NHS Funding (York and North Yorkshire)

George Freeman Excerpts

Wednesday 7th January 2015 Westminster Hall

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

Thank you, Mrs Riordan, for calling me to speak. It is a pleasure to serve under your chairmanship this afternoon.

I start by congratulating my hon. Friend the Member for York Outer (Julian Sturdy) on securing this debate, with the support of our hon. Friends the Members for Skipton and Ripon (Julian Smith), and for Malton (Miss McIntosh), and I congratulate them all on their contributions to the debate. I am very aware of the personal interest of my hon. Friend the Member for York Outer in health matters affecting his constituents, and of course his interest in NHS allocations, including this question of fairness for rural areas.

I will also take this opportunity to pay tribute to all the North Yorkshire MPs who have worked so hard together on this issue since 2010: my hon. Friends the Members for Selby and Ainsty (Nigel Adams), for Skipton and Ripon, for Thirsk and Malton, and for Harrogate and Knaresborough (Andrew Jones), the hon. Member for York Central (Sir Hugh Bayley), my right hon. Friend the Member for Richmond (Yorks) (Mr Hague), and my hon. Friend the Member for Scarborough and Whitby (Mr Goodwill). I know they have had one meeting, if not more, with the Secretary of State for Health, and as a group they have been an effective and forceful lobby on this important issue, which we in the Department of Health all take seriously.

Of course, the whole House will agree that good-quality patient care is something we all expect, regardless of which part of the country, or indeed which county, we live in. As my hon. Friend the Member for York Outer has signalled, the question is how we work within the overall NHS budget—I welcome his acknowledgement of the Government’s increasing that budget—to determine how funding for each area should be assessed and decided. He made the key point: that it must be done in a way that is fair to all citizens and patients, wherever and whoever they are, and that where someone lives should not in any way unreasonably distort their access to health care. It is the NHS—the national health service—and those initials should mean something.

My hon. Friend will be aware that I, too, come from a very rural constituency—Mid Norfolk—where many of the issues he has identified chime, including ambulance response times and the extra time that clinical staff and patients take to travel around. Of course, there are other issues and problems, which he has highlighted: hidden deprivation, ageing and elderly populations, and isolation and loneliness compounding conditions such as dementia, making it harder to set up initiatives such as dementia cafés.

Health funding is an issue I have taken an interest in for a long time. Years ago, I did some work in County Durham to unpack the index of local conditions and the standard assessments in local government spending. When we unpack those formulae, we discover that those used to allocate funding for deprivation are all inner-city indicators: they are all about high-rise blocks, the percentage of black and minority ethnic people, and density. They are all urban indicators, as if only urban areas really experience deprivation. So my hon. Friend is raising an important point, which goes to the heart of much of the way that Whitehall allocates funding.

I will say something about how allocations within the NHS are made under the arrangements we have put in place. As my hon. Friend is aware, NHS England is the independent organisation responsible for managing the budget and the day-to-day workings of the NHS. It supports clinical commissioning groups—the local groups of GPs and other health professionals who commission NHS services on behalf of their patients. To make sure that the taxpayer has a say in how that money is spent, the Government provide direction and strategic ambitions for the NHS through a document called “the mandate”. The current 2014-15 mandate was reviewed and updated in December. There are eight key areas, which are about making general improvements; the Government deliberately leave the NHS free to make decisions about how these objectives should be met. They are: helping people to live well for longer; managing ongoing physical and mental health conditions; helping people to recover from episodes of ill health or injury; making sure that people experience better care, and integrated care; providing safer care, with a greater emphasis on patient safety; promoting NHS innovation; supporting the NHS to play a broader role in society; and making better use of our health resources.

NHS England has been given £98.7 billion this year, rising to £101 billion in 2015-16, to achieve the objectives in the mandate. I welcome my hon. Friend’s support for the extra £2 billion that the Secretary of State recently announced. NHS England has the responsibility to ensure that that money is well spent.

The first thing to say on the financial aspect of the mandate is that we have protected NHS funding in this Parliament, as my hon. Friend acknowledged. In 2014-15, all CCGs received a funding increase matching inflation. Furthermore, like all CCGs in England, North Yorkshire CCGs will benefit from the £2 billion of additional funding announced in the autumn statement. As I say, those CCG allocations and the formula used to decide what they should be are the responsibility of NHS England. NHS England itself commissions some services directly, including all primary care, as well as making allocations to individual CCGs. So these allocations to CCGs, although they are crucial, are only one part of a broader picture. In making those allocations, NHS England relies on advice from the Advisory Committee on Resource Allocation. As my hon. Friend will be aware, ACRA provides advice on the share of available resources provided to each CCG, in order to support equal access for equal need, as specified in the mandate.

NHS England does not set income on an equal “cost per head” basis across the whole country. Instead, allocations follow an assessment of the expected need for health services in an area, and funds are distributed in line with that, which means that areas with a high health need, including rural areas, should receive more money per head. There have sometimes been suggestions that a single per capita payment should be made across all CCGs, but I am not sure that that would not in fact lead to further discrepancies. As my hon. Friend will be fully aware, the key question is what overall weighting should be given to a range of factors, including age, disability, rurality and disease prevalence. As he himself acknowledged, there is no simple answer that would please everyone; this process requires the making of difficult judgments.

Without knowing that background, it can sometimes be hard for people to understand what are misleadingly presented as huge anomalies in allocations to CCGs. In the Vale of York, the funding is £1,067 per head; in my constituency of Mid Norfolk, it is £1,050; and in central Manchester, an urban area with an urban CCG, it is £1,085. I appreciate that those small differences add up over large populations, but they are not huge variations. The objective is to ensure a consistent supply of health services across the country, with health funding following —as best the system can map it—health need. That is one of the reasons why the data steps that we are putting in place are so important to allow us to monitor disease and health need.

NHS England has reviewed the funding formula and made welcome changes that take into account three important factors in driving health care need: population growth, deprivation and the impact of an ageing population. That should go some way towards helping to address the points my hon. Friend made.

NHS England now believes, and tells us, that it has a funding formula that sets recurrent allocations to CCGs more accurately and fairly, which is what the formula is supposed to do. However, I welcome the scrutiny that my hon. Friend and other colleagues from North Yorkshire are rightly insisting that it be put under.

By reflecting changes in population around the country and better targeting of pockets of deprivation, the NHS should be able to offer the best services to patients where they need them. I know there is a perception in North Yorkshire that the area is relatively underfunded. However, the NHS in North Yorkshire has benefited from increased funding, and when the Vale of York CCG’s funding is compared to that of other CCGs across the country, it is evident that it is not a significant outlier in terms of either funding per head of population or the level of funding relative to the formula. I appreciate that those are average figures; my hon. Friend will know better than I do the specific details of his own constituency.

At a time of continued pressure on the public finances, the additional funding we have provided for the NHS underlines the priority that this Government place on it. It means that the NHS will continue to benefit from stable, real-terms increases in funding, which will allow us and NHS England to get those formulae more and more accurate. Next year, the recurrent allocations of all CCGs in North Yorkshire will grow by 1.94%, an increase of almost £17 million. I am delighted that these increases will ensure that CCGs, including those in North Yorkshire, can continue to meet ever-growing demands for services, while investing in new services.

As time is short, with my hon. Friend’s permission perhaps I could write to him on the specific points he raised about back pain and IVF.

[Miss McIntosh]

I have a very simple question. Obviously, we as Back Benchers scrutinise the Department of Health, but who scrutinises and monitors NHS England?

[George Freeman]

As Ministers, we are responsible and ultimately accountable to Parliament for that. However, I am conscious of the time, so perhaps I could pick that point up in a letter to my hon. Friend.

As I said, I welcome the attention my hon. Friend the Member for York Outer and other North Yorkshire MPs are bringing to this issue, and I hope I have signalled that I consider it a substantive concern. Citizens in this country, rural or urban, demand and expect a national health service—rightly so, because they have contributed to it—and they expect national access on a fair basis. The structure we have put in place is really about giving NHS England the clinical freedom to ensure that funding decisions are made on the right basis. No system will be perfect, but as Ministers we are absolutely committed to ensuring that the system we have is as accountable and transparent as possible, and to providing the security of funding to allow that process to be pursued.

I know from my own experience in County Durham and in my Norfolk constituency that these are important issues. It is about ensuring that our citizens in rural areas get equal access to health services. My hon. Friend the Member for York Outer and other colleagues are doing exactly the right thing in raising this issue. I will happily address in writing the points I have not had time to address this afternoon. I look forward to writing to colleagues with more detailed answers to the specific points they have raised.

Question put and agreed to.

Pharmaceutical Price Regulation Scheme

George Freeman Excerpts

Thursday 11th December 2014 Written Statements

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

I am announcing today the level of payment due from members of the pharmaceutical price regulation scheme (PPRS) in 2015 to keep health service spend on branded medicines within the levels agreed under the scheme. The PPRS payment percentage for 2015 will be 10.36%.

The PPRS is a voluntary scheme agreed between the Department of Health, acting on behalf of the UK Government and Northern Ireland, and the branded pharmaceutical industry, represented by the Association of the British Pharmaceutical Industry (ABPI), under sections 261 to 262 of the National Health Service Act 2006. The current PPRS commenced on 1 January 2014 and lasts for five years, ending on 31 December 2018.

The PPRS allows patients access to the medicines they need while maintaining affordability for the NHS and providing stability for industry in support of the Government’s innovation and growth agenda. There is an agreed, fixed limit on the vast majority of NHS spend on branded medicines with additional expenditure above this level paid for by the pharmaceutical companies. Spend will stay flat in 2014 and 2015. Annual growth will be limited to 1.8% in 2016, 1.8% in 2017 and 1.9% in 2018. Small companies with less than £5 million of sales a year to the health service are exempted.

In the interests of transparency we are publishing our estimates of aggregate PPRS payments in 2014-15 and 2015-16. It must be stressed that these are only estimates at this stage. The Department is committed to publishing outturn quarterly aggregate sales and payments data for the PPRS on an ongoing basis.

In England, PPRS payments are taken into account in the allocations to NHS England through the mandate. All the payments will go back into spending on improving patients’ health and care.

The Department has published a document setting out further details entitled “2014 Pharmaceutical Price Regulation Scheme: revised forecasts and profile of payment percentages”. Copies have been placed in the Library and are available to hon. Members from the Vote Office and to noble Lords from the Printed Paper Office.

