Access to medically assisted procreation - Search
Belgium - Legal regulation or practice and access to MAP
Title of the law: Medically Assisted Procreation and Destination of Supernumerary Embryos and Gametes Act of 6 July 2007
Entry into force 27 July 2007
Published in: the Moniteur belge [Official Gazette] on 17 July 2007, p.38575
Articles 26 and 55, paragraph 2, of the Act, inserted by a law of 10 April 2014 and entered into force on 10 May 2014 provides that if the two authors of the parental project are two women, they are considered as a single woman, when counting the maximum of six women who can give birth to children from gametes or surplus embryos from one donor or donor couple.
Croatia - Legal regulation or practice and access to MAP
- Title of the law: Act on Medically Assisted Fertilisation
- Date of adoption and entry into force: Adopted on 18th July 2012.
- Entered into force: 4th August 2012.
- Published in: Official Gazette No 86 from 27th July 2012
- Indicate if process of revision is ongoing and, in your answers, provide information on provision in the draft law: Revision of the Act is planned for the last quarter of the 2016. Revision will be primarily focused on the technical aspects, i.e. harmonisation with acquis communautaire in this field (EU tissues and cells directives).
Denmark - Legal regulation or practice and access to MAP
- Title of the law: Act on medically assisted procreation in connection with medical treatment, diagnosis and research etc. (Loi no. 460/1997)
- Date of adoption and entry into force: 1 October 1997
- Published in Danish Law Journal
- Indicate if process of revision is ongoing and, in your answers, provide information on provision in the draft law: The law was last recently amended in January 2021.
Lithuania - Current debate and specific situations
19. Is there an important current debate in your country on these or related issues? Yes. Surrogacy is widely discussed in Lithuania
20. Delegations are invited to provide information, in this section, on particular cases encountered in their country, and especially their case-law. NA
Cyprus - Legal regulation or practice and access to MAP
- Title of the law: Not Applicable
Croatia - Right to know about his or her biological origin for children born after MAP
16. Is donation of sperm/oocytes/embryos anonymous? No. After reaching the age of 18 a person born from the MAP procedure is allowed to have access to data on identity of biological parent(s).
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
After reaching the age of 18, every person born from a MAP procedure is allowed to have access to data on identity of biological parent(s).
Parents do have a right to access the donor data in the case of medical indication.
Both, child and parents should require data access from the MAP Registry.
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 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 No; iii. For a court Yes
18. Is it possible to contest maternity and paternity of children born utilising MAP and under which conditions? Yes. Contest is regulated within the Family Law. It is possible to contest maternity or paternity only in the cases when MAP procedure was performed without consent.
Cyprus - Financial aspects
3. Are MAP procedures covered by the social security system? No. The Ministry of Finance covers the cost of MAP procedures.
4. Are there specific criteria for such coverage? Yes. Specific criteria for such coverage are: (1) infertility (2) for women under 40 years old.
5. Is the financial coverage limited to a number of MAP procedures? Yes. The financial coverage is limited to only one (1) MAP 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.
Georgia - Right to know about his or her biological origin for children born after MAP
16. Is donation of sperm/oocytes/embryos anonymous?
LHC: no specific provisions are included in the LHC on this issue.
*DL-RHRR:
Donation of gametes and embryo is not anonymous; however information on the identity of a gamete donor is confidential. Also, any personal data collected about a couple or single women applying for MAP is confidential.
United Register of Gamete Donors will include data about the identity of gamete donors as well as of couple.
These data are confidential. However, the law may make exceptions for specific cases; e.g. “when the disclosure of information on the donor’s genetic characteristics is necessary for the health purposes of the child, born as a result of medically assisted reproductive technologies”.
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 Yes. LHC: no specific provisions are included in the LHC on this issue. The answers given to question 17 are based on DL-RHRR.
a. Identity of the donor(s)
i. For the child him or herself; ii. For the parents; iii. For a court No
b. Certain health information concerning the donor(s)
i. For the child him or herself; ii. For the parents; iii. For a court Yes. Health data of the gamete donor, particularly information about the donor’s genetic characteristics, could be disclosed from the register of gamete donors if this is necessary for the health purposes of the child, born as a result of MAP.
c. Other information
i. For the child him or herself NA; ii. For the parents; Yes. A couple or a single woman has the right to request and receive information on the donor’s age, appearance, ethnic background, and health condition.
- Obligation of gamete donor to provide information about his/her health:
According to the DL-RHRR gamete donors are obligated “to give the medical personnel complete and comprehensive information on his/her health condition prior to gamete donation.”
- Right of the gamete donor to receive information about his/her health:
According to the DL-RHRR gamete donors are entitled to receive “information concerning his/her own health, which may be discovered as a result of monitoring the child born after utilizing assisted reproductive technologies.”
iii. For a court NA
18. Is it possible to contest maternity and paternity of children born utilising MAP and under which conditions? There are no specific provisions on this subject in family law at present.
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
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)
France - Financial aspects
3. Are MAP procedures covered by the social security system? Yes. Medically assisted procreation is considered a health care activity. Law N°2021-1017 of August 2nd 2021 provides for the possibility of reimbursement of MAP by social security under the same conditions for unmarried single women, female couples and heterosexual couples. The MAP procedure is covered by national solidarity. The beneficiaries are exempt from the co-payment.
