Download New genetic technologies in human beings and Human rights

New genetic technologies in human beings
and Human rights
A proposal for Recommendation entitled “Genetically Engineered Human Beings”,
(Doc. 13927) was submitted to the Committee on Social Affairs at the Parliamentary
Assembly of the Council of Europe. On March 15, 2016, the Belgian senator, Petra de
Sutter was designated as the rapporteur.
On November 30, 2016, the title was changed to “The use of new genetic technologies
in human beings”.
The Assembly will be asked to vote and comment on the Committee’s
recommendations on the risks and challenges of regulating and using these
techniques, from health, ethical, and human rights viewpoints.
This paper intends to clarify challenges related to human rights and to modifying the
human genome.
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Introduction
The discovery of the CRISPR-Cas9 technique allowing DNA to be modified in any cell and its’
large-scale implementation in 2012, makes it widely accessible for research teams. Other
enzymes capable of cutting DNA (nuclei) have already been explored and used (TAL effector
nucleases (TALENs) Zinc Finger Nuclei (ZFN)
CRISPR-Cas9 is a novel technique since it has revolutionized research with a simple, costeffective, easily employed genetic tool. It can thus be applied for modifying DNA in all types of
vegetable, animal or human cells. « This technology functions as genetic scissors to cleave DNA
and can easily be designed for targeting any and all genes. Henceforth, it is now possible to
modify gene expression, to switch it ‘on’ or ‘off’ to change, repair or remove genes. According
to one of the two discoverers of CRISPR-Cas91, Emmanuelle Charpentier: “It quickly emerged
as the ‘Swiss Army knife’ of genetic manipulation”. One of the most important applications
would be for therapy for some human genetically-transmissible disorders. Co-discoverer of
CRISPR-Cas9 with the French scientist, Charpentier, the biologist Jennifer Doudna is calling for a
clear definition of which applications are ethically acceptable or not. The future possibility of
using germline cells (gametes) and human embryos is raising numerous and serious ethical
issues.
Since last April 2015, there has been an international uproar, when researchers in China
published the results of their gene editing on several non-viable human embryos in Protein &
Cell2.
In October 2015, a UNESCO panel of experts called for a moratorium on “editing” of human DNA
to avoid unethical tampering with hereditary traits3.
The UNESCO International Bioethics Committee (IBC) argued in its’ report “that the alternative
would jeopardize the inherent and therefore equal dignity of all human beings and renew
eugenics.”
In the United States in November 2015, the “Center for Genetics and Society” 4 organized an
open letter signed by dozens of research scholars, scientists and health practitioners from
several countries throughout the world, calling for strengthened prohibitions against using
genetically engineered human embryos or gametes for reproduction5.
In April 2016, the European Group on Ethics (EGE) and Science and New Technologies
published a statement on gene editing6. As to human germline editing, the EGE is of the view
that there should be a moratorium on gene editing of human embryos and gametes, which
would result in the modification of the human genome. The EGE members have diverging
positions regarding clinical applications, as distinct from basic fundamental research. The
boundary between the two fields is not always a clear-cut distinction; they are sometimes
blurred or overlapping. Some individuals call for complete prohibition, by upholding article 3
1
The Florida Genetics Symposium (2016) http://ufgi.ufl.edu/emmanuelle-charpentier-to-serve-as-keynote-for-florida-geneticssymposium-2016/
2Liang, P., Xu, Y., Zhang, X. et al. Protein Cell (2015) 6: 363. doi:10.1007/s13238-015-0153-5
http://link.springer.com/article/10.1007/s13238-015-0153-5
3UNESCO panel of experts calls for ban on “editing” of human DNA to avoid unethical tampering with hereditary traits (2015)
http://www.unesco.org/new/en/media-services/single-view/news/unesco_panel_of_experts_calls_for_ban_on_editing_of_hu/
4
http://www.geneticsandsociety.org/article.php?id=8999
5 Open Letter Calls for Prohibition on Reproductive Human Germline Modification by Center for Genetics and Society.
http://www.geneticsandsociety.org/article.php?id=8999
6European Group On Ethics In Science And New Technologies. Statement on Gene Editing.
http://ec.europa.eu/research/ege/pdf/gene_editing_ege_statement.pdf#view=fit&pagemode=none )
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in the Charter of Fundamental Rights of the European Union. Others call for continuing basic
research. They have called for a broad public debate on these issues.