Attachments can be viewed online at: http://www. parliament.uk/writtenstatements

Sickle Cell Anaemia

George Freeman Excerpts

Wednesday 10th December 2014 Westminster Hall

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

It is a great pleasure to serve under your chairmanship, Mr Owen, and to respond to the right hon. Member for Wolverhampton South East (Mr McFadden), whom I congratulate on securing the debate. I hugely welcome the opportunity to discuss this issue.

Sickle cell anaemia is a really terrible condition and diagnosis for all those who are affected, but especially for our African and Afro-Caribbean communities. I want to start by acknowledging the work that the right hon. Gentleman has done for his constituency and his community, and I join him in paying tribute to the all-party parliamentary group on sickle cell and thalassaemia, chaired by the hon. Member for Hackney North and Stoke Newington (Ms Abbott). I also pay tribute to the Sickle Cell Society, the Wolverhampton sickle cell care and social activity centre and the patient groups. As with so many rare diseases, it is the advocacy of the few that in the end leads to changes in mainstream provision, and I am serious about paying tribute to that. The right hon. Member for Wolverhampton South East made a number of important points that I will try to deal with in detail. If I run out of time, perhaps he would allow me to follow them up in more detail in writing.

I stress that for those who have had a sickle cell diagnosis, it is a life-changing moment. All of us who are involved in policy making should not take our eyes off the personal suffering that patients—those with the diagnosis—and families and loved ones experience. Some 250,000 people in the UK carry the sickle cell trait, with about 15,000 affected by sickle cell anaemia, as the right hon. Gentleman knows. For those affected, it can mean a life of constant pain management, including, often, extensive periods of hospitalisation when the pain is bad, blood transfusion and red cell therapy, and tiredness, dizziness, palpitations, jaundice and gallstones. All those in combination mean that people are denied the quality of life that the rest of us take for granted.

However, as the hon. Member for Strangford (Jim Shannon) pointed out, the worst aspect of all is a substantially reduced life expectancy. Even today, sickle cell sufferers will, on average, survive until their 40s or 50s. Even though that is a massive improvement on the position 40 years ago, when the average life expectancy was only 14 years of age, it is still a shock when the rest of us are expecting to live very much longer than that. We can only pay tribute to the bravery shown by the people who have to deal with all the problems that this condition brings. However, bravery and resilience are not enough; we need to look at the way in which we support and treat people and bring on innovative care pathways and medicines. That is why we are continuing to invest in improving services, especially blood, bone marrow and stem cell services, which are vital for the condition.

Let me say something about what we are doing. In England, NHS Blood and Transplant provides blood for transfusion services. There is targeted donor recruitment, extended donation testing, and supplements, through a national frozen blood bank suitable for the long-term storage of blood for those with rare conditions. NHSBT’s therapeutic apheresis services provide a range of services to patients through NHS trusts from its six units situated across England, in Bristol, Liverpool, Oxford, Sheffield, Manchester and Leeds. Those units undertake procedures that provide direct treatment to patients with a range of medical conditions, as well as collecting stem cells from both patients and donors. Therapeutic apheresis treatments and services provide both life-saving and life-enhancing treatments for patients referred in sickle cell crisis or for ongoing sickle cell management. NHSBT is working with commissioners further to improve access to automated red cell exchange for sickle cell patients as part of those services.

One option for patients is a stem cell transplant, which requires genetically matched stem cell units, either from bone marrow donated by an adult donor or through stem cells harvested from cord blood. In the past four years, the Government have provided an additional £12 million of new money to help with transplant services. The Department of Health, working in partnership with NHSBT and the Anthony Nolan charity, has overseen the delivery of improvements way above what we originally anticipated.

The achievements include the following. More than 60% of black, Asian and minority ethnic patients are able to find a well matched donor now, compared with 40% at the beginning of the Parliament, and 258 more UK patients received a potentially curative stem cell transplant in 2013-14 than in 2010-11. The process for stem cell provision has been significantly streamlined, with single access searching in both England and Wales. I am delighted to say that there are now 60,000 young donors on the so-called fit panel, whose volunteers are eight times more likely to have donated stem cells than other registry volunteers.

Increasing use of UK-sourced cord blood to meet the needs of UK patients is crucial. This year, more than 25% of cord blood transplants will use donations from UK donors, costing about half the price of imported units. That compares with 10% in 2010. The time taken to provide stem cells from adult donors has improved. The right hon. Member for Wolverhampton South East knows that that is a crucial issue. Samples for confirmatory HLA—human leukocyte antigen—typing are provided from more than 80% of donors within 15 days now, compared with 35% in 2010.

The NHS and its key delivery partners are committed to continuing service improvement—I will say more about that in a moment—in collaboration with patients and patient group representatives, which is crucial. In the NHS today, if a child is diagnosed with sickle cell anaemia, they will be referred to a care team in a specialist sickle cell centre. Those are specialist units usually based, as the right hon. Gentleman knows, in large hospitals and staffed by front-line health care professionals with a high level of expertise in treating people with sickle cell anaemia. A detailed treatment and care plan, which outlines future medical care, is now drawn up for each patient, and parents are given information and support to help them to manage their child’s condition.

Due to the complexity of sickle cell anaemia, multidisciplinary teams are now assembled. Typically, they include paediatricians, haematologists, clinical psychologists, social workers and specialist nurses. The purpose of the care plan is to avoid sickle cell crises and to provide adequate pain relief when a crisis does occur, as well as reducing the risk of serious complications developing, such as infections, stroke and other associated symptoms of sickle cell anaemia.

Clearly, we want to see improvements in health care services for all types of patients. The right hon. Gentleman made that point well. The Government have committed to specific strategic plans in key areas. One of those plans is “The UK Strategy for Rare Diseases”, which covers sickle cell anaemia. The strategy sets out a shared UK vision for all those affected by rare diseases. It is owned by each country in the UK and commits them to more than 50 commitments. The strategy focuses on five areas: empowering patients, identifying and preventing rare diseases, diagnosis and earlier intervention, the role of research and, most importantly of all, co-ordination of care. As I have said, people suffering from long-term conditions are resilient, but that resilience can easily be undermined by the constant to-ing and fro-ing that occurs when a patient’s care pathway is not properly managed.

[Mr McFadden]

I thank the Minister for outlining the nature of the specialist care teams that are in place. He is right, but the critical point made by the report from the peer review exercise was that although that approach worked well in some places, it did not work as well in others. The specialists whom he talked about—the specialist consultants and specialist nursing staff—were not always there in sufficient numbers, and there is still something of a lottery, some might say, or at least unacceptable variability in the quality of treatment and the understanding of the condition, depending on where the patient lives. I therefore want to press the Minister on the recommendations from the peer review exercise, which were all about making the best the norm. What will he and the Department do to ensure that those recommendations are followed through on in that way?

[George Freeman]

The right hon. Gentleman makes a good point. I have my eye on the clock, and I will deal with it.

I conclude my opening remarks by saying that it is no longer acceptable to make the patient fit the pathway. We need to fit the pathway around the nature and progression of the disease in patients. These patients in particular have to see a wide range of professionals, and we need to look at that model. The final thing that I want to mention in terms of our strategic response is the genome project. We are funding 100,000 full genome sequences, to be put together with phenotypic data, with cancer and rare diseases as the initial focus. I am confident that that will quickly start to unlock some insights into possible preventions and new treatments.

The right hon. Gentleman made a number of important points, and I want to acknowledge them. If I cannot deal with all of them now, I will come back to him in writing. He made points about the lack of understanding among GPs across the system; the need for better care pathways to try to reduce hospital admissions; the importance of data underpinning our understanding of good outcomes, best and worst practice and variability; and the important insights in the report. I want to come back to his two specific requests. I would be delighted to ask the various organisations involved to give me a progress report on where they have got to in implementing the various measures, and I will obviously share that with him; perhaps we will have an opportunity to debate it. I will also happily ask NHS England and the National Institute for Health and Care Excellence to look at the health economics of free prescriptions in terms of short-term costs unlocking longer-term savings. I cannot prejudge the outcome of that, but I will happily look into the issue.

In the three minutes left to me, I want to touch on a couple of the specific points that the right hon. Gentleman made. How do we promote understanding and get sickle cell disease higher up the agenda? The 100,000 genomes project also includes a substantial investment in training in rare diseases for clinicians across the NHS as we launch our genetic medicines service. NHSBT and the Anthony Nolan charity continue to promote donations of blood and stem cells, but there is also the issue of the training that goes with that. The Department of Health is working with those key delivery partners to see what more can be done to improve not only donation, but the understanding of the condition and the training across the system.

The right hon. Gentleman asked what measures were being put in place to support care for people with long-term conditions. Our aim is to make the NHS among the best in Europe at supporting people with long-term conditions such as sickle cell disease. In the past, we have not done as well in that area as we would have liked. Through the mandate, we have asked NHS England to make measurable, tangible progress and commitments to supporting people with ongoing health problems to live healthily and independently. The NHS outcomes framework contains a range of improvement areas, and I will happily ask it to give me a progress report on that work.

NHS England is tasked with responding to the UK rare diseases strategy. Earlier this year, as the right hon. Gentleman will be aware, it issued a statement of intent that sets out how it intends to play its part in delivering that strategy; and in the recent NHS England “Five Year Forward View”, it has set out various commitments on exploring specialist centres for rare diseases to improve the co-ordination of care for patients in line with the strategy. I understand that NHS England will be looking to those specialist providers to develop networks of services, integrating different organisations and services around patients. As I said, I will happily ask for a progress report and share it with the right hon. Gentleman. Possibly we will have a chance to debate that in a format similar to this.

I again pay tribute to the right hon. Gentleman’s leadership on this issue. I think that the advocacy of Members of Parliament and particularly those with high concentrations of patients who are especially heavily affected by this condition, along with that of patient groups and charities, will be seen in years to come to have played a major part in helping to drive new care pathways and the integration of research, medicine and care, so that patients who are suffering are given the support that they need.

Patient Safety and Medical Innovation

George Freeman Excerpts

Tuesday 9th December 2014 Commons Chamber

[The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)]

I thank my hon. Friend the Member for Totnes (Dr Wollaston) for securing this Adjournment debate and giving the House, albeit only a few of us, the chance to debate what is, I agree, a very important issue that is the subject of live discussion in another place. I also thank my hon. Friend the Member for Cambridge (Dr Huppert) for his comments.

