Final Approval of SoHO Regulation

The recently adopted EU regulation updates and extends the 20-year-old regulations on substances of human origin (SoHO), which include blood, tissue, cells and breast milk. Following interinstitutional discussions in December, the final document was approved in Parliament on 24 April 2024 with 461 votes in favor, 56 against and 66 withholds. The regulation aims to harmonize safety and quality standards across Europe and improves protection for both donors and recipients of these substances. It also facilitates the cross-border movement of SoHO, which is particularly important in medical emergencies and supply cases.

The regulation implements a holistic approach and excludes solid organs, but sets clear rules for all other SoHO, such as fecal microbiota and human breast milk. It obliges all facilities working with SoHO to register in order to ensure compliance with safety and quality standards. These measures are to be supported and monitored by existing technical bodies, including the European Center for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines and Healthcare (Council of Europe).

An important component of the regulation is the common procedure for the assessment and authorization of SoHO preparations. In addition, national supervision will be strengthened and EU-wide support measures for national authorities will be introduced, including training and IT solutions. Another innovation is the establishment of a SoHO coordination body to support the implementation of the regulation in the Member States and ensure legal clarity. The new EU digital SoHO platform will collect all necessary information and increase reporting and visibility for citizens.

With regard to compensation for living donors, the text recognizes that all forms of compensation, including lump sum payments, are compatible with the principle of voluntary, unpaid donation. This regulation is intended to ensure that the EU Charter of Fundamental Rights, which prohibits the commercialization of the human body, is respected.

The new regulation will be approved by the Council later this spring and published in the Official Journal of the European Union. There will be a three-year transition period before most provisions apply and a four-year period for some specific provisions, which means that the Regulation will enter into force in the middle of 2027. The EU Commission is also planning to adopt a series of legal acts to implement certain provisions in detail. Finally, the EU Commission has published a Q&A document on its website. For more information, read the full content of the regulation “Standards of quality and safety for substances of human origin intended for human application”.