Draft Human Medicines (Amendment) Regulations 2026

Caroline Johnson Excerpts

Tuesday 3rd March 2026 General Committees

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is a pleasure to serve under your chairmanship, Mrs Harris. The Opposition do not intend to divide the Committee on these regulations, as anything that improves trust in medicines and vaccines is important. We need to increase the uptake of vaccines; it has fallen gradually and continues to fall, and we need to reverse that.

I have a couple of technical questions. As the Minister said, the principle behind the amendment to regulation 3 of the 2012 regulations is to make prescribing pharmacists equivalent to doctors and dentists. However, regulation 3(8) currently refers to,

“another doctor or dentist…of the same…practice.”

Given that pharmacists will now also be included, should that be amended to “another doctor, dentist or pharmacist”, or “a doctor or dentist”?

Regulation 5 redefines an “occupational health vaccinator” and refers to a list in part 4 of schedule 16 to the 2012 regulations. That significantly broadens the list to include individuals such as speech and language therapists who are not accustomed to dealing with injectable medications, but appears to exclude operating department practitioners, who, as the Minister will be aware of from his practice, are used to dealing with injectable medications. Could the Minister explain the reason for removing those practitioners from the list?

Regulations 8 and 9 talk about the vaccine group direction. The patient group direction is essentially a group prescription, where a clinician signs off the circumstances in which medication—say, paracetamol —may be given by a non-prescriber. We had such a direction for the covid-19 vaccine during the pandemic. This vaccine group direction would be different, so why does the Minister feel that we need a different process to the patient group direction that is already available for vaccines, which are prescription medicines? Instead, those directions can be signed by someone who is not a clinician—such as a manager in the Department of Health or, in fact, a private company—and they do not need to have any clinical skills or qualifications at all. A clinician, or one of the people listed, must decide whether the conditions have been met, and they can then give the patient the medicine without having prescribed it.

I want to ask a couple of questions on this issue. How does that improve trust, when we have a vaccine-sceptic population and lots of material on social media, some of which is not entirely accurate? How does allowing a prescription to be written by someone with no clinical experience help with trust and those rates? Is there a plan to contract out vaccine provision to the private sector, because that is what this provision allows for? Who is ultimately responsible? Is it the non-clinician who signs the vaccine group direction? Who is the clinician ultimately responsible for the decision to give the vaccine in the event that someone has an allergic reaction or an adverse reaction of some other type?

[Dr Ahmed]

I am grateful to the shadow Minister for her support; she is a learned Member of this House, and I know she takes these matters extremely seriously both here and in her own clinical practice.

She raised a technical point on whether the sub-paragraph should include the word “pharmacist”, given the updating of the regulations—I am very happy to explore that further to ensure that the wording is optimal. I also want to reassure her on the point she made about the workforce; training and a governance framework will be set up by the UK Health Security Agency, which will oversee all of this. Whether it is an operating department practitioner or anyone else, there will be a basal level of training that can reassure all Members of this House, whether we are the clinician prescribing the vaccination or the citizen receiving it. This will be overseen very tightly by the UKHSA.

[Dr Johnson]

Before the Minister moves on, can I just ask him why ODPs appear to have been removed from the list?

[Dr Ahmed]

I am not clear on why they have been removed from the list. However, I certainly expect that anyone who is reasonably trained will be able to deliver vaccines in the settings that we have proposed, which include community hospitals and everywhere in between, when we need to think about hard-to-reach communities.

The shadow Minister also asked a question on vaccine group direction versus patient group direction. The primary difference is that the VGD allows for the separation of the decisions to treat and provide consent by a registered healthcare professional, which still need to exist, from the administration of the vaccine, which is then done by a separate individual. That is not possible under a PGD, so it is about separating the roles. However, I reassure her that the consent process in prescriptions is paramount, and she is right that it must continue to be if we want to invite people’s confidence in the vaccination process.

--- Later in debate ---

[Dr Johnson]

Can the Minister confirm that the vaccine group direction—unlike a patient group direction, which ultimately needs to be signed by a clinician—would not need to be signed by a clinician, and can instead be signed by a senior manager either within a company or department?

[Dr Ahmed]

I will clarify that for the shadow Minister, but we are both cognisant of the wider point that clinicians ultimately take responsibility for prescriptions and informed consent of the vaccination process, and that will still continue. Healthcare professionals will still be seeking consent for treatment; the VGD simply means that they can be separate to the person who is then administering the vaccine in practice. There is no suggestion that there will not be clinical oversight or governance of this process—it is quite the opposite. This provision is designed to tighten governance frameworks and make them more transparent.

As I set out at the start of the debate, the proposed amendments aim to support the ongoing development of a vaccination system that is fit for the future. They are designed to build upon the benefits that HMRs have provided to date, as well as wider lessons learned during the pandemic, including recent polio and MMR catch-up programmes. In amending these regulations, the Government are seeking to maintain important safety measures while also increasing the effectiveness of the system’s supply chains and workforce in vaccination programmes.

The science unequivocally tells us that, after clean water, vaccination is the most effective public health intervention for saving lives and promoting good health. It is therefore a solemn duty of this Government to do all we can in this space to support the health system’s ability to deliver vaccines for all those eligible and, in turn, help support vaccine uptake. Given the overall support of the proposals in the consultation, and the ongoing need to support the continued safe and effective supply, distribution and administration of vaccines both now and in future, it is our intention to make permanent the provisions discussed during the debate. I commend the draft regulations to the Committee.

Question put and agreed to.

Eating Disorders Awareness Week

Caroline Johnson Excerpts

Thursday 26th February 2026 Westminster Hall

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is a pleasure to serve under your chairmanship, Ms Vaz. I congratulate the hon. Member for Bath (Wera Hobhouse) on securing this important debate and on her work in this area.

Eating disorders are deeply complex conditions. On the surface, disordered eating can take a variety of forms, including restricting the amount or the type of food eaten; binge eating large amounts of food in a short period and then purging that food through forced vomiting; excessive exercise; and laxative misuse to avoid weight gain. Beneath that surface lay a horde of drivers, such as control, shame, anxiety, obsessive-compulsive disorder, poor body image, and mysophobia, which is also known as germophobia.

The covid pandemic provoked intense scrutiny of germs and cleanliness, took away people’s control over when they could go out and when they could see their friends, and drove their activities from the personal to the online, so it comes as no surprise that it saw a spike in eating disorder referrals. By early 2021-22, 3,400 people were treated for an eating disorder, compared with 1,900 in the same period in 2019-20.

The last Government introduced the mental health investment standard to increase mental health spending in local health systems, and it also included a pledge to increase mental health spending as a proportion of total health spending every year. With mental health accounting for over 20% of demand for health services, and a 2021 report finding that eating disorders cost the UK economy a £9.4 billion per year—

[Valerie Vaz (in the Chair)]

Can I ask you to speak up, please? People in the Gallery cannot hear.

[Dr Johnson]

I am sorry.

The last Government’s work to channel more resources into mental health could not have been more welcome. This year, 2025-26, will be the first since 2016-17 that mental health spending has not risen as a proportion of health spending. That contravention of the mental health investment standard has raised alarm bells at the Health and Social Care Committee. Can the Minister enlighten us as to why the Government have decided to break the mental health investment standard after nearly a decade of progress? Does he think the percentage is now about right? Does it concern him that some ICBs have cut funding for mental health services? How does he expect that to impact on patients suffering from eating disorders?

I am particularly concerned about the impact on children and young people, and I declare an interest as a consultant NHS paediatrician. Some 6.4% of adults have a diagnosed eating disorder, but 12.5% of 17 to 19-year-olds have been diagnosed with an eating disorder since 2023. That amounts to one in five girls in that age group—four times the prevalence in boys. What specific action is the Minister taking to improve early intervention?

The previous Government got the ball rolling on establishing mental health support teams in schools, and had reached 35% coverage by the time of the general election, with a commitment to increase that to 100% of schools and colleges in England by 2030. Does the Minister plan to build on that work? What further action is he taking to improve links between eating disorder services, schools and families to ensure a joined-up approach to accessing specialist help and early diagnosis, which, as we have heard, is critical?

The hon. Member for Didcot and Wantage (Olly Glover) spoke of the challenges of transition. As a paediatrician, I see the challenges of transitioning many paediatric and adolescent conditions between children’s and adult services, but can the Minister say what he is doing specifically for those transitioning with eating disorders?

