Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
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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.

Medical Training (Prioritisation) Bill

Caroline Johnson Excerpts
Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
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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.

Judith Cummins Portrait The First Deputy Chairman
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I call the Liberal Democrat spokesperson.

Health and Social Care

Caroline Johnson Excerpts
Monday 26th January 2026

(1 week, 3 days ago)

Written Corrections
Read Full debate Read Hansard Text Read Debate Ministerial Extracts
Wes Streeting Portrait The Secretary of State for Health and Social Care (Wes Streeting)
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… 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.

Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
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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 Portrait Wes Streeting
- Hansard - - - Excerpts

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

(2 weeks, 1 day ago)

General Committees
Read Full debate Read Hansard Text Read Debate Ministerial Extracts
Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
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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 ---
Zubir Ahmed Portrait Dr Ahmed
- Hansard - - - Excerpts

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.

Caroline Johnson Portrait Dr Johnson
- Hansard - -

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?

Zubir Ahmed Portrait Dr Ahmed
- Hansard - - - Excerpts

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.

Caroline Johnson Portrait Dr Johnson
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Will this post-market surveillance continue if a device ceases to be registered?

Zubir Ahmed Portrait Dr Ahmed
- Hansard - - - Excerpts

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.

Caroline Johnson Portrait Dr Johnson
- Hansard - -

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

Zubir Ahmed Portrait Dr Ahmed
- Hansard - - - Excerpts

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

(3 weeks, 2 days ago)

Commons Chamber
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Lindsay Hoyle Portrait Mr Speaker
- Hansard - - - Excerpts

I call the shadow Minister.

Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
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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 Portrait Karin Smyth
- View Speech - Hansard - - - Excerpts

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 ---
Lindsay Hoyle Portrait Mr Speaker
- Hansard - - - Excerpts

I call the shadow Minister.

Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
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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?

Advanced Brain Cancer: Tissue Freezing

Caroline Johnson Excerpts
Wednesday 7th January 2026

(4 weeks, 1 day ago)

Westminster Hall
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Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
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It is a pleasure to serve under your chairmanship this morning, Mr Western. I thank the hon. Member for Caerphilly (Chris Evans) for securing this debate, and the cancer charities, including Brain Tumour Research and Brain Tumour Charity, who provide invaluable support to my constituents. I also thank Owain’s family for their important campaign. I want to recognise the contribution of the hon. Member for Mitcham and Morden (Dame Siobhain McDonagh), who has shown such incredible energy and dedication to the cause over the last few years. It is impressive to get a trial up and running that offers real hope to people, so I thank her for that work.

Each year sees around 13,000 new cases of brain and central nervous system cancers and 5,500 deaths. As has been said already this morning, brain cancers are the leading cause of cancer-related death for those under the age of 40. As a doctor and a granddaughter, I have witnessed the devastation that brain cancers can exact on patients and their loved ones. Despite advances in detection, neurosurgery and radiotherapy, the mortality for brain cancers has barely changed since 2000, whereas the most common cancers have seen substantial decreases over the same period. Demographics are working against us. Epidemiological modelling indicates that a quarter of the growth in brain cancer cases can be attributed to population ageing, a pattern that is expected to continue in the coming decades.

Research published last year found that in England the median survival for patients with a glioblastoma was seven months. It rose to 16 months for patients with the most aggressive treatments. The reason those patients survived longer is because they had access to personalised treatments, experimental drugs or trial pathways, and much of that begins with tissue freezing. Two people can be diagnosed with glioblastoma, but their underlying genetics can be completely different. Frozen tissue enables a pathologist to undertake gold standard genomic sequencing, which not only leads to a more precise diagnosis, but helps doctors predict how a tumour is likely to behave, identify more personalised treatment strategies based on the genetic mutations driving the tumour, and determine whether the patient would be able to benefit from clinical trials that are available.

