Medicines Regulation

Nick Thomas-Symonds Excerpts

Tuesday 21st November 2017 Westminster Hall

[Helen Goodman (Bishop Auckland) (Lab)]

I beg to move,

That this House has considered the future of medicines regulation.

What a pleasure it is to see you in the Chair, Mr Davies. I am very pleased that you have been elevated to the Panel of Chairs. Yesterday, the European Parliament agreed to move the European Medicines Agency from London to Amsterdam. Today, we are asking the Minister to tell the British Parliament what will happen to medicines regulation in this country after we have left the European Union. My concern arises from the fact that I have a GlaxoSmithKline plant in Barnard Castle in my constituency that employs 1,200 people. Winston Churchill decided that production should take place in the middle of the Durham countryside, so it would not be hit by Hitler’s bombs; I certainly hope that it will also survive the Government’s Brexit.

[Nick Thomas-Symonds (Torfaen) (Lab)]

I congratulate my hon. Friend on securing this timely and important debate, and declare an interest as the chair of the all-party parliamentary group on off-patent drugs. Does she agree that, irrespective of what happens with the Brexit negotiations, the Government should guarantee that any patient who needs access to drugs will not wait any longer as a result of Brexit?

[Helen Goodman]

In one sentence, my hon. Friend gets to the nub of the issue; I will probably take 20 minutes to reach it. He is absolutely right. The problem is that the Government did not make a plan, and as yet have not resolved how they will regulate medicines from 1 April 2019. I have been asking about that for a year. We have had no clear explanation, no policy statement, and no impact assessment. The Government refused to debate the matter in the course of the legislation for triggering article 50. We have not been able to debate it properly as part of the scrutiny of the European Union (Withdrawal) Bill, which is in Committee today, in parallel with our debate.

We are therefore extremely interested to hear what the Minister will say, especially as two months ago there were leaks from the Department of Health that the Secretary of State was flirting with the idea that we should leave the EMA and join the American Food and Drug Administration. I was particularly surprised that that was being floated, because the Association of the British Pharmaceutical Industry has said consistently that it thinks that we should be aligned with EMA standards. Alignment with Europe on regulation of medicine does not simply mean having the same rules on exit day; it means having a mutual recognition agreement with the EMA, and continued alignment of future regulations as they change, which they inevitably will.

Mental Health Units (Use of Force) Bill

Nick Thomas-Symonds Excerpts

2nd reading: House of Commons
Friday 3rd November 2017 Commons Chamber

[Mr Steve Reed (Croydon North) (Lab/Co-op)]

I beg to move, That the Bill be now read a Second time.

Seni Lewis was a young graduate embarking on his life, aged 23, and living with his parents in Thornton Heath, when he suffered his first ever mental health episode. His parents recognised what was happening and took him to their local hospital. Seni ended up in the Bethlem Royal mental health hospital in Croydon. His parents stayed with him all day, but had to leave at 8 o’clock in the evening. Seni became very agitated when he realised they had gone, and he tried to leave, too. According to the coroner, the staff lacked the training to deal with him, and although there are no allegations that he attacked anyone, they called the police. Eleven police officers took Seni into a seclusion room and, using pain compliance techniques—the kind used against violent criminals—they took it in turns to hold him face down on the floor for 30 minutes in total. His hands were cuffed behind his back, and his legs were in restraints. They held him like that until he could no longer breathe, and he suffered a heart attack. He went into a coma, and four days later Seni was dead.

The coroner criticised Seni’s treatment as “disproportionate and unreasonable”. No patient entering a hospital for care should suffer and die in the way that Seni did. But the family’s agony did not end there. It took seven years of struggle by Seni’s grieving parents until an inquest was finally opened only this year. The coroner found severe failings by the police and the mental health services, and she gave the stark warning that

“there is a risk that future deaths will occur unless action is taken.”

That action is this Bill. What happened to Seni Lewis is not an isolated incident. According to the Independent Advisory Panel on Deaths in Custody, 46 mental health patients died following restraint between 2000 and 2014.

[Nick Thomas-Symonds (Torfaen) (Lab)]

I am grateful to my hon. Friend for bringing forward this very important Bill. Many families in my constituency have contacted me, including some affected by autism, and they are very concerned about the kind of face-down restraint that he has described so movingly in talking about this case. Does he agree that it is very important to have boundaries on the use of this restraint, and that families have some certainty about what can and cannot happen in such facilities?

[Mr Reed]

I completely agree, and I am delighted that the National Autism Society fully supports the Bill and its provisions.

I was talking about the number of patients who have died following the use of restraint, and the many more who have been seriously injured. Government guidelines say that face-down restraint is so dangerous it should not be used at all, but it was used over 9,000 times in the last year alone, including 2,500 times against children as young as seven. People who have been restrained talk about the experience with horror. They say that it is frightening, painful and humiliating, and they feel stripped of their dignity. In the words of one woman:

“It made me feel like a criminal, like I had done something wrong, not that I was ill and needed to get better.”

Statistics from the campaign group Agenda show that women are more likely to be restrained face down on the floor than men. Up to half of all women in mental health hospitals have been physically or sexually abused by men. Subjecting these women to face-down restraint by groups of men adds to the trauma that in many cases led to their mental illness in the first place.

It is difficult to understand clearly from the existing data what exactly is going on. There is no standardised way of recording why, when or how restraint is used. However, from their own data, there appear to be wide discrepancies between mental health providers. Some restrain as few as 5% of patients, while others restrain over 50%. There is no good reason for that variation.

Pompe Disease

Nick Thomas-Symonds Excerpts

Tuesday 31st October 2017 Commons Chamber

[Nick Thomas-Symonds (Torfaen) (Lab)]

I am delighted to have secured this debate to raise awareness of the very rare condition known as Pompe disease. I hope that the very holding of this debate will contribute to that, and I look forward to the Minister’s response, and hope that he will set out some constructive suggestions on what we will do going forward to deepen knowledge and understanding of this awful disease.

My journey towards an involvement with Pompe disease and securing this debate began when I was visited in my constituency surgery by my constituent John Foxwell. He is a polymath. He is an award-winning author and publisher, specialising in communication technology. He worked for his community, too. He lives in my constituency at present, but he previously lived in Devon where he was both an elected councillor and served as mayor, and was also a trustee and director of his local food bank.

Drawing widely on his experience as a teacher and headteacher, John Foxwell has contributed to UK Government policy over the past 20 years. He has managed national educational projects including the first education action zone and the Building Schools for the Future project, and contributed to education White Papers. His reports on education have been drawn on by international companies. Prior to that, he worked in buying and merchandising for a multinational cycle and auto retailer. Knowing the importance of communication, he also founded companies that assisted those who come to the UK from other countries, developing translation tools and assisting community cohesion.

Now, however, John Foxwell has had to leave that remarkable career behind him. He has to spend up to 15 hours a day on a mechanical ventilator to enable him to breathe, as his diaphragm is paralysed. He cannot walk far, or lift or bend or lie flat—if he did, he would struggle to breathe—and he falls easily. A common cold could cause him to go into respiratory failure and die. His life expectancy is significantly reduced. His wife has had to give up her own job to look after him. She is one of an army of carers across the country whose work needs to be recognised right across the House.

John Foxwell is one of only about 150 people in the UK who have Pompe disease. The condition is named after a Dutch medic called Joannes Cassianus Pompe. Given that he was Dutch, his surname was probably pronounced “Pompa”, but the disease has become known as “Pompey” disease. He was born in Utrecht in September 1901, and later studied medicine at the city’s university. His breakthrough came in December 1930, when he carried out a post-mortem on a baby girl who had died at the age of just seven months. He discovered that her heart had become enlarged and that the muscle tissue in the heart had become like a mesh. He thought that a substance build-up was causing that to happen to the heart muscle and came to the conclusion that that substance was glycogen. In other words, the sugar strings that store energy in cells had not broken down as they should have done, due to a faulty gene inherited from the little girl’s parents.

Dr Pompe became a pathologist at the Hospital of Our Lady in Amsterdam in June 1939, and after the German invasion of the low countries in the second world war, he became a part of the Dutch resistance. He was involved in finding places for Jewish people to hide from Nazi persecution. His laboratory at the hospital housed a radio transmitter that was used to send messages from the Dutch resistance to the United Kingdom. He was eventually arrested by the Nazis in February 1945, after the transmitter was detected. On 15 April 1945, he was executed as part of a reprisal for the Dutch resistance blowing up a railway bridge. The discoverer of this disease seems to have been a very brave man indeed.

