National Health Service (Amended Duties and Powers) Bill

Bob Stewart Excerpts

Friday 21st November 2014 Commons Chamber

[Sir Tony Baldry]

I am not entirely sure what point my hon. Friend is trying to make. The fact is that the Commonwealth Fund found that the NHS is the best health care system in the world. I hope that he and everyone in the House takes pride in that. The NHS has many challenges—we are all conscious that with an ageing demography and advances in medical technology, every health care system faces challenges—but we should take pride in being the best.

We also need to be honest about what has gone before. There was an enormous amount of rewriting of history and revisionism in the speech of the hon. Member for Eltham. For those of us who have been in the House for some time, it may be worth looking back and reminding ourselves about what happened in the not-too-distant past.

In the introduction to the NHS plan of July 2000, the then Secretary of State for Health, Alan Milburn, wrote:

“This NHS Plan sets out the steps we now need to take to transform the health service so that it is redesigned around the needs of patients. It means tackling the toughest issues that have been ducked for too long.”

I do not think anyone would ever disagree with that as a statement of intent. He went on:

“For the first time the NHS and the private sector will work more closely together not just to build new hospitals but to provide NHS patients with the operations they need.”

[Bob Stewart (Beckenham) (Con)]

I am big fan of the NHS. It is my NHS too. I was badly hurt in the Army in 1997, and the NHS sent me to get fixed as a private patient, because the NHS could not do it. I am very grateful to the NHS. That was under a Labour Government, and I hope such a scheme continues.

[Sir Tony Baldry]

My hon. Friend makes his own point very well in his own way. It is important for all of us to remember that the NHS is our NHS and our constituents’ NHS. It does not belong to any particular political party; it is a national heath service.

Alan Milburn concluded that the “major reforms”, which included working more closely with the private sector, would

“deliver real benefits for NHS patients”.

Chapter 11 of the NHS plan of July 2000, on “Changes in the relationship between the NHS and the private sector”, said:

“The NHS is a huge organisation. Using extra capacity and extra investment from voluntary and private sector providers can benefit NHS patients… The time has now come for the NHS to engage more constructively with the private sector”.

Under the heading, “The basis for a new relationship”, it went on:

“Ideological boundaries or institutional barriers should not stand in the way of better care for NHS patients…By constructing the right partnerships the NHS can harness the capacity of private and voluntary providers to treat more NHS patients…Under our proposals a patient would remain an NHS patient even if they were being treated in the private sector. NHS care will remain free at the point of delivery, whether care is provided by an NHS hospital, a local GP, a private sector hospital or by a voluntary organisation.”

Off-patent Drugs Bill

Bob Stewart Excerpts

Friday 7th November 2014 Commons Chamber

[Jonathan Evans (Cardiff North) (Con)]

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

Only a handful of MPs are ever successful in the private Members’ Bill ballot, so I am delighted and honoured that, 22 years after I was first elected to the House, and now in my final year of parliamentary service, I have at long last joined this rather select group and have the opportunity to promote a Bill on such an important matter.

First, let me thank the Bill’s sponsors, and MPs from all parts of the House, who have shown such support and interest in my Bill. The passionate welcome it has received has been truly amazing, although not surprising given the challenges it addresses.

Just yesterday, the letter page of The Times led with a joint appeal to the Minister and the Government in favour of the Bill from the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia and Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia Care, Breast Cancer Care and the Cure Parkinson’s Trust. I should particularly like to thank Jenny Goodare and Mia Rosenblatt of the Breast Cancer Campaign for all the help they have given me in introducing my Bill.

Why question access to off-patent drugs? The problem goes back many years and is caused by a gap in the licensing system. The system is set up on the basis that a pharmaceutical company that wants to market any new drug acts as the drug’s sponsor throughout the process. That is fine and clearly understandable when the company anticipates many years of patent protection for its new product, but the essence of the problem that my Bill addresses is that no mechanism is in place to ensure the routine availability of existing drugs where patent protection has expired and where the drugs may be clearly shown later to be clinically effective but in a new way and for a new purpose.

Every time previously licensed drugs are shown to be effective for a new purpose, a new licence is needed to certify the drug’s safety at whatever the dose may be and for that purpose, and it must then be authorised to be marketed for such use. However, if a drug is no longer patent protected, no organisation or individual will take on the role of seeking any necessary licence for that treatment, because, after the patent has expired, other drug companies can produce and market generic versions of the drug, so the price of the product is driven down through the simple expedient of competition. It follows that the incentive for any pharmaceutical company to act as an advocate or sponsor for an off-patent drug and apply for a new licence is lost.

The outcome of all this is that off-patent drugs that should be routinely available at extremely low cost effectively have no sponsor. Without a change in the system, no one is ever likely to make licence applications for off-patent drugs, even when they may be effective for new purposes. In fact, it remains illegal to advertise and sell such drugs for such purposes if the drug is not licensed. What this all boils down to is that off-patent, repurposed drugs are not routinely available on the NHS, despite minimal costs to the taxpayer and the clear, clinically proven health benefits.

We may hear mention today of the ability of general practitioners to prescribe a drug outside the terms defined by the licence, which is known as off-label prescribing—in fact, Madam Deputy Speaker, given our earlier experience today, we may hear a lot about that—but the reality in clinical practice is much more complex and there are many disincentives to prescribing off label. A small number of clinicians may well be comfortable prescribing drugs off label in certain limited circumstances, but we know from the chemoprevention example, which the Minister quoted in the earlier debate, that this is not happening on any substantial scale. We also know that the absence of a licence is deterring many clinicians and GPs from prescribing these life-saving drugs in their new indications. Medical charities and senior distinguished clinicians have said that it is just not good enough to rely on the promotion of better information about off-label indications between clinicians.

[Bob Stewart (Beckenham) (Con)]

Are off-patent drugs likely to be found in a chemist’s shop? Do chemists keep stores of these drugs?

[Jonathan Evans]

Invariably, such drugs have been licensed for other uses, but it transpires that they are being researched, as I will outline in my further remarks, and that research is showing that they can be used effectively in another way. The kernel of the problem that I am seeking to highlight is that, without licensing, they are not being used in that way.

A licence gives a clear indication to GPs that a drug is both safe and effective, so it is preferable that indications that could achieve such a licence are supported. We face an unacceptable situation where cost-effective drugs are not made routinely available for new and proven effective uses. Although a small number of people might be fortunate enough to get the drug, a far greater number with exactly the same condition, in exactly the same clinical circumstances but with a different GP, will not. That is the worst form of inequality.

I want to highlight one scandalous example of the failure, red tape and bureaucracy of our current licensing system. The passive approach to the flaw that I have highlighted has meant that, for all of 15 years, the chemoprevention drug tamoxifen was routinely available to women in the United States of America to prevent the development of breast cancer but not to thousands of women at risk here in the UK, not because the research evidence is any different in the United States of America and the UK but because under our licensing system there is just no one to request that this treatment should become routinely available. So for 15 long years nothing whatsoever happened, and thousands of women here in Britain were denied treatment that it has been clinically proven could have prevented the development of breast cancer in many cases.

It was not until 2013 that the National Institute for Health and Care Excellence—NICE—eventually recommended the use of tamoxifen in the UK in its guidelines on the management of familial breast cancer, but that still stopped short of licensing, because of the flaw to which I have referred. As a result, the NICE guidance has proved insufficient to ensure equal access and there is no evidence that it has significantly changed clinical practice. The uptake of these treatments is lower and less uniform than if the drug were licensed. Furthermore, owing to the infrequency with which NICE guidelines are updated and their impact, this mechanism could not be widely employed to make off-patent drugs available, and I believe that the example of tamoxifen starkly confirms this.

[Jonathan Evans]

I am grateful to the hon. Gentleman for that contribution. If he will forgive me, I will not go further down the path of responding because of the point that he made at the end.

