Oral Answers to Questions
George Freeman Excerpts(9 years ago)
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Maggie Throup (Erewash) (Con)
3. What steps the Government are taking to improve diagnostic testing in primary care.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
The Government are determined to improve and invest in diagnostic testing in primary care. Diagnostics and breakthroughs in innovative diagnostics are key to a 21st-century NHS. That is why we have set up the medical technology strategy group, which I chair, to look at accelerating diagnostics into the system; the cancer strategy taskforce; the Prime Minister’s GP access fund; the new models of care programme; and the accelerated access review, which is looking to accelerate those diagnostics with particular value to patients and the system. We have also introduced the new guidelines for the National Institute for Health and Care Excellence, and, through the genomics programme, we are investing in 21st-century molecular diagnostics, which will come to shape the future.
Maggie Throup
C-reactive protein point-of-care testing could reduce the number of prescriptions for antibiotics, contribute to the UK’s anti-microbial resistance strategy, and save the NHS millions of pounds each year. Ahead of my Adjournment debate on this issue next Monday, will the Minister agree to look at this type of testing as a way of saving the NHS money and providing appropriate patient treatments?
George Freeman
My hon. Friend makes an excellent point. We are completely committed to tackling anti-microbial resistance, and reducing the volume of antibiotics prescribing is vital to that. We are a world leader in this field in tackling AMR. We have an expert group looking at how to improve diagnostic services in relation to AMR, and it has already identified what diagnostics are currently in use and what new technologies are on the horizon, including C-reactive protein point-of-care testing. The group is currently formulating conclusions. The public health Minister, my hon. Friend the Member for Battersea (Jane Ellison), is looking forward to responding to my hon. Friend’s debate on Monday to set out more of the detail.
Mr John Baron (Basildon and Billericay) (Con)
The Government have done a very good job in getting one-year cancer survival rates into the DNA of the NHS as a means of encouraging clinical commissioning groups to promote earlier diagnosis—cancer’s magic key. Does the Minister agree that we all need to ensure that we keep the CCGs’ feet close to the fire as regards these one-year figures so that we do not just improve diagnostic testing in primary care, but improve screening rates, GP referral rates and awareness campaigns as a means of ensuring that we save the thousands of lives that are needlessly lost through late diagnosis?
George Freeman
My hon. Friend is absolutely right. I pay tribute to his work on this through the independent cancer taskforce. The aim is to save 30,000 more lives a year by 2020. We are working with Harpal Kumar and Cancer Research UK on implementing its recommendations. NICE has set out new guidelines on clear ambitions and standards on how quickly patients should be referred for diagnostics. There is good news in that in 2014-15, compared with 2009-10, over 4.3 million more imaging and endoscopy tests were commonly used to diagnose cancers, but I agree that we have much more still to do.
Simon Danczuk (Rochdale) (Lab)
4. What steps he is taking to reduce suicide rates.
Jo Churchill (Bury St Edmunds) (Con)
7. What progress has been made by Genomics England in making the UK the world leader in genomic medicine.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
The Genomics England project, which was launched by my right hon. Friend the Prime Minister, has electrified the global life and health science community. We are the first nation on earth to commit to sequencing 100,000 entire genomes of NHS patients, which will be combined with patient records to unlock NHS and UK leadership in the fast-emerging field of genomic medicine, focusing initially on rare diseases and cancer. I am delighted to report that we have the genomes of 5,000 patients fully sequenced and that 11 genomic medicine centres have been set up. We have identified first diagnostics and treatments for some rare diseases; 2,500 researchers are involved in the project; the cost of sequencing a genome has fallen from £5,000 to £1,000; and, importantly, NHS England is setting the international standard on ethics and patient consent in genomic medicine.
Jo Churchill
Does the Minister agree that the world-leading Genomics England will deliver a personalised and patient-centred revolution in modern healthcare by combining the talent of global companies such as AstraZeneca with that of UK-based companies such as Congenica in my region, to the benefit of patients with cancer and other rare diseases, the vitality of our NHS and, through jobs and innovation, the strength of our economy?
George Freeman
My hon. Friend makes a great point. I pay tribute to Congenica, a small company in Cambridge that is doing extraordinary work. I recently went to open Illumina’s global research and development headquarters, which is a £160-million commitment. As well as the significant investment in technology and research in the UK, NHS England is leading genomic medicine across the UK, not just in the Oxford-Cambridge-London triangle, but through 11 genomic medicine centres across the country, which are bringing genomic diagnostics to the benefit of us all.
John Pugh (Southport) (LD)
The Minister will know of the case of one-year-old Layla Richards, who was saved from leukaemia by genome editing at Great Ormond Street hospital. What specific help does he give for such hands-on pioneering work?
George Freeman
The hon. Gentleman makes an excellent point. Genome editing is the latest in a suite of technologies that is rapidly emerging in genomics. Through the Genomics England programme, we are actively supporting those tools and intermediate technologies, and through the accelerated access review that I have launched, we are looking to harness those breakthroughs to support new treatments and new flexibilities for the National Institute for Health and Care Excellence and NHS England on targeted treatments.
Oliver Colvile (Plymouth, Sutton and Devonport) (Con)
8. What progress he has made on implementing a new contract for junior doctors; and if he will make a statement.
Access to Medical Treatments (Innovation) Bill (Money)
George Freeman Excerpts(9 years ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
I beg to move,
That, for the purposes of any Act resulting from the Access to Medical Treatments (Innovation) 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.
The House debated the Access to Medical Treatments (Innovation) Bill on Friday 16 October, when it received its Second Reading. I pay tribute to my hon. Friend the Member for Daventry (Chris Heaton-Harris) for the huge amount of work that he put in to get the Bill to a point where it can enjoy majority support in this House and the other place, and for his open approach to dealing with all the stakeholders with an interest in it.
I want to reiterate what I said on Second Reading. Although the Government support the intention behind the Bill to promote access to medical innovation—an intention which sits four-square within my ministerial responsibilities—the mechanisms of any Bill need to be considered on their merits. We are neither supporting nor opposing this Bill, but working with those with an interest in it and the sponsors to do what we can to help to get it to a place where it could contribute to the landscape for medical innovation that we are putting in place.
This money resolution is not a signal of Government support or otherwise for the Bill; it is merely a convention of the House once a Bill has received its Second Reading. We have brought forward this resolution to allow the Bill to progress to Committee stage, reflecting that convention, and the will of the House for further debate.
Dr Sarah Wollaston (Totnes) (Con)
On a point of order, Madam Deputy Speaker. Is it in order for the Government to be neutral on a Bill if the payroll vote is whipped for that vote?
Madam Deputy Speaker (Natascha Engel)
That is a matter for the Government, rather than for the Chair.