In my role as chair of the APPG on emerging drugs and online behavioural trends, I know the effect of social media on children’s and young people’s behaviours. Researchers from University College London, who examined evidence from 50 studies in 17 countries, found that social media usage is linked to eating disorders in young people, as it viciously promotes the idea that it is essential to be thin and fit, triggering a potentially extreme preoccupation with body image, weight and shape. Those obsessions are compounded by AI content, which can depict simply unachievable so-called perfection. As the hon. Member for Bath said, there are harmful videos online, with algorithms driving that harm, and those who look at these things seeing them more and more.

I recently held a policy debating competition among year 10 and year 12 students in my constituency, where students chose the topic of debate. Many of them spoke in favour of a social media ban for children as young as 16. It is a difficult issue, and that is not a perfect solution, but having just got a new mobile phone myself, I wonder why, when someone buys a phone, it cannot be set at a fixed age that can be changed only by the adult who pays the bill. A change in the law to restrict social media for under-16s would help to reduce that problem. I am interested in the Minister’s thoughts on that.

NHS guidance on eating disorders for ICBs has been raised in the debate. The NHS has refreshed that guidance, which is welcome, but patients will feel the difference only if it is actually implemented. The Minister has confirmed that there will not be a dedicated strategy for eating disorders, and there is no mention at all of eating disorders in the 70,000-word 10-year plan. Is the Minister confident that the refreshed guidance for ICBs will be sufficient on its own to improve care for people with eating disorders and to get waiting lists down? Does he have a strategy for how it will be enforced?

We have talked about the effects on families and carers. What action is the Minister taking to engage families, carers and supportive charities in plans for care? What support is available for parents, carers and siblings?

Workforce is key to delivering this strategy. We know that waiting times for eating disorder treatment are getting worse; analysis from Beat found that, in some cases, people with eating disorders face a three-and-a-half-year delay between falling ill and starting treatment. For someone with an eating disorder, that is three and a half years deeper into the illness. As we have heard, that makes it all the more difficult to treat the patient effectively and quickly pull them out of that difficult, dark place. What steps is the Minister taking to increase workforce capacity to help treat these patients and restore some stability and normality to their lives? I feel as though I ask this question every time, but the NHS long-term workforce plan is still not with us, having been delayed from last year, so when will it be published, and what tangible action will it take to boost the NHS eating disorders service?

It is not just about hiring more staff; it is also about where we are hiring them. That is important work, but more needs to be done to build on the progress. The Healthcare Quality Improvement Partnership produced a highly detailed report about in-patient eating disorder service provision in the UK. As expected, there were blackspots for those vital services in many rural and coastal areas, such as in Lincolnshire. For adults and families in constituencies such as mine, where the closest service may be an hour’s car journey away, accessing eating disorder services is remarkably difficult. The Government have been insistent that rural and coastal areas will not be left behind on healthcare, but the blackspots tell us otherwise.

[Dr Arthur]

I thank the hon. Member for giving way—I have to say that she is one of my favourite Tories. Does she agree that there is a real inequality here? A one-hour car drive is a challenge, but if someone does not have a car, it is even more difficult. If they have a child, they might have to take a day off work to take them somewhere. So getting services, or capacity in the community, closer to people should absolutely be the ambition, shouldn’t it?

[Dr Johnson]

I completely agree. This is not just about people who have a car; for people who do not have a car and who are reliant on public transport, it can be even more difficult. People also struggle to take time off work because of the financial cost. For those who do have a car, there is also the cost of the petrol or diesel to get to the appointment. I would appreciate it if the Minister could update us on what he is doing to ensure that the neighbourhood and community slant of the three pillars of his health improvement plan are working in that regard.

As the hon. Member for Bath said, in-patient services are limited in capacity. In my paediatric practice, I have seen patients waiting on acute general paediatric wards—sometimes for several weeks—but those are really not the right place for them to be cared for. Could the Minister update us on what he is doing about increasing capacity in regional services?

I would like to speak a little about two other types of eating disorder: avoidant/restrictive food intake disorder and Prader-Willi syndrome. ARFID involves limiting the amount or variety of food consumed. It is not just picky eating. I have seen a teenager who lives on just plain pasta, nuggets and chips, and a younger boy who lives on a single flavour of one brand of milkshake and no solid food at all. That can be driven by fear and sensory and other issues. What is the Minister doing to make sure that services are available for these young children? NHS England’s refreshed eating disorder guidance recommends:

“ICBs should develop and deliver ARFID care pathways”.

What steps is the Minister taking to improve early diagnosis of ARFID, and what work will be done to train primary carers to identify it in children and adults, particularly in cases of neurodivergence?

Prader-Willi syndrome is a rare genetic disorder causing excessive appetite and overeating, which can lead to dangerous weight gain and restricted growth. Around 2,000 people live with Prader-Willi syndrome in the UK, and there is no cure. It is not mentioned in the NHS guidance, so what work is the Minister doing to ensure that people suffering from PWS have access to the care they need? What steps are we taking to expand genetic testing at birth to identify PWS and improve early access to treatment for these patients?

To sum up, mental health challenges are on the rise, and eating disorders are no exception. I urge the Minister to implement a clear approach to tackling eating disorders for adults, children and young people.

--- Later in debate ---

[Dr Ahmed]

I wholeheartedly agree. The Government are committed to ending the revolving door for many conditions—this is an exemplar, in many ways—by joining up care and the streams of information that underpin it. One of our main commitments in our 10-year health plan is to have more joined-up care, to move it from sickness to prevention and to move from hospital into community, where that join-up can happen.

This community can thrive only when it is built on a foundation of timely, effective care. That is why we are focused on reforming eating disorder services so that people can access help when they need it, not after their condition has escalated. That approach underpins the new NHS guidance for children and young people’s eating disorder services, published last month, which is clear that care should be timely, joined up and delivered as close to home as possible.

As many here know, demand for mental health support, including eating disorder services, rose sharply during the pandemic, and the rise has been sustained thereafter. Although services remain under significant pressure, as a result of the additional investment there are some green shoots in system capacity and capability to better meet rising demand and reduce the waits that hon. Members have described.

In December 2025, 83.3% of routine referrals to children and young people’s community eating disorder services and 78.8% of urgent referrals started treatment within four weeks and one week respectively. That is a marked improvement in performance, compared with the situation six months earlier. In June last year, only 72.2% of routine referrals and 63.7% of urgent referrals were seen within four weeks and one week respectively. Although those are encouraging signs, I am under no illusion: too many children and young people are still waiting far too long for support. That is exactly why further reform and delivery are needed.

The Government’s long-term approach to mental health reform is set out in the 10-year health plan, which is clear in its direction. It shifts care from hospital to community, from sickness to prevention and, of course, from analogue to digital, which will be so important when it comes to having joined-up care. I assure hon. Members that those shifts are not abstract principles, but practical changes that are already being embedded. I know that they matter deeply for people living with eating disorders, and the families and loved ones who support them.

But I recognise that plans alone do not deliver care. Delivery depends on people and having the right workforce with the right skills in the right places. That is why, on top of the workforce plan that will come to fruition in late spring or early summer, we are investing in the workforce. We are committed to providing an additional 8,500 new mental health professionals across child and adult mental health services, to cutting waiting times and to ensuring that people access treatment and support earlier than ever before.

We are also working to strengthen skills and capability across the system. NHS England has introduced comprehensive training to ensure that staff across mental and physical health services can recognise eating disorders early and respond safely and effectively. That training supports clinicians working not only in the community but in primary and, crucially, acute care settings, where I used to work. I often saw such patients on my acute general surgical receiving ward rounds. The training includes specialist programmes, including the Royal College of Psychiatrists’ eating disorders credential, expanded access to family-based therapies, cognitive behavioural therapy for eating disorders, and dedicated training on ARFID, which the hon. Member for Sleaford and North Hykeham (Dr Johnson) mentioned. That work is about giving staff the skills, confidence and, crucially, clarity they need to deliver safe, high-quality care and reduce some of the avoidable harm that we have discussed today.

I am pleased to say that funding for children and young people’s eating disorder services has increased significantly, from £46.7 million in 2017-18 to an actual spend of £106.3 million in 2024-25. With that extra funding, we have focused on enhancing the capacity of community eating disorder teams across the country, because we know that timely, effective care leads to better outcomes, supports recovery and helps to prevent conditions escalating to the point at which hospital admission becomes inevitable.

