Assignment Prompt & Instructions
– 2 years ago
**files (6)**
– ## Homework-ProposalforResearchPaper.docx
– ## Soni-2024-RecentDevelopmentsintheRegulationofHeritableHumanGenomeEditing.pdf
– Harris-1997-GoodbyeDollyTheethicsofhumancloning.pdf
– Lavi-2018-CloningInternationalLawTheScienceandScienceFictionofHumanCloningandStem-CellPatenting.pdf
– Barthetal.-2020-GeneticEndowmentsandWealthInequality.pdf
– Greely-2021-CRISPRPeopleTheScienceandEthicsofEditingHumans.pdf
**## Homework-ProposalforResearchPaper.docx**
**What is your narrowed research topic?**
The Ethical, Societal, and Scientific Implications of Legalizing Genetic Modification and Cloning in Humans
****Why have you chosen this topic? How does this topic affect you personally? (It does.) Be specific.****
**I have chosen this topic because genetic modification and cloning have the potential to revolutionize medicine and human health. The idea of eliminating genetic disorders, extending human lifespan, and enhancing physical and cognitive abilities is both fascinating and controversial. This topic presents a vision of the future where chronic diseases and genetic limitations become obsolete. However, genetic cloning cannot be taken lightly, and there are concerns about the disastrous implications it could bring. By exploring this topic, I hope to find strong arguments that consider both the potential benefits and the ethical concerns.**
****What kind of foundational or base knowledge might your team need before starting your research journey?****
**·**
****Scientific Basis:** Understanding the different techniques through which cloning or genetic modification can be carried out.**
**·**
****Historical Context:** Reviewing past cloning experiments, including the most famous one, Dolly the sheep.**
**·**
****Ethical and Legal Considerations:** Examining the concerns raised by bioethicists, religious groups, and politicians regarding this issue.**
**·**
****Public Perception:** Investigating media reactions and understanding public fears regarding this new technology.**
**·**
****Current Regulations:** Reviewing the existing laws on this topic in the USA, Europe, and China.**
****How much do you already know about the topic?****
**I believe I understand the basic concepts behind genetic modifications and cloning. Additionally, I am aware that in the past, experiments have been conducted on cloning animals, as well as some attempts at genetic modifications in humans. However, I need to delve deeper into the ethical debate, legal frameworks, and the social consequences if this technology is adopted on a global scale.**
****Offer at least three potential perspectives to explore in your research.****
**·**
****Scientific and Medical Advances:** The potential to eliminate genetic diseases such as cancer. Applications in regenerative medicine and organ transplantation. Preventive medicine or a definitive cure for multiple diseases.**
**·**
****Ethical and Social Concerns:** The debate over "designer babies" and the implications of genetic inequality. Religious or philosophical arguments against genetic modification. Concerns about harmful genetic modifications or the loss of genetic diversity.**
**·**
****Political and Legal Considerations:** Comparing the different regulations among the three major global powers: the USA, the EU, and China. Potential changes in these regulations. The role of governments and international organizations in regulating genetic modifications and cloning.**
****Ask yourself: Who is impacted by this topic? Who cares about this topic? Who researches this topic, or works in this field? Who might be making things better or worse?****
**· Individuals with Genetic Disorders.**
**· Scientists and Medical Researchers.**
**· Ethicists and Religious Groups.**
**· Lawmakers and Government Agencies.**
**· Pharmaceutical and Biotech Companies.**
**· The General Public.**
**Ask yourself: Who is impacted by this topic? Who cares about this topic? Who researches this topic, or works in this field? Who might be making things better or worse?**
**· Genetic modification in humans**
**· Human cloning ethics**
**· Legalization of genetic engineering**
**· Benefits of human cloning**
**· Ethical concerns in genetic modification**
**· Future of gene therapy**
**· Human genome editing regulations**
**· Medical advancements through cloning**
**· Societal impact of designer babies**
**· Cloning laws in USA, EU, and China.**
**## Soni-2024-RecentDevelopmentsintheRegulationofHeritableHumanGenomeEditing.pdf**
Vol.: (0123456789)
1 3
Bioethical Inquiry (2024) 21:15–18
https://doi.org/10.1007/s11673-023-10332-w
RECENT DEVELOPMENTS
Recent Developments in the Regulation of Heritable Human
Genome Editing
S. Soni
Received: 15 November 2023 / Accepted: 18 December 2023 / Published online: 3 April 2024
© The Author(s) 2024
Abstract In 2018, the Chinese scientist He Jiankui
presented his research at the Second International
Summit on Human Genome Editing in Hong Kong.
While it was intended that he facilitate a workshop,
he was instead called on to present his research in
heritable human genome editing, where he made
the announcement that he had taken great strides in
advancement of his research, to the extent that he
had gene-edited human embryos and that this had
resulted in the live births of two children. While his
research ethic and methodology was interrogated, he
insisted that two children, twin girls, had been born
healthy and that there was another pregnancy (at the
time) where birth of a third gene edited child would
be imminent. This announcement generated a ripple
effect in the scientific community and exposed the
gaps in regulation and absence of law relating to the
technology. This resulted in a flurry of activity and
conversation around regulation of the technology,
which scientists stated was not ready for human trials.
This article reviews the Third Summit which was held
in London in March 2023 and comments on the lat-
est developments in the regulation of heritable human
genome editing.
Keywords Genome editing · Health · Bioethics ·
Autonomy · Law · Regulation
Introduction
Human genome editing has the potential to revolu-
tion human health. By using gene editing tools such
as CrisprCas9 to alter the DNA of an organism, gene
editing can make molecular changes to that organ-
ism’s DNA to obtain a desired outcome. Research in
gene editing has targeted issues in health including
the improvement of health outcomes as well as dis-
ease control. In this respect we have seen research on
the use of gene editing to improve crops to make them
hardier and more resistance to environmental stresses.
We have also seen research on the use of gene edit-
ing to alter the genomes of mosquito to remove their
ability to transmit diseases such as malaria. We have
also seen research on cattle, with a view to alter their
genomes to render them horn-less. However, none of
that research has attracted as much human investment
and attention as the research on potential applica-
tions of gene editing technology to resolving issues in
human health.
In 2018, when He Jiankui made his revelation that
he had altered the genomes of two children for the
purposes of rendering them resistant to HIV infec-
tion, the news received mixed reactions. While the
scientific community largely condemned his flagrant
disregard for the safety of the children involved, the
S. Soni (*)
School of Law, University of KwaZulu-Natal, Scottsville,
Pietermaritzburg 3209, South Africa
e-mail: sonish@ukzn.ac.za
[http://crossmark.crossref.org/dialog/?doi=10.1007/s11673-023-10332-w&domain=pdf](http://crossmark.crossref.org/dialog/?doi=10.1007/s11673-023-10332-w&domain=pdf)
[http://orcid.org/0000-0001-6678-6008](http://orcid.org/0000-0001-6678-6008)
It is urgent robust laws for human genome editing. Scientific advancements outpace regulatory measures.
