Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
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.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the impact of current legislation on substances of human origin on the UK’s ability to compete globally in life sciences growth and innovation.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
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.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to reduce waiting times for diagnostic cardiology services, and what assessment they have made of the potential role of digital health solutions in improving patient outcomes.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
We inherited a broken National Health Service, and reducing elective waiting lists is a key part of getting it back on its feet and building an NHS that is fit for the future. To that end we have committed to achieving the NHS Constitutional standard that 92% of patients should wait no longer than 18 weeks from referral to treatment by March 2029. Cutting waiting times for diagnostic tests, including those for cardiology, is a crucial step in reducing the elective waiting list.
My Rt. Hon. Friend, the Chancellor of the Exchequer announced at the October statement £600 million of capital to support the reduction of diagnostic waiting lists, which includes continued investment in new and expanded community diagnostic centres (CDCs), new acute hospital diagnostic equipment, and investment in digital diagnostic capabilities.
Between July 2024 and August 2025, existing CDCs have carried out a total of 286,260 echocardiography tests and 260,040 electrocardiography tests. Many CDCs are also implementing innovative cardiac pathways to speed up diagnosis and access to treatment for patients with symptoms suggestive of cardiac disease. Our Elective Reform Plan commits to building up to five new CDCs in 2025/26, alongside increasing the operating hours of existing sites so that more offer services 12 hours a day, seven days a week.
The NHS is investing in digital health solutions to improve patient outcomes in cardiology. This includes enabling remote patient monitoring, early intervention, and greater patient engagement through personalised management plans and educational tools. These solutions allow for continuous data collection from home, which helps clinicians detect and respond to deterioration sooner, potentially preventing hospital admissions and improving long-term health management. They also support early detection, diagnosis, and monitoring.
In addition, NHS England has invested in digital capability which is helping to speed up the reporting of tests routinely used in cardiology services, including artificial intelligence cardiac computed tomography and magnetic resonance imaging.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, with regard to The Hughes Report published on 7 February 2024, when they will provide interim compensation to people impacted by sodium valproate.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is carefully considering the work by the Patient Safety Commissioner and her report, which set out options for redress for those harmed by valproate and pelvic mesh. This is a complex issue involving input from different Government departments. The Government will provide a further update to the Patient Safety Commissioner’s report.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the potential savings to the NHS and social care services from adopting value-based procurement of incontinence care for people living with dementia, in particular having regard to the impact on hospital admissions, staffing costs and laundry costs.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has been working in partnership with NHS England and the NHS Supply Chain to develop national Value Based Procurement (VBP) Standard Guidance which will be published in early 2026. The guidance shifts the procurement focus from upfront cost to how a product can best deliver improved patient outcomes and value.
The Department is conducting live pilots to test the draft standard guidance, with National Health Service trusts and integrated care boards, from September to December 2025. Insights from the pilots will be used to refine the guidance and implementation plans ahead of final publication, including the support needed for NHS trusts to adopt the guidance.
Under the 10-Year Health Plan, those living with dementia will benefit from improved care planning and better services. Supporting this, the VBP Standard Guidance will enable the procurement of the most effective products that improve patient experience and outcomes, including for those living with dementia and requiring absorbent incontinence products, as well as improve NHS efficiency.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what support they will provide to NHS trusts in rolling out value-based procurement to ensure that patient outcomes such as dignity and quality of life are prioritised alongside value for money as assessed in the context of reductions in whole system costs.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has been working in partnership with NHS England and the NHS Supply Chain to develop national Value Based Procurement (VBP) Standard Guidance which will be published in early 2026. The guidance shifts the procurement focus from upfront cost to how a product can best deliver improved patient outcomes and value.
The Department is conducting live pilots to test the draft standard guidance, with National Health Service trusts and integrated care boards, from September to December 2025. Insights from the pilots will be used to refine the guidance and implementation plans ahead of final publication, including the support needed for NHS trusts to adopt the guidance.
