3:14 PM
 | 
Oct 11, 2018
 |  BC Innovations  |  Strategy

Border security for China’s genomes

Balancing protection and translation for China’s genomic data troves

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 over consent procedures in a Harvard University study that collected blood samples from 16,000 Chinese individuals. But they have taken on extra significance in the last few years, particularly as the volume of data and number of domestic and foreign players involved in genomics have grown far greater than the rules’ authors likely envisioned.

This year, MOST said two high profile cross-border genomics partnerships had violated its policies. The agency announced it had revoked administrative licenses for a genetic study of severe mental disorders in the Han Chinese population by researchers at University of California Los Angeles (UCLA) and Shanghai Jiao Tong University, and a genetic study of depression in Chinese women by researchers at University of Oxford and Peking University, but did not disclose the reasons for its decision.

The issue of genetic data access has also come up from the U.S. side as part of the trade tensions ratcheting up between the U.S. and China.

“The notion is that genetic data is a national treasure.”

Mao Mao, BGI

On Oct. 10, the U.S. Treasury Department issued an interim rule creating a new pilot program that extends the authority of the Committee on Foreign Investment in the United States (CFIUS) to review foreign investments in biotech companies, and stop investments it believes pose a threat to U.S....

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