Sadly, all existing off-patent drugs that reduce the risk of people developing breast cancer fall into this category. The leading proven chemoprevention drugs are tamoxifen and raloxifene. These drugs, which reduce the risk of breast cancer developing in high-risk women by around a third, are not licensed for this purpose. With nearly half a million women in England and Wales eligible for these low-cost treatments, there is an urgent need to address the barriers to chemoprevention drugs being prescribed. The cost of tamoxifen is 6p a day; the cost of raloxifene is 61p a day. A third chemoprevention drug, anastrozole, originally developed as a hormone therapy, has been shown to reduce the risk of breast cancer developing by a half, and with fewer side effects. The evidence is there, but what action can be taken to ensure the routine availability of these treatments? The answer is none, or very little.

[Bob Stewart]

Without trying to talk out anything, may I say that I totally support what my hon. Friend is trying to do? Could NICE not do this sort of thing?

[Jonathan Evans]

My hon. Friend, yet again, anticipates another part of my remarks. The second part of my Bill is about giving a certain responsibility to the Secretary of State to encourage NICE to promote technology appraisals. I will deal with that in a little more detail in due course. He is quite right, but not exclusively: licensing is the major problem.

Major new research will be published in the next few months that provides evidence that bisphosphonates—drugs that were originally licensed for the treatment of bone fractures in adults with advanced cancer—are effective in the early stages of breast cancer in reducing the risk of the disease spreading to the bone in post-menopausal women. That analysis of phase 3 clinical trials is likely to show that, in post-menopausal women with early breast cancer, this therapy reduces the 10-year risk of breast cancer spreading to the bone by 34% and the risk of dying from breast cancer by 17%.

I should like us to reflect on that for a moment: a 17% reduction in the risk of women dying from breast cancer. What would be the cost of any new treatment that could deliver such results? It would probably be tens of thousands of pounds, and we would want to pay that for such impressive results. However, zoledronic acid, a type of bisphosphonate drug, can be given to post-menopausal women every six months for three to five years, and that can reduce the risk of breast cancer spreading to the bone by a third and the risk of death from breast cancer by a sixth, and it would cost less than 5p a day.

Yet bisphosphonates are off-patent drugs that are produced relatively cheaply by numerous pharmaceutical companies as generic drugs, as my hon. Friend the Member for Beckenham (Bob Stewart) mentioned earlier. It is therefore pretty certain that under the current flawed licensing system no organisation would seek a licence to use that treatment in preventing secondary breast cancer, even when the evidence is published, so the drugs will not be routinely available to the women who clearly need them.

I want to pay tribute to the distinguished breast cancer clinicians and researchers who have been speaking out about this issue for years. Sixteen of them wrote to The Times on the day of the Bill’s First Reading, stating:

“For some time it has been clear that there is a real barrier to licensing old drugs for new purposes, even when there is evidence that they are effective. This means that treatments which could bring real benefit to the lives of people and in some cases be life-saving, with minimal cost, are not routinely available”.

It is not just access to cancer treatments at stake; the current system will fail us for any medical condition in future if we do not correct the flaw. The Multiple Sclerosis Society makes it clear that strong preliminary evidence has shown that a number of repurposed medicines could be effective in the treatment of multiple sclerosis, but the UK currently lacks a system by which old drugs can be relicensed. In the past week the society wrote directly to the Minister in support of my Bill, in a letter co-signed by Professor Sue Pavitt, chair of the UK’s MS clinical trials network, and other leading specialists in the field. They cited the example of simvastatin, a drug originally licensed for treating high cholesterol that has been shown to be effective in slowing brain atrophy in secondary progressive MS by over 40%. Although final evidence from a phase 3 clinical trial is required to confirm those results, if successful that drug would address a significant unmet need, as there is currently no treatment that can slow or stop the deterioration seen in progressive MS.

The MS Society has pointed out that, given that simvastatin’s patent has expired, the treatment would require a licence in order to be made widely available on the NHS to people with multiple sclerosis, and it argues that the mechanism to achieve that just does not exist, despite the repurposing of previously licensed drugs being a fast and cost-effective way to provide new treatments. Those eminent clinicians and the MS Society strongly support my Bill and the mechanism it would create to provide access to medicines that could help tens of thousands of people with untreatable multiple sclerosis.

The treatment of Parkinson’s disease could greatly benefit from the Bill. I know that Tom Isaacs, president and co-founder of the Cure Parkinson’s Trust, has written to the Minister in the past week to point out clearly the charity’s full support for the Bill. Tom has said:

“Parkinson’s may not be a death sentence, but at the moment it is a life sentence. There is increasing evidence that a number of off-patent drugs have the ability to slow, stop or reverse our condition. Under these circumstances, the ability for patients to have a clearly defined way to make these medications accessible is now imperative.”

I think that it is now appropriate to turn to the detail of the Bill, given that the Minister might do so, Madam Deputy Speaker. To address the anomaly I have outlined, the Bill introduces a new advocate—the Secretary of State or a body appointed by him—for off-patent, repurposed drugs in the existing UK licensing system. The advocate would have to act in the public interest, and in circumstances where no other body had taken on the role of seeking a licence. The level of evidence required to trigger the advocate to seek a licence for an off-patent drug in a new indication would have to be significant. The treatments referred under the mechanism would be required to meet exactly the same standards for a licence for any other treatment, so nobody is lowering the bar in the licensing process. The Bill does not seek to make any unproven treatments available to patients; it simply seeks to address a clear market failure in the current system and to allow proven drugs to be considered for a licence after their patents have expired.

Clinicians have also suggested the supplementary provision in the Bill for NICE to appraise off-patent drugs in new indications where these are unlicensed—the point made earlier by my hon. Friend the Member for Beckenham, who sadly is no longer in his place. It is anticipated that that exceptional route would be used rarely. Regulations would outline the specific and significant standards that would need to be met before the provision was triggered. Although it may already be possible under existing legislation for NICE to appraise drugs for an unlicensed indication, the Bill would simply place a duty on the Secretary of State to direct NICE to conduct a technology appraisal for an off-patent drug in a new indication that satisfies the evidence threshold.

The Minister has stated publicly:

“The Government firmly believe that cost-effective, clinically appropriate drugs and devices should be routinely available to NHS patients.”—[Official Report, 1 September 2014; Vol. 585, c. 141.]

I recognise and applaud the admirable steps that this Government have taken to improve access to new cancer treatments. The cancer drugs fund has been established for England and now has a budget of £280 million a year. It is an incredible scheme that has improved access to treatments for thousands of patients in England, and I have seen for myself the disadvantages that my constituents have faced by not having an equivalent fund in Wales.

On the CDF, we are currently spending millions on new treatments, so why not improve access to treatments that cost just pennies but that we know can save or improve lives? In future there will be drugs for other conditions, including Parkinson’s, multiple sclerosis, breast cancer and Alzheimer’s, that could benefit from the Bill. We cannot wait 15 years longer than other countries for our constituents to get these treatments, as happened with tamoxifen, and then tolerate a postcode lottery in their availability to our constituents.

--- Later in debate ---

[Mr David Nuttall (Bury North) (Con)]

I congratulate my hon. Friend the Member for Cardiff North (Jonathan Evans) on bringing this fairly short, but very important, Bill before the House. I am delighted to be named as one of its sponsors. I have to say that I am perhaps the least well qualified of them all. My right hon. Friend the Member for North Somerset (Dr Fox) and my hon. Friends the Members for Bracknell (Dr Lee) and for Totnes (Dr Wollaston) are all real doctors. The fact that they are real doctors and have felt it appropriate to lend their names to this Bill is, in itself, something of which the House should take careful note.

This Bill is required because when a drug whose patent has expired is found to be effective in treating a different condition from that for which it was originally licensed, doctors are reluctant to prescribe it because it is not licensed for its new use. As I understand it, the Bill would put the onus on the Secretary of State to take steps to secure licences for clinically proven off-patent drugs for their new use when no other body has taken on that role.

