Written question asked by Baroness Ritchie of Downpatrick (Labour) on Monday, 6 October 2025, in the House of Lords. It was due for an answer on Monday, 20 October 2025. It was answered by Baroness Merron (Labour) on Tuesday, 21 October 2025 on behalf of the Department of Health and Social Care.
Advanced Therapy Medicinal Products
- Question
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To ask His Majesty's Government what steps they plan to take to support innovators’ confidence in developing cell and gene therapies in the UK; and what plans they have to amend substances of human origin legislation to accommodate new innovations in the collection and use of substances of human origin products.
- Answer
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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.
Secondary information
- Type
- Written question
- Reference
- HL10833
- Session
- 2024-26
- Grouped for answer
- Yes
- Subjects
- Advanced therapy medicinal products Substances of human origin
- Link
- View this Written question on www.parliament.uk
Librarians' tools
- Timestamp
- 2025-10-21 10:50:19 +0100
- URI
- http://data.parliament.uk/writtenparliamentaryquestion/lords/2024-26/HL10833
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