PANS and PANDAS

Maria Caulfield Excerpts

Tuesday 12th September 2023 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

It is a pleasure to serve under your chairmanship, Mr Dowd, and to respond to this debate. To be clear, I can respond only on healthcare services in England, and not on behalf of Ministers in Scotland, Wales and Northern Ireland, because health is a devolved issue. I can, however, give a commitment to hon. Members that I am happy to work with colleagues in the devolved nations on this very important issue.

I welcome the shadow Minister, the hon. Member for Erith and Thamesmead (Abena Oppong-Asare), to her place. It is slightly disappointing that she chose to be so political—I thought we had quite a good cross-party consensus in this debate. I thank the hon. Member for North East Fife (Wendy Chamberlain) for providing the opportunity to raise awareness of paediatric acute-onset neuropsychiatric syndrome, or PANS, and paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections, known as PANDAS.

We have heard from Members how important the issue is. I thank them for describing the experiences of their constituents and the issues that they have faced. I recently met the chair of the all-party parliamentary group on PANS and PANDAS, my hon. Friend the Member for Aberconwy (Robin Millar), to discuss the lack of guidance on diagnosis, treatment and assessment for children who suffer from either of those conditions, and about the lack of awareness across the medical profession in all parts of the health service. I absolutely agree that we need more research and evidence to improve our understanding of the conditions and to better support the families affected.

[Sir Julian Lewis (New Forest East) (Con)]

The Minister will have heard the excellent speech made by my hon. Friend the Member for South West Bedfordshire (Andrew Selous), who talked about taking it on himself to send leaflets to his GPs to raise awareness. Does the Department have a mechanism for alerting all GPs to these conditions, which seem to be relatively unknown? If so, could GPs be encouraged by her Department to consider prescribing amoxicillin or a similar antibiotic at a very early stage, because that seems to be an almost risk-free option?

[Maria Caulfield]

The Department does not regularly write to GPs because the NHS is operationally independent, but NHS England does and we can certainly speak to NHS England colleagues. They send out regular bulletins on a range of issues to GPs, so I will speak to my primary care colleagues to see whether that is possible. We do not have enough information at the moment about how many children in the UK are affected by PANS and PANDAS. In the US, scientists have suggested that the prevalence there could be as high as one in 200 children.

We have specifically talked about the United Kingdom and England today. Although there is a classification now by the World Health Organisation, very few countries issue guidance on the diagnosis, treatment, assessment and management of PANS/PANDAS, because the scientific evidence is so sparse. When I met my hon. Friend the Member for Aberconwy, we talked about how we can get that evidence base so that we can issue guidance to primary and secondary care providers. We know that symptoms tend to come on suddenly.

We heard from my hon. Friend the Member for North Devon (Selaine Saxby) about the example of Jack and the difference that a diagnosis made. It is often following an infection that children who are healthy and developmentally on track suddenly start exhibiting OCD or other neuropsychiatric symptoms. The hon. Member for Brentford and Isleworth (Ruth Cadbury) is correct that very often a course of antibiotics can improve and tackle some of the symptoms that parents say can change a child overnight such that they can no longer attend school and are suddenly plagued by anxiety and other neurological symptoms.

PANS and PANDAS require a clinical diagnosis based on specific signs and symptoms observed by a clinician. There are currently no lab tests or biomarkers that specifically diagnose those conditions. There is also an element of excluding other diagnoses in the process of diagnosing PANS and PANDAS. That means other illnesses or diseases are considered first rather than assuming it could be PANS and PANDAS.

Although there are currently no national or European clinical guidelines on assessment, investigations or diagnosis, a multidisciplinary team referral often helps speed the process up. That is why we need our primary care colleagues to be aware that this could be the cause of symptoms and to get those referrals in as quickly as possible.

[Ruth Cadbury]

I thank the Minister for her response. She mentions the fact that there is no lab test that can diagnose PANS/PANDAS, but is that not true for other neurological conditions that I mentioned, such as ME and some of the ongoing conditions that people are experiencing from long covid? Sometimes a lab test does not exist because of the nature of what caused the symptoms. Perhaps the medical profession and NHS England need to think slightly outside the box in their search for answers.

[Maria Caulfield]

I absolutely agree with the hon. Lady. NHS England has been happy to work on such issues with the working group. It is embarking on work to roll out a nationwide surveillance study designed to identify the signs and symptoms because, again, it is probably unlikely that we will reach a definitive test that will ever give us a diagnosis, and it is about matching symptoms with a diagnostic criteria. NHS England has committed to doing that, and the Department is happy to support it in its work.

There is the issue about how quickly antibiotics should be prescribed and dispensed, but while one antibiotic may work for one child, it may not work for another, and it is sometimes a case of trial and error before the appropriate treatment is found. Although there is an evidence base for the treatment of symptoms, such as obsessions, compulsions and tics, it is recommended that children and families affected should be offered evidence-based treatments. That is why we absolutely need to build that research base to provide evidence-based guidance to clinicians, whether they are in primary or secondary care. At the moment, NICE says that it does not have the evidence base to put that guidance together, whether that relates to psychological treatments or to medications such as antibiotics. The commitment I can give today is to push and work with the working group, organisations and Members in this place to try to develop that research base.

[Robin Millar]

I have been struck by a couple of things in the debate—one is the cross-party consensus, but another is the uniform distress that Members have relayed. On the point the Minister just made about whether treatment is psychiatric or medical, one of the key points is that PANS/PANDAS is often confused as being psychiatric when it is an infection that has proven susceptible to treatment with antibiotics. That is the kind of basic step forward that we are hoping for today.

[Maria Caulfield]

I absolutely agree. I acknowledge that while the symptoms mimic a mental illness, there is very often a physical cause for those developments. That is why we need to build that evidence base with research to back the guidance that we can give to clinicians who, as colleagues have said, may not be aware of the condition or how to manage it.

Training on PANS is now included in the Royal College of Paediatrics and Child Health curriculum. In April 2021, the British Paediatric Neurology Association issued a consensus statement with the faculty of child and adolescent psychiatry at the Royal College of Psychiatrists. Following concerns about variation in how it was being interpreted across the UK, the new PANS PANDAS working group, as we have heard today, which is being supported by NHS England, issued a statement recommending the development of appropriate service models and pathways back in February. I am keen that we support the working group in its important work bringing the key organisations together so that we can get that consensus out to clinicians in the field.

The work that the working group has done highlights that all children presenting with acute onset neuropsychiatric symptoms should receive a full medical evaluation and signposts clinicians to existing international peer review treatment guidelines. As I have said, while NICE currently has no plans to issue guidance, should the evidence base develop further, and should there be an opportunity to do that, we would look to update clinical policy. NHS England would then consider the development of care pathways for those living with PANS/PANDAS. The key is building that evidence research base.