Dr Pompe had discovered what came to be known as the first category of the disease, the infantile variety that presents in small babies who fail to thrive, and that often leads to death from heart failure in the first year of life. Life expectancy in those case is, alas, less than two years. The second category is “late onset” where, as the name suggests, symptoms do not become apparent until later on in life. As is the case with my constituent John Foxwell, progression is generally slower, but it is characterised by skeletal muscle wasting that causes mobility issues and breathing problems.

Those who suffer from the disease receive support from Muscular Dystrophy UK—I put on the record my thanks to it for sending a briefing in advance of this debate—and the Association for Glycogen Storage Disease (UK), which also provides support to sufferers here. The standard treatment for Pompe disease is enzyme replacement therapy. The faulty gene that is inherited from sufferers’ parents stops the creation of an enzyme called acid alpha-glucosidase—I will refer to it as GAA from here on—that breaks down the sugar strings of energy in muscle cells. The enzyme replacement therapy involves a genetically engineered enzyme that assists with regulating glycogen—the sugar strings— and is received into the body by regular infusions. The trade name for the enzyme is Myozyme, which is available from the pharmaceutical company Sanofi Genzyme.

The availability of Myozyme differs slightly around the country. In England, it is directly commissioned by NHS England under specialised criteria. In Wales, where my constituent lives, the All Wales Medicines Strategy Group recommended to the Welsh Government that Myozyme should be endorsed within the NHS in Wales for the treatment of Pompe disease, but there is a specific restriction in that it is not endorsed for late-onset Pompe disease on grounds of insufficient evidence of clinical effectiveness.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Gentleman on presenting such a wonderful account of the gentleman involved in the history of the disease. Like others, I have been contacted by Muscular Dystrophy UK, and rare diseases come up here often and are a particular interest of mine. This is ultimately a question for the Minister, but does the hon. Gentleman agree that the Department of Health must ensure that there is adequate support for the centres across the UK that provide highly specialised care for patients with this rare muscle-wasting disease? I think the Minister will respond to that, but the hon. Gentleman’s speech encapsulates what we are all trying to achieve here.

--- Later in debate ---

[Nick Thomas-Symonds]

I am grateful to the hon. Gentleman. I entirely agree that support for the different centres across the country is absolutely vital. While we all know that health is a devolved matter, awareness is so important and is something that we can still promote across the United Kingdom.

My constituent’s particular issue with accessing treatment is that he falls into a category that does not have general commissioning for late-onset Pompe disease, meaning that he would be left having to make an individual funding request, only some of which are successful. However, the reality is that nobody has a chance of accessing the treatment if the disease is not diagnosed in the first place, which was the real challenge facing John Foxwell. His diagnosis took over seven years. Many consultants told him that his diaphragm was paralysed—that was pretty obvious—but they made no link to the disease that was causing the paralysis. John went through some incredibly difficult periods of low appetite, when he was living only on jelly and milkshakes. Unable to function and to continue with the wonderful career that I described, he moved back to Wales, where he was originally from, to die.

Then the diagnostic break came. Nevill Hall Hospital, Abergavenny, is in the constituency of the hon. Member for Monmouth (David T. C. Davies), but none the less it serves a number of my constituents in Torfaen. A respiratory consultant at the hospital gave my constituent a mechanical respirator, which helped him significantly. In addition, he was advised to see a neurologist, who conducted a series of tests, including a genetic test that finally identified late-onset Pompe disease.

Pompe disease is incredibly complex, and it requires a multi-disciplinary approach. The medical disciplines required include geneticists, pulmonologists, neurologists, cardiologists, respiratory therapists, physiotherapists, dieticians and clinical psychologists. Conditions that cross the medical disciplines in that way are, of course, a challenge for our NHS across the country, but it is a challenge that we can and must meet.

I will conclude with an email that my constituent sent to me, which shows where he is at the moment:

“Now I am almost a recluse as I find that leaving the house is extremely challenging. I don’t know the future, but I do know, from statistical testing in other countries, that there are many more people with Pompe Disease out there that are needing to be diagnosed and that I want to be able to assist…in understanding the disease and supporting them when they need help. I am creating Pompe Wales, a Pompe Disease specific charity, to be able to help others who have Pompe, to be able to make the medical professionals aware of Pompe and its symptoms and to link with other Pompe organisations around the world”.

That shows that those who suffer from the disease, named after Dr Pompe, share characteristics with him—they are determined and courageous. But, for them to be able to fight this disease, it must first be identified. The only way to do that is to raise awareness across the medical professions. Nobody should suffer unduly because of falling victim to a disease that is extraordinarily rare.

[The Parliamentary Under-Secretary of State for Health (Steve Brine)]

I congratulate the hon. Member for Torfaen (Nick Thomas-Symonds) on securing this debate. I often think this about Adjournment debates, but this shows how excellent the House of Commons is in that it can debate a Finance Bill and then discuss a condition like Pompe disease.

I read the hon. Gentleman’s article in The Times this morning. The article was well written, and it set out very clearly the heart-breaking impact that this disease has had on his constituent’s health. I am sure his constituent appreciates very much the way he has taken up the issue. Well done for getting an article in The Times!

I hope my response will go some way to reassuring the hon. Gentleman and his constituent that the importance of understanding how to recognise and treat rare diseases such as Pompe disease is increasingly recognised by policy makers and healthcare service providers, not just in England but across the UK and internationally.

The hon. Gentleman spoke movingly about the subject, and he is of course right to praise the army of carers in our country. Carers Week is a big deal in my constituency, as I am sure it is in his, and he is absolutely right to praise the work of Muscular Dystrophy UK. When I was a Back-Bench MP, I was a member of the all-party parliamentary group on muscular dystrophy, which was chaired by a now former Member. Having grown up with friends who suffered with muscular dystrophy, and who ultimately lost their fight, I have a lot of time and respect for Muscular Dystrophy UK.

The number of rare disease patients can be very small. For example, Pompe disease has an estimated prevalence of one in every 40,000 births, but collectively some 3.5 million people in the UK alone are affected by what we term, in policy terms, rare diseases. To put this in context, one in 17 people will therefore suffer from a rare disease at some point in their lives. As we have heard, patients with Pompe disease are deficient in or completely lacking the activity of an enzyme that affects the ability of cells to degrade glycogen, causing its build-up in the body cells, which impairs their ability to function normally. Pompe disease often affects neonates—newborn children—and becomes apparent from within a few days to a few months after they have been born. Sadly, affected infants often require long periods in paediatric intensive care units, with many going on to require long-term mechanical ventilation, as the hon. Gentleman said.

[Nick Thomas-Symonds]

I thank the Minister for that positive introduction to his speech. One issue that my constituent raised with me was that because this disease is genetic it can be picked up by a blood test from birth. He has asked whether such testing could be done on a more regular basis. I understand that this is difficult because the disease is so extraordinarily rare, but I flag it up for the Minister’s attention.

[Steve Brine]

The hon. Gentleman makes a good point, and I know my officials will be listening carefully to what he says. I may come to touch on that point, if I do not deal with it specifically, but I am sure he will remind me.

Some patients with Pompe disease are treated with an enzyme replacement therapy called Myozyme, which is a direct replacement of the missing enzyme via infusion therapy. Myozyme dramatically alters the natural history of the disease in infants, but many patients still require complex long-term follow-up, as the hon. Gentleman’s constituent does.

NHS England commissions its service for patients with Pompe disease from eight national centres; five of these are for adults and three are for children. The centres provide an inclusive, holistic, multi-disciplinary service—the point the hon. Gentleman rightly makes—for patients with lysosomal storage disorders. That is the wider term for these conditions, including Pompe disease. The centres provide rapid diagnosis, an assessment of disease burden, provision of disease-specific therapy, advice on symptom control and palliative care, where this is, sadly, necessary for patients with untreatable disorders. In conjunction with patient advocacy groups, the centres also provide support for affected families. We of course support these centres utterly—that point was put on the record so well, as usual, by the hon. Member for Strangford (Jim Shannon).

As the hon. Member for Torfaen says, late-onset Pompe disease may not become apparent until later in childhood, adolescence or most commonly, as in the case of his constituent, Mr Foxwell, in adulthood. Although late-onset Pompe disease is usually milder than the infant forms of the condition, patients can experience progressive muscle weakness in the legs and trunk—the main body—and it can affect the muscles that control breathing, which is why the mechanical ventilation becomes necessary. As we have heard, as the condition progresses, breathing problems can become more serious and often prove fatal.

