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, what steps he is taking to increase the availability of histotripsy treatment on the NHS.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Histotripsy is a non-invasive ultrasound treatment that destroys tumours without the need for surgery or radiation. It was one of eight transformative technologies supported through the Government’s Innovative Devices Access Pathway (IDAP) pilot. This programme aimed to streamline patient access to medical devices that address an unmet clinical need in the National Health Service.
Through the IDAP, an Unmet Clinical Need Authorisation was granted by the Medicines and Healthcare products Regulatory Agency, exempting the manufacturer from certain regulatory requirements under specific conditions given the critical unmet need of liver cancer, allowing early market access. Histotripsy is now available for conditional use in the NHS for patients with liver tumours. NHS treatments will begin in October 2025 as a first in Europe, strengthening the United Kingdom’s position as a global leader in medical innovation.
Asked by: Maya Ellis (Labour - Ribble Valley)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to help ensure that UKMDR audit fees remain affordable for UK based businesses who source medical devices from overseas manufacturers.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
In Great Britain, medical devices are regulated under the Medical Device Regulations 2002 (MDR 2002), which is available at the following link:
https://www.legislation.gov.uk/uksi/2002/618/contents/made
Manufacturers of the lowest risk medical devices can self-declare the conformity of their devices against these regulations, and manufacturers of medium and high-risk medical devices must seek third party conformity assessment from an approved body to obtain a UK Conformity Assessed (UKCA) marking.
Fees are set by the approved body themselves and vary depending on the specific service provided.
To protect supply, the government continues to accept CE-marked medical devices on the Great Britain market until 30 June 2028 or 2030, depending on the type of device and the legislation it complies with. If a device has a valid CE marking, the manufacturer is therefore not required to also obtain a UKCA marking. We will consult further on our long-term approach to the recognition of CE-marked medical devices later this year.
The Medicines and Healthcare products Regulatory Agency (MHRA) is currently developing a reformed regulatory framework for medical devices, designed to protect patient safety, while improving access to innovative medical devices. This will introduce an international reliance framework, allowing the MHRA to use the expertise and decision-making of other regulatory partners to introduce a new, streamlined, route to market for certain devices with prior approval from comparable regulatory countries (Australia, Canada and the US). This will reduce unwarranted regulatory burden on manufacturers of medical devices with overseas approval.
Asked by: Baroness Northover (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to support the reclassification of medicines with long histories of safe prescribing to be sold over the counter.
Answered by Baroness Merron - 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.
A Reclassification Alliance was established between industry, the MHRA, and the Department to explore opportunities for improving the reclassification of medicines in the UK. The MHRA has developed an updated reclassification procedure and in April 2024 published updated reclassification guidance. In November 2024, the MHRA also held a reclassification webinar for industry, which focused on the updated procedure and reclassification guidance. In addition, earlier this year, the Government published a list of conditions and categories identified for potential reclassification.
The Government is committed to ensuring that medicines are available to patients in the most convenient and accessible manner, provided that it is safe to do so. The reclassification of medicines from prescription-only to over-the-counter status is a vital part of this commitment. The reclassification agenda aligns with broader Government initiatives, including the NHS 10-Year Health Plan and the Health Sector Strategy, which aim to improve patient access and reduce pressure on general practice through enhanced pharmacy services.
The MHRA welcomes discussions with industry as to how we can assess more applications, especially of novel types, which will aid patient choice in the UK.
Asked by: Callum Anderson (Labour - Buckingham and Bletchley)
Question to the Department for Business and Trade:
To ask the Secretary of State for Business and Trade, what trade barriers his Department has identified in the Chinese market in (a) healthcare, (b) automotive and (c) professional services sectors.
Answered by Chris Bryant - Minister of State (Department for Business and Trade)
We have identified the following challenges: in healthcare, complex regulatory approval processes for medicines and medical devices; in automotive, certification requirements, consumption taxes and tariffs; and in professional services firms face restrictions on business operations, onerous licencing, data localisation requirements, and limited recognition of qualifications. We regularly raise market access issues with Chinese authorities through diplomatic channels and ministerial engagements, including during the Secretary of State's recent visit to China.
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, what steps he is taking with international regulatory bodies to harmonise the regulation of weight loss drugs.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care and regulates medicine, medical devices and blood components for transfusion in the UK. The MHRA is responsible for ensuring medicines meet appropriate standards of safety, quality, and efficacy.
Weight loss medicines, like all medicines, are regulated nationally, but global harmonisation happens through bodies like the International Committee for Harmonisation (ICH), which the MHRA is a full member of.
The ICH guidelines include common standards for safety, efficacy, and quality. In addition, the World Health Organisation provides international norms.
Differences remain in how countries balance risks and benefits, meaning access and approval of weight loss medications can still vary worldwide. This is so that each approval matches the pathway of care in their country.
To support our post-marketing signal monitoring processes, the MHRA contributes to the International Post-Market Surveillance (IPMS) teleconference between the regulatory authorities in the US, Canada, Australia, New Zealand, Switzerland and Singapore. Each authority provides topics to discuss, and share information, which has on occasion included safety topics relating to weight loss medications.
