Asked by: Martin Wrigley (Liberal Democrat - Newton Abbot)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department is taking steps to ensure that (a) patients and (b) clinicians are able to (i) understand and (ii) challenge decisions made by non-deterministic AI systems.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
In the United Kingdom, the majority of artificial intelligence (AI) products being used in health and social care are regulated as medical devices. This means they are subject to stringent safety, performance, and efficacy requirements, primarily set out in the Medical Devices Regulations 2002, with robust monitoring by the Medicines and Healthcare products Regulation Agency. These requirements also apply to non-deterministic AI systems that are medical devices used in the National Health Service, such as large language models.
The National Institute for Health and Care Excellence (NICE), an arms-length body of the Department, makes recommendations on the safety and cost-effectiveness of products for health and social care services in England. NICE routinely evaluates medical technologies, including innovative AI-enabled technologies, which are assessed in NICE’s Early Value Assessment programme, for those technologies that are most needed and in-demand.
NHS England is also developing guidance for those adopting or considering adopting AI technologies, which is expected to support the safe uptake of these technologies and alleviate concerns that clinicians currently have when buying and using these technologies.
Although many generative AI systems need minimal intervention from users, clinicians still need to review and approve the text which has been produced. AI tools are to be used to support clinicians with their own decision making, rather than to make decisions on the clinicians’ behalf. AI augments, rather than replaces, human expertise.
To ensure that clinicians understand the tools they are working with, we have developed tailored guidance for users and regulators. Through public dialogue, we’ve involved patients and the public in deciding how and why access to health data should be granted for AI research and development. In addition, to bridge the gap between policy and practice we have launched the AI Ambassador Network, which currently has 5,000 members.
Asked by: Ian Roome (Liberal Democrat - North Devon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, which bodies are responsible for (a) monitoring (i) shortages and (ii) unavailability of NHS prescription medicines, (b) overseeing the manufacturing locations of brands licensed for use in the UK and (c) assessing potential supply risks where multiple brands are produced by the same third-party manufacturer.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The Department has overall policy, strategic, and operational responsibility for ensuring the continuity of the supply of medicines to the National Health Service in England. The Department works closely with NHS England, which has delegated responsibility for managing the continuity of supply for medicines procured on Medicines Procurement and Supply Chain Team frameworks. Manufacturers have a legal requirement to inform the Department of any supply issues. We work closely with industry, the NHS, manufacturers, and other partners across the supply chain to make sure patients across the United Kingdom can access the medicines they need.
The supply of medicines, including procurement, storage, allocation, and distribution is a devolved matter. However, we regularly engage with the devolved administrations to discuss potential supply issues.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices, and blood components for transfusion in the UK. The Home Office issues controlled drug licences for companies that possess, manufacture, produce, or supply controlled drugs in England, Wales, or Scotland, and Department of Health (Northern Ireland) for Northern Ireland.
Asked by: Manuela Perteghella (Liberal Democrat - Stratford-on-Avon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if his Department will issue guidance to (a) GP practices and (b) Integrated Care Boards on shared care agreements for ADHD patients diagnosed privately in line with NICE guidelines.
Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)
General practitioners (GPs) are independent contractors that provide services within the National Health Service. The General Medical Council (GMC) has published the guidance, Good practice in proposing, prescribing, providing and managing medicines and devices content. This includes guidance on shared care arrangements between a specialist service and the patient’s GP to help GPs decide whether to accept shared care responsibilities for any condition. The guidance is available at the following link:
NHS clinicians need to be content that any prescriptions, or referrals for treatment, are clinically appropriate. The British Medical Association has issued guidance, underpinned by the GMC guidance, which outlines that shared care with private providers is not recommended due to the general NHS constitution principle of keeping as clear a separation as possible between private and NHS care. Shared care may be appropriate where private providers are providing commissioned NHS services and where appropriate shared care arrangements are in place. All shared care arrangements are voluntary, so even where agreements are in place, practices can decline shared care requests on clinical and capacity grounds.
If a shared care arrangement cannot be put in place after the treatment has been initiated, the responsibility for continued prescribing falls upon the specialist clinician; this applies to both NHS and private medical care.
We are supporting a cross-sector taskforce that NHS England has established to look at attention deficit hyperactivity disorder (ADHD) service provision and support across sectors, and their impact on patient experience. The taskforce is bringing together expertise from across a broad range of sectors, including the NHS, education and justice, to better understand the challenges affecting people with ADHD including timely access to services and support.
