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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.

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
22 June 2020 - by Georgia Everett 
Chinese authorities are collecting blood samples from across the country to build a genetic map of its roughly 700 million males...
6 January 2020 - by Dr Laura Riggall 
Professor He Jiankui, the Chinese scientist who created the world’s first genome-edited babies, has been sentenced to three years in prison for violating medical regulations...
19 August 2019 - by Dr Helen Robertson 
The international commission on the Clinical Use of Human Germline Genome Editing met for the first time last week to discuss the governance and use of embryo genome editing...
12 August 2019 - by Shaoni Bhattacharya 
China has approved a national research ethics committee to advise its government, following the 'CRISPR-babies' scandal last year...
3 June 2019 - by Georgia Everett 
An international commission has been assembled to provide guidance on the development of therapies using human germline genome editing...
25 February 2019 - by Isobel Steer 
A gene called CCR5 has been shown to affect people's ability to recover after stroke. It is the same gene at the heart of the recent controversial case of genome edited babies in China...
18 February 2019 - by Dr Sam Sherratt 
The World Health Organization is convening an 18-member committee of scientific experts from around the globe next month with the goal of developing international standards for the oversight of human genome editing...
3 December 2018 - by Rachel Siden 
Authorities in China are moving to suspend the research activities of the scientists who claim to have modified the genomes of twin girls with CRISPR-Cas9...
26 November 2018 - by Shaoni Bhattacharya 
The first births from genome-edited human embryos have been announced by a Chinese researcher amid widespread condemnation, and fears over safety...
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