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Gene Editing Against the Courtroom: The Ethics and Regulation of Gene Making

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Authored By: Ashley Voon Xuan Yu

Brickfields Asia College

Introduction

Human enhancement through gene editing has always been a controversial topic subject to much debate. With the development of new nanostructures that supercharges Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) machinery, concerns regarding the ethical and social repercussions of gene-editing technology are raised once again.[1] Such examples serve as an illustration of how the progress in modern genetics challenges medical ethics. Mentions of genetic enhancement usually evokes reactions of cringe and thoughts of Nazi eugenics programmes, not to mention theological debates of whether the approach to genetic modification aligns with a certain religious belief.

That being said, the power to rewrite genetic code can pose to have morally legitimate medical uses, but until scientists can choose to deliver its gene-editing machinery safely into relevant cells and tissues, this revolution of medicine remains out of reach. A scientist’s inherent ability to create requires interdisciplinary collaboration in creating guidelines for the multitude of complex ethical issues as a direct result of this power. In particular, gene editing through the perspective of medicine results in many ethical and psychosocial implications. A strong balance of innovation and bioethics is required to address issues such as synthetic biology and genetic screening.

This article will analyse the relationship between the approach taken by the legislation in regards to gene making. A brief introduction of the history of gene editing methods will be first laid out to set the basis of legislations meant to govern such gene editing methods. Next, an analysis regarding the practical and ethical concerns of such legislations will be held, before proceeding to evaluate the impact of such legislations in practice.

History of Gene Therapy

The complex evolution of gene therapy began with the discovery of the DNA double helix. This has led to the discovery of multiple techniques to perform gene editing. Restriction enzymes paved the way for modern gene editing, allowing scientists to cut DNA into fragments for the purposes of studying, as well as recombining or joining nucleotide sequences through inserting new DNA materials. This was usually done with the aim of identifying gene expressions and regulation. Some cutting limitations still remained.[2]

Precise gene editing was successful through zinc finger nuclease (ZFN), where multiple ZFNs combined will initiate dimerization. This process allows for recognition of longer nucleotide sequences and an amplification of specificity, which improves target adaptation. However, these nucleases are challenging to design and lack target accuracy. This led to the introduction of transcription activator-like effector nucleases (TALENs) that brought high customizability at the cost of longer time of construction.[3]

Perhaps the most crucial development was CRISPR-cas9, initial protection systems used by bacteria repurposed for gene editing.[4] This can be done by inducing double-stranded DNA breaks or RNA cleavages at specific locations in living cells and organisms. This discovery along with TALENs has led to the revolution of life sciences and brought unprecedented precision and expedition to genetic engineering,[5] allowing for recognition of new gene sequences which has accelerated scientific breakthroughs in different disciplines from synthetic biology to agricultural sciences.[6] These tools wield power to change mutations responsible for heritable human diseases, such as through somatic cell gene therapy. Records of such success include the prevention of a disease known as Severe Combined Immune Deficiency (SCID), where new genes were inserted into vectors, activating the initially absent enzyme adenosine deaminase (ADA) gene.[7]

While gene editing could definitely be used for good, it inevitably leads to ethical concerns of genetic classism by the unequal access caused by social economic classes once gene editing is normalised. Additionally, this can also lead to various ‘off target’ effects where its impact is passed on for generations to its descendants through the ‘germ line’, inciting fears that embryo editing could have lasting, unintended consequences. This has already been put in practice by He Jiankui, a genome-editing researcher at the Southern University of Science and Technology of China in Shenzhen who created the world’s first gene-edited babies by disabling a gene named CCR5 attempting to make the twin girls immune to HIV.[8]

The ethical red lines scientists are willing to cross highlights recklessness in pursuit of innovation, where the twin girls would require lifetime monitoring.[9] Additionally, its actual immunity against a virus that is both preventable and treatable has yet to be proved. This ‘success’ comes with a price, where mutations in CCR5 genes are connected to shorter lifespan.[10] If a cost is exchanged for such immunity, does it not defeat the purpose of gene editing in the first place? Why go forward with heritable genome editing when it clearly costs a price that is unknown and further develop in the later descendants? Does this not cross the line into human experimentation? Would this then constitute a breach of human rights?