We know more can be done to diagnose rare conditions earlier. Currently, the average rare-disease patient consults five doctors, can receive up to three misdiagnoses and waits four years before receiving their final diagnosis. These delays in diagnosis often mean that opportunities for timely interventions can be missed and/or that patients may be given unsuitable or harmful treatments to treat their misdiagnosed condition; more than half of patients wait for more than one year after the first symptoms and some have waited over 20 years. Although not a great term, I am reliably informed that this is called a “diagnostic odyssey”, which causes uncertainty and distress for those affected, as well as considerable costs for health and social care budgets. We should remember that.

The 100,000 Genomes Project—

[Nick Thomas-Symonds]

rose—

[Steve Brine]

I was going to touch on that project, but before I do I shall give way to the hon. Gentleman again.

[Nick Thomas-Symonds]

I am grateful to the Minister for giving way again. Before he moves on to the genomes project, I just wanted to touch on the issue of the diagnostic odyssey. My constituent’s diagnostic odyssey was seven years, and clearly although the symptoms, particularly the issue involving the diaphragm, were very apparent and were picked up, this was about making the link from there to the rare disease. Clearly, one always has to take into account statistical probabilities—there is no direct criticism of any medic or anything like that here—but part of trying to reduce that diagnostic time must be about increasing awareness among the medical profession of many of these rare diseases.

[Steve Brine]

Yes, I absolutely agree. I also have ministerial responsibility for cancer—if only I had a pound for every time I heard early diagnosis mentioned in the office. I shall explain how I think the rare diseases strategy can help with that. Of course, it is important not just for rare diseases, but what the hon. Gentleman says is absolutely right.

The 100,000 Genomes Project addresses parts of the unmet diagnostic need I have described. It focuses on patients with a rare disease and their families and on patients with cancer. The sequencing of an individual’s genome is increasingly utilised as a diagnostic tool in cases where an individual has unrecognised signs and symptoms and to support the diagnosis of a rare disease. I am pleased to say that around 25% of patients whose genome is sequenced through the project now receive a diagnosis for the first time. In addition, despite their often chronic and progressive nature, the associated long-term complications of some rare diseases can be targeted and addressed early if they are diagnosed as such. That is clearly the holy grail. The UK rare diseases policy board has been tasked with looking at the diagnostic issues—the odyssey that I mentioned—and I look forward to it reporting its initial findings to me. I am told that they will come in early 2018, so I shall look out for them.

I assure the hon. Gentleman that the Government are and remain dedicated to improving the lives of all patients with rare diseases. The publication of the UK strategy for rare diseases in 2013 represented a significant milestone for all patients with rare diseases, and it is now being implemented throughout the country. The strategy set out our strategic vision and contains 51 commitments, concentrating on raising awareness, better diagnosis, which has been touched on, and patient care. It also has a strong emphasis on the importance of research in our quest to better understand and treat rare diseases. Research is so important. The Government are committed to implementing the strategy in full by 2020, and we know that the real test of success will be when patients and families affected by rare diseases experience real improvements.

The Minister of State, Department of Health, my hon. Friend the Member for Ludlow (Mr Dunne), announced in a 28 March Westminster Hall debate on the implementation of the strategy that NHS England will produce an implementation plan for the commitments in the strategy that it has lead responsibility for, and I shall hold NHS England to account ministerially. The Department of Health is now working collaboratively across stakeholders to produce the implementation plan for all those commitments that fall outside NHS England’s remit. Both NHS England and the Department are aligning the publication of those complementary plans, and I want them on my desk by the end of the year.

We appreciate the fact that any specific rare disease is, by its nature, very rare, so we should be honest about the fact that there is often a scarcity of patients and expertise in any single country. The diagnosis, treatment and management of rare diseases strongly benefit from cross-border collaboration. Through an EU initiative on patients’ rights in cross-border healthcare, European reference networks were set up throughout European countries earlier this year. These virtual networks act as centres of knowledge, skills and expertise in the field of rare diseases and complex conditions, and provide a platform to create partnerships between healthcare providers here in the UK and throughout Europe.

The UK is already a key player, leading six ERNs—more than any other member state—and participating in 23 of 24 networks, including what is known as the Metab ERN, which covers rare hereditary metabolic disorders such as Pompe disease. Six NHS trusts participate in the Metab ERN, which aims to ensure a joined-up approach to care by bringing together paediatric and adult metabolic physicians throughout the EU. That is really important. The ERNs are a cornerstone of the UK rare diseases strategy, and the Government are committed to ensuring that no patient should be put at a disadvantage through the UK’s exit from the EU—and that is a priority for me. Therefore, an important element of our future plan will be to continue to play a leading role in promoting and ensuring public health—I am also the Public Health Minister—both in Europe and around the world. Hopefully, that will further strengthen the long tradition of international collaboration, which our clinicians and scientific community have in this country, and often lead across Europe and the world.

Let me touch further on research. The full potential for improving our knowledge of rare diseases and our work towards better treatment and, hopefully, prevention can only be realised by continued research into rare diseases. That is why the National Institute for Health Research has established 20 biomedical research centres that develop new groundbreaking treatments, diagnostics and care for patients with a wide range of diseases.

The centres enrolled patients across 60 NHS trusts and, in partnership with Genomics England, led a pilot for the rare diseases element of the 100,000 Genomes Project that has delivered the sequencing of whole genomes of more than 12,000 bioresource participants.

[Nick Thomas-Symonds]

rose—

[Steve Brine]

I think that I can anticipate the hon. Gentleman’s intervention. Go for it.

[Nick Thomas-Symonds]

I am very grateful to the Minister for his generosity in giving way. My constituent has been unable to demonstrate the exceptionality required to access the treatment through an individual funding request. In reality, there is only this one standard treatment. One thing about the research into rare diseases that the Minister has referred to is the need to discover more options for treatment rather than having only one realistic one, as is the case so much of the time.

[Steve Brine]

I completely agree with the hon. Gentleman. That is why I said that research is absolutely central to this. Let us be honest: this country has led the world in this field. We have an absolutely fantastic record and long may that continue, because people’s lives benefit and depend on that. Once again, he is spot on. Let me conclude my point. In 2016-17, the NHIR research infrastructure supported studies into Pompe disease across nine of its centres and facilities.

The hon. Gentleman referred to national variations in access to Myozyme treatment for Pompe disease across the UK. In England, NHS England funds this treatment for all patients, regardless of age or the form of the disease. In Scotland, the Scottish Medicines Consortium does not accept Myozyme for routine use, but it is funded for children and adults by its ultra-orphan drugs risk scheme. NHS Scotland also provides any patients with particularly complex needs access to highly specialised services in England. In Wales, I understand that the treatment is funded for children and adults with late onset of the juvenile form of the disease, but not the adult form where the symptoms are less severe.

As the hon. Gentleman will be aware, healthcare in Wales is a devolved matter, but I am sure that he will raise any concerns with the Welsh Government. I was delighted to hear about the setting up of Pompe Wales, which he talked about in his speech. It sounds really interesting. Obviously, it is in Wales, so perhaps he could send me details of it when it becomes available.

[Nick Thomas-Symonds]

The Minister is entirely right. It is commissioned in Wales for the infantile aspect. There is no general commissioning for late onset. There has to be what is called an individual patient funding request, where a patient has to demonstrate certain things, including exceptionality.

[Steve Brine]

The hon. Gentleman has put that clearly on the record.

Finally, it is worth noting that the rare disease landscape has been greatly transformed since the UK strategy was published in 2013, especially considering Brexit, the evolving legacy of the 100,000 Genomes Project and new emerging technologies such as genome editing. The recent independent chief medical officer’s report “Generation Genome”, which I said at Health questions was a landmark piece of work, and the “Life Sciences: Industrial Strategy” make it clear that genomics has an important role to play in future healthcare delivery, including the treatment of rare diseases. The House of Commons Science and Technology Committee is also currently engaged in an inquiry into genomics and genome editing in the NHS, and I look forward to seeing its report in due course. I can assure the hon. Gentleman that we will harness the remarkable prospects that these new developments present for the benefit of our rare diseases patients. The NHS has always harnessed new technology to lead the world, and it will continue to do so in this field.

I thank the hon. Gentleman once again for highlighting these issues in this debate and in today’s media for his constituent and for all those who suffer from Pompe disease and other rare diseases. I hope that I have helped to reassure them a little that the Government and the NHS are working hard to tackle these conditions and to help to improve the lives of people suffering from Pompe disease and other rare diseases because, ultimately, that is what we are here for.

Question put and agreed to.

Autism Diagnosis

Nick Thomas-Symonds Excerpts

Wednesday 13th September 2017 Westminster Hall

[Bambos Charalambous (Enfield, Southgate) (Lab)]

I beg to move,

That this House has considered a waiting time standard for autism diagnosis.

