Title: Legal Responses to Crossing Ethical Boundaries
–A Global Approach to Strengthening Review and Criminal Accountability for Human Genome Editing
Abstract: Genome editing technologies, represented by CRISPR-Cas9, are profoundly reshaping the paradigms of disease treatment and human reproduction, while at the same time repeatedly striking against the boundaries of bioethics and criminal law. This article proceeds from two dimensions—somatic cell genome editing (therapeutic editing) and human embryo genome editing (germline editing)—to systematically argue for the urgency and necessity of strengthening ethical review and legal enactment. Using major international genome editing scandals and criminal precedents as points of entry, the article reveals the individual harms, intergenerational injustice, and destruction of the common heritage of humanity caused by technological misuse. It also introduces ethical resources such as Kant’s “humanity as an end,” Habermas’s “species ethics,” and Sandel’s “case against perfection” to analyze the slippery slope effects of “sliding from therapy to enhancement” and “sliding from individual choice to new eugenics.” On this basis, the article proposes a three-tier prevention and control system of “ethical review—administrative licensing—judicial intervention,” and emphatically argues for the legitimacy and institutional design of imposing criminal accountability for serious ethical violations. Written from an international perspective in an impartial and balanced manner, the article endeavors, through rigorous logical reasoning, to contribute a systematic normative framework to the global governance of genome editing.
Keywords: genome editing; ethical review; germline modification; somatic cell therapy; criminal accountability; human dignity; global governance
I. Introduction
At the end of 2023, the world’s first CRISPR-based somatic cell gene editing therapy, “Casgevy,” successively received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA) for the treatment of sickle cell disease and transfusion-dependent beta-thalassemia [1]. This marks the formal entry of gene editing from the laboratory into routine clinical treatment, bringing hope of alleviation or even cure to countless patients suffering from genetic diseases. Yet, only five years earlier, the former Chinese scientist He Jiankui bypassed all ethical review and created the world’s first gene-edited babies, implanting embryos with the CCR5 gene knocked out into a mother’s womb and resulting in the birth of twin girls, an event that sent shockwaves through global public opinion [2]. These two incidents, like the two sides of the gene editing coin, reflect the immense promise and the abyssal risks of humanity’s control over the blueprint of life.
Amidst the immense tension between technology and ethics, an unavoidable proposition has emerged: when facing a tool capable of rewriting the genetic information of a species, why must ethical review be strengthened? Why is legal enactment so urgent? And how can abstract ethical principles be translated into an institutional system that is simultaneously normative, guiding, and coercive? Centering on this core inquiry, this article conducts a comprehensive exposition along the two pathways of somatic cell gene editing and human embryo gene editing, demonstrating the inexorable logic of strengthening ethical review and constructing a foundational basis for criminal accountability.
II. Somatic Cell Gene Editing: Ethical Concerns Amid Therapeutic Benefits
Somatic cell gene editing modifies only the non-reproductive cells of a patient, and the genetic alterations are not passed on to offspring. In form, it occupies the same ethical category as existing medical interventions such as organ transplantation and molecular targeted therapy. However, this by no means implies that it does not require stricter ethical scrutiny.
(I) Safety Uncertainties and the Black Hole of Informed Consent
Although gene editing tools continue to be iteratively upgraded, risks such as off-target effects, large fragment chromosomal deletions or rearrangements, and abnormal clonal proliferation of edited cells remain fundamentally impossible to eliminate [3]. Because the effects of gene editing on the human body are lifelong and irreversible, even decades of follow-up may not exhaustively ascertain all possibilities of long-term carcinogenesis or functional decline. Under these conditions, the so-called “informed consent” given by patients is actually built on a gray foundation of incomplete cognition. The function of ethical review is precisely to protect, to the greatest extent possible in such an asymmetrical information landscape, research subjects from being pushed into an abyss of unknowable risk by academic prestige, commercial interests, or their own despair.