We have the evidence to sufficiently demonstrate that PANS and PANDAS are discrete disease entities. I hope that answers the question by the hon. Member for North East Fife on whether we recognise that. We absolutely do, but we do not have the evidence and research base on assessment, diagnosis, treatment and management. However, the Department is funding research into rare diseases through the National Institute for Health and Care Research, which is spending over £1 billion a year every year on research particularly into rarer conditions. It welcomes funding applications for research into any aspect of human health, which would include PANS and PANDAS. Applications are subject to peer review and judged in open competition, with awards made on the basis of importance to the topics of patients, health and care services.

The National Institute for Health and Care Research does not just provide funding; it will also provide guidance, whether for academics, clinicians, researchers, the working group, charities or any other organisation. I am happy to organise introductory meetings with the National Institute for Health and Care Research. It has met other groups to explore the types of research it would support and that would build an evidence base. I strongly encourage researchers with an interest in this area to come forward with proposals so that we can develop that evidence base and make real inroads.

Other countries are not necessarily leading the way. Not many countries have international guidance on the issue. I cannot remember which hon. Member referred to this, but the UK and the devolved nations have an opportunity to take a lead, build that evidence base and develop guidance on that basis.

I assure colleagues that I am committed to ensuring that those with PANS and PANDAS get the care they need. We need more high-quality research into these conditions. That is the only way we can get better outcomes for patients. I am happy to meet both the APPG and the working group to take this forwards, because there is an opportunity to develop our knowledge, increase awareness and ultimately to have better outcomes for those children affected.

Suicide Prevention Update

Maria Caulfield Excerpts

Monday 11th September 2023 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

Every suicide is a tragedy with devasting impacts on individuals, loved ones and communities. Today we are publishing a new National Suicide Prevention Strategy for England, which refreshes the national strategy for England that was published in 2012.

The strategy considers the latest evidence collected through our mental health call for evidence and discussions with experts, including those who have experienced the suicide of a loved one, academics, those who work within suicide prevention and the Government’s National Suicide Prevention Strategy Advisory Group.

I am incredibly grateful to everybody who took the time to provide feedback to ensure that the new strategy reflects the most pressing challenges and opportunities.

The result is a new cross-Government and cross-sector strategy for the next five years, with a core message that suicide prevention is everybody’s business. Over the next five years, we intend to reduce the suicide rate—with initial reductions in half this time. The strategy also sets out measures to improve support for people who have self-harmed and those bereaved by suicide.

Together, this strategy lays out over 100 concrete actions across national Government Departments, the NHS, local government, employers, the voluntary sector and many others. It includes new priority areas of action, such as improving online safety, addressing the links between suicide and factors such as gambling and domestic abuse, and combating different methods of suicide.

We have already provided funding to improve access to crisis support and support the voluntary sector to deliver suicide prevention activity including:

The £10 million from 2023 to 2025 to support non-profit organisations to meet the increased demand seen in recent years and support a range of diverse and innovative activity that can prevent suicides, including targeting groups of concern identified in this strategy.

Over £2.3 billion more a year for mental health services by March 2024 compared to 2018-19 , with £57 million specifically for suicide prevention and suicide bereavement services.

The £150 million capital investment made available to urgent and emergency care mental health pathways, including mental health ambulances, crisis cafes, children and young people’s places of safety and new mental health assessment spaces.

We will continue to review progress and update actions to prevent as many suicides as possible. I look forward to continuing to work with members of this House, the National Suicide Prevention Strategy Advisory group and colleagues across the NHS, local government and the voluntary sector to deliver on our ambition to reduce suicides.

I will deposit a copy of the strategy in the Libraries of both Houses.

[HCWS1012]

Hormone Pregnancy Tests

Maria Caulfield Excerpts

Thursday 7th September 2023 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I thank the hon. Member for Bolton South East (Yasmin Qureshi) for securing the debate and all right hon. and hon. Members who have taken part in it. We cannot help but be moved by the many cases that have been brought forward this afternoon. This is the first time I have been able to speak either in this Chamber or in Westminster Hall on Primodos because, as many Members have said, there were legal proceedings that ended in May. The claimants had until 11 August to make an application for permission to appeal, which they did not do in that time, so today is my first opportunity since that legal action to speak on it. A second claim is being issued by those who believe that they were harmed by hormone pregnancy tests, against Bayer/Schering. That claim was stayed pending the outcome of the first case and, given that the first claim was struck out by the court, there are now discussions regarding the next steps with that claim. However, I am free to speak today on the issues that we have discussed in the debate.

I want to be clear, as a Minister who is responsible for patient safety, that the patient safety element is the most pressing and important part of my role. Baroness Cumberlege is also a constituent of mine, so hon. Members can be assured that she lobbies outside Parliament as well as inside.

Baroness Cumberlege conducted a review, and the Government have accepted and made progress on most of those recommendations. As has been said, an apology was issued by Government Ministers at the time when they responded to that report. We have appointed an independent Patient Safety Commissioner, and Henrietta Hughes is doing an outstanding job holding the Government to account.

I will touch on the issues around redress in just a moment. We have set up the mesh centres for those affected by pelvic mesh; I meet regularly with those female campaigners to hear their feedback on the effectiveness of those centres, and there is work going on to review that. The MHRA itself is revising its practice as a result of Baroness Cumberlege’s report.

[Dame Angela Eagle]

I think the Minister for her generosity in giving way, but this sounds like a typical civil service-drafted speech, if I may say so, mentioning everything but the issue we are talking about. We are not talking about mesh; we are talking about Primodos, and we want to hear about redress. Can she now please address those points?

[Maria Caulfield]

I can show the hon. Lady my remarks—they are on the back of this paper, and I have been writing them down during this debate. I am only two minutes into my speech and I am addressing some of the points that were made. I will of course come on to Primodos as well.

It is important to recognise that we did take those issues in Baroness Cumberlege’s review seriously. We could not look at the issue around Primodos at that time because of the legal case, which I have touched on, but there have been some reviews. My hon. Friend the Member for Mid Norfolk (George Freeman) was here just before this debate. In his time as Minister for Life Sciences, he took the campaigns and the evidence around Primodos so seriously that he set up the expert review in 2014 to look at the evidence that was in place. I hear very loudly this afternoon some concerns about that expert working group and that maybe evidence was either misinterpreted or not looked at, but that expert working group did look at the evidence at that time and also issued a public call for evidence.

[Sir Mike Penning]

The so-called expert group changed the remit that it was given, with no recourse, as I understand it, to any Minister for permission to do so. It changed the terms of what it was supposed to look at, which is not what it was asked to do in the first place.