1. What is CRISPR-Cas9 and how does it work
 Definition
This new revolutionary genome editing technique called CRISPR-Cas9 makes it possible for
scientists to insert, remove and correct genes in DNA simply and efficiently. CRISPR is the
acronym for: Clustered Regularly Interspaced Short Palindromic Repeats observed in certain
bacteria.
The technique combines the use of two elements which act as “molecular scissors “to cut
DNA:
- On one side there is the CRISPR sequence, coupled to a short RNA sequence, preselected
and capable of detecting the matching sequence of DNA to be cut. This laboratory
designed “CRISPR RNAs” or crRNA” is a sort of “head-hunter” which guides the system to
matching sequences of DNA.
- Then the Cas-9 enzyme comes into play to bind the target DNA at 2 active sites, one for
each part of the DNA double helix to shut off the targeted gene.
 Mode of Action
The technique acts as a sort of « Swiss Army knife », and thus modifying DNA becomes as
simple as “cut and paste” application in Word documents.
It has now become readily possible to remove, replace, or insert a new gene in a DNA
sequence. Once the DNA has been cut, it will repair itself, possibly introducing a mutation (an
error).
2. Possible Applications
 Basic Research
This technique could prove widely useful for understanding the role of certain genes in all
fields of scientific research (health for humans and animals, agriculture, etc); for instance, by
analyzing a cell’s activity where a gene had been removed compared to the original cell.
 Human health and genetic therapy
Genetic therapy could lead to spectacular progress in medical history and genetic engineering
and is a promising adventure for science and medicine, even though it should be noted that
there are very few diseases where only one single gene is responsible. Therefore, genetic
therapy is not a rapid cure7 for the majority of disorders, which are caused by numerous genes
as well as environmental and life-style risk factors.
7
Report of the International Bioethics Committee (IBC) on Updating Its Reflection on the Human Genome and Human Rights - 2
October 2015 http://unesdoc.unesco.org/images/0023/002332/233258E.pdf
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This technique holds therapeutic promise to treat or improve the quality of life for many
patients, such as those with some hereditary disorders or diseases linked to genetic
mutations. CRISPR-Cas9 thus shows promise for genetic therapy. Several clinical trials 8 have
started, for example, for certain types of cancer, or for treating sickle-cell anemia9.
Other studies, in experimental phase or in animal testing phase, are in progress, for example
Duchenne’s muscular dystrophy10.
 Embryos and Germ cells
Using genetic modification techniques on germline cells is possible, for basic fundamental
research, as well as for making “designer babies”. China, as well as other countries, has
already announced using in vitro human embryos for research purposes. In February 2016, the
UK Human Fertilisation and Embryology Authority (HFEA) approved for researchers to
genetically edit human embryos11. In April 2016, the Swedish authorities also allowed this
type of research on human embryos.
The purpose of this type of research may be to increase our understanding of how the first
moments in life function, the mechanisms involved for embryo implantation, the evolution of
germ cells, the causes of some forms of infertility, or miscarriages. But they also could involve
modifying certain genetic characteristics in embryos, by trying to remove the genes
responsible for some diseases, or to select or improve other criteria.
3. Ethical Challenges
Ethical principles should always guide diagnostics procedures and genetic therapy. However,
we must point out the risk to see the marketplace determine which procedures deserve to be
performed and draw the boundary line between what is acceptable and what is not.
The technique « itself » is not an ethical problem. The problem comes from its applications.
There are two different categories of cells:

Somatic cells
These cells make up the large majority of an individual’s cells. They include all cells which are
not germline cells (gametes).
Targeting somatic cells for genetic modification (on adults or children) has no other serious
ethical issues than those of any specific treatment: find the correct balance between benefit
and risk, informed consent, etc.
