Health Service Medical Supplies (Costs) Bill

Jo Churchill Excerpts

2nd reading: House of Commons & Programme motion: House of Commons
Monday 24th October 2016 Commons Chamber

[Dr Whitford]

That is an area that needs to be looked at. A narrow definition that covers only blades and swabs and that does not take into account our hugely expensive infrastructure would not make sense. When we buy those kinds of machines in Scotland, we tend to consider central procurement and assessment, which opens up the potential for massive savings. A lot more work will have to be done in Committee and then in regulation to make the process function in the way that everyone wants it to function.

We need something much more radical. That aspiration may not happen with this Bill, so it will have to come later. Patients in the UK face a delay of about five years to access new medicines. If we compare cancer survival rates, we will see that we are often ahead when it comes to patients with early disease. We are one of the earliest nations doing population screening for breast cancer. However, we start to fall behind when it comes to people with more aggressive or advanced disease. I think that that is where our poorer outcomes and survival rates by comparison with European countries come from, because it is palpable on the ground. Part of that is sometimes the eye-watering initial prices of new drugs. Yes, we can set methods to try to control that, but a lot of those drugs do not get through the system introduced by the National Institute for Health and Care Excellence because they are expensive. In my interactions with some of the major pharmaceutical players since I have been in the House, I have discovered an appetite for a different way of doing it. Prices could be much lower but there could be a guaranteed number of patients before a drug became generic. We might need to look at risk sharing, because at the beginning we often do not know whether a drug will really be as good as it is cracked up to be. If the price starts, like some cancer drugs, at £100,000, we will struggle to get it through any of our pricing systems.

Something else we have to deal with is the question of how we expect pharmaceutical companies to make a profit on drugs that we never intend to use. We need new antibiotics, but any brand-new class of antibiotics—we have not had such a class for 30 years—will have to be left on the shelf. The existing system will simply not fund research for such a drug. While the Bill tidies up some of the issues that we face now, we need to do much more blue-skies thinking on equipment, drugs and the way in which we develop different things. Otherwise we will have interminable debates, such as those in which I have participated in Westminster Hall: in one debate, we say that we want more research on, for example, brain tumours, but the next week we have a debate on the fact that we cannot access a brand new drug that has been developed by the pharmaceutical industry in the UK.

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

The hon. Lady is making an informed and impassioned speech. Does she agree that we are entering a new landscape, and some drugs that have been discovered can be used for multiple treatments for different cancers, or even for other diseases? We therefore need an even more flexible approach so that we can benefit from those drugs and optimise patient outcomes.

[Dr Whitford]

Absolutely. We have entered the realms of using immunotherapies such as Herceptin for cancer. Equally, in the mid-2000s, people went to court to try to access that drug, which halves the risk of metastatic disease—and we end up spending much more on patients with that stage of the disease. We give Sofosbuvir in Scotland for hepatitis C because it is almost curative, so we have fewer new hepatitis C patients. We need a much more rounded way of looking at the costs and benefits of new drugs. The genetic drugs that we are likely to use in future will be even more eye-wateringly expensive, but then again, they may have a bigger impact.

The Bill tidies up loopholes, but I have concerns about the involvement of the devolved Administrations in the design of the schemes, access to data and ensuring that the funding for PPRS, which we use for our new drugs fund, is maintained. There is a call for us to do something much bigger and much more blue skies in future.

--- Later in debate ---

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

It is a pleasure to follow my hon. Friend the Member for Erewash (Maggie Throup).

We all know the background and I will not waste everybody’s time by going over it again. We know about the ageing population and about bearing down on the costs, to which my hon. Friend the Member for Salisbury (John Glen) and the right hon. Member for North Norfolk (Norman Lamb) alluded earlier. We know that advances in science are going faster than we can legislate. One of my local clinical commissioning groups, Ipswich and East Suffolk, suffered an exorbitant increase in Epanutin capsules two years ago and had to find another £600,000 in six months. Looking at drugs more widely, as my hon. Friend the Member for South Suffolk (James Cartlidge) mentioned earlier, not prescribing paracetamol in that particular CCG would save £1 million a year.

The measures in the Bill aim to manage the cost of drugs. The measure on efficient data collection, so that we start to have good decision making based on evidence, is also most welcome. Last autumn, the Secretary of State consulted publicly on how to address the problem of excessively priced unbranded generic medicines, and the industry and others fed back. They were glad of the dialogue. As I said, drug costs are unsustainable. A saving of some £90 million per health area was identified. My own CCG area could save £1 million per annum from unused repeat prescriptions. Nationally, it would mean that more than 12,000 more community nurses could be employed. We need to start making these decisions about where we want to be spending our money. With the pressure on social care, something alluded to by the right hon. Member for North Norfolk, these are decisions we are going to have to make as a Government and as patients.