My hon. Friend the Member for Totnes is a tireless campaigner for good health care and good medicine, as Member of Parliament for Totnes, as a member of the medical profession, and as Chair of the Health Committee. I very much welcome her contribution. I will first deal with the points that she made, then set the scene and provide a little context about the Government’s view of this Bill, and then close with what I hope may be some reassurance about our commitment to patient safety.

My hon. Friend made a number of important points, which I repeat merely to signal that I have heard them loud and clear. She said that the Bill might risk creating a carte blanche, or open door, situation as an inadvertent side effect of unjustified and unsubstantiated claims. My hon. Friend the Member for Cambridge mentioned homeopathy and other non-evidence-based forms of medicine. My hon. Friend the Member for Totnes highlighted the danger of relying too heavily on the protection of a clinician merely seeking the endorsement of a fellow clinician. Implicit in her concern is the fact that most of us could probably find one person in life to support our own prejudices, however well intentioned.

My hon. Friend highlighted the risk of unethical approaches and the danger of back-door promotions, which none of us wants to see. On the danger of undermining public and patient trust in clinical trials, she knows that I am passionate about achieving precisely the opposite. We are very proud in this country that more and more of our patients are enrolling in clinical trials. The NHS is running a fabulously successful programme of promoting research medicine, and this year the numbers are up by 24% or 25%. That is good for patients, good for NHS research, and good for our life sciences sector.

My hon. Friend has highlighted the danger of accidental errors across the system today. We live with that risk, but I hear her point that it would be a disaster if the Bill inadvertently made errors more likely, rather than less. She also raised concerns about the Bill not promoting evidence-based medicine or requiring claims to be based on clear patient benefit. She made a specific point about the Cancer Act 1939, which I will follow up and deal with by letter, if I may.

Most concerning of all, my hon. Friend ran through a very long list of medical and health organisations that she described as being opposed to the Bill. I will look into that following the debate because—I will say more about this in a moment—we do not want the measure to be divisive or to alienate or undermine the consensus about the importance of good medical research in the UK and the NHS. I take that point seriously. My hon. Friend flagged up the letter from 100 oncologists that appeared in newspapers recently. Since that was published, there have been a number of discussions about—and, indeed, amendments tabled to—the Bill in the Lords. I want to have a look and make sure which, if any, of those concerns are extant as the Bill completes its passage through the Lords. I will say more about that in a moment.

My hon. Friend the Member for Cambridge endorsed those comments. I note in particular his comments about the importance of evidence-based medicine. As with so many issues that we deal with in this House, a good test is to ask: would I apply this to myself? Certainly, for myself and my family, I am a strong believer in evidence-based medicine. I am a believer in innovation as well, but my hon. Friend made an important point. I particularly enjoyed his mention of the politician’s syllogism: “We must do something; this is something; ergo, we should do it.” I assure him that that is not in any way the reason for the Government’s benign support for the Bill’s principles and the case it seeks to make to promote innovation. I align myself hugely with his comments about not wanting to open the door to quackery.

[Dr Wollaston]

Lord Saatchi has said that 20,000 people support his Bill, but if people are asked whether they are in favour of medical innovation, they are likely to answer yes, and if the same people are asked whether they are likely to support medical anecdotes, I think they are likely to say no. Sometimes the answer depends on the question being asked.

[George Freeman]

I am sure my hon. Friend is right. She makes an excellent point about the nature of the question having an impact on the answer one gets. I have repeated the concerns because they bear repetition and are important, and I want to signal that I am taking them seriously.

I want to set the scene in terms of the Government’s commitment to patient safety, the context in which innovative medicines are being developed, and the changes in the sector that are challenging some of the traditional methods of drug development. I will then address some of the specific points that my hon. Friends the Members for Totnes and for Cambridge have made and say something about the Government’s position on the Bill.

The Government’s response to the Mid Staffordshire NHS Foundation Trust public inquiry, led by Sir Robert Francis, “Hard Truths: The Journey to Putting Patients First”, demonstrated beyond any doubt, I hope, the Government’s absolute commitment to creating a new culture of openness, compassion and accountability and a renewed focus on patient safety right at the heart of the NHS.

The truth is that the NHS is one of the safest health care systems in the world. I am delighted to report that, in the recent Commonwealth Fund report comparing the US health care system with those of 11 other nations, the UK came top. However, there is always scope to improve health care standards universally and to reduce avoidable harm further. That is why the Secretary of State set the ambition this June, at the launch of the Sign up to Safety campaign, to reduce avoidable harm by half and save 6,000 lives over the next three years.

We have put patient safety right at the heart of the Government’s agenda for health. For that reason, I am delighted that the Government are actively supporting the Bill on patient safety sponsored by my hon. Friend the Member for Stafford (Jeremy Lefroy). The Bill has several important provisions on the use of data to drive safety across the system and to ensure transparency and accountability in health outcomes.

Why do we need to look at mechanisms for promoting innovation? My hon. Friend the Member for Totnes was kind enough to signal her awareness that the Government—particularly me, as the first Minister for life sciences—have taken an active role in trying to promote it. The reason is that we face a challenge in the field of drug discovery and development, as well as in medical technology generally. There is a challenge and an opportunity.

The challenge is that the more we know about disease, genetics and data—the datasets at our disposal in the NHS, and the history of drug reactions and the way in which patients respond to diseases differently—the more we realise that patients respond to the same disease or the same drug in different ways, and that those ways can often be predicted. These insights are beginning to change the way in which drugs are developed.

Increasingly, we do not need the one-size-fits-all, blockbuster drugs that we have traditionally expected the industry to bring us after long, slow, protracted and increasingly expensive clinical trials and randomised, double-blind trials. Of course, those trials have a strong part to play in our system, but the more we know about the nature of disease and the extraordinary breakthroughs that our biomedical and life sciences sector is making, the more the agenda shifts to designing around patients, as well as around tissues, data and genomics. That is why the Government are so committed to shifting our policy landscape to support the extraordinary role that our NHS can play globally. It is a uniquely well positioned, integrated national health care system, with extraordinary leadership in genomics and informatics, which the Government are actively supporting.

My hon. Friend made the point that the randomised, double-blind trial has given medicine great service in the 20th century, and I agree. As we move further into the 21st century and see the transformational power of new technologies, it is equally true that the system of expecting the industry to go away and spend 10 to 15 years, and an average of £1.5 billion, to develop a new drug—many of them fail in late-stage clinical trials, because of some toxic side effect in one patient or a few small number of patients—is leading to a crisis in the industry and in the pipeline for new drugs and new treatments, and to patients increasingly suffering because we cannot give them innovative medicines.

Part of the agenda for this Government and all western Governments is to look at how to accelerate the way in which our health systems support research and to bring innovative medicines, as well as devices, diagnostics and other innovations, to benefit patients more quickly.

[Jim Shannon (Strangford) (DUP)]

I apologise for not being in the Chamber at the beginning of the debate, Madam Deputy Speaker, but I did not realise that the business had moved on so fast. In the university in Belfast, we have developed some great partnerships in relation to finding new drugs. Nearby Belfast city hospital works together in partnership with the university to address the issue of innovation for new drugs and to address how best to utilise them and make them available. I know that the Minister is aware of that, but does he recognise that such a partnership—with Queen’s university, financed by big business, alongside the NHS in the form of Belfast city hospital—is a precedent for how to innovate?

[George Freeman]

The hon. Gentleman makes an important point. I want to take this opportunity to pay tribute to the work being done in that cluster at Queen’s. I am delighted to say that I will be coming in the new year to support it and to show, as the UK Minister, that there are great clusters in Scotland, Northern Ireland and Wales. I very much look forward to that visit.

The truth is that the landscape is changing. Part of the challenge that we all face is to find ways to accelerate earlier access to innovative treatments for patients, and earlier access for those developing innovative drugs, devices and diagnostics to our health system, so that we can more quickly design innovations that are more targeted and personalised. We are seeing the first genuinely personalised cancer therapies and drugs that, in the unfortunate event that one is diagnosed with cancer, can be designed around one’s genetic profile. I was at a seminar on that development this morning. It is changing the landscape of drug development. We are keen to ensure that we benefit from it in the UK and that we use every mechanism in the NHS to support it.

[Dr Wollaston]

Does the Minister accept that a doctor who uses such innovative treatments within the NHS is protected under existing law and that we do not need new legislation to make them available to patients?

--- Later in debate ---

[George Freeman]

I will happily come on to the existing law and the protections within it.

Three weeks ago, I announced a major review of the landscape of innovative medicines development, which will involve a review of NICE and the Medicines and Healthcare Products Regulatory Agency. It will look closely at how we can develop a new landscape for the quicker development of innovation with patients in the NHS.

I reassure the House that the Government are committed in all this work to putting patient safety first and developing a landscape of evidence-based medicine. I have listened carefully to the concerns of my hon. Friends the Members for Totnes and for Cambridge. I reassure them that I and the Government take their concerns very seriously.

Lord Saatchi has identified the threat of litigation as a potential barrier to innovation. The purpose of his Bill is to set out a series of steps and a clearer legal framework that will make it less likely for doctors to be put off reasonable innovation because of the rather circular defence that the best treatment is one that is already well established. The intention of the Bill is to tackle the risk that the fear of clinical negligence could undermine the commitment of doctors to embracing innovation in the system. It does not claim to be a panacea or silver bullet to solve all our innovation challenges, but to be one measure in the broader landscape.

In Committee in the House of Lords, the Government supported Lord Saatchi’s amendments to the Bill, which added an objective test of responsibility to the doctor’s decision to innovate. The amendments exclude any doctors who act irresponsibly from enjoying the protections of the Bill.

The amended Bill provides a number of other safeguards for patients, including the requirement for doctors to take full account, in a responsible way, of the views of other appropriately qualified clinicians. My hon. Friend the Member for Totnes argues that that does not go far enough. I would be interested to hear the views of Members of the upper House who are more qualified than I am when they debate Third reading at the end of the week. The package of amendments is intended to ensure that there is expert peer review of any doctor’s proposal. Furthermore, it ensures that the doctor must act responsibly in taking account of that review, thereby applying an objective standard to their conduct. In addition, the Bill requires any doctor to consider the risks and benefits associated with the proposed treatment, alternative treatments and doing nothing. That provides a further safeguard.

