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Written Question
Dementia: Diagnosis
Thursday 25th April 2024

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.


Written Question
Maternity Services: Complaints
Wednesday 24th April 2024

Asked by: Kwasi Kwarteng (Conservative - Spelthorne)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether her Department has had discussions with NHS England on ensuring that (a) reviews, (b) investigations and (c) complaints processes relating to maternity services include consideration of the (i) impact of ethnicity on the care received and (ii) potential role of (A) racism and (B) discrimination.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

NHS England, along with the devolved administrations and the Crown Dependencies, funds Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries to collate ethnicity data, in relation to all perinatal and maternal deaths across the United Kingdom. They publish annual surveillance reports which provide comparators of rates of mortality for women and babies from different ethnic groups. They also publish confidential enquiries, assessing care provision along the whole care pathway, to identify areas requiring improvement.

The Maternity and Newborn Safety Investigations programme provides independent, standardised, and family focused investigations to provide learning to the health system. This includes analysis of data to identify key trends, and collaboration with system partners to escalate safety concerns.


Written Question
Department for Work and Pensions: Departmental Responsibilities
Wednesday 24th April 2024

Asked by: Alison McGovern (Labour - Wirral South)

Question to the Department for Work and Pensions:

To ask the Secretary of State for Work and Pensions, whether he is taking steps to ensure that his Department's (a) policy and (b) guidance is (i) trauma-informed and (ii) co-produced with lived-experience experts.

Answered by Mims Davies - Minister of State (Department for Work and Pensions)

The DWP is committed to being a more Trauma Informed organisation. We have a dedicated programme which will integrate the six key pillars of the approach as defined by the Office for Health Improvements and Disparities (December, 2022) which are safety, trustworthiness, choice, empowerment, collaboration and cultural consideration. Our programme looks at these six pillars within the contexts of application to our colleagues, our customers, our culture, and the context of our interaction- whether that is a physical, telephony, digital or postal interaction. We are learning from best practice demonstrated by organisations such as NHS Education Scotland, Work Services Australia and the Wales ACES Hub to shape the future prioritisation of this work.

The integration programme is in its early phases, and we appreciate that it will take time to realise the benefits of changes we implement. We are learning from the continued progress of leaders in the field including programmes such as the Scottish National Trauma Transformation Programme. We recognise that an important aspect of many programmes is policies and procedures and intend to replicate this focus within our own work whilst recognising that the programme does not seek to change what the department does, instead we are impacting how we do this, which will extend to supporting our policy development.

We recognise that any truly trauma informed system is shaped by lived experience experts and we fundamentally believe in the co-production of this programme. This is why we have an extensive network of diverse internal and external stakeholders who are engaged in shaping the programme through ongoing forums and insight activity. We are also currently collaborating with the University of Salford on research which explores how trauma informed the department is through conversations with customers, colleagues and external stakeholders. The outcome of this research will help to shape the future priorities of the programme. Finally, we are currently exploring how we establish our own co-production forums for the programme taking advice from expert stakeholders to ensure we create a safe, empowering space for lived experience experts to whilst establishing trust in the ongoing aims and progress of the programme.


Written Question
Medical Equipment: Reviews
Monday 22nd April 2024

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.


Written Question
Medical Equipment
Monday 22nd April 2024

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.


Written Question
Medical Equipment
Monday 22nd April 2024

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.


Written Question
Ambulance Services: Bullying and Discrimination
Monday 22nd April 2024

Asked by: Geoffrey Cox (Conservative - Torridge and West Devon)

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 help tackle (a) sexism, (b) racism and (c) bullying behaviour within the ambulance service; and if she will establish an independent body to review complaints made by ambulance workers.

Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)

Everyone working in the National Health Service must feel safe from any form of bullying, harassment, discrimination, or abuse, and feel confident that they can raise concerns, which will be taken seriously and acted on.

The Department welcomes the publication of the NHS England commissioned independent review into ambulance sector culture. NHS England has established a Delivery Board to deliver the review’s important recommendations. This includes actions led by the Office of the Chief Allied Health Professions at NHS England, and the Association of Ambulance Chief Executives, on stopping misogyny and improving sexual safety in the ambulance service. This programme of work will build on the work already underway through the NHS People Plan, and the Equality, Diversity and Inclusion Improvement Plan


Written Question
Olanzapine: Shortages
Monday 22nd April 2024

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.


Written Question
Midwives: Wellingborough
Friday 19th April 2024

Asked by: Gen Kitchen (Labour - Wellingborough)

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 the recruitment and retention of midwives in Wellingborough constituency.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

We are investing an additional £186 million a year to improve maternity and neonatal care and grow the workforce. On top of this, the Government and NHS England are investing nearly £35 million over three years, from 2024/25 to 2026/27, to further improve maternity safety across England, with specialist training for staff, additional numbers of midwives, and support to ensure maternity services listen to, and act on, women’s experiences to improve care. As announced at the Spring Budget, we are further increasing the number of midwives by funding an additional 160 new posts over three years, to support the continued growth of the maternity and neonatal workforce.

On retention, the NHS Long Term Workforce Plan sets out how to improve culture and leadership to ensure that up to 130,000 fewer staff leave the National Health Service over the next 15 years. This includes: implementing actions from the NHS People Plan that have been shown to be successful; implementing plans to improve flexible opportunities for prospective retirees, and delivering the actions needed to modernise the NHS pension scheme; and committing to ongoing national funding for continuing professional development for nurses, midwives, and allied health professionals, so NHS staff are supported to meet their full potential. These measures apply across the country, including for midwives in the Wellingborough constituency.


Written Question
Northern Care Alliance NHS Foundation Trust
Friday 19th April 2024

Asked by: Mike Amesbury (Labour - Weaver Vale)

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 implications for her policies of the independent report by Carlo Breen into the Northern Care Alliance NHS Foundation Trust’s historic management of concerns in relation to a Consultant Spinal Surgeon, published on 7 March 2024.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Northern Care Alliance NHS Foundation Trust commissioned the Spinal Patient Safety Look Back review in 2021. A report detailing the findings was published in July 2023. A second report was commissioned by the trust to review the historic management of concerns raised in relation to a particular surgeon. The findings of this report were published on 7 March 2024, and relate to issues that include bullying, speaking up, the duty of candour, governance, and the quality of disciplinary investigations at the trust.

The Government is already taking action in relation to policies relevant to the report’s findings. This includes strengthening leadership, the statutory duty of candour, and speaking up to promote an open and transparent learning culture in the National Health Service. We also expect NHS organisations to have robust policies in place to tackle bullying and harassment.