Written questions by Mierlo.

Pursuant to the Answer of 7 March 2025 to Question 35541 on Hormone Replacement Therapy, what discussions he has had with the Medicines and Healthcare products Regulatory Agency on the adequacy of the process for applying for UK licenses for HRT implant manufacturers.

The processes of the Medicines and Healthcare products Regulatory Agency (MHRA) are now performing within the expected timelines, and are meeting company commitments. Guidance has been updated on 3 April 2024 to aid the rapid approval of medicines, ensuring that quality, safety, and efficacy assessments are completed.The assessment of hormone replacement therapy products falls within these overall processes, and we are working closely with Department’s medicines supply to ensure the early flagging of issues, so they can be resolved by either companies or the MHRA.

Pursuant to the Answer of 7 March 2025 to Question 35541 on Hormone Replacement Therapy, what discussions he has had with the Medicines and Healthcare products Regulatory Agency on the adequacy of the number of (a) manufacturers that produce and (b) importers of HRT implants.

Oestrogen and testosterone hormone replacement therapy (HRT) implants are not licenced in the United Kingdom. The Department is working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure safe access to these products. We have also reached out to specialist importers who can source unlicensed medicines in order to find alternative sources of both HRT implants for UK patients. We will continue to work closely with the MHRA, and the National Health Service to ensure suitable alternatives are available for patients.The MHRA has held regular discussions with the importer of the unlicenced medicine and the Department is actively looking at this to ensure ongoing supply from this and other sources. Stakeholder groups, including the Patient Safety Commissioner and the British Menopause Society, have also been kept actively informed.

Pursuant to the Answer of 7 March 2025 to Question 35541 on Hormone Replacement Therapy, what discussions he has had with the Medicines and Healthcare products Regulatory Agency on encouraging manufacturers to apply for a UK license for HRT implants.

Oestrogen and testosterone hormone replacement therapy (HRT) implants are not licenced in the United Kingdom. The Department is working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure safe access to these products. We have also reached out to specialist importers who can source unlicensed medicines in order to find alternative sources of both HRT implants for UK patients. We will continue to work closely with the MHRA, and the National Health Service to ensure suitable alternatives are available for patients.The MHRA has held regular discussions with the importer of the unlicenced medicine and the Department is actively looking at this to ensure ongoing supply from this and other sources. Stakeholder groups, including the Patient Safety Commissioner and the British Menopause Society, have also been kept actively informed.

What recent discussions he has had with the UK National Screening Committee on timelines for implementing in-service evaluation of newborn screening for spinal muscular atrophy.

The UK National Screening Committee (UK NSC) is working with the spinal muscular atrophy (SMA) partnership board to scope out the potential shape of the in-service evaluation into SMA. The partnership board includes clinicians, academics, patient representatives, the National Institute for Health and Research (NIHR), NHS England, and the UK NSC. The final decision on the exact format, scale, and duration will be determined following a successful NIHR tendering process. The timescale for the implementation of the SMA in-service evaluation will not be confirmed until after the 2025 Spending Review.The UK NSC is aware that screening for SMA and severe combined immunodeficiency uses the same test, and as such there may be saving opportunities through economies of scale, if the two conditions are determined to be suitable for a screening programme. This is still under consideration by the committee.

What information the UK National Screening Committee has provided on the (a) format, (b) scale and (c) duration of the upcoming in-service evaluation of newborn screening for Spinal Muscular Atrophy in the NHS.

The UK National Screening Committee (UK NSC) is working with the spinal muscular atrophy (SMA) partnership board to scope out the potential shape of the in-service evaluation into SMA. The partnership board includes clinicians, academics, patient representatives, the National Institute for Health and Research (NIHR), NHS England, and the UK NSC. The final decision on the exact format, scale, and duration will be determined following a successful NIHR tendering process. The timescale for the implementation of the SMA in-service evaluation will not be confirmed until after the 2025 Spending Review.The UK NSC is aware that screening for SMA and severe combined immunodeficiency uses the same test, and as such there may be saving opportunities through economies of scale, if the two conditions are determined to be suitable for a screening programme. This is still under consideration by the committee.

What assessment he has made of the potential merits of launching newborn screening for Spinal Muscular Atrophy alongside the upcoming launch of newborn screening for severe combined immunodeficiency.

The UK National Screening Committee (UK NSC) is working with the spinal muscular atrophy (SMA) partnership board to scope out the potential shape of the in-service evaluation into SMA. The partnership board includes clinicians, academics, patient representatives, the National Institute for Health and Research (NIHR), NHS England, and the UK NSC. The final decision on the exact format, scale, and duration will be determined following a successful NIHR tendering process. The timescale for the implementation of the SMA in-service evaluation will not be confirmed until after the 2025 Spending Review.The UK NSC is aware that screening for SMA and severe combined immunodeficiency uses the same test, and as such there may be saving opportunities through economies of scale, if the two conditions are determined to be suitable for a screening programme. This is still under consideration by the committee.

