PROTECTION OF THE HUMAN EMBRYO AND FOETUS
THE ITALIAN NATIONAL BIOETHICS
COMMITTEE STATEMENT CONCERNING THE PRELIMINARY DRAFT PROTOCOL OF THE
BIOETHICS COMMITTEE OF THE COUNCIL OF EUROPE
31 March 2000
I. The Italian National Bioethics Committee (in Italian
CNB), having been charged to make observations concerning the
preliminary draft Protocol on the Protection of the Human Embryo
and Foetus, examined the draft text being prepared by the Council
of Europe, carefully analysing the successive preliminary drafts
presented at the periodic meetings and preceded by the despatch
of material to be studied to all the participants. In detail, the
restricted documents submitted to the attention of the Committee
are as follows:
- CDBI.CO.GT3/Rap.1 Groupe de travail sur la
protection de l'embryon et du foetus humains. Rapport de la
septième réunion (9-11 février 1998);
- CDBI.CO.GT3/Rap. 9 Id. Rapport de la neuvième
réunion (25-27 janvier 1999);
- CDBI (99)12. Division between CDBI.CO.GT2 and
CDBI.CO.GT3 of issues relating to the research on pregnant women,
embryo in vivo, foetus, and also concerning the research on
embryonic and foetal cells and tissues; advantages and
disadvantages of the different possibilities. Document prepared
by the Secretariat at the request of the CDBI Bureau for the use
of CDBI in providing guidance to CDBI.CO.GT2 and
CDBI.CO.GT3.
- Avant Projet de principes retenus par le Groupe de
Travail relatifs à la constitution et au sort des embryons
in vitro (document updated to 19-21 May 1999). Annexe IV;
- CDBI.CO.GT3/Rap. 10. Avant Projet de Protocole sur la
protection de l'embryon et du foetus humains. Réunion
conjointe avec CDBI.CO.GT2 (28 septembre 1999). Annexe III;
- CDBI/Rap. 17. Id. Rapport de la 17ème
réunion (6-9 décembre 1999). Annexe V.
In this way it was possible to pay constant attention to any
changes of approach liable to exert a significant effect on the
content of the Avant Projet, as set out in document sub 6, to the
provisions of which are explicitly referred to.
The considerations made by individual members and discussed by
the Committee have been translated into observations either
concerning the identification of the agreed principles or else
issues that, although apparently marginal or terminological,
actually had substantial implications concerning the
interpretation and application of the Avant Project.
The method of analysis adopted was aimed at satisfying the type
of evaluation requested from the Committee concerning both the
basic philosophy of the document and, from a more analytical
point of view, the examination of the provisions set out in it
and all possible interpretative solutions. Nevertheless, analysis
of the Avant Projet was limited to a consideration of the
principles and provisions stated in the documents examined.
However, even with these limitations, it was performed very
thoroughly; moreover, equal rigour was applied to making
proposals, in the awareness that, once approved, the Protocol
will probably be considered definitive with regard to issues
involving the formation and use of human embryos.
II. The first observations regard the definitions part of
the Avant Projet, in particular art. 2 describing the biological
concepts of "embryo" and "foetus" also as regards their juridical
implications.
Art. 2 states that: "The term "embryo" applies to the zygote and
all subsequent stages of its development until the completion of
implantation. The term "embryo" does not apply to
[non-totipotent] embryonic cells. The term "foetus" applies to
each further development stage of the embryo from the completion
of implantation until birth".
The definition of embryo is acceptable; however it would be
preferable to specify: that, on the basis of such a definition,
in order to consider the individual cell an embryo, it would be
necessary for the two chromosome sets, both maternal and
paternal, already "drawn", be combined into a single nucleus
(syngamic phase), as it is not sufficient for them to be situated
in the same cytoplasm and confined in the two nuclei (presyngamic
phase); and, with reference to isolated embryonic cells, it is
necessary to ensure that no damage is suffered by the embryo from
which they are taken and the need to ensure the use made thereof
respects existing legislation.
