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.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to Section 9 Conflicts of interest in the Policy paper entitled Independent Medicines and Medical Devices Safety Review: update report on government implementation, published on 22 December 2022, and the Patient Representative Working Group, what patient groups were represented on that Working Group; how those patient groups were chosen and by whom; how many people in total were in the Working Group; and how many times the Working Group had met as on 6 January 2023.

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

The Department selected patient representatives through engagement with NHS England and the Devolved Governments. Our intention was to form a voluntary group that best represented patients across the four nations. Since March 2022, we have held two Patient Representative Groups (PRG). Four patient representatives attended each of the sessions. We expect to hold another PRG early in 2023 to discuss feedback on pilot systems.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will provide an update on plans for financial redress for those harmed by (a) mesh implants, (b) Primodos and (c) Sodium Valproate.

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

The Government’s response to the Independent Medicines and Medical Devices Safety Review did not accept the recommendation to establish separate redress schemes. We have worked with NHS Resolution to launch online claims gateways to support patients who may wish to bring a clinical negligence claim in relation to pelvic mesh and sodium valproate. We are improving the safety of medicines and medical devices through high standards for industry to market and manufacture products with the aim of reducing harm in future.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when he plans to substantively respond to Questions (a) 124936 on Surgical Mesh Implants: South East, due for Answer on 23 February, (b) 127247 on Medicines and Medical Devices Safety Independent Review, due for answer on 25 February and (c) 131025 on Members: Correspondence, seeking a response to a letter dated 6 December 2021 from the Rt hon. Member for New Forest East about a vulnerable constituent and due for answer on 3 March; for what reason none of the substantive answers have yet been forthcoming; and what steps he plans take to ensure that Questions receive a substantive answer on the date they are due.

Answered by Edward Argar - Minister of State (Ministry of Justice)

I refer the Rt hon. Member to the answers to Questions 124936, 127247 and 131025.

We take parliamentary scrutiny incredibly seriously and it is fundamentally important that hon. Members are provided with accurate and timely information to enable them to hold the Government to account. We are working rapidly to provide all Members with accurate answers to their questions, while supporting the Government’s response to the COVID-19 pandemic.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department plans to take in response to the letter to the Parliamentary Under-Secretary of State from Marie Lyon, Association for Children Damaged By HPT, Kath Sansom, Sling The Mesh, Emma Murphy and Janet Williams, In-Fact, on behalf of people damaged by vaginal mesh, sodium valproate and Primodos on the implementation of the recommendations of the Independent Medicines and Medical Devices Safety Review 2020 led by Baroness Cumberlege.

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

The Department’s central correspondence team have no record of receiving this letter. We would be happy to respond formally if the letter could be re-sent to the Department.

The Government’s response to the Independent Medicines and Medical Devices Safety Review accepted the majority of the nine strategic recommendations and 50 actions for improvement. The recommendations and actions for improvement included vaginal mesh and sodium valproate. We aim to publish an update on implementation of the accepted recommendations in the summer.

Question to the Department of Health and Social Care:

To ask Her Majesty's Government what plans they have to reconsider their response to the recommendation in the report of the Independent Medicines and Medical Devices Safety Review First do no harm, published on 8 July 2020, that separate schemes should be set up to meet the cost of providing additional care and support to those who have experienced avoidable harm from hormone pregnancy tests, valproate and pelvic mesh interventions.

Answered by Lord Kamall

The Government did not accept this recommendation and there are no plans to reconsider this response. Our priority is to make medicines and devices safer and we are pursuing a wide range of activity to further this aim. The response explains the changes that have been put in place since the Independent Medicines and Medical Devices Safety Review report’s publication and the further action the Government will take to implement the recommendations accepted and to improve patient safety.

Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the report by the Independent Medicines and Medical Devices Safety Review First do No Harm, published on 8 July 2020, what negotiations have taken place between the Department of Health and Social Care and Her Majesty’s Treasury about redress for those who have suffered harm from (1) Primodos, (2) sodium valproate, and (3) pelvic mesh.

