New rules governing the regulation of human gene editing in China are not going far enough, leading experts warn.
Dr Joy Zhang, from Kent University, who is the world’s leading expert on the management of gene editing in China, said authorities in the country ruled by the Chinese Communist Party are vulnerable to “regulatory malpractice.”
She told BBC: “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.”
The regulations had been updated after a protest five years ago by a Chinese scientist who claimed he had created the world’s first gene-edited infant. China said at the time the new laws were consistent with international rules.
They establish requirements for ethics approvals, monitoring, and oversight, but scientists are concerned they might not extend to the private sector. Gene editing is a new technology that allows scientists to make precise changes to DNA.
Scientists think that it can be used to fix a number of hereditary diseases. It is controversial, however, as it carries with it the potential for permanently altering an individual’s genetic make-up, which would then be passed on to his or her descendants.
The world’s leading scientists in this area were shocked when Dr. Shenkui, of Shenzhen, Guangdong province, claimed five years ago that she had created the world’s first genetically modified infant twins, nicknamed Lulu and Nana.
The girl’s DNA had been altered while in the earliest stages of their embryonic life, in a way Dr He claimed would make them HIV-resistant. He was fined and sentenced in 2019 to three years in prison.
No-one except Dr. Hsieh had treated the twins. After he was released last month, it emerged he was planning to open a clinic in Hong Kong, using gene editing research to develop a treatment for children suffering from a rare hereditary muscular condition called duchenne muscular dystrophy (DMD).
Immigration officials announced that they had terminated his visa, finding he had a felony conviction. The new rules closed the loophole that allowed Dr. Hsi to avoid regulations that had previously applied only to experiments on humans at hospitals, such as drug trials. The updated rules apply to all research institutions and anything that involves humans, including tissue, organs, and embryonic cells.
The organizer of the summit, Professor Robin Lowell-Badge of Crick Institute, where the conference is being held, said that he was concerned there was still too much secrecy around 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 Yanin Peng of the Chinese Academy of Sciences said that the government had been “accelerating” laws and regulations on 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 wants more details on the updates in Chinese regulations. She added China is not alone in struggling to regulate the private sector.
”I saw [that in the updated rules] research should be in line with ethical principles and I would want to know which ethical principles, where they are set out and whether they are open to questioning,” she said.
