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1713932

registered interest
date	25/04/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to the paper entitled The Future of Clinical Research Delivery: 2022 to 2025 implementation plan, published on 30 June 2022, what progress has been made on the Find, Recruit and Follow-up service for clinical trials.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	23739
answer	answer is ministerial correction date of answer 30/04/2024 answer text <p>Since publication of the Future of Clinical Research Delivery, we have developed early versions of several products as part of the Find, Recruit and Follow-up Service, to deliver secure data enabled study feasibility and recruitment within established governance and legal requirements, across England and other parts of the United Kingdom.</p><p> </p><p>These products include: NHS England’s DigiTrials self-service feasibility tool, which identifies suitable locations for studies by establishing where the largest groupings of eligible people are based; NHS England’s DigiTrials recruitment service, which is currently in its second phase of pilots and will enable the National Health Service to more easily approach patients about research relevant to them; the Medicines and Healthcare products Regulatory Agency’s Clinical Research Practice Datalink, which allows participating general practices to identify potentially eligible patients for relevant studies more easily; and the Be Part of Research registry, which allows people to proactively register their interest in participating in research.</p><p> </p><p>These tools have been developed to increase the efficiency and effectiveness of the clinical research process, and also improve our ability to widen access to research opportunities, increase the resilience and sustainability of the healthcare system, and reduce the burden on the NHS workforce.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 30/04/2024 10:48:51 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1713933

registered interest
date	25/04/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials: Contracts
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to the policy paper entitled Full government response to the Lord O'Shaughnessy review into commercial clinical trials, last updated on 8 December 2023, what her Department's planned timetable is for expanding the national contract value review programme to phase 1 and 2a clinical trials.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	23740
answer	answer is ministerial correction date of answer 30/04/2024 answer text <p>The National Contract Value Review (NCVR) process applies to commercial clinical studies. NHS England is working in partnership with the devolved administrations, the National Institute for Health and Care Research, and other partners, to pilot the use of the NCVR process for phase I and IIa of commercial clinical trials. The ambition is to make the use of NCVR for phase I and IIa of commercial clinical trials mainstream from October 2024.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 30/04/2024 09:57:50 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1694639

registered interest
date	07/03/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Oesophageal Cancer: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether her Department has made an assessment of the potential merits of increasing the use of the capsule sponge test to detect oesophageal cancer.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	17597
answer	answer is ministerial correction date of answer 18/03/2024 answer text <p>NHS England commissioned an evaluation to assess the impact of the capsule sponge test in secondary care, for patients on a routine reflux pathway. The evaluation report was completed in September 2023 and the national pilot will conclude in March 2024.</p><p>On 26 February 2024, NHS England published the results of the capsule sponge test pilot for secondary care routine reflux and Barrett’s surveillance cohort, which began in January 2021, and launched at 30 hospitals across England. The pilot tested over 8,500 patients with the capsule sponge test. Evaluation of a cohort of patients showed almost eight out of 10 patients, who completed a test, were discharged without the need for further testing, freeing up endoscopy capacity for higher risk patients and those referred for urgent tests for oesophageal cancer. Patients with positive results from the capsule sponge test who were referred on for an endoscopy had the highest prevalence of Barrett’s oesophagus, at 27.2%, compared to zero patients with negative results who completed an endoscopy.</p><p>NHS England has not committed to national uptake of capsule sponge, but will continue to support integrated care boards (ICBs) and local systems to deliver in their area. The evaluation report was published and shared with local National Health Service systems including Cancer Alliances, NHS providers, and ICBs to support with local service provision. The evaluation findings should be interpreted and used locally, based on need.</p><p>NHS England is continuing to explore other capsule sponge use cases, including in primary and community care settings jointly funded by the National Institute for Health and Care Research and Cancer Research UK. Separately to this, the CYTOPRIME2 project is funded through the NHS Cancer Programme’s Innovation Open Call and is assessing the feasibility and safety of using capsule sponge in a primary care setting, and evaluating key outcome metrics.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 18/03/2024 10:11:50 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1694642

