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22. Medically Assisted Procreation: European Legislation and Ensuing Ethical Issues
Keywords
Medically assisted procreationInformed consentHeterologous fertilizationRight to know genetic originsMitochondrial donationEuropean legislative frameworkThe history of artificial fertilization shows that such techniques was originally meant as therapy for infertility in heterosexual couples because the element of biological lineage is no longer the foundational value on which to base procreation. Medically assisted procreation is by now a deeply rooted phenomenon in modern society, and appears to be constantly growing [1].
The artificial fertilization made a “reproductive revolution” with ethical and controversial aspect between restricted (up) and enlarged (down) ethical criteria relationship to culture of different countries
Intrauterine donor sperm insemination
Surrogate motherhood falls within the wider context of medically assisted procreation, although it does not constitute a specific technique in and of itself: the use of multiple procreative procedures represents the “means” by which the various forms of surrogacy are implemented [4].
Surrogacy has grown to become a somewhat widespread practice, and is currently the only choice for women who suffer from sterility, or are otherwise ill, or no longer fertile on account of age, and male homosexual couples who are determined to have children of their own, with a genetic bond to at least either member of the couple. Various kinds of surrogacy are currently in use. By traditional surrogacy, the practice is defined in which the fertilized oocyte belongs to the surrogate mother who bears the child, whereas the sperm is provided by the male in the couple who requested the procedure. In other instances, the surrogate mother is implanted an oocyte that was fertilized by donor sperm (traditional surrogacy and donor sperm); or both gametes may belong to the couple and, after in vitro fertilization, the oocyte is implanted into the surrogate mother’s uterus (so-called gestational surrogacy); otherwise, in vitro fertilization may take place between the mother-to-be’s oocyte and donor sperm, prior to implantation, (defined as gestational surrogacy and donor sperm); in a different scenario, neither the prospective legal parents nor the surrogate mother may have any genetic tie with the newborn, and an in vitro fertilization procedure is carried out relying on oocyte and sperm both coming from donors (characterized as gestational surrogacy and donor embryo) [5].
No matter how controversial and opposed to it may be, due to its questioning the society’s founding principles more than any other procreative process, surrogacy is rather widespread worldwide, and the nations that have legalized it, among which Georgia, Greece, the United Kingdom, Russia, and Ukraine, have drawn women who could not otherwise have a pregnancy, due to sterility or age-related issues [6, 7]. There are then two different ways of approaching reproductive technologies: on the one hand, as a greater power of choice for couples in terms of timing and methods of procreation, on the other hand, as a therapy for sterility.
22.1 European Legislative Framework
The absence of an European unitary law determines the presence of multiple country legislations
In Europe, medically assisted procreation is regulated ranging from permissive standards (mirrored by regulations in Spain and Britain) and relatively stricter ones (such as those in place in Germany and France). Some countries have no targeted legislation in place, and medically assisted procreation is regulated through general health laws; others still have no legislation at all, but rather rely on “guidelines” that fail to encompass such a crucial aspect of health care from the social, ethical, and legal perspectives [8].
It is worth outlining the fundamental standards governing such a crucial area of medicine in some European Union member states.
22.2 Italian Legislation
In Italy law n. 40, passed on 19th February 2004, containing “norms regulating medically-assisted procreation” allows heterosexual couples, either married or unmarried, with sterility or infertility issues, to avail themselves of medically assisted procreation procedures. Resorting to such techniques is only legal once it has been proved that the issues leading to the couple’s inability to have a pregnancy cannot be solved otherwise. Sterility and/or infertility must be medically documented. In its previous form, the law banned heterologous fertilization (in article 4) and embryo research (article 13). Provisions only allowed clinical research and trials for the purpose of preserving the health and development of the embryos used. It banned the following practices:
- 1.
Eugenic selection of embryos and gametes
- 2.
Cloning via nuclear transfer
- 3.
Fertilization of a human gamete with one from different species, i.e., the attempted creation of human–animal hybrids and chimeras
Twelve years after the law’s enactment, several court rulings on the merits, at both a national and European level, have voided some of its restrictive provisions: the ban on cryopreservation of embryos, along with the limit of three embryos for each implantation, has been amended by ruling n. 151, from 8th May 2009; according to the court, gynecologists should execute the fertilization of a greater number of embryo than strictly necessary for implantation, based on the most updated and accredited technical and scientific standards. In such a way, a greater amount of zygotes can be used, thus giving hope to those couples who have lower-quality embryos. The embryos produced but not implanted out of medical choice must be stored via cryopreservation [9, 10].
The ban on heterologous fertilization has been voided by ruling n. 162, from 10th June 2015
The above cited rulings confirm that embryo protection is essential, and it should not be achieved through bans and restrictions, but rather with the harmonization of women’s health as they undergo the treatments.
22.3 French Legislation
France has opted for a therapeutic approach to assisted procreation, as a means to solve sterility and infertility cases or avert the risk of passing on hereditary diseases. Access to medically assisted procreation is legal for heterosexual married couples, or those who entered into a civil union, thus barring singles and same-sex couples. Donation is regulated by the public health care code, which mandates that consent be granted by both donors and receivers. Article L. 1244-2, subsection 1 of the same code makes consent from sperm and oocyte donors mandatory, as is that from the couple’s other member. Consent, privately drafted and signed (registered by a notary or a civil court, the so-called Tribunal de grande instance) may be withdrawn at any time prior to treatment. France has thus adopted an intermediate approach, half way between a liberal and conservative one, in that it allows access to medically assisted procreation, while banning preimplantation diagnosis, in order to treat pathological infertility or avert the transmission to children of hereditary severe conditions carried by parents. Particularly, article 311-19 c.c., in keeping with the principle of donor anonymity as an element of donation gratuity, asserts that “no parental ties shall be established between donors and children born from medically assisted procreation” and that consent granted by sterile or infertile couples entails the ban on any action aimed at questioning parenthood, whether legal or biological. Embryo and gamete donation is legal [13–15].
22.4 Spanish Legislation
In Spain, a rather permissive set of regulations is in place
The law allows free, consensual, and anonymous donation. In fact, one of the law’s guiding principles is the ban on any form of trade and commercialization of human body parts and cells, along with donor anonymity and guaranteed privacy in terms of personal data and door identity [18].
22.5 German Legislation
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