Written questions by Downie.

What assessment his Department has made of the potential merits of supporting a nationally recognised clinical definition of advanced Parkinson’s disease across the NHS.

Awaiting answer.

What assessment his department has made of the (a) potential merits of developing a Modern Service Framework for neurological conditions and (b) potential impact such a framework on people with (i) Parkinson's disease and (ii) advanced Parkinson’s disease.

Awaiting answer.

What steps his Department is taking through improved management and treatment to help reduce the cost of care for advanced Parkinson’s patients.

Awaiting answer.

Whether his Department has made an a) estimate of the number of NHS refrigerators and other medical equipment containing cellular internet of things modules manufactured by Chinese companies and b) assessment of the risks relating to remote access and device control of such equipment.

The Cyber Security Strategy for Health and Care to 2030 sets out a vision for a cyber resilient health and care sector, including focusing on the greatest risks and harms. Through the mandatory Data Security and Protection Toolkit (DSPT), we set a cyber security standard for National Health Service organisations proportionate to their risk profile and in response to the cyber threat. Adherence to this standard, in addition to the standards and guidance that we publish around procurement of medical devices, will help organisations to ensure that their networks are secure and that risks with associated Internet-of-Things medical devices are suitably understood and mitigated. The strategy is available at the following link:https://www.gov.uk/government/publications/cyber-security-strategy-for-health-and-social-care-2023-to-2030/a-cyber-resilient-health-and-adult-social-care-system-in-england-cyber-security-strategy-to-2030 Individual organisations are responsible for the procurement of medical devices. No estimate of the number of NHS refrigerators and other medical equipment containing cellular internet of things modules manufactured by Chinese companies is currently held nationally. As part of the procurement, risk assessments of equipment will be carried out in accordance with the Guidance on protecting connected medical devices, which is available at the following link:https://digital.nhs.uk/cyber-and-data-security/guidance-and-resources/guidance-on-protecting-connected-medical-devices Implementation of these guidelines and standards are monitored through the mandatory DSPT which is independently audited for NHS trusts. To further strengthen the resilience of the NHS critical supply chain, the Cyber Security Supply Chain Charter has been published. The charter allows current and future suppliers to publicly pledge to be a trusted partner to health and care system. We have a dedicated workstream in the Cyber Improvement Programme that is focused on this particular risk, developing tools and processes to increase cyber assurance and resilience. The charter is available at the following link:https://digital.nhs.uk/cyber-and-data-security/guidance-and-resources/cyber-security-charter-for-suppliers-to-the-nhs

What data his Department holds on (a) which NHS trusts provide staff with statutory paternity leave and pay, (b) which NHS trusts provide staff with enhanced paternity leave and pay and (c) levels of take up of those across trusts.

The Department does not hold data on the uptake of these arrangements by National Health Service trusts in England.Employing organisations are legally bound to provide two weeks of statutory paternity leave and pay where individuals meet the required eligibility criteria.The national terms and conditions for staff on Agenda for Change, resident doctor, specialty and specialist doctor, and consultant contracts provide an enhanced paternity pay offer which uprates statutory pay to full pay where the additional eligibility criteria, as set out in the respective national contracts, is met.

What methods the NHS uses to sterilise equipment to help prevent vCJD contamination; how long these methods have been used for; and what assessment he has made on the effectiveness of these methods.

The National Health Service in England employs a stratified approach, combining extended autoclaving, enhanced washing, prion specific chemicals, and the destruction of high-risk instruments. The Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care, published in 2013 and owned by the Department, outlines the decontamination practices and the various ways to sterilise reusable medical devices used in acute care in England. This technical memorandum is available at the following link:https://www.england.nhs.uk/publication/decontamination-of-surgical-instruments-htm-01-01/The Advisory Committee for Dangerous Pathogens (ACDP) issued new guidance to the NHS in April 1998 in response to the variant Creutzfeldt-Jakob disease (vCJD) outbreak, to improve decontamination practices. Its guidance is reviewed and updated to ensure it remains accurate, effective, and compliant with current scientific evidence, and was last updated in November 2021. The ACDP’s guidance is available at the following link:https://www.gov.uk/government/publications/guidance-from-the-acdp-tse-risk-management-subgroup-formerly-tse-working-groupSince decontamination measures were put in place, there have been no confirmed cases of vCJD via surgical instruments in England.