8
First CRISPR clinical trial gets green light from US panel – Nature 22 June 2016
http://www.nature.com/news/first-crispr-clinical-trial-gets-green-light-from-us-panel-1.20137?WT.mc_id=TWT_NatureNews
9
CRISPR/Cas9 β-globin gene targeting in human haematopoietic stem cells Nature 539, 384–389 (17 November 2016)
http://www.nature.com/nature/journal/v539/n7629/full/nature20134.html
10CRISPR helps heal mice with muscular dystrophy Science 31 December 2015 http://www.sciencemag.org/news/2015/12/crisprhelps-heal-mice-muscular-dystrophy
11
HFEA approves licence application to use gene editing in research (2016) http://www.hfea.gov.uk/10187.html
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The technique has not yet been completely perfected, and numerous “off-target” effects have
been observed (genetic modification for cells which were not targeted). This “collateral
damage” needs to be taken into account, and a rigorous study protocol implemented before
any clinical trials.

Germ cells and human embryos
Germ cells are the gametes: spermatozoids and ovocytes. Since it is now feasible to modify
any cell whatsoever, this qualso applies to the human embryo and germ cells. There lies the
major ethical and even health issues.
Safety is the essential criterion for all pharmaceuticals and medical treatments when they are
applied to human beings. This is even more crucially important when it concerns a procedure
capable of inducing significant effects on the life of individuals who in the future might be
considered as “custom-ordered”, without their consent, and also transmit these genetic
modifications to future generations.
Health Risks for Unborn Children
When the technique is used on human embryos, in view of giving birth to the child, he
becomes a “lifelong guinea pig” for the technique employed to design his DNA.
 The « off-target » effects are unpredictable and completely unverifiable. They may lead to
the unintentional modification of other genes by mistake.
 Risk of « mosaics ». When applied to human embryos at the zygote stage (first embryonic
cell) or a stage with only a few cells, the technique could “correct” all or part of these cells.
But it will be impossible to verify that all the embryo’s cells have genuinely been modified.
Although one cell could be tested with Pre-implantation diagnosis, it is impossible to verify all
the cells without destroying the embryo, since the embryo itself would have to be sampled
and its’ DNA sequenced. Thus « mosaics » can result, whereby certain cells are modified, and
others not. The consequences on embryonic development and the health of the unborn child
can only be verified at his birth or even years later. Animal tests have already demonstrated
that in most cases, the desired genome modification was only found in a small minority of
newborns. Besides, mosaics were often observed . Finally, in animals where the DNA was
modified, the phenotype (observable physical characteristics) did not always correspond to
the one expected12.
 Risks of «collateral damage ». Modifying a gene, for example, by choosing to remove a gene
responsible for a certain disease, can have unexpected and negative results. Some genes
qualified as “defective” may in fact, have a “protective” role for another disease13. In
addition, after cutting and “repairing” the DNA (whether or not a new gene is inserted),
mutations are still possible.
12
Genetic editing of human germline cells and embryos. (2016) French national academy of Medicine. http://www.academiemedecine.fr/wp-content/uploads/2016/05/report-genome-editing-ANM-2.pdf
13 Limits to our Understanding. Eric Lander, Broad Institute of Harvard and Massachusetts Institute of Technology (MIT) International
Summit of Gene Editing, Washington (Dec 2015) http://www.nationalacademies.org/gene-editing/Gene-Edit-Summit/SlidePresentations/index.htm
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In March 2017, Chinese researchers published their experience on human embryos which
demonstrated the off-target and mosaic effects14.
Several animal studies or even experiments on human embryos, are sometimes recommended
as pre-requirements for verifying the reproducibility and the (targeting) performance of the
technique prior to implementing the method. Although contributing complementary
information, experiences conducted in animal models and human material in vitro will never
bring complete reassurance for a technique being used to give birth to genetically-modified
human beings. By definition, every human embryo is unique, composed of a genetic heritage
from his biological father and mother.
Thus if a procedure is used to genetically modify a zygote, the “results” of the experiment are
also unique. Genomic interactions, the epigenetic15 factors make this embryo a nonreproducible unique case, thus making the child a “guinea pig”.
Risks for future generations
Any modifications in an individual’s genome at the embryonic stage of development, will also
affect his germ cells, (ovocytes for women, and spermatozoids for men). Thus, any modification
will be irrevocably transferred to future generations with unpredictable consequences.
Numerous researchers protest that we don’t yet know enough about genetic interactions and
possible unintended consequences of modifying the human genome. Even by eliminating some
negative side-effects, other problems could occur, which could expose the individual or the
entire human race to other potential risks, as serious as those which were initially targeted.
