Asked by: Chi Onwurah (Labour - Newcastle upon Tyne Central)
Question to the Department for Science, Innovation & Technology:
To ask the Secretary of State for Science, Innovation and Technology, which Department is responsible for foreign direct investment into research and development in the UK.
Answered by Andrew Griffith - Minister of State (Department for Science, Innovation and Technology)
The Department for Business and Trade (DBT) is responsible for the promotion and facilitation for foreign direct investment (FDI). DSIT works closely with DBT to promote global collaboration and investment opportunities in R&D.
FDI is a key source of R&D funding, accounting for 14% of UK R&D investment. Our collaborative approach resulted in the successful 2023 Global Investment Summit, securing over £29 billion, including investments in AI, life sciences and quantum.
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: 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: 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.
Asked by: Chi Onwurah (Labour - Newcastle upon Tyne Central)
Question to the Department for Science, Innovation & Technology:
To ask the Secretary of State for Science, Innovation and Technology, with reference to the UK Science and Technology Framework, last updated on 9 February 2024, what assessment her Department has made of its progress against the goal of working with industry and philanthropic partners to increase inward investment by Summer Recess 2023.
Answered by Andrew Griffith - Minister of State (Department for Science, Innovation and Technology)
DSIT has made significant strides towards enhancing collaboration with industry and philanthropic partners to bolster investment.
Last year’s successful Global Investment Summit attracted more than £29 billion, including landmark investments in AI, life sciences and quantum. We will continue to build on our collaborative approach to increase philanthropic and private investment, including working with DBT and the Office for Investment, to further our investment ambitions.
We announced £25 million for UK Biobank conditional on philanthropic match-funding within a consortium. So far, we have secured £16 million from philanthropists Eric Schmidt and Ken Griffin, and work is underway to secure further donations.
Asked by: Earl of Dundee (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what incentives they are offering to medical partnerships to assist type two diabetes sufferers through research into both stem-cell and non-stem-cell treatments for diabetes type one sufferers.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is delivering improvements as part of the Vision for the Future of UK Clinical Research Delivery to make the United Kingdom a world leader in clinical research, attracting investment from commercial companies to deliver cutting edge research in a range of disease areas, including diabetes. For example, we introduced the National Contract Value Review to standardise costing and contracting for commercial research in the National Health Service.
This has reduced set up times for clinical research by a third which makes running research in the UK more efficient for commercial companies.
The National Institute for Health and Care Research’s (NIHR) Clinical Research Network (CRN) supports conduct of clinical research in the NHS, providing tailored support for both non-commercial organisations and the life sciences industry. The CRN has a Diabetes Speciality Group to support research across key priorities in diabetes.
The NIHR works in partnership with Diabetes UK to deliver the joint UK Strategy for Clinical and Applied Diabetes Research. The NIHR also funds a Global Health Research Unit on Diabetes and Cardiovascular Disease in South Asia, creating partnerships between research organisations in Bangladesh, India, Pakistan, Sri Lanka and the UK.
Asked by: Earl of Dundee (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what incentives they are offering to commercial operators to form medical partnerships to advance stem-cell and non-stem-cell treatments for diabetes type one sufferers.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is delivering improvements as part of the Vision for the Future of UK Clinical Research Delivery to make the United Kingdom a world leader in clinical research, attracting investment from commercial companies to deliver cutting edge research in a range of disease areas, including diabetes. For example, we introduced the National Contract Value Review to standardise costing and contracting for commercial research in the National Health Service.
This has reduced set up times for clinical research by a third which makes running research in the UK more efficient for commercial companies.
The National Institute for Health and Care Research’s (NIHR) Clinical Research Network (CRN) supports conduct of clinical research in the NHS, providing tailored support for both non-commercial organisations and the life sciences industry. The CRN has a Diabetes Speciality Group to support research across key priorities in diabetes.
The NIHR works in partnership with Diabetes UK to deliver the joint UK Strategy for Clinical and Applied Diabetes Research. The NIHR also funds a Global Health Research Unit on Diabetes and Cardiovascular Disease in South Asia, creating partnerships between research organisations in Bangladesh, India, Pakistan, Sri Lanka and the UK.