China is a multi-ethnic country with a large population offering unique human genetic resources. International cooperation in the field of human genetic resources is increasing. Therefore, the collection, preservation, and usage of human genetic resources are very important for China. Against this background, China’s State Council, the country’s top administrative authority, issued the Regulation of Human Genetic Resources (the “Regulation”) on 28 May 2019.
In 1998, Interim Measures for the Management of Human Genetic Resources (“1998 Interim Measures”) was issued by the Human Genetic Resources Management Office. As the 1998 Interim Measures were issued by a ministry-level authority, they are relegated to a lower legal hierarchy compared to measures issued by the State Council and laws issued by the Standing Committee of the People’s Congress. This means that do not contain adequate authority within the relevant legal hierarchy. It only has 12 clauses briefly specifying the responsible department and application documents for international cooperation and transfer of human genetic resources abroad.
It has been more than 20 years since the 1998 Interim Measures came into effect. The 1998 Interim Measures have not perfected the allocation of legal liability, i.e. who is the responsible person/party and what liabilities are to be assumed, and contain a vague penalty clause. Penalties have only been imposed in three cases since the 1998 Interim Measures were issued, although interesting these have all been in recent years (2015, 2016, and 2018), which is perhaps indicative of the growing significance and use of human genetic resources.
Moreover, the existing management system has problems such as unclear responsibilities of all involved parties and an inadequate hierarchical framework with respect to management.
Regulation of human genetic resources
As a result of these issues, the State Council, issued the Regulation on 28 May 2019. The Regulation, which came into effect on 1 July 2019, replaces the 1998 Interim Measures and is significantly more detailed (including 47 clauses). It aims to:
(1) effectively protect and reasonably use human genetic resources and
(2) safeguard public health, national security, and public interests.
What are human genetic resources?
For the first time, the Regulation formally defines “human genetic resources.” Under the Regulation, the term “human genetic resources” includes the “materials of human genetic resources” and “information on human genetic resources.” The term “materials of human genetic resources” means genetic materials such as organs, tissues, and cells which contain human genomes, genes, and other genetic substances.
- Restrictions on foreign entities
- Transferring Chinese human genetic data out of China
- Increasing penalties for violations
- Impact on relevant businesses