Abortion Services Commissioning: Northern Ireland

Maria Caulfield Excerpts

Tuesday 14th December 2021 Westminster Hall

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

I am grateful to the hon. Member for Pontypridd (Alex Davies-Jones) for securing the debate. The Northern Ireland Office Ministers regret that they are unable to be here today, but I am sure they welcome the opportunity to have this debate and hear the wide-ranging views on abortion in Northern Ireland. It is an extremely emotive and sensitive subject and it is important that we have that debate in this place.

It is now more than two years since the Northern Ireland (Executive Formation etc) Act 2019 was passed, where Parliament stepped in and decided that women in Northern Ireland should have access to the same healthcare rights as women in England, Scotland and Wales. Even though the law was changed two years ago, it is true that services have not been commissioned in full.

The Northern Ireland (Executive Formation etc) Act placed a duty on the Secretary of State for Northern Ireland to ensure that abortion services which meet the recommendations are put in place and implemented. He has a legal duty to uphold that. As we have heard today, it is true that women have to access abortion in the rest of Great Britain, even though early medical abortion is available in four of the five trusts in Northern Ireland and BPAS has stepped in to provide an interim referral service for women and girls on a temporary basis.

Women and girls who require surgical abortions and post-10 week abortions still have to travel to Britain. The only way for the legal obligations to be met is through local commissioning. The Secretary of State has been clear with the Northern Ireland Department of Health and the Northern Ireland Executive about the commissioning of abortion services that are consistent with the regulations passed in 2019. Despite continuous engagement by the Secretary of State, he remains frustrated that progress is not being made.

As a result of the ongoing delay in commissioning services specifically by the Department of Health and the Northern Ireland Executive, Members will be aware that in July this year, the Secretary of State issued a direction to the Northern Ireland Department of Health, the Minister of Health, and the Health and Social Care Board to commission and make abortion services available by no later than 31 March 2022.

[Ian Paisley]

I thank the Minister for giving way because that point is absolutely vital. By the Secretary of State recommending to the Minister in Northern Ireland that he commission these services, is that not an acceptance that these services are devolved matters? Conversely, matters that are reserved, such as the protocol, can be debated here—and posed and changed here—if that is the Government’s position. If the Government’s position is that this matter is devolved, it should remain devolved.

[Maria Caulfield]

I thank the hon. Member. I was going to come on to the point he raised in his remarks, but will touch on it now, if I may. Health is a devolved matter and that is very much recognised. It was frustrating. It was a free vote, and he knows how I voted and I would do the same today. However, at the time, there was no functioning Assembly. This Parliament had to make decisions, not just on this issue, but other issues such as budgetary matters. As a member of the Northern Ireland Affairs Committee at the time, I remember making the case to MLAs that this was why it was so important to get the Assembly up and running, because decisions were made in this place that did not reflect and respect devolution. Decisions were having to be made in this place on devolved matters.

[Colum Eastwood (Foyle) (SDLP)]

I totally agree that this is a very sensitive issue and there are strongly held views on it, but it is as if we are sometimes speaking in a vacuum. Yes, there was a political vacuum in Northern Ireland when the law was made, but there was also an issue around the law, where the High Court clearly stated in the Sarah Ewart case that the Northern Ireland Executive were falling foul of the law in terms of human rights protections around fatal foetal abnormality and sexual assault.

Whatever people might think about the law that this place brought in, the Northern Ireland Executive did not bring in a law to deal with that issue. Nobody that I have heard who opposes the law here has come up with a solution to deal with the fact that Sarah Ewart and many other women were forced, when the baby was not able to be born or to survive, to carry to full term. Those people were left without any recourse by our Northern Ireland Executive, so it is all very well talking about devolution and everything else, but when responsibility lay with the Northern Ireland Executive, they did not lift the ball, did not deal with it and left women, such as Sarah Ewart, in a very invidious position.

[Maria Caulfield]

We are left with the law that was passed in 2019, so the Secretary of State is now under a legal duty to implement it. He has directed the First Minister and the Deputy First Minister to include it on the agenda for the Executive Committee. That is not taken lightly because, while I understand the points the hon. Gentleman has just made, health is a devolved matter, but the UK Government have to uphold their legal duties in terms of the decision.

The Secretary of State for Northern Ireland has taken the decision in line with his statutory duty. He recognises that it is an unprecedented step, but it was taken after allowing a year for the commissioning of services since the Northern Ireland Office provided a framework in spring 2020. The Secretary of State has clearly stated that fully commissioned services must be provided by March next year. If it becomes clear before that deadline that the Department of Health, or indeed the Northern Ireland Executive, are not making progress, he will have to take further steps to ensure that his legal duties are upheld.

I know that I am running out of time, but I will just follow up on a couple of comments. The hon. Member for Pontypridd asked about progress, and I hope that I have set out that the Secretary of State has set the deadline of March and is monitoring progress closely. On the issue of exclusion zones, my understanding is that there is a Bill before the Assembly, brought forward by an MLA, that is being debated on that very issue, and in terms of devolution, the decision will be made there.

On the importance of devolution, which was raised by my hon. Friend the Member for Congleton (Fiona Bruce) and hon. Members for North Antrim (Ian Paisley), for Strangford (Jim Shannon) and for Upper Bann (Carla Lockhart), absolutely, health is a devolved matter and these decisions are devolved for a reason. My plea to MLAs now is the same as when I was on the Back Benches in 2019 and being forced to make these decisions: however fragile the Assembly is, it is important that it keeps going so it can make these devolved decisions. Colleagues have set out clearly the importance of that, which I recognise.

The Secretary of State has said that he is committed to continuing to work closely with colleagues and stakeholders in Northern Ireland. It has always been our position that these services should be delivered locally. I am grateful to all hon. Members. I know that this is a sensitive and difficult issue to debate, but I thank everyone for debating it in such a sensitive and respectful manner. With that, I draw my remarks to a close.

Sickle Cell Treatment

Maria Caulfield Excerpts

Wednesday 8th December 2021 Westminster Hall

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

It is a pleasure to serve under your chairmanship, Mrs Miller. I thank the right hon. Member for Wolverhampton South East (Mr McFadden) for securing this important debate, for all his hard work chairing the sickle cell and thalassaemia all-party parliamentary group and for the report it has put together. It is a crucial report that highlights some of the gaps in the treatment, management and experience of those with sickle cell disease. I also thank the hon. Member for Vauxhall (Florence Eshalomi) for sharing her experience. Hearing first-hand experience of what it is like to have a family member going through a sickle cell crisis and the experience of healthcare is extremely helpful.

Anyone who has read the “No One’s Listening” report cannot fail to be moved by some of the findings. It is such an important issue when we consider that the majority of patients who suffer with sickle cell are black. The tragic death of Evan highlights some of the disparities that are part of this issue. Managing the disease is much more than a physical problem. I thank the APPG and the Sickle Cell Society for the work they have done to shine a light on the challenges facing sickle cell patients. Any failure in care is one failure too many.

I want to reassure all colleagues here that the Government are not just listening; action is taking place right now. I think colleagues will be pleased by some of the changes already made since the report was done, which we want to build on. I am happy to work with the APPG and Members across the House to address the gaps highlighted in the report.

As the shadow Minister, hon. Member for Leicester West (Liz Kendall), said, working with the sickle cell community is vital if we are to address these issues. NHS England is doing that, working with the community to develop a new service. The specifications have outlined a new model of care for the development of 10 haemoglobinopathy co-ordinating centres for sickle cell disease care in England, each leading a network of care and overseeing specialist teams and local centres.

What this means—what many have described in the debate today—is that those specialist centres, which is where patients experience really good care, feel very confident and get great advice, are now able to reach out to local centres and share their experience, so if a patient does not have access to a specialist centre, they can still access that specialist care through their local facilities. That is only just starting, but it is making a huge difference to the experience of patients and in supporting staff, many of whom might never have encountered a sickle cell patient. Some might have, but that might have been a long time ago. Having the support of specialist input is crucial.

In addition, the National Haemoglobinopathy Panel has been set up to run a national multidisciplinary meeting and to provide clinical leadership and co-ordination for those haemoglobinopathies co-ordinating centres, so that patients’ cases can be reviewed by a national group of specialists, and recommendations and support can be fed in.

NHS England also provided funding last year and this year to develop and update a national register—a database of UK patients with red cell disorders. Previously, although testing has been available for babies to identify whether they have sickle cell, that has never been fed into the NHS. With the new register, GPs and hospitals can all identify who in their local communities has sickle cell, and they can start to plan resources and services accordingly. Hopefully, no one will slip through the gaps, and when a patient turns up at A&E they will be identified as a sickle cell patient without having to explain all the issues that they face.

[Janet Daby]

I thank the Minister for what she is saying about the list that will be created for babies. Will there be a similar list of professionals in certain areas who have experience of working with sickle cell patients? The Minister is saying that the list will be set up retrospectively, but it would be good to know what resources are already available.

[Maria Caulfield]

The hon. Member makes an excellent point. The HCCs—the 10 specialist networks that have been set up around the country—will do just that. People will be registered, so that anyone who lives where there is a sickle cell community but no specialist provision is available can feed in and advice can be passed back and forth. This is the start of the process of making that happen in practice. There has not yet been an evaluation because the service is very new, but it is expected that when it publishes the results of its activity a significant improvement in standards will be seen. The results will be used to target areas of concern. We will see where improvements have been made and where improvements still need to be made. Once the service starts to report back, I think colleagues will be pleased with the progress.