Gene-editing regulation across jurisdictions

He’s experiment and research is merely the beginning of many more. In 2019, Denis Rebrikov, a combative Russian biologist aims to cure deafness through gene editing.[11] Clearly, regulation and prevention must be done in order to curate safe environments for research and innovation. Rosario Isasi separates gene editing legislation into two important waves, the first one catering to the derivation of embryonic stem cells which was largely accepted, and the other regarding reproductive cloning that is largely prohibited. Current regulatory guidelines are in fact set up, and Tetsuya Ishii research notes that 29 out of 39 countries have implemented rules that can be interpreted as restricting genome editing for clinical use. However, such restrictions especially in major developed countries including Japan, China and India are not legally binding.[12] Furthermore, rules in nine other countries including Russia and Argentina are mostly ambiguous, with more clarification needed. In particular, The United States forbids federal funding for research involving human embryos, but does not officially ban the use of human gene editing in clinics. On the other hand, countries that ban clinical use of gene editing like France, allows research that accords to restrictions and does not attempt to generate live birth.[13] Overall, it is clear that regulations at best feature a range of approaches, some choosing to criminalise gene editing like Australia and others providing unenforceable or ambiguous guidelines.[14] It is evident that there is a strong need for international guidelines that can at least guide national lawmakers in their approach to gene editing.

Human Fertilisation and Embryology Act 1990

The Human Fertilisation and Embryology Act (HFE) was passed by the British Parliament in 1990, further receiving amendment in 2008. This article will mainly focus on this act as it served as the first legislation that entailed the regulation of human reproductive technologies.[15] Main influences in drafting the act include the 1987 white paper ‘Human Fertilisation and Embryology: a Framework for Legislation’[16] as well as the 1984 Warnock Report.[17] Along with the act, the Human Fertilisation and Embryology Authority (HFEA) has been established as an independent regulator of fertility treatment and research of human embryos. Two parts will be scrutinised in this article, including the activity for which licence for research with human embryos can be granted (Schedule 2 2(3a)(1)) and the prohibitions on placing an embryo (other than permitted embryo) in a woman (s3(2)).

Activity for which licence for research with human embryos can be granted

The definition of permitted eggs, sperm and embryo must first be clarified. The HFE defines permitted genetic material under two categories, notably egg or sperm and embryo. Both genetic materials should be free from alterations to nuclear, mitochondrial DNA or the addition of external cells.[18] Schedule 2 entails all of the requirements that the HFEA are required to enforce when licensing professions and institutions to use or store human embryos. These include the creation of embryos in vitro (a) and also the procuring, keeping, testing or distribution of embryos or usage of gametes. In particular, the 2008 amendment clarifies that research for gene editing and modification is prohibited for developing embryos[19], except for legally approved techniques meant for mitochondrial disease prevention. It can only be done on embryos not developed beyond 14 days and should be destroyed afterward. The duration of 14 days is crucial, preventing the experimentation on a biological individual.[20] Therefore, it could be said that the 14-day limit is implemented to build public trust while providing legal protection to human embryos.[21] This aligns with the Warnock’s Committee’s view.[22]  It is to note that this is only allowed for somatic editing to body cells not meant for passing to offspring. Germline editing and hereditary genome editing is prohibited.

Prohibitions on placing an embryo in a woman

Section 3(2) HFE specifically prohibits the placement of an egg, sperm or embryo. The only exception to this prohibition is in 32A(5), where combined with subsequent regulations, allows for the clinical use of MRTs[23], yet it is unclear on who should receive the treatment.[24] Nevertheless, it is clear that He’s experiment would similarly never have been allowed to proceed in the United Kingdom. Yet, with such rapid advancement of CRISPR, how can the legislation attempt to balance the interests of innovation and ethicality?

Gene editing -Treatment or Enhancement?

Constructing legislation for any new technology would require a use of precise linguistic terminology to ensure that both the general public and the treatment itself is utilised and perceived the way it is intended.[25] This poses a key question – while the UK Parliamentary Office of Science and Technology (POST) explicitly refers to hereditary human genome editing as a form of therapy, the House of Commons Science and Technology Committee (HCSTC) questions if gene editing constitutes medical treatment especially when the ‘patient’ has yet to exist.[26]

Many have argued that ‘treatment’ constitutes situations of treatment and prevention of serious genetic diseases for the well-being of a future child. This approach can be seen in both scientists and also legislators alike.[27] This should not include genetic enhancement, and should be instead a ‘one-off treatment that would benefit the individual born and perhaps their children.[28] Scientifically, such treatment merely serves as the basis of assisted reproductive technology, not for the design or construction of a completely new life.[29]

Internationally, the World Health Organisation chooses to retain ‘treatment’ only for prenatal and postnatal somatic genome editing aimed for treating genetic disorders.[30] Interestingly, this approach emphasises on correction and prevention rather than treatment in regards to the future child. A key question should then be answered – in the event that a treatment aimed for prevention develops unpredictably, would the child be able to take action against the medical centre for the aftereffects? Afterall, there seems to be some recognition in regards to the protection of the embryo’s rights.