[Maria Caulfield]

I hear my right hon. Friend and, as I said, I will come on to that specifically towards the end of my remarks.

There were further evidence reviews. Hon. Members have touched on the evidence from Heneghan et al., and from Brown et al. in 2018. Those were looked at, and again there was no evidence of causality found in those reviews.

[Hannah Bardell]

Will the Minister give way?

[Maria Caulfield]

I will, but I need to make some progress on addressing the points made.

[Hannah Bardell]

Causality is one of the key issues here, because it is very difficult to prove. The only way it can be proven is if those tests were done on pregnant women, and we all know that would be utterly ridiculous and absurd. However, we do know that there was association, and the bar has been set so high that it has become impossible for people to get justice. That responsibility lies at the door of the Government. Thalidomide campaigners were able to settle with the company. We need to look at how we can make that happen for Primodos campaigners, but the Government also need to look at lowering the bar.

[Maria Caulfield]

I take the hon. Lady’s point that causality is a high bar. I am just going through the fact that there have been a number of reviews of the evidence so far. Baroness Cumberlege, when she set out the remit for her review, also stated from the outset that she would not be able to touch on causality for many of those reasons. There have been a number of reviews of the evidence, but I hear from right hon. and hon. Members some concerns that those reviews still have not got to the bottom of the issues that the families and those affected by Primodos feel that they have faced.

On the next steps, I have heard hon. Members. I heard my right hon. Friend the Member for Chipping Barnet (Theresa Villiers), who was clear about the drug being taken even after evidence had emerged. I heard from my hon. Friend the Member for Stourbridge (Suzanne Webb) about the effect on her constituent Helen and her family. I heard from my right hon. Friend the Member for North East Somerset (Sir Jacob Rees-Mogg) about his experience in Government and why these things often take so long. And, of course, I heard my right hon. Friend the Member for Maidenhead (Mrs May), who set up the Cumberlege review in the first place. My hon. Friend the Member for Leigh (James Grundy) has lobbied me hard outside this place on behalf of his constituent Marie Lyon and the many others who have been affected.

Now that we are in between the first and—potentially—second court cases, I am keen to meet and get to the bottom of right hon. and hon. Members’ concerns.

[Mrs May]

I wonder whether the Minister might clarify one point about the second court case. The Government were a party to the first court case; that was the argument that they used for being unable to come to a decision. Are the Government a party to the second court case? If not, the second court case seems to me irrelevant.

[Maria Caulfield]

I will come to that in a minute. We are in between cases, and I want to make progress while we do not have a live case. Discussions are ongoing at the moment.

I am the Minister with responsibility for patient safety, and on this matter, I, rather than officials, wrote my speech. We all know that tragic events and accidents can happen, but I am weary of meeting families up and down the country who are victims of the injustice in the health service at the moment. I and the Secretary of State met the families at the Countess of Chester Hospital only last week. I met the families from Tees, Esk and Wear valleys, whose young children died by suicide. I met, as you will know, Mr Deputy Speaker, the families whose children died in east Kent, where there was an inquiry. I met Janet and Emma, the sodium valproate campaigners from In-FACT—the Independent Fetal Anti-convulsant Trust—and the women who lead the mesh campaign. I hear day in, day out about the injustice that many have to face, and about the fight to get answers to basic questions when things go wrong.

I am very happy to say from the Dispatch Box that I will meet the all-party parliamentary group, the hon. Member for Bolton South East, and other hon. Members who have taken part in the debate. I am very happy to commit to a meeting with my hon. Friend the Member for Leigh and with Marie Lyon, as well as with any other families who wish to meet, to discuss the Primodos case. If there are concerns that evidence was left out or not scrutinised, or that evidence in previous reviews is disputed, I am very happy to look again at that evidence and to leave no stone unturned until we absolutely get to the facts of the matter.

The right hon. Member for Kingston and Surbiton (Ed Davey) mentioned the letter that has gone out to those taking part in court cases. I do not want people to be in a position where they feel that they cannot get justice simply because they cannot afford to, so I commit to looking at that matter and addressing the points that he made as soon as I get to the Department.

I do not want to come back to the Dispatch Box to discuss the issues around Primodos on an ongoing basis. If patients feel that there has been an injustice, and that there is evidence to support that, I am very happy to look at it again. There may be future court cases, as my right hon. Friend the Member for Maidenhead said, but we are at a point where we can look at that now.

[Mrs May]

I am sorry; I did not say that there may be future court cases. The Minister herself referred to a second court case, and I asked a simple question about whether the Government would be a party to that case. I am grateful, and I am sure that the families will be grateful, that the Minister has opened the door to sitting down with and hearing directly from the families and campaigners. She says that she is prepared to look at any evidence that comes forward. The Cumberlege review is the evidence; it sets it out very clearly. That is all the Government need.

[Maria Caulfield]

To be specific on that point, the Government are involved in a second claim. We are not sure whether that claim will go forward—discussions about that are ongoing. As the appeal timed out on 11 August, I am happy to commit today to looking at the evidence and the Cumberlege review. Baroness Cumberlege is my constituent, and I am sure she will be pushing me for that.

[Ed Davey]

To follow on from the point made by the right hon. Member for Maidenhead (Mrs May), the Cumberlege review has concluded. There are recommendations. Is the Minister saying from the Dispatch Box that the Government are not accepting those recommendations? We want to hear that they are going to implement those recommendations, not hear more evidence—implement them!

[Maria Caulfield]

Finger pointing is not exactly effective. As I set out at the beginning of my remarks, we have accepted the majority of those recommendations. We could not accept the Primodos ones while there was an ongoing court case. I have given my commitment from the Dispatch Box to review the outstanding recommendations in relation to Primodos, because I want to get to the bottom of this once and for all and provide justice for the families. I have heard from Members across the House about their concerns and the outstanding recommendations of the Cumberlege review, and my commitment is to look at those now.

[Hannah Bardell]

It seems to me that we are caught up in a quagmire of bureaucracy. We have had the Cumberlege review. We know what the results are. The Government said incessantly that they would not address the Primodos matter because of the court case. We now know that the court case was, in some respects, flawed, because the complainants and victims were not able to take their case forward as their information was withheld by the legal firm. As the right hon. Member for Kingston and Surbiton (Ed Davey) said, they are now being treated in a hostile manner by the Government by being told that they will be sued for over £10 million if they take another case forward. That is an utterly preposterous situation. If the Minister really wants to get to the bottom of it, she needs to implement fully the Cumberlege review and ignore the nonsense that has gone on in the courts.

