Access to medically assisted procreation - Search
Italy -
Right to know about his or her biological origin for children born after MAP
16. Is donation of sperm/oocytes/embryos anonymous? sperm Yes/oocytes Yes/embryos No
17. Is it possible to obtain information about the biological origin of a child born after gametes of embryo donation?
i. For the child him or herself NA; ii. For the parents NA; iii. For a court NA
a. Identity of the donor(s)
i. For the child him or herself NA; ii. For the parents NA; iii. For a court NA
b. Certain health information concerning the donor(s)
i. For the child him or herself Yes; ii. For the parents Yes; iii. For a court NA
c. Other information
i. For the child him or herself NA; ii. For the parents NA; iii. For a court NA
18. Is it possible to contest maternity and paternity of children born utilising MAP and under which conditions? No. In the case of reproduction using a heterologous donor - even if prevented by law - the donor cannot disown the child (Art 9). The mother of the child after MAP cannot declare her wish not to be entered in the birth registers as provided for by dpr no 396 (2000).
Belgium -
Legal aspects
1. Is access to medically assisted procreation (MAP)
a. restricted to heterosexual couples? No
b. possible for women not living in a heterosexual couple? No
The 2007 Act makes no mention of such a restriction. Each centre is free to accept or refuse requests from homosexual couples.
Switzerland -
Legal regulation or practice and access to MAP
- Title of the law: Federal Act on Medically Assisted Reproduction (Reproductive Medicine Act, RMA), Reproductive Medicine Ordinance (RMO)
- Date of adoption and entry into force RMA: 18.12.1989 / 1.1.2001 and RMO: 4.12.2000 / 1.1.2001
- Published in: https://www.admin.ch/opc/fr/classified-compilation/20001938/index.html , and
- https://www.admin.ch/opc/fr/classified-compilation/20002342/index.html
- Revision: June 5th,2016, popular vote on the revision of the RMA regarding the regulation of Preimplantation Genetic Screening (PGS) and Preimplantation Genetic Diagnosis (PGD) (prohibited until now)
Luxembourg -
Financial aspects
3. Are MAP procedures covered by the social security system? Yes
4. Are there specific criteria for such coverage? Yes. Age limit of woman – 40 years old.
5. Is the financial coverage limited to a number of MAP procedures? Yes. Four attempts.
Luxembourg -
Legal aspects
1. Is access to medically assisted procreation (MAP)
a. restricted to heterosexual couples? No
b. possible for women not living in a heterosexual couple? Yes. Selection on the basis of a psychologist’s opinion and following the recommendations formulated by the National Ethics Commission.
United Kingdom -
Right to know about his or her biological origin for children born after MAP
16. Is donation of sperm/oocytes/embryos anonymous?
sperm No / oocytes No / embryos No
Due to amendments to the Human Fertilisation and Embryology Act – the law overseeing the use of fertility treatment in the UK – donor conceived people born after 1 April 2005 can request identifying information about their donor from the HFEA once they reach 18 years old. This, however, means that there are different information access rights depending on when the donor conceived person was conceived. These are set out below.
17. Is it possible to obtain information about the biological origin of a child born after gametes of embryo donation?
i. For the child him or herself Yes; ii. For the parents No; iii. For a court Yes
The HFE Act 1990 (as amended) allows donor conceived people to apply for non- identifying information about the donor, if available, such as family medical history, hair/eye colour and interests, when they reach 16. If they were conceived after 1 April 2005, when the donor conceived person reaches 18 years old, they may apply to the HFEA to receive identifying information about their donor.
Parents of children conceived through donor conception can access non identifying information about the donor from the HFEA.
Section 34 of the HFE Act 1990 permits the Authority to make disclosure where it is necessary for the purposes of instituting proceedings under the Congenital Disabilities Act.
a. Identity of the donor(s)
i. For the child him or herself Yes; ii. For the parents No; iii. For a court Yes
b. Certain health information concerning the donor(s)
i. For the child him or herself Yes; ii. For the parents Yes; iii. For a court Yes
c. Other information
i. For the child him or herself Yes; ii. For the parents Yes; iii. For a court Yes
18. Is it possible to contest maternity and paternity of children born utilising MAP and under which conditions? Yes.
Whether patients’ own gametes are used in assisted fertility treatment or whether donor gametes are used, where the couple is either married or in a civil partnership, both parents will be the legal parents of any child born from the treatment from the date of birth of the child. The law endeavours to put couples who have had assisted fertility treatment in a similar position to couples who conceive naturally as regards legal parenthood and parental responsibility. It is however possible for the father or second parent (in the case of a female same sex couple who are in a civil partnership) to resist legal parenthood but only where the person can demonstrate that he or she did not consent to their partner’s treatment (see section 35(1) and section 42(1) of the HFE Act 2008).
When donor gametes are used in treatment, and where the couple having treatment is neither married nor in a civil partnership, the second parent (i.e. not the birth mother) can acquire legal parentage if the agreed parenthood conditions are met (see section 37 and 44 of the HFE Act 2008). In cases where the agreed parenthood conditions are not met, parenthood will be in question and in order to establish legal parenthood, the couple would need to seek a declaration of parenthood from Court.