Unfortunately, as we have heard, access to genomic sequencing is characterised by stark geographic inequality. High volume specialist centres, typically in urban areas, are more likely to have established tissue freezing and integrated genomic diagnosis than centres serving more rural communities. A report by the Tessa Jowell Centre of Excellence found a nearly 300% increase in whole genome sequencing activity since 2021, and around three in 10 NHS centres within its network were still not requesting it. Among centres that do freeze tissue, the activity rates vary from zero samples to several hundred, and diagnostic times are worsening. The median time from tissue collection to final integrated molecular diagnosis in 2024 was 21 days, whereas the benchmark is 14 and only 30% met that. What does the Minister intend to do to improve that speed?

Tissue freezing is a basic requirement for advanced testing, but every year thousands of patients’ tissue samples are soaked in formaldehyde and embedded in wax blocks. Although formalin-fixed paraffin-embedded tissue preservation has been used in pathology labs since the early 20th century, it is not adequate for molecular work because it causes the cross-linking and fragmentation of nucleic acids and protein, meaning that any DNA or RNA that is extracted is degraded and often unsuitable for genomic sequencing and creating those important personalised cancer therapies. The British Neuro-Oncology Society has described FFPE as “suboptimal”. It results in patients being locked out of cutting-edge treatments, regardless of clinical suitability, with knock-on effects on patient outcomes and the pace of scientific research. Will the Minister explain why FFPE, rather than tissue freezing, is still determining access to personalised brain cancer treatment for some NHS patients?

The Government’s 10-year health plan anticipates that by 2035 half of all healthcare interactions will be informed by genomics. That is a bold mission, but the contributions to today’s debate show that there is a gap between where Ministers want to be and where we are at the moment. In response to a written parliamentary question, the Government acknowledged:

“Information on the number of NHS trusts in England that have facilities for fresh freezing brain cancer tissue samples is not currently collected.”

That is a serious problem, because without the data it is difficult for Members and cancer charities to ascertain whether progress is being made, and for the Minister to make progress on delivery. Will the Minister confirm whether her Department has plans to start collecting that information? If it does not, why not?

Patients should always be fully informed before they have treatment, and it has been disturbing to hear today that some have not been given all the information, particularly about what will happen to the tissue afterwards and the potential consequences of that. What are the Government doing to improve the consent process in such cases to ensure that, before the biopsy, patients are fully informed about what is happening to their tissue and are given the choice?

We have heard that sometimes only a small percentage of the tissue is frozen, limiting the treatment options available. Will the Minister tell us why that is the case, and what she is doing to improve the proportion that is frozen? Every trust taking brain cancer samples must have the capacity and facilities to freeze the tissue they obtain.

We are all waiting for the delayed cancer plan, which we expect to be published on World Cancer Day. I have said before that I think delaying it for presentational purposes is wrong, but I hope it will be published soon. Will the Minister confirm that the cancer plan will deliver fully informed consent, provide the necessary capability—both human resource and equipment—for freezing, and ensure that the research landscape improves, in terms of both ease of access and financial metrics, to encourage UK research investment?

Everyone in this House wants treatments to improve and a cure to be found. I know the Minister is hugely committed to this issue and is working hard on it. I am interested to hear her response and to see the cancer plan, which she has been working on, as soon as possible.

Less Survivable Cancers

Caroline Johnson Excerpts
Tuesday 6th January 2026

(4 weeks, 2 days ago)

Westminster Hall
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Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
- Hansard - -

It is a pleasure to serve under your chairmanship, Mr Efford. I congratulate the hon. Member for Wokingham (Clive Jones) on securing this important debate.

It is sadly the case that one in two of us will get cancer in our lifetime. We all know someone who is battling cancer, someone who has beaten it and, sadly, someone whose life has been cut short by it. Cancer survival rates have consistently improved, but they are still far from where we would like them to be. When we talk about less survivable cancers, we refer particularly to six types of cancer with low survival rates: pancreatic, liver, brain, oesophageal, stomach and lung cancers. Over 90,000 people in the UK are diagnosed with one of the less survivable cancers every year—20% of cancer cases—but those cancers are responsible for 42% of cancer deaths in the UK.