 Evolution takes place slowly. From the beginning of time, the world has observed
genetic evolution. Whether natural, spontaneous, or “man-made”, for example by
domesticating animals or cross-breeding species. But whether naturally-occurring or “in
the wild” the process has always been slow, completely incomparable to the speed used
in this technique. This is a break with the past. A major question is: what if “something
goes wrong” in these modifications? Can we go back “re-edit” these genes16?
 Risk of « creating improved humans ». Disorders which could theoretically be “treated at
the embryonic stage” are rare. With gigantic investments in the field of genetics from
companies such as Google, and the foreboding of transhumanism, the risks of ethical
transgression headed towards selecting genes to improve or “increase” human beings’
performance are a serious concern. For geneticist, Axel Kahn, “Many of those who argue
that this new tool should be used for correcting genetic disorders, are thinking of
improving the human race”17.
14
CRISPR/Cas9-mediated gene editing in human zygotes using Cas9 protein. Molecular Genetics and Genomics.
https://link.springer.com/article/10.1007%2Fs00438-017-1299-z
15 Genetics is the study of genes while epigenetics is the study of complementary biological mechanisms that switch gene activity in
a cell either on or off. Epigenetics involves studying changes in organisms caused by modification of gene expression (active versus
inactive genes) rather than changes to the genetic code itself, but could nevertheless be transferred during cell division. Compared
to making changes to the underlying DNA sequences, epigenetic changes are reversible. Factors having an impact on epigenetics
include environment, life-style, emotions... and are still not well-defined.
16 Report on "The manufacturing of a new human race?" held on September 30th, 2015 by the Commission of the social questions,
the health and the sustainable development of the Council of Europe.
http://website-pace.net/documents/19855/1360734/AS-SOC-2015-PV07ADD2-FR.pdf/86475863-8979-497a-9760-06cd9a0e1aa3
17
La recherche. Hors-Série. Hérédité. « Demain, un bébé sur mesure ». Mars 2017.
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“Embryonic therapy » to prevent transmission of certain rare forms of genetic disorders?
For some genetically transmissible disorders, all the embryos are automatically affected. The
use of Pre-implantation Diagnosis, authorized by some laws to analyze and select certain
embryos, and then only implanting the ones unaffected by the disorder, would therefore not
apply. This is the case in autosomal dominant diseases18, when one of the two partners is
homozygote19. This is the case in Huntington’s disease, or in the case of an autosomal
recessive disease (muscular dystrophy for example) when both partners are homozygote.
Gene editing techniques like CRISPR-Cas9 are exalted in the outlook of avoiding transmission
of genetic diseases, by applying the technique to the couple’s gametes or on the embryo,
conceived in vitro.
This future outlook involves serious human and ethical issues. Those who suffer must be
heard, supported and accompanied in their pain. This is not the only solution for avoiding
genetically transmissible diseases for couples known to be carriers. Adoption is also an option,
for example, so there is no stringent obligation to provide a solution, at all cost, to allow these
couples to have a biological child, if the process has unpredictable risks for the child and thus
for the family.
Sometimes this technique is cited as a means of permanently eradicating certain genetic
diseases. Yet, there is a non-negligible risk of mosaics, meaning that human germ cells might
possibly not be edited correctly. Thus it is impossible to purport with certainty that a disease
could be eliminated20. Eric Lander, Biology Professor at Massachusetts Institute of Technology
(MIT) who participated at the Gene Edit summit in Washington declared: “We’re crummy at
the subject. We are terrible predictors of the consequences of the changes we make” 21.
The unknowns (such as mosaics, collateral damage, and off-target effects) are too
unpredictable and dangerous for the child’s health, which could result in complicated
situations. The future health and development of the child can never be “guaranteed”.
4. What are the consequences for Human Rights?
Human Dignity
Dignity is a significant ethical subject treated by UNESCO’s report in the Universal Declaration on
the Human Genome and Human Rights22. Article 1 insists that “the human genome underlies the
fundamental unity of all members of the human family, as well as the recognition of their
intrinsic dignity and diversity.” UNESCO defines the human genome as “mankind’s heritage” on
18
A genetic disease is considered autosomal, when the gene expressing the disease is located on an “autosomal” chromosome
(meaning any chromosome other than the two sex chromosomes X and Y). Dominant means one mutated allele (of the two) is
enough for the disease to be expressed. Each gene has 2 alleles, one with genetic DNA from the father and one from the mother.