The current system allows for some to be inside and others to be outside the system. That limits its robustness. It is for this reason that I support the Bill wholeheartedly. The system does not target those who do not play fair and we need to stamp down on them. It is better patient outcomes that I am passionate about. We all play a part, including the pharma industry, due in no small part to the unique infrastructure in this country. This industry is important to us. As my right hon. Friend the Member for Chelmsford (Sir Simon Burns), my hon. Friend the Member for South West Bedfordshire (Andrew Selous) and my right hon. Friend the Member for Cities of London and Westminster (Mark Field) have all alluded to, we need to be supportive of those companies that work positively for patients and engage in trying to find solutions. Indeed, the Association of the British Pharmaceutical Industry supports the Government increasing their powers where market failure has occurred. There is a balance to be had to ensure that new drugs are developed.

That brings me to the matter of repurposed and off-label drugs, those that have another use than that for which they were originally formulated, for example Everolimus, Rituximab, Cycloserine, Viagra and Thalidomide. As the hon. Member for Wolverhampton South West (Rob Marris) said, Thalidomide was originally developed for morning sickness. Lately, it has been found to be very beneficial for the treatment of some cancers and skin conditions. We need to understand new uses for approved drugs for the speediest of transitions from bench to bedside. As they have not gone through new trials, we need to be mindful that they are not new drugs; and just because the target is, for example, prostate cancer and not breast cancer, these drugs should still be costed accordingly.

[Dr Philippa Whitford]

I wonder whether the hon. Lady remembers the time we spent in the House last November debating the Off-patent Drugs Bill. I flagged up the concern that a doctor prescribing a drug with a licence for a use takes precedence over an off-patent drug that may actually be the same. With the sort of gaming we have seen, there is a real concern that drug companies will tweak a drug in the slightest manner and then start selling it to the NHS at hundreds and thousands of pounds, when in actual fact an off-patent drug would do the same job. That has still not been dealt with.

[Jo Churchill]

I thank the hon. Lady for making the point so succinctly. I am also grateful to the Secretary of State for his clarification and the comments that have been made about the medical technologies industry, which I believe needs looking at. I would be grateful if we could know whether the savings made are likely to be reinvested in patients, particularly given my position as chair of the all-party group on personalised medicine, and in the latest medicines and treatments.

The Bill is designed to stop individuals making vast sums of money and taking advantage of a loophole. I back the Government’s aim of value for money and fair prices for optimum patient outcomes. I am heartened by the cross-party support for the Bill and look forward to it making positive progress.

European Medicines Agency

Jo Churchill Excerpts

Wednesday 12th October 2016 Westminster Hall

[Jim Shannon]

I thank the hon. Lady for her intervention and the knowledge she brings to this Chamber and the House. I hope that we can improve on what she refers to when we get into the Brexit negotiations, and through our negotiations outside Europe when article 50 is triggered next year.

Let us work together to allow the EMA and the MHRA to come to an arrangement to continue what has been a great partnership to date and has achieved many results. According to the Financial Times, the EMA outsources up to a third of its work to the MHRA, and that work is responsible for a third of the MHRA’s income. A report in The BMJ states that that work makes the UK an attractive location to carry out clinical trials. The hon. Lady outlined that in her intervention, and I know that the Minister will respond and the shadow Front-Bench spokesman will add his comments.

That relationship, which has been proven to work, does not have to die because the EMA may—I emphasise “may”—move its headquarters. Work must be undertaken to underline the fact that although we will not be in the EU, we will remain the best in Europe at this type of clinical work. We have many things to be thankful for in our experience of it. We all understand the red tape in Europe, and I find it very hard to believe that the only reason why the work was outsourced to the MHRA was the location of the EMA.

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

It is a pleasure to serve under your chairmanship, Mr McCabe. I want to return to the point made by the hon. Members for Cambridge (Daniel Zeichner) and for Central Ayrshire (Dr Whitford). The Government need to be aware of the connectivity between the university sector, the clinical trials sector, the pharmaceutical sector and beyond, and of the importance of where the EMA sits in that. I would be grateful for an assurance from the Minister that we are putting everything we can into ensuring that the situation is sorted effectively and quickly.

[Jim Shannon]

I thank the hon. Lady for her intervention and for the knowledge she brings to these debates. She is right in saying that we want a continuation of the good work with universities. Queen’s University Belfast has a partnership with pharmaceutical companies throughout the world, doing clinical trials and marvellous work, as do many other universities across the whole United Kingdom of Great Britain and Northern Ireland. We could do that even better, and we should be doing so.

