New EU Regulation 2024/1938: Quality and Safety of Substances of Human Origin (SoHO)

Regulation (EU) 2024/1938, approved on June 13, 2024, introduces new standards aimed at improving the quality and safety of substances of human origin (SoHO) used in medical treatments. This regulation replaces previous Directives 2002/98/EC and 2004/23/EC, which governed blood, tissues, and cells, integrating a broader and more modern perspective.

The main updates of the Regulation primarily address the expanded scope, now covering a wider range of substances of human origin, including blood, tissues, cells, breast milk, and intestinal microbiota. This update also includes specific cells such as lymphocytes, essential for immunotherapies, due to the growing demand for advanced therapies like cancer immunotherapy, which has seen a 10% increase in clinical applications in recent years.

Another key aspect is donor protection, as the donation of SoHO must be voluntary and free of charge. All donors undergo rigorous medical screenings to minimize risks, with particular attention to plasma donors, whose contributions are fundamental for producing plasma-derived medicinal products (PDMPs). The regulation aims to reduce the EU's reliance on imports, which are still necessary to meet a significant portion of the demand.

In terms of safety and standards, the regulation introduces enhanced measures to prevent cross-contamination, requiring that each facility follow uniform criteria for the collection, processing, and distribution of SoHO. Inspections are scheduled every four years to ensure compliance, extending the previous biennial inspection interval.

The regulation also supports innovation and research through a central platform for data sharing among Member States, aimed at reducing approval times for new technologies by up to 30%. This measure facilitates the adoption of emerging technologies and promotes large-scale clinical studies, particularly for gene and cell therapies.

The regulation applies to all substances of human origin used in medical treatments. This includes:

• Blood and blood components, such as red blood cells, platelets, and lymphocytes, which are essential for cell therapies and immunotherapies.
• Human tissues and cells, including stem cells collected from bone marrow or umbilical cord blood.
• Reproductive cells (oocytes and sperm).
• Breast milk and intestinal microbiota.

The number of blood donors in the EU has increased significantly in recent years, with more than 20 million donations made annually from a population of approximately 450 million.

• Solid organs: Solid organs, such as the heart, liver, and kidneys, are not regulated by this new regulation. They are governed by distinct legislation, such as Directive 2010/53/EU.
• Direct breast milk donation: Breast milk donated by a mother to feed her own child is not regulated by this regulation. However, if breast milk is collected and distributed by specialized entities, it is subject to these new standards.

• Healthcare entities operating with SoHO, such as blood collection centers, tissue banks, and assisted reproduction laboratories.
• Healthcare professionals involved in the collection, processing, and application of SoHO.
• Donors and recipients: each year, more than 6 million patients in the EU benefit from SoHO-based therapies.
• National authorities, responsible for monitoring and ensuring the safety of processes.

Regulation (EU) 2024/1938 marks an important step in enhancing safety and transparency in the management of substances of human origin, supporting a more innovative healthcare system across the EU.

Sources:

1. European Blood Alliance: Updated data on the blood and plasma donation sector in Europe, including dependencies on third countries and the role of plasma: EBA - Risposta alla proposta di regolamento SoHO European Blood Alliance - Panoramica
2. European Commission Health: Official information on the review of EU legislation for SoHO, including impacts and public consultations: Public Health - Documento Legislative review on blood, tissues, and cells
3. European Commission - SoHO Directive: Details on quality and safety requirements for substances of human origin, including donor protection and promotion of innovation: Public Health - Panoramica normativa SoHO