George Freeman
The debate on Second Reading raised a large number of issues, which clearly need to be addressed and I have no doubt will be addressed in Committee. We cannot second-guess where that Committee will get to or the shape of any Bill that might subsequently return to the Floor of the House.
The costs associated with this Bill, were it to be implemented in its current shape, arise from the establishment and maintenance of a database by the Health and Social Care Information Centre. Early discussions on costing with the HSCIC, which is leading on the construction of a number of databases and data streams crucial to the operation of the NHS, have provided an indicative costing of between £5 million and £15 million for developing the database of innovative medicines that the Bill anticipates.
Mr John Baron (Basildon and Billericay) (Con)
My hon. Friend has implied broad Government support for the Bill. Can he provide any evidence to suggest that litigation is preventing doctors from innovating in medical science and practice generally? That is the premise on which the Bill is based.
George Freeman
My hon. Friend makes a good point. That is the premise on which the Bill introduced by Lord Saatchi in the other place earlier in the year in the previous Parliament was predicated. My hon. Friend is right that it is a controversial proposition that fear of litigation for medical negligence is putting clinicians off innovating. The evidence that the Government received through the consultation was that some clinicians do feel that that is a problem, but very few saw it as the principal problem or the principal obstacle. A number of clinicians made the point that several factors have acted in recent decades to slow down the rate of innovative prescribing and other procedures in surgery and elsewhere, not least increasing central control of procurement from NHS England, which puts in place very tight procurement guidelines, as well as a general sense of an increasingly litigious society, which is just one of a number of factors cited in an extensive range of barriers to innovation.
Dr Philippa Whitford (Central Ayrshire) (SNP)
Does the Minister not recognise the concern of the Association of Medical Research Charities and many within the profession about what the Bill opens up? The position when I started 30-odd years ago was that doctors could do what they liked. We have spent decades protecting people, slimming down the ethics paperwork to run trials, and I do not see that the Bill is necessary. I think it is dangerous. The problem is that people think it is about access to new drugs. It is not. Any drug that is licensed we can prescribe. This says that doctors can try what they like. That is quite scary.
George Freeman
The hon. Lady makes a series of interesting points. Her criticisms would perhaps apply more to the Bill introduced by Lord Saatchi in the other House. Let me confirm that this Bill has nothing at all to do with clinical research. It is to do with clarifying the freedoms that she is right to say that clinicians enjoy today. Clinicians are free to prescribe any treatment for their patients that they feel is appropriate on the basis of the clinical evidence.
The specific problem that the Government recognise, whether or not this Bill is the appropriate mechanism to deal with it, is that in order for clinicians to feel confident in making an innovative prescription or adopting an innovative procedure, the biggest barrier is the lack of information on what innovative procedures are out there already and being used by other clinicians. It was with that in mind that the registry was originally proposed in the Bill introduced by Lord Saatchi. It was originally intended as a registry of innovative practices that clinicians adopted under the procedures in the Bill, which merely clarify the existing protections already afforded by medical negligence law. It was felt that that registry would be a helpful innovation in itself.
The Government’s view is that, as we build an infrastructure for the provision of information to clinicians to support off-label use of medicines and access to the latest information on innovative treatments, that registry could provide a much more interesting function of providing to clinicians, at the click of a mouse, an up-to-date registry of innovative medicines that are available and off-label and other treatments that other clinicians are already using. I want to stress that this Bill, which has a very different structure from the original Bill introduced by Lord Saatchi, has nothing to do with research at all. It is purely to do with supporting innovative prescribing by clinicians by providing them with information on innovations that they might consider.
Dr Whitford
Does not this undermine our existing structures of clinical research? Those protect the patient through ethics and research being reviewed, whereas this allows a couple of doctors to say, “We’re going to give you liquorice for your cancer”, and that can get put on to a database. Many in the profession are anxious about this.
George Freeman
I want to make two things absolutely clear. First, this Bill, in law, would have no impact at all on clinical research. We in the Department have been very clear about that. If it in any way changed the basis on which clinical research is regulated, it would be a very serious matter, because we lead the world in terms of our ethical and regulatory controls on research, and it is vital that we do not affect that.
Secondly, it would be a matter of very serious concern if this Bill were to undermine patient or public trust and confidence in our NHS, our research medicine and our clinical trials infrastructure. I flagged up on Second Reading the fact that I do have some concerns. Some of those relate to the way in which this debate is conducted, although I am not making any comment about the hon. Lady’s intervention. It is very important that we explain to people what this Bill does and does not do. If we mislead them, it is not surprising that we will get a lot of unnecessary fear. It is very important that we clarify that this has nothing to do with clinical research.
Dr Wollaston
Does the Minister accept, however, that the Association of Medical Research Charities, the Academy of Royal Medical Colleges, the British Medical Association, and an A to Z of other organisations involved with medical research are very clear that this does undermine participation in medical research? He should listen to those concerns and acknowledge that they are genuine.
George Freeman
Yes, indeed; I have listened. I acknowledged those concerns on Second Reading and said I was concerned about them. This is merely a debate about the Bill—there is no change in the law—and it is only this debate that is upsetting people at the moment. It is therefore very important that we carry it out in a way that makes it clear to them what this Bill does and does not achieve.
I am concerned that the passage of the Bill, the conduct of the debate, and any legislation that may survive the process of parliamentary scrutiny do not in any way undermine public or patient trust and confidence in clinical research or mainstream medicine. Were it to do so, I would be very concerned and the Government would be unable to support it. I have made it very clear to my hon. Friend the Member for Daventry that that is the No. 1 consideration, and as this is his private Member’s Bill, it is his task to get it to a point at which the Government would feel able to support it. Public trust and confidence in our NHS and in our clinical research infrastructure is crucial.
Mr Baron
May I add to the voice of my hon. Friend the Member for Totnes (Dr Wollaston) and suggest that not just the bodies she mentioned but many of the cancer bodies, charities and communities are very concerned about this Bill? Let me bring the Minister back to the issue of evidence. The pursuit of justice starts with evidence, and there is no evidence that litigation is deterring doctors from innovating. This Bill, in many respects, addresses a non-existent problem. If it is not necessary to legislate, it is necessary not to legislate.
George Freeman
As my hon. Friend knows, I have a lot of respect for his logic and his position, so let me be very clear again. As I tried to explain, I accept that if one were setting out a list of the biggest barriers to the uptake of innovation, fear of negligence would not be No. 1 on the list. However, it is equally true, as has been put to us during the consultation on this Bill, that it is a consideration. It is very important that the mechanism is proportionate to that obstacle. I think that that is the point he is really making, and I could not agree more. I signalled on Second Reading, and signal again now, that for the Government the most interesting part of this Bill is about access to information on innovative medicines and treatments for clinicians, who already have the freedom to innovate.
