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China drafts new regulations on 'high risk' biomedical technologies

4 March 2019
Appeared in BioNews 989

The Chinese government has announced new regulations on genomic technologies in response to a Chinese scientist's claim to have created genome-edited babies.

The reforms, announced on Tuesday by the Chinese National Health Commission, target 'high-risk biomedical technologies' and will apply to both germline and somatic cell research. 

'It is very reasonable to set tight regulations on germline editing,' Dr Wei Wensheng, a molecular biologist at Peking University in Beijing, told Science Magazine. 'On paper, there is nothing wrong but in a practical sense, if it takes too long to get permissions, it could be a bottleneck that will slow down research.'
 
Each 'high-risk' trial – those involving genome editing, gene transfer and regulating gene expression – will need the approval of China's highest administrative authority. Low or medium risk research, which is yet to be defined, will need institutional and provincial approval. Possible grounds for rejection include breaches of informed consent, unclear sources of funding and conflicts of interest. 

Scientists found to have breached the new laws will face penalties including warnings, fines, lifetime bans from research and even criminal charges. 

The regulations follow the widespread condemnation of Dr He Jiankui, a researcher at the Southern University of Science and Technology in Shenzhen who in November 2018 claimed to have used CRISPR/Cas9 to edit the DNA of embryos which were subsequently implanted, giving rise to genome-edited twins (see BioNews 977).

'Now the industry will develop at a slower pace,' Professor Kehkooi Kee from Tsinghua University in Beijing told Associated Press. 'The government will be more cautious with research funds, and private organisations, such as charities and startups, will be less likely to invest.' 

These draft laws are open to comments from citizens until the 27 March, however, no date for them to come into effect has been announced.

SOURCES & REFERENCES
China drafts rules on biotech after gene-editing scandal
ABC News |  27 February 2019
China drafts rules on biotech after gene-editing scandal
Washington Post |  27 February 2019
China prepares new gene-editing rules after scientist claims he tampered with DNA of twins
The Independent |  27 February 2019
China tightens its regulation of some human gene editing, labeling it ‘high-risk’
Science |  28 February 2019
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