Overview and facts

The law was widely criticized 7]–12] and Italian Courts heard more than 30 challenges to various aspects of the law itself
13]. In particular, many Italian couples applied the Civil Courts to be granted access
to PGD and donor insemination 13].

Strict interpretations of both the law and the Ministry of Health’s subsequent guidelines
led to infertile couples affected by genetic diseases being denied the right to resort
to PGD. Over the years, rulings from many Italian Civil Courts (Court of Cagliari,
Court of Florence, 2007) 14] have recognized the right of infertile couples affected by genetic diseases to access
PGD. Through PGD it is possible to define the genetic composition of embryos prior
to embryo transfer. Chromosomal abnormalities, X-linked diseases or single gene disorders
are the well-known medical indications for PGD 15]. Scientific debate widened to include other controversial uses such as inherited
cancer predispositions 16], human leukocyte antigens (HLA) typing used to select (an) embryo(s) for intrauterine
transfer with a view to giving birth to an unaffected HLA matching sibling 17], sex-selection for non-medical reasons 18], all of which sparked heated ethical discussion 19], 20].

In Europe at the time, national regulations differed across the board. In some countries,
such as Germany and Switzerland, PGD was prohibited by law, whereas in France, the
United Kingdom, Spain, Denmark, and Belgium it was permitted. In countries such as
Finland and Portugal, PGD was practised without government regulations 15].

Within this international scientific and legislative background, the Italian Constitutional
Court in 2009 finally declared that the maximum limit of three embryos was constitutionally
illegitimate, as was the consequent obligation to implant all three embryos produced,
thus opening the way for infertile couples to resort to PGD 21].

The consequences were not slow in coming, and resulted in deep changes on the Italian
reproduction scene 22], 23]. The official figures for 2012 (Ministry of Health) showed a change in the application
of MAR procedures compared to the period before the 2009 Constitutional Court ruling:
an increase in cycles by embryo thawing techniques and a decrease in fresh technique
cycles, compared to a steady increase in these cycles in previous years. Thawing and
freezing procedures increased for embryos and decreased for oocytes. Analysis shows
that following legalization, the number of referrals asking for PGD significantly
increased 24], 25]. These results strongly indicate that Italian women and couples contemplating a future
pregnancy would consider the use of PGD.

PGD was a particularly troubled issue. Until 2015, couples who were fertile but carriers
of genetic disease were discriminated against, in that the Italian law denied these
couples access to MAR and PGD, which could only be carried out as part of MAR procedures
following the 2009 ruling of the Constitutional Court. Couples who were fertile but
carriers of genetic disease brought the question of their right to obtain PGD to the
attention of Italian Civil Courts (Court of Salerno, 2010). Judges allowed these fertile
couples to resort to assisted reproduction, and above all, to PGD. In 2012 the European
Court of Human Rights (ECtHR) (28 August 2012) affirmed that the prohibition to access
MAR for fertile couples violated article 8 of the European Convention on Human Rights
(ECHR) and condemned Italy 26], 27]. Recently, the Court of Rome has questioned the constitutional legitimacy of forbidding
access to fertile couples who are carriers of transmissible genetic disease which,
in fact, prevents aware and responsible procreation. Civil judges underlined the fact
that the limit of access to MAR for fertile couples violates the right of such couples
to health and autonomy as well as the right to procreate. In such cases, in an attempt
to fulfil a legitimate desire to have a child unaffected by a serious genetically
transmissible disease, the couple, and particularly the woman, must embark on a natural
pregnancy knowing that she might have to abort, with increased risk for her physical
and mental health. On 5 June 2015, the Constitutional Court ruled that also fertile
couples who are carriers of transmissible genetic disease have the right to access
MAR and PGD.

