Written questions by Smith.

If (a) he and (b) the Minister for Public Health and Prevention will meet the hon. Member for Lancaster and Wyre to discuss further safety issues to prevent avoidable harm from Sodium Valproate in pregnancy.

The Medicines and Healthcare products Regulatory Agency (MHRA) is taking proactive steps to inform the public on the very latest safety issues relating to sodium valproate in pregnancy. The MHRA has, most recently in May 2025, approved updated safety and educational materials to support the implementation of the pregnancy prevention programme and the regulatory measures announced in the November 2023 National Patient Safety Alert, as well as the September 2024 Drug Safety Update. We would welcome the Hon. Member to write to the Department, where we can provide due consideration to any points raised.

What discussions he has had with the Chancellor of the Exchequer on the potential merits of providing interim payments for people avoidably harmed by Sodium Valproate.

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.

What steps he is taking to ensure that disabled children with a diagnosis of Foetal Valproate Syndrome between the ages of 16yrs old and 18 yrs old receive the full amount of care which was given during their paediatric years.

Everyone who has been harmed by sodium valproate has our deepest sympathies.NHS England recognises that healthcare transition should be need and complexity based, not managed solely on diagnosis or what is routinely provided. Its Children and Young People’s Transformation Programme, along with key stakeholders, has developed a framework to aid the design of healthcare transition pathways that reduce health inequalities and improve health outcomes for all young people.The guidance outlines key principles and examples of models of care for those aged between zero and 25 years old, including clearer accountability and improved services for those aged 16 to 17 years old. NHS England is due to publish this guidance later this summer.

What steps is he taking to ensure that people harmed by the drug Valproate in pregnancy will be fully compensated.

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.

Whether he has allocated funding for Valproate (a) financial redress and (b) interim payments.

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.

What steps his Department is taking to ensure that disabled children between the ages of 16 and 18 with a diagnosis of foetal valproate syndrome receive the full amount of care that was provided during their paediatric years.

Everyone who has been harmed by sodium valproate has our deepest sympathies.NHS England recognises that healthcare transition should be need and complexity based, not managed solely on diagnosis or what is routinely provided. Its Children and Young People’s Transformation Programme, along with key stakeholders, has developed a framework to aid the design of healthcare transition pathways that reduce health inequalities and improve health outcomes for all young people.The guidance outlines key principles and examples of models of care for those aged between zero and 25 years old, including clearer accountability and improved services for those aged 16 to 17 years old. NHS England is due to publish this guidance later this summer.

With reference to the oral contribution of the Parliamentary Under-Secretary of State for Health and Social Care in the debate of 27 March 2025 on Hughes Report: First Anniversary, Official Report, column 472WH, what his planned timetable is for considering the costs of the Patient Safety Commissioner's report on valproate.

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.

What steps his Department is taking to support (a) GPs and (b) other healthcare professionals to distribute the pregnancy prevention program for people prescribed Sodium Valproate.

The Medicines and Healthcare products Regulatory Agency (MHRA), taking advice from the Commission on Human Medicines (CHM), has worked to raise awareness among healthcare professionals and patients of the risks of valproate when taken during pregnancy through several updates to the valproate Summary of Product Characteristics for healthcare professionals, as well as Patient Information Leaflets and educational materials. The magnitude and type of risks associated with valproate use in pregnancy have been communicated in articles in the MHRA’s bulletin, Drug Safety Update, and letters through the NHS Central Alerting System, supported by messages from professional bodies and reinforced through changes to clinical guidelines and improved alerts in general practitioner prescribing systems.The valproate Pregnancy Prevention Programme, implemented in 2018, 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.In January 2024, the MHRA communicated in an article in Drug Safety Update advice from the CHM 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 (PPP) are undertaken by a single specialist.In May 2025, further updates to the PPP’s educational materials have been made available to all healthcare professionals and patients electronically, and these will be sent to healthcare professionals in a hard copy format that can provided to patients, to support the discussions between healthcare professionals and patients.

Whether his Department has met with Sanofi to discuss the topic of redress for people affected by Sodium Valproate in pregnancy since July 2024.

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.

What estimate he has made of the number of potential claimants for redress for valproate.

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.

How many children who are diagnosed with having an Autistic Spectrum Disorders also have a diagnosis of Foetal Valproate Syndrome.

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.

How many children with a diagnosis of Foetal Valproate Syndrome also have a diagnosis of (a) Spina Bifida, (b) neural tube defects, (c) Cardiac/heart malformations, (d) Kidney malformations and (e) cleft lip and/or palate.

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

What steps his Department is taking to reduce the four out of 10 cases of cancer which are preventable.

