Asked by: Rupert Lowe (Independent - Great Yarmouth)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what aggregated safety data, including adverse-event summaries, the MHRA has recorded relating to the use of puberty blockers in under-18s since 2010; and whether the Department has been informed of any safety signals during that period.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate to inform regulatory decisions.
Puberty blockers are also known as gonadotrophin-releasing hormone (GnRH) analogues. These medicines are licenced for conditions such as young children who enter puberty too early, also known as precocious puberty, prostate cancer, and endometriosis. The use of GnRH analogues to suppress puberty in children and young people with gender dysphoria is off-label prescribing. This means that the use of these medicines for this purpose is outside of the licensed uses, and as such the benefits and risks of the medicine for use in this specific population have not been assessed. The MHRA does not regulate off-label use.
The MHRA has received three United Kingdom suspected adverse drug reaction reports in which a GnRH analogue has been reported as being used in a child or young person for the purpose of puberty suppression in gender dysphoria. The GnRH analogues included in this search were buserelin, leuprorelin, goserelin, gonadorelin, nafarelin, and triptorelin. Please note it is not mandatory to provide information on indication when submitting an adverse drug reaction report.
It is important to note that a reaction reported to the Yellow Card scheme does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. Underlying or concurrent illnesses may be responsible, or the events could be coincidental.
The MHRA has not identified any safety signals which concern the off-label use of the GnRH analogues for the purpose of puberty suppression in gender dysphoria. However, we acknowledge that there is a clear lack of clinical evidence for the safety and efficacy of using these medicines for gender incongruence and/or dysphoria in those aged 18 years old and under. That is why NHS England and the National Institute for Health and Care Research have commissioned a carefully designed clinical trial to assess the relative benefits and harms of puberty suppressing hormones on young people’s physical, social, and emotional well-being.
Asked by: Ian Sollom (Liberal Democrat - St Neots and Mid Cambridgeshire)
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 reverse the long-term decline in the amount spent on medicines as a percentage of the NHS budget.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
We continue to support the United Kingdom’s world leading life sciences sector through investment, innovation and reform as set out in our Life Sciences Sector Plan and 10-Year Health Plan, through which we committed to accelerating growth in net spend on innovative medicines to unlock the potential for patients.
As announced as part of our world-leading agreement with the United States, we will increase the amount which the UK pays for life-changing medicines by 25% through changes to the way that medicines are evaluated by the National Institute for Health and Care Excellence (NICE), including an increase to the NICE cost-effectiveness threshold. In this way, we are increasing the value that we place on innovations that deliver improvements to patient health, ensuring faster patient access for vital medicines for cancer, rare diseases and other conditions.
We are giving a clear signal that we want to bring innovative medicines to National Health Service patients, encouraging the life sciences industry to prioritise the UK as an early launch market, and help get the newest available treatments to those who need them.
Asked by: Lord Wigley (Plaid Cymru - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what estimate have they made of the effect of the agreement recently concluded between the UK and USA as part of the Economic Prosperity Deal on the cost of purchasing drugs for the NHS for each of the financial years 2025/26, 2026/27, 2027/28, and 2028/29; and whether any such costs were included in planning for the recent Budget 2025.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
Every patient deserves access to the best possible treatment. This deal is a vital investment that builds on the strength of our National Health Service and world leading life sciences sector.
Costs will start smaller but will increase over time as the National Institute for Health and Care Excellence (NICE) approves more life improving and lifesaving medicines. Total costs over the Spending Review period are expected to be approximately £1 billion. But the final costs will clearly depend on which medicines NICE decides to approve and the actual uptake of these. This is not something that we can pre-empt at this time as it depends on which drugs come to market, and which are assessed as approved for use on the NHS accordingly.
At the Spending Review we delivered a record real terms increase for day-to-day spending for the NHS in England up to April 2029. This deal will be funded by allocations made at the Spending Review, where front line services will remain protected through the record funding secured. Future year funding will be settled at the next Spending Review.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the extent to which patients and their families have been engaged in NICE's project to appraise the effectiveness of vorasidenib.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) is the independent body that makes evidence-based recommendations for the National Health Service on whether new medicines should be routinely funded by the NHS on the basis of an assessment of clinical and cost effectiveness. NICE develops its guidance through extensive engagement with interested parties, including patient groups.
NICE is currently evaluating vorasidenib for treating astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations after surgery in people 12 years old and over. As part of the appraisal process, NICE’s independent committee was provided with evidence submissions from three patient groups. The committee also heard expert personal perspectives from two patient experts.
