After He Jiankui's Case: Chinese Legislative Modifications in Human Embryo Gene Editing

INTRODUCTION

The world was shocked by the scandal that He Jiankui (Jiankui for short) had used clustered regularly interspaced short palindromic repeats (CRISPR) to edit human embryos, two of which became living babies in October 2018. ¹ The scandal of Jiankui placed China at the center of the global legal debates, ² and illustrated substantial defects in Chinese human embryo gene editing legislation. In 2018, Chinese legal status of human embryo was not clear, ³ and the legal supervision for human embryo gene editing was loose to some extent. ⁴

Although Chinese administrative law had stipulated some rules for human gene editing, and Chinese Criminal Law could also use the crime of illegal medical practice to define Jiankui's behavior, it is still insufficient to regulate this kind of conduct. ⁵ Gene editing is moving too quickly for processes of critical reflection, such as law and regulation, to keep pace. ⁶

Therefore, Chinese legislators devoted themselves to improve human embryo gene editing legislation. Within 3 years after Jiankui's case, China successively formulated the Regulation on the Administration of Human Genetic Resources (“Regulation”), Amendment (XI) to the Criminal Law [“CACL (XI)”], and the Biosecurity Law (“CBL”), exerting a significant influence on legal regulations for human embryo gene editing. This article intends to discuss Chinese current legal status and rules in both administrative law and Criminal Law for human embryo gene editing after such legislative modifications, and further systematically evaluates the values and the defects of these modifications.

LEGAL STATUS OF HUMAN EMBRYO GENE EDITING

Human embryo gene editing technology has to go through three status reaching applications: laboratory research, clinical research, and medical behavior. Laboratory research refers to research related to in vitro embryo gene editing. For example, Dr. Wang Junjiu did successfully human embryo gene modifications ex vivo. ⁷ When the edited embryo was transplanted back to the human body to test/realize the treatment or prevention functions, it becomes a clinical research/medical behavior. In this definition, Jiankui's behavior can be both clinical research and medical behavior.

Each status mentioned needs legal permission. Before Jiankui's case, the legal status of human embryo gene editing was vague and scattered. In the field of administrative law, there were no “laws” or “administrative regulations” (considered to be higher level laws in China) to confirm, and only sporadic provisions existed in some lower level laws. In the field of criminal law, this problem is even more serious. There is no explicit regulation on human embryo gene editing. In Jiankui's case, the court convicted He Jiankui for the crime of illegal medical practice, but this conviction is suspected of analogical interpretation.

Therefore, the legal status of Jiankui's behavior aroused extensive discussion in Chinese academic circles. As a result, most scholars believe that human gene editing technology possesses outstanding technical advantages for treatment, ⁸ and that human gene editing should be researched and applied in a limited scope under the supervision of laws. ⁹ Besides, the legal framework should be transparent, diverse, and dynamic since the close connection between individual destiny and the humankind destiny when constructing this technology. ¹⁰ In general, Chinese academics have a conditional open attitude toward laboratory research on human embryo gene editing, with signs of great significance to the further development and innovation of this technology.

On this background, China has confirmed the legal status of human embryo gene editing with its latest legislation. Section 4 of the regulation, promulgated by The State Council in July 2019, defines that human embryo gene editing is laboratory research and is mainly supervised by the Ministry of Science and Technology (MOST). The MOST has put the Measures for Administration for Biotechnology Research and Development Safety (“Administration”) into effect in July 2017, which proposes the biotechnology hierarchy with three types, high risk, medium risk, and low risk. All three types explicitly cover the related human embryo gene editing behaviors. In this way, China has cleverly established the legal status of human embryo gene editing with a higher level of legal documentation, linking it to previous laws.

Although human embryo gene editing is defined as laboratory research, it should be noted that clinical research is still strictly restricted. This is mainly reflected in the Ethical Guiding Principles for the Research of Human Embryonic Stem Cells (“Principle”). Section 6 of the Principle stipulates that embryo cannot be transplanted back into the human body after in vitro gene editing. It means that clinical research, with disease treatment and prevention as the main research content and patients as the main research object, is forbidden to transplant the embryo back into the human body after in vitro gene editing to observe the disease treatment or prevention effect. Therefore, clinical research on human embryo gene editing is virtually illegal.

