Council of Europe, Ad Hoc Committee of Experts on Bioethics, Report on Human Artificial Procreation

Council of Europe, Ad Hoc Committee of Experts on Bioethics, Report on Human Artificial Procreation (Strasbourg: 1989).

I. Scope and definitions

The principles set out hereafter shall apply to the techniques of human artificial procreation, in particular to artificial insemination, to the methods involving the removal of ova such as in vitro fertilisation, as well as methods that involve donation of semen, ova or embryos and to acts and procedures on embryos made possible by these techniques.

For the purpose of the application of these principles:

a. artificial insemination
means the introduction of sperm into a woman's genital tract by any means other than ***ual intercourse;
b. in vitro fertilisation
means the fusion of an instrumentally removed human ovum with a spermatozoon induced in a culture vessel;
c. embryo
means the result of the fusion of human gametes at all usages of development before the foetal stage;
d. donor
means a person, other than the surrogate mother, who provides his/her gametes or an embryo for the benefit of another person;
e. surrogate mother
means a woman who carries a child for another person and has agreed before pregnancy that the child should be handed over after birth to that person.



II. General conditions for the use of artificial procreation techniques

Principle 1

1. The techniques of human artificial procreation may (subject to the circumstances covered by paragraph 1 of Principle 7 below) be used for the benefit of a hetero***ual couple when appropriate conditions exist for ensuring the well-being of the future child and only when:

a.

- other methods of treatment of fertility have failed or are not appropriate in the particular case or offer no prospect of success; or
- a serious risk exists of transmitting to the child a grave hereditary disease; or
- there is a serious risk that a child would suffer from some other disease which would result in his early death or severe handicap; and

b. there is a reasonable chance of success and there is no significant risk of adversely affecting the health of the mother or the child.

2. The techniques of human artificial procreation must be not used for obtaining particular characteristics in the future child, in particular for the purpose of selecting the *** of the child except where, in conformity with sub-paragraph a. of the preceding paragraph, a serious hereditary disease linked with the *** is to be avoided.

Principle 2

Any act required by artificial procreation techniques and procedures carried out on embryos and manipulations connected therewith must be performed under the responsability of a physician and within an establishment authorised by the competent authority of the state or an authority set up by the state for that purpose.

Principle 3

No person may be compelled or required to take a direct part in the performance of acts mentioned in the present principles to which he/she has an objection on the grounds of conscience.

Principle 4

1. The techniques of artificial procreation may be used only if the persons concerned have given their free informed consent, explicitly and in writing, in accordance with national requirements.
2. Before obtaining such consent, the physician and the establishment using the techniques of artificial procreation must ensure that the persons concerned are given appropriate information and counselling about the possible medical, legal, social and, where relevant, genetic implications of this treatment, particularly, those which might affect the interests of the child to be born.

Principle 5

The physician and the establishment using the techniques of artificial procreation shall make appropriate inquiries and investigations in order to diagnose and to reduce the risk of transmission of a hereditary or infectious disease, or any other factor which may present a danger to the health of the woman or the future child.

Principle 6

The physician and the establishment using the techniques of artificial procreation must keep records of any information needed in order to fulfil or prove that they have fulfilled the obligations imposed upon them under these principles.



III. Storage of gametes and embryos

Principle 7

1. A single person who is at risk of infertility or of another hazard that may impair his or her future procreative capacity may deposit his/her gametes for his or her own personal future use, provided that at the time of the artificial procreation all the requirements set out in these principles are fulfilled.
2. Where a person who has deposited his/her gametes for his/her own future use dies during the storage period or cannot be traced on the expiry of that period, the deposited gametes shall not be used for artificial procreation.
3. Gametes shall not be stored for a period longer than fixed by national legislation or any other appropriate means.
4. Artificial procreation with the semen of the deceased husband or companion shall not be allowed.

Principle 8

1. Only the minimum number of ova shall be fertilised as is strictly necessary to ensure the success of the procreation.
2. Embryos shall not be stored for a period longer than fixed by national legislation or any other appropriate means.
3. The destination of embryos stored for the use of a couple for procreation but not used by term may be decided upon only with the consent of both members of the couple.



IV. Donation of gametes and embryos

Principle 9

1. No profit shall be allowed for donations of ova, sperm, embryos or any element collected from them. Only loss of earnings as well as travelling and other expenses directly caused by the donation may be refunded to the donor.
2. A person or a public or private body which is authorised to offer gametes for the purpose of artificial procreation or research shall not gain any profit from such offer.
3. Donations of gametes for artificial procreation shall not be subject to any discriminatory conditions. The donor can, at any moment before their use, require that his/her gametes shall not be used for the initially intended purpose and give instructions about the use which should be made of them.

