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, whether the Government has made an assessment of the potential merits of piloting a no-fault compensation model for individuals harmed by sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has not yet undertaken an assessment of the potential merits of piloting a no-fault compensation model for individuals harmed by sodium valproate.
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, how many Yellow Card reports relating to harm from sodium valproate, including prenatal exposure, have been received since 2000; and what regulatory action followed.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) publishes data received via the Yellow Card scheme in the form of interactive Drug Analysis Profiles (iDAPs). These interactive profiles display a complete listing of all suspected adverse drug reactions (ADRs) that have been reported to the MHRA via the Yellow Card scheme for particular drug substances. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies. You will be able to find information here for several different data points such as the number of ADR reports by year, age and sex, as well as information of the types of reactions included in the reports for valproic acid. Guidance concerning the interpretation of the information included is provided at the bottom of each iDAP page. It is particularly important to note that reports are not confirmed side effects to a medication and that incidence cannot be derived since a number of factors influence the reporting of ADRs.
Warnings about possible risks associated with the use of valproate during pregnancy are included in the product information. These have been updated as new data has emerged. The Pregnancy Prevention Programme was introduced in 2018, due to concerns that pregnancies exposed to valproate continued to be reported. A further review by the Commission of Human Medicines on the reproductive risks of valproate resulted in additional regulatory action being implemented in January 2024 to help ensure women receive the information on reproductive risks and are only prescribed valproate if two specialists consider and document that there is no other effective or tolerated treatment. Communications about these updates were distributed to healthcare professionals in the United Kingdom via the MHRA’s bulletin Drug Safety Update.
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 steps he has taken to ensure that people who have brought forward cases relating to the unsafe prescription of sodium valproate are not denied access to justice due to their (a) cases being complex and (b) disability.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS Resolution (NHSR) is the body that manages clinical negligence and other claims against the National Health Service in England, and a full list of their clinical schemes can be found at the following link:
https://resolution.nhs.uk/services/claims-management/clinical-schemes/
NHSR has published in their most recent Annual Report and Accounts, for 2024/25, that they offer simplified processes for vaginal mesh claims and sodium valproate claims to be reported to them by unrepresented claimants. They refer to these simplified processes as gateways. Further details can be found on page 41 of their NHS Resolution Annual report and accounts 2024/25, at the following link:
https://resolution.nhs.uk/wp-content/uploads/2025/07/NHS-Resolution-ARA-24-25_ACCESSIBLE.pdf
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, whether his Department has estimated the lifetime public cost of not compensating individuals with complex disabilities caused by sodium valproate exposure, including costs to the NHS, social care and the Department for Work and Pensions.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department of Health and Social Care has not made an estimate of the lifetime public cost of not compensating individuals affected by in‑utero exposure to sodium valproate, including potential costs to the National health Service, social care services, or the Department for Work and Pensions.
I met with the Patient Safety Commissioner in December 2025, to discuss progress on the Hughes Report which made recommendations for redress for those harmed by sodium valproate exposure. I made clear the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders as the Government considers the issue of redress.
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 the Government records deaths where harm caused by sodium valproate exposure is listed as a contributing factor.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Office for National Statistics (ONS) collects and publishes mortality statistics for deaths registered in England and Wales. Deaths in which harm caused by sodium valproate exposure is a contributing factor are not captured as a distinct, searchable category in ONS mortality statistics. Further information on mortality statistics is available on the ONS website, at the following link: