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: Alison McGovern (Labour - Wirral South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions her Department has had with cancer treatment support groups on the use of direct funds to support patients and their families.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Government is working jointly with NHS England on implementing the delivery plan for tackling the COVID-19 backlogs in elective care, and plans to spend more than £8 billion from 2022/23 to 2024/25 to help drive up and protect elective activity, including cancer treatment, which encompasses recovery spaces. Additionally, and as outlined in the 2024/25 NHS England Planning Guidance, NHS England are providing over £266 million in cancer service development funding to Cancer Alliances, to support delivery of the operational priorities for cancer.
The Department and NHS England meet regularly to discuss a wide range of issues regarding cancer. The Department's ministers and officials also frequently meet with key stakeholders within the cancer community, including discussions on support for patients and their families. As stated in the NHS Long Term Plan for Cancer, where appropriate, every person diagnosed with cancer will have access to personalised care, including needs assessment, a care plan and health and wellbeing information, and support. NHS England provides personalised cancer care and support plans, to support both patients and their families at all stages of their cancer journey. This is being delivered in line with the NHS Comprehensive Model for Personalised Care, empowering people to manage their care and the impact of their cancer, and maximise the potential of digital and community-based support. NHS England estimates that approximately 80% of cancer multidisciplinary teams are now offering Personalised Care and Support Planning, ensuring physical, practical, emotional, and social needs are identified and addressed at all stages of the cancer pathway. Additionally, Personalised Stratified Follow Up pathways, which adapt care to the needs of individual patients after cancer treatment, are being rolled out by cancer multi-disciplinary teams, and are required for at least eight cancer types by 2023/24.
General practice surgeries also conduct cancer care reviews at regular intervals after cancer diagnosis, to offer support with any needs patients may have. This includes providing access to other specialist-led services who work alongside patients’ medical teams, to support patients and their families, such as counsellors, rehabilitation specialists, or social prescribers, who can connect you to community groups or services for more support. This is part of NHS England’s drive to universal personalised care that will see at least 2.5 million people benefiting from personalised care by 2023/24.
NHS England and the integrated care boards are responsible for commissioning and ensuring the healthcare needs of local communities in England are met, including for cancer patients. NHS England provide access to a personal health budget, which is an amount of NHS money that is allocated to support the health and wellbeing needs of a patient if eligible. More information is available at the following link:
https://www.nhs.uk/nhs-services/help-with-health-costs/what-is-a-personal-health-budget/
Asked by: Alison McGovern (Labour - Wirral South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what funding has her Department allocated to provide recovery spaces for families of cancer treatment patients.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Government is working jointly with NHS England on implementing the delivery plan for tackling the COVID-19 backlogs in elective care, and plans to spend more than £8 billion from 2022/23 to 2024/25 to help drive up and protect elective activity, including cancer treatment, which encompasses recovery spaces. Additionally, and as outlined in the 2024/25 NHS England Planning Guidance, NHS England are providing over £266 million in cancer service development funding to Cancer Alliances, to support delivery of the operational priorities for cancer.
The Department and NHS England meet regularly to discuss a wide range of issues regarding cancer. The Department's ministers and officials also frequently meet with key stakeholders within the cancer community, including discussions on support for patients and their families. As stated in the NHS Long Term Plan for Cancer, where appropriate, every person diagnosed with cancer will have access to personalised care, including needs assessment, a care plan and health and wellbeing information, and support. NHS England provides personalised cancer care and support plans, to support both patients and their families at all stages of their cancer journey. This is being delivered in line with the NHS Comprehensive Model for Personalised Care, empowering people to manage their care and the impact of their cancer, and maximise the potential of digital and community-based support. NHS England estimates that approximately 80% of cancer multidisciplinary teams are now offering Personalised Care and Support Planning, ensuring physical, practical, emotional, and social needs are identified and addressed at all stages of the cancer pathway. Additionally, Personalised Stratified Follow Up pathways, which adapt care to the needs of individual patients after cancer treatment, are being rolled out by cancer multi-disciplinary teams, and are required for at least eight cancer types by 2023/24.