I pay tribute to hon. Members who have shared their personal stories in this debate, because behind each statistic is an individual. As I prepared for this debate, I thought of my granda, who died of brain cancer; my Nana Burton, who died of lung cancer; and of my husband’s good friend and confidante, Richard, who died of oesophageal cancer.

A key reason for the troublingly disproportionate mortality rate for less survivable cancers is their later-than-average diagnosis. Just 28% of less survivable cancers are diagnosed at stages 1 or 2, which is well below the 54% rate for cancers as a whole. That cuts survival rates significantly. Pancreatic cancer is particularly lethal, with less than 7% of people with pancreatic cancer in the UK surviving beyond five years.

I am pleased that the last Conservative Government launched the targeted lung health check programme in June 2022. It led to more than 5,500 people being diagnosed with lung cancer by January 2025, with 75% of cases found at stages 1 or 2 through screening. That is encouraging progress, but clearly there is much more work to be done to improve the diagnosis rates for all six less survivable cancers.

I have personally been supportive of the current Government’s Tobacco and Vapes Bill, which will ban the sale of tobacco to young people born after 1 January 2009. That will tackle one of the key risk factors for lung cancer. Will the Minister update us on the Bill’s progress, given that it was introduced on 5 November 2024 and has still not passed through Parliament? Prevention is said to be a big focus for the Government, so what is the Minister doing to improve prevention and to get the Bill passed?

The APPG on less survivable cancers launched an inquiry into earlier detection and faster diagnosis in March 2025 and found that doubling early diagnosis could save an additional 7,500 lives a year. What is the Minister doing to implement the inquiry’s recommendations, which were published last June? In particular, what is she doing to explore the benefits of technology in commissioning new detection tests? What assessment has she made of the new VAPOR breath test for pancreatic cancer, which could support GPs in diagnosing less survivable cancers from unclear symptoms?

I am hopeful that many of the answers to these questions, and others posed by hon. Members, will be found in the forthcoming national cancer plan. The Government have delayed that plan, along with several others, until 2026. We are now in 2026, so can the Minister confirm when the plan will be published? Rumours were swirling that it had been delayed for presentational purposes until World Cancer Day in February, but there are now further rumours that it may be delayed until early March. Can the Minister give us a date?

It is encouraging to see that NHS staff carried out over 3 million cancer checks in 2024, double the number carried out a decade prior. However, as with much of the war against cancer, this is another case of positive progress with more work needing to be done. Much of that work is dependent on the workforce.

The last Government built five new medical schools, including one in Lincolnshire, which are now producing their first medical graduates. However, British graduates need British jobs, and heavy competition from a surging number of international medical graduates is leaving many British graduates without a job. What action is the Minister taking to improve the recruitment of British graduates from British medical schools? Can she confirm when the further delayed 10-year NHS workforce plan will be published? Can she also assure us that that workforce plan, in combination with the long-anticipated cancer plan, will make provision to increase the number of oncologists, radiologists and specialist cancer nurses across the NHS?

As other Members have said, research is absolutely critical if we are to beat cancer, particularly the less survivable cancers, where new technologies for testing and treatment could save lives. Yet the cutting-edge, world-leading research that Britain has to offer does not feel as though it has the Government’s backing. Merck has scrapped its plans for a £1 billion research centre in King’s Cross and has announced plans to make 125 scientists redundant. AstraZeneca has halted a £200 million expansion of its research site in Cambridge and abandoned a £450 million vaccine manufacturing investment in Liverpool. Eli Lilly and Sanofi have both expressed frustration at the undervaluation of innovative medicines in the UK.

When I raised life sciences in a previous debate on cancer, the Minister for Secondary Care, the hon. Member for Bristol South (Karin Smyth) said that the Government

“want to make this country the best place to do life sciences.”—[Official Report, 23 October 2025; Vol. 773, c. 464WH.]