In essence, the Bill would put an end to a postcode lottery. Patients are left in limbo. Until they go to their GP, they do not know whether they are registered with a GP who is prepared to take this risk. The Bill would remove that postcode lottery and give security to millions of patients. If the process has been followed and the drug licensed for its new use, whichever GP they are registered with will have the confidence and security of being able to prescribe it for its new use.

I am pleased to say that the Bill has the support of many charities: the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia & Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia CARE, Breast Cancer Care, and the Cure Parkinson’s Trust. That is a wide range of charities, all of which, for their own individual reasons, can see the sense of having a new procedure in place to bring back to life drugs that are found to be of new use but are off-patent.

The Bill also has the support of many of my constituents. I thank all those who have taken the time and trouble to write to me personally to express their support for the Bill and to urge me to continue to support it. I am delighted to do so.

[Bob Stewart]

A lot of us have received letters from constituents, including me, and I am absolutely delighted that we are here to support the Bill and get it through as fast as possible.

[Mr Nuttall]

I am grateful to my hon. Friend for that intervention.

This Bill will cut through the red tape that exists at the moment. It aims to get drugs off the shelves and into the hands of the patients who need them. I hope it receives the wholehearted support of this House.

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

I am delighted to have the opportunity to address the Bill. I start by congratulating my hon. Friend the Member for Cardiff North (Jonathan Evans) on bringing it before the House and raising this very important issue. As he has said, he and I have met Department officials and we very much agree on the Bill’s objective to promote off-label use of medicines. The only disagreement is on the mechanism to achieve that and whether the mechanisms proposed by the Bill are the right ones. That disagreement continues, and for that reason the Government want to work with my hon. Friend and the campaigners and charities that support the Bill to find a way to achieve our agreed aims.

I want to set out some of the background, outline my proposals and explain why the issue is not quite as straightforward as we would all like to think it is. If only we could legislate to get the right drugs into the right patients at the right time, the world would be a lot easier, but we are not able to do that.

[Bob Stewart]

Do I take it from what the Minister has just said that the Government support getting through the Second Reading as fast as possible?

[George Freeman]

Let me be clear. What I am saying is that the Government support the intention behind the Bill, which is to achieve greater use of off-label drugs in different indications, but we disagree with the Bill’s proposal for legislation to require the Medicines and Healthcare Products Regulatory Agency to license them. For reasons that I will set out, we do not think that is the problem or, therefore, that the proposal is the right solution. Nevertheless, I welcome the fact that the issue has been raised. It sits foursquare with my mission as the Minister with responsibility for life sciences. I am already working on it and am very keen to make sure that the active work streams I am pursuing embrace the intent behind the Bill.

I pay tribute to my hon. Friend the Member for Cardiff North for his work. The House has often debated this issue and I am well aware of the strength of feeling among Members of all parties about the importance of, and urgency involved in, getting both new and existing medicines to patients more quickly.

I should also like to take this opportunity to pay tribute to my hon. Friend for his service in this House. As he has said, this is his last year, and I am sure I speak for all of us in paying tribute to and thanking him for all he has done, not only in contributing to the quality of this institution, but in campaigning on this issue.

As my hon. Friend and others may know, I came to this House and my ministerial position after a career in biomedical research—a subject that is very close to my heart—so I am delighted to be able to discuss it and the Bill this morning. During my 15 years working in biomedical research, I saw first hand the serious challenges involved in bringing a new drug to market. I want to address how the landscape of drug development and discovery is changing; the profound way in which technology is changing what is possible; how the economics of 21st-century drug discovery are changing; and the resulting challenges and opportunities for us to do exactly what my hon. Friend seeks to promote, which is greater and more novel use of existing drugs for those patients who will benefit. I will then deal with the key points raised by him.

A rapid transition is taking place from a model of 20th-century drug development whereby the NHS, patients and the health system waited passively and all too patiently for the introduction of new drugs that had been tested, proven and developed with the claim that they would work and were safe for everybody. Over the past several decades, the regulatory barrier required to justify that claim has got higher and higher, as have the costs of developing drugs. On average, it typically takes 10 to 15 years and £1 billion to £1.5 billion to develop a new drug.

My hon. Friend referred to patent life. Members will know how the industry works, but it is worth repeating that, in order to justify the enormous sunk cost of the billions of pounds required to bring a new drug to market, the law provides for the inventor of a new drug to have a patent for 20 years. That mechanism ensures that those who successfully bring an innovation to market are able to get some exclusivity on sales, which allows them to pay for those sunk costs. When a drug becomes off-patent, the generics market kicks in and anybody can make the drug, provided it is made to the right standard and is safe, which allows all of us to benefit from that drug at a vastly reduced price. Indeed, one of the major challenges facing the sector is that, as the cost and time taken to develop a drug increases, the pharmaceutical industry’s pipeline of new drugs is not sufficient. The problem is referred to as the patent cliff, and the sector is going through a radical transition to try to deal with it.

The problem is that the more we know about genetics and the way in which different patients respond to different drugs and diseases, the more we realise that the blockbuster, one-size-fits-all drug that we have got used to the industry giving us is not what we need. What we need are drugs that are much more targeted at patients and their underlying genetic and pharmacokinetic profile. We want drug discovery to be driven by our increasingly sophisticated understanding of how different patients respond to different drugs and diseases.

Underlying that problem is an extraordinary opportunity for this country. In order to reorientate drug discovery around patients, we need an infrastructure that allows people to work in world-class research hospitals with access, at the very highest ethical and regulatory level, to tissues, biomarkers, electronic patient data and longitudinal cohort studies. Nowhere in the world is better equipped to lead that model of translational, personalised and stratified medicine than Britain with the NHS, and through my appointment the Government have signalled their commitment to exploit that opportunity.

We believe there is a real opportunity for the UK and the NHS to lead in the emerging field of stratified and targeted medicines, because no other territories in the world have our 50-year history of an integrated public health system, the records that go with it, its ethical and regulatory standards or its world-class centres of research excellence. If we embrace that model, using genomics and data to understand better how different patients respond, we will also be able to look back at the pharmacopoeia of known and existing drugs and re-profile them for use in particular patient groups, because it will have become clear that they will be effective for them.

My hon. Friend might be interested to know that the re-profiling of drugs is itself a major subsector of the life sciences sector. Whole companies, analysts and investors are devoted to mining the pharmacopoeia to find secondary uses, with the intention, of course, of re-patenting the secondary, novel use of an existing drug through tweaking the chemistry and providing the basis for a proprietary claim. Good luck to them—I wish them well—but what my hon. Friend and I want to see is the ability better to use that information in order to find existing drugs which, in their current form, would have a benign impact on a particular patient group. Doctors are perfectly free to use those drugs at the moment.

The truth is that whichever model of drug discovery we pursue, any drug has to be licensed as safe by the MHRA—or, in Europe, by the European Medicines Agency—and then NICE carries out a technology appraisal and makes a recommendation to the NHS about whether such a drug or device has a sufficient cost-benefit to be worth using. Despite all that, the decision on what to prescribe in the end rests, rightly, with clinicians. We cannot and should not legislate to tie clinicians’ hands. Rightly, it is up to clinicians to decide what to use for their patients.

I want to submit to the House and to my hon. Friend that the challenge does not relate to passing legislation to require the MHRA to license the new use of an existing drug, because the lack of a licence is not the restraining factor. In this landscape, the restraining factor is the lack of information for clinicians about off-label use. We need to encourage greater off-label use through NICE, and to have a culture within our health system that actively supports it. In a moment, I will talk about what we are doing and might do to encourage that.

I want to pick up the confusion that may exist about the difference between off-patent and off-label drugs. A drug is off-patent when its patent protection has expired, which means that anyone can produce an identical drug at their own cost. A drug is off-label when it can be used for a new indication for which it was not originally intended. However, clinicians are perfectly able to use drugs for off-label purposes: we do not require the MHRA to license drugs for such a reason, and many drugs are already used in that way.