(II) The Blurring of the Boundary Between Therapy and Enhancement
A more insidious ethical risk than safety concerns is the slippery slope of gene editing from “therapy” toward “enhancement.” If using gene editing to restore normal immune function in a child with severe combined immunodeficiency can still be understood as therapy, then editing the myostatin gene to enhance muscle circumference and strength in a healthy person has already crossed into the realm of “enhancement.” The World Anti-Doping Agency has already listed gene editing as a prohibited method; however, the temptation of underground genetic modification always exists and may be carried out under the guise of “genetic optimization” or “health promotion.” Once medical interventions are captured by the logic of consumerism, the intrinsic purpose of medicine is subverted. Michael Sandel has already warned that this “impulse to pursue perfection” would completely turn children into “products of parental will,” strangling the fundamental character of life as a gift [4].
(III) Distributive Justice and Transnational Disorder
The exorbitant cost of gene therapy also poses a severe ethical challenge. Taking Casgevy as an example, the cost per course of treatment exceeds 2.2 million US dollars, which almost entirely excludes the vast majority of low- and middle-income groups from the circle of beneficiaries. If gene enhancement technologies continue to open up to the market, the economically advantaged strata of society may be the first to convert their wealth into biological advantage, creating a “genetic divide.” A Rawlsian conception of justice requires that social and economic inequalities be arranged to the greatest benefit of the least advantaged, whereas uncontrolled gene editing could move in the opposite direction, solidifying a strict correspondence between natural endowments and class identity.
Simultaneously, the unevenness of regulatory standards across different countries has spawned a dangerous “gene therapy tourism.” Some private clinics exploit regulatory vacuums to sell unapproved so-called gene and stem cell therapies to seriously ill patients, already leading to catastrophic outcomes such as severe infections, tumors, and even blindness [5]. This demonstrates that superficial review by ethics committees alone has become virtually useless, and it must be upgraded to a system of state-mandated licensing and full-chain traceability.
III. Human Embryo Gene Editing: Transgenerational Harms and the Ethical Red Line
Unlike somatic cell editing, germline gene editing directly modifies sperm, eggs, or early embryos, and its effects will accompany all cells of the future individual and permanently enter the human gene pool through marriage and reproduction. This is a fundamental issue concerning the integrity of the human species.
(I) Future Generations That Cannot Consent and Irreversible Genetic Erosion
The most fundamental ethical dilemma of embryo gene editing is that the edited individual does not yet exist and, even more so, cannot express consent. Even if parents act with the intention of “doing the best for the child,” this one-way genetic determination has already thoroughly broken the symmetrical relationship between generations. In The Future of Human Nature, Jürgen Habermas profoundly points out that a genetically manipulated individual will never be able to regard the origin of his or her own life as a contingent gift of nature, and his or her sense of autonomous morality in the face of the “maker” will suffer structural trauma [6]. From the perspective of Kantian deontology, the iron law that “a human being is an end and never merely a means” demands to be upheld at the very beginning of life—treating embryos as objects for genetic improvement, no matter what lofty reasons are invoked, already degrades the future person into a projection of some external will.
(II) The Specter of Designer Babies and New Eugenics
Once any legal opening is created for germline gene editing, even for the medical purpose of preventing severe hereditary diseases, it is highly susceptible to having its boundaries continuously pushed under the drive of commercial and technological inertia. At first, it is to eliminate lethal mutations like those causing Huntington’s disease or cystic fibrosis; soon it may expand to conditions such as deafness or dwarfism, which communities do not unanimously identify purely as “diseases,” and then point toward the customization of non-pathological traits like height, intelligence, or skin color. This is no longer a distant hypothesis: among some wealthy classes, a technological desire has already emerged, progressing from selecting embryos based on genetic carrier information to proactively editing them. Francis Fukuyama labels this trend “new eugenics”—it is no longer imposed top-down by the state, but appears in the guise of consumer free choice and parental care, yet equally, if not more profoundly, erodes the natural premise that “all men are created equal” [7]. Once humans become products that can be ordered from a catalogue, the assumption of equality upon which liberal democracy rests ceases to exist.
