International Health Regulations

Mike Penning Excerpts

Tuesday 14th May 2024 Commons Chamber

[Andrew Stephenson]

The hon. Gentleman makes an important point. I talked about the leadership shown by the UK Government when we had the G7 presidency back in 2021. In addition to the UK supplying vaccines around the world, as of 2022, an estimated 2.7 million covid-19 deaths had been prevented due to the COVAX-supported vaccination programmes in different countries around the world. We need to work internationally. Sharing data can head off future pandemics, and a good accord would deliver the data sharing and collaboration that can prevent future health emergencies, rather than tie the hands of domestic Governments in responding appropriately to such emergencies.

[Sir Mike Penning (Hemel Hempstead) (Con)]

May I say on behalf of the volunteers and others in the vaccination centres around the country during the pandemic, which I had the honour of working in, that the key is that vaccines are available to us before we give them to anyone else in the world? I am listening to what the Minister is saying, but does he agree that collaboration does not mean compulsion in any way or form?

[Andrew Stephenson]

As a volunteer vaccinator during the pandemic, I 100% agree with my right hon. Friend. We have to look after our own people—our own citizens; the people we are elected to represent—first. We are investing heavily in the British life sciences sector to ensure that it is even more prepared for any future pandemic. We are ensuring that we have more domestic manufacturing capability, so that we can have more vaccines ourselves without being reliant on other countries. However, at the point where a new pandemic is emerging in a part of a world far from our shores, we still need to ensure that the data—particularly the pathogen data—is shared early, so that world-beating British companies, whether the tiny life sciences start-ups or the big pharmaceutical companies, can use it to produce the drugs that will hopefully ensure that it does not become a full-blown pandemic and does not cost as many lives as the last one.

Fibrodysplasia Ossificans Progressiva

Mike Penning Excerpts

Thursday 7th September 2023 Commons Chamber

[Sir Mike Penning (Hemel Hempstead) (Con)]

I beg to move,

That this House has considered funding for the prevention of fibrodysplasia ossificans progressiva.

Thank you very much indeed, Mr Deputy Speaker. I am pleased you have pronounced it rather than me; from now on, perhaps we will just use FOP, which is what most people—including the families—call it, but the scientists do not.

FOP is a genetic condition; it is not an illness or a disease, as it is called all too often. It is very rare—one in a million. In this country, about 70 people alive have FOP, including about 30 young people and children. If we replicate that around the world, it is a very rare condition. The condition is probably the biggest nightmare for any parent, or anybody who loves a child.

Let me give an example: I played rugby, and I bruised very regularly. I stopped playing fairly recently, but when I did play rugby, I would bruise. For those who have FOP, there is a good chance that that bruise will turn to bone—skeletally, it will turn to bone. Most of us want our young children to be inoculated, and we have been through an inoculation process during covid, which I was very much involved with, but if someone with FOP has an injection there is a good chance that that trauma will turn to bone. I have circulated privately to the Minister, Mr Deputy Speaker and others some photographs of what that trauma can end up like and does end up like.

I got involved in this issue when a couple came to see me in my constituency and said, “Our daughter has FOP”—as a dyslexic person, I cannot say it to this day, although I have practised and practised. I had no idea what they were talking about. It is a bit like the previous debate: when we first heard about Primodos and the problems with it, most of us in this room had never heard of it. FOP is much rarer than the conditions suffered by the victims of Primodos that we have been talking about, or of mesh, valproate or any of those things, but the effects on those individuals and their families and loved ones are profound.

My constituent said to me that, as a mum, she looked at her baby and thought there was something wrong with her toes. The initial diagnosis from most paediatricians would be bunions—bunions on a new-born baby. My wife has bunions, but it is nothing to do with what she was born with; it is to do with the quality of the shoes she wore as a young lady. She will not mind me saying that, because we have discussed this case before. It is only sometimes, when people get in front of the right expert, that they get the diagnosis for what is a completely incurable, progressive condition and find out what they have. That is what happened with my constituents. There are three consultants in this country who have that capability, and they were lucky that they got in front of one. I pay tribute to the Portland Hospital where the diagnosis took place.

What does this mean for a young person? There are young people in the Gallery this afternoon who have the condition. I think the little ’un has gone home now because she was rather tired, and she helped me deliver a letter to the Prime Minister at No. 10 earlier today. What does it mean for them? It means that their whole life is different. Do we want to wrap our children up in cotton wool? No, of course we do not. Even if they have FOP, do we want to wrap them up in cotton wool? No, we do not, but they have to be extremely careful about inoculations, bruising, sport, and rough and tumble.

My constituents are very lucky. I have a very forward-thinking planning department in my local authority, which used the delegated powers it has to grant planning permission on the green belt—the green belt that I fight to protect in my constituency—so a specialist house could be built for Lexi, and she has the facilities where she can have the safe upbringing she needs. Lots of people were very worried about permission being given in that way because the condition is so rare, and I had people saying to me, “Are you really sure this baby’s got this condition, and is this not just circumventing the planning rules?”. It was only when I circulated some of the photographs, which many colleagues in the House have, that people said to me, “Okay, we get it,” and two of them actually said, “We’re really sorry. We get it.”

Because the condition is very often not visual in the early stages, there is no understanding of it. It is a bit like a mental health condition. We have much better ideas about mental health these days, but when we walk up to someone, we do not know whether they have such a condition. If people go up to Lexi today, they would not know that she has FOP, but they will do in the next few years, when it will become pretty obvious. The interesting thing about FOP is that there is no set plan or rule for it. In some cases it progresses very fast, the bone grows very quickly and the effects on the skeleton, movement and mobility are very quick, but in others there are short bursts of it, while sometimes there is nothing for years and then it will progress again.

Given the reason for this debate—and I apologise to the Minister, to whom I have spoken privately about this—I did not want the Minister for Health and Secondary Care on the Front Bench. I wanted the Minister for Science, Research and Innovation on the Front Bench. It is nothing personal, but this is not an NHS issue. It is a condition that needs scientific expertise in research and trials, which is in the Science Minister’s portfolio. I understand why, as soon as we start talking about anything to do with health, the Health Department goes, “That’s ours,” but on this particular occasion, it is not.

[Liz Twist (Blaydon) (Lab)]

Can I just say that I concur with the right hon. Gentleman’s comments about research and health research? There is a concern about how it is being handled.

[Sir Mike Penning]

I thank the hon. Lady for that intervention.

Earlier, we had a short statement on Horizon, which was excellent in that the Science Minister was on the Bench, and when I asked the Secretary of State a few questions about FOP, he agreed to meet us in short time. The great news is that we will meet the Science Minister. The key to what was announced earlier is that work was being done before covid—and there is work on FOP being done around the world—and there was funding from Horizon for trials on FOP. The big issue was that covid interrupted the trials, not our leaving the EU. I am sure some colleagues will say, “Ah, that’s what it’s all about.” No, it was nothing to do with that; it was covid that affected it. I put that on the record straightaway, and we now have the great situation that Horizon is back on stream.

One of the reasons I wanted to see the Science Minister on the Front Bench was to ask him this question. Perhaps colleagues in his office can elaborate on this before I meet him. The trials were halted because of covid, but have we got to start from scratch again or can we move on with those trials? I am old-fashioned and I used to be called a Eurosceptic, but we are now out of the European Union, so that is great. One of the things that was said is, “Well, you don’t want to co-operate with Europe,” but of course we want to co-operate with Europe. The announcement today on Horizon is a classic example, and the classic example of why we have to collaborate not just with Europe but with America and other parts of the world is that this condition is so rare and we could not do trials here. The scientists in America have a much bigger base on which they are able to do trials, and we need to learn from them and they need to learn from us.

So it looks sensible that we will be back in the European trials, but I am petrified about whether we will have to wait for Horizon to announce bidding on a certain part of the scientific research, and then wait a couple of years for that decision to be made. That is what tends to happen with these projects, but we are already in the middle of the project.

In trying to work out the best route forward—I am not a scientist; I am looking at this as a dad—we need two things. Research is going on into how we prevent the progression of FOP in the bone structure when there are traumas, and whether there is something early on that we can turn off. Is there research out there that can predict that? At the moment there is not, I understand. We have two situations. Can we in some way look at the future and at anybody who, family-wise or genetically, is likely to get this condition? Secondly, if a child has got it, how can we slow down progression? The families here with me today, and those in FOP Friends, would argue that they have this condition so they need help and research now, but we also need research to prevent what is going on genetically.

It also worries me how we need to spread knowledge about FOP around the world, not just in this country. In some parts of the world, almost no FOP babies are born. Just on a law of averages, that is not possible, and it has already been proven that there is no cultural link. Some genetic conditions are linked to what part of the world someone might have come from, but apparently they have already done research on FOP, and that is not the case. What is happening in parts of the world where babies are not born deformed and people do not instantly know. That sort of research desperately needs to be done. Lots of work is being done in Boston and around the world, but it is key that we are back as an associate of Horizon. Can we start not from scratch but halfway through and where we were before covid hit the project?

In a perfect world, we in this Chamber, and the families, would like to be able to press a button, perhaps give a tablet, and stop this progression. It is the most awful thing to be sitting there, waiting for your child to perhaps have a bump, a bruise or a progression. As a group, FOP Friends make sure that everybody talks to everybody. It is better learning from other people who are in the same situation and not having to reinvent the wheel every five minutes. As I said earlier, people are desperate not to wrap their child in cotton wool, and to give them as much of a normal life as possible. Earlier I was talking to the chair of FOP Friends. He was playing badminton with his son who has got FOP, and I think he loses on a regular basis. There are things that can be done, but the problem with the condition is that it is not the same in every child. It will be different in every child, and it is different in its progression.

That is why this debate is so important, and I thank the Backbench Business Committee for agreeing to it. It is not a normal sort of debate. We have had a debate in Westminster Hall on this issue, which has such a dramatic effect on the lives, futures, aspirations and dreams of those families whose lives are affected by FOP. I thought, and my colleagues thought—some of them could not be here today—that we should bring this subject to the Floor of the House, so that we could find out where this research is going.

[Liz Twist (Blaydon) (Lab)]

I thank the right hon. Member for Hemel Hempstead (Sir Mike Penning) for bringing this debate to the Chamber and for all the work he has been doing to raise these important issues within Parliament. It was good to hear such a fulsome and good description of the condition and how people are affected by FOP. As chair of the all-party parliamentary group on rare, genetic and undiagnosed conditions, I am glad to be able to take part in this debate to highlight the issues facing people with FOP.

We have heard from the right hon. Member about just how debilitating this condition is. Usually caused by a gene mutation, FOP is the only known condition where the body changes one organ to another. Bone forms in muscles, tendons and other connective tissues, progressively and irreversibly restricting movement. This severely limits the ability of those affected to perform the most basic tasks of daily life. Children with FOP lose their independence just at the point they should be gaining it. Many of the issues affecting families of children with FOP are experienced by other people across the rare disease communities, including long diagnostic odysseys.

[Sir Mike Penning]

I apologise for interrupting so early in the hon. Lady’s speech; she is generous in giving way. One of the bits that I think I missed in my speech is that FOP is not a disease; it is actually a genetic condition. For the families, that is really important. Americans talk about FOP as a disease rather than a condition, but really and truly it is a genetic condition that someone is born with, rather than something that someone would contract.

[Liz Twist]

I thank the right hon. Member for making that clear. He is right that it is important for the families. Sometimes in this House—even in our APPGs—we use a kind of shorthand about issues to bring people together. FOP is indeed, as he said, a genetic condition.

The rare disease community has some issues in common, including those long diagnostic odysseys. How long do people have to wait for their condition—I will use that term—to be recognised? There is a lack of clinical awareness with many of these conditions and limited treatment options for far too many people.

FOP, as the right hon. Member has said, is perhaps one of the rarest and most disabling of these conditions, with no treatment or cure. Within the rare conditions community, a diagnostic odyssey, as he will know, refers to a common scenario in which delays to accessing the right support and the right treatment—where it exists—can cause irreversible deterioration of an individual’s condition. While there is no treatment for FOP, repeated investigations, such as biopsies, can trigger the condition’s progression. That can be triggered by trauma, too. Furthermore, delayed diagnosis prevents parents from taking action to keep their children safe from situations and activities that could trigger injuries and flare-ups.

Unfortunately, a diagnostic odyssey is the norm for many children with FOP. Getting a diagnosis takes one and a half years on average, and more than half of people with FOP get the wrong diagnosis in the first instance, as we have heard. Despite genetic tests being available, FOP is not included in the national genomic test directory for rare and inherited conditions. Can the Minister explain why it is not included in that directory? What plans do the Government have to change that position?

The real hope for FOP, as we have heard, is new research. Like much of the research into rare conditions, it is likely to have far-reaching benefits for more common illnesses, such as osteoporosis, childhood brain cancer and heart disease. At the moment, the Government are overseeing a decline in research and international life science competitiveness, with commercial clinical trial activity in the NHS declining over recent years. We have heard from the right hon. Member for Hemel Hempstead about the STOPFOP trial, which is supported by funding from the European Union’s Innovative Medicines Initiative as part of Horizon 2020. Is it not ironic that we are discussing this on the day we have heard that we are now in the Horizon programme? Thank goodness we are; it is an important move. However, there have been two years of wasted opportunities and uncertainty for people going through trials and research, such as people with FOP.

