The Department continues to take forward work to explore redress for those affected by pelvic mesh and sodium valproate, which includes recommendations made by the Patient Safety Commissioner in the Hughes Report. We recognise the importance of these issues for all those affected. This remains a cross-Government policy area involving multiple organisations, and given the complexity of the issues involved, it is important we get this right.

I met with the Patient Safety Commissioner in December 2025, to discuss progress following the Hughes Report and have made clear the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.

The Department does not hold information regarding the number of children that have been harmed by sodium valproate use during pregnancy, or those who have received a diagnosis of foetal valproate spectrum.

The National Disease Registration Service in NHS England collects and quality assures data about people with congenital conditions and rare conditions across the whole of England.

In the most recent official statistics on congenital conditions in England, the 2022 Congenital Condition Official Statistics Report, which contains information on congenital conditions detected in babies delivered in England between 1 January and 31 December 2022, as well as in previous publications of this series back to its inception in 2018, there were no foetus' or babies reported to have a diagnosis of fetal sodium valproate syndrome.

It is likely that while some of the individual conditions, for instance neural tube defects, cardiac, oro-facial clefts, and/or limb difference, that can be associated with this condition are recorded on the register, the overarching diagnosis of fetal sodium valproate syndrome may not yet be registered because fetal sodium valproate syndrome may take more than a year after birth to be confirmed as a diagnosis, so the number reported in any year is the minimum level in the population.

The National Disease Registration Service is assessing the feasibility and reliability of better ascertainment of fetal sodium valproate syndrome by linking the congenital condition register to primary care prescription data.

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.

The NHS England-commissioned Fetal Exposure to Medicine Pilot project covers assessment, expert advice, and treatment planning for people impacted by sodium valproate and other anti-seizure medications.

On the question of interim payments to valproate families, 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, including a recommendation for a two-stage financial redress scheme, comprising of an interim scheme and a main scheme.

This is a complex issue involving input from different Government departments, including the Cabinet Office. The Government will provide a further update to the Patient Safety Commissioner’s report.

Everyone who has been harmed from sodium valproate has our deepest sympathies.

Early diagnosis and the effective monitoring of foetal valproate syndrome is being considered as part of NHS England’s commissioned Fetal Exposure to Medicine Pilot project. The pilot project is being led by the Newcastle Upon Tyne NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot project started in December 2024 and will run for 18 months, and provides assessment, expert advice, and treatment planning for people impacted by sodium valproate and other anti-seizure medications. The pilot project will be presenting initial learning and key themes, including any additional investment requirements identified, to NHS England at the end of September to inform discussions about future service delivery models and options for wider coverage across England.

Commissioners will consider additional funding requests, alongside the need to maintain all existing services and other statutory funding duties.

The department does not have any plans to collect information on the numbers of children with special educational needs (SEN) who have foetal valproate spectrum disorder.

The department is committed to improving support for all children and young people with special educational needs and disabilities (SEND), including those with foetal valproate spectrum disorder. The SEND code of practice makes it clear that meeting the needs of a child with SEN does not require a diagnostic label. Instead, we expect teachers to monitor the progress of all pupils and put support in place where needed.

Research already exists that shows evidence of an increased risk for children of neurodevelopmental disorders, such as autism, when exposed to Valproate during pregnancy. This includes the Medicines & Healthcare products Regulatory Agency’s publication, Valproate: review of safety data and expert advice on management of risks.

As this link is already identified in the evidence and research available, NHS England has no plans to collate further information about the number of children with autism also diagnosed with foetal valproate syndrome.

NHS England is exploring options for strengthening the provision of specialist training for healthcare professionals when supporting people impacted by sodium valproate through its Fetal Exposure to Medicine Pilot project. The pilot project is being led by the Newcastle Upon Tyne NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot project started in December 2024 and will run for 18 months, and provides assessment and expertise to support diagnosis and treatment planning for people impacted by sodium valproate and other anti-seizure medication. The pilot project will be presenting initial learning and key themes, including staff development and training recommendations for healthcare professionals, to NHS England at the end of September. This will inform wider discussions about service delivery models and wider coverage across England.

Everyone who has been harmed from sodium valproate has our deepest sympathies.

To improve the support available to children and adults impacted by sodium valproate, NHS England commissioned a Fetal Exposure to Medicine Pilot project. The pilot project is being led by the Newcastle Upon Tyne NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot project started in December 2024 and will run for 18 months, and provides assessment, expert advice, and treatment planning for people impacted by sodium valproate and other anti-seizure medication. The pilot project will be presenting initial learning and key themes to NHS England at the end of September to inform discussions about future service delivery models and options for wider coverage across England.

Everyone who has been harmed from sodium valproate has our deepest sympathies. The information requested is not collected centrally.

The National Disease Registration Service in NHS England, which collects and quality assures data about people with congenital anomalies and rare diseases across the whole of England, is assessing the feasibility and reliability of better ascertainment of foetal sodium valproate syndrome by linking data in the congenital anomaly register to primary care prescription data. Further information on the National Disease Registration Service is available at the following link:

https://digital.nhs.uk/ndrs

The Department will continue to work across Government and with the National Health Service to reduce waiting times to access support for the mental and physical health needs of people with rare conditions like foetal valproate spectrum disorder.

There are mechanisms in place 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. These are considered to be more targeted than a public awareness campaign.

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, and describes the neurodevelopmental disorders and major congenital malformations associated with the use of valproate in pregnancy, with information available electronically and in a hard copy format for healthcare professionals.

