After Scandal, China Proposes New Rules for Gene Editing
China has proposed new rules for gene editing and other "high risk" biomedical technologies. The proposals come three months after a Chinese researcher was widely criticized after claiming he had created the world's first genetically-edited babies.
A draft of the measures was published this week on the website of China's National Health Commission. The new rules would cover gene editing, stem cell experiments and biological products created for the human body, the Chinese government-supported Global Times newspaper reported.
Future projects considered high-risk would have to be approved and managed by health department officials from the State Council, China's national cabinet, the report said. Biomedical research projects considered to have small or medium risk would be managed by local health departments, it added.
The new rules would also require research experiments to pass academic and ethical examinations, the Global Times reported.
Violations of the rules would result in punishment for medical organizations or individuals, the draft proposal said. Punishments could include large fines or a ban on future research. Individuals could also face criminal prosecution.
The back story
These rules come after Chinese researcher He Jiankui reported last November that he had helped make the world's first genetically edited babies. He said he had edited – meaning changed – the genetic material of two human embryos. The embryos developed into twin girls, who were born.
He Jiankui said he had performed the gene editing to help protect the babies from infection with HIV, the virus responsible for the disease AIDS. He said the process had "worked safely" and the two girls were "as healthy as any other babies."
His claims were quickly condemned by members of the world scientific community, who denounced them as "irresponsible." The Chinese government ordered a halt to the work soon after news media reported on the experiment.
This kind of gene editing is banned in the United States and many other countries. Such changes to a person's DNA can pass to future generations and risks harming other genes.
The researcher's employer, Southern University of Science and Technology of China, said it did not know about his activities. China's Ministry of Science and Technology called the experiment "unacceptable."
He Jiankui spoke to a reporter with The Associated Press the month before his project was made public. At the time, he said he believed gene editing of human embryos resulting in live births was legal in China. The country had no law specifically banning it.
But China's official Xinhua News Agency reported last month He Jiankui had broken national guidelines and would be punished for any legal violations. Xinhua did not specify which laws were violated, but noted he had created a false ethical examination.
Along with the twins, another embryo yet to be born reportedly resulted from He Jiankui's experiment. All three are to remain under medical observation with regular visits from government health department officials, Xinhua reported.
I'm Bryan Lynn.
1.biomedical technologies 生物医学技术
With the rapid development of modern biomedical technologies, more and more new drugs are needed.
2.Along with 随着
He came along with some friends.
3.medical observation 医学观察
Some have already been removed from medical observation.
4.human embryos 人类胚胎
In the United states, President Bush has restricted the use of cloned human embryos in research.
5.At the time, he said he believed gene editing of human embryos resulting in live births was legal in China.
At the time 当时
I was not in Britain at the time.
I was just in grade school at the time, but I remember it perfectly.
6.Violations of the rules would result in punishment for medical organizations or individuals, the draft proposal said.
result in 导致
The government has been extremely reluctant to expedite investigations that might result in his trial
Fatigue and stress quickly result in a dull complexion and a furrowed brow.
中国出台了针对基因编辑和其它“高风险”生物医学技术的新规定 。该提案出台的三个月前，一名中国研究人员声称创造了全球首批基因编辑婴儿招致广泛批评 。
该措施的草案于本周在中国国家卫生委员会网站上公布 。据政府支持的《环球时报》报道，新规定将涵盖基因编辑、干细胞实验以及为人体制造的生物制品 。
该报道称，未来被认为存在高风险的项目必须得到国务院卫生部门官员的批准和管理 。报告还称，被认为具有中低风险的生物医学研究项目交由当地卫生部门管理 。
提案草案指出，违反规定的医疗组织或个人将面临处罚 。处罚措施包括巨额罚款或禁止参与未来科学研究，个人也可能会面临刑事指控 。
去年11月，中国研究人员贺建奎（He Jiankui）报告称，他帮助创造了全球首批基因编辑婴儿，中国政府随后出台了规定 。贺建奎称，他编辑（改变）了两个人类胚胎的遗传物质 。这些胚胎发育成一对双胞胎女婴并顺利出生 。
贺建奎称，他进行基因编辑是为了帮助这些婴儿免受艾滋病毒的感染，这种病毒会引发艾滋病 。贺建奎表示，这一过程“十分安全”，两个女孩和其他婴儿一样很健康 。
他的声明很快遭到全球科学界同仁的谴责，称他的言论是“不负责任”的 。中国政府在新闻媒体报道该实验后迅速下令停止这项研究 。
在美国和其它许多国家，这种基因编辑事被禁止的 。人类遗传物质的改变可能会遗传给后代并危害其它基因 。
贺建奎所在的中国南方科技大学声称对此事并不知情 。中国科技部称，该实验“不可接受 。”
贺建奎在项目公开前一个月接受了美联社的采访 。当时他说，他认为基因编辑人类胚胎并让其出生在中国是合法的 。中国没有专门的法律禁止这类行为 。
但是新华社上月报道称，贺建奎违反了国家指导方针，并将因违法行为受到惩罚 。新华社并未具体阐述贺建奎违反的相关法律，但是该媒体机构指出，贺建奎制造了一份虚假的道德审查 。
据报道，除了这一对双胞胎，贺建奎的实验还包括一个尚未出生的胚胎 。据新华社报道，这三组实验对象将继续接受医学观察，并定期前往政府卫生部门接受检查 。