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Recommendation 2115 (2017)
The use of new genetic technologies in human beings
1. Genetic engineering techniques
have been applied in the medical field for several decades now. However,
new technologies are developing very rapidly: recent discoveries
related to the human genome have opened the door to new opportunities
and unprecedented ethical concerns. On the one hand, this improved knowledge
of our make-up as human beings brings with it welcome potential
to diagnose, prevent and eventually cure diseases in the future.
On the other hand, it raises complex ethical and human rights questions, including
– but not limited to – unintended harm which may result from the
techniques used, access and consent to such techniques, and their
potential abuse for enhancement or eugenic purposes.
2. In particular, recent advances in genome editing are bound
to result in germ-line interventions in human beings quite soon,
for example with the birth of children whose genome has been altered,
with unforeseeable consequences ensuing as their descendants will
also be affected. The scientific consensus is that these techniques
are not “safe”, leading to a de facto moratorium.
Other techniques, however, such as pronuclear transfer technology
(the “three-parent” technique) – used to avoid maternal inheritance
of mitochondrial disease – have been used and resulted in the birth
of two babies (one of them for reasons other than the treatment
of mitochondrial disease), despite considerable ethical controversy
and scientific uncertainty about the long-term effects.
3. Deliberate germ-line editing in human beings would cross a
line viewed as ethically inviolable. Indeed, the 1997 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”), binding on the 29 member States which have
ratified it, posits in its Article 13 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”. The
convention does, however, also establish a specific procedure for
its amendment (Article 32), which should be read in conjunction
with Article 28, which imposes on States parties to ensure 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”.
4. Numerous scientific and ethical bodies are starting to make
recommendations to establish an appropriate regulatory framework
for genome editing and germ-line interventions in human beings,
including most recently the United States National Academy of Sciences
and National Academy of Medicine, and the European Academies Science
Advisory Council. There is currently a prohibition on interventions
aimed at modifying the germ line in human beings in all European
Union, and many Council of Europe, member States.
5. The Parliamentary Assembly thus recommends that the Committee
of Ministers:
5.1. urge member States
which have not yet ratified the Oviedo Convention to do so without
further delay, or, as a minimum, to put in place a national ban
on establishing a pregnancy with germ-line cells or human embryos
having undergone intentional genome editing;
5.2. and, in addition, develop a common regulatory and legal
framework which is able to balance the potential benefits and risks
of these technologies aiming to treat serious diseases, while preventing abuse
or adverse effects of genetic technology on human beings;
5.3. foster a broad and informed public debate on the medical
potential and possible ethical and human rights consequences of
the use of new genetic technologies in human beings;
5.4. instruct the Council of Europe Committee on Bioethics
(DH-BIO) to assess the ethical and legal challenges raised by emerging
genome editing technologies, in the light of the principles laid
down in the Oviedo Convention and the precautionary principle;
5.5. recommend that member States, on the basis of the public
debate, the DH-BIO assessment and the common regulatory and legal
framework devised, develop a clear national position on the practical use
of new genetic technologies, setting the limits and promoting good
practices.