P-341 From cross-border reproduction to embryos and gametes transit: the peculiar italian case examined from ethical, legal, and comparative standpoint
Authors: Dalla Costa S , Reguera Cabezas M , Bernabeu A , Bernabeu R 
Published: July 2024

Abstract

Study question
Is the transportation of gametes and embryos by land or air from a foreign country the solution for the lack of donors supply in Italy?

Summary answer
In Italy, post-2014 Court ruling made heterologous fertilization legal. Yet, gamete acquisition is tough, pushing clinics to foreign banks, facing transport risks.

What is known already
The international flow of human gametes, expanding due to the growth in reproductive medicine, is regulated by European Directives aiming for uniform EU regulations to maximize health protection via standardized quality and safety. However, diverse national regulations, especially regarding gamete donation, create complex scenarios. In Italy, for instance, regulatory constraints and insufficient legislative support force ART centers to import gametes, mainly from Spain, leading to ongoing cross-border transport of biological material, a process fraught with challenges.

Study design, size, duration
This study reviews European and Italian regulations on human cell and tissue circulation, focusing particularly on Italy. Directive 2004/23/EC, initiated by the European Parliament and Council, aims to regulate the use of human reproductive biological material, promoting donorship and uniform quality and safety standards across EU member states. Later Directives, including (EU) 2015/566, specifically address gamete transfer within the EU, differentiating between intra-EU distribution and import from non-EU countries.

Participants/materials, setting, methods
We have meticulously analyzed the legislation applied by the European and non-European states included in the study, examined the role of the European legislator, and conducted a comparative analysis of the effects produced on society. Official data published on this topic by the Italian Ministry of Health have also been collected and analyzed.

Main results and the role of chance
Aligning with both national and European legal frameworks, as well as adhering to scientific guidelines, is crucial for the secure transport of gametes and embryos. The importance of effective risk management and minimizing liability cannot be overstated, requiring clear communication about consent, transport methods, data sharing, and managing unforeseen events. Despite efforts, European legislation struggles to harmonize effectively, ensuring uniform rights across the continent.
In Italy, the demand for donated sperm and oocytes has surged following the invalidation of certain legal restrictions on the use of donated gametes. However, the availability of donated human gametes within Italy falls short of meeting this demand. According to the Italian Ministry of Health, in 2020, there were over 3,100 requests for donated oocytes, but only 60 instances of fresh oocyte donations were recorded in Italy, necessitating imports primarily from Spain.
A key factor in the low donation rates is Italy’s ban on compensating donors for their inconvenience and lost work time. Similarly, semen donations in Italy are inadequate, with 75% of male gametes imported from abroad. The lack of financial incentives, coupled with the significant influence of the Catholic Church and limited public awareness about infertility issues, contributes to Italy’s shortage of donors.

Limitations, reasons for caution
Not applicable.

Wider implications of the findings
The absence of a decision by the Italian legislator regarding the issue of donors leads to various problems: we refer to the costs that affect the centers, inevitably impacting patients who opt for treatment in Italy; or, conversely, in the travel costs for those who decide to seek treatment abroad.

Trial registration number
not applicable