Abstract

Abstract Study question Given cross border reproductive care, is the lack of specific regulation on egg and sperm donation in Italy ethically acceptable nowadays? Summary answer Nowadays Italy has no national clear legal frame for donors, recipients, and donor-conceived persons. This setting hinders an ethical protection of competing interests and rights. What is known already The Italian Law on ART (40/2004) has undergone major changes; after sperm and egg donation ban lift, the Italian law n. 40 has not been replaced. Gamete donation is therefore allowed, but without specific national regulation. Moreover, given the lack of public information on donation and consequently the shortage of donors, many people still opt for CBRC. In this context, the only legal certainty is that no filiation link arises between donor and donor-conceived children. Political and legal debate on the right to know one's origins is missing. Legally speaking, gamete donation in Italy is actually in half-light. Study design, size, duration -- -- Participants/materials, setting, methods When it comes to ART, national legal frame has to be considered in a comparative view, since CBRC is a fact. Therefore, questioning the lack of specific regulation on egg and sperm donation in Italy has required a comparative analysis with other European legal systems, such as France, Spain and United Kingdom. Main results and the role of chance -- -- Limitations, reasons for caution When advocating a legal change, it should be considered the surrounding political environment; among Italian institutions a growing mistrust of science might be spotted nowadays. This, combined with the very well know Catholic heritage, is undoubtedly a reason for caution Wider implications of the findings A legal change in Italy, backed by a promotion of public information on gamete donation, might entail also an increase in the number of donors and enabling many people to avoid CBRC. The rights of donors, recipients and donor-conceived persons would be protected and more patients could be treated. Trial registration number not applicable

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