Access To Medical Treatments (Innovation) Bill

Jo Churchill Excerpts

Friday 29th January 2016 Commons Chamber

[Chris Heaton-Harris (Daventry) (Con)]

Members may be aware that unlike the initial stages of my Bill, the journey of the Off-patent Drugs Bill promoted by the hon. Member for Torfaen (Nick Thomas-Symonds)—which is, coincidentally, further down on the Order Paper today—enjoyed widespread support from Members of this House, and outside this place among a whole host of charities and non-governmental organisations. My old colleague Jonathan Evans, a former Member of the European Parliament and the former Member for Cardiff North, introduced a similar Bill on these matters, which also gained widespread support. I have watched the progress of these Bills closely and read the briefings provided on them by several charities, and I could not help but notice the obvious links with my Bill and the importance of the subject it covers—increasing the use of effective off-label drugs.

The amendments that we are considering seek to work with the ideas of the Off-patent Drugs Bill and meet the same goal of spreading the use of off-label drugs. I am very grateful to the hon. Member for Torfaen for working with me, and others, so closely to include some of his very good ideas and thoughts in my Bill. He deserves a huge amount of credit for the work he has put into this, alongside the hon. Member for Central Ayrshire (Dr Whitford) and my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who have been unbelievably strong champions of these issues.

The new clauses and amendments I am supporting do not reflect exactly the original Bill introduced by the hon. Member for Torfaen. That Bill sought to require the Secretary of State to seek licences for off-patent drugs in their new purposes. As the Government stated at the time, as the licensing authority in the UK, the Secretary of State cannot take up such a duty. However, that does not mean that a similar end result of increasing the use of such drugs cannot be achieved by other means. I very much hope that we can do so through this Bill.

Breakthroughs in research mean that several existing drugs have been found to be highly effective in treating conditions other than the ones for which they were originally produced. They potentially have huge life-saving effects and can alleviate the suffering of many people for many conditions. There are so many well-known examples. They were widely discussed on Second Reading of the Off-patent Drugs Bill, so I will not repeat all of them. The list includes the likes of tamoxifen and zoledronic acid, and of course the simple drug aspirin, which has so many other benefits in so many areas. The examples mentioned when we debated the hon. Gentleman’s Bill speak for themselves in showing us why his new clauses and amendments are so important.

As the hon. Gentleman has said in support of his Bill, doctors are nervous of prescribing off-label drugs. Even if a GP strongly believed in prescribing an off-label drug to a patient, they could well be put off. There are several reasons for that, and they were detailed in briefings circulated at the time. One is the matter of personal liability, which I will talk about in relation to other amendments. General Medical Council guidance shows that clinicians can currently prescribe off-label drugs, but that there are significant disincentives to do so. It states that a licensed treatment should be considered before an off-label or unlicensed treatment. It also indicates a greater level of responsibility for the doctor prescribing off-label, and therefore a potentially greater risk of liability, which would be a disincentive for a doctor in prescribing an off-label drug. Before a clinician has even started down this track, they are wary of picking an off-label medicine.

There is little incentive for a pharmaceutical company to pay for a licence when a drug can be manufactured generically. There is no incentive for any company to market the drug for a new indication, and there is no proper guidance for the use of such a drug. Without any stamp of approval, any marketing or any mechanism to provide guidance, there is nothing to encourage clinicians to use an off-label drug, other than their own medical knowledge.

Drugs without a licence for their second use are not marketed, so there is a lack of awareness, and the prescribing of them therefore varies when a new indication arises. There is no trusted and simple way to spread information about off-label drugs that are working. That means that some doctors may use the drug if they know of the indication, but lots may not. Without a system for sharing such information and spreading knowledge about these drugs, medical professionals deciding whether or not to prescribe them have to spend a huge amount of time reading the literature and undertaking research. The explicit mention, through the new clauses and amendments, of the inclusion of such drugs in the database will ensure that information about them is shared and reviewed, and that appropriate evidence is provided. By spreading awareness, the new clauses and amendments will therefore help to make prescribing more consistent.

On Second Reading of the Off-patent Drugs Bill, the hon. Member for Central Ayrshire said that experts in certain fields will prescribe many off-patent drugs whenever they feel it is necessary. For example, off-label prescribing is quite common in the treatment of secondary cancers. Experts in that area will have experience and will be aware of the evidence for use, but many other medical professionals will not be in such a position. If a drug is not in the “British National Formulary”, the dose cannot be checked.

When a clinician uses a drug every day or a specialist in a field sees conditions regularly, they know what works and what is best, and will therefore feel very comfortable in prescribing off-label. However, every medical professional is not an expert in every field. For the majority of the time, patients are not with such specialists. Their first point of call is not a clinical physician working in only one field, but a GP in their local practice or a nurse in their local surgery. I believe that the database has huge potential in helping to spread the knowledge and expertise required for better and further use of such drugs.

I hope that the amendments I have tabled will be agreed by the House—I believe they represent common sense—and that the Minister will listen to Members who have tabled the other amendments and new clauses. Although some of them are probing amendments, a huge amount of effort has gone into all of them. He is aware of the time and cross-party work that has gone into getting the Bill to this point. That has basically been driven by the hon. Members for Torfaen and for Central Ayrshire, my hon. Friend the Member for Bury St Edmunds and, to a certain extent, me. I would like to think that we will have got to a certain place by the end of today’s sitting, and that we can all leave the Chamber feeling that we have done some good.

[Jo Churchill (Bury St Edmunds) (Con)]

I congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on his success in bringing the Bill so far. The fact that we have reached even this stage is no small testament to his hard work on the Bill, particularly the discussions about the removal of the areas of concern—clauses 3 and 4—and the fact that he has been gracious enough to allow me and the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford) to badger or cajole him into allowing us to table new clauses 1 to 6, but specifically my new clauses 4 and 6.

The Minister was not in the Chamber on 6 November to hear the arguments of the Members who proposed and supported the Off-patent Drugs Bill. Since then, however, he has engaged with many of us, for which I thank him. We felt that his Department’s response simply was not correct. Doctors may have been able to prescribe medicines for uses outside their licence or off-label where that was in the best interest of their patients, as the guidance says, but they just did not do so, or at least not consistently throughout the medical profession or the field and irrespective of the patient’s postcode. The prescribing of such drugs is more common in oncology, paediatrics, pain management and palliative care, which adds to the lottery effect for the patient.

The need for an action plan for an off-patent drug pathway is undeniable. When there is a strong indication of effectiveness, their routine use for an alternative indication should be secured. For example, the use of bisphosphonates, which were originally developed to treat osteoporosis, are now commonly used by 36,000 women living with secondary breast cancer in this country. Those drugs have already been through phased trials. No one in this place is suggesting that the highest levels of safety should not be applied to drug research and licensing at all times, but efficacy should drive clinicians’ decision making.