Principle 10

The number of children born from the gametes of any one of the donor shall be limited by national legislation or any appropriate means.

Principle 11

1. In principle, in vitro fertilisation shall be effected using gametes of the members of the couple. The same rule shall apply to any other procedure that involves ova in vitro or embryos in vitro. However, in exceptional cases defined by the member states, the use of gametes of donors mays be permitted.
2. The donation of embryos not used by a couple to another couple for the purpose of artificial procreation may be allowed in exceptional cases by member states.

Principle 12

The transfert of an embryo from the uterus of one woman to the uterus of another shall not be allowed.

Principle 13

1. The physician and the staff of the establishment using the techniques of artificial procreation shall maintain the anonymity of the donor and, subject to the requirements of the national law in legal proceedings, shall keep secret the identity of the members of the couple as well as the fact of artificial procreation. Where it is necessary in the interests of the child's health or for the purpose of genetic counselling, information on the genetic characteristics of the donor can be given.
2. However, national law may provide that the child, at an appropriate age, may have access to information relating to the manner of his or her conception or even to the identity of the donor.



V. Determination of maternity and paternity

Principle 14

1. The woman who gave birth to the child is considered in law as the mother.
2. In case of utilisation of sperm of donor:

a. the mother's husband is considered as the legimate father and, if he has consented to the artificial procreation, he may not contest the legitimacy of the child on the grounds of artificial procreation;

b. if the couple is not married, the mother's companion who gave his consent cannot oppose the establishment of parental responsibilities in relation of the child, unless he proves that the child was not born as a result of a artificial procreation.

3. Where the gametes donation is made through the intermediacy of an authorised establishment, no filial relationship may be established between the donor of the gametes and the child conceived as a result of artificial procreation. No proceedings for maintenance may be brought against a donor or by a donor against a child.



VI. Surrogate motherhood

Principle 15

1. No physician or establishment may use the techniques of artificial procreation for the conception of a child carried by a surrogate mother.
2. Any contract or agreement between surrogate mother and the person or couple for whom she carried the child shall be unenforceable.
3. Any action by an intermediary for the benefit of persons concerned with surrogate motherhood as well as advertising relating thereto shall be prohibited.
4. However, states may, in exceptional cases fixed by their national law, provide, while duly respecting paragraph 2 of this principle, that a physician or an establishment may proceed to the fertilisation of a surrogate mother by artificial procreation techniques, provided that:

a. the surrogate mother obtains no material benefit from the operation;

b. the surrogate mother has the choice at birth of keeping the child.



VII. Acts and procedures carried out on embryos

Principle 16

The fertilisation of ova in vitro and the obtaining of embryos by lavage shall not be permitted for research purposes.

Principle 17

1. No act or procedure shall be permitted on any embryo in vitro other than those intended for the benefit of the embryo and for observational studies which do no harm to the embryo.
2. When a state allows, in addition, investigate and experimental procedures other than those mentioned in the preceding paragraph for a preventive, diagnostic or therapeutic purpose for grave disease of embryos, it shall require that the following conditions be fulfilled:

a. the purpose cannot be achieved by any other method; and

b. the embryo shall not be used after fourteen days from fertilisation, any period of storage by freezing or by any other means not included; and

c. the consent of the couple has been given according to paragraph 3 of Principle 8 and, if the embryo has resulted from fertilisation in vitro using donor's gametes their consent shall also be required; and

d. a properly constituted multidisciplinary ethical committee has given its approval.

3. The splitting of the cells of an embryo may be allowed by member states only in order to use a part of it for diagnostic purpose if it is designed to establish a serious illness or anomaly in the future child and if conditions b, c and d mentioned in paragraph 2 above are satisfied.

Principle 18

The introduction into a woman's uterus of a human embryo which has been subjected to any act or procedure other than those mentioned in paragraph 1 and 3 of the preceding principle shall be prohibited.

Principle 19

Once it has been implanted, an embryo resulting from fertilisation in vitro shall not undergo experimentation in utero.

Principle 20

The use of the techniques of artificial procreation to create identical human beings by cloning or any other method shall be prohibited.

Principle 21

1. The placing of an human embryo in the uterus of another species or vice versa shall be prohibited.
2. The fusion of human gamete with the gamete of another species shall also be prohibited. The same apply to the fusion of embryos or other procedure likely to produce a chimera.
3. However, member states may allow the fusion of human and animal gametes for investigation aimed at diagnosing infertility, provided that the development of any resulting hybrid cells ends at the two-cell stage.