[Maria Caulfield]

I do not want to test your patience, Mr Deputy Speaker, because I know that I am over time, but I have made the commitment to review the Cumberlege recommendations for Primodos patients. For those who have been affected by sodium valproate and mesh, we are making huge progress. Only this week, we introduced a statutory instrument so that sodium valproate can only be dispensed in the manufacturer’s original packaging. We have the pregnancy prevention programme, which is drastically reducing the number of babies born to those taking sodium valproate. We are installing the registry, so that women on sodium valproate are better cared for and not taking that medication. Now that 11 August has passed and the claim was not followed up, I am looking at the Primodos recommendations as well. My commitment is to come back to the House and update Members on the progress on those matters.

--- Later in debate ---

[Maria Caulfield]

Will the hon. Lady give way?

[Yasmin Qureshi]

We want to sit down with the Minister, and we want her to say to us, “This is what we are going to do about the Primodos case.” We do not want the Minister to tell us the problems. We want a system of redress right now—that is what we want from the Minister—and I hope that when we have that meeting, she and her officials will present to us the practical action they are going to take so that all the people who have been suffering for decades and decades actually get justice. We want her to tell us not about what has happened before or about the court cases, but about the actions she will take based on what the Cumberlege review said. [Interruption.] The Minister is muttering, but in the past it has sometimes taken us months and months to get a meeting with Ministers. I am glad that she has reassured us, and I hope that we will get a meeting in the next couple of weeks and that her and her officials will present a concrete plan for how to get redress for the victims. [Interruption.]

[Yasmin Qureshi]

I am sorry; I did not realise the Minister was asking to intervene. I give way.

[Maria Caulfield]

I just wanted to reiterate that I have pledged to meet the APPG and all its members. I have also pledged to look at the recommendations specifically in relation to Primodos. I think it is important to meet the families and the APPG, so that we can make progress on this issue.

[Yasmin Qureshi]

I thank the Minister for that intervention. I look forward to meeting her and her officials, and to a great scheme that will help the victims of Primodos. I remind her that if we do not get our meeting, or if we do not get a satisfactory result, we will be back again—all of us. We have been fighting for the past 10 or 12 years, and we will continue to fight this campaign, because the whole House is united behind it. I hope we will get positive news at our next meeting.

Question put and agreed to.

Resolved,

That this House notes that children were born with serious deformities due to the hormone pregnancy test drug Primodos, which was taken by expectant mothers between 1953 and 1975; further notes that official warnings were not issued about Primodos until eight years after the first reports indicated possible dangers; observes that the report by the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests in 2017 was inconsistent with other academic reports; notes that the Independent Medicines and Medical Devices Safety Review, First do no harm, found that Primodos caused avoidable harm; further notes that the Government has refused to acknowledge the recommendations by the Independent Medicines and Medical Devices Safety Review relating to Primodos families; and calls on the Government to fully implement the recommendations in the Independent Medicines and Medica al Devices Safety Review and to set up a redress fund for families affected by Primodos.

Draft Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023

Maria Caulfield Excerpts

Tuesday 5th September 2023 General Committees

[The Chair]

Before I call the Minister, I just want to confirm that if gentlemen wish to remove their jackets, they are free to do so.

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I beg to move,

That the Committee has considered the draft Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023.

It is a pleasure to serve under your chairmanship, Ms Nokes. I will set out the purpose of the draft statutory instrument. The Human Medicines Regulations 2012 set out when medicines need to be prescription only and the requirements of pharmacists selling or supplying prescription-only medicines. This draft statutory instrument makes two amendments to the Human Medicines Regulations. First, it enables original pack dispensing of medicine when original packaging is required. Secondly, it requires whole-pack dispensing of medicines containing valproate.

The first amendment, under proposed new regulation 217B, will enable the pharmacist to dispense 10% more or less of the medicines compared with the quantity prescribed if they can dispense them with the manufacturer’s original packaging. Dispensing in the manufacturer’s original packaging brings a number of benefits. First, it improves patient safety because original packaging contains clear instructions and information about the medicines. Secondly, it frees up pharmacy time by reducing the amount of time spent splitting packs and counting packs and strips. However, the responsible pharmacist will need to make a judgment as to whether to use this 10% discretion. For example, the flexibility should not be applied to some medicines, such as courses of steroids or antibiotics, and the exact quantity prescribed should be the quantity supplied.

Original pack dispensing will not apply to controlled drugs, where the exact quantity prescribed will continue to need to be dispensed. Nor will it apply where a medicine is already dispensed in a full pack, for example because it is in a form that is not practical to dispense in the exact quantity ordered.

While the flexibility of 10% will not enable all prescriptions to be dispensed in the manufacturer’s original packs, it will deal with the issues of whether a month’s supply is for 28 or 30 days, and with multiples. For example, if a prescription is for 28 days but the pack has 30 tablets, currently the pharmacist has to remove those two extra tablets. The new flexibility will enable the full pack to be supplied and vice versa. The amendments for original pack dispensing will apply across Great Britain and they are enabling, so pharmacists can decide whether to utilise the original pack dispensing with the flexibility of plus or minus 10%.

A transitional provision has been included, so pharmaceutical services in England will need to further negotiate with Community Pharmacy England on pricing arrangements following the draft regulations. I understand that in Scotland, however, they are ready to move forward with this, so it will apply immediately.

[Valerie Vaz (Walsall South) (Lab)]

The Minister gave the example of 28 days or 30 days. Will pharmacists be able to explain to patients that they will not necessarily have to take them for 30 days?

[Maria Caulfield]

Absolutely, and pharmacists are very keen to do this. This will often be used for repeat medication. A GP may prescribe a month’s pack—which, depending on the supplier, will be for either 28 days or 30 days—but when dispensing the packs the pharmacist will be able to give advice to patients so that they are absolutely clear on the instructions, which will also be written on the pack.

That goes to my point that by ensuring that patients receive the necessary information that is included in the original manufacturer’s packaging, they will be supported in taking their medicines more safely and effectively. The amendments will lead to a reduction in the use of plain dispensing packaging—those little white boxes—so that patients can stop getting lots of small snips from blister strips. When they get full strips, that will make it easier for them to manage the supply and support compliance, because they will be able to identify more easily whether they have taken their tablet that day and how many they have left.

Original pack dispensing also helps pharmacists and their staff to become more efficient, as the number of times they have to snip blisters, repackage medicines and source extra patient information leaflets is reduced, freeing up time for other tasks such as providing clinical services to patients. The benefits of original pack dispensing will be synergistic with the benefits of expanding hub and spoke arrangements, which we are rolling out across the pharmacy sector. The use of hub and spoke dispensing arrangements has been consulted on, and we will publish that consultation in due course. Both today’s measures and the expansion of hub and spoke dispensing are a commitment to the community pharmacy contractual framework and are important foundations in transforming community pharmacy.

