The European Council has adopted a new regulation to improve the safety and quality of blood, tissues and cells used in healthcare, while also facilitating the cross-border circulation of these substances in the European Union. The regulation, called “Substances of Human Origin” (SoHO), expands the scope of SoHO to also include human breast milk and intestinal microbiota.

A broader definition of human substances is introduced, including foetal tissues and embryos, which until now had different regulations in different Member States. An EU-level SoHO Coordination Committee is established to support Member States in implementing the Regulation, together with common procedures for the authorization and evaluation of SoHO preparations.

Member States will be required to designate a national authority for SoHOs, which will authorize preparations and ensure independent and transparent oversight. Additional requirements are established for the licensing and inspection of facilities that process, store, release, import, or export SoHO.

The regulation provides for the establishment of a common IT platform, the EU SoHO platform, for registering and exchanging information on related activities. Furthermore, an early warning system is introduced to address serious incidents or reactions that may pose a risk to recipients or donors.

According to the new regulation, SoHO donations will, in principle, be voluntary and free, without financial incentives for donors. However, living donors may receive compensation or reimbursement, in accordance with national legislation.

Through these provisions, the aim is to guarantee greater protection for donors, recipients and children born through medically assisted reproduction. The new rules aim to strengthen the existing legal framework, while improving flexibility to adapt to scientific and technological advances.

The regulation will now be signed by the Council and the European Parliament and will enter into force following its publication in the Official Journal of the EU.