B Explanatory memorandum
by Mr Stefan Schennach, rapporteur
1 Introduction
1. “[R]ecent advances in genome
editing are bound to result in germ line interventions in human
beings quite soon”.
Note These were the words
of the Parliamentary Assembly’s former rapporteur Ms Petra De Sutter (Belgium,
SOC) introducing her 2017 report on the use of new genetic technologies
in human beings, which were also reflected in the adopted recommendation.
One year later, her prediction had already become a reality. In
November 2018, it was announced that, as a result of unsanctioned
work by a Chinese researcher, at least two twin girls had been born
with modified genes with the aim of conferring on them immunity
to the HIV/AIDS virus. The act was strongly criticised by ethicists
and scientists worldwide due the premature nature and high risk
of unwanted side effects (on-target and off-target effects). This
led to renewed calls for a worldwide moratorium on establishing
a pregnancy with germ line cells or human embryos having undergone intentional
genome editing
Note, but also to calls for a “rigorous,
responsible translational pathway toward clinical trials” for when
heritable genome editing in human beings is considered “safe enough”.
2. If, and this needs to be expected, the technology develops
further to the point that unwanted side effects no longer pose a
common and obvious problem, voices will be raised in favour of lifting
the current more or less official moratorium. There has been a shift
in the scientific community and among those involved in risk evaluation
to move from the notion of “safe” to the notion of “acceptable risks”
to greenlight a move towards possible application. The evaluation
of the risks at stake and the question of who should decide on whether these
are “acceptable” remain a key issue. The question is no more “whether”
but “how”. In fact, voices are already being raised in favour of
the creation of a regulatory pathway to permit germ line modifications,
even though a survey published in 2020 showed that 75 of the 96
countries which have policy documents relevant to the use of genome
editing to modify early-stage human embryos, gametes, or their precursor
cells prohibit their use to initiate a pregnancy – and no country
explicitly permits it.
Note The position
the Council of Europe wants to take in future concerning intentional
heritable genome editing in human beings must thus be made clear already
now, before use of the technology can be deemed “safe”.
3. It is my opinion that our member States should maintain and
reinforce the clear position of prohibition of any intervention
seeking to introduce a modification in the genome of any descendants,
postulated in Article 13 of the Council of Europe 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 (ETS No. 164, “Oviedo Convention”). This
is the necessary response to protect the human genome, safeguard
future generations’ human rights and enforce shared bioethical principles.
The Council of Europe should also take this message to the rest
of the world via its Committee of Ministers, Parliamentary Assembly,
and Steering Committee for Human Rights in the fields of Biomedicine
and Health (CDBIO).
2 Heritable genome editing in human beings:
definition and context
4. Gene editing technologies constitute
promising tools both in the fields of biomedical research and clinical application.
Note These techniques
are opening the pathway to genetically personalised, or “precision”
treatments. However, the early promise of such treatments has not,
or not yet, been fully realised.
Note This is because there are very few
genetic diseases which are well understood and involve only single
genes. Most genetic diseases are multifactorial, involving several
genes and also environmental factors. With so few beneficiaries
for “precision”-treatments of rare genetic disorders, the cost of
research and treatment is very high – which in turn has sparked
questions of whether the money would not be better invested in public
health measures to fight more common (non-genetic) diseases.
Note
5. When used to modify the human germ line, these new technologies,
such as CRISPR-cas9, raise crucial legal and ethical implications.
Note These techniques can be used to make
alterations of the human genome itself: that is to say the alterations
made will be inherited by future generations. Because of the potential
unintended, unpredictable, and undetectable effects both on the
person born with the modified genome and the descendants, such as
off-target effects and mosaicism, at the present stage their use
in human beings is still considered unsafe by scientists.
Note
6. Human genome editing has different fields of potential application.
If unwanted side-effects could be eliminated, germ line editing
would be a new option to prevent, diagnose or treat genetic diseases.