Let me be clear that we do not want the Bill to prevent patients from taking doctors to court when there is a good reason to do so. Doctors who follow the steps set out in the Bill or the steps required in normal practice should be able to demonstrate more easily that they have acted responsibly, because they will have considered the necessary steps in advance of any innovation. However, by invoking the freedom to innovate that is set out in the Bill, one does not in any way avoid the scrutiny of the courts. Doctors will still have to justify their actions if any case is brought against them, just as they do now.

[Dr Huppert]

At the beginning of the Minister’s comments, he said that he and the Government were keen to ensure that this would not be a divisive issue, and that they would not progress with it if it became one. He now sounds like he is being very supportive of the Bill. Will he provide an assurance that if the Bill continues to have the vast weight of medical and legal expertise against it, whether that is expressed in the House of Lords or by the organisations that my hon. Friend the Member for Totnes mentioned, he will ensure that the Government do not back it?

[George Freeman]

I am merely trying to set out a balanced review of the arguments. In closing my speech, I will give an assurance that I hope will satisfy my hon. Friend on that point.

On protection, under existing common law and in the Bill doctors must show that they have acted responsibly. They cannot simply go through the motions and seek advice from an inappropriate source as that would not be “responsible”, which is the key test in the Bill and common law. Even if doctors follow the steps in the Bill when deciding to adopt an innovative treatment, they might still carry it out negligently and be subject to a negligence claim in the same way. When something goes wrong it is right that patients are free to seek compensation, and that will continue to be the case. The Government do not want any undermining of protection for patients against clinical negligence.

My hon. Friend the Member for Totnes made a point about the Bill not requiring doctors to seek the prior agreement of an appropriately qualified doctor, and instead being required only to take account of their views. I would not want the Bill to give a carte blanche to quackery or non-evidence based medicine. The Bill requires a doctor to take full account of the views of at least one appropriately qualified doctor, just as any responsible doctor would be expected to do, and they would not be able to ignore certain views or give them minimal weight by just “noting” them unless there were reasonable grounds for doing so. All doctors will be bound by the core and primary duty of responsibility and care to their patients. If the Bill were to require the explicit agreement of another doctor to innovate—that is one suggestion made in the other place—we are worried that that would open the possibility of a new negligence action against the countersigning doctor and lead to more confusion. We would not be able to give the countersigning doctor any certainty about their legal position, and they would not be able to rely on provisions in the Bill.

My hon. Friend made a point about undermining confidence in clinical trials. Although the Bill has raised awareness of innovation in medical treatment, it does not confer additional rights on patients to demand innovative treatment. It will still be for the doctor to decide the most appropriate course of treatment in discussion with their patient and using their best professional clinical judgment. Nothing in the Bill allows doctors to bypass any processes or requirements set by their trust when undertaking innovative treatments in the NHS, which includes ensuring that the commissioner would fund the treatment if it is to be provided within the service.

Individual innovation is important but no substitute for medical research and testing the efficacy of new treatments in a systematic way. A large part of my work is about ensuring that we use all of our £1 billion a year for the National Institute for Health Research infrastructure in the NHS, to ensure—as the Prime Minister set out in his speech when launching our life science strategy—that every willing patient is a research patient and every hospital a research hospital, and that we learn from evidence that we develop daily in our interaction with patients. Lord Saatchi and Ministers are determined that doctors should learn from innovative medicine as we go along, and a large part of the NIHR and our data programme is about ensuring that we pick up and track innovations and outcomes more accurately across the system.

[Dr Wollaston]

Does the Minister accept that that cannot happen under the Bill, and that those things will remain a series of unlinking anecdotes? In medical science and for the safety of patients no one will be able to track whether there were unintended consequences or benefits, and it will not advance the cause of medical innovation whatsoever.

[George Freeman]

I would be interested to see the Bill once it has completed its passage through another place and ensure that it contains adequate provision for evidence-based medicine, and that, by encouraging innovation, we are not in any way encouraging medicine that is not supported by the best evidence available.

My hon. Friend spoke about consultation. The Department of Health carried out a full consultation on the issues raised in the Bill, which ran from February to April this year. It was delighted to receive 170 responses to that consultation, making clear a range of opinions. Responses came from a range of audiences, professional bodies, patients and clinicians. Four regional public consultation events were also held. Lord Saatchi attended those events and it was in no small part thanks to his involvement that a number of changes were made to strengthen the oversight mechanisms in the Bill. At every stage, the Department of Health has engaged with Lord Saatchi to develop amendments to align the policy of the Bill with the legal and expert clinical advice we have taken, including from Sir Bruce Keogh.

[Dr Huppert]

The Minister is being very generous, although we do appear to have quite a lot of time. He talked about 170 responses. How many were supportive of the Bill and how many were not?

[George Freeman]

I do not have that information at my fingertips, but I will happily look into it and come back to my hon. Friend if I may.

Crucially, following the Committee stage, Lord Saatchi and the Government have continued to engage with peers and key stakeholders. Let me take this opportunity, on the question of the Government’s support, to reiterate that this is a private Member’s Bill. This is not a Government Bill. We are very supportive of the Bill’s aims and intent to promote a culture and regulatory framework that is supportive of innovation within the NHS, but it is equally important that we do not in any way damage or undermine public or patient confidence in research in this country and in the NHS. I stress that the Bill has not been given Government time. We are supportive of its principles, but it is very important that when it leaves the House of Lords, where it will have been subject to extensive scrutiny by very eminent medical and legal opinion, it comes to us in a format, even if not every single point is unanimously supported, that has the very strong support of our most senior lawyers and medics.

I want to close by highlighting the fact that the Bill has generated substantial interest, both in Parliament and outside. In many ways, if those concerns can be reflected in high-quality scrutiny and the tabling of amendments, we should be able to demonstrate that democracy works and end up with a Bill that both achieves the aims of Lord Saatchi and reassures those with concerns. I want to be clear that, as the Bill completes its passage in the House of Lords, I hope it returns to this House in a form that the vast majority of medical opinion and respectable bodies in the medical field feel able to support. It is not our intention to have a Bill that undermines public or patient trust in research medicine.

We cannot legislate for best practice; we can only legislate to support our front-line clinicians to do what they believe is best for their patients. At the heart of that is a sacrosanct duty of care that all clinicians share, and which the Bill does not in any way weaken or undermine. That duty is to do what is best for patients.

I want to close with some supportive quotes the Bill has received from a number of important people, lest the House should form the view that it is unanimously opposed, which is not the case. Dame Sally Davies, the chief medical officer, has said:

“I am confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”

Sir Bruce Keogh, at NHS England, said:

“Encouraging innovation in medicine and protecting patients are both of vital importance. That is why I am pleased that amendments have been devised to address concerns about patient safety.”

Sir Michael Rawlins, president of the Royal Society of Medicine, said that the Bill will allow responsible innovation and treatment:

“I believe the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science.”

A letter to The Telegraph from 40 leading medical professionals, including David Walker, professor of paediatric oncology at Nottingham university, and Riccardo Audisio, the president of the Association of Cancer Surgery, said the Bill

“legally protects doctors who try out innovative new techniques or drugs on patients when all else has failed. This Bill will protect the patient and nurture the innovator. It will encourage safe medical advancement, while at the same time deterring the maverick, thereby recalibrating the culture of defensive medicine. Finally, it will work with evidence-based medicine and provide new data that will inspire and support new research.”

I hope very much that that is the case and that when the Bill leaves the House of Lords, the vast majority of qualified senior opinion in this field is able to agree with it. It is absolutely our intention to support the Bill’s noble intent to promote medical innovation, but equally our intention is to not undermine in any way the Government’s commitment to patient safety or the duty of care that all clinicians share and owe to their patients.

Question put and agreed to.

Branded Medicines (NHS)

George Freeman Excerpts

Thursday 4th December 2014 Commons Chamber

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

It is a pleasure to respond to this debate and to follow the hon. Member for Copeland (Mr Reed) and my right hon. Friend the Member for South Cambridgeshire (Mr Lansley). It is a shame that there are not more Members present, because I know that the debate has been warmly welcomed across the House. I congratulate the Backbench Business Committee on granting it and my right hon. Friend on securing it.

I would like to take this opportunity to pay tribute to my right hon. Friend for all his work in this field, both as the Member for South Cambridgeshire—I do not think there is a constituency that more represents this cluster—and as the former Secretary of State for Health, because he led many of the initiatives that he spoke about so eloquently this afternoon. He is as well placed as anybody to describe the evolution of policy in that space, and it is my great privilege, as the first Minister for life sciences, to inherit that baton of leadership.

I also want to acknowledge the very helpful comments and questions from my hon. Friend the Member for North Herefordshire (Bill Wiggin) on whether there is more of an opportunity for the NHS to become more of a partner in the development of novel medicines. He is absolutely right, and I will come to that in a moment. He also raised the question of off-label drugs, as did the hon. Member for Copeland, and I will also address that shortly. The hon. Gentleman also requested an update on progress in this field and some detail on the review of innovative medicines that I announced two weeks ago. I am grateful for his support for that and for his recognition of NICE’s work on value-based assessment.

My right hon. Friend the Member for South Cambridgeshire set out eloquently, and incredibly helpfully for the House, the challenge we face and the evolution of policy in this area. He talked fluently about the challenge facing the Government, and indeed all mature western democracies, with an ageing population, a demographic time bomb and the rise of chronic diseases. As the Chancellor reminded us in yesterday’s autumn statement, we inherited a very serious structural deficit in the public finances and huge pressure on our budgets. We have to balance the requirement to spend our drugs budget as effectively as we can for patient benefit, but in a way that supports our leadership in medical research for the benefit of patients. That goes to the heart of my mission as the new Minister for life sciences: how do we embrace science, research and innovation so that we spend every health pound more effectively? It is about embracing precision medicines, cutting out waste and ensuring that we deliver maximum health benefit for patients through our health budget, but in a way that attracts inward investment to our economy to equip us better to pay for the modern medicines that we will all need.

My right hon. Friend highlighted that NICE has led the world in health economics on the 20th century model, which is really based on an averaging of health economic benefits, as he explained, and that is under increasing pressure from some of the breakthroughs in science that are bringing us a new generation of stratified and personalised—in some cases, literally—medicines, which do not fit well with the model of averaged, whole-population health economic assessments.

