Lord Kamall

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 the Commission on Human Medicines, the MHRA’s independent advisory committee, where appropriate, to inform regulatory decisions including amending the product information.

The MHRA has received a total of 112 reports through the Yellow Card scheme for all antidepressant medications of reports of completed suicide which have been received between 1 January 2015 and 25 February 2025. The following table shows a yearly breakdown thereof:

Source: MHRA

Note: List of antidepressant medications included in the search were: escitalopram, citalopram, paroxetine, fluoxetine, fluvoxamine, sertraline, venlafaxine, duloxetine, reboxetine, amitriptyline, clomipramine, dosulepin, dothiepin, doxepin, imipramine, lofepramine, nortryptiline, trimipramine, trazodone Isocarboxazid, tranylcypromine, moclobemide, phenelzine, agomelatine, vortioxetine, L-tryptophan, esketamine, mianserin, mirtazapine.

It is important to note that anyone can report to the MHRA’s Yellow Card scheme and the recording of these reports in the Yellow Card database does not necessarily mean that the adverse reactions have been caused by the suspect drug. Many factors must be considered in assessing causal relationships, including temporal association, the possible contribution of concomitant medication, and the underlying disease. We encourage reporters to report suspected adverse reaction reports, the reporter does not have to be sure of a causal association between the drug and the reactions; a suspicion will suffice.

The number of reports received cannot be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug, is known. All fatal reports including those reporting completed suicide are assessed by the MHRA and cumulative information is reviewed at regular intervals. Warnings about the risk of suicidal behaviours are contained in the product information for all licensed antidepressants and these warnings are based on causality assessments of individual case reports and the totality of evidence from clinical trials and the scientific literature.

The number of fully qualified general practitioners (GPs) increased by 535 full-time equivalent between July 2024 and December 2024. This data includes estimates for practices that did not provide fully valid staff records. This does not include recently qualified GPs employed through the Additional Roles Reimbursement Scheme (ARRS).

Information on the number of recently qualified general practitioners for which primary care networks are claiming reimbursement via the ARRS is currently being collated and is not yet published. We are working to verify the data and establish its reliability, which is necessary before any dataset can be published.

The Department is committed to maximising our potential to lead the world in clinical trials and ensuring clinical trials are more accessible, including for children and young people. The Department does not hold data on the overall percentage of children and young people with cancer that are enrolled in clinical trials nationwide, but does collect data on participation through National Institute for Health and Care Research (NIHR) funded infrastructure.

The Department funds research and research infrastructure through the NIHR. NIHR-funded infrastructure is enabling clinical trial participation for children and young people with cancer. In particular, the NIHR Clinical Research Network, now the NIHR Research Delivery Network, supported 15 cancer studies which children and young people were eligible for between 2021/22 and 2023/24, and across all these studies, 715 total participants were recruited during this timeframe.

The NIHR provides an online service called Be Part of Research which promotes participation in health and social care research by allowing users to search for relevant studies and register their interest. This makes it easier for people to find and take part in health and care research that is relevant to them.

Through the NIHR, the Department also jointly funds the Experimental Cancer Medicine Centre Paediatric Cancer Network with Cancer Research UK and the Little Princess Trust, which brings together clinicians and translational scientists to run early phase clinical trials for children and young people with cancer.

The research participant experience is an essential part of delivering a world-class research system with participant feedback providing research delivery teams, study sponsors and the Department with actionable data to improve accessibility of health and care studies, and increase recruitment rates and retention of participants.

The Department-funded National Institute for Health and Care Research (NIHR) has operated the Participant in Research Experience Survey (PRES) since 2015/16, which aims to offer as many research participants as possible the chance to contribute their experiences of taking part in research. PRES currently operates nationally across the NIHR Research Delivery Network portfolio and is offered to all participants in eligible cancer studies including young people.

To improve data collection on research experience, NIHR is currently exploring a national roll-out of a digital PRES which will increase ease and access for participants to provide feedback on their experience. This system will also be scalable beyond the NIHR Research Delivery Network Portfolio.

