China issues guidelines on genetic resource management
By Liu Yang, Zhao Jing
The Ministry of Science and Technology and the Ministry of Justice on Wednesday answered questions from the press. The draft regulations were reviewed at an executive meeting of the state council on March 20, 2019, and will be taking effect on July 1.
The Deputy Minister of the Ministry of Science and Technology Xu Nanping said human genetic resources are strategic resources. We are still studying the origin of life and disease prevention, and human genetic resources play an important role in further research. Biotechnology is one of the frontiers of technological innovation. China is vying to improve the quality of health for the people.
In recent years, human genetic resources are increasingly becoming an important strategic resource, which is of great significance for safeguarding public health, national security, and social and public interests. China has a large multi-ethnic population with unique advantages of human genetic resources, which provides unique conditions for the development of life sciences and related industries. However, with the development of the situation, some new situations and problems have emerged in the management of human genetic resources in China. The rights and interests of Chinese units are not guaranteed in the international cooperative scientific research using Chinese human genetic resources. Illegal outflow of human genetic resources occurs constantly; the interim measures can no longer meet the needs of management, and there are some problems such as not having a high enough legal level, not having a sound legal responsibility, not having clear provisions on punishment, not having clear responsibilities of all parties in the actual work, and not having proper hierarchical management.
In 2018, the Ministry of Science and Technology received more than 28 hundred applications, of which 85 percent have been approved, all applications were approved within 20 days, the fast approval rate is to enhance the international cooperation.
In 1998, the Interim Measures for the Management of Human Genetic Resources jointly formulated by the Ministry of Science and Technology and the Ministry of Health.
The regulation will further simplify the approval process, related drugs and medical devices, and clinical research work. Those that don't involve the exit of human materials go abroad do not need to be examined and approved but need to be put on record for management, to speed up the process. In addition, in the management process, the management of the website combined with new requirements, strengthen the construction of e-government. It is convenient for applicants to work online and use the Internet to handle and approve normative matters. Publish the text of the guide and demonstration for appliers to take as reference.
The regulation says the state supports the rational use of human genetic resources to carry out scientific research, develop the biomedical industry, improve diagnosis and treatment technology, improve China's capacity for biological security, and improve people's health care. The collection, preservation, utilization and external provision of human genetic resources shall not endanger the public health, national security and social public interests of China, and shall comply with ethical principles, protect the legitimate rights and interests of resource providers, and comply with the corresponding technical specifications; The sale or purchase of human genetic resources shall be prohibited.
The provision or use of human genetic resources for scientific research in accordance with the law and the payment or collection of reasonable costs shall not be regarded as the sale or purchase of human genetic resources; Those who carry out biotechnology research and development activities or carry out clinical trials shall abide by the relevant laws, administrative regulations and relevant provisions of the state on the administration of biotechnology research and clinical application; Fourth, in the interim measures for preservation, the examination and approval of the collection and preservation of Chinese human genetic resources, the use of Chinese human genetic resources for international cooperative scientific research and the exit of human genetic resources materials shall be clarified, and the examination and approval conditions and procedures shall be improved.