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Call for global regulation of gene editing after China case

Genetic editing of human embryos should be subject to stiffer worldwide regulation after a scientist claimed to have used gene-editing technology to alter the DNA of two new babies in China, an expert has said.27 Nov 2018

Earlier this week, the MIT Technology Review reported that clinical trials had been conducted by researchers at Southern University of Science and Technology, in Shenzhen, in an effort to eliminate a gene called 'CCR5' in embryos in a bid to create babies that are resistant to HIV.

Associated Press subsequently reported that He Jiankui, one of the researchers, said he had worked with seven couples, altering embryos and implanting them back into the mother. So far the work has resulted in one pregnancy, with twin girls born with altered DNA earlier this month, it said. His claims have not yet been independently verified, according to the report.

The Southern University of Science and Technology distanced itself from He's work, saying it was "deeply shocked" by news of the research, which it said it had been informed of by the media. It said the research was "conducted outside of the campus" and had not been reported to the institution. Its Department of Biology Academic Committee said He’s "conduct in utilising CRISPR/Cas9 to edit human embryos has seriously violated academic ethics and codes of conduct".

A group of 122 Chinese academics and scientists have labelled He's research as "a major blow to the image and development of Chinese life sciences on the global stage", while the Shenzhen City Medical Ethics Expert Board has said it will begin an investigation into the research, the MIT Technology Review said.

Asawari Churi, a member of the intellectual property law and life sciences teams at Pinsent Masons, the law firm behind Out-Law.com and a former research scientist in molecular biology, said international rules should govern the use of gene editing technologies.

"CCR5 is a receptor naturally found on a number of cells including infection-fighting T cells," Churi said. "Whilst it is true that HIV is known to hijack this receptor to infect the cell, CCR5 is believed to have a protective function against other microbial infections. For example, some studies have shown that individuals deficient in CCR5 are known to be at a higher risk of developing West Nile virus illness which can cause paralysis and fatal neurological disease. Other studies have shown a link between CCR5 deletions and early death in patients with multiple sclerosis."

"Nowadays, in most cases, HIV is very well controlled with drugs. It is therefore unclear why He felt it was important to make the babies resistant to HIV – not completely immune – given the downsides," she said.

"Although He’s claims are as yet unverified, this is a very worrying development. It is generally believed that China’s regulations governing research ethics are not as stringent as they are in other parts of the world.  Whether or not this is true, it is safe to say that it is extremely unlikely that such an experiment would have been approved anywhere in Europe at the present time. As an example, the UK’s Human Fertilisation and Embryology Authority approved CRISPR-editing of human embryos in 2016, but requires that the embryos be destroyed within days," she said.

"The changes to the genome made by He are potentially heritable. This means that they could be passed on to the next and subsequent generations. It is easy to see how gene editing technologies can be used to potentially alter the genetic makeup of the human race. CRISPR is of particular concern due to its efficiency and ease of use. There is currently no internationally agreed-upon regulatory framework governing the use of gene editing technologies. This study strongly emphasises the need to have one in place as soon as possible," Churi said.