Apr. 22 2024
Source Page: Trade and business facts and figuresFound: • The Life Sciences sector generated £108.1 billion in turnover in 2021/22, a 13% increase year on
Apr. 22 2024
Source Page: I. List of ministerial responsibilities. 88p. II. List of non-ministerial departments and executive agencies. 22p. III. Letter dated 19/04/2024 from Alex Burghart MP to the Public Administration and Constitutional Affairs Committee regarding documents for deposit, and copying them for deposit in the House libraries. 1p.Found: Hon Andrea LEADSOM MP Parliamentary Under Secretary of State (Minister for Public Health, Start for Life
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: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Answer of 23 June 2023 to Question 189729 on Medicines and Healthcare products Regulatory Agency, whether she plans to initiate a priority review 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 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: Peter Kyle (Labour - Hove)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what progress his Department has made on the £100 million AI Life Sciences Accelerator Mission.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Prime Minister announced a new artificial intelligence (AI) in healthcare fund, backed by £100 million, at the AI Safety Summit. The Department for Science, Innovation and Technology is responsible for this fund, and the Department of Health and Social Care is working closely with them to identify areas where rapid deployment of AI could create transformational breakthroughs in healthcare. We are particularly focused on innovations in Life Sciences, which could accelerate our fight against devastating conditions like cancer and chronic mental ill-health, aiming to diagnose these conditions earlier and improve treatments. The Department for Science, Innovation and Technology will provide an update on our progress later in Spring.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what progress they have made with the proposed amendments to the Part IX of the Drug Tariff, including any impact assessments on the future provision of medical technologies in the UK; how these proposals meet the ambitions of the Life Sciences Vision; and what steps they are taking to ensure that there is sufficient patient choice following the outcome of the consultation.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The consultation response on the proposed amendments to Part IX and the final impact assessment is expected to be released in May 2024, and will outline the Government’s response.
The Department believes that it is currently difficult to identify which devices are broadly comparable, and whether more expensive devices provide added value. The proposed amendments that were consulted on intend to increase meaningful choice, not to decrease choice for clinicians and patients. Comparison between products can increase awareness of different brands amongst prescribers.
These proposals support the Life Sciences Vision, and are designed to increase innovation and alignment between partners in the health and care system. The enhanced assessment process will allow comparison between products based on their merits, increasing transparency and competition, and encouraging new products and small and medium sized businesses to enter the market. The proposed introduction of environmental attributes in social value scoring increases the vision to help the National Health Service meet Net Zero.
The Department is aware that there are some very good devices in use, relied upon by clinicians and patients. Part IX will remain a list of devices available to be prescribed in the community via the FP10 prescription route. Any amendments that are taken forward will happen gradually, with review points and engagement with stakeholders, including industry, patient representatives, clinicians, and NHS organisations. The Department will share a timeline of proposed changes taken forward, in due course.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how they plan to formally engage with the wider health sector and industry partners on the next stages in the development of proposed changes to Part IX of the Drug Tariff, following the conclusion of the consultation on these proposals.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The consultation response on the proposed amendments to Part IX and the final impact assessment is expected to be released in May 2024, and will outline the Government’s response.
The Department believes that it is currently difficult to identify which devices are broadly comparable, and whether more expensive devices provide added value. The proposed amendments that were consulted on intend to increase meaningful choice, not to decrease choice for clinicians and patients. Comparison between products can increase awareness of different brands amongst prescribers.
These proposals support the Life Sciences Vision, and are designed to increase innovation and alignment between partners in the health and care system. The enhanced assessment process will allow comparison between products based on their merits, increasing transparency and competition, and encouraging new products and small and medium sized businesses to enter the market. The proposed introduction of environmental attributes in social value scoring increases the vision to help the National Health Service meet Net Zero.
The Department is aware that there are some very good devices in use, relied upon by clinicians and patients. Part IX will remain a list of devices available to be prescribed in the community via the FP10 prescription route. Any amendments that are taken forward will happen gradually, with review points and engagement with stakeholders, including industry, patient representatives, clinicians, and NHS organisations. The Department will share a timeline of proposed changes taken forward, in due course.
Apr. 19 2024
Source Page: G7 Non-Proliferation Directors Group statement, April 2024Found: private sector to identify and promote stronger biosafety and biosecurity tools and measures for the life
Apr. 19 2024
Source Page: G7 foreign ministers' statement in Italy, April 2024Found: paramount to promote and establish effective regulatory biosafety and biosecurity measures for the life