Patients, too, have a voice on this issue. I found my patient’s voice after my second primary cancer, and I wanted to use it for the benefit of others. Here I am now asking the Minister—not for the first time—to use his position to find a way to unleash the potential of research in this country and to unblock the system for everyone. My oncologist told me that a second primary cancer was luck—bad luck, but just luck—and I hope that we can all improve the odds just a little bit today.

I believe in the power of patients, clinicians, charities and pharmaceuticals to do the right thing—to increase their knowledge for those whose daily lives are dominated by serious disease and debilitating illnesses, and to ensure that treatments exist to help them. Particularly in the area of off-patent repurposed drugs, they need to be supported by key players, such as NICE, the MHRA, NHS England and medical research charities.

I assure the Minister that it is not mere chance the new clauses and amendments are supported by Members from all four corners of our nation. It is to show solidarity with our constituents—north to south, east to west—who want a co-ordinated approach. One of the most frustrating things for patients is the clogged nature of our drugs pathway. It seems to be beyond us to get drugs licensed, whether repurposed or not, and to the patient in a timely way. I ask the Minister to provide a timeline to support any action that can be taken.

New clauses 2 and 3 would require the National Institute for Health Research to develop and introduce a mechanism for gathering and recording evidence. Last week, I was surprised to learn from Professor Bruce, a clinician at the NIHR working in the musculoskeletal biomedical research unit, that in 50 years only one drug has been licensed for the treatment of lupus. Sadly, that licensed drug has spent four years being considered by NICE and is not available for wider use. To avoid the heavy use of steroids for the condition, rituximab is often used—a drug that was originally developed for lymphoma and rheumatoid arthritis.

Access to Medical Treatments (Innovation) Bill

Jo Churchill Excerpts

Friday 29th January 2016 Commons Chamber

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

The hon. Member for Daventry (Chris Heaton-Harris) may have to shake his watch a little longer. I call Jo Churchill.

[Jo Churchill]

I spoke earlier about the new clauses we tabled, but I did not emphasise my own need for us not to paralyse the database. It is vastly important, given the wider horizon of genomics and informatics, and we have not even touched on how it could accelerate the whole system and improve patient outcomes significantly. We need to put patients at the front and centre of the process, and allow enough flex for the system to be the best and the database to be the finest in the world. We have the finest scientists, the greatest charities and some of the best academic minds at our disposal.

The database may also revolutionise the life sciences industry, to which my hon. Friend the Member for Newton Abbot (Anne Marie Morris) has just referred. That industry generates 1% of our export market from one drug. The power for this billion-pound industry to grow and to improve health—not only in our own country, but across the world—has to be seen to be believed. It costs upwards of £1 million to take a drug to market. What on earth would incentivise a company to do that if it could not get some sort of payback? We must not tie the hands of the people who can find the answers. Many such companies start as micro-companies, spun off from the great universities of our country, but many of them fail in what they call “death valley”. Our health system needs to modernise, digitise and reform to collect, collate and use our health data in the right way.

I believe that clinical trials are vital. I would take part in one, as a dear friend of mine recently did, to give other people a better chance of beating their disease. That is why we must not constrain the database in a way that, like a straitjacket, would completely constrict the industry and academia. At the same time, we must maintain the rigour in dealing with science for which our country is so famed. I believe that the power behind that science is patient data, and every patient holds an answer. With the support of clinicians and charities, and with a strong sense of purpose from the Government, I want data to be used for the benefit of patients. I will stand here and make my point over and again for these five years if we wreck the ability for a database to be a power for good in this Chamber today.

[Dr Philippa Whitford]

I wonder whether the hon. Lady will clarify what she is saying. The database that is referred to in the Bill will share information on drugs and trials that ought to be available to anyone, whether a pharmacist, a GP or a doctor. It is simply about information sharing. Is she referring more to a database of patient information from which we can learn in the future? Obviously, that is outwith the scope of the Bill, but it has been held back by the various data challenges that have been faced.

[Jo Churchill]

I apologise. Yes, I have confused the two, because I really believe that if we are not careful, what we do today will have an effect on our ability to bring that second broader database to fruition, which would give us the information we need to drive the trials, the life science industry and so on. Databases need to be fit for purpose. I could not have put it better than the hon. Lady did. We want the database that we are talking about today to be fit for purpose, but we do not want to put too many constraints or too much rope around it if that will stop us moving forward with clinical trials and with the whole area of genomics and patients.

I want every life to mean or have meant something. A patient should be able to choose to give knowledge as their legacy. Data hold the answers—the answer for my constituent whose two-year-old had a brain tumour; the answer for a family I know who have diabetes in several generations; the answer for a family member whose humour is tested by Parkinson’s that attacks his body. Personalised medicine should be a reality. As was pointed out in a paper yesterday, we are doing great things with CRISPR—clustered regularly interspaced short palindromic repeats—and across the piece.

Like me, every patient is somebody’s parent, partner, child or friend. That must not be forgotten. If the database we are discussing allows for information to be given that is appropriate to the individual, with care taken by the clinician right through the pipeline, it has to become a force for good. We should not wrap it up in too many constraints, but should allow it to develop. We must allow the Under-Secretary of State for Life Sciences to give us a lead in how to proceed in this field in the most effective manner.

The use of data offers the possibility to accelerate medical trialling from seven to two years and to link research together to find new insights. My glasses are not rose-tinted. I would want assurances about the use of my data, as any sensible person would. I want the recommendations of the accelerated access review to be implemented. The use of health data will be central to solving this country’s health challenges, not least in terms of cost, and its economic challenges. Our medical future will be uncertain unless we unleash the potential of information about patients for patients. I therefore support the Minister’s proposal.

[Chris Heaton-Harris]

It is always a pleasure to follow my hon. Friend the Member for Bury St Edmunds (Jo Churchill). Her knowledge and the way she goes about her business in the Chamber on this subject mean that it is always worthwhile to listen to her. What she says is powerful and she beats a trail that many will follow. She will get to the place she wants to get to eventually. I am very hopeful that this process today is one step along the way. I hope she gets some comfort from the fact that she is beginning to open doors, open minds and, in this case, open up information to registered medical practitioners about a host of treatments that they might not have known existed.

First, I will deal with what I perceive to be a Government amendment, amendment 15, which was tabled by my hon. Friend the Minister. I will then deal with the amendments tabled by the hon. Member for Lewisham East (Heidi Alexander).

--- Later in debate ---

[Chris Heaton-Harris]

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

It is a tiny bit of a relief to get to this point in the proceedings. I guess I should start by thanking a number of people, the first of whom is the inspiration for this Bill. As I explained in my Second Reading speech, I followed in some detail what Lord Saatchi had been doing in another place, especially when his Bill reached its Report stage and Third Reading, and I thought some of his ideas were very much worthy of legislation in this place. Unfortunately, the inspiration for his Bill was the terrible loss that he suffered, but I would like to think that what we have done here today will be a true and lasting legacy for him to remember his wife by.