The second regulation, proposed new regulation 217C, is about the whole-pack dispensing of valproate. “Valproate” is a term for medicines containing sodium valproate, valproic acid and valproate semisodium; it includes various brands such as Epilim. Valproate is an effective medicine prescribed for the treatment of epilepsy and bipolar disorders, but it is associated with birth defects and neurological disabilities in babies exposed to it during pregnancy. The risk to children of mothers who have taken valproate during pregnancy of having neurodevelopmental disorders is estimated at 30% to 40%, in addition to an 11% risk of congenital abnormalities.

A number of measures are already in place to try to prevent pregnancies while women are taking valproate, such as the pregnancy prevention programme, which has already reduced the number of pregnancies exposed to valproate. But the latest data suggests that in England at least three pregnancies a month are still being exposed to medicines containing valproate. More needs to be done.

The regulations will require that patients receive only the manufacturer’s complete original packs, with limited exceptions in specific circumstances. The manufacturer’s original packs contain specific warnings and pictograms. There is a patient card along with statutory patient information leaflets, which outline the risks of taking the medicine. If patients are concerned about taking valproate, they should talk to their healthcare provider and should not stop taking their medicines without medical supervision.

The provision will be mandatory across Great Britain. There is no transition period and it will apply as soon as the regulations come into force. I hope I have set out the rationale for original pack dispensing for the majority of medicines and using the specific manufacturer’s complete original pack when dispensing valproate medicine. I commend the regulations to the Committee.

--- Later in debate ---

[Maria Caulfield]

I thank the Opposition for their support; it is very welcome and appreciated. I, too, pay tribute to Baroness Cumberlege for her work in this area, and to groups including In-FACT—the Independent Fetal Anti-convulsant Trust—which have been campaigning for a long time for better protection and support for women taking valproate.

Let me answer the hon. Lady’s questions. On greater flexibility, that is being looked at as a wider piece in community pharmacy by the pharmacy Minister, my hon. Friend the Member for Harborough (Neil O’Brien). There can be flexibility when there is a shortage of medicine; the hon. Lady brought up the example of HRT. When there is a shortage of a product, we issue a serious shortage protocol, which gives pharmacists flexibility when they have a pack on their shelf that is not quite what the prescription says. As she says, the prescription may be for 10 micrograms; if the pharmacist has two packs of 5 micrograms, or a different form of the medicine, there is flexibility under the SSP to dispense that, rather than sticking to the prescription. We are looking at whether that needs to be part of a wider piece of work on medicines overall.

The hon. Lady touched on Pharmacy First. The pharmacy Minister will update the House shortly on that; there is work going on around Pharmacy First and its roll-out. The hon. Lady touched on reimbursement. She is absolutely right: there are cost issues that community pharmacies will rightly want to iron out. That is why we have put a transitional arrangement in the SI: so that discussions with Community Pharmacy England on funding and reimbursement of costs can be hammered out before the SI is put into practice. That is the next stage. Once we have agreed to the SI, we will go into negotiations on pricing and reimbursement, so that the measures meet pharmacy’s needs when it comes to costs; the aim is not to put costs on pharmacy by introducing these measures.

I hope that I have reassured the hon. Lady that we are looking at the issues she mentioned. In particular, we issue serious shortage protocols quite regularly when we have a shortage of medicine, and that gives pharmacists a degree of flexibility in dispensing, without the need for further regulation. I thank Members on both sides of the Committee for their support today. I hope that I have reassured them that we are acting with urgency on valproate, and that original pack dispensing will give pharmacists flexibility, which will free up their time, so that they can focus more on clinical activity.

Question put and agreed to.

Autumn Vaccination Update

Maria Caulfield Excerpts

Monday 4th September 2023 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

On 8 August 2023, the independent Joint Committee on Vaccination and Immunisation (JCVI) published advice on who should be offered a covid-19 booster vaccine in autumn 2023. The Government accepted this advice.

Covid-19 Booster Vaccine Eligibility

Those eligible are:

Residents in a care home for older adults

All adults aged 65 years and over;

Persons aged six months to 64 years in a clinical risk group;

Frontline health and social care workers;

Persons aged 12 to 64 years who are household contacts of people with immunosuppression;

Persons aged 16 to 64 years who are carers and staff working in care homes for older adults.

More detail on eligibility criteria can be found in the UK Health Security Agency’s (UKHSA) Green book.

Autumn Vaccine Campaign Timings

On 30 August, the Government announced that this year’s autumn flu and covid-19 vaccine programmes will start earlier than planned as a precautionary measure following the identification of a new covid-19 variant, which was first announced in the UK on Friday 18 August.

While this variant is not currently classified as a variant of concern, advice from UKHSA suggests that speeding up the autumn vaccine programme will deliver greater protection, supporting those at greatest risk of severe illness and reducing the potential impact on the NHS. There is no change to the wider public health advice at this time.

The annual flu vaccine will be made available to these groups at the same time wherever possible, to ensure they are protected ahead of winter.

The vaccination campaign was previously due to commence in early October 2023. Vaccinations are now set to start on 11 September, with adult care home residents and those most at risk to receive vaccines first. NHS England has announced full details of the accelerated roll-out, and those who fall into higher-risk groups are being encouraged to take up the jab as soon as they are invited.

Vaccines to be Used as Part of Autumn Booster Vaccination Campaign

The JCVI advice on which vaccines should be used as part of this autumn’s booster vaccination campaign was also published on 30 August. The Government have accepted this advice, and I am informed that all four parts of the UK intend to follow the JCVI’s advice. The JCVI has advised the following products for use in the autumn campaign:

Pfizer-BioNTech mRNA bivalent BA.4-5 or monovalent XBB (subject to licensure)

Moderna mRNA bivalent BA.4-5 or monovalent XBB (subject to licensure)

Sanofi/GSK monovalent (beta variant)

The vaccine offered will depend on a person’s age and local supply considerations. Children under 12 years of age will be offered a paediatric (5-11 years) or infant (6 months to 4 years) formulation of the Pfizer-BioNTech mRNA monovalent XBB vaccine (subject to licensure).

Those eligible for vaccination are encouraged to take up the offer of the vaccine as soon as they are called to ensure they head into winter with the best protection.

Notification of liabilities

I am now updating the House on the liabilities the Government has taken on in relation to further vaccine deployment via this statement and accompanying departmental minute laid in Parliament containing a description of the liability undertaken. The agreement to provide indemnity with deployment of further doses increases the contingent liability of the covid-19 vaccination programme.

I will update the House in a similar manner, as appropriate, as and when any future deployment decisions impact the contingent liability of the covid-19 vaccination programme.

[HCWS997]

East Kent Hospitals University NHS Foundation Trust: Independent Review

Maria Caulfield Excerpts

Thursday 20th July 2023 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I wish to inform the House of the Government’s full response to the report of the independent review into the maternity and neonatal services at East Kent Hospitals University NHS Foundation Trust, which will be published today on gov.uk.