Asked by: Manuela Perteghella (Liberal Democrat - Stratford-on-Avon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps is he taking to ensure that individuals diagnosed with ADHD by private specialists can access NHS treatment.
Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)
General practitioners (GPs) are independent contractors that provide services within the National Health Service. The General Medical Council (GMC) has published the guidance, Good practice in proposing, prescribing, providing and managing medicines and devices content. This includes guidance on shared care arrangements between a specialist service and the patient’s GP to help GPs decide whether to accept shared care responsibilities for any condition. The guidance is available at the following link:
NHS clinicians need to be content that any prescriptions, or referrals for treatment, are clinically appropriate. The British Medical Association has issued guidance, underpinned by the GMC guidance, which outlines that shared care with private providers is not recommended due to the general NHS constitution principle of keeping as clear a separation as possible between private and NHS care. Shared care may be appropriate where private providers are providing commissioned NHS services and where appropriate shared care arrangements are in place. All shared care arrangements are voluntary, so even where agreements are in place, practices can decline shared care requests on clinical and capacity grounds.
If a shared care arrangement cannot be put in place after the treatment has been initiated, the responsibility for continued prescribing falls upon the specialist clinician; this applies to both NHS and private medical care.
We are supporting a cross-sector taskforce that NHS England has established to look at attention deficit hyperactivity disorder (ADHD) service provision and support across sectors, and their impact on patient experience. The taskforce is bringing together expertise from across a broad range of sectors, including the NHS, education and justice, to better understand the challenges affecting people with ADHD including timely access to services and support.
Asked by: Julia Buckley (Labour - Shrewsbury)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the adequacy of access to shared care arrangements for adults diagnosed with ADHD.
Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)
We are supporting a cross-sector taskforce that NHS England has established to look at attention deficit hyperactivity disorder (ADHD) service provision and support across sectors, and their impact on patient experience. The taskforce is bringing together expertise from across a broad range of sectors, including the National Health Service, education and justice, to better understand the challenges affecting people with ADHD including timely access to services and support.
General practitioners (GPs) are independent contractors that provide services for the National Health Service. The General Medical Council has published guidance on “Good practice in proposing, prescribing, providing and managing medicines and devices content”. This includes guidance on shared care arrangements between a specialist service and the patient’s GP to help GPs decide whether to accept shared care responsibilities for any condition. The guidance is available at the following link:
NHS clinicians need to be content that any prescriptions, or referrals for treatment, are clinically appropriate. All shared care arrangements are voluntary, so even where agreements are in place, practices can decline shared care requests on clinical and capacity grounds.
If a shared care arrangement cannot be put in place after the treatment has been initiated, the responsibility for continued prescribing falls upon the specialist clinician; this applies to both NHS and private medical care.
Asked by: Lord Dodds of Duncairn (Democratic Unionist Party - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether any physical checks are required on medical products or medical devices moving from Great Britain to Northern Ireland; and, if so, which legislation requires them.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
Internal market movements of medical devices and products follow the same rules as other goods and can avail the support provided by the United Kingdom’s Government to move goods into Northern Ireland free of unnecessary paperwork, checks, and duties.
Regarding specific regulations for medical devices or medicines, no regulatory declarations are required for the movement of medicines or medical devices from Great Britain to Northern Ireland. Medical devices across the whole of the UK are highly regulated, and devices placed in the Northern Irish market must be accompanied by a declaration of conformity in line with the EU Medical Device Regulations (2017/745) and EU In Vitro Device Regulations (2017/746), which apply under the Windsor Framework, in order to ensure dual market access to the UK’s internal market and the European Union's single market. Regulations in Great Britain are broadly similar to those applying in the Northern Ireland, including the conformity assessment process.
No physical checks are required for medicines or medical devices moving from Great Britain to Northern Ireland.
Asked by: Lord Dodds of Duncairn (Democratic Unionist Party - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what declarations are required for the movement of medical products, including medical devices, from Great Britain to Northern Ireland; and which legislation requires them.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
Internal market movements of medical devices and products follow the same rules as other goods and can avail the support provided by the United Kingdom’s Government to move goods into Northern Ireland free of unnecessary paperwork, checks, and duties.
Regarding specific regulations for medical devices or medicines, no regulatory declarations are required for the movement of medicines or medical devices from Great Britain to Northern Ireland. Medical devices across the whole of the UK are highly regulated, and devices placed in the Northern Irish market must be accompanied by a declaration of conformity in line with the EU Medical Device Regulations (2017/745) and EU In Vitro Device Regulations (2017/746), which apply under the Windsor Framework, in order to ensure dual market access to the UK’s internal market and the European Union's single market. Regulations in Great Britain are broadly similar to those applying in the Northern Ireland, including the conformity assessment process.
