On October 17, the Standing Committee of the People’s Congress adopted a new law titled People’s Republic of China Biosecurity Law (“Biosecurity Law”).  The main purpose of China’s Biosecurity Law is to safeguard Chinese human genetic resources by providing comprehensive rules for their collection, preservation, utilization and provision.  The emphasis on security of human genetic resources in China is nothing new.  Indeed, on May 28, 2019, the China’s State Council promulgated the amended Human Genetic Resources Administrative Regulations (“Human Genetic Resources Regulations”), replacing the previous interim measures and took effect on 1 July 2019.  The new Biosecurity Law will take effect on April 15, 2021, and along with the already implemented Human Genetic Resources Regulations, will have significant implications on how clinical trials can be conducted in China.  Below, in a question and answer format, we are summarizing how these regulatory requirements can impact the way clinical trials are conducted in China. 

• What are “human genetic resources”?

Human genetic resources are divided into two subcategories, including:

• Human genetic materials, referring to genetic materials such as organs, cells and tissue that contain the human genes and the genome;
• Human genetic information, referring to information and data generated from human genetic materials.

The human genetic information generally is subject to lower regulatory requirements compared to human genetic materials in terms of cross-border transfer. You need to decide first which subcategory the human genetic resources at issue falls into before identifying compliance requirements. The process is usually straightforward, with human genetic materials usually in the form of substances and human genetic information mostly generated in an electric form.

• How will the Human Genetic Resources Rules affect your studies in China?

If you are a pharmaceutical company, medical laboratory, research institution, contract research organization or a data management service provider rendering service to the foregoing, the Human Genetic Resources Rules likely already affected your businesses or research projects in China.

Under the Human Genetic Resources Rules, a foreign party, including foreign organization and individual as well as their controlled entity (such as a foreign-invested company established in China), is not allowed to collect, utilize, preserve or export (collectively as “process”) Chinese human genetic resources all by itself. Instead, it has to collaborate with Chinese partners. In other words, you will not be able to process Chinese human genetic resources without partnering with a Chinese entity. In addition, depending upon the type of research activities you intend to carry out, you need to either seek an approval or a record-filing in advance with the China Human Genetic Resources Management Office (“CHGRMO”) operated within the Ministry of Science and Technology.

• What regulatory procedures are required to process Chinese human genetic resources?

As a general rule, carrying out scientific researches and studies in China that involve the processing of Chinese human genetic resources require an prior approval from the CHGRMO, with an exception that the performance of clinical trials in China for the purpose of obtaining marketing authorization for a drug or medical device only requires completing a prior record-filing with the CHGRMO, provided that no human genetic materials (but only human genetic information) will be exported from China.

• Can the prior approval and record-filing requirements be exempted?

A few exceptions to the prior approval and record-filing requirements are clinical diagnosis and treatment activities, blood collection and supply services, investigation of crimes or law violations, doping detection and funeral and interment activities. For instance, in cross-border telemedicine activities where the patient’s human genetic information will be transferred to the foreign medical institution for second opinions, prior approvals and record-filing requirements as provided under the Human Genetic Resources Rules are not applicable.

• Can the foreign party have 100% ownership on research achievements?

Under the Human Genetic Resources Regulations, where a patent application is filed as a result of an international scientific research and study using Chinese human genetic resources, the application must be jointly filed by both the Chinese party and the foreign party and patent rights will be jointly owned by both parties. The co-ownership requirements generally apply to fundamental scientific studies towards the Chinese human genetic resources per se. Clinical trials initiated by a foreign sponsor and conducted in China seeking commercialization of a drug or medical device would not fall into such scope. Therefore, clinical trial data/results in relation to the efficacy and safety of a particular drug or medical device manufactured by the foreign sponsor would not be subject to the co-ownership requirement and can be solely owned by the foreign sponsor.