Use of genetic resources regulated
The State Council, China’s Cabinet, has published a regulation on the management of human genetic resources that will take effect from July 1.
The regulation aims to enhance protection of human genetic resources, promote proper use and tighten regulation and supervision, according to a State Council statement yesterday.
Premier Li Keqiang signed a State Council decree to publish the regulation.
According to the regulation, human genetic resources refer to substance containing human genes, such as organs and cells, as well as information about human genes.
The Chinese government will conduct surveys on human genetic resources and introduce a system to record and register major pedigrees in human genetics and those in specific regions, according to the regulation.
Foreign organizations and domestic institutions founded or controlled by foreign entities will have to work with Chinese partners if they need human genetic resources in China for scientific research, the document said.
Any act to make human genetic resources information open to the public or to provide such information to foreign countries should be recorded. Such an act must be subject to a security review if it might affect public health, national security or public interest.
The country supports proper use of human genetic resources for scientific research, development of pharmaceutical industry and medical treatment, the statement said.
Those who collect, store, use and provide human genetic resources in China for foreign entities must not undermine public health, national security or public interests, according to the regulation.
They should follow ethical codes, protect the legal interests of providers and abide by appropriate technical standards, it added. It stated that biological research and relevant clinical tests should comply with Chinese laws and administrative regulations and rules.
The regulation also clarified the procedures for obtaining relevant administrative approvals, entrusted the government departments for science and technology to step up supervision, and enhance the penalties.
Those who store human genetic resources without approval or use them in international researches without approval may be fined from a minimum 500,000 yuan (US$72,500) to a maximum 5 million yuan.
Those who collect human genetic resources without the consent of the provider or cajole the provider into consent may be fined from a minimum 500,000 yuan to a maximum 1 million yuan.
The regulation bans trading human genetic resources. Offenders will be fined a minimum of 1 million yuan to a maximum of 10 million yuan.