The management of human genetic resources has become stricter, and six companies involved have been fined for violating regulations.

Interim Measures for the Management of Human Genetic Resources1998Year6It has been more than 20 years since its implementation in January. The protection and development system formed by this method has a profound impact on the development of life science and biotechnology in China. With the rapid development of gene technology, the treasure house of human genetic resources has been given new value, and the competition and competition for genetic resources among countries has become more intense.

In the competition and competition for human genetic resources, some enterprises have been criticized and punished by the Ministry of science and technology for violating the relevant provisions of the Interim Measures for the management of human genetic resources.2018Year7In January, the Ministry of Science and Technology punished AstraZeneca, Eide Biology and Kun Hao Ruicheng Pharmaceutical Research and Development Co., Ltd. respectively. The relevant penalty decision shows that AstraZeneca transferred the remaining samples of the approved project to Ed Biology and Kun Hao Ruicheng Pharmaceutical Research and Development Co., Ltd. without permission to carry out scientific research activities beyond the scope of approval. The Ministry of Science and Technology issued a warning to AstraZeneca, confiscated and destroyed the human genetic resources materials used in violation of regulations, revoked the two existing administrative licenses and other administrative penalties; and issued a warning, confiscation and destruction of the genetic resources materials involved in the case against Ed Bio and Kun Hao Ruicheng Pharmaceutical Research and Development Company, which illegally accepted and preserved AstraZeneca samples.

Of course, AstraZeneca is not the first company to be punished for violating the Interim Measures for the Management of Human Genetic Resources. Early in2015In 2002, Huada Gene and Shanghai Huashan Hospital were fined for transmitting some information on human genetic resources from the Internet for conducting an international cooperative study with Oxford University in the United Kingdom on a large sample case-control study on unipolar depression in Chinese women without permission.2016In the year, Suzhou WuXi AppTec without permission will5165A human genetic resource was warned by the Ministry of Science and Technology as an illegal exit of dog blood.

It can be seen from the above cases that a considerable number of companies have weak legal awareness and weak national security awareness, and even some companies disclose information related to national and people's security at will for personal gain. It also reflects from the side that there are indeed loopholes in the publicity and supervision of human resource management in recent years.

According to the Interim Measures for the Administration of Human Genetic Resources, human genetic resources refer to organs, tissues, cells, blood, preparations, recombinant deoxyribonucleic acid (DNA) Constructs and other genetic materials and related information. Article 4 stipulates that the state shall implement a declaration and registration system for important genetic families and genetic resources in specific regions. Units or individuals that discover and hold important genetic families and genetic resources in specific regions shall report to the relevant departments in a timely manner. Without permission, no unit or individual may collect, collect, trade, export, situation or provide it in other forms.

In the final analysis, the management of human genetic resources through administrative examination and approval is to realize the rational use of human genetic resources and the rational distribution of intellectual property rights and other rights and interests in international cooperation. Article 17 of the Interim Measures for the Management of Human Genetic Resources stipulates that my country's research and development institutions have the exclusive right to hold information on human genetic resources in my country, including important genetic families and genetic resources in specific regions, as well as data, materials, and samples. Permission is not allowed to transfer to other units. Foreign cooperative units and individuals who have obtained the above-mentioned information shall not disclose, publish, apply for a patent or disclose it to others in other forms without permission. Article 19 stipulates that when Chinese and foreign institutions conduct cooperative research and development on my country's human genetic resources, the principles for handling intellectual property rights include that if the results of cooperative research and development fall within the scope of patent protection, the two parties shall jointly apply for a patent, and the patent right shall be shared by both parties.

Judging from the current national conditions, strict approval is necessary and compliant. Today, my country's human genetic resources are still facing the risk of loss. There are many ways for foreign organizations to seize my country's human genetic resources, and the methods are hidden, resulting in the illegal outflow of a large number of important human genetic resources in my country. Even in the normal academic cooperation, there are also cases of foreign cooperation personnel "breaking the bridge" and not sharing the results with Chinese scholars after cooperative research.2017Year, preprint in biology"BioRxiv"On the website, there is an article that reveals the genetic structure of the Chinese population by analyzing the largest Han Chinese genome data at present; in the same year, a research paper based on the same batch of data was published in the sub-journal of Nature. The genetic and evolutionary characteristics of the Chinese population are also analyzed. The former has no Chinese authors and units at all, and the latter has only one Chinese author, not the main researcher. These cases show that Chinese scientists and researchers have not received corresponding rights in intellectual property rights.

With the rapid development of genome research and sequencing technology, the commercialization of industry companies is getting higher and higher, and the value of human genetic resources will be further enhanced. The relevant departments of the state have more standardized and strengthened the management of genetic resources. The resource management office has begun to require enterprises to record the information of genetic resources, and the resource management office has inspected the record situation and record information.

Of course, the protection of human genetic resources is not the ultimate goal. Any resource that is only protected but not developed and utilized does not actually constitute a resource. Only the protection and use together will be able to grasp the value of resources. The main purpose of establishing the regulations on the management of human genetic resources in China is to establish a unified national human genetic resources sample bank network and information database, and to make effective use of relevant resources on the premise of ensuring the security of samples and data.