China's new rules for editing human genes worry experts

The world's leading scientists in this field were astonished when Doctor He Zhankui from Shenzhen, five years ago, said that he had created the first babies in the world with edited genes - twins whose nicknames were Lulu and Nana. The girls' DNA was altered while they were in the early embryonic stages in a way that Dr. He claimed would make them resistant to HIV infection

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Laboratory, Photo: TEK IMAGE/SCIENCE PHOTO LIBRARY
Laboratory, Photo: TEK IMAGE/SCIENCE PHOTO LIBRARY
Disclaimer: The translations are mostly done through AI translator and might not be 100% accurate.

China's new rules to regulate human gene editing are not thorough enough, warns Chinese scientists.

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

The regulations were amended after protests five years ago when a Chinese scientist said he had created the world's first genetically engineered babies.

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

They set the rules for ethical approval, oversight and inspection, but scientists worry that these rules may not apply to the private sector.

Dr. Zhang, one of the main speakers at the international summit on human genome editing in London, she told BBC News:

"My biggest concern is that the new measures fail to address a chronic and growing problem in trying to tackle private business ventures that take place outside conventional scientific institutes.

"The new rules may have trouble keeping up with the flurry of innovation happening in China."

Gene editing is a new technique that allows scientists to make precise changes to DNA. Scientists believe that it can be used to treat many hereditary diseases.

However, it is controversial, because it increases the possibility of permanent changes in a person's genetic makeup that will be passed on to their offspring.


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A controversial experiment

The world's leading scientists in this field were astonished when Dr. He Zhankui of Shenzhen, Guangdong Province, claimed five years ago that he created the world's first babies with edited genes - twins nicknamed Lulu and Nana.

The girls' DNA was altered while they were in the 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 but He had access to the twins. But he said at a recent scientific meeting that they are in good health.

Since his release, it emerged last month that he plans to set up a clinic in Hong Kong to research the use of gene editing to develop a treatment for children with a rare inherited muscle disorder called Duchenne muscular dystrophy.

Immigration officials announced they had revoked his visa when they discovered he had a criminal record.

The new rules close loopholes that allowed He to avoid regulations that previously only applied to human experiments in hospitals, such as drug trials.

The updated regulations cover all research institutions and everything related to humans, including work on tissues, organs and embryonic cells.

He JiankuiLab

Summit organizer Professor Robin Lovell-Badge of the Crick Institute, which is hosting the event, said he was concerned there was still too much secrecy surrounding Chinese research.

"I understand why China wants to be a leader 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 proper management and oversight, and I'm concerned that it still isn't there."

Speaking at the summit, Dr. Yangin Peng of the Chinese Academy of Sciences said the government had "stepped up" laws and regulations on gene editing.

"China has significantly tightened legislation and regulations," he said. "Permanent, legacy changes are prohibited, the government has adopted a precautionary approach and our laws are in line with international rules."

Françoise Bayliss, a Canadian bioethicist at Dalhousie University, said she wanted more details on the amended Chinese laws.

"I saw that [in the updated rules] research should be in accordance with ethical principles, and I would like to know what ethical principles, where they are set and whether they are open to debate," she said.

She added that China is not the only country struggling with how to regulate the private sector.

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

Dr. Pierce Millett of the Washington-based International Biosafety Initiative said that "China is probably leading the way in revising the rules in this area."

SEBASTIAN KAULITZKI/SCIENCE PHOTO LIBRARY

Many scientists have questioned how Dr. He was allowed to return to clinical research after prison.

"I, like many people, have wondered if there is any individual or institution in China that supports or protects He Zhankui," Zhang said.

But she added that she now thinks that "we are seeing a simple case of regulatory negligence".

This led her to believe that "without clarification on the case of Dr. He, the recent talk of good governance - hypocritical."

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

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