I should also like to thank the Under-Secretary of State for Life Sciences and all the officials in the Department who have given me advice—nearly always constructive and helpful—especially a gentleman called Peter Knight, who very kindly hosted a round-table for a whole host of organisations, and anyone else who was interested. It was only the people who were being really stroppy about the Bill who refused to come. He kindly explained what the database could and should be doing, and what its potential was, which alleviated a huge amount of concern. He also enlightened a number of people on the direction of travel that we were taking. I thank my hon. Friend the Minister and all his officials for their help and understanding.

Most of all, however, I would like to thank the hon. Members who are in the House today. I was a Member of the European Parliament, and I guess we have Europeanised the system here. I am not a great European—I like to consider myself a decent Eurosceptic—but there are some practices in the place where I used to work that enable you to listen to people on all sides of an argument, and that allow you to evolve and learn from their better experience and knowledge and put that into your own work. I want to thank the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford), and of course my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who is an unbelievable force of nature. I am sure that she will make waves for the Minister if he does not stick to some of the promises he has made today. I also thank Her Majesty’s loyal Opposition, who all the way through this process have been willing to engage with me, to listen and to criticise, completely and correctly. I therefore thank the hon. Members for Lewisham East (Heidi Alexander) and for Ellesmere Port and Neston (Justin Madders).

Where we have got to now is not a bad place. I have received a briefing from Empower, which is one of the charities that is keen to ensure that patients get the best treatment. I will quote from its briefing, because this is not something I would ever say about myself. It states:

“We are particularly pleased by the ingenious step of absorbing Nick Thomas-Symonds’ Off-Patent Drugs Bill into the amendments. Mr Heaton-Harris’ database of innovation combined with off-patent access to medicines is a hugely positive step forward, and one Empower fully supports.”

The briefing included a note from Graham Silk, a gentleman who was doing some media on this yesterday, having joined Empower’s drive for spreading innovation. He said:

“I was diagnosed with leukaemia in 2001, and I’m still here today because of medical research facilitated by the patient data of the leukaemia community. I was one of the lucky ones by being in the right place at the right time. But we need to start taking luck out of the equation by spreading this information faster and wider. This database could have the power to do just that.

Indeed the drug that saved my life has already shown early promise in other conditions, the off-patent provisions in the Bill could also see patients granted access to a far broader set of treatments which would really open up our health system.

I am looking forward to continuing Les Hatpin’s legacy”—

Les was the power behind Empower—

“by working with Parliament, policy makers, and frankly anyone who will listen, to see our health service modernise and digitise to the benefit of patients.”

[Jo Churchill]

That clearly encapsulates what we need to be doing: putting the patient at the centre, backed up by a charity, such as that leukaemia charity, and supported by clinicians. We could not want a more virtuous situation.

[Chris Heaton-Harris]

I completely concur with my hon. Friend. I would like to think that Graham, when he looks at our proceedings today, will be pleased at where we have got to, and the process by which we have got here, and is looking forward to his wishes becoming fact.

There have been some questions about whether the database is required at all. I will talk about this gently, because I do not want the cross-party consensus to break down at such an important moment in proceedings. I know—I have learned a huge amount in this process—that there are many mechanisms already available for sharing treatments, but they are far from being available to all medical practitioners, and in my view they are insufficient. Besides that, there is no comprehensive database of treatments that are not regulated under the Medicines and Healthcare Products Regulatory Agency; there are just many smaller ones, such as registries for specific diseases or databases for particular regions.

For example, the most recent figure I could find for the total number of registers used by medical professionals is from 2002. Back then the Department of Health commissioned a report into disease registers in support of the White Paper, “Saving Lives: Our Healthier Nation”. The report found that there were well over 200 registers in existence in England. The number of disease registers already in existence in England was obviously large, although possibly larger than was generally appreciated. Even though the review was not exhaustive, it identified about 250 registers. The report stated:

“We would not be surprised if there were more than 400 specific registers in existence in England.”

That rendered the situation on data collection at best confusing, and at worst it makes finding evidence and navigating through that data almost impossible. I hope that the database set out in the Bill will provide clarity through the vast web of registries, information and data that already exist and help clinicians find evidence for innovative treatments simply and quickly.

That is particularly important today, because research has come on in leaps and bounds, meaning that a huge number of new treatments are coming into the NHS and innovative ideas are everywhere. There is great potential for what this could do. South London and Maudsley NHS Foundation Trust has developed a computer system that allows it to carry out research using the information from the trust’s clinical records. The system is known as the clinical record interactive search system, and it is anonymised. It is hoped that it will make a very real and positive difference to future treatments and care. The system allows clinicians and researchers at the hospital to look at real life situations in large quantities. This makes it easier to see patterns and trends such as what works for some and does not work for others. For example, case registers have been used extensively in mental health research, which was commented on earlier. Recent developments in electronic medical records and in computer software to search and analyse these in an anonymised format have the potential to revolutionise this research tool. The case register has been hailed as representing a new generation of this research design, building on a long-running system of fully electronic clinical records and allowing for in-depth analysis of data while preserving anonymity through technical and procedural safeguards.

Historically, medical records of some kind have always been kept. In keeping with the tradition of careful, methodical scientific observation, they have frequently been developed into disease registers through which the incidence, course and health service use of specified diseases can be monitored and investigated. In the context of changing social, political, professional and technological factors, a large number of psychiatric registers were constructed throughout the 20th century. However, owing to the expense of maintenance, often then carried out manually, the limited information available, which relied on data sheets completed by clinicians in addition to their routine workload, the practical difficulties of monitoring data quality, and limited funding, many of these programmes closed, and a vast amount of the information collected, which could have been useful, was lost.

Now we live in a time in which rapid technological advances and other developments over the past decade have led to new possibilities for the development of data-sharing. With electronic clinical records increasingly complementing handwritten notes, large volumes of clinical information are contained in an electronic format. The possibility of what we can do with this is unbelievably exciting. So far, we have not really harnessed the data that we already have. There is so much potential to make great changes, and this Bill is a tiny pigeon step in the right direction.

There has obviously been a huge amount of interest in this Bill from a whole host of groups. Some have concluded that the database is not needed, some have concluded that it is a good idea, and some have raised a number of questions about it. I would like specifically to thank the Association of the British Pharmaceutical Industry for its briefing on my Bill, which was circulated to Members of Parliament this week. It states its concern that the Bill will promote the prescription of unlicensed medicines and says that that is worrisome because there is hierarchy of risk involved with prescribing off-label and unlicensed medicines that makes unlicensed treatments the more risky route. It is completely correct. Promoting the prescription and use of these treatments when that is best thing to do for patients, is, I would like to think, exactly the sort of information that the Bill will share around the place to enable people to do the best thing.

With the amendments tabled today, the Bill promotes treatments in clinical trials, which are by their very nature unlicensed, as well as off-label drugs, other licensed but perhaps underused or very new treatments, and other unlicensed treatments. Clearly, it will not change the fact that, under MHRA guidance, more risk is involved when using unlicensed drugs. This, rightly, will remain the case, as these drugs have not received regulatory approval and are not yet deemed safe for use. No guidance or law of liability is changed at all by this Bill, with the tabled amendments. However, the Bill will spread information behind how these drugs are being used and allow responsible registered medical practitioners to access more information, much more quickly, to make better decisions for themselves.

