In Part A of this series, we discussed how to identify the related parties (especially the foreign entities) which may be involved in the Chinese human genetic resources (“HGR”) activities in the eye of the Ministry of Science and Technology of the PRC (the “MOST”), the authorized governmental authority to supervise and administer the HGR practice in China. In this Part B, we will clarify how to identify HGR materials based on the HGR regulations and our experience.
Under the Chinese HGR regulatory regime, collection, storage, utilization and provision to foreign entities of Chinese HGR shall comply with HGR related regulations (mainly including the Biosecurity Law and the Administrative Regulations on Human Genetic Resources (“HGR Regulations”)). According to the HGR Regulations, HGR includes HGR materials (“HGR Materials”) and the information generated from the HGR Materials (i.e. HGR information). HGR Materials refer to genetic materials such as organs, tissues and cells that contain genetic substances such as human genomes and genes. Due to the complexity of the actual situation, whether certain materials will be regarded as HGR Materials is controversial in practice.
I. Key Issues
1. Examples of HGR Materials under HGR Regulations
According to the relevant guidelines of the HGR Regulations issued by the Human Genetic Resources Administration of China (“HGRAC”), which is the internal office of the MOST and authorized to handle the filing and approval matters of HGR, the HGR Materials include without limitation the following samples: whole blood, serum, plasma, urine, stool, blood cells, cerebrospinal fluid, bone marrow, bone marrow smear, blood smear, tissue section and other samples. It should be noted that any other materials that contain human genetic substances will also be regarded as HGR Materials, no matter whether such materials is included in the above list or not.
2. How to Identify Chinese HGR Materials
The main purpose of the HGR Regulations is to protect the legal utilization of Chinese HGR and to safeguard the public health, national security and public interest of the PRC. Therefore, the HGR Regulations mainly stipulate the requirements and limitations on collection, storage, utilization and provision of Chinese HGR. However, the HGR Regulations keep silent on the meaning and scope of Chinese HGR. Based on our consultation with HGRAC, Chinese HGR may refer to the Chinese individuals’ HGR materials and the information derived therefrom and it appears that HGRAC may tend to identify Chinese HGR based on the nationality of the subject(s) as follows.
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Following the above, the HGR collected from non-Chinese individuals and imported into the PRC for various usage will not be subject to the HGR Regulations[1]. Besides, if the nationality of a Chinese individual has been changed to another country at the time of collection of his/her HGR, such HGR will not be regarded as Chinese HGR in the eye of the MOST in practice.
3. Whether the Microbiomes Collected from Human Skin Fall into the Scope of HGR Materials
The microbiomes collected from the surface of skin are composed of bacteria, fungi and viruses[2]. The microbiomes themselves may not contain any human genetic substance, and thus will not be considered as the HGR Materials under the HGR Regulations. Whether the microbiomes of a natural person is specific to such natural person is irrelevant to the determination of whether the microbiomes should be interpreted as the HGR Materials.
However, the samples to be tested may also include certain skin cells on which the microbiomes may live. Since those skin cells could contain human genetic substance, such skin cells will fall into the scope of the HGR Materials under the HGR Regulations.
4. Exception of the HGR Materials
Though the HGR Regulations did not specify any exception of the HGR Materials, the HGRAC official indicated that in practice, certain cell strains as standard commercialized products will not be regarded as the HGR Materials under the HGR Regulations (e.g. the Hela Cell Lines), whose genetic substance has been changed during the continuous sub-culture process, to certain extent that the genetic trait of the original sample subject no longer exists. Therefore, if any genetic materials can be proved to meet the above-mentioned conditions, such materials will not be considered as the HGR Materials in the view of the HGRAC.
II. Suggestions on Identification of HGR Materials
- Before conducting any clinical study, IIT (i.e. Investigator-Initiated Trials) or other activities that may need to collect human samples, the company shall have a clear view on what kind of samples will be collected and confirm both internally and with the cooperative parties (e.g. the site, CROs) whether HGR Materials will be involved in these activities on a case-by-case basis.
- If the company purchases certain cell strains in China as commercialized products from third party suppliers for any study, it is suggested to confirm with the suppliers whether such cell strains are collected from Chinese or foreigners and require the suppliers to provide evidence (e.g. import declaration documents).
If they are collected from Chinese, the company shall further confirm from technical perspective on whether such products could be interpreted as being sub-cultured and whether they belong to any exception as mentioned in the above item 4. If such cell strains are neither collected from foreigners nor could be interpreted as the exceptions of HGR Materials, HGRAC filing or approval for such study is required.
- For the genetic materials that it is difficult to determine whether they are HGR Materials or not under the HGR Regulations, it is suggested to consult with your legal counsel or the HGRAC on a named basis.
III. Conclusion
The HGR Regulations provide a relatively broad definition of HGR Materials. The companies (including both Chinese entities and foreign entities) that may have access to any human samples or may conduct any activities involving such human samples shall be sensitive and cautious about the identification of Chinese HGR Materials to avoid any non-compliance of the HGR Regulations.
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However, it is worth noting that the import and usage of such non-Chinese’s HGR should be subject to other PRC laws and regulations, e.g. selling certain non-Chinese HGR (e.g. cell, tissue and organ) within the PRC is still prohibited.
“Our skin is home to millions of bacteria, fungi and viruses that compose the skin microbiota.” —— Allyson L. Byrd, Yasmine Belkaid & Julia A. Segre, the human skin microbiome, Nature, January 15, 2018 (https://www.nature.com/articles/nrmicro.2017.157).