It was because of the quality of service and the tendering process that we showed that this was the best place for the work to be carried out, and that will remain so no matter where the EMA locates its headquarters. I cannot blame the Republic of Ireland and other countries for putting down a marker that their country could be the home of the EMA when it is time for it to move. If this were an opportunity for business in my constituency, I would also be highlighting our ability to take the business on board. However, panic stations need not be manned tomorrow, because those countries are hoping that an opportunity will arise when we leave in the not-too-distant future.

It is clear that countries that are members of the EEA are covered by the EMA and have access to the centralised marketing authorisation procedure. That is important, as it may mean that the UK could continue to have that procedure after leaving the EU, but it will depend on the negotiations and the UK’s resulting position in the single market. If the UK did not become a member of the EEA, pharmaceutical companies would need to apply separately for marketing authorisations from the MHRA for a medicine they wished to supply in the UK. That will be covered the negotiations.

We must have faith in the negotiations and in those who have been tasked with the job. Let us support the Ministers who have been given that job and encourage them to move forward. I hope they will read the Hansard report of this debate. We are not in the main Chamber, but the contributions made here are important in formulating policy and moving forward.

I have been contacted by Muscular Dystrophy UK, which has asked me to ask some questions of those who will enter the negotiations so that they are recorded in Hansard. I am happy to do so. Will the Government ensure that there is a parallel approval system for new treatments, so that after the UK exits the EU, EMA approvals that are granted apply to the UK at the same time? Will the Government increase the capacity of the MHRA and the National Institute for Health and Care Excellence so that the regulatory and approval processes are faster and can cope with the growing number of emerging treatments for rare diseases in forthcoming years? It is important to underline the issue of rare diseases—I think every hon. Member in the Chamber today has spoken about it at some point. We are all aware of the need for medicines, investigations and work to find new medicines to heal people better.

Those questions need to be considered, and a constructive approach that accepts there will be a change and seeks to influence the way the change takes place is the best way forward as we begin to work on the details that will shape our new position in Europe outside the EU. Let us focus on that.

I am nothing if not a realist, and my decision to support Brexit was not made on a whim or through emotion. It was made after thoughtful consideration that on the whole, we can do better for our country than the way things stand. That will come about through massive change and an overhaul of systems, and this is one of the changes that must happen. The onus is now on the Government, and particularly the team that is working on the negotiations, to ensure that we address the matter and gain the best possible outcome. I thank the hon. Member for Cambridge for giving us the chance to make a contribution to finding the way forward and highlighting the work that must be done to ensure that our MHRA, and indeed our system for clinical trials, continues to encourage work to be carried out here. We need to cement partnerships so that we can make the United Kingdom of Great Britain and Northern Ireland a better place for pharmaceutical companies.

Comparative Healthcare Economics/NHS Finance

Jo Churchill Excerpts

Tuesday 7th June 2016 Commons Chamber

[Dr Murrison]

I think the hon. Gentleman and I are on the same side of the Brexit debate, and I certainly would welcome the extra money that would be spent on the NHS in the event that we leave the European Union, so fingers crossed for 23 June.

The Health Consumer Powerhouse report highlights poor accessibility and an “autocratic top-down management culture” here, in contrast to top-performing Holland’s removal of what Health Consumer Powerhouse calls “healthcare amateurs”—that is to say, politicians and bureaucrats—from decision making. Unhappily, that sounds rather familiar. Earlier this year, Dame Julie Moore slated fellow senior NHS managers for “gross incompetence” and poor leadership.

The question is, what, apart from its management, accounts for the UK’s lacklustre ranking? Despite the UK’s innovative cancer drugs fund, Health Consumer Powerhouse found, for example, relatively poor availability of the latest oncology interventions and therapeutics, including radiotherapy. Sadly, that rings true, and we remember the high-profile case of Ashya King, the five-year-old with medulloblastoma, who was taken by his parents in 2014 from Southampton general hospital to Spain and then the Czech Republic for proton beam therapy, which was not available here.

The much-vaunted Commonwealth Fund report that some use to claim that the NHS is super-efficient and effective actually contains just one element that deals directly with health outcomes—a composite of deaths amenable to medical care, of infant mortality and of life expectancy at 60, it puts the UK 10th out of 11, the US being bottom. Tenth out of 11 sophisticated healthcare economies is not where I want the UK to be, and not where the Minister wants the UK to be either. The British public would expect us to be doing rather better against a raft of healthcare outcomes where the UK is firmly in the wake of our immediate northern-European neighbours France, Germany, Holland, Belgium and Denmark.