The ABPI also wrote that the database undermines the UK medicines regulatory system and gives doctors the ability to prescribe unlicensed or off-label medication. As I have said, that is perhaps not terribly bad, but I would like to think that we are not undermining any regulatory system. The Bill simply does not contain provisions that would do so. I want to give the ABPI some help with its questions, and I would like to think that this debate—the points made by the Minister about how he will use the power, and those made by hon. Members on both sides of the Chamber underlining the cross-party nature of the provisions—shows that the Bill is worthy to be sent by this House to the other place and that it will do patients, registered medical practitioners and our NHS the world of good.

Cancer Drugs

Jo Churchill Excerpts

Tuesday 19th January 2016 Westminster Hall

[Jo Churchill (Bury St Edmunds) (Con)]

I thank my hon. Friend the Member for Mid Derbyshire (Pauline Latham) for calling a debate on an issue that is important not only to me and several of my constituents, but to the broader population.

The Cancer Drugs Fund is not fit for purpose. As the chief executive of Cancer Research UK, who chaired the independent taskforce that looked into the fund, pointed out, we have several problems. First, curative treatments cannot be accessed readily enough. Also, insufficient data are collected in the system to prove the benefits of drugs and their effectiveness for patients. Although we welcome the data collection that is taking place now, it is a little too late.

We continue to lag behind other countries in cancer recovery rates and appropriate prescribing. Indeed, 20% of cancer patients present at our accident and emergency wards, and the later a patient presents, the poorer the outcome. As the hon. Member for Scunthorpe (Nic Dakin) said, certain cancers, such as pancreatic cancer, are devastating in the speed with which they attack the individual.

It must be remembered that the Cancer Drugs Fund is unique: cancer is the only condition with a dedicated fund. My constituents and I welcome the Prime Minister’s support, but I am a little concerned that cancer is being labelled as a special disease. My surgery often includes patients with other diseases, and we must look across the piece. My concern is that we should have a road map from the accelerated access review so that we can learn how to drive forward advances not only for cancer, but for all areas of medicine. Standing in this hall takes me back six months, to when I first spoke here, about a constituent’s access to the rare-disease drug everolimus.

In a system that is challenged financially, we need to be very sure that any drug for whatever illness is effective and offers value for money. Within that landscape, the CDF has gone from its original four-year spend of £650 million to a six-year spend of £1.27 billion. It could be argued that it has been a victim of its own success.

With improved access to medicines for nearly 80,000 people, but with ever-increasing need and demand, it is right that the Cancer Drugs Fund should sit alongside the cancer strategy as part of the entire commissioning pathway. Non-surgical cancer treatments such as drugs can and should be incorporated into a treatment package of surgery and radiotherapy to deliver an integrated and effective approach. There is a need for radiotherapy machines right across our hospitals, because they deliver extremely high survival rates for cancer patients. We therefore need to be careful about these issues.

For me, the rub has been the lack of thought given to the removal of drugs, and like my hon. Friend the Member for Mid Derbyshire, I have been approached on this issue by constituents—particularly those suffering from pancreatic cancer and, given my history, those with breast cancer. A review in September led to 23 separate treatments being removed from the Cancer Drugs Fund, before we understood what the new horizon will look like for the charities and pharmaceutical companies, how the pathway will progress and whether we have a solution to ensure that our constituents can access drugs. In short, this removed the clinical choice from doctors and, more importantly, from patients. Those patients are my constituents and friends. With the loss of Imnovid and Revlimid—two drugs for myeloma—and the removal of breast, bowel and pancreatic cancer drugs for all those patients, life suddenly became less certain. A new CDF should have clear entry and exit levels for promising drugs. It needs to be a trial area, and defined as such; if, as proposed, it is to be brought into NICE, we need answers to some of the questions that other hon. Members have asked about how the Minister will hold NICE to account. In the cancer drug future, once a drug was approved it would be made available for routine use and would go into baseline commissioning. That would take some of the fear about whether someone would get it out of the system.

What remains to be seen is whether new drugs will have to meet the current inflexibilities of the cost-effectiveness criteria. That is a concern for cancer charities and pharmaceutical companies, which predominantly have the care of the patient, and patient outcomes, at their heart. To deliver cost-effective and timely treatments, as the hon. Member for Strangford (Jim Shannon) pointed out, we need a flexible new system. The NICE appraisal process is slow and unwieldy. It should be flexible enough to cope with new cancer drugs and—the Minister is aware of my interest in this—off-patent and repurposed drugs, which can also be effective in the area in question. That is about gathering and delivering the data on the patient for the patient, to allow drugs to be recommended and prescribed, or to make it possible to return to an individual pathway for a funding request. However, that merely sends us back to where we are today—people not knowing whether they will get the drug or not.

The irony of our system is that with the vibrancy of our life science industry, drugs are often readily available in Europe or Scotland before patients in England and Wales can access them. That is the bigger problem. We have improved one-year survival rates in the UK; but despite that we lag behind many other countries and our five-year survival rates have shown little progress. More must be done. In the world of pharmaceuticals and, more importantly, genomics, advances are happening at pace. We need a space where we can trial medicines for use not only in big cohorts but for rarer cancers and diseases. We need a landscape that will allow for the personalised medicine that is coming down the tracks to us. Cancer will not wait for NICE. Nor will it wait for the patient. I know: I have been diagnosed with cancer and pre-cancerous tumours on several occasions. That is why I challenge the Minister on behalf of other cancer patients and my constituents in need to ensure that the CDF delivers reforms that will improve patient access to effective cancer medicine.

New Cancer Strategy

Jo Churchill Excerpts

Thursday 19th November 2015 Commons Chamber

[Jo Churchill (Bury St Edmunds) (Con)]

I am vice-chair of the all-party parliamentary groups on cancer and on breast cancer. I welcome the strategy and the hard work of those who have put it together. Looking at a situation with a fresh pair of eyes is always beneficial, for all the reasons that my hon. Friend the Member for Basildon and Billericay (Mr Baron) pointed out.

My hon. Friend the Member for Castle Point (Rebecca Harris) and the hon. Member for Scunthorpe (Nic Dakin) highlighted one of the problems: there are more than 200 types of cancer, which makes it highly complex to deal with unless we have an overarching strategy. That goes not only for the cancers and their different forms, but for how we approach the use of drugs, research into them, and so on.

The new cancer strategy has the ability to be transformational, inspiring us to lead the world or at least to match those who are ahead of us. That is where we should be in patient outcomes. For me there are positives, but in order to achieve these things we need full implementation and adequate funding. There are some key asks—the national ambition for early diagnosis is probably one of the principal ones. As individuals we can help in diagnosis by presenting early enough. Some 20% to 40% of people find out that they have cancer only when they present at accident and emergency, and by then it is usually too late, so early diagnosis is key. My hon. Friend the Member for Basildon and Billericay referred to the figures for bowel cancer. Some cancers have much better outcomes if diagnosed early. That gives people a better quality of life and a better journey through the cancer path.