Further information on legal parenthood can be found on these pages of the HFEA website:
https://www.hfea.gov.uk/treatments/explore-all-treatments/becoming-the-legal-parents-of-your-child/
Definitions of mother and father in accordance to (HFE) Act 2008 are as follows:
Meaning of "mother"
(1) The woman who is carrying or has carried a child as a result of the placing in her of an embryo or of sperm and eggs, and no other woman, is to be treated as the mother of the child.
(2) Subsection (1) does not apply to any child to the extent that the child is treated by virtue of adoption as not being the woman’s child.
(3) Subsection (1) applies whether the woman was in the United Kingdom or elsewhere at the time of the placing in her of the embryo or the sperm and eggs.
Meaning of "father"
35 Women married at time of treatment
(1) If -
(a) at the time of the placing in her of the embryo or of the sperm and eggs or of her artificial insemination, the woman was a party to a marriage, and
(b) the creation of the embryo carried by her was not brought about with the sperm of the other party to the marriage, then, subject to section 38(2) to (4), the other party to the marriage is to be treated as the father of the child unless it is shown that he did not consent to the placing in her of the embryo or the sperm and eggs or to her artificial insemination (as the case may be).
(2) This section applies whether the woman was in the United Kingdom or elsewhere at the time mentioned in subsection (1)(a)
United Kingdom -
Current debate and specific situations
19. Is there an important current debate in your country on these or related issues? As referred to at 18 above, in cases where the agreed parenthood conditions of the HFE Act 2008 have not been met, legal parenthood does not automatically follow for the second parent. In such cases one of the only remedies for the second parent to seek a declaration of legal parenthood from the Court. See for example the recent case (Neutral Citation Number: [2015] EWHC 2602 (Fam) which can be found here: https://www.judiciary.gov.uk/wp-content/uploads/2015/09/parentage.pdf
20. Delegations are invited to provide information, in this section, on particular cases encountered in their country, and especially their case-law.
R (TT) v Registrar General for England and Wales & Ors ((2019) EWHC 2384 (Fam))
The case concerns a transgender man (TT) who has a gender recognition certificate (GRC) confirming that he is male for all legal purposes except the limited exceptions set out in the Gender Recognition Act 2004 (GRA). TT had artificial insemination using donor sperm in a licenced fertility clinic, fell pregnant as a result, gave birth to a child, in 2017. He tried to register the birth as the father but was refused by the Registrar General (RG) who was only able to register the birth with TT as the mother. The birth has remained unregistered.
The judgement was handed down on 25 September 2019. The judge supported the Government’s position that a person who gives birth to a child (i.e. including a trans man such as TT) will be the child’s mother. The Government’s view is that the judgment has no effect on the availability of regulated fertility treatment in the UK. The Government considers that regulated fertility treatment is currently, and will remain, equally available to all (trans) women and (trans) men under the Human Fertilisation and Embryology Acts.
Ukraine -
Financial aspects
3. Are MAP procedures covered by the social security system? No. First step is made to cover one cycle in case of bilateral tubectomy.
4. Are there specific criteria for such coverage? Yes.
- Only tubal factor of infertility.
- Age up 35 years.
5. Is the financial coverage limited to a number of MAP procedures? Yes. Only one IVF procedure.
Germany -
Sperm/oocyte/embryo donation
6. Is donation of sperm Yes/oocytes No/embryos* permitted in your country? Yes.
*Embryo donation per se is not regulated by law. However, the Embryo Protection Act provides that an oocyte may only be artificially fertilised for the purpose of bringing about a pregnancy in the same woman from whom the oocyte has been obtained (Section 1(1) number 2 of the Embryo Protection Act) and that it is prohibited to remove an embryo from a woman before its nidation is completed, in order to transfer it to another woman (Section 1(1) number 6 Embryo Protection Act). In addition, the Embryo Protection Act incorporates provisions aimed to prevent the creation of supernumerary embryos in the course of artificial fertilisation (especially the ban on the artificial fertilisation of more oocytes than can be inserted into a woman within one cycle – Section 1(1) number 5 Embryo Protection Act). Consequently, permissible embryo donation is only conceivable in exceptional instances where an artificially created embryo can unexpectedly no longer be transferred to the woman from whom the oocyte originated.
7. Are there specific compensation arrangements for donations of sperm/oocytes/embryos? No
8. Are there specific criteria for donation of sperm Yes/oocytes/embryos?
Gametes may be used for medically assisted procreation only after full medical assessment and if their use is medically indicated and the protection of the recipient’s and the child’s health is guaranteed (Section 6(1) of the Tissues and Cells Regulation of the Transplantation Act). The use of sperm cells for heterologous fertilisation as a medically assisted procreation technique furthermore requires that the sperm donor is medically assessed as suitable for sperm donation with regard to his age, state of health and medical history and that the use of the donated sperm will not pose any health risks to others. The necessary donor information must be collected by questionnaire and by means of a subsequent personal interview with the donor by the physician.
An age limit exists for eligibility to cost coverage by the health insurance funds (see response to question 4).