What support is the Minister providing to businesses in the life sciences and pharmaceutical industries to make that political slogan a reality? What work is she doing with her colleagues in the Departments for Science, Innovation and Technology and for Business and Trade to revive lost life sciences investment and to use British research, which has the world-class facilities needed to innovate and save lives? As my hon. Friend the Member for Berwickshire, Roxburgh and Selkirk (John Lamont) said, it is important that we work together as a United Kingdom. What work is the Minister doing with our counterparts in Scotland in particular?

As my hon. Friend the Member for Keighley and Ilkley (Robbie Moore) said, there is a growing crisis in the hospice sector. Hospice care, provided for those with terminal illnesses such as some cancers, improves symptom control, comfort and support—it adds life to days. What is the Minister doing to press the Chancellor to recognise that her tax and national insurance changes are creating a crisis in the hospice sector, and what is she doing to save hospices from closure in many cases?

In summary, I am concerned that, 18 months in, the absence of definitive Government action for the cancer community has left us without a cancer plan or a workforce plan, while critical research continues to be driven out of this country. I encourage the Minister to provide clarity for cancer sufferers, cancer charities and the cancer workforce, who are doing such sterling work to improve people’s lives, and to get on with innovating lifesaving treatments to improve the tragic survival rates for the less survivable cancers.

Puberty Suppressants Trial

Caroline Johnson Excerpts
Wednesday 17th December 2025

(1 month, 2 weeks ago)

Commons Chamber
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Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
- View Speech - Hansard - -

(Urgent Question): To ask the Secretary of State for Health and Social Care if he will make a statement on the pathways puberty blockers trial.

Wes Streeting Portrait The Secretary of State for Health and Social Care (Wes Streeting)
- View Speech - Hansard - - - Excerpts

Let me just start by acknowledging the sensitivities around this issue and the strong beliefs held around this House. For all the division and divided opinion, I believe that there is a determination shared by everyone in this House to do the right thing by a vulnerable group of children and young people. It is for those reasons that I am taking the course of action that I am. Put simply, that is to follow expert clinical advice and take an evidence-led approach.

The Cass review found shocking levels of unprofessionalism, a lack of clinical oversight and puberty blockers prescribed to children without sufficient evidence that doing so was safe or beneficial to those children and young people. What Dr Hilary Cass uncovered was a scandal. That is why, on coming to office, I made the temporary ban brought in by my predecessor, the right hon. Member for Louth and Horncastle (Victoria Atkins), a permanent one. Dr Cass also recommended a thorough study to establish how best to support children and young people who suffer gender incongruence. That is the pathways study.

The study has four main parts, one of which is the clinical trial to study the effects of puberty-suppressing hormones on young people’s physical, social and emotional wellbeing. The other aspects of the pathways study will track the physical, social and emotional wellbeing of all young people attending UK NHS gender services. It will look at young people’s thinking and brain development, following both those who are and are not taking puberty-suppressing hormones, and it will gather evidence directly from young people, parents and staff about their experiences of living with gender incongruence.

The bar for the trial to be approved was extremely high and oversight will be rigorous. Children cannot consent to being on the trial, so places will require parental consent, as well as the assent of young people. It is because protecting and promoting the health and wellbeing of affected young people is our primary concern that there are also strict eligibility criteria in place to join the pathways clinical trial. As such, the number of young people who would expect to qualify for the trial will also be low. Participants must undergo thorough mental and physical assessments and will be followed over a number of years with regular wellbeing checks. Puberty blockers have also been used to delay puberty in children and young people who start puberty much too early. Use in those cases has been extensively tested and has met strict safety requirements for that use.

The study is led by King’s College London and the South London and Maudsley NHS foundation trust. It has been carefully checked by independent scientists who advise the National Institute for Health and Care Research and by the Medicines and Healthcare products Regulatory Agency, and received approval from a research ethics committee. I am treading cautiously in this area because the safety of children must come first.