General practice surgeries also conduct cancer care reviews at regular intervals after cancer diagnosis, to offer support with any needs patients may have. This includes providing access to other specialist-led services who work alongside patients’ medical teams, to support patients and their families, such as counsellors, rehabilitation specialists, or social prescribers, who can connect you to community groups or services for more support. This is part of NHS England’s drive to universal personalised care that will see at least 2.5 million people benefiting from personalised care by 2023/24.
NHS England and the integrated care boards are responsible for commissioning and ensuring the healthcare needs of local communities in England are met, including for cancer patients. NHS England provide access to a personal health budget, which is an amount of NHS money that is allocated to support the health and wellbeing needs of a patient if eligible. More information is available at the following link:
https://www.nhs.uk/nhs-services/help-with-health-costs/what-is-a-personal-health-budget/
Asked by: Andrew Selous (Conservative - South West Bedfordshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if she will make a comparative assessment of the cost to the NHS of different kinds of absorbent continence products based on the (a) item price and (b) patient experience and outcome including (i) whole system cost, (ii) laundry cost and (iii) environmental impact.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Government is working with NHS England and partner organisations across the health system to develop a standardised methodology, to assess the full value of medical technologies. This initiative underlines our commitment in the Medtech Strategy, published in February 2023, ensuring the right product, in the right place, at the right price. The methodology will seek to look beyond upfront cost to consider patient outcomes, whole system costs, supply resilience, and the environmental impact when procurement decisions are being made.
The methodology will provide a consistent approach to assessing value, and will be implemented at both the national and local level. This approach aims to ensure that procurement decisions support both short-term efficiencies and long-term benefits, drawing out the value to patients and the healthcare system. The Government appreciates contributions from the industry and procurement communities, and will invite stakeholders to provide feedback on the initial proposal in due course.
In terms of implementation, we will look to align and integrate this initiative with NHS England’s Central Commercial Function's ongoing work under their strategic framework, which aims to create commercial playbooks for standardising practices and processes across the National Health Service.
Regarding the specific point raised around absorbent continence products, the Disposable Continence tender is due to be issued to the market later this year. To ensure that the NHS’s requirements are considered during the procurement process, NHS Supply Chain is undertaking significant engagement across the health and social care system. This includes customers in the acute and wider community setting, suppliers, trade associations, professional bodies, and end user reference groups, to understand their requirements from a commercial, value, sustainability, and supply resilience perspective.
NHS Supply Chain is currently working with suppliers of disposable continence products to understand the value-based procurement and sustainability offerings on the purchase of continence products. NHS Supply Chain has identified a trust who are committed in supporting us in understanding this value in the form of a pilot study, and potential case study. More information can be provided once these studies have been finalised and confirmed.
Asked by: Jim Shannon (Democratic Unionist Party - Strangford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to increase the public's awareness of the side effects that can arise from taking weight loss drugs such as Ozempic.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in ensuring the safety, efficacy, and quality of medicines and healthcare products available to patients in the United Kingdom. Patient safety remains the MHRA’s highest priority, and they take every opportunity to encourage reporting of any safety concerns to the Yellow Card scheme, which helps to improve the safe use of medicines and medical devices for everyone.
New medicines including, Mounjaro and Wegovy, are intensively monitored to ensure that any new safety concerns are identified promptly. The Commission on Human Medicines and the MHRA encourages the reporting of all suspected reactions to newer drugs and vaccines, which are denoted by an inverted Black Triangle symbol. This symbol appears next to the name of a relevant product in drug safety updates, the British National Formulary and the Nurse Prescribers’ Formulary, the monthly index of medical specialities, the electronic medicines compendium, and advertising material. Patient information leaflets accompanying licensed medicines in the UK must include a description of the adverse reactions which may occur in normal use of the medicinal product, as well as information on how to report them. All adverse reactions must be reflected in the leaflet, in language that the patient will understand.
The MHRA has received a small number of reports of falsified and unlicenced medicines being sold illegally online as a treatment for weight loss. The agency has issued public health messaging warning of the dangers of buying such medicines from illegal trading sources online.
