The Regulation on Standards of Quality and Safety for Substances of Human Origin (SoHO) Intended for Human Application (also referred to as the SoHO Regulation) came into force in the European Union (EU) in August 2024.
Under the Windsor Framework, the SoHO Regulation will apply in Northern Ireland but not Great Britain. The Regulation repeals existing Directives 2002/98/EC (relating to blood and blood components) and 2004/23/EC (relating to tissues and cells) and will take full effect from August 2027, following a three-year transition period.
Compared to previous Directives, the Regulation expands the range of activities and materials subject to quality and safety standards. It introduces an open definition of what classifies as SoHO and uses technical guidance to establish specific standards. This aims to enable the Regulation to keep pace with scientific and technical advancements. The Regulation also intends to enhance protection for donors and recipients. It shifts from establishing minimum standards to pursuing high levels of human health protection. Additionally, the Regulation seeks to harmonise standards across Europe while providing sufficient flexibility for legislation to adapt to scientific and clinical developments. The Regulation contains requirements to ensure a continuous supply of ‘critical’ SoHO and to uphold the voluntary unpaid donation of human blood, tissues, and cells. The latest Explanatory Memorandum from the UK Government offers further information about the regulation.
The HTA has commenced work to implement the SoHO Regulation in Northern Ireland and to assess any implications for establishments regulated by the HTA in Great Britain. This work will occur over multiple phases, concluding at the end of 2027. The first phase of this project aims to determine the responsibilities of the HTA and those we regulate under the SoHO Regulation. This will allow us to develop any relevant processes or guidance for those affected by the new European Regulation within the HTA’s remit.
Our priority is to ensure that the transition is managed effectively and that safety and quality standards for substances of human origin are upheld. Engaging with those affected by the new requirements is crucial to implementing the SoHO Regulation. If you would like to learn more about our work on implementing the SoHO Regulation or wish to express your interest in attending any future stakeholder engagement concerning the EU SoHO Regulation, please email us at policy@hta.gov.uk.