What discussions he has had with the British Association of Dermatologists on the suitability of Severity of Alopecia Tool scores to determine treatment for alopecia.

There have been no discussions between the current health ministers in England and the British Association of Dermatologists (BAD) on the suitability of the Severity of Alopecia Tool’s (SALT) scores to determine treatment for alopecia areata.However, we understand that BAD has acknowledged that whilst SALT is a helpful tool, it does not fully capture the overall impact of alopecia areata on an individual's life, including psychological distress and hair loss in other areas. Its 2024 living guideline for managing people with alopecia areata considers factors beyond scalp hair loss, such as other body hair loss, to assess the severity of alopecia areata.

What guidance his Department has issued to health boards on the prescription of Ritlecitinib to treat alopecia.

The National Institute for Health and Care Excellence (NICE) is the independent body that makes recommendations for the National Health Service in England on the use of new medicines, based on an assessment of clinical and cost effectiveness. The NHS in England is legally required to fund medicines recommended in NICE technology appraisal guidance, normally within three months of the publication of final guidance.The NICE issued guidance in March 2024 that recommends ritlecitinib, within its marketing authorisation, as an option for treating severe alopecia areata in people 12 years old and over. Whilst severity is not specifically defined in the guidance, the evidence submission by the medicine’s manufacturer defined ‘severe’ as a Severity of Alopecia Tool score of more than 50 out of 100. The guidance also acknowledges that living with severe alopecia areata can have a profound impact on psychosocial health. At the present time, there are no plans to update this guidance.As health is a devolved issue, information relating to guidance on the use of ritlecitinib in Scotland would be held by the Scottish health authorities.

On what age of patient health boards are advised to use Ritlecitinib to treat alopecia.

The National Institute for Health and Care Excellence (NICE) is the independent body that makes recommendations for the National Health Service in England on the use of new medicines, based on an assessment of clinical and cost effectiveness. The NHS in England is legally required to fund medicines recommended in NICE technology appraisal guidance, normally within three months of the publication of final guidance.The NICE issued guidance in March 2024 that recommends ritlecitinib, within its marketing authorisation, as an option for treating severe alopecia areata in people 12 years old and over. Whilst severity is not specifically defined in the guidance, the evidence submission by the medicine’s manufacturer defined ‘severe’ as a Severity of Alopecia Tool score of more than 50 out of 100. The guidance also acknowledges that living with severe alopecia areata can have a profound impact on psychosocial health. At the present time, there are no plans to update this guidance.As health is a devolved issue, information relating to guidance on the use of ritlecitinib in Scotland would be held by the Scottish health authorities.

Whether he plans to update guidance on the use of Ritlecitinib to treat alopecia.

The National Institute for Health and Care Excellence (NICE) is the independent body that makes recommendations for the National Health Service in England on the use of new medicines, based on an assessment of clinical and cost effectiveness. The NHS in England is legally required to fund medicines recommended in NICE technology appraisal guidance, normally within three months of the publication of final guidance.The NICE issued guidance in March 2024 that recommends ritlecitinib, within its marketing authorisation, as an option for treating severe alopecia areata in people 12 years old and over. Whilst severity is not specifically defined in the guidance, the evidence submission by the medicine’s manufacturer defined ‘severe’ as a Severity of Alopecia Tool score of more than 50 out of 100. The guidance also acknowledges that living with severe alopecia areata can have a profound impact on psychosocial health. At the present time, there are no plans to update this guidance.As health is a devolved issue, information relating to guidance on the use of ritlecitinib in Scotland would be held by the Scottish health authorities.

How many health boards have used Ritlecitinib to treat alopecia in the last 12 months.

The NHS Business Services Authority and NHS England only hold prescribing data for ritlecitinib in England. As health is a devolved issue, information relating to the use of ritlecitinib by Scottish health boards would be held by the Scottish health authorities.

What assessment he has made of the effectiveness of Severity of Alopecia Tool scores to determine the correct treatment of alopecia.