I understand that researchers would have to apply for new funding from the scheme to carry on with the STOPFOP trial. How will the Government ensure that funding continues to be available to allow the trials to continue, and to ensure real progress in diagnosing and treating FOP?

As the right hon. Member for Hemel Hempstead said, time really is of the essence if we are not to lose the benefit of the work already done and if we are to give those with FOP, and those who may be born with the condition in future, the best chance of the earliest possible diagnosis and treatment.

[Jim Shannon (Strangford) (DUP)]

It is a pleasure to follow the right hon. Member for Hemel Hempstead (Sir Mike Penning) and the hon. Member for Blaydon (Liz Twist). I thank them for their contributions, particularly the right hon. Gentleman for setting the scene.

FOP is an extremely rare condition, but it is important that the matter is aired in the Chamber and the right hon. Gentleman has done that well. He is probably right that the relevant Minister is not here. That is no disrespect to the Minister who is here—we know that he is an honourable person, who will respond positively within his remit. If another Minister needs to take the matter on board, we look to the Minister who is here to make the case persuasively to them, and hopefully we will get a response.

When the right hon. Member for Hemel Hempstead asked me whether I would come along to support him, I automatically said that I would, because the debate is about a health issue, health is one of my portfolios and I wanted to understand the condition. I have always had a particular interest in rare diseases. Long before I came here, I was a member of the Northern Ireland association for rare diseases. I am therefore particularly interested in the subject.

I will be honest: I knew little about FOP. I had to research it, and the right hon. Member for Hemel Hempstead gave me some pointers. It was so interesting to read about it and to learn how rare it is and how little we know about it. FOP is an exceptionally rare genetic condition, where soft tissue develops into bone, creating a second skeleton. The right hon. Gentleman illustrated the condition clearly when he described the bruise, the bump, the jag or the discomfort. Around 70 known individuals are diagnosed in the UK, and the disorder has been described as impacting “one in a million.” That gives an idea of the rarity of the condition.

The House is tasked with highlighting the issue and raising awareness, and I hope that the debate will do that. As far as I am aware, there are only two known cases in Northern Ireland, and they are twin sisters. I do not have their permission to name them, and I would not do that, but there has been public information about the case.

[Sir Mike Penning]

My hon. Friend has touched on the really important point of the lack of diagnosis. If we know that one in a million children will be born with it, the calculation for the world population is pretty obvious. We are nowhere near identifying the numbers that should be out there. In my constituency and in any other hon. Member’s constituency, there are probably children who have been born with the condition. However, the length of time it takes to get a diagnosis—because the test is not part of the programme—is the most important thing. The condition can be tested for if there is a will.

[Jim Shannon]

The right hon. Gentleman has made a simple request about diagnosis. Perhaps awareness can be raised of the simple test, which it is so important to do. I understand that the twins in Northern Ireland are rightly keen to raise awareness of the issue.

Such rare diseases are often ignored. Most people—including me before this debate—have little or no idea what it is or, more importantly, what we can do to raise awareness. But today we can use our position as MPs to highlight the issue, with the co-operation of the Minister and the shadow Minister. I cannot for a moment imagine what it must be like to grow up with a condition about which there is little or no information, not to mention what it would have been like when the twins were children, when there was no cure or treatment for the condition.

Early and correct diagnosis is key to changing the life of someone suffering with FOP, as the right hon. Gentleman said. This debate is a request for hope and for progress for our constituents. The purpose of this debate is funding, with the hope of a potential trial of the existing drug Saracatinib, originally developed by AstraZeneza as a cancer drug. The underlying issue is that if the STOPFOP trial is not completed, the money spent on it will be wasted. Given the progress of trials and the advancement in medication, it is right that every effort should be made to try to find that money to ensure that the investigation into that treatment takes place.

[Sir Mike Penning]

Like all clinical trials and all things in health, there are other things the trial could help with. I am not a scientist, but it has been put to me that while we are looking at clinical trials into FOP, there may be help for osteoporosis—brittle bones—and skeletal damage, particularly that suffered by the military. Even though we are talking about a tiny percentage of the population with FOP, the population with brittle bones is huge. It seems that there is very little cure for it apart from taking calcium tablets. If we get the principle right on what is causing the bone growth, perhaps the research can be extended past FOP and we can help millions of people in other areas.

[Jim Shannon]

The right hon. Gentleman is absolutely right. Whenever trials take place there are always benefits, although perhaps not the intended ones. None the less, the focus can be larger, whether it be brittle bones or whatever. What was originally a cancer drug has been found to be beneficial to those with FOP.

As initial funding for the trial is running out, the main asks are to ensure that additional funding is allocated, while ensuring that secured funding extends to allow the trial to include children, especially the screening of new-born infants—as the right hon. Gentleman has referred to. Many have said that early and correct diagnosis is key to changing the life of someone with FOP, so I cannot imagine how the trial could not extend to newborns and extremely young children.

Raising awareness is how we will improve treatment for the condition. I have been made aware that there are only three knowledgeable FOP clinicians in the whole of the United Kingdom of Great Britain and Northern Ireland. That leaves patients often finding themselves treated by doctors with little or no FOP knowledge, which is rather disappointing, but focuses attention on those three clinicians. Like other conditions, patients must battle to be heard. Being aware of what to look out for is crucial: shortened or turned-out toes in young children raise concern, but if combined with tumour-like swellings, FOP is almost certain. It has also been raised that many patients are given biopsies and misdiagnosed with cancer. Others have had limb amputations, which perhaps was not the right way forward, but a response to not being quite sure what the problem is.

Having better access to a wider pool of experts would make a huge difference in diagnosing and treating people correctly. The charity FOP Friends, based in Oxford, is fantastic at supporting families. I have also seen some of the social media pages of parents of children who have FOP. Their work is absolutely incredible.

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[Sir Mike Penning]

I thank the hon. Gentleman for giving way—thank goodness we have plenty of time to debate this issue. As he alluded to, there was a petition on social media, which was signed by well over 100,000 people. The Government’s response—I should have mentioned this to the Minister—is that they have funded research into FOP, but I am afraid that does not appear to be the case. They have funded research into rare diseases, not FOP. That is probably crucial when it comes to the public’s belief in what we do in this place.

[Jim Shannon]

The Minister took note of what the right hon. Gentleman said, so I have no doubt that there will be a response. The Minister has a genuine interest in the subject and I hope we will all be encouraged by what will have been said.

The parents are the main drivers of the campaign and the effort going into it is truly incredible. Many different people are making an effort with FOP Friends, whether the families, clinicians, those involved in clinical trials, ourselves as Members of Parliament, and, ultimately, the shadow Minister and the Minister.

To conclude, I thank the right hon. Member for Hemel Hempstead again for raising this issue with us today. He speaks so highly of his constituents. He does it all the time, by the way, but he did it again today. He has indicated to me that he is not running for Parliament again. We will miss his constant and compassionate commitment, interventions and speeches in this Chamber. He does not always do what his party wants him to do, but he always does what is right and that is what I admire about him as an individual.

It is important that we do all we can to help those with this condition to cope. We must do more to fund research into this trial. I sincerely look forward to hearing about developments in the future. To give those with FOP a better quality of life just like the rest of us, we need the Government and the Minister, from whatever Department, to help deliver just that.

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[Karin Smyth (Bristol South) (Lab)]

It is a pleasure to be here this afternoon. I thank the Backbench Business Committee for granting the debate and pay tribute to the right hon. Member for Hemel Hempstead (Sir Mike Penning), who secured it and who has tirelessly campaigned on this issue with his constituents and the charity FOP Friends, who I understand have joined us today in the Public Gallery. I pay tribute to the families’ tenacity and bravery in raising the profile of this rare condition, and in continuing to do so. I also thank my hon. Friend the Member for Blaydon (Liz Twist), the hon. Member for Strangford (Jim Shannon) and the hon. Member for Inverclyde (Ronnie Cowan) for being here this afternoon.

One of the great privileges of our role here is learning from the experience—sometimes the very difficult and harrowing experience—of our constituents, and learning from them about subjects that we might not ordinarily have come across. I have certainly learnt a great deal from preparing for the debate, and also this afternoon. I am grateful to the right hon. Member for Hemel Hempstead for helping me to understand the impact of this condition, which he has done so eloquently and powerfully today on their behalf. I know that he worked with my office and other offices to ensure that all of us were well informed.

As we have heard, this is an ultra-rare condition, affecting only one person in 1 million, and there is currently no cure. However, we also know that what action can be taken is effective, both in diagnosis—which is crucial—and in care, and that people can some people can enjoy have good general health and reach old age, which I have been told is now over 60. It is my birthday this week, so that is quite close. I do not think it is old age, but they can certainly live for quite some time.

Early diagnosis is vital to managing the progression of FOP, and the average age of diagnosis, as I understand it, is around eight years old—as we have heard, the early signs include under-turned big toes—but greater awareness would mean earlier diagnosis for children with FOP. Families who understand that something is not quite right would be comforted to have that diagnosis. As we know, young children are not particularly careful or robust and, although we understand the dangers of immunisations into muscle, it would be a positive step forward for FOP.

Fifty-two per cent of people with FOP initially receive an incorrect diagnosis, creating more delays in care, with swellings due to flare-ups often being misdiagnosed as cancer or other diseases, which leads to unnecessary and potentially harmful procedures.

[Sir Mike Penning]

There have been limb amputations, and the damage that does to the muscle means it almost invariably turns into bone. Surgeons do not amputate a limb for the sake of it, and with the best will in the world, amputation is often more damaging and does not help the patient; if anything, it makes it worse.

[Karin Smyth]

I thank the right hon. Gentleman for his clarification about that, which adds to the trauma that people are living with.

A genetic test can confirm the diagnosis, and we expect to hear whether the Minister has made any assessment about including the test in the national genomic test directory for rare and inherited diseases. Given the commitment in the rare diseases action plan, it would be helpful if the Minister outlined what discussions he has had on new-born screening for FOP and the inclusion of digital education resources relating to FOP. As we have heard, there are only three knowledgeable clinicians in the UK. Access to information and guidance on FOP would make a huge difference for all those living with this condition.

Accepting that the Minister and I are the B team, and scientists would have been preferable, it is important that there is good care to help people with the condition who may be immobilised at a fairly young age. Care for FOP and other rare diseases is specialist and complex, and it reaches across the health and social care systems. I am sure I speak for him when I say that we are both very pleased to talk about the impact on the wider health service. We know that we are very short of care staff more generally, which is not helpful for people who need care or their families. Those living with this condition are vulnerable to some of the wider issues in the care service.

More generally, it would be helpful if the Government could outline more support in the workforce plan, including in social care. Without an increase in the number of care workers, those living with rare diseases such as FOP will struggle to get the care they need. That is why we think it should happen, and it would be helpful to hear what steps the Government are taking to support the care workforce for people living with this condition.

We have heard that research is the greatest hope for those living with this condition, and the right hon. Member for Hemel Hempstead has argued passionately, as have others, for the need to continue funding the STOPFOP trial. The amount of money raised by FOP Friends and the progress that has been made are an incredible achievement. We know that research into FOP will have benefits and implications for more common illnesses, such as osteoporosis, childhood brain cancer and heart disease.

Obviously, we are all pleased to hear that, after a very difficult and uncertain two years of frankly unnecessary negotiations—which have halted or delayed collaboration and research—we will now be involved in the Horizon programme, which will be crucial to making progress in this area. A key commitment in the rare diseases action plan is to improve the Be Part of Research platform to make it easier for people living with rare diseases to participate in research, should they choose to do so. Again, it would be helpful to hear from the Minister what the Government are doing to support those who wish to take part in the trial.

As we have heard, FOP can be devastating. The families want to live in good health and live their best life with their loved ones. I give my heartfelt commendation to those living with this condition and their families. I am pleased that people have come here today and I am sure that that visit to Downing Street was a really positive. The fact that we are debating this issue today is a testament to their hard work and commitment.

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[Will Quince]

The hon. Lady pre-empts my next sentence, but let me give way to my right hon. Friend before I continue.

[Sir Mike Penning]

I will await the next sentence with interest. I have been to Oxford and met many of the scientists who are carrying out the research, but bidding for this sort of funding is enormously complicated. It takes forever and a day to fill in the bids—a lot of time, and time is money for a scientific facility—and will not help with FOP because it does not fit into the categories that the Minister refers to. It is so rare that we have to bid for funding across Europe or with the Americans. Is there any way that we could simplify the process, so that researchers could know earlier whether they have a chance of getting the funding or if they are wasting their time?

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[Sir Mike Penning]

This is a learning process for all of us, and it is not just about FOP. As I understand it, Horizon asks for bids on certain aspects. A bidder can only bid if they fit into those criteria and then they have to wait for up to two years to run the project. The FOP project had to stop because of covid. To start all over again would be very difficult. I wonder whether the Minister will join me in that meeting to see whether we can slot into the process, rather than start all over again.

[Will Quince]

I thank my right hon. Friend for his intervention. Again, he has pre-empted what I was about to say next. I listened intently to his question to the Secretary of State during the statement earlier today, where he secured a meeting with the Minister of State for Science, Research and Innovation. Of course, I would be very happy to join him at that meeting. I share with him the view that if there is an opportunity for that research to be continued, we certainly do not want to see it start from scratch. At the moment, my understanding is that that research relates only to adults and my right hon. Friend, understandably and rightly, would like it to be extended to children.

