A Chinese scientist recently claimed to have edited the DNA of human embryos and created the world’s first genetically edited babies, although his claim has not been verified so far. Chinese authorities reportedly said the incident as reported by the media “blatantly violated China’s relevant laws and regulations,” and ordered an investigation into the scientist’s claim.
It seems it is not the first time that Chinese scientists conducted research on gene editing in human embryos, but the previous research does not seem to have violated Chinese law. So what does Chinese law say about it?
1. 2003 Ethics Guidelines
There does not appear to be a law passed by the National People’s Congress that governs gene editing in human embryos. The most relevant provisions concerning such research may be a set of ethics guidelines jointly issued by China’s Ministry of Science and Technology and the then-Ministry of Health (currently the National Health Commission) in 2003, the Guidelines for Ethical Principles in Human Embryonic Stem Cell Research (Ren Peitai Ganxibao Yanjiu Lunli Zhidao Yuanze (Guo Ke Fa Sheng Zi [2003] No. 460, Dec. 24, 2003)) (hereinafter “Guidelines”).
Under the Guidelines, research of gene editing in human embryos is allowed but with specific restrictions. Article 6 of the Guidelines states:
Research in human embryonic stem cells shall be in compliance with the following behavioral norms:
- Where blastula is obtained from external fertilization, somatic nucleus transplantation, unisexual duplicating technique or genetic modification, the culture period in vitro shall not exceed 14 days from the day of fecundation or nuclear transplantation.
- Implantation of human blastula obtained and used in research as provided in the preceding paragraph into human or any other animal reproductive systems shall be prohibited.
- Combination of humane germ cell with that of other species shall be prohibited. (Translation provided by Westlaw China, by subscription.)
Thus, according to the Guidelines, human embryos used in research are not allowed to develop for more than 14 days. And more importantly, it is prohibited to implant such genetically modified embryos into a human or animal body for the purpose of reproduction.
The Guidelines also provide that the research is subject to reviews by the ethics committee within the researcher’s own institution. According to article 9 of the Guidelines, hospitals and research institutions engaging in embryonic stem cell research must establish institutional ethics committees that consist of research and executive personnel in the areas of biology, medical science, law, and social sciences. A more recent departmental rule issued by the National Health and Family Planning Commission in 2016 further requires any biomedical research involving humans to be subject to ethical review, and provide more detailed rules on the review. (Sheji Ren de Shengwu Yixue Yanjiu Lunli Shencha Banfa [Measures for the Ethical Review of Biomedical Research Involving Humans] (Oct. 12, 2016, effective Dec. 1, 2016).)
Under the Guidelines, allowed sources of embryonic stem cells used in research include: unwanted gametes or blastulas from in vitro fertilization (IVF) procedures; embryo cells from miscarriages or voluntarily induced abortions; blastulas or single split blastocysts from somatic cell nuclear transfer technology; or donated germ cells (art. 5).
In addition, the Guidelines specifically prohibit any research on human reproductive cloning (art. 4). Buying or selling human gametes, cytulas, embryos, or embryonic tissue is also prohibited (art. 7).
2. 2001 Measures on Assisted Reproductive Technology
Creating babies with the genetically modified embryos may also violate a departmental rule issued by the Ministry of Health in 2001 on assisted reproductive technology (ART), the Measures on Administration of Assisted Human Reproduction Technology (Renlei Fuzhu Shengzhi Jishu Guanli Banfa (MOH Decree [2001] No. 14, Feb. 20, 2001, effective Aug. 1, 2001)) (hereinafter “ART Measures”). Article 13 of the ART Measures provides that performing ART in China must abide by the Technical Standards of the Assistant Human Reproductive Technology, the latter specifically prohibit any genetic manipulation of human embryos for reproductive purposes (§3(9)).
Furthermore, according to the ART Measures, ART may only be performed in medical institutions that have been specially approved and registered to perform ART; without the approval of the government health authority, any organizations or individuals may not perform ART (art. 12). The ART Measures also require informed consent, and any ethics issues involved must be submitted to the ethics committee for discussion (art. 14.)
In conclusion, it appears research of gene editing in human embryos is allowed in China, subject to restrictions, approvals, and ethics reviews, but using such genetically modified embryos to create babies is prohibited.
3. Penalties?
It may not be easy to determine the legal liabilities of the relevant persons in accordance with the existing Chinese laws and regulations. The 2003 ethics guidelines contain no penalties for violations. The ART Measures provide that medical institutions violating the measures are punishable by a fine of up to 30,000 Chinese yuan (about US$4,300), and responsible persons may be subject to administrative punishments (art. 22). The same article mentions criminal prosecution is possible in accordance with the Criminal Law. However, the Criminal Law does not contain a specific crime such as creating gene-edited babies. A lawyer in China has suggested that some crimes in the Criminal Law may be applicable, such as the crime endangering public safety or the crime of illegal medical practice.
