Regulation No. 568/1997 on Artificial Fertilization

Artificial fertilization:

Conception as a result of artificial insemination or in vitro fertilization.
Artificial insemination: Process whereby the sperm is placed in or near the genitalia of a woman by other means than copulation. In vitro fertilization: Process whereby the ovum which has been removed from the woman's body is fertilized with the sperm outside the body.
Gamete: Ova and sperm.
Embryo: Fertilized ovum in any stage of development, from the time of fertilization until it develops into a foetus.
Donor: An individual providing another individual with gamete. Surrogacy: Artificial fertilization of a woman who intends to carry a child for another woman and who has consented to it before the pregnancy to give the baby up immediately after the birth.
Scientific research: Research conducted with the aim to achieve further knowledge, making it, inter alia, possible to improve health and cure diseases. An evaluation of the research made by the Scientific Ethics Committee or an ethics committee, pursuant to Article 29 of Act No. 74/1997 on the Rights of Patients, must have
revealed that scientific and ethical views do not oppose its implementation.

Artificial fertilization may only be carried out in a health institution which has obtained a license from the Minister for that purpose and is operated under the supervision of a gynaecologist and obstetrician.

Artificial fertilization must only be carried out if the following conditions have been met:

a) A woman undergoing the operation must have been married continuously for at least three years or cohabiting with a man continuously for at least three years.

b) A woman undergoing the operation and her husband or cohabitant must have applied for artificial fertilization and their formal consent to have the operation must have been testified on a special form issued by the relevant health institution for this purpose.

c) As a rule, both partners shall be 25 years of age at the commencement of the treatment. As a rule, the woman shall not be older that 42 years at the commencement of the treatment. It is permitted to derogate from the specified age condition of the woman if a stored embryo, stored ovum or donor ovum is being used. The woman shall, however, never be older than 45 years when the embryo is transplanted and the husband or cohabitant, as a rule, shall not be older than 50 years.

d) The mental and physical health and the social conditions of the couple shall be sound.

e) Other operations to overcome infertility must have failed or be unavailable.

A couple requesting artificial fertilization shall apply for it on a form pursuant to Article 3 (b). A doctor decides if the artificial fertilization will take place. During an evaluation of whether a couple applying for artificial fertilization meets the condition of Article 3 (d), their ability to ensure conditions favourable to the development of the child shall be taken into consideration. If the doctor believes it necessary, he is obliged, with the consent of the couple, to insist on a certificate from the relevant experts regarding the mental and physical health of the couple. In the same manner, he shall insist on certificates from a social worker or another person who is able to provide information on the social conditions of the couple. If the couple does not consent to the aforementioned gathering of information, the doctor is authorized to decline artificial fertilization. If the doctor has reservations as to whether the social conditions of the couple are satisfactory with regard to the upbringing of a child he can seek the opinion of child welfare authorities.

Once an application for artificial fertilization has been approved, the couple shall before an approval pursuant to Article 3 (b) is given, be provided with information on the treatment and any possible medical, social and legal implications. The information shall be given both verbally and in writing on a special form, cf. Article 3 (b).

If a doctor refuses artificial fertilization, a complaint may be filed with the Directorate General of Public Health. The time limit to file the complaint is three months from the date of communication of the refusal. The Directorate General of Public Health shall without delay send the complaint to a special committee appointed by the Minister for a period of four years at a time. The committee shall be made up of three representatives, and an equal number of substitutes, thereof one lawyer, one doctor and one social worker. The decision of the committee is final.

Before the artificial fertilization is carried out, the health institution in charge of the operation shall inform the couple in question about the possibility of professional counselling by psychologists or social workers and the institution shall provide it if the couple requests such counselling.

Artificial insemination with donor sperm shall only be carried out if the fertility of the man is impaired, he has a serious hereditary disease or there are other medical reasons to use of donor sperm.

In vitro fertilization shall only be carried out with the gamete of the couple. It is however permitted to use donor gamete if the fertility of the man or the woman is impaired, either of them has a serious hereditary disease or there are other medical reasons to use of donor gamete. It is prohibited to carry out in vitro fertilization unless the gamete of either partner or either cohabitant is used. Donation of embryos and surrogacy is prohibited.

Storage of gamete and embryos is only permitted in health institutions licensed by the Minister to carry out artificial fertilization.

Gamete can only be stored for the purpose of:

a) personal use at a later time,

b) donation for research purposes, or

c) donation of gamete for use in artificial fertilization.

A person providing gamete shall formally consent to the storage which is in keeping with the stated purpose, provided that he or she has received information on how the storage affects the gamete and the general conditions regarding the storage of gamete laid down in acts on artificial fertilization and in this Regulation.

It is permitted to store embryos for the purpose of transplanting them into the woman who provided the ova or the wife or the cohabitant of the man who provided the sperm. The storage of embryos for other purposes is prohibited.

Embryos may be stored on the condition that the man and the woman providing the gamete give their formal consent for the storage which is in keeping with the stated purpose, provided that they have previously received information on how the storage affects the embryos and the general conditions regarding the storage of embryos laid down in acts on artificial fertilization and this Regulation. Embryos can only be used in accordance with the consent of those providing the gamete.

Before a stored embryo is transplanted into the uterus of a woman who provided the ova or the wife or the cohabitant of a man who provided the sperm, their formal consent shall be sought again. The same applies when artificial insemination is carried out with the sperm of a husband or a cohabitant which has been stored for later use.

