Unité de recherche et d'enseignement en bioéthique, Centre Médical Universitaire, Université de Genève, 1211 Genève 4, Switzerland
Email: andrea.boggio{at}medicine.unige.ch
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Abstract |
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Key words: cryopreservation/embryos (legal status of)/fertilization/medically assisted reproduction/preimplantation testing
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Introduction |
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MAR: admissible techniques |
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For each group of treatments, the Guidelines indicate the medical indications that suggest choosing a specific technique, and the technical and administrative procedures that physicians must follow in treating the couple.
Oocyte and sperm donation is forbidden. Consequently, couples who are unable to reproduce because one member of the couple is infertile may not seek donation. Critics of the 2004 legislation have pointed out that oocyte and sperm donations are legal in many European countries. In fact, France, Great Britain, Spain, Greece and Belgium allow oocyte and sperm donation. Consequently, Italian couples are able to seek treatments that are not allowed in Italy by travelling to other EU countries, circumventing the prohibition by resorting to so-called reproductive tourism (Pennings, 2004). That European couples living in countries with more restrictive regulations have sought MAR treatments in more liberal countries has been documented (Baetens et al., 2000
; Vandervorst et al., 2000
; Pennings, 2001
). It is very likely that the extremely restrictive Italian law will force couples increasingly to seek treatment for infertility in foreign countries. Although reproductive tourism may be seen as an opportunity to enjoy moral pluralism (Pennings, 2004
), it raises domestic issues of inequality of access to heath care, which is covered by public health insurance and thus accessible to all citizens. Besides the moral issue, reproductive tourism raises also constitutional issues. The constitutional rights to health care and to equal protection (Italian Constitution, 1947, Art.3 and 29
) are jeopardized if access to some medical treatments for infertility depends upon the economic means of infertile couples and their ability to secure those treatments in a foreign country.
Finally, surrogate motherhood is prohibited. Consequently, all surrogate mother contracts, which require the surrogate mother to consent to third party adoption of the child following birth and to facilitate the transfer of child custody, are null under the Italian Civil Code (1942, art.1325), because the law views them as being against public policy.
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Cryopreservation and transfer of embryos |
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The number of oocytes that can be fertilized is limited to three, and none of them can be transferred at a later time. Freezing embryos is therefore prohibited under normal circumstances, and if the first attempt to implant the fertilized embryos is unsuccessful, the patient will have to undertake a second hormone-based treatment to stimulate ovulation. If the first implantation fails, the mother-to-be may have to undertake repeated hormonal treatment and laparoscopies, thus imposing an undue burden on their health. Moreover, [m]any centres report a reduction in the success rates for women aged >35 years and a steep increase in multiple pregnancies in those aged <35 years, who are often implanted with three embryos (Turone, 2004).
Cryopreservation is allowed only under exceptional circumstances such as unforeseeable health conditions of the woman, making transfer of embryo(s) impossible. Thus, implantation may be delayed if the woman's severe and documented medical conditions could affect the outcome of the fertilization process. One can only speculate on which circumstances would justify a delay in the procedure. Italian policymakers clearly intended to permit deviations from the general ruleno general recourse to cryopreservation techniquesonly under exceptional circumstances such as serious medical conditions that render physical transfer of the embryo impossible. A severe physical injury due to a car accident is likely to justify embryo cryopreservation.
In contrast with the principles of Law 40/2004 as enacted by the Parliament, the Ministry of Health Guidelines provide that the transfer of embryos cannot be imposed upon patients. This provision is in contrast with the rule imposing the transfer of all embryos unless the unforeseeable health conditions prevent a successful embryo transfer. However, the Guidelines prevent physicians from coercing women to be subject to non-voluntary implantations. This rule seems consistent with the voluntary nature of the procedure. Therefore, cryopreservation may be once again necessary as a practical matter. However, the legal framework does not regulate in detail when cryopreservation is required. The Guidelines simply state that the fertilized embryos must be cryopreserved for the shortest time possible and until its extinguishing (Italian Ministry of Health, 2004). The language is unclear and Italian policymakers must provide further guidance.