Let me assure my hon. Friend and other hon. Members that, as the new Minister for life science, I have responsibility for the National Institute for Health Research, which underpins clinical research in the NHS with £1 billion a year. It looks not just at new drugs, although we are very good at that, but at the whole pharmacopeia and how existing medicines are used, and provides research on side effects, efficacy and outcomes for the MHRA and NICE.

We have created a new department at the heart of the Government to tackle precisely the issues that my hon. Friend has raised. I have been in post for only 100 days, but I want to talk about what we are doing to try to accelerate access for patients to new medicines, and to existing medicines with novel indications. I am sure that he is delighted to know that, as the hon. Member for Copeland (Mr Reed) reminded the House, my principal mission is to accelerate access to new drugs, including to new uses for existing drugs, for the benefit of NHS patients.

My hon. Friend the Member for Cardiff North was kind enough to refer to the Government’s commitment to the cancer drugs fund. He rightly identified that our real commitment is to ensure that if patients suffer because of NICE recommendations in relation to particularly expensive drugs, additional money is made available to prevent that from happening. The problem is one of health economics and NICE appraisals, rather than of licensing by the MHRA.

My hon. Friend made a very eloquent case, which I support, for the use of off-label drugs. We disagree not on the aim of promoting off-label use, but merely on the mechanism for doing so. As the Minister with responsibility for NICE, I am delighted to assure him and the House that we already have the power to instruct NICE to undertake technology appraisals. I hope that what I will say in a moment about how we intend to use that power and about the work we are doing on a series of ways to accelerate access to new drugs will reassure him that, far from our having any sense of complacency, we are bending our backs to consider every avenue in order to find value within the current pharmacopeia and to support clinicians actively embracing innovative uses of drugs.

It is for that reason that we have decided—controversially in some quarters—to support Lord Saatchi’s Medical Innovation Bill, which is in the House of Lords. It seeks to contribute to this landscape by making it clear in statute that clinicians have the freedom, and should be supported in using the freedom, to embrace innovative uses of both existing and new drugs in the treatment of cancer. His Bill is about making very clear that those freedoms exist, and that clinicians have a duty, under their Hippocratic oath, to explore every innovative opportunity that there is a good clinical basis for believing will be safe and to the benefit of their patients.

The truth is that the problem is as much cultural as legislative. That is the principal reason why the Government are not able to support this Bill, but very much support its aims. I want to say something about what we propose to do to achieve the progress that we all want more quickly and effectively.

So that there is no doubt, let me say that our position is basically that the Bill is not needed. Anyone can apply for a licence for a medicine, and doctors can already prescribe medicines for uses outside their licence, where that is in the best interests of their patients. Doctors do so every day: when they make such a judgment, it is safe, legal and right for them to do so if they feel that they have a basis for doing so.

The truth is that licensing gets a medicine licensed; it does not get it into clinical practice. Whether clinicians use the medicine is driven by NICE guidance, and doctors ultimately decide what is best for their patients. That is why pharmaceutical companies invest so heavily in promoting their products. In turn, NICE exists, as an independent source of advice in the NHS, to provide our clinicians with independent, world-leading advice on the cost-effectiveness and the clinical cost-benefits of new drugs.

If we want to accelerate the uptake of innovative medicines, I suggest that we focus our efforts on NICE guidance and on supporting our medical profession to adopt innovation. Our concern is that the Bill may, completely inadvertently, impede progress on that by making doctors feel that they should not use medicines except for their licensed indications, which is the opposite of the message that we want to send. I understand that that is not the intention of the Bill, but we believe that it might be an inadvertent side effect.

What are we doing? The Government believe that the real issue involves better informing and enabling clinicians to embrace new indications, not dealing with a supposed problem of licensing. We are taking steps with NHS England and NICE to support local drugs and therapeutics networks, and improve how they pick up new evidence and translate it into clinical practice. Indeed, one role of the NIHR is to gather data—that word again—on which drugs are working and on outcomes across the system, and to feed such information back into guidance that is continually updated.

We are also working with hospitals and GPs to support them to work together on delegated prescribing, and to consider how they can change clinical pathways to reflect the very latest evidence across the system. The truth is that we need more evidence about what is working, and we are now gathering that evidence through the NICE associates network and our contacts with local clinicians.

As I have explained to my hon. Friend in our meetings and conversations, we will set up a round-table discussion in the new year, alongside NHS England and NICE, to bring everyone together, review the evidence and agree a strategy and a timetable for action. I am more than happy to extend an invitation to him and those supporting his Bill, as well as Association of Medical Research Charities, to engage actively in that process and to help us to develop a strategy for achieving what we all want, which is the greater use of off-label medicines in areas where the evidence suggests that they can deliver patient benefit.

I can go further and confirm that that is part of a major piece of work that I am leading on how we can and should reissue and revise our guidance to NICE and the MHRA—and review our ambitions as a country in this 21st-century landscape—to make Britain genuinely the best model of patient-centred research. Through the NIHR and our NHS infrastructure, we want to be the best place in the world for people to come to and develop new medicines, or indeed new uses for existing medicines. We want specialist tertiary research hospitals with cohorts of data, to develop new models of commissioning through evaluation, and evaluation through commissioning—two sides of the same coin—so that we can get drugs to patients far quicker than under the traditional model of 10 to 15 years and the £1 billion drug development.

There are undoubted benefits to the use of off-label drugs where there is evidence about their safety, efficacy and side effects. Guidance from the MHRA and the GMC is clear that there is a hierarchy in the use of medicines. In treating patients, clinicians must first consider using a licensed medicine within its licensed indication. If that will not meet the patient’s needs, clinicians can consider a licensed medicine outside its licensed indication. Only if that is not suitable should they consider a medicine that is not licensed at all. A great many medicines can offer benefits to patients when prescribed outside their licensed indications—my hon. Friend has already mentioned tamoxifen and raloxifene for the prevention of familial breast cancer.

My hon. Friend also rightly identified that there can be delays and barriers to using off-patent drugs for new indications. The reasons for that are complex—if only they were so simple that we could solve them with one private Member’s Bill—and in part relate to reluctance by some clinicians to prescribe drugs for conditions for which they are not licensed. There are also issues about the system’s ability to pick up emerging evidence and translate it into new guidance and clinical practice, and about how hospital specialists and GPs can work together to achieve that, by adapting pathways where needed.

What the Bill seeks is already allowed. That is the key reason why, despite agreeing with the Bill’s aim that patients should have access to appropriate drugs, the Government are unable to support it. Medicines are already prescribed legally, safely and appropriately outside their licence indications to large numbers of NHS patients, both in hospitals and in general practice. No funding, legal or regulatory barriers in the system prevent patients from being prescribed a clinically necessary medicine that is not licensed for the treatment indicated. Indeed, doctors regularly prescribe drugs outside their licensed indications. For example, many medicines prescribed to children are unlicensed for paediatric use because historically they have not been formally trialled in children. Two key conditions must be met in such prescribing. First, the clinician must be satisfied that the unlicensed indication meets the clinical needs of the patient and that no suitable licensed alternative is available. Secondly, he or she must explain to the patient that the drug is not licensed, so that they are clear about that.

Evidence suggests that patients trust their clinicians, and that those who are suffering actively embrace research medicine and are keen to be made aware of available drugs that may be not have been originally licensed for that purpose, as long as there is good evidence for it and the clinician supports its use. That position is well established and supported explicitly in guidance to prescribers by the General Medical Council and the Medicines and Healthcare Products Regulatory Agency. Therefore, if a doctor chooses not to prescribe a medicine off label where one is indicated for the patient, that is unlikely to be simply because of the medicine’s licensing status. If a clinician believes that the lack of a licence prevents them from prescribing a drug, that is a different issue to which I will return in a moment.

Under the law regulating medicines, anyone can apply for a licence for a new use for an existing out-of-patent medicine. The Bill seeks to place that responsibility on the Health Secretary, so that he either takes steps to secure licences for off-patent drugs and new indications, or appoints a body to do so. In truth, licensing gets a medicine licensed, but it does not do what we want, which is get it into clinical practice. That requires clinicians to use and prescribe drugs, which is why we have NICE guidance.

