Abstract
Preimplantation diagnoses were implicitly banned by Article 13 of Law no. 40/2004. However, in recent years, the Italian Courts have removed this implicit prohibition to a great extent. The Constitutional Court did not formally cancel the law at first (ruling 369 of 24 October 2006). The Court of Cagliari then interpreted this prohibition in accordance with the Italian Constitution, and permitted preimplantation diagnosis to ensure pregnant women the right to express their informed consent on the ongoing treatments. The Court of Bologna (ruling of 29 June 2009) followed the same direction. This vexed legal path culminated in a judgement by the Court of Salerno (ruling of 13 January 2010) which allowed a fertile couple to undergo artificial insemination even though they were carriers of a genetically transmitted disease, by interpreting Articles 1, paragraph 2 and 4, paragraph 2 of Law no. 40/2004, in accordance with the Constitution. The ultimate consequence of these substantial restyling efforts by the Italian Courts is that the previously forbidding “face” of Law 40/2004 has basically changed to become broader and more reassuring.
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Notes
- 1.
The Law no. 194/1978 had recognized the right of the woman to terminate her pregnancy in the event of abnormalities or malformation of the child in the womb, at a time when scientific knowledge did not even extend to diagnosing malformations prior to the pregnancy.
- 2.
A number of charges were brought, ranging from breach of the Oviedo Convention, to excessive power for manifest injustice, irrationality and breach of the principles governing the protection of health.
- 3.
This case involved a married couple who were healthy carriers of Beta-thalassaemia. They had unsuccessfully requested the health authorities in Cagliari (A.S.L. 8) to carry out a preimplantation diagnosis of the embryos as a previous pregnancy — even though obtained by medically assisted procreation — had unfortunately aborted, since the fetus had Beta-thalassaemia: from which, due to the well-grounded fear that a new embryo could also be affected by this genetic disease, the judge suspected a possible clash between a provision prohibiting the aforesaid preimplantation diagnosis since it only permitted observational checks (and, in any case, for the exclusive purpose of protecting the health of the embryo) with Articles 2, 3 and 32 of the Constitution.
- 4.
…which establishes that prior to availing of these techniques “or at any stage of application of medically assisted procreation techniques”, the doctor must provide detailed information to the parties that have legitimate access “on the possible health and psychological side effects that may result from application of the techniques, the probabilities of success, and the risks involved”.
- 5.
This time it was a couple in their thirties from Milan who raised the issue. The woman was a carrier of a serious genetic disease, leading to excessive growth of bone cartilage (exostosis): since there was a high risk that this malformation could be transmitted to a child — or it could even be fatal — the couple went to the Demetra centre in Florence, requesting a preimplantation diagnosis and adaptation of the procedures to meet the health requirements of the woman (who risked a multiple birth). Upon the curt refusal by the centre to carry it out, the couple finally decided to turn to the site www.madreprovetta.org to request advice and take legal action to obtain an interlocutory injunction pursuant to Article 700 of the Italian Code of Civil Procedure.
- 6.
Even in this case, the event was unfortunately repeated for a couple who went to a centre for assisted procreation, asking to use the genetic preimplantation diagnosis in order to avoid the 50% risk of transmitting the disease for which the woman was a carrier. The director of the medical centre was hesitant — and noted that despite the ruling on the invalidity of the specific ministerial guidelines by the Lazio Regional Court (preceded by two rulings on the merits by the Cagliari and Florence Courts), the situation was uncertain with respect to the validity of preimplantation diagnoses, and that the “new” guidelines were of no great help either (prohibiting any type of selection of the embryos or gametes for eugenics purposes and allowing clinical and experimental research on each embryo for therapeutical or diagnostic purposes only). The couple responded by taking the matter before the Court of Bologna who, considering the existence of the elements of a prima facie case, and the risk of harm due to delay, urgently ruled that the claimants had the right to avail of preimplantation diagnoses to only transfer the embryos that did not carry the specific disease the woman carried.
- 7.
Even though there is an element of strain in the number of six embryos expressly identified as “minimum” by the Court of Bologna, even though this was an indication that would be in line with normal medical practice.
- 8.
In accordance with the principle of “best scientific practice”, this centre will have to carry out the preimplantation diagnosis and transfer only those embryos that do not have the genetic mutation carried by the parents.
- 9.
…especially in the Florentine decision (where the husband had serious oligospermia problems resulting from a rare tumoral genetic disease “with a 50% possibility of this being transmitted to the children, and a probability of transmitting the actual tumour to the child” and the wife had cystic fibrosis and was a healthy carrier of beta-thalassaemia) and the Bologna decision (where the woman suffered from Becker’s muscular dystrophy, which had already been genetically transmitted to a son, following which the couple became infertile for no apparent reason).
- 10.
…which, as we have seen, opened up the option of using preimplantation diagnosis, even if the man is a carrier of sexually transmittable viral diseases due to infection by the HIV or hepatitis B or C viruses, equating those cases — which require “the adoption of precautions that would preclude procreation” — with those of “severe male infertility due to ascertained causes and certified by a doctor”.
- 11.
Where “the use of medically assisted procreation is only permitted when it has been ruled to be impossible to otherwise remove the causes that prevent procreation, and in any case limited to cases of unexplained sterility or infertility certified by a doctor or in the cases of ascertained sterility or infertility certified by a doctor”.
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© 2012 Springer-Verlag Italia
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Agosta, S. (2012). Preimplantation Diagnosis of the Embryo: Legislative Inflexibility in vitro and Attempts at Greater Flexibility in vivo. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_13
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DOI: https://doi.org/10.1007/978-88-470-2032-0_13
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