There is significant deficiencies in global governance concerning heritable genome editing.
16 Bioethical Inquiry (2024) 21:15–18
1 3
Vol:. (1234567890)
general population remained divided on the issue.
On the one hand people were concerned that he had
subjected our weakest and most vulnerable to what
amounted to human experimentation (the children’s
genomes were edited when they were at the embry-
onic stage of development), but on the other hand
many people applauded his attempt at reducing esca-
lating HIV rates. If gene editing has the potential to
eradicate diseases such as HIV, cancer, and others,
then on what basis should we stop the scientists who
are trying to do this?
Heritable Human Genome Editing
Human genome editing utilizes gene editing tech-
nology to make changes to human DNA to achieve
a desired change in the genome. We may distin-
guish between somatic editing, which is gene edit-
ing applied to somatic cells. This type of gene edit-
ing does not create heritable changes and the changes
to the DNA remain with the individual themselves.
Apart from establishing the safety and efficacy of
the therapy and obtaining the required approvals to
bring the therapy to market, this type of gene edit-
ing remains largely uncontroversial. On the other
hand, heritable genome editing remains concerning
as it involves editing the DNA of embryos or gam-
etes, which results in alterations to a genome that is
heritable by future generations. Beyond establishing
merely safety and efficacy, this type of gene editing
is fraught with legal and ethical issues. Since 2018,
there has been significant movement in the form of
international debate, the drafting of reports and the
creation of working groups to consider the ethical
and legal issues surrounding heritable genome editing
(National Academy of Medicine et al. 2020). This has
also stimulated academic debate (Angrist et al. 2020).
The Third International Summit on Heritable
Human Genome Editing
The Third International Summit on Human Genome
Editing, which was convened by the U.K. Royal
Society, U.K. Academy of Medical Sciences, U.S.
National Academies of Sciences and Medicine, and
the World Academy of Sciences, aimed to discuss
progress, promise, and challenges in research,
regulation, and equitable development of human
genome editing technologies and therapies. The
Summit attracted leading scientists in the field,
policymakers and also featured the first patient who
had been treated for sickle cell anaemia using gene
editing technology. The findings of this third meeting
emphasized that remarkable developments had been
made in the field of somatic human genome editing,
however the high cost of somatic therapies was
highlighted as unsustainable and participants called for
a global commitment to ensuring equitable access to
treatment. The finding in respect of heritable genome
editing however was not as positive. Here the finding
was that this type of gene editing remains unacceptable
as safety and efficacy had not been established,
and that the governance frameworks and ethical
principles which would apply to responsible use of the
technology were not in place (Organizing Committee
of the Third International Summit on Human Genome
Editing 2023). In this regard, there has been a move in
the South African jurisdiction to address these issues.
The Scope of the Law
In 2020 Baylis et al. undertook a policy survey of
106 countries in order to obtain a clear and accu-
rate understanding of the global policy landscape
for human germline and heritable genome editing
(Baylis et al. 2020). That study revealed that 96
out of the 106 countries surveyed had policy docu-
ments which were relevance to the use of heritable
human genome editing. These documents included
legislation, regulations, guidelines, codes, and
ratification of international treaties. But law takes
time to be enacted. The majority of the legal canon
which exists today is based on historic law, which
has been measured against the “supreme” laws of
a country which include Constitutions and other
documents which codify the fundamental human
rights. The written law which exists today does not
describe or mention gene editing because the tech-
nology did not exist at the time that the laws were
drafted. However, we can try to find some guidance
by considering the two broad types of law, which is
hard law and soft law. Hard law exists in the form
of legislation and statutes, and there are legal con-
sequences for violating these laws (such as fines or
imprisonment). Soft law does not carry the force of
There is a global acknowledgment of the need for cohesive policies. International efforts are necessary to address these new challenges.
This summit reflects ongoing efforts to balance scientific innovation with ethical considerations.
This consensus emphasizes the current ethical stance against heritable genome editing.
17Bioethical Inquiry (2024) 21:15–18
1 3
Vol.: (0123456789)
true law and exists in the form of guidelines as to
what may be permissible in a given set of circum-
stances. For instance, codes of conduct and good
practice guidelines for a medical practitioner would
fall into this class. While they highlight what is per-
missible, they themselves are not identified as law
by the law-making bodies of a country. They can
however indirectly have legal consequences for a
person, for instance if a medical practitioner does
not follow good practice guidelines, they may lose
their licence to practice medicine and that has the
legal consequence of the medical practitioners not
being able to lawfully practice medicine any longer.
The distinction between these two types of law
is important, because we need the hard law to be
able to enforce legal principles of good governance
that come with a penalty where these laws are con-
travened. A large part of Jiankui’s ill-reception was
based on the disregard for ethics in science, as well as
his methodologies employed at various stages in his
research. This included the ethical approvals which
were obtained, where the experiments were con-
ducted, and how he approached potential participants
to participate in the research and permit the editing of
their embryo’s genome. However, a significant ques-
tion at the time was whether Jiankiu had broken any
laws when conducting his research. There were no
laws in China at the time which prohibited gene edit-
ing, and for that reason in the end Jiankui was charged
with practicing medicine without the required licence,
which was the only charge which the Chinese authori-
ties could lawfully bring against him. The children
themselves were gene edited at the embryonic stage,
at which point they did not possess any legal recogni-
tion as they were not legally recognized persons who
would be capable of possessing legal rights, duties,
and responsibilities. Because embryos do not pos-
sess legal personhood, they do not have rights in the
manner which people generally do. However, there
is ethical and moral significance which embryos do
attract and this can be seen in the law and regulations
surrounding research which involve human embryos.
The most significant rule in this regard is the “14-day
rule” which prohibits research on a human embryo
once it reaches the 14th day of development. This rule
has been enshrined in the law in the legal systems of
many countries, including South Africa, where we
see it in a Regulation which supports South Africa’s
National Health Act 61 of 2003.
South Africa’s Suggestions
The Baylis study noted that South Africa did not
have “any relevant information” regarding heritable
human genome editing. However, research has shown
that while gene editing is not expressly mentioned in
extant law, there are two statutes which may possibly
be applied to the technology in a regulatory fashion
(Thaldar and Shozi 2022). The first is the Medicine
and Related Substances Act 101 of 1965, where the
definition of “medical devices” may be interpreted so
as to include gene editing tools. If this were the case,
then gene editing tools such as CrisprCas9 would fall
under the ambit of the South African Health Prod-
ucts Regulatory Authority. The second possible stat-
ute which could be interpreted so as to apply in the
context of heritable human genome editing is the
National Health Act 61 of 2003. This statute prohib-
its human cloning as it involves “the manipulation
of genetic material in order to achieve the reproduc-
tion of a human being.” It has been argued that the
legal permissibility of heritable human genome edit-
ing may rest on the way in which the words repro-
duction of a human being is interpreted. If interpreted
to mean human reproduction, then heritable human
genome editing would be unlawful. However, if inter-
preted narrowly so as to mean the replication of a
human being, then the statute would not prohibit gene
editing methods that result in heritable changes, and
both preclinical and clinical trials for the technology
would be subject to ethical clearance requirements
by a health research ethics committee in terms of the
same statute.