To increase transparency in accessing available data on participants’ experiences of research, the PRES dashboard can be accessed by users from across the research system with the following email address domains: nhs.uk, nhs.net, nhs.scot, dh.gsi.gov.uk, ac.uk, hscni.net, nrs.org.uk, mhra.gov.uk, gov.uk, ncri.org.uk.

Local authorities are best placed to understand and plan for the needs of their population, which is why the Care Act 2014 places a duty on them to shape their care market to meet the diverse needs of all local people.

Local authorities also have a temporary duty under the Care Act 2014 to ensure continuity of care if a provider exits the market due to business failure. This is to ensure that people continue to receive the care and support they need.

Patient safety is the highest priority for the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA uses a range of metrics to monitor and improve its management of safety.

Specific safety metrics include the total number of safety signals identified for further assessment, the percentage of adverse drug reaction reports processed within agreed timescales, the percentage of potential signals evaluated within five working days, the number of defective medicinal product recalls, and the number of interventions conducted by the Criminal Enforcement Unit that are assessed to have disrupted or degraded an identified criminal threat. Performance against these metrics is outlined in the MHRA’s Annual Report and Accounts. Further metrics are used internally within the MHRA to monitor performance for all types of medicinal products, including medical devices.

For blood components, the MHRA works with the Serious Hazards of Transfusion Steering Group, to measure safety outcomes associated with transfusion and make recommendations to the system to reduce safety incidents through an annual report.

In 2024, the MHRA updated their reporting processes and established a new set of eight key performance indicators. These were outlined in its 2024/25 Business Plan.

We remain committed to rolling out fracture liaison services across every part of the country by 2030.

The Government and NHS England support the clinical case for services which help to prevent fragility fractures and support the patients who sustain them. Officials continue to work closely with NHS England to explore a range of options to provide better quality and access to these important preventative services.

In the meantime, we are investing in 14 high-tech DEXA scanners, which are expected to provide an extra 29,000 scans to ensure people with bone conditions get diagnosed earlier.

The Department does not hold a central list of all establishments to which a general practitioner can refer a patient for a scan.

The Organisation Data Service, operated by NHS Digital, holds and publishes unique identification codes and accompanying reference data for organisations that are involved in health and social care in England and beyond. This covers a wide variety of National Health Service and non-NHS organisations, such as NHS trusts and independent sector healthcare providers, including those that provide diagnostic scans.

A list of community diagnostic centres (CDCs) is published by NHS England, and is available on the NHS.UK website, in an online only format. Where a newly opened CDC starts to deliver activity, this will be captured in an updated publication. This includes temporary CDC sites that are delivering services on an interim basis whilst the permanent CDC site is under construction.

The research plan is not complete yet, but it will consider what data should be used, including diagnosis codes, and how people's choices to opt-out will be respected.

The Government inherited an undeliverable commitment to implement charging reforms in October 2025, as funding was not guaranteed and preparations for full rollout were not on track. Whilst there are no current plans to promote specific private insurance products for funding future social care costs, we have announced the independent Casey Commission into adult social care as part of our critical first steps towards delivering a National Care Service.

The Commission will consider the long-term transformation of adult social care, including what long-term and sustainable funding solutions should look like. It will build on the expert proposals of other reviews, including that of Sir Andrew Dilnot, into care funding and support.

The Department works closely with NHS England to monitor a variety of metrics relevant to patient safety, including four-hour accident and emergency performance, Category 2 ambulance response times, bed occupancy, and rates of seasonal infectious disease. NHS England publishes monthly statistics that can be found on the NHS.UK website.

Additionally, during the winter period, NHS England publishes additional weekly situational reports. This data can also be found on the NHS.UK website. My Rt Hon. Friend, the Secretary of State for Health and Social Care also recently met with hospital trusts and social care organisations to reiterate the importance of maintaining patient safety over winter.

The national approach on priorities for winter planning were issued by NHS England on 16 September 2024, setting out the key steps to be taken to support the delivery of high-quality care for patients this winter. Provisions for resourcing of hospital beds and ambulances for this winter are an operational matter for the National Health Service.

The NHS is managing extra demand over the winter period, by strengthening same day emergency care, offering more falls services for older people, and with upgraded 24-hour live data centres.