Besides, CACL (XI), promulgated in December 2020, specifies human embryo gene editing as a medical practice, is a crime. CACL (XI) put forward whoever implants any genetically edited or cloned human embryo into the body of a human being is “the crime of illegal medical practice.” When He Jiankui used relevant medical technology to edit human embryo genes and implanted them into the human bodies to fight AIDS, it constitutes the crime of illegal medical practice.

In summary, the legal status of human embryo gene editing is more determined now: As a laboratory research, human embryo gene editing is permitted, but as a clinical research or a medical behavior, human embryo gene editing is illegal.

GRADUALLY COMPLETE LEGAL SYSTEM IN ADMINISTRATIVE LAW

Under the regulations of multiple subjects, human embryo gene editing should obey multiple rules. The most important rules come from the CBL. Promulgated in April 2021, the CBL possesses supreme legal authority in regulation for Chinese human embryo gene editing. According to Chapters IV and V of the CBL, first of all, human embryo gene editing shall conform to ethical principles and be without harm to public health, national security, or public interest. Second, human embryo gene editing needs to establish corresponding risk prevention measures, including biosecurity training, regular reporting, and other relevant systems.

Third, the behavior should be identified according to the risk classified management system and should obtain approval from the government. Fourth, it is worth noting that the CBL has added new restrictions to the behavior subject. That is, human embryo gene editing should be conducted in medical institutions with appropriate conditions, and if it involves human clinical operation, it should be operated by professionals who have corresponding qualifications.

The CBL supplemented Chinese fundamental law in the field of human embryo gene editing. However, the provisions from this law are too principled to follow and require reference to other laws. The concrete rules for human embryo gene editing are actually stipulated in the regulation. According to Sections 8, 9, and 20 of the Regulation, if people want to conduct human embryo gene editing, they need to accept an ethical review, obtain written consent from genetic resource providers, and avoid harming public health, national security, or public interests. Centered on the “CBL-regulation,” Chinese administrative laws for human embryo gene editing have formed a relatively complete system.

First, “Principle,” jointly promulgated by the MOST and the former ministry of health in 2003, stipulates that human embryo gene editing is limited to research purposes. It means that if people conduct human embryo gene editing for medical or reproductive purpose, it violates Chinese administrative laws. According to Section 6 in the Principle, since embryo cannot be transplanted back into the human body after in vitro gene editing, human embryo gene editing cannot serve medical or reproductive purposes. Even for research purposes, professionals must terminate the research on blastulas exceeding 14 days after fertilization or nuclear transfer, which is limited to “laboratory research.” This standpoint has not been changed until now.

Second, Section 8 to Section 10 in the Administration stipulate a more specific code of conduct when legal entities conduct human embryo gene editing practices compared with the regulation. That is, the behavior should be taken through risk assessment and effective supervision, and in the event of accidents, urgent treatment, effective reporting, and data recording should be utilized. The purpose of these rules is to establish a complete and safe human embryo gene editing research and development system.

Third, as the regulation stipulates, human embryo gene editing needs ethical review, prior written consent from resource suppliers, and more specific rules on the mentioned matters are stipulated in the Measures for the Ethical Review of Biomedical Research Involving Humans (“Measure”) promulgated by Chinese former National Health and Family Planning Commission in 2016. Section 18 of the Measure specifies in detail the six ethical principles that human embryo gene editing research should satisfy. As an extension of the regulation, Principles 3 to 6 of the Measure further clarify the rules of conduct for human embryo gene editing, emphasizing privacy protection and compensation.