By considering the meaning of the provisions of
these two statutes, a set of five ethical principles have
been suggested which may be used to draft possible
guidelines, as there are currently no guidelines on
genome editing in South Africa which could assist the
South African Health Products Regulatory Authority
or health research ethics committees (Thaldar et al.
2020). In summary, they are the following:
Principle I: Given its potential to improve the lives
of the people of South Africa, heritable human
genome editing should be regulated, not banned.
Principle II: Heritable human genome editing’s
clinical applications should be made accessible to
the public only if they are proven to be safe and
effective.
18 Bioethical Inquiry (2024) 21:15–18
1 3
Vol:. (1234567890)
Principle III: Non-therapeutic heritable human
genome editing should be regulated in the same
way as heritable human genome editing, with the
rider that it should not in any legally relevant
sense cause harm.
Principle IV: The decision whether to use herit-
able human genome editing in a prospective child
should, subject to principles I, II, and III, be left to
the prospective parents.
Principle V: Concerns about exacerbating social
inequalities should be addressed by measures to
increase access.
These principles were embodied in suggested
regulatory guidelines have been submitted for possi-
ble inclusion in the revised National Health Research
Ethics Guidelines which set out the norms and stand-
ards for research in South Africa.
Concluding Comments
Human genome editing presents the possibility of
curing serious illness, as well as removing serious
illness from an individual’s family tree. If it remains
unregulated, there will remain a tension between
the scientific community which wants to develop
its research into marketable therapeutics and health
needs of the broader population. Properly regulated,
the risk of unethical research will be reduced and a
rights-based approach to science will ensure that
scientific progress may continue within legal param-
eters, and the legal rights of clinical trial participants
as well as patients are protected. It is hoped that the
suggestions submitted in respect of the South African
national ethics guidelines will be well received and
that South African developments may bring us closer
to a clinical pathway to heritable human genome
editing.
Funding Open access funding provided by University of
KwaZulu-Natal.
Declarations
Competing interest The author(s) declare no competing
interests.
Open Access This article is licensed under a Creative Com-
mons Attribution 4.0 International License, which permits
use, sharing, adaptation, distribution and reproduction in any
medium or format, as long as you give appropriate credit to the
original author(s) and the source, provide a link to the Crea-
tive Commons licence, and indicate if changes were made. The
images or other third party material in this article are included
in the article’s Creative Commons licence, unless indicated
otherwise in a credit line to the material. If material is not
included in the article’s Creative Commons licence and your
intended use is not permitted by statutory regulation or exceeds
the permitted use, you will need to obtain permission directly
from the copyright holder. To view a copy of this licence, visit
http:// creat iveco mmons. org/ licen ses/ by/4. 0/.
References
Angrist M, R. Barrangou, F. Baylis, et al. 2020. Reactions to
the National Academies/Royal Society Report on Her-
itable Human Genome Editing. CRISPR Journal 3(5):
332–349.
Baylis, F., M. Darnovsky, K. Hasson, and T.M. Krahn. 2020.
Human germline and heritable genome editing: The global
policy landscape. The CRISPR Journal 3(5): 365–377.
National Academy of Medicine, National Academy of Sci-
ences, The Royal Society, and the International Commis-
sion on the Clinical Use of Human Germline Genome
Editing. 2020. Heritable Human Genome Editing.
https:// nap. natio nalac ademi es. org/ read/ 25665/ chapt er/1.
Accessed November 11, 2023.
Organizing Committee of the Third International Summit
on Human Genome Editing. 2023. Statement from the
Organizing Committee of the Third International Summit
on Human Genome Editing. https:// royal socie ty. org/ scien
ce- events- and- lectu res/ 2023/ 03/ 2023- human- genome-
editi ng- summit/. Accessed November 11, 2023.
Thaldar, D., M. Botes, B. Shozi, et al. 2020. Human germline
editing: Legal-ethical guidelines for South Africa. South
African Journal of Science 116(9/10): 1–7.
Thaldar, D., and B. Shozi. 2022. South Africa’s latest medi-
cally assisted reproduction draft regulations: Close, but no
cigar. Tydskrif vir die Suid-Afrikaanse Reg (1): 1–24.
Publisher’s Note Springer Nature remains neutral with regard
to jurisdictional claims in published maps and institutional
affiliations.
[http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/)
[https://nap.nationalacademies.org/read/25665/chapter/1](https://nap.nationalacademies.org/read/25665/chapter/1)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
– Recent Developments in the Regulation of Heritable Human Genome Editing
– Abstract
– Introduction
– Heritable Human Genome Editing
– The Third International Summit on Heritable Human Genome Editing
– The Scope of the Law
– South Africa’s Suggestions
– Concluding Comments
– References
**Harris-1997-GoodbyeDollyTheethicsofhumancloning.pdf**
This file is too large to display. [View in new window](https://www.sweetstudy.com/files/harris-1997-goodbyedollytheethicsofhumancloning-pdf)
**Lavi-2018-CloningInternationalLawTheScienceandScienceFictionofHumanCloningandStem-CellPatenting.pdf**
This file is too large to display. [View in new window](https://www.sweetstudy.com/files/lavi-2018-cloninginternationallawthescienceandsciencefictionofhumancloningandstem-cellpatenting-pdf)
**Barthetal.-2020-GeneticEndowmentsandWealthInequality.pdf**
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**Greely-2021-CRISPRPeopleTheScienceandEthicsofEditingHumans.pdf**
This file is too large to display. [View in new window](https://www.sweetstudy.com/files/greely-2021-crisprpeoplethescienceandethicsofeditinghumans-pdf)
**Greely-2021-CRISPRPeopleTheScienceandEthicsofEditingHumans.pdf**
This file is too large to display. [View in new window](https://www.sweetstudy.com/files/greely-2021-crisprpeoplethescienceandethicsofeditinghumans-pdf)
**## Homework-ProposalforResearchPaper.docx**
**What is your narrowed research topic?**
The Ethical, Societal, and Scientific Implications of Legalizing Genetic Modification and Cloning in Humans
****Why have you chosen this topic? How does this topic affect you personally? (It does.) Be specific.****
**I have chosen this topic because genetic modification and cloning have the potential to revolutionize medicine and human health. The idea of eliminating genetic disorders, extending human lifespan, and enhancing physical and cognitive abilities is both fascinating and controversial. This topic presents a vision of the future where chronic diseases and genetic limitations become obsolete. However, genetic cloning cannot be taken lightly, and there are concerns about the disastrous implications it could bring. By exploring this topic, I hope to find strong arguments that consider both the potential benefits and the ethical concerns.**
****What kind of foundational or base knowledge might your team need before starting your research journey?****
**·**
****Scientific Basis:** Understanding the different techniques through which cloning or genetic modification can be carried out.**
**·**
****Historical Context:** Reviewing past cloning experiments, including the most famous one, Dolly the sheep.**
**·**
****Ethical and Legal Considerations:** Examining the concerns raised by bioethicists, religious groups, and politicians regarding this issue.