9. Are there specific non-medical criteria for selection of gametes/embryos to be used for MAP? No
10. Are there special measures for the prevention of consanguinity? No. As part of a voluntary commitment physicians, sperm banks and laboratories have limited the number of offspring from a sperm donation to 15 (Richtlinien des Arbeitskreises für Donogene Insemination zur Qualitätssicherung der Behandlung mit Spendersamen in Deutschland).
11. In a homosexual couple, is a legal relationship possible between a child and the partner of the legal parent? Yes.
German law includes the following provisions governing the legal relationship between the child and the spouse of the legal parent:
- Authority of the spouse/registered partner of a parent who has the sole parental care (decision-making authority) about the child to have a say in matters of daily life (so-called “small care” – Section 1687b(1) of the Civil Code, Section 9(1)of the Act on Registered Life Partnership). In case of imminent danger, the spouse/registered partner is also entitled to perform all acts necessary for the child's welfare (Section 1687b(2) of the Civil Code, Section 9(2) of the Act on Registered Life Partnership).
- Right of contact with the child, if a “family-like social relationship” has evolved between the parent’s spouse and the child (Section 1685(2) of the Civil Code),
- In case the child has been living in one household with one parent who dies or is no longer able to exercise parental care or whose parental care has been suspended, the court may deny the other parent’s request to give the child to him or her and order that the child should stay with the spouse/registered partner of the first parent (ex officio or by request of that spouse), provided the child has been living in that household for a longer time (Section 1682 sentence 2 of the Civil Code). Similar rules apply for staying with the partner of a deceased parent or a parent who cannot exercise his or her parental care.
Pursuant to Section 1741(2) sentence 4 of the Civil Code/Section 9(7) sentence 1 of the Act on Registered Life Partnership, a spouse/registered partner is entitled to adopt his or her spouse’s/registered partner’s biological child. According to Section 1742 of the Civil Code/Section 9(7) sentence 2 of the Act on Registered Life Partnership, a spouse/registered partner may also adopt the child adopted by his or her spouse/registered partner. There is no longer a distinction between heterosexual and homosexual married couples, registered partners or between married and unmarried stable couples in case they want to adopt the child of their partner (Section 1766a of the Civil Code). In addition, married couples regardless of the sex of the spouses may adopt any other child as common parents, whereas unmarried couples and registered partners do not have this option to become common parents of the child simultaneously. They have to adopt the child successively.
Germany -
Financial aspects
3. Are MAP procedures covered by the social security system? Yes
MAP is a medical therapy under Section 27a of Book V of the Social Code.
The medical services covered by the statutory health insurance also include medical interventions aimed to induce a pregnancy. MAP measures must be medically diagnosed as necessary and have reasonable chances of success.
The Statutory Health Insurance Modernisation Act [GKV-Modernisierungsgesetz] reasonably restricted the entitlement to MAP measures from 1 January 2004 onwards. Since then Section 27a of Book V of the Social Code specifies that 50% of the costs are covered by the health insurance fund, so that the insured equally share in the costs of MAP interventions with a co-payment of 50%.
To reduce the financial burden caused by the 2004 cutback in costs covered by the statutory health insurance fund, in 2012 the Federal Ministry for Family Affairs launched the federal initiative “Hilfe und Unterstützung bei ungewollter Kinderlosigkeit” (assistance and support for involuntary childlessness). The funds are paid from both the federal budget and the budget of the Länder in which the couples concerned have their principal residence. Currently, twelve of the sixteen Länder participate in the initiative. Federal funding is generally provided for the first four treatment cycles of in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). Couples can be reimbursed up to 25 per cent of the share they have to pay in addition to the costs covered by the health insurance fund.
Until 2015, only married couples were entitled to additional federal financial assistance. Today, also unmarried couples living in a non-marital long-term relationship can receive federal financial assistance under the amended federal guidelines on financial assistance for assisted reproduction procedures (Richtlinie über die Gewährung von Zuwendungen zur Förderung von Maßnahmen der assistierten Reproduktion), which took effect on 7 January 2016. However, pursuant to Section 27a of Book V of the Social Code, entitlement to benefits from the statutory health insurance fund is still restricted to married couples only.
4. Are there specific criteria for such coverage? Yes.
The criteria included in Section 27a of Book V of the Social Code:
Coverage of part of the costs by the statutory health insurance funds is subject to the following requirements:
- the measures must be medically diagnosed as necessary
- according to medical diagnosis, the intervention must be reasonably likely to induce a pregnancy
- the procedure may be performed up to three times
- only married couples are eligible (non-married couples are not)
- only the spouses’ egg and sperm cells may be used (homologous system)
- prior to treatment, the spouses must have themselves thoroughly informed about the medical and psychosocial aspects involved by a physician other than the one who will perform the treatment
- MAP may only be performed by physicians or facilities that are suitably qualified and have obtained an appropriate licence from the authority responsible under the law of the federal Land
Any method other than homologous fertilisation is excluded from the mandatory package of benefits and services of the statutory health insurance system.
The restriction of eligibility to married couples is in accordance with the German Constitution (cf. Judgment of 28 February 2007 – 1 BvL 5/03, BVerfGE 117, 316).
Eligibility is subject to age limits of between 25 and 40 years for women and between 25 and 50 years for men.