Let me turn to the steps that the Government are taking to tackle rare diseases and conditions more broadly. In 2021, we published the UK rare diseases framework, which embodies our commitment to building a brighter future for people living with rare diseases and conditions. The framework identified four key priority areas: helping patients get a faster diagnosis; increasing awareness of rare diseases among healthcare professionals, which is something that my right hon. Friend is particularly passionate about; delivering more co-ordinated care; and, alongside that, improving access to specialist care, treatment and drugs. Since then, as was alluded to by the hon. Member for Inverclyde (Ronnie Cowan), all four nations of the United Kingdom have published rare disease action plans to suit their healthcare systems, and we very much work—and have to work—in collaboration on that.

In England, we published our second rare disease action plan on 28 February this year, which also marks International Rare Diseases Day. In that, we set out 13 new actions to drive improvements across the health system and we are committed to publishing action plans throughout the lifetime of the framework.

I touched on awareness of FOP and rare conditions and diseases more broadly, because my right hon. Friend rightly highlighted how a lack of awareness of FOP in the medical community can lead to under-diagnosis, missed diagnosis and, sadly, unnecessary examinations, which can exacerbate symptoms. That is why improving healthcare professionals’ awareness of rare diseases and conditions is central to the rare diseases framework. I am pleased to inform the House that we are making good progress in that regard. NHS England has developed GeNotes, which is an online resource that puts information about genetic diseases and conditions at the fingertips of healthcare professionals. I am pleased to tell the House that resources dedicated to FOP will be added to GeNotes. That will help more clinicians to diagnose this awful condition, and sufferers will receive the treatment that they need more quickly.

My right hon. Friend has raised newborn screening with me privately. The hon. Member for Bristol South (Karin Smyth) also raised newborn screening for FOP. They are both right that antenatal and newborn screening can be a vital tool in the early diagnosis of rare diseases. National screening programmes are implemented on the advice of the United Kingdom National Screening Committee, which makes independent evidence-based recommendations to Ministers in all four nations. While I understand that there are currently no plans for a national newborn screening programme specifically for FOP, I highlight that proposals for new conditions can be submitted to the National Screening Committee’s annual call for new topics.

--- Later in debate ---

[Sir Mike Penning]

What an excellent debate we have had. I apologise if I was in any way rude to the two Front Benchers when I said that I would have preferred the Science Minister. I will have the Science Minister later, so that is perfectly okay. I am very grateful to today’s Minister, who set out some things that we did not know.

On screening, if we know about this early, we will save the NHS money. I know that an independent body looks at rare diseases and conditions, but for this particular life-changing and life-shortening condition, the aspirations and dreams of parents are changed dramatically the earlier they know, because the earlier they know, the earlier we can get those at FOP Friends who have been through it themselves helping them. The more we can screen, the more we will find—the one in 1 million figure shows that we do not know about enough people, because it does not work that way—and the more chance we will have of getting consultants who specialise in this area, rather than the three that we have currently. The more active we are in this area, the more scientists will want to come to this country and work at Oxford with the team there, and with other teams. That means that there will be a future for the families who are so badly affected.

I am enormously grateful to the House and to the Backbench Business Committee for granting a debate on a subject that most people freely admit they knew absolutely nothing about until bits of paper came across from my office. In particular, I thank Jon Mole from my office, who has contacted nearly everybody’s office and said, “What more do you need?”, including those on the Front Bench, because it is really important that we have that knowledge. I remember saying to him the other morning, “Have you given that to so-and-so?”, and he said, “Yes, it’s already gone.” For instance, with the letter to the Prime Minister this morning, which I know the Minister received, I was told five minutes before coming into the Chamber that he had it.

There was a lovely moment outside No. 10 with the families and the affected children and young people. Little Lexi handing the letter in at the door of No. 10 was a very moving moment. Let us hope that with the ministerial meetings we are going to have and with the great news about having partnerships with Europe, rather than being run by Europe, which is really important, particularly with Horizon—[Interruption.] Members knew I would get that in. Let us hope that with those things and with the nations of this country and this great Parliament coming together and saying, “We need to do something about this,” we can do it. FOP affects so few people, but the scientific research could affect a lot of families and help them in the future.

Question put and agreed to.

Resolved,

That this House has considered funding for the prevention of fibrodysplasia ossificans progressiva.

Accountability in the NHS

Mike Penning Excerpts

Wednesday 30th November 2022 Westminster Hall

[Sir George Howarth (in the Chair)]

I will call Sir Mike Penning to move the motion, and then will call the Minister to respond. There will be no opportunity for the Member in charge to wind up, as is the convention for 30-minute debates.

[Sir Mike Penning (Hemel Hempstead) (Con)]

I beg to move,

That this House has considered accountability in the NHS.

It is a pleasure to serve under your chairmanship, Sir George. I called this debate on accountability in the NHS. As a nation, we love our NHS which does a fantastic job for us, day in, day out. However, like any human being or organisation, sometimes it makes mistakes. When the NHS makes mistakes, the process of trying to get an apology or a mistake rectified is invariably a bureaucratic nightmare.

I have a couple of examples I would like to raise. I have permission from one to use their name, but I probably will not do so, because I will yet again pass correspondence to the Minister. I appreciate that the Minister here, my hon. Friend the Member for Colchester (Will Quince), is not responsible in the Department for this subject. The relevant Minister, my hon. Friend the Member for Lewes (Maria Caulfield), is on the Floor of the House answering questions, and I thank this Minister for explaining why she is not here.

We in Parliament are here to speak up for those who sometimes cannot speak up for themselves. When something goes wrong, Sir George, you would think we could get answers for constituents and get matters rectified, but within the NHS there is a lack of ministerial accountability, which I will come to in a moment. The complaints procedure eventually ends up with the ombudsman, but it takes for ever. There is a feeling in my constituency that, when things go wrong, the longer the process can be delayed, the more people will just accept what has happened. In some cases, they will sadly not be around any more. For their families and loved ones, this short debate is very important.

Probably the most dramatic example for me, not of the physical effects of surgery but of the effect on someone’s life, concerns one of my constituents. The NHS decided in 1986 that he needed an operation on his nose, but the operation that took place was not the one that was supposed to. I will use the language: it was botched. It was probably not intentional; it was a mistake but, to this day, that has had detrimental effects on his quality of life.

My constituent tried to go through the process of getting it rectified. I have tried to find out what was going on. He has pushed from pillar to post by different trusts: University College London and West Hertfordshire. I have written to previous Ministers over the years, only to be told that Ministers do not interfere in individual cases. I accept that but, when we reach a situation where there is nowhere else to go, ministerial accountability is important.

[Tim Farron (Westmorland and Lonsdale) (LD)]

I am grateful to the right hon. Gentleman, not least for the sensitivity of the issues he is raising. Ministers under Governments of all colours have sought to keep NHS operational matters at arm’s length. Does he agree that that reduces accountability and effectiveness? I am thinking more generally about the current huge backlog in cancer diagnosis and treatment. I do not see any direct and urgent Government intervention. Does the right hon. Gentleman think that is partly the result of the lack direct operational accountability for Ministers to the service?

[Sir Mike Penning]

I thank the hon. Member for his intervention. We have seen during covid that, actually, when things get really bad, Ministers can step in and Prime Ministers can step in, but when we talk about individual cases, they cannot.

In the case I am referring to, I ended up writing to the Minister, to be told to go to the ombudsman. I got fobbed off by the ombudsman, after we had been to the trust three or four times. I then wrote to the Minister again—this is over the course of years—to be told to take legal advice. This particular person has now been told, “Go back to your GP and get them to re-refer you if you’ve still got problems.” He has problems because they did not do the operation properly in the first place, and it has had a massive long-term effect on this gentleman’s quality of life.

That is not the only case. I have been here for nearly 18 years, and I worked for a Member of Parliament for many years before that. In every constituency, this sort of case is brought before the MP. I have another example. Last summer, in the middle of heatwave in July, when the temperatures were unbelievably high, a very vulnerable young lady was brought in for a scan at my local hospital. She is the most vulnerable young lady. Her mother cares for her 24/7. She has carers in. She is a wheelchair user or bed-bound. She was left on a trolley in the heat for five hours when her ambulance did not arrive.

When I contacted the trust and said, “What happened there?” it blamed the ambulance trust. When I contacted the ambulance trust, it said, “No, it was cancelled by the trust—it was their fault.” I do not care whose fault it was. It was the NHS’s fault that this happened to a very vulnerable young lady. She had no drink and no food. She was very, very ill. The ambulance trust said that the return journey was cancelled because she was so poorly on the trolley—well, she was so poorly because she had been left there for five hours!

Trying to get to the bottom of what happens within the NHS when something goes wrong is so difficult. We have seen terrible situations in maternity services and in trusts around the country. These problems need to be addressed early on, instead of the drawbridge being brought up and people having to go through a massive complaints procedure where they have to complain three times before going to the ombudsman, and then the ombudsman will say it is out of time, and if they are not careful, they cannot go to court because that is out of time too. Is that the way we want our NHS to be seen by the public, who love the NHS?

The NHS sees the NHS as a single entity. As MPs—and I was a shadow Health Minister for four and a half years—we understand that it is not a single entity. It is a set of silos where everybody passes the buck back and forth. What we need is joined-up thinking. When Members like myself write to Ministers about these issues, the answer is not to say, “Nothing to do with me, guv” and pass it down the line to the ombudsman or a lawyer. That surely costs more money and does not put the NHS in a particularly good light with my constituents who have had their operations botched

[Jim Shannon (Strangford) (DUP)]

I congratulate the right hon. Gentleman on securing the debate. He talks about silos, and I want to give him an example of that in my constituency. Many people await their care packages in order to be released from hospital and get better at home. On the other hand, there are people waiting urgently for hospital beds who cannot get one. Does he agree that there must be greater communication between trust managers and social care workers to ensure efficiency of care in the community, which would free up hospital beds and allow people to be treated quicker? In other words, we should do away with the silos and get things co-ordinated.

[Sir Mike Penning]

I completely agree with the hon. Gentleman. I know that right next to my constituency, my hon. Friend the Member for Watford (Dean Russell) goes to Watford General Hospital and looks at the boards to see whether people can medically be discharged, but they cannot because there is a lack of joined-up thinking.

This is different. This is about the need for the NHS, when it may or may not have made a mistake, to address it full-on at the start. It should not draw up the drawbridge, with people having to go through the long, drawn-out procedure of making complaints and going to the ombudsman. For a Minister to say to a colleague and fellow MP, “Perhaps this person needs to take legal advice,” is not the attitude we should have towards people who have done the right thing. The NHS has said that they should have an operation, and the NHS has mucked up and botched—I use that word under privilege. At the same time, the person’s life has been detrimentally affected for years and years to come.

I know the Minister is not the Minister responsible, but because we are all constituency MPs, I guarantee that before he was in his position, people were at his surgeries or wrote to him to say, “This happened to me within the NHS. What can you do to help me do something about it?” Somewhere along the line, perhaps the short debate we are having today will nudge the Department of Health and Social Care and the Government —I was a Minister in several Departments—to look at ministerial oversight.

[Daisy Cooper (St Albans) (LD)]

The right hon. Gentleman is making a fantastic speech. In the light of this week’s shocking reports from Byline Times about the amount of sexual abuse and rapes that have occurred in hospital settings, does he agree that to improve accountability, we need the Government not only to urgently repeal the five-year rule, which limits some people from making complaints to the NHS, but to have clear, systematic and consistent data collection on all sexual misconduct across all hospital settings?

[Sir Mike Penning]

As usual, I agree with the hon. Lady. We do not agree on everything, but we agree on 99% of things.

This is the crux of the matter, and there are two real issues here. In the case that I spoke about earlier, which goes way back to the ’80s, the gentleman’s mental and physical health has not been great. Other people, including the extreme examples alluded to by the hon. Lady, may be mentally affected in a way that I and many of the people in this room probably cannot understand. To have a block exclusion post five years seems so arbitrary in the modern world. The Government really must look at whether there should be an arbitrary rule and perhaps leave it to others to decide, rather than setting down in regulation the exceptional circumstances that might well have been in place. Trusts do have delegated powers—many more powers than I think they should have—and I know the new Act will help that, but it does not take into consideration the points that we have tried to raise in this morning’s debate.

If we had this debate on the Floor of the House, I think we would have a full Chamber of colleagues. Rather than talking down the NHS, they would be saying, “When things go wrong, we need to address them.” When I was Police Minister, there was a big mistake under my portfolio, and I went before the House, explained that mistakes were made on the funding formula and put my hands up. I took a lot of flak for that, but it was a way to address things going forward. With the NHS being such a massive organisation, and an organisation that the public want to be able to trust, it must be better for us to address the issues at the start of a complaint.

The Under-Secretary of State for Health and Social Care, my hon. Friend the Member for Lewes, did not write the letter that I mentioned; it was written by her officials, who desperately want to defend the NHS. The complaint was not about the NHS in general; it was about a specific issue that we need to address. We are all here as Members of Parliament because we are supposed to represent the taxpayer—representation through taxation. I should be able to represent my constituents in that way without being told to go to the ombudsman. I know I have to go to the ombudsman, because I have been here a very long time, so I am capable of working that out. I am also capable of working out that we are outside the time limit, given the five-year rule.

We need a change of mindset. I do not want individual Ministers to say, “This operation should take place, that one shouldn’t, and the hospital should have this number of wards”, but there has to be ministerial oversight when things go well, and when things go wrong.