On 1 December 2024, the number of patients in England remaining in hospital who were medically fit to be discharged was 12,086.

An impact assessment of the cut in winter fuel payment on hospital admissions this winter has not been produced. The Government has taken action to ensure low-income households are protected this winter.

We have made necessary decisions to fix the foundations of the public finances in the Autumn Budget. Resource spending for the Department will be £22.6 billion more in 2025/26 than in 2023/24, as part of the Spending Review settlement. The employers’ National Insurance rise will be implemented in April 2025. We will set out further details on allocation of funding for next year in due course.

We recently announced a proposed funding uplift for general practice for 2025/26 of £889 million, representing a 7.2% cash growth, estimated at approximately 4.8% real terms growth. This is the largest uplift to general practice (GP) funding since the beginning of the five-year framework and means we are reversing the recent trend with a rising share of total National Health Service resources going to GPs.

We committed to restoring the front door of the NHS by shifting the focus of the NHS out of hospitals into the community. We know when patients are not able to get a GP appointment, they end up in accident and emergency, which is worse for the patient, and more expensive for the taxpayer. That is why it is key that we increase the capacity of appointments for GPs. We have already committed to recruiting over 1,000 newly qualified GPs from this October through an £82 million boost to the Additional Roles Reimbursement Scheme which will increase the number of appointments delivered in general practice.

Primary care providers, including GPs, are valued independent contractors that provide almost £20 billion worth of services in the NHS. Every year we consult with each contracted sector about the services it provides, and the money providers are entitled to in return. As in previous years, this issue will be dealt with as part of that process. We have recently begun discussions on the annual GP contract.

Following the initial discussion with the National Data Guardian, NHS England decided not to pursue the topic of adding a patient-facing function to GP Connect. It would have had a limited application and been technically and legally complex to implement, as noted in section 6.7.4 of the National Data Guardian 2023-2024 report, and would not have provided sufficient benefit, additional to the existing function of Subject Access Requests. There was, therefore, no exploratory work completed on this subject.

There are multiple ways for a patient’s record to be accessed. Any patient-facing feature needs to take all these different routes into account and, as noted by the National Data Guardian, NHS England is considering whether this functionality might be possible in the Government’s plans for a single care record.

In response to the range of pressures facing local authorities, the Government will make available up to £3.7 billion of additional funding for social care authorities in 2025/26.

In England, the Department of Health and Social Care is responsible for nutrition legislation including food supplements, fortified foods, nutrition and health claims, foods for specific groups, and nutrition labelling.

The Government has been working closely across all four nations to implement the policy to fortify non-wholemeal flour with folic acid to reduce the risk of neural tube defects in babies. In England, this change has been implemented via amendments to The Bread and Flour Regulations 1998 alongside other changes and will come into force in December 2026.

This is a complex policy, which has required careful consideration of the evidence, advice from scientific committees and involved much scientific debate. It has been taken forward as a measure across the United Kingdom and has involved two consultations and coordination across the four nations and across successive governments in each nation.

The Department for Environment, Food and Rural Affairs published responses to the second public consultation in January 2024. The Government has prioritised swift action to protect unborn babies and moved rapidly to reach agreement with the other nations and lay the legislation in England on 14 November 2024.

The length of time needed to develop policies varies depending on the complexity of the policy and other factors.

We have taken 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 employer National Insurance rise will be implemented in April 2025, and the Department will set out further details on the allocation of funding for next year at the earliest opportunity.

We have taken 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 employer National Insurance rise will be implemented in April 2025, and the Department will set out further details on the allocation of funding for next year at the earliest opportunity.

NHS England’s Diabetes Programme uses a range of communication channels, including mainstream and social media, to share information about the latest technologies that are available for people with Type 1 diabetes. NHS England works closely with its partners, including Breakthrough T1D, Diabetes UK and the Association of British Clinical Diabetologists Technology Network to amplify key messages.

A new decision support tool has been designed to support people to understand what diabetes treatment technologies are available on the National Health Service, supporting discussions between someone living with type 1 diabetes and their healthcare professional about the technology they are eligible for and supports shared decision-making about the person’s care in managing type 1 diabetes.