When admission is necessary, stronger community care can reduce length of stay when it is safe. We recognise the concerns that in-patient capacity remains under pressure in some parts of our country. There are reports of individuals being discharged at very low body mass due to bed availability, as the hon. Member for Bath highlighted. Discharge decisions must always be about clinical judgment and patient safety, not capacity constraints. NHS England reassures me and continues to work with providers and integrated care boards to ensure that sufficient specialist provision and safe step-down pathways will be in place.

[Dr Caroline Johnson]

The Minister’s speech is very interesting. He talks about an increase in capacity, much of which will require workforce. I noticed that when he mentioned the workforce plan, he said “spring or early summer”, which is a change from his previous wording, which was always “spring”. Is that a sign that it is being delayed further?

[Dr Ahmed]

As always, the hon. Lady reads too much into my words. I am a Scot, so for me, spring and summer sometimes mean the same thing—and indeed winter. I can reassure her that there was no subtext to that nuance earlier in my speech. We remain committed and are on track to deliver on the workforce plan.

We recognise concerns, of course, and NHS England is addressing them. Prevention must be central to how we respond to eating disorders, particularly for children and young people. That is why we are also providing £13 million to strengthen the role of mental health support teams in schools and colleges through enhancements, so that concerns about disordered eating and body image can be identified and addressed much earlier. Acting sooner improves outcomes, reduces the need for more intensive treatment later and helps to ensure that our young people get the support they need, at the right time.

We are encouraged by the progress being made, but I am under no illusions. I know that sustained improvement depends on clear, consistent expectations for high-quality care across the whole pathway. That is why, alongside the 10-year health plan, we are developing a modern service framework for severe mental illness, which I can reassure the House will include eating disorders, to help to reduce avoidable harm from them and improve outcomes for persons affected by them. However, to get it right, we need expert input across the system, so my noble Friend Baroness Merron, the Minister responsible for mental health, will be hosting a roundtable discussion with eating disorder charities, clinicians and those with lived experience, to ensure that the modern service framework delivers meaningful improvements for people with eating disorders, with lived experience at the heart of it.

We have spoken, rightly, about online safety issues as they intersect with mental illness and eating disorders. As a parent, I of course remain deeply concerned about the widespread availability online of harmful material promoting eating disorders, suicide and self-harm, which can be far too easily accessed by people, including young people, who may be vulnerable. The UK’s Online Safety Act 2023 makes platforms—including social media, search and pornography services—legally responsible for keeping people, especially children, safe online. All providers must mitigate the risks of illegal harm on their services, and all providers of services likely to be accessed by children must take steps to mitigate their risks to children, especially as regards content related to eating disorders.

Oral Answers to Questions

Caroline Johnson Excerpts

Tuesday 24th February 2026 Commons Chamber

[Mr Speaker]

I call the shadow Minister.

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

I declare an interest as a consultant paediatrician in the NHS. Prevention of ill health is crucial. It is particularly important in children, perhaps most especially when one is trying to prevent ill health in children caused by doctors. I have expressed concerns previously about the puberty blockers trial, as have many in both Houses. The trial has now been paused due to a Medicines and Healthcare products Regulatory Agency letter. When were Ministers first aware of that letter and when were they first aware of the concerns described within it?

[Ashley Dalton]

The regulators are doing their job. This is a perfectly ordinary occurrence in certain research trials. As the hon. Member has made the House aware—I am sure it was already aware—the trial has been paused. We will leave the regulators and the clinicians to do their jobs to ensure that all the trials, including this one, are done in an appropriate fashion.

[Dr Johnson]

That is a very interesting answer. Before Christmas, the Secretary of State had confidence in an allegedly vigorous and rigorous process. Fertility preservation techniques have not deteriorated over the last few months. The ages at which children reach the Tanner stages of puberty have not changed over the last few months, but the MHRA’s view has. Why? Given that this is such a scrutinised trial, does that not call into question the MHRA’s wider competence and due diligence? Will the Minister publish the MHRA’s letter from November referred to in the more recent correspondence published on Friday?

[Ashley Dalton]

What the hon. Member highlights is part of this rigorous process. That is what happens. Why the MHRA has changed its view is a question for the MHRA, but it is up to the MHRA to raise these issues through the process. That is why we run such trials. [Interruption.] It is an independent regulator.

Hughes Report: Second Anniversary

Caroline Johnson Excerpts

Wednesday 11th February 2026 Westminster Hall

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is an honour to serve under your chairmanship, Dr Allin-Khan. On behalf of the Opposition, I thank the hon. Member for Chesham and Amersham (Sarah Green) for securing today’s debate. She has campaigned tirelessly on this issue, giving a voice to thousands of women who have been let down by the state. I also thank Henrietta Hughes for the Hughes report.

Thousands of pregnant women were prescribed sodium valproate between 1973 and 2017 despite growing evidence of harm. In 1972, scientists found in animal studies that it was harmful to foetuses, and in 1984, foetal valproate syndrome entered the medical literature. Studies in the 2000s highlighted the link between valproate and birth defects. I remember, as perhaps you do, Dr Allin-Khan, learning about it at medical school. Yet it was only in 2018 that the valproate pregnancy prevention programme came into force, which was too late for more than 20,000 children with entirely preventable disability.

Over 10,000 women in England were harmed by pelvic mesh. Mesh kits were issued in the 2000s to treat urinary incontinence and prolapse, despite a lack of long-term safety data. Women suffered hideous complications: mesh tearing through tissue, bleeding, infection and sexual dysfunction. Shockingly, it took until 2018 for NHS England to suspend the routine use of these implants.

I want to raise the case of a lady, now in her 30s, who had a mesh implant put in to prevent a hernia in her abdominal wall, something that is often missed from the discussions about mesh. She describes how she is unable to leave her home because there is a hole in her stomach wall where the mesh has eroded. It cannot be removed. The surgeon described it as being stuck in there like chewing gum. She described her wish for a family. She described the smell of the constant infections. She described the fear of waiting for the next infection and wondering whether the sepsis from it will kill her. Yet there seems to be no way for her to get this mesh removed.

The previous Government did not sit on their hands. The former Health Secretary, my right hon. Friend the Member for Godalming and Ash (Sir Jeremy Hunt), commissioned the independent medicines and medical devices safety review after hearing from over 700 affected people and medical stakeholders. The previous Government issued a formal apology to victims and appointed a Patient Safety Commissioner. They began to establish a network of centres to provide treatment, care and advice for those affected by the implanted mesh. I would be grateful for an update on that from the Minister, particularly in the light of the case that I described.

In 2022, the previous Government asked the new commissioner to report on options for compensating victims. Dr Henrietta Hughes did so in February 2024, a full 24 months ago, and that report set out what justice should look like for victims: an interim redress scheme and a permanent one to follow. As my right hon. Friend the Member for New Forest East (Sir Julian Lewis) said, it was a package of clear, practical steps to right the wrongs done to so many women. Yet two years on, we are no further forward.

After the 2024 election, the hon. Member for Chesham and Amersham asked the Government when they would respond to the Hughes report. The response was that the Government would consider the recommendations and meet with the commissioner. In January 2025, when asked by Baroness Ritchie of Downpatrick, the Government said they were “carefully considering” report and would provide an update “at the earliest opportunity.” In March, in this very room, a Government Minister said that recommendations were being actively considered and that a report was coming “at the earliest opportunity.” In that debate, the Minister suggested that research by Dr Rebecca Bromley was material. Can the Minister update us on that research?

In October, when the hon. Member for Rushcliffe (James Naish) asked whether funding had been allocated for redress, a Minister said that recommendations were being carefully considered and a response would come at the earliest opportunity. In December, when the shadow Secretary of State for Health and Social Care, my right hon. Friend the Member for Daventry (Stuart Andrew), asked whether financial support was forthcoming, the Government said that recommendations were—still—being carefully considered. Last month, when my hon. Friend the Member for Harrow East (Bob Blackman) asked whether funding was forthcoming, a Minister said the Government were “carefully considering” the report and an update was coming “in due course”.