Donor insemination

In 2010 and 2011, following the requests of infertile couples, the Civil Courts of
Milan, Florence and Catania questioned the prohibition of gamete donation imposed
by law 40/2004 and referred this issue to the Constitutional Court 13]. In April 2014, the Court (n. 162/2014) condemned as unconstitutional the ban on
heterologous fertilization. Until this judgment, the restrictions imposed by the law
had driven many infertile Italian couples to choose to go abroad so as to have wider
access to assisted procreative treatments 28]–30]. A 2010 study showed that of the six countries studied, Italy was in first place
for cross-border reproduction care: Italian patients numbered 31.8 % of the total
31]. This figure has remained constant since the first study by the national Observatory
on Procreative Tourism, testifying to the fact that the demand for infertility treatments
in Italy has not received an adequate response 32]. In 2011, at least 4,000 Italian couples travelled abroad: half of these found it
necessary to leave Italy because they sought donor insemination; the other half left
for no apparent reason to have treatment which was also available in Italy. This trend
has remained constant since the law came into force when, in a single year, there
was an almost 200 % increase in the number of Italian couples who went abroad for
reproductive reasons. This phenomenon constitutes a reproductive ‘exile’ 33] in that Italian infertile couples feel barred from accessing MAR in their home country.

In the rulings mentioned above, Italian judges raised doubts regarding the constitutional
legitimacy of the ban on donor insemination imposed by the law. All infertile couples
should have an equal opportunity to resort to the most effective MAR procedures so
as to resolve their inability to have children. Because of this ban, couples affected
by infertility which could not be treated unless by gamete donation were denied the
right to satisfy their desire for a child and make their own procreative choices.
The ban on sterile couples resorting to gamete donation was, therefore, a violation
of personal liberty, autonomy and the right to comprehensive healthcare for women
that must include birth control, abortion and sexual and reproductive health. Furthermore,
this ban represented a great disparity in health care, creating a gap between couples
who could, legitimately, fulfil their desire for a child and achieve full reproductive
health through approved assisted reproduction and the more numerous group whose rights
were denied because they could not resort to gamete donation. This was also a violation
of the Italian Constitution (art. 2) which ensures equal rights to all citizens, equal
medical care (art.32), and also of the National Health System law which guarantees
comprehensive healthcare for all citizens without discrimination. On the contrary,
blatant discrimination exists, on an economic basis, between couples with fertility
problems: only those with economic means to seek treatment abroad can fulfil their
desire to have a child.

The poignancy of the quests of infertile Italian couples for heterologous MAR is further
demonstrated by the fact that immediately following the Constitutional Court judgment
on heterologous MAR, there were approximately 3,500 queries from couples to access
donor insemination at the Italian CeCOS centres (centres for the study and preservation
of human oocytes and sperm) 34], once again reflecting the dissatisfaction of infertile women and couples regarding
the deficiencies in their home country.

The response of the constitutional judges was unequivocal. A couple’s decision to
become parents and to form a family is an expression of their fundamental freedom
to self-determination which concerns both personal and family matters. The decision
on whether or not to have a child affects the most intimate and untouchable part of
the individual. As such, this decision must be incoercible, as long as it does not
endanger other constitutional values, and even if it involves resorting to MAR procedures
with donors.

In the judgment of April 2014, the Constitutional Court ruled that gamete donation
techniques were immediately applicable within the regulatory framework currently in
force. There is no danger of a legislative void since all the unchanged/unrepealed
parts of law 40/2004 remain in force. Heterologous MAR is therefore perfectly legitimate
‘even if only in different-sex couples, married or cohabiting, and only in potential
childbearing age women’. However, many factors may still hinder women’s and couples’
access to heterologous MAR.

Recommended changes

There are several controversial aspects of Law 40/2004, some of which derive from
the original form of the law, including criteria for accessing therapy, and withdrawal
of consent to MAR procedures.

The Italian law states that access to MAR should be limited to adults of different
genders, of fertile age, with medically-certified sterility or infertility. They should
be married or living together, and both living. In 2007, following a Ministerial Decree,
a sexually transmissible disease in the man was deemed to be a condition of sterility
such as to guarantee access to MAR for these couples.

