Assisted human reproduction

1. Assisted human reproduction Dr. Renzo Pegoraro President of the Fondazione Lanza Padua-Italy

2. European overview

3. Principles of the new Italian law (19/02/04) • Art.1.2 - The recourse to assisted reproduction is permitted only in cases of diagnosis of sterility or infertility and if it was shown that it is impossible otherwise to remove the interference with procreation. • Art. 5.1 - Access to assisted reproduction is only permitted to couples of diverse sex, married or living together, with a potential fertility and when both persons are alive.

4. Principles of the new Italian law (19/02/04) (2) • Art. 4.2 - Principles of graduality and minimal invasion, with the aim of avoiding the use of technologies that are invasive and psychologically damaging to the partecipants. • Art. 4.3: NO ASSISTED REPRODUCTION TECHNOLOGIES HETEROLOGUS, and so, no donation of gametes (12.1) • Art. 13 and 14 - Strong respect of embryo: embryo is primarily safeguarded. • Art. 6 - Informed consent: information to be provided to the couple is prescribed.

5. The informed consent (art. 6) • One week must elapse between the consent and procedure: during this time both the couple can withdrawn their consent. • The consent cannot be removed when the procedure started. The embryos should be implanted but the law is not clear.

6. The Informed Consent (art. 6) Information about: • - medical and psychological aspect; • - bioethics issues; • - probability of success and risks; • - level of invasivity; • - costs; • - possibility of adoption;

7. Respect of embryo • Freezing of embryos: is prohibited, except when some unexpected complications require to interrupt the procedure. • Creation of more embryos than needed for transfer: is prohibited, not more than 3 embryos. • Research on embryo: is permitted only for diagnostic/therapeutic research that will not compromise development and health of the embryo.

8. Respect of embryo (2) • Selection of embryos for transfer with eugenic goal: is prohibited. • Genetic manipulation: is permitted only for diagnostic/therapeutic interventions that will not compromise development and health of the embryo. • Creation and transplantation of chimera or hybrid: are prohibited. • Cloning: is prohibited.

9. Principle of respect • Embryo: strong respect. • Future children: wish to guarantee the identity and the nurture of children (heterosexual couples, homologus procreation). • Woman: principles of graduality and minimal invasion. • Couple: not heterologus reproduction, not use of technologies which can psychologically damaging.

10. Comments • The human assisted reproductive technology (hRT) seems to be considered as an acceptable intervention in case of sterility or infertility. • The Italian law is characterized by a strong respect for embryo and children’s identity. • We are waiting for: - New rules by the Ministry of Health about guidelines on procedures and definition of reproductive technologies (art. 7.1) - The Regions’s Act for technical and organizative standards, caracteristics of professionals, criteria for authorization of the public and private structures

11. Problems not resolved, about: • The refusal of implantation of embryos after (e.g.) PGD positive for some deseases, because: - it is possible to revoke the consent before the fertilization (art. 6.3), but it is possible the PGD by request (art. 14.5): probably they will be frozen (as art. 14.3); - no selection of embryos (art. 13.3) but embryos diagnosis (PGD) is possible (art. 14.5).

12. Catholic Church teaching Donum vitae (1987): 2,5 “…Church remains opposed from the moral point of view to homologous ‘in vitro’ fertilization. Such fertilization is in itself illicit and in opposition to the dignity of procreation and of the conjugal union, even when everything is done to avoid the death of the human embryo…”. “…Certainly, homologous IVF and ET fertilization is not marked by all that ethical negativity found in extral-conjugal procreation…”.

13. Prenatal diagnosis (PND) • It is a genetic analysis to define if a foetus is affected by genetic disease. • Non invasive prenatal diagnosis: it permits to analyze ‘out of foetus’ (e.g. ecography, bi-test, tri-test). • Invasive prenatal diagnosis: it permits to see foetus in the uterus (e.g. amniocentesis, villocentesis).

14. Prenatal diagnosis: ethical issues 1. PND ‘in se’: • Medical indications • Risk-benefits evaluation • Risks: for the mother, for the foetus… • Benefits: for the mother, for the foetus • Informed consent There is a correlation with pregnancy… It is necessary: an interdisciplinary (pre and post-) genetic counselling for the couple!

15. Prenatal diagnosis: ethical issues 2. PND and abortion: • Responsibility of the couple – woman • Responsibility of the physician (problem of the moral cooperation – refuse to do it) • Determinated correlation between PND and abortion: PND not acceptable • No determinated correlation: PDN acceptable

16. Prenatal diagnosis: cultural issues • Risk of ‘eugenic mentality’ • Acceptance of pregnancy only after the PND • The idea of ‘perfect baby’ not only ‘healthy baby’

17. Catholic Church teaching Donum vitae (1987): 1,2 “…For prenatal diagnosis makes it possible to know the condition of the embryo and of the foetus when still in the mother’s womb. It permits, or makes it possible to anticipate earlier and more effectively, certain therapeutic, medical or surgical procedures. Such diagnosis is permissible, with the consent of the parents after they have been adequately informed, if the methods employed safeguard life and integrity of the embryo and the mother…”

18. Preimplantation diagnosis (PGD) • It is a generic exam on embryo which is not still implanted in uterus (generally after IVF). • There is not pregnancy and there are not problems immediately related • Problem of status of embryo and respect of embryo

19. PGD: ethical issues • Approach of ‘selection’, risk to favour lack of respect for embryo • Clear eugenic approach: not transfer embryo with disease or with other caractheristic not desired • The problem is: to permit or not PGD (with the conseguence of that)?

20. An other European overview: to choose sex of the embryo is permitted ? • Italy: no. • Denmark: no, except when there is a risk of ereditary disease related to sex. • Finland: it is not defined by law. • France: it is not defined by law. • Germany: no (law on protection of embryo). • Portugal: no, except when there is a risk of ereditary disease related to sex. • UK: no, except when there is a risk of ereditary disease related to sex. • Spain: no, except when there is a risk of ereditary disease related to sex.

21. Convention of Oviedo(04/04/1997) • Art.11: Not discrimination -“Each type of genetic discrimination must be avoided”. • Art.14: Not sexual selection – “Selection of sex is prohibited, except when there is a risk of ereditary disease related to sex”. • Art.18: Research on embryos ‘in vitro’- “If research on embryo is admitted, law should guarantee protection of embryo”.

22. Unesco Universal Declaration on Human Genoma (11/11/97) • Art. 2 - “…dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity...“ • Art.6 – “Nobody can be discriminated on his genetic characteristics…”

23. German Episcopal Conference and Evangelical Church in Germany: combined declaration (1997). “…medical, juridical an ethical aspects of this method (the preimplantation dignosis) are controversial, Church can not express a final opinion concerning that…”. Churchs should devote to transfer that “human life is a value which should be accepted and safeguarded. Life is a gift of God for each believer”.

24. German Episcopal Conference and Evangelical Church in Germany: combined declaration (1997). • Pro-preimplantation dignosis: less heavy situation for couple and especially for woman. It is less negative not to transfer embryo then to have an abortion later. • Against pre-implantation diagnosis: risk to damage embryo; what is final destination for ill embryo? Every selection creates a distinction between life which is worthy to live or not. • PDG seems to create more problems then to resolve that.