The European Union has just ushered in a new era with a transformative regulation on Substances of Human Origin (SoHO), effectively modernizing a framework that had been in place for two decades! This sweeping reform is set to bolster the safety, quality, and cross-border circulation of these vital substances, keeping pace with scientific advancements and ensuring top-notch protection for both donors and recipients throughout the EU.
This new legal framework supersedes the former directives concerning blood, tissues, and cells, which have been in place for around two decades. By adopting a holistic approach to SoHO, the regulation better safeguards recipients, children born through medically assisted reproduction, and donors of these substances.
Effective Date and Scope:
Mark Your Calendars: Published on July 17, 2024 in the Official Journal of the EU, this regulation will be applicable across all EU Member States starting August 7, 2027.
Addressing EU-Level Challenges:
The old Blood and Tissues and Cells (BTC) directives were leaving gaps. Here’s what’s changing:
- Protection Levels Upgraded: Patients, donors, and children born from donated eggs, sperm, or embryos will now be shielded from preventable risks due to outdated legislation.
- Cross-Border Harmony: Clear, consistent oversight among Member States to smooth out those cross-border exchanges.
- Innovative Therapies Unleashed: More robust support for cutting-edge treatments, plus strategies to prevent interruptions in the BTC supply chain.
- Simplified Systems: A unified IT system to reduce unnecessary burdens.
Regulation Objectives:
Future-Proof Framework: This initiative is designed to be resilient and flexible, making it capable of accommodating new tech and evolving risks without ever compromising on safety and quality.
Broadening the Scope of SoHO:
- Going Beyond Blood, Tissues, and Cells: Now encompassing human breast milk and intestinal microbiota, with provisions to include future human-origin substances.
- Comprehensive Coverage: From donor registration and testing to collection, processing, and beyond to clinical outcome monitoring—this regulation has it all.
Key Features of the New Regulation
- Enhanced Scope: All SoHO, including the new additions, with a future-ready approach.
- High safety and quality standards, aligned with up-to-date technical regulations.
- Extended Protective Measures: New patient groups, donors, and offspring from assisted medically assisted reproduction, are now protected.
- Harmonization Across Member States: Facilitating cross-border SoHO exchange, enhancing patient access to necessary therapies.
- Innovation and Accessibility: safe, effective, and accessible innovation, led by public health services and voluntary, unpaid donations.
- Crisis Preparedness: Measures to handle emergencies and maintain supply.
- Digital-Ready Policies: For smoother, more efficient operations.
- Contribution to the European Health Union: Pooling expertise and resources for greater efficiency and impact.
Common EU Framework:
Quality and Safety Overhaul: Here’s how:
- EU-level SoHO coordination board: to support Member States in implementation.
- Streamlined Authorization Processes: EU-wide procedures for preparation authorization and assessment.
- Mandatory Designation of Authorities: Each Member State must have national authorities overseeing SoHO activities.
- Inspection and Authorization Criteria: Setting additional authorization and inspection requirements for any SoHO-handling establishment.
- EU SoHO Platform: for registering and exchanging information.
Reinforced Oversight by Competent Authorities:
- Registration Requirements: For all entities impacting SoHO safety and quality.
- Mandatory Authorizations: For processing, storage, release, import, or export entities.
- Risk-Based Evaluation and Authorization: To ensure safe use of SoHO preparations.
Collaboration and Expertise Development:
- Supporting existing technical bodies like the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) to update technical guidelines.
- Continuous Supply Measures: Encouraging measures to ensure continuous SoHO supply, helping Member States in crisis situations.
- SoHO coordination committee: to assist in regulation implementation and advice on regulatory status.
- Digital EU SoHO platform: for vigilance and increased transparency.
Voluntary and Unpaid Donation:
Donation Standards: As a principle, donations should be voluntary and unpaid, though living donors can be compensated or reimbursed according to national laws.
Safety and Vigilance:
Rapid Alert Systems: to manage incidents or reactions posing risks to recipients or donors. Member States must ensure a sufficient and resilient SoHO supply, including national emergency plans to address potential shortages.
Next Steps:
- August 7, 2027: The regulation will be applicable.
- 2028 Compliance Deadline: For Member States and the European Commission to verify whether already authorized establishments meet the new definition and to transmit information about SoHO preparations on the EU platform.
- Sanction Framework by 2028: Member States must determine applicable sanctions to ensure adherence.
Conclusion:
The new SoHO regulation is a game-changer, offering enhanced safety and quality and donors and recipients protection while fostering innovation and unity across the EU. This rigorous, forward-thinking framework is set to advance healthcare outcomes and keep the EU at the forefront of medical science.
Stay Informed:
Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application: