China’s policies on sharing genomic data have so far produced cumbersome but manageable hurdles for cross-border clinical trials and translational research. But the explosive growth of its genomics industry, and the backdrop of rising political tensions, present challenges to domestic and foreign companies aiming to translate China’s data troves into precision medicines for its population.
The regulations require foreign companies to find domestic partners for any work involving Chinese genomic data or biological samples, and to have their project approved by the Ministry of Science and Technology of the People’s Republic of China (MOST).
The goal is to protect what China calls its “human genetic resources” from exploitation by foreign entities.
“The notion is that genetic data is a national treasure,” said Mao Mao, CSO of BGI Genomics Co. Ltd. and CEO of early cancer diagnostic start-up SeekIn Inc. “The regulation is trying to keep Chinese genetic data from being widely distributed.”
It is not yet clear whether the policies have helped or hurt China’s growing biotech ecosystem.
On one hand, the need for local partners may open up new opportunities for Chinese companies, hospitals and universities. On the other, requiring government approval for every new project introduces uncertainty and extra legwork, creating disincentives for foreign drug developers.
The rules aren’t new; they date back to 1998 when the Chinese government responded to an outcry