Fourth, for practitioner/researcher's legal responsibilities, after the enactment of the CBL, biosecurity administrative responsibilities have been improved to a certain extent, with overall tougher penalties. However, clauses of targeted responsibility for the illegal human embryo gene editing have not yet been built. According to Section 74 and Section 75 of the CBL, people who illegally conduct bioresearch activities should surrender corresponding administrative responsibilities, including high fines, temporary or permanent prohibition in relevant activities, or the revocation of relevant licenses.

Other laws supplement the responsibilities on this basis. Section 39 and Section 43 of the regulation add that illegal behaviors will be recorded in the credit records and will be made public to society. Sections 47 to 49 of the Measure and Section 11 of the Administration add some light sanctions such as criticisms and warnings to illegal behaviors.

In summary, the initially incomplete code of conduct and legal responsibilities for human embryo gene editing in Chinese administrative law have gradually become a complete system after the enactment of the regulation and CBL. The rules for human embryo gene editing are established centering on “CBL–regulation,” with the principle restricting the practice's purpose, the administration stipulating extra requirements for legal entity, and the measure concretizing ethical reviews and written consent. The practitioner/researcher's legal responsibilities as a whole have been strongly supplemented. After Jiankui's case, with the promulgation of the “CBL-regulation,” related laws start to present an integrated and multifaceted regulation for human embryo gene editing.

“DOUBTFUL DEVELOPMENT” IN CRIMINAL LAW

In Jiankui's case, Chinese court judged that Jiankui and two other people were crime of illegal medical practice, which sparked an intense discussion in Chinese academic circles. The CACL (XI), which came into effect in March 2021, added the criminal rule for human embryo gene editing as a response to the discussion. The provision is listed as one of the illegal medical practice crimes in Section 5 (Crime of Endangering Public Health), Chapter VI (Crime Against Social Administration). It stipulates that whoever implants any genetically edited or cloned human embryo into the body of a human being or animal, or implants any genetically edited or cloned animal embryo into the body of a human being shall be sentenced to imprisonment and/or a fine.

During the discussion, there were two separate views. ¹¹ Supporters believed that careless human embryo gene editing practices would infringe on multiple legal interests, leading to the rise of genetic discrimination and eugenics. ¹² It also violated human ethics and human dignity, causing immeasurable and devastating consequences in the event of medical accidents. ¹³ In addition, Chinese administrative rules before Jiankui's case for the behavior were not strict enough to regulate human embryo gene editing. ¹⁴ Therefore, as the last barrier to protect social and personal legal interests, criminal law should intervene in the regulation of human embryo gene editing.

In contrast, those opponents mainly believed that criminal law had the principle of modestly restraining behavior, ¹⁵ which meant it did not cover rare and unusual behaviors. Given the high operating costs and high technical requirements of human embryo gene editing, Jiankui's reckless violation of law was a unique case. If criminal legislation procedure was initiated just because of a unique case, it might undermine the stability of criminal law and would probably waste judicial resources. Furthermore, opponents believed that the intervention of criminal law would be a detriment to the development of the relevant technologies.

The innovative development of gene editing technology would bring so many benefits to mankind that the risk of legal interest infringement could be endured. The harshness and deterrence of criminal punishment might hinder the development of such technology. Therefore, it was improper to sacrifice the possibility of future benefits to prevent the occurrence of unknown risks. ¹⁶ Handing over the case to administrative legislation would be more appropriate.

The promulgation of CACL (XI) responds to the controversy existed in academic circles and reconciles the conflict between two parties to a certain extent. From this point of view, CACL (XI) is a development. First, CACL (XI) clarifies that criminal law will intervene the regulation of human embryo gene editing. It is true that criminal law is inappropriate to regulate rare matters or prematurely intervene in newly sprouted things. However, it is thoughtless to define Jiankui's behavior as a rare matter only because of its high operating costs and high technical requirements. In fact, gene editing experienced changes and innovations over three generations and has developed into a rather mature technology.

As the third-generation technology, CRISPR is the “finest scalpel” ^7,9 used to edit genes in the history of biomedicine, whether in application cost, efficiency, or accuracy. From the perspective of scientific research, gene editing is by no means a rare and unusual matter. In addition, with further development of the technology, fields involved will continue to expand. In light of the potential infringement on legal interests in the expanding fields, it is appropriate to apply criminal law to draw the boundary.

