Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what progress they have made with the proposed amendments to the Part IX of the Drug Tariff, including any impact assessments on the future provision of medical technologies in the UK; how these proposals meet the ambitions of the Life Sciences Vision; and what steps they are taking to ensure that there is sufficient patient choice following the outcome of the consultation.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The consultation response on the proposed amendments to Part IX and the final impact assessment is expected to be released in May 2024, and will outline the Government’s response.
The Department believes that it is currently difficult to identify which devices are broadly comparable, and whether more expensive devices provide added value. The proposed amendments that were consulted on intend to increase meaningful choice, not to decrease choice for clinicians and patients. Comparison between products can increase awareness of different brands amongst prescribers.
These proposals support the Life Sciences Vision, and are designed to increase innovation and alignment between partners in the health and care system. The enhanced assessment process will allow comparison between products based on their merits, increasing transparency and competition, and encouraging new products and small and medium sized businesses to enter the market. The proposed introduction of environmental attributes in social value scoring increases the vision to help the National Health Service meet Net Zero.
The Department is aware that there are some very good devices in use, relied upon by clinicians and patients. Part IX will remain a list of devices available to be prescribed in the community via the FP10 prescription route. Any amendments that are taken forward will happen gradually, with review points and engagement with stakeholders, including industry, patient representatives, clinicians, and NHS organisations. The Department will share a timeline of proposed changes taken forward, in due course.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how they plan to formally engage with the wider health sector and industry partners on the next stages in the development of proposed changes to Part IX of the Drug Tariff, following the conclusion of the consultation on these proposals.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The consultation response on the proposed amendments to Part IX and the final impact assessment is expected to be released in May 2024, and will outline the Government’s response.
The Department believes that it is currently difficult to identify which devices are broadly comparable, and whether more expensive devices provide added value. The proposed amendments that were consulted on intend to increase meaningful choice, not to decrease choice for clinicians and patients. Comparison between products can increase awareness of different brands amongst prescribers.
These proposals support the Life Sciences Vision, and are designed to increase innovation and alignment between partners in the health and care system. The enhanced assessment process will allow comparison between products based on their merits, increasing transparency and competition, and encouraging new products and small and medium sized businesses to enter the market. The proposed introduction of environmental attributes in social value scoring increases the vision to help the National Health Service meet Net Zero.
The Department is aware that there are some very good devices in use, relied upon by clinicians and patients. Part IX will remain a list of devices available to be prescribed in the community via the FP10 prescription route. Any amendments that are taken forward will happen gradually, with review points and engagement with stakeholders, including industry, patient representatives, clinicians, and NHS organisations. The Department will share a timeline of proposed changes taken forward, in due course.
Asked by: Baroness Finlay of Llandaff (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 negative impact on pharmaceutical research investment in the UK of the refusal by National Institute for Health and Care Excellence to approve tofersen for SOD-1 MND patients in the UK.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) has not yet started its evaluation of tofersen for treating amyotrophic lateral sclerosis caused by SOD1 gene mutations, and has therefore not published any guidance or recommendations on whether tofersen should be available for National Health Service patients. In developing its recommendations, the NICE will follow its published methods for health technology evaluation, which will include a thorough assessment of the available evidence. This takes into account all health-related costs and benefits, including health benefits not only to patients but, where relevant, to other people such as carers. The NICE’s aim is to publish its guidance on tofersen as close as possible to the date it receives its marketing authorisation.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what consideration was given to the costs of complicated grief in families of patients dying from SOD-1 MND during the evaluation process that led to the decision to decline access to tofersen for NHS patients.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) has not yet started its evaluation of tofersen for treating amyotrophic lateral sclerosis caused by SOD1 gene mutations, and has therefore not published any guidance or recommendations on whether tofersen should be available for National Health Service patients. In developing its recommendations, the NICE will follow its published methods for health technology evaluation, which will include a thorough assessment of the available evidence. This takes into account all health-related costs and benefits, including health benefits not only to patients but, where relevant, to other people such as carers. The NICE’s aim is to publish its guidance on tofersen as close as possible to the date it receives its marketing authorisation.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department for Work and Pensions:
To ask His Majesty's Government whether the needs of men who are incontinent, but not classified as disabled as defined under the Equality Act 2010, are recognised and provided for with appropriate facilities to dispose of sanitary pads under the Workplace (Health, Safety and Welfare) Regulations 1992, and the Approved Code of Practice; and when they plan to next review the Approved Code of Practice.
Answered by Viscount Younger of Leckie - Parliamentary Under-Secretary (Department for Work and Pensions)
The Health and Safety Executive (HSE) are reviewing the Approved Code of Practice (ACOP) and guidance of the Workplace (Health, Safety and Welfare) Regulations 1992 regarding provision of disposal facilities in workplace toilets only, to ensure they meet the needs of both men and women. There will be a public consultation on any changes in summer 2024 and the updated ACOP and guidance will be published in spring 2025.
HSE is the workplace regulator, therefore the legislation and guidance will only apply to toilets for use by workers in workplaces, made available to them as a place of work.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government when the UK National Screening Committee will publish (1) plans, and (2) timelines, for its in-service evaluation of newborn screening for spinal muscular atrophy.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Stakeholders will be kept updated on the progress of the in-service evaluation (ISE) for newborn screening for spinal muscular atrophy (SMA) via the UK National Screening Committee’s blog, which is available in an online only format. The most recent update was published on 24 January 2024, and detailed the progress of the SMA ISE, which is available in an online only format.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many babies born in England between January 2012 and December 2022 had neural tube defects; and how many pregnancies were terminated in that period because of neural tube defects.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
In the period January 2012 to December 2021, there were 8,052 mentions of congenital malformations of the nervous system under Ground E abortions for residents of England and Wales within both nations. Information on neural tube defects is published by number of mentions rather than number of pregnancies terminated, and it is possible for a pregnancy to have more than one neural tube defect. Data for January to December 2022 is not yet available and is due to be published in January 2024.
Data from the National Congenital Anomaly and Rare Disease Registration Service shows that between 2015 and 2021, there were 3,124 babies born in England who had neural tube defects.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what percentage of applications to undertake clinical trials that require MHRA approval are completed within 30 days; and how many such applications were received in the last 12 months.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
A total of 587 valid clinical trial authorisation applications were received and assessed during the period of July 2022 to June 2023. Out of the 587, 100 applications were assessed within 30 days (17.04%).
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to protect public policy being influenced by the commercial interests of the tobacco industry.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government takes obligations to protect public policy from the commercial interests of the tobacco industry under the Framework Convention on Tobacco Control very seriously. The ‘Guidance for government engagement with the tobacco industry’ was published on 19 June 2023 to support Government Departments and public bodies to adhere to Article 5.3 and remind them of their commitments. This document builds on established measures that the Department has put in place internally to limit interactions with the tobacco industry and ensure the transparency of the interactions that do occur. A copy is attached.
Asked by: Baroness Finlay of Llandaff (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they will take together with NHS England to ensure that children currently in receipt of the NHS Special Schools Eye Care Service who attend day special schools will continue to access the service to meet their needs.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The NHS Long Term Plan made a commitment to ensure that children and young people with a learning disability and/or autism in special residential schools have access to sight checks in school. To fulfil that commitment, NHS England commenced a proof-of-concept programme in 2021, piloting sight testing and the dispensing of glasses in special schools.
NHS England are currently considering the evaluation of this special school programme, to determine how services to meet the eye care needs of children with learning disabilities in school settings should be commissioned and will set out next steps shortly.