On Monday, May 27, 2024, the European Council adopted new rules on substances of human origin (SoHO).

The regulation on substances of human origin (SoHO) will ensure better protection for donors and recipients, as well as for children born following medically assisted reproduction. The new rules aim to strengthen the existing legal framework while also increasing flexibility in order to keep up with scientific and technical developments.

Voluntary and unpaid donations

Member states will be able to compensate living SoHO donors, following the principle of voluntary and unpaid donation and based on transparent criteria, including fixed allowances or through non-financial forms of compensation. The conditions for such compensation will be established in national legislation.

Promotion and publicity activities in support of SoHO donations (for example, campaign billboards or posters, television, newspaper or magazine advertisements) must not refer to compensation. National authorities will therefore have to ensure that compensation is not used as an incentive to recruit donors.

Safeguarding supply

EU countries will establish and regularly update “national SoHO emergency plans”, setting out measures to ensure the security of supply for critical substances.

Next steps

The regulation will now be signed by both the Council and the European Parliament. It will then enter into force following publication in the EU’s Official Journal.

Useful links

Council of the EU Press Release – here.

Text of the Regulation – here.

EU Health Policy background information – here.