**
**·**
****Public Perception:** Investigating media reactions and understanding public fears regarding this new technology.**
**·**
****Current Regulations:** Reviewing the existing laws on this topic in the USA, Europe, and China.**
****How much do you already know about the topic?****
**I believe I understand the basic concepts behind genetic modifications and cloning. Additionally, I am aware that in the past, experiments have been conducted on cloning animals, as well as some attempts at genetic modifications in humans. However, I need to delve deeper into the ethical debate, legal frameworks, and the social consequences if this technology is adopted on a global scale.**
****Offer at least three potential perspectives to explore in your research.****
**·**
****Scientific and Medical Advances:** The potential to eliminate genetic diseases such as cancer. Applications in regenerative medicine and organ transplantation. Preventive medicine or a definitive cure for multiple diseases.**
**·**
****Ethical and Social Concerns:** The debate over "designer babies" and the implications of genetic inequality. Religious or philosophical arguments against genetic modification. Concerns about harmful genetic modifications or the loss of genetic diversity.**
**·**
****Political and Legal Considerations:** Comparing the different regulations among the three major global powers: the USA, the EU, and China. Potential changes in these regulations. The role of governments and international organizations in regulating genetic modifications and cloning.**
****Ask yourself: Who is impacted by this topic? Who cares about this topic? Who researches this topic, or works in this field? Who might be making things better or worse?****
**· Individuals with Genetic Disorders.**
**· Scientists and Medical Researchers.**
**· Ethicists and Religious Groups.**
**· Lawmakers and Government Agencies.**
**· Pharmaceutical and Biotech Companies.**
**· The General Public.**
**Ask yourself: Who is impacted by this topic? Who cares about this topic? Who researches this topic, or works in this field? Who might be making things better or worse?**
**· Genetic modification in humans**
**· Human cloning ethics**
**· Legalization of genetic engineering**
**· Benefits of human cloning**
**· Ethical concerns in genetic modification**
**· Future of gene therapy**
**· Human genome editing regulations**
**· Medical advancements through cloning**
**· Societal impact of designer babies**
**· Cloning laws in USA, EU, and China.**
**## Soni-2024-RecentDevelopmentsintheRegulationofHeritableHumanGenomeEditing.pdf**
Vol.: (0123456789)
1 3
Bioethical Inquiry (2024) 21:15–18
https://doi.org/10.1007/s11673-023-10332-w
RECENT DEVELOPMENTS
Recent Developments in the Regulation of Heritable Human
Genome Editing
S. Soni
Received: 15 November 2023 / Accepted: 18 December 2023 / Published online: 3 April 2024
© The Author(s) 2024
Abstract In 2018, the Chinese scientist He Jiankui
presented his research at the Second International
Summit on Human Genome Editing in Hong Kong.
While it was intended that he facilitate a workshop,
he was instead called on to present his research in
heritable human genome editing, where he made
the announcement that he had taken great strides in
advancement of his research, to the extent that he
had gene-edited human embryos and that this had
resulted in the live births of two children. While his
research ethic and methodology was interrogated, he
insisted that two children, twin girls, had been born
healthy and that there was another pregnancy (at the
time) where birth of a third gene edited child would
be imminent. This announcement generated a ripple
effect in the scientific community and exposed the
gaps in regulation and absence of law relating to the
technology. This resulted in a flurry of activity and
conversation around regulation of the technology,
which scientists stated was not ready for human trials.
This article reviews the Third Summit which was held
in London in March 2023 and comments on the lat-
est developments in the regulation of heritable human
genome editing.
Keywords Genome editing · Health · Bioethics ·
Autonomy · Law · Regulation
Introduction
Human genome editing has the potential to revolu-
tion human health. By using gene editing tools such
as CrisprCas9 to alter the DNA of an organism, gene
editing can make molecular changes to that organ-
ism’s DNA to obtain a desired outcome. Research in
gene editing has targeted issues in health including
the improvement of health outcomes as well as dis-
ease control. In this respect we have seen research on
the use of gene editing to improve crops to make them
hardier and more resistance to environmental stresses.
We have also seen research on the use of gene edit-
ing to alter the genomes of mosquito to remove their
ability to transmit diseases such as malaria. We have
also seen research on cattle, with a view to alter their
genomes to render them horn-less. However, none of
that research has attracted as much human investment
and attention as the research on potential applica-
tions of gene editing technology to resolving issues in
human health.
In 2018, when He Jiankui made his revelation that
he had altered the genomes of two children for the
purposes of rendering them resistant to HIV infec-
tion, the news received mixed reactions. While the
scientific community largely condemned his flagrant
disregard for the safety of the children involved, the
S. Soni (*)
School of Law, University of KwaZulu-Natal, Scottsville,
Pietermaritzburg 3209, South Africa
e-mail: sonish@ukzn.ac.za
[http://crossmark.crossref.org/dialog/?doi=10.1007/s11673-023-10332-w&domain=pdf](http://crossmark.crossref.org/dialog/?doi=10.1007/s11673-023-10332-w&domain=pdf)
[http://orcid.org/0000-0001-6678-6008](http://orcid.org/0000-0001-6678-6008)
It is urgent robust laws for human genome editing. Scientific advancements outpace regulatory measures.
There is significant deficiencies in global governance concerning heritable genome editing.
16 Bioethical Inquiry (2024) 21:15–18
1 3
Vol:. (1234567890)
general population remained divided on the issue.
On the one hand people were concerned that he had
subjected our weakest and most vulnerable to what
amounted to human experimentation (the children’s
genomes were edited when they were at the embry-
onic stage of development), but on the other hand
many people applauded his attempt at reducing esca-
lating HIV rates. If gene editing has the potential to
eradicate diseases such as HIV, cancer, and others,
then on what basis should we stop the scientists who
are trying to do this?
Heritable Human Genome Editing
Human genome editing utilizes gene editing tech-
nology to make changes to human DNA to achieve
a desired change in the genome. We may distin-
guish between somatic editing, which is gene edit-
ing applied to somatic cells. This type of gene edit-
ing does not create heritable changes and the changes
to the DNA remain with the individual themselves.
Apart from establishing the safety and efficacy of
the therapy and obtaining the required approvals to
bring the therapy to market, this type of gene edit-
ing remains largely uncontroversial. On the other
hand, heritable genome editing remains concerning
as it involves editing the DNA of embryos or gam-
etes, which results in alterations to a genome that is
heritable by future generations. Beyond establishing
merely safety and efficacy, this type of gene editing
is fraught with legal and ethical issues. Since 2018,
there has been significant movement in the form of
international debate, the drafting of reports and the
creation of working groups to consider the ethical
and legal issues surrounding heritable genome editing
(National Academy of Medicine et al. 2020). This has
also stimulated academic debate (Angrist et al. 2020).
