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Law and Ethics in Medically Assisted Reproduction in Italy

 

P.G. Artini, M. Ruggiero, O.M. Di Berardino, V. Cela, A.R. Genazzani

Department of Reproductive Medicine and Child Development

Division of Obstetric and Gynaecology

University of Pisa

 

On February 2004, the first law (law 40/04) regulating Assisted Reproduction Technology (ART) in Italy was approved. The legislator decided to lay down a very restrictive text, enacting that recourse to ART is allowed only in order to support reproductive problems arising as a result of human sterility or infertility.

Moreover ART is admitted only for married or cohabiting couples, ruling out treatments for gay couples, single people, and fertile couples carrying genetic diseases. Such a restrictive regulation derives from a close interpretation of the constitutional principle that the family is based on the marriage between adult people with different gender.

An overarching philosophy that inspires and conditions the new law is the sanctity of human life from its inception. The law establishes the rights of the embryo over those of the mother (Benagiano and Gianaroli, 2004; Turone F. et al., 2004). The article 1 guarantees the rights of all the involved subjects, including the conceived embryo. This article is very controversial because it seems in contrast with the Italian law (law 194/78), which regulates voluntary pregnancy interruption.

Mother's psychological and physical health is strongly protected by (law 194/78), on the contrary (law 40/04) defends embryo rights, suggesting an unbalancing between mother and embryo interest.

The most controversial technical aspects of this new legislation are twofold: first, the number of oocytes to be fertilized is limited to three; second, all obtained embryos must be simultaneously transferred to the woman's uterus.

No more than three oocytes are allowed to be fertilized per cycle, so there is the real possibility to obtain no embryo: this significantly constrains the medical decisions to select the best stimulation and obtain the best oocytes.

Moreover, since that all produced embryos must be implanted in each single cycle, (law 40) consequently prohibits cryopreservation of embryos. Therefore, if the cycle fails to obtain pregnancy, women must undergo the entire ovarian stimulation protocols again.

(law 40) aims at preventing the loss of any early human embryo; however natural human fecundity rarely exceeds 0.3 and the majority of all fertilized human oocytes are naturally lost in the very early stages (Wang et al., 2003).

On the one hand, the fertilization of only three oocytes impairs the chances of success of an older woman, since fertilization rates decline with age (Lim et al., 1997); on the other hand, the transfer of three embryos may be excessive in a young woman (Jones et al., 2003), suffering an increased risk of multiple pregnancies.

These prohibitions and unconditional limits contrast the latest scientific achievements in the field. In the international scenario practitioners aim to decrease the number of transferred embryos in a given cycle (Gerris and Van Royen et al., 2000; Dhont, 2001) to prevent multiple pregnancies. Multiple pregnancies, associated to obstetric complications, perinatal morbidity, congenital malformations and maternal and fetal mortality, and psychological and social problems (Elster and the Institute for Science, 2000), are on the contrary significantly growing in Italy after (Law 40) introduction.

Moreover, after fertilization, the couple cannot change its mind; the only exception is due to medical problem for women, not foreseeable before fertilization (art. 6.4 and art. 14.3). This duty is prescribed by an informed consent that the couple and the responsible doctor must sign seven days before the access ART.

As already pointed out, the main principle of the law is that ART is reserved to couple affected by sterility or infertility, consequently medical procedures are directed toward the protection of the health of the woman and of the couple. This decision mainly affects two categories of patients: first, couples that cannot bring pregnancy to a conclusion because of the risk of transmitting a genetic disease; second, couples whose infertility/sterility problems cannot be solved using their own gametes.

On the one hand, couples carrying genetic anomalies with risk of transmission, for which there is a very high risk of conceiving a malformed fetus, cannot be helped through ART, since (law 40) requires to implant all embryos at the same time, and most of all without preimplantation genetic diagnosis (PGD). PGD is typically performed in order to avoid having a child with a genetic disease (Cameron C and Williamson R. 2003). It is worth noticing that exclusion of PGD contrasts with the article 14 of the Convention on Human Rights and Biomedicine, stating that "the use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child's sex, except when serious hereditary sex-related disease could be avoided" (Council of Europe, 1996).