In most of the cases germ line editing is, however, not the only
possible option for parents wishing for a child, including those
seeking to have a genetically related child unaffected by a genetic
disease. Apart from adoption, egg, sperm or embryo donation, the
treatment of the genetic disease directly in the affected child
(somatic gene therapy, working at the level of epigenetics, or,
possibly, by “one-generation” germ line editing) would provide alternatives.
7. Another possibility is in vitro fertilization (IVF) combined
with pre-implantation genetic diagnosis (PGD) which, however, requires
the ethically disputed PGD-selection of embryos. In the very rare
cases, where both parents’ germ cells carry the defect (and the
gene involved is dominant), deliberate germ line editing could be the
only option for these parents to have a genetically related child
without the genetic disease – but would also require PGD, since
the success rate of genome editing is never 100%.
Note Even if side-effects can be eliminated in
the future, the technique may have unknown effects on future generations.
Note
8. There are three possible forms how deliberate germ line editing
in human beings could be conducted: modifications could be either
directed directly on the embryo in the pronuclear or one-cell-stage,
on the germ cell, for example an egg or a sperm cell, or on a stem
cell (precursor cell). According to the general understanding, germ
line editing interventions imply that the genetic alterations are
hereditary and thus transferred to future generations. Some researchers
are exploring the option of “one-generation germ line therapy” whereby
future descendants remain unaffected by the genome editing intervention.
Note
9. Another possible field of application of deliberate germ line
editing is human enhancement, namely the optimisation of certain
characteristics and abilities via genetic modification. As will
be examined in more detail in chapter 5, the deliberate alteration
of the human genome to enhance the human species would cross the line
of ethical inviolability and could foster the “production” of individuals
or groups with specific genetic characteristics or qualities, thus
enlarging the pathway to discrimination and throwing into doubt
the survival of the human race as we know it.
3 The
Oviedo Convention and the international prohibition of heritable
genome editing in human beings
10. The International Committee
of Bioethics (IBC) was founded by UNESCO in 1993 and tasked with devising
an international instrument to protect the human genome. Given the
controversies surrounding genomics research and the number of open
and partly hidden conflicts during the preliminary work of the IBC, it
soon became clear that UNESCO would not be able to adopt a legally
binding convention.
Note Instead, States opted for a declaration,
and the Universal Declaration on the Human Genome and Human Rights
was adopted unanimously and by acclamation at UNESCO’s 29th General
Conference on 11 November 1997. The Declaration was endorsed by
the UN General Assembly the following year. The Declaration regards
the human genome as the “heritage of humanity”. It should be protected
and passed on to future generations and advances in science need
to be considered in the light of human rights. Further to this,
the IBC believes that interventions on the human genome should be
admitted only for preventive, diagnostic or therapeutic reasons and
without enacting modifications for descendants and has called for
“a moratorium on genome editing of the human germ line”.
Note
11. The only internationally binding framework in this field is
the 1997 Oviedo Convention, binding on the 30 member States which
have ratified it. Its Article 13 posits that “an intervention seeking
to modify the human genome may only be undertaken for preventive,
diagnostic or therapeutic purposes and only if its aim is not to introduce
any modifications in the genome of any descendants”.
12. Further, the Oviedo Convention provides for the freedom of
scientific research, subject to the protection of human rights.
Note Yet,
“where the law allows research on embryos
in
vitro, it shall ensure adequate protection of the embryo”
(Article 18’1)). The creation of human embryos for research purposes
is prohibited under Article 18(2).
13. Article 28 imposes on States Parties to see to it that “the
fundamental questions raised by the developments of biology and
medicine are the subject of appropriate public discussion in the
light, in particular, of relevant medical, social, economic, ethical
and legal implications, and that their possible application is made the
subject of appropriate consultation”. In conjunction with this,
the Oviedo Convention establishes a specific procedure for its amendment
in Article 32.
14. CDBIO assesses the ethical and legal challenges raised by
emerging genome editing technologies regarding the Oviedo Convention.