The Third International Summit on Heritable
Human Genome Editing
The Third International Summit on Human Genome
Editing, which was convened by the U.K. Royal
Society, U.K. Academy of Medical Sciences, U.S.
National Academies of Sciences and Medicine, and
the World Academy of Sciences, aimed to discuss
progress, promise, and challenges in research,
regulation, and equitable development of human
genome editing technologies and therapies. The
Summit attracted leading scientists in the field,
policymakers and also featured the first patient who
had been treated for sickle cell anaemia using gene
editing technology. The findings of this third meeting
emphasized that remarkable developments had been
made in the field of somatic human genome editing,
however the high cost of somatic therapies was
highlighted as unsustainable and participants called for
a global commitment to ensuring equitable access to
treatment. The finding in respect of heritable genome
editing however was not as positive. Here the finding
was that this type of gene editing remains unacceptable
as safety and efficacy had not been established,
and that the governance frameworks and ethical
principles which would apply to responsible use of the
technology were not in place (Organizing Committee
of the Third International Summit on Human Genome
Editing 2023). In this regard, there has been a move in
the South African jurisdiction to address these issues.
The Scope of the Law
In 2020 Baylis et al. undertook a policy survey of
106 countries in order to obtain a clear and accu-
rate understanding of the global policy landscape
for human germline and heritable genome editing
(Baylis et al. 2020). That study revealed that 96
out of the 106 countries surveyed had policy docu-
ments which were relevance to the use of heritable
human genome editing. These documents included
legislation, regulations, guidelines, codes, and
ratification of international treaties. But law takes
time to be enacted. The majority of the legal canon
which exists today is based on historic law, which
has been measured against the “supreme” laws of
a country which include Constitutions and other
documents which codify the fundamental human
rights. The written law which exists today does not
describe or mention gene editing because the tech-
nology did not exist at the time that the laws were
drafted. However, we can try to find some guidance
by considering the two broad types of law, which is
hard law and soft law. Hard law exists in the form
of legislation and statutes, and there are legal con-
sequences for violating these laws (such as fines or
imprisonment). Soft law does not carry the force of
There is a global acknowledgment of the need for cohesive policies. International efforts are necessary to address these new challenges.
This summit reflects ongoing efforts to balance scientific innovation with ethical considerations.
This consensus emphasizes the current ethical stance against heritable genome editing.
17Bioethical Inquiry (2024) 21:15–18
1 3
Vol.: (0123456789)
true law and exists in the form of guidelines as to
what may be permissible in a given set of circum-
stances. For instance, codes of conduct and good
practice guidelines for a medical practitioner would
fall into this class. While they highlight what is per-
missible, they themselves are not identified as law
by the law-making bodies of a country. They can
however indirectly have legal consequences for a
person, for instance if a medical practitioner does
not follow good practice guidelines, they may lose
their licence to practice medicine and that has the
legal consequence of the medical practitioners not
being able to lawfully practice medicine any longer.
The distinction between these two types of law
is important, because we need the hard law to be
able to enforce legal principles of good governance
that come with a penalty where these laws are con-
travened. A large part of Jiankui’s ill-reception was
based on the disregard for ethics in science, as well as
his methodologies employed at various stages in his
research. This included the ethical approvals which
were obtained, where the experiments were con-
ducted, and how he approached potential participants
to participate in the research and permit the editing of
their embryo’s genome. However, a significant ques-
tion at the time was whether Jiankiu had broken any
laws when conducting his research. There were no
laws in China at the time which prohibited gene edit-
ing, and for that reason in the end Jiankui was charged
with practicing medicine without the required licence,
which was the only charge which the Chinese authori-
ties could lawfully bring against him. The children
themselves were gene edited at the embryonic stage,
at which point they did not possess any legal recogni-
tion as they were not legally recognized persons who
would be capable of possessing legal rights, duties,
and responsibilities. Because embryos do not pos-
sess legal personhood, they do not have rights in the
manner which people generally do. However, there
is ethical and moral significance which embryos do
attract and this can be seen in the law and regulations
surrounding research which involve human embryos.
The most significant rule in this regard is the “14-day
rule” which prohibits research on a human embryo
once it reaches the 14th day of development. This rule
has been enshrined in the law in the legal systems of
many countries, including South Africa, where we
see it in a Regulation which supports South Africa’s
National Health Act 61 of 2003.
South Africa’s Suggestions
The Baylis study noted that South Africa did not
have “any relevant information” regarding heritable
human genome editing. However, research has shown
that while gene editing is not expressly mentioned in
extant law, there are two statutes which may possibly
be applied to the technology in a regulatory fashion
(Thaldar and Shozi 2022). The first is the Medicine
and Related Substances Act 101 of 1965, where the
definition of “medical devices” may be interpreted so
as to include gene editing tools. If this were the case,
then gene editing tools such as CrisprCas9 would fall
under the ambit of the South African Health Prod-
ucts Regulatory Authority. The second possible stat-
ute which could be interpreted so as to apply in the
context of heritable human genome editing is the
National Health Act 61 of 2003. This statute prohib-
its human cloning as it involves “the manipulation
of genetic material in order to achieve the reproduc-
tion of a human being.” It has been argued that the
legal permissibility of heritable human genome edit-
ing may rest on the way in which the words repro-
duction of a human being is interpreted. If interpreted
to mean human reproduction, then heritable human
genome editing would be unlawful. However, if inter-
preted narrowly so as to mean the replication of a
human being, then the statute would not prohibit gene
editing methods that result in heritable changes, and
both preclinical and clinical trials for the technology
would be subject to ethical clearance requirements
by a health research ethics committee in terms of the
same statute.
By considering the meaning of the provisions of
these two statutes, a set of five ethical principles have
been suggested which may be used to draft possible
guidelines, as there are currently no guidelines on
genome editing in South Africa which could assist the
South African Health Products Regulatory Authority
or health research ethics committees (Thaldar et al.
2020). In summary, they are the following:
Principle I: Given its potential to improve the lives
of the people of South Africa, heritable human
genome editing should be regulated, not banned.
Principle II: Heritable human genome editing’s
clinical applications should be made accessible to
the public only if they are proven to be safe and
effective.
18 Bioethical Inquiry (2024) 21:15–18
1 3
Vol:. (1234567890)
Principle III: Non-therapeutic heritable human
genome editing should be regulated in the same
way as heritable human genome editing, with the
rider that it should not in any legally relevant
sense cause harm.
Principle IV: The decision whether to use herit-
able human genome editing in a prospective child
should, subject to principles I, II, and III, be left to
the prospective parents.
Principle V: Concerns about exacerbating social
inequalities should be addressed by measures to
increase access.
