Asked by: John Glen (Conservative - Salisbury)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to help improve coordination between health, education, and social care services for families affected by sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Everyone who has been harmed from sodium valproate has our deepest sympathies.
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support, including co-ordination with non-health care services.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the NHS in Newcastle and Manchester. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, better coordination of care, and reduced reliance on emergency care. Findings from the pilot will inform future decisions on the commissioning of services, subject to funding.
In addition, we work closely with the Department for Education and across the Government to ensure co-ordination between health, education, and social care services for children and their families. The Health and Opportunity Missions of the Government highlight the importance of joined up working and integrated delivery.
Asked by: Manuela Perteghella (Liberal Democrat - Stratford-on-Avon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to help tackle the harm caused by sodium valproate to people in (a) England, (b) Warwickshire, and (c) Stratford-on-Avon.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Everyone who has been harmed from sodium valproate has our deepest sympathies.
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the NHS in Newcastle and Manchester. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, better coordination of care, and reduced reliance on emergency care. Findings from the pilot will inform future decisions on the commissioning of services, subject to funding.
The Government is also carefully considering the Patient Safety Commissioner’s recommendations made in the Hughes Report, which includes proposed approaches to redress for those harmed by sodium valproate. I recently met the Patient Safety Commissioner to provide an update on the ongoing health initiatives led by the Department regarding sodium valproate and pelvic mesh, and agreed to providing an update on her report recommendations in due course.
Asked by: Claire Young (Liberal Democrat - Thornbury and Yate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential merits of providing compensation to patients treated with rectopexy mesh for rectal prolapse as part of its work on redress following the recommendations of the Hughes Report, published on 7 February 2024.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
As set out in the Hughes Report, the Government is carefully considering the Patient Safety Commissioner’s (PSC’s) recommendations, including the proposed approaches to redress for those harmed by pelvic mesh. The Hughes Report did not cover patients treated with rectopexy mesh for rectal prolapse. This is because rectal prolapse does not fall within the original definition of Pelvic Organ Prolapse that the PSC and the Independent Medicines and Medical Devices Safety Review adopted, namely a pelvic organ bulging into the vagina.
However, that is not to dismiss the very real concerns of these patients. We are considering whether rectopexy mesh should be included in the scope of the work on redress, as for example, NHS England has carried out a market engagement event to understand which of its currently commissioned mesh centres would be willing to provide mesh removal surgery for colorectal patients. A decision around which centres will be designated will be made following findings from the audit of existing mesh centres.
This is a complex, cross-Government policy area involving multiple organisations. This work requires coordinated input from several departments, and we will provide a further update in due course. I met with the PSC in December 2025, to discuss progress following the Hughes Report. I have subsequently written to Dr Hughes about the actions we are undertaking to ensure service-level interventions are embedded in the National Health Service specific to making a real-life impact on those affected by pelvic mesh and valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether NHS England plans to commission specialist multidisciplinary services for people affected by sodium valproate exposure, including care coordination, to help reduce emergency admissions and diagnostic times.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of the adequacy of the diagnostic time taken and levels of misdiagnosis among individuals harmed by sodium valproate, and its impact on long-term outcomes.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of whether NHS care pathways are adequate for individuals harmed by sodium valproate that require lifelong, multidisciplinary care.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what guidance exists for Integrated Care Boards on supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department has taken since 2020 to implement the IMMDS Review recommendations on redress for those harmed by sodium valproate; and if he will publish a timetable for delivery.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The previous administration accepted seven of the nine recommendations of the Independent Medicines and Medical Devices Safety Review, whether in full, in part, or in principle, including issuing an unreserved apology on behalf of the healthcare system, appointing Dr Henrietta Hughes as the first Patient Safety Commissioner for England, and establishing nine specialist mesh centres now operating across the country.
This is a complex, cross Government policy area involving multiple organisations. As set out in the Hughes Report, the Government is carefully considering the Patient Safety Commissioner’s recommendations, including the proposed approaches to redress for those harmed by sodium valproate. This work requires coordinated input from several departments, and we will provide a further update in due course.
I met with the Patient Safety Commissioner in December 2025, to review progress on the Hughes Report and made clear that the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the feasibility of establishing a dedicated, no-fault compensation scheme for individuals harmed by sodium valproate exposure, in the context of the recommendations of the Independent Medicines and Medical Devices Safety Review (2020).
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has not yet undertaken an assessment of the feasibility of establishing a dedicated, no-fault compensation scheme for individuals harmed by sodium valproate exposure, in the context of the recommendations of the Independent Medicines and Medical Devices Safety Review (IMMDS).
The previous administration accepted seven of the nine recommendations of the IMMDS Review, whether in full, in part, or in principle, including issuing an unreserved apology on behalf of the healthcare system, appointing Dr Henrietta Hughes as the first Patient Safety Commissioner for England, and establishing nine specialist mesh centres now operating across the country.
This is a complex, cross-Government policy area involving multiple organisations. As set out in the Hughes Report, the Government is carefully considering the Patient Safety Commissioner’s recommendations, including the proposed approaches to redress for those harmed by sodium valproate. This work requires coordinated input from several departments, and we will provide a further update in due course.
I met with the Patient Safety Commissioner in December 2025, to discuss progress following the Hughes Report and made clear that the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of the MHRA’s effectiveness at communicating known risks of sodium valproate, particularly in pregnancy, prior to 2018.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
As with all medicines, the safety of valproate has been kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA), ensuring the product information reflects what is known about valproate.
The known risks of valproate are outlined in the Summary of Product Characteristics and Patient Information Leaflet. Over the years information about the reproductive risks has been updated as data emerged. The MHRA also issued communications via their bulletins Current Problems and Drug Safety Update on valproate, particularly the reproductive risks.
The report of the Independent Medicines and Medical Devices Safety Review published in 2020 examined how the healthcare system, including MHRA and its predecessors, responded to risks from medicines and medical devices, including valproate, and annex C of the report includes a timeline of key events including communications and updates to the product information undertaken by the MHRA.
Since 2016, the MHRA has carefully reviewed feedback from patients and healthcare professionals within the Valproate Stakeholder Network (VSN) to assess the effectiveness of communications on the risks of sodium valproate use during pregnancy. The VSN also informed the design of a pictogram warning on the medicine carton and blister pack.
In addition, the MHRA has rigorously monitored the effectiveness of the communication of the known risks through healthcare professional and patient surveys started in 2014, which have formed part of a European Union wide post authorisation safety study for valproate.