The education and awareness of medical professionals was raised by everyone in the debate, and was highlighted in the “No One’s Listening” report. Health Education England has recently made improvements to the medical curriculum in relation to sickle cell and thalassaemia, and now the curriculum has, as core competencies, modules on those. Health Education England has held discussions with royal colleges to ensure that the curriculum is delivered to all four nations.

There are now two e-learning modules with sickle cell content—NHS screening programmes and the maternity support worker programme—and other e-learning programmes on wider areas, such as anaesthesia, radiology and pain management, are also including sessions on sickle cell. We are making some progress on that, but for me, as someone who has worked in healthcare, that education needs to be ongoing. It is great for people to get some education when they are students, but if they do not come across a sickle cell patient for five or six years, that learning might be at the back of their mind. We also need to focus on ongoing education.

NHS Blood and Transplant is working really hard to improve the service experienced by patients. Given that, until recently, blood transfusions were one of only two treatments for these conditions, much work has been done on that. NHS Blood and Transplant submitted, I believe, evidence to the report and described a number of areas in which it is involved that could be improved. Some of that is being worked on right now, including improving matching of more donors of African descent, improving co-ordination of care and improving consistent access to red cell exchange services. Some work is being done specifically on that area.

As has been mentioned by many colleagues, we know that sickle cell disease is particularly common in people with African or Caribbean family backgrounds. Health inequalities are made much worse if someone has sickle cell or has experienced covid, and we know that in maternity, women from black and Asian ethnic groups have disproportionately negative outcomes. I am meeting the Equalities Minister fairly soon to look at the specific areas of health where black communities in particular are disproportionately affected and have poorer outcomes. I am happy to update colleagues—we are very keen to look at those areas—and to work jointly with the Equalities Minister to improve outcomes in those areas.

The Office for Health Improvement and Disparities, launched this October, plans to tackle health disparities across the UK. The NHS Race and Health Observatory has also developed a new evidence-focused remit to tackle ethnic health inequalities, and sickle cell is one area that it is looking at. Coinciding with the launch of the APPG report in November, the observatory appointed a sickle cell expert, Dr Carl Reynolds, to drive forward work in this area. He is reviewing the evidence that contrasts sickle cell care with other rare genetic diseases, to examine the robustness of sickle cell patient care pathways within the NHS. That work will additionally support the work of other organisations and build on many of the report’s findings.

I will just touch on research and treatment. As, I think, the right hon. Member for Wolverhampton South East said, a new drug has been developed, and recommended by NICE, for sickle cell disease—the first in more than 20 years. It is expected to reduce the number of times that a patient will end up in A&E and go through a crisis. Research is vital to develop new drugs and improve treatments, and I want to reassure colleagues that funding is available.

The National Institute for Health Research has £1 billion per year set aside for research, researchers on any condition can apply for funding from that pot. It is often the case that researchers for rare diseases such as sickle cell do not come forward with proposals because there tend to be far more researchers and clinicians for better-known conditions, and far more charities driving researchers forward to apply for research funding. Not only funding, but help and guidance is available. If there is research that clinicians or academics want to do in this area, we are very keen to see them come forward and apply for that funding. If they are not successful, they will receive feedback as to why that was. Funding is available; it is not ringfenced for any particular condition, so researchers on all conditions may apply.

In conclusion, I again thank all members of the APPG for their hard work on behalf of the sickle cell community, but also for their important report, which highlights many of the discrepancies and gaps that sickle cell patients have been facing. Deaths such as Evan’s, simply because of a lack of care and expertise when he was admitted to hospital, are unacceptable, and we want to change that. I think that today’s debate really highlights how much work there is to do

[Bell Ribeiro-Addy]

Before the Minister sits down, there is one point that I do not believe she has touched on—prescriptions. I should be grateful if she would let us know whether the Government have any plans to make prescriptions free for people who require medication for sickle cell.

[Maria Caulfield]

The hon. Member makes a good point. Most patients are probably young, of working age, and have to pay for their prescriptions, but around 89% of all community prescriptions are not paid for—they are free at the moment—and for those with long-term conditions, such as sickle cell, there are the prepayment certificates covering prescriptions for around £2 per week, no matter how many items they have to order. If, say, someone needed three items, that gives a saving of around £228 per year. I know that that does not give free prescriptions, but it is an existing system that patients are often not told about, and it can offer huge savings. I am happy to discuss that with the hon. Member after this debate.

I want to reassure colleagues that a huge amount is being done by the Department to improve the treatment of sickle cell patients. Clear and positive work is under way. It is quite new and innovative, and we hope it will make a difference in a very short space of time. There are still gaps in the provision of services.

[Kate Osamor]

I thank the Minister for the update that she has just given us, but she has not said anything about the bottleneck in A&E. Patients arrive and they are not listened to and not believed. What work will the Government do on that area of hospital treatment?

[Maria Caulfield]

The hon. Member makes an excellent point. There are NICE guidelines on sickle cell, so I will ask departmental colleagues to look at how often they are not followed. The issue was raised about analgesia not being given within half an hour of someone presenting. That is in NICE guidance, and the guideline should be followed in A&E or other areas where patients are admitted. I am happy to look at the prevalence of that not happening and why not. Again, I think that a lot of it is not deliberate. Much of it is to do with the education of staff, who might be in busy A&E departments with lots of people in pain, and they might not realise the impact on a sickle cell patient who does not get analgesia in a timely manner.

[Greg Clark]

On the point about A&E, I welcome, as I am sure colleagues do, the commitment to look at the figures. Given that we have APPG reports, could the Minister perhaps circulate them, through the NHS, to A&E departments to remind them of the current NICE guidance?

[Maria Caulfield]

My right hon. Friend makes an excellent point. I am happy to work with departmental officials to look at how, if the NICE guidelines are there, we can make sure they are distributed so that all clinical areas are aware of them, particularly, as the point was made, to areas where there is a high prevalence of sickle cell that are more likely to see someone admitted to A&E. I am happy to take that forward.

I want to reassure colleagues that progress is being made. I want to place on the record my thanks to all those in specialist units who work really hard behind the scenes to improve the care for sickle cell patients and to get information out to the NHS across the board. Where there are gaps, I am happy to work with the APPG to make sure we address those.

Fibrodysplasia Ossificans Progressiva

Maria Caulfield Excerpts

Monday 6th December 2021 Westminster Hall

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

I thank my hon. Friend the Member for Carshalton and Wallington (Elliot Colburn) for leading us in this debate. It is incredible that a condition that affects fewer than 100 people across the UK has generated so much support, and that is testament to everyone involved. I particularly pay tribute to my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) for always putting his weight behind the campaign, and for sharing the experience of his constituent, Lexi, and the impact that this condition has on her life and that of her family. I also thank the campaigners, and their FOP friends, for their important work in this space, as well as all those across the United Kingdom who are affected. We heard the story of Oliver from the hon. Member for Wythenshawe and Sale East (Mike Kane), and it is through such stories that we learn about the full impact of this disease. This is not just a condition that young children have to live with, because there are ordinary day-to-day things that they can no longer do, and that may worsen their condition or shorten their life expectancy.

We heard from the hon. Member for North Antrim (Ian Paisley) about Zoe and Lucy—the two people we know of in Northern Ireland who have this condition. If nothing else, this debate has highlighted and raised awareness of the condition, and there may be parents out there whose children have similar symptoms and who might now think about pushing for investigations to see whether they are affected. It is important that rare diseases such as FOP get the attention and resources that other more common conditions routinely receive. Although rare diseases, by their very nature, are rare, today we have heard that collectively one in 17 people will be affected by a rare disease at some point in their lifetime. That amounts to 3.5 million people in the UK.

The Government have recognised the issues and challenges faced by people with rare diseases such as FOP. For too long such diseases have been the Cinderella of conditions, and resources have traditionally been targeted to those most affected by other conditions. This Government are the first to change that and to raise the profile of rare diseases, in terms not just of awareness, but also of resources.

As we have heard, FOP is a rare genetic condition when abnormal bone development occurs where bone should not normally grow. It has the most debilitating effects, whether reducing mobility or even leading to respiratory or heart failure. The tragic situation is that although some medication can treat some of the symptoms, there is no effective treatment for the disease, and certainly no cure. We have heard about the effect that the condition has on life expectancy for some of the youngest people in our society. We are not 100% sure of the causes of FOP, because although a genetic mutation happens, we do not know whether it is a hereditary condition. In some cases it is hereditary, but in many it happens spontaneously. There is a huge amount of research that needs to be done, not just on curative treatment, but on understanding the cause. That is what the petitioners have called for today—research into that area. It is frustrating with rare diseases that, in any clinical research, the more people who are affected, the quicker the results are.

[Sir Mike Penning]

I think it is important that I correct the Minister’s point. There is no evidence at all that this is hereditary. The gene is affected at conception. That has been researched, and we know that gene testing can happen. For the record, can we please make clear that this is not a hereditary condition?

--- Later in debate ---

[Maria Caulfield]

I was pretty clear that it happens spontaneously in the cases that we know of. It is a genetic condition, but not necessarily hereditary.

Finding quick answers to research questions requires a large number of people to be involved. The frustrating thing with rare diseases is that they affect so few people that, even if there was a wealth of research, the low numbers mean that research results are often frustratingly slow. That is no one’s fault; it is the nature of rare diseases. That is why the Government have brought in the rare diseases framework. We want to pool resources to bring research into many rare diseases forward.

The Government are committed to increasing spending on research by 2026-27 by £22 billion, moving further on our target of having 2.4% of our GDP in research and development by 2027. We recognise that research is the answer to most of the questions that have been asked today, and we are significantly increasing funding for it. Members of all parties raised the UK rare diseases framework, which is central to our ambition and was launched in January, setting, for the first time ever, four main ambitions for rare diseases.

The first ambition is to get a faster diagnosis. We have heard how important that is for FOP. The longer children have symptoms that are not diagnosed as FOP, the more likely they are to come to harm. Playing in the playground or even coming into contact with people who have colds or the flu can make their condition significantly worse. Getting a faster diagnosis is crucial.

The second ambition to increase awareness among healthcare professionals is crucial. Even something as innocent as doing a biopsy to try and find out the cause can have negative effects. As a nurse of 25 years, I have never come across a case of FOP. I am sure there are many GPs and hospital doctors who will be in the same position. Increasing awareness is crucial.

The third ambition is the better co-ordination of care. There should be a treatment pathway that should be followed by anyone affected by this condition or any rare disease. For me, what is most crucial and will be of the most benefit to parents and those affected by the disease is our fourth ambition: improving access to specialist care, treatment and drugs. We have heard today that there are only three specialists dealing with this condition. It is important to support those who specialise in this. They are the ones who will be asking the valid research questions and who will be able to undertake the research. For me, that ambition is crucial.

Alongside industry, medical research charities and specialists, the Government are funding research into rare conditions such as FOP via the National Institute for Health Research and UK Research and Innovation. The Department of Health and Social Care is investing over £1 billion every year to fund and enable research. I am concerned to hear that campaigners and FOP Friends are not finding that the specialist centres can access that funding. In the past five years, the NIHR has funded one study into FOP at its biomedical research centre, which has specifically looked at the potential for repurposing saracatinib, an ovarian cancer drug, to see whether it will work with this condition.

Seven other studies relevant to FOP are also being funded. If those working in this field are not able to access funding for their research projects, the Clinical Research Network offers a flexible package of free support to help plan, place and successfully deliver clinical research in any field of rare diseases. I am happy to meet campaigners and specialists if they are not getting access to that support, because it is available to them.

[Sir Mike Penning]

The Minister has taken the words right out of my mouth. Will she and specialist civil servants in her Department meet the campaigners? Not a huge group—just a few people to come together to work out how they can get access and make a successful bid so that the children can get the help that they need?

[Maria Caulfield]

Absolutely. I would be very happy to do that. Part of this will probably be the co-ordination of what funding, help and support there is for researchers, and then bringing the researchers together.

I reassure those who signed the petition that the NIHR does not ringfence funds for research. The fund is open to everyone, whether they have one of the most common diseases in the country or one of the rarest. The £1 billion research fund is available to all, and funding applications are available for any aspect of human health. When applications come forward, they are subject to peer review, so research colleagues look at it and judge it, with awards being made on the basis of clinical need—clearly, today we have heard of a clinical need that exists—the value to healthcare services, value for money and scientific quality, so there is no barrier to people applying for the funding.

Since 2010, the Medical Research Council has contributed funding to three projects underpinning relevance to FOP and underlying conditions as well—a total of £6.6 million. Outside those studies, UKRI and NIHR have also looked at supporting musculoskeletal health, which, although not directly FOP-specific, will have relevance to that condition.

[Andrew Selous]

I just want to take the Minister back to a point she made a moment ago about the trials for new drugs being limited to a very small number of people because FOP is a rare disease. I wonder what the solution to that is. Do we try to get people with FOP all the way around the world to participate in a trial? I am not sure how many people would be needed for a trial for it to be validated by the Minister’s Department. There were 107 in the trial that I mentioned, which I presume is too small. I wonder how we overcome that when in each individual country there are only a very small number of people to do the trials on.

[Maria Caulfield]

Absolutely. Just to be clear, it is not the Government who would validate the trials; it would be the scientific community. If it is drug-related, the Medicines and Healthcare products Regulatory Agency would go on to change licences if it found a treatment that was applicable to FOP. In many conditions with such low numbers, often there are global studies, and the funding would not be restricted to a UK-based study. If it was part of a global study, I am sure that that would be acceptable. That is why it would be helpful to meet so that the support and mentorship available to researchers who are thinking of applying for funding could bottom out some of those issues.

I want to reassure colleagues who raised concerns that rare diseases are being pushed up the agenda. The rare diseases framework that was published in January is the first of its kind, and should reassure parents and children with FOP that this is an absolute priority. For too long, rare diseases, because numbers are low, have not had the significance, priority and attention that more common diseases with lots of campaigners and patients have had. The framework will push this to the top of the agenda.

The second reassurance I can give is that funding is available; there is £1 billion per year for clinical research across the board. Just because it is a rare disease does not exclude FOP from these funds. From a practical point of view, it does make research harder, as my hon. Friend the Member for South West Bedfordshire (Andrew Selous) highlighted. However, this does not mean that FOP researchers cannot apply for these funds; there are other criteria that are applied to low-volume scenarios.

Thirdly, I want to reassure Members that clinical research is happening. There are one or two studies that have taken off in this area; often that is the catalyst that needs to happen. I am hearing from colleagues across the House, who have constituents who are affected, that there is a desire to do more research. Very often, this desire is what is needed more than anything to find the researchers who want to do the research and have research questions—whether those are about diagnosis, treatment, or, ultimately, a cure. The funding is there to help support that, and there is practical help and support to bring those studies to fruition. Let me reassure colleagues that, as the Minister, I believe that research is the answer to many of the questions that have been asked today. I am very aware of how distressing this condition is, and the impact that it has on both the quantity and quality of a young person’s life. The Government are committed to ensuring that all rare diseases get better access to the resources that are there. With particular regard to FOP, I am sure that we can work with colleagues across the House to deliver answers to some of the questions they have asked today.

Oral Answers to Questions

Maria Caulfield Excerpts

Tuesday 23rd November 2021 Commons Chamber

[John Spellar (Warley) (Lab)]

7. What assessment he has made of the viability of the community pharmacy sector.

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

The community pharmacy contractual framework outlines a transformational programme of work to integrate community pharmacies into the NHS, delivering more clinical services and making them the first port of call for many minor illnesses. The framework commits £2.5 billion annually to the sector to support that ambition.

[John Spellar]

That is a welcome response from the Minister, and shows that she and the Department now seem to recognise our pharmacies for their magnificent efforts during the pandemic, providing frontline primary care and delivering and encouraging vaccination. Will she further recognise their expertise and dedication, and push rapidly forward with integrating pharmacies into the delivery of primary care—thus also, of course, easing pressure on GPs and hospitals?

[Maria Caulfield]

The right hon. Gentleman will find no greater supporters of community pharmacists than this Government. That is why we launched the community pharmacist consultation service, where GPs and NHS 111 can refer patients directly to pharmacy services. We now see pharmacies dealing with minor ailments such as sore throats, coughs and colds, providing the new medicines service and providing public health services such as weight management and stop smoking services. We place on record our thanks to all in community pharmacies.

[Rob Butler (Aylesbury) (Con)]

Community pharmacies in my constituency have played a crucial role during the pandemic, not least in providing vaccines, as at Hughenden Valley. Will my hon. Friend join me in thanking them, as well as the pharmacists working in GP surgeries such as Meadowcroft surgery in Aylesbury, which I visited last week? Their growing role in primary care is an important part of our efforts to improve the health service and ensure that patients get the best possible care.

[Maria Caulfield]

My hon. Friend makes some excellent points, and I put on record again our thanks to community pharmacists and all community pharmacy teams. During the pandemic, more than 1,500 community pharmacy-led covid vaccination sites have been set up, delivering 15 million covid vaccinations so far, and this winter more than 3.8 million flu vaccines have been delivered through community pharmacies, which shows that they are leading the way in primary care.

[Dave Doogan (Angus) (SNP)]

The role of community pharmacies across Angus and Scotland during the pandemic cannot be underestimated. The way they were able to alleviate pressure on clinical services and the wider NHS must be noted. That is why the Scottish Government have introduced their NHS Pharmacy First Scotland service, backed by £7.5 million last year and going up to £10 million. Can the Minister assure me that the lessons we have learned in Scotland are accepted by Whitehall, and would she like to come to see the lessons we have learned in Scotland? I would be happy to accompany her.

[Maria Caulfield]

As I have said, this Government are leading the way in England in the way community pharmacies are transforming services in primary care. That is why we have the new medicines service, where patients with conditions such as asthma and high blood pressure or who are on blood-thinning medication are able to go and see their pharmacist as a first port of call in managing their medication. We will be expanding those services and are in discussion with community pharmacists about how we take that forward.

