Found: review, which was a review of all the historical evidence on Primodos, as well as on vaginal mesh and sodium

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Hughes Report: Options for redress for those harmed by valproate and pelvic mesh, published by the Patient Safety Commissioner on 7 February 2024, whether she has made an assessment of the potential implication for her policies of the provision of financial redress for people harmed by valproate and pelvic mesh.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government is now carefully considering the PSC’s recommendations and will respond substantively in due course.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to The Hughes Report, published on 7 February 2024, if she will make an assessment of the potential merits of providing interim payments to victims of sodium valproate.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government is now carefully considering the PSC’s recommendations and will respond substantively in due course.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what her planned timetable is for making a decision on redress for people affected by mesh implants following the publication of The Hughes Report on 7 February 2024.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report, and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government is now carefully considering the PSC’s recommendations, and will respond substantively in due course.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what her Department's planned timescale is for responding to the Patient Safety Commissioner's report entitled The Hughes Report: Options for redress for those harmed by valproate and pelvic mesh, published on 7 February 2024.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report, and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government is now carefully considering the PSC’s recommendations, and will respond substantively in due course.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason the compensation scheme for people suffering from the effects of vaginal mesh operations does not cover all those impacted by the use of the same materials in rectopexy procedures.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report, and our sympathies remain with those affected by sodium valproate and pelvic mesh.

While the PSC does not include rectopexy mesh within her proposed definition of directly harmed patients for the purposes of her redress recommendations, we note that the PSC has said in her report that the Government needs to consider how to investigate issues related to harm caused by other uses of mesh going forward. The Government is now carefully considering the PSC’s recommendations, and will respond substantively in due course.

Found: in offspring, when used in pregnancy ever been reported by the marketing authorization Holder of a) Sodium

Found: offspring, when used in pregnancy ever been reported by the marketing authorization Holder of a) Sodium

Found: .: 99-66-1 (sodium valproate: 1069- 66-5) Rat NOAEL Dose Cmax AUC Rat LOAEL Dose Cmax

Found: members considered the group’s aims, and what had gone well and not so well previously in relation to the Sodium

Question

To ask the Scottish Government how many children have been affected as a consequence of their mothers being prescribed sodium valproate during pregnancy.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

We do not know the numbers of children affected because the information has not been collected historically.

In response to the Independent Medicines and Medical Devices Safety Review (IMMDSR), the Scottish Government commissioned Public Health Scotland (PHS) to establish a medicines in pregnancy surveillance asset. This resource will support monitoring and reporting to progress improvements in the safe use of valproate and other teratogenic medicines in Scotland. Its first output is due to be published by PHS in April 2024 and will include prescribing data and trends for valproate and other anti-seizure medicines.

Question

To ask the Scottish Government what arrangements are in place to compensate any children that have been affected as a consequence of their mothers being given sodium valproate during pregnancy, and when it expects compensation payments to commence.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

The Scottish Government will await the view and any decisions by the UK Government in relation to redress for anyone who was affected by exposure to valproate.

As set out in our letter to MSPs, this is because the recommendations on redress the UK Government is considering may involve a new agency and schemes that would be funded via a levy on manufacturers of medicines and medical devices and the Scottish Government has only limited powers under the devolution arrangements to impose levies.

We will of course update the Parliament about any important developments.

Question

To ask the Scottish Government, in light of it approaching four years since the report of the Independent Medicines and Medical Devices Safety Review, First Do No Harm, was published, and that three years have nearly passed since the Scottish Government published its plan for delivering on its commitment to implement, in full, the recommendations of the review, whether it will (a) provide an update on its delivery plan and (b) confirm when it expects to implement the remaining recommendations of the review to improve the lives of those impacted by sodium valproate, Primados and mesh implants.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

There has been progress in implementing the Scottish Government’s delivery plan:

• the Patient Safety Commissioner for Scotland Act 2023 established a Parliamentary Commissioner on patient safety
• the Glasgow Complex Mesh Surgical Service offers mesh removal surgery, and women can also choose an NHS England surgeon or an independent provider
• 25 women have had the costs of previously arranged private mesh removal surgery reimbursed
• the NHS Scotland Scan for Safety Programme for implantable medical devices is planned to roll out across territorial boards by the end of March 2026
• on valproate, the Medicines and Healthcare products Regulatory Agency introduced regulatory measures for the prescribing of valproate and we are working closely with the agency to support their implementation

The Scottish Government considers, further to the undertaking offered in 2021, that it is taking appropriate action to pursue the outcomes sought by all of the recommendations of the 2020 report insofar as they relate to devolved matters.