With regard to the definition of foetus it is acknowledged that
the definition adopted is a broad one, which involves an
anticipation of the transition from the embryonic phase to the
foetal phase in the narrow sense. This is interpreted as an
intention to extend protection, which is generally greater for
the foetus, to cover an earlier stage of development.
III. The provision regulating consent (art. 4), which
merely refers to the "person(s) concerned" is deemed generic and
evasive. Art. 4 runs as follows: "An intervention on the human
embryo or foetus may only be carried out after the person(s)
concerned, as indicated by law, has (have) given free, informed
and documented consent". It would thus be preferable to make a
clearer distinction between the phase preceding implantation of
the embryo in the woman's uterus - for which the provision is
adequate as it stands - and the subsequent phase, which marks the
beginning of pregnancy. In the latter phase it would be
preferable to specify that the pregnant woman's consent is
essential and must be obtained also in the case of medical,
surgical or diagnostic intervention on the foetus throughout the
period of pregnancy. It was, however, also pointed out by some
that the father's role cannot be considered secondary, above all
with reference to decisions having no bearing on the mother's
health but which are important for the protection of the unborn
child's health (for example, prenatal therapy).
IV. Art. 6, in prohibiting the maintenance of an embryo
in culture beyond 14 days after its formation, seems to refer
implicitly to the distinction between embryo and pre-embryo, a
distinction that however would seem to have been superseded by
the above-mentioned extended definition of foetus. Art. 6
actually states that: "It is prohibited to maintain an embryo in
culture for research purposes beyond 14 days or until the
appearance of the primitive streak".
It is debatable whether it is suitable to use time as a
criterion to determine the degree of protection of the embryo. On
this point there was disagreement among the members of the
Committee.
V. The final version of art. 7 does not allow it to be
decided whether the expressions in parentheses - "in vitro
fertilisation procedure" and "intervention on embryo in vitro"
are to be given a disjunctive or a conjunctive interpretation.
Art. 7 actually states that "a. The parties shall ensure that any
[in vitro fertilisation procedure][intervention on embryo in
vitro] shall only be carried out in conditions of technical
competence and health safety. b The parties shall ensure that any
[in vitro fertilisation procedure][intervention on embryo in
vitro] shall only be carried out in the framework of duly
approved centres by competent body".
The Committee proposes that a unifying formulation should be
adopted and suggests combining also the conditions laid down in
paragraphs a and b, prohibiting any action "unless under rigorous
conditions of technical competence and health safety, in the
framework of centres duly approved by the competent body".
VI. The provisions governing the right to be informed
(arts. 11 and 12) should be expressed more analytically, for
example, after the style of the Directive 95/46/EC on the
treatment of personal data (art. 11), in which a distinction is
made between essential information (defined ad hoc) and
supplementary information (indicated by way of example). Art. 11
of the European protocol actually states that: "Persons who
donate their gametes must be appropriately informed, prior to the
donation, of the possible different uses of their gametes
according to the law. Their explicit and documented consent
thereto is required. As long as the gametes have not been used,
the gamete donor can withdraw his/her consent". On the other
hand, art. 12 states that: "Prior to any IVF procedure, the
persons concerned shall be informed of the whole procedure and
its implications. In particular, they shall be informed of all
possibilities according to the national law relating to the
number of embryos to be formed, to be transferred, of the
possible destination of embryos which may not be transferred
immediately and of storage conditions and termination of
embryos."
It is also necessary to emphasize the need for the information
to be comprehensible; and the need for the information to be
given in a suitable fashion (according to the conditions of the
beneficiary) stated in art. 11 (information of gamete donors)
should be repeated in art. 12 (information for persons involved
in an IVF procedure). For those subject to the latter norm it
should be considered necessary to provide information relating to
the medical, in particular genetic, aspects, to the
psychological, bioethical and juridical aspects of the chosen
fertilisation technique, to the chances of success, to the risk
of damage to the physical and mental health of the persons
involved and for the unborn child, also with reference to the
possible conditions of the latter.
The decision-making freedom accorded to the couple in deciding
the embryos' fate (art. 13) was discussed. Art. 13 actually
states that: "The destination of embryos shall be decided in
accordance with the decisions freely expressed by the persons
concerned prior to the IVF procedure, within the framework of the
national law and in accordance with the professional standards.