4. Are there specific criteria for such coverage? Yes. The law of August 2, 2021 removed the criterion of infertility, MPA procedures are covered at 100% by the Assurance Maladie for a maximum of : - 6 inseminations (only one artificial insemination per cycle) to obtain a pregnancy; - 4 in vitro fertilization attempts to achieve a pregnancy. This coverage is the same for everyone (heterosexual couple, couple made up of 2 women, unmarried woman) Knowing that, for the retrieval or the collection in a project of AMP, there are conditions of ages: - oocyte retrieval can be performed in women up to their 43rd birthday; - Sperm collection can be performed in men up to their 60th birthday; And for the performance of MPA: - until her 45th birthday for the woman, unmarried or within the couple, who will carry the child; - until his 60th birthday for the person in the couple who will not carry the child.
5. Is the financial coverage limited to a number of MAP procedures? Yes. The health insurance system will cover six inseminations and four complete cycles, i.e. concluded by embryo transfer. Any IVF cycle broken off before embryo transfer, irrespective of the stage at which it is abandoned, will not be counted by the health insurance system. Reimbursement is subject to a preliminary agreement procedure.
Should pregnancy and delivery occur, the count restarts from zero, and coverage is provided for four new attempts. This does not apply to miscarriages or extrauterine pregnancies.
Georgia - Medical aspects
2. Are there specific criteria for access to MAP?
Medical reasons:
a. Infertility:
For a heterosexual couple? LHC: Yes, DL-RHRR: Yes;
For women not living in a heterosexual couple? LHC: No, DL-RHRR: Yes
2bi
LHC: Yes
“Risk of transmission of a genetic disease”
DL-RHRR: Yes
a) “Proven likelihood of the transmission of a serious genetic disease to a naturally conceived child from a woman or man, that may result in a child’s severe disability and/or premature death.”
b) “Proven likelihood that a child from natural insemination will be born with a non-genetic disease that may result in grave disability and/or premature death.”
b. Risk of transmission of a disease
For a heterosexual couple?; LHC: Yes “Risk of transmission of a genetic disease” DL-RHRR: Yes
a) “Proven likelihood of the transmission of a serious genetic disease to a naturally conceived child from a woman or man, that may result in a child’s severe disability and/or premature death.”
b) “Proven likelihood that a child from natural insemination will be born with a non-genetic disease that may result in grave disability and/or premature death.”
For women not living in a heterosexual couple? LHC: No, DL-RHRR: Yes
a) “Proven likelihood of the transmission of a serious genetic disease to a naturally conceived child from a woman or man, that may result in a child’s severe disability and/or premature death.”
b) “Proven likelihood that a child from natural insemination will be born with a non-genetic disease that may result in grave disability and/or premature death.”
Accordingly, the draft law of Georgia on Reproductive Health and Reproductive Rights permits access to medically assisted reproductive technologies for heterosexual couples or single women only if at least one of the conditions listed below are met:
- A woman and/or man of reproductive age is infertile, other alternatives available in the country for treating infertility have proved ineffective; or such treatment hasn’t yet been carried out, but there is a reason to assume that it will be ineffective, as attested by a duly authorised state medical institution;
- There is a proven likelihood of the transmission of a serious genetic disease to a naturally conceived child from a woman or man, which may result in a child’s severe disability and/or premature death;
- There is a proven likelihood, that a child from natural insemination will be born with a non-genetic disease, that may result in grave disability and/or premature death;
- A woman carries a disease due to which the pregnancy may endanger the woman’s life and/or health.
c. Other There is one more medical criterion, but only for accessing surrogacy: existence of a disease due to which the pregnancy may endanger the woman’s life and/or health.
Georgia - Legal aspects
1. Is access to medically assisted procreation (MAP)
a. restricted to heterosexual couples?
LHC: Insemination-No; IVF-Yes
a) At present the law gives access to artificial insemination to heterosexual couples as well as to single women.
b) However in vitro fertilization (IVF) is accessible only to couples.
DL-RHRR: No. Draft law gives access to medically assisted procreation (artificial insemination as well as in vitro fertilization procedures) to heterosexual couples as well as to single women.
b. possible for women not living in a heterosexual couple?
LHC: Insemination-Yes; IVF-No
a) Law gives access to artificial insemination to single women. However, the Law does not specify whether women should be living in heterosexual couple or not.
b) IVF is not accessible for single women.
DL-RHRR: Yes. Draft law gives access to medically assisted procreation (artificial insemination as well as in vitro fertilization procedures) to single women.
Lithuania - Financial aspects
3. Are MAP procedures covered by the social security system? Yes. The compensation is available to people who have entered into a marriage or registered partnership agreement in accordance with the law and have been diagnosed with infertility (female, male or both). The woman must be at least 42 years old.The compensation is available to people who have entered into a marriage or registered partnership agreement in accordance with the law and have been diagnosed with infertility (female, male or both). The woman must be at least 42 years old.
4. Are there specific criteria for such coverage? Yes. When the woman is 42 yearl old and the partners are infertile
5. Is the financial coverage limited to a number of MAP procedures? Yes. A maximum of 2 treatment cycles per couple is reimbursed
Lithuania - 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? No
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.