According to the Strategic Action Plan 2020-2025, adopted at the
16th meeting of its precursor committee, the Committee on Bioethics
(DH-BIO), on 19-21 November 2019, it is of the greatest importance
to embed human rights in technologies with an application in biomedicine.
Hence, the actions promoted include examining the practical and
legal implications of Article 13 of the Oviedo Convention in the
light of the developments in genome editing as well as analysing
the necessity of an amendment to this Article.
15. In accordance with Article 32 of the Oviedo Convention, in
2020, DH-BIO started re-examining Article 13 of the Convention,
with a view to “providing for clarifications on terms or aspects
of the provisions of Article 13 without revising its wording”.
Note DH-BIO set up a drafting group in 2021 to
provide clarifications on the terms “preventive, diagnostic and
therapeutic” and to avoid misinterpretation of the applicability
of this provision to “research”.
16. At its 1st plenary meeting in 2022, the CDBIO concluded the
final step of the re-examination process of Article 13 of the Oviedo
Convention, with the adoption of the clarifications on the scope
of the provisions with regard to research and the purposes limitation
provided for any intervention on the human genome. As regards “research”,
the main clarifications are that the provisions of Article 13 apply
to any intervention seeking to modify the human genome, including
in research, and that the limitations of permittable purposes to “preventive,
diagnostic and therapeutic” also apply in research. With regard
to the permitted purposes for genetic alteration, the CDBIO has
clarified the following: an intervention for a “preventive” purpose
has the aim of avoiding the occurrence of a disease or disorder.
The term “disease” refers to a disease or disorder defined in accordance
with internationally accepted medical standards. An intervention
for a “diagnostic” purpose should be understood as intervention
undertaken to identify a disease or disorder, or a genetic variant
or factor associated with the development of a disease or disorder,
again identified in accordance with internationally accepted medical
standards. An intervention undertaken for a “therapeutic” purpose
will aim at controlling symptoms of a disease or disorder, slowing
or reversing its progression or provide a cure, for example by removing
its underlying cause.
Note The clarifications were presented
to the Committee of Ministers on 27 September 2022.
17. In light of these clarifications, it can be concluded that
the Oviedo Convention constitutes an international legal framework
and a guiding set of ethical principles which restrict the scientific
use of gene editing technologies in human beings and impose a strong
precondition of legal and ethical legitimacy for such activities.
Therefore, these shared ethical principles should drive the international
debate on germ line and embryo editing in human beings: as already
highlighted by the Assembly in its 2017 Recommendation, the member
States which have not done so should ratify the Oviedo Convention,
as well as develop a clear national position of prohibition of germ
line and embryo editing in human beings in order to avoid a vacuum
of legal and ethical certainty both at the international and national
levels.
Note
4 Opinions
in the international debate
18. The issue of germ line editing
in human beings is one of the major bioethical dilemmas of today
and it is the object of a widespread international debate. Many
international fora and groups of experts are addressing it: the
main ones are the IBC, the Expert Advisory Committee on Developing
Global Standards for Governance and Oversight of Human Genome Editing
of the World Health Organization (WHO), the European Group on Ethics
in Science and new Technologies (EGE) and the International Commission
on the Clinical Use of Human Germline Genome Editing.
19. The IBC set out its position in the 2015 Report on updating
its reflection on the Human Genome and Human Rights. On this occasion,
it reiterated its support for a moratorium on germ line editing
in human beings, recalling the necessity to consider scientific
development in light of human rights. By identifying the human genome
as “one of the premises of freedom itself and not simply raw material
to manipulate”, numerous arising ethical challenges were taken into
consideration, such as the respect for autonomy and privacy, the
threats to principles of justice and solidarity and the responsibility
towards future generations. More recently, IBC has adopted a report
on the principle of protecting future generations: affirming that
the principle of intergenerational justice must go hand in hand
with the precautionary principle, it recalled that such germ line editing
in human beings must not be applied until it is scientifically validated
and considered ethically acceptable. It finally recommended that
States build a shared global standard and pass regulation to protect the
human genome and to prohibit genetic alterations of the human germ
line.
