Question to the Department of Health and Social Care:

To ask His Majesty's Government whether they have established a timeline for reforming substances of human origin legislation; and when draft legislation is expected to be published.

The Substances of Human Origin (SoHO) Regulation Review Programme launched in 2024 to consider recent changes that the European Union (EU) has made to its SoHO Regulation ((EU) 2024/1938) as well as stakeholder proposals for legislation in this area. It is reviewing patient safety, the 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. Once the review has concluded a decision will be made about potential changes to legislation.

In addition, recognising the transformative potential of cell and gene therapies, the Department has stood up an advanced therapies co-ordination group to create a joined-up ecosystem that will support the development, regulation, and delivery of cell and gene therapies in the UK.