6:12 PM
Nov 30, 2018
 |  BioCentury  |  Politics, Policy & Law

China’s germline growing pain

How China’s response to CRISPR fallout could elevate its global research reputation

Editor's Note: This article was updated on Dec 03, 2018 at 10:54 AM PST

How Chinese regulatory authorities respond over the long term to the CRISPR baby furor could influence its industry’s success on the global stage, as domestic and international stakeholders seek reassurance that the authorities are on the case.

Arguably, this was a controversy waiting to happen. Until this past week, China had not taken a clear stance on human germline gene editing, even though Chinese labs had broken international norms in this field in the past.

”It is shocking and unacceptable. We are resolutely opposed to it.”

Nanping Xu, China Ministry of Science and Technology

On the heels of the country’s vaccine manufacturing scandal in July, the new controversy feeds into the growing burden on Chinese regulators to both create and enforce standards that meet the scientific community’s expectations.

The vaccine case led to a high-level resignation, with the departure of Jingquan Bi as head of China’s State Drug Administration (SDA, now National Medical Products Administration (NMPA)), and a greater focus at the agency on quality control (see “Thinking Beyond Bi”).

On Nov. 26, Jiankui He announced via YouTube that he had used CRISPR-based gene editing to mutate the CC chemokine receptor 5 (CCR5; CD195) gene in single-cell embryos, creating HIV-resistant embryos, prompting outrage globally among the scientific and lay communities. Jiankui He is affiliated with the Southern University of Science and Technology in Shenzhen, but has been on unpaid leave since February for undisclosed reasons.

Chinese authorities took an unambiguous position.

In a Nov. 29 interview on CCTV, China’s Ministry of Science and Technology (MOST) Vice Minister Nanping Xu said: “The clinical operation of genetic editing for human embryos is strictly prohibited in our country. The genetically edited baby incident reported by the media has blatantly violated China’s relevant laws and regulations, and has also broken through the bottom line of morality and ethics that the academic community has adhered to. It is shocking and unacceptable. We are resolutely opposed to it.”

Domestic and international stakeholders are looking for longer-term solutions.

Chinese researchers were among the first to condemn Jiankui He’s actions. In an open letter, 124 biomedical researchers in the country said it was a “huge blow to the global reputation and development” of Chinese research.

One concern is that it feeds into a narrative of rogue practices that could harm China’s progress.

“Their reputation has always been a bit uncertain because of the prior problems,” including the vaccines scandal, said Arthur Caplan, professor of bioethics at New York University School of Medicine. “This adds more fuel to the fire.”

The Chinese researchers called on “relevant regulatory authorities and research institutions to quickly enact strict regulation, and conduct a comprehensive investigation of this incident.”

“There has been a failure of self-regulation by the scientific community because of this lack of transparency.”

David Baltimore, California Institute of Technology

Calls for a heavier hand have come from China’s business community, too. BayHelix, a global non-profit organization of Chinese business leaders in the life sciences and healthcare industries, urged “scientific and investment communities, healthcare institutions and regulatory bodies to be highly vigilant against such unscrupulous conduct and to implement rules and procedures to regulate this fast-evolving field.”

Dan Zhang, chairman of Chinese CRO Fountain Medical Development Ltd., agrees that some level of “checks and balances” needs to be added to the existing academic research infrastructure.

While industry-sponsored trial protocols are...

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