The legal framework
Directive 2004/23/EC sets quality and safety standards for the donation, procurement, testing, storage and distribution of human tissues and cells, including gametes and embryos. It requires accreditation of establishments, traceability from donor to recipient, notification of serious adverse events, and the principle of voluntary unpaid donation. Eligibility — couples, single women, age limits, anonymity — remains entirely national, which is why cross-border fertility travel happens within the Union itself.
It is precisely because eligibility is not harmonised that patients cross a border: Spain, Belgium and Czechia allow what other states refuse, while applying the same safety standards.
The traceability requirement has a useful practical consequence: an establishment must be able to identify a gamete donor for thirty years, even where national law keeps the donor anonymous to the child.
Same-sex couples: no European rule either requires or forbids access for female couples to assisted reproduction: it is wholly a national competence, which is why people travel between member states.
Key points
| Instrument | Directive 2004/23/EC and its implementing directives |
|---|---|
| Subject | Quality, safety and traceability of tissues and cells |
| Donation | Principle of voluntary, unpaid donation |
| Traceability | Donor to recipient and back, for thirty years |
| Eligibility | Entirely national; the Union does not harmonise it |
In practice
- Check first what kind of instrument it is: a regulation applies directly, a directive must be transposed and leaves differences between states.
- Consult the consolidated version on EUR-Lex, which incorporates every amendment.
- Identify the national transposing statute: that is what a court will actually apply.
- Where the meaning is disputed, look for Court of Justice judgments on the point.
- For a cross-border dispute, check whether a national contact point or a European network can help.
Cost and coverage
Consulting Union law costs nothing: EUR-Lex publishes every text free of charge, in twenty-four official languages and in consolidated form. Any cost lies in legal advice, where the interaction between the European text and the national transposing statute becomes decisive — common with directives, rare with regulations.
Where to go
- EUR-Lex, the official portal of Union law, publishing every text in twenty-four languages
- The European e-Justice Portal, for cross-border procedures
- Your Europe, the Commission's information service for citizens
- SOLVIT, the network that resolves misapplication of Union law by an administration
- The European Consumer Centre in your country, for cross-border consumer disputes
Worth knowing
Do not confuse the European Union with the Council of Europe: the European Convention on Human Rights and the Strasbourg Court are not EU bodies and cover forty-six states, including Switzerland and the United Kingdom.
Frequently asked questions
Does the Union decide who can have treatment?
No. Eligibility is entirely national; the Union governs only safety and traceability.
Can donation be paid?
The Directive lays down voluntary unpaid donation; permitted compensation varies between states.
Can gametes move between states?
Yes, between accredited establishments, subject to the Directive's traceability and safety requirements.
Why do the rules differ so much?
Because bioethics is a national competence: the Union harmonises safety, not access.
Official sources and links
- UN Human Rights Office — ratified treaties and country reviews
- ILO NATLEX — national legislation database