The Department of Health holds a small number of licences for anthrax vaccine in the case of national emergency, but the Government rightly view that very much as an exception. Our concern is that if the Secretary of State were to become a routine applicant, or instructed someone else to do that on his or her behalf, they might be open to accusations of interfering in the market and a conflict of interest. There might even be a case for claiming a conflict of interest between the Secretary of State’s role as an applicant competing in the medicines market, and their statutory role as overseer of the system. Ultimately, we worry that that could compromise the Secretary of State’s responsibility for the UK medicines licensing system, were they to become a regular applicant. The idea of a body set up by the Secretary of State to apply for licences does not seem proportionate to the scale or nature of the challenge. If the issues under consideration will not be resolved simply by granting more licences—I do not think they will—there is no need for such new bureaucracy.

We believe that the provisions on NICE in the Bill are unnecessary. The fact that NICE has recommended the unlicensed use of tamoxifen and raloxifene in its clinical guidance should reassure hon. Members on that point, and I stress that we are actively discussing that matter with NICE and wish to promote it. I know my hon. Friend is concerned about the level of uptake of those drugs, despite NICE’s approval, and by focusing on the NICE appraisal process and guidance with an associated legal funding requirement, the Bill seeks to remove a perceived funding barrier to the implementation of off-label drugs that are proven to be clinically and economically effective. However, we believe that in practice it is unlikely that drug costs will be the key factor determining prescribing behaviour, when we are talking about generic drugs that in many cases will cost a few pence a day.

The framing of NICE’s clinical guidelines reflects the strength of the underpinning evidence. For example, where evidence strongly supports the use of intervention, NICE often states that that should be offered to patients. On the other hand, where the evidence of benefit is less strong, NICE typically states that intervention should merely be “considered”. It is entirely appropriate that the uptake of NICE’s recommendations reflects the strength of the evidence base. For the two drugs mentioned by my hon. Friend and me, NICE concluded that the evidence strongly supports their use for women at high risk of breast cancer, but was less strong for women at moderate risk. As such, its recommendations are worded differently, depending on a woman’s risk levels. Specifically, and importantly, NICE states that the drugs should be “offered” to women at high risk, and “considered” for women at moderate risk.

The Bill would require the Secretary of State to ask NICE to appraise certain new indications for off-patent drugs, whether licensed or unlicensed, rather than issue any form of guidance. Again, the Government believe that that is unnecessary, as there is currently no legislative barrier to Ministers asking NICE to appraise drugs outside their licensed indication. We tend to do so only exceptionally where there is clear evidence that that is the right course of action—an example would be drugs used to prevent transplant rejection in children. More frequently, NICE looks at the off-label use of drugs in the context of its clinical guidelines across the whole care pathway. Guidelines are generally considered a more appropriate vehicle for guidance on off-label indications, as they can set use more clearly in context. The question of mandated funding is unlikely to be critical if the drugs concerned are older or lower cost generics. NICE recognises the primacy of the medicines regulator in matters of safety and efficacy, and liaises with the MHRA in developing any clinical guidance recommendations relating to off-label use.

Let me explain why I am concerned that supporting the Bill could be counter-productive. That is not my hon. Friend’s purpose or intent, but it is a possible accidental side effect. The Government are concerned that the Bill could lead to clinicians and patients being concerned that something is not right about the use of a medicine outside its licensed indication, and that clinicians may be deterred from prescribing a drug, and patients from taking it. As I have explained, off-label prescribing is safe, legal, and when it is the right clinical choice for the patient, that is the right thing for the clinician caring for them to do. Given the large amount of such prescribing that goes on in the NHS every day, seeking to license every drug for every indication or each potential combination would be a gargantuan task. In many cases, the formal evidence base may not exist in a form that would support a licensing application.

Access to medicines that are important to patient care could be impeded because we worry that we would be seen to have set a new higher threshold for their use. That is precisely the opposite of what the Bill is seeking to achieve. We are, however, keen to take proportionate action to investigate whether non-legislative improvements can be made to support the use of appropriate medicines and benefit NHS patients. I was struck by the opinion and evidence that has been presented on access to medicines, such as the potential issues in transferring care from a specialist to a GP.

I might add that such issues are in no way unique to unlicensed medicines’ use. There are areas where there is far too much variation in the use of licensed NICE-appraised medicines. We are working hard with the NHS to address that, but there is no single magic bullet.

Ebola

Bob Stewart Excerpts

Monday 13th October 2014 Commons Chamber

[Mr Hunt]

The hon. Gentleman speaks movingly and well about the incredible gravity of the situation, and he rightly says that we need full international support on it. In such a situation there are a number of things we are much better tackling as part of an international effort; we are very proud of our 659 NHS volunteers, but volunteers from the whole of Europe could go out and play a part. They need reassurance that they will be safe if they end up contracting the virus, because the truth is that there is no 100% guarantee of safety, even for people who follow the correct procedures—that is why these people are so brave. The hon. Gentleman is absolutely right in what he says, and I reassure him that that is exactly the conversation I have been having with international colleagues: we do need a co-ordinated effort.

[Bob Stewart (Beckenham) (Con)]

The military have superb experience of dealing with contaminated areas. Are contingency plans in place to bring the military services into line to help, should that be required?

[Mr Hunt]

We are doing that already: we have made a commitment of 750 military personnel, who will be going to the affected region to help; we have military engineers helping to build the 92-bed facility in Kerry Town; and Royal Fleet Auxiliary Argus is on the way to Sierra Leone. We are tapping into that expertise, and it has a vital role to play.

Special Measures Regime

Bob Stewart Excerpts

Wednesday 16th July 2014 Commons Chamber

[Mr Hunt]

I thank my hon. Friend for his interest in his local hospital and I agree with him that the trust has made good progress. There is a simple way to ensure that these things get acted on quickly and that is to make sure they are public. When things are public—when they are transparent and everyone knows about them—the NHS and Ministers have to act, and that is the purpose of this system.

[Bob Stewart (Beckenham) (Con)]

Will my right hon. Friend confirm that if someone dies or is hurt in a residential care home, the directors of that home will also be held culpable under law?

Mitochondrial Transfer (Three-Parent Children)

Bob Stewart Excerpts

Wednesday 12th March 2014 Westminster Hall

[Jacob Rees-Mogg]

I was going to come on to that. As an aside, the reason we were able to determine that Richard III’s body was his was through the female line, and because we could establish the continuity of the DNA. I do not believe Government promises of secrecy. They promised that to sperm donors historically. Governments cannot be relied upon, because society becomes more open and so demands greater openness. I have no doubt that if the technique is ultimately used the donors will be identified and people with three or potentially four parents will find out.

[Bob Stewart (Beckenham) (Con)]

On that point, the worry that occurs immediately to me as I listen to my hon. Friend is that if someone does not know who the third or fourth person who created them is, through sheer chance they may well find themselves marrying their brother or sister.

[Jacob Rees-Mogg]

That is a risk, and there are others. Already in the United States a different price is charged depending on the educational qualifications of the donor. There are worries about eugenics, a point I was going to come on to.

Care Bill [Lords]

Bob Stewart Excerpts

Tuesday 11th March 2014 Commons Chamber

[Jim Dowd]

I accept absolutely the hon. Gentleman’s point. The wording of the clause is such that the powers are virtually unfettered—they are untrammelled. It does not say that an administrator can make recommendations about neighbouring trusts or nearby trusts; it says that they can make a recommendation about any trust anywhere in the entire health economy. It will be a threat to every single Members’ community willy-nilly, because it will be the new norm.

I will come on to what Lewisham experienced previously, but there used to be clinically led reconfiguration panels. This Government seem to have eschewed them. They are difficult and complicated, but they need to be so because this is a premier public service that matters so much to people in every part of this country. They are eschewing that in favour of an administrative route that will give them untrammelled powers.

[Bob Stewart (Beckenham) (Con)]

rose—

[Jim Dowd]

I give way to the gallant hon. Gentleman.