[Jane Hunt (Loughborough) (Con)]

8. What steps his Department is taking to roll out the covid-19 vaccination to 12 to 15-year-olds.

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[Gordon Henderson (Sittingbourne and Sheppey) (Con)]

13. What recent steps he has taken to help ensure that everyone in Sittingbourne and Sheppey constituency has access to a GP.

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

The Kent and Medway clinical commissioning group has informed us that all practices in the area have open lists and are accepting new patients. It has also informed us that practices in Sittingbourne and Sheppey are being prioritised for support to help them manage the high levels of demand they are currently facing.

[Gordon Henderson]

I think the Minister has been misled by my local CCG. I can tell her that all the GPs in my area are oversubscribed and people are finding it very difficult to get an appointment with their GP, even including a virtual appointment. Indeed, some patients struggle even to speak to a receptionist, because the phones are engaged for hours on end. I understand that the NHS is planning to give GPs an upgrade of their telephone systems, but such upgrades will be of no use whatever unless doctors have the resources needed to recruit and train additional receptionists to answer the phones. What assurances can my hon. Friend give me that GPs will get those resources?

[Maria Caulfield]

We recognise the difficulty that patients have had in particular with telephone access and GPs have fed in that phone lines have been busier than ever. That is why the Secretary of State, through the winter access fund, has addressed the issue in two ways: the availability of the cloud-based telephone system that GPs and primary care networks can be a part of, which will help to build their telephone capacity; and the £250 million winter access fund, which GPs can use to either recruit more telephone receptionists and train up existing telephone receptionists or build up more resources. I am very happy to discuss that further with my hon. Friend.

[Jill Mortimer (Hartlepool) (Con)]

T1. If he will make a statement on his departmental responsibilities.

--- Later in debate ---

[Sarah Green (Chesham and Amersham) (LD)]

Women across the country have lost jobs and life savings as a result of chronic pain and disability caused by complications after the use of medical mesh. Many, including one of my constituents, have had to pay for corrective surgery overseas. The Government have so far refused to set up agencies to provide financial redress, as was recommended in the Cumberlege report. Will the Secretary of State revisit the Cumberlege report, and in particular the need for financial redress?

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

Women who have suffered are being helped and supported through the difficult choices that they are having to make. The Government have set up eight specialist mesh centres across the country to provide them with the specialist treatment that they need. Our priority is patient safety, preventing anything like this from happening again, and supporting women who have been affected. There is no evidence that a redress system would improve patient safety or improve the outcome for those women.

[Andrew Selous (South West Bedfordshire) (Con)]

T8. As ear syringing is no longer being undertaken in local surgeries, and as self-care does not work for many people, will the Government make sure that microsuction is at least available in every primary care network area? Otherwise, we are leaving people to go deaf.

[Maria Caulfield]

Local commissioners are responsible for meeting the health needs of their local population and should continue to ensure appropriate access to ear wax services. However, should a CCG not routinely commission ear wax removal or the suction method that my hon. Friend refers to, a patient can request an individual funding request. I am happy to help my hon. Friend if that is not happening locally.

[Andrew Gwynne (Denton and Reddish) (Lab)]

Cancer targets are not being met. This September had the worst figures on record for both the 31-day and the 62-day targets; the 62-day target has not been met since 2015. Extra funding is welcome, but where is the detailed implementation plan that was promised to follow?

[Maria Caulfield]

I reassure the hon. Gentleman that cancer has remained an absolute priority for the NHS during the pandemic, as it will continue to be. The funding that has been awarded to deal with long-term electives includes funding for cancer referrals. Some amazing work is being done by our cancer alliances, which are looking to deal with the urgent backlog that has developed during the pandemic.

[Mr David Davis (Haltemprice and Howden) (Con)]

T9. In the next week or so, the Secretary of State will receive the Goldacre report on maximising the use of data in the national health service for both research and operational reasons. The Department has failed dramatically, a couple of times in the past decade, to maximise the use of this enormously important resource. Will he undertake to read the report, consider carefully the policies in it with a view to implementing them quickly, and publish it before the end of January?

--- Later in debate ---

[Sir Robert Neill (Bromley and Chislehurst) (Con)]

T10. I refer to my interest as chair of the all-party parliamentary group on stroke and as the husband of a stroke survivor.Mechanical thrombectomy can be a game-changer for sufferers of strokes, greatly reducing the levels of disability they are left with. NHS England committed itself to a full roll-out of mechanical thrombectomy availability by 2022, but we are lagging seriously behind. Where are the plan and the investment to bring the programme back up to date and on track?

[Maria Caulfield]

I know that my hon. Friend has a personal interest in improving stroke services. I can reassure him that the national stroke service model was published by NHS England and NHS Improvement in May this year, and that as of 1 April there are 20 operational integrated stroke delivery networks, bringing together key stakeholders to improve the diagnosis, treatment and rehabilitation of those who have suffered a stroke.

[Daisy Cooper (St Albans) (LD)]

Ambulance response times are at their highest since records began. A month ago, on 22 October, I tabled a parliamentary question asking the Secretary of State how many ambulance trusts had moved into level 4—the level at which potential failures creep into the service. I am still awaiting an answer. Will the Minister answer that question today, please?

Automated External Defibrillators: Public Access

Maria Caulfield Excerpts

Thursday 18th November 2021 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 Hollobone. I thank the hon. Member for Strangford (Jim Shannon) for securing this debate, and also for his passion and dedication in championing this cause. He will know of my interest in the subject before I became a Minister. If anyone can get these changes through, it will be him. I thank him for that. I also thank my hon. Friend the Member for Sedgefield (Paul Howell), who is the No. 2 in these proceedings.

This is such an important issue. Twelve young people a week in this country die from sudden cardiac arrest. As we have heard, there are 30,000 cardiac arrests a year. This is not an insignificant issue. Behind every single one of those people is a family and a community. As we heard from my hon. Friend the Member for Newcastle-under-Lyme (Aaron Bell) when he spoke of the tragic news of Sam Benson, the impact will last forever.

I reassure hon. Members that the treatment and prevention of cardiovascular disease and access to defibrillators is a priority for the Government. There has been some significant progress in the last two years. We know that about 90% of sudden cardiac arrests are fatal, but if a defibrillator is used in the first three to five minutes, survival can be around 50% to 70%. Again, it makes a significant difference if someone has a sudden cardiac arrest out of hospital.

The Government are supporting a number of measures and working with key stakeholders. I want to highlight some of the work being done to ensure the best possible access to defibrillators and that people feel confident to use them. Hon. Members may be aware that “The NHS Long Term Plan”, published in January 2019, includes a section on cardiovascular disease and defibrillators. The NHS has committed to developing a national network of first responders and access to automated external defibrillators, which will save roughly 4,000 lives a year by 2028. It is high on our agenda, but it is important that we deliver on it now. I think that is the key message from the hon. Member for Strangford, because the chance of survival from a cardiac arrest occurring out of hospital doubles if someone received CPR or defibrillation, so it makes a difference.

I will highlight some of the work that has been done, notably with the British Heart Foundation, which a number of Members have mentioned today. We have worked with the British Heart Foundation to put in place The Circuit, a national network providing evidence of where defibs are in all our communities. If someone calls 999 or contacts the emergency services, ambulance services can identify for them where their nearest defibrillator is.

The Circuit is now live and covers 10 ambulance services, including Scotland, Wales and Northern Ireland. It is working with the two remaining ambulance services, London and South East Coast ambulance services, to get them on to the system. We expect that to happen in the first half of next year. That means all our ambulance services will be able to direct people to the nearest defibrillator ahead of the ambulance attending to the person in need. Currently, 33,237 defibrillators are registered with the eight live ambulance services in England, so we now have a network that we can direct people to.

Although defibrillators do not yet need to be legally registered with the British Heart Foundation, we are working with manufacturers, stakeholders and partners to promote the registration of all defibrillators. My ask of colleagues here this afternoon and anyone who is watching is please to register a defibrillator with the British Heart Foundation. Please do check it is on the register, because it is crucial that the ambulance service can give directions to the nearest defibrillator if someone has a cardiac arrest. We can also ensure that existing defibrillators are managed and looked after and that the register is a live register. We all know that things happen in our communities—defibrillators can be vandalised, or a building can be taken out of use and the defibrillator goes with it. It is important that this is a live piece of work.

The NHS is also working with St John Ambulance. Again, a number of Members have mentioned its excellent work to increase the importance of CPR. It is true that although people do not need training in order to use a defibrillator—my hon. Friend the Member for Sedgefield put it well—it is about educating them so that they are confident in using them. I want to reinforce the message that no harm can be done with a defibrillator; simply stick the stickers to someone’s chest, turn the machine on, and it will tell us exactly what to do. In some cases, it will not be appropriate, in which case it will say exactly what will happen. It is a valuable piece of kit; almost idiot-proof, in that you cannot get it wrong. We want to give the public the absolute confidence that if they come across a defibrillator, they should feel free to use it, but that overall CPR training is also vital.

[Paul Howell]

Just to clarify the point about a defibrillator telling someone if it will not work, it actually will not work as a machine if it is used in the wrong way.

[Maria Caulfield]

My hon. Friend is absolutely right. That gives people added reassurance that they can do no harm, because the machine is totally in control.