It is a pleasure to serve under your chairmanship, Mr Howarth. During the last general election campaign, I attended a hustings in Enfield, Southgate organised by the local branch of the National Autistic Society. Following that meeting, and after further discussions with constituents and others on issues related to autism, I decided to request a debate on the matter. During this debate, I will briefly describe the effects of autism and explain the National Institute for Health and Care Excellence’s diagnostic assessment standard. I will also question why that standard is not being adhered to, explain the impact of late diagnosis and propose a way forward to the Minister.

As some people may be aware, autism is a lifelong developmental disability that affects how a person communicates with and relates to others and makes sense of the world around them. It is a spectrum condition and affects individuals to varying degrees.

[Nick Thomas-Symonds (Torfaen) (Lab)]

All my constituents who contacted me about this issue are very concerned about the time taken for diagnosis. Does my hon. Friend agree that it is important to have a consistent approach right across the country—like in Wales, where last year the Welsh Government introduced a national autism strategy?

[Bambos Charalambous]

My hon. Friend makes a valid point: consistency is required across the range.

Young-onset Parkinson’s Disease

Nick Thomas-Symonds Excerpts

Monday 6th March 2017 Commons Chamber

[Nick Thomas-Symonds (Torfaen) (Lab)]

During the 2015 general election campaign, I attended a concert in my constituency in aid of Parkinson’s. It was organised by a constituent of mine, Len Burbidge, and I want to pay tribute to the tremendous work that Len does on this issue locally. That night, I signed a pledge to raise awareness of Parkinson’s in this House, should I be elected, and I have sought to do that in parliamentary debates and as a member of the all-party group on Parkinson’s. I pay tribute to the group’s chair, my hon. Friend the Member for Bridgend (Mrs Moon), for the work that she does, and to the work that is done for the group in the other place by Baroness Gale of Blaenrhondda.

I am delighted to have secured the debate this evening, particularly because it is now 200 years since Dr James Parkinson published his famous 1817 essay “An Essay on the Shaking Palsy”. Some 60 years later, a French doctor, Jean-Martin Charcot, spoke about “la maladie de Parkinson”, from which we have coined the term “Parkinson’s disease” to describe the condition. According to figures from Parkinson’s UK, some 120,000 people are affected by the condition in the UK today. We know about the three principal symptoms—the tremor, the muscle stiffness and the slowness of movement—but unfortunately there is still no cure 200 years later.

When I talk about the number of people affected by the condition, I must point out that the data available on those with Parkinson’s are perhaps not as accurate as we would like. We know that several thousand people of working age have the condition. I want to pay tribute to Gaynor Edwards from the charity Spotlight YOPD for the work that she has done to raise the profile of this issue. She has guesstimated that there are 6,500 people affected who are under the age of 50, but it would be a significant step forward if we could accurately estimate not only the prevalence of Parkinson’s in the population as a whole, but the number of people of working age who have the condition. I would be grateful to the Minister for some assurance that we can look at how the data are collected.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Gentleman on bringing this matter to the House. We have 4,000 sufferers in Northern Ireland, one in 20 of whom was diagnosed with Parkinson’s when they were under the age of 60—in other words, still of working age. He spoke about the importance of finding a cure, but in order to do so, we need a research programme. Does he agree that the Government should be placing more emphasis on early diagnosis and finding a cure?

[Nick Thomas-Symonds]

I entirely agree with the hon. Gentleman.

I have been provided with a number of emails by the charity Spotlight YOPD, and I have permission to use them in this debate. Interestingly, one of those contributions is from someone with Parkinson’s who is based in Edinburgh. They say:

“My main concern is the lack of clinical trials to participate in, compared to many other conditions, there’s hardly anything at all going on for PD.”

I will talk in a moment about the care that people receive, but I agree with the hon. Gentleman that research into a cure is absolutely central to this debate.

I want to talk about a constituent of mine, Hayley Huxley, to whom I have been speaking in recent weeks. She was diagnosed with Parkinson’s at the age of 25. She is now 30 and has two young children. I want to reflect on what she set out in an email to me, because it is indicative of what people go through. She says:

“It all started when I was 24. I went back to work after maternity leave on my first child and noticed I couldn’t use my right hand properly to write. I went to the doctors 3 times and they just put it down to carrying a car seat, pulled muscle, etc. The 4th time I went I got referred to a specialist and went for tests”,

and she was diagnosed at 25.

Hayley speaks movingly of the challenges that she has faced, such as working part time due to fatigue and having to

“fight my way through the PIP assessments”.

In the end, she was able to get the appropriate number of points. She also speaks about access to a neurologist, saying that she has not seen one since she was diagnosed five years ago. Indeed, she has not seen her Parkinson’s nurse since July 2015. She speaks about managing her medication, going through childbirth without taking medication for eight months, the rigidity in her right arm and leg, and the restless leg that she gets.

[Mrs Madeleine Moon (Bridgend) (Lab)]

Is my hon. Friend aware of the Parkinson’s KinetiGraph watch? It is new on the market and was developed by Global Kinetics Corporation. It monitors the medication taken by a Parkinson’s patient and will send a message over the internet to a consultant with information about whether the medication is at the right level and has been taken at the right time, thereby enabling people to stay in work longer and to control their tremors much better.

[Nick Thomas-Symonds]

I am grateful to my hon. Friend for that point. The device sounds remarkable and could assist people with the condition.

Hayley spoke about the restless leg she experiences if her medication is not taken at the right time or if she is under stress. The way in which Hayley has dealt with the condition is inspirational. When I saw her yesterday in advance of this debate, she said that while those who fit into what is called the young-onset group have particular needs, there is a collective sense of need for everyone with the condition. The photographer who was with us yesterday, Ron McCann, also has Parkinson’s and is aged 69. Over the course of the weekend, I was contacted on social media by a member of the male voice choir in my hometown of Blaenavon, who spoke about a chorister in his 80s who is battling the condition and has found that singing has assisted him.

While there are issues that unite all with the condition, including access to the drug Duodopa, which was the subject of a recent debate in Parliament, those who are diagnosed at a younger age have specific needs. The first issue is with being diagnosed in the first place, because the condition can go undiagnosed. Those who have contacted Spotlight YOPD talk movingly about what happens at that moment of diagnosis. Keith from Newark says:

“Parkinson’s for younger people (under 50) is a different kettle of fish...It completely changes your life but you don’t know at the time and no one actually tells you.”

Gaynor from Rye says:

“I’ve never felt quite so lonely as when I was diagnosed. Mourning for the future I thought I had—suddenly old before my time with a fear of dependency—and no one there to gather me up; no one to depend on.”

Jordan, 21, an MSc student in Liverpool, says that

“the GP kept saying, ‘He’s too young, he’s too young,’ and said it was a psychological problem.”

Even when the diagnosis is established, there then comes a whole set of new challenges. On top of dealing with the condition, there are all the pressures of family and working life.

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

I am a huge admirer of the hon. Gentleman’s speech and I commend him on bringing this matter before the House. Does he agree that cases such as those that he has outlined can often be helped if there is a local support group? Such groups provide a lot of information and can effectively lobby local health services on matters such as Parkinson’s nurses? Would he recommend the setting up of such groups around the country?

[Nick Thomas-Symonds]

I entirely agree with the hon. Gentleman that local support groups are hugely important, which leads me on to the mental health issues that often come with Parkinson’s. Although access to a neurologist is highly important, we must not neglect access to mental health support.

Prescription charges remain a bone of contention in England. Pre-payment certificates are available to reduce costs, but there is still a cost. England could do with following the lead set by the Welsh Government in 2007 by abolishing prescription charges altogether.

There are also issues of engagement with medical services. Again, I can refer to specific cases. Jon, a father of three who was diagnosed at the age of 49, says:

“People with Parkinson’s can often have problems in hospital.”

Why? People with Parkinson’s are often deprived of their medication because, obviously, they hand in their medication when they go into hospital, yet maintaining a regular medication regime is very important and the person themselves is often best placed to do that.

I spoke a moment or two ago about access to neurological services. Alison, a mother of three based in Cheltenham, says:

“I feel let down by an NHS system that offers me one 10 minute appointment with a neurologist each year and I have to chase this to get it.”

Neurological services clearly need to be more accessible than that.

I do not make my next point in an ideological way, and I am pleased that the former Minister with responsibility for disabled people, the hon. Member for North Swindon (Justin Tomlinson), is in the Chamber. Irrespective of political views, I want to address the efficiency of the social security system as it actually works. I pay tribute to the work of Parkinson’s UK, and particularly to that of Natasha Burgess. On employment and support allowance, for example, which will involve a work capability assessment, the problem with something like Parkinson’s is that it is a variable condition.