No physical checks are required for medicines or medical devices moving from Great Britain to Northern Ireland.
Asked by: Martin Wrigley (Liberal Democrat - Newton Abbot)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department has made an assessment of the potential merits of establishing a mutual recognition agreement with the European Medicines Agency; and if he will make an assessment of the potential impact of such an agreement on access to (a) medicines and (b) medical devices.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
We are focused on strengthening our relationship with the European Union, forging a stable, positive relationship that benefits the United Kingdom. We have always been clear that we will not return to the single market, customs union or freedom of movement.
The Trade and Cooperation Agreement between the UK and the EU currently provides for mutual recognition of inspections and acceptance of official Good Manufacturing Practice documents. In addition, the Medicines and Healthcare products Regulatory Agency works closely with a range of international regulatory authorities, including the European Medicines Agency, through several international regulatory groups such as the International Council for Harmonisation, the International Coalition of Medicines Regulatory Authorities and the International Medical Device Regulators Forum.
Asked by: Victoria Collins (Liberal Democrat - Harpenden and Berkhamsted)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he plans to issue guidance to ensure that people diagnosed with ADHD through private healthcare can access NHS prescriptions without additional assessment.
Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)
General practitioners (GPs) are independent contractors that provide services within the National Health Service. The General Medical Council (GMC) has issued guidance on “Good practice in proposing, prescribing, providing and managing medicines and devices content”. This includes guidance on shared care arrangements between a specialist service and the patient’s GP to help GPs decide whether to accept shared care responsibilities, which is available at the following link:
NHS clinicians therefore need to be content that any prescriptions, or referrals for treatment, are clinically appropriate. If a shared care arrangement cannot be put in place after the treatment has been initiated, the responsibility for continued prescribing falls upon the specialist clinician; this applies to both NHS and private medical care.
We are supporting a cross-sector taskforce that NHS England has established to look at attention deficit hyperactivity disorder (ADHD) service provision and support across sectors, and their impact on patient experience. The taskforce is bringing together expertise from across a broad range of sectors, including the NHS, education, and justice, to better understand the challenges affecting people with ADHD, including timely access to services and support.
Asked by: Dan Carden (Labour - Liverpool Walton)
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 potential merits of a public inquiry into the safety of PIP breast implants.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
There are currently no plans to commission a public inquiry into the safety of Poly Implant Prothèse (PIP) breast implants.
As part of the Medicines and Healthcare products Regulatory Agency’s (MHRA) market surveillance for medical devices, we worked with the National Health Service and other health partners to ensure the PIP issue was properly investigated. PIP breast implants were withdrawn from the market in 2010. It is important to note that while PIP implants are associated with a higher risk of rupture, leading to symptoms such as tenderness or swollen lymph glands, there is no evidence linking ruptured PIP implants to serious long-term health issues.
As with any medical device, breast implants do not come without risks. The current advice from the MHRA remains that anyone with a PIP breast implant should consult with their doctor about the possibility of removal. The NHS and MHRA provide guidance for patients on the available options for PIP implant removal. This is available at the following link:
https://www.nhs.uk/conditions/pip-implants/
Since PIP breast implants were withdrawn, two independent reviews have identified lessons learnt, specifically the Howe Review in 2012 and the Keogh Review in 2013. The health system has since enacted important changes. As a result of the Keogh Review, since 2016 the Breast and Cosmetic Implant Registry collects data on all types of breast implant and removal surgeries in England and Scotland, aiming to help detect emerging safety issues and trace patients if necessary.
The MHRA is developing a future regulatory framework for medical devices that will ensure that patients have access to the safe and effective medical devices they need. The first step is the introduction of new Post-Market Surveillance regulations, which will come into force in June, and will put in place strengthened legal requirements for how manufacturers monitor and report on their devices once they are being used in the real world. We intend to follow this with updates to the UK Medical Device Regulations later this year, which will bring further improvements to device traceability and patient safety by introducing additional measures that must be taken before a product can be placed on the market. This will include requirements for unique device identifiers, implant cards, new rules to ensure that claims are consistent with the intended purpose, and changes to the classification of some medical devices, such as implantables, to better reflect the potential risks to patients and ensure risk proportionate requirements for manufacturers.