Asked by: Andrew Rosindell (Conservative - Romford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps she has taken to support research and development of the ACI-24 Alzheimer’s disease treatment.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Department funds research through the National Institute for Health and Care Research (NIHR). The Government is strongly committed to supporting research into dementia, including Alzheimer’s disease treatment, and has committed to doubling funding for dementia research to £160 million per year, by the end of 2024/25.
In addition, the NIHR’s infrastructure provides funding for clinical expertise, specialist facilities, the workforce, and support services, which underpin research across a range of clinical areas, including Alzheimer’s disease treatments. Specifically, the NIHR’s Oxford Health Clinical Research Facility (CRF) has enabled the delivery of the ABATE part 1 trial, which seeks to study the effects of the ACI-24 vaccine in those diagnosed with early-stage Alzheimer’s disease. The NIHR’s CRFs are purpose-built facilities for early-phase, experimental medicine, and supporting life science companies throughout the research process from study, design, data collection, and trial management.
Asked by: Geoffrey Cox (Conservative - Torridge and West Devon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to help tackle (a) sexism, (b) racism and (c) bullying behaviour within the ambulance service; and if she will establish an independent body to review complaints made by ambulance workers.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
Everyone working in the National Health Service must feel safe from any form of bullying, harassment, discrimination, or abuse, and feel confident that they can raise concerns, which will be taken seriously and acted on.
The Department welcomes the publication of the NHS England commissioned independent review into ambulance sector culture. NHS England has established a Delivery Board to deliver the review’s important recommendations. This includes actions led by the Office of the Chief Allied Health Professions at NHS England, and the Association of Ambulance Chief Executives, on stopping misogyny and improving sexual safety in the ambulance service. This programme of work will build on the work already underway through the NHS People Plan, and the Equality, Diversity and Inclusion Improvement Plan
Asked by: Rupa Huq (Labour - Ealing Central and Acton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the report by Bite Back entitled Fuel us, don't fool us, published in February 2024, what steps she is taking to implement the 9 pm watershed restriction of unhealthy food and drink adverts online and on television.
Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)
On 1 October 2025, the Government will introduce a United Kingdom-wide 9pm TV watershed for less healthy products and a restriction of paid-for advertising of these products online. The Government and regulators are now carrying out crucial processes to prepare for implementing and enforcing the regulations by 1 October 2025. The Government welcomes Bite Back’s report, Fuel Us Don’t Fool Us and will consider its wider recommendations.
Asked by: Andrew Selous (Conservative - South West Bedfordshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps she is taking with NHS England to (a) promote the adoption of the principles of value-based procurement in the purchase and dispensing of absorbent continence products and (b) help ensure that those principles continue to be adopted in the context of short-term savings being pursued by NHS organisations.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Government is working with NHS England and partner organisations across the health system to develop a standardised methodology, to assess the full value of medical technologies. This initiative underlines our commitment in the Medtech Strategy, published in February 2023, ensuring the right product, in the right place, at the right price. The methodology will seek to look beyond upfront cost to consider patient outcomes, whole system costs, supply resilience, and the environmental impact when procurement decisions are being made.
The methodology will provide a consistent approach to assessing value, and will be implemented at both the national and local level. This approach aims to ensure that procurement decisions support both short-term efficiencies and long-term benefits, drawing out the value to patients and the healthcare system. The Government appreciates contributions from the industry and procurement communities, and will invite stakeholders to provide feedback on the initial proposal in due course.
In terms of implementation, we will look to align and integrate this initiative with NHS England’s Central Commercial Function's ongoing work under their strategic framework, which aims to create commercial playbooks for standardising practices and processes across the National Health Service.
Regarding the specific point raised around absorbent continence products, the Disposable Continence tender is due to be issued to the market later this year. To ensure that the NHS’s requirements are considered during the procurement process, NHS Supply Chain is undertaking significant engagement across the health and social care system. This includes customers in the acute and wider community setting, suppliers, trade associations, professional bodies, and end user reference groups, to understand their requirements from a commercial, value, sustainability, and supply resilience perspective.
NHS Supply Chain is currently working with suppliers of disposable continence products to understand the value-based procurement and sustainability offerings on the purchase of continence products. NHS Supply Chain has identified a trust who are committed in supporting us in understanding this value in the form of a pilot study, and potential case study. More information can be provided once these studies have been finalised and confirmed.