My right hon. Friend made the point fluently that it is ironic that we are a leading centre for research, but unless we also become a leading centre for adopting these new medicines, we will struggle to retain that. We set that out very clearly three years ago in the life sciences strategy. The Prime Minister was very clear about that. We do not believe that we can rest on our laurels simply as a 20th economy with a strong pharmaceutical footprint; in the 21st century we have to use all our resources, including our NHS, to accelerate the discovery of new medicines and their adoption into the system.

[Mr Jamie Reed]

I wish the Minister every success in that mission and offer the fulsome support of the Opposition in ensuring its success, but does he agree—I do not wish to divert him too much—that critical to that success is that Britain remains in the European Union?

--- Later in debate ---

[George Freeman]

I thank the hon. Gentleman for that warm support for this mission. We are ambitious for this country in life sciences research, and ambitious for Europe too. One of the things I am exercised by is the danger of the European Union putting in place a regulatory framework that does not support 21st-century leadership in regenerative medicine, in stem cells, and in the use of data. In the new year, I will lead a delegation to the European Commission to highlight the fact that this new landscape requires a new regulatory framework. I very much hope that we can persuade the European Union to embrace that so that Britain can lead in a Europe that leads in a global sector.

My right hon. Friend talked about institutional and cultural barriers to rapid adoption of new medicines and the need for a new system. I strongly agree with the tenor of his thinking. It must be a system in which we put patients right at the heart of the assessment of need and in which clinicians are empowered and supported to make decisions based on what their patient needs. The new model of 21st-century research and medicine is about accelerating a much more patient-centred model of research, not just so that we design drugs around patients and their genetics and data, but so that the patient voice is stronger in the allocation of resources. That is a challenging but important agenda that we need to embrace.

My right hon. Friend reminded us that this formed a lot of the thinking behind the original concept of value-based pricing and the need for us to move towards a new mechanism for reimbursing innovations on the basis of the impact that they have in populations. I strongly support all that. He highlighted the cancer drugs fund—a really important measure that seeks to make sure that, in cancer, the therapeutic area that has most challenged the traditional method of health economics, we do not allow patients to suffer from lack of access given the increasing stratification of new drugs that do not fit well with the NICE model. I pay tribute to his leadership on this. I am very proud that we have managed to increase the funding of the cancer drugs fund at a very difficult time for the public finances, with another £160 million this year bringing the total to £280 million. More than 60,000 patients have benefited from that.

My right hon. Friend is right, however, to signal that the cancer drugs fund is, in essence, a stop-gap mechanism to make sure that we are able to update the systems, protocols and procedures within NICE for adopting and procuring innovative medicines. We do not intend to have a specific fund for every therapeutic area or, indeed, additional assessment measures within NHS England on top of those already faced by the industry through NICE. It is crucial that we use this window of opportunity to put in place the new system to adapt NICE’s mechanisms and procedures to the new landscape. That is precisely what the review that I announced a couple of weeks ago is about.

My right hon. Friend made a number of comments about the pharmaceutical price regulation scheme. His overall message that price should reflect the value of new medicines and that we should, as far as we can, pay on results, paying a premium to innovations that have particularly high impacts and patient benefits. I suggest that that should apply equally to med tech as to pharmaceuticals. That is part of what was originally conceived of in the value-based pricing proposals that he brought forward. I agree with all that, and I think it is the direction of travel. In a moment, I will explain how the review and the work we are pursuing in the Department of Health is intended to pick up that thinking and drive it forward.

I welcome my right hon. Friend’s reference to the importance of new methodologies. I have discussed this with NICE. He will not be surprised to hear, as it is an organisation that is constantly looking to update its procedures, that it is actively looking at these challenges and welcomed my review as creating a forum for it to share things with industry and charities. I particularly welcomed his mentioning the role of charities. Increasingly, we will see charities as sponsors of drugs alongside big pharma and small companies. As he said, the system is very heavily geared around big pharma as the main developer of new drugs, but that is increasingly not the case. We need a policy and reimbursement landscape that reflects the needs of not-for-profit and smaller company sponsors.

Clinical validation of whether an innovative drug or device is going to work in patients is key, and I know that that is the most valuable moment of all for organisations, because I used to work with them. We should not forget that there is also value in the developers of an innovation being told that it will not work in patients. The “slow no” is the death knell for so many innovative companies and charities. We should look to embrace a model in which we can add value by helping the developers of innovations not to pursue those that will not work well and to target those that can be channelled towards those patients who will benefit most.

I hear loud and clear my right hon. Friend’s call for us to urge NICE to develop a more value-based assessment and to explore all mechanisms in the PPRS for innovative medicines. I am very happy to agree with those two things and take up the challenge to support them. I agree with my right hon. Friend’s analysis that we have a window of opportunity in which it is important that we set out a new framework so that, beyond the cancer drugs fund, NICE is able to provide a holistic, comprehensive model for assessing the new range of medicines that come on stream, and that we do not have to set up additional funds for different types of medicines with additional burdens of assessment both within and outside NICE. That is precisely what the review I have announced is about and I will deal with some of those specific points.

My right hon. Friend made an excellent speech that captured and set the scene and the challenge we face. I will summarise in my own words the problem. We are moving from a 20th-century model of drug discovery and pharmaceutical innovation whereby typically a new drug takes 10 to 15 years to come to market and costs $1 billion to $1.5 billion. It follows a linear process that starts with deep university biological research and then, if we are lucky, it gets spun out into a company or licensed and sent to industry. If we are lucky, it will then get financed through various stages and taken through phases 1, 2, 3 and 4 of trials, with hugely costly international studies. Then it is approved as safe by the Medicines and Healthcare products Regulatory Agency or the European Agency for the Evaluation of Medicinal Products. Then it is approved by NICE as being of suitable cost-benefit for recommended use in the NHS, and then it has to be taken up by clinicians in the service.

The truth is that that model is not working well enough for anyone, but most importantly, as my right hon. Friend has pointed out, it is not working for patients. It is coming under pressure for a series of reasons, partly because the industry is struggling with the time cost of a 10 to 15-year development pipeline, leaving it with innovations it needs premium pricing for to justify the huge sunk costs at a time when we are facing a demographic time bomb. Given the rising cost of disease, we need to get maximum value out of every pound. We cannot afford to pay premium prices for every new innovation, so we need a new model.

The great challenge that that represents is also a great opportunity for this country, because the new model will be about designing innovations around particular patient groups. Yesterday, we believed that what we thought were blockbuster diseases required blockbuster drugs, but today, the more we know about disease, patient data and genomics, the more we know that certain patients respond to the same disease—and, indeed, the same drug—in different ways. If we can use that insight with industrial partners, a new generation of treatments can be designed around patient groups and introduced to them dramatically earlier, which is a completely new value proposition, principally for patients, but also for the NHS. That will allow us to become something of a partner in innovation and unlock the basis of a new model of reimbursement.

I do not pretend that that is easy, or we would be able to do it overnight. We will certainly not be able to do it by Christmas, by the election or even within a year or two. It might involve a 10-year programme of deep and long-term change, but we are definitely committed to embracing it and to laying a policy foundation for it.

I want to say something about the PPRS, because it plays a very important role in this landscape. We negotiated and agreed this important deal with the industry. It contains mechanisms for supporting innovative medicines, not least the exclusion for small companies—those with a turnover of less than £5 million—and the exclusion of new medicines brought on stream from January this year. The review we have announced—

Oral Answers to Questions

George Freeman Excerpts

Tuesday 25th November 2014 Commons Chamber

[Norman Baker (Lewes) (LD)]

5. What recent assessment he has made of the potential medicinal benefits of cannabis.

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

Cannabis is classified as a class B drug under the Misuse of Drugs Act 1971, as my right hon. Friend knows. To sell cannabis or preparations made from it as a medicinal product would necessitate obtaining a licence from the Medicines and Healthcare products Regulatory Agency. Cannabis in its raw form is not authorised as a medicinal product in the UK. However, certain cannabis extracts are contained in Sativex spray, which is the only medicine produced from the cannabis plant that is approved for use as a medicinal product in the UK. It is licensed for use in treating spasticity in multiple sclerosis and was approved in June 2010.

[Norman Baker]

Over the last year or so, I have met a number of credible people from all walks of life and with a range of medical conditions who have told me that the only substance that helps their medical condition is cannabis. However, they cannot secure it through the NHS and they risk getting a criminal record if they try to obtain it for themselves. Will the Minister look at the much wider availability of cannabis for medicinal purposes in other countries and try to find a way to help those in need in our country?

[George Freeman]

As a former Home Office Minister, the right hon. Gentleman will be aware of the difficulties of getting this policy right. I do not believe that anyone in the House thinks that we ought to allow the prescription of a controlled substance willy-nilly without good evidence. I should like to draw his attention to this evidence from Cancer Research UK, which states:

“At the moment, there simply isn’t enough evidence to prove that cannabinoids—whether natural or synthetic—work to treat cancer in patients, although research is ongoing. And there’s certainly no evidence that ‘street’ cannabis can treat cancer.”

We continue to keep this matter under close observation, and there is good evidence of science being done by companies and by the National Institute for Health Research.

[Ian Austin (Dudley North) (Lab)]

Has the Minister assessed whether the use of cannabis can result in paranoid and deluded behaviour, leading people to believe, for example, that it is possible in this country to mount a huge conspiracy to pervert the course of justice involving the police, the ambulance services, the security services, the Government of the day and the media, and to pretend that someone who had killed themselves had actually been murdered?

[George Freeman]

The hon. Gentleman makes an interesting parliamentary point, but my responsibilities cover only the licensing of cannabis for medicinal purposes.

[Mark Pritchard (The Wrekin) (Con)]

Cannabis no doubt has some limited medicinal benefits for some illnesses, but will the Minister put it on record that it is not the Government’s intention further to liberalise any licensing of cannabis, especially in the light of the Institute of Psychiatry’s empirical evidence that abuse of the substance can lead to severe mental illness?

[George Freeman]

My hon. Friend makes an important point, and I am happy to give him that undertaking. We have to be careful to maintain a distinction between recognising the damaging effects of the recreational use of cannabis and the specific medicinal benefits of some of its derivatives, when tested and proven, in medicinal products. We intend to make that distinction very clear.

[David T. C. Davies (Monmouth) (Con)]

6. How many patients have received treatment through the cancer drugs fund since the inception of that fund.

--- Later in debate ---

[Andrew Stephenson (Pendle) (Con)]

8. What steps his Department is taking to accelerate access to innovative medicine and health care technology in the NHS.

