China Tightens Regulations After Gene-Editing Scandal

On Wednesday, China's National Health Commission (NHC) began polling citizens' in a bid to implement more severe regulations on human genetic modification. They also published draft rules on biomedical experiments, which proposes a rigorous approval process and supervision of genetic testing

RELATED:
China: Genetically Edited Monkeys Will Aid Biomed Research

​​​​​According to the proposed measures, only the NHC will be able to approve high risk genetic studies. Those who violate the provisions will be banned for life from developing biomedical research and will have to pay of heavy fines. If any institution is found to be somehow involved  with the offenders, it will be closed.

The Chinese government seeks to eliminate any possibility of repeating the gene-editing scandal involving He Jiankui, a biophysics professor at the Southern University of Science and Technology, who violated current laws, evaded supervision, falisfied documents and illegally recruited volunteers to carry out an experiment whereby two twin girls were born with genetic modifications.

Jiankui raised funds for his research starting in June 2016 and received was supported by national and international colleagues. Between Mar. 2017 and Nov. 2018, he recruited eight mixed-status couples made up of HIV-positive men and HIV-negative women, achieving two in-vitro pregnancies and, finally, the birth of Lulu and Nana.

The babies came into the world using the Crispr-Cas9 technique to alter their DNA and theorestically make them completely resistant to the AIDS virus. That procedure, also known as 'genetic scissoring', allows researchers to remove and replace a genome’s unwanted parts, much the same way that a bug in a computer program might be corrected.

Both Jiankui and the institutions involved in this case of gene-editing will receive sanctions in accordance with China's regulations and their crimes will be transferred to justice.

Meanwhile, the girls, their mother, and the other volunteer who is still pregnant will continue medical supervision to observe their progress.​​​​​​​

When Jiankui announced the twins’ birth last year, he was widely rejected by the scientific community inside and outside China. Multiple voices were concerned about the violation of laws, the lack of ethical restraints, and scientific protocols, plus the biological risks for the twins and their future offspring.​​​

Professor Jiankui’s gene-editing experiment, however, could have had unintended consequences.

According to the MIT Technology Review, the deletion of a gene called CCR5 not only made the Chinese twins HIV resistant but also improved their brain abilities to form new connections.

“It did affect their brains,” Alcino Silva, a University of California neurobiologist, explained that “the simplest interpretation is that those mutations will probably have an impact on cognitive function in the twins ... that is why it should not be done.”