People's Daily reported on November 26 that He Jiankui, a scientist from Shenzhen, China, announced the day before the Second International Summit on Human Genome Editing that a pair of genetically edited babies were born in China in November. The genes of the twins have been modified to make them naturally resistant to AIDS after birth. According to the People's Daily, the world's first genetically edited baby that is immune to AIDS. It also means that China has made a historic breakthrough in the field of disease prevention in gene-editing technology.
According to He Jiankui, this genetic surgery modified the CCR5 gene that forms a protein doorway that allows HIV, the virus that causes AIDS, to enter a cell. It has been shown that about 10% of the Europeans have inherited a genetic mutation known as CCR5-Ä32 that prevents the virus from entering the cells of the immune system.
This world record set by Chinese researchers immediately became much-talked about in the scientific community and media worldwide. From the public information, most people in the scientific community are shocked by the use of gene editing technology to assist in the reproduction of such babies, which is considered to be contrary to ethics and morality. More than a hundred Chinese scientists have issued a joint statement saying that the biomedical ethics review of this so-called research is ineffective; direct human experimentation is described as lunacy and is condemned.
Dr. Kiran Musunuru, a genetic editing expert at the University of Pennsylvania and editor of the Journal of Genetics, said that this is an "experiment on human beings that is not morally or ethically defensible". In addition, Dr. Kiran also questions the two infants' natural resistance to AIDS and the unknown risks they would face in the future. Dr. Eric Topol, who heads the Scripps Research Translational Institute in California, also stated that this is "far too premature".
The Chinese media has dug up more information about He Jiankui. He has more than just scientific ambitions; he is also an entrepreneur. Corporate information shows that he holds 7 company shares and is the legal representative of five companies. He Jiankui holds 27.42% of the shares of Shenzhen Direct Genomics Co., Ltd., which has claimed to have come out with the world's most accurate gene sequencer. There are also reports that He Jiankui's research and business cooperation has support from the "Putian Group" of private hospitals.
Currently, the issue of "genetically edited babies" has become a phenomenal high-profile event in China. The Chinese National Health Commission has requested the Department of Health of Guangdong Province to seriously investigate and verify the matter; while the Shenzhen's Medical Ethics Committee has launched an investigation into the ethical issues involved in the incident on November 26, and verifying the authenticity of the ethical review of the research project as reported by the media; the results of the investigation will be announced to the public in a timely manner. With the continuous follow-up of the media and the constant participation of all walks of life, it is believed that more details will surface, and more disputes on the issue of ethics will be triggered.
As an independent think tank, Anbound focuses more on and analyzes this issue from a public policy perspective; we are concerned with policy-related issues. The question that must be asked is that, does China have the policies in the use of genetic editing technology in the field of assisted reproduction? Is there a specific policy application or is the past policy being applied temporarily? Who is responsible for the policy applicability of this technology?
Examining genetic editing techniques from these questions, we find that China lacks clear and targeted policies in this area, but some policies can be applied to "genetically edited babies". First, in Article 6 of the Ethical Guidelines for Research on Human Embryonic Stem Cells were enacted by the Ministry of Science and Technology and the Ministry of Health of China on December 2003, it is stated that to conduct human embryonic stem cell research, the following behavioral norms must be observed: (1) blastocyst obtained from IVF, human somatic cell nuclear transfer, parthenogenesis or genetic modification techniques, its in vitro culture period shall not exceed 14 days starting from the day when fertilization or nuclear transfer is performed; (2) it shall be prohibited to implant embryos created by means described above into the womb of human beings or any other species. In this way, the research project on the "genetically edited babies" has directly violated this regulation.
Second, the Ethical Review of Biomedical Research involving Human Beings promulgated by the Chinese National Health and Family Planning Commission in 2016 stipulates that the medical and health institutions engaged in biomedical research involving human subjects must form an ethical review committee; if such institutions do not have an ethics committee, they shall not carry out biomedical research work involving human subjects. Within 3 months from the date of the establishment of such an ethics committee, it must register to the authority and the medical research information system. After reviewing the medical ethics committee of the Shenzhen HarMoniCare Women & Children's Hospital, the related research was not registered as required.
It can be seen that there is no clear definition of genetic editing technology and application in China, and there is no direct constraint policy; the two binding provisions are ethical guidance on research. Since ethical and moral constraints have no rigid and mandatory effects, it is not surprising that they are not observed in actual implementation. In contrast, the EU regulation of genetic editing technology is very strict and straightforward. According to informed sources, even some large-scale genetic research institutions in China have less than satisfactory ethics committees; this is related to the overall standard of the Chinese science academic community in related fields.
In our view, it is not difficult to argue about technology and issues, but from the impact on the public, there can be no big mistakes on the policy side. Judging from the past policy history of China, due to the ambiguity of the policy, China has suffered a lot of losses on many issues. Many so-called new technologies have been invested with a lot of resources, but they have been stopped not long afterward. There are many lessons in this regard, such as policies related to the electric vehicles, steel de-capacity, P2P, small hydropower, internet finance, financial industry clean-up and rectification and so on. Many policies have been adhered to for a year and a half, then they are changed, or they are nominally maintained but being practically abandoned.
Final analysis conclusion:
From the technical perspective, many genetic technologies, including genetic modification and genetic editing, are neutral and can neither be good nor bad. However, from the perspective of public policy, it is very different. If there is no clear policy norm or supervision for the use of genetic technology, or if there is wrong policy orientation, it would be like opening Pandora's Box. Therefore, China needs to work on the policy norms in related fields as soon as possible, not just focusing on small profits while neglecting the lack of public policies.
