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: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment she has made of the potential impact of medication costs on community pharmacies.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
Through the medicine margin survey, the Department assesses whether the reimbursement arrangements pay pharmacy contractors as agreed as part of the community pharmacy contractual framework (CPCF). The medicine margin survey considers what pharmacies paid for medicines by looking at their invoices compared to the amount reimbursed by the National Health Service. Where the survey finds that they have been underpaid, we increase the pharmacy contractors’ payments, and where they have been overpaid, we decrease payments.
Furthermore, where pharmacies cannot purchase products at or below the Drug Tariff NHS reimbursement price, Community Pharmacy England can request that the Department reassesses the reimbursement price. If a new reimbursement price is issued, this is known as a concessionary price.
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 increase the scope of the Pharmacy First programme.
Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)
Pharmacy First was launched on 31 January 2024, and as the service embeds, we will monitor and evaluate the service, and keep the conditions covered by Pharmacy First under review.
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 increase core community pharmacy funding.
Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)
As part of the Community Pharmacy Contractual Framework five-year deal, we committed £2.6 billion every year to community pharmacy, and agreed not to recover £212 million in over delivered fees and margin from community pharmacies in recent years. In addition, we are now investing up to £645 million across 2023/24 and 2024/25 in Pharmacy First, for more blood pressure checks and more contraception consultations in pharmacy. We have begun the consultation with Community Pharmacy England on the national funding and contractual framework arrangements for 2024/25.
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, what assessment he has made of the adequacy of the (a) funding and (b) guidance provided to public bodies delivering menstrual (i) products and (ii) services.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
No specific assessment has been made.
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, what steps his Department is taking to reduce the time taken to diagnose migraines.
Answered by Will Quince
To reduce the time taken to diagnose conditions such as migraines, NHS England has published a delivery plan for recovering access to primary care. As part of this plan, the National Health Service will deliver on the commitment of 26,000 more direct patient care staff and 50 million more appointments in general practice by March 2024.
NHS England’s national programme of neurology service improvement is led by the National Neuro Advisory Group (NNAG), which convenes public bodies, expert bodies, clinicians, academics, and patient voice organisations. NNAG is not a decision-making body, but it does make formal recommendations to NHS England about how neurology services should be commissioned and improved.
One of the bodies that advises the NNAG is the NHS Getting It Right First Time (GIRFT) programme for neurology. In September 2021, GIRFT published its National Specialty Report for Neurology, which describes the delivery of neurology services in England and makes recommendations for their improvement. The report is available at the following link:
https://gettingitrightfirsttime.co.uk/medical_specialties/neurology/
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, if he will make an assessment of the potential merits of offering migraine specialist services at women’s health hubs.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
No specific assessment is planned.
In July we announced that the £25 million investment in women’s health hubs is being distributed to every integrated care board (ICB), with each ICB receiving £595,000 in total over 2023/24 and 2024/25. ICBs have been asked to use the funding to establish or expand one women’s health hub within their system.
It is important that services are provided in a way that best meets population needs and reduces health inequalities, and ICBs will determine which specific services their hub will offer. To support ICBs to establish women’s health hubs, we have published a cost-benefit analysis, and a core specification. The core specification sets out which services ICBs could consider incorporating into their hub model, either in terms of provision or signposting. Specialist services for migraines are not listed in the core specification, but this does not prevent women’s health hubs from providing or signposting to migraine services.
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, what steps his Department plans to take with NHS Hampshire and Isle of Wight Integrated Care System to increase the delivery of endoscopy procedures for patients in Gosport constituency.
Answered by Will Quince
£2.3 billion was awarded at the 2021 Spending Review to transform diagnostic services over the next three years to increase diagnostic capacity, including for endoscopy services. This funding will also increase the number of Community Diagnostic Centres up to 160 by March 2025, including a number delivering endoscopy services.
Cutting National Health Service waiting lists, including for endoscopy services, is one of this government’s top priorities. This is a shared ambition amongst integrated care systems (ICSs), including the NHS Hampshire and Isle of Wight ICS. Priorities are set locally through joint strategic needs assessments as part of joint forward plans across the ICS and partnering NHS trusts.
There are currently nine sites delivering diagnostics for Hampshire and the Isle of Wight. This includes the provision of endoscopy services at some sites.
In the South East Hampshire Locality which includes Portsmouth, Fareham and Gosport, 1,908 additional endoscopy tests have been delivered closer to people’s homes, increasing earlier access to endoscopy procedures.