Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what interim arrangements are in place to ensure timely access to clinically appropriate treatments for patients with rare cancers, including metastatic ocular melanoma, while longer term commissioning decisions are under consideration.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government supports Scott Arthur’s Private Members Bill on rare cancers which will make it easier for clinical trials into rare cancers, including metastatic ocular melanoma patients, to take place in England by ensuring the patient population can be easily contacted by researchers. This will ensure that the National Health Service will remain at the forefront of medical innovation and is able to provide patients with the newest, most effective treatment options, and ultimately boost survival rates.
The Department remains committed to ensuring that rare cancer patients, including those with metastatic ocular melanoma, have timely access to treatment and tailored medical support.
Tebentafusp is a licensed treatment for uveal melanoma and has been recommended by the National Institute for Health and Care Excellence (NICE) and funded by NHS England since December 2024. Since funding commenced, over 100 patients have been registered to start treatment. At present, NHS England is not aware of any delays in access to Tebentafusp for eligible patients.
Alongside Tebentafusp, a policy proposition for melphalan chemosaturation was accepted onto the NHS England policy development work programme in March 2025, in line with the Methods for National Clinical Policies. Development of this policy is ongoing following receipt of the external evidence review. Progress updates are published through the NHS England Clinical Commissioning Work Programme, and NICE is concurrently updating its guidance. Until revised guidance is issued, the NHS continues to follow the recommendations in the current version.
The development of a Clinical Commissioning policy will determine both if the evidence is now sufficient to enable making the treatment routinely available and, if it is, whether to allocate service development funding to implement it across the NHS in England.
NHS England’s Individual Funding Request (IFR) Policy provides the framework through which requests outside routinely commissioned arrangements are considered. The IFR framework was last reviewed in 2022 and ensures fairness, consistency, and transparency in decision‑making across all applications relating to medicines, devices, or surgical interventions that fall within NHS England’s commissioning responsibilities.
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 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.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social 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.
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 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.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social 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.
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 has been made of whether NHS care pathways are adequate for individuals harmed by sodium valproate that require lifelong, multidisciplinary care.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social 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.
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 guidance exists for Integrated Care Boards on supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social 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.
Asked by: James McMurdock (Independent - South Basildon and East Thurrock)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps the Government is taking to increase public awareness of the Medicines and Healthcare products Regulatory Agency Yellow Card scheme for reporting medicine side effects and product issues.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to improving patient safety and strategically runs regular public health campaigns to raise awareness of patient safety in healthcare products and the importance of reporting to the Yellow Card scheme, which relies on voluntary reporting by healthcare professionals and the public, including patients, parents, and care givers. Further information on the MHRA is available at the following link:
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
A primary platform for education and awareness is the MHRA’s dedicated Yellow Card scheme website, which is regularly updated with educational resources, including Continuing Professional Development accredited e-learning modules, waiting-room videos, posters, and real-world case studies to support understanding of how and what to report as well as the importance of reporting. In 2025, the MHRA launched a new Yellow Card Partner Toolkit containing a package of materials specifically designed to support other organisations and networks in encouraging patient reporting.
To strengthen local engagement with the public, the MHRA commissions six Yellow Card Centres across the United Kingdom, covering the North and Yorkshire, the North West, the West Midlands, Scotland, Wales, and Northern Ireland, and which focus on education and the promotion of reporting with the public and healthcare professionals, as well as their representative organisations within their regions.
Additionally, all MHRA safety alerts and guidance signpost users to the Yellow Card scheme, and by law, every patient information leaflet that comes with a medicine includes information signposting patients to report suspected side effects via the Yellow Card scheme. There is also information on the importance of reporting to the Yellow Card scheme on all repeat paper prescriptions given to patients.
On World Patient Safety Day, most recently 17 September 2025, the MHRA announced that statutory relationships, sex, and health education guidance for schools in England would, for the first time, include information on recognising side effects and reporting them via the Yellow Card scheme. This initiative introduces children and young people to patient safety early, empowering them to speak up and contribute to safer healthcare.
The MHRA also proactively promotes awareness through presence at conferences such as the annual Health and Safety Journal Patient Safety Congress. In addition, the MHRA also supports a number of campaigns including MedSafetyWeek, which is now an annual international social media campaign which includes 117 countries that the MHRA initiated 10 years ago, to raise awareness of medicines safety and adverse incident reporting.
The MHRA has worked with the National Health Service to ensure that there are links to Yellow Card across every single NHS page relating to a medicine or vaccine, and the MHRA is also building upon this by working with NHS colleagues to support better links between the NHS app and Yellow Card, aiming for increased visibility of the Yellow Card scheme and improved reporting of suspected reactions by the public.
Together, these measures increase public awareness of the Yellow Card scheme, helping protect patient safety and strengthen monitoring of medicines and medical devices.
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 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.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
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, what assessment has been made of the MHRA’s effectiveness at communicating known risks of sodium valproate, particularly in pregnancy, prior to 2018.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
Asked by: James McMurdock (Independent - South Basildon and East Thurrock)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency plans to update its public communications strategy to increase the reporting of adverse reactions to medical supplements.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicines, for human use, medical devices, and blood components for transfusion in the United Kingdom.
If a “medical supplement” was covered by the definition of a medicinal product as set out in the Human Medicines Regulations 2012, or the definition of a medical device under Medical Devices Regulations, it would fall under the remit of the MHRA and would be subject to the relevant regulatory requirements. Food supplements are regulated by the Food Standards Agency.
Ongoing efforts to raise awareness of the Yellow Card scheme will enhance public understanding of the scheme’s remit and the range of healthcare products it covers, including the reporting of suspected side effects associated with herbal and/or homeopathic medicines, as set out in existing information and general awareness materials available on the Yellow Card scheme website.