What we have heard from Ministers is so frustrating. For 18 months, Members have asked what is being done, and time and again, this Labour Government have refused to give a clear answer. I note that the previous debate was responded to by the Under-Secretary of State for Health and Social Care, the hon. Member for West Lancashire (Ashley Dalton), and both she and the Under-Secretary of State for Health and Social Care, the hon. Member for Glasgow South West (Dr Ahmed), have answered questions on the matter. We have a different Minister today, and it is a delight to see her, but perhaps she can confirm which Minister takes responsibility for this issue in the Commons.

I have some further questions for the Minister. On which date did work begin on a response to the Hughes report? How many civil servants are working on the response? Have there been any conversations with the Treasury about the costs of the redress scheme? If work has been taking place, why is it invisible? If, in fact, nothing has been done, why have the Government persisted in telling Members that a response is forthcoming? Why, despite Dr Hughes visiting the Department in December, has nothing materially changed? Will the Government, as my hon. Friend the Member for North West Norfolk (James Wild) asked, make an interim payment this calendar year?

Over the weekend, the Patient Safety Commissioner told ITV:

“This is a disgraceful way that patients and families are being treated by those in power.”

She is absolutely right. The state’s No. 1 duty is to protect the public from harm, yet after inflicting harm, the state has failed to make things right. This is part of a pattern under Labour whereby systemic failings, particularly those affecting women, go unresolved. Every day that victims of mesh and valproate do not receive justice, confidence in health professionals is undermined.

We know that the Chancellor is fast running out of other people’s money, but it is wrong to balance the books on the backs of those who are suffering. Justice is the state’s duty. It is not optional. It is not something just to be carefully considered for years on end, indefinitely, while women and children suffer. The Government can respect the victims and the work of the Patient Safety Commissioner today by answering our questions, or they can continue their parade of platitudes and evasions. I look forward to the Minister’s response.

Brain Tumour Survival Rates

Caroline Johnson Excerpts

Monday 9th February 2026 Commons Chamber

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

I thank the hon. Members for Mitcham and Morden (Dame Siobhain McDonagh) and for Witney (Charlie Maynard) for bringing forward this debate on a very important subject. The hon. Member for Mitcham and Morden talked about the people she had met who had experienced brain cancer and brain tumours. For me, this debate is about my grandfather, who sadly died of a brain tumour some years ago.

Some 12,000 people have a brain tumour diagnosed each year, and this debate is supposed to focus on how we improve the survival rates for this condition, which are very poor. It is the leading cause of cancer deaths among children and adults under 40. The five-year survival rate is poor and—unlike the rate for many other cancers over the last few years—has not really moved at all. How can we improve the survival rates for people with brain tumours? There are essentially three areas that we can look at: prevention, early diagnosis and better treatment.

On prevention, if we look on the NHS website to see how we can prevent a brain cancer or brain tumour, it talks about having a good diet and preventing obesity. These things are important, but not specific to brain cancer. It also talks about trying to avoid head injury, for example by wearing helmets. What about early diagnosis? Some people have genetic conditions, such as neurofibromatosis, Li–Fraumeni syndrome, tuberous sclerosis and Von Hippel-Lindau syndrome, that make them genetically predisposed to having tumours in their central nervous system. Those individuals can receive regular screening, which can help identify these tumours at a much earlier stage, but what about people who do not have such conditions?

[Sir John Hayes (South Holland and The Deepings) (Con)]

I apologise, Madam Deputy Speaker, for intervening despite not being here for the beginning of the debate. My hon. Friend will know that I chair the all-party parliamentary group for acquired brain injury, and I am also president of the Lincolnshire Brain Tumour Support Group—she is right about the connection between the two. Does she think it would be advisable for those who have suffered a brain injury to be screened routinely, given the correlation between an earlier brain injury and the later advent of cancer?

[Dr Johnson]

My right hon. Friend invites me to speak outside my area of expertise; I am afraid I do not know the answer to that.

[Peter Prinsley]

Will the shadow Minister take an intervention?

[Dr Johnson]

I will, particularly if the hon. Gentleman has an answer for my right hon. Friend.

[Peter Prinsley]

I cannot understand how there can be a relationship between head injury and brain tumour. Repeated injury causes some neurological conditions, particularly for footballers, whom we see getting early dementia, but I do not see a connection between head injury and brain tumour. Does the shadow Minister?

[Dr Johnson]

It is certainly something that I have read about. I am happy to be corrected by the hon. Gentleman if he feels that my resources are incorrect, but that was certainly one of the suggestions for how to prevent these tumours. I do not think that prevention will necessarily be the major way in which we improve the survival rate. I also do not think that it will be early diagnosis, but I would like to finish talking about that. Regular screening for people with genetic disorders can really help to identify tumours early, and the second thing that can help is access to diagnostic tests. The Conservative Government introduced community diagnostic centres across the country, which increased the number of scanners available to those who needed a scan to identify whether they had a brain tumour. This Government have said that they will double the number of scanners available. Can the Minister comment on whether they are on track with that?

We need the workforce plan, so that we have the people to perform and interpret the scans. I do not know whether the Minister has had any tips on whether the workforce plan is imminent, but can he give us a date for when it is likely to be published? It has been delayed, but it is important. We have the cancer plan, but so much of it is dependent on the workforce plan. Thirdly, opticians have a role to play. Since a South Tees project pioneered in 2015, opticians have been able, during regular eye tests, to identify people who have signs of brain tumours, and to refer them, when necessary. Encouraging people to get regular eye tests may contribute to early diagnosis.

The fourth thing that can help with early diagnosis is symptom awareness—among both the general public and healthcare professionals. I want to talk about HeadSmart, a 2011 programme about the types of symptoms that could help identify a brain tumour. It had quite significant cut-through with both healthcare professionals and the public. It halved the time for a scan, and for diagnosis of children with brain tumours. It also improved the cognition of survivors, but it did not significantly improve the survival rate. While early diagnosis helps a bit, it is very difficult—particularly in children, who are quite neuroplastic, so symptoms appear quite late. The location and type of tumour are more important in the treatment and prognosis, and there are many different types. That makes this area of medicine extremely complicated, so I think the answer is that we need better treatments.

Treatments currently include steroids, chemotherapy, radiotherapy and surgery, but there are many others with promise. Convection-enhanced delivery enables chemotherapy to be delivered across the blood-brain barrier more effectively. Many hon. Members have talked about freezing, and last month there was a debate on the topic of freezing brain tumour samples; does the Minister have an update following that debate? His colleague, the Under-Secretary of State for Health and Social Care, the hon. Member for West Lancashire (Ashley Dalton), said that she would look at the detail and report back, so I hope that he will have an update for us this evening. Gene therapy has also shown a lot of promise, and there has been talk this evening about the trial in which an adeno-associated virus is used as a vector to seek out the glioblastoma cells and use the patient’s immune system to kill the tumour cells. That trial has promise; if it works, it could lead to real improvements in treatment.

Research will be key. BioNTech’s 2023 partnership promised that there would be 10,000 patients in cancer vaccine trials by 2030, but new innovators face barriers. This is a global fight; work is going on right across the globe, and we need to make the UK’s environment one that stimulates and supports research, so that British people can have the earliest possible access to the newest treatments. At the moment, the wider economic picture for research is not great, and we have seen some researchers pull out of investments in the UK. Taxation, national insurance, employment rules and the speed of adoption by the NHS are all factors that I hope the Minister will try to improve.

The hon. Members for Edinburgh South West (Dr Arthur) and for Strangford (Jim Shannon) talked about the devolved Administrations. Could the Minister comment on how he and his team are working with those Administrations to encourage research right across the United Kingdom? I also wanted to talk about rural areas, because it is all very well encouraging trials in the UK or England, but so many of those trials are in the centre of London, or in the other big cities; it is much more difficult for people living in rural areas, such as my constituents in Sleaford and North Hykeham, to access them. Could the Minister please update the House on how he is making it easier for research to occur in rural spots?

The hon. Member for Witney summed it up perfectly when he said that ambition is important, but actions, not words, are the key. We need specific, measurable targets, not just warm words—this Government have been very good at warm words on health, but much poorer on delivery. For the sake of the one in two people who will get cancer, and all their friends and loved ones, I hope that on this occasion, there is more action, not just words.

Medical Training (Prioritisation) Bill

Caroline Johnson Excerpts

Committee of the whole House
Tuesday 27th January 2026 Commons Chamber

[The First Deputy Chairman of Ways and Means (Judith Cummins)]

I call the shadow Minister.

