Written questions by Blackman.

Whether the Government has made an assessment of the potential merits of piloting a no-fault compensation model for individuals harmed by sodium valproate.

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.

What assessment has been made of the MHRA’s effectiveness at communicating known risks of sodium valproate, particularly in pregnancy, prior to 2018.

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.

Whether interim compensation payments have been considered for families involved in the first ten claims of the FAC litigation concerning sodium valproate.

The Department has not specifically considered interim compensation for the families involved in the Fetal Anti‑Convulsant litigation. On redress more broadly, I met with the Patient Safety Commissioner in December 2025, to discuss 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.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.

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.

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.

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).

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.

What data NHS England holds on emergency admissions, emergency care and levels of unmet need among individuals harmed by sodium valproate.

The requested data is not centrally held. NHS England does not hold data on admissions or attendances that specifically identifies individuals harmed by sodium valproate.

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.

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.

Whether the Government records deaths where harm caused by sodium valproate exposure is listed as a contributing factor.

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:https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/methodologies/userguidetomortalitystatisticsjuly2017#:~:text=Mortality%20statistics%20are%20gathered%20using,data%20for%20the%20previous%20period

What assessment he has made of the implications for his policies of international no-fault compensation schemes for medicine-induced harm, including those in New Zealand, Sweden and Denmark, in relation to sodium valproate.

The Department’s consideration of the Hughes Report’s recommendations for redress for those harmed by sodium valproate will take account of how other countries have chosen to approach this issue.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 Patient Safety Commissioner in December 2025, to discuss progress following the Hughes Report, and made clear the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.

How many Yellow Card reports relating to harm from sodium valproate, including prenatal exposure, have been received since 2000; and what regulatory action followed.

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.

What assessment has been made of whether NHS care pathways are adequate for individuals harmed by sodium valproate that require lifelong, multidisciplinary 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.

What learning has been implemented following the coroner’s finding that harm from sodium valproate exposure contributed to the death of Jake Aldcroft.

Everyone who has been harmed from sodium valproate has our deepest sympathies.Action has been taken to minimise the risk of foetal harm associated with valproate, and to ensure that healthcare professionals are also able to support any babies and families that are affected. The valproate Pregnancy Prevention Programme ensures that women and girls taking valproate understand the potential risks should they become pregnant, are using effective contraception, and are regularly monitored. It is supported by educational materials for healthcare professionals and patients.The programme was updated in January 2024 to reflect updated Medicines and Healthcare Products Regulatory Agency advice that valproate must not be started in new patients, either male or female, younger than 55 years old, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.

What guidance exists for Integrated Care Boards on supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.

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.

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.

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.

Whether the Government plans to mandate structured medication reviews for patients receiving long-term sodium valproate, particularly as part of antiepileptic polytherapy.

There are no current plans to mandate Structured Medication Reviews (SMRs) specifically for patients receiving long-term sodium valproate. NHS England has, however, provided substantial funding to expand the number of clinical pharmacists working in primary care networks, with a key part of their role being to undertake SMRs for groups of patients who are most likely to benefit. Whilst treatment with sodium valproate does not, in itself, guarantee an SMR, an SMR might be triggered if a patient meets certain criteria, for example, if they are considered to have complex and problematic polypharmacy or if they are in a care home.

What steps are being taken to ensure cumulative drug toxicity and polypharmacy risks are actively monitored in people prescribed sodium valproate.

There are established systems within the National Health Service to ensure that cumulative drug toxicity and polypharmacy risks are actively monitored in people prescribed sodium valproate. In practice, this involves establishing arrangements for assessing, reviewing, and monitoring the ongoing need for treatments, and, given that sodium valproate is almost invariably initiated in secondary care, clear shared-care arrangements between secondary and primary care clinicians, supported by the involvement of pharmacists, to minimise the risks associated with cumulative drug toxicity and polypharmacy.

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.

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.

Whether conditions arising from sodium valproate exposure are consistently recognised and coded within NHS diagnostic systems.

The National Health Service in England collects data on patients suffering adverse effects of medication and on drug poisoning. While adverse conditions arising from sodium valproate would be captured in this data, the data does not go to the level to identify sodium valproate and is not aligned to coding within NHS diagnostic systems.

Whether medicine-induced harm from sodium valproate is systematically captured within NHS patient safety, incident and mortality data.

The National Health Service in England operates a comprehensive central database, the Learn From Patient Safety Events (LFPSE) service, which is a national NHS system for the recording and analysis of patient safety events that occur in healthcare. It collates all records of patient safety incidents made by healthcare providers. Where local healthcare providers identify and record incidents related to sodium valproate, that information will be collated by the LFPSE.On mortality data, 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:https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/methodologies/userguidetomortalitystatisticsjuly2017#:~:text=Mortality%20statistics%20are%20gathered%20using,data%20for%20the%20previous%20period

What steps are being taken in response to inaccuracies, omissions and loss of NHS medical records relating to historic sodium valproate prescribing.

Affected patients who feel there are inaccuracies or omissions in their medical record can ask for their records to be amended. NHS England’s guidance on amending patient and service user records is available at the following link:https://transform.england.nhs.uk/information-governance/guidance/amending-patient-and-service-user-records/Where patients are not satisfied with the response to their request, they can make a complaint to the Information Commissioner’s Office.