China's new human gene-editing rules worry experts

New rules in China to regulate gene editing in humans don't go far enough, a leading expert has warned scientists.

Dr Joy Zhang of Kent University, a global expert on the governance of gene editing in China, said authorities are susceptible to "regulatory negligence".

The regulations were updated following an outcry five years ago when a Chinese scientist said he had created the world's first gene-edited babies.

China says the new laws are in line with international rules.

They set requirements for ethical approval, supervision and inspection, but experts worry that they may not apply to the private sector.

Dr Zhang, one of the main speakers at an international human genome-editing summit in London, told BBC News: "My biggest concern is that the new measures fail to cover a chronic and increasing problem in trying to deal with private ventures that are taking place outside of conventional scientific institutes.

"The new rules may struggle to keep up with the burgeoning innovation that is happening in China.''

Gene editing is a new technique that enables scientists to make precise changes to DNA. Scientists believe it could be used to correct many inherited diseases.

It is controversial, though, because it raises the possibility of making permanent changes to a person's genetic make-up that will be passed down to their offspring.

The world's leading scientists in the field were stunned when Dr He Jiankui, from Shenzhen in Guangdong Province, claimed five years ago that he had created the world's first gene-edited babies - twins nicknamed Lulu and Nana.

The girls' DNA had been altered while they were at an early embryonic stage in a way that Dr He claimed would make them resistant to HIV infection.

He was fined and sentenced to three years in prison in 2019. No-one, other than Dr He, has had access to the twins. But at a recent scientific meeting, he said they were in good health.

Upon his release, it emerged last month that he was planning to set up a clinic in Hong Kong to research using gene editing to develop a treatment for children with a rare inherited muscular disorder, called Duchenne Muscular Dystrophy. Immigration officials announced that they had rescinded his visa after they discovered he had a criminal record.

The new rules close the loopholes that enabled Dr He to evade regulations, which previously only applied to experiments on human beings in hospitals, for example for drug trials. The updated regulations cover all research institutions and everything relating to humans, including work on tissues, organs and embryonic cells.

The summit organiser, Prof Robin Llovell-Badge, from the Crick Institute, where the meeting is being held, said he was concerned that there was still too much secrecy in Chinese research.

''I understand why China wants to be leaders in technology, but there are some areas that require special attention and gene editing is one of them," he said.

''It has to be done properly and with the appropriate governance and oversight, and I'm concerned that they are not there yet.''

Speaking at the summit, Dr Yangin Peng, of the Chinese Academy of Science, said the government has "accelerated" laws and regulations in gene editing.

"China has considerably tightened its legislation and regulations," he said. "Permanent, inherited changes are banned, governance has adopted a precautionary approach and our laws are in line with international rules."

Dr Francoise Baylis, a Canadian bioethicist from Dalhousie University, said she wanted more details of the updates to China's rules.

''I saw [that in the updated rules] research should be in line with ethical principles. I would want to know which ethical principles, where they are set out and whether they are open to questioning,'' she said.

She added that China was not alone in grappling with how to regulate the private sector.

''We have similar issues in North America, so I think it is wrong to focus on China,'' she said.

Dr Piers Millett, of the International Biosafety and Biosecurity Initiative, based in Washington, acknowledged that: ''China is probably leading the way in revising the rules in this area.''

Many scientists have wondered how Dr He could be allowed to return to clinical research after serving time in prison.

"I, like many people, had been wondering whether there had been an individual or institution in China that had been backing or protecting He Jiankui," said Dr Zhang.

But she said she now thought that "we are looking at a simple case of regulatory negligence".

That led her to believe that "without getting clarifications on Dr He's case, the recent talk of good governance is hypocritical".

"I worry less about what He Jiankui is up to, and more about the Chinese authorities are doing," she said.

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(editor-in-charge：Press center7)