[Mrs Moon]

Unpredictable.

--- Later in debate ---

[Nick Thomas-Symonds]

Precisely. A work capability assessment might not be the best way to assess people with a fluctuating condition. Additionally, on the personal independence payment, there are far too many people at my surgeries who end up having to go all the way to a tribunal to be awarded what they should have been given in the first place.

[Jessica Morden (Newport East) (Lab)]

My hon. Friend is making an excellent case. The Minister for Disabled People, Health and Work recently said during a debate that she would be talking to the Treasury and Motability about letting PIP claimants keep their vehicle while they appeal decisions that have gone against them. The removal of Motability vehicles has affected people with young-onset Parkinson’s. Does my hon. Friend agree that we deserve to hear what progress has been made on that issue?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend. That point is particularly pertinent because of the number of people who are succeeding on appeal.

I have an email from Phil from Kent, who was diagnosed with Parkinson’s at the age of 45. He says:

“In…2015 I was awarded 17 points (the Higher Rate) for the Daily Living Component and 10 points…for the Mobility Component of Personal Independence Payment.”

He felt that that was accurate, but the assessment was downgraded when he was seen a year later. He has an appeal ongoing, but he simply says this:

“I want the DWP to understand that Parkinson’s disease is a degenerative condition…It does not get better!”

That is precisely right.

The Government have the laudable aim of halving the disability employment gap.

[Justin Tomlinson (North Swindon) (Con)]

Before the hon. Gentleman comes off the subject of PIP, I wish to pay tribute. He is making a really important speech, and it is a real credit to Parkinson’s UK, which was one of the most engaged groups during my time as Minister for disabled people—I thank the hon. Member for Bridgend (Mrs Moon) for arranging the initial introduction. I urge the Minister to take the opportunity to meet Opposition Members as soon as possible to explore all these constructive options, which are so typical of the hon. Gentleman. I also wish to thank my local Parkinson’s UK members, who are now holding regular coffee mornings in my office as a way to engage, to share best practice and to continue to highlight the improvements that we all, collectively, need to make.

[Nick Thomas-Symonds]

I am grateful for that intervention from the former Minister. He takes a constructive approach, for which I am very grateful.

The aim of halving the disability employment gap is laudable, but I have a slight concern, in that we also have to recognise that people with Parkinson’s will need support when they leave work, at which point returning will, sadly, not always be a realistic option.

As I sum up, I want to speak about the people who battle this condition. Pete from Brighton says:

“At heart…we YOP suffer a triple indignity: the disease itself, with all that it entails; our not being considered disabled enough by the system; and the lack of awareness ensuring that we are considered to be practically useless by society at large.”

Karen from Birmingham says:

“my medication is not helping me through the night and sleeping is impossible. I am literally paralysed during the night.”

We should not forget the daily battle that people with Parkinson’s face, but nor should we forget where we started this debate—with Dr James Parkinson and that essay of 200 years ago. In addition to having medical expertise, he was also something of a political activist, writing leaflets under the pseudonym “Old Hubert” and speaking about those who lived in poverty. He argued for political reform, and I am convinced that if he was still here today, he would be speaking up for all those who have Parkinson’s, who suffer and who battle with this condition every day. I hope that this debate has at least gone some way to raising awareness of the particular problems that people face.

--- Later in debate ---

[David Mowat]

In principle, I would be delighted to come to Swindon, or my hon. Friend could join the meeting with Parkinson’s UK. I am sure there is a way forward.

[Nick Thomas-Symonds]

It would also be extremely useful for the Minister to facilitate a meeting with another charity called Spotlight YOPD, which has done tremendous work in this area.

[David Mowat]

I heard that charity mentioned and yes, that would of course be a sensible thing to do; the focus of this debate is on YOPD, so that would be appropriate.

There is an issue with GP awareness and diagnosis, partly because there is sometimes an assumption that if someone is young and has dizziness, aching muscles and some of the other early symptoms, those can be symptomatic of more benign conditions, and it is genuinely quite hard to diagnose young-onset Parkinson’s disease. It is important to note that the Royal College of General Practitioners’ neurology training emphasises that all GPs must have a knowledge of the epidemiology of Parkinson’s. The applied knowledge test, which all GPs, wherever they come from, have to pass before they can be a GP, has modules on Parkinson’s and the fact that it can potentially come to people before they are 50 years old, even though it does not usually do so. It is important that we continue to focus on that.

The National Institute for Health and Care Excellence has guidelines on Parkinson’s. Most relevant is the guideline on the best practice on the diagnosis and management of the disease. The draft is currently out for public consultation and will be updated and reissued in April. That guideline also emphasises the fact that early onset is possible and that if patients present with stiffness and slowness of movement, Parkinson’s needs to be considered, because quite often it still is not.

A second NICE guideline, which is also being worked on, is on the more general theme of suspected neurological conditions, with a particular focus on people outside the normal age ranges presenting with symptoms. That applies to children, young people and adults. Such a focus is potentially useful in the identification of early-onset Parkinson’s.

Once the condition is diagnosed, it is obviously important to start treatment. That tends to imply, in England at least, referring a person to one of the 25 neurological centres around the country. A management plan should be put in place by a multi-disciplinary team, consisting of neurologists, neuro-surgeons, nurses and psychologists. Once that plan is in place, treatment can take place through normal primary and secondary care pathways.

[Nick Thomas-Symonds]

The Minister mentioned psychologists in that list. Does he agree that mental health is a vital part of that package?

[David Mowat]

I heard the hon. Gentleman say that in his speech, and I agree with him. We know that we have some work to do in our health system generally in getting mental health to catch up with the rest of the ways that we treat health. I use the phrase “parity of esteem”, and that is something that must happen. Younger people with Parkinson’s are unlikely to be in a major support group of others who have the disease at their sort of age. They can feel lonely, isolated and all that goes with that. In particular, the hon. Gentleman mentioned Hayley and her young family. Yes, he is absolutely right to emphasise that issue, as we do need to have much more mental health provision in our GP practices. We are determined to achieve that by 2020, with 3,000 mental health therapists in GP practices in England.

The hon. Gentleman mentioned the workforce and 10-minute appointments. We have increased the number of neurologists working in NHS England by something like 30% since 2010. The figure has increased to 1,300, so something like 300 more neurologists are needed in NHS England. As the incidence of neurological conditions continues to increase—Parkinson’s will continue to increase as the population ages—we will need to continue with that expansion. That is clearly a priority.

I wish briefly to talk about the new neurology advisory group, which was set up in September 2016 and is led by Professor Adrian Williams, a neurologist. A member of that group is Steve Ford from Parkinson’s UK. The group’s role is to better align services across the country. Currently, there is a disparity in treatment between different clinical commissioning groups and different GP practices. To an extent, that disparity is inevitable, but we need to do what we can to minimise it, and that group will be looking to do that. It will also be responsible for working as part of a neurology intelligence network, which is all about getting data. The very first challenge from the hon. Gentleman was that the figures that I had quoted and that he had quoted were all estimates. We do not gather data in the format that can be used. The estimates came from a report of Parkinson’s UK, and they were based on 2009 data. We need to do much better than that. It is only by having more reliable data that we can track the way in which the disease is developing and can ensure that we have adequate and effective treatments and networks in place.

The hon. Member for Strangford (Jim Shannon) mentioned research. Yes, in the end, research will help us to find a cure. We spend something like £1 billion a year through the National Institute of Health Research. Of that, the spend on neurology has increased over five years from £30 million—it is not the biggest area—to something like £55 million this year. That is something that we should continue to press for, and I am sure that both the hon. Gentleman and Parkinson’s UK will do that.

I agree with the thrust of what the hon. Gentleman said about the DWP. Indeed, the Government’s Green Paper, which was published in October 2016, talked about removing continuous assessment processes for people with progressive diseases, such as Parkinson’s. I understand that the DWP is working towards developing the criteria for switching off assessments, and I think that he and I would both agree that the sooner that is applied in this case, the better.

In conclusion, early-onset Parkinson’s is a very tough condition that around 5,000 or 6,000 people across the country have. It is tough to diagnose and there is no cure, although it can be partially managed. I congratulate the hon. Member for Torfaen again on raising awareness of the condition, both today and over the past year or so through the campaign. I also thank Parkinson’s UK for the work it does. I hope that this discussion has been helpful. I would be delighted to meet the hon. Gentleman, the hon. Member for Bridgend, Parkinson’s UK and perhaps even my hon. Friend the Member for North Swindon to talk about how we can take this forward.

