China this week announced a new law restricting the collection and use of genetic resources from people in the country — including biological samples that yield DNA, such as blood, and data gleaned from sequencing them. There will be hefty fines for unauthorized collection or use of genetic material.
The law, which goes into effect on 1 July, formalizes restrictions on such activities that have been in place since 1998. Scientists working for foreign organizations will still need to collaborate with a domestic research organization to do research with genetic material from Chinese citizens and to take DNA resources outside of China, and such collaborations require the science ministry’s approval.
The ministry restricted export of biological samples and introduced other interim restrictions on the use of genetic resources in 1998. The decision followed outrage in the Chinese media when it was revealed that an international pharmaceutical company had collected blood from thousands of Chinese people for genetic research.
Last year, the government publicized three cases involving five companies and one Chinese hospital that had broken the rules by transferring samples or publishing sequence data without government permission. The companies and hospital were given warnings, forced to destroy the samples and data, or required to pass a data-privacy examination before participating in international research projects again. Some of those companies said they were not aware of parts of the rules — for example, that transferring samples even within China required approval.
The finalized law carries harsher penalties than did previous drafts of the law that were released for public comment. The fine for unauthorized collection of genetic resources or data can be up to 10 million yuan (US$1.4 million), up from 200,000 yuan in a 2012 draft. Individuals or organizations found breaking the law can also be blacklisted from any research involving genetic resources for up to five years or, in extreme cases, permanently. Previous drafts mentioned only temporary blacklisting.
Geneticist Paul Flicek of the European Bioinformatics Institute in Hinxton, UK, says that China’s law is in line with data-privacy regulations in other regions, such as Europe’s General Data Protection Regulation. Breaking that rule can result in much higher fines, up to 4% of a company’s annual global turnover.
Whether the Chinese law will present an obstacle to international research will depend on how it is enforced, says Flicek. “It is too early to tell what will happen,” he says.
The law also clarifies that researchers at Chinese institutions do not need additional approval from the ministry to publish genetic data in journals, as long as doing so does not harm public health, national security or the national interest. But researchers will need ministry approval to collect genetic data from “important families, specific areas or exceeding specific amounts” — terms that the law says the science ministry will define later.
“The new law is clearer on how we can do research and do international collaborations,” says Xu Xun, director of Shenzhen-based genomics company BGI Research, one of the companies that was punished for breaking the earlier restrictions.