Recessive disorders mean that both alleles have mutations for the individual to be affected by the disease.
19 If an individual has 2 identical alleles, it is known as being homozygote, compared to a heterozygote which has 2 different alleles
on each of its homologous chromosomes.
20 National Academies Press. January 2017.
21Eric Lander talks CRISPR and the infamous Nobel ‘rule of three’, Washington Post, 21 april 2016
22Universal Declaration on the Human Genome and Human Rights, adopted by acclamation at UNESCO's 29th General Conference
on 11 November 1997, endorsed by the United Nations General Assembly in 1998.
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a worldwide level, underlining the exceptional value which must be protected and transmitted
to future generations.
Experimental procedures on the human genome are extremely risky. UNESCO points out the
risk of placing “in peril the inherent dignity, which means the dignity all of human beings”.
Eugenics
Technology could be used to prescribe which genes an embryo should have or not, making it
possible to “design” custom-made children, inevitably leading to eugenic abuses. There is
often a fine line between “repairing” and “improving”.
A worldwide problem
Scientific research and its’ applications have a global impact on the market. In practice, what
is legally authorized in one country becomes “permitted”. For example “medical tourism”
related to artificial reproduction techniques and surrogacy, present major ethical issues for
different States. Therefore, it is crucial for the States and their governments to adhere to the
principle of sharing worldwide responsibility for the engineering of the human genome,
especially for the stakes involved in modifying germ lines.
Biohazards
The Director of American National Intelligence addressed this issue in a paragraph of his
annual statement to the US Senate. Given the accelerated pace of development for genome
editing and the different regulatory standards applicable in the countries, he points out the
threat of creating potentially harmful biological agents or products, with their deliberate or
unintentional misuse which might have far-reaching economic and national security
implications23.
5. The 3-parent IVF case
Although the technique used is different, the ethical issues are identical.
Also known as « a mitochondrial replacement technique », it is an artificial reproduction
procedure aimed at avoiding diseases transmitted by mitochondria. The disease is only
transmitted by the mother, via the defective mitochondria in the ovocyte. Mitochondria are
small “energy factories”, present in every cell of the body, carrying mitochondrial DNA, which
accounts for 1% of the total human genome.
The « 3-parent IVF » uses DNA from the biological mother, inserted into the egg cells provided
by the donor (previously enucleated) and paternal DNA from his spermatozoid. Thus a child is
conceived with a triple DNA parental heritage (nuclear DNA from the father and the mother +
mitochondrial DNA from the egg donor).
23Statement
for the Record Worldwide Threat Assessment of the US Intelligence Community Senate Armed Services Committee.
Genome Editing, page 9. James R. Clapper. Director of National Intelligence, 9 feb. 2016.
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Since there is no ban for this technique, children have thus already born using this technique
in Mexico and the Ukraine24. The technique is authorized in the United Kingdom.
Using this technique, any modifications to the genome (by the mitochondrial DNA) are
transmissible by the mother to future generations.
For numerous scientists, this technique raises serious concerns regarding efficacy and safety25.
At the American Society for Reproductive Medicine’s annual meeting on October 19, 2016 in
Salt Lake City, Dr Zhang, whose experiments led to the “first genetically modified baby”,
admitted that he didn’t know whether the child was in good health. Indeed, non-negligible
quantities of defective mitochondria were transmitted in the first embryonic cell, and thus are
present in each and every cell of the young boy .
In April 2017, Dr. Zhang published in Reproductive Medecine Online 26, revealing that the little
boy demonstrated a “neonatal mitochondrial DNA (mtDNA) mutation load of 2.36–9.23% in his
tested tissues.” This is evidence that a non-negligible rate of “diseased” mitochondria from his
biological mother were transferred to the zygote, the first fertilized cell, which could have
repercussions on the child’s health. The report states that the boy is currently healthy at 7
months of age; although long-term follow-up of the child’s longitudinal development remains
crucial. The authors state that a non-negligible quantity of cytoplasm is inevitably transferred
with the nucleus in the donor’s ovule. Thus it is impossible to certify that disorder they assert
“eradicating » has totally disappeared. The baby will be closely followed (every 3 months in the
first year of age), then every 6 months until age 3, then annually until 18 years old if he is
asymptomatic (or doesn’t demonstrate any worrisome side-effects). After 18 years, they hope
to assess his fertility function.