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

Accelerating access for patients to innovative medicines and health care technology is central to my mission as the UK’s first Minister for life sciences. Breakthroughs in genetics and the use of data are unlocking a new era of precision medicines, earlier diagnosis and remote monitoring, which can dramatically improve patient outcomes, and the efficiency of our health service. That is why I announced last week a major review of the role of the regulators, the Medicines and Healthcare Products Regulatory Agency and the National Institute for Health and Care Excellence, in accelerating innovation in the NHS.

[Andrew Stephenson]

I know that the Secretary of State has already visited Airedale general hospital to see its telemedicine service. Earlier this month, I visited Marsden Grange care home in Nelson to look at the service from a patient’s perspective. The service is reducing pressure on the ambulance service, local GPs, A and E departments, and, crucially, improving patients’ experiences. How can we ensure that telemedicine is much more widely used?

[George Freeman]

My hon. Friend makes an excellent point. As with Airedale, the Marsden Grange care home initiative shows that we can improve patients’ outcomes, deliver more health for the same amount of money and make our system much more efficient. That is why we so strongly support telemedicine, why NHS England has undertaken a rapid review of the 3 million lives programme and why, last week, we launched our review to accelerate the adoption of innovative med-tech and e-health technologies into the NHS.

[Mr Barry Sheerman (Huddersfield) (Lab/Co-op)]

What is the good of innovation if we do not use it? For the 1 million people who suffer from atrial fibrillation, the three new NICE-approved drugs are a life saver; they make life worth living. But only about 6.5% to 7% of people have been prescribed the new drugs, as they are being blocked by clinical commissioning groups and GPs. What will the Minister do about that?

[George Freeman]

The hon. Gentleman is right to raise the matter. We have all seen it coming in recent years. Extraordinary advances in science are developing a huge range of new products, which our system is having to adjust to cope with, and that is precisely why I launched the review last week with NICE and the MHRA. We must look at these transformational technologies that bring new opportunities to our services and at how we can design a system that is better able to target innovations to the patients who need them.

[Mark Menzies (Fylde) (Con)]

18. Dementia is an abhorrent disease that affects thousands of people across the UK, and a significant number in my constituency of Fylde. With that in mind, what steps is the Minister taking to ensure that dementia sufferers have access not only to the most innovative medicine but to the most advanced early diagnosis?

[George Freeman]

My hon. Friend makes an important point. Dementia is one of those diseases where the loved ones and the carers of patients often suffer every bit as much as the patients. That is why, under the Prime Minister’s leadership, we have launched the G8 dementia summit to bring together the world to tackle the disease. We have launched a dementia strategy. Diagnosis rates in Britain have gone from 42% to 55% in two years. We have launched a new dementia service and doubled research spending. We will have 250,000 staff trained by next March, and, from April, we will be investing £3.8 billion into the Better Care fund. It is an important disease that deserves our priority.

[Lilian Greenwood (Nottingham South) (Lab)]

The Ear Foundation recently published a report that estimates that the real cost of adult hearing loss is at least £30 billion a year. I hope that the Minister has read it. What is he doing to ensure that adults who could benefit from improved hearing technologies, including cochlear implants, do so, and when does he plan to publish the action plan on hearing loss that has long been promised?

[George Freeman]

I am not aware of the veracity of the £30 billion figure, but I will happily look at it, and I happily undertake to look at the progress of the report and the work that the hon. Lady raised.

[Mr Adrian Sanders (Torbay) (LD)]

20. It is a well-established fact that type 1 diabetics who have insulin pumps are much more able to control their condition than those who do not, yet the take-up of insulin pumps in the UK compared with Europe and America is pitiful. What is the Department doing to increase the commissioning of insulin pumps? In the long run, the costs go down with better control.

[George Freeman]

My hon. Friend raises a important example of an innovation that, despite costing a little extra at the beginning, saves substantially downstream. One of the challenges in our national health service is tackling a series of ways in which the system is not well geared to incentivising such innovations. NHS England recently set out its five-year forward view, which has, for the first time, a strong commitment to tackling such issues, and we are working with it to see what we can do to remove barriers and promote incentives for earlier adoption.

[Mr Russell Brown (Dumfries and Galloway) (Lab)]

What steps are being taken to ensure that emerging treatments for Duchenne muscular dystrophy that receive conditional approval are available through the early access to medicines scheme as early as possible?

[George Freeman]

I was delighted, when we launched the early access to medicines scheme earlier this year, to see the very strong support that we got from the Duchenne dystrophy group. Dystrophy is one of those terrible diseases that desperately need the fast-tracking of new medicines. As I said, last week we launched a major review of our landscape for the earlier adoption of innovative medicines in the NHS, so that patients in the most severe clinical need can take part in cutting-edge research and we get drugs to patients more quickly.

[Mark Durkan (Foyle) (SDLP)]

9. What recent representations he has received on access to off-patent drugs; and if he will make a statement.

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

The hon. Gentleman will be aware of the debate in the House two weeks ago in which I gave a very full statement of the Government’s position on off-patent and off-label drugs. We want to promote their wider use, but we do not believe that the Bill presented to the House is the right mechanism for achieving that.

[Mark Durkan]

Will the Minister borrow from the approach taken with the Medical Innovation Bill, and commit to consulting on whether the Government should support, or how they might pursue, the key purposes of the Off-patent Drugs Bill?

[George Freeman]

As I said in the debate, we absolutely support the Bill’s intention, which is to promote the greater use of off-label and off-patent drugs, but that must remain a decision for clinicians exercising their judgment about what is best for their patients. We do not think it right that the Government should be put in the position of effectively sponsoring new drug licence applications to the Medicines and Healthcare Products Regulatory Agency. I have convened a round table working group with all the stakeholders to try to look at how we can maximise information to clinicians to promote the use of off-label and off-patent drugs.

[Mr David Crausby (Bolton North East) (Lab)]

10. How many (a) NHS trusts and (b) foundation trusts are forecasting a deficit.

--- Later in debate ---

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

I pay tribute to my hon. Friend for his tireless campaigning on the issue of cancer drugs. I can assure him that the cancer drugs fund now administered by NHS England continues to fund effective cancer drugs which have been not been recommended by the National Institute for Health and Care Excellence. Over 60,000 patients in England have benefited from the fund since October 2010. That is why we announced a £160 million boost to the fund earlier this year.

[Eric Ollerenshaw]

Will my hon. Friend look again at the CDF’s proposal to delist 42 cancer drugs, including Abraxane, which was put on the list only nine months ago and is the first new drug in nearly 40 years to produce an extension of life for pancreatic cancer patients?

[George Freeman]

I am grateful to my hon. Friend for his notice. I have spoken to NICE. It is appraising the use of Abraxane for pancreatic cancer and has not yet published its final guidance. It would not be appropriate for me to intervene at this point. Obviously, we respect NICE’s clinical independence. Abraxane is available through the CDF for patients meeting specific clinical criteria. I understand that the NHS England’s CDF panel plans to reassess the inclusion of Abraxane in the national list, but no decisions have yet been made.

[Mr Jamie Reed (Copeland) (Lab)]

It is a pleasure to follow the hon. Member for Lancaster and Fleetwood (Eric Ollerenshaw). Everyone in every part of the United Kingdom wants to improve access to cancer medicines. When the Prime Minister launched the cancer drugs fund in the home of Clive Stone, he promised to get

“more drugs to people more quickly”.

Mr Stone recently criticised proposals to remove a number of drugs from the fund, writing in his local newspaper that

“People are going to die, there is no doubt about it. Why don’t people keep their promises?”

Additionally, the Breakthrough Breast Cancer campaign has said that it is

“deeply concerned that several very effective breast cancer drugs appear on the list of drugs at risk of delisting”.

We all know someone affected by cancer in some way. What does the Secretary of State have to say to those patients relying on those drugs that are being removed from the fund?

[George Freeman]

The first thing I would say is that we have given an undertaking that any patients currently on drugs will not have the drug removed. Secondly, we are dealing with some very difficult issues. We have had extraordinary breakthroughs in the progress and rate of development of new cancer drugs, and we need to have a system for ensuring that the cost-benefits—the health economics—are done properly. NICE leads the world in making these difficult clinical judgments and we support its independence in doing so, but we need to ensure that we are not turning this issue into a political football. I notice that the shadow Health Secretary said that this was good politics but not good policy. It is really important that we ensure that when we set a benchmark on this debate we are guided by what is best for patients.

--- Later in debate ---

[Greg Mulholland (Leeds North West) (LD)]

My constituent, six-year-old Sam Brown, is one of 100 people with the rare disease Morquio. His family live in a state of anxiety because they do not know whether the drug Vimizim will be approved for further use on 15 December. Will a Minister please meet me and Katy and Simon, Sam’s parents, to give Sam the Christmas present he needs and to keep Sam smiling?

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

I would be delighted to meet my hon. Friend and his constituents to review that very important issue.

[Mark Reckless (Rochester and Strood) (UKIP)]

Last month one patient waited 35 hours in Medway’s A and E, and in the past year 10 patients have waited more than 24 hours. I was grateful to the Secretary of State for taking up my invitation to visit the hospital. What progress has been made specifically on turning around the A and E department?

Health and Social Care (Safety and Quality) Bill: Money

George Freeman Excerpts

Tuesday 25th November 2014 Commons Chamber

[The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)]

I beg to move,

That, for the purposes of any Act resulting from the Health and Social Care (Safety and Quality) Bill, it is expedient to authorise the payment out of money provided by Parliament of any increase attributable to the Act in the sums payable under any other Act out of money so provided.

I will, if I may, pay tribute to my hon. Friend the Member for Stafford (Jeremy Lefroy) for his tireless work on this Bill, particularly for his championing of the cause of information sharing, which sits right at the heart of the Government’s commitment to transparency in health care.

Question put and agreed to.

Innovative Medicines and Med-tech Review

George Freeman Excerpts

Thursday 20th November 2014 Written Statements

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

I am today announcing an external review of the pathways for the development, assessment, and adoption of innovative medicines and medical technology.

Technological advances including digital diagnostics, cell therapy, genomics and stratified medicines are fundamentally changing the health care landscape and the way in which these advances are developed and utilised. These advances have real potential to transform prevention and treatment, improving patient outcomes. Yet they are increasingly challenging traditional systems of regulation, assessment and adoption, the subject of growing public and professional debate.