When he plans to publish the report on economic review into community pharmacy.

NHS England commissioned Frontier Economics to undertake an independent economic analysis of National Health Service pharmacy funding in 2024. This work is now complete and was published on 28 March 2025 on Frontier Economics’ website.

How many phase (a) one, (b) two and (c) three dementia clinical trials there have been in the UK in each of the last ten years; and how many participants were recruited for each of those trials.

The Department delivers dementia research via the National Institute for Health and Care Research (NIHR). The Department does not hold information centrally on clinical trials hosted in Wales and Scotland. The Department is therefore unable to provide how many phase one, phase two, and phase three clinical trials for dementia have taken place in Wales and Scotland in each of the last 10 years.The following table shows the number of phase one, two, and three trials in England for dementia, supported by the NIHR Research Delivery Network, from 2014/15 to 2023/24:YearPhase 1Phase 2Phase 32014/15-12172015/16115182016/17-12242017/18114262018/19112182019/2021362020/211882021/22213112022/23411112023/244139In addition, the following table shows the number of participants recruited into phase one, two, and three trials in England for dementia, supported by the NIHR Research Delivery Network, from 2014/15 to 2023/24:YearPhase 1Phase 2Phase 32014/15-7556632015/16108431,1652016/17-4646252017/1834154712018/19125777,4732019/2046004402020/21248462021/22635612022/23468752023/2415123190Note: studies are sometimes conducted across multiple phases, for example a study may cross phase one/two or phase two/three. Therefore, figures cannot be totalled.

How much funding was allocated to dementia research by (a) the National Institute for Health and Care Research, (b) UK Research and Innovation and (c) other public bodies in each of the last five years.

The Government’s responsibility for delivering dementia research is shared between the Department of Health and Social Care, with research delivered via the National Institute for Health and Care Research (NIHR), and the Department for Science, Innovation and Technology, with research delivered via UK Research and Innovation (UKRI).The following table shows NIHR and UKRI spend data for dementia research across five financial years, from 2019/20 to 2023/24:YearNIHRUKRITotal2019/20£29,000,000£56,600,000£85,600,0002020/21£21,900,000£63,700,000£85,600,0002021/22£30,300,000£56,000,000£86,300,0002022/23£35,100,000£64,800,000£99,900,0002023/24£42,800,000£96,300,000£139,000,000Total£159,100,000£337,400,000£496,400,000 Spend for dementia research is calculated retrospectively, with a time lag due to annual reporting cycles, therefore 2023/24 is the most recent year for which we have data. The Department does not centrally hold data on dementia research funding from other public bodies.The NIHR welcomes funding applications for research into any aspect of human health and care, including dementia. These applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money, and scientific quality. All NIHR programmes welcoming applications on dementia enables maximum flexibility both in terms of the amount of research funding a particular area can be awarded, and the type of research which can be funded.

If he will consider the final costs and benefits statement for programmes delivered under the National Programme of Technology, published on 6 June 2013, in his plans for (a) an NHS Federated Data Platform and (b) a single patient record.

We are keen to draw on the lessons from the National Programme for IT in delivering the Federated Data Platform and the single patient record.NHS England publishes information each quarter on the benefits being realised by the Federated Data Platform, with further information available at the following link:https://www.england.nhs.uk/digitaltechnology/nhs-federated-data-platform/solution-exchange/fdp-uptake-and-benefits/

If he will make an assessment of the potential impact of closing NHS England on the (a) timeline for the production of the NHS 10-year plan and (b) publication date of that plan.

We do not envisage that the changes set out by the Prime Minister on 13 March 2025 will affect the publication of the 10 Year Plan. We still intend to publish the plan later in the spring.The changes will set the National Health Service up to deliver on the three big shifts needed to make the service fit for the future, from hospital to community, from analogue to digital, and from sickness to prevention.

Whether his Department has plans to link pharmacy funding to inflation and National Living Wage increases.

We have taken the necessary decisions to fix the foundations in the public finances at the Autumn Budget, and this enabled the Spending Review settlement of a £22.6 billion increase in resource spending for the Department from 2023/24 outturn to 2025/26.The Department has considered the increases in the National Living Wage when consulting on the funding arrangements for community pharmacy. We have now agreed with Community Pharmacy England to increase the community pharmacy contractual framework to £3.073 billion from April 2025. This deal represents the largest uplift in funding of any part of the National Health Service, at over 19% across 2024/25 and 2025/26. This shows a first step in delivering stability for the future and a commitment to rebuilding the sector.