We are also using technology, and there are some exciting apps—the hon. Member for Delyn (Rob Roberts) talked about having apps. Some mobile technology works with the NHS to help people play a role in becoming first responders. If people know how to do CPR—the hon. Member for Gordon (Richard Thomson) seems to be trained up in that—I encourage them to use the GoodSAM app, which allows members of the public who can do CPR and feel confident about using a defibrillator to receive alerts. If someone collapses in the local area, they will get an alert on their phone, which will tell them where the nearest defibrillator and the person who needs help are. It integrates with ambulance dispatch systems and has a crowd-sourced map of defibrillators, including those in vehicles. The platform now has more than 19,000 volunteers and partnerships with 80 organisations, including the NHS and ambulance trusts.

We are also reassured that the British Heart Foundation is developing an app. It will link to The Circuit and show people where their nearest defibrillator is. Technology is being used to help communities to help themselves.

[Rob Roberts]

On a different but related subject, in this place and in the main Chamber, the Pensions Minister, our hon. Friend the Member for Hexham (Guy Opperman), has talked about how he is working with the BBC and other broadcasters to do some kind of nationwide campaign to raise awareness of pension credit. Is that something the Department of Health and Social Care could work on for this subject?

[Maria Caulfield]

The hon. Gentleman makes an excellent point. Some of the developments have been over the past two years and, during covid, they have not necessarily had the publicity they deserve. We all have a role in promoting initiatives. There is work to be done so that people are aware of the apps and initiatives.

In our communities, defibrillators are available at airports, shopping centres, train stations and community centres. School-age children are at low risk, but it can still happen, as I said earlier. As a result, and thanks to the work of the Oliver King Foundation, huge pressure was placed on the Department for Education, so defibs are now available for schools and other education providers across the UK to purchase through the NHS supply chain. They can get those important pieces of equipment at reduced cost. As of January this year, more than 5,000 defibs had been purchased through the defibrillators for schools programme, so we are getting defibs out into our schools.

Since May 2019, the Government have required all new and refurbished schools in Department for Education school building programmes to have at least one defib in their buildings. We are pushing that out for new and refurbished schools, but that does not cover all schools in the network.

[Graham Stuart (Beverley and Holderness) (Con)]

To get defibrillators into the community, I established the Community Access Defibrillators for East Yorkshire campaign. I formed a committee and worked with the highly estimable Warren Bostock of the Yorkshire ambulance service, challenging him with the question: “What would a complete network look like?” His initial response was, “How long is a piece of string?”, but he came up with rules and a map showing all the communities that did and did not have defibrillators—60-plus did not—and over the past two or three years we have been working on that. We now have that figure down to fewer than 20 and hope that in the next 12 months we will have it down to zero. Colleagues might be interested to hear the history of that, to get a template that can be applied elsewhere. If we have clarity about where we ought to have defibrillators, we can ensure that we have them there. In parallel, if we work on awareness and confidence, as discussed, we could save even more than the 4,000 lives that the Minister so rightly highlighted earlier.

[Maria Caulfield]

I thank my hon. Friend for his hard work in his community. There are some excellent examples of where defibrillators have been rolled out. Many communities now have them, but if we have them mandated in public buildings, we can address the gaps outside them with excellent work such as my hon. Friend’s. That is the point that the hon. Member for Strangford is making with his forthcoming private Member’s Bill.

We are also providing training, and CPR training is so important. From September of last year, all state-funded schools have been required to teach first aid as part of the new subject of health education, which was introduced alongside relationship education. Primary school children are taught basic first aid now, and pupils in secondary schools are taught further aid, such as administering CPR and the purpose of defibrillators, so hopefully the next generation will be far more confident than perhaps we are in performing CPR and using defibrillators.

Separately, Sport England has announced that it is working with the Football Foundation in support of the Premier League initiative to put £3 million into providing defibs for grassroots football clubs. A number of people mentioned Christian Eriksen. We also had the case of Fabrice Muamba in 2012. Very often in sports facilities, these are crucial pieces of kit that can save lives. We heard about the supporter at Newcastle who also benefited.

This is an incredibly important issue. I want to reassure the hon. Member for Strangford and all hon. Members here today that we absolutely take it seriously. It is an absolute priority to improve the lives and healthcare outcomes of people who suffer cardiac arrest outside a hospital. I hope that the work in the last two years, although perhaps it is not as well known, as the hon. Member for Delyn points out, shows that we are making key progress in some of the really important areas. But there are gaps in provision. We have heard that what matters is not just where defibs go but that they are outside, with 24-hour access. There are tricky issues such as whether to have a code on a defib. All these things need to be nailed down. I am happy to work with colleagues. This work does not involve just the Department of Health and Social Care; some of it needs the Department for Levelling Up, Housing and Communities, the Department for Education, or the Department for Digital, Culture, Media and Sport. It is a cross-Government approach, and I am happy to work with Members to bridge any gaps that still exist.

Health and Social Care

Maria Caulfield Excerpts

Monday 15th November 2021 Ministerial Corrections

The following are extracts from the debate on the Second Reading of the Menopause (Support and Services) Bill on 29 October 2021.

[Maria Caulfield]

The Under-Secretary of State for Work and Pensions, my hon. Friend the Member for Mid Sussex (Mims Davies), is hosting a roundtable with organisations including the British Chambers of Commerce and the Federation of Small Businesses to improve support for and understanding of the menopause, which will make recommendations to Parliament in November… The Women and Equalities Committee, chaired by my right hon. Friend the Member for Romsey and Southampton North, is about to hold an inquiry on menopause and the workplace. I look forward to its recommendations…I wish briefly to touch on the women’s health strategy, because I mentioned it in the debate last week. It will be published towards the end of the year.

[Official Report, 29 October 2021, Vol. 702, c. 538.]

Letter of correction from the Under-Secretary of State for Health and Social Care, the hon. Member for Lewes (Maria Caulfield)

Errors have been identified in my speech.

The correct information should have been:

[Maria Caulfield]

The Under-Secretary of State for Work and Pensions, my hon. Friend the Member for Mid Sussex (Mims Davies), is hosting a roundtable with organisations including the British Chambers of Commerce and the Federation of Small Businesses to improve support for and understanding of the menopause, which will make recommendations to the Department for Work and Pensions in November…The Women and Equalities Committee, chaired by my right hon. Friend the Member for Romsey and Southampton North, is currently undertaking an inquiry on menopause and the workplace. I look forward to its recommendations…I wish briefly to touch on the women’s health strategy, because I mentioned it in the debate last week. We are aiming to publish it towards the end of the year.

[Maria Caulfield]

For a woman currently prescribed HRT on a three-monthly interval, moving to a 12-monthly repeatable prescription will make a saving of £66 a year.

[Official Report, 29 October 2021, Vol. 702, c. 539.]

Letter of correction from the Under-Secretary of State for Health and Social Care, the hon. Member for Lewes (Maria Caulfield).

An error has been identified in my speech.

The correct information should have been:

[Maria Caulfield]

For a woman currently prescribed HRT on a three-monthly interval, moving to a 12-monthly repeatable prescription will make a saving of £56.10 a year.

Medical Cannabis: Alleviation of Health Conditions

Maria Caulfield Excerpts

Thursday 4th November 2021 Commons Chamber

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

I congratulate the hon. Member for Inverclyde (Ronnie Cowan) on bringing forward this debate. As has been said, this is the second day in a row that we are debating this important issue, and I appreciate the depth of feeling on it. I know there are many Members who wished to speak today but who have not been able to, including the hon. Member for Gower (Tonia Antoniazzi) and my hon. Friends the Members for Dover (Mrs Elphicke)—Teagan Appleby is her constituent—and for South Derbyshire (Mrs Wheeler).

As I said yesterday, I have huge sympathy for the issues, problems and struggles that patients and their families are facing. They are trying desperately to access these drugs. No one wants a resolution to this more than me and the Secretary of State, who, as has had been said a number of times, changed the law when he was Home Secretary to try to resolve this situation.

Yesterday, I confirmed the Government’s absolute commitment to take an evidence-based approach to unlicensed cannabis-based products for medicinal use in order to ensure that there is evidence that they are effective but also safe. A number of colleagues have asked why the Government cannot accept non-randomised controlled trials as evidence. The Government are not involved in the process of licensing the medicines; that is done by the independent regulator. The Government’s responsibility is in changing the law, which has already been done, but I very much take the point that we should be able to influence the speed at which the licensing process can take place. I will point out in my remarks how we are doing that.

I am willing to work with colleagues across the House, whether that is the hon. Member for Manchester, Withington (Jeff Smith), with his private Member’s Bill, or SNP Members. This is a non-political issue that we want to see resolved, but the Government are not the body responsible for licensing medication or assessing the worthiness of the research, whether that is randomised controlled trials or any other form of evidence.

Before I set out what is being done, I want to provide an update on the matter of Bedrocan, because the hon. Member for North Tyneside (Mary Glindon), my hon. Friend the Member for Reigate (Crispin Blunt) and the hon. Member for Inverclyde all mentioned it. The commercial agreement between Transvaal Apotheek and UK specialist medicines manufacturer Target Healthcare is progressing, and the MHRA and the Home Office are working with those companies to ensure that all regulatory standards for manufacturing these medicines are met.

