China: New regulations for human gene research

Here, Jaqueline Zhao and Tim Jackson discuss the new regulations coming into force for China in 2019, after the gene-editing scandal which created international headlines

The Regulations on Administration of Human Genetic Resources (the “new Regulations”) entered into force on the 1st July 2019. These new Regulations were announced on 28 May 2019 by the China State Council and create a report-and-registration mechanism for research involving human genetics and human genetic resources.

The new Regulations were developed based on the Interim Measures for Administration of Human Genetic Resources from 1998 (the “Interim Measures”) which were not considered to be effective enough to regulate new areas of research in human genetics. The Interim Measures were abolished as of 1 July 2019 when the new Regulations became effective.

It may also be that local and international reaction to Chinese scientist He Jiankui’s claim to have created the world’s first genetically edited babies in 2018 incentivised the development of the new Regulations to make sure that such research is adequately regulated.

China Daily online commented that:

“A declaration jointly signed by 122 Chinese scientists and published online expressed strong opposition to and condemnation of this experiment, calling what He did “crazy”. (1)

Under the new Regulations, foreign entities, and entities founded or controlled by foreign entities or foreign individuals will have to work with Chinese partners if they need human genetic resources from China for scientific research. International cooperation involving research utilizing human genetic resources between foreign and Chinese partners will be subject to approval by the Ministry of Science and Technology (MOST).

MOST approval is not required where international cooperation involving research utilizing human genetic resources between foreign and Chinese partners is for the sole purpose of acquiring market entrance permission of pharmaceuticals and medical devices. However, the case type, quantity, and use, of the human genetic resources needed, must be recorded with MOST and its local counterparts prior to the commencement of the international cooperation.

The actual mechanisms for requesting approval and recording of information with MOST remain to be specified.

The new Regulations also introduce new requirements for making human genetic resource information available to the public or for providing such information to other countries. This will be subject to a security review if it might affect public health, national security or public interest.

The new Regulations also update the requirements surrounding any patent and non-patent rights that are generated using China’s human genetic resources. Any patent applications resulting from collaborative research between a foreign entity and a Chinese entity by utilization of China’s human genetic resources shall be jointly filed and the patent application and ownership shall be shared.

If patent protection is not sought, cooperation agreements to establish the rights of use, assignment and distribution of benefits of the research results by utilization of China’s human genetic resources can be entered into. In the absence of such an agreement, each entity will have the right to use the results and benefits shall be shared according to contribution. Both entities will need to consent to any transfer of the research results to another entity.

Unlike the situation under the Interim Measures, there is no reference to the implementation of the joint patent rights in the Regulations. Therefore, it is open to the patent owners to agree on how the rights granted under the patent can be used. In the absence of such an agreement, the laws of the country involved will apply.

Jacqueline Zhao said:

“While requiring joint patent ownership may appear restrictive, allowing the rights to use the patent to be negotiated is commercially sensible.”

The Regulations grant MOST the right to impose significant penalties for breaching the Regulations, an important advance over the Interim Measures. Under the Regulations:

• anyone who stores human genetic resources without approval or uses them in international research without approval, maybe fined from 500,000 yuan to 5 million yuan (~USD725,000)
• anyone who collects human genetic resources without the consent of the provider or cajoles the provider into consent may be fined from 500,000 yuan to 1 million yuan (~USD150,000)
• anyone who trades in human genetic resources may be fined from 1 million yuan to 10 million yuan (~USD1,500,000).

It is also expected that further legislation will follow which, together with these new Regulations, will form an entire chain of surveillance for research involving human genetics and human genetic resources. This is likely to include, amongst other things, legislation covering safety management in biotechnology research and administrative requirements for clinical application of biomedical technologies.

On a related note, foreign capital investment is prohibited in China for the development and application of human stem cells, and genetic diagnosis and treatment technologies. This is pursuant to the Special Administrative Measures (Negative List) for Foreign Investment Access from July 2018.

In practice, the new Regulations will need to be read in conjunction with related legislation such as this Negative List when considering any targeted investment in this area.

Reference

1. http://www.chinadaily.com.cn/a/201811/27/WS5bfd3203a310eff30328b5a3.html

Jacqueline Zhao

Tim Jackson

IP firm, Rouse