The Guidelines also provide for the frozen embryos that existed at the time the law was enacted. To deal with this issue, all institutions that produced embryos before February 2004 must advise the Ministry of Health of the number of embryos that had been produced and disclose the personal information of the couples who had resorted to MAR (Law 40/2004, Art.17, sec.2). Furthermore, the Guidelines distinguish between embryos that are likely to be implanted and abandoned embryos, i.e. embryos that have not been claimed back by the requesting couple or that have been produced at the request of women who are not of potentially fertile age (Italian Ministry of Health, 2004). While the same institutions shall keep those embryos that had been produced and that are likely to be implanted in the future, the Guidelines provide that abandoned embryos will all be gathered in a central repository located in Milan. Governmental sources report that these embryos number 24 000 (De Bac, 2004
).
Finally, it is noteworthy that both private and public hospitals may treat couples. As a general principle, if the treatment occurs in a public hospital, the national health care system bears the costs relating to the treatment. Both private and public fertility clinics may treat infertile patients only if listed in an ad hoc registry compiled by the Ministry of Health. This branch of the Italian Government may thus authorize institutions interested in performing MAR and monitor their operations after the authorization occurs.
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Preimplantation testing |
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This provision raises issues of health for both women and newborns. The limitations on preimplantation testing have rapidly reached Italian courts (Turone, 2004). In May 2004, a trial judge denied the request of a married couple in which the woman was the carrier of the thalassaemia gene to have the embryos-to-be-implanted tested for thalassaemia and to prevent implantations of the embryos that would eventually result positive. The judge reasoned that, under the circumstances, preimplantation testing would be equal to an abortion as procedure to select foetuses based on their health conditions ... [thus resulting in] a eugenic utilization of abortion, which the law [on abortion] expressly forbids (Trial Court of Catania, 2004
).
The law also presents a legal paradox. As a practical matter, under the current law, the treating physician is required to implant all embryos unless a therapeutic abortion is permissible. Under the rules governing therapeutic abortion (Law 22 May 1978, n.194, art.4, 6), which permit this kind of abortion if the pregnancy imposes a severe risk on the woman's health, the treating physician may avoid implanting the fertilized embryos in the woman's womb if the transfer imposes a severe risk on her health. The health of the patient rather than the potential dysfunction of the embryo determines the physician's decision. Moreover, once informed of genetic disease that will potentially affect the newborn, the parents may choose to have an abortion after the implantation. The requirement to impose on all embryos a regime of legalized abortion is illogical from a policy and ethical perspective, and medically inefficient. One way around the legal paradox is offered by the fact that the law does not sanction women who refuse the transfer of embryos. As a practical matter, this gap gives women some discretion to decline the transfer of embryos who tested positively for genetic diseases (Flamigni, 2004).
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Eligibility |
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Heterosexual coupleswhether married or living togetherin which both persons are aged 18 years and of potentially fertile age have access to MAR treatment (Law 40/2004, Art.5). Homosexual couples, minors and singles, i.e. individuals who are not in a heterosexual relationship, cannot access MAR procedures. Also post-menopausal women cannot undergo MAR treatment. In fact, the Ministry of Health Guidelines require that embryos that have been produced at the request of women who are not of potentially fertile age shall not be implanted but rather collected in a central repository (this provision will be discussed later) (Italian Ministry of Health, 2004
). Finally, all couples who are not infertile but are carriers of genetic diseases may not access MAR. On the other hand, a couple in a de facto relationship qualifies for treatment. However, the Parliament avoids defining in detail what a de facto relationship is, specifying only that it occurs whenever a man and a woman live together.
Both parents-to-be must be alive at the time the treatment for MAR begins. However, if the man's death occurs between the time of fertilization and implantation, the process is not interrupted and all fertilized embryos must be transferred to the woman's womb.
The eligibility provisions raise several constitutional issues of inequality of access. Under the Italian Constitution, all citizens have equal social dignity and are equal before the law, without distinction of sex, race, language, religion, political opinion, personal and social conditions. (Italian Constitution, Art.3). Moreover, the Constitutional Court may declare the law unconstitutional as being against the freedom of reproduction (Italian Constitution, Art.2, 29 and 31) and the freedom of self-determination (Italian Constitution, Art.13) if the Court finds that the law unreasonably limits the possibility of determination in reproductive choices of people who are in a relationship but do not live together, to single women, homosexuals, carriers of genetic diseases, etc.
