China announces heavy fines for unauthorized collection of DNA



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China announced this week a new law limiting the collection and use of genetic resources from people in the country, including biological samples producing DNA, such as blood, and data obtained of their sequencing. There will be heavy fines for the collection or unauthorized use of genetic material.

The law, which will come into force on July 1, formalizes restrictions on activities in place since 1998. Scientists working for foreign organizations will still have to work with a national research organization to research genetic material from Chinese citizens. and use DNA resources outside of China, and such collaborations require the approval of the Ministry of Science.

The ministry limited exports of biological samples and imposed other temporary restrictions on the use of genetic resources in 1998. This decision followed the indignation of the Chinese media when it was released. it was revealed that an international pharmaceutical company had collected blood from thousands of Chinese for genetic research purposes.

Last year, the government announced three cases involving five Chinese companies and one hospital that had broken the rules by transferring samples or publishing sequence data without government authorization. Companies and the hospital have been warned, forced to destroy samples and data or required to pass a confidentiality review of data before re-participating in international research projects. Some of these companies said they were not aware of certain parts of the rules – for example, the transfer of samples even to China had to be approved.

Large fines

The finalized law provides for tougher penalties than previous versions of the law published for comment. The fine for unauthorized collection of genetic resources or data may be up to 10 million yuan ($ 1.4 million), compared to 200,000 yuan in 2012. Individuals or organizations found guilty of violating the law may also be blacklisted for research involving genetic resources for up to five years or, in extreme cases, permanently. Previous versions only mentioned temporary blacklists.

Geneticist Paul Flicek of the European Institute of Bioinformatics in Hinxton, UK, said that Chinese law complies with data privacy regulations in other regions, such as the EU's general data protection regulation. . Breaking this rule can result in much heavier fines, up to 4% of a company's overall annual turnover.

Will Chinese law be an obstacle to international research, it will depend on how it is applied, says Flicek. "It's too early to say what will happen," he says.

The law also specifies that researchers from Chinese institutions do not need additional authorization from the ministry to publish genetic data in journals, as long as it does not harm public health, national security or in the national interest. However, researchers will need approval from the ministry to collect genetic data from "large families, specific areas or specific amounts" – which the law says the Ministry of Science will define later.

"The new law clearly states how we can conduct research and international collaborations," said Xu Xun, director of the Shenzhen-based genomics company BGI Research, one of the companies punished for violating previous restrictions.

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