However, many couples and groups are still excluded from MAR in Italy. Same-sex couples,
single women, post-mortem insemination, surrogacy and gestational carriers are still
banned. These are challenging and unresolved topics non only in Italy 35] but everywhere 36], 37].

Whether this discriminates against single women or homosexual couples, or whether
it is an affirmation of the rights of children born from MAR to grow up in a traditional
family with both male and female role models for their healthy psychosocial development,
is still a matter for debate. There are studies which demonstrate that raising children
in family units with homosexual parents does not have a significant negative impact
on cognitive development and function, emotional adjustment, gender identity or behaviour
when compared with children of heterosexual couples or single mothers 38], 39]. However, there is some debate about the risks for the child. This mainly concerns
the psychosocial risks of growing up in a non-nuclear familial environment. Critics
fear negative repercussions for the wellbeing of the child (and, later, of the adult)
40]. However, results from empirical studies so far are to a large extent reassuring
41]. In the recent position statement of ESHRE’s Task Force on Ethics and Law, it is
reported that ‘assisted reproduction in non-standard situations is morally sound in
many cases. There is no good reason to a priori dismiss access in these situations – such categorical dismissal would imply discrimination’
40].

In its present form, though with changes introduced following the numerous decisions
by Italian judges, law 40/2004 still reinforces and protects a very narrow concept
of the ‘appropriate’ family unit as being one composed of children with heterosexual
parents who are married or in a stable cohabiting relationship. This is in opposition
to the rights and autonomy of women and couples in relationships to reproductive freedom,
stressed as the basic right of all couples and individuals to make free and accountable
decisions. And yet in Italy, despite the impact of prevalent Catholic thought, and
albeit more slowly than in other countries, profound changes are occurring in the
traditional family, with a higher number of single-parent families, single person
households, childless couples, and same-sex couples 42]. A recent Italian study suggested that, despite the societal pressures that Italian
same-sex couples have to face, these relationships appear resilient, and fare well
both overall and in the specific domains of functioning compared to heterosexual couples
both in Italy and the United States 43].

There is a lack of consensus among Italian healthcare professionals regarding the
bans imposed by the law. For example, in a recent cross-sectional study involving
224 healthcare professionals working with assisted reproduction in Brazil, Italy,
Germany and Greece, it was reported that even in Germany and Italy, where insemination
is illegal for single women, almost a quarter of the professionals (24.4 %) claimed
that they would agree to perform the procedure 44]. This highlights once again the gap that exists not only between Law 40/2004 and
Italian couples, but also between the law and Italian healthcare professionals. Thus,
the law does not seem to reflect the new social needs and the ongoing cultural changes
that are now present in Italy.

A further point of great concern is the withdrawal of consent to MAR procedures. The
law underlines the need for informed consent, which must be expressed in writing by
both members of the couple. This can be revoked by either person until the time the
oocyte is inseminated. From this moment on, the physician may decide not to proceed
solely on medical grounds. The law states (art.6) that the woman cannot withdraw consent
to the technique from the time of fertilization. Respect for autonomy is a central
principle in Italian healthcare, and it implies that patients should not be coerced
into medical treatments. The idea that the patient’s autonomy is something valuable
that has to be protected emanates from the Italian Constitution (articles 2,3, 13,
and 32). Article 6 of Law 40 is a striking example of how this law infringes upon
women’s autonomy and appears to be the result of assigning a higher value to the protection
of embryos than to the interests and rights (including autonomy) of infertile women.
As consent withdrawal is still not permitted by the law, the protection of women’s
right to autonomy and health requires careful consideration. We argue that respect
for women’s personal decisions constitutes a reason to oppose this article, whose
dubious legitimacy has been highlighted in recent years by the Civil Court of Florence
(2008). However, at the time of writing there has been no definitive ruling by the
Italian Constitutional Court on this matter. Finally, women who are not allowed to
withdraw their consent to the technique from the time of fertilization, may paradoxically,
once pregnancy has begun, make the decision to terminate the pregnancy, under the
Italian law (194/1978) on voluntary termination of pregnancy. However, women’s experiences
of abortion are complex; confronting an unwanted pregnancy is not easy and deciding
to terminate it is anything but straightforward. Abortion is a stressful experience
45], and the risks of both surgical and medical abortion for women’s health are well
known 46]. Thus it seems that prohibiting the withdrawal of consent is still deeply problematic
for the health and autonomy of Italian women.