The second part of the Bill, as we understand it—we have taken substantial legal advice—does not in any way change the law on medical negligence; we would struggle if it did. Rather, it sets out a clear pathway for doctors seeking to enjoy the freedoms that are already in law to make it very clear what the procedure would be. People might say that these are fairly marginal improvements and ask whether they really merit the time of the House, but it is not for me to judge what is or is not an appropriate use of Parliament’s time. However, I do understand that my hon. Friend the Member for Daventry is trying to tackle, through a small measure, something that we all have an interest in, which is increasing access to innovative medicine.
The focus on provision of information that is reflected in the Bill’s new title and structure has the potential for an interesting mechanism. That is why we have looked at what the costs might be of putting such a database together. The figure that I have given is based on the understanding that further significant scoping work would be required were the Bill to become law, including consideration of the modification of existing coding systems to capture an innovation in medical notes, the data flow and the searching capability before the information centre—the HSCIC—was able to provide a robustly costed solution. Until proposed options and variables undergo additional policy refinement, including the development of a proper specification, it is not possible to offer a further estimate of supporting costs. The affordability of any specific proposal and future investment in technology more generally will also need to be considered in the light of the forthcoming spending review settlement, and the work of the National Information Board, which is putting in place a broader framework for the flow of information in the NHS.
Medical practitioners are already required to comply with the General Medical Council and BMA guidance on record keeping, and the recording of an innovation for front-line staff is therefore based on existing practice. Thus no additional costs are foreseen for medical practitioners or their own organisation. Officials in the Department of Health are currently drafting an impact assessment to examine the estimated impact of the Bill and to understand better the likely costs and benefits of the proposals.
The database proposed by the Bill—should it survive parliamentary scrutiny—may ultimately improve the flow of information to clinicians on the range of innovative treatments that are already available. Those treatments might include off-label uses of medicines, about which the House is interested in connection with another Bill. In our view, the biggest barrier to the flow of information through the system is the lack of incentives or proper reward for innovation. That is to do with how we reward patterns of activity, rather than the promotion of health and healthcare. The lack of availability of data and information is one of the biggest barriers. Subject to whatever scrutiny and changes the Bill may undergo in Committee, we think that there is a potential prize worth winning, but I appreciate that the Committee will need to go through the Bill in some detail.
Justin Madders (Ellesmere Port and Neston) (Lab)
I will not detain the House for long, as my hon. Friend the shadow Health Secretary set out in detail our concerns about the Bill on Second Reading. I will say in summary that the Opposition believe the Bill to be at best unnecessary, and at worst a danger to patients.
The Bill is strongly opposed by a number of medical royal colleges, including the Royal College of Surgeons, the Royal College of Pathologists and the Royal College of Paediatrics and Child Health. There is strong opposition from several medical research charities, including Cancer Research UK, Alzheimer’s Research UK and the British Heart Foundation. There is also strong opposition from bodies such as the Wellcome Trust, the Patients Association and Action against Medical Accidents.
Given the range and depth of concern, I do not understand how the Minister can be so comfortable in supporting the Bill, even though he contends that he is not supporting it. I ask him to reconsider the Government’s position. We will see very shortly whether the point made by the hon. Member for Totnes (Dr Wollaston) is correct, and whether the Government are as neutral on the Bill as they state.
George Freeman
The hon. Gentleman will be familiar with the procedures of the House, but I just want to confirm that once the House has given a private Member’s Bill a Second Reading, the convention is that the Government, even when they robustly oppose it, always table a money resolution so that the Committee need not concern itself with that matter. Doing so is not a signal of Government support; it is absolutely in line with the convention of the House with all private Members’ Bills, whether we oppose or support them.
Justin Madders
I am grateful to the Minister for his clarification. As I say, we shall see very shortly whether that is the case.
I understand that the part of the Bill to which the money resolution primarily relates will give the Secretary of State the power to set up a database. As the shadow Secretary of State set out on Second Reading, we consider that unnecessary because, under section 254 of the Health and Social Care Act 2012, the Secretary of State and NHS England have the power to direct the Health and Social Care Information Centre to establish and operate a system for the collection or analysis of information. I note that, in a recent letter to the shadow Health Secretary, the Minister said:
“Under section 254 of the Health and Social Care Act the Secretary of State has the power to direct the Health and Social Care Information Centre to establish and operate a system for the collection or analysis of information of a description specified in the direction.”
I understand that the Minister’s argument is that he thinks it is appropriate to give the Secretary of State an express power, but I am not convinced by that and neither are many in the medical profession, including the Royal College of Surgeons.
We believe that the Bill attempts to address a problem, namely the fear of litigation, that simply does not exist and for which the profession has provided no evidence. There is a risk that it will undermine the methodical and reasoned approach to research that already exists. In the context of the £30 billion challenge that the NHS faces and the financial problems that are taxing us all, we note that the Bill may prove to be a step in the wrong direction. We will vote against the money resolution for the Bill, and we will no doubt see what the Government make of it when they have considered their research on the costs.
George Freeman
It is not for me to defend this private Member’s Bill, promoted by my hon. Friend the Member for Daventry (Chris Heaton-Harris), but I want to deal with two or three points that have been raised in connection with the Government’s view of clinical research and patient safety, both of which are very important.
The hon. Member for Central Ayrshire (Dr Whitford) made an impassioned plea that patient safety not be undermined. I reiterate that the Bill will in no way have any impact on our clinical research approvals and ethical regulatory infrastructure, which are world-class and a much prized jewel in our crown. The Bill merely—by saying merely, I do not mean to undermine its potential impact—deals with freedoms to prescribe innovatively, which already exist and are enjoyed by clinicians. It is important that everyone understands that doctors are already free to prescribe medicines. They have sovereignty in prescribing treatment to their patients where they believe there is good clinical evidence.
The hon. Lady made a point about the importance of evidence. The part of the Bill that the Government think is of particular interest is the mechanism for accelerating the giving of evidence to clinicians on currently available innovations—both innovative medicines and the off-label innovative use of existing medicines. It is worth bearing in mind the House’s interest in accelerating off-label use through the provision of information. Patient safety and patient protection are absolutely key, and we will do nothing, and allow nothing, that undermines that.
My hon. Friend the Member for Totnes (Dr Wollaston) raised a range of concerns. They are all legitimate, but I think the place to address them is in Committee. I reiterate that nothing in the Bill will interfere in any way with UK clinical research infrastructure.
In response to the point that the hon. Member for Ellesmere Port and Neston (Justin Madders) made about whether the Government support the Bill, let me be very clear: the Government neither oppose nor support the Bill. We are prepared to work with the Bill’s sponsors to get it to a place where it supports the environment that we want to see.