Healthcare is a devolved matter, and our response outlines information for England only. The Scottish Government is responsible for the activities and decisions of health boards in Scotland.We have made no assessment of the effectiveness of the Severity of Alopecia Tool’s (SALT) scores in determining the correct treatment of alopecia areata. The National Institute for Health and Care Excellence (NICE) is responsible for issuing clinical guidance in England, including clinical guidelines on the treatment and care for specific conditions, as well as health technology assessments on new and existing medicines and technologies. It develops its guidance and recommendations independently from the Government, informed by scientific evidence, clinical expertise, and stakeholder input.Technology appraisal guidance published by the NICE in March 2024, code TA958, recommends ritlecitinib for treating severe alopecia areata in people aged 12 years old and over.Whilst severity is not specifically defined in the guidance, the evidence submission by the medicine’s manufacturer defined ‘severe’ as a SALT score of more than 50 out of 100. The guidance also acknowledges that living with severe alopecia areata can have a profound impact on psychosocial health.It is the responsibility of a clinician to make decisions appropriate to the circumstances of their patient, while also ensuring they are taking account of appropriate national guidance on clinical effectiveness, as well as the local commissioning decisions of their respective integrated care boards in England.Responsible clinicians should work with their patients and decide on the course of treatment, with the provision of the most clinically appropriate care for the individual always being the primary consideration.

What factors health boards are advised to use in addition to Severity of Alopecia Tool scores when determining the correct treatment for alopecia.

Healthcare is a devolved matter, and our response outlines information for England only. The Scottish Government is responsible for the activities and decisions of health boards in Scotland.We have made no assessment of the effectiveness of the Severity of Alopecia Tool’s (SALT) scores in determining the correct treatment of alopecia areata. The National Institute for Health and Care Excellence (NICE) is responsible for issuing clinical guidance in England, including clinical guidelines on the treatment and care for specific conditions, as well as health technology assessments on new and existing medicines and technologies. It develops its guidance and recommendations independently from the Government, informed by scientific evidence, clinical expertise, and stakeholder input.Technology appraisal guidance published by the NICE in March 2024, code TA958, recommends ritlecitinib for treating severe alopecia areata in people aged 12 years old and over.Whilst severity is not specifically defined in the guidance, the evidence submission by the medicine’s manufacturer defined ‘severe’ as a SALT score of more than 50 out of 100. The guidance also acknowledges that living with severe alopecia areata can have a profound impact on psychosocial health.It is the responsibility of a clinician to make decisions appropriate to the circumstances of their patient, while also ensuring they are taking account of appropriate national guidance on clinical effectiveness, as well as the local commissioning decisions of their respective integrated care boards in England.Responsible clinicians should work with their patients and decide on the course of treatment, with the provision of the most clinically appropriate care for the individual always being the primary consideration.

Whether Severity of Alopecia Tool scores are the only factor that health boards are advised to use when determining the correct treatment for alopecia.

Healthcare is a devolved matter, and our response outlines information for England only. The Scottish Government is responsible for the activities and decisions of health boards in Scotland.We have made no assessment of the effectiveness of the Severity of Alopecia Tool’s (SALT) scores in determining the correct treatment of alopecia areata. The National Institute for Health and Care Excellence (NICE) is responsible for issuing clinical guidance in England, including clinical guidelines on the treatment and care for specific conditions, as well as health technology assessments on new and existing medicines and technologies. It develops its guidance and recommendations independently from the Government, informed by scientific evidence, clinical expertise, and stakeholder input.Technology appraisal guidance published by the NICE in March 2024, code TA958, recommends ritlecitinib for treating severe alopecia areata in people aged 12 years old and over.Whilst severity is not specifically defined in the guidance, the evidence submission by the medicine’s manufacturer defined ‘severe’ as a SALT score of more than 50 out of 100. The guidance also acknowledges that living with severe alopecia areata can have a profound impact on psychosocial health.It is the responsibility of a clinician to make decisions appropriate to the circumstances of their patient, while also ensuring they are taking account of appropriate national guidance on clinical effectiveness, as well as the local commissioning decisions of their respective integrated care boards in England.Responsible clinicians should work with their patients and decide on the course of treatment, with the provision of the most clinically appropriate care for the individual always being the primary consideration.

What guidance his Department provides to health boards on whether they should consider (a) the mental health impacts of alopecia and (b) other factors prior to prescribing Ritlecitinib.