registered interest
date	07/03/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	NHS: Artificial Intelligence
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps her Department is taking to attract and retain workers with skills in artificial intelligence into the NHS workforce.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	17600
answer	answer is ministerial correction date of answer 12/03/2024 answer text <p>We provide targeted upskilling and training for clinical staff through the Fellows in Clinical AI programme, and are developing specialised roles within our Digital, Data, and Technology workforce. Furthermore, the AI and Digital Healthcare Technologies Capability framework outlines the necessary capabilities for artificial intelligence (AI) across the National Health Service workforce.</p><p> </p><p>We have also set out core foundations to drive AI-related education training in two published reports that focus on understanding and developing the healthcare workforce’s confidence in AI. These include developing fundamentals for the full workforce and advanced training, where it is required. The reports on understanding and developing confidence in AI are available, respectively, at the following links:</p><p> </p><p><a href="https://digital-transformation.hee.nhs.uk/binaries/content/assets/digital-transformation/dart-ed/understandingconfidenceinai-may22.pdf" target="_blank">https://digital-transformation.hee.nhs.uk/binaries/content/assets/digital-transformation/dart-ed/understandingconfidenceinai-may22.pdf</a></p><p> </p><p><a href="https://digital-transformation.hee.nhs.uk/binaries/content/assets/digital-transformation/dart-ed/developingconfidenceinai-oct2022.pdf" target="_blank">https://digital-transformation.hee.nhs.uk/binaries/content/assets/digital-transformation/dart-ed/developingconfidenceinai-oct2022.pdf</a></p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 12/03/2024 17:12:13 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1683307

registered interest
date	18/01/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	NHS: Standards
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 11 December 2023 to Question 5383 on NHS: Standards, what steps her Department is taking to to ensure quality improvement across (a) NHS England, (b) Integrated Health and Care Boards and (c) NHS Hospital Trusts.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	10452
answer	answer is ministerial correction date of answer 23/01/2024 answer text <p>NHS Improving Patient Care Together is the single improvement approach to support all National Health Service organisations, systems, and providers at every level, including NHS England, to have the skills and techniques to deliver continuous improvement. Information and resources are available at the following link:</p><p> </p><p><a href="https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.england.nhs.uk%2Fnhsimpact%2Fabout-nhs-impact%2F&amp;data=05%7C02%7CFrancesca.Day%40dhsc.gov.uk%7C679a326c09594acdc07e08dbfc005597%7C61278c3091a84c318c1fef4de8973a1c%7C1%7C0%7C638380850600125951%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=3fC5Kj0WuJz7kdclLWI9HRzV20VSjoxtP%2BMzeb3RHbk%3D&amp;reserved=0" target="_blank">https://www.england.nhs.uk/nhsimpact/about-nhs-impact/</a></p><p> </p><p>The performance of integrated care boards (ICBs) in the exercise of their functions is assessed, annually, by NHS England. The NHS Oversight Framework describes NHS England’s approach to the oversight of ICBs, and is available at the following link:</p><p> </p><p><a href="https://www.england.nhs.uk/nhs-oversight-framework/" target="_blank">https://www.england.nhs.uk/nhs-oversight-framework/</a></p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 23/01/2024 09:17:35 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1682875

registered interest
date	17/01/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cystic Fibrosis: Medical Treatments
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether NICE’s assessment of the costs and benefits of funding a medication takes into account the size of the community affected; and what discussions NICE has had with patients on the use of Kaftrio for the treatment of cystic fibrosis.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	10116
answer	answer is ministerial correction date of answer 23/01/2024 answer text <p>The National Institute for Health and Care Excellence (NICE) does not take the size of the affected community into account when making recommendation on the clinical and cost effectiveness of medicines.</p><p>In 2017, a Budget Impact Test was introduced to mitigate the affordability challenge that higher cost medicines for large patient populations can present to the National Health Service, even at a cost-effective price. If the estimated budget impact of a medicine exceeds £20 million in any of the first three years of its use, NHS England may engage in commercial discussions with the company to mitigate the impact that funding the medicine would have on the rest of the NHS.</p><p>NICE is currently developing guidance for the NHS on the clinical and cost effectiveness of Kaftrio and other cystic fibrosis medicines and is engaging with patient groups as part of the appraisal process. NICE recently consulted on its draft recommendations and is now engaging with key stakeholders to determine the most appropriate next steps. This includes exploring potential commercial solutions.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 23/01/2024 14:50:02 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1683034

