weight and other growth and development indicators, questionnaire information, video/image result data, etc.).
2. Foreign entities recognition
Article 21 of the Regulations defines foreign entities as foreign organizations or institutions formed or actually controlled by foreign organizations or individuals. The Implementation Rules specify the scenarios of “actual control,” including:
The foreign organization or individual holds or indirectly holds 50% or more of the shares, equity, voting rights, property shares, or other similar rights and interests of an institution.
The foreign organization or individual holds or indirectly holds less than 50% of the shares, equity, voting rights, property shares, or other similar rights and interests of the institution, but the voting rights or other rights and interests enjoyed by it or him are sufficient to dominate or exert a significant impact on the decision-making, management, and other acts of the institution.
The foreign organization or individual is able to dominate or exert a significant impact on the decision-making, management, and other acts of the institution through investment relations, agreements, or other arrangements.
Any other circumstance prescribed by laws, administrative regulations, and rules.
Note that the Implementation Rules specify that institutions with actual control of domestic investment formed in Hong Kong and Macao shall be deemed Chinese entities rather than “foreign entities.”
3. Scope of collection approval
The Regulations provide that entities collecting China's human genetic resources of “important genetic families” and specific regions, or the collection of human genetic resources of the types and quantities prescribed by the MOST, need MOST approval. The Implementation Rules adjust the scope of the collection that requires approval:
They define “important genetic families” as groups with blood relationships with genetic diseases, special genetic constitutions, or physiological characteristics, with members affected by genetic diseases, special genetic constitutions, or physiological characteristics involving three or more generations, excluding common diseases such as hypertension, diabetes, red-green color blindness, and hemophilia.
They define “human genetic resources in specific regions” as the genetic resources of personnel that live in isolated or special environments for a long period of time and have special physical characteristics or have adaptive traits in physiological characteristics. The division of specific regions may not be based on whether the regions are inhabited by ethnic minorities.
The requirement of specified categories has been canceled. And, the Implementation Rules specify that “The collection of human genetic resources used for large-scale population studies involves more than 3,000 persons. Large-scale population studies shall include but not be limited to cohort studies, cross-sectional studies, clinical studies, and constitutional studies. The collection of human genetic resources involved in clinical trials in order to obtain China's marketing authorization for a relevant drug or medical device shall be excluded, and an application for administrative licensing for the collection of human genetic resources is not required.”
4. Filing requirements for international cooperation
Article 22 of the Regulations provides that “In order to obtain the licensing for the listing of relevant drugs and medical devices in China, the clinical trials conducted through international cooperation at clinical institutions by using China's human genetic resources are not subject to approval provided that they do not involve the transport of materials of human genetic resources out of China. However, the type, quantity and use of human genetic resources to be used shall, before both parties to the cooperation conduct clinical trials, be submitted to the science and technology administrative department of the State Council for recordation.” The Implementation Rules clarify the scenarios that do not need to be approved, including:
The collection, testing, and analysis of human genetic resources involved and the disposal of remaining human genetic resource materials, among others, are carried out in a clinical medical treatment and health institution.
The involved human genetic resources are collected in a clinical medical and health institution and are subject to the testing, analysis, and disposal of remaining samples by the domestic entity designated in the clinical trial plan for the marketing authorization for a related drug or medical device.
Implications for U.S. Higher Education Institutions
In order to ensure compliance with the Regulations and Implementation Rules, U.S. higher education institutions utilizing Chinese HGR materials or information to conduct activities should consider the following:
A U.S. higher education institution, or an entity directly controlled by the U.S. higher education institution (an “affiliated entity”), may not collect or preserve China's human genetic resources within the territory of China or provide China's human genetic resources to entities located outside of China.
If a U.S. higher education institution or its affiliated entity intends to use China's human genetic resources to conduct scientific research, it must work with Chinese research institutions, higher education institutions, medical institutions or enterprises (collectively “Chinese entities”) to get international cooperation approval from the MOST. If the U.S. institution intends to transfer the human genetic resources outside of China, it may either apply for transfer approval at the same time it files for international cooperation approval or submit a separate application for approval before engaging in the transmission of HGR.
U.S. higher education institutions must ensure that Chinese entities and their researchers fully participate in the research throughout the entire cooperative process. All records and data information in the research process, among others, must be completely open to the Chinese entities, and backup must be provided to the Chinese entities. An application for a patent on the results of scientific research conducted through international cooperation by using China's human genetic resources must be jointly filed by both parties to the cooperation, and the patent right shall be jointly owned by both parties.
Any post-approval modification of cooperation partner(s), research purpose, research content, cooperation term, or type, quantity or use of human genetic resources involved in the research program, or applicant, the leading entity, the contract research organization, or the third-party laboratory will require new approval from the MOST.
Both parties must jointly submit a report on cooperative research to the MOST within six months after the cooperation is completed.
If a Chinese partner of the U.S. institution provides China’s human genetic resources to the U.S. institution, the Chinese partner must submit the human genetic resources to the MOST for backup. If it may affect China's public health, national security, and public interest, the Chinese partner must pass the security review.