Hormone Pregnancy Tests

Debate between Mike Penning and Maria Caulfield

Thursday 7th September 2023 Commons Chamber

[Maria Caulfield]

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

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

[Sir Mike Penning]

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

[Maria Caulfield]

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

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

Cumberlege Report

Debate between Mike Penning and Maria Caulfield

Thursday 3rd February 2022 Westminster Hall

[Maria Caulfield]

Yes, absolutely. Part of the consultation we will announce shortly will look at international comparisons. One concern we have about some of the no-fault schemes is the caps on the amount of compensation that can be given. I think some countries have a £1 million cap. I am not an expert on how much compensation these ladies should be due, but we want to make sure that, if we set up systems like that—we are not closed to those ideas—they actually address the issues that these specific women face. We will look at those options in the round.

[Sir Mike Penning]

May I press the Minister and draw her back to the Cumberlege report? What she is talking about going forward sounds really good, and the proof will be in the pudding, as my grandmother would have said. But recommendation 4 of Baroness Cumberlege’s report for the Government talks about—this is my word—compensation. That is so important because, as we heard, some of these people have been caring for their loved ones for the last 50 years. They are not going to be here forever, and they feel enormously vulnerable that their loved ones, who they have looked after for all that time, will be left without their needs being met.

This is not all about the ladies who, for instance, took Primodos tablets. It is about the outcomes—in order words, their children, who are living with this today. We quite rightly concentrate when talking about sodium valproate, mesh and Primodos on what happened at the time, but the consequences of that are these people who are now in their mid-50s and 60s. What will happen to them? They will fall back on the state for PIP and other benefits when actually, recommendation 4 says in black and white that the Government should have sorted it out.

[Maria Caulfield]

I thank my right hon. Friend for making that point. Compensation can be claimed now. Our concern about setting up a specific body to oversee that is that that would not address the fundamental problem of why it is difficult to get compensation. However, it is a fundamental right of anyone who believes they suffered from clinical negligence to seek compensation, and we actively encourage that.

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[Maria Caulfield]

If the hon. Lady writes to me about that specific case, I am happy to look at it.

The Government published their response to the review in July last year and accepted the majority of the recommendations for improvement. I want to update Members on those because we are absolutely committed to making rapid progress in all the areas in our response. We have committed to publishing an update on the progress of all the recommendations that we accepted, and we aim to publish that in the summer. If colleagues want to hold my feet to the fire, they will certainly get a formal update in the summer.

We have made strong progress on some of the changes.

[Sir Mike Penning]

It is fortunate that we have so much time because we can ask lots of questions. Marie Lyon, the Primodos campaigner, has effectively been told by the Minister’s predecessor, “See you in court”. I do not know about the experiences of the other conditions, but the Primodos campaigners do not have money. They have the will, but they are completely exhausted. They pinned all their hopes on the Government accepting the report’s recommendations. These people will not get a no win, no fee arrangement or a pro bono. They will have to try to fundraise, and they will, but is that morally right when the baroness’s report and its recommendations, published by the Government, say that they should not have to go through that?

[Maria Caulfield]

Specifically on Primodos, there is pending litigation so it is difficult for me to comment while that is in progress, but, depending on the outcome, the Government will respond to that.

--- Later in debate ---

[Maria Caulfield]

That is why we introduced NHS Resolution to facilitate a quicker method of getting compensation to those who have been harmed through clinical negligence. I encourage hon. Members to look at the work of NHS Resolution. We are doing more to ensure a better experience for patients, but we are fundamentally committed to ensuring that those who have been harmed get the support they need.

[Sir Mike Penning]

The Primodos victims—I am not allowed to talk about the court case—have had no choice. They are in court now because the Government would not take on Cumberlege recommendation 4. It is all well and good talking about what will happen in the future, but they are living with this now. They are in court today. Surely the Government should settle with them now. Like the Minister has said several times, these things get settled out of court. Well, settle with Primodos victims now and they will not have to go through that.

[Maria Caulfield]

I cannot speak on active litigation claims, but between 70% to 80% of claims are settled out of court because that is the avenue we want to go down. It is not in anyone’s interest to go to court. I am happy to keep hon. Members updated. There will be a formal review in the summer, but I am happy to have my feet held to the fire to ensure we deliver on the Cumberlege review for those patients who have suffered.

Fibrodysplasia Ossificans Progressiva

Debate between Mike Penning and Maria Caulfield

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?

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[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.

Medical Cannabis under Prescription: Children with Epilepsy

Debate between Mike Penning and Maria Caulfield

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.