My constituent has given me permission to raise his case. I think it would be more useful not to put his name on the record here, but I will pass another letter to the Minister, which I hope might get a little more positivity when the Minister responsible writes back to me, rather than a response that fobs us off and says, “Please go away.”

[The Minister of State, Department of Health and Social Care (Will Quince)]

It is a pleasure to serve under your chairmanship, Sir George. I congratulate my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) on bringing this important debate to the House today. I know from our numerous conversations over the years that he is a tireless champion of healthcare provision, not just within his own constituency, and an advocate for instilling accountability and a learning culture throughout the NHS as a whole. Today, he has raised some difficult cases, albeit anonymised. I know the Under-Secretary of State for Health and Social Care, my hon. Friend the Member for Lewes (Maria Caulfield), who is responsible for patient safety, looks forward to receiving more information and will be happy to meet our right hon. Friend to discuss the cases further.

I assure my right hon. Friend that this Government share his commitment to ensuring that the NHS delivers excellent care to all of its patients. We will never tire in striving to ensure that patient safety and high-quality care are at the heart of all patient care in our country. I am of the firm view that accountability for excellence applies at all levels of patient care, from the individual clinician caring for an individual patient through to Parliament’s role, as my right hon. Friend set out, in ensuring accountability for healthcare delivery by the NHS. It is essential that the commitment to excellence is central.

My right hon. Friend rightly says that we love our NHS. Of course we do. However, we recognise that on rare occasions—not as rare as I would like—patient care falls short of the very high standards that we expect. He talked about getting answers for his constituents as a Member of Parliament. That is hugely important. I apologise that ministerial responses have not been as full as he hoped they would be. I will certainly look into that, because those responses are important. As a constituency MP, I too have cases from constituents who have raised concerns, either about their GP or their acute trust, and the level of service provided.

My right hon. Friend rightly raises questions about why the NHS as an organisation does not more often simply say “sorry” when things go wrong. It is, as he sayd, a human business and things do go wrong.

I hear what he said about ministerial responses. He is also right to say that Ministers are unable at present to respond to individual cases. There are reasons for that. As the hon. Member for St Albans (Daisy Cooper) and the hon. Member for Westmorland and Lonsdale (Tim Farron) said, the NHS is a complex organisation. We have NHS England, integrated care boards, integrated care systems, primary care networks, acute trusts, mental health trusts and ambulance trusts, and there is a question about whether Ministers or bodies such as NHS England and individual trusts should hold a level of operational accountability or delivery responsibility. That is a fair question, raised by the hon. Member for Westmorland and Lonsdale, but it is a tricky balance to reach.

Ultimately, who is responsible for any failings within the NHS? Well, that is me. Who is responsible for delivery of services through the NHS? Not me. That position presents some challenges. Ministers have the ability to set the strategy at national level, but there is a big difference between the strategy, the approach, the culture and the leadership set in Whitehall and what actually happens at grassroots level at individual trusts. However, although I do not have direct operational responsibility, trust me when I say that every single day I am thinking about every single case where an ambulance is delayed and people have to wait too long; about all the 7.1 million people in our elective backlog, and about all those who do not get the excellent care that they rightly deserve and expect through our NHS. That is because I am the one who is responsible for that. I get the letters, and sometimes the responses are not as full as we would want, because I do not have at my fingertips all the information I need to be able to respond in the way I would like. We need to look at that.

My right hon. Friend rightly says that most people do not want to sue or take legal action against our NHS. They are desperately sad about what has happened, and they may be disappointed or even angry, but that does not mean that they want to seek financial redress or sue a hospital trust. They know the implications of that—the money comes out of operational budgets.

Having been the responsible Minister, I am acutely aware that we have an annual clinical negligence bill of £2.6 billion, which is huge. Understandably, I would rather spend that £2.6 billion on NHS frontline services. I have huge sympathy with my right hon. Friend’s view that we should collectively put our hands up, explain what went wrong and why, demonstrate how we are learning from that as an organisation, and clearly explain the steps that we are taking to put it right. We collectively as Ministers have a role to play in that. I will reflect on his comments and explore what more we can do.

The Government have made significant strides to advance patient safety over the last decade. As I said, it remains a top priority not just for the Government but for me personally. We are creating a transparent learning culture across health systems. That is key to avoiding tragedies in the first place, and essential to driving the improvements that we want to see. As my right hon. Friend pointed out, patient feedback has to be at the heart of that. Patients have to have the opportunity to share their experiences.

It is vital that clinicians reflect upon the lessons learned and translate them into opportunities to improve their practice. That is vital for not just the individual consultant, doctor, nurse or allied health professional, but the NHS as a whole. We have to listen and learn from individual patient stories. Accountability is a thread that has to run through every single level of the NHS—from individual patient complaints and the learning they generate to organisational responsibility for the standard of patient care, through to integrated care boards and the delivery of high-quality outcomes and access to care for their populations.

The accountability owed to partner organisations and local patients is just as important as accountability to national bodies. As my right hon. Friend pointed out, that is why we passed the Health and Care Act 2022, which embeds the principle of accountability throughout the NHS and our health and care system.

[Sir Mike Penning]

The Minister is being generous in his comments to myself and to colleagues. The issue for colleagues and patients is that the over £2 billion bill, the delayed operations and the waiting lists would be remarkably smaller problems if we had addressed them right at the start. The biggest point, going back to my constituent, is that the wrong operation was done in 1986. That gentleman has been back and forth with the NHS, with help from myself and others, which must have cost the NHS a small fortune in legal fees. Instead of addressing the individual issue to stop it getting bigger, the NHS fobbed and fobbed it off and passed it back around.

I know we are short on time and the Minister wants to conclude. My final point is that when Ministers send out letters, it is often the trust that we are complaining about that has drafted the letter to their officials, which actually ends up coming to us. In a classic example the other day, I was thanked for being so supportive of the refurbishment of Watford General Hospital, when actually I have opposed it for the last 20 years. The trust wanted to send that message to the Minister, rather than address what we needed to address, which is patient safety. The stress on patients in this particular case is huge.

[Will Quince]

My right hon. Friend is right that there is a lot more that we can do. Reflecting what he has just said, I will touch on some of the measures that have been put in place over recent years.

In 2019 there was the NHS patient safety strategy. We introduced, for the first time ever, a patient safety commissioner. There is the Health Service Safety Investigations Body, which will be an arm’s length body from April 2023 and which was the brainchild of the Chancellor when he was Secretary of State for Health and Social Care. As my right hon. Friend pointed out, there has also been huge investment in maternity services following those awful cases, not just to boost staff numbers, but to improve leadership and culture. There have also been changes to the Care Quality Commission, with the single framework coming in from January next year.

My right hon. Friend is absolutely right that some cases take far too long, especially some of the neonatal cases. Those are often the cases that result in the largest payments made, but it can take many years before patients and families get the redress they needed. The Health Services Safety Investigations body is designed to be far more upfront about where something goes wrong. It is much better to learn the lessons in the period immediately after something has gone wrong than several years after the event, looking back retrospectively on what could have been done differently. We need to learn the lessons now and ensure that as few patients as possible go through the same experience. Clinicians, not just within that trust but across the integrated care board, or, where appropriate, across our NHS, should learn those lessons.

My right hon. Friend the Member for Hemel Hempstead has hammered home the point again about ministerial responses. I hear him, and I will speak with my hon. Friend the Member for Lewes to see what more we can do in that space. Those points are well made. However, it is difficult because of the number of NHS acute trusts and the fact that we rely on information about what happened on the ground. It is a huge and complex organisation, but I understand, recognise and take his point that ministerial responsibility and oversight is important.

We need to know the facts, and not just the facts as they are presented by a trust, in whose interest it might be to paint a rosier picture than it actually is on the ground—or to not paint the full picture. That is why it is so important that Ministers engage with local Members of Parliament to get the facts. They are the ones who are meeting with the trust executives and the board, as well as their constituents and the clinicians and health professionals on the ground delivering care, who will often—for want of a better word—whistleblow about what is actually happening in a trust, and not give the rose-tinted view that the executives of a trust may want.

This has been a hugely important debate. It speaks to issues that are at the heart of our NHS. It is about getting it right first time and the excellent and consistent patient care that we rightly expect from our NHS. I hope, to some extent, that I have assured my right hon. Friend the Member for Hemel Hempstead of the importance that the Government place on quality, excellent patient care and accountability. His points have been well made. I will reflect on them, as will my hon. Friend the Member for Lewes. I look forward to working with him to improve the situation across our NHS.

Question put and agreed to.

Oral Answers to Questions

Mike Penning Excerpts

Tuesday 1st November 2022 Commons Chamber

[Steve Barclay]

In fact, around 80,000 more GP appointments a day are happening, so significantly more demand is being met. The Government have invested an extra £1.5 billion to create an additional 50 million general practice appointments by 2024, increasing and diversifying the staff available for those patients seeking care.

[Sir Mike Penning (Hemel Hempstead) (Con)]

One way GPs can get better outcomes for their patients is to see them face to face if possible, particularly with prostate cancer in men. Men just do not present themselves to their GP as often as they should. Today is 1 November—Movember—so what is the Secretary of State going to do to promote men’s coming forward to see their GPs so that we can get this disease eradicated?

[Steve Barclay]

First, I pay tribute to the work my right hon. Friend is doing to raise awareness of this issue. It is important that those patients who want access to face-to-face appointments are able to get them, and campaigns such as Movember are a great way of raising that awareness.

Procurement of Evusheld

Mike Penning Excerpts

Wednesday 12th October 2022 Westminster Hall

[Daisy Cooper]

I thank the hon. Member for his intervention.

Let us move on to the facts. Is Evusheld safe and effective? Yes, it is. The Medicines and Healthcare products Regulatory Agency approved it in March, seven months ago. Is there enough scientific evidence? Yes, there is ample evidence.

[Sir Mike Penning (Hemel Hempstead) (Con)]

The hon. Lady and I have had conversations about this issue and about my own constituents. What I cannot understand is that the RAPID C-19 committee has looked at this 11 times. These are supposed to be experts that are looking at it. She is quite right to want evidence that proves that the committee is wrong. How come we have got into a situation where Government scientists are saying one thing and the rest of the scientific community is saying something completely different?

[Daisy Cooper]

I thank the right hon. Member for his intervention. That is exactly the question I would like the Minister to answer.

There are two significant problems with the most recent report published last week. First, it effectively says that the RAPID C-19 group looked at the results of a trial run on actual people in December 2021 and concluded that the evidence was so good that they were going to recommend that Evusheld be rolled out to patients. However, in May of this year, they looked at non-clinical data—test tubes, petri dishes and the like—and decided that the results were not good enough. It does not take a rocket scientist to work out that high concentrations of a virus in a petri dish do not translate to tests in real human beings.

Health and Care Bill

Mike Penning Excerpts

Consideration of Lords amendments
Wednesday 30th March 2022 Commons Chamber

[Edward Argar]

I hear my right hon. Friend’s gentle but firm urgings, and I hope that he will welcome the progress that we have made.

[Sir Mike Penning (Hemel Hempstead) (Con)]

The Cumberlege report was fantastic. The Minister accepted some of what it said but not in relation to Primodos, especially in the area of compensation. Can we look at that again?

[Edward Argar]

I am always happy—or the relevant Minister is always happy—to meet my right hon. Friend on any matter relating to the Department’s work.

Turning to the Health Services Safety Investigations Body—HSSIB—and patient safety, we intend to support the development of a learning culture across the NHS. With that in mind, I would like to turn to Lords amendments 66 and 109. The related clauses concern how we balance the need for those who speak to the HSSIB to feel safe to speak openly and candidly to HSSIB staff, while ensuring that coroners can fulfil their judicial functions. This has been, throughout the passage of the Bill, a difficult balancing act with no perfect answer, which has been given much thought and attention, and on which reasonable people can come to equally valid but different views. However, I have concluded that there is significant strength of feeling in both this House and the other place on whether coroners should have access to protected material held by the HSSIB.

I am grateful to my colleagues in the Ministry of Justice, in particular the Under-Secretary of State for Justice, my hon. Friend the Member for Corby (Tom Pursglove), and to the Chief Coroner for considering the different views judiciously. Recognising that, the Government have decided to accept their lordships’ amendment, which removes the ability of senior coroners to access protected material held by HSSIB through relying on certain powers under the Coroners and Justice Act 2009. We hope that will give reassurance and strengthen the ability of the HSSIB to deliver what we all want across this House, which is to support an open learning culture across the NHS.

This group of amendments also includes a substantial number of amendments to improve public health. In the other place, we brought forward amendments to enable the smooth and effective implementation of restrictions on the advertising of less healthy food and drink. I urge the House to accept Lords amendments 101, and 123 to 128, which allow the necessary preparatory work to take place before the restrictions are due to come into force on 1 January 2023. They also introduce the ability to delay that implementation date via secondary legislation, should that be deemed necessary.

Cumberlege Report

Mike Penning Excerpts

Thursday 3rd February 2022 Westminster Hall

[Alec Shelbrooke (Elmet and Rothwell) (Con)]

I beg to move,

That this House has considered the Cumberlege Report.