Furthermore, nationally commissioned self-management resources have been put in place, including DigiBete, designed for children and young people aged between zero and 25 years old with type 1 diabetes in ten languages and MyType1 Diabetes, which is available to all adults living with type 1 diabetes.

As part of NHS England’s focus on improving equity of access to diabetes technology, diabetes care is one of the five clinical areas of focus for integrated care boards to achieve system change and improve care within the Core20Plus5 for children and young people . Core20PLUS5 is a national NHS England approach to support the reduction of health inequalities at both national and system level. The approach defines a target population cohort and identifies five focus clinical areas requiring accelerated improvement. The aim of this work is to increase access to real-time continuous glucose monitors and insulin pumps for people in the most deprived 20% of the national population and people from ethnic minority backgrounds.

There are no current plans to produce or publish a follow-up report to the independent review by Professor Sir Mike Richards, Diagnostics: Recovery and Renewal. The Department will publish a ten-year plan for the National Health Service in spring 2025.

The Secretary of State for Health and Social Care has been clear that the Government will not tolerate National Health Service managers who silence whistleblowers. The Government recognises the importance of strong and accountable leadership in supporting whistleblowers and fostering a positive, compassionate culture within the NHS. That is why we have committed to introducing professional standards for and regulating NHS managers. We are currently considering the most appropriate and effective means of delivering this.

The Employment Rights Act 1996, as amended by the Public Interest Disclosure Act 1998, gives legal protection to those who speak up in the public interest. The legislation is intended to build openness and trust in workplaces by ensuring that workers who hold their employers to account are treated fairly. In 2018, enhanced legal protections were introduced that made it unlawful for NHS employers to discriminate against job applicants on the grounds that they have made a protected disclosure in the past. This complements the longstanding legal provisions within the Public Interest Disclosure Act 1998.

There is a network of more than 1,200 local Freedom to Speak Up Guardians throughout healthcare in England, whose role is to help and support staff who want to speak up about their concerns. NHS England has also published a national Freedom to Speak Up policy, which provides the minimum standard for local Freedom to Speak Up policies across the NHS, which NHS organisations are required to adopt. Workers who wish to speak up can also receive advice and support from Speak Up Direct.

We are determined that alongside the 10-Year Health Plan, there will be a long-term plan for adult social care to build consensus on the reform needed to create a National Care Service. We have now launched the Change NHS website, where everyone can submit their ideas and experiences to help us build a health service fit for the future and inform the 10-Year Health Plan. We will listen to and co-design the plan with the public and health and care staff.

This Government, since taking office, has not held any such conversations.

NHS England is developing the NHS Federated Data Platform (FDP) Solution Exchange, a catalogue of products for trusts and integrated care boards to improve efficiency and patient care. This is in an early phase of release and will develop over the coming months to include opportunities for suppliers of innovative solutions.

For developers the solution exchange provides a safe and secure space to create and test new ideas to strict NHS FDP standards, using synthetic data. New innovations will be reviewed and tested for suitability before being made available in the NHS FDP Solution Exchange Product Catalogue.

During Autumn and Winter 2024-25, the programme will host a series of sessions to describe the opportunities this will provide for National Health Service organisations developing their own products and those jointly or independently developed by third party suppliers. This will include how products are prioritised and assessed for inclusion in the Solution Exchange.

The SURMOUNT-REAL clinical trial of tirzepatide, announced on 15 October 2024, is being developed between Health Innovation Manchester, The University of Manchester, and Eli Lilly and Company, with further details about the study to be published by these organisations at a later date, following on from relevant approvals.

The study will evaluate the real-world effectiveness of tirzepatide in weight loss, diabetes prevention, and the prevention of obesity-related complications for people living with obesity. Additionally, data will be collected on healthcare resource utilisation, health-related quality of life, and changes in participants’ employment status, including sick days from work.

The evidence generated will seek to increase the global evidence base on the long-term impacts of weight loss medicines more broadly, and the placement of the trial is a clear vote of confidence in the United Kingdom from a global healthcare stakeholder, working with our brilliant and regionally diverse life sciences sector to improve understanding of a priority healthcare field.

