NEW GUIDELINES ON MEDICALLY ASSISTED PROCREATION IN ITALY PUBLISHED. THE MAIN CHANGES (ALSO) THANKS TO TWO ITALIAN CONSTITUTIONAL COURT JUDGMENTS

On 9^th May 2024, the new guidelines on medically assisted procreation (MAP) were published updating the previous guidelines dated 2015.

In Italy, MAP is governed in its fundamental contents by Law No. 40 of 19^th February 2004, which delegates the concrete definition of procedures and techniques to special guidelines adopted by the Italian Ministry of Health, with the support of the Italian Institute of Healt and the opinion of the Italian Higher Health Council.

The primary purpose of these guidelines is to provide binding indications to authorised centres on the performance of MAP techniques, ensuring full compliance with the provisions of law 40/2004. Over the years, among other things, this law has been the subject of rulings by the Italian Constitutional Court on several occasions, thus substantially modifying its structure.

One of the main innovations within the new guidelines concerns the revocation of the couple's informed consent to MAP, an issue in respect of which many interpretative doubts had arisen also considering the different interests involved. In particular, the guidelines reiterate that a period of not less than seven days must elapse between the couple's manifestation of their will and the beginning of the application of the technique, providing for the revocation of informed consent by each of the subjects accessing the technique up to the moment of fertilisation of the ovum - as already established by art. 6, law no. 40/2004 - or, in the case of a pre-implantation genetic diagnosis that has diagnosed a pathology of the embryo relating to abnormalities or malformations of the unborn child, and determining a serious danger to the woman's physical or psychological health, until the moment of transfer.

In the first case, the guidelines transpose sentence No 161/2023 of the Italian Constitutional Court, which, at the outcome of a complex balancing of the interests involved, deemed reasonable and constitutionally legitimate the time limit for revoking consent to MAP up to the assisted fertilisation of the ovum, thereby protecting, on the one hand, the formation of the will of the future parents and, on the other, the right to life of the unborn child.

The consequences of the irrevocability of consent, explicitly transposed by the guidelines, therefore take the form of the possibility of proceeding with implantation even if the conditions for access to MAP have ceased to apply, such as the couple's relationship ceasing to exist - an event that may in practice occur even more so in cases where implantation of the embryo is postponed in time to protect the woman's health.

In the second case, the guidelines transpose sentence 229/2015 of the Italian Constitutional Court, which had introduced the possibility of not proceeding with implantation when the pre-implantation genetic diagnosis has detected a major pathology in the embryo.

Still on the subject of consent to MAP, the guidelines state that, at the time of access to MAP techniques, applicants must be told, clearly and in writing, that after the assisted fertilisation of the ovum, consent to MAP cannot be revoked and the woman may request the implantation of the embryo even if her partner has died, as specified in ruling No. 13000/2019 of the Italian Supreme Court.

Moreover, the guidelines also provide a novelty about the costs of cryopreservation of embryos that are not immediately transferred. In the absence of a legal provision to that effect, in fact, the previous guidelines established that such costs had to be borne exclusively by the healthcare facility providing MAP services. Instead, the new guidelines now state that the facilities will only have to bear the costs in the first year, after which the costs will be borne by the couple accessing MAP.

In conclusion, the new guidelines, in recalling the most recently emerged jurisprudential principles, now clarify important issues that had given rise to complex interpretative doubts resulting from the need to reconcile different interests involved.

The hope is that this update will be the first step towards an organic reform of the matter that also involves law 40/2004, which is now, as confirmed by the Italian Constitutional Court's rulings, in some respects inadequate to the times of scientific progress.

Author: Avv. Daniela Di Palma e Dott.ssa Marta Minnici