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1694640

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	Disease Control: Drugs and Vaccination
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 ensure adequate manufacturing capabilities for new (a) vaccines and (b) drugs in a pandemic.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	17598
answer	answer is ministerial correction date of answer 14/03/2024 answer text <p>An established clinical countermeasures programme is a core component of our pandemic preparedness and response capability, including vaccines and therapeutics. The UK Biological Security Strategy, published in June 2023, reaffirms our ambition to scale up discovery, development, and manufacturing of therapeutics and vaccines within 100 days.</p><p>In the Autumn Statement 2023, the Chancellor announced £520 million for Life Sciences manufacturing to build resilience for future health emergencies and capitalise on the United Kingdom’s world-leading research and development. This follows previous investment through the Biomanufacturing Fund, to incentivise the manufacture of vaccines and therapeutics, to improve the UK’s health resilience to future pandemics.</p><p>In September 2023, the UK Health Security Agency agreed a deal for millions of life-saving vaccines to be produced, with end-to-end manufacturing in the UK, if a future influenza pandemic is ever declared. The advance purchase agreement means healthcare company CSL Seqirus will be on standby to produce over 100 million pandemic influenza vaccines from their manufacturing plant in Liverpool.</p><p>In December 2022, the Government and Moderna entered a strategic partnership to set up mRNA research, development, and manufacturing facilities in the UK. Under the partnership, Moderna will build a new Innovation and Technology Centre in the UK, with the capacity to produce up to 250 million vaccines per year, in the event of a pandemic.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 14/03/2024 17:19:30 answering member 4492 label Biography information for Maria Caulfield
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

1682581

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 her Department has made of the potential merits of the use of Kaftrio in the NHS.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	9818
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 9817 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

1675652

registered interest
date	05/12/2023
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, who is responsible for continuous process improvement in (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	5383
answer	answer is ministerial correction date of answer 11/12/2023 answer text <p>In April 2023, NHS England published their delivery and continuous improvement review. Through the review, NHS England set an expectation that all National Health Service providers, working in partnership with their integrated care boards, will embed a quality improvement method aligned with the improvement approach to support increased productivity and enable improved health outcomes.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 11/12/2023 15:27:36 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4124 label Biography information for Chi Onwurah