--- Later in debate ---
Caroline Johnson Portrait Dr Johnson
- View Speech - Hansard - -

I must first declare my interest as a consultant paediatrician who has looked after children with gender dysphoria in the past and is likely to do so in the future. We must remember that we are talking about vulnerable children.

The first and most obvious question is: why? Why have this Government chosen to fund experiments with puberty blockers on physically healthy children? Despite saying he was comfortable with this trial in a briefing to MPs, the Secretary of State told the media on Friday and the Select Committee this morning that he is in fact uncomfortable with it. Why is it even being considered before the data linkage study is complete?

Some 9,000 children went through the Tavistock clinic, and many of them came out regretting being encouraged to irreversibly damage their bodies. We should look carefully at those outcomes before we make the same mistakes. What steps is the Secretary of State taking to secure the data from the Tavistock and have it analysed? What steps is he taking to hold to account those obstructing access to data linkage information? What assessment has he made of the motivations of those obstructing that data, when this is a study to safeguard children?

And what of the trial itself? We know that 226 children will go through this trial. Is that a limit or a target? Those children will be randomised to get puberty blockers now or in a year’s time, and all will be analysed at two years. They will still be children. They might be only 11 years old. How can the results demonstrate a meaningful outcome? The control group is not properly randomised, but chosen from the Horizon intensive trial group. Is the Secretary of State concerned that this will introduce bias?

The criteria for getting puberty blockers in this trial require just one parent to consent and the clinician to think that it will benefit the child, but on what basis will the clinician decide? The Cass review said that the vast majority of children with gender dysphoria would recover, with only a few persisting with trans identities into adulthood. It is not possible to predict which those children will be, so does the Secretary of State accept that the vast majority of children in this, his Streeting trial, who will be given drugs will be physically healthy children whose distress would get better without any puberty blockers, and that the vast majority of the children in this trial are therefore being unnecessarily experimented on with risky medications under his leadership?

Wes Streeting Portrait Wes Streeting
- View Speech - Hansard - - - Excerpts

The shadow Minister asks, “Why?” There is a simple answer. It is because this was recommended by Dr Cass in the Cass review, which was commissioned by my predecessor, Sir Sajid Javid. I think that was the right thing to do, and it is why, when my predecessor brought forward the Cass review, I supported it in opposition. I certainly did not try to play politics with an extremely vulnerable group of children and young people.

I will tell the hon. Lady why. It is because, under the previous Government, those puberty-suppressing hormones were prescribed without proper oversight, supervision or safety, yet we did not hear a peep about that fact for years until Dr Cass, commissioned by Sir Sajid Javid—who deserves enormous credit—did the study, which was published and widely supported and which contained this recommendation. The Conservatives may have changed their tune in opposition, but I remember what they said in government when they published the Cass review and supported its recommendations, so I think their response now is a real shame.

The shadow Minister accuses me of inconsistency, so let me be clear. Am I comfortable that this clinical trial has undergone the proper process and ethical approval to ensure the highest standards and supervision? Yes, I am comfortable about that. Am I uncomfortable about puberty-suppressing hormones for this group of young people for this particular condition? Yes, I am—because of risks. It is why I was also uncomfortable when I upheld the temporary ban by my predecessor and then put in place a permanent ban. The reason I was uncomfortable with that, too, is because I had to look children and young people, and their parents, in the eye when they told me in no uncertain terms that that decision was harmful to them, as have many other clinicians who have opposed that decision.

Whatever my discomfort in this extremely sensitive area, the reason that I have made this decision is that I am following clinical advice and, as Health Secretary, it is my responsibility to follow expert advice. Had the Tavistock clinic faced such challenge and scrutiny a decade ago, we would not be in this mess. The Conservatives were right to commission the Cass review and they were right to accept its recommendations. I accept that there is now a difference on this particular recommendation, but I would urge Members not to walk away from the cross-party consensus we built behind that approach but to build on the work that Dr Cass has done.