It is a pleasure to serve under your chairmanship, Mr Rosindell. I have secured a debate about fulfilling the recommendations of the Cumberlege report because I do not feel that we are making enough progress. We had a debate on the Floor of the House in July and a written ministerial statement on 21 July. To stay in order, Mr Rosindell, I will only say that the Minister’s answer to the debate and the written ministerial statement were disappointing, in many ways. In my opening remarks, I will seek to address why I believe that to be the case and, fundamentally, ask for certain updates. We are talking about people whose lives have been destroyed. Many hon. and right hon. Members will bring their own examples about various parts of the report, whether they are about Primodos, sodium valproate or mesh, but I will focus my comments on mesh.

I will not spend too much time going over the examples I gave during the debate in July, which can be looked up in Hansard, but I will say that people were given an operation that many did not need, which many were convinced that they should have. Some people did not even know it had happened to them. It took many years for the problems that arose to become apparent, and so those people have effectively been dismissed.

Like many Members, I have constituents who have had their lives stopped, especially women, although I will mention how the issue affects men as well. One constituent, who I have mentioned before, was a physiotherapist in her 40s who had had a child. She had mild incontinence after giving birth and was told to have the mesh implant, which she went ahead and did. Her entire life has been destroyed by that. Trying to remove it was described to her as being like “trying to take hair out of chewing gum”. We should consider that image when we think about the difficulty of the operation. We must not forget that the NHS did this, and the NHS has a responsibility to deal with it. I will make that point several times.

I have been contacted by a lady who is a constituent of my hon. Friend the Member for Thornbury and Yate (Luke Hall). Her name is Paula Goss and both she and he have given me permission to talk about her case. She set up Rectopexy Mesh Victims and Support in March 2019 after she was unable to find much research or information about the meshes that she had had put in. The group now has over 1,100 members, as well as members who have sacrocolpopexy vaginal mesh and hernia mesh. She is the ambassador and advocate for rectopexy and hernia mesh on the Mesh UK Charitable Trust, which has a further 2,000 members.

She had rectopexy mesh in 2014 as she was unable to clear her bowels. She was ill-informed by the now dismissed surgeon, who, as she found out from her notes, inserted three meshes—in the bowel, vagina and posterior. She says:

“All mesh types don’t necessarily show complications straightaway. My Pre mesh insertion issues started again around 9 months after the op, in which I was passed from pillar to post by all medical professionals saying my issues were the menopause or in my head. This went on from 2015 until September 2018 when I was admitted to hospital with a blocked bowel and bladder and had to have enemas and catheters, still they would not connect this to the mesh, upon doing a CT scan at this time they also found a large ovarian tumour, it was then discussed by my gynae oncologist at the BRI and Southmead NBT to do a joint op to remove the tumour and the mesh, due to the incompetence and lack of mesh removal experience at Southmead I ended up having the ovarian tumour removal in January 2019. Thankfully, after testing it was a large benign fibroma, following up with Southmead they then stated that they wouldn’t remove my mesh but would do an op to give me a permanent stoma—again, brushed aside and fobbed off, I sought a second opinion in London privately, whilst we are by no means rich, you can’t put a price on your health...I had to pay £32,000 for my removal, it took over 10 hours and they could not get all of it…two protacks in particular sit very close to the bifurcation of the inferior vena cava on the left and the common iliac on the right. Pre mesh removal I was found to have a heart murmur and I suffered pericarditis quite a few times. My histology on my meshes showed that I was not a candidate for polypropylene and should not have this inserted again…When I discovered I had hernias again I was neglected by the local hospital who at first refused to do a scan, saying I must have an ulcer. it was thanks to my private mesh removal surgeon who contacted my GP and insisted that I was referred for a CT which then clearly showed two large incisional hernias.

The consultant at Southmead stated he would only fix my hernias with polypropylene mesh. After I told him that I couldn’t have that, there was no option but to again look down the private route. Thankfully, my colorectal mesh removal surgeon was able to do this and a date was set for 6 January 2020. However, my hernia started to strangulate and I was luckily rushed to London by my husband, and had this op done on 28 November 2019. This cost £43,000.

This operation was by far the toughest and took a long time to get over, due to ending up with a seroma and now a hiatus hernia due to the trauma to my abdomen.

My journey has not been, and is still not, plain sailing, but I am one of thousands.

Whilst vaginal mesh gets a lot of coverage, ours does not. Rectopexy affects men, women and children…All three main types of mesh need to be included and talked about—bowel mesh, vaginal mesh…sacrocolpopexy and colporrhaphy vaginal mesh and hernia mesh...One of our rectopexy mesh ladies found out that the surgeon who put mesh in also removed her ovary without consent, she sadly committed suicide due to this event.

One of our rectopexy patients was just 15 when she had her mesh inserted. She’s early 20s now and now suffers complications and doesn’t even know if she will ever be able to have children.

We have other ladies in their 20s and early 30s suffering, who may not be able to have children.

We have many rectopexy bowel men on our sites who feel they have nowhere to go and no one who will listen to them.

This is the same for all hernia mesh victims too.

There are many real victims’ journeys that need to be listened to and taken seriously.”

That is what the report did, and why it was so appreciated by the victims, as they were finally being taken seriously. That is where the report’s value lies. Today, I once again push for it to be implemented in full as far as possible, and for recommendation 3 about redress, recommendation 4 and recommendation 5 to be reconsidered.

Recommendation 1 was for an apology. That apology was received in July 2020, given by the Government, but, as good as it was, their actions depend on whether they can justify what they are doing on recommendation 9. Recommendation 2 is:

“The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.”

The Government accept recommendation 2, and I ask the Minister for the latest update on that appointment. On 2 December last year, in the other place, the noble Baroness Cumberlege asked Her Majesty’s Government

“when the process to appoint the Patient Safety Commissioner will commence; and when they expect the Commissioner to be in post.”

In response, the noble Baroness Chisholm of Owlpen said:

“My Lords, we are making good progress towards appointing the first patient safety commissioner for England. We expect the appointment of the postholder by spring 2022.”—[Official Report, House of Lords, 2 December 2021; Vol. 816, c. 1443.]

As I said, I would like an update on where we are in that process.

Recommendation 3 is that:

“A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”

The Government do not accept recommendation 3. As set out in the Government’s statement,

“We have no current plans for a redress agency…We do not believe it is necessary to create a new agency for redress as it is already possible for the Government and others to provide redress for specific issues where that is considered necessary. Neither do we believe that creating an agency would succeed in making products safer as the report suggests, or that grouping existing redress schemes through a single front door would add value for harmed patients.”—[Official Report, 21 July 2021; Vol. 699, c. 72WS.]

I do not accept that it is already possible to provide redress where necessary, because my inbox, and I am sure those of several right hon. and hon. Members, suggests that that is simply not true. It is too vague and takes too long. When I talk about recommendation five, I will discuss where that issue comes to a head.

I come back to my point, which is that the NHS did this to people. I have said it before and I say it again: the problem is very similar to the thalidomide scandal. Eventually we got justice for thalidomide victims. People are just being fobbed off—I have many examples—and that is exactly what happened with thalidomide. Mr Rosindell, can you imagine living an active life, as we all do, and the NHS recommending something that means that you can no longer take part in what you were doing? Imagine being physically and mentally restricted and unable to fulfil your life’s ambitions. A full quango might not need to be set up, but at the very least we need a ring-fenced department in the NHS to bring those areas together.

[Sir Mike Penning (Hemel Hempstead) (Con)]

Baroness Cumberlege specifically states in her report that her terms of reference prevented her from talking about individual compensation and redress. Is my right hon. Friend suspicious, like me and probably many others, that that was specifically written into the plan so that she could not do what my right hon. Friend is asking for?

[Alec Shelbrooke]

That is where we have to dig into recommendation 4:

“Separate schemes should be set up for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim”.

The Government do not accept recommendation 4. That is exactly the same situation as with thalidomide. One of my earliest campaigns in 2012 was to extend the grant to victims, and my hon. Friend the Member for North Dorset (Simon Hoare) took that campaign further to make it a permanent grant. People will not recover from what happened, whether it was drug-induced or operation-induced.

My constituent who has had mesh removed emailed me only today to say that four years down the line things are better, but they have not improved to the point where she can really live her life. She says she is mentally exhausted and does not want to go on. She had a thriving physiotherapy career that she cannot go back to. She is only in her 40s and has the rest of her life to live. The Government have a responsibility because the Government run the NHS. I interchange the words “NHS” and “Government”, but the NHS is the Government. That is where this situation falls on the Minister:

“While the Government are sympathetic to the experiences of those patients who gave evidence to the report, our priority is to improve the future safety of medicines and medical devices.”—[Official Report, 21 July 2021; Vol. 699, c. 72WS.]

Trying to prevent further catastrophe is obviously very important—that is one thing—but thousands of people will suffer for the rest of their lives thanks to this treatment.

I will draw the distinction between this surgery and breast-enhancement surgery. Many people have had that done privately and then when there have been complications, they have had the operation to sort it out on the NHS. There is often a lot of debate around whether that is right or wrong. That is not where I want to go today. However, if we are willing to do that for things that people have had done privately, why are we not willing to redress the issues of people who have had things done by the NHS?

We are talking about women from their teens all the way up. Some people think the problem is with the elderly end of the population, but we are talking about those in their teens upwards. As I said, we did recognise the situation with thalidomide. I know that costs come into it, but there is a moral responsibility to redress the situation.

--- Later in debate ---

[Sir Mike Penning (Hemel Hempstead) (Con)]

It is a pleasure to serve under your chairmanship, Mr Rosindell.

Groundhog day—here we go again. This is almost the identical debate that we had before. If this was in the main Chamber, especially if it was not on a Thursday afternoon, the Chamber would be full, because there is not one constituency that does not have somebody affected by the three conditions. As the hon. Member for Chesham and Amersham (Sarah Green) said just a moment ago, what is the point of commissioning a report or having an inquiry and then ignoring the key components of its conclusions?

I congratulate my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) on securing the debate. Sadly, I think we will end up having more. I am a loyal member of Her Majesty’s Government. I am absolutely aghast that we are here again discussing this. I thank my right hon. Friend the Member for Maidenhead (Mrs May), our former Prime Minister, for her support. The report would not be here today without her.

I congratulate Baroness Cumberlege, along with Marie Lyon, who ran the fantastic Primodos campaign. There was some worry about the experts that the baroness had around her, and we questioned her on those points to make sure that the inquiry was truly independent. At the start, the all-party parliamentary group was very sceptical because we had been let down by the expert working group. What an oxymoron that is! It is an insult to experts. Those on the group might be experts in their particular field, but they are not experts in people.

I want to talk in particular about Primodos. As several colleagues have said, very vulnerable women went to their GP for help, because they thought that they might be pregnant. They were myriad different ages, from myriad different parts of the country and certainly from different economic backgrounds. This touched everyone. They went to their GP and said, “I think I might be pregnant.” That GP, in an NHS GP’s surgery, pulled open a drawer, gave them some tablets and said, “This will tell you whether you are pregnant”—no advice, no concerns, no documentation.

These days, I have to take some medication and it is like “War and Peace” when I open the packet—even if I buy an aspirin. Although that is understandable, as aspirin can be very dangerous, so I will not use that example—perhaps ibuprofen or something. Clearly, that is because the industry, the pharmas, know that they have to cover themselves because they might be sued.

The side-effects for some of those ladies and their families and loved ones have been so traumatic. Some had miscarriages, some were told to abort the child and some went on to have children with abnormalities that were frightening then and today. The type of disabilities were similar to those of thalidomide, and one might have thought that we would have learned the lesson of thalidomide—tainted blood, as my right hon. Friend the Member for New Forest East (Dr Lewis) alluded to earlier. But no—we have not learned those lessons.

Some people are alive today, but many have passed away. What is the Department waiting for? Is it, as with thalidomide, for these people to die early? That is why the fund for thalidomide ran out—the Department thought there was enough money in the fund, but people lived, because they have character and they survived, so we are about to top up the fund. These people, too, have lived, with unbelievable conditions. We, in Parliament and as a Government, surely should be here for them.

When the initial report of that expert working group was produced, many of us in the Chamber said that it was a complete whitewash. It was indeed a complete whitewash. The all-party parliamentary group had some evidence sessions with members of the working group, and I asked, “Who gave you the authority to change the ministerial guidance on what your report should look like?” They said, “Oh, we just thought that we would change it.” It was all about the evidential base—it was easier for them to come to the conclusions that they wanted to come to.

We said it was a whitewash, and the Government did the right thing: they got Baroness Cumberlege to look at the three areas—I apologise to the other groups, because I completely agree with everything that was said, as I have constituents in the same situations that have been mentioned. But what is the point of saying to these people, “Here’s the report by the baroness, and the Government accept some of it”?

I had the honour of being the Policing Minister when my right hon. Friend the Member for Maidenhead was the Home Secretary. The Hillsborough inquiry report was difficult. Governments of all colours had previously rowed away from the issue, because in general they were probably frightened about the conclusions—the conclusions were frightening. However, we did the right thing and we honoured the report. That is absolutely what should have happened with this report.

The Government, though, are turning around to say to these families that I am talking about today, and to the families involved with the other two conditions: “If you don’t like what we are saying, sue us.” I have been told that we have to be slightly careful not to go too much into the legal side of this, but they have fought all their life to look after their loved ones and to say, “This is not on me.” They were worried about the ladies who took the tablets, but men—the fathers of these children—have been told, “This was probably genetic. That happens.” That does happen, but this happened because NHS doctors gave these tablets to patients in an NHS surgery and did not tell them the risks, even though they knew them. Back in 1967, Primodos was removed because of the risks, yet it was still available in 1978. I had been in the Army for four years in 1978; it was not that long ago. They knew the risks, but they continued.

