China’s Implementation Rules on the Administrative Regulations on Human Genetic Resources (hereafter referred to as HGR Implementation Rules or the Rules), declared by the Ministry of Science and Technology (MOST), took effect on July 1, 2023.
The HGR Implementation Rules is supplemental to and aligned with the superior law and regulation issued previously:
Biosecurity Law of the People’s Republic of China (enforced on April 15, 2021);
Administrative Regulations on Human Genetic Resources of the People’s Republic of China (also known as HGR Administrative Regulations) (enforced on July 1, 2019).
The above law and regulation left the pharmaceutical industry with ambiguity about the definitions of human genetic resource information and foreign stakeholders. Both are now more clearly addressed by the HGR Implementation Rules.
The Rules also alleviates some administrative burden by waiving application requirements for biopharmaceutical researchers and clinical trial sponsors in certain scenarios. It also sets obligations for stakeholders who use HGR.
1. Definition of Human Genetic Resource
According to the Rules, human genetic resource (HGR) information includes human gene data, genomic data, and other information generated during the use of HGR materials. HGR information excludes clinical data, imaging data, protein data and metabolic data.
The exclusion makes the definition more precise than that in the HGR Administrative Regulations enforced in 2019. Thus, companies may rest assured that the HGR Implementation Rules are not enforced on them if they do not use the information that belong to the defined scope.
2. Definition of Foreign Stakeholders Who Use HGR
The Rules states that only Chinese scientific research institutes, higher education institutions, healthcare institutions, and companies are allowed to collect and preserve China’s human genetic resources, or provide the sources abroad.
The Chinese entities include those based in Hong Kong SAR and Macao SAR with investment from and actual control by organizations of the Chinese mainland.
As for foreign-invested companies based in China, they will be categorized as foreign entities if they meet any of the following four conditions:
Overseas organizations or individuals hold or indirectly hold more than 50% of the shares, equity, voting rights, property shares, or other similar rights & interests of the organization;
Overseas organizations or individuals hold or indirectly hold less than 50% of the organization's shares, equity, voting rights, property shares or other similar rights & interests, but their voting rights or other rights & interests are sufficient to dominate or impact the institution's decision-making, management, and other actions;
Overseas organizations or individuals, through investment relationships, agreements, or other arrangements, are sufficient to dominate or impact the institution's decision-making, management, and other actions;
Other circumstances stipulated by laws, administrative regulations, and rules.
As per the above definition of foreign entities, part of foreign-invested companies in China can still collect and preserve HGR resources as long as the Chinese side takes the actual control of the corporations.
However, international biotech companies should also be aware that their activities may be limited by the Foreign Investment Negative List issued by the National Development and Reform Commission and the Ministry of Commerce. The list bans foreign investment towards the development & application of diagnostic & therapeutic technologies involving the use of human stem cells and genes, though the specific technologies are not particularized.
Thus, with the HGR Implementation Rules and other related regulations in consideration, companies need to weigh up the foreign share in financing.
3. Waiver of Certain Applications for HGR Collection
China requires administrative approval for HGR collection, but waives the requirement for the following scenarios:
HGR collection for high blood pressure, diabetes, red-green color blindness, or hemophilia.
HGR collection for clinical trials for China’s marketing authorization of drugs and medical devices.
4. Obligations of Foreign Stakeholders in International Research
To carry out international scientific research using Chinese HGR, foreign stakeholders should ensure that their Chinese partners, including institutions and researchers, substantively engage in the whole process of research.
Foreign stakeholders should share relevant rights & interests with Chinese partners, keep China HGR-generated records and data open to the Chinese partners, and provide backups to them.
Apart from the key points above, the HGR Implementation Rules stipulates that an online platform for requesting HGR administrative approval should be established by competent administrations led by MOST, with detailed guidance documents expected to be rolled out later.
Contact BaiPharm if you’d like to keep updated and compliant with China pharmaceutical regulations.