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

I will speak to the amendments tabled by the Opposition. First, amendment 9 would require that from 2027, priority is given to British citizens on UK foundation programmes, and that they are prioritised for interviews and places on specialty training programmes. Clause 4 defines a UK medical graduate as a

“a person who holds a primary United Kingdom qualification within the meaning of the Medical Act 1983 (see section 4(3) of that Act)”.

However, it does not include

“a person who spent all or a majority of their time training for that qualification outside the British Islands.”

The Secretary of State has stated his intention to prioritise UK medical graduates, but he has failed to protect all British citizens in doing so. Our amendment would ensure that British citizens who study on an eligible medical course overseas were still prioritised in the Bill. There are many scenarios in which we may need to ensure that we protect British citizens. Consider, for example, a spouse, partner or child of a serving member of the UK armed forces who completes relevant training overseas while their relative is posted in Cyprus; a student at Queen Mary University of London who has completed the bachelor of medicine and bachelor of surgery course at its Malta campus but received a UK medical degree; a young British citizen who has studied in the US or France, owing to a family relocation; or, given that the largest bottleneck is not in training places but in getting a place in medical school at all in some cases, a British student who has gone to study overseas because of their fervent desire to become a doctor.

Those are all entirely possible and plausible scenarios in which British citizens have completed their relevant training, and wish to bring their skills back and to relocate in their homeland for the rest of their career, but may not be covered by the Government’s prioritisation model. The Government’s prioritisation model is based on where the degree was taken, rather than also considering who did it. The Secretary of State must ensure that we do not overlook our own citizens if we are to fairly address the competitive landscape for training posts. The Opposition therefore urge the Government to accept amendment 9.

Amendment 10 is a probing amendment to explore the effects of the Bill on military personnel. As a Member of Parliament representing an area with a large armed forces community, I know that medical trainees are an integral part of our serving community. The world is becoming an increasingly dangerous place, and junior trainees may be sent abroad earlier in their career than is currently the case. It is clearly wrong to penalise people who are doing brave work caring for our armed forces. They ought to be provided with optimal opportunities, and the Secretary of State has a duty to ensure that they are not overlooked. I would be grateful if the Minister covered that in her response.

New clause 3 would require the Government to make an annual report to Parliament about the Bill’s impact on the number of international students at UK medical schools, and the financial impact on UK medical schools. We talked about the bottleneck, and the balance between UK and international students training at UK medical schools; clearly, becoming a UK graduate will now come with a significant premium. What impact will that have on British children getting to make their choices and become doctors if they want to? What incentives does it provide to universities to increase the number of international students, and what effect will that have overall on UK medical schools?

New clause 2, tabled by my hon. Friend the Member for Runnymede and Weybridge (Dr Spencer), is about places for UK foundation and speciality training programmes, and the importance of allocation on merit, because we all want the very best doctors. When I became a doctor—believe it or not, it was 25 years ago this year, Madam Deputy Speaker—I applied for a job as a junior house officer, as it was called then. I applied for the jobs I wanted, I was interviewed by the consultants who would have been supervising my training, and then I was offered the jobs.

The experience of students today is very different. They are allowed to put in a preference and say which deanery or foundation area they would like to work in, but that is all. After that, the application goes into a computer system, which gives them a single rank that is not based not on anything they have done at university, or on whether they got good results or worked hard, or anything like that. The computer system will do a first pass, and if the first choice is available, it will give the student their first choice. If it is not available because by the time its gets to that student those places have gone, the computer system will miss the student and go on to the next one. When it has completed its full pass of the list, it will start again, and when it comes to that student next time, it will give them the highest preference that is still available.

Once the student has been allocated a foundation deanery, the process starts again within the locality, and I mean “locality” in the loosest possible sense. Take those applying for the Trent rotation; they could be posted in Lincoln, Boston, Nottingham, Derby or Burton. The doctor has no control over where they will go, and very little ability to express a preference. My hon. Friend the Member for Weald of Kent (Katie Lam) spoke about a student in her locality who had not been able to get a place, despite being at the top—third, I think—of their university class. It is clearly not fair to give people no opportunity to control their future. By the way, there is no right of appeal, so having been given their place, the choice for the student is: that place or no place.

The hon. Member for Sunderland Central (Lewis Atkinson) spoke about ordinary children from the north-east. Having once been an ordinary child from the north-east, I agree that it is important that people have opportunity, but it is equality of opportunity, not equality of outcome, that matters. I worry that the system creates equality of outcome. We therefore support new clause 2, tabled by my hon. Friend the Member for Runnymede and Weybridge.

Amendment 1 would require the Bill to take effect on the date of Royal Assent, as opposed to a date at the discretion of the Secretary of State for Health and Social Care. The Bill is deemed necessary emergency Government legislation to prioritise medical graduates in the United Kingdom for places on medical training programmes. When he announced the Bill in an attempt to avert industrial action by resident doctors in December, the Secretary of State told the House that he had been working intensively with his team to

“to see how quickly we could introduce legislation”—[Official Report, 10 December 2025; Vol. 777, c. 430.]

However, the Bill does not commit to a date when these measures will be enacted. Instead, the power lies in the hands of the Secretary of State, giving him a clear bargaining chip for future negotiations. It is clear that the Government intend to pass this legislation urgently, as they have said. However, without a commencement date, there are clear concerns that the Bill is just a negotiating tactic to prevent industrial action by resident doctors, and can be scrapped at a later date. There remains the prospect of further industrial action, despite the legislation being introduced. The Secretary of State should not be asking Parliament to pass a Bill that he has no intention of enacting if the British Medical Association plays ball and holds off on strikes. Either the Secretary of State thinks that this is emergency legislation that we need to get on with and enact, or he does not.

It is vital that the legislation is enacted straight away, because students are due to be given their training programme places now, and they need to decide where they are going to live. They cannot put their life on hold, and measures to prioritise UK doctors cannot be held off, until the Secretary of State has finished dangling a carrot in front of the British Medical Association. The Opposition are clear: while we are supportive of the principles of the Bill, it must be used for offers made this year.

Amendment 8 would clarify that under clause 5, a UK foundation programme is a programme where the majority of training takes place inside the United Kingdom. A foundation programme is defined as

“an acceptable programme for provisionally registered doctors”

in section 10A of the Medical Act 1983. It is vital to clarify that a UK foundation programme is a programme where a majority of training takes place inside the United Kingdom. That is because the General Medical Council can approve foundation programmes overseas. If it is not explicit that a foundation programme needs to be in the United Kingdom, a loophole is created whereby a foundation programme could be approved overseas, creating a back way into the system and circumventing the measures that the Government have tried to put in place. I encourage the Minister to look at that carefully as the Bill progresses.

In summary, we support the Bill, but we have concerns about some of the clauses, so we have tabled amendments that we hope the Government will look at carefully.

[The First Deputy Chairman]

I call the Liberal Democrat spokesperson.

Medical Training (Prioritisation) Bill

Caroline Johnson Excerpts

2nd reading
Tuesday 27th January 2026 Commons Chamber

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

I am pleased to respond on behalf of the Opposition, but first I should declare my interest as a consultant paediatrician and member of the British Medical Association.

Medicine is a vocation, but it is also an art and a science, and training takes a long time. After, in general, five years as a medical student, new resident doctors need to train further in a specialism such as orthopaedics, ophthalmology or, in my case, paediatrics. Postgraduate training varies in length and structure among the specialties, but in broad principle it is divided into a foundation programme and more specialist training. The foundation programme is two years long and teaches a variety of skills. Specialist training is more specific, and there are well over 60 different specialties that people can choose from. It is those two phrases—the foundation programme and specialist training—that the Bill refers to.

We are in a situation where there has been a huge surge in the number of applications per training post. One reason for that is the substantial increase in the number of medical school places. That was caused by action by the previous Conservative Government to improve the number of doctors in the long term. The previous Government opened five medical schools—at Sunderland, Anglia Ruskin, Kent and Medway, Edge Hill and, very close to my constituency, Lincoln. The first students at those universities graduated in 2023, 2024 and 2025, which increased the number of students looking for posts.