On testing the will of the House, I can assure the hon. Gentleman that the Government always support money resolutions, even on Bills to which they are blatantly opposed. That is the convention, so he will be testing and proving nothing other than that we will stick to the convention of always supporting the money resolution to a Bill.
Question put.
Green Investment Bank
George Freeman Excerpts(9 years ago)
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The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)
It is a great pleasure to serve under your chairmanship, Mr Percy. We started the debate under Mr Crausby, and I nearly addressed you as him. It is a genuine pleasure to respond to the debate. We have had a gem of a debate; as other hon. Members have observed, we have covered a huge amount of ground, and I think we have covered all the main issues.
The hon. Member for Cardiff West (Kevin Brennan) rattled off a veritable machine-gun volley of questions. A bit like the football results, the answers are coming out of my teleprinter as I begin my speech, and I am confident that, by the end, I will have the detail to deal with all the questions that have been asked.
I thank my hon. Friend the Member for Beverley and Holderness (Graham Stuart) for raising this issue, which he has done with the support of hon. Members from all parties. I also congratulate him on his tenacity. He recently met my right hon. Friend the Secretary of State, along with E3G and the Aldersgate Group. He was also a distinguished member of the Committee that considered the draft Climate Change Bill back in summer 2007, and he served with great distinction for four years on the Environmental Audit Committee. He is not a Johnny-come-lately on this subject, but somebody who has been interested in it for some time.
Despite one or two of the comments made earlier, I am not filling in for anybody. I am here as a Minister at the Department for Business, Innovation and Skills, and I have a long interest in green energy. I served at the Department of Energy and Climate Change as a Parliamentary Private Secretary. In a 15-year career in investment in technology companies, I saw that this country and its economy have great strength in clean tech and green tech. As a Minister with responsibilities for science, technology and innovation at BIS, I know the Department wants to do everything it can to unlock UK leadership in the clean-tech sector. Energy costs are a major issue for UK business, and making sure we have a clean, green, lean, resilient economy for the 21st century is of strategic national interest for the Department. It is therefore a pleasure to respond to the debate on behalf of the Department’s ministerial team.
Unusually, we have the luxury of time this afternoon, although you will pleased to know, Mr Percy, that I do not intend to exceed my great-great-great-uncle Gladstone’s record of speaking for more than three and a half hours in the House. However, I do have the chance to set out the full context and to deal with all the questions that have been raised. If I fail, perhaps I can write to hon. Members to pick up any points I have missed.
I am struck by the degree of common interest among all parties in the House. Everyone present wants the Green Investment Bank to flourish and celebrates the success it has had. We start from a good place; we all want the same thing—a green investment bank that brings about growth in the sector and its activity, taking on UK leadership in that space. I congratulate and thank the chairman, chief executive and staff of the Green Investment Bank for their work. They have taken the initiative and made a great success of it. It is a tribute to them that we are engaged in a conversation about options for what we can do with the institution. We should not overlook that.
Since its establishment in 2012, the Green Investment Bank has committed more than £2 billion to 55 green projects and seven funds, and has pulled in £6 billion of additional private investment. It invests on fully commercial terms, achieving strong returns without the need for soft loans or grants. It does so because it can draw on its specialist expertise to assess commercial risks properly and to identify sound investment opportunities that can provide good commercial returns. That is how it has been able to attract new sources of finance into green sectors for the first time—by demonstrating to the wider market that investing in green can be profitable and is not the preserve only of Government subsidy. Achieving that demonstration effect and attracting new sources of private capital into green sectors are crucial since Government funding alone will not achieve the transition to a clean, green and resilient economy that we all want.
An example of the bank’s success is the important role it played in securing a £500 million financing deal for the Westermost Rough offshore wind farm off the coast of Yorkshire. That is a new offshore wind project in the early construction phase that involves the first use in the UK of new larger and more efficient turbines. It represents a step forward for that important sector. The deal demonstrates what the Green Investment Bank does well—attracting private investment into such important projects. Its leadership has helped to stimulate not just UK or European but global private interest in renewable energy. I looked earlier in the debate at the latest data from Bloomberg New Energy Finance and the eighth United Nations Environment Programme report on global trends in renewable energy investment. The sector globally was up 17% in 2014. That was the first time it was back up in four years, as it had had a quiet three years. It has now raised £270 billion for green energy globally. Renewable power, excluding large hydro, around the world, has gone from between 8% and 8.5% to just over 9%, so there is success globally.
In the UK between 2010 and 2014 we raised £42 billion in the green energy sector and renewable electricity generation has gone from 6% to 19%. That is a stunning achievement in anyone’s books. There are 11,550 firms here in the supply chain, with 460,000 employees. Since 2010, on average, if the peaks and troughs are evened out, more than £7 billion a year has been invested in UK renewables, and renewable energy capacity in the UK trebled between 2010 and 2014. That is in no small part because of interest in the Green Investment Bank and the work that it has done.
Caroline Lucas
I apologise to the Minister because I have another meeting and so will not be able to hear his full reply now; but I will check it in Hansard later. I am sorry.
I have two things to say. First, the Minister was bigging up renewables investment in the UK, but to bring him down to earth I remind him of an article from earlier in the year saying that the UK has just hit a 12-year low in attracting renewables investment. We need to be aware of the context. Secondly, does he agree that a privatised Green Investment Bank will become more risk-averse and therefore contribute to market failures, rather than helping to eradicate them?
George Freeman
No, I do not accept that. The hon. Lady’s party is committed to promoting green technologies and investment, but I do not think her insistence that the sector is in decline will be encouraging for investor sentiment. We all have a duty, whatever our policy differences, to contribute to confidence in the sector.
Philip Boswell
The Minister talked about the Government promoting green energy; but there are wind and solar energy subsidy cuts. I was Shell’s contracts lead on the carbon capture project, moving it from Longannet to Peterhead, and with the way things are going I am waiting for a backtracking announcement on that. The Green Investment Bank is a unique British success story, still in its infancy and much admired around the world. Does the Minister agree that privatising it is an exercise in blind ideology, and that it ignores common sense?
George Freeman
The hon. Gentleman has made his point eloquently. Not surprisingly, I do not agree, and I will explain why. Perhaps I can just say something about the rationale for the move.
Several hon. Members have asked why the Government want to move the Green Investment Bank into private ownership if it is already so successful. One or two said, “If it ain’t broke, don’t fix it.” I want to explain why it ain’t broke, and why we want to allow it to go on and succeed. Moving the bank into private ownership is the natural next step for the company, now it has proved itself to be a successful commercial enterprise making a strong rate of return on its investments. We want it to be able to grow and develop its balance sheet, get access to private capital markets and borrow, none of which it can do at the moment, as a public sector entity. It is because we want it to flourish that we want to give it those freedoms.
