Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure medicine shortages do not impact clinicians' ability to prescribe medicines that are best suited to the patient.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The resilience of UK supply chains is a key priority, and we are continually learning and seeking to improve the way we work to both manage and help prevent supply issues and avoid shortages. In August, the Government published a policy paper, ‘Managing a robust and resilient supply of medicines’, which outlines the steps the Department and NHS England are taking to enhance resilience in our supply chains. As part of that work, we continue to engage with industry, the Medicines and Healthcare products Regulatory Agency, and other colleagues across the supply chain as we progress work to co-design and deliver these actions.
While we cannot always prevent supply issues from occurring, we have a range of well-established processes and tools to manage them when they arise and mitigate risks to patients. These include close and regular engagement with suppliers, use of alternative strengths or forms of a medicine to allow patients to remain on the same product, expediting regulatory procedures, sourcing unlicensed imports from abroad, adding products to the restricted exports and hoarding list, use of Serious Shortage Protocols (SSPs), and issuing National Health Service communications to provide management advice and information on the issue to healthcare professionals including pharmacists, so they can advise and support their patients.
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to decrease the level of the impact of medicine shortages on patients.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The resilience of UK supply chains is a key priority, and we are continually learning and seeking to improve the way we work to both manage and help prevent supply issues and avoid shortages. In August, the Government published a policy paper, ‘Managing a robust and resilient supply of medicines’, which outlines the steps the Department and NHS England are taking to enhance resilience in our supply chains. As part of that work, we continue to engage with industry, the Medicines and Healthcare products Regulatory Agency, and other colleagues across the supply chain as we progress work to co-design and deliver these actions.
While we cannot always prevent supply issues from occurring, we have a range of well-established processes and tools to manage them when they arise and mitigate risks to patients. These include close and regular engagement with suppliers, use of alternative strengths or forms of a medicine to allow patients to remain on the same product, expediting regulatory procedures, sourcing unlicensed imports from abroad, adding products to the restricted exports and hoarding list, use of Serious Shortage Protocols (SSPs), and issuing National Health Service communications to provide management advice and information on the issue to healthcare professionals including pharmacists, so they can advise and support their patients.
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent discussions he has had with NHS England on Innovative Medicines funding for givinostat.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Department officials have regular discussions with NHS England on a number of topics, including funding for innovative medicines.
The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service on whether new licensed medicines should be routinely funded by the NHS independently, based on an assessment of their costs and benefits. The NHS in England is legally required to fund medicines recommended by NICE, normally within three months of the publication of final guidance.
NICE is currently evaluating givinostat for the treatment of Duchenne muscular dystrophy and, following a call for evidence, its Appraisal Committee will meet to consider its recommendations on 23 October 2025. NICE currently expects to publish final guidance in January 2026.
If recommended by NICE in draft guidance, my Rt Hon. Friend, the Secretary of State for Health and Social Care, has been clear that NHS England should aim to work with the pharmaceutical company, Italfarmaco, to provide early interim funding for givinostat through the Innovative Medicines Fund, which has made available £340 million of ringfenced funding for the NHS to fund early access to medicines. This could potentially speed up access to givinostat by up to five months.
To avoid the possibility of creating a way to circumvent the appraisal process, NHS England is unable to fund givinostat prior to the publication of draft NICE guidance that recommends the treatment.
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions he has had with the National Institute for Health and Care Excellence on securing long term access to cerliponase alfa.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Officials in the Department have had a number of discussions with colleagues in the National Institute for Health and Care Excellence (NICE) about the ongoing appraisal of cerliponase alfa (Brineura) for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2). The Government understands the devastating impact of this condition on those affected, and how important the availability of effective new treatments is to patients and their families.
An agreement has now been reached between NHS England and the manufacturer of Brineura, BioMarin, that secures continued access for patients who have already started treatment with Brineura or who begin treatment before the end of this year.
NICE is, at present, unable to recommend Brineura for routine National Health Service funding for new patients in its draft guidance published in August. This decision comes after commercial negotiations between NHS England and BioMarin failed to secure a price for the treatment that properly reflects the limited evidence of its long-term effectiveness.
I recognise how disappointing this will be to all those affected, but I would like to underline that NICE has not yet concluded its appraisal. Stakeholders, including patient groups and the company, have had an opportunity to appeal the final draft guidance. If no appeal goes ahead, NICE expects to publish its final recommendations on cerliponase alfa in October.
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 March 2025 to Question 35541 and and the Answer of 12 May to Question 50770 on Hormone Replacement Therapy, (a) what progress has been made and (b) what further steps are being taken to ensure a continued supply of HRT implants for patients.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is continuing to work closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure safe access to oestrogen and testosterone hormone replacement therapy (HRT) implants, which are not licensed in the United Kingdom.
The MHRA has been working closely with the current importers of the product and is also looking to encourage other applications for a licensed medicinal product. The MHRA is currently assured that there are over 13 months of product in the UK based on currently available stocks and usage rates.
As oestrogen and testosterone HRT implants are not licensed in the UK, we are encouraging applications to supply products through the licensed medicines route.
