Asked by: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she plans to develop a Priority Review programme for medical devices.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Priority Review programme is not currently planned, but the Government is taking other significant steps for medical device regulatory reform, as part of a broader Medical Technology Strategy. Further information on the Medical Technology Strategy is available at the following link:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices, and designates United Kingdom Approved Bodies to conduct conformity assessments against the relevant regulatory requirements. The MHRA works closely with Approved Bodies to ensure their timely assessment.
Following a consultation on the future regulation of medical devices in 2021, the MHRA is leading a programme of work to introduce updated regulations for medical devices that prioritise patient safety, improve patient access to innovative medical devices, and ensure the UK remains an attractive market for medical technology innovators. In January of this year, the MHRA published a MedTech Regulatory roadmap that sets out the main activities in implementing the future regulations throughout 2024 and 2025. An international recognition framework for medical devices will form part of the future regulatory framework, which will provide an alternative route to the UK’s market, by leveraging approvals from comparable international regulators. The MHRA aims to publish an outline of the International Recognition Framework for medical devices later this spring, aligned to the Life Sciences Council, subject to necessary approvals.
In addition, the MHRA is leading the reform of the medical devices regulatory landscape and includes a new pathway to accelerate access to safe, innovative medical devices to help meet the unmet needs of patients. The Innovative Devices Access Pathway aims to bring new medical technologies and solutions to the National Health Service, to support the medical needs that are not currently being met. There are eight innovative medical technologies included in the pilot phase.
We are working alongside others to further the Life Sciences Vision, particularly improving regulation and regulatory processes around medical devices, and supporting broader ambitions in the vision aligned to the conditions set out in the Major Conditions Strategy. As we work to update the medical devices regulatory landscape, the MHRA is taking the Major Conditions Strategy into consideration, including the six groups of major health conditions.
The National Institute for Health and Care Excellence (NICE) is not a regulator but makes recommendations for the NHS on whether selected medical devices should be routinely adopted by the NHS, based on an assessment of their costs and benefits. Medical devices are prioritised for the NICE’s evaluation, in line with NICE’s published topic selection manual.
Asked by: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether (a) the Medicines and Healthcare products Regulatory Agency and (b) NICE will prioritise the regulatory timelines for medical devices that (i) respond to conditions outlined in the Major Conditions Strategy and (ii) where there is unmet need.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Priority Review programme is not currently planned, but the Government is taking other significant steps for medical device regulatory reform, as part of a broader Medical Technology Strategy. Further information on the Medical Technology Strategy is available at the following link:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices, and designates United Kingdom Approved Bodies to conduct conformity assessments against the relevant regulatory requirements. The MHRA works closely with Approved Bodies to ensure their timely assessment.
Following a consultation on the future regulation of medical devices in 2021, the MHRA is leading a programme of work to introduce updated regulations for medical devices that prioritise patient safety, improve patient access to innovative medical devices, and ensure the UK remains an attractive market for medical technology innovators. In January of this year, the MHRA published a MedTech Regulatory roadmap that sets out the main activities in implementing the future regulations throughout 2024 and 2025. An international recognition framework for medical devices will form part of the future regulatory framework, which will provide an alternative route to the UK’s market, by leveraging approvals from comparable international regulators. The MHRA aims to publish an outline of the International Recognition Framework for medical devices later this spring, aligned to the Life Sciences Council, subject to necessary approvals.
In addition, the MHRA is leading the reform of the medical devices regulatory landscape and includes a new pathway to accelerate access to safe, innovative medical devices to help meet the unmet needs of patients. The Innovative Devices Access Pathway aims to bring new medical technologies and solutions to the National Health Service, to support the medical needs that are not currently being met. There are eight innovative medical technologies included in the pilot phase.
We are working alongside others to further the Life Sciences Vision, particularly improving regulation and regulatory processes around medical devices, and supporting broader ambitions in the vision aligned to the conditions set out in the Major Conditions Strategy. As we work to update the medical devices regulatory landscape, the MHRA is taking the Major Conditions Strategy into consideration, including the six groups of major health conditions.
The National Institute for Health and Care Excellence (NICE) is not a regulator but makes recommendations for the NHS on whether selected medical devices should be routinely adopted by the NHS, based on an assessment of their costs and benefits. Medical devices are prioritised for the NICE’s evaluation, in line with NICE’s published topic selection manual.
Asked by: Daniel Kawczynski (Conservative - Shrewsbury and Atcham)
Question to the Foreign, Commonwealth & Development Office:
To ask the Minister of State, Foreign, Commonwealth and Development Office, if he will make an assessment of the potential merits of imposing sanctions on perpetrators of oil corruption in Libya.
