HONG KONG – In the aftermath of last year's highly controversial case of a researcher announcing the birth of two gene-edited babies in China, the National Health Commission (NHC) released a set of draft regulations that increases scrutiny over the use of new high-risk biomedical technologies, such as gene editing, stem cell technology, cloning and assisted reproduction.

The rules require government approval before clinical research and translational application involving those new technologies can go ahead. They also stress the role of ethical reviews.

The draft rules aim to address an ethical debate sparked by He Jiankui, an associate professor at the Southern University of Science and Technology in Shenzhen, who claimed in November to have used CRISPR/cas9 gene editing technology to edit the genes of twin embryos to make them resistant to HIV infections. (See BioWorld, Nov. 27, 2018.)

The announcement stirred an uproar in the medical community domestically and abroad, raising questions about Chinese scientists' ethics and the country's regulatory loopholes.

On Tuesday, the NHC said the proposed regulations aim to "ensure medical safety, and uphold human dignity and wellbeing."

"Biomedical technology is the fastest growing and most challenging in life sciences. While it provides new means for diagnosing and treating diseases to improve human health, it also brings along issues concerning privacy protection, biosafety, public safety and social ethics if clinical research and application are inappropriate," the NHC noted.

Wang Yifang, a medical ethics expert with the School of Medical Humanities at Peking University, told BioWorld that He's case is a "wake-up call for the science sector."

"This draft regulation definitely stemmed from the issues we have had. When there is a case, it will push forward legislation in that aspect, just like everywhere else," he said.

With the new rules, Chinese regulators would create a system to review and approve clinical research and the application of the new biomedical technologies.

According to the rules, such clinical research will be managed based on two levels of risk. Low- and medium-risk research projects have to be reviewed and approved by the provincial health authorities, while the high-risk ones must be approved by national health regulators under the State Council.

And what the NHC means by high risk includes all genetic engineering related projects that involve applying gene editing, gene regulation, stem cell, somatic cell and mitochondrial replacement.

Technologies related to xenogeneic cells, producing new biological products for use in humans using synthetic organisms and genetically engineered flora transportation, as well as assisted reproduction are also defined as high risk.

At the same time, health regulators will look at academic and ethical reviews when considering whether to approve clinical studies as well as technical and ethical reviews for translational application of technologies.

For that, the regulations specify what to look for in academic and ethical reviews, such as if the clinical study is legal, reasonable and ethical and if the subjects are given comprehensible information to understand the risks.

The regulations also stipulate that only top hospitals as well as institutions that have qualified researchers and the ability to ensure the safety and ethics of the research can embark on such studies.

Projects that are considered illegal, unethical, and unsafe and inefficacious in animal tests will not get the approval to move ahead.

Accountability

To step up deterrence, any institutions or individuals who initiate clinical studies without approval will face hefty fines and be barred from research work. The regulations also include stricter accountability for institutions and institutional leaders that would be held accountable for clinical research occurring on-site.

Serious offenders would even have their licenses or qualification revoked and receive a lifetime ban from research work.

To date, it is unclear what has happened to He, the creator of the gene-edited babies that shocked the world. After the scandal, Chinese authorities said he would be punished for any legal violations.

He has received fierce criticism among his peers in the science arena.

"We are deeply disturbed and we strongly condemn the relevant personnel and institutions that blatantly challenge the ethical bottom line and insult science," said Huai Jinpeng, party chief and executive vice chairman of the China Association for Science and Technology.

Peking University's Wang told BioWorld that the enhanced regulation signified a change in China's approach.

"In the past, we focused on catching up and surpassing other countries. In a competitive environment, everyone was pursuing technological breakthrough. Researchers [were] mostly concerned about how fast the project could go rather than whether the project was ethical," he added.

Wang said he believes that from now on, China will place more emphasis on legality and compliance.

The newly proposed regulations are open to feedback from the public until March 27.