Found: IMMDSR (Cumberlege) Review—July 2020 First Do No Harm, The report of the Independent Medicines and Medical

Found: the Independent Medicines and Medical Devices Safety Review (IMMDS Review) – also known as the ‘First

Question

To ask the Minister for Women and Equalities, If she will make an assessment of the potential impact on women's health of the Government's progress on implementing the recommendations of the report of the Independent Medicines and Medical Devices Safety Review entitled First Do No Harm, published on 8 July 2020.

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

Patient safety and women’s health is a top priority for this Government.

That’s why since the ‘First Do No Harm’ report we have:

o Appointed England’s first Patient Safety Commissioner

o Setup specialist centres for women impacted by mesh

o Piloted ways doctors can declare their interests

o And launched a national mandatory Medical Device Outcome Registry.

Beyond this, we published the first Women’s Health Strategy for England, which set out our plans for improving how the health and care system listens to women.

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.

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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government when they intend to implement all of the recommendations contained 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 Independent Medicines and Medical Devices Safety (IMMDS) Review was clear in its finding that the healthcare system failed to listen to patients’ concerns on the issues covered by the review. The Government’s 2021 response to the review set out which of the review’s recommendations the Government had accepted. We also published an update in an online-only format in December 2022 setting out progress made against those recommendations, which includes appointing the first ever Patient Safety Commissioner in England to champion patients’ voices in relation to the safety of medicines and medical devices. In April 2023, the Government also responded to the recommendations made by the Health and Social Care Committee in its report ‘Follow-up on the IMMDS report and the Government’s response’, published in January 2023. A copy of the follow-up report is attached.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of 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 Independent Medicines and Medical Devices Safety (IMMDS) Review was clear in its finding that the healthcare system failed to listen to patients’ concerns on the issues covered by the review. The Government’s 2021 response to the review set out which of the review’s recommendations the Government had accepted. We also published an update in an online-only format in December 2022 setting out progress made against those recommendations, which includes appointing the first ever Patient Safety Commissioner in England to champion patients’ voices in relation to the safety of medicines and medical devices. In April 2023, the Government also responded to the recommendations made by the Health and Social Care Committee in its report ‘Follow-up on the IMMDS report and the Government’s response’, published in January 2023. A copy of the follow-up report is attached.

Found: more harm than good to all involved, and breaches the fundamental health professional principle of ‘first

Found: The report also aligns with recommendations made in the ‘First do no harm’ report of the Independent

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.

Found: aim of the review was to: Baroness Cumberlege was appointed Chair of the review group and its report 'First

Found: First do no harm.