On 16 September, the Home Office granted a six-month licence, which will allow Target to move on to testing its equipment and procedures using cannabis from the Netherlands and validating their production of Bedrocan oils. Departmental officials continue to work closely with the Dutch Government, Transvaal, the Home Office and the MHRA to ensure continuity of supply until domestic production can be established, and I will keep the House updated on progress. I hope that is a little glimmer of hope on that issue.

I am aware that there is huge patient demand for access to medical cannabis, and that many are convinced it is helping them with an array of medical conditions from chronic pain to cancer. To date, however, much of the evidence suggesting cannabis could be effective as a treatment is anecdotal. While that has some strength in observational studies, from the regulator’s point of view it often needs more robust clinical data.

There are two licensed cannabis-based products and one synthetic cannabinoid that mimics the effects of THC, which is the element I think most campaigners are looking for. We do have Sativex to treat severe spasticity in adults with multiple sclerosis, Epidyolex for the treatment of two rare forms of epilepsy and Nabilone for nausea and vomiting, so we are making some progress. I hear from campaigners that the THC element remains outstanding. Those products that are licensed are proof that when manufacturers invest in clinical trials, the potential of cannabis as a medicine can be realised. Clinical trials generate the data needed by our world-leading medicines regulator, the Medicines and Healthcare products Regulatory Agency, to assess for safety, and it is then for NICE to approve the NHS funding element of that.

Let me reiterate that this is a multiple-step process. Orkambi has been mentioned; the issue with that was not licensing—it had a licence—but NHS funding. If we get to the licensing stage, the Government can do a huge amount more to fast-track things and be involved in discussions. Licensing, however, is an independent process, and that is the point at which we are stuck.

[Crispin Blunt]

I used that parallel as an example. I totally respect my hon. Friend’s point about licensing progress—of course she is correct—but this is about thinking imaginatively to work our way through the problems to the right solution. That applies desperately in this situation, as it did with Orkambi.

[Maria Caulfield]

Absolutely. The Government are committed to trying to resolve the blockage to licensing, which is the main factor hindering the prescription of these drugs. The Health and Social Care Secretary changed the law when he was Home Secretary, but that was not the end of the issue, and that is why we are taking these next steps. It is important not to dismiss the importance of licensed medication. We know from history that when medication that may have a good clinical effect is not tested thoroughly, there can be grave consequences, just as with thalidomide. The safety of a medicine is as important as its efficacy. I am not casting aspersions on cannabis, but the regulator has responsibility for all medicines, and it takes that issue very seriously.

[Dr Julian Lewis]

That argument would surely carry more weight if the people doing the testing outlined some sort of timeline and plan for concluding a testing programme, rather than apparently letting things drift on aimlessly for years on end.

[Maria Caulfield]

I take my right hon. Friend’s point. I will come on to that, and to timelines for the research that is in progress. Many of the products that we are talking about have not been licensed by any licensing authority across the world, including the Food and Drug Administration, the European Medicines Agency and our domestic MHRA. This is not just a UK problem; it is not the UK Government who are holding this back.

As I said yesterday, I encourage manufacturers of these products to invest in clinical trials. Part of the Department’s work is providing funding for the National Institute for Health Research, which is actively opening its arms to charities, academics, researchers, manufacturers and third-sector organisations. Funding is available for clinical trials, if anyone wants to come forward with one, be it a randomised control trial, an observational study, a randomised control trial without a placebo arm, or a phase 1, 2 or 3 clinical study. The MHRA is willing to provide advice and support to any potential applicants who want to conduct a clinical trial or seek a licence for their medicines. There is funding and support; we need researchers to come forward with clinical trials.

[Ronnie Cowan]

A lot of research institutes are restricted in what they can do because they are trying to access a category 2 product. If it was category 4, life would be a lot simpler for them.

[Maria Caulfield]

The hon. Gentleman makes an excellent point, and going forward we perhaps need to unblock some of the blockages in that area. I take that point on board.

Clinical trials and the licensing process provide evidence and information that doctors rely on to support their treatment decisions. Many clinicians have fed back that they are reticent to prescribe these products until there is more evidence, because ultimately they are responsible for their patients when it comes to a treatment’s safety and effectiveness. Doctors are particularly unwilling, given the THC element of cannabis products; there is some emerging data and evidence of harm, particularly to children, including effects on the developing brain and heart. That is why the evidence base is so crucial, but I am happy—I say this especially to the hon. Member for Manchester, Withington, who sponsors the Medical Cannabis (Access) Bill—to consider what blockages could be unblocked to speed that process up.

Doctors are right to be cautious when prescribing any product if they are not confident in the evidence base. As I said yesterday, I am clear that prescription remains a clinical decision, as does prescription of any medication. It would be inappropriate for the Government to force clinicians to prescribe a medicine, but we will try to unblock some of the licensing blockages.

Let me highlight some of the studies that are starting to take off. This might have been mentioned, but from 1 April we have the establishment of clinical trials for NHS England and the NIHR. We have introduced a national patient registry, which will record patient outcomes, with a view to its being rolled out across the devolved Administrations. It is England-only at the moment. We are aiming to record the data of those who receive the medicines, and to consider side-effects, efficacy and a whole range of issues, in order to support clinicians working with patients, and to start to build an evidence base.

In addition, a randomised control trial is being set up. It has three arms, which will include one arm with CBD or THC, and one arm with a placebo. We expect it to open fairly soon. Those looking to access these drugs—children in particular—will be able to do so in a blinded way and can take part in the study. If the data come through relatively quickly, that will open up opportunities to submit evidence to the MHRA.

[Ronnie Cowan]

Who would offer a child who is on medication that stops them having 100 seizures a day a random test that potentially contains a placebo?

[Maria Caulfield]

I take the hon. Gentleman’s point, but many children are not accessing this medication, and this is a route to that. As I explained in yesterday’s debate, clinical randomised control trials with a placebo arm have extremely strict rules, and if one arm of the study is showing incredible progress and doing better than the other arms, the study must be stopped, patients unblinded, and everyone switched to the arm that is doing the best. In some circumstances, that has enabled people to access drugs under clinical research in a much quicker way. It does have some advantages.

[Christine Jardine]

That is all very well, but it brings us back to the fact that there are children who are already benefiting from the drugs. Even the NHS has asked whether it would not be beneficial to have an alternative trial, such as an observational one, and to use that evidence, rather than having a clinical trial with all these pitfalls.

[Maria Caulfield]

I take the hon. Lady’s point, but the MHRA, which is the regulator, and other regulators around the world have a tier of research that they will accept. The randomised controlled trial method is the gold standard, and the more randomised controlled data someone has, the more likely they are to get a trial approved quickly. Of course observational studies will be used. That is why, if researchers have a large group, want to do observational studies—we heard about the Sapphire clinic from the hon. Member for Inverclyde—and come forward with observational data, I encourage them to speak to the MHRA to see whether that is the sort of research that would be acceptable. It is important that they have those discussions with the regulating body, because it may well accept some of that evidence.

Until manufacturers, researchers, academics and those using these drugs in practice come forward with whatever research they feel would be acceptable and have those discussions, we will go round in a circle. I am keen that if observational studies are acceptable, we support them to happen. Whatever it takes, in research terms, to get a licence through, the Government are there, providing funding, advice and support. However, ultimately, they are not the body that can make that decision; but I think there is a willingness around the House to try to find a resolution.

It will take time to generate further evidence and see the results of clinical trials. The Health Secretary and I are committed to doing everything in our power to accelerate this work. There have been some helpful suggestions this afternoon that we may need to go away and look at.

I thank everyone again. Although this is the second debate on this subject in two days, I know that it will not be the last; the private Member’s Bill will come forward next month. I want to put on the record my commitment to this issue. It is extremely difficult. In yesterday’s debate, we heard constituents’ stories relayed by their MPs, including the hon. Member for Middlesbrough (Andy McDonald). They really are very moving testaments, and we want to find a way forward. We have changed the law, but that has clearly not been enough. We need to find a resolution, so that we can get these medications licensed if the clinical evidence is there, and we need to work with the regulator.

[Dr Cameron]

I know that the Minister is committed to this issue. Could the Government perhaps appoint a lead clinician for this issue, to give clinicians across the United Kingdom confidence, and to drive the issue forward at pace, so that we see movement in the short term?

[Maria Caulfield]

The hon. Lady makes a good point. If there are clinicians who want to take a lead on this, there is obviously scope to look at that, but we must be clear that we have to license and support research for this medicine in the way we would any other. I have given a commitment today to working with hon. Members on both sides of the House to demonstrate how seriously the Government take this issue.

Medical Cannabis under Prescription: Children with Epilepsy

Maria Caulfield Excerpts

Wednesday 3rd November 2021 Westminster Hall

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

I would like to start by congratulating my hon. Friend the Member for South Leicestershire (Alberto Costa) on securing the debate. He lobbies on this issue almost daily, representing constituents such as Maya and Evelina so well. I fully appreciate the strength of feeling and the impact that this issue has on some of the most vulnerable children in their daily struggle with drug-resistant epilepsy. That is why, three years ago, my right hon. Friend the Secretary of State for Health and Social Care, who was then Home Secretary, changed the law to recognise the need to allow unlicensed cannabis-based products to be prescribed by specialist doctors. The Government are supportive and have used many levers, which has been quite challenging at times.

