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 discussions he has had with his international counterparts on the relevance of the UN Convention on the Rights of Persons with Disabilities to individuals harmed by sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
My Rt Hon. Friend, the Secretary of State for Health and Social Care, has not had specific discussions with international counterparts regarding the relevance of the UN Convention on the Rights of Persons with Disabilities to individuals harmed by sodium valproate. Our focus remains on improving the safety of sodium valproate, so it is not used for women or girls of childbearing potential unless a pregnancy prevention plan is in place and other treatments are ineffective or not tolerated. The Government is also carefully considering the recommendations made by the Patient Safety Commissioner in The Hughes Report, which sets out options for redress for those harmed by 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 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 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:
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, 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, 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 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.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
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, whether interim compensation payments have been considered for families involved in the first ten claims of the FAC litigation concerning sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
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 he has made of the potential merits of providing financial compensation to people harmed by sodium valproate by using the same compensation process as for thalidomide survivors.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department’s consideration of the Hughes Report’s recommendations for redress for those harmed by sodium valproate will include comparison with the compensation process for thalidomide survivors. However, 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 that the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.