George Kerevan
Surely it was in the legislation, and in the way the bank was set up, that it could borrow. It is perfectly able to borrow. There is no prohibition on that. It is just that the Treasury does not want that notionally on its books. The bank can legally borrow now.
George Freeman
It could indeed. The difference between us is that the level of borrowing needed in this country has been far too high. The Government’s view is that we need to reduce the country’s borrowings, not increase them, and we want to liberate the bank; we want to allow institutions to grow and flourish without saddling the next generation with more public sector debt.
George Kerevan
I was merely correcting the Minister, who tried to give the impression that the bank cannot at the moment go to the markets and borrow. It can, and I think that the markets would in due course give it all the money it wanted, because it has been so successful. There is no need to change the legal model to enable the bank to borrow. That is my point.
George Freeman
I respect that. The point I am making is that the Government have a strategic commitment to the British people, and it was not the least of the reasons we were returned to office—to get our public debts under control. The hon. Gentleman’s party may take a more cavalier view of public debt, and I respect that, but our view is that we need to get it under control. For that reason, but not only that reason, institutions that can borrow today, thus contributing to exacerbating the public sector debt problem, need to be liberated to get access to the flourishing private capital markets that the Green Investment Bank has played no small part in creating. The figures that I gave earlier on the extent of the global sector are relevant to that.
To complete my comments on the rationale for the decision, I looked this morning at research on market interest, and interest in acquiring a stake in the Green Investment Bank is likely to come from large-scale institutional investors such as UK pension funds, infrastructure private equity funds and sovereign wealth funds—specialist investors with an interest in green infrastructure. The bank has already successfully attracted similar investors into its managed fund for investment in offshore wind. Many of those investors do not currently invest in individual green projects. Allowing them to acquire a stake in the bank will provide a vehicle for them to invest in the area for the first time. That is a part of developing a more active private sector market in renewables and green energy. Through the bank’s portfolio of renewable energy and green infrastructure projects we hope to widen the pool of investor exposure and stakeholders in the sector. The sale of the bank is partly about enabling that new pool of capital to be brought to bear, helping to accelerate investment.
Graham Stuart
Do the Government have any preference, then, as to the number of investors that might come to the Green Investment Bank? He has talked about some taking a stake—perhaps pension funds; but what if a major international bank offered for 100% of the bank, and that was the highest offer? Would they sell to a single institution, and would there then be a danger that that would just be swallowed up in a much larger organisation, so that the purpose of the bank could eventually be diluted?
George Freeman
The overriding principle is that we want to ensure that the bank is put on a footing where it has the freedom to operate and is able to raise the necessary capital without being jeopardised by having an investor base that is too fragmented and small to be effective, or too small or too large an interest to be sustainable. Both of those represent risks. We will need to take a view and ensure that we give it the best possible chance to be able to carry on and fulfil its remit. I will say something about its green remit in a minute.
Graham Stuart
I know that it is difficult and, I imagine, sometimes commercially sensitive but I would like to press the Minister. Is it the Government’s view that the sale to a very large global bank would be a bad thing? He has described it as a risk. I know that the Government will take a view but do they have a view that they can share with the House today? We are trying to find out what the Government are going to do with this bank.
George Freeman
Our view is that we want to give the Green Investment Bank the best possible chance of having a stable and secure future and being able to raise the sort of money that it needs out of the market. Having been an investor myself in much smaller companies, I would say that anyone involved—my hon. Friend is aware of this—will know that there is no perfect shareholder structure. Often having a very small number, particularly if it is one, can create risks of its own. Having far too many small investors can mean that it is a struggle to raise the capital needed. A happy balance will need to be struck, but the judgment will have to give the Green Investment Bank the best chance of fulfilling its remit. I will say something about its green remit in just a moment. My hon. Friend made an important point.
Crucially, the plans are not being imposed by the Government on a reluctant bank. They have the full support of the company and its independent board and chair, Lord Smith of Kelvin, and others. Lord Smith of Kelvin said:
“I welcome this. You can’t keep going back to the Government for more and more money. If we want to build something that is sustainable and durable, we need private capital. This was always going to happen.”
He also said:
“The UK Government led the world in their vision and commitment in setting up the world’s first dedicated green investment bank, so we are delighted to have their support as we enter a new phase and seek additional investors in our business.”
Shaun Kingsbury, the chief executive officer, said:
“That is why I believe the decision announced by the Business Secretary is the right one. It is the option that gives us the best chance of creating the greatest green impact.”
Other important commentators have concurred. Richard Howard, head of environment and policy at the think-tank Policy Exchange, said at the evidence session of the Environmental Audit Committee yesterday that the legislation may not be needed to maintain the green focus, and that if we remove that legislation and allow someone to invest, that investor would come along and invest because they are interested in supporting what the Green Investment Bank is doing. He said that private capital funds have got involved precisely because the bank has a track record in these areas and that they are buying into a pool of expertise in investing in green projects.
The Environmental Audit Committee’s report on green finance in March 2014 said that the Green Investment Bank
“needs to be able to raise significant further private sector capital for investment alongside the Bank’s programmes, and to borrow itself to enlarge the scale of its work…The Government must make an early and clear statement about the Green Investment Bank’s long-term future beyond the 2015–16 horizon of its Spending Review funding settlement”,
which answers one of the points made earlier.
Kevin Brennan
I am grateful to the Minister for giving way. That is all very well but the problem is that is all just opinion. Today, we are seeking more of an assurance that the Minister can guarantee that when the bank is privatised, it will not lose its green focus. Nothing that we have heard so far gives that guarantee. Is he coming to that?
George Freeman
I am coming to that. I have been very generous in giving way. Perhaps I should crack on and then I could answer the points that I keep being asked.
In consultations on the Green Investment Bank in May 2012, Greenpeace said:
“If it’s going to be more than an empty gesture, the bank’s got to have the borrowing powers necessary to support the green shoots of the UK’s renewables industry.”
It recognised that the sector is moving fast.
On the freedom to borrow and to raise capital, by giving the bank access to private funding, we will enable it to grow in accordance with its ambitious green business plan, giving it access to a much greater volume of capital than if it remained in public ownership. I commend that plan to any Members who have not looked at it, as it is a legal document that investors are investing in and will be the subject of all the legal constraints of a company sale. Crucially, it will give the bank much greater freedom to operate, removing a number of constraints that apply to it because it is a Government-owned enterprise, and enabling it to borrow freely on the capital markets without impacting on public sector debt. Hon. Members who take a view that public sector debt is not a national priority or issue will not find that argument compelling. Those of us who believe that that debt is an issue will find it compelling. That is firmly the view of the Conservative party.