[Bob Stewart]

I thank the equally gallant hon. Gentleman and a neighbouring Member of Parliament. I, too, have never understood why Lewisham hospital had to be involved in this exercise, and I still fail to see why it has to suffer as a consequence of the failure of other hospitals that, although they are outside my constituency, affect my constituents deeply.

[Jim Dowd]

The hon. Gentleman is right. We have discussed the impact of this on our constituents many times.

I will try to shed some light on why Lewisham was put in the firing line, and why such administrative vehicles are so dangerous and antithetical to good health care. On 24 July 2012, the then Secretary of State invited the Members for Bexley, Bromley and Greenwich to a meeting in his office. That is entirely logical, because South London Healthcare Trust covers Bexley, Bromley and Greenwich. Strangely, he also invited the Members for Lewisham. My right hon. Friend the Member for Lewisham, Deptford (Dame Joan Ruddock) was unfortunately unable to attend, but my hon. Friend the Member for Lewisham East (Heidi Alexander) and I did attend.

--- Later in debate ---

When the trust special administration process was first introduced in 2009, Labour Ministers told the House that it was to be used only as a last resort, and that must remain the position of the coalition Government today. I believe that that is the case.

[Bob Stewart]

What worries me is the trigger for the process. What level of debt would have to be achieved in order for one of these extraordinary witchfinders-general suddenly to appear in our area to sort out our hospitals?

[Paul Burstow]

The hon. Gentleman anticipates my next point. It is far from clear how the judgment should be made that a trust is failing. In my view, the gateway to the process should be a narrow one, and it should be jealously guarded. My concern is that so many trusts are sitting on top of private finance initiative debt, and that hospitals could be at risk as a consequence. That debt amounts, over time, to about £70 billion; a significant burden has been hung around the neck of the NHS. I want to ensure that we have processes that can recognise and manage that without tipping organisations into crisis unnecessarily.

--- Later in debate ---

[Nick de Bois]

And the answer is not just with consultations. The issue facing us today, and why I cannot support clause 119, is simply this: the argument on reconfigurations, with the greatest respect to all hon. Members, will not be won by politicians or even by senior managers in the NHS. There has to be a clinically led argument from GPs upwards throughout the acute sector. For many, many years they have not made the case. The process has been littered with broken promises over the years, regardless of the good intentions of politicians. I can do nothing tonight that would suggest a further breach of trust by weakening the power of consultation, even though I accept that consultation has not had its finest hour—or, in my case, its finest 10 years.

I have faith that the voice of the British public, and the intent behind the Health and Social Care Act 2012 in particular, on which I was engaged over many weeks, is to bring clinical decision making to the front line and to empower local people, local authorities and patients further. That has been a great step. The second reason why I find it difficult to run with clause 119, and why I support the amendment tabled by the right hon. Member for Sutton and Cheam (Paul Burstow), is that he recognises the need to extend the consultation to all key stakeholders, not least to those in trusts that could be affected through no fault of their own, to extend their powers as well. That went to the heart of the 2012 Act. Indeed, we are blessed with two former Ministers in the Chamber, with whom I spent many happy hours on those Benches—it was not acrimonious at all. This was a core principle behind what we were trying to do.

Let us deal with the exceptional cases. I accept entirely that there is no master plan to run through configurations on the basis of the proposed changes, but I cannot ignore the fact that the proposed legislation we are being asked to approve allows for changes to be made in circumstances that would leave a democratic deficit and subjugate clinical judgment because of a stressful financial situation.

[Bob Stewart]

Where is the limit? That is what worries me. It is like pouring water on a tile—one cannot stop it. It might go much further than the adjacent trust area; it could go anywhere.

[Nick de Bois]

Yes, indeed. Again, I am trying to be as balanced as I can. I recognise that no single institution can stand in isolation, and I think that that is broadly accepted. However, to make decisions within 40 days on institutions, when we do not know which institutions will be affected or how they will be affected, is demanding too much of a service that is so valued by the public.

--- Later in debate ---

[Dr Poulter]

I will give way to the former Secretary of State in one moment, but I would like to make some progress. I have been very generous in giving way.

The Government are grateful to Members for raising these important issues, but, regretfully, we cannot accept the amendment. The amendment makes two key changes. First, it gives commissioners of other trusts affected by the recommendations of an administrator at a foundation trust the power to define essential services at those trusts. That would be cumbersome and impractical and draw the focus away from the trust in administration and undermine the need for recommendations affecting other providers to be “necessary and consequential”, which is something that my right hon. Friend the Member for Sutton and Cheam believes in and raised in Committee.

Secondly, protecting essential services gives the administrator their focus for the trust in administration; it is a critical part of the process. Asking commissioners at other trusts to define their essential services would incorrectly indicate an equivalence in the administrator’s role between the failed trust and other successful providers.

Clause 119 recognises the need to give other commissioners a clear role and a proper say. It already extends the existing requirement on an administrator at a foundation trust to obtain the consent for their recommendations from each commissioner of the failing trust, and also from each commissioner of any affected trust. NHS England support must be sought in cases where not all commissioners agree.

Let me be absolutely clear. Under subsections (3), (4) and (6), the commissioners who are asked to agree and draft the final TSA report already include commissioners from affected trusts. It may be hard to spot that in the clause, as it amends existing legislation.

Clause 119 also requires the administrator to consult other affected commissioners. He or she must publish a summary of the consultation responses and take them properly into account when making final recommendations. The Secretary of State or Monitor will need to be satisfied that the administrator has carried out their administration duties properly, including showing proper regard for the statutory guidance.

Commissioners of other affected trusts will therefore have every opportunity to make their views known. However, I would like to thank my right hon. Friend the Member for Sutton and Cheam for bringing the matter to our attention. The Government agree that it is important for other local commissioners to be able to protect their essential services. We will update the guidance to make it clear that the agreement of commissioners to the TSA report should include their agreement that essential services have been protected at other trusts, as well as at the failing trust, so that all local commissioners have an equal say, with NHS England arbitrating in the event of disagreement. Furthermore, I would like to invite my right hon. Friend to chair a committee of MPs and peers to consider the draft guidance and ensure that his concerns are properly addressed before the regime is used.

[Bob Stewart]

My disquiet stems from the fact that when the TSA was put into South London Healthcare NHS Trust there was no mention that it would go beyond its borders and into Lewisham. I do not think that was very clever. That is what worries me about the Government’s plans.

[Dr Poulter]

The spirit of the previous Government’s legislation was to look at the wider health economy when a trust is in extremis and has reached the point at which it is failing patients, either because of its financial failure or the direct effect that has on the quality of patient care. There then needs to be a wider look at the whole health economy. I know the Princess Royal university hospital in my hon. Friend’s constituency very well. I also know Lewisham hospital very well, having done some of my medical training there. They cannot be seen in isolation from King’s college hospital, Woolwich, Sidcup and all the other hospitals in the area, because they look after patients in that part of London as part of an integrated health and care service. When a hospital fails in that way, it has to be looked at holistically. It is a power of last resort, to be used when a trust is in extremis, not a routine power, which is why we have the TSA process set up by the previous Government.

Francis Report

Bob Stewart Excerpts

Wednesday 5th March 2014 Commons Chamber

[Grahame M. Morris (Easington) (Lab)]

I am honoured to be able to participate in this debate, and it is champion to follow my hon. Friend the Member for Rotherham (Sarah Champion) in the debate—

[Bob Stewart (Beckenham) (Con)]

Champion!

[Grahame M. Morris]

Thank you very much, Bob.

I want to make three points. First, I want to consider the context of the Francis report. I have the honour of serving on the Health Committee; we have held several inquiries and had the opportunity to meet and question Robert Francis on several occasions, so I am pleased to participate in this debate to consider where we are, one year on.

I also want to touch on mental health. As often happens when one speaks at the tail end of the debate, that has been raised by other hon. Members, but the issue is close to my heart. The third issue I want to discuss is the impact on social care. Although the Secretary of State kept implying that Francis is about acute hospitals, in fact his recommendations extend across the spectrum. The ideas and proposals in the 290 recommendations are just as valid for mental health and social care as they are for acute hospitals.