The Department is working closely with the MHRA to ensure safe access to these products. The Department have also reached out to specialist importers, who can source unlicensed medicines, to find alternative sources of both HRT implants for UK patients. The Department will continue to work closely with the MHRA and the National Health Service to ensure that suitable alternatives are available for patients.
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that NICE appraisals for (a) Duchenne muscular dystrophy and (b) other rare, progressive conditions take into account urgency of access.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) aims wherever possible to issue guidance on new medicines close to the time of licensing to ensure that patients can benefit from rapid access to clinically and cost-effective new medicines. NICE’s ability to do so is contingent on the company notifying NICE of its launch plans at an early stage and providing a timely evidence submission.
The Life Sciences Sector Plan sets out the measures we are taking that will mean that patients are able to access medicines three to six months faster, including improved alignment between decisions from the Medicines and Healthcare products Regulatory Agency and NICE guidance publication.
The Life Sciences Sector Plan is available at the following link:
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that the impact on carers is included in NICE technology appraisals for rare and progressive diseases.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
NICE’s technology appraisal process allows its independent committees to take societal benefits, such as health-related quality-of-life for carers and impact on personal social services, into account. NICE’s methods are set out in its published health technology evaluations manual, which is available at the following link:
https://www.nice.org.uk/process/pmg36.
Evaluations should consider all health effects for patients, and, when relevant, carers. When presenting health effects for carers, evidence should show when the condition is associated with a substantial effect on carer’s health-related quality of life and how the technology affects carers. This applies for all therapies, including therapies for rare diseases. NICE appraisals specifically consider health-related quality of life, for both patients and carers, rather than quality of life as a whole.
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 14 July 2025 to Question 64336 on Vamorolone, what the consequences are for (a) Integrated Care Boards and (b) NHS Trusts for not making NICE recommended medicines available within 90 days of publication of relevant guidance.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Commissioners have a statutory responsibility to make funding available for a medicine or treatment recommended by a National Institute of Health and Care Excellence (NICE) technology appraisal (TA) or highly specialised technology evaluation (HST) within the timeframe recommended in that guidance, usually within three months of the TA or HST being published.
Under the National Health Service Constitution, patients have a right to receive all medicines and treatments recommended by NICE if they and their healthcare professional think that the medicine is right for them. In practical terms, the effect of this legal obligation and the NHS constitution is that all NICE-approved treatments must be included in local formularies for use in line with the TA or HST recommendations and with no additional funding or formulary restrictions.
The only exception is if the technology is not relevant to the care provided by the organisation; for example, cancer treatments would not need to be included in the formulary of a mental health trust, and treatments for dementia would not need to be included in the formulary of a specialist children’s hospital. There is no provision to take affordability into account when adding NICE-approved medicines to local formularies.
NHS enforcement guidance relating to its statutory accountability and oversight role, under the NHS Act 2006, the 2012 Act and the 2022 Act is available at the following link:
https://www.england.nhs.uk/long-read/nhs-enforcement-guidance/
The evolving NHS operating model will strengthen capabilities and clarify roles in overseeing performance. As set out in the 10-Year Health Plan for England, we will move to a Single National Formulary (SNF) for medicines within the next two years. The SNF will play a role in driving rapid and equitable adoption of clinically and cost-effective innovations.
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 27 January to Question 25553 on Methylphenidate Shortages, if he will make an assessment of the adequacy of the current supply of methylphenidate for ADHD.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has worked closely with industry stakeholders, and, following extensive collaborative efforts, previous issues have been resolved and all strengths of lisdexamfetamine, atomoxetine capsules, atomoxetine oral solution, guanfacine prolonged-release tablets and methylphenidate prolonged-release tablets and prolonged-release capsules are now available.
We continue to support the NHS England Attention Deficit Hyperactivity Disorder (ADHD) taskforce, which brings together expertise from the National Health Service, education, and justice sectors to coordinate a system-wide response to rising demand. In collaboration with NHS England’s national ADHD data improvement plan, we are developing future growth forecasts to support improved demand planning. These forecasts will be shared with industry to help ensure a more responsive and sustainable supply of ADHD medicines.
In parallel, we are also engaging with new suppliers for ADHD medicines to increase supply capacity and resilience.
The Department also maintains and regularly updates a list of currently available and unavailable ADHD products on the Specialist Pharmacy Service website. This resource supports prescribers and dispensers in making informed decisions with patients. The list is available at the following link:
www.sps.nhs.uk/articles/prescribing-available-medicines-to-treat-adhd
Asked by: Freddie van Mierlo (Liberal Democrat - Henley and Thame)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, which NHS Trusts will be involved in the Rapid National Investigation into maternity and neonatal services.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
On 14 August 2025, my Rt Hon. Friend, the Secretary of State for Health and Social Care, announced the appointment of Baroness Amos as Chair of the Independent Maternity and Neonatal Investigation, with further information available at the following link:
https://www.gov.uk/government/news/baroness-amos-to-spearhead-maternity-and-neonatal-investigation#
The investigation will carry out rapid reviews of up to ten trusts with specific issues. The Chair is working closely with families to finalise the terms of reference, including the selection criteria to select the trusts, which will be announced as soon as possible.