These principles were embodied in suggested
regulatory guidelines have been submitted for possi-
ble inclusion in the revised National Health Research
Ethics Guidelines which set out the norms and stand-
ards for research in South Africa.
Concluding Comments
Human genome editing presents the possibility of
curing serious illness, as well as removing serious
illness from an individual’s family tree. If it remains
unregulated, there will remain a tension between
the scientific community which wants to develop
its research into marketable therapeutics and health
needs of the broader population. Properly regulated,
the risk of unethical research will be reduced and a
rights-based approach to science will ensure that
scientific progress may continue within legal param-
eters, and the legal rights of clinical trial participants
as well as patients are protected. It is hoped that the
suggestions submitted in respect of the South African
national ethics guidelines will be well received and
that South African developments may bring us closer
to a clinical pathway to heritable human genome
editing.
Funding Open access funding provided by University of
KwaZulu-Natal.
Declarations
Competing interest The author(s) declare no competing
interests.
Open Access This article is licensed under a Creative Com-
mons Attribution 4.0 International License, which permits
use, sharing, adaptation, distribution and reproduction in any
medium or format, as long as you give appropriate credit to the
original author(s) and the source, provide a link to the Crea-
tive Commons licence, and indicate if changes were made. The
images or other third party material in this article are included
in the article’s Creative Commons licence, unless indicated
otherwise in a credit line to the material. If material is not
included in the article’s Creative Commons licence and your
intended use is not permitted by statutory regulation or exceeds
the permitted use, you will need to obtain permission directly
from the copyright holder. To view a copy of this licence, visit
http:// creat iveco mmons. org/ licen ses/ by/4. 0/.
References
Angrist M, R. Barrangou, F. Baylis, et al. 2020. Reactions to
the National Academies/Royal Society Report on Her-
itable Human Genome Editing. CRISPR Journal 3(5):
332–349.
Baylis, F., M. Darnovsky, K. Hasson, and T.M. Krahn. 2020.
Human germline and heritable genome editing: The global
policy landscape. The CRISPR Journal 3(5): 365–377.
National Academy of Medicine, National Academy of Sci-
ences, The Royal Society, and the International Commis-
sion on the Clinical Use of Human Germline Genome
Editing. 2020. Heritable Human Genome Editing.
https:// nap. natio nalac ademi es. org/ read/ 25665/ chapt er/1.
Accessed November 11, 2023.
Organizing Committee of the Third International Summit
on Human Genome Editing. 2023. Statement from the
Organizing Committee of the Third International Summit
on Human Genome Editing. https:// royal socie ty. org/ scien
ce- events- and- lectu res/ 2023/ 03/ 2023- human- genome-
editi ng- summit/. Accessed November 11, 2023.
Thaldar, D., M. Botes, B. Shozi, et al. 2020. Human germline
editing: Legal-ethical guidelines for South Africa. South
African Journal of Science 116(9/10): 1–7.
Thaldar, D., and B. Shozi. 2022. South Africa’s latest medi-
cally assisted reproduction draft regulations: Close, but no
cigar. Tydskrif vir die Suid-Afrikaanse Reg (1): 1–24.
Publisher’s Note Springer Nature remains neutral with regard
to jurisdictional claims in published maps and institutional
affiliations.
[http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/)
[https://nap.nationalacademies.org/read/25665/chapter/1](https://nap.nationalacademies.org/read/25665/chapter/1)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
– Recent Developments in the Regulation of Heritable Human Genome Editing
– Abstract
– Introduction
– Heritable Human Genome Editing
– The Third International Summit on Heritable Human Genome Editing
– The Scope of the Law
– South Africa’s Suggestions
– Concluding Comments
– References
**Harris-1997-GoodbyeDollyTheethicsofhumancloning.pdf**
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**Lavi-2018-CloningInternationalLawTheScienceandScienceFictionofHumanCloningandStem-CellPatenting.pdf**
This file is too large to display. [View in new window](https://www.sweetstudy.com/files/lavi-2018-cloninginternationallawthescienceandsciencefictionofhumancloningandstem-cellpatenting-pdf)
**Barthetal.-2020-GeneticEndowmentsandWealthInequality.pdf**
This file is too large to display. [View in new window](https://www.sweetstudy.com/files/barthetal-2020-geneticendowmentsandwealthinequality-pdf)
**Greely-2021-CRISPRPeopleTheScienceandEthicsofEditingHumans.pdf**
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**## Homework-ProposalforResearchPaper.docx**
**What is your narrowed research topic?**
The Ethical, Societal, and Scientific Implications of Legalizing Genetic Modification and Cloning in Humans
****Why have you chosen this topic? How does this topic affect you personally? (It does.) Be specific.****
**I have chosen this topic because genetic modification and cloning have the potential to revolutionize medicine and human health. The idea of eliminating genetic disorders, extending human lifespan, and enhancing physical and cognitive abilities is both fascinating and controversial. This topic presents a vision of the future where chronic diseases and genetic limitations become obsolete. However, genetic cloning cannot be taken lightly, and there are concerns about the disastrous implications it could bring. By exploring this topic, I hope to find strong arguments that consider both the potential benefits and the ethical concerns.**
****What kind of foundational or base knowledge might your team need before starting your research journey?****
**·**
****Scientific Basis:** Understanding the different techniques through which cloning or genetic modification can be carried out.**
**·**
****Historical Context:** Reviewing past cloning experiments, including the most famous one, Dolly the sheep.**
**·**
****Ethical and Legal Considerations:** Examining the concerns raised by bioethicists, religious groups, and politicians regarding this issue.**
**·**
****Public Perception:** Investigating media reactions and understanding public fears regarding this new technology.**
**·**
****Current Regulations:** Reviewing the existing laws on this topic in the USA, Europe, and China.**
****How much do you already know about the topic?****
**I believe I understand the basic concepts behind genetic modifications and cloning. Additionally, I am aware that in the past, experiments have been conducted on cloning animals, as well as some attempts at genetic modifications in humans. However, I need to delve deeper into the ethical debate, legal frameworks, and the social consequences if this technology is adopted on a global scale.**
****Offer at least three potential perspectives to explore in your research.****
**·**
****Scientific and Medical Advances:** The potential to eliminate genetic diseases such as cancer. Applications in regenerative medicine and organ transplantation. Preventive medicine or a definitive cure for multiple diseases.**
**·**
****Ethical and Social Concerns:** The debate over "designer babies" and the implications of genetic inequality. Religious or philosophical arguments against genetic modification. Concerns about harmful genetic modifications or the loss of genetic diversity.**
**·**
****Political and Legal Considerations:** Comparing the different regulations among the three major global powers: the USA, the EU, and China. Potential changes in these regulations. The role of governments and international organizations in regulating genetic modifications and cloning.**
****Ask yourself: Who is impacted by this topic? Who cares about this topic? Who researches this topic, or works in this field? Who might be making things better or worse?****
**· Individuals with Genetic Disorders.**
**· Scientists and Medical Researchers.**
**· Ethicists and Religious Groups.**
**· Lawmakers and Government Agencies.**
**· Pharmaceutical and Biotech Companies.**
**· The General Public.**
**Ask yourself: Who is impacted by this topic? Who cares about this topic? Who researches this topic, or works in this field? Who might be making things better or worse?**
**· Genetic modification in humans**
**· Human cloning ethics**
**· Legalization of genetic engineering**
**· Benefits of human cloning**
**· Ethical concerns in genetic modification**
**· Future of gene therapy**
**· Human genome editing regulations**
**· Medical advancements through cloning**
**· Societal impact of designer babies**
**· Cloning laws in USA, EU, and China.**
**## Soni-2024-RecentDevelopmentsintheRegulationofHeritableHumanGenomeEditing.pdf**
Vol.: (0123456789)
1 3
Bioethical Inquiry (2024) 21:15–18
https://doi.org/10.1007/s11673-023-10332-w
RECENT DEVELOPMENTS
Recent Developments in the Regulation of Heritable Human
Genome Editing
S. Soni
Received: 15 November 2023 / Accepted: 18 December 2023 / Published online: 3 April 2024
© The Author(s) 2024
Abstract In 2018, the Chinese scientist He Jiankui
presented his research at the Second International
Summit on Human Genome Editing in Hong Kong.