20. In December 2018, WHO established the Expert Advisory Committee
on Developing Global Standards for Governance and Oversight of Human
Genome Editing (“WHO Committee”) to examine the scientific, ethical,
social, and legal challenges associated with human genome editing
(somatic and germ line).
21. The WHO Committee reaffirmed the statement by the WHO Director-General
in March 2019 that it would be irresponsible at this time for anyone
to proceed with the clinical application of germ line genome editing.
The WHO Committee recommends that WHO should work with others to
institute and develop international collaboration for effective
governance and oversight. In addition, germ line editing should
only take place in jurisdictions with domestic policy and oversight.
The WHO Committee further suggests creating and hosting a registry
for human genome editing used in clinical trials, which should include
data from germ line editing technologies if at some point, they
should be approved.
Note WHO thus
supports the call by the EGE to “establish a public registry for
research on germ line genome editing”.
Note
22. In the United States, the International Commission on the
Clinical Use of Human Germline Genome Editing, a collaboration by
the Academy of Medicine, the National Academy of Sciences, and the
Royal Society, published a report on the issue in 2020. According
to the report, germ line editing should be prohibited until it has
been clearly established that it is possible to make precise genomic
changes efficiently and reliably without undesired changes in human
embryos. Further, any clinical use should proceed cautiously, with
initial uses restricted to a limited set of circumstances,
inter alia, severe monogenetic disease
and no or very poor alternatives for having a genetically related
child without the disease. The report calls for every country to ensure
that the requirements have been met for initial responsible use,
prior to approving the use of germ line editing. The report hence
entails a certain openness leaving the decision at a country-level
while establishing an international scientific advisory panel and
an international body for related discussions and international oversight.
Note
23. The human rights framework for germ line editing in the European
Union is the Charter of Fundamental Rights which in Article 1 secures
everybody’s rights to be treated with dignity. Article 3 prohibits
“eugenic practices, in particular those aiming at the selection
of persons”. The EU Clinical Trials Directive bans gene therapy
trials “which can result in modifications to subject’s germ line
genetic identity”.
Note It is, however, unclear whether
this ban applies to germ line gene editing research. In general,
the regulatory framework is considered patchy and lacking coherence.
Note
24. The international debate has been enriched by the EGE, an
independent and multidisciplinary body which advises the European
Commission. In a recent position paper, EGE addressed the need to
consider the numerous bioethical implications arising, and proposed
a balance between potential benefits and risks in the use of germ
line editing techniques in human clinical application.
Note By putting
the accent on the principles of social justice and equality, the
heritability of genetic intervention by future generations has been
declared a potential challenge to human biodiversity and a potential
doorway to genetic make-up and human enhancement. Consequently,
EGE has recommended that EU member States be engaged in global governance
initiatives and promote an inclusive debate on germ line editing.
25. In addition, the European Society of Human Genetics and
the European Society of Human Reproduction and Embryology have expressed
similar opinions. After having supported the moratorium on establishing
a pregnancy with genetically modified germ line cells or human embryos,
Note both
societies widely examined the bioethical implications, also highlighting
potential societal risks, such as the breach of the dignity of people
with disabilities, the risks of human enhancement and the growth
of inequalities. However, these societies would be in favour of
regulating the use of germ line editing in human beings if and when
safety concerns are overcome.
26. Ultimately, at the international level, the World Medical
Association has also called for a germ line editing specific ethical
and legal framework while condemning its use in human clinical application
at this stage.