The draft guidance was shared with all stakeholders as well as being published on the NICE website for public comment as part of the consultation which took place between 15 October and 4 November 2025. The committee reviewed the consultation comments at the committee meeting on 20 November 2025. NICE currently expects to publish final guidance in January 2026.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they plan to publish the draft service specification for the Genomic Medicine Service, and if so, when.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The NHS Genomic Medicine Service’s (NHS GMS) service specification, published in July 2025, sets out future testing strategy, including focus on improved turnaround times and requirements to deliver the Genomic Population Health Service, in line with the 10-Year Health Plan. The final service specification was published in Autumn 2025 following stakeholder feedback. The new NHS GMS will be operational from April 2026 and will set out the new model up to 2036.
Asked by: Jeremy Hunt (Conservative - Godalming and Ash)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when he plans to publish the report into the cost of clinical negligence being prepared by David Lock KC.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The rising costs of clinical negligence claims against the National Health Service in England are of great concern to the Government. Costs have more than doubled in the last 10 years and are forecast to continue rising, putting further pressure on NHS finances.
As announced in the 10-Year Health Plan for England, David Lock KC is providing expert policy advice on the rising legal costs of clinical negligence and how we can improve patients’ experience of claims. The review is ongoing, following initial advice to ministers and the recent National Audit Office’s report.
The results of David Lock’s work will inform future policy making in this area. No decisions on policy have been taken at this point, and the Government will provide an update on the work done and next steps in due course.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Baroness Merron on 7 November (HL11405), what monitoring processes are in place to ensure that the national sample handling guidance for the whole genome sequencing of solid tumours is being implemented fully.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The performance of the NHS Genomic Medicine Service is monitored quarterly through an assurance framework, which ensures all seven NHS Genomic Laboratory Hubs are operating to national quality standards. This identifies and minimises any potential variation and ensures consistent delivery of the criteria outlined in the National Genomic Test Directory.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what plans they have to change their genomic testing strategy.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The NHS Genomic Medicine Service’s (NHS GMS) service specification, published in July 2025, sets out future testing strategy, including focus on improved turnaround times and requirements to deliver the Genomic Population Health Service, in line with the 10-Year Health Plan. The final service specification was published in Autumn 2025 following stakeholder feedback. The new NHS GMS will be operational from April 2026 and will set out the new model up to 2036.
Asked by: Luke Evans (Conservative - Hinckley and Bosworth)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he plans to continue the Mental Health Investment Standard.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Despite the challenging fiscal environment, the Department expects all integrated care boards to continue to meet the Mental Health Investment Standard in 2025/26. Spending on mental health support in 2025/26 is forecast to increase compared with 2024/25, reaching £15.6 billion. This represents an increase of £688 million in cash terms.
The Government recognises the need for a new approach to mental health in order to reduce waiting times, improve the quality of care, and increase the productivity of mental health services. Funding is a key component of this. The NHS Medium Term Planning Framework therefore sets out that integrated care boards will be required to meet the Mental Health Investment Standard over the next three years by protecting mental health spending in real terms, ensuring that spending increases in line with inflation.
Asked by: Ben Obese-Jecty (Conservative - Huntingdon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has he made of the impact of the findings by the study of 1,005 GPs entitled “General practitioners’ adoption of generative artificial intelligence in clinical practice in the UK: An updated online survey”, published in the Digital Health science journal on 25th November 2025 that stated that 35% of doctors used AI for writing documentation, 27% for differential diagnoses and 24% for treatment or referrals despite having no formal training or oversight.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is aware of the study published in Digital Health on 25 November 2025 regarding the adoption of generative artificial intelligence (AI) by general practitioners (GPs). AI has the potential to transform health and care services by improving health outcomes, enhancing patient safety, and reducing costs. However, it is crucial to rigorously and regularly evaluate AI technologies to ensure they work safely, ethically, and effectively in different clinical settings.
The Department is currently assessing the implications of these findings through engagement with NHS England, the General Medical Council, and other stakeholders. Guidance is also being developed to ensure safe and ethical use of AI in clinical settings, which includes requirements for training and accountability, and working with regulators such as the Medicines and Healthcare products Regulatory Agency and the National Institute for health and Care Excellence to develop evaluation pathways for AI tools. This is to ensure the AI tools meet standards equivalent to other regulated medical technologies, and whether additional safeguards or standards needed to mitigate risks to patient safety and data security are explored.
We will continue to monitor emerging evidence and ensure that any integration of AI into clinical practice is underpinned by appropriate oversight, transparency, and professional responsibility.