In Government ownership, the bank must compete for funding along with all other Government expenditure needs, in a necessarily tight public spending round. We do not want to constrain it because of that. For all those reasons it makes sense for the Green Investment Bank’s investment activity to be funded by private capital where possible and to minimise the need for public funding, which fits with our original strategic policy aim of getting the market to work in tackling green policy challenges. Part of the coalition’s strategic intention was to try to generate, support and de-risk that early green investment market here and globally. As a number of Members have mentioned, the bank has been very successful in that first phase.
I want to touch on the need for repeal of the legislation, which a number of hon. Members have talked about. The reason that we need to repeal the legislation on the bank contained in the Enterprise and Regulatory Reform Act 2013 is so that the company can be reclassified to the private sector rather than remain as a public sector body. That is essential to achieving the benefits of private ownership, including the aim that the bank should be free to borrow and raise capital without affecting public sector debt. It has become apparent that, unless we repeal that legislation, there is a major and uncarryable risk that the bank would remain classified to the public sector, even after a sale, because the legislation will be likely to constitute a continued public sector control over the company’s business. The hon. Member for Cardiff West asked whether this was wise in terms of the drafting of the original legislation that set up the bank. I cannot comment on that because I was not involved in it. Our advice now is very clear. If we want the bank to be able to operate in the way that we do, that piece of legislation needs to be repealed. While the decision was not arrived at lightly in any way, we are clear that it is a necessary step if we are to achieve our aims.
Mr Iain Wright
This is a really important point. Given the Government’s determination to move the bank off the public books, does the Minister accept that there are no safeguards whatever to ensure that a privatised Green Investment Bank will continue with the green purposes that are currently enshrined in that legislative lock in the Enterprise and Regulatory Reform Act?
George Freeman
I am trying to remember the beginning of the hon. Gentleman’s question. Will I confirm that there are no safeguards? No, I will not confirm that. It will not be set out in legislation in the way that it is at the moment, but there will be a whole series. The shareholder agreement has not been drawn up yet. Despite the earlier comments of the hon. Member for East Lothian (George Kerevan) about articles of association, the funding and raising of subscription moneys for companies like this is a major legal undertaking. The business plan will be a material document in that process. The bank has set out what it is raising money to invest in. That has to be done when money is being raised. That is all subject to incredible legal scrutiny. The investors who are investing in the company have to sign warranties and give undertakings to their own investors that they are investing in what they say they are. Although they will not be set out in legislation, there are a number of safeguards to ensure that the bank will continue to operate in the green investment space.
John Mc Nally
Does the Minister agree with me—this is the firm view of me and the Scottish Government—that the UK Government’s amendments to the Enterprise Bill to remove public sector controls on the Green Investment Bank would require a legislative consent motion in the Scottish Parliament, given the impact on devolved law?
George Freeman
The hon. Gentleman makes an important point about the devolution settlement. I will come to that. I am not ducking it; it is an important point that I will come to.
On the protection of the bank’s green mission and green values, the Government recognise that people will rightly be concerned about whether repealing the legislation means that the bank’s focus on green investment is in any way diluted. Let me be very clear. As the Secretary of State has sought to make clear in his written statements on the matter, the Government’s intention is that, following a sale, the Green Investment Bank should continue to focus on green sectors, mobilising more private capital and further accelerating the transition to a green economy. As somebody said earlier, the clue is in the name on the tin. Green investment is what the Green Investment Bank does and where its value lies, and that will be the basis of its offering and the offer it makes to investors. It is clear from preliminary feedback that potential investors are interested in the Green Investment Bank precisely because of its unique green specialism, business plan and investment track record. We fully expect that potential investors will wish to maintain that focus and will be bound by the prospectus and green business plan that the bank is putting at the heart of that subscription.
As a key part of any sale discussions, potential investors will be asked to confirm their commitment to those values and the plan, and they will be asked to set out how they propose to protect them. The Government envisage that that will involve new shareholders agreeing to retain the specific green objectives in the bank’s articles of association and to ensure that the bank continues to be required to invest in a way that achieves a positive green impact.
The Government also expect that new shareholders will maintain the bank’s existing standards for reporting on its green investment performance and will continue to provide for independent assurance of that reporting. We fully expect that approach to be effective in securing the outcome we want, which is that new shareholders readily commit to maintaining the Green Investment Bank’s green mission and values.
Mr Iain Wright
That cannot be reconciled with the Government’s intention to get the Green Investment Bank off the national accounts. The Office for National Statistics has criteria for determining whether an entity is on balance sheet or off balance sheet, and those criteria will include a Government right to control via contractual agreements and via regulation such that a unit cannot diversify its activities. The Minister can say that the Government intend, wish and hope, but does he accept that they are impotent on the future operations of the Green Investment Bank?
George Freeman
The hon. Gentleman and I are in violent agreement. Let me make it clear that we will not put in legislation or in regulation—
George Freeman
Let me answer the question. We will not put a binding contract in regulation or legislation, but we will ensure—here is the point—that when the Green Investment Bank goes to raise funds in a subscription round, the subscription agreement and all the legal documentation will be based on the bank’s current mission to be a green investment bank. The bank’s green business plan will be a material document in the context of that funding round, and investors will be investing in that mission, that plan and those values. As I have said, we will build in a series of protections to ensure that the vehicle in which they are investing is clearly committed to that green mission.
I want Members to understand that we have taken legal advice, and in order to comply with state aid and Treasury rules on public sector financing, and in order to give the bank the freedom that we want to give it, it is essential that we do not bind it with statutory, legislative and regulatory instruction but ensure that, in its offering to the market, the intention of the bank is clear. That is the right mechanism for us to ensure the bank’s green mission.
Kevin Brennan
Some might observe that assurances were sought ahead of the Royal Mail privatisation and that those assurances lasted about five minutes after the privatisation happened. Leaving that aside, the initial investors may well come in on the prospectus that the Minister is putting before the House today, but there is nothing to say that that will last for any period of time. Within a pretty short period of time, we could be looking at a very different kind of institution. Can he give us any guarantees about that?
George Freeman
I think I have made it clear that I will not commit the Government to giving statutory and legislative guarantees that would constrain the operation of the bank, not because we do not want to see the bank continue doing what it is doing, but because we have been clearly advised that once such guarantees are given, we will not be able to allow the bank to have the freedom that we want it to have or to be able to raise money that does not count towards public sector debt. We have made it clear that we want the bank to continue doing more of what it has been doing, such as investing in green energy and catalysing that market. I do not know whether the hon. Gentleman has seen the bank’s green business plan, which is a clear document. When investors invest in any entity, particularly a bank, the entity has to set out a prospectus and a business plan into which the investors are investing. That document will clearly set out the bank’s green activities. It will be very clear that people will not be investing in a company that can do something outside of that.
