Asked by: Sarah Green (Liberal Democrat - Chesham and Amersham)
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 to respond to the Patient Safety Commissioner's report entitled 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.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
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 to respond to the Patient Safety Commissioner's report entitled 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.
Asked by: Derek Thomas (Conservative - St Ives)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when she plans to respond to the report by the Patient Safety Commissioner 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.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the HM Treasury:
To ask the Chancellor of the Exchequer, if he will make provision for compensation to those affected by sodium valproate in the forthcoming Budget.
Answered by Laura Trott - Chief Secretary to the Treasury
On 7 February, the Patient Safety Commissioner published The Hughes Report, which provides recommendations for redress for those harmed by valproate and pelvic mesh.
The Government is carefully considering these recommendations and will respond to the report in due course.
Asked by: Daniel Kawczynski (Conservative - Shrewsbury and Atcham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps she is taking to ensure that men who have taken Sodium Valproate receive compensation for (a) fertility and (b) other health effect.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Our sympathies remain with those affected by sodium valproate. The Government is carefully considering the Patient Safety Commissioner’s recommendations as set out in the Hughes Report: Options for redress for those harmed by valproate and pelvic mesh, published on 7 February 2024, and will respond substantively in due course.
As part of the Medicines and Healthcare products Regulatory Agency’s ongoing monitoring of valproate safety, we continue to rigorously review all emerging data on valproate.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020, what discussions they have had regarding the provision of monetary compensation for people adversely affected by clinical and surgical pelvic mesh.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work looking at redress for people harmed by pelvic mesh and sodium valproate. The work is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take.
The Patient Safety Commissioner office has stated that the report setting out the findings from this work is expected to be published on 7 February this year. The Government will consider the report’s findings before deciding how to proceed on this matter.
The Government published its response to the Independent Medicines and Medical Devices Safety review in July 2021, which did not accept the recommendation to establish a redress agency, this position remains unchanged.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what recent assessment they have made of the recommendation for an Independent Redress Agency in the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work looking at redress for people harmed by pelvic mesh and sodium valproate. The work is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take.
The Patient Safety Commissioner office has stated that the report setting out the findings from this work is expected to be published on 7 February this year. The Government will consider the report’s findings before deciding how to proceed on this matter.
The Government published its response to the Independent Medicines and Medical Devices Safety review in July 2021, which did not accept the recommendation to establish a redress agency, this position remains unchanged.
Asked by: Gavin Williamson (Conservative - South Staffordshire)
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 - South Staffordshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department has plans to raise awareness among (a) healthcare professionals and (b) patients of the safe (i) prescription and (ii) use of sodium valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Information to support the safe use of medicines such as valproate is provided in the product information which consists of the summary of product characteristics for healthcare professionals and the patient information leaflet that is supplied with each pack of medicines. The Medicines and Healthcare products Regulatory Agency has issued many communications in its Drug Safety Update bulletin informing and raising awareness among healthcare professionals about safety concerns associated with valproate, particularly the risks associated with use of valproate during pregnancy.
Preparations are underway to introduce new measures to ensure all healthcare professionals and patients are aware of the reproductive risks associated with valproate which will be supported by a comprehensive information once the details are finalised.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent discussions he has had with the Patient Safety Commissioner on a timetable for compensation for people harmed by sodium valporate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Government has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work looking at redress for people harmed by sodium valproate. The work is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take.
The Patient Safety Commissioner is expected to publish a report of her current work examining options for redress for those harmed by sodium valproate and pelvic mesh in early 2024. Ministers will consider the report’s findings before deciding how to proceed on this matter.