While it was intended that he facilitate a workshop,
he was instead called on to present his research in
heritable human genome editing, where he made
the announcement that he had taken great strides in
advancement of his research, to the extent that he
had gene-edited human embryos and that this had
resulted in the live births of two children. While his
research ethic and methodology was interrogated, he
insisted that two children, twin girls, had been born
healthy and that there was another pregnancy (at the
time) where birth of a third gene edited child would
be imminent. This announcement generated a ripple
effect in the scientific community and exposed the
gaps in regulation and absence of law relating to the
technology. This resulted in a flurry of activity and
conversation around regulation of the technology,
which scientists stated was not ready for human trials.
This article reviews the Third Summit which was held
in London in March 2023 and comments on the lat-
est developments in the regulation of heritable human
genome editing.
Keywords Genome editing · Health · Bioethics ·
Autonomy · Law · Regulation
Introduction
Human genome editing has the potential to revolu-
tion human health. By using gene editing tools such
as CrisprCas9 to alter the DNA of an organism, gene
editing can make molecular changes to that organ-
ism’s DNA to obtain a desired outcome. Research in
gene editing has targeted issues in health including
the improvement of health outcomes as well as dis-
ease control. In this respect we have seen research on
the use of gene editing to improve crops to make them
hardier and more resistance to environmental stresses.
We have also seen research on the use of gene edit-
ing to alter the genomes of mosquito to remove their
ability to transmit diseases such as malaria. We have
also seen research on cattle, with a view to alter their
genomes to render them horn-less. However, none of
that research has attracted as much human investment
and attention as the research on potential applica-
tions of gene editing technology to resolving issues in
human health.
In 2018, when He Jiankui made his revelation that
he had altered the genomes of two children for the
purposes of rendering them resistant to HIV infec-
tion, the news received mixed reactions. While the
scientific community largely condemned his flagrant
disregard for the safety of the children involved, the
S. Soni (*)
School of Law, University of KwaZulu-Natal, Scottsville,
Pietermaritzburg 3209, South Africa
e-mail: sonish@ukzn.ac.za
[http://crossmark.crossref.org/dialog/?doi=10.1007/s11673-023-10332-w&domain=pdf](http://crossmark.crossref.org/dialog/?doi=10.1007/s11673-023-10332-w&domain=pdf)
[http://orcid.org/0000-0001-6678-6008](http://orcid.org/0000-0001-6678-6008)
It is urgent robust laws for human genome editing. Scientific advancements outpace regulatory measures.
There is significant deficiencies in global governance concerning heritable genome editing.
16 Bioethical Inquiry (2024) 21:15–18
1 3
Vol:. (1234567890)
general population remained divided on the issue.
On the one hand people were concerned that he had
subjected our weakest and most vulnerable to what
amounted to human experimentation (the children’s
genomes were edited when they were at the embry-
onic stage of development), but on the other hand
many people applauded his attempt at reducing esca-
lating HIV rates. If gene editing has the potential to
eradicate diseases such as HIV, cancer, and others,
then on what basis should we stop the scientists who
are trying to do this?
Heritable Human Genome Editing
Human genome editing utilizes gene editing tech-
nology to make changes to human DNA to achieve
a desired change in the genome. We may distin-
guish between somatic editing, which is gene edit-
ing applied to somatic cells. This type of gene edit-
ing does not create heritable changes and the changes
to the DNA remain with the individual themselves.
Apart from establishing the safety and efficacy of
the therapy and obtaining the required approvals to
bring the therapy to market, this type of gene edit-
ing remains largely uncontroversial. On the other
hand, heritable genome editing remains concerning
as it involves editing the DNA of embryos or gam-
etes, which results in alterations to a genome that is
heritable by future generations. Beyond establishing
merely safety and efficacy, this type of gene editing
is fraught with legal and ethical issues. Since 2018,
there has been significant movement in the form of
international debate, the drafting of reports and the
creation of working groups to consider the ethical
and legal issues surrounding heritable genome editing
(National Academy of Medicine et al. 2020). This has
also stimulated academic debate (Angrist et al. 2020).
The Third International Summit on Heritable
Human Genome Editing
The Third International Summit on Human Genome
Editing, which was convened by the U.K. Royal
Society, U.K. Academy of Medical Sciences, U.S.
National Academies of Sciences and Medicine, and
the World Academy of Sciences, aimed to discuss
progress, promise, and challenges in research,
regulation, and equitable development of human
genome editing technologies and therapies. The
Summit attracted leading scientists in the field,
policymakers and also featured the first patient who
had been treated for sickle cell anaemia using gene
editing technology. The findings of this third meeting
emphasized that remarkable developments had been
made in the field of somatic human genome editing,
however the high cost of somatic therapies was
highlighted as unsustainable and participants called for
a global commitment to ensuring equitable access to
treatment. The finding in respect of heritable genome
editing however was not as positive. Here the finding
was that this type of gene editing remains unacceptable
as safety and efficacy had not been established,
and that the governance frameworks and ethical
principles which would apply to responsible use of the
technology were not in place (Organizing Committee
of the Third International Summit on Human Genome
Editing 2023). In this regard, there has been a move in
the South African jurisdiction to address these issues.