Answered by Anne-Marie Trevelyan - Minister of State (Foreign, Commonwealth and Development Office)
Oil corruption in Libya hinders the progress on the political process and facilitates the entrenchment of the status quo, threatening Libya's stability and future development. The UK continues to work with partners to tackle issues such as financial transparency and oil smuggling. UN Security Council Resolution 1970 and domestic UK legislation gives the UK the power to sanction individuals and entities who threaten the peace and stability of Libya. It would be inappropriate, however, to speculate on future designations as it could reduce their effectiveness.
Asked by: Pat McFadden (Labour - Wolverhampton South East)
Question to the Department for Work and Pensions:
To ask the Secretary of State for Work and Pensions, with reference to the policy paper entitled Transforming for a digital future: 2022 to 2025 roadmap for digital and data, updated on 29 February 2024, when his Department first assessed each of the red-rated legacy IT systems in his Department to be red-rated.
Answered by Paul Maynard - Parliamentary Under-Secretary (Department for Work and Pensions)
DWP has mature, industry standard mechanisms for assessing the risk of its core IT systems which has been implemented and running for decades. The first time DWP reported figures to the cross-government initiative led by CDDO was November 2022.
Asked by: Maria Eagle (Labour - Garston and Halewood)
Question to the Ministry of Defence:
To ask the Secretary of State for Defence, how many vacant posts in his Department have been withdrawn since the introduction of internal restrictions in July 2023.
Answered by Andrew Murrison - Parliamentary Under-Secretary (Ministry of Defence)
In response to the Government's policy announcement to implement a cap on Civil Service headcount, the Department is currently reviewing its future Civil Service workforce requirement aligned to this direction. Vacancies are being reviewed as part of workforce planning and prioritisation activity. Until this work is completed it is not possible to provide specific numbers of posts vacant/not being actively recruited.
Asked by: Maria Eagle (Labour - Garston and Halewood)
Question to the Ministry of Defence:
To ask the Secretary of State for Defence, how many posts in the Defence Infrastructure Organisation are (a) vacant and (b) not being actively recruited for.
Answered by Andrew Murrison - Parliamentary Under-Secretary (Ministry of Defence)
In response to the Government's policy announcement to implement a cap on Civil Service headcount, the Department is currently reviewing its future Civil Service workforce requirement aligned to this direction. Vacancies are being reviewed as part of workforce planning and prioritisation activity. Until this work is completed it is not possible to provide specific numbers of posts vacant/not being actively recruited.
Asked by: Maria Eagle (Labour - Garston and Halewood)
Question to the Ministry of Defence:
To ask the Secretary of State for Defence, how many posts in Strategic Command are vacant but are not actively being filled as of 17 April 2024.
Answered by Andrew Murrison - Parliamentary Under-Secretary (Ministry of Defence)
In response to the Government's policy announcement to implement a cap on Civil Service headcount, the Department is currently reviewing its future Civil Service workforce requirement aligned to this direction. Vacancies are being reviewed as part of workforce planning and prioritisation activity. Until this work is completed it is not possible to provide specific numbers of posts vacant/not being actively recruited.
Asked by: Maria Eagle (Labour - Garston and Halewood)
Question to the Ministry of Defence:
To ask the Secretary of State for Defence, how many vacant posts in the Defence Infrastructure Organisation are being actively recruited for.
Answered by Andrew Murrison - Parliamentary Under-Secretary (Ministry of Defence)
In response to the Government's policy announcement to implement a cap on Civil Service headcount, the Department is currently reviewing its future Civil Service workforce requirement aligned to this direction. Vacancies are being reviewed as part of workforce planning and prioritisation activity. Until this work is completed it is not possible to provide specific numbers of posts vacant/not being actively recruited.
Asked by: Maria Eagle (Labour - Garston and Halewood)
Question to the Ministry of Defence:
To ask the Secretary of State for Defence, how many posts in Navy Command are (a) vacant and (b) not being actively recruited for.
Answered by Andrew Murrison - Parliamentary Under-Secretary (Ministry of Defence)
In response to the Government's policy announcement to implement a cap on Civil Service headcount, the Department is currently reviewing its future Civil Service workforce requirement aligned to this direction. Vacancies are being reviewed as part of workforce planning and prioritisation activity. Until this work is completed it is not possible to provide specific numbers of posts vacant/not being actively recruited.
Asked by: Maria Eagle (Labour - Garston and Halewood)
Question to the Ministry of Defence:
To ask the Secretary of State for Defence, how many vacant posts in Strategic Command have been withdrawn since the introduction of internal recruitment restrictions in July 2023.
Answered by Andrew Murrison - Parliamentary Under-Secretary (Ministry of Defence)
In response to the Government's policy announcement to implement a cap on Civil Service headcount, the Department is currently reviewing its future Civil Service workforce requirement aligned to this direction. Vacancies are being reviewed as part of workforce planning and prioritisation activity. Until this work is completed it is not possible to provide specific numbers of posts vacant/not being actively recruited.