Clearly, the failings at Mid Staffs were absolutely shocking. I am sure that Members on both sides of the House who believe in the values of the NHS will, like me, have been appalled by those terrible events, but it is important not to conflate those terrible events with a wider diagnosis of the state of the NHS. We should think of the tremendous dedication and effort put in by the hundreds of thousands of NHS staff—I think the NHS is the biggest employer in Europe outside of the red army; it is a substantial employer—who make it such a national treasure that is ingrained in our psyche. I want to place on record the thanks of Labour Members, and, I think, the whole House, for their efforts.

[Bob Stewart]

I’ll intervene on that point.

[Grahame M. Morris]

Well, that’s very kind of the hon. Gentleman.

NHS

Bob Stewart Excerpts

Wednesday 5th February 2014 Commons Chamber

[Jim Shannon (Strangford) (DUP)]

Thank you for calling me, Madam Deputy Speaker. I will certainly leave sufficient time for the hon. Member for Walsall South (Valerie Vaz) to follow me.

It is a pleasure to speak in this debate. When it comes to the NHS, the nub of the matter is the same for both Government Members and Opposition Members. We have a real pride and interest in it, and we want it to do well. Over our years in this world, we and our families have all been recipients of its services, so it is very important.

The issue is a UK-wide one. Recently in Northern Ireland, some tough decisions have had to be made to close some A and E departments at particular times, and there have certainly been bumps in that process and better preparation might have prevented those problems. Such a decision was taken by the chief executive of the trust in my Down district council area. The hon. Member for South Down (Ms Ritchie) and I had an opportunity to meet the chief executive to discuss the issue and put forward our constituents’ viewpoint, but our opinion was not met favourably. The chief executive felt that there was no other option, and that other hospitals in the area could cope with the additional pressures. That decision has come under close scrutiny and review, and the savings or outcomes are not yet fully known, but the decision was taken and it stands.

The thrust of this debate is about improving patient care. The Government amendment to the Opposition motion mentions

“compassionate care, integration…and patient safety.”

We could combine the wording of both the motion and amendment and look for the same thing, and it is important to do so.

The NHS is one of the things that we can most be proud of in the UK—a system by which all people are entitled to a high level of care at no cost other than their tax and national insurance contributions. However, no matter how much money is spent in the Health Department, there is always a need for more. The portfolio of a Health Minister or Secretary of State is not one that I would take on for, as we used to say, all of the tea in china, and that is a lot of tea. I take my hat off to my colleague Edwin Poots at home, and all those who have to make tough decisions. I sometimes feel that I could not make such decisions, but I understand why they have to do so.

In preparation for this debate I considered the differences between how A and Es are run and the different quality of care in A and Es in different areas. In delving into the subject, I came across the last three words of the Opposition motion, which are “improving patient care”. I was shocked by a briefing I received from Macmillan Cancer Support, which was referred to by the hon. Member for Worsley and Eccles South (Barbara Keeley). Macmillan is very close to my heart, as I believe it is to many in the Chamber, because of the issues it deals with. I was left with no option but to use this opportunity to highlight the care of the cancer sufferers and survivors, whom we all know.

According to Macmillan Cancer Support, between 2015 and 2020 the number of people living with or beyond cancer in the UK will rise from 2.5 million to 3 million. By 2020, almost half the people living in the UK will be diagnosed with cancer during their lifetime. Just this week, I had an opportunity to go to the Backbench Business Committee—I was seeking a debate on another issue—and the hon. Member for Basildon and Billericay (Mr Baron) asked for a debate on cancer. The figures and headlines that we have seen this week indicate that cancer is a time bomb. It is frightening stuff. It used to be said that one in three people would be intimately affected by cancer, with a diagnosis for either themselves or an immediate family member; now that is changing to a cancer diagnosis for one in every two people.

In the run-up to that, we must certainly get our ducks in a line—if I may use such terminology—to ensure that we are ready, and that patient care will be of top quality, no matter what people’s postcode. The fact is that although our palliative care is second to none and there have been improvements in diagnosis rates, the UK is not to the fore in survival rates. Given that we face one in every two people having a cancer diagnosis in the very near future, that needs to change and to become a priority. If we can deal with a diagnosis early, we can improve survival rates. That is what we should all try to achieve.

Macmillan highlighted that a recent study on cancer survival rates in 29 countries in Europe—the Eurocare-5 research—has shown that the UK continues to lag behind other European countries. Macmillan is pleased to learn that the UK five-year survival rates for melanoma are 85% compared with the European average of 83%.

[Bob Stewart (Beckenham) (Con)]

Will the hon. Gentleman give way?

[Jim Shannon]

I am happy to give way, although I am mindful of the time.

[Bob Stewart]

I am a man. One of the problems with being a man is cowardice. The cancer survival rates would increase hugely if people like me would man up and get themselves checked out more often than they do. I am pointing the finger at myself.

[Jim Shannon]

The hon. Gentleman is correct in respect of prostate cancer. Medical organisations are also trying to highlight that problem.

Despite the improvement, I am concerned that the overall survival rates for nine out of 10 common cancers are lower than the European average. We have low survival rates for kidney, stomach, ovarian and colon cancers, and intermediate survival rates for rectum, breast and prostate cancers, cutaneous melanoma and non-Hodgkin’s lymphoma. Furthermore, the UK has one of the lowest survival rates in Europe for elderly patients. One reason for the rise in cancer rates is that people are living longer. Given that we have an ageing population, it is essential for the Government and the NHS to prioritise cancer care and early diagnosis.

Both the motion and the amendment refer to an integrated system. This week, we had the climax of the Committee stage of the Care Bill. The Minister who is responding to this debate said that he had visited Northern Ireland to see how our integrated care system works. The hon. Member for Leicester West (Liz Kendall), who was here earlier, expressed a wish to come to Northern Ireland to see how that system works. I hope to facilitate that for her so that the Opposition can understand the system that we have back home. We must have early diagnosis. That relies on patients informing their GPs of their symptoms, but also on the correct referrals being made and tests carried out when patients present at A and E departments. That should be considered when there is any shift around in care for those in A and E. If somebody is sent home with painkillers and told to make an appointment with their GP, how does that link up to the integrated system?

As I stated at the beginning of my comments, no matter how much money is allocated to the Department of Health, it will never be enough to meet the needs. For that reason, the Department is tasked with making savings. I understand that that is essential, but it is also important that the care that people receive through the NHS is second to none. There is a way of balancing those demands. Tough decisions need to be made and changes must be put in place, but the priorities must be clear. I ask for cancer care, including early diagnosis and support services, to be prioritised. I hope that everyone agrees that the most important words in the motion are “improving patient care”. On that, I think the House can unite.

Dementia Care and Services

Bob Stewart Excerpts

Tuesday 7th January 2014 Commons Chamber

[Alec Shelbrooke]

My hon. Friend eloquently describes the work going on in her constituency to raise funds for this very important issue. I wish to add my congratulations to my hon. Friend the Member for Chatham and Aylesford (Tracey Crouch) on her dedicated work and on securing the debate last month, as well as to the right hon. Member for Salford and Eccles (Hazel Blears) and my right hon. Friend the Member for Sutton and Cheam (Paul Burstow). I hope that the recent momentum achieved by the efforts of the all-party parliamentary group to shed light on this issue will result in achieving the aim—backed by NHS England—of 66% of people with dementia receiving a formal diagnosis by 2015. It can be done, as some CCGs already have a 70% diagnosis rate. Can the Minister shed any light on why individual CCG diagnosis rates are so varied and do not add up to the NHS England ambition of 66%? Are there any plans to investigate further the effectiveness of homocysteine tests on the NHS?

