Ethical analysis of the European normative framework on fertility preservation.

BACKGROUND: Fertility preservation involves storing reproductive tissues or cells to enable reproduction later in life. It is often part of assisted reproduction but is also used independently. Our research aim is to study the European normative framework of fertility preservation in view of identifying and ethically analysing the main topics of regulation. METHODS: A systematic literature search in EUR-Lex, national legal databases, Science Direct, Web of Science, PubMed, and a subsequent thematic and ethical analysis were performed. Altogether, 63 documents, including 37 law-informing documents and 26 guidelines, were analysed. RESULTS: Ten thematic topics were identified: (I) definitions of fertility preservation; (II) age limits for fertility preservation; (III) type of preserved reproductive biomaterial; (IV) posthumous usage; (V) informed consent; (VI) state/health insurance funding; (VII) storage period; (VIII) social egg freezing; (IX) requirements for partnership status; (X) special provisions for transgender individuals. These topics were assessed against the four bioethical principles. Legal norms mostly reflected the principle of justice, while guidelines focused on beneficence. Among all topics, the most permissively regulated were social egg freezing, partnership status, and fertility preservation for transgender individuals. In contrast, age limits were the most strictly regulated. Overall, the European framework seeks to balance equal access for diverse groups - such as single women, couples, and transgender individuals - with the aim to keep reproduction within traditionally accepted age limits. CONCLUSION: Laws and guidelines dealing with fertility preservation were not equally inclusive for all user groups and they did not provide sufficient guidance on ethically challenging aspects. Our focus was on identifying and ethically analysing common gaps and inconsistencies in the European normative framework rather than suggesting concrete legal changes. The ethical analysis, based on the four principles of bioethics, enabled us to make concrete suggestions for improving the guidelines - particularly by adding ethical content related to the studied topics.