OPINION OF THE GROUP OF ADVISERS ON THE ETHICAL IMPLICATIONS OF BIOTECHNOLOGY TO THE EUROPEAN COMMISSION
Reference: Own initiative
Rapporteur: Prof. Stefano Rodota ******************************************************************
February 20, 1996
European Commission Statement on Prenatal Diagnosis
The Group of Advisors on the Ethical Implications of
Biotechnology of the European Commission made the following
statement on Ethical Aspects of Prenatal Diagnosis (PND) on
February 20, 1996. The Group said that genetics services should
be available to all equally, of high quality, and voluntary, and
should protect privacy. There should be no discrimination
against people with disabilities or those who do not terminate a
pregnancy. Final decisions should be made by the couple. The
Group said that given the variability of expression for many
genetic disorders, it was inappropriate to make list of
disorders that qualify for PND.
A summary of the report, provided by Dr. Margareta Mikkelsen of
the John F. Kennedy Institute, Glostrup, Denmark, appears below.
The on-going ethical debate, the scientific progress which is
rapidly enlarging the medical scope of PND, the variability of
many genetic diseases and fetal anomalies in their expression,
severity, or prognosis render inappropriate the listing of
illnesses or handicaps that qualify for PND.
A framework, based on general ethical principles, is preferable
to determine which PND and associated genetic counseling will be
offered to women and couples. In this context, a "case-by-case"
approach would have the advantage of minimizing reference
explicitly to a model of normality, which would lead to
The use of PND must rely on the free and informed consent of the
woman or couple concerned. No prenatal genetic testing must be
imposed by law, by public health services or by any other
institution or person. Tests should be done only at the request
of the woman or couple after they have been fully informed,
namely by genetic counseling.
All should have equal access to the PND services available and
the associated genetic counseling. Access to the test should not
be influenced by the potential decision of the woman or couple
in the case of an unfavorable result. Resort to PND should not
be considered as a condition for access to any kind of service
Careful genetic counseling, both before and after the test, and
disclosure of the result of a PND to the woman or couple
concerned are an integral part of PND and should not be
separated from sampling and testing.
The offer and use of PND presuppose good quality social and
medical services, especially adequately trained staff, suitable
equipment and reliability of the techniques. Safeguards against
unethical or unprofessional practices must be in place for all
centers offering these procedures. These centers must be
Because the consequences of the information can be of the
greatest importance to all concerned, it is an ethical
imperative that counseling, which requires a specific
competence, should be of good quality and widely available. This
implies that there must be sufficient trained medical, nursing
and other professionals to provide one-to-one counseling when
PND is performed.
In accordance with the subsidiarity principle, the European
Union should strive to achieve a high and comparable level of
quality of the training of the professionals, namely concerning
the genetic counseling, and of the services provided in
different Member States.
Although the techniques of PND can be expected to become less
invasive and easier to perform, for example, by maternal blood
analysis, the decisions the woman or the couple have to make
will remain just as difficult. It will become increasingly
important to ensure that genetic counseling is not separated
from testing. For these reasons, and the fact that termination
of pregnancy can be one outcome, PND should always be performed
in a medical context, no matter how simple the testing procedure
The principle of free and informed consent implies that the
genetic counseling of the woman or the couple must be
non-directive, professional, and respectful of their autonomy.
The decision to terminate the pregnancy or to give birth to a
child with a disease or a disability is a very difficult one.
The interest of the individuals concerned should take precedence
over any collective benefit to society.
The final choice of whether to continue or to terminate the
pregnancy is the prerogative of the woman or the couple alone.
No discrimination should be made as a consequence of either of
these decisions. Moreover, the woman or couple should not be
later penalized for the choice they have made.
Good medical and social conditions must be ensured, when the
pregnancy is continued, for people with disabilities, members of
the family or people caring for the disabled person, avoiding
any exclusion or discrimination against them. Good medical,
social, and psychological conditions should also be guaranteed
when the pregnancy is terminated.
PND should always be considered as a medical act and be offered
on the basis of specific medical indications. The choice of sex
or other characteristics for non-medical reasons is an ethically
unacceptable indication for PND and should be prohibited.
Confidentiality of the results of the test is an ethical
imperative. Genetic data should not be released, except with the
free and informed consent of the woman or couple. If the genetic
data are relevant to the interest of other family members, the
woman or couple should be strongly recommended by the genetic
counselor to allow the release of such data to these family
In this context, the processing of genetic data (including its
collection, compilation, conservation, circulation and
communication) should be subject to appropriate protection
measures within the framework established by the directive on
data protection. However, the specificity of the genetic
information requires particular measures of protection, because
it may also concern members of the family.
Public information and education have to be promoted so that the
public gains an objective and correct picture of the
possibilities and limitations of PND.
Dorothy C. Wertz
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