The Regulations on the Management of Human Genetic Resources, which will come into force on July 1, will strengthen the management of human genetic resources and encourage their rational use.
The document, issued by the Chinese Government, stipulates the management of Chinese human genetic resources, including their collection, preservation, utilization, as well as the provision of such resources in China to overseas parties. In particular, it specifies the conditions to meet and procedures to go through in order to get administrative approval where necessary for the collection and preservation of genetic resources, and for international cooperation involving such resources.
However, even after the promulgation of these regulations, people are still worried about international cooperation involving human genetic resources since such resources differ from other natural resources in that they are of great significance for understanding life and pathogenesis, developing disease prevention and intervention strategies, and promoting population health. The abuse of genetic resources as weapons will lead to a crisis for the human race.
The Chinese Government has always attached great importance to the protection and proper utilization of human genetic resources. In 1998, it formulated the Interim Measures for the Administration of Human Genetic Resources, specifying strict measures governing the collection, preservation, and utilization of Chinese human genetic resources, and the provision of such resources in China to overseas partners.
However, illegal activities involving human genetic resources have not been eliminated. For example, in July and February of 2017, the bioRxiv website and Science Data respectively published an article analyzing the genetic and evolutionary characteristics of the Chinese population based on the largest Han genome data to date. However, neither the authors of the two articles nor other main researchers involved are Chinese scholars. That is to say, there is an illegal outflow of human genetic data from China. More worrisome is that in November 2018, the first genetically edited human babies, a pair of twins, were born, revealing illegal practice of an individual Chinese medical practitioner, which was strongly criticized by medical and legal professionals.
In addition to illegal activities involving human genetic resources, problems have occurred in authorized international cooperation. In January 2018, the Ministry of Science and Technology revoked the administrative license it had granted to two human genetic resource projects. One is a joint research project between Shanghai Jiao Tong University and the University of California, Los Angeles, on the genetic alignment of serious mental illness in the Han Chinese population. The other is a joint research project between Peking University and the University of Oxford on the causes and genetic basis of major depression among Chinese women. The two projects were revoked on the ground that they violated laws and rules.
The Regulations on the Management of Human Genetic Resources are designed to address the problems exposed during the implementation of the Interim Measures for the Administration of Human Genetic Resources, and to meet further social and economic needs.
China, with about 1.4 billion people from 56 ethnic groups, is endowed with invaluable human genetic resources. When it comes to international human genetic cooperation, projects must be selected in a prudent way ensuring that genetic resources are effectively protected. International cooperation in this field should focus on studying pathogenesis, promoting health, and enhancing research and development capability.
To prevent illegal international activities involving human genetic resources, the Regulations on the Management of Human Genetic Resources stipulate that foreign organizations, individuals and the institutions established or actually controlled by them shall not collect or preserve Chinese human genetic resources within the territory of China, nor shall they provide Chinese human genetic resources to overseas parties. Also, if foreign entities need to utilize Chinese human genetic resources for scientific research, they shall abide by Chinese laws, administrative regulations and relevant government policies, work in collaboration with Chinese scientific research institutions, universities, medical institutions and enterprises, and obtain permission from administrative departments.
However, the punishments specified in the regulations, including meting out fines and noting the misdeeds on the perpetrators' credit records, do not seem to be harsh enough to deter violations.
Supervisory authorities may need to consider more measures to ensure the legitimacy of international cooperation. Moreover, it may be necessary to include penalty clauses for violations in the Criminal Law.