Although unmarried heterosexual couples are not entitled to benefits from the statutory health insurance fund pursuant to Section 27a of Book V of the Social Code, they can receive the voluntary financial assistance offered through the federal initiative “Hilfe und Unterstützung bei ungewollter Kinderlosigkeit”.
5. Is the financial coverage limited to a number of MAP procedures? Yes. Pursuant to Section 27a of Book V of the Social Code three attempts to induce a pregnancy are partially covered by the health insurance funds. The payment of expenses by the health insurance funds has been limited to 50% of the costs approved along with the treatment schedule.
Greece -
Right to know about his or her biological origin for children born after MAP
16. Is donation of sperm/oocytes/embryos anonymous? Yes.
The law adopts the principle of anonymity regarding any donation, therefore, the identity of the donor cannot be revealed under any circumstances.
According to Art 8, para 6 of the new law, medical information that concerns the donor are kept in an anonymous codified form in the Cryopreservation Bank and in the National Registry of Donors and Receivers.
17. Is it possible to obtain information about the biological origin of a child born after gametes of embryo donation?
i. For the child him or herself Yes; ii. For the parents Yes; iii. For a court Yes
The child and his legal representative may have access only to medical data which are kept in secrecy and in a codified form in Cryopreservation Banks.
Law 2472/1997 on the “Protection of individuals with regard to the processing of personal data” qualifies health data as “sensitive” kind of information and stipulates special permission of the Data Protection Authority (Article 7).
According to Art 20, para 3 of Law 3305, access to the National Registry of Donors and Receivers is permitted only to the child and for reasons related to his health, with the permission of the Data Protection Authority and as long as the conditions of Law 2472/1997 regarding protection of personal data are fulfilled. The parents may have access to information only when they act as representatives of the child. The Court may order access.
a. Identity of the donor(s)
i. For the child him or herself No; ii. For the parents No; iii. For a court No
The law adopts the principle of anonymity regarding any donation, therefore, the identity of the donor cannot be revealed under any circumstances. The child and his legal representative may have access only to medical data which are kept in secrecy and in a codified form in Cryopreservation Banks.
b. Certain health information concerning the donor(s)
i. For the child him or herself Yes; ii. For the parents Yes; iii. For a court Yes
The child or the parents (acting as representatives of the child) can have access to health information which are kept in secrecy and in a codified form in Cryopreservation Banks but not to the identity of the donor. The Court also may authorize access to health information.
c. Other information
i. For the child him or herself No; ii. For the parents No; iii. For a court No
18. Is it possible to contest maternity and paternity of children born utilising MAP and under which conditions? Yes.
Contestation of maternity and paternity: contestation of paternity is not allowed when the father has provided consent at the beginning of the treatment.
Also, according to Law 3089/02, consent before a notary public of a man and a woman living in a free union takes place in order to guarantee their affiliation with the child to be born. As a result of that, contestation of the voluntary affiliation is forbidden.
In the case of surrogate motherhood, according to the law, the woman to whom the Court’s approval has been given is considered to be the legal mother of the child. Exceptionally, either the commissioning, or the surrogate mother, may contest this in Court, under conditions provided for by the law.
Georgia -
Current debate and specific situations
19. Is there an important current debate in your country on these or related issues?
Debates took place about the draft Law on Reproductive Health and Reproductive Rights among the representatives of various professionals, especially medical professionals, representatives of church and religious groups, representatives of Ministry of Health and Social Affairs, etc.
As the above draft Law is more specific than the Law on Health Care it will change existing legal situation (details are already specified throughout the questionnaire).
20. Delegations are invited to provide information, in this section, on particular cases encountered in their country, and especially their case-law.
English versions of the following legislation related to MAP are presented in the Addendum:
- Law on Health Care (Relevant articles from Chapter XXIII Family Planning) [see Addendum];
- Draft Law on Reproductive Health and Reproductive Rights [see Addendum].
Germany -
Current debate and specific situations
19. Is there an important current debate in your country on these or related issues? No
20. Delegations are invited to provide information, in this section, on particular cases encountered in their country, and especially their case-law. See section I above for links to the updated versions of German laws
Latvia -
Sperm/oocyte/embryo donation
6. Is donation of sperm/oocytes/embryos permitted in your country? Yes
7. Are there specific compensation arrangements for donations of sperm/oocytes/embryos? No
8. Are there specific criteria for donation of sperm/oocytes/embryos? Yes.
For sperm age limit 18-45.
For oocytes 18-35.
If checking on sexually transmitted disease STD, Hepatitis B, C are positive.
If General health are not in good condition.
If in anamnesis have genetic diseases.
9. Are there specific non-medical criteria for selection of gametes/embryos to be used for MAP? Yes
10. Are there special measures for the prevention of consanguinity? Yes. No more than three children can be born from one donor, furthermore, special means are taken if the children born from donor have genetically hereditary disease.
11. In a homosexual couple, is a legal relationship possible between a child and the partner of the legal parent? No
Malta -
Sperm/oocyte/embryo donation
6. Is donation of sperm/oocytes/embryos permitted in your country? Yes.
Regarding ‘embryos’ this is when the couple do not use the remaining frozen embryos; government can then take custody through the Authority set up by the Embryo protection Act and give them up for adoption.