The Government recognises the importance of primary and secondary prevention, to reduce the number of people with cancer.There are significant national programmes across vaccination, screening, and education, which have the potential to support both reductions in cases of cancer, and increases in early diagnosis rates. For example, human papillomavirus (HPV) vaccination has led to a substantial reduction in cervical cancer cases. All children aged 12 to 13 years old in England, those in Year 8, are offered the HPV vaccine, and NHS England is taking action to increase uptake, as outlined in the NHS Cervical Cancer Elimination Plan. In addition, the NHS Cervical Screening Programme provides all women between the ages of 25 and 64 years old with the opportunity to be screened routinely to detect certain types of HPV infection, which is the cause of 99.7% of cervical cancer.Smoking is the cause of 72% of all lung cancers, and in response to this, the Government is committed to creating a smoke-free generation through the introduction of the Tobacco and Vapes Bill, which will gradually end the sale of tobacco products across the country.The Government and the National Health Service also recognise that a healthy lifestyle can help reduce the biggest risk factors of certain cancers. To address risks related to overweight and obesity across the United Kingdom, the Government has laid secondary legislation to restrict advertisements of less healthy food and drink products, and is taking steps to ensure the Soft Drinks Industry Levy remains effective. In England, to promote physical activity, the NHS’s Better Health Campaign signposts people to digital support like the NHS Active 10 walking app. The Department will continue to work across the Government to understand how to reduce alcohol-related harms in England and the UK. The Government and the NHS recognise the importance of physical activity for the prevention and management of long-term health conditions.The National Cancer Plan, planned for publication later this year, will set out how we will fight cancer on all fronts, from prevention to diagnosis, treatment, and research.

Whether the National Cancer Plan will place a priority on (a) recognising and (b) addressing the cancer risks associated with alcohol.

Alcohol has been identified as a causal factor in more than 200 medical conditions, including mouth, throat, stomach, liver and breast cancers. The Government is committed to reversing the trend on alcohol-specific deaths and shortening the amount of time people spend in ill-health related to due to alcohol-related harm.Under our Health Mission, the Government is committed to prioritising preventative public health measures to support people to live longer, healthier lives. The Department will continue to work across Government to better understand how we can best reduce alcohol-related harms. Furthermore, the National Cancer Plan will cover the entirety of the cancer pathway, from referral and diagnosis to treatment and ongoing care- as well as prevention and research and innovation. The plan will build on the shift from sickness to prevention set out by the 10-Year Health Plan and will seek to reduce risk factors.The United Kingdom Chief Medical Officers’ low-risk drinking guidelines state: “The risk of developing a range of health problems (including cancers of the mouth, throat and breast) increases the more you drink on a regular basis” and that “To keep health risks from alcohol to a low level it is safest not to drink more than 14 units a week on a regular basis”. The low risk drinking guidelines are available at the following link:https://assets.publishing.service.gov.uk/media/5a80b7ed40f0b623026951db/UK_CMOs__report.pdf

What steps his Department is taking to (a) recognise and (b) address the increased risk of developing cancer associated with alcohol consumption.

Alcohol has been identified as a causal factor in more than 200 medical conditions, including mouth, throat, stomach, liver and breast cancers. The Government is committed to reversing the trend on alcohol-specific deaths and shortening the amount of time people spend in ill-health related to due to alcohol-related harm.Under our Health Mission, the Government is committed to prioritising preventative public health measures to support people to live longer, healthier lives. The Department will continue to work across Government to better understand how we can best reduce alcohol-related harms. Furthermore, the National Cancer Plan will cover the entirety of the cancer pathway, from referral and diagnosis to treatment and ongoing care- as well as prevention and research and innovation. The plan will build on the shift from sickness to prevention set out by the 10-Year Health Plan and will seek to reduce risk factors.The United Kingdom Chief Medical Officers’ low-risk drinking guidelines state: “The risk of developing a range of health problems (including cancers of the mouth, throat and breast) increases the more you drink on a regular basis” and that “To keep health risks from alcohol to a low level it is safest not to drink more than 14 units a week on a regular basis”. The low risk drinking guidelines are available at the following link:https://assets.publishing.service.gov.uk/media/5a80b7ed40f0b623026951db/UK_CMOs__report.pdf

Whether his Department has made an assessment of the potential impact of introducing mandatory health labelling on alcoholic drinks on public health.

In ‘Fit for the Future: 10 Year Health Plan for England’, the Government has committed to strengthen and expand on existing voluntary guidelines for alcohol labelling by introducing a mandatory requirement for alcoholic drinks to display consistent nutritional information and health warning messages. The Plan is available at the following link:https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-futureCurrently there is voluntary guidance on communicating the United Kingdom Chief Medical Officers' low risk drinking guideline, which recommends labels include info that to keep health risks from alcohol to a low level it is safest not to drink more than 14 units a week on a regular basis, and to include a warning against drinking during pregnancy. The Department has commissioned a National Institute for Health and Care Research study on understanding the impact of alcohol calorie labelling on alcohol and calorie selection, purchasing, and consumption. This study is due to report in 2026.

Whether his Department plans to consult on the potential merits of introducing mandatory standards for the labelling of alcohol products to include information on the risk of (a) drinking during pregnancy, (b) liver disease and (c) cancer.

In ‘Fit for the Future: 10 Year Health Plan for England’, the Government has committed to strengthen and expand on existing voluntary guidelines for alcohol labelling by introducing a mandatory requirement for alcoholic drinks to display consistent nutritional information and health warning messages. The Plan is available at the following link:https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-futureCurrently there is voluntary guidance on communicating the United Kingdom Chief Medical Officers' low risk drinking guideline, which recommends labels include info that to keep health risks from alcohol to a low level it is safest not to drink more than 14 units a week on a regular basis, and to include a warning against drinking during pregnancy. The Department has commissioned a National Institute for Health and Care Research study on understanding the impact of alcohol calorie labelling on alcohol and calorie selection, purchasing, and consumption. This study is due to report in 2026.