The National Institute for Health and Care Excellence (NICE) is the independent body that makes recommendations for the National Health Service in England on the use of new medicines, based on an assessment of clinical and cost effectiveness. The NHS in England is legally required to fund medicines recommended in NICE technology appraisal guidance, normally within three months of the publication of final guidance.The NICE issued guidance in March 2024 that recommends ritlecitinib, within its marketing authorisation, as an option for treating severe alopecia areata in people 12 years old and over. Whilst severity is not specifically defined in the guidance, the evidence submission by the medicine’s manufacturer defined ‘severe’ as a Severity of Alopecia Tool score of more than 50 out of 100. The guidance also acknowledges that living with severe alopecia areata can have a profound impact on psychosocial health. At the present time, there are no plans to update this guidance.As health is a devolved issue, information relating to guidance on the use of ritlecitinib in Scotland would be held by the Scottish health authorities.

What guidance his Department has issued to health boards on the factors that should be used to determine the severity of alopecia prior to a decision on treatment.

Healthcare is a devolved matter, and our response outlines information for England only. The Scottish Government is responsible for the activities and decisions of health boards in Scotland.We have made no assessment of the effectiveness of the Severity of Alopecia Tool’s (SALT) scores in determining the correct treatment of alopecia areata. The National Institute for Health and Care Excellence (NICE) is responsible for issuing clinical guidance in England, including clinical guidelines on the treatment and care for specific conditions, as well as health technology assessments on new and existing medicines and technologies. It develops its guidance and recommendations independently from the Government, informed by scientific evidence, clinical expertise, and stakeholder input.Technology appraisal guidance published by the NICE in March 2024, code TA958, recommends ritlecitinib for treating severe alopecia areata in people aged 12 years old and over.Whilst severity is not specifically defined in the guidance, the evidence submission by the medicine’s manufacturer defined ‘severe’ as a SALT score of more than 50 out of 100. The guidance also acknowledges that living with severe alopecia areata can have a profound impact on psychosocial health.It is the responsibility of a clinician to make decisions appropriate to the circumstances of their patient, while also ensuring they are taking account of appropriate national guidance on clinical effectiveness, as well as the local commissioning decisions of their respective integrated care boards in England.Responsible clinicians should work with their patients and decide on the course of treatment, with the provision of the most clinically appropriate care for the individual always being the primary consideration.

If he will conduct an audit of health infrastructure classified as critically important to national interests to identify whether they contain Chinese-made components.

The United Kingdom will not compromise on economic security and will continue to prioritise national security and resilience. We will continue to cooperate with China on trade and investment, recognising that there will also be areas where we need to challenge non-market policies and protect sensitive sectors of the economy. We will continue to support UK business to engage with the second largest economy in the world, while being clear-eyed to any risks, and ensuring security and resilience. The national technical authorities, namely the National Protective Security Authority and the National Cyber Security Centre, provide advice to critical national infrastructure, including in the health sector, on best practice for security and resilience. The Department does not comment on specific policy matters related to its critical national infrastructure.

Whether the National Institute for Health and Care Research has undertaken research on the potential impact of psychedelic medication on the treatment of severe mental health conditions.

The Department commissions research through the National Institute for Health and Care Research (NIHR). The NIHR is supporting psilocybin research via the NIHR King’s Clinical Research Facility and the NIHR Maudsley Biomedical Research Centre, where researchers are developing and evaluating the efficacy and safety of psilocybin therapy for use in the National Health Service and other healthcare settings. The NIHR continues to welcome funding applications for research into any aspect of human health, including research on the potential impact of psychedelic substances for the treatment of severe mental health conditions.

What testing requirements are in place in the approval process to identify the different impacts of medicines on men and women.

As part of the approval process for new drugs, the impact of sex, on men versus women, is assessed on pharmacokinetics, or exposure, pharmacodynamics, and overall efficacy and safety. The data is assessed in terms of whether any dose adjustments are warranted. Data in pregnant and breast-feeding women is also required where relevant.

What assessment he has made of the potential impact of differences in approved medicines on (a) men and (b) women.

The Medicines and Healthcare products Regulatory Agency is responsible for approving medicines in the United Kingdom before they are made available to the wider public. This involves a rigorous assessment using data from clinical trials to assess safety and efficacy.If data suggests that a medicine may have a different effect on men and women, this is considered within the assessment process. Every medicine is assessed on a case-by-case basis, as several factors may impact the performance of a specific product.Post authorisation, where there is identified or potential differences between men and women in safety or effectiveness, this can be monitored in the risk management plan. The agency keeps the safety and effectiveness of all medicines under continual monitoring in all populations. Should any differences in outcomes between men and women be identified, the agency will take appropriate regulatory action.