Donation of gametes is only possible by a ‘confidential agreement between the donor and the licensee:’
7. Are there specific compensation arrangements for donations of sperm/oocytes/embryos? No
8. Are there specific criteria for donation of sperm/oocytes/embryos? Yes.
No age limit stated
The Embryo Protection authority ensure high standards. In the case of adoption of embryos a medical practitioner must declare the prospective parent physically fit.
See also 6 above.
Donation of embryos remains confidential and anonymity of the biological parents is entrenched into the law. Besides, all parental and filial rights are relinquished. That is to say, for example, the donated embryo would have no right to inherit the biological parents who gave up the embryo. Conversely the former would have no right on the latter.
9. Are there specific non-medical criteria for selection of gametes/embryos to be used for MAP? No
10. Are there special measures for the prevention of consanguinity? Yes. There is an official register kept by the Authority. Article 4, Section 3 states that ‘the Authority shall make all reasonable efforts to match prospective adoptive parents with the embryos who require an adoption placement’.
11. In a homosexual couple, is a legal relationship possible between a child and the partner of the legal parent? Yes
Luxembourg -
Right to know about his or her biological origin for children born after MAP
16. Is donation of sperm/oocytes/embryos anonymous? Yes. This depends on the legislation of the countries from which the donations originate.
17. Is it possible to obtain information about the biological origin of a child born after gametes of embryo donation?
i. For the child him or herself; ii. For the parents; iii. For a court NA
a. Identity of the donor(s)
i. For the child him or herself; ii. For the parents; iii. For a court NA
b. Certain health information concerning the donor(s)
i. For the child him or herself; ii. For the parents; iii. For a court NA
c. Other information
i. For the child him or herself; ii. For the parents; iii. For a court
This depends on the legislation of the countries from which the donations originate.
18. Is it possible to contest maternity and paternity of children born utilising MAP and under which conditions? No. See Art.312 of the Civil Code cited in the section I – relevant instruments or draft instruments.
Malta -
Legal regulation or practice and access to MAP
- Title of the law: Embryo Protection Act 2018
- Date of adoption and entry into force: 2018
- Published in: Laws of Malta; Government Gazette
Malta -
Legal aspects
1. Is access to medically assisted procreation (MAP)
a. restricted to heterosexual couples? No
b. possible for women not living in a heterosexual couple? Yes
Surrogacy is not allowed but donation of sperm is allowed and therefore homosexual female couples can use sperm donation or adoption of frozen embryos
San Marino -
Sperm/oocyte/embryo donation
16. Is donation of sperm/oocytes/embryos anonymous? Na
17. Is it possible to obtain information about the biological origin of a child born after gametes of embryo donation?
i. For the child him or herself ; ii. For the parents; iii. For a court NA
a. Identity of the donor(s)
i. For the child him or herself ; ii. For the parents; iii. For a court NA
b. Certain health information concerning the donor(s)
i. For the child him or herself ; ii. For the parents; iii. For a court NA
c. Other information
i. For the child him or herself ; ii. For the parents; iii. For a court NA
18. Is it possible to contest maternity and paternity of children born utilising MAP and under which conditions? NA
Serbia -
Medical aspects
2. Are there specific criteria for access to MAP?
Medical reasons:
a. Infertility:
For a heterosexual couple? Yes; For women not living in a heterosexual couple? Yes
b. Risk of transmission of a disease
For a heterosexual couple Yes?; For women not living in a heterosexual couple? Yes
c. Other N/A
Serbia -
Legal aspects
1. Is access to medically assisted procreation (MAP)
a. restricted to heterosexual couples? Yes
b. possible for women not living in a heterosexual couple? Yes
Azerbaijan -
Current debate and specific situations
19. Is there an important current debate in your country on these or related issues? NA
20. Particular cases encountered in your country, and especially your case-law, in relation to the questions appearing in Sections I and II above
The law on reproductive health is being elaborated. Many aspects of MAP were included during discussions on the draft law.
Andorra -
Current debate and specific situations
19. Is there an important current debate in your country on these or related issues? If so, what might the implications be?
NA
20. Particular cases encountered in your country, and expecially, their case-law
NA
Azerbaijan -
Medical aspects
2. Are there specific criteria for access to MAP?
- Medical reasons:
a. Infertility
i. for a heterosexual couple? Yes
ii. for women not living in a heterosexual couple? Yes
b. Risk of transmission of a disease (please specify the risk and/or disease)
i. for a heterosexual couple? Yes
ii. for women not living in a heterosexual couple? Yes
Azerbaijan -
Legal aspects
1. Is access to medically assisted procreation (MAP)
a. restricted to heterosexual couples? Yes
b. possible for women nnot living in a heterosexual couple? Yes
Italy -
Réglementation ou pratique et accès à la PMA
- Titre de la législation : Règles en matière de procréation médicalement assistée.
- Date de l’adoption et de l’entrée en vigueur 19 février 2004 n°40
- Publiée dans : Gazzetta Ufficiale della Repubblica Italiana (publication officielle contenant les éléments des nouvelles lois).