NHS England commissioned Dr Bill Kirkup CBE in February 2022 to undertake this review following concerns about the quality and outcomes of care. This inquiry was published in October 2022 with five recommendations for the healthcare system.

I want once again to express my thanks for the role the families have played in this review. I remain deeply sorry for the harm and pain that have been a result of the failings of the trust to provide safe care and treatment.

The Government informed the House of their interim response on 7 March 2023, and the fuller response published today sets out in detail how each recommendation is being implemented.

This response has been informed by extensive engagement with stakeholders from across the healthcare system and voluntary sector as well as by the insight and views from those families I met with in June, for which I am grateful.

While the issues set out by Dr Kirkup were a result of an investigation into one trust, many will resonate across the wider system. That is why our response sets out the existing work that is already underway to drive forward system-wide improvements, such as the implementation of the three-year delivery plan that was published in March 2023 by NHS England. This plan is clear on how maternity and neonatal care will be made safer, more personalised, and more equitable for women, babies and families. It will be an important supporting role in the implementation of the East Kent recommendations, and we recognise there is more that we can do.

Today, I want to draw the attention of the House to the key new action we are taking that will create the conditions needed in order for the improvements to be successful and sustainable.

I will chair the new national oversight group to bring together the key people from the NHS and other organisations to look across maternity and neonatal improvement programmes and the implementation of recommendations from this and other maternity reviews. At a local level in East Kent, I will convene a local forum bringing together the NHS, the Care Quality Commission and Members of Parliament whose constituents have been affected to share information and updates. I am also pleased to announce that Dr Kirkup has been appointed to support Government action in relation to recommendations 2 and 3.

It is with a firm determination that we must learn the lessons from this inquiry, as well as those before it, to implement meaningful change to prevent further inquiries into failings in maternity and neonatal services across England being needed.

[HCWS981]

Hyperemesis Gravidarum Awareness

Maria Caulfield Excerpts

Wednesday 19th July 2023 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

It is a pleasure to serve under your chairmanship, Ms Nokes. I begin by thanking my hon. Friend the Member for Hyndburn (Sara Britcliffe) for a very moving speech. I express my condolences to Jess’s family and to Eddie, her partner, and let us also remember baby Elsie. My hon. Friend could not have expressed any better the impact on a whole family, a community and an individual, and I agree with every word she said. We met recently to discuss Jess’s case, and I am happy to continue to work with my hon. Friend on this issue.

Unfortunately, there are many women like Jess going through this. They are probably watching or listening to the debate, and will take comfort from the fact that they are not on their own, and that there are many others who feel like this. Every pregnant woman who is living or has lived with hyperemesis gravidarum or a difficult pregnancy—particularly those like Jess, who had such an active life before becoming pregnant—will recognise that isolation and loneliness. It is an all-encompassing feeling of not being physically well, which takes a toll on mental health as well.

To echo my hon. Friend’s words, hyperemesis gravidarum is a severe form of nausea and vomiting. She is right that we need to move away from the term “morning sickness” and to instead use the term “pregnancy sickness”, and we should also be aware that HG is very different from pregnancy sickness. Any woman who has experienced nausea or vomiting during the early stages of pregnancy knows how debilitating that is. However, when that continues week after week, and they see other pregnant mothers glowing and thriving in pregnancy, and sharing photos on Instagram and social media, it adds to the difficulty, and the feeling of isolation because they are not dealing with pregnancy in the same way as many others.

Hyperemesis gravidarum can affect between one and three in every 100 pregnancies, so it is not a small number. Thousands of women are affected. It can affect an individual’s mood and their ability to work. Many mums are keen to work for as long as they can, because they want to take as much maternity leave as possible after they have given birth. The effect of not being able to work, and the effect of HG on home life, particularly if mums have other children for whom they care, cannot be overestimated.

Although most women can be treated at home or as an out-patient, some need to be admitted to hospital. As my hon. Friend said, if they are not able to eat or keep fluids down, it is vital that medical care is there when they need it. Too many women are left feeling isolated and unsupported. There is stigma and a taboo; there is little understanding that this condition is very different from morning sickness, and that it affects women’s mental health, as well as their physical ability to cope with their pregnancy.

I absolutely agree that more needs to be done to address this issue. The National Institute for Health and Care Research is awarding funds for research on the causes of the condition, the way it can be managed and the nutritional impact on pregnancy. The women’s health ambassador, Professor Dame Lesley Regan, who is an obstetrician, is keen to look at hyperemesis gravidarum, because in her clinical practice she has seen its effect on women. She will host a webinar on hyperemesis gravidarum on 27 September in her role as chair of Wellbeing of Women, which is a leading women’s health charity. That public webinar, which is free for people to sign up to and attend, will explore the experience of patients with this condition and provide options for treatment, support and self-care. I encourage anyone who has been affected by it or has an interest in it to sign up. The details will be published on the Wellbeing of Women website. If the women’s health ambassador is championing improvements in this area, that is the start of the conversation. It will start Jess’s legacy, in terms of raising awareness for other women.

Mental health support is often not accessible. This is not the only case of women not being listened to when it comes to women’s health. Ahead of the women’s health strategy, we issued a call for evidence, to which we received more than 100,000 responses. Whether it was on endometriosis, the menopause or fertility issues, the overwhelming response was that women are often not listened to when they ask for help, either because healthcare professionals were not aware of the conditions that women were raising, or because the attitude of healthcare professionals, whether to pregnancy, the menopause or puberty, was, “This is part of a woman’s cycle, and you just have to get on with it.” We want to end that stigma.

There are so many interventions that can help women throughout their life course, regardless of their condition or the life change that they are going through. Through the women’s health strategy, we want to change that attitude, so that when women ask for help, they have a positive experience and feel supported.

We are looking at perinatal mental health. Tragically, the most common cause of death in new mums is suicide; that is absolutely extraordinary. It is tragic to hear that Jess died by suicide because she felt so isolated and helpless in dealing with her condition. We will hopefully publish the suicide prevention strategy very soon, and new mums—indeed, mums in general—will be a priority group in it. We recognise that there is not support for mums during and after pregnancy. We want to address the fact that suicide is the leading cause of death.

We are doing that already. Mental health services around England are expanding to include new mental health hubs for new, expectant or bereaved mums. We are opening up 33 of them, which will provide psychological therapy, maternity services and reproductive healthcare for women with mental health needs following trauma or loss, or directly related to their experience of pregnancy or birth. Those will be available in England from March 2024. I know that is no consolation to Jess’s family, but we are absolutely addressing that as quickly as we can.