George Freeman
It will be up to the investors and the bank to determine where the green energy market goes in the longer term. None of us in this room is able to predict where the bank should be investing, given the pace of investment. I have seen a number of interesting technologies—hydrogen cells and some of the battery technology are extraordinary stuff—and we want the bank to be free to invest in different sectors.
George Freeman
I will take these two interventions, and perhaps I can then crack through the questions.
Kevin Brennan
I want to ensure that this is on the record. I said “fracking” from a sedentary position, and I think the Minister accepted that it is possible, under the current privatisation plans, that the Green Investment Bank might be involved in investing in fracking projects.
George Freeman
I want to take specific advice, but I will write to the hon. Gentleman on whether any constraints are envisaged on what may or may not constitute green investment. My understanding is that we want to give the bank the freedom to invest in a range of different technologies. Indeed, part of the bank’s mission is to be able to catalyse investment in a much wider range of technologies that will be key to building a 21st-century green economy.
Graham Stuart
The Government announced that they will privatise the bank so that it can access capital, as the Minister has set out. The letter announcing that privatisation stated that the bank will be guaranteed by the statutes. Those statutes have suddenly gone, and promises have been made to the Treasury. It feels as if the Government machine has already decided to privatise this bank, but the basis on which the Government are privatising the bank has changed. Will it be possible to go back? The Treasury is rightly trying to address the deficit and the debt, but there is a conversation to be had, because the bank is not being privatised on the basis that was originally proposed. There is a risk that this thing will not do what we want it to do. The Climate Change Act 2008 commits us to action, and if that action costs more, we would be back to cutting off our nose to spite our face.
George Freeman
My hon. Friend makes a good point, and I know he has raised it with my right hon. Friend, the Secretary of State for Business, Innovation and Skills. It flows from everything I have said that we are determined to ensure that the Green Investment Bank is able to continue being a green investment bank. Given the constraints under which we are operating, we need to be creative in exploring every option. I am open to my hon. Friend’s suggestions about how we might be able to do that in a way that does not compromise the bank’s ability to operate in the way we want.
George Freeman
Well, the shadow Minister should see the list of questions I have been asked, not least by the shadow Minister himself. I will try to answer those questions and, if I fail, the hon. Member for Hartlepool (Mr Wright) can intervene at the end.
I was asked whether the management of the Green Investment Bank would prefer a statutory lock. The chief executive officer allegedly said that he is “agnostic” about privatisation, but he did say that he prefers a statutory lock. He also said that he wants the ability to raise funds from the private sector, and he understands the need to remove the statute and the statutory constraints.
My hon. Friend the Member for Beverley and Holderness asked how the shareholder framework document will change. Clearly, the framework document will need to change as the shareholding changes. When the bank was set up in 2012, the document’s primary purpose was to set out that the bank should operate independently so that the Government could not interfere in its investment decisions and to ensure the bank’s green ethos. Privatisation will further increase that operational independence, but the bank’s green ethos is now entrenched. The Green Investment Bank is what it is, and it is what is in its business plan, which will be a material document in the shareholder subscription round.
My hon. Friend also asked whether the market failures that the bank was set up to address have now improved to such an extent that we no longer feel the bank needs to operate in the same way. He is right that the bank was set up shortly after the banking crisis in the depths of the dark period of 2010, 2011 and 2012, when the economy was moving very slowly, to rectify a lack of long-term liquidity in the market. It is true that long-term funding for infrastructure projects has recovered strongly, as illustrated by the data I gave earlier. There was a lack of specialist green infrastructure investors, particularly at scale, which is what the bank has now become. The bank has helped to support such infrastructure projects, and we intend that the bank will remain a specialist green investor after privatisation. That is what the bank does, and it is what an acquirer will be buying. We want to let the bank off the leash to do more of that.
The hon. Member for Brighton, Pavilion (Caroline Lucas), who is no longer in her place—she gave her apologies—asked whether a profit-maximising bank would be in danger of crowding out investment because it would be just like any other bank. In fact, the Green Investment Bank is already profit maximising; it has turned its first profit. It exists to prove that it is possible to be green and profitable. That is in the bank’s very DNA; we want to show that the green economy is a real economy. That is how we will attract the private sector capital that we need. The GIB’s expertise can do so regardless of whether it is in the private or the public sector, of course, but we want to give it the freedom to raise that money.
The hon. Lady also asked whether other countries are copying us. It is true that we were in the vanguard when the Conservative-led coalition set up the Green Investment Bank, and we have been copied. It is our ambition to be in the vanguard as we take the market forward. We need to raise not just hundreds of millions or billions, but tens of billions—actually, over the next decade or so, we need to raise hundreds of billions—of money for green infrastructure. There is no way that any Government could fund all of it, even if they wanted to. We need to go to the next stage by leading private sector capital into the market.
Several hon. Members, including my hon. Friend the Member for Beverley and Holderness, asked whether the bank cannot raise debt anyway, and whether we had explored all the options. The truth is that equity raising by the bank will effectively score like debt to the public sector once that equity is invested, so this is not just about debt, but about ensuring that the bank has the right financial mix to operate. My hon. Friend also asked about the European fund for strategic investments, a £300 billion pot for capital raising, and whether the bank will still be encouraged and able to access that money.
The Government are aware of the European funding for infrastructure investment, and are examining how best to make use of that facility—my hon. Friend makes a good point. In our view, that does not alter the case for moving the bank into private ownership. We absolutely need to ensure that it can access funding. The Government and devolved Administrations are actively considering, along with other UK institutions, how they can work alongside the bank to maximise the impact for the bank and others of accessing that European funding. The EFSI guarantee can be used by the bank to co-invest in and co-finance with both public and private institutions, so privatising the bank does not in itself preclude benefiting from the European fund.
Graham Stuart
For the record, is the Minister saying that the bank’s change from its current status to privatised will have no impact whatever on its ability to access those funds, to which we are contributing so many billions of pounds?
George Freeman
I would not want to go as far as to say that it will have no impact. What I am saying is that we are actively ensuring that the bank will still be able to access funds from the EFSI. It may have to do so through consortiums with other parties, in a slightly different way from how it did when it was a state-owned bank.
My hon. Friend asked whether citizens would have the opportunity to invest directly. We are exploring all options as part of the sale. I would point out that the bank is still a very young company that has only just broken even, meaning that it is pretty unlikely to have a sufficient track record to attract much interest from the retail market, but we are obviously keen to grow the level of retail investor exposure into the market as it matures. He and others asked whether we and the bank had considered raising green bonds. Issuing bonds is absolutely one of the things that the bank will be free to do if it chooses. At present, it is prevented from doing so, as it would score against public sector debt in the same way as borrowing.