Let me turn to the important questions raised by shadow Minister. There will be two groups within the trial, as well as a further control group of children and young people with gender incongruence who do not receive puberty-suppressing hormones. At least 226 participants are required in order to detect a statistically significant difference between the two treatment groups. However, this is not a target and no young person will find themselves on this trial because there is a drive to make sure that a certain number of young people are participating. In order for anyone to participate in this trial, it has to have the most robust clinical oversight from clinicians within the service, as well as national oversight and the consent of parents. It is only where young people will be deemed to benefit that they will be on this programme.

The shadow Minister asks about the data linkage study. That is important. The data linkage study will be undertaken, but when it is completed it will not provide us with the same evidence as this clinical trial. That is why Dr Cass made a distinction between this trial and the data linkage study.

The hon. Lady also asks about the motivations of those who withheld data. That is an extremely important question. It is utterly appalling that anyone in a position of responsibility in the NHS withheld data on a very vulnerable group of children and young people. I accept that there were many well-meaning people involved in these services at the Tavistock clinic, but the fact that Dr Cass found such a lack of rigour, such a lack of standards and such a lack of proper oversight is disgraceful. It is the clinicians who are well meaning and ideologically driven who have given me the most cause for concern in this whole debacle and who have done more harm to children, young people and the trans community than most other people who have taken part in this debate.

I appreciate the work that Dr Cass has done, and I am glad that she is in the other place, bringing welcome scrutiny. Were she not supportive of this approach, I might think again, but she has made her recommendation and given her support. I am following clinical advice. It is not comfortable, but I do believe it is the right thing to do, on balance.

Transgender People: Provision of Healthcare

Caroline Johnson Excerpts
Tuesday 16th December 2025

(1 month, 2 weeks ago)

Westminster Hall
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Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
- Hansard - -

It is a pleasure to serve under your chairmanship, Mr Turner. I congratulate the hon. Member for North Warwickshire and Bedworth (Rachel Taylor) on securing this important debate. I declare an interest: I am an NHS consultant paediatrician and I have cared for those with gender dysphoria in the past, and am likely to do so in the future. As we discuss a fairly heated topic, we need to remember that there are people experiencing significant challenges, and they deserve the very best healthcare based on need and the best evidence.

One challenge is that name and sex records are sometimes different from how people are referred to in a ward. The previous Conservative Government launched the Sullivan review, which found that a failure of NHS bodies to record biological sex meant that some people were not invited to sex-specific screening. It recommended that we should not combine questions on sex and gender, and that putting politics before patients threatens clinical care. When will the Government formally respond to the Sullivan report? When does the Minister expect to implement its important recommendations? How will the Government ensure that intimate care is provided by someone of the same biological sex where possible?

I would also like to raise the issue of phalloplasty, which is a major surgery on healthy bodies, creating a penis. According to the NHS website, it causes urinary incontinence, loss of sexual function, and in 3% of cases, necrosis and loss of the penis. Is the Minister confident that the NHS is doing the right thing with this surgery?

I want to move on to talk about children with trans identity. We have been talking about the puberty blockers trial. Why is that trial occurring? Drugs are, unusually, being given to children with physically healthy bodies. Despite telling Members of this House that he was comfortable with the trial, the Secretary of State said on Friday to the media that he was “uncomfortable”. Why is it being considered before the completion of the data linkage study recommended in the Cass report?

Some 9,000 children went through the Tavistock gender identity and development services. Many regretted irreversible damage to their bodies. Why have the Government chosen to experiment on a new batch of children before the data linkage study recommended by the Cass report is complete? What steps is the Minister taking to secure that data? What steps is she taking to hold to account the people who are obstructing the data linkage study? What assessment has she made of the motivation of those obstructing a study that, at its heart, is designed to protect children?

What of the trial itself? Some 226 children will receive puberty blockers—is that a limit? Will there be no more by law? They will be randomised into treatment now or treatment after 12 months, and analysed after just two years. When someone receives the drug for only a year, they will still be a child. What meaningful results can be obtained over that period?