The strategy asks for a definite diagnosis within four weeks of referral, to be achieved by 2020. Ensuring that CCGs are held to account for improving one-year survival rates is crucial to drive early diagnosis. How will we hold the CCGs to account and make sure that rates are improving from June 2016? Linked to this is the way in which we improve cancer commissioning, as we have heard. The current picture is fragmented and confused.

Accountability, responsibility and transparency are needed, and with modern advances in medicines and diagnostics flexibility is hugely important, as is communication. Currently no one body or person at local, regional or national level holds responsibility, and this does not aid clarity in the system. Clinicians and patients are liable to fall foul of duplication or fall through the gaps, wasting precious time and resources, which neither the NHS nor the patient on the receiving end can afford.

The creation of cancer alliances can support the commissioning process and ensure that the strategy is delivered. Living with and beyond cancer is a growing challenge. There will be 3 million of us by 2020 and 4 million by 2030. Speaking from personal experience, I know that being a cancer patient is at times a bit of a challenge. Being medicalised is no fun, as I know, but both the new five-year guidelines on living with and beyond cancer and the new quality of life metric that has been spoken about are vital to drive service improvements. As the hon. Member for Alyn and Deeside (Mark Tami) said, sometimes it is the not-so-obvious things that people need help with. His child needed help in comfortably settling back in at school and ensuring that those around him understood the journey, too.

Scan anxiety sits heavily on people who are being tested to see whether they have cancer. The hon. Member for East Kilbride, Strathaven and Lesmahagow (Dr Cameron) did a lot of work in that area before she came to this place. It puts a great deal of pressure not only on the individual but on their family.

Under the strategy, those living with secondary cancer have emerged as a very distinct group. For example, 36,000 women are living with secondary breast cancer, and to date their needs have been neglected. The ambition of the strategy is to focus on the long-term quality of life, including for those who

“are living with an advanced and incurable form of the disease”.

This highlights the importance of multi-disciplinary teams in planning the care of all cancer patients.

The NHS is changing and adapting. Ensuring that the organisation has the right skills in the right places is the key to delivery not only of our cancer strategy but of many of the ambitions we hold. The strategy asks for everyone to have access to clinical nurse specialists, and I would wholeheartedly support that. Today, as I stand here, I would like to say a huge thank you to our nursing profession—a highly skilled group of people. I know from constituents and others that their professionalism, care, and, at times, very “no nonsense” approach has been as important as anything else in the recovery process.

If the aims of the strategy are to be achieved, working smarter and doing things differently may well be the key. Nurse consultants are now becoming a feature in the profession, and workforce planning will be crucial. The strategy focuses on the needs of older people and those from the black and minority ethnic community, who are often much more reticent about going to seek help. We know that we are living in an ageing society. The upside is that we are living longer; the downside is that there are more health challenges. In 1949, at the start of the health service, 50% of our population died before they were 60. Thankfully, that is not the case nowadays, but the strategy highlights the need to focus on treatment for older people—another sign of the changes in our NHS.

The cancer strategy is to be applauded in calling for a national action plan to address obesity. That is welcome, but there are individual responsibilities too. Obesity is a known causal risk factor in breast cancer and many other cancers. There is good evidence to show that five 30-minute bits of exercise a week, like a brisk walk, would help not only with obesity but with the likelihood of the disease recurring. There is plenty for people to do in this regard.

I would like to mention drug innovation and the cancer drugs fund. How will the cancer strategy’s recommendations on NICE guidelines on the use of bisphosphonates be taken forward? I would really appreciate understanding a little more about how we are going to use off-patent drugs and drugs that have been shown to have a secondary purpose beneficial to cancer patients. I would like to see communication between clinicians, pharmaceutical companies and others so that we can ensure, along with the accelerated access review and the cancer drugs fund, that we are getting to patients, in a timely fashion, the drugs they need and deserve.

Finally, I ask that the right accountability structures are in place, and that the national cancer advisory board ensures that what needs to be done is being done to secure optimum patient outcomes for all.

Oral Answers to Questions

Jo Churchill Excerpts

Tuesday 17th November 2015 Commons Chamber

[Ben Gummer]

My hon. Friend raises a terribly important matter. Clinical outcomes can be assessed in a complete sense only if they include end-of-life care for those for whom there is no clinical outcome in the commonly received understanding of the term. If that is what is happening in his clinical commissioning group area, it is unacceptable. I point him to the work that the Government are doing on a paperless NHS to ensure that the kind of bureaucratic muddle he has identified no longer occurs.

[Jo Churchill (Bury St Edmunds) (Con)]

7. What progress has been made by Genomics England in making the UK the world leader in genomic medicine.

[The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)]

The Genomics England project, which was launched by my right hon. Friend the Prime Minister, has electrified the global life and health science community. We are the first nation on earth to commit to sequencing 100,000 entire genomes of NHS patients, which will be combined with patient records to unlock NHS and UK leadership in the fast-emerging field of genomic medicine, focusing initially on rare diseases and cancer. I am delighted to report that we have the genomes of 5,000 patients fully sequenced and that 11 genomic medicine centres have been set up. We have identified first diagnostics and treatments for some rare diseases; 2,500 researchers are involved in the project; the cost of sequencing a genome has fallen from £5,000 to £1,000; and, importantly, NHS England is setting the international standard on ethics and patient consent in genomic medicine.

[Jo Churchill]

Does the Minister agree that the world-leading Genomics England will deliver a personalised and patient-centred revolution in modern healthcare by combining the talent of global companies such as AstraZeneca with that of UK-based companies such as Congenica in my region, to the benefit of patients with cancer and other rare diseases, the vitality of our NHS and, through jobs and innovation, the strength of our economy?

[George Freeman]

My hon. Friend makes a great point. I pay tribute to Congenica, a small company in Cambridge that is doing extraordinary work. I recently went to open Illumina’s global research and development headquarters, which is a £160-million commitment. As well as the significant investment in technology and research in the UK, NHS England is leading genomic medicine across the UK, not just in the Oxford-Cambridge-London triangle, but through 11 genomic medicine centres across the country, which are bringing genomic diagnostics to the benefit of us all.

NHS (Charitable Trusts Etc.) Bill

Jo Churchill Excerpts

Friday 6th November 2015 Commons Chamber

[Jo Churchill (Bury St Edmunds) (Con)]

I thank my hon. Friend the Member for Aldridge-Brownhills (Wendy Morton) for bringing forward this Bill. I have listened attentively to Members’ wonderful stories about the charitable trusts in their constituencies and the great work that goes on up and down the country. I support the Bill, however, because it seems to encompass all that my party stands for. It gives power to individual initiative and, as my hon. Friend the Member for Eddisbury (Antoinette Sandbach) said, it provides independence. As we have heard, it allows NHS charities more control over their own destinies. That seems to fit perfectly with the ethos of freedom from outside influence, to which many of my hon. Friends have alluded.