Pursuant to the Answer of 16 May 2025 to Question 51501 on Sodium Valproate: Compensation, which Government departments he is having discussions with on developing a timetable for implementation of the recommendations of the Hughes Report.

The Government is carefully considering the valuable work done by the Patient Safety Commissioner and the resulting Hughes Report, which set out options for financial and non-financial redress for those harmed by valproate and pelvic mesh. Department officials are liaising with other parts of the Government, including the National Health Service, the Department for Work and Pensions, the Ministry of Housing, Communities and Local Government, the Department for Business and Trade, HM Treasury, and the devolved administrations, on the needs of patients and on the recommendations. We will be providing an update to the Patient Safety Commissioner’s report at the earliest opportunity.

What steps he is taking with Cabinet colleagues to support women with epilepsy.

The Government is committed to prioritising women’s health, placing women’s equality at the heart of our agenda and ensuring women’s health is never again neglected.At a national level, there are several initiatives supporting service improvement and better care for patients with epilepsy, including women, such as the RightCare Epilepsy Toolkit, and the Getting It Right First Time Programme (GIRFT) for Neurology and the Neurology Transformation Programme (NTP).The GIRFT National Specialty Report made recommendations designed to improve services nationally and to support the National Health Service to deliver care more equitably across the country. The National Specialty Report highlighted differences in how services are delivered and offered an unprecedented opportunity to share successful initiatives between trusts to improve patient services nationally.Building on the GIRFT National Specialty Report, the NTP has developed a model of integrated care for neurology services to support integrated care boards (ICBs) to deliver the right service, at the right time for all neurology patients, including providing care closer to home. A toolkit is being developed to support ICBs to understand and implement this new model.The RightCare Epilepsy Toolkit includes specific recommendations regarding supporting women with epilepsy. For example, it states that support should be provided to women with epilepsy who are pregnant and those who are of childbearing age which makes clear the risks of certain anti-epileptic drugs that are known to cause birth defects, such as sodium valproate.The Toolkit also makes clear that it is equally important to provide clear information and guidance on the risks of stopping an anti-epileptic drug treatment, which include Sudden Unexpected Death in Epilepsy, that is not related to causing birth defects, and the risks that poses to the mother and unborn baby to support balanced informed decisions on care.

With reference to the Answer of 27 January 2021 to Question 137239 on Prescription Drugs, what information his Department holds on the number of patients who have been prescribed drugs categorised under the (a) (i) clonazepam and (ii) other benzodiazepines, (b) z-drugs, (c) antidepressants, (d) opioids, (e) pregabalin and (f) gabapentin drug groups in the (A) last 12 months and (B) the previous 12 month period for which data is available.

The following table shows the number of items dispensed and claimed for reimbursement for each of the categories requested, covering the most recently published 12-month period and the 12 months prior:Drug groupFinancial yearTotal number of itemsClonazepam2022/231,048,0812023/241,059,421Other benzodiazepines2022/237,156,8452023/246,814,129Clonazepam and other benzodiazepines2022/238,204,9262023/247,873,550Z-drugs2022/235,316,6272023/245,113,574Antidepressants2022/2386,263,7222023/2489,131,582Opioids2022/2339,401,5172023/2439,046,206Pregabalin2022/238,775,6992023/249,180,793Gabapentin2022/237,413,7592023/247,408,375Source: NHS Business Services Authority.In addition, the following table shows the patient identifiable information for the number of items dispensed and claimed for reimbursement for each of the categories requested, for the most recently published 12-month period and the 12 months prior:Drug groupFinancial YearTotal number of unique identified patientsPercentage of items where the patient has been identifiedClonazepam2022/2385,61398.22%2023/2485,19198.16%Other benzodiazepines2022/231,253,96297.06%2023/241,186,00197.01%Clonazepam and other benzodiazepines2022/231,324,79297.21%2023/241,256,94197.17%Z-drugs2022/23795,959 98.29%2023/24764,743 98.27%Antidepressants2022/238,563,148 99.16%2023/248,747,095 99.22%Opioids2022/235,593,035 98.92%2023/245,562,718 98.94%Pregabalin2022/23786,403 99.36%2023/24823,231 99.41%Gabapentin2022/23808,562 99.36%2023/24799,144 99.41Source: NHS Business Services Authority.Notes:for clonazepam and other benzodiazepines, this is the number of unique patients who have received any combination of clonazepam and/or other benzodiazepines, and no patient is counted twice even where multiple medications have been received;the figures for pregabalin and gabapentin refer to the combined category of gabapentinoids; andthe data in this answer in both tables on opioids, is not directly comparable to data from the previous Parliamentary Questions, PQ137238 and PQ137239, referenced in the question, as these tables refer to opioids in general, while the previous Parliamentary Questions referred to opioid analgesics only.