EU Regulation on Substances of Human Origin officially adopted

The Regulation on Substances of Human Origin (SoHO) has been officially adopted by the EU Institutions, following the European Parliament’s approval on 24 April and the formal adoption by the Council of the European Union on 27 May. The new Regulation aims to improve the safety and quality of blood, tissues and cells used in healthcare. It covers a wide range of activities from the registration and testing of donors, collection and processing, to human application and clinical outcome monitoring of SoHO. The Regulation seeks to strengthen the existing legal framework while also increasing flexibility to keep up with scientific and technical advancements.

Key Takeaways

Principle of Voluntary and Unpaid Donation (VUD)

Under the new Regulation, donations of SoHO should be voluntary and unpaid as a principle. While donors should not be incentivised financially to donate, all forms of compensation or reimbursement, including fixed-rate payments to living donors, are acceptable if done in accordance with national legislation.

Cross-Border Circulation of SoHO in the EU

The Regulation aims to increase harmonisation and facilitate cross-border exchanges and access to SoHO by:

• Setting up an EU-level SoHO coordination board to support Member States in implementing the Regulation.
• Introducing common EU-wide procedures for the authorisation and assessment of SoHO preparations.
• Requiring Member States to designate a SoHO national authority and other competent authorities to authorise SoHO preparations and ensure independent and transparent oversight of SoHO-related activities.
• Establishing additional authorisation and inspection requirements for establishments that process, store, release, import, or export SoHO.
• Creating a new common IT platform, the EU SoHO platform, to register and exchange information on related activities.

Broadened Scope of Legislation

The adopted Regulation broadens the scope of SoHO to include human breast milk and intestinal microbiota. It also aims to future-proof the EU’s legislation by covering other SoHO that may be applied to humans in the future and by allowing more flexible future updates. The Regulation will facilitate innovation through a common EU procedure to assess and authorise new SoHO preparations, proportionate to the associated risks.

EUCOPE Perspective

EUCOPE commends the Regulation’s introduction of measures that will make SoHO accessibility within Europe easier. Supporting the principles to ensure a reliable supply of critical SoHO including plasma, we believe the Regulation can promote the EU’s strategic autonomy and reduce dependence on imports from third countries. EUCOPE particularly appreciates the Regulation’s recognition of diverse compensation methods across EU Member States, a feature we strongly advocated for. A flexible and future-proof legislative framework will enable Member States to establish and maintain plasma collection models and infrastructure that cater to their specific healthcare system needs.

Next Steps

The Regulation will come into effect in mid-2027, three years after its adoption, with an additional year for certain provisions to be implemented.

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For further information about our work on the SoHO Regulation or to join our Cell & Gene Therapy Working Group, contact us.