People ask me why GPs were doing this. It was because drugs company salespeople were going into the GP surgeries and pushing their product at the doctors, promoting it so they could earn more and more money. We need pharmaceutical companies. Many of the medicines that we have today would not have been invented without pharmaceutical companies. However, when they get it wrong, we have to hold them to account. They got it wrong, and the Department of Health got it wrong, and thus Governments—it does not matter what colour they were; I do not care—got it wrong.

We touched earlier on why we are fighting this. I had the honour of serving in six or seven Departments—I lose track sometimes; it was three at one time, I think—and I was told lots of times by my officials that we needed to fight or challenge something. That happened lots of times at the Home Office; my right hon. Friend the Member for Maidenhead is nodding away. I was the Disabilities Minister at the Department for Work and Pensions, and I asked why we were not settling with these people, because we had made a mistake. I was told that the Treasury counsel thought we might have a case, with about a 30% chance of success. Come on, guys.

At the end of the day, Governments are worried about saying, “Excuse me; we got it wrong and we are going to put it right.” The Government are going to put it right, we hope, but mistakes will still happen. That is the nature of medicine, I am afraid. But when we get it wrong, and doctors get it wrong, for once in their lives I wish they would just turn around and put their hands up. That is what I hear from my constituents in the complaints that come through my office; I am sure it is the same for all colleagues in this room. We see these reports and the amount of compensation that is to be paid, and they are challenged, and then eventually people get their money. There is something wrong.

I have sat in the Minister’s chair on more than one occasion and been bombarded, quite rightly at times. However, this is not about the Minister; it is about Government, and the structure of Government. Using the Minister as a conduit, this needs to go further, back up to the top and, at the end of the day, to the Treasury. The reason why people in government are so worried is because this could set a precedent. They are worried about whether it will cost the Treasury lots of money. Let us be honest: it will cost the Treasury lots of money, sometimes in ways that it is not even expecting. We have already talked about PIP and access to work. We could go on about the amount in benefits that this is costing Government anyhow. As well as that, the decent thing to do is to honour recommendation 4 of the Cumberlege report. It does not use the word “compensation” because Baroness Cumberlege was not allowed to use that; the terms of reference given to her were written to make sure that she could not. However, it says that this has been done to these people, we got it wrong, they trusted the Government and the Government have to compensate them.

I will say one final thing. The NHS is a wonderful organisation. Around the world, people look at our NHS and say, “We wish we had that. We wish we could do that.” This is damaging the NHS. This, tainted blood and thalidomide—we could go on about other things—are a danger. We rightly addressed tainted blood and thalidomide, thank goodness; the campaigning by the thalidomide action groups was absolutely phenomenal. This needs to be resolved before it damages the NHS even more. Colleagues will retire or leave. Some people—particularly those affected by Primodos—will pass away. But we will not go away. We will go on and on and on about it in this House until compensation—recommendation 4—is provided to our constituents, and that is the right thing to do.

[Sir Graham Brady in the Chair]

--- Later in debate ---

[Feryal Clark (Enfield North) (Lab)]

It is a pleasure to serve under your chairmanship, Sir Graham. I pay tribute to the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) for securing this important debate and for his continued campaigning on women’s issues. We have heard today harrowing accounts of women’s experiences. It is really important that we hear those accounts and that they are repeated over and again, because we need to remind ourselves that these are real human beings who have to live with this day in, day out. It is important that we record that in this House.

I thank right hon. and hon. Members for their powerful contributions to the debate. As a fairly new Member—I believe I am the newest Member in the Chamber—and having taken some time off for maternity, I have spent less time here than most Members present, so this is the first time that I am hearing about the progress that has been made on the Cumberlege review. It is really depressing to hear that we have not made much progress on the recommendations.

The pressing thread throughout the debate has been the patronising attitude to women’s voices, as was mentioned by the right hon. Member for Maidenhead (Mrs May), which continues. I take this opportunity to pay tribute to campaigners for their tireless work around the Cumberlege review—particularly the Association for Children Damaged by Hormone Pregnancy Tests, without which the review would have never taken place and we would not be here today.

We have heard that Baroness Cumberlege’s excellent review looked into the use of Primodos, the use of sodium valproate during pregnancy, and the use of pelvic mesh implants. Those medicines and medical devices have caused untold physical, developmental and emotional harm to tens of thousands of women. It is almost four years since the independent medicines and medical devices safety review was announced, but it is over 50 years since these treatments started to be used and, as has just been mentioned, women have been trying to get their voices heard for decades.

[Sir Mike Penning]

The hon. Lady may be new to the House, but she is doing very well in trying to understand the position. In the case of Primodos, that was not a drug that was going to cure anything; it was simply a tablet that told the person who took it whether they were pregnant. There were other methodologies around at the time that were deemed to be safe, but GPs continued to give out Primodos when they knew it was not safe. It is quite a clear, difficult thing: GPs were giving out a drug years after the relevant bodies said it should not be given.

[Feryal Clark]

I totally agree with the right hon. Gentleman. I am the mother of an eight-month-old, and during my pregnancy I trusted my GPs and everything they said. I was vulnerable, like all mothers, and I believed that they wanted the best for me. It is absolutely devastating that GPs knew the impact of these drugs yet continued to give them out to women. I thank the right hon. Gentleman for that contribution.

I have constituents in Enfield North who were impacted on by these medicines. My constituent Chris was given Primodos in June 1970 to find out whether she was pregnant. Her daughter Emma is now 51 years old and has suffered throughout her life from limb deformation, spinal problems, scoliosis, joint problems and mental health problems. She lives in chronic and intense pain that does not go away, and she can no longer work full time.

The review set out nine ways in which the Government could have delivered justice, made the lives of those affected—such as Chris and Emma—a little easier, and tried to prevent future incidents. Given the shocking accounts that we have heard today—accounts that the Government have been hearing for years—and the evidence in the review, one would have expected the recommendations to be accepted in full, but that is not the case. As we have heard, the Government have accepted four recommendations, but there are two that they have not accepted. They have accepted two other recommendations in part, and one in principle.

I am pleased that there has been an apology and that there is legislation for a patient safety commissioner. I am pleased that there are specialist centres for the care of those with complications from mesh implants, although I hope the Minister will address the serious concerns we have heard about that. I am also pleased about the changes to how doctors’ conflicts of interest are reported.

However, that is not why we are here today. Implementing those recommendations alone is not good enough. The Government have refused to establish a redress agency for those harmed by such medicines and medical devices, or to set up a separate scheme to meet the costs of providing additional care and support to those who have experienced avoidable harm, which would make a huge difference to families in meeting their exceptionally challenging needs every day. My constituent Emma worries about her ability to keep working and her financial stability. If a scheme were available to support her financially, she would not have to worry.

The Government claim to care about women’s health and making a change. Their vision for women’s health, announced in December, is

“to improve the way in which the health and care system listens to women, and to reset our approach to women’s health by placing women’s voices at the centre of this work.”

They then directly cited Baroness Cumberlege’s review, stating:

“Independent reports and inquiries—not least the report of the Independent Medicines and Medical Devices Safety Review…have found that it is often women whom the healthcare system fails to keep safe and to whom the system fails to listen.”

The Government accept the review and use it, but will not deliver on it. They will not truly listen to those who have been campaigning for justice for years and do right by the families. They will not take the opportunity to reset their approach to women’s health and place women’s voices at the centre of their work by implementing all the recommendations.

In November, I wrote to the Secretary of State for Health and Social Care to ask him to consider establishing a taskforce to implement all the recommendations of the review to put these injustices right. I am still waiting for a response. How can the Government claim that they are taking the review and women’s health seriously if they cannot even respond to a letter from a Member?

Will the Minister please commit to implementing the remaining recommendations? If not, will she explain how not implementing the full recommendations of the Cumberlege review changes anything, or helps to create a system that keeps women safe and listens to them? It is time for her to stand up for the families affected by Primodos, sodium valproate and surgical mesh, and for the Government to stand by their vision by implementing the recommendations in full. Otherwise, we will fail these families and these women again and again.

--- Later in debate ---

[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.

--- Later in debate ---

[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

Mike Penning Excerpts

Monday 6th December 2021 Westminster Hall

[Mike Kane (Wythenshawe and Sale East) (Lab)]

It is a pleasure to serve under your chairmanship, Sir Roger, and a real honour to follow the hon. Member for Carshalton and Wallington (Elliot Colburn), whose speech was exemplary. I thank him for leading this e-petition debate and I thank those who secured it. To get more than 100,000 signatures for something so rare is incredible. I also thank the right hon. Member for Hemel Hempstead (Sir Mike Penning), who leads admirably on this subject across the House. He has my full support on anything going forward.

[Sir Mike Penning (Hemel Hempstead) (Con)]

I will hold you to that.

[Mike Kane]

The right hon. Member heckles me: he will hold me to that, and so he should. He will not find me wanting.

It is a great honour to talk about FOP today. I am here on behalf of a young constituent, Oliver, who lives in my constituency of Wythenshawe and Sale East, with his brothers Leo and Harry and his mum and dad, Chris and Helen. I welcome Chris, who is here today in the Gallery, and thank him for taking the time to tell me about Oliver and how FOP has impacted their family life.

Oliver, who is now 14, was diagnosed with FOP in 2009. It impacts one in 2 million people. There are just 800 diagnosed cases in the world and only 50 in the UK. It is effectively a single letter that changes or mutates in the genome and over time results time in bone growth in muscles, ligaments and tendons. Usually, children are severely impacted by the time they are 10 years old. They are often contorted and immobile by the age of 20 and have an average life expectancy of around 40 years.

I have enjoyed hearing about Oliver and how he loves to read, play badminton and go to scouts, including to camp, where he slept in a hammock in the rain—not something I would do, but a mark of his extraordinary resilience. Oliver and his family really have shown resilience in the face of adversity, as do many families who suffer with the condition.

It is right for me also to pay tribute to the staff and pupils at Oliver’s school, Sale High in my constituency, who have given Oliver the opportunity to become more independent and to make friends on his own terms. They let him leave lessons shortly before the end of class—apart from history, where he insists on staying until the end because it is his favourite subject—so that he is not jostled in the corridor while moving from classroom to classroom. Those small adjustments give Oliver and his friends the opportunity to live as every 14-year-old should, with increasing independence and agency. May I place on record my personal thanks to Jayne O’Grady, who I know well as headteacher at Sale High School? She does a remarkable job, and I look forward to continuing to work with her to improve the fabric of that school, which is so desperately needed.

Oliver’s family and the wider FOP community have been phenomenal in their efforts to secure funding for FOP. The charity that they have set up, FOP Friends, is the only charity in the UK that focuses on research into the condition. It receives no Government funding at all. It is believed that advances in FOP research could have implications for more common bone conditions. If we know why bone forms in the way it does in FOP, researchers think that the same knowledge could be applied to people with limb damage and osteoporosis, and it could be helpful in cases of joint replacement. Developments made in FOP could eventually save the NHS money in care costs.

Although rare diseases are individually rare, within the population they are quite common, affecting one in 17 people at some point in their lifetime. The Government recognise the challenges faced by people affected by rare diseases, including ultra-rare conditions such as FOP, and in January 2020 they published the UK rare diseases framework, whose goal is,

“to help patients receive a final diagnosis faster”.

It also seeks to raise awareness of rare diseases among healthcare professionals. For example, there are only three doctors in the UK who have a specialist interest in FOP.

In summing up, I pay tribute to Oliver and ask if there is more that we can do to enable people like Oliver and others diagnosed with rare diseases in the UK to feel confident that we hear them and will support research into FOP, in line with the Government’s own framework.

[Sir Mike Penning (Hemel Hempstead) (Con)]

I have served under your chairmanship for many years, Sir Roger, and it is a pleasure to do so again today. Many of us in this room are parents, grandparents or godparents to children. What is so amazing about the petition we are debating is how quickly over 100,000 people said, “We have to do something about this,” for such a rare condition. Petitions come and go, but we only have to look at the photographs to see what the condition does to human beings. We only have to Google FOP and look at the videos on Facebook and other sites to see the devastating effect it has on people’s life expectancies and on their loved ones.

For me, every child deserves the chance to have a childhood, but the condition—for all intents and purposes—removes that. It is a life-damaging, life-reducing condition that is so rare, as my colleagues have said, that very often when it is presented to top physicians and consultants with over 30 years of experience, they have never seen it before. In my constituents’ situation, when Alex and Dave first saw Lexi—they already had a lovely child, Ronnie, who is now three—they looked at the child, like we all do when we first see our grandchildren or children, and said, “There is something wrong.” When they said to the specialists that “There is something wrong with her feet”, they were told that she had bunions —she was a new-born child. Rightly, they questioned it. They questioned it and questioned it and, in the end, Lexi was probably the youngest child in this country to be diagnosed with FOP.

The family joined what is now FOP Friends, and that community has been formed to try to do two things. One thing is to understand how and why FOP progresses and how to stop that progression—I will come back to that in a second. The second thing is to try to understand for other parents how not to have a child with a genetic change at conception and to actually allow things to be addressed. That research is being done only in one place in the country, and that is Oxford University. It is purely funded by FOP Friends.