On the other hand, couples that are unable to reproduce because one member of the couple is infertile cannot recur to ART, since oocyte and sperm donation is definitely forbidden, as well as the use of surrogate mothers. Therefore (law 40) seems to consider only the concept of reproduction as the transmission of a specific chromosomal set, rather than a choice founded on love and personal and familiar responsibility. The Italian law also highlights that genetic parents must agree with the social parents; thus eliminating the possibility of legal action aimed at the disavowing of paternity (Schenker et al., 2003; Harris et al., 2003).

The article 13 forbids "any experimentation on any human embryo... the production of human embryos for research or experimentation purposes". It is argued that the embryo is a person from the moment of fertilization. Thus, while not yet an actual person, it should be treated and respected ad a person because of the inherent potential to develop into human being. Nevertheless, this conclusion contrasts with most ethical international committees, stating that research can be morally justified, because it has a relatively low moral status  (NHI 1994; ESHRE 2001).

In conclusion, the Italian law presents a very restrictive text. It limits the access to ART to infertile or sterile couple, it strictly defends the embryo rights, it bans embryo freezing or destroying, it also forbid the PGD or the use of embryos for research. Moreover, the law 40/04 opens a strong ethical debate about the moral status of embryos, and in particular on PGD diagnosis and embryonic stem cell research. Hopefully the still very active discussion in the medical and scientific community will create consensus toward less restrictive solutions to help patients and research in this field.

References

  • Benagiano G and Gianaroli L (2004) The new Italian IVF legislation. Reprod Biomed Online 9, 117-125.
  • Cameron C., Williamson R. (2003) Is there an ethical difference between preimplantation genetic diagnosis and abortion? J Med Ethics; 29:90-2.
  • Council of Europe (1996) Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine. Convention Rights and Biomedicine. Council of Europe, Strasbourg.
  • Dhont (2001) Single embryo transfer. Semin Reprod Med. 19, 251-258.
  • Elster and the Institute for Science, Law and Technology Working Group on Reproductive Technology (2000) Less is more: the risk of multiple births. Fertil Steril, 74, 617-623.
  • ESHRE Task Force on Ethics and Law, 2001 The moral status of the pre-implantation embryo Hum Reprod 16, 1409-1410.
  • Gerris and Van Royen (2000) Avoiding multiple pregnancy in ART: a plea for single embryo transfer. Hum Reprod, 15, 1884-1888.
  • Harris J. (2003) Assisted reproductive technological blunders (ARTBs). J Med Ethics; 29:205-6
  • Jones HW (2003) Multiple births: how are we doing? Fertility and Sterility 79, 17-21.
  • Lim AS, Tsakok MF (1997) Age-related decline in fertility: a link to degenerative oocytes? Fertility and Sterility 68, 265-271.
  • National Institure of Health (1994) Fial Report of Human Embryo Research Pannel.
  • Law 194, 22 maggio 1978 Norme per la tutela sociale della maternità e sulll'interruzione volontaria della gravidanza. Gazzetta Ufficiale della Repubblica Italiana. 22 maggio 1978 n° 40.
  • Law 40, 19 febbraio 2004 Norme in materia di procreazione assistita. Gazzetta Ufficiale della Repubblica Italiana. Serie generale 45, 5-12, 24 February 2004.
  • Schenker JG. (2003) Ethical aspects of advanced reproductive technologies. Ann NY Acad Sci; 997:11-21.
  • Turone F. (2004) Italy passes new law on assisted reproduction. BMJ;328:9.
  • Wang X, Chen C, Wang Let al. (2003) Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertility and Sterility 79, 1517-1521.
 
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