In Ukraine the procedure has been used solely for overcoming infertility and not for
preventing hereditary mitochondrial disease27. The hypothesis is that a donor’s ovule
(especially if she is young) would improve the embryo’s growth and development. This would
resolve certain problems in artificial reproduction (cases of women with an advanced age, or
unsuccessful IVF cases where embryos don’t develop correctly). There is truly a “hidden side
to the 3-parent IVF technique”28.
24http://www.sciencealert.com/world-first-in-ukraine-as-three-parent-baby-born-to-an-infertile-couple
25Three-person
embryos may fail to vanquish mutant mitochondria. (2016) Nature. http://www.nature.com/news/three-personembryos-may-fail-to-vanquish-mutant-mitochondria-1.19948
26Live birth derived from oocyte spindle transfer to prevent mitochondrial disease, Reproductive Biomedicine Online, avril 2017.
http://www.rbmojournal.com/article/S1472-6483(17)30041-X/fulltext
27Exclusive: ‘3-parent’ baby method already used for infertility (oct 2016). https://www.newscientist.com/article/2108549-exclusive3-parent-baby-method-already-used-for-infertility/
28Is “3-parent IVF” just an alibi for treating infertility? - http://www.alliancevita.org/en/2016/10/is-3-parent-ivf-just-an-alibi-fortreating-infertility/
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Conclusion
Modifying the genome of human germ lines (embryos or gametes) has serious consequences
for Human Rights. Encouraging research on human embryos will inevitably lead to strong
temptations to follow through to the next step by procreating children with genetic
modifications, as for the 3-parent IVF technique. The risks involved are greater than the
potential expected benefits.
Therefore, as for research on cloning human embryos, this research on modifying the
genome of human embryos should be banned worldwide.
In the Oviedo Convention, Article 13 stipulates 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 modification in the genome of any descendants”.
Extreme vigilance is requested for any attempts to re-interpret or modify this article which
prohibits assisting the birth of genetically modified human beings.
April 2017
Alliance VITA launched the first campaign « Stop GM Babies » in 2016 to get citizens involved in the
ethical debate regarding CRISPR-Cas9 technology and to raise awareness at the French and
international level. http://www.stopbebeogm.fr/
www.alliancevita.org
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Appendices
Appendix 1. Chronological dates in the international debates regarding CRISPR-Cas9
and human embryos
For the past several years, many international teams have been performing research on these
topics. In 2012, Jennifer Doudna and Emmanuelle Charpentier made a publication on the
discoveries that had been made.
 March 2015 : An appeal for a moratorium in the scientific community for using this
technique on human embryos29.
 April 2015 : A Chinese research team announces having crossed the red line boundary, by
using CRISPR-Cas9 in its’ laboratory on non-viable human embryos30.
 September 2, 2015 : The Academy of Medical Sciences and other leading UK research
organizations have signed a joint statement in support of the continued research and
financing for genome editing techniques in particular those using CRISPR-Cas931.
 October 5, 2015 : The International Bioethics Committee (IBC) at UNESCO: calls for a
moratorium on this specific technique for editing human DNA reproductive cells in order to
avoid unethical tampering with hereditary traits, and could renew eugenics 32.
 November 2015 : Open Letter from the Center for Genetics and the Society calls for
prohibition on reproductive human germline modification33.
 December 1-3, 2015 : Washington Conference « Gene Edit Summit » mainly treating ethical
issues related to the use of CRISPR-Cas9.(ref x)
 December 9, 2015 : Symposium at the University of London. Organized by the Progress
Educational Trust (PET) whereby the UK Government’s Chief Scientific Advisor, Professor Sir
Mark Walport, announced that he “believes that there are circumstances where genetic
editing of human embryos could be acceptable, and that the UK should lead the way34.