[Bob Stewart (Beckenham) (Con)]

Is this not a very human problem? Diagnosis rates will depend entirely on whether people go to see their doctor, who, using a simple test, identifies whether someone has dementia. It is a bit unfair to say one CCG has a better rate than another because the determinant of the rate of identification is whether people go to see their doctor or are taken to see them by family and carers.

[Alec Shelbrooke]

I seem to be one page behind the House in my speech this evening, because interventions keep pre-empting the next part of my speech. My hon. Friend is correct that we need wider support. I have become a dementia friend, as I know many other hon. Members have.

The aforementioned points all combine in reality to have an impact on post-diagnostic support, as well as the support for those who have not been diagnosed but need care. In my constituency, some inspiring examples make me feel optimistic that dementia can be dealt with effectively and compassionately. I have seen at first hand that such support, delivered well and early in a person’s dementia journey can lead to better outcomes.

--- Later in debate ---

[The Minister of State, Department of Health (Norman Lamb)]

I congratulate my hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) on securing another debate on dementia. It is important that we maintain the pressure, keep talking about this subject and keep challenging ourselves to take the necessary further steps. I am delighted to hear he is a dementia friend. I hope that everyone in the Chamber this evening is a dementia friend. [Interruption.] There is lots of nodding, which is encouraging.

[Bob Stewart]

Will the hon. Gentleman define exactly what a dementia friend is so that those of us who are not yet one can understand what we should do?

[Norman Lamb]

I am delighted by that intervention, because it gives me the opportunity to say something very quickly about the initiative being taken by the Alzheimer’s Society. If someone applies to be a dementia friend, they can go along to an hour-long session on understanding dementia better. It is very illuminating to go through that process. We got the initial idea from Japan, where it has gathered enormous momentum. If we can get a million people across society who better understand dementia, it could have an enormously powerful impact by making our communities more dementia-friendly and understanding and giving people with dementia a better life. I would therefore encourage my hon. Friend to become a dementia friend.

The right hon. Member for Salford and Eccles (Hazel Blears) talked about her constituency office. I will accept the challenge she laid down. I absolutely accept the case she makes. We are all serving the public, and it is critical that we make our own facilities friendly for people with dementia and their carers. My constituency office staff do not know this yet, but I will encourage them to go through this process, as all right hon. and hon. Members should.

I was struck by the constituency examples that my hon. Friend the Member for Elmet and Rothwell gave. He mentioned Paul Mancey of Orchard Care Homes, which is ensuring that people entering care homes get proper care and support and that their particular needs are met, and the Springfield Healthcare initiative.

Roaccutane

Bob Stewart Excerpts

Tuesday 3rd December 2013 Westminster Hall

[Sir Nick Harvey]

My hon. Friend makes an important point. The point when people are at the greatest risk can be as long as six months after taking the drug. In the case of John Medland, the impact was swift and profound, but in other cases, it has occurred some time later.

[Bob Stewart (Beckenham) (Con)]

Is it possible, therefore, that there is a link? If the drug is a toxic chemotherapy agent, it may well have a permanent effect on the brain. Consequently, after the person stops taking the drug, it can affect their personality. Could that be the reason?

[Sir Nick Harvey]

My hon. Friend tempts me beyond my limited medical expertise, but the logic of what he is describing sounds convincing. The other point to be made about the delay in some cases is that the numbers on the incidence of suicide and psychotic disorder that I quoted a few minutes ago are highly likely to be gross underestimates. For example, just this morning, I had a telephone call from someone in Cornwall who had heard a morning bulletin on his local BBC radio station referring to this debate. He said that for the first time, the penny dropped with him. He had attempted suicide and been forced out of the Royal Navy, but he had never before put the two things together. With the benefit of many years’ hindsight, he realised that it happened just months after he had used Roaccutane to deal with acne. I therefore think that it is fair to say that we are looking at numbers far greater than we first thought.

--- Later in debate ---

[The Minister of State, Department of Health (Norman Lamb)]

I congratulate my hon. Friend the Member for North Devon (Sir Nick Harvey) on securing this debate, and I say right at the start that I take the issue that he raises extremely seriously. I cannot begin to imagine what families have gone through after suffering such tragic losses, but if I was in their shoes, I would be campaigning and fighting, just as they are. I applaud the work that they have done in raising an issue that is obviously of intense concern to them.

Roaccutane is the brand name for the drug substance isotretinoin—my hon. Friend and I have both had some difficulty in pronouncing it. During my speech, I will refer to “Roaccutane”, although it is one brand name of that drug. I am grateful to my hon. Friend for providing this opportunity to update the House on issues relating to the prescribing of this medicine. I will aim to address the serious concerns that have been raised about the safety of Roaccutane, including the adverse psychiatric effects that my hon. Friend and other Members have expressed concern about.

Roaccutane is a derivative of vitamin A that is used for the treatment of severe and resistant acne; it is important to stress that. My hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) made the point that it is used only in those cases.

Acne is a common condition that affects around 80% of adolescents at one time or another; it affects adults more rarely. Although acne is not life-threatening, it can have a significant impact on the lives of sufferers. In its severe forms, acne can be both extremely debilitating and distressing, causing real disfigurement and permanent scarring. It can also have a genuine impact on someone’s mental health. Many forms of acne will respond well to treatment with topical preparations or systemic antibiotics. For severe and resistant acne, however, effective treatment options are more limited.

Roaccutane has been authorised in the UK since 1983. It is available worldwide and has been used by millions of people. Roche, which first licensed Roaccutane, has withdrawn its product for commercial reasons in a number of countries, including the USA. However, other brands of the same drug—so-called generic drugs—are still available in those countries. It is a highly effective oral treatment for severe and resistant acne. However, all effective medicines are associated with a risk of side effects in some people. I appreciate that the side effect, or potential side effect, that we are talking about is of the most serious nature possible.

Unfortunately, it is impossible to predict which individuals will suffer a side effect from a medicine, but a medicine will be issued a licence only if it is considered that the benefits of treatment in the licensed indications outweigh the risks of side effects. The risks and benefits of Roaccutane were carefully considered at the time of licensing and, because of the known safety profile of this drug, it is licensed for use only for severe forms of acne that are resistant to other treatment. Since licensing, the safety of Roaccutane has been closely monitored by the Medicines and Healthcare products Regulatory Agency, with expert advice from the Commission on Human Medicines.

Roaccutane is a medicine that is highly effective at doing what it is designed to do. It is associated with some serious side effects. Roaccutane is harmful to the unborn foetus and therefore must not be taken during pregnancy. When Roaccutane is taken, common side effects include dryness of the skin and the lining of the mouth, nose and eyes. The dryness of skin that is associated with Roaccutane can take the form of cheilitis, which is cracking or inflammation of the lips. This condition can become very severe, chronic and debilitating in some patients. There has also been significant concern about the possibility that Roaccutane may be associated with psychiatric adverse effects, such as depression and suicidal behaviour.

Roaccutane is licensed for use only for severe forms of acne that are resistant to other treatment. This narrow indication for use is not the only restriction on its use in the UK. As my hon. Friend the Member for Romsey and Southampton North said, it can only be given by, or under the supervision of, a consultant dermatologist. The intention behind restricting prescribing in this way is to ensure that the health professionals with the most experience, and who are best placed to give patients advice about the important safety issues related to the drug’s use, make the prescribing decisions.

To underpin the discussions between prescriber and patient, all licensed medicines have a summary of product characteristics, which contains important information for prescribers, and are accompanied by an information leaflet for patients.

[Bob Stewart]

The nephew of a constituent, Elliot Brandon, was prescribed this drug by the doctor, but neither he nor his mother were given any indication that there might be side effects. That has to be stopped. We have to correct that, as soon as possible.

[Norman Lamb]

I was going to make that point. It is important that proper advice is given to patients when a drug is prescribed. My hon. Friend raises a serious concern on behalf of his constituent. I accept his point. The patient information leaflet is an essential document if the patient is to be fully aware of the possible risks of treatment and make informed choices about their care. Of course, unless they are directed to it and advised to read it by the clinician, the chances are that they will never read it. That is an important point.