Question put and agreed to.

Agenda for Change: NHS Pay Restraint

Nick Thomas-Symonds Excerpts

Monday 30th January 2017 Westminster Hall

[Catherine McKinnell]

I absolutely agree. It is hard to emphasise enough my support for people working across the NHS in increasingly challenging circumstances, without whom our health service would, quite frankly, cease to exist.

[Nick Thomas-Symonds (Torfaen) (Lab)]

The way to show respect for our nurses and other NHS staff is to act now to remove the cap, as has been described, and listen to the independent pay review body.

[Catherine McKinnell]

My hon. Friend makes an important point. It is not enough for us to state our support for our NHS workers; we must show it through real action.

Breast Cancer Drugs

Nick Thomas-Symonds Excerpts

Thursday 26th January 2017 Commons Chamber

[Siobhain McDonagh]

Breast cancer knows no boundaries, whether class, social or geographic. Anything that reduces access to better forms of treatment is detrimental.

The ability to lead an enriched and longer life as a result of medical advances should not be limited only to those who can afford private healthcare. Those advances should be accessible to us all. This debate will focus particularly on the provision of the breast cancer drug Kadcyla, which is under threat. Most Members will be aware of the lease of life that Kadcyla has brought to thousands of women in England with incurable secondary breast cancer. These women rely on Kadcyla to enrich their lives and to give them extra precious years to live. Indeed, in many ways it is a revolutionary drug. By targeting cancer cells directly, it helps to reduce the number of side effects, boosting women’s quality of life immeasurably. Members who have heard these women talk about their experiences will be humbled to learn of the distress and despair that they face as a result of NICE’s decision to provisionally reject the future use of Kadcyla on the NHS.

Today we are all supporting Breast Cancer Now’s “Keep Kadcyla” campaign to encourage NICE to reverse its decision and enable continued access to the drug, which both improves the quality of life and extends the lives of thousands of women in this country, on the NHS. Since NICE’s decision was announced at the end of December, thousands of people throughout the country have had their views heard. They have signed the petition and contacted their local MPs to ask that we do not give up on women, on the children who are dependent on mothers, and on the families who want that precious extra time with their loved ones. That is why we are all here today: to raise our collective voice in support of these women and defend the treatment that allows them to live their lives.

The focus of much of what I have to say today will be on Kadcyla, but we also need to consider other specific breast cancer drugs, as well as the broader issue of how decisions about access to treatment are made. Unfortunately, we are yet to see any improvements in access to off-patent drugs, some of which can prevent the development of certain cancers, thereby saving countless lives, as well as saving the NHS a great deal of money. Just a few months ago, the front pages of national newspapers highlighted the poor access to vital bisphosphonate drugs, which can prevent women from developing secondary cancer, yet the Government have barely acknowledged the problem of access to such treatment. I look forward to hearing from the Minister about when we can expect tangible results regarding access to off-patent drugs, including bisphosphonates. To be clear, many of the women who today owe their lives to Kadcyla might never have developed secondary breast cancer had they had access to bisphosphonate drugs in the first place.

[Nick Thomas-Symonds (Torfaen) (Lab)]

I will discuss off-patent drugs in my own speech, but on bisphosphonates, which are in the category of repurposed drugs, is my hon. Friend as concerned as I am about the results of the UK-wide survey undertaken by the UK Breast Cancer Group in March last year, which showed that currently only 24% of breast cancer clinicians are offering bisphosphonates to patients? That is something that the Government could urgently address.

[Siobhain McDonagh]

I completely agree with my hon. Friend and hope to say a little more about that later in my speech.

This debate is about not just Kadcyla, but the lives of the thousands of women who rely on it to survive, so I want to share the words and experiences of two of my friends whose lives have been transformed by having access to Kadcyla. One of my friends is present today—I went to primary school with her, but I shall not tell the House just how many years ago that might have been. Her name is Samantha, and she said:

“When I got the breast cancer diagnosis, I glibly thought—oh it’s OK I’ll get cured, but sadly about 18 months ago I found out that this wasn’t the case and my cancer had spread to my liver. And that’s when I really knew that my cancer meant business!

And that is where Kadcyla comes in. You see for breast cancer, although I coped and kept going with surgery, chemo and radiotherapy, it was grim. I worked a bit, but regular chemotherapy is not a doddle. Exhaustion and hair loss is just the least of it.

Putting on a brave face and wearing a wig is just a surface issue, getting up vomiting and going to work to deal with the VAT is about the hardest thing I have ever done. It wasn’t simply because I don’t have enough sick pay at work to cover my mortgage, I actually like work—work allows me to make my contribution, and I think that’s pretty near the most important thing, making my life make a difference. And Kadcyla? Well that means that my life isn’t over, it really gives me hope.

There is a big hole where my 45 mm tumour used to be in my liver, and scar tissue and other bits, but I am cancer free without having to take another year off my life. My work is precious; I have kept the business going. Eight people are employed, because I could keep going, and Kadcyla made it possible for me.”

--- Later in debate ---

[Nick Thomas-Symonds (Torfaen) (Lab)]

I begin by thanking the Backbench Business Committee for selecting this very important topic for debate this afternoon. I pay tribute to my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) for the passionate but very thoughtful way in which she introduced the debate. I endorse everything that she said. On the drug Kadcyla, she said, quite pithily, that, first, it works and, secondly, it has far fewer side effects than many other cancer drugs. I was also very proud to have backed the “43p a day” campaign that she mentioned.

I declare an interest as the chair of the all-party group on off-patent drugs and should also say that one of my first actions as a Member of this House in 2015 was to become a breast cancer ambassador. I was very proud to do that, as the person who inspired me to come into politics, my grandmother, died of the disease some years ago.

I was lucky enough in my early months in this House to be drawn in the ballot for a private Member’s Bill. I introduced the Off-patent Drugs Bill, and although it was talked out in quite controversial circumstances on 6 November 2015, I was none the less pleased after that to work on a cross-party basis to achieve legislative progress. I pay tribute to the hon. Members for Central Ayrshire (Dr Whitford), for Bury St Edmunds (Jo Churchill) and for Daventry (Chris Heaton-Harris), and to the former Minister for Life Sciences, the hon. Member for Mid Norfolk (George Freeman), for the work that was done in those months to make legislative changes which were incorporated in the Access to Medical Treatments (Innovation) Bill, which received Royal Assent in March last year.

I want to come to the pledges that were made on 29 January 2016 and how things have moved forward since. I say to the Minister that in setting out a number of questions about this matter, I do not necessarily expect them all to be answered in detail in her closing remarks. If there are aspects that she feels she cannot answer in detail, I would be grateful if she wrote to me about them after the debate.

On 29 January 2016, I and others in the House tabled a package of amendments to the Access to Medical Treatments (Innovation) Bill. Some were substantial and went into the Bill. Others were probing amendments designed to extract the promises that I have talked about. The then Minister for Life Sciences said:

“Broadly, the intention of the package of amendments is to introduce off-label repurposed medicines in the Bill, and to put it four square at the heart of the agenda.”

That is precisely what we sought to do that day. He added:

“I wholeheartedly supported the intention of his Bill and its predecessor, but not the mechanism. We now have a mechanism that will work”—

we had spoken that day about the mechanism.

One of the amendments requested an action plan, but the Minister decided he did not want that on the face of the Bill. However, he said:

“let me set out my commitment and that of the Government to pursuing this agenda with time and rigour.” —[Official Report, 29 January 2016; Vol. 605, c. 543.]

[Dr Huq]

I remember very well my hon. Friend’s Bill and the shameful way it was talked out by the professional filibusterers on the Government Benches. However, does he not agree that any action plan needs to look at these things in the round? It should look at the poor post-diagnosis support and information that patients get across other types of cancer, not just breast cancer. It should also look at the limited availability of the effective drugs we have talked about, which do not have side effects, and at the fact that drugs have been de-listed from the Cancer Drugs Fund.

[Nick Thomas-Symonds]

I certainly agree that the pathway has to be comprehensive, and I will come back to it in a moment.

In addition that day, the then Minister for Life Sciences said he would

“explore mechanisms for ensuring NICE can look at evidence and develop evidence-based guidance on off-label medicines, so that doctors are aware of which drugs are being used in an off-label indication…NICE is now looking at ways to collect evidence on repurposed medicines.”

He spoke about the “British National Formulary”, and I am pleased about the progress that has been made on it, which I will come back to in a moment.

