The study, authored by Dan Yang of the Humanities School at Jinan University in Zhuhai, takes a comparative legal approach combined with doctrinal legal analysis. Rather than treating the 2018 incident as a closed chapter, Yang examines the ethical guidelines, the applicable legal framework and the criminal provisions drawn from relevant jurisprudential domains that governed the case. The analysis draws on legal and policy documents, case-related reports from official and authoritative media, and scholarly literature. Its central claim is that the key issue raised by the incident lies in the clinical application of germline editing, a practice that Chinese criminal statutes simply did not address when the edited babies were born.

The technical distinction at the heart of the case matters enormously for understanding why the law struggled to respond. Somatic genome editing, which alters the genes of an individual patient’s cells and affects only that person, has a long history of regulated clinical research. Germline genome editing, by contrast, changes the DNA of embryos, sperm or eggs, meaning any modifications are heritable and pass to future generations. The safety implications are profound: off-target edits, mosaicism and unknown long-term effects cannot be consented to by the person most affected, the future child. Clinical application of germline editing in infants therefore raises safety concerns of a categorically different order, alongside broader social concerns about inequality, eugenics and the commodification of human reproduction.

Before the 2018 incident, China possessed a patchwork of ethical guidelines and administrative regulations touching on assisted reproduction and embryo research, but no dedicated criminal offence covering the implantation of gene-edited embryos. This meant that prosecutors could not charge the conduct itself as a distinct crime. Instead, the case was prosecuted under the offence of illegal medical practice, a charge that captures practising medicine without proper qualification or authorisation rather than the specific act of creating genome-edited babies. Yang’s analysis demonstrates that this mismatch between the gravity of the conduct and the available legal tools was not merely a technicality; it left the central harm unaddressed by criminal law and relied on a provision designed for a different problem.

The study argues that criminalisation of the clinical application of germline editing was warranted, and the Chinese legislature evidently came to agree. In 2021, Amendment (XI) to the Criminal Law of the People’s Republic of China introduced a new offence of illicit implantation of gene-edited or cloned embryos. This provision made it a crime to implant gene-edited or cloned embryos into a human body, closing the most conspicuous gap exposed by the He Jiankui affair. For the first time, the conduct at the centre of the 2018 scandal had a name in the criminal code, giving prosecutors, judges and researchers a clear statutory boundary.

Yet Yang contends that the new provision remains in need of refinement, and the study advances specific recommendations for its improvement. The details of those recommendations are grounded in the doctrinal analysis of how the offence is drafted and how it interacts with the surrounding regulatory framework. Criminal statutes governing emerging biotechnologies must balance several competing demands: they must be specific enough to give fair warning about what is prohibited, broad enough to cover foreseeable variations of the prohibited conduct, and calibrated so that legitimate research, such as laboratory studies on embryos that are never implanted, is not swept into the criminal net. Striking that balance is notoriously difficult when the underlying science is evolving rapidly.

The comparative dimension of the study is significant because China is not alone in grappling with these questions. Jurisdictions around the world have taken markedly different approaches to germline editing, ranging from outright statutory bans backed by criminal penalties to regulatory prohibitions without criminal sanction. The 2018 incident served as a wake-up call internationally, prompting renewed debate about whether existing frameworks were adequate. By situating the Chinese experience within this broader landscape, the study contributes to a global conversation about how criminal law should respond to technologies that touch the human germline, and what lessons the first criminal-law response to a real genome-editing scandal can offer other nations.

One of the study’s most sobering observations is that, although several years have passed since the incident, impulses and initiatives aimed at advancing the clinical application of human germline genome editing in infants continue to emerge. The He Jiankui case did not extinguish the ambition to edit the human germline for reproductive purposes; it merely demonstrated the risks of doing so without oversight. This persistence is precisely why Yang argues that re-examining the ethical oversight and legal framework remains essential, particularly the role of criminal law in addressing both safety concerns and the broader social concerns that accompany attempts to alter the inherited genetic makeup of humanity.

The structure of governance that emerges from the analysis is layered. Ethical guidelines set professional norms and review requirements for research involving human embryos. Administrative regulations govern licensing and oversight of medical and reproductive institutions. Criminal law sits at the apex as the instrument of last resort, reserved for conduct so dangerous or socially harmful that it must be prohibited outright rather than merely regulated. The 2018 incident revealed that when the lower layers of this system fail, the absence of a criminal backstop leaves society without an adequate response. The 2021 amendment added that backstop, but the study’s recommendations suggest that the task of calibrating it is ongoing.

For the international scientific community, the study offers a rare doctrinal account of how one nation translated scandal into statute. It clarifies the key facts of the incident, demonstrates that the central legal problem was the uncriminalised clinical application of germline editing, defends the decision to criminalise, and identifies where the new offence falls short. As genome-editing tools grow more precise and more accessible, the question Yang poses in the study’s title, whether something has been a crime or should be criminalised, will confront legislatures far beyond China. The answer developed in this case study, that criminal law has a necessary but carefully bounded role in governing the human germline, is likely to shape that debate for years to come.

Subject of Research: Criminal law and ethical governance of human germline genome editing in China following the 2018 gene-edited babies case

Article Title: Has it been a crime or should it be criminalised? A case study on genome-edited babies and the improvement of criminal statutes in China

Article References: Has it been a crime or should it be criminalised? A case study on genome-edited babies and the improvement of criminal statutes in China. (n.d.). https://doi.org/10.1038/s41599-026-09376-1

Image Credits: AI Generated

DOI: 10.1038/s41599-026-09376-1

Keywords: genome editing, germline editing, He Jiankui, criminal law, China, bioethics, CRISPR, gene-edited babies, Criminal Law Amendment XI, embryo research, legal reform, research ethics