Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what evidence (a) his Department and (b) the MHRA have on the numbers of people harmed by Sodium Valproate in pregnancy.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
Everyone who has been harmed from sodium valproate has our deepest sympathies. The Department does not collect information about the numbers of people harmed by sodium valproate in pregnancy.
The Medicines and Healthcare products Regulatory Agency has received 1,169 United Kingdom spontaneous suspected adverse drug reaction reports for sodium valproate related to use during pregnancy, from the initial licensing of the medicine up to 24 June 2025. The majority of reports relate to birth defects or developmental delays in the child.
These are well documented risks for women taking sodium valproate during pregnancy, and as such sodium valproate must not be prescribed to women under the age of 55 years old who are able to have children, unless two specialists independently consider and document that there is no other effective or tolerated treatment, and the patient fulfils the conditions of a Pregnancy Prevention Programme.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what data his Department holds on the number of people affected by Valproate.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
Everyone who has been harmed from sodium valproate has our deepest sympathies.
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:
The information requested is not held centrally.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans his Department has to financially respond to increases in the number of children affected by Valproate in pregnancy.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
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 in due course.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if monies will be noted in the April budget which includes the interim payment for people impacted by Valproate.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The Spring Statement demonstrated that the Government has taken the decisions necessary to provide security, reform the state, and grow the economy. The Government remains committed to holding only one major fiscal event a year, to give families and businesses the certainty they need on tax and spending changes.
The Government is carefully considering 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. 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.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many and what proportion Integrated Care Boards do not provide funding for IVF services.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
All 42 integrated care boards offer at least one cycle of in vitro fertilisation.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to help increase the provision of covid-19 booster vaccinations to community pharmacies.
Answered by Maria Caulfield
Community pharmacies have been taking part in the COVID-19 vaccination programme since January 2021. NHS England has recently changed the model for procuring COVID-19 vaccination services to an opt-in model. All community pharmacies who applied, and met the minimum requirements, received a contract to deliver COVID-19 vaccinations. This enabled more pharmacies to support the autumn 2023/24 booster campaign, administering COVID-19 vaccinations alongside flu vaccinations, which are also increasingly being administered in these settings.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the adequacy of funding allocated by his Department to community defibrillator projects.
Answered by Will Quince
No assessment has been made. The Government’s £1 million Community Automated External Defibrillators (AED) fund will provide an estimated 1,000 new defibrillators across England, with the potential for this to double as successful applicants will be asked to match the funding they receive partially or fully.
As of 22 September 2022, community organisations can now apply for a grant to fund a life-saving defibrillator for their local area. Applications for funding will be submitted to Smarter Society and the London Hearts Charity, who will assess each application against set criteria, ensuring that each AED is placed where they are needed most. They have designed engagement and application processes to appeal to a wide and diverse audience.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the consultation entitled Original pack dispensing and supply of medicines containing sodium valproate, published in November 2021, what assessment his Department has made of the potential impact of the (a) proposal to always dispense those medicines in the original manufacturer's packaging and (b) other proposals in that consultation on consumers.
Answered by Will Quince
The amendments to the Human Medicines Regulations 2012 to enable original pack dispensing of medicine and require whole-pack dispensing of medicines containing valproate were signed on 13 September 2023 and come into force on 11 October 2023.
An impact assessment was published on 19 March 2023 and is available at the following link:
https://www.legislation.gov.uk/uksi/2023/1015/impacts
This impact assessment was informed by responses to the consultation that we held on the proposals and sets out the Department’s assessment of the impact of the regulation changes for original pack dispensing and whole pack dispensing of medicines containing valproate.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he plans to take steps to secure financial redress for the victims of Primodos.
Answered by Maria Caulfield
The Government published its response to the Independent Medicines and Medical Devices Safety (IMMDS) review in July 2021, which did not accept the recommendation to establish separate redress schemes for the three interventions covered by the review. This included a redress scheme for those harmed by Primodos.
Our priority is to make medicines and devices safer, and the Government is pursuing a wide range of activity to further this aim. The 2021 response, and the Government’s December 2022 update to the response, explains the changes that have been put in place since the IMMDS Review report’s publication, and the further action the Government will take to implement the recommendations accepted and to improve patient safety.
In the recent House of Commons debate of 7 September 2023 on hormone pregnancy tests, I committed to review the outstanding recommendations in relation to Primodos.
Asked by: Gavin Williamson (Conservative - Stone, Great Wyrley and Penkridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has held discussions with Bayer on the potential effects of Primodos.
Answered by Maria Caulfield
Whilst the Medicines and Healthcare products Regulatory Agency (MHRA) has not had discussions with Bayer more broadly on the topic of Primodos and adverse effects in pregnancy, it has held discussions with Bayer on whether Bayer held scientific data for consideration by the Expert Working Group on Hormonal Pregnancy Tests. All data considered by the Group were published, and further discussions between MHRA and Bayer were therefore held to discuss whether the data required redaction of names or personal information prior to publication.