We also recognise the importance of supporting women’s health in the workplace. My hon. Friend is quite right that there are laws in place to protect women when it comes to maternity leave and discrimination around pregnancy. I am happy to work with the Under-Secretary of State for Work and Pensions, my hon. Friend the Member for Mid Sussex (Mims Davies), on raising awareness of this condition, because employers are not aware that it is very different from early-stage morning sickness or pregnancy sickness, and that female employees will need help, support and understanding. They should not be afraid that the situation will eat into their maternity leave or, as my hon. Friend the Member for Hyndburn said, statutory sick pay. I am happy to have discussions with my hon. Friend the Under-Secretary of State for Work and Pensions. We have been working closely on the menopause in the workplace, so I am happy to take that up.

Hyperemesis gravidarum is not included in the women’s health strategy, which looks at the priority areas of women’s health, although pregnancy is. I would like to address that, because I have heard clearly from my hon. Friend, through what she said about Jess’s tragic experience and the outcome for her family, how difficult this issue is. I take on board that many healthcare professionals, particularly those whom a woman will see before she sees a midwife, will not have had training or support in understanding the extent of this condition. As my hon. Friend said, even midwives do not get specific training on HG.

I suggest that, following the webinar in September that the women’s health ambassador is leading, we organise a roundtable with her to discuss the findings, and see how we can take some of this forward. Through the National Institute for Health and Care Research, we have money for research, which could be on managing the condition; psychologically supporting women who are struggling with its devastating and debilitating effects; or the use of drugs such as Ondansetron. We need an evidence base, so that we can support primary care teams and midwives in giving medication safely to pregnant women. There could be research on hydration and nutrition support for those not able to keep down food and fluids; on the training and education of medical staff and midwives; on removing the stigma and taboo; or on raising awareness among healthcare professionals, the public and pregnant women. They may not realise that HG is a condition for which they should be able to get help and support, and that it is not just them being unable to cope with morning sickness. Some women do feel that, when they actually have a condition that makes their experience different from what many women go through.

The offer is on the table; I can meet my hon. Friend to see if we can draw some findings from Jess’s terrible experience, so that we can eliminate the chance of that happening to other women. In the minutes that I have left, I extend my thanks to my hon. Friend, and say to Jess’s family that I am so sorry to hear of their experience. I am happy to support Jess’s legacy, so that we change the experience for pregnant women who suffer with hyperemesis gravidarum, and never again hear such a tragic story.

Question put and agreed to.

HPV Vaccinations

Maria Caulfield Excerpts

Wednesday 19th July 2023 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

It is a pleasure to serve under your chairmanship, Dame Maria. I thank my hon. Friend the Member for Mole Valley (Sir Paul Beresford) for bringing this important issue to the Chamber today. I know that he has done a great deal of campaigning on this, particularly vaccination for boys, and that he has clinical experience. We have discussed this, as we have both seen at first hand the horrific effects of head, neck and oral cancers on individuals and the difficult treatments they have to undergo, including surgery and radiotherapy. People are often not aware that HPV vaccination relates to head and neck cancers as well as cervical cancer.

HPV causes about 99% of all cervical cancers, but thanks to our world-leading vaccination programme that protects girls and boys, we have seen an 87% reduction in cervical cancers in vaccinated women compared with previous generations. Our ambition is to work to eliminate cervical cancer, and the HPV vaccination programme is a key part of that, but we are also looking at the data on the impact on rates of head and neck cancers as well as other cancers. Vaccination is a game changer in preventing some cancers caused by HPV.

The UK was one of the first countries in the world to introduce an HPV vaccination programme, back in 2008. Since then, millions of vaccines have been delivered, stopping the transmission of HPV, protecting individuals and saving lives. The programme has been evolving and we have made a number of significant changes, including introducing more effective vaccines, reducing the number of injections required and making the programme universal; in 2019, it was offered to boys as well as girls. Those changes have further strengthened what was already a very successful programme, and it is a key priority for the Government to increase uptake rates of the vaccine to at least pre-pandemic levels. That is a good place to get to, but of course we want to go further if we can.

Although we are not back to pre-pandemic levels yet, we are seeing encouraging recovery among older school-age children, as those who missed their vaccination during the pandemic are being caught up with. The vaccine is mainly delivered by school-based vaccination teams, and this delivery model, in combination with alternative vaccination sites for those who are not in mainstream education, has been very successful in getting our uptake rates pretty high.

Pre-pandemic levels of vaccination were consistently high across the board. To try to get back to those levels, anyone who missed their immunisation for whatever reason will remain eligible until their 25th birthday. They can catch up via their schools, alternative sites such as community centres, and GP practices, so there is a range of routes through which a young person who missed their vaccination can still access it until they are 25.

There is a separate HPV programme for gay and bisexual men, who are also at risk from HPV. The JCVI advises that they are at an increased risk of the virus and its effects on particular cancers. That is why there is a separate programme available through specialist sexual health services and HIV clinics, and the vaccine can be accessed until a man’s 46th birthday. There are two separate programmes, with multiple ways in which people can get the vaccination, and we encourage them to do so.

We have raised the eligibility age over the course of the programme and offered the vaccine to boys as well as girls. Using recent evidence, we are able to compare pre-covid vaccination rates of girls, but we are not able to with boys, because they have only been offered the vaccine since 2019. We are looking at the data, which will take years to develop, on the effect of vaccinating boys on preventing cervical cancer in future partners and on other types of cancer caused by HPV.

We are now evolving how many doses we give. When the programme started, people were offered three doses. That has since been brought down to two doses, and from September this year, a single dose will be sufficient to vaccinate fully against HPV. The hon. Member for Strangford (Jim Shannon) asked how we can be sure that a single dose will be effective. The JCVI looked at the evidence and recommends a single dose. We know from vaccination rates that young people often come for one dose, but may not return for the second. If we are happy that a single dose is effective, that will get our vaccination rates up. My hon. Friend the Member for Mole Valley highlighted the example of Australia, where a single-dose vaccine is used, with good success rates. The JCVI, the World Health Organisation and the Scientific Advisory Group for Emergencies all recommend moving to a single dose, because the clinical evidence is that it is just as effective as two doses.

Moving to a single dose will allow our vaccination teams to focus on catching up with those who have not turned up for any vaccines. That is our key priority: reaching out to those groups that have not come forward, because of the implications of trying to prevent cancer in an individual and, as my hon. Friend the Member for Mole Valley said, trying to capture the herd immunity effect. There may be some people who cannot have the vaccine for some reason. Getting as many people vaccinated as possible means we are reducing the risk of cancer when they are older.

I can reassure the hon. Member for Strangford that these changes are based on scientific review and advice from independent experts and the JCVI. They all aim to strengthen the programme further and ensure that more people have access to effective vaccines to prevent HPV infection and future cancers.