Can we explain why UK healthcare outcomes are not as good as those of peer group nations through differences in the level of healthcare funding? We can expect an opinion from the House of Lords, which last week set up a Select Committee under Lord Patel to examine the sustainability of the NHS—that is, the “what next?” question. I would be very surprised if it did not conclude that the answer is to bring spend up to the level enjoyed in countries such as France, Germany and Holland. After all, closing the gap with the EU15 in health spending as a proportion of GDP was a goal explicitly set in 2000. However, Conservative Members tend to be somewhat wary of making spend a proxy for outcome. It is not enough just to write big cheques and consider the job done. Can we do better with what we have? There are apologists for our low spending on health who cite the supposed efficiency of the NHS, but simply asserting that the NHS is more efficient than health services in other countries does not make it true.

I do not know what is in the Minister’s speaking notes, but there is a very good chance that he will use the New York-based Commonwealth Fund analysis on comparative healthcare to support a contention that the NHS is very efficient and thus ameliorates the relatively low UK spend on healthcare. The report’s methodology rewards close examination. I am sure he will have read it thoroughly, but if not, I commend it to him. In my opinion, its methodology renders the sorts of deductions that have been made unsafe. The only reliable element of the analysis that is used to claim that the NHS is relatively efficient is the percentage of national expenditure spent on administration and insurance, meaning that the UK comes in at fifth out of 11. Given that the nature of our system means that insurance and transactional costs are very low, that is hardly something to crow about. Other markers of efficiency rely on patient and practitioner surveys and include items such as time spent filling out financial transaction forms. UK-relevant metrics, such as rehospitalisation rates, were found to be comparatively poor. I conclude that it would be unsafe to make claims about the relative efficiency of the NHS based on contestable reports like that of New York’s Commonwealth Fund.

Let us suppose for one moment that the NHS is fairly efficient—not very efficient, because Carter and others suggest that that would be unwise, but fairly efficient. Indeed, I have no reason to suppose that it is institutionally profligate. If it is fairly efficient, we will not be able to squeeze many more efficiencies from it beyond the Stevens assumptions, but we will still be left with relatively poor outcomes and still needing to know “what next?” Simon Stevens still believes that we can squeeze £22 billion in efficiencies from the NHS. Much of this, presumably, is predicated on productivity gains that are contingent on holding down salaries and wages—a challenge if incomes in the economy rise. This is what I think he means by “strong performance”—strong indeed, because the implied productivity gains of 2.4% are well in excess of anything that has been achieved by the NHS historically and well beyond expectations for the wider economy. It also depends on sustained spending on social services and public and preventive health. Both, in the event, have been impacted by cuts to local government funding—cuts that I supported and accept were entirely necessary to repair the public finances, but cuts nevertheless.

So “what next?” will inevitably mean a step change in input—in money—if not by the end of the five year forward view period, then without doubt during the next decade and beyond. Here again, it is instructive to look across the channel, where we find some good news for Ministers. The Office for National Statistics has just tweaked its approach to health accounting to comply more closely with that of the OECD, and obligingly, this increases the UK’s spend on public and private healthcare combined from 8.7% of GDP to 9.9%. Most of this is due to re-badging a slice of publicly funded social care as healthcare spend. Of course, none of this accountancy changes by one penny the amount spent on care, but it impacts on the international spending league table. It means that we overtake southern European countries such as Spain, Portugal, Italy and Greece. However, we still lag well behind Germany, France and the Netherlands—my chosen basket of similar European countries.

So what next? Data from the Kings Fund and the Institute for Fiscal Studies suggest that income tax must rise by at least 3p in the pound simply to offset the fall in NHS spending as a proportion of GDP predicted over the rest of the decade. But all that will do is arrest the UK’s relative downward trajectory towards being the sick man of Europe. To bring spend up to the EU15 average would now involve an 8p increase. That eye-watering sum may be toned down a little bit by the new Office for National Statistics method for calculating healthcare spend, but probably not greatly if the comparison we actually want to make is with our closest European neighbours France, Germany and the Netherlands.

So, if we accept that big fistfuls of money are needed, the question becomes, “How are we to get it?” The Labour party does not know. It has yet to say how much it thinks the NHS budget should be, despite every encouragement from me and others to do so. All we know is that the party opposed the Stevens uplift at the general election. Maybe the unaccustomed reticence about pledging money from the party of fiscal incontinence is an indication of the sheer scale of the spending challenge that even Labour has perceived in a rare lucid moment.

Although I have every confidence in my right hon. Friend the Chancellor, a precipitous growth in the economy seems unlikely, and further borrowing should not be an option. In fact, half the £350 million per week that we send to the EU—a figure, net of rebate and subsidy, that I personally rely on—would, by my reckoning, halve the difference. I fervently hope that it will be in play after 23 June, but it would still leave a gap. How will that gap be closed? It is said that if we want a social healthcare system, we must choose between Bismarck and Beveridge. For my part, I cannot see how the transaction costs implicit in insurance-based models or large-scale schemes of co-payment would improve productivity or efficiency in our NHS—this despite the fact that the UK healthcare economy is distinguished from others by the small scale of its private provision.