My right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) hit the nail on the head when he said that this is now more a clinical issue than a political one. In many cases, doctors are unwilling to prescribe medicinal cannabis; we heard from a number of Members that we may be down to just one clinician left who is willing to do that. The main reason is that these products are still unlicensed. The way that medicine works in this country is that the Medicines and Healthcare Products Regulatory Agency will license a product after significant research, not just into the efficacy—we have heard from many Members that there is a strong feeling that these medicines work—but into the adverse events and potential side effects. In prescribing these medications, the clinicians will take responsibility both for the drugs working and for any impact of those drugs.

[Sir Mike Penning]

This is the argument that always comes up in the briefings for Ministers. If it is not safe, how are prescriptions being given for free on the NHS? If it is safe, give it to the rest of them. It cannot be right that time and again Ministers use the argument about safety, when prescriptions are given free on the NHS.

[Maria Caulfield]

These are clinical decisions. No one is saying that these products are not safe, but there is not the evidence base to get the licence. The MHRA does this for every single medicine, not just medicinal cannabis.

I want to set out how we can get to a place where we can get these drugs licensed and clinicians will feel confident in prescribing them. We recognise that, for many children, these drugs improve their quality of life—individuals have reported improvements—but without that research evidence base, the MHRA will not give a licence. The MHRA is an independent body—it is not controlled by the Government—and the clinicians will take advice and guidance from it. We may agree or disagree with how the MHRA licenses a medicine, but that is the process for all drugs. It is not just the MHRA—no country in the world has licensed this product. The Food and Drug Administration has not; the European Medicines Agency has not; the MHRA has not. The solution is in pushing the clinical research needed for a licence to be granted, which would open up prescribing for clinicians around the country.

[Andy McDonald]

Do the Minister and the MHRA not recognise that there is an abundance of practical evidence from the families who have scrimped and saved and raised money through charitable activities to fund the administration of the drug, and that it works? Surely that is persuasive. These families have not got time to wait for the research that the Minister is talking about, and I am yet to hear anybody tell me what harm would be done if that drug were to be given to those who need it and want it.

[Maria Caulfield]

There are concerns, particularly around the THC element, that there could be some effect on the developing brain and on heart conditions. Research is needed not just on the effect of the drugs, but on their safety.

I want to point out that the Government have made funds available for good-quality research. That does not have to be done by the manufacturers; it can be done by charities, clinicians or researchers. A range of people can come forward to carry out clinical research. The MHRA—

[Ronnie Cowan]

Will the Minister give way?

[Maria Caulfield]

I will not; I have only a couple of minutes left.

The MHRA is well equipped to provide advice to any applicants wishing to conduct clinical trials.

[Christine Jardine]

Will the Minister give way?

[Maria Caulfield]

I have literally got two minutes left.

Currently, 13 trials are ongoing across the United Kingdom. In the previous 12 months, six of the other trials of cannabis-based products were completed, so some research is coming through the pipeline to help with that evidence base. I want to touch on one—the randomised clinical control trial mentioned by my hon. Friend the Member for South Leicestershire.

It is true that one study has three arms, one of which is a placebo. Having worked in clinical research myself, I reassure my hon. Friend that there are strict ethical guidelines for any clinical research. If someone is allocated to the placebo arm but it is clear when monitoring the research that one arm is doing significantly better than another, the trial has to be unblinded. Anyone on a placebo arm is automatically put on the arm that is doing best. I worked on clinical research for breast cancer, when we were trying to get Herceptin licensed, and for some patients that was the quickest way to get the drug. If there is clear evidence that one arm is working far better than others, patients can be moved on to that arm. It is a way of fast-tracking the drug for licensing.

I reassure Members that I absolutely understand the issue. The Government have changed the law to allow use of medical cannabis, but unless we give clinicians the confidence that the drugs, first, work—a feeling that they do seems to be the consensus in the Chamber—and, secondly, have a safety profile, they will not prescribe them. We can debate it forever in the House, but the clinicians have to be convinced. The way to do that is to get the product licensed, and the way to do that is to get good-quality research that the MHRA can look at to feel confident in licensing that drug.

The Government’s view is that there is funding for such research. My commitment to Members present today is that I will work with other colleagues to see whether we can speed up applications for research, encouraging them to come forward. For many Members, that is not the answer that they wanted to hear; they want me to stand up and say, “The drugs will be available tomorrow and we have people to prescribe them.”

[Ronnie Cowan]

We have to re-categorise cannabis from schedule 2 to schedule 4. That will open the gateway to medical research. Right now, it is hard for a lot of medical researchers to gain access to the product in the first place.

--- Later in debate ---

[Maria Caulfield]

The licensing process is independent of Government, but we have levers to speed that up to ensure that the research coming through the pipeline—I have outlined some studies already in progress—will help the evidence base. We have been here before with other drugs in other sectors and we have manged to get there. We have another debate on Thursday, at which I am sure Members will press me further, but my commitment is that we will use every lever possible to get the research and the licensing process through, so that doctors across the country feel confident to prescribe this medicine, which makes such a difference to young people’s lives.

Endometriosis and Polycystic Ovary Syndrome

Maria Caulfield Excerpts

Monday 1st November 2021 Westminster Hall

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

I thank the hon. Member for Coventry North West (Taiwo Owatemi) for securing the debate, as well as all the petitioners who made it happen. I join everyone in paying tribute to Sir David Amess; I know he would have been here, holding my feet to the fire on what I was going to do about the important issues that have been raised.

Members on all sides of the House have spoken about the challenges faced by women suffering from endometriosis and PCOS. I pay tribute to the hon. Member for Streatham (Bell Ribeiro-Addy), who could not have put it better on not only the struggle for diagnosis, but the trauma of going through treatment. That is not an uncommon experience, unfortunately. There are serious issues to address. As my hon. Friend the Member for Thurrock (Jackie Doyle-Price) said, the conditions affect a significant number of women across the country. We are not talking about a small problem; its effects are on a wide scale.

Members have spoken about the pain, the heavy periods or lack of periods, and the facial hair or hair loss. However, it is about not only the symptoms, but the long-term implications. Fertility is an issue for both conditions, but they also affect relationships, the quality of life and mental health. The effects are wide-ranging.

It is unacceptable that the average diagnosis time for endometriosis is seven to eight years and that 40% of women take 10 or more appointments even to get to the stage of getting tests done and being diagnosed. It is imperative to have a greater focus on women’s health and to address some of those inequalities.

Although hon. Members have rightly said that this is not just about fertility, if it is about fertility for some women, those seven to eight years may be the only chance they have. That is seven to eight years too long. That is why we are embarking on England’s first women’s health strategy, which will set out a new agenda. I can confirm that it will include a section on gynaecological conditions, including endometriosis and polycystic ovary syndrome, and it will look at the research element. In the short time I have, I cannot expand too much, but I will announce more details shortly, because we hope to publish that before the end of the year.

I know that many, many women, men and families will be listening to this debate, and I want to put it on the record that I hear the concerns and issues that are being faced. I have my listening ears on and we will be taking steps to deal with some of the issues. The NICE guidelines on endometriosis are really clear. They list the symptoms that should be picked up and addressed, and that should alert healthcare professionals to the need to refer women, not gaslight them. It is concerning that, despite the NICE guidelines, many women are struggling in the way that they are. For PCOS, the clinical knowledge summary highlights symptoms that should be picked up and that should be flags for referral and care.

I take the point of the hon. Member for Belfast East (Gavin Robinson). We heard from the hon. Member for Arfon (Hywel Williams) that, when there are issues in Wales, women can access services in Liverpool. I am happy to meet the hon. Member for Belfast East to see what options are available for women in Northern Ireland.

In the short time I have, I want to turn to research—the subject of today’s debate. We have a world-class research system, as the vaccine rollout has shown, but we know that women are under-represented generally in research, whether that is older women, women from ethnic minority groups, women of childbearing age or women with disabilities. There is evidence that research is not addressing women’s issues. It is crucial that we have an evidence-based approach to dealing with endometriosis and PCOS because that is how we will ensure that the gold standard of treatment is being followed and that women know what they should expect. That is half the problem: women are in the dark about how they should be treated and their condition managed.

Funding is available. Over the past five years, the National Institute for Health Research has funded £8.52 million of endometriosis research. There is a £2 million trial on peritoneal endometriosis, looking at surgery versus non-surgical interventions to manage chronic pain. There is a study of endometriosis in primary care and the experience of both GPs and patients to see what is going wrong at the diagnosis stage. A practical toolkit has been put together to help patients and clinicians. We are also funding a study interviewing up to 80 women about what it is like to have a urogynaecological condition and the experiences they go through. There is £6.65 million of research into PCOS, including a £2 million randomised control trial looking at fertility options for women whose eggs are not being released from their ovaries.

Research is happening. My plea to researchers is that funding is not the barrier. There is a really robust system whereby research is presented, whether from clinicians, researchers, charities or other organisations, and judged on its merits in terms of what it is trying to achieve. The funding envelope is not the barrier. I encourage those who want to do research to come forward. If that is not happening, I am very happy to work with the APPG to find out where the gaps are and, if the research is not being accepted or funded, where we can do better.