The true control group of those not receiving the drugs is not randomised, but chosen or matched from a different trial—the Horizon Intensive trial. Is the Minister concerned that that may introduce a bias? The criteria for getting puberty blockers under the trial require that one parent consents, not necessarily both—one might disagree—and the clinician must think it will benefit the child, but on what specific criteria will the clinician make that decision? Is the Minister concerned to ensure that ideology does not affect judgment?

The Cass review said that the majority of children with gender dysphoria will recover from their distress without any medication, and that it is not currently possible to predict which children they would be. Does the Minister accept that the vast majority of children in this, the Streeting trial, are physically healthy children whose distress would get better without puberty blockers, and that this Labour Government are choosing to give potentially dangerous drugs to children, most of whom will not need them?

Acquired Brain Injury Action Plan

Caroline Johnson Excerpts
Thursday 4th December 2025

(2 months ago)

Westminster Hall
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Caroline Johnson Portrait Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
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It is a pleasure to serve under your chairmanship, Dame Siobhain. I congratulate my right hon. Friend the Member for South Holland and The Deepings (Sir John Hayes) on securing a debate on a subject that I know is important to him, to many of our constituents and to the whole House. The brain is so important. It is responsible for moving and thinking, homeostasis, consciousness, our senses and how we interpret the world—essentially, it makes us the people that we are. Acquired brain injuries are therefore an important issue.

As other hon. Members have said, acquired brain injuries are the leading cause of death and disability in those aged between one and 40. Every 90 seconds, someone somewhere in this country—over 330,000 people per year—is admitted to hospital with acquired brain injury. They can have difficulties with walking, with talking, with moving, with thinking skills, with tiredness and fatigue, and with changes in personality. People can have one large brain injury with devastating effects, but they can also have multiple, small, almost unnoticed brain injuries, the cumulative effect of which can be quite severe, and the long-term effects of which can lead to dementia.

The previous Government began work on an acquired brain injury plan and made a public call for evidence in 2022. Unfortunately, that work was interrupted somewhat by the general election. It has been picked up by the current Government, who say they will publish such a plan; it is nearly the end of the year, and I hope they are not going to break that promise, and add to the list of the many other plans that they have delayed. Will the Minister tell us when the plan is going to be published? When it is published, will it include the evidence given in response to the 2022 public call for evidence by so many stakeholders, charities and other relevant organisations?

What should that plan contain? I will look at it from the perspective of this Government, who are looking for the three shifts in healthcare. First, they want to move toward prevention. It seems sensible to prevent brain injury in the first place, if we can, and we know some things that we can do. When I was a teenager, horse-riding and skiing were usually done without helmets; that would be very unusual now. We have not been so successful with cycling: people know that wearing a helmet is wise, to prevent brain injury, but if we looked outside into Parliament Square, we would see lots of cyclists, many of whom are not wearing a helmet that could protect them from brain injury. What are the Government doing to make people more aware of ways that they can protect themselves from brain injury? Concussion management guidance for those taking part in elite, amateur and school sport is important, as others have said today.

Stroke is a form of acquired brain injury and I spoke to representatives of the Stroke Association earlier this term. They talked about two things that can help to prevent or limit brain injury from stroke: first, blood pressure checks and identifying previously undiagnosed hypertension, and secondly, mechanical thrombectomy, which limits the injury that occurs.

The previous Government rolled out blood pressure checks to thousands of pharmacies across the country. Will the Minister update us on what further steps have been taken to identify undiagnosed hypertension since she came into office? The previous Government also began to roll out mechanical thrombectomy. I understand that this Government intend to ensure that a universal service for that technique is available by Easter next year. Essentially, mechanical thrombectomy is when an interventional neuroradiologist takes a wire into the vessels, floats it up into the brain and mechanically removes a clot. It is particularly helpful for people who have had a large stroke where the damage is not yet complete in the brain. Damage can be limited significantly by the use of that very clever procedure.