The innovative medicines and medical technology review will consider how our health care and regulatory systems can best respond and adapt to this new landscape of innovation. We are strongly placed to do this: our £1 billion National Institute for Health Research programme provides a platform for testing and evaluating medical innovations, and we have internationally—renowned expertise in evidence—based assessments of the health economics of drugs and devices.

The review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices. It will focus on innovative types of product: in particular, drugs based on stratified medicine, new diagnostics, and digital health technologies. It will examine the pathway from “first in human” trials, through licensing and health technology appraisal, to commissioning, reimbursement and clinical practice. It will set out both short and long-term options for action by Government and relevant bodies—including the National Institute for Health and Care Excellence, Medicines and Healthcare Products Regulatory Agency and NHS England.

We expect the review to recognise the public spending environment in which the NHS operates, and the overriding need to ensure value for money. It will respect the parameters of the 2014 pharmaceutical price regulation scheme for branded medicines, and take account of the existing statutory responsibilities of NHS bodies and the European legislative frameworks for the regulation and procurement of medicines and medical technologies. It will start early in 2015 following the appointment of an independent organisation to lead the work, and report back in the summer.

Health Services (Halifax)

George Freeman Excerpts

Thursday 20th November 2014 Commons Chamber

[The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)]

I congratulate the hon. Member for Halifax (Mrs Riordan) on securing this debate. I know that this is an issue of concern to her and to my hon. Friend the Member for Calder Valley (Craig Whittaker), as well as to a number of other Members locally. The issues around proposed changes to health services in Calderdale and Huddersfield have been debated in this House before.

Of course, the configuration of health services is an important issue for many Members and their constituents. We all agree that patients should receive the best and safest care possible. I know these issues are of keen interest locally, with Members from across the political parties taking a close interest in the changes. People always worry about any change in the NHS, because it is such a loved and respected institution. However, it is not right to play on these anxieties. Change is necessary to ensure that the NHS can offer modern, high-quality care fit for the 21st century.

It is slightly disappointing that the hon. Lady has adopted such a partisan approach. In the period running up to an election, NHS reform is not well served by party politics, and I note the hon. Lady’s refusal to accept interventions from my hon. Friend the Member for Calder Valley. I think we need to hear from people on both sides of the House. I have taken the trouble this week to talk to staff and doctors at the front line locally who are leading the work on this issue, to hear from them what they are planning and what they hope to achieve. I hope that hon. Members, including the hon. Lady, take the time to do the same; I know they would appreciate it.

Let me say a few words about our general approach to reconfiguration before touching on the specifics of the case. The Government are clear that the design of front-line health services, including A and E, must be a matter for the local NHS. It is local clinicians—not me or anyone in Whitehall—who will make decisions about health care in Halifax. That is how it should be. The NHS has a responsibility to ensure that people have access to the best and safest health care possible, and to plan for the future to ensure that safe and sustainable services are available to all patients now and in generations to come.

Reconfiguration is about modernising the delivery of care and facilities to improve patient outcomes, to develop services closer to home and, most importantly, to save lives and improve patient safety. That is why we must allow the local NHS continually to challenge the status quo and look for the best way of serving patients. All these service changes are being led by clinicians and are based on a clear, robust clinical case for change that delivers better outcomes for patients.

The health economy across Calderdale and Huddersfield is working to develop a shared vision for the future provision of high-quality, sustainable services. This work is necessary to respond to the challenges facing the local health economy. As in many areas, the NHS in Calderdale and Huddersfield needs to adapt to an ageing population, increased prevalence of long-term and lifestyle-related illnesses, the needs and aspirations of patients and increased pressure on our public finances. The truth is that local services are currently fragmented, with some duplication and inconsistency of outcomes. There is a need to reduce preventable hospital admissions and enable and support people to live in their own homes for as long as possible. I welcome the fact that the local NHS is looking into how community and in-hospital services can be provided to deliver the best outcomes for local patients.

[Craig Whittaker]

The Minister will recall that the hon. Member for Halifax (Mrs Riordan) did not say whether she had read the strategic review of our area’s health authority, but if she had, she would have seen that it contains no proposals to close the Halifax A and E. Can the Minister confirm that?

[George Freeman]

My hon. Friend has made an excellent point. I think it important to be guided by what the local professionals—clinicians and NHS staff—are saying. I have spoken to them this week, and I can indeed confirm that there are no plans to close the A and E at present. A clinically led consultation is taking place, quite properly, and before the local NHS leadership recommends any decisions, they will be the subject of public consultation with local people.

[Mrs Riordan]

I can tell the hon. Member for Calder Valley (Craig Whittaker) that I have read the strategic review. Let me also make it clear that when the consultation began, the acute trust recommended the closure of the Halifax A and E.

[George Freeman]

As I have said, the local NHS leadership is looking at all the issues on behalf of the patients whom they are there to serve. My point is merely that playing party politics is not helpful. We need to be guided by the local clinical experts. It is important for the NHS to engage widely on the future provision of health services, and it has done that over the last three years. Thousands of local people have given their views on what matters most to them, and that feedback is shaping thinking locally.

Local clinical commissioning groups are focusing on the phased delivery of improvements in community services ahead of any changes in hospital services. Our health system is evolving to adapt to the new landscape of modern medicine, and I think it is in the interests of our patients to encourage that, provided that it is led by clinical decision making. Local commissioners recognise the need for change in hospital services, and I suspect that, as a user, the hon. Lady would recognise that as well. The local NHS believes that the way in which services are currently organised in Halifax does not deliver the safest, most effective and most efficient support to meet patients’ needs. Patients rightly expect that when they see the initials “NHS”, they can expect the very best service that is available, and when they do not receive that service, it is incumbent on the system to adapt so that they do.

The trust is affected by shortages in middle-grade doctors and the high use of locums in A and E, which has an impact on the safety of patient care, and difficulties are involved in providing senior consultant cover overnight and seven days a week. Those are classic problems, which often affect smaller hospitals. We need to ensure that we are delivering the very best care to our patients.

There is often a need for inter-hospital transfers owing to the lack of co-location of first-class services on both sites. The co-location of emergency and acute medical and surgical expertise can result in significant improvements in survival and recovery outcomes, most notably for stroke and cardiac patients. Those who are most seriously ill, with life-threatening conditions, have a much greater chance of survival if they are treated by an experienced medical team that is available 24/7.

It is right for the local NHS to address those challenges to ensure that it can continue to deliver safe, sustainable, high-quality services. Heaven forbid that the hon. Lady should fall ill and require any of those services, but I am sure that, were that to happen, she would want to receive the very best care, and that if that were available in Huddersfield, she would want to be treated in the best possible place. To that end, Calderdale and Huddersfield NHS Foundation Trust has considered a number of options for the future delivery of services, one of which involves one hospital delivering planned care and the other delivering unplanned care. At this stage, no proposals have been ruled in or out. Preferences have been expressed in regard to how services can best be delivered, but no decisions have been made, and I can confirm that there are no formal proposals for changes in hospital services.

In August, the local CCGs decided to delay public consultation on hospital services. While they are signed up to the need for change, they have chosen first to focus on the delivery of improvements in community services in order to build confidence in the changes and demonstrate to local people the benefits they are confident they will deliver. That seems to me entirely appropriate. The CCGs are following a process of change. They understand the need to take people with them, and to build confidence in the changes that they propose. It is incumbent on all Members to encourage and support our NHS leadership locally in building that public confidence in the services.

Change can be difficult to explain to patients, particularly the most vulnerable and elderly patients whose focus is, rightly, on the immediate availability of care. Patients’ reasonable anxieties are often exacerbated by speculation in the media about potential changes and their possible local impact. Services are sometimes described as closing when in fact they are simply being provided in a neighbouring facility or changing for the better in response to advances in treatment.

I know that local people care deeply about the future of their local health services and will want to be involved in decisions about the future of their local hospitals. This is, and should be, a locally led process. Local people should continue to make their views known to those developing proposals for the future of local services, as they have done throughout the engagement process. I also want to encourage them to listen to the reasoning behind any proposals from local NHS clinicians and management for any service changes. I encourage the hon. Lady to work with the local NHS as it further develops its proposals. I know that the CCGs have met hon. Members and are happy to continue to do so.

When talking about potential changes to hospital services, it is important to remember that it is the services, the people and the co-ordination—not the bricks and mortar—that really matter in getting people the right care at the right time. The flexibility and co-ordination of services are just as important as how they are geographically configured. In supporting our local NHS we often end up supporting the current institution—the building in its present location and configuration—but we need to allow the service to evolve and allow our local clinicians and NHS leadership to develop the best possible provision for the people it is designed to serve.

The NHS is one of the great institutions in the world; it is one of this country’s great legacies. Ensuring that it is sustainable and that it serves the best interests of patients sometimes means taking tough decisions. Freezing a service in aspic out of love for it will not allow the NHS to develop and maintain its leadership in the provision of 21st century health care. These decisions are made only when representatives of the local NHS, working in collaboration with local people and local authorities, are convinced that what they are proposing is absolutely in the best interests of their patients.

I make no apology for the fact that it is this Government who have taken these decisions out of the hands of the politicians and the mandarins in Whitehall and put them into the hands of local clinicians and local NHS managers who have the interests of local patients at heart and who are driving those decisions in their interests. It is important that the NHS in Calderdale and Huddersfield develops solutions that will allow it to provide high quality, safe, effective and sustainable services to local people for generations to come.

[Craig Whittaker]

I recall when the Labour Government took the acute services from Halifax and sent them to Kirklees in 2005. I campaigned strongly against that at the time, but I was wrong because it appears that we now have a greater life-saving institution locally. Can the Minister tell me whether there is any evidence around the country that having specialists in one place, rather than having them split between several sites, does in fact save lives?

[George Freeman]

My hon. Friend makes an important point. There is a huge amount of evidence—which the Department is keen to publish and disseminate in order to inform the debate—that in many areas, particularly in relation to respiratory and cardiac conditions and to diabetes, the centralisation of services in specialist centres drives up clinical outcomes, improves patient safety and prevents avoidable death. Patients have a right to expect us to put in place a framework that allows the NHS to evolve. We need to find ways of ensuring that those services that are best provided locally—community-based services—are provided in that way, and that those requiring increased specialisation in centres of excellence and expertise that operate 24/7 are also available. That is what the local NHS leadership is endeavouring to do, and we should support them in that because it is in the interests of the patients, whose NHS this is.

