A further Step for the SoHO Regulation

In the news "Final Adoption of the SoHO Regulation" and "New Regulation on Blood, Blood Products and Plasma", you could already read about the development of the SoHO Regulation. Recently, on 27 May 2024, the EU member states have adopted ground-breaking regulations aimed at improving the safety and quality of blood, tissues and cells in healthcare. These measures not only aim to improve standard safety, but also facilitate the cross-border exchange of these important substances within the EU.

The regulation includes a variety of measures to better protect donors and recipients and ensure the quality of substances of human origin (SoHO). From the registration and testing of donors to the monitoring of clinical outcomes, the regulation covers all relevant steps.

The core elements include:

• Extended scope: Inclusion of breast milk and gut microbiotics.
• SoHO Coordination Body (SCB): Supporting Member States in the implementation of the Regulation.
• Common EU procedures: Standardised authorisation and evaluation of SoHO preparations.
• National SoHO authorities: Appointment of independent, transparent supervisory authorities.
• Additional authorisation and inspection requirements: Strict requirements for establishments processing, storing or transporting SoHO.
• EU SoHO platform: New IT platform for registration and information exchange.
• Rapid alert system: response mechanism in the event of serious incidents or reactions.

The issue of compensation for donors was particularly controversial. According to the new regulation, SoHO donations should be voluntary and free of charge. Nevertheless, living donors can be compensated in accordance with national legislation.

Another highlight of the regulation is the rapid alert system, which is activated in the event of serious incidents or reactions in order to protect donors and recipients. Member states are also obliged to ensure an adequate supply of critical SoHO and to develop national contingency plans.

Once signed by the Council and the European Parliament, the regulation will enter into force in mid-2027 with its publication in the Official Journal of the EU. The full text of the Regulation "Standards of Quality and Safety for Substances of Human Origin" (SoHO) is available for download.