At the time there was also a widespread expansion of existing medical school places—and, of course, there was the pandemic. During the pandemic, students who had applied for medical school and accepted offers found themselves unable to take their exams, and teacher-assessed grades meant that there was a huge increase in the number of successful applicants who got the grades they needed. There were more compared with the number that was statistically expected. The Government lifted the cap, and there was a huge number of medical students in that period. Many of them qualified last summer. That is why there is a huge increase in the number of local graduates.

In response to my hon. Friend the Member for Farnham and Bordon (Gregory Stafford), the Secretary of State talked about his pledge to double medical school places, but there does not appear to have been an increase in the number of medical school places this year, and a statement from the Department for Health and Social Care at the weekend suggests that it is not a Government commitment. When the Secretary of State was asked whether he stands by his pledge, he seemed to say no, so I would appreciate it if the Minister clarified that issue.

In 2024 at a visit to the Royal Derby hospital, the Secretary of State said that that site would be part of delivering the doubling of the number of medical school places that Labour is committed to in order to ensure that the NHS has the staff it needs to treat patients on time. He then encouraged people to vote for that in the 4 July general election. Will he clarify whether he stands by his pledge, and if so, when does he expect to start delivering on it?

UK factors are not the main cause for the rise in numbers. The BMA has published figures from freedom of information requests that show that the number of UK graduates applying for training programmes went up from 9,273 in 2023 to 12,305 in 2025, which is an increase of about a third. Over the same period, the number of international medical graduates applying for specialist training went from 10,402 in 2023 to 20,803 in 2025, which is a doubling of applications.

The surge in numbers has left British graduates facing unemployment. Some may pursue careers overseas and not return. The valuable contributions from international medical graduates are appreciated, but many complete training and return to their home nation, which could leave us with a potential shortage in the long term of consultants and GPs.

The Government are right to step in to prioritise local talent. As such, we support the principles behind the Bill. However, there are some issues that we have questions about. First, the foundation programme applications are in progress. An application window closed on 8 October, and pre-allocation outcomes were due in mid-December. Foundation school applications due on 26 February are also to be delayed. The foundation programme website states that allocations can only occur once the Bill receives Royal Assent. That delay in itself, and the uncertainty associated with it, is difficult enough for young doctors and their families. Yet the Secretary of State creates an extra layer of uncertainty by adding clause 8 and the right to withhold activation of the Bill to a day of his choosing. Why is he doing that?

What are the foundation programme and the people who run it to do? Should they wait, based on, “Will he, won’t he?” and, “When will he allocate it, when will he not?” Should they allocate places anyway, on the basis, as has been said already, that people need to know where they will live and sort out their arrangements? Or will they have to reallocate if the Secretary of State activates it, after it was allocated on the basis that he had not done that yet? That is not the way to treat professional, hard-working people.

As my hon. Friend the Member for Farnham and Bordon said in his speech, this is not just about doctors; it is about patient safety now and in the future. The Conservatives have submitted an amendment that would activate the Bill on Royal Assent. I urge the Secretary of State to do what is right for the country and for patient safety and support it.

Secondly, Labour has forgotten the British people—those we represent and should prioritise. I will say more as we consider the specific amendment, but under Labour’s Bill, foreign nationals completing a primary medical degree in Iceland, Norway, Liechtenstein, Switzerland and the UK are in a priority group. Yet a British citizen who trained in the USA, Canada, France or even the Malta campus of a UK medical school are not.

The hon. Member for Sunderland Central (Lewis Atkinson) talked about the likelihood of international medical graduates leaving the UK after training, but surely that is an argument to ensure that British trainees are prioritised wherever they have trained—if the degree is suitable. The Conservative amendment ensures that British people are always front and centre, and we urge the other Opposition parties to back it. The issue of British citizens was raised earlier too. I want to clarify for the avoidance of all doubt that when we say “British citizens” we mean those from England, Wales, Scotland and Northern Ireland.

There are other clarifications, which I will be grateful if the Minister can address when winding up. On military doctors, what position is in place to ensure that military resident doctors are able to access the posts that they need? What impact will the Bill have on them, particularly if, as the world is more dangerous now, they spend more time overseas in future than at present?

As Conservatives, we believe in meritocracy and, as such, I support new clause 2 tabled by my hon. Friend the Member for Runnymede and Weybridge (Dr Spencer). We all want excellent doctors and—I will say more about this in Committee—a random allocation does not encourage excellence. It produces stress and uncertainty, it does not encourage excellence, so I support the amendment.

We agree with the principle of the Bill, but we encourage the Government to accept amendments that encourage excellence, to think through the detail, to put politics aside and do what is right for the country, to prioritise British citizens and to activate the Bill immediately on Royal Assent.

Health and Social Care

Caroline Johnson Excerpts

Monday 26th January 2026 Written Corrections

[The Secretary of State for Health and Social Care (Wes Streeting)]

… We have invested more than £131 million to improve maternity and neonatal care facilities, brought in a new maternity care bundle, we are implementing a programme to reduce the two leading causes of avoidable brain injury during labour, and we have increased maternal mental health services. There is so much more to do, however, to guarantee safety now and into the future, and also to ensure truth, justice and accountability for past failures.

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

The maternity and neonatal plan is due in the spring, nearly two years after the Secretary of State took office. The maternity review has been delayed. There are no signs of the 1,000 additional midwives the Secretary of State said he would train. Gynaecology waiting lists are rising, with the number waiting for admission 6% higher than it was a year ago. The Secretary of State has an opportunity to save many lives, and I know that he wants to use all the opportunities available to him. May I ask him to concentrate on making more improvements in maternity care?

[Wes Streeting]

Let me just point out that in the 18 months for which I have had the privilege of holding this post, we have invested more than £131 million in 122 infrastructure projects across 49 NHS trusts to improve the safety of neonatal care facilities. We have implemented a new programme to reduce the two leading causes of avoidable brain injury during labour…

[Official Report, 13 January 2026; Vol. 778, c. 737.]

Written correction submitted by the Secretary of State for Health and Social Care:

Draft Medical Devices (Fees Amendment) Regulations 2026

Caroline Johnson Excerpts

Wednesday 21st January 2026 General Committees

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is a pleasure to serve under your chairmanship, Ms Jardine. I agree that post-market surveillance is important for patient safety, but predictability for businesses and reducing the burden on them is also important.

On 12 May 2025, the Minister for Secondary Care, the hon. Member for Bristol South (Karin Smyth), said that the SI that we were discussing on that occasion—the Draft Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025—would increase the fees across the MHRA for devices from June. That included fees for various things, most of which were increased by between 9% and 16%, but some fees, such as for clinical investigation charges, were increased much more. She said at the time that this would

“ensure cost recovery until 2027”.—[Official Report, First Delegated Legislation Committee, 12 May 2025; c. 3.]

It is now January 2026 and the Government are back for more money. Why is that? They increased the fees for regulation 53 of the Medical Devices Regulations 2002—a regulation that the regulations that we are debating today also affect—from £240 to £261 back in June, and they plan to increase them again.

Let us consider why. In May, I raised some questions about the impact assessment produced for that legislation, for two reasons. First, it did not appear that the national insurance increase or the reduction in the national insurance threshold had been accounted for in the calculations. Secondly, the impact assessment assumed a 2.2% pay rise for civil servants for the years 2024-25 to 2026-27. Even then, that level was below inflation.

Regarding staff costs, the Minister in that debate said she thought they were NHS staff, but she later wrote to me to confirm that the national insurance contribution hikes were payable by the MHRA because the staff were civil servants. In response to my written questions, the Minister declined to say whether national insurance was included, but assured the House that the MHRA had “modelled…future costs”, that the uplift would be enough until April 2027 and that the MHRA would find “efficiency savings” if required to manage any future shortfall.

I asked the MHRA, by way of a freedom of information request, what increases it faced in national insurance costs as a result of reductions in the thresholds and increasing the rate. It said that it faced a yearly cost of £1.9 million. I also asked:

“What estimate has the MHRA made of the additional cost arising from the difference between”

the pay rise estimated in the impact assessment and the actual pay rise that was given. The answer was £1.2 million. That is a shortfall of £3.1 million, or 20% of the increase in fees from the last SI.

The MHRA said at that time that

“we believe that, while this extra cost”

—national insurance—

“was not included, our fees cost-recovery methodology and approved fees are still sufficient to cover projected costs over the next two years, without any negative impact on service delivery or financial sustainability.”