[Barbara Keeley]

The Minister has not yet covered the serious point I made earlier about the backlog in gynaecology. Some 80% of women who are confirmed or suspected to have endometriosis have had their NHS appointments postponed or cancelled because of the pandemic. In my remarks, I quoted somebody who will now have to wait 18 months to two years for her surgery. That is not acceptable.

[Maria Caulfield]

I absolutely take the hon. Lady’s point. In the spending review, money for elective procedures was allocated to clear some of that backlog. People are waiting a long time, and every effort will be made to clear the backlog as soon as possible.

I reassure colleagues that we want to ensure not just that there is an evidence-based pathway for both endometriosis and PCOS in the NICE guidelines, but that it is followed in clinical settings, so that women know what to expect; in clinical education, to improve both undergraduate and postgraduate training, so that clinicians have the knowledge that they need on both conditions; and in primary care, to ensure good robust knowledge among GPs about both conditions, which are not just about bad periods or abdominal pain, and about the referral pathways that should be followed. On school education, it is so important that young women know what is and is not acceptable in relation to both conditions, so that they are pushing GPs rather than waiting seven to eight years for diagnosis or 10 to 12 appointments for an answer.

Research can make a real difference in a number of areas. Before I hand back to the hon. Member for Coventry North West, I reassure colleagues that funding is available. I urge all researchers who want to conduct research in this area to submit applications and bids, because there is no way that we will deal with many of the issues that have been raised today without them.

[Munira Wilson]

Will the Minister give way?

[Maria Caulfield]

I will not because the hon. Member for Coventry North West needs time to wind up.

I reassure people that funding is available, and that I am committed to working with the APPG to ensure that it reaches the places it needs to reach.

Menopause (Support and Services) Bill

Maria Caulfield Excerpts

2nd reading
Friday 29th October 2021 Commons Chamber

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

Once again, I thank the hon. Member for Swansea East (Carolyn Harris) for all her work in raising awareness on the menopause both in the House and publicly. The menopause, for once, has taken centre stage in the press, in Parliament, among the public and, most importantly, among women. The menopause revolution is here.

The menopause is being debated for the second week running, as last week the hon. Lady and my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) secured a general debate to mark World Menopause Month. I believe that this is the first time that the menopause has been debated twice in two weeks. I pay tribute to everyone who has spoken in the debate—both this week and last—including the hon. Members for Pontypridd (Alex Davies-Jones), for Luton South (Rachel Hopkins), for Leicester West (Liz Kendall) and for Liverpool, Wavertree (Paula Barker) as well as my hon. Friends the Members for Stourbridge (Suzanne Webb) for Meon Valley (Mrs Drummond), for Thurrock (Jackie Doyle-Price), for Cities of London and Westminster (Nickie Aiken) and for North Devon (Selaine Saxby). I could go on. Every one of them raised experiences from either their own lives or those of their constituents.

We have heard how important this issue is: it directly impacts 51% of the population, and the effects are wide-ranging and often debilitating. Let us be clear, however, that it also indirectly impacts the remaining 49% of the population. The menopause is everyone’s business. Let me therefore update the House on the work that the Government are doing to break down the taboos and improve menopause care for women. It covers three main areas: healthcare; the workplace; and the women’s health strategy.

On healthcare, we know and have heard many times that people often think the menopause is just a woman’s period stopping and hot flushes starting, but it is so much more than that. There are the night sweats, the fatigue, the unexplained anxiety, the brain fog, the headaches and the insomnia. It is important to break down the taboos surrounding menopause so that women can discuss those symptoms with their healthcare professionals and access high-quality healthcare support.

The NICE guidelines are clear that an individualised approach should be adopted at diagnosis and investigation and in managing the menopause. However, the work carried out earlier this year by the menopause improvement programme found that those guidelines are not being consistently followed, and HRT is often not prescribed despite being a safe and appropriate treatment for most menopausal women. We must ensure that those guidelines are followed.

We have recently made a huge amount of improvement in the workplace. With one in four women in the workplace being menopausal or post-menopausal, it is important that employers create a supportive environment. The Chartered Institute of Personnel and Development, the British Menopause Society and the Faculty of Occupational Medicine among others have provided workplace guidelines, which I encourage all employers to explore. As we heard in the House last week, many employers are starting to lead the way, and I pay tribute to all the businesses that have shown such leadership in the area.

The Under-Secretary of State for Work and Pensions, my hon. Friend the Member for Mid Sussex (Mims Davies), is hosting a roundtable with organisations including the British Chambers of Commerce and the Federation of Small Businesses to improve support for and understanding of the menopause, which will make recommendations to Parliament in November. Flexible working options, whether part-time working or job sharing, go a long way to help women in the workplace. The Government’s consultation on making flexible working the default is currently open, and I urge everyone to respond ahead of the 1 December closing date. The Women and Equalities Committee, chaired by my right hon. Friend the Member for Romsey and Southampton North, is about to hold an inquiry on menopause and the workplace. I look forward to its recommendations.

The NHS is leading the way; with a 77% female workforce, it has many measures in place already. I am pleased to say that the civil service will shortly have a menopause policy in work, to follow the guidelines and support the women in our civil service. I wish briefly to touch on the women’s health strategy, because I mentioned it in the debate last week. It will be published towards the end of the year.[Official Report, 15 November 2021, Vol. 703, c. 1MC.] We had more than 110,000 responses to the consultation earlier in the year, and we found that for those between the ages of 40 to 49 and 50 to 59 the menopause was the key issue, and it will be a priority in the health strategy, when it is published.

This Bill is why we are all here today, and I pay tribute to the hon. Member for Swansea East, because there is no doubt that she has made a difference to women’s lives across the country, with the support of other hon. Members, in all parts of this House. Clause 1 seeks to exempt HRT from NHS prescription charges, which are set out in the National Health Service (Charges for Drugs and Appliances) Regulations 2015. Those regulations apply to England only and are amended annually. They set out the prescription charges payable per drug that is dispensed. The charges apply unless someone is exempt because of age, income or other medical exemption, such as epilepsy. It is common for HRT to be prescribed at relatively short intervals, three-monthly or even monthly, in a minority of cases, and a prescription charge applies each time. As we have heard today, a course of HRT treatment often requires more than two medicines, oestrogen and progesterone, or different preparations—patches, tablets, creams and so on. Sometimes that means that women have to pay two charges, even if these products are supplied in a combination pack or included on the same prescription.

I am pleased to announce that although the Government cannot exempt HRT from prescription charges entirely, we have listened carefully to the argument and, as a result, we will amend the regulations to reduce the costs and improve access to HRT. We will do that by reducing the costs of repeatable prescriptions for HRT for women experiencing menopausal symptoms, so that instead of paying for a repeat prescription every month or every three months, the prescriber can issue a batch of prescriptions for up to 12 months with one signature and one prescription charge. The prescriber will set the interval between the issues of the medicine and the number of times the prescription can be repeated, and of course this will be done on clinical grounds. Repeatable prescriptions can be issued either electronically or on paper.

What that will mean in real terms for women is that where it is clinically appropriate, one prescription charge can be paid per year. For example, where a woman currently takes two hormone treatments, oestrogen and progesterone, and receives a repeatable prescription every month, she pays £18.70 each time, which makes a total of £224 every year. Under the changed system, she would pay just £18.70 each year. That is a saving of £205. [Hon. Members: “Hear, hear!”] I feel like the Chancellor, Madam Deputy Speaker. For a woman currently prescribed HRT on a three-monthly interval, moving to a 12-monthly repeatable prescription will make a saving of £66 a year.[Official Report, 15 November 2021, Vol. 703, c. 2MC.] However, we are going further, as we are also committing to reviewing the double hormone issue. The hon. Lady has made a compelling case for our taking this further, to reduce the cost of living, because it is important that we look at this clearly. I am happy to take that away to look at it further, working with her and other colleagues, and NHS colleagues, to see what progress we can make on that specific issue.

As has been described so eloquently today, the cost of HRT is not the only issue, which takes us on to clause 2. A UK-wide menopause strategy is tough, because health is a devolved matter, and we heard last week about the Scottish Government’s plans for a women’s health plan to address many of these issues. In England, we have our own women’s health strategy, in which the menopause will be at the top of the priority list. However, I recognise that there is work to be done on medical school training, workforce support, access to HRT and other therapies—and just recognising that the menopause actually exists. So today I commit to establishing a new menopause taskforce, with the hon. Member for Swansea East as a co-chair. The taskforce will encourage faster action and join up the dots across the system to take a coherent approach to improving support for those experiencing the menopause. The hon. Member set out in her speech, and we have heard today, that menopause should not be a partisan issue. I hope that she will accept my invitation to co-chair the new taskforce.

I hope that I have reassured hon. Members across the House of the Government’s commitment to this issue. It was telling that the Secretary of State was here earlier to hear these very issues. The Government are committed to reducing the cost of prescriptions, to introducing a menopause taskforce and to making the menopause a priority in the women’s health strategy. I heard the hon. Member on Radio 4 this morning, saying that the aim is to keep women wonderful. As a Conservative and as Government Minister, I probably should not say this, but: up the revolution!