We proposed—this would have applied to NHS England—that there should be a new system of national commissioning for repurposed drugs. Again, our amendment was not accepted, but this pledge was given:

“The NHS is hungry to look at all options for promoting off-label and repurposed drug use.” —[Official Report, 29 January 2016; Vol. 605, c. 544-45.]

I hope that that pledge can be repeated by the Minister at the Dispatch Box today. There was also a commitment to consult all relevant stakeholders. Again, I would hope that that is fairly uncontroversial and can be repeated.

Let me come now to where we have got to. When I intervened on my hon. Friend the Member for Mitcham and Morden, I quoted the worrying statistic about bisphosphonates, which really do provide a case in point. They are used to treat osteoporosis, but they are very effective in their secondary form—the repurposed form—where someone has primary breast cancer, and they certainly help to prevent that from spreading to the bone. The statistic that only 24% of clinicians are prescribing bisphosphonates is very worrying, and it does need to be addressed, because there should be no barrier in the system to their being far more widely prescribed than they are.

Let me come to the working group. I understand that it will conclude at the end of next month. I am very grateful for the fact that I will be meeting officials from the Pharmacy and Medicines Directorate in the next few weeks to discuss this issue. However, if there is to be a pathway, I would appreciate it if the Minister was prepared to share it with me in draft form before that meeting, so that comments could be made on it, particularly going back to the pledges made last year.

The “British National Formulary” has begun work. Indeed, I looked up bisphosphonates specifically on BNF Online before I came to the debate. What makes the 24% statistic even more worrying is that BNF Online says:

“The use of bisphosphonates in patients with metastatic breast cancer may reduce pain and prevent skeletal complications of bone metastases.”

That is there already—it is in the prescriber’s bible, if you like—so the Minister really should focus on why it is not filtering through the system in the way that it should.

In addition, there is a pilot licensing scheme that brings together medical research charities and generics manufacturers to license off-patent drugs for their new purposes. If the Minister could comment on whether she is looking for that to become a fully fledged scheme, that would be helpful.

The scheme is an interesting development, because my Bill, in its original form, would actually have put a duty on the Secretary of State for Health to seek licences for drugs in their new indications, and that was the bone of contention between me and the then Minister, who thought that it was too onerous for the Secretary of State to have that duty.

Looking back at that debate, I think the other interesting thing is that a point was made about the EU’s licensing scheme. It was said that any changes could run a coach and horses through that scheme, but given that we will not be members of the European Union by the end of this Parliament, I would be interested to hear how the Minister thinks the end of the Brexit process will affect this issue. If the European licensing scheme was seen by the Minister at the time as posing something of a problem, perhaps she can tell us if she will consider whether the pilot licensing scheme can now become fully fledged and how she sees things developing here in the UK without the European scheme.

I appreciate that I have put a lot of points to the Minister. As I said, I am perfectly happy for her to write to me about them. However, we should not forget the difference that this off-patent drugs agenda can make to people’s lives. Those who face this disease show incredible bravery. For example, we have my hon. Friend the Member for Bristol West (Thangam Debbonaire) in the Chamber with us, and Bonnie Fox, a constituent of the hon. Member for Croydon South (Chris Philp), is in the Public Gallery. We in this House, as legislators, owe a duty to all who suffer from this terrible disease to take all possible steps to make what are extraordinarily cheap drugs as readily available throughout our country as possible.

--- Later in debate ---

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

I congratulate my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) on securing this debate. She made an extraordinarily powerful and emotive speech. I join her in wishing everybody who is here today in the Public Gallery and everybody who is watching this debate at home all the very best for the future. It is also a pleasure to follow the hon. Member for Milton Keynes South (Iain Stewart), who made a very powerful speech citing the personal testimony of his constituent, whose case he argued eloquently. My hon. Friend the Member for Torfaen (Nick Thomas-Symonds) spoke eloquently about his grandmother being his inspiration for going into politics, and her dying of the disease. We come into politics for many different reasons, the profession of public pain being one. Nye Bevan did not create the NHS in 1948; he created it much earlier when his father died of pneumoconiosis in his arms before the time of the NHS. I hope that I can pronounce the drugs that I am going to mention just as well as the hon. Member for Portsmouth South (Mrs Drummond) did.

We have heard lots of statistics today. Stats, in themselves, are shocking, and it is also important to remind ourselves that behind every statistic there is a human story. The lives of women, all too often young women and mothers, are being cut cruelly short. We have heard many important interventions about access to breast cancer drugs for treatment of secondary breast cancer. At the heart of the motion is also the issue of how we can improve access to innovative new breast cancer drugs and off-patent drugs used for breast cancer. The use of such drugs relates not only to the treatment of breast cancer but to its prevention. I am immensely proud of the fact that my constituency is home to the Nightingale centre— Europe’s first breast cancer prevention centre—and the charity Prevent Breast Cancer. I am a Mancunian MP, so my constituency also benefits from close proximity to the Christie hospital, the largest single-site cancer centre in Europe, treating more than 44,000 patients a year.

The Nightingale centre opened at University Hospital of South Manchester—Wythenshawe hospital—in July 2007. It offers state-of-the-art diagnostic and treatment services to women and men with breast cancer and co-ordinates the NHS breast screening programme for the entire Greater Manchester area. It also provides training facilities aimed at addressing the shortage of breast cancer specialists, and it houses many of the Prevent Breast Cancer researchers who are looking at ways to predict and prevent breast cancer.

In the Prevent Breast Cancer research unit, several drugs that are now out of patent are being repurposed for preventing cancer from coming back. Women with a family history or other factors that make them high risk are known to benefit from these drugs, which prevent the disease. But women in that position find it difficult to obtain these inexpensive, tried-and-tested drugs because they are currently not listed in the “British National Formulary” as specifically licensed for the new purpose of prevention, despite successful clinical trials. There are currently three drugs in that situation: Tamoxifen, Raloxifene and Anastrozole.

[Nick Thomas-Symonds]

Will my hon. Friend give way?

[Mike Kane]

I would be happy to give way, having got the names of those drugs right.

[Nick Thomas-Symonds]

I understand that a new policy is being put together by those in charge of the “British National Formulary”, which will set out how they will get more off-label drugs into the formulary. Does my hon. Friend agree that the sooner that policy is available for us to see the better?

[Mike Kane]

I congratulate my hon. Friend on doing so much work in this area since he came to Parliament. We can only hope that what he says is true; perhaps the Minister can give us more information on that point in her summing up.

The Prevent Breast Cancer research unit has more out-of-patent drugs under investigation for breast cancer prevention which may be even better for the future. As well as doing everything we can to extend the life of women with secondary breast cancer, we must do all we can to prevent breast cancer from occurring in the first place. As we all know, the adage is that prevention is better than cure. For those with secondary cancer, for whom cure is currently out of reach, many people will be striving to achieve that for the next generation.

At the moment, the system is standing in the way. A solution to make those drugs more widely available that would cost very little money indeed would be to ask NICE to list such drugs as approved for the new indication of prevention in the “British National Formulary”—following the evaluation of relevant clinical trials, of course—so that doctors can have confidence in prescribing them. The requirement to obtain a new Medicines and Healthcare Products Regulatory Agency licence for the new indication is expensive and impractical for repurposed medications, because they usually lack a sponsoring pharmaceutical company to champion the new use of the generic drug. I am sure the Minister would agree that such a small change would be transformative in the prevention of breast cancer. I hope that she will ask NICE to consider that change to the way in which drugs are listed in the “British National Formulary” to allow drugs that have been evaluated for a new purpose, such as prevention, to be listed as approved for that purpose.

When we lose someone prematurely to cancer, grief obviously follows. It has been my experience that when we lose someone to breast cancer, the grief is particularly poignant. Tonight, my thoughts and prayers will be with all my constituents who have either succumbed to the disease or are battling it, and with their families who carry the consequences. I lost my cousin Maura Kane to the disease, and my two friends Tom and Claire both lost their mothers to it. I stand in solidarity with my constituent and friend Sheila Higgins, who is battling this disease. She has been like a mother to me for the last two decades. Finally, my parliamentary assistant Suzanne Richards came back to work after Christmas with a clean bill of health. She was diagnosed with a virulent strain last year, but she had world-class treatment at the Wythenshawe and Christie hospitals. Today is her birthday, but it is a birthday that many of us feared she would never see—happy birthday, Suzanne.

European Medicines Agency

Nick Thomas-Symonds Excerpts

Wednesday 12th October 2016 Westminster Hall

[Daniel Zeichner (Cambridge) (Lab)]

I beg to move,

That this House has considered the future of the European Medicines Agency.