- Indiquer si une révision est en cours et, dans vos réponses, fournir des informations sur les dispositions du projet de loi :
Le 12 juin 2005 a eu lieu un référendum populaire pour modifier plusieurs dispositions de cette loi. L’abrogation de ces dispositions a été rejetée, le taux d’abstention ayant été de 74 % (51 % de votes favorables auraient été nécessaires pour changer la loi).
Résumé
1. Protection des désirs de maternité/paternité et règles d’exercice des droits découlant de la loi n° 40/2004.
L’accès aux techniques de procréation assistée est réservé à des couples hétérosexuels majeurs, mariés ou menant une vie commune, dont les membres sont tous deux vivants et en âge de procréer.
Il est interdit aux personnes célibataires et aux homosexuels.
Le couple qui demande un accès aux techniques de procréation (médicalement) assistée doit produire un certificat médical attestant l’existence d’une stérilité ou d’une infertilité pour lesquelles il n’existe aucune autre solution possible.
Le consentement, écrit et librement révocable jusqu’au moment de la fécondation in vitro de l’ovocyte, est obligatoirement précédé d’une information sur le plan technique, juridique, et éthique ainsi que sur le coût des procédures et sur les conséquences possibles des techniques de procréation assistée pour l’enfant à naître.
Lors de l’entretien avec le responsable du centre médical, les couples sont également informés des possibilités d’adopter un enfant ou de devenir famille d’accueil d’un enfant en vue de son adoption (loi n° 184 du 4 mai 1983).
Un délai de réflexion de sept jours doit être respecté avant le début des procédures de procréation assistée.
Ces techniques sont appliquées de manière progressive en commençant par les moins invasives afin d’éviter de recourir à des interventions dont le caractère invasif, au plan technique et psychologique, les rend plus pénibles pour les personnes concernées.
Le médecin responsable du centre médical est en droit de prendre la décision de ne pas recourir aux techniques de procréation assistée, exclusivement pour des raisons médicales ou de santé.
La cryoconservation des gamètes masculins et féminins est autorisée, à condition que les personnes concernées aient été informées et y aient donné leur consentement écrit.
La loi, dans sa formulation d’origine, interdisait le recours à des techniques de type hétérologue (avec don de gamètes d’un tiers extérieur au couple). L’intervention de la Cour constitutionnelle (arrêt n° 162 de 2014) a supprimé cette interdiction.
2.Protection de l’enfant à naître
Le statut juridique de l’enfant né par techniques de procréation assistée est celui d’un enfant légitime ou reconnu par le couple. Le désaveu de paternité est exclu en cas de fécondation hétérologue. Le donneur de gamètes n’acquiert aucun lien juridique de parenté avec l’enfant né (aucun droit ni devoir).
La mère ne peut plus, au moment de l’accouchement, déclarer sa volonté de ne pas être connue, comme cela est autorisé pour la conception naturelle (Décret du Président de la République n° 396 du 3 novembre 2000).
3.Protection de l’embryon
Il est interdit de procéder à la cryoconservation ou à la suppression d’embryons, sous réserve des dispositions de la loi n° 194 du 22 mai 1978 (loi sur l’interruption volontaire de grossesse).
La loi, dans sa formulation d’origine, disposait que les techniques de production d’embryons, compte tenu de l’évolution technique et scientifique et de ce qui pourra être établi à l’avenir par des orientations juridiques du ministre de la Santé, ne peuvent conduire à la création d’un nombre d’embryons supérieur à celui strictement nécessaire à la réalisation d’un transfert unique et simultané, ce nombre ne pouvant en aucun cas être supérieur à trois.
Lorsque le transfert des embryons dans l’utérus se révèle impossible pour raison majeure grave et prouvée, ayant trait à l’état de santé de la femme et non prévisible au moment de la fécondation, la cryoconservation des embryons est autorisée jusqu’à la date du transfert, qui sera effectué aussitôt que possible. Depuis la décision n° 151/2009 de la Cour constitutionnelle, la détermination du nombre d’embryons à créer et à transférer dans le cadre d’une procédure d’implantation reste à l’appréciation du médecin qui tient compte de l’état de santé de la femme. Il ne doit pas être supérieur au nombre strictement nécessaire à la procréation.
En vertu de la loi sur la procréation médicalement assistée, il est interdit de procéder à la réduction embryonnaire de grossesses multiples, sauf dans les cas prévus par la loi n° 194 du 22 mai 1978 (loi sur l’interruption volontaire de grossesse).
Les sujets visés à l’article 5 sont informés du nombre et, s’ils le demandent, de l’évaluation des embryons produits à transférer dans l’utérus.
À la suite de la décision n° 96 du 5 juin 2015, la Cour constitutionnelle a levé l’interdiction qui était faite aux couples fertiles porteurs connus de maladies génétiques graves de recourir au diagnostic génétique préimplantatoire. Les maladies en question doivent répondre aux critères de gravité énoncés à l’article 6, paragraphe 1, lettre b) de la Loi n° 194 du 22 mai 1978 et être détectées par les prestataires publics de soins de santé compétents. Il appartient au Parlement de définir les critères d’agrément de ces structures.
Toute expérimentation sur l’embryon humain est interdite.
