The key point is that the old regime was mainly based on the EU Tissue and Cells Directive (2004/23/EC) and related implementing acts, whereas the new regime is the SoHO Regulation, Regulation (EU) 2024/1938.
Unlike a directive, a regulation applies much more uniformly across Member States. It was published in July 2024, repeals the old tissue/cells framework, and most of its provisions will apply from 7 August 2027.
1) Legal structure: directive vs. regulation
Old framework:
The Tissue and Cells Directive set minimum rules, but left significant room for national implementation. That led to uneven rules and practices between and across Member States.
New framework:
The SoHO Regulation is intended to create a more harmonised and directly applicable EU framework for quality and safety across Member States. One of the express reasons for the reform was that the old directives allowed too much divergence, which complicated cross-border exchange.
2) Scope: reproductive cells are more explicitly covered
Old framework:
Eggs and sperm were covered as tissues/cells, but within a broader and older structure that did not reflect many developments in assisted reproduction over the last decades.
New framework:
The SoHO Regulation explicitly covers reproductive SoHO, including sperm, oocytes, embryos, and reproductive tissues, and is designed to address medically assisted reproduction more clearly and more modernly.
3) Who is protected: stronger recognition of donor-conceived children
Old framework:
The old system primarily focused on safety and quality for donors and recipients.
New framework:
A major development is that the new framework also expressly focuses on protecting children born from medically assisted reproduction using donated sperm or eggs. This is one of the clearest policy shifts in the new legislation.
4) Donor protection: more explicit and stronger
Old framework:
The directive framework already required donor selection, testing, and general protection, but it was less explicit and less updated in relation to modern donor protection practices.
New framework:
The SoHO Regulation strengthens the protection of living donors before, during, and after donation, with greater emphasis on risk management, adverse event reporting, follow-up where relevant, and protection of privacy and personal data. This is particularly important for egg donation, where the medical burden and risks are materially greater than for sperm donation.
5) Compensation: clearer limits around financial incentives
Old framework:
The principle of voluntary and unpaid donation already exist under the present EU framework, but practice varied across countries and the boundaries around compensation were not always as clearly operationalised.
New framework:
The SoHO Regulation keeps the principle of voluntary and unpaid donation, but sharpens the framework around compensation. Donors may still receive compensation or reimbursement for expenses and inconveniences, but Member States must ensure that compensation does not become an improper financial incentive. The new regime also increases transparency around national compensation rules.
6) Technical requirements: more dynamic quality and safety standards
Old framework:
Technical requirements for donor testing, procurement, processing, storage, and distribution were largely based on older directives and implementing directives. Updating the rules could be slow.
New framework:
The new system is designed to be more adaptable. The Commission highlights that technical rules can be kept more up to date with support from expert bodies such as ECDC and EDQM, so requirements can better respond to new infectious risks and scientific developments. For sperm and egg donation, that means the technical compliance environment will likely become more current and more responsive over time.
7) Traceability and vigilance: stronger end-to-end control
Old framework:
Traceability and serious adverse event/reaction reporting already existed, but implementation uneven.
New framework:
The SoHO Regulation strengthens traceability, oversight, reporting, and vigilance obligations. In practice, sperm banks, egg banks, and fertility clinics should expect more robust documentation, clearer allocation of responsibilities, and more structured reporting requirements.
8) Cross-border exchange: more harmonisation, but not full ethical unification
Old framework:
Cross-border exchange was possible, but divergent national implementation often created barriers and compliance inconsistencies.
New framework:
One of the express aims of the SoHO Regulation is to facilitate safer and more reliable cross-border exchange. That matters directly for sperm and egg banks operating internationally. However, the Commission also makes clear that healthcare organisation and authorised practices remain national competences. So, the EU is harmonising quality and safety rules, not erasing national ethical choices.
9) What does NOT become fully harmonised
This is crucial for the fertility sector. The SoHO Regulation does not fully unify sensitive national rules such as:
• donor anonymity vs. identity-release systems,
• eligibility rules for recipients,
• family limits/offspring limits per donor,
• broader ethical choices about how assisted reproduction is organised.
The Commission expressly states that these kinds of healthcare decisions remain primarily with Member States, i.e. clinics and banks should not assume that the new regulation removes national differences on these issues.
10) Practical impact on egg and sperm donation
For fertility clinics, sperm banks, and egg banks, the practical shift is this:
Under the old directive framework, compliance was often more nationally fragmented and based on a legal structure that had become dated.
Under the new SoHO Regulation, operators should expect:
• more uniform EU compliance expectations,
• stronger donor-protection requirements,
• explicit attention to the welfare/safety interests of donor-conceived persons,
• tighter traceability and vigilance,
• clearer scrutiny of compensation models,
• and more structured oversight for cross-border activities.
In conclusion
The old EU tissue/cells regime regulated egg and sperm donation mainly as part of a broader, ageing directive framework, whereas the new SoHO Regulation creates a more modern, stricter, and more harmonised system especially on donor protection, traceability, vigilance, and the recognition of children born from donation, while still leaving core ethical issues such as anonymity and donor limits largely to national law.