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Legal status and rights of the newborn |
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Medical research on human embryos |
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Reproductive cloning, i.e. a procedure aimed to obtain a human being from one cell, possibly identical, in terms of genetic patrimony, to a different human being whether dead or alive, is forbidden (Law 40/2004, Art.10, sec.7). More specifically, the new regulations explicitly forbid:
Unfortunately, neither the law nor Guidelines define embryo. Contrary to Germany (Deutscher Bundestag, 1990) and Switzerland (Assemblée fédérale de la Confédération suisse, 1998, Art.2
), Italian lawmakers avoided taking a position on whether an embryo exists from fertilization (sperm penetration into the oocyte) or syngamy (fusion of the maternal and paternal pronuclei). Although banning research on embryos, both the German and Swiss laws allow the cryopreservation of an oocyte after penetration by sperm but before a zygote is formed (ootid). Italian practitioners have already pointed out the problems left open by the normative gap. Recently, Carlo Flamigni, a medical expert in MAR techniques and a member of the National Bioethics Committee, announced his provocative intention to admit to the Bologna authorities that he froze an ootid. Maybe I'll be arrested ... but maybe the judge will decide that, according to the law, the ootid and even the zygote can be frozen, since neither was cited in the law, Flamigni added (Turone, 2004
). From a practical point of view, the ambiguity of the legal notion of embryos could be used to circumvent the ban on the selection of embryos to be implanted to the advantage of couples who carry genes for monogenic diseases. In fact, conducting genetic screening of the ootids before syngamy is not expressly outlawed. However, there is need for legal certainty in this area to provide clear guidance to practitioners on the delicate issues of whether individual human life begins with the formation of the unique genome after the diploid chromosome set has been formed from parental DNA.
The sanction for illegal reproductive cloning is jail time ranging from 10 to 20 years. Finally, all experiments on embryos, i.e. including genetic cloning, eugenic procedures, and mixing human genes with genes from other species are criminally punished under the new law.
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The role of physicians and the patient/physicians relationship |
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Both the mother-to-be and father-to-be must provide informed consent to the treatment in writing 7 days prior to beginning the fertilization process. Both may withdraw consent at a later time up until the oocyte is fertilized. Withdrawal of consent is thus time sensitive: once fertilization occurs, the process is irreversible. This provision has raised concerns among policymakersmostly from the left-wing coalitionclaiming that a lack of flexibility imposes a burdensome limitation on the woman's right to choose whether or not to have a pregnancy. In fact, although unexpected events such as the death of a partner may happen between the time of fertilization and implantation, they cannot stop the process, even if the woman has changed her mind and no longer wants to proceed with the treatment. The law punishes physicians who treat couples without obtaining their informed consent prior to treatment. Interestingly, the patients of illegal treatments are never punished under the law unless they engage in marketing oocytes, sperm or embryos, or participate in reproductive cloning.
Physicians and their assistants may object to MAR based on moral beliefs. In objecting, they must give notice of this to the medical institutions where they perform medical services. At any rate, they may revoke their statements of conscious objection at any time; however, their revocation will only be effective for 30 days after it is made.
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The ethical and political debate |
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Moreover, the law is also the outcome of political bargaining between Catholics and the liberal members of Parliament who wanted certain forms of MAR, such as IVF and artificial insemination, legalized. In fact, the law affirms that medically assisted conception in itself is not unethical, but that certain forms must be prohibited. Procreation is thus moral even though disconnected with sexual activity, a principle in contrast with the teachings of the Roman Catholic Church. Furthermore, although denying singles and homosexual couples access to MAR techniques, the law does not limit access to IVF to married couples, recognizing de facto relationships.
It is also interesting to note the division between the members of the Italian National Bioethics Committee. The Committee Chairman and one of its Catholic members publicly endorsed the new regulations on several occasions. On the other hand, six Committee membersalong with a group of intellectualssigned a harsh letter expressing great concern about the recently enacted law. The signatories of the letter view the new regulations as a radical attack to civil growth in [Italy] ... [which] imposes bans and harsh limitations providing for sanctions often inspired by a senseless view of punishment. Most of all, the letter argues that the law breaches the constitutional principle of separation between church and statean argument often endorsed by other commentators in the public debate (Levi Montalcini et al., 2003).
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Conclusion |
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References |
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Deutscher Bundestag (1990) Embryo Protection Act. Adopted on December 13, 1990.
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Submitted on December 16, 2003; resubmitted on January 29, 2004; accepted on February 23, 2005.