Second, CACL (XI) is an extension of administrative laws. Criminal law is highly punitive and deterrent, which administrative laws can never reach. Criminal law is necessary to regulate human embryo gene editing practices that have major ethical risks. It can punish offenders through penalties, including deprivation of life, liberty, and property. In administrative laws, however, offenders are generally not deprived of personal freedom, only receiving restrictions on their property and qualifications, which is fundamentally distinct from the penalties.

If human embryo gene editing technology is used for commercial purposes, in view of the extravagant profits, people probably will not be constrained by their own morals. At this time, if only administrative laws are used for regulation, neither property restrictions nor qualification restrictions can effectively punish or deter the behavior. Therefore, it is necessary to use the criminal law as an extension of administrative laws to enhance the punitiveness.

Third, CACL (XI) is in support of Jiankui's judgment, and the subsequent similar cases are no longer suspected of analogical interpretation, maintaining the stability of the Chinese criminal law system. As mentioned before, there is no legal definition for “medical practice” before Jiankui's case in China, and the definition of human embryo gene editing as “medical practice” is far from people's recognition. Therefore, clear stipulations from the CACL (XI) play an important role in the advancement and development of gene editing technology, avoiding the chaos of having different judgments for future similar cases.

In fact, as the only section in the entire Chinese criminal law that directly involves gene editing, CACL (XI) pioneered modern biotechnology risk regulation and provided a legal basis for the criminal regulation of illegal human gene-editing experiments. It implements the “prevention principle,” reflecting an orientation of dealing with biotechnology risks and providing far-reaching impacts.

However, CACL (XI) only adds one gene-editing crime also containing some problems. First, punishing illegal human embryo gene editing as the crime of illegal medical practice does not reflect the essential characteristics of human experimentation crimes, nor does it appropriately evaluate the behavior's social harm. ¹⁷ Human embryo gene editing technology may infringe on a type of new legal interest, ¹⁸ which cannot be simply described by endangering public health or even a more general concept, social administration.

For example, off-target effects in human embryo gene editing will lead to genetic mutations, and genetic mutations will pollute the gene pool. These will not only rouse genetic discrimination, but also infringe the right of offspring. ¹⁹ In this case, illegal human embryo gene editing does not only endanger “social administration,” but also endanger the stability of the human gene pool, and the personal dignity specified in the constitution. ²⁰

Second, as modern biotechnology develops, constantly emerging new gene editing technologies will cause more serious risks and social crises. If gene-editing crime is restricted under the frame of the “illegal medical practice,” it may be relatively difficult to be integrated into the future criminal law. Jiankui's team developed a fetus by directly acting on the human body using gene editing, which is undoubtedly a crime of illegal medical practice. However, if other genetic crimes are separated from medical practice and are unable to be included in the crime of illegal medical practice, they may create a state of confusion in criminal law. Therefore, the overall regulations from the criminal law on genetic crime may not be appropriate as expected in the future.

CONCLUSION

This article systematically discusses Chinese current legal status and rules for human embryo gene editing in both administrative laws and Criminal Law. After He Jiankui's case, China has made great modifications in genetic legislation. As already mentioned, the legal status of human embryo gene editing becomes more determined. China has gradually formed a complete system in administrative law, centering on “CBL –regulation,” and has experienced a “doubtful development” in criminal law. We must admit that the establishment of such a legal system in just 3 years after He Jiankui's case is remarkable. But there is still a long way for China to push forward genetic legislation.

China's legislation on the behavior is still immature and should continue to be modified. It is a gradual and flexible process in which consensus can be gradually built up. ²¹ For example, administrative clauses of targeted responsibility for illegal human embryo gene editing should be soon built, and criminal genetic legislation may need to be restructured in the future. Overall, we believe that China will establish a scientific and complete legal system for human embryo gene editing at a proper time.