The Illegality of He’s Research and the Rights of an Unborn Child

International law’s approach to the rights of an unborn child still remains in development.  Similarly to the HFE, the Oviedo Convention holds that gene editing should only be undertaken for preventive, diagnostic or therapeutic measures and should not be meant for inheritance of any descendants.[31] Article 3 of the ECHR holds that everyone is entitled to the right to respect for both physical and mental integrity, in particular where there must be free and informed consent of the person concerned (Art 3(2)(a)) and no eugenic practices (Art 3(2)(c)).[32] He’s experiment was clearly an illicit human experimentation, violating the prohibition on heritable human genome editing (Art 13) and the requirement that research on human beings must only be conducted if there is no alternative of comparable effectiveness and the risks are not disproportionate to potential benefits (Art 16) of the Oviedo Convention. The unnecessary medical risk taken by his experiment just to provide HIV resistance when methods to safely prevent HIV transmission already exist makes such risky experiments all the more redundant. Does this not destroy the public’s trust and further dismantle the weight given to these legislative guidelines, especially when he was sentenced to a mere three years in prison?[33]

While the experiment of the twin sisters still remains as an evolving case, and while he claims that the girls are completely immune to HIV and suffer no side effects, it is simply too early to come to any conclusive conclusions. In the event where these girls develop aftereffects that can be proved to be a direct result of the gene editing, is it possible to argue under Article 3 that there was no free and informed consent of the treatment? Unlike the embryo protection mentioned above, these girls have already grown past the 14-day stage and have already developed into a proper human being. How would they be able to enforce protection for both themselves and their future offspring affected by the genetic treatment? This remains to be an open question.[34]

Conclusion

He’s experiment on heritable human genome editing serves as a chilling reminder on the importance of constructing properly regulatory legislations as well as tightly enforcing them. While it is argued that the current legislations, at least observed in the United Kingdom, serves its purpose, little can be said for other jurisdictions. He’s lenient sentencing when compared to the impact of his recklessness, suggests that current legislative frameworks remain insufficient to prevent the serious consequences of unregulated gene editing.[35]

Bibliography

Primary Sources

UK Secondary Legislation

  • Human Fertilisation and Embryology Act 1990
  • The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, SI 2015/1730

EU Legislation

  • European Convention on Human Rights

Treaties and Conventions

  • Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention)

Secondary Sources

Books

Journal Articles

Command Papers

  • Department of Health and Social Care, Human Fertilisation and Embryology: A Framework for Legislation (Cm 259, 1987)

Newspapers

Websites and Blogs

Podcasts

[1] ‘Scientists just made CRISPR three times more effective’ (ScienceDaily, 7 September 2025) https://www.sciencedaily.com/releases/2025/09/250907024543.htm accessed 13 May 2026

[2] Leslie Pray, ‘Restriction Enzymes’ (Nature Education, 2008) https://www.nature.com/scitable/topicpage/restriction-enzymes-545/ accessed 13 May 2026

[3] ‘Gene Editing Techniques’ (Cytosurge) https://www.cytosurge.com/applications/gene-editing-techniques accessed 13 May 2026

[4] Ibid

[5] Martin Jinek and others, ‘A Programmable Dual-RNA–Guided DNA Endonuclease in Adaptive

Bacterial Immunity’ (2012) 337(6096) Science 816 https://doi.org/10.1126/science.1225829 accessed 13 May 2026

[6]  Thomas Gaj and others, ‘Genome-Editing Technologies: Principles and Applications’ (2016) 8 Cold Spring Harbour Perspectives in Biology 1 https://doi.org/10.1101/cshperspect.a023754 accessed 13 May 2026

[7] Laura Garcia-Perez and others, ‘Successful Preclinical Development of Gene Therapy for Recombinase-Activating Gene-1-Deficient SCID’ 17 Molecular Therapy: Methods and Clinical Development 666 https://doi.org/10.1016/j.omtm.2020.03.016  accessed 14 May 2026

[8]‘Chinese Scientist Claims World’s First Gene-Edited Babies’ BBC News (26 November 2018)

accessed 15 May 2024 https://www.bbc.com/news/world-asia-china-46368731 accessed 14 May 2026