That letter was dated 1 August 2025, which is after that PMS legislation came into effect. There was a significant difference between the calculations that the MHRA produced and the £3.1 million figure, which raises questions about their accuracy and the grip that the Government have on the detail and our public finances.

The Government are now here again, wanting to increase the registration fee by an additional 15% to £300, but this time with no impact assessment. The regulations that we are discussing today not only increase the registration fee by 15% from April 2026, but add a maintenance fee of £300 for each device in a category listed, starting with

“the fee period immediately following that in which the person paid the fee for the device registration…due on the first day of each…period”.

That would seem to mean that if a device is registered between now and April, they pay £261 now and £300 on 1 April, which will presumably incentivise delaying any current registrations. I can see that the Minister has adjusted for this in future years, but he does not seem to have done so for those registering this year.

I am interested in how sure the Minister is that his estimate for the increase in the post-market surveillance of £17 million is robust, given that we are back six months after the Government were sure they had enough. This year, the de minimis assessment says that £6 million will come from grant in aid from DHSC, £4.9 million from DHSC financial support and £6.1 million from the fee income. The current registration fees are predicted to produce £1.6 million, leaving a difference of £4.5 million to be covered by fee increases.

The de minimis assessment’s best estimate says that the MHRA needs to make £4.3 million of that, which is £300 a year on each of the devices, in the way that the Minister described. However, it also says that

“we plan to seek approval for full cost recovery fee for subsequent years”,

which the Minister has confirmed is his plan today. Why is that not in today’s regulations? Is that because it would have required an impact assessment? How much will this cost businesses? This will be a further £10.9 million and, if £300 a year will get the Minister £6.1 million, then for £17 million he will need about £836. That is a massive increase on businesses coming down the track next year, which I do not think he has fully considered.

Burdens on businesses are important because they stifle activity and innovation. This Government have already added significant burdens to businesses: higher taxes and national insurance rates, the reduction of the national insurance threshold, the Employment Rights Act 2025 and, for family-owned businesses, the business property relief. They are now adding further costs, and I am concerned about the effects on innovation and early access to devices for patients.

What is the Minister’s assessment of international comparators? In recent times we have seen a loss of pharma investment in the UK. Will the extra fees this year, and the prospect of hikes next year, deter investment? There is no impact assessment, so how can we be sure? I am particularly concerned about small businesses and microbusinesses. The de minimis assessment says that it is not possible to exempt microbusinesses. Why is it not possible? It is a political choice not to exempt them, but it is certainly possible to produce regulations that do.

As the Minister described, the consultation revealed widespread concern, with only 10% support. Changes have been made following discussion with a trusted advisory group. Who is in the trusted advisory group? Whose voices from micro and small businesses were heard in that group? There has been no further consultation and no impact assessment on the regulations the Minister has presented today.

I also have some specific questions about obsolescence. Do businesses need to pay a registration maintenance fee for putting a product on the market to sell or lease? That was previously a single charge that lasted for the product’s lifespan, however long that would be. There is now an annual fee. What provision is made for the clinical use and post-market surveillance of items that cease to be registered because a company goes bust or stops selling the item? Can the item still be used? How would a clinician know that the lapse of a previous licence had stopped, particularly if it was a personal piece of medical equipment such as a stethoscope? How does that affect post-market surveillance?

Could registration be discontinued for some items, where someone has several categories possible, in order to register another category and force obsolescence? For example, I have seen one case where the failure to produce spare parts lead to an entire trust having to replace every single defibrillator, at great expense. If a company went bankrupt and was no longer able to pay its post-market surveillance fee, the item would no longer be registered. How would that work?

I also want to ask about categories. Originally, as described in the consultation, the GMDN category was level 5, which is extremely specific. It is now level 2, which is better, but microbusinesses still pay the same charges as larger businesses, so a business selling one product would pay the same as a business selling dozens of products in the same category. Also, there is no accounting for the size of the product or the surveillance required. For example, the charge for an MRI scanner, worth £2 million, would be the same for as a single-use scalpel worth less than £1. Is that fair? I appreciate that people may sell more scalpels than scanners, but what about an umbilical artery dilator, of which not too many are used, at £24 each? Producers of inexpensive but highly specific and useful devices may be disadvantaged. What will the effects be on costs for patients? Again, there is no impact assessment, so we do not know. How much of the cost produced by these regulations does the Minister expect to be transferred back to the Government in paying for more expensive devices?

Overall, there are many more questions raised than answered by these regulations. Patient safety is paramount. There is, of course, a cost to ensure that devices are properly and proportionately regulated, but the Government also need to be responsible and careful with money. As they are, the regulations are a blunt tool adding costs to businesses and a promise of much more cost to come. There is no proper impact assessment, and there is a risk to small businesses and microbusinesses and to inexpensive, low-volume items. As such, I cannot support the regulations.

--- Later in debate ---

[Dr Ahmed]

I turn first to the Opposition spokesperson, the hon. Member for Sleaford and North Hykeham. Like me, she is a scholar of medicine, and she practiced in the NHS throughout all 14 years of the last Government. She will know, possibly at first hand, that the MHRA as a regulatory body has not been fit for purpose for a long time. It has lagged behind the inventions and innovations now available to patients, particularly in medical technology. She will also know it is this Government who are placing the MHRA at the service of patients by being bold in our reforming agenda and our leadership in regulating medical technology.

The proof point of that reform is our consultation with trusted groups, including trade associations such as the Association of British HealthTech Industries, the British In Vitro Diagnostics Association and the British Dental Association, all of which were consulted extensively over the course of these regulatory proposals, and with which I engage on a regular basis to garner their support, so that at every step of the way our life sciences sector plan is facilitated by our regulatory institutions and authorities. Indeed, the MHRA was present last week in front of a number of innovative biotechnology companies, whose message was loud and clear: they view the UK’s regulatory framework as first in class, innovative and forward-thinking, and they therefore see investing in our country as an attractive proposition.

On the impact assessment, I assure the Opposition spokesperson and the hon. Member for Winchester that we are not avoiding an impact assessment. In fact, we are supporting industry with a phased approach to fees, and we are open to an ongoing consultation and dialogue as this fee structure comes into place next year and the year after.

My hon. Friend the Member for Worcester is a learned Member of this House, and I entirely take on board his comments regarding insulin pumps. Wherever possible, in the discussions that I have had with my officials and the MHRA, we have said that this fee structure should include the totality of a device, rather than its component parts. I am very happy to take his comments back to my officials, so that we can make sure that he and his constituents are satisfied that there are no unintended consequences in that regard. I thank all Members for their contributions, and thank you, Ms Jardine.

[Dr Johnson]

The Minister is making a great speech, but he is not answering lots of the questions—I appreciate that he may not have all the answers. Can he commit to answering them by letter? Will he also talk about the possibility of obsolescence? If an item ceases to be registered—he is encouraging people to deregister things that they are no longer selling—can it still be used in the NHS? How would a doctor know whether something had ever been registered in the past and was safe?

[Dr Ahmed]

I am happy to write to the hon. Lady to give her a fuller answer. She knows that procurement in different parts of the NHS rightly reflects local clinical practices, although there are overarching national frameworks for buying such products. Innovation lends itself to the fact that, over time, patients will want to choose and move on to newer forms of devices that treat their conditions in line with the latest clinical evidence. I am very happy to write to her more extensively on obsolescence and her other questions.

I would like to address some points made on the following topics: the impact on SMEs; the impact on market attractiveness more extensively; GMDN suitability and transparency; clarity on costs; and the evaluation of value for money. I also want to make some points regarding Northern Ireland. On SMEs, as the Opposition spokesperson highlighted, I recognise that new regulatory costs can be felt more sharply by smaller firms, and the MHRA has listened carefully. That is why the fee has been designed to spread costs more equitably across the sector, and the majority will pay only £300 per year.

Following consultation feedback, charging is based on the number of GMDN level 2 categories that a manufacturer’s registered device falls into, rather than the much more granular level 5. That matters for SMEs because they are more likely to have closely related product variants that may attract multiple level 5 terms, but sit more generally within a single level 2 category. Under this approach, multiple products in one level 2 category are therefore charged once per year, reducing the need for repeat charges on minor product variations.