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. It was advised that women and girls of childbearing potential already receiving valproate should have their treatment discussed by two specialists at their next annual review. The requirement for two specialists to review these patients is a one off, and subsequent annual reviews required under the Pregnancy Prevention Programme are undertaken by a single specialist.

Further information on the valproate pregnancy prevention programmes is available at the following link:

https://www.gov.uk/drug-safety-update/valproate-pregnancy-prevention-programme-actions-required-now-from-gps-specialists-and-dispensers

In addition, there are 14 Maternal Medicine Networks, in place across England, who provide expert care to women with complex medical conditions, including epilepsy, before, during, and after pregnancy, to ensure appropriate investigation and management to improve maternal and foetal outcomes.

The department does not hold statistics on how many children with foetal valproate spectrum disorder are issued with education, health and care (EHC) plans.

Information on the primary type of need for all children and young people with EHC plans is available here: https://explore-education-statistics.service.gov.uk/data-tables/permalink/f9f635d7-6712-4e64-172f-08ddbed4c851.

The government recognises that children who have Foetal Valproate Spectrum Disorder (FVSD) can present with a range of learning needs, and thus schools have a legal responsibility to support them. Schools must use their best endeavours to make sure a child or young person gets the special educational provision they need, this includes monitoring the progress of pupils regularly and putting support in place where needed, which may include a specialist assessment.

The special educational needs and disabilities (SEND) code of practice sets out that all schools should apply a ‘graduated approach’ when deciding on the provision to be made for a particular child or young person with special educational needs, such as FVSD.

Pupils at school with medical conditions should be properly supported so that they have full access to education. In 2014, the government introduced a duty on schools to support pupils with all medical conditions and published statutory guidance intended to help governing bodies meet their legal responsibilities. This guidance sets out the arrangements they are expected to make, based on good practice. Schools should ensure they are aware of any pupils with medical conditions and should have policies and processes in place to ensure these can be well managed.

‘Supporting pupils at school with medical conditions’ can be found here: https://assets.publishing.service.gov.uk/media/5ce6a72e40f0b620a103bd53/supporting-pupils-at-school-with-medical-conditions.pdf.

The department is committed to improving support for all children and young people with SEND, including those with FVSD.

The government recognises that children who have Foetal Valproate Spectrum Disorder (FVSD) can present with a range of learning needs, and thus schools have a legal responsibility to support them. Schools must use their best endeavours to make sure a child or young person gets the special educational provision they need, this includes monitoring the progress of pupils regularly and putting support in place where needed, which may include a specialist assessment.

The special educational needs and disabilities (SEND) code of practice sets out that all schools should apply a ‘graduated approach’ when deciding on the provision to be made for a particular child or young person with special educational needs, such as FVSD.

Pupils at school with medical conditions should be properly supported so that they have full access to education. In 2014, the government introduced a duty on schools to support pupils with all medical conditions and published statutory guidance intended to help governing bodies meet their legal responsibilities. This guidance sets out the arrangements they are expected to make, based on good practice. Schools should ensure they are aware of any pupils with medical conditions and should have policies and processes in place to ensure these can be well managed.

‘Supporting pupils at school with medical conditions’ can be found here: https://assets.publishing.service.gov.uk/media/5ce6a72e40f0b620a103bd53/supporting-pupils-at-school-with-medical-conditions.pdf.

The department is committed to improving support for all children and young people with SEND, including those with FVSD.

The government recognises that children who have Foetal Valproate Spectrum Disorder (FVSD) can present with a range of learning needs, and thus schools have a legal responsibility to support them. Schools must use their best endeavours to make sure a child or young person gets the special educational provision they need, this includes monitoring the progress of pupils regularly and putting support in place where needed, which may include a specialist assessment.

The special educational needs and disabilities (SEND) code of practice sets out that all schools should apply a ‘graduated approach’ when deciding on the provision to be made for a particular child or young person with special educational needs, such as FVSD.

Pupils at school with medical conditions should be properly supported so that they have full access to education. In 2014, the government introduced a duty on schools to support pupils with all medical conditions and published statutory guidance intended to help governing bodies meet their legal responsibilities. This guidance sets out the arrangements they are expected to make, based on good practice. Schools should ensure they are aware of any pupils with medical conditions and should have policies and processes in place to ensure these can be well managed.

‘Supporting pupils at school with medical conditions’ can be found here: https://assets.publishing.service.gov.uk/media/5ce6a72e40f0b620a103bd53/supporting-pupils-at-school-with-medical-conditions.pdf.

The department is committed to improving support for all children and young people with SEND, including those with FVSD.

Everyone who has been harmed from sodium valproate has our deepest sympathies. Information about the number of children diagnosed with an autistic spectrum disorder and a diagnosis of foetal valproate syndrome is not collected centrally.

As part of National Health Service reform, the Department has launched a transformation programme, led by a senior responsible officer. The Department is engaging with partners to ensure their experiences and interests are considered in shaping the future NHS.

The valuable work done by the Patient Safety Commissioner and the resulting Hughes Report, which set out options for redress for those harmed by valproate and pelvic mesh, is being considered by the Government. This is a complex area of work, involving several Government departments, and it is important that we get this right. We will be providing an update to the Patient Safety Commissioner’s report at the earliest opportunity.

Everyone who has been harmed from sodium valproate has our deepest sympathies. Information about the number of children diagnosed with an autistic spectrum disorder and a diagnosis of foetal valproate syndrome is not collected centrally.