Traversing Uncharted Territory? The Legislative and Regulatory Landscape of Heritable Human Genome Editing in Australia

Published date01 March 2024
DOIhttp://doi.org/10.1177/0067205X241236212
AuthorOlga C Pandos
Date01 March 2024
Subject MatterArticles
Article
Federal Law Review
2024, Vol. 52(1) 75102
© The Author(s) 2024
Article reuse guidelines:
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DOI: 10.1177/0067205X241236212
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Traversing Uncharted Territory?
The Legislative and Regulatory
Landscape of Heritable Human
Genome Editing in Australia
Olga C Pandos*
Abstract
In 2018, the birth of the worldsf‌irst CRISPR Babiesrendered the global community in disbelief. This
was the catalyst for an international moratorium on Heritable Human Genome Editing (HHGE). For
the f‌irst time, the international community was prompted to consider a pathway forward to regulate
HHGE. In light of the evolving maturity of Clustered Regularly Interspaced Short Palindromic Repeats
(CRISPR) as a biotechnology, it is timely to evaluate Australian federal legal and regulatory frameworks
governing human genome editing. The response to HHGE must carefully balance the need to prevent
unethical applications, against the progress of research to improve and ref‌ine the technology. This article
argues Australias federal legislative regime must be reviewed to ensure it has the necessary capabilities
to effectively regulate HHGE. It applies three schools of thought which offer an instructive theoretical
lens to understand how Australian law has responded to advancements in technology. In addition, an
analysis of the governing federal legislation reveals three regulatory gaps complexity, operational
ambiguity and inconsistent legislative objectives. Together, these gaps may be indicative of a legislative
and regulatory landscape that is no longer f‌it for purpose.
Accepted 14 June 2023
I Introduction
In 2018, the birth of the worldsf‌irst CRISPR Babiesrendered the global community in disbelief.
This reckless ethical disasterwas the catalyst for an international moratorium on Heritable Hum an
Genome Editing (HHGE).
1
This disaster was said to be caused, in part, by a failure of self-
* Lecturer in Law and PhD Candidate in TechnologyLaw & Ethics, The University of Adelaide, Australia. Olga has degrees in
Law (Hons) and Science (majors in Biochemistry and Genetics).Olga is a recipient of the Australian Government Research
Training Program Scholarship. I sincerely thank my supervision panel, in particular, Prof Peter Burdon and Prof John Williams
AM for their constructive comments regarding earlier versions of this manuscript. Please note that this article ref‌lects law and
practice as at May 2023.
1. Henry T Greely, CRISPRd Babies: Human Germline Genome Editing in the He Jiankui affair(2019) 6(1) Journal of
Law and the Biosciences 111, 113.
regulation by the scientif‌ic community, [due to] a lack of transparency.
2
For the f‌irst time, the
international community was prompted to consider a pathway forward to regulate HHGE, to avoid
another CRISPR Babies event.
In light of the evolving maturity of Clustered Regularly Interspaced Short Palindromic Repeats
(CRISPR) as a biotechnology,
3
it is timely to evaluate current legal and regulatory frameworks
governing human genome editing in Australia. The development of a regulatory framework requires
the examination of unique bioethical and legal issues through a future-oriented lens, to foster a
robust, effective mechanism for the application of CRISPR in humans.
The legal and regulatory response to HHGE must carefully balance the need to prevent unethical
applications, against the progress of research to improve and ref‌ine the technology. Bioethics,
particularly in the context of emerging biotechnologies, is arguably the foundation of an effective
regulatory regime. It provides a guide to forecast and navigate some of the challenges a regulatory
regime will be required to address, manage and possibly resolve. The application of CRISPR
technology in human germline cells is a controversial area, confronting societys well-established
norms and expectations concerning the relationship between law, science and ethics.
This article argues Australias legislative regime must be reviewed to ensure it has the necessary
capabilities to effectively regulate HHGE. The intent of this article is twofold. First, it explores how
history has led to Australias regulatory approach, by focussing on one aspect: the relationship
between law and science. Second, it identif‌ies the regulatory shortcomings of Australias current
legal governance framework.
This article is conf‌ined to a discussion of HHGE and does not consider somatic genome editing or
mitochondrial donation.
4
While signif‌icant developments have been made in somatic genome
editing,
5
this article intends to advance a discussion concerning the regulation of HHGE, which
remains in need of greater interrogation and consideration. As noted by Giovanni Rubeis and
Florian Steger [a]lthough there are no clinical applications of [germline genome editing] available
at the moment, it is important to have an intense ethical debate at this early stage in order to be
prepared for coming developments.
6
While this article does not offer an ethical evaluation of
HHGE, this conclusion remains relevant. This article serves to contribute to the literature con-
cerning the regulatory approach to HHGE.
7
Part II discusses the connection between history and technology, as a means to illustrate the
ongoing fraught relationship between the two disciplines. It is through this historical and theoretic al
lens that we can gain a better understanding regarding the laws response to emerging technologies.
2. Ibid 138.
3. For the purposes of this article, the terms technologyand biotechnologywill be used synonymously.
4. Somatic genome editing refers to genetic edits that are not heritable.
5. Robin Lovell-Badge et al, Statement from the Organising Committee of the Third International Summit on Human
Genome Editing(Statement, International Summit on Human Genome Editing, 8 March 2023).
6. Giovanni Rubeis and Florian Steger, Risks and Benef‌its of Human Germline Genome Editing: An Ethical Analysis
(2018) 10(2) Asian Bioethics Review 133, 134.
7. Giulia Cavaliere, Katrien Devolder and Alberto Giubilini argued an emerging biotechnology is accompanied by ethical
questions that arise at two levels. The f‌irst level raises substantive ethical questions, which consider the moral identity of
the technology and its associated ethical concernsdue to its application. The second level refers to how we should regulate
[the technology] and who should decide about how to regulate it: Giulia Cavaliere, Katrien Devolder and Alberto
Giubilini, Regulating Genome Editing: For an Enlightened Democratic Governance(2019) 28 Cambridge Quarterly of
Healthcare Ethics 76. For the purposes of this article, its focus would fall within the second level of ethical questions. The
authors also argue that [l]imited attention has been devoted to questions regarding [the emerging technologys] reg-
ulation: see Giulia Cavaliere, Katrien Devolder and Alberto Giubilini, Regulating Genome Editing: For an Enlightened
Democratic Governance(2019) 28 Cambridge Quarterly of Healthcare Ethics 76, 77.
76 Federal Law Review 52(1)

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