[Jim Shannon]

First, I welcome the Minister’s response, which is very positive. I mentioned people in my constituency who are medically qualified in their particular sector. They may not have all the evidence that the Minister referred to. Would the Minister please email me to let me know when that information will be available? Thank you.

[Maria Caulfield]

Absolutely, we can send the hon. Gentleman the information provided by the JCVI on its recommendations. I think the hon. Gentleman also asked why it is a one-off and not a regular dose. The evidence and studies show that, when someone is vaccinated against HPV, the protection lasts for at least 12 years. It could well be longer but, because the programme is not that old, we have only that level of data. There is certainly at least 12 years of protection from that initial vaccination. We will send him that information; we quite rightly want people to be able to ask questions and be reassured by the evidence we are able to provide.

HPV vaccination is one of the most cost-effective ways to protect people from both the infection and related cancers. We are keen to ensure that vaccination levels are as high as possible. Pre-pandemic, the programme reached 80% coverage for two doses. Those were good levels of protection that we would like to get back to, and then go higher. Covid-19 disrupted the roll-out, because young people were not able to go to school, and the vaccination teams were not able to roll out those programmes. Despite catch-up work and teams working extremely hard, we are seeing a decrease in uptake in vaccination. That is of concern because of the future implications.

We are committed to recovering the HPV programme back to pre-pandemic levels. We have seen some recovery when we have done catch-up work. To put it in context, HPV vaccine coverage decreased by 7% in year 8 girls, and 8.7% in year 8 boys. That is quite a significant drop. We have figures only for girls pre-pandemic, but these rates are about 18% lower than pre-pandemic coverage. That shows that my hon. Friend the Member for Mole Valley is quite right to raise this issue, and that there is work to do. I am happy to commit to meeting with my counterpart in the Department for Education, the Minister for Schools, to see how much further we can go to support schools and make the vaccination roll-out more effective.

I will also meet with the screening team to see how we can drive up those rates further and whether we need better communication, for both young people and parents, about what a difference vaccination can make to a young person’s life. To a young person at school, cervical cancer or head and neck cancer seem a long way off, but vaccination is so important for the future, not just for them but for future partners. I commit to my hon. Friend the Member for Mole Valley that we will do more to get those rates back up, because it is in the interests of young people.

I thank my hon. Friend for raising the debate. I encourage him to keep holding our feet to the fire on this issue, because it is important that it does not drop off the radar. He was quite right to raise the issue of the covid vaccination. We have been extremely successful as a country, particularly in the initial roll-outs, in vaccinating the whole country at 12-weekly intervals and then with ongoing booster programmes for vulnerable people in the community. We do well with our flu vaccine roll- outs as well. We need to put this programme on a par with other vaccination programmes and I am keen to make progress.

I commit to working with my DFE counterparts and raising the profile of how important the HPV vaccination programme is. I commend my hon. Friend for all his work in this area, particularly his clinical work. He has picked up head and neck cancers at an early stage, and people will have benefited from his clinical expertise. The ideal is for them not to develop that cancer in the first place, and that is where we all want to get to. We are committed to increasing the uptake of the vaccination across all eligible groups, and I will keep the House updated on our progress.

Question put and agreed to.

Women and Equalities

Maria Caulfield Excerpts

Monday 17th July 2023 Ministerial Corrections

[Margaret Ferrier]

Current legislation requires all public facilities to have sanitary bins in female and gender-neutral toilets. However, as highlighted by the Boys Need Bins campaign, hygiene bins need to be provided in men’s toilets. What steps is the Minister taking to introduce legislation that addresses that issue?

[Maria Caulfield]

I reassure the hon. Lady that work is going on in that space. My ministerial colleagues from the Department for Work and Pensions are looking at this, and will be updating the House shortly.

[Official Report, 12 July 2023, Vol. 736, c. 338.]

Letter of correction from the Minister for Women, the hon. Member for Lewes (Maria Caulfield):

An error has been identified in my response to the hon. Member for Rutherglen and Hamilton West (Margaret Ferrier).

The correct response should have been:

[Maria Caulfield]

I reassure the hon. Lady that work is going on in that space. My ministerial colleagues from the Department for Environment, Food and Rural Affairs are looking into this.

North East Ambulance Service NHS Foundation Trust: Independent Review

Maria Caulfield Excerpts

Wednesday 12th July 2023 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

Following a request by the Department of Health and Social Care, in May 2022, NHS England commissioned an independent review into concerns raised about compliance with coronial processes at North East Ambulance Service NHS Foundation Trust. Today, NHS England published the findings from this review.

I am grateful to Dame Marianne Griffiths for chairing this review and for the work she and her team have undertaken into investigating this important issue. The review was tasked with examining patient safety and governance processes at the trust which included consideration of previous investigations and reports on this matter. I am grateful to everyone who contributed to this review—the families and the staff—whose participation will enable lessons to be learnt.

The review found that significant leadership, cultural and behaviour issues contributed to the overall failings experienced by the families. For example, appropriate documentation was not provided to HM Coroners and, when submitted as part of the coronial process, documents had been amended to downgrade a serious incident into an event needing lesser scrutiny. This review makes 18 recommendations which cover governance, leadership, culture, and commissioning. The report has been published on NHS England’s website and is available here: https://www.england.nhs.uk/north-east-yorkshire/our-work/publications/ind-investigation-reports/

In the last decade, the Government have introduced substantial measures to reduce harm to patients, including a statutory duty of candour, legal protections for whistle-blowers, medical examiners across the NHS and legislation to establish the Health Services Safety Investigations Body. It is important that the right processes are put in place by trusts to make sure safeguards are properly implemented and there is continuous learning.

NHS England has also introduced a patient safety strategy which sets out how the NHS will support staff and providers to share safety insight and empower people—patients and staff—with the skills, confidence and mechanisms to improve safety. I also welcome the National Guardian Office’s review, published in February, into speaking up in ambulance trusts to ensure that ambulance services are a safe place to work, and staff feel confident and supported when issues need to be raised. Action includes the NHS launching an independent review into broader cultural issues in ambulance trusts.

Ambulance services are receiving £200 million of additional funding this year to grow capacity and improve response times, alongside 800 new ambulances, including specialist mental health ambulances. We have also made significant investment in the ambulance workforce, with the number of NHS ambulance staff and support staff increasing by over 40% since 2010.

Alongside the review report, the trust has issued an assurance statement and I am pleased that both the trust and the integrated care board have accepted the findings and recommendations and have set out some of the work already in train to address the concerns.

I will continue to work with the trust and NHS England to address the concerns raised in Dame Marianne’s review and ensure that lessons are learnt to improve patient safety across the wider healthcare system.

A copy of the report will be deposited in the Libraries of both Houses.

[HCWS933]