Under the 10-Year Health Plan, those living with dementia will benefit from improved care planning and better services. Supporting this, the VBP Standard Guidance will enable the procurement of the most effective products that improve patient experience and outcomes, including for those living with dementia and requiring absorbent incontinence products, as well as improve NHS efficiency.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the impact of value-based procurement of absorbent incontinence products on maintaining dignity and quality of life for people living with dementia in NHS and social care settings.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has been working in partnership with NHS England and the NHS Supply Chain to develop national Value Based Procurement (VBP) Standard Guidance which will be published in early 2026. The guidance shifts the procurement focus from upfront cost to how a product can best deliver improved patient outcomes and value.
The Department is conducting live pilots to test the draft standard guidance, with National Health Service trusts and integrated care boards, from September to December 2025. Insights from the pilots will be used to refine the guidance and implementation plans ahead of final publication, including the support needed for NHS trusts to adopt the guidance.
Under the 10-Year Health Plan, those living with dementia will benefit from improved care planning and better services. Supporting this, the VBP Standard Guidance will enable the procurement of the most effective products that improve patient experience and outcomes, including for those living with dementia and requiring absorbent incontinence products, as well as improve NHS efficiency.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what discussions they have had with the Scottish Government and Northern Ireland Executive about establishing a national allergy register in the UK.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to improving care for people with allergies, and ensuring that they receive high-quality care and support and access to the latest treatments.
NHS England does not collect national data on allergy prevalence or services, nor does it issue specific guidance. In conducting health needs assessments to inform their commissioning decisions, integrated care boards will have access to a wide range of data sources, including public health data, hospital statistics, primary care data, and social care metrics.
Data regarding all anaphylaxis-related deaths in England and Wales are documented by the Office for National Statistics, and the British Society for Allergy and Clinical Immunology also holds a register to capture and learn from fatal cases of anaphylaxis, which has been operational since 1992, namely the UK Fatal Anaphylaxis Registry (UKFAR).
NHS England’s National Patient Safety Team is working with the UKFAR to develop a mechanism for sharing relevant patient safety information relating to anaphylaxis incidents, including the reporting of anaphylaxis in hospitals. The aim will be for the UKFAR to extract and share patient safety incidents reported to the national databases, the National Reporting and Learning System and the Learn from Patient Safety Events service, relating to severe allergic reactions. Work has been progressing on this, and a search strategy has been agreed upon.
For these reasons, the Government has had no discussions with the Scottish Government or Northern Ireland Executive about establishing a national allergy register in the United Kingdom. However, the Department co-chairs the Expert Advisory Group on Allergy, which brings together external allergy stakeholders, the Department and representatives from the devolved governments, to discuss the development of an external national allergy strategy that will be presented to the four governments of the UK to respond in early 2026. The group aims to support the growth and delivery of comprehensive specialist allergy services across the UK.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they will take to establish a national allergy register for England and Wales.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to improving care for people with allergies, and ensuring that they receive high-quality care and support and access to the latest treatments.
NHS England does not collect national data on allergy prevalence or services, nor does it issue specific guidance. In conducting health needs assessments to inform their commissioning decisions, integrated care boards will have access to a wide range of data sources, including public health data, hospital statistics, primary care data, and social care metrics.
Data regarding all anaphylaxis-related deaths in England and Wales are documented by the Office for National Statistics, and the British Society for Allergy and Clinical Immunology also holds a register to capture and learn from fatal cases of anaphylaxis, which has been operational since 1992, namely the UK Fatal Anaphylaxis Registry (UKFAR).
NHS England’s National Patient Safety Team is working with the UKFAR to develop a mechanism for sharing relevant patient safety information relating to anaphylaxis incidents, including the reporting of anaphylaxis in hospitals. The aim will be for the UKFAR to extract and share patient safety incidents reported to the national databases, the National Reporting and Learning System and the Learn from Patient Safety Events service, relating to severe allergic reactions. Work has been progressing on this, and a search strategy has been agreed upon.
For these reasons, the Government has had no discussions with the Scottish Government or Northern Ireland Executive about establishing a national allergy register in the United Kingdom. However, the Department co-chairs the Expert Advisory Group on Allergy, which brings together external allergy stakeholders, the Department and representatives from the devolved governments, to discuss the development of an external national allergy strategy that will be presented to the four governments of the UK to respond in early 2026. The group aims to support the growth and delivery of comprehensive specialist allergy services across the UK.