The Ministry of Science and Technology announced a number of administrative punishment decisions in their official website. Due to violations of Human Genetic Resources Management Regulations, six companies including AstraZeneca, PharmaTech, Huashan Hospital and Huada Gene were punished.

China Youth Online reporter of China Youth Daily found that the recent ticket is on July 31, 2018, and the farthest can be traced back to September 7, 2015. The six tickets involved illegal transshipment and acceptance of the remaining samples of approved projects, illegal international scientific research cooperation, and even human serum as dog plasma illegal exit.

The tickets published on the website of the Ministry of Science and Technology show that the three administrative penalty decisions issued on July 12 and July 31, 2018 involved the same incident. The China Human Genetic Resources Management Office surveyed that AstraZeneca Investment (China) transferred the remaining samples of the approved projects to Xiamen Aide Biomedical Technology company and Kunhao Ruicheng Pharmaceutical R&D (Beijing) without permission. They carried out research activities beyond the scope of approval. Among them, Kunhao Ruicheng received 567 tube samples and deposited it without permission from AstraZeneca. Xiamen Aide received 30 tube samples without permission and is intended to be used for kit research  activities.

According to Article 4 of the Interim Measures for the Management of Human Genetic Resources, the State implements a declaration and registration system for important genetic families and genetic resources of specific regions... No unit or individual may collect, trade, export or exit without authorization or provided in other forms. Article 11 stipulates that all international cooperation projects involving human genetic resources in China must be submitted for approval by the Chinese partner. After passing the examination, an application is submitted to the China Human Genetic Resources Management Office, and the contract can be formally signed upon approval.

The Ministry of Science and Technology decided to warn AstraZeneca, Kunhao Ruicheng and Xiamen Aide, confiscate and destroy illegally utilized human genetic resources materials. And canceled the two administrative licenses of AstraZeneca. From the date of the decision was delivered, the Ministry of Science and Technology would stop accepting applications from AstraZeneca for the international cooperation activities on human genetic resources in China, and would accept the application after the acceptance of rectification.

In addition, the administrative penalty decision on October 21, 2016 showed that 5,165 human genetic resources (human serum) were illegally discharged as dog plasma without permission. This act violates Articles 4 and 16 of the Interim Measures for the Management of Human Genetic Resources. Article 16 states that when carrying, mailing or transporting human genetic resources for export or exit, they shall report to the customs truthfully, and the customs shall release them according to the export and exit certificates issued by the China Human Genetic Resources Management Office.

The Ministry of Science and Technology decided to warn Suzhou PharmaTech, confiscate and destroy the human genetic resources materials in the project, since the date of the decision was delivered, the Ministry of Science and Technology suspended the acceptance of the international cooperation and exit activities from Suzhou PharmaTech on human genetic resources in China. The application for exit activities shall be resumed after the rectification and acceptance is passed.

The other two tickets are related to the international research cooperation on “a large sample case-control study of Chinese women with unipolar depression” conducted by Huashan Hospital affiliated to Fudan University. According to the survey conducted by the China Human Genetic Resources Management Office, it was found that Huashan Hospital and Shenzhen Huada Gene Technology Service conducted an international cooperation study on human genetic resources in China with the University of Oxford without permission. Huashan Hospital and Huada Technology passed out partially inherit human genetics resource information through the Internet without permission.

The Ministry of Science and Technology made a penalty decision on September 7, 2015. Huashan Hospital and Huada Science and Technology should stop the implementation of the research as soon as they receive this decision, destroy all non-exit genetic resources materials and related research data in the research. From the date of delivery of this decision, Huashan Hospital and Huada Science and Technology should stop international cooperation on human genetic resources in China, and should only be carried out after the rectification and acceptance is passed.

(Image taken from the official website of the Ministry of Science and Technology)

Source: China Youth Daily, China Youth Online

Time: 2018.10.26