I have worked with colleagues in Pennsylvania and around the world on FOP, and we do not know how many children are born with FOP around the world. They are born with it; it happens at conception. We do not really know how many children are born with it, because in other parts of the world they do not even understand what FOP is. There is a really dynamic specialist in America, who has worked with families over many years. In America, there are groups that come together from all over America. I saw a video of them barn dancing together only the other day. Many of them are frozen in their skeletons. I circulated some photographs to colleagues earlier on. Those photographs—for anybody who has a heart—are heartbreaking. An eight-year-old child in one of those photographs has a deformity in her spine, which is frightening for the parents.

What we need to do, perhaps, is say this to the Government, from across the House and across society. The Government are doing wonderful work. Governments have done wonderful work, but this Government in particular are doing wonderful work in the area of rare diseases and conditions. But this disease is so rare that it falls out the bottom. How can it be right, in this day and age, that we have to fundraise? There was a wonderful fundraising event done by my local football club, Hemel Hempstead Town football club, to raise money for research. That research will benefit the NHS and, as was said earlier, will have knock-on effects for other conditions, on how bone structure grows and how it does not grow, on why it grows and where it grows.

As a result of this condition, there is a child, my constituent, who is probably never going to crawl. She will probably walk before she crawls. She is never going to have that experience. Her parents will never have the experience of saying, “Where has she gone?”, which we have all had with our children when they have been crawling away and exploring life, because her neck is now starting to freeze, at 10 months of age.

What I would say to the Minister is this. We can go into great detail, as my colleague and hon. Friend the Member for Carshalton and Wallington (Elliot Colburn) did, about the different types of research. We can go into the different reasons as to why we cannot do it. I am sure the Minister will turn round and say, “Well, I can’t give a blank cheque, so let’s see what the research can produce.” But until we know how much money we have for the research, we cannot actually say what can be done.

There is a small group of us in this Chamber today. My hon. Friend the Member for South West Hertfordshire (Mr Mohindra) could not be here with us this afternoon, but I know he wanted to be. However, I have spoken to lots of colleagues across the House, and we are not going to go away. Of course, much depends on what the Minister says. She may shock us all and write a blank cheque, although I fully understand why she probably will not. But we do need some progress. We need to say that these children are so important. It does not matter if there is one in a million or 500 in a million. These children’s lives and their futures are important, and we need some progress so that they can possibly see some light at the end of the rainbow.

These parents are doing everything they can for their loved ones. Is it not about time that the Government, and we in Parliament, did everything we can for these children? By the way, I think we probably need to fill the House of Commons main Chamber in a debate on this subject, because the more people hear about it, understand it, see the photographs, see the distress and see children who had their childhood robbed from them when they were conceived, the more chance we might have of getting the money in the two areas where we need the research.

[Ian Paisley (North Antrim) (DUP)]

Thank you, Sir Roger, for calling me to speak in this debate. I add my congratulations to the mover of the motion on the petition today, the hon. Member for Carshalton and Wallington (Elliot Colburn). I am grateful that we all have an opportunity to speak about this rare disease and how it affects some of our constituents.

It is absolutely amazing that we are actually having this debate, when we consider how rare this disease is. That says something about the temerity of and strength of feeling among those who are in FOP Friends, those who suffer from the condition and those in our society who are just genuinely concerned about it. This matter weighed so heavily upon them that it had to be brought to the House. When I consider that one in a million or one in 2 million may have this condition, it is amazing that they have been able to lobby, cajole, persuade and encourage people to sign this petition and get it to the Floor of the House. That fact should not just be left on its own. It should not be underestimated just how significant an effort has been made by so few. It is important.

My constituency has, I think, the largest petitioning group in Northern Ireland—658 petitioners—and across every constituency in Northern Ireland between 100 and 200 constituents did this, yet in Northern Ireland there are known to be only two cases. That says something about the power of lobbying, and it puts a great onus on Members of this House that our communities have felt so strongly that this matter has to be debated even though it affects a very small section of our society. That is what Parliament is about: helping the most vulnerable; helping those who are left behind and can be forgotten. It is absolutely certain that without this debate, FOP would hardly have been heard of. It would have been discussed among those who had a genuine interest in it, or a connection with someone who has the condition or with their family, but to debate it on the Floor of the House is incredibly important—indeed, it is a landmark, and it is important to say so.

Each Member who has spoken so far has mentioned an individual who they have known, and I have been contacted by Lucy Fretwell and Zoe, her sister, who both have this condition. It is incredibly rare that one sister would have this condition, but both do. They wrote to me to say that FOP

“only affects one in a million people. Unfortunately, FOP has affected my sister and I and we have been diagnosed with the disease. Zoe and I have been living with it for 30 years. We are the only two people in Northern Ireland that suffer from FOP.”

She was so concerned that this matter must be debated, and she implored Members to be in this debate, so it is a privilege for me to speak for Zoe and Lucy today.

[Sir Mike Penning]

Part of this debate is about the fact that we do not really know how many people have this condition. I have referred to the misdiagnoses that we have seen—we can google them. People have had amputations in other countries because they thought this condition was cancerous, and the amputation made it worse. If we had better diagnosis and better expertise and knowledge out there, I think the figures would be much higher in the province.

[Ian Paisley]

The right hon. Gentleman is absolutely right: it is only through awareness that we know this condition is probably much broader and deeper in our society. Those few who have been diagnosed are obviously encouraged and energised to write to us and lobby about it, but he is absolutely right that they are only the tip of the iceberg. Those people know about the condition, but many others do not. I for one do not believe that over 3,000 people from Northern Ireland petitioned us on this matter because of two people. There are many more across our society, but we have to look at the facts that are in front of us and relay them to the House.

I will make one other point in today’s debate, which is that the Government have a framework for dealing with rare diseases. That UK framework is critically important, because it commands the Government to do two things: help patients and increase awareness. Today, we are doing the second part of that. We are increasing awareness by having this debate and encouraging the Government to be more active and respond on these matters. Increasing awareness is vitally important, but when it comes to helping patients, no Member of this House can do anything about that. It is the Government who can do something about it by doing what these petitioners ask for: directing resources into research into this rare disease, making sure that that research not only is dedicated and focused, but hopefully leads to outcomes.

If there is any country in the world that should be proud of what medical research delivers, it has to be this nation. Look at what we have delivered over the past two years through targeted, effective research. If that is what we can do under emergency conditions, what more could we do if there were some targeted research and resources directed at this condition?

Like many others, I implore the Government to listen to the pleas of Lucy, Zoe and the many thousands of others who we are aware of. I encourage the Government to respond positively to this petition.

--- Later in debate ---

[Ms Anum Qaisar (Airdrie and Shotts) (SNP)]

It is a pleasure to serve under your chairmanship, Sir Roger. I thank the hon. Member for Carshalton and Wallington (Elliot Colburn) for leading this important debate. I am not aware that anyone from my constituency of Airdrie and Shotts has been diagnosed with FOP, but I thank everyone who signed the petition, including 104 people from my constituency.

I thank the hon. Member for Wythenshawe and Sale East (Mike Kane) for so clearly setting the scene. I echo his comments about more funding being required. I was heartened to hear that Oliver’s school is making appropriate changes to accommodate him. As a former teacher of social subjects, I am especially pleased to hear that history is one of his favourite subjects—that brings me great joy.

I completely agree with the right hon. Member for Hemel Hempstead (Sir Mike Penning), who said that FOP is incredibly rare and that it is indicative of democracy that so many people have signed the petition. I thank him for telling Lexi’s story and for all the work that he does to raise awareness of FOP.

As the hon. Member for North Antrim (Ian Paisley) said, the power of lobbying is so vital to democracy, so I welcome the fact that this rare disease has been brought to the House’s attention. He spoke powerfully about sisters Lucy and Zoe and how they are the only known cases in Northern Ireland. I echo his comments about the genuine concern that misdiagnosis could mean that the figures are higher than we think. I also thank the hon. Member for South West Bedfordshire (Andrew Selous), who spoke powerfully of the positive progress that has been made in tackling and raising awareness of this rare disease.

Let me take a moment to thank Chris for launching the petition. As has been said, Chris and his family created FOP Friends after his son, Oliver, was diagnosed with this rare disease. At the time of Oliver’s diagnosis, there was no charity in the UK that focused on supporting those with the disease. Since its creation, FOP Friends has helped to support those with FOP and their families, and to raise genuine, good public awareness about the need for medical research into the disease.

There is no known cure for FOP. The disease is caused by a mutation in a gene, a mutation that was only discovered some years ago. The rarity of the disease means that research in the United Kingdom has been limited, as has been stated already. Only the University of Oxford has a dedicated programme looking into FOP, with most of the funding for the research coming from donations from charities such as FOP Friends.

[Sir Mike Penning]

I just want to pick the hon. Lady up on something. If I am wrong, perhaps the record will be corrected, but I think that all the funding—all of it—comes from fundraising by FOP Friends. That is a very important point.

[Ms Qaisar]

The right hon. Member is correct that all the funding comes from FOP Friends. I misread my notes, for which I apologise.

The lack of proper funding for research is holding back progress in finding a cure. Further progress can be made by improving the levels of potentially international co-operation in research into the disease.

The benefits of finding a cure for FOP are numerous. As was said by the hon. Member for South West Bedfordshire, those benefits might not just be limited to helping those with FOP. By improving our knowledge of what causes FOP and potentially finding a cure, the medical profession may gain invaluable insight to help it to combat more common health problems, such as osteoporosis, fractures and even battlefield injuries.

In January 2021, the UK rare diseases framework was released. It aims to improve the lives of those living with rare diseases, such as FOP, and it proposes a four-nation approach to support those living with a rare disease. That includes nation-specific action plans that aim to improve the effectiveness of combating rare diseases. It is hoped that the framework will help patients to receive quicker diagnosis, will increase awareness within the healthcare profession about spotting the signs of rare diseases, such as FOP, and will improve access to specialist care, treatment and drugs.

The Scottish Government understand the importance of the framework and are committed to implementing the 51 commitments outlined within it. They also welcome the progress that has been made in Scotland in delivering genomic medicine and in empowering patients through the UK’s rare diseases forum. Of course, still more can be done. Over the next two years the Scottish Government will continue to develop an action plan that works closely with the rare diseases community. The consultation will ensure that those with a rare disease, including FOP, are appropriately reflected in governmental policy. That will ensure that those with rare diseases have proper access to services in areas such as mental health and social care. The Scottish Government remain fully committed to ensuring that there is continual improvement in supplying patient-centric care that is safe and effective for those living with a rare disease.

To better detect rare diseases such as FOP, the Scottish Government have allocated an additional £4.3 million over the next two years to ensure that regular genetic testing includes tests for rare diseases. Improvements in genetic testing will help to increase the number of rare diseases picked up by these tests, allowing doctors to provide the correct support and treatment for patients. The Scottish Government are committed to doing what they can to improve the lives of those living with rare diseases, but they fully appreciate that more still can be done.

[Sir Mike Penning]

I appreciate that this is a devolved matter, but in many cases these children do not have two years. The hon. Lady has seen some of the photographs, so she knows the condition that will deteriorate further with these life-threatening diseases while the consultation goes on for two years. As I say, I appreciate the matter is devolved to Scotland, but as with England and Wales, Scotland has to say, “Two years is too long. Let’s sort it out now.”

[Ms Qaisar]

I thank the right hon. Member for his contribution. I do not think that anyone would disagree that all Governments need to do more in tackling the problem. He spoke, very powerfully, of his constituent, and it is incredibly important that Ministers in all four nations are listening very clearly.

In conclusion, I hope that the Minister, and the Government, will agree that more funding is required to combat rare diseases such as FOP. I look forward to hearing her contribution. The petition has helped to raise awareness of an incredibly rare disease, and I again want to put on record my thanks to the family for bringing the issue to the Floor of the House and encouraging people to sign their petition. It highlights the need for action by Governments to combat rare diseases. I hope it is not too long until we find a cure for FOP, for Oliver and for loads of other children like him across the four nations.

[Feryal Clark (Enfield North) (Lab)]

It is a pleasure to serve under your chairmanship, Sir Roger. I thank the hon. Member for Carshalton and Wallington (Elliot Colburn) for introducing the debate on behalf of the Petitions Committee. As we have heard, despite fibrodysplasia ossificans progressiva—or FOP—being an ultra-rare disease affecting only one in a million, more than 111,000 people have signed the petition, including 162 people from the hon. Member’s constituency and 108 from my own, showing the high level of public support for the issue.

I pay tribute to the contribution from the right hon. Member for Hemel Hempstead (Sir Mike Penning), whose constituent, Lexi, has recently been diagnosed with FOP, and to Lexi’s mother, Alex, and father, Dave, who have been instrumental in the petition’s success while also raising awareness and money for research themselves. I was pleased to see that there were signatures from across the country, but the support from Hemel Hempstead massively outweighed that from anywhere else, evidencing the incredible drive and leadership shown on Lexi’s behalf. Again, I pay tribute to the right hon. Member. He and colleagues who have spoken today have all highlighted the issues around the lack of funding and the need to raise awareness.

We have heard lots of excellent contributions, so I also pay tribute to my hon. Friend the Member for Wythenshawe and Sale East (Mike Kane) and the hon. Members for North Antrim (Ian Paisley) and for South West Bedfordshire (Andrew Selous) for highlighting their constituents’ cases and the issues around funding and the lack of awareness. It is incredibly shocking that the only source of funding for research into the disease is from FOP Friends, so I also recognise, and thank it, for the work it has done.