The Scope of the Law
In 2020 Baylis et al. undertook a policy survey of
106 countries in order to obtain a clear and accu-
rate understanding of the global policy landscape
for human germline and heritable genome editing
(Baylis et al. 2020). That study revealed that 96
out of the 106 countries surveyed had policy docu-
ments which were relevance to the use of heritable
human genome editing. These documents included
legislation, regulations, guidelines, codes, and
ratification of international treaties. But law takes
time to be enacted. The majority of the legal canon
which exists today is based on historic law, which
has been measured against the “supreme” laws of
a country which include Constitutions and other
documents which codify the fundamental human
rights. The written law which exists today does not
describe or mention gene editing because the tech-
nology did not exist at the time that the laws were
drafted. However, we can try to find some guidance
by considering the two broad types of law, which is
hard law and soft law. Hard law exists in the form
of legislation and statutes, and there are legal con-
sequences for violating these laws (such as fines or
imprisonment). Soft law does not carry the force of
There is a global acknowledgment of the need for cohesive policies. International efforts are necessary to address these new challenges.
This summit reflects ongoing efforts to balance scientific innovation with ethical considerations.
This consensus emphasizes the current ethical stance against heritable genome editing.
17Bioethical Inquiry (2024) 21:15–18
1 3
Vol.: (0123456789)
true law and exists in the form of guidelines as to
what may be permissible in a given set of circum-
stances. For instance, codes of conduct and good
practice guidelines for a medical practitioner would
fall into this class. While they highlight what is per-
missible, they themselves are not identified as law
by the law-making bodies of a country. They can
however indirectly have legal consequences for a
person, for instance if a medical practitioner does
not follow good practice guidelines, they may lose
their licence to practice medicine and that has the
legal consequence of the medical practitioners not
being able to lawfully practice medicine any longer.
The distinction between these two types of law
is important, because we need the hard law to be
able to enforce legal principles of good governance
that come with a penalty where these laws are con-
travened. A large part of Jiankui’s ill-reception was
based on the disregard for ethics in science, as well as
his methodologies employed at various stages in his
research. This included the ethical approvals which
were obtained, where the experiments were con-
ducted, and how he approached potential participants
to participate in the research and permit the editing of
their embryo’s genome. However, a significant ques-
tion at the time was whether Jiankiu had broken any
laws when conducting his research. There were no
laws in China at the time which prohibited gene edit-
ing, and for that reason in the end Jiankui was charged
with practicing medicine without the required licence,
which was the only charge which the Chinese authori-
ties could lawfully bring against him. The children
themselves were gene edited at the embryonic stage,
at which point they did not possess any legal recogni-
tion as they were not legally recognized persons who
would be capable of possessing legal rights, duties,
and responsibilities. Because embryos do not pos-
sess legal personhood, they do not have rights in the
manner which people generally do. However, there
is ethical and moral significance which embryos do
attract and this can be seen in the law and regulations
surrounding research which involve human embryos.
The most significant rule in this regard is the “14-day
rule” which prohibits research on a human embryo
once it reaches the 14th day of development. This rule
has been enshrined in the law in the legal systems of
many countries, including South Africa, where we
see it in a Regulation which supports South Africa’s
National Health Act 61 of 2003.
South Africa’s Suggestions
The Baylis study noted that South Africa did not
have “any relevant information” regarding heritable
human genome editing. However, research has shown
that while gene editing is not expressly mentioned in
extant law, there are two statutes which may possibly
be applied to the technology in a regulatory fashion
(Thaldar and Shozi 2022). The first is the Medicine
and Related Substances Act 101 of 1965, where the
definition of “medical devices” may be interpreted so
as to include gene editing tools. If this were the case,
then gene editing tools such as CrisprCas9 would fall
under the ambit of the South African Health Prod-
ucts Regulatory Authority. The second possible stat-
ute which could be interpreted so as to apply in the
context of heritable human genome editing is the
National Health Act 61 of 2003. This statute prohib-
its human cloning as it involves “the manipulation
of genetic material in order to achieve the reproduc-
tion of a human being.” It has been argued that the
legal permissibility of heritable human genome edit-
ing may rest on the way in which the words repro-
duction of a human being is interpreted. If interpreted
to mean human reproduction, then heritable human
genome editing would be unlawful. However, if inter-
preted narrowly so as to mean the replication of a
human being, then the statute would not prohibit gene
editing methods that result in heritable changes, and
both preclinical and clinical trials for the technology
would be subject to ethical clearance requirements
by a health research ethics committee in terms of the
same statute.
By considering the meaning of the provisions of
these two statutes, a set of five ethical principles have
been suggested which may be used to draft possible
guidelines, as there are currently no guidelines on
genome editing in South Africa which could assist the
South African Health Products Regulatory Authority
or health research ethics committees (Thaldar et al.
2020). In summary, they are the following:
Principle I: Given its potential to improve the lives
of the people of South Africa, heritable human
genome editing should be regulated, not banned.
Principle II: Heritable human genome editing’s
clinical applications should be made accessible to
the public only if they are proven to be safe and
effective.
18 Bioethical Inquiry (2024) 21:15–18
1 3
Vol:. (1234567890)
Principle III: Non-therapeutic heritable human
genome editing should be regulated in the same
way as heritable human genome editing, with the
rider that it should not in any legally relevant
sense cause harm.
Principle IV: The decision whether to use herit-
able human genome editing in a prospective child
should, subject to principles I, II, and III, be left to
the prospective parents.
Principle V: Concerns about exacerbating social
inequalities should be addressed by measures to
increase access.
These principles were embodied in suggested
regulatory guidelines have been submitted for possi-
ble inclusion in the revised National Health Research
Ethics Guidelines which set out the norms and stand-
ards for research in South Africa.
Concluding Comments
Human genome editing presents the possibility of
curing serious illness, as well as removing serious
illness from an individual’s family tree. If it remains
unregulated, there will remain a tension between
the scientific community which wants to develop
its research into marketable therapeutics and health
needs of the broader population. Properly regulated,
the risk of unethical research will be reduced and a
rights-based approach to science will ensure that
scientific progress may continue within legal param-
eters, and the legal rights of clinical trial participants
as well as patients are protected. It is hoped that the
suggestions submitted in respect of the South African
national ethics guidelines will be well received and
that South African developments may bring us closer
to a clinical pathway to heritable human genome
editing.
Funding Open access funding provided by University of
KwaZulu-Natal.
Declarations
Competing interest The author(s) declare no competing
interests.
Open Access This article is licensed under a Creative Com-
mons Attribution 4.0 International License, which permits
use, sharing, adaptation, distribution and reproduction in any
medium or format, as long as you give appropriate credit to the
original author(s) and the source, provide a link to the Crea-
tive Commons licence, and indicate if changes were made. The
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the permitted use, you will need to obtain permission directly
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http:// creat iveco mmons. org/ licen ses/ by/4. 0/.
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Publisher’s Note Springer Nature remains neutral with regard
to jurisdictional claims in published maps and institutional
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[http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/)
[https://nap.nationalacademies.org/read/25665/chapter/1](https://nap.nationalacademies.org/read/25665/chapter/1)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
[https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/](https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/)
– Recent Developments in the Regulation of Heritable Human Genome Editing
– Abstract
– Introduction
– Heritable Human Genome Editing
– The Third International Summit on Heritable Human Genome Editing
– The Scope of the Law
– South Africa’s Suggestions
– Concluding Comments
– References
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