La recherche clinique et expérimentale sur l’embryon humain est autorisée à condition que les buts en soient exclusivement thérapeutiques et diagnostiques, en vue de la protection de la santé et du développement de l’embryon.
Sont interdites :
(a) la production d’embryons humains aux fins de recherche ou d’expérimentation ou à toutes fins autres que celles prévues par la loi. Interdiction des dons d’embryon à des fins de recherche : dans l’arrêt Parrillo c. Italie (requête n°46470/11) du 27 août 2015, la Cour européenne des droits de l’homme a reconnu que l’interdiction faite à une femme de donner à la recherche scientifique des embryons résultants d’une fécondation in vitro n’était pas contraire à son droit au respect de sa vie privée (il n’y avait pas de violation de l’article 8 (droit au respect de la vie privée) de la Convention européenne des droits de l’homme). Elle a également affirmé que les embryons humains ne sauraient être réduits à des « biens ». La Cour a considéré qu’il convenait de reconnaître à l’Italie une large marge d’appréciation dans cette affaire, qui mettait en jeu des questions morales et éthiques sensibles, d’autant plus qu’il n’y avait pas de consensus européen sur la question délicate du don d’embryons non destinés à l’implantation. La Cour constitutionnelle a rejeté un recours récent sur ces questions, affirmant qu’il appartenait au législateur de modifier la loi.
(b) toute forme de sélection dans un but eugénique, des embryons et des gamètes, ou des interventions qui, au moyen de techniques de sélection, de manipulation, ou par des procédés artificiels, visent à altérer le patrimoine génétique de l’embryon ou du gamète, ou à en prédéterminer les caractéristiques génétiques, à l’exception des interventions à des fins diagnostiques et thérapeutiques. Cela dit, l’arrêt n° 229/2015 de la Cour constitutionnelle n’a supprimé l’interdiction de la sélection d’embryons que dans des circonstances particulières, considérant qu’il ne s’agissait pas d’une infraction lorsqu’elle vise à prévenir l’implantation d’embryons nés de couples présentant un risque de transmission de maladies génétiques graves, conformément à l’article 6, 1 B de la loi 194 (relative à l’interruption de grossesse) dans des structures publiques désignées. Une question de constitutionnalité concernant l’article 13 (paragraphes 3, alinéa b) et 4) de la Loi n° 40/2004 a été soulevée. Le jugement rendu est conforme à l’arrêt précité.
Il souligne toutefois la protection nécessaire a conférer à l’embryon humain à la protection nécessaire, rappelant que « l’enjeu est ici la nécessité de protéger la dignité de l’embryon, à laquelle aucune autre réponse que la cryoconservation ne peut actuellement être apportée. Un embryon, quel que soit le statut juridique plus ou moins déterminé associé au début de la vie, ne saurait être réduit à un simple matériau biologique ».
(c) des interventions de clonage par transfert de noyau ou de scission précoce de l’embryon ou d’ectogenèse, à des fins de procréation ou de recherche ;
(d) la fécondation d’un gamète humain par un gamète d’espèce différente et la production d’hybrides ou de chimères.
4. Sanctions
Le texte de la loi 40/2004 prévoit différentes sanctions progressives en cas de violation de la loi, qui s’appliquent aux médecins et aux Centres autorisés mettant en œuvre les techniques de procréation assistée.
L’homme ou la femme auxquels sont appliquées les techniques ne peuvent être sanctionnés que s’ils n’ont pas suivi les procédures prévues. La sanction pour insémination hétérologue a été supprimée. Les sanctions qui restent en vigueur sont définies à l’article 12 de la Loi n° 40/2004.
5. Autorisations
Un système d’autorisation régionale des structures jugées adéquates est prévu, sur la base :
(a) des données techniques, scientifiques et d’organisation de ces structures ;
(b) des qualifications du personnel.
Les conditions requises sont établies par actes des Régions.
Il existe un Registre obligatoire des structures autorisées, établi et tenu par l’Institut supérieur de la santé, qui suit l’application des techniques de procréation médicalement assistée, les embryons formés et les enfants nés à la suite de l’application de ces techniques.
L’Institut supérieur de la santé prépare le rapport annuel à présenter au Parlement.
Après la décision n° 162/2014, le ministère de la Santé a approuvé les Lignes directrices pour l’application des techniques de reproduction hétérologues au couple qui reçoit le gamète. En ce qui concerne le don de gamètes, l’Italie adoptera la Directive UE 2006/17, ALL.III, PAR.3,4 et ses modifications ultérieures. Le texte sera approuvé dans le système normatif (sous la forme d’un décret gouvernemental). L’un des éléments fondamentaux issus du système juridique Italien est le principe selon lequel le don de sperme et d’ovocyte doit être un acte volontaire, altruiste et non rémunéré.
Ireland -
Legal regulation or practice and access to MAP
Until recently in Ireland the provision of assisted human reproduction (AHR) services was largely unregulated. However, in April 2015 Parliament passed the Children and Family Relationships Act which deals with the limited topic of parentage in the case of donor assisted human reproduction. Under the Children and Family Relationships Act 2015, gamete and embryo donation are permitted on a non-anonymous basis. In addition, this legislation provides for the establishment of a national register of gamete/embryo donors, recipients and donor-conceived children (the National Donor-Conceived Person Register), which will allow donor-conceived children to access certain information regarding the gamete/embryo donor involved in procedures leading to their conception.