(III) The Landmark Significance of the He Jiankui Case and the Criminal Law Response
The 2018 He Jiankui gene-edited babies incident is an extreme epitome of the ethical loss of control in global germline genome editing: forging ethical review documents, deceiving informed consent, ignoring off-target risks, and ultimately exposing twin baby girls permanently to unknown biological consequences. In 2019, the People’s Court of Nanshan District, Shenzhen, sentenced He Jiankui to three years in prison for “illegal medical practice” [8]. Yet the very classification as “illegal medical practice” exposed the normative deficiency of the criminal legislation at that time regarding gene editing behaviors.
This lesson rapidly catalyzed legal reform. The Criminal Law Amendment (XI) of the People’s Republic of China, effective from March 1, 2021, added Article 336 bis, which clearly stipulates that implanting a gene-edited human embryo into a human body, if the circumstances are serious, is punishable by fixed-term imprisonment of not more than three years, and if the circumstances are especially serious, by fixed-term imprisonment of not less than three years and not more than seven years. The significance of this clause lies not only in the creation of a specific offense, but also in the fact that, for the first time, the criminal law explicitly and directly declares the clinical implantation of germline gene editing as a crime that endangers the bottom line of human ethics. From this point on, ethical review is no longer a soft norm for internal academic circulation, but a rigid node for the ex-ante deterrence and ex-post accountability of the criminal law.
IV. The Landscape of Global Legal and Ethical Governance: The Weakness of Soft Law and the Rise of Hard Law
(I) Consensus and Limitations of International Ethical Declarations
Since the Nuremberg Code and the Declaration of Helsinki, the ethical norms for human subject research have formed a framework jointly supported by multiple international instruments. Article 11 of UNESCO’s 1997 Universal Declaration on the Human Genome and Human Rights explicitly states that germline genetic interventions contrary to human dignity should be prohibited; the 2005 Universal Declaration on Bioethics and Human Rights emphasizes that the human genome is the common heritage of humanity. In 2021, the World Health Organization issued its Governance Framework for Human Genome Editing and specific recommendations, calling for a global pause on any clinical application of germline genome editing and the establishment of an international registry system [9]. These documents crystallize a cross-cultural moral consensus, but their deficiency is equally apparent: they lack a sanctioning mechanism with coercive force, and in the face of intentional violators and underground commercial operations, they are virtually a dead letter.
(II) The Fragmentation of National Hard Laws and Regulatory Vacuums
Currently, over 40 countries worldwide have explicitly prohibited or strictly restricted human germline genome editing through legislation, and some have simultaneously imposed criminal penalties. For example, Canada’s Assisted Human Reproduction Act provides for a maximum of 10 years’ imprisonment for the illegal editing of human embryos; France has incorporated germline genome editing into its Criminal Code, punishable by several years of imprisonment and heavy fines; the United Kingdom, while renowned for the strict administrative review of its Human Fertilisation and Embryology Authority (HFEA), treats unauthorized gene editing as a criminal offense. However, a considerable number of jurisdictions still confine relevant prohibitions to administrative regulations without criminal liability deterrence, and a few regions even deliberately maintain ambiguity to attract investment in “biomedical tourism.” This fragmented landscape provides space for the underground gene editing industry chain to maneuver, greatly diminishing the effectiveness of global governance.
(III) The Jurisprudential Legitimacy of Criminal Accountability
Configuring criminal penalties for germline gene editing and other serious ethical violations is not an overreach of “legal moralism,” but precisely the necessary choice for the criminal law to protect the most fundamental legal interests. Violations in somatic cell editing may infringe upon individual rights to life and health, but germline editing goes beyond individual legal interests to directly threaten the intergenerational security of the common heritage of humanity—future generations cannot appear as plaintiffs in the current civil litigation system, and only through punishment, the most severe means of public law, can this gap in rights protection be filled. It is precisely based on this logic of “infringement upon the legal interests of third generations and of the human group” that the international community has ample reason to criminalize certain extreme acts of gene editing and even to promote international discussions on including them within the category of crimes against humanity.