This announcement was made as part of a collaboration agreement between Eli Lilly and Company and Government unveiled at the International Investment Summit, as part of an intended £279 million package of investment from Eli Lilly and Company into the UK's innovation and research ecosystem.

We are proposing a single or unified health record as a vision for the future, to develop in consultation with the public and healthcare professionals. Ensuring that patients’ confidential information remains protected and is seen only by those who need to see it will be a priority. Public engagement next month will help us understand what safeguards patients would want to see.

Pregnant women with folate deficiency are at greater risk of neural tube defects (NTDs). Currently government advice recommends that women who could become pregnant take a daily supplement of folic acid before conception and up until the 12th week of pregnancy. However, we know that around 50% of pregnancies in the UK are unplanned. Government is therefore looking at this UK-wide measure to mandate the fortification of flour with folic acid to reduce the number of NTDs in pregnancies as a priority.

The Scientific Advisory Committee on Nutrition (SACN) and the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) have considered the proposed level of fortification in depth.

The proposed policy is to fortify non-wholemeal wheat flour at 250 micrograms per 100 grams. Fortification above this level would allow for greater reductions in NTD risk but would increase the risk of people exceeding the recommended upper level of folic acid intake.

An upper limit of 1 milligram per day was set in the UK by the UK Expert Group on Vitamins and Minerals in 2003, which was later reviewed and agreed by COT in 2018. In 2006 and 2009, SACN concluded that it was also necessary to minimise exposure to high intakes of folic acid because there was still uncertainties regarding folic acid and cancer risk at high intakes.

The UK Government and devolved governments addressed concerns on the interaction of folic acid with treatments and medications for different conditions, such as cancer and epilepsy, in the consultation on the policy proposal in 2021. In addition, information on the presence of folic acid will be included on the ingredients list on product labels to inform consumers. In 2023, COT published a risk assessment of the potential risks of allergic reaction (hypersensitivity) to folic acid if flour is fortified with folic acid at 250 micrograms per 100 grams.

There is agreement from both SACN and COT that the proposed levels of fortification are appropriate and provide a balanced approach to fortification.

The level of folic acid fortification will be kept under review as part of the monitoring and evaluation of the policy, which would assess both positive and postulated negative impacts.

The Department does not hold the information on what percentage of general practice (GP) surgeries and primary care centres currently offer an online booking option for GP appointments.

NHS England has published on its website an overarching National Health Service Federated Data Platform (FDP) data protection impact assessment (DPIA), an overarching NHS FDP information governance framework, and overarching NHS FDP privacy notice and privacy notices, for each national FDP product.

NHS England plans to publish an overarching NHS Privacy Enhancing Technology DPIA, and a DPIA for each national FDP product on the NHS England website in autumn 2024. These will be placed in the library of the House.

The government is carefully considering the valuable work done by the Hughes Report and will respond in due course.

While this was an IT outage, not a cyber security incident, the National Health Service has robust cyber security measures in place, and is increasing cyber resilience across health and social care.

Health and care organisations are required to have business continuity plans in place, which we will continue to strengthen, to minimise disruption in the event of an IT outage or cyber incident. As outlined in The King’s Speech, the Government’s new Cyber Security and Resilience Bill will strengthen our defences and ensure that essential digital services are protected by expanding the remit of the existing regulation, putting regulators on a stronger footing, and increasing reporting requirements, to build a better picture in Government of cyber threats.

As of April 2024, 97% of general practices in England have cloud-based telephony systems in place. The Government has pledged to deliver a modern appointment booking system to end the 8:00am scramble, and ensure that there is an online booking option for all that wish to use it.

The Government is considering the recommendations of The Hughes Report, and to prevent future harm, the Medicines and Healthcare products Regulatory Agency, NHS England, and others have taken action to strengthen oversight of valproate prescribing and mesh procedures. For example, nine specialist mesh centres are in operation across England, ensuring that women with complications of mesh inserted for urinary incontinence and vaginal prolapse get the right support in every region, and we have maintained the national pause on the use of pelvic mesh, which has been in place since July 2018.