The MHRA estimates that around 56% of manufacturers will pay a single unit fee of £300 a year, and SMEs are most likely to fall into that group, because they typically have a narrower product range than the larger companies. The MHRA is not offering waivers or special SME rates. The charge is designed to be proportionate, and any waiver would simply shift costs elsewhere. The intention is to keep the charge predictable and proportionate, and to phase it in.

Finally, SMEs stand to benefit from a stronger PMS framework, leading to earlier identification of issues, fewer surprises and a more risk-proportionate and predictable regulatory approach that supports responsible innovation. I must make it clear that we are not asking for more money: we are simply changing the MHRA’s regulatory framework to put it on a more sustainable footing so that in the future it is less reliant on the taxpayer and, therefore, more pro-innovation, more pro-market and better able to have a healthier commercial relationship with new and established companies.

On innovation and UK attractiveness, a robust PMS framework is not a brake on innovation—far from it. It helps to make the market more predictable and investable, as per my conversations over the last couple of weeks with major and smaller biotech industry firms. In developing this instrument, we have ensured that the Secretary of State must have regard to three considerations set out in the Medicines and Medical Devices Act 2021: safety, availability, and the attractiveness of the whole of the United Kingdom as a place to research, develop, manufacture and, crucially, supply medical devices. This fee supports safety by ensuring the MHRA has sustainable funding for strengthened PMS, so that risks can be identified and acted on sooner. It supports availability by underpinning a stable and predictable system of oversight that helps to maintain continued safe access to effective devices.

[Dr Johnson]

Will this post-market surveillance continue if a device ceases to be registered?

[Dr Ahmed]

The anticipation would be that post-market surveillance will continue if devices are still used in a clinical setting.

PMS supports UK attractiveness by strengthening confidence in the market for patients, clinicians and investors, and by resourcing a more risk-proportionate, innovation-friendly approach to regulation, including making better use of real-world evidence and enabling more flexible and efficient regulatory burdens over time. A stronger PMS framework will also reduce uncertainty for innovators by enabling earlier proportionate action and helping to avoid sudden escalations that can disrupt plans or supply. By improving real-world evidence and post-market detail, it will also strengthen confidence in the UK as a place to generate evidence, invest and bring new devices to patients.

Hon. Members, including the hon. Member for Sleaford and North Hykeham, asked questions about global medical device nomenclature as the basis for apportioning costs. GMDN is internationally recognised for naming and grouping medical devices and is already used for UK device registration through the DORS, since 2018. Using GMDN categories means that the fee can be calculated from information that manufacturers already provide, making it less onerous, rather than creating a new system for reporting requirements purely for charging purposes. That helps to minimise the administrative burden across the sector, including for SMEs.

Category-based charging is also a practical and broadly proportionate proxy for the breadth of devices and types a manufacturer places on the market and, therefore, the likely level of PMS activity. It avoids a per-device approach and the complexity and burden of trying to calculate an actual PMS cost for each manufacturer.

On transparency, the MHRA is improving DORS, so as of 1 April account holders can see the chargeable GMDN level 2 categories linked to their registrations. Ahead of the go-live, MHRA has written directly to all manufacturers with their estimated fees so that they can check in advance their registration data and plan their budgets accordingly.

On clarity of costs, the consultation proposed an annual fee of £210 per GMDN term at level 5. The feedback was clear that that would be disproportionate, because level 5 is more granular in some areas than in others, exposing SMEs and manufacturers of devices such as in vitro diagnostics and surgical instruments to higher costs. In response, the MHRA redesigned the fee, so its charging is based now on the GMDN level 2 category, which is much broader, and consistent across product ranges. The unit price is higher because there are fewer level 2 categories than level 5, so the amount to recover is spread across fewer units, and the cost base has been updated to reflect inflation since the consultation.

The fee is also being introduced with a phased approach to give manufacturers time to adapt. The PMS has been fully subsidised by the DHSC in the year 2025-26, and this instrument introduces a part-subsidised annual fee model by 2026-27. The intention is to move to a fully cost recovery annual fee from 2027-28, once the new arrangements are embedded and a full impact assessment can be prepared.

On value for money and evaluation, the main objective of strengthening post-market surveillance is to improve health outcomes by increasing the quality and quantity of safety and performance data, and reducing the time from identifying a risk to making a corrective action. That supports patient safety and continued access to safe, effective devices and enables a more risk-proportionate, pro-innovation approach to regulation by strengthening the evidence base and supporting earlier proportionate action where needed.

[Dr Johnson]

If a device ceases to be registered, can a doctor still use it in the NHS—legally?

[Dr Ahmed]

As the hon. Lady knows, doctors are able, in certain circumstances, to prescribe unlicensed treatments to their patients if they feel it is a proportionate act to take. It is not something that is in guidelines or routinely recommended, but is at times at the discretion of individual clinicians. Clearly, that would be a peripheral activity, and something that could be looked at by local governance processes; but I am confident that these regulations strengthen the current post-market surveillance, so we are moving to a place of greater safety for the totality of the system.

The fee funds around 102 staff working across key areas, including medical device safety and surveillance yellow cards, software and diagnostics, and compliance and safety data. Roughly three quarters of these posts are existing roles, previously funded through the DHSC subsidy, with around one quarter being new posts that the MHRA expects to fill by the end of March 2026. Performance will be monitored through indicators such as the volume and quality of vigilance reporting, field safety corrective action and trend reporting, signal detection, and timeliness from the initial signal through to alerts and the corrective action being applied. The MHRA is committed to strengthening its internal metrics and producing new KPIs to track performance. These will be reviewed through the biennial fees uplift process to ensure that costs remain efficient and proportionate, and to avoid over or under-recovery.

I turn briefly to Northern Ireland. As hon. Members know, the regulatory position is different from that of Great Britain: under the Windsor framework, the EU devices regulations apply in Northern Ireland. This means that devices placed on the NI market must meet relevant EU requirements. The European Commission has recently announced that EUDAMED registration will become mandatory by May 2026. EUDAMED is the European Commission’s database that collects and stores data about devices on the EU and NI market. It is free for users, as it is funded centrally by the European Commission. In practice, that means that manufacturers, or their representatives, of devices—other than those that are custom-made—that are placing them on the EU or NI markets must register their devices on EUDAMED from 28 May 2026.

Out of a desire to avoid duplicative obligations, we are taking forward a separate piece of regulation that will mean that on 28 May 2026, devices other than custom-made ones, placed on the NI market will need to be registered with EUDAMED and will no longer need to be registered with MHRA, so the fee will not apply. Under EU regulations, custom-made devices are excluded from EUDAMED. They will still need to be registered with the MHRA, and will incur the fee.

Taken together, these regulations put the funding of the strengthened PMS on a clearer, more sustainable footing, so that those who benefit from access to the UK market contribute fairly to the ongoing regulatory work that supports their access. The fee has been redesigned in response to consultation feedback, is being phased in to give the sector time to adapt, and uses existing registration data to keep the administrative burden on business low.

Ultimately, this is about maintaining confidence in the safety and performance of medical devices, supporting continued access, and ensuring that the MHRA has the capacity to act quickly and proportionately if issues arise. I am happy to write to hon. Members if there any detailed points that I have not addressed; I have taken on board the comments of the hon. Member for Sleaford and North Hykeham and I am happy to write to her and the Committee. For those reasons, I invite the Committee to support these regulations for the sake of patient safety and our commercial environment, and I commend them to the Committee.

Question put.

Oral Answers to Questions

Caroline Johnson Excerpts

Tuesday 13th January 2026 Commons Chamber

[Mr Speaker]

I call the shadow Minister.

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

The Secretary of State has previously said that he accepts all the recommendations in the Cass review. One such recommendation is that the Secretary of State mandate the release of data for the data linkage study. Can the Minister tell us what specific steps have been taken to mandate the release of that data?

[Karin Smyth]

We absolutely stand by that work, and we are working with NHS England to make sure it is mandated to do exactly that.

--- Later in debate ---

[Mr Speaker]

I call the shadow Minister.

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

The maternity and neonatal plan is due in the spring, nearly two years after the Secretary of State took office. The maternity review has been delayed. There are no signs of the 1,000 additional midwives the Secretary of State said he would train. Gynaecology waiting lists are rising, with the number waiting for admission 6% higher than it was a year ago. The Secretary of State has an opportunity to save many lives, and I know that he wants to use all the opportunities available to him. May I ask him to concentrate on making more improvements in maternity care?