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Regulation 2

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25 views2 pages

Regulation 2

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bartubakir08
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© © All Rights Reserved
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Editorial

Human genome editing: ensuring responsible research


In 2018, during the Second International Summit on clinical trial for heritable germline editing is prohibited.
Human Genome Editing in Hong Kong, Jiankui He While this, in effect, makes some reproductive editing

Tek Image/Science Photo Library/Getty Images


shocked the world by announcing the birth of two illegal, it falls short of a ban on the practice itself.
children whose genomes he had edited using CRISPR Similar ambiguities exist in many countries, and as the
technology. Following widespread condemnation and technologies involved become cheaper and more widely
a criminal investigation, he was sentenced to 3 years in available, the risk increases.
prison. The case caused international outcry and brought A better international consensus is essential on how
to the fore the need to reconsider the serious ethical, to advance gene editing while safeguarding humanity’s
scientific, and social issues of heritable human genome collective genepool. There is broad agreement that
editing. As science advances, especially in non-heritable, altering embryo DNA for reproductive purposes should
somatic gene editing for treatment of previously remain forbidden; a 2020 study showed that 75 of
incurable diseases, regulatory gaps are becoming 96 surveyed countries have banned it. However, many do
exposed. Governance of gene editing research was a not have effective oversight and governance mechanisms
major discussion point at the Third International Human to enforce existing regulations. In some countries,
Genome Editing Summit in London, on March 6–8, with although altering embryo DNA is generally forbidden,
widespread recognition for the need to build on existing exceptions are allowed, making more likely the possibility
guidelines to develop global standards for governance that the technology is used for a banned purpose. The
and oversight of human genome editing. As He’s lack of policy alignment between countries raises the
unconscionable actions showed, the ethical and scientific possibility of scientists exporting their research to evade
risks are substantial. constraints established in their home jurisdictions.
Gene editing regulations must consider the aims and How will a global consensus be enforced? The UN is the
consequences of the different practices involved. Somatic only body in a position to do so, and the prospect of an
genome editing interventions (eg, targeted therapies such international legally binding treaty to govern genome
as chimeric antigen receptor T cells or small interfering editing was raised at the Second International Summit
RNA gene therapies) are not transmitted to offspring in 2018, but has seemingly proceeded no further.
and are widely used. Heritable genome editing—also The Oviedo Convention, a legally binding instrument
called germline editing—is aimed at research on human established by the European Council, permits somatic For the study on altering
embryo DNA practices in
fertilisation and embryology or for reproductive purposes. genome modifications for preventive, diagnostic, or various countries see CRISPR J
From a genetic point of view, germline editing is of most therapeutic purposes, and prohibits germline editing, but 2020; 3: 365–77

concern because alterations are passed to offspring, only 29 countries have enacted it into law. For more on China’s new
human gene-editing rules see
with the risk of perpetuating unexpected and undesired It is almost 20 years since scientists announced the https://www.bbc.co.uk/news/
changes through generations. It is impossible for our mapping of the human genome. Now they are editing science-environment-64857311
For more on the Third
unborn descendants to give consent. it, and the promise of a truly personalised medicine, International Human Genome
Loopholes and ambiguities in regulation need to tailored to an individual’s genetic makeup, is becoming Editing Summit see https://
royalsociety.org/science-events-
be closed urgently to enable scientists to be held to reality. The first CRISPR-based technology, for sickle cell and-lectures/2023/03/2023-
account. In China, He’s prosecution was based on disease, is expected to soon be approved by US regulators. human-genome-editing-
summit/
practising medicine without a licence, rather than Such advances have the potential to bring enormous
For more on existing guidelines
specifically based on a provision governing assisted benefits for humankind, but also bring unique social and for gene editing see https://nap.
reproduction or genome editing. China has since ethical challenges. Resolving these challenges will involve nationalacademies.org/
catalog/25665/heritable-
instituted new regulations, widely seen as a response to ongoing conversations within and outside the scientific human-genome-editing and
the He case, but they have been criticised in press reports community. To protect legitimate genetic research—to https://www.who.int/
publications/i/
for not doing enough to cover private companies. close loopholes in regulations and establish a global item/9789240030060
Wording of legislation needs to be explicit and clear. consensus on oversight and regulation—will require For more on the Oviedo
Convention see https://rm.coe.
In the USA, use of funds by the FDA for the purpose of governance that is as dynamic as the science. n The Lancet int/strategic-action-plan-final-
accepting and reviewing any application to begin a e/1680a2c5d2

www.thelancet.com Vol 401 March 18, 2023 877


Reproduced with permission of copyright owner. Further reproduction
prohibited without permission.

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