P-389 "Time is the nurse and breeder of all good": storage periods for embryos and gametes across Europe
Authors: Lawford Davies J , Hoppe N , Lorenz M 
Published: June 2023

Abstract

Study question
What are the justifications, advantages and disadvantages of contrasting storage regimes for embryos and gametes across Europe?

Summary answer
Permitted storage periods vary significantly between countries, often lack justification for the limitations they impose, and may compromise individual rights.

What is known already
Storage periods for gametes and embryos vary significantly across Europe, as does the margin of discretion to grant extensions and adjustments to such periods. This fragmented regulatory landscape adds significant complexity to how cryobanks, clinics and patients are able to plan future treatment options. In addition, it creates an effect which may negatively impact on stakeholders' ability to freely choose where in Europe services are obtained, as well as when: when treatment is delayed because of personal health issues, the clock may not stop ticking on the maximum storage period.

Study design, size, duration
We have analysed and reviewed the regulation of storage periods in a number of European countries, and have put a particular focus on states which have strongly diverging periods. This assessment examined the policy underpinning the relevant rules, and the consequences of the regime for stakeholders. Our review considered both the legal and ethical aspects of each system and its consequences.

Participants/materials, setting, methods
Information about storage periods was obtained from legislation, policy documents and publications from national regulators. We also looked at case-law regarding storage issues in certain states.

Main results and the role of chance
Storage periods for gametes and embryos vary significantly across Europe, as does the margin of discretion to grant extensions and adjustments to such periods. This fragmented regulatory landscape adds significant complexity to how cryobanks, clinics and patients are able to plan future treatment options. In addition, it creates an effect which may negatively impact on stakeholders' ability to freely choose where in Europe services are obtained, as well as when: when treatment is delayed because of personal health issues, such as concurrent cancer treatment, the clock may not stop ticking on the maximum storage period.
A regulatory field which so clearly impacts EU Freedom of movement rights, as well as human rights contained both within EU law and the Council of Europe's Convention on Human Rights, should be capable of justification based on robust scientific and clinical evidence. This appears to be inconsistent with the variation we have identified in storage periods across the jurisdictions we have considered.

Limitations, reasons for caution
The assessment of domestic legal approaches requires an appropriate understanding of the language, as well as of the legal system. Whilst an informative assessment is possible based on policy overviews, a robust assessment of jurisdictions where the official language is not English or German is outwith the paper's scope.

Wider implications of the findings
The paper's conclusion is that the fragmentation of legal requirements in relation to the storage of embryos and gametes is neither ethically sound nor appropriately legally justified. It impacts negatively on individuals' rights and on commercial interests. More harmonisation is desirable in this field.

Trial registration number
Not applicable