Question put and agreed to.

Off-patent Drugs Bill

George Freeman Excerpts

Friday 7th November 2014 Commons Chamber

[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.

[Mr Chope]

I am listening intently to what the Minister is saying. Is he concerned that he has not persuaded a whole host of clinicians and medical charities of his case?

--- Later in debate ---

[George Freeman]

I am not sure it is quite as simple as that. There is a significant and substantial ongoing series of discussions in the sector at the moment on issues such as the cancer drugs fund, specialist commissioning and whether we should be ring-fencing different medicines and therapeutic areas. The truth is, for reasons I described earlier, that the landscape is changing dramatically. I totally understand that charities that rightly support greater use of off-label medicines would like to think it is possible for us to legislate for these drugs to be put into use, but from the conversations I have had, it is apparent that clinical opinion is very varied. Nobody I have spoken to in the clinical profession wants the Government to go down the slippery road of starting to legislate for particular uses of particular drugs, which is effectively what this mechanism seeks to begin to do.

I commit today to working with NHS England, the MHRA, NICE and patient and professional groups to explore in depth the issues around the cultural challenges on unlicensed and off-label prescribing in general. We know that we need to look at the issue of clinical leadership. We need to take steps to improve how new evidence is translated into prescribing practice, and how hospitals and GPs work together and how that works within the care pathway. I am absolutely committed to doing what needs to be done and what can be done now within the existing system, and to looking at the evidence to ensure we adopt the approach most likely to succeed. Most trusts have robust governance arrangements set up to consider innovative treatments that clinicians may want to prescribe. A trust’s drug and therapeutics committee, or indeed the clinical ethics committee, provides an opportunity for doctors and pharmacists to explore the clinical and patient safety implications of doing so.

I am delighted to confirm that we have begun to work with NHS England and other stakeholders including NICE to get a handle on this and to accelerate the use of off-label drugs. I restate the invitation to interested Members to come and join the project. We are absolutely committed to looking at why there may be delays in translating new evidence and research into clinical practice, including why some clinicians are reluctant to prescribe drugs outside of their licensed indications when many others are not, and to consider what further arrangements might be put in place to assist in implementing new evidence into care pathways. This is a problem we face across the system, with variable uptake of NICE guidance. It is one of the central objectives of my new role in the Department of Health to drive consistency of uptake across the system.

I believe this offers the prospect of a more appropriate, sustainable and rapid approach to this problem that can apply to a range of different drugs and clinicians.

[Mr Nuttall]

The Minister has just used the word “rapid”. How quickly will these drugs become available?

[George Freeman]

I am not clear which particular drugs my hon. Friend is referring to, but let me answer in a generic way. I would like us to become a place where, instead of it taking 10 or 15 years and $1 billion to bring innovative drugs to market, we use the NIHR platform and our investment in genomics to become a country where for some cancers we could be getting drugs to the most needy patients through the early access to medicine scheme that I have been championing and that the Department launched earlier this year. Potentially, we could be getting drugs to patients five, six, seven or eight years earlier than would normally be the case through the traditional model of phase one, two, three, four.

[Jonathan Evans]

The drugs the Minister is talking about are new drugs. They are not a mechanism for using existing licensed drugs for which the patent has expired, which, under current circumstances, are not being prescribed to people who need them. That is what this debate is about.

[George Freeman]

I well understand that. The off-patent is a distraction; it is the question of off-label. The truth is that clinicians are free today to do it. My hon. Friend’s point about timing is very well made. I would merely say that at this stage, with the working party I am putting together and the strategy I would like us to launch—I would very much appreciate his input—I think we should be looking at setting some very clear goals and targets for speeding up that use. In particular, we should ensure that where there is evidence of an innovative and new use for an existing drug off label and there is good evidence to suggest it, we roll it out across the system. It is both the speed of first adoption and the speed of roll-out across the system.

This offers the prospect of a more appropriate and sustainable approach that can apply to a range of different drugs. We can use it to tackle this problem much more quickly and to get new drugs into use much more effectively. More specifically, we are looking to gather further evidence around potential barriers by focusing first on NICE’s updated guidelines on familial breast cancer, through the NICE associates network, and asking it further to promote its implementation. I will also ask NICE whether it would be prepared to use one of the patient decision aids it is piloting for further support.

To draw all the strands together and look at the issues at national level, we plan to arrange a national round table of the key stakeholders to be co-hosted by my Department with NHS England and NICE. We intend to use the initial meeting to identify what the various participant stakeholders might usefully do to help to address the cultural and clinical leadership issues and what other practical steps might help. The request I make to those who support the Bill is that we review the need for any further guidance or legislation in the light of that work when it has been completed. I am delighted to extend an invitation to my hon. Friend to be a part of that.

In conclusion, I very much appreciate the points that have been made today. I recognise the very real concerns that have led to the drafting of the Bill. I am absolutely committed to investigating and getting to the bottom of the reasons why new evidence is not being picked up and implemented consistently, as well as why some clinicians may be reluctant to prescribe in this way, and, crucially, the important role of NICE in supporting that with updated guidance. I am committed to doing so with the involvement of all interested parties.

The Government remain firmly of the view that improvement in this area can best be achieved through a combination of measures, and that resorting to legislation to demand regulatory measures is not a magic bullet. It will not solve the issues we believe are actually responsible for this problem, and it carries the risk of some serious and unintended consequences. It is for those reasons that the Government cannot support the Bill. However, I reiterate that we support the intention of promoting greater use of off-label medicines. We are committed to looking seriously at this and to launching a strategy and a work plan, with specific targets for increasing the rate of use of off-label medicines, with all the key agencies and to invite stakeholders in the sector, in particular medical research charities and the AMRC, to help us with that. New uses for existing drugs is something we actively support. The truth is that, as much as we would love to, we could not and should not go down the slippery road of starting to legislate for the use of medicines that should be, and are rightly, a matter for clinicians.

[Jonathan Evans]

I thank all who have contributed to the debate, including the Minister. In fact, other than the Minister everybody has spoken in favour of the proposition contained in the Bill. I am especially grateful to my hon. Friend the Member for Bury North (Mr Nuttall), who has been involved from the inception in supporting the Bill. I am grateful for the intervention of my hon. Friend the Member for Christchurch (Mr Chope), who has been such a source of great support in this process, which, even after 22 years, is relatively new to me. He, of course, is something of a Friday expert. I am also grateful to my hon. Friend the Member for Beckenham (Bob Stewart) for his interventions and his clear articulation of support for the Bill. Let me also thank the shadow Minister and those on the Labour Benches who have made it clear to me and to the charities their complete support.

The problem is that the Government take one view on the Bill, whereas charities, clinicians and others are saying that the current situation is unacceptable. It is not good enough to argue against going down the road of legislation, given that we already have a legislative process for licensing. For instance, it is the law that if a drug has not had a licence, it cannot be effectively marketed in the UK. The reason GPs often do not routinely prescribe life-saving medicines is that the rules in essence make it illegal to market them in that way. It is not surprising, therefore, that GPs, given that legislative background and the litigious world of the medical and legal profession, decide to avoid something unless it is licensed. It is not as though the charities sector has not provided the Department with a welter of information on why GPs are not doing it. The lack of licensing is at the core of it.

As the Minister knows, I respect him and his background career, and we have had several conversations about the Bill, but the proposition that passing the Bill would damage the current situation is simply laughable. I do not know who wrote that line for the Minister, but that proposition needs to be re-examined. Nothing in my Bill would cause a GP to say, “Well, actually, I was going to prescribe something, but I’m not going to now.” With due respect to him, that was the weakest of his arguments.

We heard earlier from the Labour Benches that several colleagues have received representations on the Bill from a wide coalition of charities covering a range of medical conditions. Yesterday, I spoke to several of my colleagues on a day trip to a constituency in southern England, and everyone spoke of having 50 or 60 constituents urging them to support the Bill and of being pleased to have received a response saying that the Government were speaking to me as the Bill’s promoter. Many people interpreted that to mean that the Government would be broadly supportive of the Bill.

For that reason, I am deeply disappointed to hear now that the Government are opposed to the principle of the Bill. I do not need to rearticulate its provision—it is a very simple Bill—but it says that in the absence of somebody applying for a licence, the Secretary of State has the duty to make that application or to appoint another public body to do it. Thereafter, the Bill makes provision for the drafting of regulations that present widespread opportunities for the Minister to address his concerns.

[George Freeman]

To clarify, we agree with the objective of the Bill, which, as I understand it, is to get greater off-label use of medicines for new indications, but we disagree about the mechanism. The Bill is very clear on the mechanism: it is to pass legislation to require the MHRA to issue licences. We believe that this is the wrong solution, but we are in alignment on the problem that needs to be solved.

[Jonathan Evans]

That is very helpful. I have always understood that a Second Reading debate is on the principle of the Bill; we then deal with the detail in Committee, and then we proceed to Report. Ever since I was first elected 22 years ago, that is how I have understood it to work. If my hon. Friend is saying, “We are not against the principle, but against the mechanism”, that is a reason to support the Bill on Second Reading and then to debate in Committee how we adjust it to take into account his concerns.

[George Freeman]

I congratulate my hon. Friend on making an extremely eloquent argument, but I cannot let that go. The point is that the principle to which we object is the passing of legislation to require the MHRA to issue licences. That is more than a vague guiding philosophy; it is the mechanism suggested, and that is why we are opposed to it. I genuinely believe we will make more progress in the next few months using my office and the organisations for which I am responsible, working with the supporters of the Bill, to drive forward these measures.

[Jonathan Evans]

So we are back to the Government being opposed to the principle of the Bill. It might have helped if Ministers had said, in response to those Members who wrote to them saying they were aware of my Bill, that they were opposed to the principle, as we have just heard from the Minister. Members were led to believe that the Government were not against the principle but were discussing these matters and that we might ultimately reach an accommodation. Now we understand that the Government are opposed to the principle.

The principle is one advanced by the clinician community and the AMRC and supported by editorials in leading newspapers in the UK this week. It is not surprising that almost every leading newspaper has urged the Government to pay attention to the arguments. The hon. Member for Copeland (Mr Reed) highlighted how people outside the House look at what we do here. As I said in my opening remarks, it is important that we pay attention to the clinician community and the AMRC. For that reason, I hope the House will support the Bill.

Question put, That the Bill be now read a Second time.