[9] Heidi Ledford, ‘The Landscape for Human Genome Editing’ (2015) 526 Nature 310 http://ibcm.blog.unq.edu.ar/wp-content/uploads/sites/63/2014/08/Situaci%C3%B3n-de-CRISPR-en-embriones-humanos-Nature-2015.pdf accessed 14 May 226

[10] Anjana Ahuja, ‘Crossing Ethical Red Lines in Gene Editing’ Financial Times (London, 27

December 2019) https://www.ft.com/content/6218346c-258d-11ea-9f81-051dbffa088d?syn-25a6b1a6=1 accessed 14 May 2026

[11] Heidi Ledford, ‘CRISPR Babies: When Will the World Be Ready?’ (2019) 574 Nature 16 https://doi.org/10.1038/d41586-019-03018-0 accessed 14 May 2026

[12] Motoko Araki and Tetsuya Ishii, ‘International Regulatory Landscape and Integration of Corrective Genome Editing into In Vitro Fertilization’ (2014) 12 Reproductive Biology and Endocrinology 108 https://doi.org/10.1186/1477-7827-12-108 accessed 14 May 2026

[13] Ibid

[14] Heidi Ledford (n 9)

[15] Human Fertilisation and Embryology Authority, ‘Modernising the Regulation of Fertility

Treatment and Research Involving Human Embryos’ (2023) https://www.hfea.gov.uk/about-us/modernising-the-regulation-of-fertility-treatment-and-research-involving-human-embryos/modernising-fertility-law/ accessed 14 May 2026

[16] Department of Health and Social Care, Human Fertilisation and Embryology: A Framework for

Legislation (Cm 259, 1987)

[17] Sarah Devaney and others, ‘Genome Editing’ in Law, Bioethics and New Technologies (Routledge

2021) https://doi.org/10.4324/9781003146612-6 accessed 14 May 2026

[18] Human Fertilisation and Embryology Act 1990, s 3ZA(2)

[19] Human Fertilisation and Embryology Act 1990, sch 2, para 4

[20] Bruce Philip Blackshaw and Daniel Rodger, ‘Why we should not extend the 14-day rule’ (2021) 47 Journal of Medical Ethics 712 https://doi.org/10.1136/medethics-2021-107317 accessed 14 May 2026

[21] Mary Warnock, ‘Should the 14-day Limit on Human Embryo Research be Extended?’ (BioNews,

30 May 2017) https://www.progress.org.uk/should-the-14-day-limit-on-human-embryo-research-be-extended/ accessed 14 May 2026

[22] Bruce Philip Blackshaw and Daniel Rodger (n 17)

[23] The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, SI 2015/1730

[24] Rosamund Scott, ‘Heritable human genome editing: correction, selection and treatment’ (2024) 32 Medical Law Review 178 https://doi.org/10.1093/medlaw/fwae003 accessed 14 May 2026

[25] European Commission, European Group on Ethics in Science and New Technologies Ethics of Genome Editing (Publications Office 2021) https://data.europa.eu/doi/10.2777/659034 accessed 14 May 2026

[26] Rosamund Scott (n 21)

[27] Ibid

[28] Ibid

[29] Giulia Cavaliere, ‘Genome editing and assisted reproduction: curing embryos, society or prospective parents?’ (2018) 21 Medicine, Health Care and Philosophy 215 https://doi.org/10.1007/s11019-017-9793-y accessed 14 May 2026

[30] World Health Organization, Human Genome Editing: A Framework for Governance (World Health Organisation 2021) https://www.who.int/publications/i/item/9789240030060 accessed 15 May 2026

[31] Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine (Oviedo Convention)

[32] Convention for the Protection of Human Rights and Fundamental Freedoms (European Convention on Human Rights, as amended) (ECHR) art 3

[33] Alexis Pedrick, ‘The CRISPR Babies’ (16 September 2025) https://www.sciencehistory.org/stories/distillations-pod/the-crispr-babies/ accessed 15 May 2026

[34] Shuang Liu, ‘Legal reflections on the case of genome-edited babies’ 5 Global Health Research and Policy 24 https://doi.org/10.1186/s41256-020-00153-4 accessed 15 May 2026

[35] Jing-ru Li and others, ‘Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance’ 20 Journal of Zhejiang University-SCIENCE B 32 https://doi.org/10.1631/jzus.B1800624 accessed 15 May 2026

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