Reference: Own initiative

Rapporteur: Prof. Stefano Rodota ******************************************************************

February 20, 1996

http://europa.eu.int/comm/european_group_ethics/gaieb/en/opinion6.pdf

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

stigmatization.

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

or benefit.

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

officially recognized.

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

is.

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

members.

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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