Other issues have arisen as a result of the recent lifting of the ban on heterologous
MAR. Following the decision of the Constitutional Court, and in the silence of the
national legislators who have not yet seen fit to intervene, Italian regions have
drawn up a document setting out operational guidelines and homogeneous clinical indications
to facilitate the immediate granting of the right to heterologous MAR throughout the
country.

The following are the key points: adequate technical provisions for the selection
of donors and the safety of the donation in compliance with the EU Tissue and Cells
Directive (EUTCD) and the supplementary technical directives 2006/17/EC and 2008/86/EC;
the establishment of a national register for tracing donor/child; the unpaid and voluntary
nature of gamete donation; the introduction of a maximum limit of births from the
same donor; the introduction of a minimum and maximum age for donors; the anonymity
of gamete donors.

The debate on open or anonymous gamete donation continues unabated 47], 48], While anonymous gamete donation has long been the preferred practice, a new focus
on the rights and interests of donor-conceived children has led a number of countries
to shift towards an open-identity system. Recently, the Ethics Committee of the American
Society for Reproductive Medicine, while acknowledging that these are very personal
choices and that the people involved can have very different opinions 49], came out in favour of disclosure to the child of donor conception and, if available,
any characteristics of the donor that may serve the best interests of offspring 50]. Some authors have analysed this issue in terms of asymmetries of harm and benefit
for both children and donors.

The open system recognizes the child’s right to know his/her biological lineage in
that it is fundamental to the donor offspring’s wellbeing and understanding of his/her
identity, as well as to choices made later in life 51]–53]. Furthermore, disclosure is the basis for open and honest communication with children
in order to avoid oppressive family secrets which may have possible negative repercussions
for family relationships 54]–56]. There are, however, those who would argue that in case of gamete donation there
are compelling reasons for not telling the child. A reason that is often given is
that it is not in the best interests of the child to know 57]. If facts about a child’s conception spread throughout the family and school environment,
this could lead to isolation and stigmatization 58]. Finally, some authors affirm that parents have a right to privacy which would be
violated were the details of conception to be released 59]. An evolving debate is now underway regarding the other parties involved, and the
possible right of the donor to information about the offspring conceived by their
donation is emerging 60]. The exchange of medical information between donors and donor-conceived individuals
could ensure the donor’s health since the latter’s access to medical information regarding
their offspring (for example in the case of genetic disease) may obviously be relevant
for clinical reasons 61]. It has been argued that information regarding offspring would allow donors to feel
positive about their donation, thus improving the psychological and social wellbeing
of donors themselves 60]. This does not automatically entail parental disclosure 60]; however, identifying information could allow the opportunity for donors to have
contact with their offspring 60], 62]. It could be beneficial for donors willing to know their offspring, although this
could open risky scenarios in which potential dangers for offspring have to be taken
into account if social parents have not informed the child about his/her conception,
and if offspring and parents are not willing to meet donors 60].

In spite of this complex debate and of the international trends, Italy is moving towards
a system of anonymous gamete donation with a maximum limit of 10 children born from
each donor.

In conclusion, Law 40/2004 has been profoundly changed over the years following the
judgments of the Italian Constitutional Court that have guaranteed more people the
right to access MAR, PGD and donor insemination. However, since issues such as the
ban of withdrawal of consent to the procedure until the time the oocyte is inseminated,
and the further liberalization of the actual criteria to access MAR (single women,
lesbian and gay couples) still remain unresolved, the decisions of the Constitutional
Court are unlikely to end the debate on MAR.