Earlier this week, I was kindly invited to visit the mechanical thrombectomy service in Romford and see the work done there. I was told about the delay that can occur due to inter-hospital transfer. The Minister, in response to written parliamentary questions, has talked about what constitutes a universal service: it is being able to access a service within four hours. One limit to that ability, as I understand it, is that when someone who has had a stroke attends a hospital that does not offer a mechanical thrombectomy service, the time it takes to transfer them to a hospital that does, after acceptance for the process, affects people’s ability to have that lifesaving in some cases, and certainly disability-saving, treatment.

When I was a junior doctor, I was lucky enough to care for people taking part in the total body hypothermia for neonatal encephalopathy trial—the TOBY trial. Essentially, we took babies who had suffered a brain injury around the time of birth and cooled their whole body to reduce the brain injury that they suffered. That was very effective, and became standard practice. What is the Minister doing to help people who want to do research into other ways of reducing brain injury? How is she helping with research, and what is she doing to sponsor it?

What work is the Minister doing with the social care teams at the Department for Education? One of the sad things that I have seen during my time as a consultant paediatrician is children with inflicted injury—particularly babies. In many cases their injuries should have been preventable because those families were known to social care before the injury occurred. What is being done to protect those extremely vulnerable children? There are other causes of acquired brain injury too. Could the Minister talk about what she thinks the most important causes are and what she and the Government are doing to reduce their incidence?

The other shift that the Government want is from hospital into the community. I was lucky to meet Headway Lincolnshire this week, which told me that there were only 12 in-patient beds available for acute brain injury rehab across Lincolnshire. That is not sufficient. When the charity provides counselling services, it has to do so online from outside the county because there is no one available in the county to provide them. What is the Minister doing to ensure that there is good neuro-rehab across the country, including in rural areas? Also, what is the Minister doing to make sure that rehab is long term? Neuro-recovery takes a long time. It is not just a case of a couple of appointments on leaving hospital; it needs to be over a more sustained period.

For people suffering complex injury, there are many professionals involved. Some people will have a physio, an occupational therapist, a speech and language therapist, nurses, doctors, carers and many others. NICE’s new neuro-rehab guidelines, published in October, talk about how it is difficult for patients to negotiate that, and they recommend a single point of contact. Does the Minister plan to ensure that that NICE recommendation is delivered? If so, how and when?

I would like to pay particular tribute to a young lady I met recently who is one of my constituents. She experienced a traumatic brain injury as a child, but with her determination, great family and community support and rehab, she has made a good recovery and is training as a nurse so that she can help others who suffer as she has. She is an incredibly impressive young woman. She highlighted to me the need for better rehab and school support. I urge the Minister to ensure that they are delivered.

The final shift that the Minister has talked about is from analogue to digital. Digital offers us huge capacity in rehabilitation from acquired brain injury. I talked to a gentleman who had had a stroke and was admitted to a rehab unit where he got involved in Wii Fit—a Nintendo game from some time ago. He was using it along with another person who was recovering from a stroke at the same time, and they became very competitive at these balance and movement games. That really helped them to recover. What is being done to make rehab more fun or competitive? Some of the exercises that people are asked to do can be quite difficult. How can we make them more enjoyable? There are apps available to improve communication, memory and fine motor skills, and virtual reality can help with cognitive rehab. How is the Minister ensuring that those are available to all who would benefit from them?

In summary, we need a detailed plan looking at prevention, acute treatment and rehabilitation. I hope it will not be delayed in the same way as all the other Government plans seem to be. I also hope that it will contain a delivery chapter that sets out not just what the Government want to do, but how they want to do it and when they want to do it by. Will the Minister confirm whether the relevant workforce will be included in the plan, or whether we will have to wait for the long-delayed workforce plan? Neuro-rehabilitation is really difficult, but many people show huge courage and determination in their work to rehabilitate. We need to support them in every way that we can.