Note
27. Three international summits have been held on Human Genome
Editing
Note,
in 2015, 2018 and early 2023. While, in 2015, this international
group of scientists called for a moratorium on making inheritable changes
to the human genome,
Note in
2018 – despite the shock revelation of the Chinese researcher at
the Summit that he had broken the moratorium – the Organising Committee
issued the following statement: “The organizing committee concludes
that the scientific understanding and technical requirements for
clinical practice remain too uncertain and the risks too great to
permit clinical trials of germ line editing at this time. Progress
over the last three years and the discussions at the current summit,
however, suggest that it is time to define a rigorous, responsible
translational pathway toward such trials. A translational pathway
to germ line editing will require adhering to widely accepted standards
for clinical research, including criteria articulated in genome
editing guidance documents published in the last three years. Such
a pathway will require establishing standards for preclinical evidence
and accuracy of gene modification, assessment of competency for practitioners
of clinical trials, enforceable standards of professional behaviour,
and strong partnerships with patients and patient advocacy groups.”
Note
28. The Organising Committee of the Third Summit – which focused
on somatic, rather than heritable human genome editing – went one
step further in its statement: “Preclinical evidence for the safety
and efficacy of heritable human genome editing has not been established,
nor has societal discussion and policy debate been concluded. (In
some cases, pre-implantation genetic testing is among the alternatives.)
Heritable human genome editing should not be used unless, at a minimum,
it meets reasonable standards for safety and efficacy, is legally
sanctioned, and has been developed and tested under a system of
rigorous oversight that is subject to responsible governance. At
this time, these conditions have not been met.”
Note
29. In May 2021, the International Society for Stem Cell Research
(ISSCR) issued updated Guidelines for Stem Cell Research and Clinical
Translation. In what can be interpreted as an “important contribution
to the project of developing a translational pathway for heritable
human genome editing”
Note (an objective proposed by the afore-mentioned
Second Summit), a new sub-category “3 A Research activities currently
not permitted” was created, and heritable human genome editing research
was moved out of the “prohibited” category into this new sub-category.
5 Human
rights and ethical issues concerning intentional heritable genome
editing in human beings
30. As can be seen in the various
reports, recommendations and statements being made (see Chapter
4), many scientists are pushing hard for what is euphemistically
called a “translational pathway” to clinical trials with intentionally
genetically modified embryos. The birth of human beings whose genome
has been intentionally modified – which is, we should recall, prohibited
by the Oviedo Convention, as well as 75 countries, and is explicitly
permitted by no country in the world – could in their view take
place as soon as “reasonable standards for safety and efficacy”
are met, “societal discussion and policy debate has concluded”, heritable
genome editing is “legally sanctioned” and “has been developed and
tested under a system of rigorous oversight that is subject to responsible
governance”. While the green light for inducing such pregnancies
has not been given (scientists consider that these minimum conditions
have not – yet – been met), preparations are obviously going ahead
with this aim in mind.
31. Personally, I find this push shocking. In the past three years,
public debate on this issue has been sorely lacking, and understandably
so: the world has been preoccupied with fighting a global pandemic
and a climate emergency, and dealing with the consequences of Russia’s
war of aggression against Ukraine. In 2020, I authored a report
entitled “Ethics in science and technology: a new culture of public
dialogue” (
Doc. 15517). The Assembly followed my recommendations, and noted
that “Developments in science and technology must respect fundamental
values and human dignity, and scientific and technological foresight
should no longer remain the exclusive remit of researchers and industry.
Public authorities have to involve citizens more widely in decision
making on science and technology, and policy options should be subject
to public debate and scrutiny, to make sure that new advances in
these domains sustain human progress.”
Note Indeed, the need
for public debate and appropriate consultation is clearly stated
as a principle in Article 28 of the Oviedo Convention, and DH-BIO
has published a “Guide to public debate on human rights and biomedicine”.
Note National parliaments have a key
role to play in this process.
