Asked by: Baroness Goudie (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure that the NHS is prepared for the arrival of new diagnostic innovations for dementia.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Health Service is a world leader in rolling out innovative treatments and has established a dedicated national programme team which is working in partnership with other national agencies and with local health systems to prepare for the potential roll out of new treatments for use in the earlier stages of Alzheimer’s disease. These plans assume that, if these new treatments are approved by the regulators, significant additional diagnostic capacity, including amyloid positron emission tomography–computed tomography, lumbar puncture and magnetic resonance imaging, will be needed both to identify patients who are most able to benefit and to provide important safety monitoring.
The national programme team is conducting preparations across the country, working alongside clinicians and local teams to identify where further funding will be required to roll out the additional tests and services needed to introduce these new and complex treatments.
NHS England is also working with partner agencies to support and inform further research into other diagnostic modalities, including blood-based biomarker and digital tests, which will help improve identification and management of Alzheimer’s disease.
Asked by: Baroness Merron (Labour - Life peer)
Question to the HM Treasury:
To ask His Majesty's Government what steps they are taking to assess and mitigate the impact of private medical insurance fees on the quality and suitability of care provided to patients with private medical insurance.
Answered by Baroness Vere of Norbiton - Parliamentary Secretary (HM Treasury)
The Government is determined that all insurers, including private medical insurers, treat consumers fairly and firms are required to do so under the Financial Conduct Authority’s rules.
The FCA requires insurers to ensure their products offer fair value, meaning the price a consumer pays for a product or service must be reasonable compared to the overall benefits they can expect to receive. The FCA has been clear that it will be monitoring firms to make sure they comply with this rule and will take action where necessary.
All providers of healthcare are regulated by the Care Quality Commission and follow a set of fundamental standards of safety and quality below which care should never fall, while the General Medical Council is responsible for regulating doctors in the United Kingdom.
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: 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: Rachael Maskell (Labour (Co-op) - York Central)
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 effectiveness of NHS speak up guardians in (a) primary and (b) secondary care settings.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
Freedom to Speak Up Guardians are a valued channel through which concerns can be raised, and have handled over 100,000 cases since the National Guardian’s Office first started collecting data in 2017. This represents over 100,000 opportunities for learning and improvement. In 2022/23 alone over 25,000 cases were raised with Freedom to Speak Up Guardians and over four-fifths, or 82.2% of those who gave feedback to their Freedom to Speak Up Guardian, said they would speak up again.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the impact of the shortage of the psychotropic medication Olanzapine, and what steps they are taking to ensure that such shortages do not affect the health and safety of patients, and wider public safety.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
We are aware that there have been supply constraints with olanzapine 210 milligram, 300 milligram, and 405 milligram powder and solvent for prolonged release suspension for injection. We worked with manufacturers to uplift production, and the issues were resolved in February 2024. We worked with NHS England to issue national communications containing advice on how to manage patients whilst there was a disruption to supply. We are not aware of any supply issues affecting oral presentations of olanzapine, or of any supply issues with any risperidone or haloperidol products.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they intend to license the drug Lecanemab for the treatment of dementia and Alzheimer’s disease; and if so, when.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency will review any marketing authorisation application received, and will consider the drug with regard to quality, safety and efficacy. We do not comment on application status or applications in progress, until a full and timely decision is made with consideration of the recommendation of Commission on Human Medicines as needed. We continue to advise that patients consult with their respective healthcare professionals regarding treatment and management options for dementia and Alzheimer’s disease.
Asked by: Andrew Lewer (Conservative - Northampton South)
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 support effective routes to market for precision medicines for (a) motor neurone disease and (b) other rare diseases in the UK.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
Should the Medicines and Healthcare products Regulatory Agency (MHRA) receive a marketing authorisation application (MAA) or applications, the MHRA will consider the drug with regards to quality, safety, and efficacy. The MHRA has procedures in place to consider drugs as part of an accelerated pathway. This is possible as part of national access collaboration, and international recognition. The MHRA would be able to consider motor neurone disease and other rare disease treatment products, under any of the procedures for the benefit of patients.