When the persons undergoing IVF procedures have decided to store
their supernumerary embryos with the view to using them in the
future, they should specify in writing their decision concerning
the destination of the embryos at the end of the storage period
and in the case of their death before the end of the storage. If
the couple subsequently disagrees, the law may provide for the
termination of storage".
The solution proposed does not seem to prohibit the commercial
exploitation of embryos explicitly enough. It is therefore
recommended that the prohibition be made more explicitly: both
those who view the present proposal as liable to encourage a
commodifying conception of the embryo and those who, conversely,
do not consider that the text of art. 13 gives rise to a similar
interpretation agree on this point.
Reservations have been expressed also concerning the indication
of the destruction of supernumerary embryos (in the case of the
couple disagreeing) as the only solution that can be provided for
by the national legislation. Also the use of the embryo by other
couples could be proposed. In this connection, in more general
terms, others suggest introducing some general indications that
can be used to define the timing, the modality and the purposes,
the couple's choices concerning the fate of the embryo. Others
again consider it would be advisable to make the same amendment
to art. 13 as that already made to art. 4, replacing "the persons
concerned" with the expression "the person(s) concerned", as in
some cases the national legislation does not exclude single
persons from accessing assisted fertilisation.
In particular, with reference to the fate of the embryos at the
end of the storage period, especially when this period is long,
the couple should be helped to evaluate alternative solutions to
the destruction of the embryo, suggesting those that offer
greater protection of the embryo.
VII. An inconsistency has been observed between
paragraphs one and two in art. 14: while paragraph one, although
setting limitations, allows the number of embryos produced to be
increased as a function of "good chances of success", paragraph
two sets a true limit, namely, that of reducing the risk of
multiple pregnancy. It has been suggested that to this limit
should be added also the need to protect the woman's health and
that of avoiding the use of multifetal pregnancy reduction. The
existence of these risks should however be explicitly mentioned
at the time consent is obtained. Art. 14 actually states: "The
number of embryos formed in vitro shall not be higher than that
which, in accordance with professional standards, allows a good
chance of the treatment succeeding being ensured. The number of
embryos transferred shall be determined, in each case, in such a
way as to limit the risk of multiple pregnancy".
VIII. As regards safety of medically assisted
fertilisation techniques it has been pointed out that the
provision is vaguely expressed; and in this regard it has been
pointed out that it is not specified whether the techniques
referred to in art. 15 are therapeutic or not. Art. 15 actually
states that: "Any clinical application concerning a new technique
for medically assisted human reproduction shall be based on the
results of prior relevant research".
In response to the doubts raised by this provision it is
postulated that it should be interpreted as a safeguarding rule
in order to avoid the techniques being applied directly without
any prior evaluation.
It is also reported that the norm is ambiguous when it
hypothesizes that all clinical applications of a new technique of
medically assisted procreation must be based on the results of
prior research.
In actual fact, if it were meant merely to indicate the
conditions of legitimacy of the, largely experimental, clinical
applications of the new techniques of medically assisted
fertilisation, in the first instance endeavouring to guarantee
the safety of the woman undergoing the treatment, although
without sidestepping the problem of protecting the embryo, it
would be advisable to specify that research involving the use of
embryos should be subjected to the same conditions as for
research on embryos in vitro. Otherwise it might be claimed that
this preliminary environment of experimentation is not subject to
any limitation.
Should the meaning of the provisions be precisely the latter,
namely not to take into consideration measures to protect the
embryo during the phase leading up to the application of
medically assisted fertilisation techniques, the criticism would
be directed at its actual content as it would seem fitting that
some form of protection should be guaranteed even when the embryo
does not represent the immediate object of the experimental
investigation, as in the case of research on embryos, but is only
its operative instrument or its product.
IX. Lastly, the Committee unanimously expresses the hope
that every effort will be made to achieve appreciable results of
harmonization, without prejudice the right of each State to
express reservations concerning individual provisions that would
not be compatible with its existing legislation.
