Tuula Rintala
European Society for Blood and Marrow Transplantation (EBMT)
Spain
The implementation of Regulation (EU) 2024/1 in August 2027 — the Substances of Human Origin (SoHO) Regulation — marks one of the most consequential shifts in the European regulatory landscape for transplantation medicine in a generation. For the haematopoietic stem cell transplantation (HSCT) community, and for the cellular therapy field more broadly, this is an important restructuring of the framework within which our centres operate, our patients are protected, and our standards are set and verified.
For over two decades, the European quality and safety framework for substances of human origin was governed by the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC), supplemented by their technical implementing directives. These instruments established foundational principles such as donor eligibility, traceability, vigilance, and quality management, but they were products of their time. Transposition into national law produced uneven implementation, variable enforcement, and persistent divergence across Member States in how standards were interpreted and applied in practice.
The SoHO Regulation replaces this fragmented edifice with a directly applicable EU instrument. The implications are far-reaching. Unlike a directive, the Regulation does not require transposition; it binds all Member States uniformly even if the processes how the Regulation is applied might still differ between the Member States.
For HSCT centres, the Regulation introduces or reinforces requirements across the full donation, procurement, processing, storage, and distribution chain. It strengthens the obligations of SoHO entities defined broadly to encompass any organisation engaged in activities involving SoHO and clarifies the role of national SoHO competent authorities in oversight, registration, and enforcement. It is important then to understand what is the role of professional societies such a EBMT and others in supporting their members in this changing landscape and where EBMT, JACIE and others can have a direct and substantial role to play.
The SoHO Regulation creates an explicit and structured space for accreditation bodies such as JACIE to operate as partners in the regulatory system, rather than simply as professional associations running voluntary schemes. Under the Regulation, national competent authorities are empowered to take into account compliance with equivalent quality and safety standards when supervising SoHO entities, and the framework invites the development of harmonised approaches at EU level. This creates both an opportunity and an obligation for JACIE: to ensure that its standards are recognised as meeting, or exceeding, SoHO regulatory requirements, and to position JACIE certification as a meaningful demonstration of compliance.
This alignment work is already underway. JACIE is reviewing the correspondence between its standards and the SoHO Regulation's requirements, identifying areas of direct equivalence, areas where FACT - JACIE standards exceed regulatory thresholds, and areas where revision or supplementation may be needed. EBMT and JACIE is also actively participating in IMPLEMENT-SOHO (https://www.ebmt.org/ebmt/news/get-involved-implement-soho-project) project in developing educational and training resources for Centres and professionals working within the SoHO field.
The SoHO Regulation will land differently across different categories of transplant centre, and it is important that EBMT and JACIE communicate honestly about this variability. Larger, well-resourced centres with established quality management systems and existing JACIE certification will, in most respects, face a process of formalisation rather than fundamental change. Their internal frameworks already address donor eligibility, traceability, adverse event reporting, and process validation. The regulatory transition will demand documentation, registration, and adaptation, but not reinvention.
Smaller centres, newer programmes, and those operating in Member States with less developed national oversight infrastructure face a more significant adjustment. For these centres, the Regulation may impose administrative requirements: registration with national competent authorities, systematic vigilance reporting, formalised quality management documentation that exceed current practice. The risk, if not managed proactively, is that compliance burden falls disproportionately on programmes that are already operating at capacity.
The longer-term question for JACIE, and for the certification model more broadly, is how the relationship between professional certification and statutory regulation will evolve once SoHO is fully implemented. JACIE's value has always been that it sets standards above the regulatory floor: Standards that reflect what best practice looks like, not simply what the law requires. As the SoHO Regulation embeds itself in national regulatory systems, JACIE must maintain its capacity to continue raising those standards, incorporating new evidence, new clinical developments including the rapidly expanding landscape of gene therapy and novel cellular products and new patient safety imperatives. The 10th Edition standards process, and the ongoing development of the IEC framework, will be central to this.
The SoHO Regulation is an important piece of legislation, and its implementation will require sustained engagement from every part of the transplantation community. EBMT and JACIE bring to this process decades of accumulated clinical, scientific, and operational expertise, translated into standards that have been tested in real transplant programmes across Europe and beyond. That expertise is the foundation of our contribution to SoHO implementation and its effective deployment is, ultimately, what advocacy and quality of care mean in practice.
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