32. What little debate has happened – both in parliaments and
in society at large – seems to me to have been pushed, possibly
in a manipulative way, by researchers and industry, seeking scientific
glory and profits, with little regard to human rights, human dignity,
and human progress. This may sound overly harsh, but how else to
describe the proposal of defining “reasonable standards for safety
and efficacy”, that is to say something that is “safe enough” and
“effective enough” when we are talking about a technology which,
with its possible side-effects which may only become apparent after
several generations, could end up wiping out the human race as we
know it? A technology which could easily be abused for eugenic or
military purposes? And to do what – help the extremely rare couples
with a monogenetic disease to have a genetically related child without the
genetic disease, where both parents’ germ cells carry the defect
(and the gene involved is dominant), and somatic or “one-generation”
gene therapy doesn’t work? I would like to recall that, in any case,
there is no “right to a child”, and even less to a genetically related
one.
33. Even if the safety concerns are eliminated in the future,
the human rights concerns, in particular with respect to the effects
on future generations, will persist. The Council of Europe has a
mandate that encompasses the promotion and protection of human rights
of all individuals and is thus responsible for carefully weighing
the human rights implications of heritable genome editing in human
beings. The CDBIO has withstood calls to “revise” Article 13 of
the Oviedo Convention which contains the prohibition of any intervention seeking
to introduce a modification in the genome of any descendants. In
2022, it clarified that Article 13 applies in the research as well
as the clinical context, and made clear that any intervention that
seeks to modify the human genome may be carried out only for preventive,
diagnostic or therapeutic purposes.
34. Allow me to quickly summarise the human rights concerns which
underpin the position of CDBIO: first, germ line modifications mean
irreversible modifications to future generations which might not
even be foreseeable. This, on the one hand, means changing the common
heritage of humanity. Making genetic modifications on humans might
have unexpected evolutionary consequences which cannot be reversed.
Since the entire effects of these modifications might not become
apparent for years or even generations, permanently altering the
germ line of human beings is considered an unbearable risk. Further,
the future generations affected are not able to give their informed
consent to these alterations. This is clearly contradictory to the
idea of the autonomy of a patient, a principle which has been a
core to research regulation for centuries.
35. Further, germ line editing even for therapeutic or preventative
measures opens the door to human enhancement.
Note Even
if an application is carried out for therapeutic reasons, the question
will arise as to whether the treatment goal (for example regaining
lung capacity) should be oriented towards the average of society
or towards the optimum. What is understood as a severe disease or
a therapeutic measure depends on subjective decision making. Commercial,
military, or scientific interests could in some cases influence
the evaluation. In addition, parents might feel pressured to accept
such germ line therapy on their future children. Enhancement measures
in general violate human dignity as they imply that the “natural”
human is less valuable than its genetically modified self. The technology
could be misused to produce individuals or entire groups with particular
qualities, which could even lead to a “weaponisation” of the use
of certain genetic technologies, for example to reduce the sleep
required of soldiers.
36. Another potential societal consequence of the use of germ
line editing in human beings is the breach of the principles of
justice, equality, and non-discrimination. The techniques in question
would most certainly not be accessible to the entire population
and not be fairly distributed. In line with the human enhancement scenario,
this would aggravate the existing social and economic inequalities,
thus prolonging the existence of discrimination and imposing a negative
impact on society.
6 Conclusions
and recommendations
37. In 2015, the UK Parliament
amended the Human Fertilisation and Embryology Act to permit the
use of mitochondrial replacement therapy, making the United Kingdom
the first country in the world to officially permit this form of
intentional germ line modification.
Note In the
case of rare genetic diseases linked to the maternal inheritance
of mitochondrial diseases, this therapy can be used to avoid passing
down such diseases. There are two ways: pronuclear transfer technology
and maternal spindle transfer. A child born from this latter procedure
has three genetic parents (with one providing the new genes of the
healthy mitochondria). Although the traits of a child are inherited
from the nuclear DNA of its parents and not the mitochondrial DNA,
the interrelation and function between the genome of the nuclei
and the mitochondria is still uncertain. The procedure is thus still
considered a risky and experimental intervention that carries serious
risks, and should not be undertaken lightly – and certainly not
out of commercial motivations.