This applies particularly to the world-renowned Great Ormond Street hospital, occupying as it does a special place in my heart, because it is where my baby brother died. It is also a place that has treated constituents of mine, and I know that they have been immensely grateful for the help and assistance that has been afforded to them. I can only think that the magnificent work done by staff at Great Ormond Street will be improved further by this Bill, fulfilling as it does J. M. Barrie’s intent that the royalties from “Peter Pan” remain with Great Ormond Street Hospital Children’s Charity in secure perpetuity. We have heard how fitting it is that we debate this today, when we have read that genetic editing has been pioneered at that hospital. We are still in the presence of a charity and a hospital that, because of the assistance it receives, drives science forward, for which we should all be grateful.

On occasion, as we have heard, charities are open to the depredations of the less charitably driven, and there is reputational risk from this. Over the years, there have been many instances where charity commissioners have been outsmarted by smooth operators in dividing charities from their funds. We must remain aware of that. This Bill, which provides tight controls over what will be independent NHS charities, particularly Great Ormond Street Hospital Children’s Charity, should ensure, as much as possible, that these funds are secure. I therefore add my voice to those of all Members across the House who support the Bill.

Off-patent Drugs Bill

Jo Churchill Excerpts

Friday 6th November 2015 Commons Chamber

[Jo Churchill (Bury St Edmunds) (Con)]

I congratulate the hon. Member for Torfaen (Nick Thomas-Symonds) on his success and on introducing this important Bill to the House today. I stand here as someone who has had cancer twice. I served on the advisory group of a national breast cancer charity and I am a breast cancer ambassador. In this House, I serve as vice-chair of both the all-party group on cancer and the all-party group on breast cancer. But I also stand here for all those survivors and for all those sufferers of MS, cancer and the many other conditions for which we know this Bill could provide effective treatment. It raises an issue that touches the lives of hundreds of thousands of people across the UK, including many of my constituents, who are living with or beyond serious diseases that have a profound effect on not only their lives, but those of their families.

For me, the Bill is about three core things: the patients, through improving access and outcomes; saving lives; and raising awareness. Although this House will debate the technicalities of the Bill as it progresses, today we are debating the principles. Why are we here? I can say from personal experience that patients and their families want to know simply that where there are treatments that could help them, they will be able to access them, regardless of where in the country they are and by which doctor or other medical professional they are being treated. For patients, the Bill serves as a lifeline. It could mean the difference between living beyond cancer or dying from it, or, for other diseases, between having an extended life or having quality of life. For those living with conditions that have fewer treatment options, it offers one simple thing: hope. It could ensure that we continue to make progress, and that our brilliant scientists make fresh breakthroughs—as they inevitably will—and when they do, people will benefit.

The Bill could have a significant impact on breast cancer, as, according to the hon. Member for Central Ayrshire (Dr Whitford), it would ensure the wider availability of preventive drugs. For women who have a family history of breast cancer and therefore a higher risk of developing the disease, Tamoxifen and Raloxifene have been shown to reduce the risk of the disease occurring in the first place by a third, which is not an insignificant amount.

Ministers have argued that this Bill is not needed. Indeed, we have just heard a Minister quite rightly questioning a Member, who is an expert on this matter, about the nuances of it. The argument is that the Bill merely regulates something that is possible for the medical profession to do already—none of us likes unnecessary regulation—but prescribing statistics show that that is simply not happening for all the reasons that have just been discussed. Such regulation could make a big impact, but the drugs have to be prescribed through every grade. That treatment is not being offered to many women, for if it were I would not be standing in this House today arguing for faster progress in this matter; I would be in my constituency.

Sometimes, Tamoxifen has side effects. Some women may not wish to use it as a preventive treatment, but the point is that they should have the choice, which they do not always have now. A woman with a high risk of breast cancer does not have many options. Sometimes, their only choice is a double mastectomy. I think of all the women around me—those in my constituency and my own daughters—and ask: is that really the only choice? This Bill would empower clinicians to offer and prescribe drugs such as Tamoxifen for as little as 6p a day. Those drugs could deliver effective treatment options and, crucially, those women at an increased risk of breast cancer could have the ability to choose the right course of treatment for them.

However, this debate goes wider than just drugs for breast cancer. A friend who was at a reception in this place last week has had a double mastectomy. She also has MS. The drug Simvastatin, which was referred to earlier and was originally licensed for cholesterol, has been shown to slow down brain atrophy by almost 40%. It also would help those who suffer from Parkinson’s. My friend also has type 2 diabetes, and there is some evidence to show that drugs for the treatment of that disease will also be potentially beneficial for those suffering from Alzheimer’s. By the way, she told me last week that she was volunteering as well as holding down her normal job—amazing.

As the research, which is also amazing, shows us, bisphosphonates that were developed to treat osteoporosis are now commonly used in the treatment of secondary breast cancer, and some 36,000 women live with secondary breast cancer in this country. zoledronic acid, a type of bisphosphonate, has been shown to reduce the risk of breast cancer spreading to the bone by 28%. Arguably, it is one of the biggest breakthroughs in terms of reducing mortality that we have seen in breast cancer research in the past 10 years. If this drug were routinely prescribed, it could save up to 1,000 lives per annum. However, it saves not only lives, but emotional trauma, physical impact, the cost on all those involved and the cost to the NHS.

I welcome the work that the Government are doing into the accelerated access review, but in the interim report that was published only last week, I saw no mention of off-patent or repurposed drugs, although I am more than happy to be corrected on that.

My personal view in this area and across the whole drugs arena, including the cancer drugs fund—where we have seen yet another removal of avostatin this week, although, thankfully, Kadcyla has remained—is that we need speedy decision making. That will help everybody in the industry, which needs to make a profit because it is seriously expensive to bring drugs from the bench to the patient, but will benefit patients and clinicians as well.

The Government support the intentions of the Bill. I feel confident that all clinicians have the ability to deliver what is best for their patients. Indeed, the cancer strategy, set out by NHS England and supported by the Government, aims to deliver a patient-centred approach. It puts saving the lives of cancer patients and improving their quality of treatment at the heart of the “Five Year Forward View”. By unlocking access to off-patent and life-saving drugs, the Bill would do that, too.

I believe that the Bill can deliver, in saving lives, in empowering clinicians, in ensuring patient choice and in saving money for the NHS—so what’s not to like? I hope therefore that my right hon. Friend the Minister will consider carefully the issues raised in the Bill.

Secondary Breast Cancer

Jo Churchill Excerpts

Wednesday 21st October 2015 Westminster Hall

[Jo Churchill (Bury St Edmunds) (Con)]

I thank my right hon. Friend—sorry, my hon. Friend the Member for North Warwickshire (Craig Tracey); I just gave him a promotion—for securing the debate.

