Summary of Key Recommendations
1. Establish an International (EU-wide) offspring limit
ESHRE supports setting an international limit on the number of families created per donor to reduce uncertainty, overwhelm, and feelings of commodification among donor-conceived people and donors. Because a worldwide treaty is unrealistic, ESHRE recommends starting with an EU-wide limit.
Recommended limits:
• Immediate limit: 50 families per donor.
– Aligns with current practices of several gamete banks.
– Should complement, not replace, national limits (countries with stricter limits keep their stricter rules).
• Long-term goal: 15 families or fewer per donor.
– The 50-family limit should be gradually reduced with close monitoring of impacts on access to treatment.
• Evaluation after 3 years to reassess whether the limit can be lowered.
2. Define limits by number of families, not number of children
Offspring limits should be set per family, not per child.
This ensures:
– Families can use remaining cryopreserved embryos from the same donor.
– Siblings can be genetically related if desired.
– Recipients retain reproductive autonomy.
3. Allow donors to set a lower personal limit
• Donors should be allowed to choose a lower limit than the regulated maximum for their own gametes.
4. Maintain cross-border exchange of gametes
• ESHRE does not recommend restricting cross-border gamete movement.
• Instead, they call for harmonised EU-wide rules so donor limits remain enforceable across borders.
5. Limit distribution time
• Gametes should not be distributed to new families more than 20 years after the first donation, to avoid large age gaps between donor siblings.
Monitoring and Compliance Recommendations
6. Create an EU-wide Donor Registry
Establish a secure EU registry to:
– Track donations within the EU and imports from outside the EU.
– Help monitor compliance with offspring limits.
– Potentially offer limited info access to donors and donor-conceived people (e.g., birth year, country, sex).
– Explore whether it could support identity disclosure where national law allows.
7. Obligations for gamete banks (before registry exists)
– Banks must self-comply immediately with the 50-family limit.
– EU clinics may only collaborate with banks that apply the recommended limits.
– Non-EU banks must comply with the EU limit if exporting to the EU.
8. Donor declaration requirement
Donors must:
– Declare all previous donations.
– Confirm they will not make private, unregulated donations.
• If previous offspring numbers are unknown, donors should not be accepted, to avoid exceeding limits.
9. Counting method
When live births are unknown, count families to whom gametes were distributed, not births, to avoid underestimating totals.
Families may be removed from the count only if it is known that:
– The donation did not lead to a birth and
– The family has no remaining embryos from that donor.
Counselling & consent recommendations
10. Transparent Counselling
Donors and recipients must be informed about:
– Applicable offspring limits.
– Risk of large offspring numbers if no international limits exist.
Recommendations for access to treatment
Strengthen donor recruitment
To prevent shortages and avoid pushing patients to unregulated private donations:
– Increase recruitment efforts.
– Use public campaigns and education programs (similar to strategies for other human tissue donations).