38. On 31 July 2023, two researchers published a paper which contends
that the model followed to persuade the UK Parliament (and later
the Australian Parliament) to authorise this procedure – in their
view, prematurely – is now being used to influence perception and
incrementally shift public consensus towards creating a regulatory
pathway to allow heritable genome editing in human beings which
changes the DNA of the nuclei (not just the mitochondria).
Note I am personally not in favour of
allowing mitochondrial replacement therapy, but the dangers associated
with this therapy are far fewer than with allowing heritable genome
editing in human beings which changes the DNA of the nuclei. The
risk involved with the necessary public debate on whether or not
to allow heritable genome editing in human beings being unduly influenced
by researchers and the fertility industry is thus also far higher
than with the debate on whether or not to allow mitochondrial replacement therapy.
39. We must remember that just because we “can” do something does
not mean we “should” do it, and even less that there should be a
“right” to do it. Mere technical possibility should not lead to
a
per se acceptance of a technology.
An example is deliberate cloning of human beings, which is – independent
of the technological possibility – banned by the Additional Protocol
to the Oviedo Convention on the Prohibition of Cloning Human Beings
(ETS No. 168) as it would “give up the indispensable protection
against the predetermination of the human genetic constitution by
a third party” and would endanger human dignity by instrumentalisation.
Note The statement in the Explanatory
Report to the Additional Protocol that “as naturally occurring genetic recombination
is likely to create more freedom for the human being than a predetermined
genetic make up, it is in the interest of all persons to keep the
essentially random nature of the composition of their own genes”, also
holds true for deliberate human germ line intervention.
40. Different voices raise the argument that in cases of severe
genetic diseases, the right to life secured in Article 2 of the
European Convention on Human Rights (ETS No. 5) as well as the right
to enjoy the benefits of scientific progress and its applications
(for example in Article 15(1)(b) of the International Covenant on Economic,
Social and Cultural Rights) should be read as permitting heritable
genome editing. One must, however, keep in mind, that there are
always alternative options to heritable genome editing. There does
not seem to be a case in which these alternatives, including possibly
“one-generation germ line editing”, could not sufficiently secure
human rights. Indeed, human rights law does not recognise a “right”
to a child, much less to a genetically related one.
41. The Assembly and the Council of Europe as a whole should thus
take a clear position today in case heritable genome editing is
considered “safe enough” by the scientific community in the future.
We need to consider that neither those affected by germ line interventions
have the possibility of consent, nor can long-term influences on
humanity be prevented. Allowing heritable genome editing is a slippery
slope towards the “improvement” of humanity. In line with the decision
at the 17th DH-BIO meeting not to amend Article 13 of the Oviedo
Convention, the ban on establishing a pregnancy with germ line cells
or human embryos having undergone intentional genome editing (with
the possible exception of mitochondrial replacement therapy and, in
the future, “one-generation germ line editing”) should thus be maintained
in my opinion, even when the technology underlying it is considered
“safe” in the future.
42. For activities not prohibited by Article 13 of the Oviedo
Convention, such as certain forms of genome research and, if technically
feasible, “one-generation germ line editing”, comprehensive laws
and regulations seem required to prevent the possible misuse of
the technology.
43. I thus suggest that the Assembly should consider the adoption
of the three following recommendations to the Committee of Ministers:
43.1 to urge member States which
have not yet ratified the Oviedo Convention to do so without further delay;
43.2 to remind the States Parties to the Oviedo Convention
of their obligation to give life to its Article 28 through the promotion
of a broad and informed public debate on heritable genome editing
in human beings and the protection of the human genome as the heritage
of humanity, as well as on future generations’ human rights;
43.3 to call upon Council of Europe member States to embrace
a clear and total prohibition of establishing a pregnancy with germ
line cells, their precursors, or human embryos having undergone intentional
genome editing of their nuclear DNA, by introducing legislation
at the national level, and opposing permissive regulation at European
and international level.