For me, the Bismarck versus Beveridge debate is pretty much settled. However, I would expect a commission to examine all possible funding streams, drawing on experience from other countries. I would expect it to look closer to home at incentives that can be given to encourage subscription to mutuals, such as the Benenden Healthcare Society, formed in 1905 by and for Post Office workers, whose headquarters in York I visited recently.

But affirming that the great bulk of healthcare in the UK should continue to be funded through general taxation does not just mean more of the same. A variable hypothecated tax would be an easier sell to the public than a general tax hike. Treasury officials, or course, hate hypothecation, but the Treasury has been softening its approach in recent years and we are now, of course, wedded to the far less economically literate practice of hypothecated spend as a proportion of GDP for selected areas of public expenditure. Despite the Treasury’s reluctance, if we are talking about several pence in the pound to bring UK health spending up to the average of neighbouring similar countries, we have to find a politically acceptable and publicly palatable way of doing so. Either way, gathering a consensus on this most sensitive and complex of public policy areas, using a vehicle on a spectrum from royal commission to non-departmental public body, surely makes sense. As a model, may I suggest the influential Pensions Commission, chaired by Adair Turner, during the last Labour Government?

If the NHS is the closest we have to a national religion, its critical friends are often seen as heretics. We saw that even at the height of the Mid Staffs scandal. How, then, are we to uphold this rallying point for national morality, decency and righteousness with the more prosaic imperatives to save and lengthen life, make sick people better, prevent ill health and match health outcomes in comparable countries? I hope that the Minister will agree that the proposal for a commission and associated national conversation—made by me and others in this House, in the other place and elsewhere—has merit. I warmly congratulate Ministers on successfully arguing the NHS’s corner at a time of austerity. However, I urge the Government to give serious thought to establishing a commission that will examine how we can properly and sustainably fund healthcare and close the widening gap that exists between us and our European neighbours.

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

I do not think that a commission is the right way to go, but does my hon. Friend agree that we sit on a new horizon, with molecular diagnostics, personalised medicine and so on, and that it is really important that we take a broader look at what our healthcare needs will be in future and how we can embrace more self-responsibility and new techniques for ensuring good patient outcomes? I said in this place in 2010 that we were lagging behind; sadly, we still are.

[Dr Murrison]

My hon. Friend is absolutely right: we are lagging behind. I hope that in the course of my remarks I have made it very clear that we are lagging behind countries with which we can reasonably be compared, particularly Germany, France and the Netherlands. The challenge is to bring our spend up to that level and to anticipate new developments and technologies. We should welcome that, because it will extend our lives and it will make us healthier for longer, but we do have to decide where the money will come from. Since the sums, I fear, will be so great, I believe that a commission would be a reasonable way to approach this matter and to have the conversation with the public about how the money will be raised.

The sands are fast running through the five year forward view hourglass. I believe it is time for Ministers to consider, “what next?”

World Autism Awareness Week

Jo Churchill Excerpts

Thursday 28th April 2016 Commons Chamber

[Brendan O'Hara (Argyll and Bute) (SNP)]

I pass on my sincere thanks to the Chair for indulging me by calling me so early in the debate. I have to return home to attend to urgent constituency business this afternoon. I also congratulate the right hon. Member for Chesham and Amersham (Mrs Gillan) on securing this very important debate.

As we have heard, autism is a spectrum condition, meaning that no two autistic people display the same characteristics. Some people with autism live relatively independent lives, while others, at the other end of the spectrum, might need a lifetime of specialist care and support. That demands that every single person living with autism be treated as an individual and that society affords each individual the respect and dignity they deserve. I have no doubt that we, as a society, aim to do that, but the question is: do we actually do it?

I recently met the National Autistic Society at the launch of its “Too Much Information” campaign, designed to help people recognise autistic behaviour and better understand how they should respond to it. It is an excellent report. It sometimes makes for uncomfortable reading, but I commend it to all Members. In it, the society published figures from a wide-ranging survey it had commissioned to look at public attitudes towards those living with autism. Its findings suggest that we, as a society, have a long way to go in affording people living with autism the respect and dignity they deserve.

Although almost every person in the United Kingdom had heard of, or was aware of, autism, only a fraction actually recognised what it meant. There is a chasm between public awareness and public understanding of autism. It is this lack of public understanding that causes great distress for those living with the condition and their families. The right hon. Lady has given us some of the findings, but they are worth repeating: 87% of parents had experienced people stopping and staring at their children while they were displaying autistic behaviour and 74% had experienced public expressions of disapproval at their children displaying autistic behaviour. Importantly, the NAS also spoke to people living with autism, and what it discovered was pretty depressing: 84% of people living with autism felt they were judged by the rest of society as being “strange”.