 April 2016 : The European Group on Ethics in Science and New Technologies publishes a
statement on gene editing35.
 February 1, 2016 : The UK Human Fertilization and Embryology Authority (HFEA) allows a
research team to carry out genome editing on human embryos for research purposes only
for the first time in the UK, with the condition that the embryos are destroyed after 14 days
gestation36.
 February 11, 2016 : Second « Human Gene Editing » Summit in Washington37.
29Nature.
Don’t edit the human germ line. http://www.nature.com/news/don-t-edit-the-human-germ-line-1.17111
& Cell. CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes.
http://link.springer.com/article/10.1007/s13238-015-0153-5)
31Human genome-editing research should proceed, say leading UK science bodies. https://acmedsci.ac.uk/more/news/humangenome-editing-research-should-proceed-say-leading-uk-science-bodies )
32http://unesdoc.unesco.org/images/0023/002332/233258f.pdf
33Open Letter Calls for Prohibition on Reproductive Human Germline Modification by Center for Genetics and Society.
http://www.geneticsandsociety.org/article.php?id=8999
34From Three-Person IVF to Genome Editing: The Science and Ethics of Engineering the Embryo.
http://www.progress.org.uk/conference2015 )
35
European Group On Ethics In Science And New Technologies. Statement on Gene Editing.
http://ec.europa.eu/research/ege/pdf/gene_editing_ege_statement.pdf#view=fit&pagemode=none )
36UK scientists gain licence to edit genes in human embryos, Nature, Février 2016. http://www.nature.com/news/uk-scientists-gainlicence-to-edit-genes-in-human-embryos-1.19270?WT.mc_id=TWT_NatureNews
37
http://nationalacademies.org/cs/groups/genesite/documents/webpage/gene_169966.pdf
30Protein
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 April 28, 2016 : The Federation of European Academies of Medicine held in Paris and
publication of a report by the French National Academy of Medicine.
 April 29, 2016 : Third « Human Gene Editing » Summit, held in Paris38.
 February 14, 2017 : Highly contentious recommendations from the American National
Academy of Science (NAS) allow the creation of genetically modified human beings.
 March 29, 2017 : the French Parliamentary Office to evaluate science and technology
published its report on “The economic, environment, health and ethical issues in
biotechnology in the light of new research techniques” 39.
Appendix 2. Surveys
The IFOP poll « French citizens and the CRISPR-Cas9 technique » performed May 18-20, 2016,
demonstrated that 91% of those questioned had not yet heard of this technique. If 76% of
French citizens were in favor of using CRISPR-Cas9 for treating genetic disorders, the same
percentage (76%) was against having recourse to this technology to perform in vitro genetic
modifications of on human embryos. Sixty-seven percent attest to being concerned, and 68%
believe that France should commit to requesting international regulations for the practice of
human genome-editing (DNA)40.
Appendix 3. Rules and Regulations
This technique has widely exceeded national and international legislation.
The Oviedo Convention: Protection of Human Rights in the Biomedicine
In 2011 France ratified this Convention which is the only legal international instrument aiming
to protect Human Rights in the biomedical field. This Convention for Human Rights and
Biomedicine was opened for signature on April 4, 1997 in Oviedo (Spain).
The Convention’s guidelines aim to protect human dignity and the identity of all humanity and
guarantee everyone, without any discrimination, by respecting his integrity and other rights
and fundamental liberties with respect to biological and medical applications. It reiterates the
principles developed by the European Convention of Human Rights in the field of Biology and
Medicine. This international convention, signed by the majority of the European Member
States, sets out fundamental principles applicable to daily medicine as well as those applicable
to new technologies in human biology and medicine.
Article 13 on human genome interventions stipulates 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 modification in the genome of any descendants”.
Article 28 provides for public debates to be held. The Council of Europe Steering Committee
on Bioethics committee launched a study to collect data on the status of legislation in the
Member States.
38http://nationalacademies.org/cs/groups/genesite/documents/webpage/gene_171145.pdf
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http://www2.assemblee-nationale.fr/content/download/52204/505402/version/1/file/Rap+Biotech+RAPPORT2903_1723.pdf
Les Français et la technique du CRISPR-Cas9. Mai 2016. http://www.ifop.com/media/poll/3394-1-study_file.pdf
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