The Government set out an ambitious programme for change in its full response to the Independent Medicines and Medical Devices Safety (IMMDS) Review in 2021. At its core, this is about improving patient safety by putting patient voice at the centre, strengthening the evidence base on which decisions are made and improving safety by embracing opportunities to reform regulatory frameworks.

I was encouraged by the appointment of Dr Henrietta Hughes as England's first Patient Safety Commissioner. Dr Hughes acts as an independent point of contact for patients ensuring that their concerns are heard and also works to support the NHS and the Government better understand what can be done to put patients first and promote their safety. The Health and Care Act also established the Health Services Safety Investigations Body to investigate patient safety incidents in England. 

It cannot be ignored that the Report of the IMMDS Review is one of several independent reports and inquiries to have concluded that our healthcare system disproportionately fails to listen to women and keep them safe. This must change. The publication of England's first ever Women’s Health Strategy sets out to expand women's health-focused education for doctors, commission new research into healthcare professionals' experience of listening to women to inform policy and update guidance for women-specific health conditions such as endometriosis.

I am encouraged by the recent publication of a one-year update on progress to implement the accepted recommendations and actions for improvement put forward by the Independent Medicines and Medical Devices Safety Review. This report shows that the Government has and will continue to make substantial progress. 

I will of course continue to engage with this issue on behalf of any of my constituents impacted by hormone pregnancy tests, mesh implants, and sodium valproate in particular.

In April 2022, the ninth specialist mesh centre opened in Bristol. Women from every region now have access to the specialist support services they need, including pain management, psychological support and surgical mesh removal. As of October 2022, over 1,900 patients had been referred for treatment.

The first annual clinical summit took place on 6 December 2022, where all 9 mesh centres came together to share best practice in setting up the centres, delivering patient-centred care, and ensuring robust data collection to support continued improvement. To ensure these centres are supporting women as intended, the Department will work with NHS England to review mesh centre outcomes and patient experience.

The Government takes safety concerns associated with sodium valproate very seriously. Significant measures were introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018 to further reduce the use of valproate during pregnancy, including the introduction of the Pregnancy Prevention Programme and smaller pack sizes to encourage monthly prescribing with a pictogram/warning image on valproate packaging.

The MHRA and NHS Digital have developed the Medicines and Pregnancy Registry to improve our ability to monitor implementation and compliance with the Pregnancy Prevention Programme. This tracks all women in England who are taking NHS-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. The latest data from the registry shows that the number of pregnant women prescribed valproate in a 6-month period has fallen from 68 women in April to September 2018, to 17 women in October 2021 to March 2022. Last year the registry was also expanded to cover other anti-epileptic drugs in addition to sodium valproate.

Existing approaches to reduce the number of pregnant women exposed to sodium valproate are important and are making a difference, but there is no room for complacency, and we still need to do more. For that reason, the independent Commission on Human Medicines (CHM) has considered a comprehensive assessment by MHRA which included input from patients and other key stakeholders and a review of the available data.

The CHM has advised that there should be greater scrutiny of the way sodium valproate is prescribed and that further risk minimisation measures are required, in particular that two specialists should independently consider and document that there is no other effective or tolerated treatment. The CHM has established an implementation group to support the safe introduction of the new measures into clinical practice. The implementation group includes representation from across the healthcare system.

The proposed new measures will be implemented over the coming months according to patient priorities so that they can be introduced safely. In the meantime, health professionals are being reminded that sodium valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated, and the Pregnancy Prevention Plan should be closely adhered to. It is important to note that patients taking sodium valproate are strongly advised to continue to do so until reviewed by a healthcare professional.

Last year the Government held a consultation on original pack dispensing and whole pack dispensing of medicines containing sodium valproate, which included a proposal that medicines containing sodium valproate are always dispensed in the original manufacturer’s packaging. This would ensure patients, and particularly women and girls of childbearing potential, always receive the patient information leaflet with warnings about taking the medicine while pregnant.

The Government has considered the responses received and will shortly publish a response to the consultation.

Following extensive scoping work the Government has concluded that the best and fastest way to deliver a medical devices information system is by increasing the scope and coverage of outcome registries.

The Government aims to increase the scope and coverage of medical device outcome registries from 15 per cent to 80 per cent of high-risk procedures over the next three years. As well as device tracking the registries will include patient outcomes and patient experience, helping us deliver on wider objectives such as better information about individual consultants’ performance, which was highlighted in the Paterson inquiry.

The IMMDS review stated that transparency of payments made to clinicians needs to improve. The Government is in a piloting phase for the declaration of doctor’s interests in NHS and independent settings. Healthcare providers will publish this information to ensure it is more accessible to patients.

During the pilot, the Government will seek feedback from healthcare providers, doctors, and patients on the feasibility and cost of establishing and maintaining systems across different healthcare settings; the content of standardised templates and guidance; and the accessibility of information for patients. Full implementation will begin in 2023. Once the Government has a system in place for doctors, it will consider systems for other healthcare professionals.