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1682680

registered interest
date	16/01/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	2
legislature	25277 pref label House of Lords
question text	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.
tabling member printed	Baroness Ritchie of Downpatrick
uin	HL1650
answer	answer is ministerial correction date of answer 24/01/2024 answer text <p>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.</p> answering member printed Lord Markham grouped question UIN HL1651 question first answered 24/01/2024 12:10:36 answering member 4948 label Biography information for Lord Markham attachment 1 file name IMMDS follow-up report (1).pdf title IMMDS follow-up report
tabling member	4130 label Biography information for Baroness Ritchie of Downpatrick

1682681

registered interest
date	16/01/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	2
legislature	25277 pref label House of Lords
question text	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.
tabling member printed	Baroness Ritchie of Downpatrick
uin	HL1651
answer	answer is ministerial correction date of answer 24/01/2024 answer text <p>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.</p> answering member printed Lord Markham grouped question UIN HL1650 question first answered 24/01/2024 12:10:36 answering member 4948 label Biography information for Lord Markham attachment 1 file name IMMDS follow-up report (1).pdf title IMMDS follow-up report
tabling member	4130 label Biography information for Baroness Ritchie of Downpatrick

1564490

registered interest
date	06/01/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	Kingston upon Hull West and Hessle
tabling member printed	Emma Hardy
uin	117892
answer	answer is ministerial correction date of answer 16/01/2023 answer text <p>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.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 16/01/2023 11:10:45 answering member 4492 label Biography information for Maria Caulfield
tabling member	4645 label Biography information for Emma Hardy

1548642

registered interest
date	05/12/2022
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	Enfield North
tabling member printed	Feryal Clark
uin	103060
answer	answer is ministerial correction date of answer 13/12/2022 answer text <p>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.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 13/12/2022 11:44:53 answering member 4492 label Biography information for Maria Caulfield
tabling member	4822 label Biography information for Feryal Clark

1434001

registered interest
date	22/02/2022
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	New Forest East
tabling member printed	Dr Julian Lewis
uin	127247
answer	answer is ministerial correction date of answer 21/03/2022 answer text <p>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.</p><p>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.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 21/03/2022 10:35:36 answering member 4492 label Biography information for Maria Caulfield previous answer version 53279 answering member constituency Lewes answering member printed Maria Caulfield answering member 4492 label Biography information for Maria Caulfield
tabling member	54 label Biography information for Sir Julian Lewis

1353130

registered interest
date	06/09/2021
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	2
legislature	25277 pref label House of Lords
question text	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.
tabling member printed	Lord Hunt of Kings Heath
uin	HL2426
answer	answer is ministerial correction date of answer 29/09/2021 answer text <p>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.</p> answering member printed Lord Kamall question first answered 29/09/2021 15:25:07 answering member 4909 label Biography information for Lord Kamall
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

1349328

registered interest
date	21/07/2021
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	2
legislature	25277 pref label House of Lords
question text	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.
tabling member printed	Baroness Cumberlege
uin	HL2261
answer	answer is ministerial correction date of answer 03/08/2021 answer text <p>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.</p> answering member printed Lord Bethell question first answered 03/08/2021 11:50:32 answering member 4708 label Biography information for Lord Bethell
tabling member	2729 label Biography information for Baroness Cumberlege

1346824

registered interest
date	14/07/2021
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	Meriden
tabling member printed	Saqib Bhatti
uin	33365
answer	answer is ministerial correction date of answer 20/07/2021 answer text <p>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.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 20/07/2021 15:33:34 answering member 1481 label Biography information for Ms Nadine Dorries
tabling member	4818 label Biography information for Saqib Bhatti

1346825

registered interest
date	14/07/2021
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	Meriden
tabling member printed	Saqib Bhatti
uin	33366
answer	answer is ministerial correction date of answer 22/07/2021 answer text <p>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.</p><p>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.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 22/07/2021 15:03:45 answering member 1481 label Biography information for Ms Nadine Dorries
tabling member	4818 label Biography information for Saqib Bhatti

1346826

registered interest
date	14/07/2021
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicines and Medical Devices Safety Independent Review
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	Meriden
tabling member printed	Saqib Bhatti
uin	33367
answer	answer is ministerial correction date of answer 26/07/2021 answer text <p>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.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 26/07/2021 12:20:18 answering member 1481 label Biography information for Ms Nadine Dorries
tabling member	4818 label Biography information for Saqib Bhatti