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

Would the hon. Gentleman agree that that reaction to people in our society with autism and their families leads to a fear of going out, as my constituent Maureen said, which, particularly for autistic children transitioning into adulthood, can in turn lead to social isolation for them and often their primary carer, which is not adequately recognised across the piece?

[Brendan O'Hara]

The hon. Lady is absolutely correct, and it is something I will touch on in a moment.

Nearly 70% of people living with autism believe that the public see them as antisocial and almost one third have been asked to leave a public place for displaying behaviour associated with their condition. As a result, as the hon. Lady just alluded to, four in every five people living with autism in the UK feel isolated from society and half do not go out for fear of how people will react to their condition. As I said, those statistics make for pretty depressing reading and should force us all to look at our behaviour and question what we are doing, as a community, to our fellow citizens that makes them prefer social isolation to the way they are treated by the public, ourselves included.

It is not all bad news, however, as the NAS report also contains some good news. Its research shows that with greater knowledge and better understanding, the general public will behave with much greater empathy towards autistic people.

Digital Records in the NHS

Jo Churchill Excerpts

Thursday 28th April 2016 Westminster Hall

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

It is a pleasure to serve under your chairmanship, Mr Wilson. I, too, congratulate my hon. Friend the Member for The Cotswolds (Geoffrey Clifton-Brown) on bringing this debate to the Chamber.

For me, data hold the key. As we move into new medical landscapes, comprehensive data sets hold vast possibilities for research and care, and we should harness and optimise their potential benefits, as my hon. Friend the Member for Twickenham (Dr Mathias) alluded to. I have been working with individuals, charities, researchers and clinicians to try to understand how to put patients at the centre of everything that is done with and for them.

Recent research by charities into patient responses shows that patients are keen for their data to be used. As my hon. Friend the Member for The Cotswolds mentioned, Data4Health was launched earlier this year. At its launch, we heard from a patient, Graham, whom my hon. Friend also mentioned. Graham was backed by a clinician, a researcher and a charity, and he spoke about his journey with leukaemia and how research had helped him get the most effective treatment. We also heard from the mother of the youngest patient to be diagnosed using cutting-edge genomics about how we are moving forward. What got those patients to a diagnosis and the correct care was a true understanding of their diseases. Data are a precious gift and we must take care to ensure that everything we do with them is in the patient’s best interest.

If we can speed up data sharing in something as simple as immunisation programmes, for example, it will be more effective. Vaccination coverage is necessary to ensure success, and at the moment data collection is, as a doctor described it to me, clunky in many areas. We still have paper records. Only recently we saw how integrated patient data might have saved a young child’s life. Patient safety and good data are therefore real and ever-present issues.

[Geoffrey Clifton-Brown]

My hon. Friend is extremely knowledgeable in this area. Is she aware of the campaign for the new-generation Bexsero meningitis B vaccine, which was developed by genomics? The NHS was the first health service in the world to allow two-month-old babies to receive that vaccine. The collection of data and the effectiveness of vaccines and drugs can put the NHS at the forefront of what is happening in the world.

--- Later in debate ---

[Jo Churchill]

Indeed, and there is a larger point than that: we also lead the world in life sciences, innovation and technology. The NHS is a critical resource; with patients’ permission, we have the ability not only to create great health for our nation, but to save money for our NHS and produce wealth for our economy. There is nothing not to like in that virtuous circle.

How much better would things be for people who go into hospital if the ambulance staff and paramedics who took them there could view their medication and understand their personal situation more fully, and therefore respond more appropriately and not waste precious time? As a doctor said to me, that is particularly important in caring for patients out of hours. Ringing other hospitals is sometimes not an option. Side effects can be worse for some patients than others, and we need to know why in order to target effective treatment. That would avoid waste and reduce the cost for individuals, their families and the system. My hon. Friend alluded to health economics studies that show potential savings ranging from as little as £16 billion to as much as £66 billion if data were deployed properly. We must grab this opportunity. The NHS needs to find cost savings, and we have an opportunity to drive the innovation that would deliver such savings.

That applies across the piece. I have just come from a debate on autism in the main Chamber, and one of the key points that was raised there was that health data are not adequate to link things up so that young children can have effective and timely diagnosis. As my hon. Friend mentioned, we had a powerful debate on meningitis in the House a few days ago, and we would benefit from data on that disease too. We also had a powerful and moving debate on brain tumours recently. Data on such issues should be linked, because the patient is an individual and how they respond to a drug or combinations of drugs is important.

