Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when his Department plans to consult on reforms to the UK’s Substances of Human Origin; and whether that consultation will include proposals on (a) innovation, (b) patient safety and (c) donor protection.

The Substances of Human Origin (SoHO) Regulation Review Programme launched in 2024 to consider recent changes that the European Union has made to its SoHO Regulation ((EU) 2024/1938) as well as stakeholder proposals for legislation in this area. It is reviewing: patient safety; intra-United Kingdom and UK-EU supply of SoHO; innovation within the sector; and health inequalities.

A key principle of the review is to maintain compatible high levels of minimum safety and quality standards for blood, blood components, tissues and cells, human breast milk, intestinal microbiota and blood preparations that are not used for transfusion, to support public health and the movement of SoHO. A targeted consultation, planned to launch by the end of 2025, will give stakeholders the opportunity to share views and highlight key issues and opportunities.