As we have heard, FOP comes from mutation of the ACVR1 gene, causing muscles, tendons and ligaments to convert to unwanted bone growth, starting from a very young age. It debilitates and disables, before progressing to cause immobility and ultimately death. While progress happens at different rates, both naturally and because of the trauma it induces, most people with FOP are immobile by the age of 30.

[Sir Mike Penning]

The hon. Lady has touched on an enormously important point that I did not mention in my comments. Lots of people think this is all about trauma—that it is all about bruising or impact—but for a lot of people with this terrible condition, there is no logic. There is no trauma; it just develops and goes through. We have the two sides of it. Trauma, yes, and that is where the research into this particular condition is so important.

[Feryal Clark]

I absolutely agree. There is a need for investment into research of all aspects of this illness. Life expectancy for people with FOP is, on average, 40 years, which is absolutely shocking. It is a horrible condition that nobody would wish on their worst enemy. It is clear that we all agree on the need to act to improve outcomes for the approximately 70 people in the UK who we know of who are suffering as well as for everyone living with it across the world. Thankfully, we know that action can be effective, both in diagnosis and care.

The average age at diagnosis is eight years old, despite the existence of genetic tests to confirm diagnoses and other signs that occur far earlier than that. Usually, the benefits of early diagnosis are common sense—it is just a matter of time, and time spent untreated is time in which a disease or condition can worsen. However, FOP is different. As I and other Members mentioned, trauma generates FOP activity, worsening the condition and speeding up its progress. Any time spent undiagnosed is time when trauma can occur unknowingly, not least in young children, who are not particularly robust or careful; I have a seven-month-old myself, so I know it is really difficult to prevent little babies from moving around. We do not need to stretch our minds to imagine the accidental trauma that could take place in a child with FOP up to the age of eight.

In the first instance, early diagnosis avoids the need for investigative diagnostic procedures that can themselves trigger irreversible FOP activity in an individual, and it does not stop there. Early diagnosis means other adaptations can be made at home and school, and my hon. Friend the Member for Wythenshawe and Sale East spoke of the adaptations made in school for Oliver. It means that alternatives can be used to potentially damaging immunisations, usually injected into muscle; knowledgeable clinical care can be established; and of course, simple behavioural changes can be made to avoid unnecessary trauma in these individuals. Those simple things can make a tremendous difference, yet the genetic test that can make that happen can be requested only by specialist clinicians, of which there are not many. Given how few people suffer from FOP, the likelihood of that request happening prior to diagnosis seems monumentally low, let alone its happening an optimal time. The directory of approved tests for the NHS genomic medicine service will be updated next April, and we heard hon. Members call for the Government to ensure that the FOP test is included. I hope to hear the Minister commit to heed those calls.

I also urge the Minister to explore other avenues, such as technology to improve doctors’ awareness of symptoms or new born genetic screening, which will have impacts far beyond FOP and could help many of the one in 17 people who live with a rare condition. The Government have already set out their vision for this in the UK rare diseases framework, so I do not think anything new is being asked for today—simply for them to follow through on their promises.

Just as with diagnosis, it is often the case that the most difference can be made to rare diseases by improving standards of care. For those living with FOP, that can also be transformative. With so few specialists or experienced clinicians, it is no surprise that levels of care vary, but that does not mean that the status quo has to be maintained. The nature of FOP means that some activity needs urgent action, and of course, specialist assistance is needed throughout. The UK rare diseases framework offers an opportunity here, too. I am keen to hear from the Minister the Government’s plans to improve care for those with FOP universally through that mechanism and to ensure that all those living with FOP now and in the future get the care that they need.

My final point is a broader one that applies to rare diseases in general. We have many of these debates, and quite rightly, because every person who lives with a rare disease has a different experience. Collectively, rare diseases affect as many as 3.5 million people across the UK. Although individual approaches are needed, a collective approach is also important. I welcomed the publication of the UK rare diseases framework, because not only can collective action help to improve standards of diagnosis, treatment and care, but individual approaches can help others. For example, as we have heard, increased research into FOP could help joint replacements, military injuries, burns, sporting injuries, osteoporosis, heart disease, chronic anaemia, and even brain cancers. That principle will apply across the rare diseases spectrum. It is disappointing that after the rare disease framework was published, the then public health Minister confirmed that no new funding had been allocated. My ask of the Minister, and my question to the Government, is simple: how will the Minister deliver on the priorities that the Government set out in that framework?

[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?

[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.

--- Later in debate ---

[Elliot Colburn]

I thank colleagues for their contributions today. I feel that the debate has demonstrated the House at its best. We have heard some really powerful contributions. It was a pleasure to hear more about Oliver’s story and life from the hon. Member for Wythenshawe and Sale East (Mike Kane). I express my thanks to him for bringing that to the debate. My right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) has been a real champion of this issue for so many years; we are truly privileged to be party to his expertise and knowledge in this area—I thank him.

[Sir Mike Penning]

There is a lot of praise going around this House for the MP for Hemel Hempstead. However, Alex and Dave Robins are the reason that my constituents have signed the petition the most. They deserve the praise—not the MP for Hemel Hempstead.

[Elliot Colburn]

My right hon. Friend is absolutely right—he has taken my next sentence out of my mouth. If he could also pass on the best wishes of the whole House to Lexi, I am sure that hon. Members—

[Sir Mike Penning]

My hon. Friend should come and see her.

Health and Care Bill

Mike Penning Excerpts

Report stage
Tuesday 23rd November 2021 Commons Chamber

[Carla Lockhart]

I will not push either of my new clauses to a vote. However, legal clarification on sex-selective abortion is urgently needed for the sake of women and the missing girls who are the victims of this abhorrent practice.

I commend the hon. Member for Congleton (Fiona Bruce). As evidence changes, so should the law, and 22 weeks’ gestation is the point of foetal viability. At heart, this is a debate about human rights, and the most basic human right is the right to life.

[Sir Mike Penning (Hemel Hempstead) (Con)]

I support new clause 19, which I signed, and will wait to see what the Minister says about it.

I want to take issue with the shadow Minister, the hon. Member for Ellesmere Port and Neston (Justin Madders), who turned around and said to Ministers, “Be careful what you wish for.” Our constituents send us here to represent how their taxation is spent in the NHS. When trusts are refusing to build new hospitals in our constituencies when they have the money to do so, and they want to refurbish hospitals and ignore public opinion and their local MPs, that is where the system goes wrong. I am not saying we should go all the way back to the old system, but there should be accountability in trusts when they do not do what our constituents would expect from them. My constituents would expect me to stand up and say this, because we want a new hospital on a greenfield site to look after the people of west Hertfordshire and our trust is refusing. If the shadow Minister ever becomes a Minister, I hope he has those powers.

[Edward Argar]

This group of amendments has clearly been popular and it is a shame that more right hon. and hon. Members did not get to speak. My remarks will be relatively brief.

On the contributions by my hon. Friend the Member for Congleton (Fiona Bruce), my right hon. Friends the Members for Gainsborough (Sir Edward Leigh) and for Basingstoke (Mrs Miller) and the hon. Member for Upper Bann (Carla Lockhart), those are deeply emotive and important issues. I entirely respect the strength and sincerity of genuinely held feelings on both sides of the debate. It is important that such matters are aired in the House, but they quite rightly remain a matter of conscience for individual Members, so I shall say no more than that it is important that everyone recognises the genuine views on both sides of the debate.

I am grateful to my hon. Friend the Member for Basildon and Billericay (Mr Baron) for tabling his new clause 19 and am happy to say that the Government are content to accept it. I know that my hon. Friend’s first concern is the quality of cancer services in this country and the welfare of the patients that they serve. I am pleased that he is keen for us, in accepting the new clause, to explore ahead of the Lords stages of the Bill whether it may give rise to any unintended consequences, with a view to supporting any changes that might need to be made. I look forward to working with him on that in the coming weeks before the Lords stages.

Medical Cannabis under Prescription: Children with Epilepsy

Mike Penning Excerpts

Wednesday 3rd November 2021 Westminster Hall

[Sir Mike Penning (Hemel Hempstead) (Con)]

May I say what a moving speech that was by the hon. Member for Middlesbrough (Andy McDonald)? That sort of personal experience is exactly what this issue is all about.

I came into politics to help. To my knowledge, I do not have a single constituent who benefits from a prescription for medical cannabis, but that does not make it any less important that I campaign on behalf of the all-party parliamentary group. I could not disagree with a single word in the speech by my hon. Friend the Member for South Leicestershire (Alberto Costa), who succeeded me as co-chair when I stepped down.

In 2015, as the Home Office Minister responsible for drug policy in Government, and sat where the Minister is sitting now, I made a speech saying that the Government were minded to allow the prescribed medical use of cannabis. I did not say that for the sake of it; I said it because the then Home Secretary, my right hon. Friend the Member for Maidenhead (Mrs May), gave me permission to do so. She went on to be Prime Minister, and one of the reasons why Alfie got his medication, and why the Caldwell family’s campaign was so successful in the Province, was that she picked the issue up and said, “We are going to do something about this.” In 2018, the then Home Secretary was able to change the law for that reason.

I say to all colleagues, and to anybody listening to the debate, that this issue is not about rolling a cannabis joint. It is about a group of children, some of whom have clicked over into adulthood now, who may well not have been here today were it not for some very brave consultants turning their backs on what the profession was telling them to do, and doing instead what was right for those children. Those consultants have come under enormous pressure not to sign the prescriptions.

When we drafted the legislation, we were very careful to ensure that it was not up to GPs alone to issue the prescriptions. We did not want to get into another opioid situation—I will not say that opioids are prescribed willy-nilly, because that would be unfair, but we know there is an opioid epidemic. We specifically said that the GP had to refer the child to a specialist, and that it would be for the specialist to decide. A few have been brave enough to do so.

Sadly, as my hon. Friend the Member for South Leicestershire mentioned, and as the parents were telling us only yesterday when they were here lobbying colleagues, some of those consultants are retiring, and of those who want to prescribe medical cannabis, some are too frightened that they will be referred to the professional body. If they do prescribe it, their employers are refusing to honour the prescription. I thought we had an NHS that was free at the point of delivery when an NHS prescription is issued.

I have no notes—I have no need for them. I have discussed this issue so many times in this Chamber, as well as in the main Chamber, where I will be tomorrow. Politicians get it; Secretaries of State get it; the Minister gets it. But parts of the medical profession do not get that they are responsible for keeping these young children alive, and that they need to get off their butts and do so.

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[Patrick Grady (Glasgow North) (SNP)]

It is a pleasure, once again, to serve under your chairmanship this afternoon, Ms Bardell. I would not often say that I agree with every word said by a Conservative Member, but in the case of the hon. Member for South Leicestershire (Alberto Costa), it is accurate. He gave an incredibly considered speech. It is great to hear the consensus that exists in this room.

We have today’s debate, my hon. Friend the Member for Inverclyde (Ronnie Cowan) has a more general debate tomorrow on the medical use of cannabis, rather than in cases of epilepsy, and the hon. Member for Manchester, Withington (Jeff Smith) has introduced a private Member’s Bill on the issue. That shows the cross-party consensus, the momentum and the urgency of the issue. Everyone today is speaking about their constituents’ experiences. I pay tribute to all the families and campaigners who have come forward and are prepared to speak out. I met with some yesterday at the End Our Pain lobby. Plenty of my own constituents have lobbied on the issue, because they have been moved by the stories they have heard, and I have a particular case.

The name of the campaign, End Our Pain, says so much. It is the pain that the individual children, and the adults, are experiencing with their medical conditions. It is the psychological pain the families are going through as well, having to watch the physical pain that their children are suffering. All that pain can be, at the very least, mitigated, if some of the steps that we have heard about are properly taken.

I have spoken previously about my constituents John and Laura and their beautiful daughter Bláthnaid, who is affected by Aicadri syndrome, which is a very severe and rare form of epilepsy. There are only several thousand cases worldwide. It is very difficult for clinicians to know what might or might not work. It is incredibly distressing for both the parents and the children, who do not understand what is happening when they go through these seizures. Many of the conventional medicines that are tried have their own side effects that cause particular difficulties, or resistance builds up, which increases a different kind of suffering.

[Sir Mike Penning]

Is the hon. Gentleman aware that doctors are prescribing off-label drugs that work for adults, particularly steroids, to these children, but they are not willing to look at medical cannabis?

[Patrick Grady]

Yes, and a few years ago we had the Off-patent Drugs Bill, which sadly did not make as much progress as it could have done. That had the potential to give doctors more freedom, which is clearly one of the messages coming out of the debate. Of course there will be an element of risk, but there has to be a way of managing and mitigating it so that doctors can feel more confident about prescribing cannabis-derived treatments.

When my constituents see the positive effects that CBD can have, they wonder what effects a drug with THC might have. When they see the benefits to other children, even though every case and condition is unique, the potential must exist there, and when the alternative is to go private and pay incredible amounts of money, which is not without its own risk, the frustration becomes very real, so the Government have to speed up the trials and the opportunity for people to take part in them. They have to look at how the licensing can improve and how we can increase the confidence of doctors. Above all, they have to listen to the voices of parents and patients, and their carers and advocates in Parliament.

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[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.