Only this morning I spoke to Mike Burrows of the wonderful Salford lung study, in which a drug is put into a real-world environment and connected with databases so that all of a patient’s health needs can be tracked. The study looks at real life and can cope with all the different variables to see the effects that a drug might have on people. As we move into an environment in which co-morbidities are ever present in our ageing population, we can immediately see how someone who takes a drug for one condition and thereby receives a benefit for another will have their health enhanced.

GlaxoSmithKline is about to produce the results of that study, which will be interesting, but Mike said to me that it has been a winner for the local health service, and that is what is important. The GPs who have been involved have seen the benefits. The hardware alluded to by my hon. Friend the Member for Twickenham, which is so often lacking in the system, has been invested in and now, with the integration of the NHS and social care, we have the ability to optimise care for the patient, which is important. The Salford study covers a quarter of a million people, and the learning from it will be rolled out across the broader Manchester landscape as devolution takes place.

The Minister is in a unique position to see data as a solution. On many challenging issues in this data-rich system, we are information-poor. Variations lead to inconsistencies. He can implement the recommendations of the accelerated access review, spearheading how we can best put to use the lessons from large-scale studies such as the Salford study, the Birmingham study mentioned by my hon. Friend the Member for The Cotswolds and studies from right across London.

There is also much to be learned from some of the devolved areas. I have spoken at length about that with the hon. Member for Central Ayrshire (Dr Whitford), who is the Scottish National party’s lead on health. We have a lot of medical expertise to harness in my party and right across the House, so that we can concentrate minds and ensure that we take the right direction of travel.

Work is going on across the Richmond group and in the pharmaceutical industry. In this place, my hon. Friend the Member for Bath (Ben Howlett), who chairs the all-party group on rare, genetic and undiagnosed conditions, my hon. Friend the Member for North West Hampshire (Kit Malthouse), who chairs the all-party group on life sciences, and I, as chair of the all-party group on personalised medicine, are discussing how we can best develop a combined piece of work in this area, because collaborative approaches always give us the best results. There is a plethora of data in the system, but, as Chris Carrigan of the National Cancer Intelligence Network says, we must harness data effectively.

In this country we have some of the best science in the world. The areas of informatics and genomics will be game changers, allowing us to develop drugs in as little as five months instead of years. We need responsive systems. It is unlikely, if not impossible, that our clinicians will be able to keep up with cutting-edge research without the use of electronics. Last year, a multidisciplinary group looked at data sharing in genetics and concluded that the current arrangements are unsatisfactory.

If we understand why drugs work better on certain groups or in distinct geographical areas, they can be targeted effectively. That is particularly the case in the area of rare diseases. A young constituent of mine who has a condition called tuberous sclerosis and those who suffer from other conditions such as Duchenne muscular dystrophy, lupus or rare cancers are in cohorts that are too small to prove efficacy. If there are only a few suffers of such conditions throughout the country, the transferral of knowledge is difficult unless information is held centrally, but the data provide the key.

[Geoffrey Clifton-Brown]

I would not have intervened on my hon. Friend if we did not have plenty of time. She has developed the interesting theme of the benefit of the life sciences to our economy. She then explained how the better use of data can speed up the development of drugs. By doing that effectively at a time when global drugs companies are looking at where it is best to locate themselves, the NHS could encourage more of them to come to the United Kingdom to develop drugs. Would that not be a huge benefit?

[Jo Churchill]

It would. That is also part of the complex environment covered by the accelerated access review, the early access scheme that my hon. Friend mentioned and so on.

We now know what the landscape for the cancer drugs fund looks like going forward. I started my journey to this place on a personal note, speaking about personalised medicine as a campaigner back in 2010 after my second bout of cancer. My dream is that anybody will be able to have my data to learn what will prevent any of my four daughters from developing any of the cancers that I unfortunately have had in my lifetime. We need to take hold of patients’ ability to gift such data. Alongside that gift, we must drive an industry where we have the ability, the innovation, the technology and—quite frankly—the brains we need. Everybody comes here for our life sciences, to lead the world in that area, and we should grab that opportunity.

As I said, the cohorts are too small to prove efficacy. Unless we hold information in a central place, that creates a problem. As has been said, confidentiality is crucial. Strict safeguards and strong governance are a given, as my hon. Friend said. Confidentiality for participants involved in clinical research is well established, but most data are either aggregated or pseudonymised.

Speaking personally, if my data, particularly on cancer, can make one other person’s journey better than mine, it is a gift. I have spoken to Graham Silk about that, and he agrees, as do the many people I have campaigned with. As Christina and Les say, being the first to gift data makes someone feel that they have done something really special. Even if it gives someone with a complex disease to a small amount of additional time, we have given someone else a very special gift.

