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JACIE Report July 2024: SoHo Conference

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Tuula Rintala
Director, Quality of Care and Advocacy
EBMT, European Society for Blood and Marrow Transplantation
Barcelona, Spain

European Union–Directorate General (DG) organised a SoHO Conference in Brussels, Belgium on 24th June 2024 in celebration of the new regulation on Substances of Human Origin (SoHO). After a two-year consultation and negotiation process European Union's new regulation on Substances of Human Origin, represents a significant shift in the governance of human-derived substances used for medical purposes. European Council adopted new rules aimed at improving the safety and quality of blood, tissues and cells on 27th May 2024 and 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.

What is SoHO?

SoHO encompasses a broad range of substances including blood, tissues, cells, breast milk, intestinal microbiota and reproductive cells that are used in medical treatments and procedures for human use. The new regulation replaces several existing directives, creating a cohesive framework that applies to all substances derived from the human body.

Key Objectives of the Regulation

Enhanced Safety and Quality Standards: The regulation sets rigorous criteria for the collection, testing, processing, storage, and distribution of SoHO. This aims to minimize the risk of contamination and transmission of diseases, ensuring that all human-derived substances are safe and effective for medical use.
Harmonised Framework: By consolidating various directives into a single regulation, the EU seeks to standardise practices across member states. This harmonisation is expected to reduce disparities and improve cooperation between countries, facilitating easier and safer cross-border exchanges of SoHO.
Innovation and Research: The regulation encourages innovation by providing clear guidelines and support for research and development in the field of human-derived substances. It aims to balance the need for stringent safety measures with the flexibility required for scientific advancements.
Transparency and Traceability: There is a strong emphasis on traceability and transparency throughout the supply chain. This includes detailed record-keeping and reporting requirements, which help track the journey of SoHO from donor to recipient, ensuring accountability at every step.

Impact on Our Community

Although the new regulation will have a significant impact in our sector, the stem cell transplantation and cellular therapy community is well placed to face those challenges. The changes in the new regulation bring several benefits and responsibilities:

Improved Patient Safety: The stricter safety and quality standards will lead to higher confidence in the treatments and procedures involving SoHO, potentially resulting in better patient outcomes.
Streamlined Processes: Harmonised regulations across the EU will simplify the legal landscape for practitioners and organisations involved in the collection and use of SoHO, reducing administrative burdens and fostering smoother operations.
Support for Innovation: Researchers and medical professionals will find a more supportive environment for developing new therapies and technologies, contributing to the advancement of medical science and the availability of cutting-edge treatments.
Increased Accountability: Enhanced transparency and traceability measures will ensure that all entities involved in the SoHO supply chain adhere to the highest standards, promoting ethical practices and patient trust.

Conclusion
The new SoHO regulation represents a proactive step towards safeguarding public health while encouraging innovation in the medical field. The Regulation will come into effect in mid-2027, three years after its adoption, with an additional year for certain provisions to be implemented. As members of the SoHO community, it is crucial to stay informed and compliant with these changes to leverage the benefits and uphold the standards expected of us. Together we have the opportunity to navigate this regulatory shift and continue to deliver safe and effective treatments to those in need.