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, pursuant to the Answer of 21 July 2025 to Question 67568 on Obesity: Drugs, what steps his Department is taking to ensure that private online clinics prescribing weight loss drugs are compliant with (a) Medicines and Healthcare products Regulatory Agency and (b) General Medical Council guidance.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The safest way to access medicines privately is to do so via a United Kingdom-registered prescriber and pharmacy, whether in-person or online. All UK prescribers, whether employed privately or by the National Health Service, are expected to take account of appropriate national guidance, and are regulated by UK regulators. Using UK-registered pharmacies also means that the medicines received will meet UK standards of safety and efficacy. The Medicines and Healthcare Products Regulatory Agency (MHRA) has reminded prescribers to explain the possible side effects of these medicines, and the risks around falsified products.
Any UK prescriber operating in a private capacity must be a healthcare professional who is regulated by a professional regulator such as the General Medical Council (GMC) for doctors, or the General Pharmaceutical Council or Pharmaceutical Society of Northern Ireland, for pharmacists.
When prescribing, doctors are expected to follow the GMC’s Good practice in proposing, prescribing, providing and managing medicines and devices, which refers to guidance from the MHRA. The General Pharmaceutical Council has strengthened safeguards for online pharmacies, including the need for extra checks to verify eligibility for obesity medicines. Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet, is available at the following link:
The Care Quality Commission (CQC) is the independent regulator of health and social care providers in England. Private online clinics that prescribe weight loss medicines need to register with the CQC for the regulated activity of Treatment of Disease, Disorder or Injury as set out by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
The CQC can take regulatory or enforcement action where they find fundamental standards have been breached.
Asked by: Lord Rennard (Non-affiliated - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the effectiveness of the National Institute for Health and Care Excellence's (NICE) evaluation processes at reflecting the pace of innovation in medical technologies, in particular for chronic conditions such as type 1 and 2 diabetes; and what assessment they have made of increasing NICE's cost-effectiveness threshold in line with the voluntary scheme growth rates since 2014.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
With the pace of innovation increasing, it is crucial now more than ever that the National Institute for Health and Care Excellence (NICE) is focused on the highest impact technologies.
The Rules-Based Pathway (RBP), recently announced in the 10-Year Health Plan and Life Sciences Sector Plan, will, for the first time, create a national pathway that guarantees funding for several rigorously selected transformative technologies each year, streamlining the route to adoption in the National Health Service for selected devices, diagnostics, and digital tools. This will give NICE a powerful lever to drive healthcare transformation and help to position the United Kingdom as a first-to-market location for cutting-edge technology.
NICE assessments have been carried out on diabetes technologies, including: insulin pumps; continuous glucose monitors; and most recently, hybrid closed loop systems. Diabetes technologies listed on Part IX of the NHS Drug Tariff are also subject to more frequent review.
The 2024 voluntary scheme for branded medicines pricing, access, and growth, which is an agreement between the Department, NHS England, and the Association of the British Pharmaceutical Industry, states that the standard NICE cost-effectiveness threshold will not change for the duration of the scheme, which ends in December 2028.
Under the current arrangements, NICE is able to recommend the majority of medicines it appraises for use on the NHS, with an approval rate of 84%.
Asked by: Lord Rennard (Non-affiliated - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the progress of the National Institute for Health and Care Excellence towards their priorities for 2025–26, including diabetes, and the impact of those priorities on patient access to novel technologies and treatments.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) will shortly be publishing its business plan, which will set out its priorities for 2025/26, following approval by the NICE Board. NICE’s priorities will include delivery of commitments outlined in the 10-Year Health Plan. These include:
- the adoption of a dynamic approach to appraisals that identifies where existing innovation should be retired and where technologies should be sequenced within the clinical pathway, to improve value and health outcomes;
- expanding NICE’s technology appraisal process to cover devices, diagnostics, and digital products, supported by the introduction of a rules-based pathway for HealthTech, to reduce variation in access to high-impact medical technologies; and
- alignment of NICE and the Medicines and Healthcare products Regulatory Agency processes, supported by information sharing and joint scientific advice, to speed up decision making and reduce the administrative burden for the system and industry, allowing new and innovative technologies to get to patients faster.
Asked by: Tom Morrison (Liberal Democrat - Cheadle)
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 ensure that regulatory frameworks at (a) Manchester Royal Eye Hospital and (b) other hospitals do not inhibit patients in obtaining (i) prosthetic eyes and (ii) novelty prosthetics through the National Artificial Eye Service.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the development and implementation of regulations for medical devices placed on the United Kingdom’s market, irrespective of the specific hospital in which they are used. All devices, including prosthetic eyes, must meet the relevant requirements of the UK Medical Devices Regulations 2002 (MDR 2002).
The MHRA is developing a future regulatory framework for medical devices that will ensure patients have access to the safe and effective medical devices they need, including prosthetic eyes and other custom-made devices. The first step is the introduction of new Post-Market Surveillance regulations, which came into force in June, putting 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 MDR 2002, which will enter into force next year, bringing further risk-proportionate improvements to ensure device traceability and patient safety. This will include additional measures that must be taken before a product can be placed on the market, including enhanced requirements for custom-made devices. To support patient access to medical technologies, the MHRA recently consulted on proposals to introduce an international reliance scheme to enable swifter market access for certain devices that have already been approved in a comparable regulator country. The agency will publish a response to that consultation in due course.
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, what steps he is taking to ensure that non-deterministic outputs from AI tools used in (a) diagnostics and (b) treatment planning can be (i) explained and (ii) validated.
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.