It is important that the risks are moderated, but we must also consider the benefits and what we can win. Many patient groups show involvement rates of getting on for 100% when people know that their information will go to others. My hon. Friend mentioned the cystic fibrosis group, which has an involvement rate of 98%. We need strong leadership to draw the strands together, a common understanding and a national agreement to optimise sharing in a safe, transparent and trustworthy way.

The risks and benefits of sharing data have to be explored, but those who talk only of the risks will miss the benefits. I would like to see a chief clinical informatics officer. I look to the Minister to lay out his vision for standardising, resourcing and futureproofing the system; drawing together the ongoing work; and achieving the momentum needed for greater data sharing to improve both the health and the wealth of our nation.

--- Later in debate ---

[Stephen Metcalfe]

My hon. Friend is very kind and generous, as always. I congratulate him on securing this important debate.

As I said, I am just sitting in for someone in the hope that at some point I might need to be released into the wild and they will cover for me. However, one thing I have found in my time in Parliament is that there is a huge crossover. One area in which I am very interested and actively involved in Parliament is science and technology. In the previous Parliament, I sat on the Select Committee on Science and Technology. In this Parliament, I chair the Parliamentary and Scientific Committee, which, for those who do not know—this is a bit of a plug for it—is the oldest all-party parliamentary group, established in 1939 to help with the war effort, to bring Parliament and science together and to look at things such as how we can improve the public’s health and food security and what we can do to improve our defences. It strikes me that we are talking about things I looked at when I was a member of the Science and Technology Committee, particularly the use of big data and the use of stratified and individual, personalised medicines. This has been quite an eye-opener for me, and I am grateful to my hon. Friend.

My hon. Friend is entirely right that huge amounts of data are now being generated across all services, especially the health service, with more and more advances in what we can test for and how data are stored. The effective use of IT is important not only in storing data—obviously, we must store data accurately and associate them with the correct patient records—but in making them accessible to others in future and in ensuring that their integrity is maintained. It will also allow clinicians who are perhaps viewing those data from a different angle and not fully understanding where they were collected to understand their use.

My hon. Friend spoke of his constituent, Les, who is an inspiration—I am sure that is why my hon. Friend used him as an example—and of the Empower: Data4Health campaign to promote the better use of data, which would have wide benefits. The use of state-of-the-art IT and the analysis of data can be of huge benefit to the wider patient body. Data can be used to spot trends, patterns or crossover between certain circumstances, particularly in those with rare conditions. My hon. Friend brought that up in the case of Christina, who suffers from a rare cancer. She does not know why she is especially prone to that, but feels that by finding other sufferers, clinicians may be able to spot patterns and therefore be able to develop appropriate treatments or preventive measures.

It is only by examining huge databases for the smallest anomalies that we can start to have a real impact on people with such rare conditions. Where there is only a small sample of people, it is very difficult to put them together and analyse them as a whole, particularly with the barriers and the silo mentality that exist across many of our public health services. People are fearful of sharing data or do not even know that the data exist. Anything we can do to break that down, so that we can take a helicopter view—I think that is the current phrase—to see patterns must be good. The example that my hon. Friend gave showed what could be achieved through better use and analysis of data. On my behalf and the Minister’s—I have no authority to speak for the Minister; I am speaking entirely as a Back Bencher— I wish Christina well for the future.

As I have said, the future for individualised and stratified medicine is very bright, but it is only one part. That is why the data aspect is very important. Some think that the changes we will experience as a society in the next 30 years will be equal to those we have experienced as a society over the past 300 years, whether in transport, education, or the way we interact as nations. The greatest changes will probably be experienced in the healthcare system. I truly believe we are on the cusp of a major breakthrough, and the collection, analysis and use of data from a much wider base than has ever previously been available will play a huge part in that.

[Jo Churchill]

I would like to say what a sterling job my hon. Friend is doing; I agree with everything I have heard so far. Does he agree that there is a big opportunity to drill down and understand more about health inequalities, which are so important in our society? When the average life expectancy in certain areas is so much more than in other areas, the use of collective data to drill down on health equalities and understand why things happen and the concomitant effect on certain diseases is really important.

[Stephen Metcalfe]

I thank my hon. Friend for those remarks; she is absolutely right. We have been talking about people suffering with rare conditions and about putting them together and spotting patterns, but tackling health inequality by comparing data from different parts of the country and by comparing, perhaps, people’s longer term histories is equally important. It may also help policy makers to find a way of developing a geographically stratified approach to tackling some of these health inequalities. Just moving on slightly, I think that part of why clinical commissioning groups were established was that they would allow doctors and clinicians locally to identify what was in the interests of the people they represented. Of course, using data to do that is vital, so I could not agree with my hon. Friend more.

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.

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.

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.