V. Constructing a Three-Tier Prevention and Control System: The Synergy of Ethical Review, Administrative Licensing, and Criminal Accountability
Standalone ethical review easily degenerates into a mere formality, while isolated criminal punishment can only operate after the fact. To form an effective closed loop, a three-tier progressive systemic prevention and control architecture of “ethical review—administrative licensing—judicial intervention” should be constructed.
First Tier: Substantive and Rigid Ethical Review. All research and clinical applications involving human gene editing must undergo substantive deliberation by an Institutional Review Board (IRB). The review should employ the four principles of bioethics by Beauchamp and Childress—respect for autonomy, non-maleficence, beneficence, and justice—as the basic analytical framework, focusing on assessing off-target risks, the feasibility of long-term follow-up protocols, the potential exploitation of vulnerable groups in subject selection, and the possible impact on the human gene pool. The review process, resolutions, and ethics approval documents must be uploaded to a unified national platform, subject to random inspection by higher-level authorities, with lifelong accountability tracing for those who violate review procedures.
Second Tier: Prior Administrative Licensing and Transparency. Somatic cell gene therapy must undergo double licensing by the national pharmaceutical regulatory agency after passing ethical review, with risk-benefit ratio as the core criterion, and an open and transparent system for clinical trial registration and result disclosure should be established. Clinical applications of germline genome editing shall not be licensed under any circumstances. Additionally, an independent, interdisciplinary national “Advisory Committee on the Ethics of Gene Technology” should be established to regularly issue ethical assessment reports to the legislature and the public, preventing administrative decisions from being unilaterally captured by industrial interests.
Third Tier: Precision and Inevitability of Criminal Judicial Intervention. Once acts such as implanting gene-edited embryos without a license, forging ethics approval documents, or deceiving research subjects with false informed consent forms occur, criminal procedures shall be initiated. Prosecutors and judges should possess professional training in bioethics, and the courts must conduct substantive evidentiary examination on “whether an act constitutes a violation of human dignity.” Simultaneously, international criminal judicial assistance should be deepened, applying the principle of universal jurisdiction to the black-market chain of transnational gene editing, thereby eliminating regulatory vacuums. The configuration of penalties should cover imprisonment, fines, and professional disqualification orders, to form a comprehensive deterrent.
The essence of the three-tier system is to reforge the “soft law” of ethics, through administrative procedures and criminal justice, into a “hard law” closed loop with binding coercive force. Researchers, capital investors, and institutions will thereby form clear legal expectations: crossing the ethical bottom line can no longer be resolved merely by publishing an apology or retracting a paper, but will entail bearing the full chain of legal consequences, from professional disbarment to penal incarceration.
VI. Conclusion
Gene editing technology is like a double-edged blade, with the medical light of curing chronic diseases inscribed on one side, and the abyssal darkness of subverting human ethics inscribed on the other. When this blade already touches the fundamental integrity of the human species, ethical review must by no means remain confined to collegial discussions among scholars and sanctionless declarations, but must deeply interlock with legal enactment and criminal accountability, jointly constructing an insurmountable boundary.
From the judicial trial of the He Jiankui case to the promulgation of China’s Criminal Law Amendment (XI), and from WHO’s global call to the successive brandishing of swords by criminal laws in various countries, the world is advancing toward a brand-new consensus: the ethical bottom line of human genome editing, especially germline modification, must be safeguarded by clear criminal legislation. This is not a mutilation of scientific freedom, but the deepest reverence for the common destiny of humanity. Only under the starry sky of Kant’s “humanity as an end,” deeply embedding the measure of ethics into the fabric of law and institutions, can we ensure that the scissors that alter the code of life always remain in the hands of reason and conscience.
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