Regulation of Biobank Establishment and Genetic Resource Storage in China

1. Introduction

China regulates biobanks and the storage of genetic resources through a combination of laws governing human genetic resources, personal information protection, biomedical research, biosafety, and medical institutions. A biobank is a facility that collects, processes, preserves, and stores biological materials—such as blood, tissue, DNA, cells, and other human samples—for medical research, diagnosis, and scientific development.

The central objective of Chinese regulation is to protect human genetic resources, prevent unauthorized foreign access, safeguard individual privacy, and ensure that biological materials are used for approved scientific purposes.

The principal legal framework is the Regulation on the Administration of Human Genetic Resources (HGR Regulation), originally adopted in 2019 and amended in 2024, alongside the Biosecurity Law 2020, the Personal Information Protection Law (PIPL) 2021, and relevant biomedical research regulations.

2. Legal Framework Governing Biobanks

A. Regulation on the Administration of Human Genetic Resources

This is the primary instrument governing the collection, preservation, utilization, and international provision of Chinese human genetic resources.

Human genetic resources include:

Human genetic resource materials: organs, tissues, cells, blood, and other biological materials containing human genomes or genes.

Human genetic resource information: genetic data, genomic sequences, and other information generated from those materials.

The Regulation establishes state supervision over the collection, preservation, research use, and international collaboration involving these resources. The Ministry of Science and Technology (MOST) historically administered this framework. Following institutional reforms, the Ministry of Science and Technology's former HGR regulatory functions were transferred to the National Health Commission (NHC) in 2024.

Biobanks must determine whether their activities fall within applicable HGR requirements before collecting or storing human samples. Establishment of a storage facility does not automatically authorize every subsequent research activity.

B. Biosecurity Law 2020

The Biosecurity Law establishes broader obligations relating to biological risks, laboratory safety, and the protection of biological resources. Biobanks must adopt appropriate storage conditions, access controls, contamination-prevention measures, and emergency procedures where applicable.

The law is particularly important for facilities storing infectious materials or conducting research involving biological risks.

C. Personal Information Protection Law 2021

Genetic information linked to identifiable individuals can constitute sensitive personal information. Under the PIPL, processing generally requires a specific purpose, sufficient necessity, strict protective measures, and a lawful basis. Where consent is the applicable basis, separate consent and additional safeguards may be required for sensitive personal information.

Cross-border transfers of personal information may also trigger separate compliance requirements. Permission to store biological samples does not automatically authorize the transfer of genetic data overseas.

3. Establishment and Operation of Biobanks

Chinese law does not create one universal licence that automatically authorizes every type of biobank. The applicable requirements depend on the institution, the materials collected, the research purpose, and the nature of the activities.

Key compliance obligations include:

Institutional authorization: Universities, hospitals, research institutes, and private entities must identify applicable institutional, medical, research, and HGR requirements.

Ethical approval: Human-subject research generally requires appropriate ethics review under applicable biomedical research rules.

Informed consent: Participants must receive relevant information about sample collection, storage, future use, privacy, and any applicable sharing arrangements.

Secure preservation: Facilities should maintain appropriate temperature controls, sample identification systems, access restrictions, inventory records, and emergency procedures.

Controlled research access: Samples and associated data should be provided only for authorized purposes and under appropriate governance arrangements.

4. Foreign Access and International Collaboration

China imposes particular restrictions on foreign access to Chinese human genetic resources. Under the HGR framework, foreign organizations and individuals, and foreign-controlled entities within the applicable statutory categories, face restrictions on independently collecting or preserving Chinese human genetic resources.

International collaborative research may require regulatory approval or filing, depending on the activity. Providing samples or genetic information abroad can trigger additional controls.

The 2024 amendments to the HGR Regulation, effective from 1 May 2024, revised the regulatory framework and its administration. Consequently, researchers must assess the current requirements for their particular activity rather than relying exclusively on the original 2019 rules.

5. Relevant Case Laws and Enforcement

Directly reported Chinese judicial decisions specifically addressing the establishment of a biobank are limited. The following case illustrates the closely related legal principles governing human genetic research.

Case 1: He Jiankui Gene-Edited Babies Case (2019)

In December 2019, the Shenzhen Nanshan District People's Court convicted He Jiankui and two collaborators for illegal medical practice involving human embryo gene editing. He received a sentence of three years' imprisonment and a fine.

Legal significance: The case demonstrated that scientific research involving human genetic material is not exempt from legal oversight. Consent documents or institutional participation cannot, by themselves, legalize activities that violate applicable medical, ethical, or regulatory requirements.

Relevance to biobanks: Although this was not a biobank-establishment case, it illustrates the importance of lawful research purposes, participant protection, and regulatory compliance when human genetic materials are collected or stored for future use.

Case 2: HGR Regulatory Enforcement

China's HGR framework provides administrative enforcement mechanisms for unauthorized collection, preservation, use, or international provision of human genetic resources. Depending on the violation, authorities may order corrective action, confiscate unlawful gains, impose fines, and restrict research activities.

These are statutory enforcement powers rather than a single biobank precedent. Any specific enforcement example should be verified against an official decision before being cited as a judicial case.

6. Conclusion

China's biobank regulatory system combines human genetic resource governance, biosafety, personal information protection, and research ethics. Establishing a facility is only the first step: lawful collection, informed consent, secure storage, authorized research use, and strict control of international access are equally important. The principal challenge is ensuring that scientific development proceeds without compromising genetic privacy, public health, or national biosecurity.