registered interest
date	17/01/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medical Treatments: Innovation
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps her Department is taking to improve the (a) adoption and (b) spread of medical technologies across the NHS.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	10124
answer	answer is ministerial correction date of answer 22/01/2024 answer text <p>In February 2023, the Government published its first ever strategy for MedTech, outlining our priorities for improving the adoption and spread of safe, effective and innovative medical technologies across the National Health Service.</p><p>As part of this effort, we are implementing solutions to streamline the innovation adoption pathway. We are focusing on clarifying signals to industry on what innovation the NHS needs, reforming regulation, providing product assessments based on real world evidence, and improving procurement processes.</p><p>We recently launched the Innovative Devices Access Pathway pilot in September 2023. The pilot will test a pre-regulatory, access pathway for eight pilot technologies that meet a clinical unmet need in the NHS. This accelerated pathway will support the adoption of transformative technologies into the NHS and to patients.</p><p>The Government is investing £30 million in the Health Tech Adoption and Acceleration Fund. Funding has been disseminated to all 42 integrated care systems to invest in proven technology that will help cut waiting lists, speed up diagnosis and deliver new and improved ways to treat patients.</p><p>The Department has partnered with the National Institute for Health and Care Excellence to develop and pilot a process for evaluations that compare similar MedTech products in use across the NHS. These evaluations will improve NHS decision makers ability to identify which products offer value for money and are worth adopting more widely.</p><p>The Medicines and Healthcare products Regulatory Agency is updating the medical device regulatory framework. The new framework is designed to protect patient safety, support innovation within the United Kingdom’s life sciences sector and improve access to innovative medical devices.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 22/01/2024 11:35:47 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1683035

registered interest
date	17/01/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medicine: Research
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps her Department is taking to support the research and development of medical technologies in the UK.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	10125
answer	answer is ministerial correction date of answer 23/01/2024 answer text <p>The Department-funded National Institute for Health and Care Research (NIHR) funds research to develop medical technologies through its research programmes, primarily the invention for innovation programme. This programme provides funding to industry and researchers to develop innovative healthcare technologies, including medical devices, which address existing or emerging health and social care needs. The NIHR also supports the development of medical technologies through its research infrastructure, primarily the Medtech and In Vitro Diagnostic Co-operatives, which will be replaced with the NIHR HealthTech Research Centres (HRCs) from 1 April 2024. The 14 NIHR HRCs will work with industry and researchers to support the whole pathway from development of medical devices, diagnostics and digital technologies, through to adoption in the health and care system.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 23/01/2024 14:44:35 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1683036

registered interest
date	17/01/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medical Equipment: Regulation
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps her Department is taking to improve the regulatory environment for medical devices and technology.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	10126
answer	answer is ministerial correction date of answer 22/01/2024 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) is progressing reforms to the Medical Devices Regulations 2002. These are outlined in the Government response to the consultation on the future regulation of medical devices in the United Kingdom published in June 2022.</p><p>On 9 January, the MHRA published a roadmap, which sets out a clear path for the development of new and robust regulations for medical devices over 2024 and 2025. The new regulations will put patient safety first, whilst enhancing the United Kingdom’s position as a world-leading environment for medical technology innovators.</p><p>In September 2023, the Department, in partnership with the MHRA, the National Institute of Care Excellence, NHS England, Health Technology Wales and Scottish Health Technology Group, launched the Innovative Devices Access Pathway pilot. The pilot provides an accelerated pathway for innovative technologies that meet an unmet need in the National Health Service, including regulatory and support to streamline their adoption into the NHS.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 22/01/2024 10:17:42 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah

1682580

registered interest
date	16/01/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Ivacaftor/tezacaftor/elexacaftor
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what assessment she has made of the adequacy of the potential cost of Kaftrio for the NHS, in the context of the cost of Kaftrio in the EU market.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	9817
answer	answer is ministerial correction date of answer 19/01/2024 answer text <p>The National Institute for Health and Care Excellence (NICE) is the independent body that develops recommendations on whether medicines represent a clinically and cost-effective use of National Health Service resources at the price proposed by the company. Companies can agree discounts on the price of medicines in the context of the NICE evaluation process.</p><p>NICE is currently developing guidance for the NHS on the clinical and cost effectiveness of Kaftrio and other cystic fibrosis medicines, and recently consulted on its draft recommendations. Kaftrio is currently available as a treatment option for eligible NHS patients under the terms of an interim access agreement, which was originally reached in 2019.</p> answering member constituency Pendle answering member printed Andrew Stephenson grouped question UIN 9818 question first answered 19/01/2024 10:14:15 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah