Asked by: Noah Law (Labour - St Austell and Newquay)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what progress he has made on the (a) establishment and (b) delivery of the MHRA Early Access Service.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
In July of this year the Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent for the development and implementation of an Early Access Service for innovative medical devices. The statement of policy intent is available at the following link:
The service aims to speed up safe access to innovative medical devices for patients, supporting the Government’s Life Sciences Sector Plan. The statement set out our intention to work with stakeholders across the life science ecosystem to further develop the policy and to build the internal capability required to deliver the service throughout 2025. Further information on our plans will be provided in early 2026.
Asked by: Shockat Adam (Independent - Leicester South)
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 support the use of medical technologies to prevent sight loss.
Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)
As outlined in the 10-Year Health Plan and the Life Sciences Sector Plan, we want patients to have fast and safe access to the most innovative technology, wherever they live in the country. Improving the adoption and procurement of medical technology will help the National Health Service secure the best outcomes for patients, including patients with sight threatening conditions, whilst also delivering greater value-for-money for the NHS.
The Department invests over £1.6 billion each year on research, including on eye care, through its research delivery arm, the National Institute for Health and Care Research.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for evaluating new medicines, medical devices, and other technologies to determine their clinical and cost-effectiveness before recommending them for NHS use.
Where a NICE technology appraisal recommends a medicine or treatment, the NHS is legally required to fund them. Where NICE guidance is not available on a particular medical technology, we would expect commissioners to take funding decisions on the basis of the available evidence of the clinical benefits.
Asked by: Shockat Adam (Independent - Leicester South)
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 improve patient access to innovative medical technologies designed to prevent glaucoma.
Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)
As outlined in the 10-Year Health Plan and the Life Sciences Sector Plan, we want patients to have fast and safe access to the most innovative technology, wherever they live in the country. Improving the adoption and procurement of medical technology will help the National Health Service secure the best outcomes for patients, including patients with sight threatening conditions, whilst also delivering greater value-for-money for the NHS.
The Department invests over £1.6 billion each year on research, including on eye care, through its research delivery arm, the National Institute for Health and Care Research.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for evaluating new medicines, medical devices, and other technologies to determine their clinical and cost-effectiveness before recommending them for NHS use.
Where a NICE technology appraisal recommends a medicine or treatment, the NHS is legally required to fund them. Where NICE guidance is not available on a particular medical technology, we would expect commissioners to take funding decisions on the basis of the available evidence of the clinical benefits.
Asked by: Rebecca Smith (Conservative - South West Devon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when the Medicines and Healthcare products Regulatory Agency plans to open its Early Access Service for innovative technologies in areas of unmet clinical need.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
In July of this year the Medicines and Healthcare products Regulatory Agency published a statement of policy intent for the development and implementation of an Early Access Service for innovative medical devices. This statement is available at the following link:
The service aims to speed up safe access to innovative medical devices for patients, supporting the Government’s Life Sciences Sector Plan. The statement set out our intention to work with stakeholders across the life science ecosystem to further develop the policy and to build the internal capability required to deliver the service throughout 2025. Further information on our plans will be provided in early 2026.
Asked by: Alex Sobel (Labour (Co-op) - Leeds Central and Headingley)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he has considered the potential merits of establishing a database of licensed weight loss injection providers that is easily accessible to the public.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
All GLP-1 medicines, which are licensed injections for weight loss, are prescription only medicines, which means they can only be prescribed by a healthcare professional.
GLP-1 medicines can be purchased privately. A consultation with a healthcare professional must happen before the prescription can be issued, so that the prescriber can carry out proper checks and make sure the patient is aware of the benefits and risks of taking the medicine.
GLP-1 medicines should not be bought from unregulated sellers such as beauty salons or via social media, or from anywhere without a prior consultation with a healthcare professional.
To guarantee receipt of a genuine GLP-1 medicine, it must be acquired from a legitimate pharmacy, including those trading online, with a prescription issued by a healthcare professional.
Patients can check if the pharmacy, online or otherwise, is legitimate. For pharmacies based in Great Britain, patients can check on the General Pharmaceutical Council’s (GPhC) website whether it is properly registered, which is available at the following link:
https://www.pharmacyregulation.org/registers
For pharmacies based in Northern Ireland, patients can refer to the Pharmaceutical Society of Northern Ireland’s (PSNI) website, which is available at the following link:
https://registers.psni.org.uk/
For further information about use of online pharmacies, patients can also refer to the GPhC’s guide on how to keep safe when getting medicines or treatment online, which is available at the following link:
The GPhC and the PSNI could also be contacted for more information on their actions on helping patients to obtain these medicines safely.
Patients can also visit the Medicines and Healthcare products Regulatory Agency’s (MHRA) #FakeMeds website for tools and resources to help purchase medicines or medical devices safely online, with further information available at the following link:
https://fakemeds.campaign.gov.uk/
To promote safe access to GLP-1 medicines and increase public awareness of these resources, the MHRA has published guidance for the public highlighting important information such as how to obtain them safely and key risks to be aware of. Further information on the MHRA’s guidance is available at the following link:
Patients can also check the credentials of the healthcare professional prescribing the medicine via the relevant United Kingdom professional regulator, such as the:
- General Medical Council for doctors;
- the Nursing and Midwifery Council for nurse independent prescribers;
- the GPhC for pharmacists in Great Britain;
- the Pharmaceutical Society of Northern Ireland; and
- the respective regulatory bodies for other non-medical prescribers.