I come to this with a slightly different hat on. As I prepared to speak, I tried to decide whether the word “cancer” or “secondary” was the scariest. For me, it is “secondary”. I have had cancer a couple of times, and the scan anxiety that the hon. Member for East Kilbride, Strathaven and Lesmahagow (Dr Cameron) talked of is so real, as is the need for joined-up services and clinical nurse specialists. We need to be able to be a person in the pipeline. Owing to the shortness of time, I will not say a lot of what I was going to say, but I will try to concentrate on what it feels like for the person.

We know the statistics. We know that 50,000 women and men—we must remember that there are men with breast cancer too—get breast cancer per year. The good news for primary breast cancer sufferers is that many of those people are survivors. Victoria Derbyshire is a fine example to us only this morning, in the papers; good luck to her with her battle.

Some of my friends and constituents to whom I have spoken have had secondary or metastatic breast cancer. It sounds hopeless, but it is not. With improved drugs and more targeted and tailored treatment, survival time is longer. Yes, there are 36,000 people living with breast cancer, but it is better quality survival that most of us want. It is about the quality of survival.

I started my journey to becoming an MP by talking in 2010 in one of the rooms in this place about primary cancers and how we had some of the poorest outcomes in Europe. Things are not so much better in 2015. We need to keep our feet to the fire and ensure we push hard on this disease, so that we start to get real progress for primary, and particularly secondary, cancers.

My hon. Friend the Member for Chippenham (Michelle Donelan) mentioned old age but those from various ethnic minorities also have extremely poor outcomes. We must pay heed to that. How can we get better outcomes? The cancer strategy for England calls for improvements from pre-diagnosis to post-treatment. That is vital but we should ensure that patients receive optimum support and interventions so that they can get on with their lives. We need to think about lifestyles and lifetimes, and about which cancer services we need, to enable people to carry on working for as long as they want, so that they feel like people, not like cancer patients. That is the important thing for people living with this disease. We want people to lead healthy, fulfilled and productive lives, whichever stage of the disease they are at. The strategy proposes the development of a national metric of quality of life, underpinned by a robust approach to measurement, which will incentivise the provision of better aftercare interventions.

We want multidisciplinary teams. They really improve outcomes for patients and, when people are diagnosed, they want people other than oncologists. They want to talk to a psychologist as the disease sometimes messes with their heads more than it does with their bodies. That important pipeline is, oh, so needed. There should be robust surveillance systems, as my hon. Friend the Member for North Warwickshire said. It is important that we know what we know, so that we know how to get to the root cause of the problem.

Since 2011, six breast cancer drugs have been available. There was a debate in this place yesterday about the cancer drugs fund. We need sustainable funding to ensure that women and men get the treatment that they need. Treatment should not be a lottery. In my view, this pot is a sticking plaster that has gone a bit curly around the edges. It needs revising and refreshing. There needs to be an efficient way of moving drugs from the cancer drugs fund into positive and routine commissioning. Currently, it is out of date and not fit for purpose.

I welcome the accelerated access review, which reports at the end of the year, and the cancer drugs fund, but I urge the Government to make some speedy decisions because, as 4 November looms, people are sitting on the edge of decision making, not knowing whether they are likely to get treatment or not. Although we have said that women and men who are on their treatment programme will still receive that treatment, it is not so certain for those who are not yet on those drugs.

We could learn a little from the Scottish Medicines Consortium because, on this, it does some things a little better than we are managing to do. It commissions and moves more swiftly. We could also unblock our pipelines. We are potentially disabling innovative medicines. We need to trial innovative drugs that can be used to prolong life and have a conversation with pharmaceutical companies if England does not want to fall behind in the race to make the medicines of the 21st century.

Research is so important, as is this debate on secondary breast cancer because science will unlock the ability to fight the disease. Geneticists on the 1000 Genomes Project have already discovered more than 100 regions of the genome that contain genetic variants. Work goes on in labs, such as the Genesis Genetics research, targeting who is susceptible and why. If we know people are more susceptible, the better they can be treated. Evidence-based is good but it charges industry and researchers with helping to drive things forward.

As a survivor and someone who has held too many women for whom secondary breast cancer has not offered longevity, I dream of a day when immunotherapy, CyberKnife and the work of drugs companies means that this insidious disease is a has-been. We need a lifetime approach, preventive medicine and preventive care. We need to watch our weight, keep healthy and be active, and the drugs that we need when we need them—in hospital or in the community.

NHS (Contracts and Conditions)

Jo Churchill Excerpts

Monday 14th September 2015 Westminster Hall

[Jo Churchill (Bury St Edmunds) (Con)]

We have a wonderful resource in the national health service, but it cannot be preserved in aspic. I am lucky enough to have been treated by these wonderful consultants, which is why I am here. Society and medical technologies are changing at an alarming pace. The importance of the central asset of NHS staff cannot be overestimated, and the interest from my colleagues today shows how much Government Members value them. I am the daughter of a nurse, and I am the mother of a health professional. I get berated long and hard on how tough things were, as my hon. Friend the Member for Lewes (Maria Caulfield) alluded to, and how tough things are. That is a constant state, but let us be realistic: there will be a deficit this year of enormous proportions. Rather than throw in yet another figure, we know the deficit is large, and we know it is a problem.

Do I believe the premise of this petition? No. Important decisions have to be made if we are to focus on the primary need of patient outcomes. The question is how we treat people efficiently, effectively and with compassion. Hospital managers and consultants may say that the changes will deliver a 21st-century model of care that will safeguard both the patient interest and the cost-effectiveness of services, but that is quite wordy and is making everything the same problem. We do not all have the same problem. I completely concur with my hon. Friend the Member for Totnes (Dr Wollaston) on rural GPs. There are rural GPs in my constituency who are already feeling stretched, and asking them to deliver two more days of cover—seven days in total—with no more staff is not the answer. We must link training and recruitment, and we must work on a delivery mechanism that means not only the 5,000 extra GPs that we have promised but less box-ticking to free up their time, which would not go amiss. It has been said that we do not have enough GPs, but it takes five years to train a GP. Anyone who starts university now will not be qualified by the end of this Parliament. We are dealing with the legacy of the tail end of the Labour Government, which is one reason why we do not have enough doctors.

I am from a business background, and I ask simply how we can do more with less. Do I believe that the way to achieve better care in our hospital settings is not to have access to seven-day patient services? No, I do not. Do I think that if a child is knocked off their bike on a Saturday or a dad has a heart attack on a Sunday, doctors and nurses should struggle to deliver optimal service without the important back-up of diagnostic services? No, I do not. Why is it that, although an acute bed costs about £900 a night, patients in our hospitals cannot be admitted or discharged as easily on Saturdays and Sundays as on Mondays and Thursdays? One problem is that we cannot discharge. It is not all about who is coming in the front door; it is also about who is going out the back door. It is a real strain.

[Victoria Prentis (Banbury) (Con)]

My local trust, Oxford University Hospitals trust, has recently started a “perfect week” scheme, in which it makes all resources available to all those who work in the hospital system. It has discovered that one main barrier to discharge on Saturdays and Sundays is that pharmaceutical staff are not available at all hours of the day and night. Would it be possible to roll out that concept of a perfect week elsewhere?