Moreover, although AHR services are not currently regulated by any specific health legislation, in February 2015, the Minister for Health received Government approval to draft a General Scheme of legislative provisions which would deal with a wide range of issues from the beginning to the end of the AHR process. Following the completion of the General Scheme, the Government approved its publication and the drafting of a Bill on assisted human reproduction based on this General Scheme. The drafting of this Bill is currently ongoing.
Under the proposed legislation, a number of practices will be regulated, including gamete and embryo donation, surrogacy and the assignment of parentage in such cases, pre-implantation genetic screening/diagnosis, sex selection for medical purposes, and posthumous assisted reproduction as well as associated research. It is also proposed that the legislation will establish a regulator to promote patient safety and good clinical practice in the area of assisted human reproduction. The regulator will maintain the National Donor-Conceived Person Register, establish the National Surrogacy Register and maintain records of all assisted human reproduction activities and services.
In January 2018 the General Scheme was submitted to the relevant parliamentary committee for review as part of the pre-legislative scrutiny process. This committee published the report of its review in July 2019, making recommendations which include proposals related to both broad policy objectives and more technical amendments. Its recommendations are being considered during the ongoing process of drafting the AHR Bill.
Norvège -
Legal regulation or practice and access to MAP
- Title of the law: The act relating to the application of biotechnology in human medicine etc
- Adopted 5 December 2003, partly into force from 1 January 2004, 1 September 2004 and 1 January 2005. Limited use of PGD was allowed (only in cases of X-linked diseases), and research on surplus embryos was banned. An amendment in force from September 2004 allowed PGD also in cases of serious hereditary diseases for which no treatment is available. New regulations regarding PGD and research on surplus embryos entered into force in July 2008; allowing research on surplus embryos under certain conditions, and PGD or PGD/HLA in situations of serious hereditary disease. New regulations regarding access to MAP for lesbian couples entered into force in January 2009. In 2013 the act was amended to allow MAP to otherwise fertile couples, where one person has a serious and chronic sexually transmitted infection. In 2020 single women who live alone were given access to MAP, and from 2021 oocyte donation is allowed. Egg donation is accessible only to couples able to use their own sperm. Same-sex female couples can donate oocytes to each other (partner donation) and use sperm from a donor.
Lithuania -
Legal regulation or practice and access to MAP
- Title of the law: The Law on the Assisted Reproduction of the Republic of Lithuania
- Date of adoption: 14th September 2016 (amended 24th May 2022, 30th May 2019 and 17th January 2017)
- Entry into force: 1st January 2017
- Published in: the Lithuanian Register of Legal Acts
In the last revision of the Law entered into force on the 1st of July 2022, the requirement to store embryos for the unlimited period of time was abolished. This requirement was replaced by a requirement to store embryos for 10 years after the assisted reproduction procedure.
Poland -
Current debate and specific situations
19. Is there an important current debate in your country on these or related issues? NA
20. Delegations are invited to provide information, in this section, on particular cases encountered in their country, and especially their case-law.
Homologous insemination in a married couple has no legal incidence: the mother’s spouse becomes the child’s biological father; the means of conception (natural or artificial) has no legal incidence, nor does consent or the lack of it.
Heterologous insemination, on the other hand, raises legal questions concerning filiation. The donor of the sperm is certainly the child’s biological father, but it is impossible to prove legal paternity as the identity of the donor is in principle unknown to the mother and the doctor is sworn to secrecy. Furthermore, no action to prove paternity may be opened in this case as Article 85 para. 1 of the Code of the Family and Guardianship makes sexual intercourse a prerequisite of such action.
The question of the legal paternity of the child thus remains open. In the case of an unmarried woman, action to prove paternity should be excluded, as the donor has the right to remain anonymous. However, if the child is born in wedlock or within 300 days of the marriage being dissolved or annulled, the mother’s husband is presumed to be the legal father. He may take action to contest his paternity within six months of finding out about the birth (art. 63). This is a peremptory time limit, after which only the public prosecutor may institute such proceedings.
The situation is more complex in the event of heterologous insemination carried out with the husband’s consent. As there are no specific legal provisions in the matter, the husband has the right to contest his paternity even though he did give his consent. Theoretically he only needs to prove that the birth was the result of MAP. However, according to a decision of the Court of Cassation on 27 October 1983: “Action by the spouse of the mother contesting paternity of a child born following MAP performed, with said spouse’s consent, with the sperm of another man may be considered contrary to public policy.” In stating its reasons, the Court stressed the importance of the child’s welfare, arguing that if it were to accept an action contesting the father’s paternity of a child born following MAP carried out with his consent using another man’s sperm, the child would, to all intents and purposes, be fatherless; it would be virtually impossible to prove the paternity of the donor because of the rules protecting his anonymity. And the donor has no interest in proving his paternity. This interpretation also takes into account the interests of the family formed subsequent to the couple’s decision to have recourse to MAP.