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, pursuant to the Answer of 14 May 2024 to Question 25493 on Life Sciences Council, for what reason the Life Sciences Council meeting of May 2024 was rescheduled; how long had the meeting been in place prior to rescheduling; and how much notice was given to the meeting participants of its rescheduling.
Answered by Andrew Griffith - Minister of State (Department for Science, Innovation and Technology)
The May 2024 meeting of the Life Sciences Council (LSC) was rescheduled due to Ministerial diary pressures and has now been confirmed for June 2024.
The May meeting was confirmed three months prior to the meeting date. Five weeks’ notice was given to meeting participants of its rescheduling.
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, whether officials in her Department have provided Ministers with written advice on meeting the public sector equality duty in relation to the (a) UK Science and Technology Framework, (b) National AI Strategy and (c) Life Sciences Vision.
Answered by Andrew Griffith - Minister of State (Department for Science, Innovation and Technology)
The department does not hold an Equality Impact Assessment for the Science and Technology Framework, as it is a high-level strategic Framework through which to deliver Government policy. Individual policies that will be delivered under the Framework have or will develop Equality Impact Assessments for their policies, in line with the Public Sector Equality Duty. As set out in the published Science and Technology Framework, many of the strands have equality considerations at the heart of what they are aiming to achieve.
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, how many times a year, on average, she meets representatives of the Life Sciences Council; and when she plans to next meet the council.
Answered by Andrew Griffith - Minister of State (Department for Science, Innovation and Technology)
The Secretary of State, alongside the Secretary of State for Health and Social Care co-chairs the Life Sciences Council twice a year. The most recent meeting took place on 23 November 2023 and the date for the next meeting is currently being agreed with members.
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, when the most recent meeting of Life Sciences Council was held; and when the council is scheduled to meet next.
Answered by Andrew Griffith - Minister of State (Department for Science, Innovation and Technology)
The last meeting of the Life Sciences Council took place on Tuesday 21 November 2023.
The date for the next meeting is currently being agreed with members.
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, what steps her Department is taking to collaborate with the Department for Health and Social Care on pandemic preparedness.
Answered by Andrew Griffith - Minister of State (Department for Science, Innovation and Technology)
Our new £520m fund will help provide the capabilities and capacities to support domestic UK health resilience and ensure a robust response to potential future health emergencies, such as influenza pandemics. The Office for Life Sciences will publish the fund’s strategic objectives, process, and assessment criteria in due course. We are working closely with DHSC to ensure that the fund will contribute to the Government’s pandemic preparedness priorities.
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, when she next plans to meet the Life Sciences Council; how many times meetings of the Life Sciences Council have been rescheduled in the last three years; and on what date the Life Sciences Council last met.
Answered by Andrew Griffith - Minister of State (Department for Science, Innovation and Technology)
The last meeting of the Life Sciences Council took place on Tuesday 21 November 2023. Since May 2021, the Life Sciences Council has been rescheduled twice, in May 2022 and May 2024. The Office for Life Sciences are currently agreeing a date for the next meeting of the Council with industry co-chairs. Once agreed, Officials will circulate the rescheduled date to members.
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.