It is a pleasure to serve under your chairmanship, Mr McCabe. I am grateful for the opportunity to secure the debate, which I called with the expectation of being answered by a Minister from the Department for Exiting the European Union. It is unclear to me why that is not happening; perhaps that could be No. 171 on our list of questions about Brexit. None the less, I am sure we can expect a robust and helpful response from the Under-Secretary of State for Health, the hon. Member for Warrington South (David Mowat), who perhaps can explain that to us.

I start by laying my cards on the table. I am old enough to remember the John Major Government and the Maastricht treaty; I was perhaps one of the few at that time who actually read it. I also remember the troubles that the then Prime Minister had. Despite those difficult times, one of his major achievements was to secure the location of the European Medicines Agency in the United Kingdom. More than 20 years on, that success by a Conservative Prime Minister is being put at risk by the foolish path being pursued by the Conservative Government today. John Major famously referred to some of his colleagues—I apologise for this, Mr McCabe— as “bastards”; now they are running the show.

Last week, the Chancellor wryly commented that no one voted for Brexit to make us poorer. I wonder how many knew about the potential impact on one of our key industries, the future of which we are discussing today. My guess is that very few knew and that very few were voting to destroy British jobs and to do reckless damage to one of our great success stories. The area of the country I represent is a world leader in pharmaceuticals and life sciences. The Cambridge biomedical campus is at the pinnacle of international research, with, just a few years ago, AstraZeneca choosing Cambridge as its location rather than elsewhere in the world—but that was before 23 June.

Given that the vast majority know nothing of all this, let us set out some of the details about the European Medicines Agency and the significant role it has played over the past two decades in providing a harmonised approach to medicines regulation throughout the European Union. It was set up in 1995 from predecessor organisations, is a decentralised agency of the European Union and is located in London. Its mission is

“to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union”.

Responsible for the scientific evaluation of human and veterinary medicines developed by pharmaceutical companies for use in the European Union, it can grant marketing authorisations for medicines that allow for their use across the 28 EU member states, as well as the countries of the European economic area—Iceland, Liechtenstein and Norway.

The EMA describes its four main functions as to facilitate development and access to medicines, to evaluate applications for marketing authorisation, to monitor the safety of medicines across their life cycle and to provide information to healthcare professionals and patients. Essentially, it is tasked with ensuring all medicines available on the EU market are safe, effective and of high quality, and it seeks to harmonise the work of existing national medicine regulatory bodies, such as the UK’s Medicines and Healthcare Products Regulatory Agency. It serves a market of more than 500 million people living in the European Union and covers a market of 25% of global pharmaceutical sales, of which the UK constitutes just 3%.

We should understand the EMA in the context of the growing global pharmaceutical market and the UK’s world-leading life sciences sector. The Prime Minister herself said in July:

“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”.

Indeed, the life sciences sector in our country has a turnover of more than £60 billion per year and generates exports worth £30 billion. In 2014 it invested £4 billion in research and development—more than any other sector. It employs 220,000 people in our country and 25% of the world’s top prescription medicines were discovered and developed in the United Kingdom. In my constituency of Cambridge alone, there are more than 160 life science companies reinforcing the strong local knowledge economy, and contributing to the economy well outside my region as well.

In passing, it is perhaps worth noting that Cambridge is one of just a handful of UK cities making a net contribution to the UK Treasury, thanks in no small part to its vibrant life sciences industry. Thus, the Cambridge view on how we secure future prosperity may perhaps be worth listening to. Cambridge, and those in this key sector, are most certainly unhappy with the current route being taken for a range of reasons and the future of the EMA is a good example. What will be its future, post-Brexit? What will be the impact on the future of our country’s life sciences industry more generally? What will be the real impact on the NHS—the real impact, not the bus slogan? The head of NHS England, Simon Stevens, has rightly insisted that the regulation of medicines and devices must be considered during the Brexit negotiations.

What are the options? As I have noted, countries inside the European economic area are included within the EMA’s centralised marketing authorisation procedure, which means that, if the UK remains part of the economic area, the process for regulating and supplying medicines in our country might see little change, which could bring stability for the sector.

[Nick Thomas-Symonds (Torfaen) (Lab)]

It is a pleasure to serve under your chairmanship, Mr McCabe. My concern is that, outside the European Union, we will be in a position in which pharmaceutical companies will have to go to the EMA to go through the process to make the drugs available, and subsequently have to do the same thing for the purposes of UK law, which will cause delay. Does my hon. Friend agree that it is important that we have parallel processes so that there is no disadvantage to patients in this country?

Oral Answers to Questions

Nick Thomas-Symonds Excerpts

Tuesday 5th July 2016 Commons Chamber

[Mr Jeremy Hunt]

I am very happy to do so. My right hon. Friend has campaigned long and hard, and rightly so, on such issues. The truth is that the guidelines under which the NHS operates for the sharing of patient-identifiable data are not as clear as they need to be. That is why I asked the Care Quality Commission to undertake an independent investigation into the quality of data protection by NHS organisations and Dame Fiona Caldicott to update her guidelines. I hope that we will have news on that soon and certainly before the summer recess, which will please my right hon. Friend.

[Nick Thomas-Symonds (Torfaen) (Lab)]

Happy 68th birthday to the NHS and thank you to its creator, Labour’s Aneurin Bevan.

According to research by the British Lung Foundation, the mortality rates for lung disease have not improved over the past 10 years. Will the Secretary of State take a lesson from the Welsh Government, which have put in place a specific strategy and delivery plan to tackle the issue?

[George Freeman]

The hon. Gentleman will know that the Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), opened an exhibition on this topic yesterday and that the Chancellor recently put an extra £5 million into mesothelioma research. Through the National Institute for Health Research, the Government are committing to invest in that disease area. We are also committed to ensuring that we drive up both research and better treatment for such diseases.

Support for Life-shortening Conditions

Nick Thomas-Symonds Excerpts

Tuesday 7th June 2016 Westminster Hall

[Stuart Andrew (Pudsey) (Con)]

I beg to move,

That this House has considered support for children and young people with life-shortening conditions.

Mr Percy, may I say what a pleasure it is to serve under your chairmanship for the first time? [Hon. Members: “Hear, hear.”]

Prior to entering Parliament, I spent most of my working life in the hospice movement, with both adults and children. I worked in hospices, including Hope House in Oswestry; East Lancashire hospice, which cares for adults in the east Lancashire area; and Martin House children’s hospice, which cares for children in the Yorkshire area. During that time, I saw children and their families at their most vulnerable, looking for any kind of solace in what are probably the most challenging circumstances that any of us could possibly imagine.

In my 14 years working in the sector, I saw the hospice movement adapt and grow to meet the needs of children and young people as medical technology and provision developed. That growth was achieved by listening and putting the patients first at all times. However, unfortunately, there are still cases across the broader palliative care sector where that does not always happen, and that is why this debate is so important. There are currently 49,000 children and young people—and the number is rising—living in the UK with life-shortening conditions.

[Nick Thomas-Symonds (Torfaen) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Percy. I congratulate the hon. Member for Pudsey (Stuart Andrew) on securing such an important debate. He just quoted a statistic. Does he agree that data collection is one of the most important factors? Robust data collection is needed so that we do not underestimate the number of children who are suffering from life-shortening conditions.

[Stuart Andrew]

The hon. Gentleman makes an important point, which I will come to later.

Some 49,000 children and young people are living with conditions that are life shortening, by which we mean conditions for which there is no reasonable hope of a cure and from which most of those young people are expected to die. The conditions can include conditions for which curative treatment may be feasible but can fail, as is often the case with cancers or congenital heart diseases; conditions for which premature death is inevitable but where there may be prolonged periods during which the child is well, such as Duchenne muscular dystrophy; progressive conditions such as Batten disease, without any curative treatment; and irreversible, but non-progressive, conditions that cause severe disability, leading to susceptibility to health complications and premature death, such as severe brain injuries.

The number of young people affected by one of those four categories of condition is equivalent to one child in every single school, and 50% of the 5,000 children who die in the UK each year will have one of those conditions. Of course, the number of people affected in other ways is much higher. Parents, siblings and other family members and friends can bring the number close to 400,000 people, which equates to more people than the population of the city of Leicester.

The 49,000 children and young people need palliative care from the point at which their condition is diagnosed or recognised—often at birth—until the end of their lives. There is an entire package of outcomes that good palliative care should achieve, which is quite different from that which adults receive given that children often need care throughout their entire life. Good care should meet children’s physical, social and emotional needs, enhancing their quality of life to ensure that the child and their family can come to terms with such life-altering issues.