If he will made an assessment of the potential merits of increasing the length of funding periods of pharmacies.

We have now concluded the consultation on funding for 2024/25 and 2025/26, and have agreed with Community Pharmacy England to increase the community pharmacy contractual framework to £3.073 billion. This deal represents the largest uplift in funding of any part of the National Health Service, at over 19% across 2024/25 and 2025/26. This shows a first step in delivering stability for the future and a commitment to rebuilding the sector.Government spending is normally agreed through spending reviews, and we are currently planning the Spending Review which will cover budgets beyond 2025/26.We agree that funding agreements that cover multiple years can bring certainty for contractors and support investment decisions, but it is also difficult to flex such agreements to take into account unforeseen events, as demonstrated in the last five-year deal for pharmacy.

What discussions he has had with the National Institute for Health and Care Excellence on the suitability of the EQ-5D questionnaire as tool for measuring caregiver quality of life improvements.

I regularly meet with the National Institute for Health and Care Excellence (NICE) to discuss a range of issues. The NICE is responsible for the methods and processes that it uses in its health technology evaluations. The NICE’s health technology evaluations manual, which was last updated in 2022 following extensive stakeholder engagement, states that its preferred measure for capturing health-related quality of life data in its health technology evaluations, whether for patients or caregivers, is the EQ-5D. The NICE can accept data using other measures, if evidence is provided that the EQ-5D is inappropriate. The NICE is aware of external work exploring how to better account for caregiver effects in health economic evaluations, for example through the work of the SHEER Task Force, and will continue to monitor and actively encourage further work in this area to potentially inform its methods in the future.

If his Department will make an assessment of the (a) adequacy of the entry criteria for the Innovative Medicines Fund and (b) whether these present barriers to patients accessing medicines in areas of high unmet need.

The Innovative Medicines Fund (IMF) was launched in June 2022, building on the successful Cancer Drugs Fund and supporting patient access to the most promising new medicines while further evidence is collected on their use to address clinical uncertainty.The IMF’s principles ensure that patients can access promising but still clinically uncertain medicines while supplementary data is collected over a time limited period, to allow for more informed decision making about patient access and long-term National Health Service funding.Since the IMF was established in June 2022, over 1,050 patients have been registered to receive treatment with 16 products, treating 16 different conditions. NHS England has made interim funding available via the IMF for 14 products, and two products have been recommended for managed access across three indications in the IMF.

What proportion of the ringfenced £340 million budget for the Innovative Medicines Fund has been spent in each year since its launch in June 2022.

The Innovative Medicines Fund (IMF) was established to provide a funding mechanism for promising non-cancer medicines recommended by the National Institute for Health and Care Excellence (NICE) for a period of managed access to address uncertainties in the evidence base. Up to £340 million has been available each financial year to support funding of medicines through the IMF. Expenditure in 2023/24 was £2 million.The relatively low level of expenditure within the IMF for 2023/24 reflects the high proportion of topics assessed by NICE as having potential for managed access which have gone on to secure a positive recommendation for routine commissioning, therefore bypassing the need for further data collection and reappraisal through the IMF.The remainder of the IMF budget is used to support pressures in the overall specialised commissioning budget and is reported as part of the overall financial position.

Whether he will make an assessment of the effectiveness of the NHS National Program for IT.

The final cost and benefits statement for the programmes delivered under the National Programme for Information Technology was published on 6 June 2013, and can be found online on the GOV.UK website.

Whether he has made an assessment of trends in the level of NHS trusts having electronic records.

No assessment of these trends has been made. Currently, we have achieved a 91% rollout of Electronic Patient Records (EPR), with work underway to provide tailored support to the remaining 19 trusts that do not yet have an EPR.The programme is forecasting to achieve 96% EPR coverage by the programme’s end in March 2026, with the remaining 4% of trusts having advanced in their plans for an EPR.

When he plans to respond to the letter of 5 February 2025 from the Hon. Member for Henley and Thame on building a new Royal Berkshire Hospital.

I replied to the hon. Member’s letter on 21 March 2025.

If he will make an assessment of the potential impact of the adequacy of access to gluten-free products on people with coeliac disease in rural areas.

In addition to the wide variety of naturally gluten-free food, a wide range of gluten-free products is now readily available for purchase. The national prescribing position in England remains that gluten free bread and mixes can be provided to coeliac patients in England, including in rural areas, on National Health Service prescription and a wide range of these items continue to be listed in part XV of the Drug Tariff.Decisions about the commissioning and funding of local health services are the responsibility of local integrated care boards (ICBs). NHS England guidance should be considered when ICBs formulate local policies, and prescribers are expected to reflect local policies in their prescribing practice. Guidance does not remove the clinical discretion of prescribers in accordance with their professional duties.