[Jo Churchill]

It is a very good idea. The lack of pharmacy provision in hospitals is often cited as one obstacle to patient discharge. The cost of not discharging someone on a Friday, meaning that they use a bed on Friday, Saturday and Sunday, is £2,700, which is a lot of money.

[Helen Jones]

The hon. Lady was not in the House when we debated this Government’s change to local government finance, but at the time, many of us warned that it would hit social care and impact on our hospitals. Does she accept that hospitals are having great difficulty discharging patients, not only at weekends but during the week, because social care is not available for them?

[Jo Churchill]

I would say that it is a mixed picture. What I am picking up from care homes in my constituency is that some wards do it more effectively than others, with better services and things better locked together. Although I accept that there may be a problem, again, I look to the leadership.

I gave birth to some of my children on a Saturday and Sunday. Their entrance did not appear any less special to the obstetrician than those of my children who appeared midweek. I am not consultant-bashing; this is reality. The NHS has been delivering consultants and staff who provide outstanding service, but one cannot deny the statistic that patients’ chance of survival is less if they are admitted to a hospital at the weekend. Even if we extrapolate from those figures to account for the fact that the people admitted at the weekend are often very poorly, and often very elderly, they tell us that there is a problem. It would be remiss of this or any Government not to ask why or to investigate the situation and consider how to provide solutions.

I will not talk about people’s pay or anything else; we have done that. Instead, I shall focus on the petition, which in my view is neither constructive nor helpful. I would like the Government to learn from the best practice of consultants and their teams. Brilliant ideas are out there if we can only harness that best practice. For example, at the virtual fracture clinic at my West Suffolk hospital, a consultant told me that he has cut the number of times that patients must visit the hospital. Work can be done remotely; even discharges can be done on the phone, and those who need further specialist help can be sent on. We need to have honest conversations about the NHS. We need to use its finite resources, including staff, more sensibly if we are to survive.

We have 1.4 million great people working in our NHS, and 1.6 million people working in our social care sector. That is one tenth of this country’s population. We all agree that a seamless pathway between the two is the best future, but I leave Members with this question. If we cannot discuss a way forward that allows us to accept change, understand and develop new ways of working, we may struggle to look after the burgeoning health population, and there may be more than contracts to think about.

Drugs: Ultra-rare Diseases

Jo Churchill Excerpts

Tuesday 16th June 2015 Westminster Hall

[Greg Mulholland]

It is absolutely disgraceful and I urge the Minister to properly take that up. We have not had answers or justifications, although there can be no justification for NHS England behaving in that way. NICE’s decision not to recommend approving Vimizim in the short term has already been deemed to be flawed by those involved, including the MPS Society and clinicians, because it fails to consider BioMarin’s offer and has assumed that the cost of the drug will be the original £395,000. How has that happened? NICE also took months to put together the interim guidance, but has given only until next Tuesday to receive the extra evidence that it has asked for. Surely that is an unfair timeline for response.

As of 28 April 2015—which, incidentally, is a year after Vimizim was approved by the European Medicines Agency, meaning that it is approved in 20 European countries, including France, Germany and the Czech Republic—the drug was still not available in the UK, because NHS England has failed to put in place arrangements for funding it. Does the Minister not share the sense of frustration, anger and disbelief that the NHS refuses to fund the drug when so many of our neighbours do? More fundamentally, Earl Howe gave patients an assurance that their access to the drugs that they need would not depend on the cost per quality-adjusted life year measure. Can the Minister tell us why his Department has gone back on that assurance? That is exactly what it appears to have done.

I appreciate that the Minister has taken the time to meet us, but I remind him of the 11-page letter that he asked the organisations to send him some 11 weeks ago. We expected him to respond to that, as it was a complaint about NHS England’s handling of the matter, yet he simply passed it on for NHS England to respond to. That is not what we asked him to do, and the response does not address the points that we made to him, at his request, about how NHS England has failed people. I ask him again to reply directly and properly, and to investigate the mishandling of the situation by NHS England.

Duchenne muscular dystrophy has been mentioned. Again, I highlight the campaigning of organisations such as Muscular Dystrophy UK, Joining Jack, Action Duchenne, the Duchenne Family Support Group, the Duchenne Children’s Trust, Alex’s Wish and the Harrisons Fund. Those groups share the MPS Society’s frustration at the process. As many hon. Members know, Duchenne muscular dystrophy is a condition affecting only boys, and numerous potential treatments are in late clinical trial. Translarna, in particular, received conditional approval funding in the EU in August 2014. This clearly effective drug is being funded in a number of countries, including Greece, even given its economic situation, yet we are still no closer to hearing whether it will be funded here. I hope to hear positive news on that drug today.

I pay tribute to the Tuberous Sclerosis Association and the work of Jayne Spink and her colleagues. For those who do not know, tuberous sclerosis is a condition that causes the growth of tumours in organs, including the brain, eyes, heart, kidneys, skin and lungs, and a range of associated health problems, including epilepsy, learning difficulties and behavioural problems. The drug everolimus has been found to be effective in shrinking the tumours, extending life and improving quality of life, but although it was licensed for use in patients with tuberous sclerosis in February 2013, NHS England has failed to draw up a prescribing policy. At least two people have already died since the drug was licensed; Chris Kingswood, a consultant nephrologist, said that Julie Brooker’s death in January 2013 was “absolutely preventable” if she had been given access to everolimus.

[Jo Churchill (Bury St Edmunds) (Con)]

My constituent William needs that drug. The issue for his family is the timeline, which the hon. Gentleman mentioned. They have waited two years and been told that it may be another year, but they have said to me that William might not have that much time and that, like the woman the hon. Gentleman just mentioned, he might no longer be with them by then. Those parents are fighting for their son.

[Greg Mulholland]

The hon. Lady is right: none of these children or families has time. All those conditions deteriorate irreversibly. She is right that it has been 28 months since the drug was approved, yet patients are no closer to accessing it. What will the Minister do to speed up a commissioning policy for everolimus?

I turn to Batten disease, another condition already mentioned. I pay tribute to the Batten Disease Family Association. Batten disease is another condition that I had not heard of until I was approached by my constituents Duncan and Lynsey Brownnutt. I have been pleased to join Duncan to support some of his amazing fundraising efforts. This summer, he is off on a wonderful cycling trip to the Arctic Circle with his friend Rod to raise money, but the day after the general election, his six-year-old daughter Ellie Mae passed away from Batten disease.

Batten disease is another condition currently without any cure. It includes increasing visual impairment, complex epilepsy with severe seizures, decline of speech, language and swallowing skills, deterioration of motor skills resulting in loss of mobility and ultimately death. Potential treatment for Batten disease is not even being considered for 25 June. If the situation of the other conditions is still unclear and their drugs have been turned down, when will action be taken on treatment for Batten disease?