Answered by Lord Bethell

The Department engaged with HM Treasury on redress prior to cross-Government approval of the response to the Independent Medicines and Medical Devices Safety Review.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the report of the Independent Medicines and Medical Devices Safety Review entitled First Do No Harm published in July 2020, what recent steps he has taken to progress implementation of the recommendation for a redress agency for people harmed by medicines and medical devices.

Answered by Nadine Dorries

The Government response to the Report of the Independent Medicines and Medical Devices Safety Review was published on 21 July. The Government stated that it did not accept recommendation three to establish a redress agency as set out in the report. The Government and others have previously established redress schemes without the need for an additional agency.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the report of the Independent Medicines and Medical Devices Safety Review report entitled First Do No Harm, published in July 2020, what recent steps he has taken to progress implementation of the recommendation that a register of the General Medical Council should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.

Answered by Nadine Dorries

The Government agrees that doctors’ financial and non-pecuniary interests should be available publicly. However, we do not think that the General Medical Council’s register is the best place to hold this information. We have engaged with healthcare professional regulators, to ensure it is a requirement that all registered healthcare professionals declare their interests and that this information is published locally by healthcare providers.

We are working with NHS England and NHS Improvement and the Independent Healthcare Providers Network to ensure this approach is consistently applied across the National Health Service and independent sector. We have worked with the Care Quality Commission to ensure that implementation is monitored. Our response has been informed by participants in a patient reference group and we have worked closely with the devolved administrations to ensure a consistent, United Kingdom-wide approach.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Independent Medicines and Medical Devices Review, published July 2020, what steps he is taking to fulfil recommendation six of that review, and whether he plans to make adverse event logging mandatory.

Answered by Nadine Dorries

In response to the Review, the Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a substantial programme of work to improve how it listens to patients and the public, to evolve United Kingdom medicines and medical devices regulation, develop a more responsive system for reporting safety incidents and strengthen the evidence to support timely and robust decisions that protect patient safety.

The Agency’s Delivery Plan published on 4 July sets out how the MHRA will deliver better patient and public involvement and a more responsive safety surveillance and risk management system. This includes the transformation of the Yellow Card reporting system where work has already begun. The MHRA is reviewing the issue of making reporting of adverse events mandatory for healthcare professionals and will be discussing this with other partners in the healthcare system with a view to making firm proposals in quarter 4 of 2021/22.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the report of the Independent Medicines and Medical Devices Safety Review report entitled First Do No Harm, published in July 2020, what recent steps he has taken to progress implementation of recommendation seven of that report on establishing a central patient-identifiable database.

Answered by Nadine Dorries

NHS Digital has put together a programme of work to establish an information system to collect information on surgical implants and devices from healthcare providers in England, currently focussed on pelvic floor, or mesh and related procedures, as a priority.

This will be followed by the development of a United Kingdom-wide Medical Device Information System (MDIS) with regulations being made under section 19 of the Medicines and Medical Devices Act 2021. This system will mean that in future, subject to regulations, we can routinely collect medical device, procedure and outcome data from public and private provider organisations across the UK and data submitted directly from patients. Formal public consultation on the MDIS regulations will begin later this year with the aim of laying the regulations 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 report of the Independent Medicines and Medical Devices Safety Review report entitled First Do No Harm, published in July 2020, what recent steps he has taken to progress implementation of recommendation five of that report on the rollout of specialist centres.

Answered by Nadine Dorries

As of April 2021, eight National Health Service trusts are working with NHS England and NHS Improvement to provide specialised services for women with complications of mesh inserted for urinary incontinence and vaginal prolapse. We continue to consider specialist centres for those adversely affected by medicines taken during pregnancy. Further detail on this recommendation will be included in the full response to the report to be published this year.