Asked by: Stuart Anderson (Conservative - South Shropshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when he expects the Medicines and Healthcare Products Regulatory Agency early access service for innovative technologies to open.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
In July of this year the Medicines and Healthcare products Regulatory Agency published a statement of policy intent for the development and implementation of an Early Access Service for innovative medical devices, which is available at the following link:
The service aims to speed up safe access to innovative medical devices for patients, supporting the Government’s Life Sciences Sector Plan. The statement set out our intention to work with stakeholders across the life science ecosystem to further develop the policy and to build the internal capability required to deliver the service throughout 2025. Further information on our plans will be provided in early 2026.
Asked by: Andrew Snowden (Conservative - Fylde)
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 effectiveness of histotripsy treatment in the NHS.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Early clinical evidence shows that histotripsy, a non-invasive focused ultrasound treatment, can safely and precisely destroy liver tumours without the need for surgery or radiation. Histotripsy remains under evaluation, and the Government continues to monitor real-world outcomes, including its effectiveness in the National Health Service. The Government is working with clinical and research experts to accelerate United Kingdom-based evidence generation to support wider NHS adoption of histotripsy.
HistoSonics developed the Edison System to delivery histotripsy, and this was selected as one of eight transformative technologies supported through the Government’s Innovative Devices Access Pathway (IDAP) pilot, which streamlines patient access to medical devices addressing unmet clinical needs in the NHS.
Through the IDAP, the Medicines and Healthcare products Regulatory Agency (MHRA) granted HistoSonics an Unmet Clinical Need Authorisation (UCNA), exempting the manufacturer from certain regulatory requirements under strict conditions, allowing early market access. This authorisation is reserved for technologies that address a critical unmet clinical need and demonstrate sufficient data for safety and early effectiveness, with evidence that the manufacturer is working towards full regulatory approval. The UCNA requires ongoing reporting to the MHRA to monitor safety and performance.
Asked by: Blake Stephenson (Conservative - Mid Bedfordshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the 10-Year Health Plan, what assessment he has made of public trust in AI for use in AI diagnosis tools.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The 10-Year Health Plan and the Life Sciences Sector Plan commit the Government to making the National Health Service become the healthcare system in the world most ready for artificial intelligence (AI). The Department is testing AI in areas that cause the most harm to health and to our economy. Supporting clinicians to make faster and more effective decisions through the testing and deployment of diagnostic support AI has been one of the key areas of the Department’s work.
This Government takes public opinion on AI deployment seriously. The Department and UK Research and Innovation have previously held public dialogue on how the public feels decisions should be made about access to their personal health data for AI purposes. Insights from these dialogues have been used to inform policymakers and future guidance for both developers and adopters of AI tools in the NHS.
To bridge the gap between policy and practice and build confidence in AI for both the public and adopters, the NHS launched the AI Ambassadors Network in January 2025, allowing clinicians and NHS staff to hear from and pose questions directly to AI experts and regulators. The network already has almost 10,000 members.
In the UK, AI products used in health and care are regulated as medical devices to ensure patient safety and are subject to stringent requirements, including those laid out in the Medical Devices Regulations 2002, and robust monitoring by the Medicines and Healthcare products Regulatory Agency. As set out in the 10-Year Health Plan, this year we will review regulations, and in 2026, we will publish a new regulatory framework for medical devices, including AI.
Asked by: James Naish (Labour - Rushcliffe)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent steps his Department has taken to approve the use of sepiapterin for people with phenylketonuria.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices and blood components for transfusion in the United Kingdom, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.
The MHRA has several licensing routes that are available to companies to support access of innovative medicines or medicines with unmet need to patients. Sepiapterin is currently not approved by the MHRA, however, it will assess any market authorisation applications for sepiapterin against the high standards of quality, safety and efficacy should an application be received.
Asked by: Jess Brown-Fuller (Liberal Democrat - Chichester)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many applications for hormone replacement therapy implant licenses were received by the Medicines and Healthcare products Regulatory Agency in the last six months; and what steps he is taking to help ensure an ongoing supply of hormone replacement therapy implant products.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices, and blood components for transfusion in the United Kingdom, with responsibility for ensuring that medicines meet appropriate standards of safety, quality, and efficacy.
The MHRA has not received any licence applications in the last six months for a new hormone replacement therapy (HRT) implant product. The MHRA has been working closely with the current importers of the product and is also looking to encourage other applications for a licenced medicinal product. The importer Smartway has assured that there are over 13 months of product in the UK based on the currently available stocks and usage rates.
Oestrogen and testosterone HRT implants are not licenced in the UK. The Department is working closely with the MHRA to ensure safe access to these products. The Department has also reached out to specialist importers who can source unlicensed medicines in order to find alternative sources of both HRT implants for UK patients. The Department will continue to work closely with the MHRA and the National Health Service to ensure suitable alternatives are available for patients.