Embryos may be stored for a maximum of five years. At the end of five years, unused embryos shall be destroyed. Gamete may be stored for a maximum of 10 years. At the end of that time, unused gamete shall be destroyed. When the gamete of a man or a woman are stored for personal use at a later time due to foreseeable infertility caused by a disease, they can apply for an extension if they have not had the opportunity to use the gamete as they have not met the conditions of Article 3 (a) and/or Article 3 (c)(1). An application for extension shall be submitted to the relevant health institution. In case of a refusal, a complaint may be submitted to the Directorate General of Public Health and the procedure provided for in Article 6 of this Regulation shall be applicable. If a person providing the gamete has died, unused gamete shall be destroyed, unless the purpose of the storage had been to donate the gamete for use in artificial fertilization. If a man and a woman who provided the gamete end their marriage or their cohabitation, or either of them dies, the embryos shall be destroyed. The owners of stored embryos and the owners of gamete shall, at the beginning of the storage period, be informed about the aforementioned rules on the maximum storage time, verbally and in writing.

If donated gamete are used, the doctor in charge of the treatment shall select the appropriate donor. A donor of gamete shall be healthy and have no hereditary diseases. Necessary tests shall be carried out to ensure that the donor is healthy and fertile and to prevent the transmission of diseases with the gamete. If imported gamete are used, the fulfillment of the aforementioned demands must be ensured. A doctor shall endeavour to realize the wishes of applicants that the build, height, colour of eyes and hair and the blood type of the gamete donor is as closely resembling the parent's as is possible.

If a donor wishes to remain anonymous, health workers are obliged to ensure that this is respected. In this case, the donor may neither receive information about the couple receiving the donated gamete or the child, nor the couple or the child receive information about the donor. If a donor does not wish to remain anonymous, the institution shall preserve information about him in a special file. If the donation of gamete leads to the birth of a child, information about the child and the couple who received the gamete shall be kept in the same file. A child born on account of a gamete donation where the donor does not wish to remain anonymous, can at the age of 18 gain access to a file pursuant to paragraph 2 for the purpose of obtaining information about the identity of the donor. If a child receives information about the gamete donor at the institution, the said institution shall as soon as possible inform the donor that the information has been given.

The prospective donor shall receive clear information beforehand on the following issues, verbally and in writing:

a) what the gamete donation entails,

b) that he can request anonymity,

c) the rules that apply on the one hand to anonymity and on the other hand to revealing the identity,

d) the medical and ethical problems that could arise in connection to donating gamete,

e) his or her legal status and that of the child that might be born as a result.

If the gamete is donated within the family, the donor shall receive counselling beforehand regarding the specific problems the donor, recipients and the prospective child might possibly encounter.

A couple that has applied for artificial fertilization where donated gamete are used shall receive clear information about the following issues, verbally and in writing:

a) what the gamete donation entails,

b) his or her legal status and that of the prospective child,

c) whether the donor does or does not wish to remain anonymous and what rules are applicable in each case,

d) that they have the right to receive professional counselling
both before the operation and due to problems that might arise later as a result of the artificial fertilization or the gamete donation,

e) that the husband or cohabitant is considered to be the father of the child conceived as a result of the artificial fertilization although donated sperm is used,

f) that the wife or cohabitant is considered to be the mother of the child conceived as a result of the artificial fertilization although donated ovum is used.

Both parties shall receive information about the aforementioned issues before they give their consent pursuant to Article 21. Both parties shall give their formal consent on the one hand regarding the artificial fertilization and regarding gamete that has been donated on the other hand. When donated gamete are used in the artificial fertilization, it must be ensured that the donor and the couple in question receive information about the medical and ethical problems that could arise in connection to the donation and reception of gamete. Furthermore, the parties shall receive clear information about their legal status and that of the child that might be born as a result.

If the gamete is donated within the family, the couple shall receive counselling beforehand regarding the specific problems the donor, recipients and the prospective child might possibly encounter.

Before artificial fertilization with donated gamete takes place, both parties shall specially give their testified consent in writing regarding the use of donated gamete in the artificial fertilization.

Any research, experiments and operations on embryos shall be prohibited.

Nevertheless, it is permitted to do research on embryos:

a) if it is part of an in vitro fertilization treatment,

b) if the intention is to diagnose hereditary diseases in the embryos themselves,

c) if the purpose is to advance the treatment of infertility, or

d) if the purpose is to increase understanding of the causes of innate diseases and miscarriages.

It is prohibited to carry out research pursuant to points c) and d) unless it meets the conditions of Article 1 (8) on scientific research and the approval of the Scientific Ethics Committee or ethics committees has been obtained pursuant to Article 29 of Act No. 74/1997 on the Rights of Patients.

It is prohibited to:

a) cultivate or produce embryos solely for research purposes,

b) cultivate embryos for more than 14 days outside the body or once the primitive streak has appeared,

c) transplant human embryos into animals and

d) perform cloning.

Infringement of these rules is subject to fines or imprisonment of up to three months, cf. Article 14 of Act No. 55/1966 on Artificial Fertilization.

Participation in such an infringement shall be punishable in the same way unless it is subject to a more severe punishment according to other laws.

This Regulation is laid down pursuant to Article 13, cf. Article 3 and 10 of Act No. 55/1996 on Artificial Fertilization, and enters into force immediately. At the same time, the working procedure of the Fertility Ward at the National Hospital of 21 April 1995 and Rules on the Freezing of Embryos of 14 December 1995 cease to apply.

Original version in Icelandic as published by the Icelandic Legal Gazette. (Opens in a new window)