Several hon. Members have asked why we are repealing the legislation. I have touched on this already, but in order to grow in line with its ambitious green business plan, the bank needs the freedom to borrow and access much larger pools of private capital, and it will have that freedom if it can borrow without affecting public sector net debt. That means getting the bank reclassified as a private enterprise and off the Government’s balance sheet. To do so, we must do two things: sell a majority of the company, and repeal the legislation. Otherwise, the company could still be classified in the public sector, even after a sale.
One or two hon. Members have asked why we cannot just retain the bank in Government ownership and allow it to borrow, citing the statement by my right hon. Friend the Chancellor that as and when debt starts to fall as a percentage of GDP, we can release borrowing restrictions on the economy generally, so why not on the bank? The problem is that, in Government ownership, the bank’s borrowing and capital raising would still count against public sector debt. Equally, it still has to compete for funding, along with all Government expenditure needs and with the pressure on the Exchequer, even as we get the debt under control. In my own field of health, for example, health demand is rising substantially, and we want to liberate the bank from having to fight in the Whitehall corridors in the same way as every other Department in spending rounds.
On top of that, private ownership will give the bank much greater freedom to operate, removing a number of constraints. It is worth pointing out that it was always envisaged that the bank should aim to mobilise maximum private capital, and it fits our strategic policy aim of getting the market to work on tackling green policy challenges. As I said, we have the full support of the management and the CEO of the company.
Let me turn to the important question of how we will protect the bank’s green mission and remit in the absence of the legislative lock. As a key part of any sale discussions, potential investors will be asked to confirm their commitment to the bank’s green values, green mission and green business plan, and set out how they propose to protect them. We envisage that that will involve new shareholders agreeing to various specific things: retaining the green objectives in the bank’s articles of association; ensuring that the bank continues to invest in a way that achieves maximum positive green impact; maintaining the bank’s existing standards for reporting on its green investment performance; and providing independent assurance of that.
We fully expect that, as part of a subscription round based on the bank’s offering to the market, its green business plan with clear long-term investment in a range of sectors and projects will deliver the safeguards that Opposition Members have asked for without the need for legislation that would curtail those freedoms. We are absolutely committed to ensuring that the bank continues with that green mission, and I am happy and open to explore mechanisms suggested by any party for safeguarding the bank’s green remit in a way that does not fall foul of those public control tests.
Graham Stuart
On that point, as we all know, when a company goes to market, it depends on the conditions at the time. It is at least feasible that when the bank goes to the market, those who wish to invest on the basis that the Minister is discussing will disappear, leaving those who will simply buy the capital and assets invested and treat the bank as a zombie fund, immediately sacking as many of the staff as possible, running it at a minimal level and calculating a reasonable return. What guarantee can the Government give, if those turn out to be the only buyers around, that they will not stay so committed to privatisation—in order to meet, rightly, the need to sort out the national debt—that they end up giving the bank away to be turned into a zombie fund, not only avoiding innovative green projects but not really developing anything at all?
George Freeman
I will happily give an undertaking that we do not intend to give anything away and allow it to be turned into a zombie fund. My hon. Friend has had conversations with my right hon. Friend the Secretary of State about the matter. The Government, as the owner, clearly have duties in all sorts of ways. We have a fiduciary duty, duties to Parliament, the public account and the law, duties to ensure that we maximise the value of our investment, and political accountability to ensure, as I have stated repeatedly in this debate, that the bank in the new structure can remain an active and committed investor, fulfilling its green values and the specific safeguards that I have just set out.
John Mc Nally
The Minister mentioned that all parties would be involved in the discussions. As a Member of the third party in the House, I am taking it for granted that we will be involved in those discussions.
George Freeman
To clarify, I was not suggesting that we have a round table on the subject; I was merely extending an open offer to anybody who has any suggestions, in addition to the safeguards that I have explained, about ways to ensure that we deliver what I set out as the Government’s clear objective, which is to ensure that if the bank is put out for subscription, the subscription makes it clear that the bank exists to deliver its mission. We are all ears, but it must be within the context of the Government’s strategic policy intention of liberating the bank from the constraints of being defined as a public sector asset, and thus liable to Treasury lending requirements.
Mr Iain Wright
The Minister talked about agreements. What will be the legal status of the agreements with potential new shareholders of the Green Investment Bank?
George Freeman
For any investor entering into a subscription agreement, the parties will be the current owners, the operating company, the bank and the other investors, so the shareholder agreement will be crucial. It is binding in law and if anyone has ever seen a subscription agreement pack, they will know that it is lever-arch files-worth of papers. However, the central point is that all the parties in that agreement come together to agree what they are investing in, and what the objectives and aims of the company are, and that is set out in the articles of association and in the subscription agreement.
We hope that there will be a substantial range of serious investors who are committed to this space and to subscribing investment moneys into the bank’s green investment plan. They are not investing in a casino or any of the things that conspiracy theorists might imagine this thing could go on to be, including a “zombie” handing out money. They are investing in a specific commercial venture, and the directors of the company will have to put a prospectus out to the market, and they will have to warrant it legally themselves, personally as well as in the usual way. So, the subscription process, in and of itself, affords significant protections to us all, as shareholders and parliamentarians.
The issue of the Government’s ambition of retaining a stake in the bank was raised; I am trying, Mr Percy, to deal with all the points that were raised this afternoon. We will consider all options for a sale and we will be guided by the ultimate test of what achieves best value for the UK taxpayer, and what best fits with the strategic intention of allowing the bank to continue to be a leader in the green investment market and to pull in private finance. I am not in a position to commit this afternoon to a particular level or stake; I do not suppose that anyone would expect me to do so. We need the flexibility to do what best achieves that value for money and the best outcome for the bank.
It is important to note that, in any event, the Government’s retaining a stake while also securing declassification would not give Her Majesty’s Government the power to exercise control over the company; it would merely provide a stake in the company. Before anyone asks, the advice we have had has been very clear that retaining special shareholder rights that would enable the Government to veto corporate policy decisions would effectively amount to state control, and would bring us back to the problem that we are trying to get around. The Government could only have the same rights as any other shareholder in the company.
Here come the tickertape answers to some of the questions that have been put. The hon. Member for Cardiff West asked if I could comment on whether the off-balance sheet treatment is the only reason for the repeal of the legislation. It is the central reason why we need to do it; it is a necessary technical step to liberate the company from the constraints that would otherwise apply. The reason for wanting the bank to be able to operate in the private market is broader than that; we want it to access private capital and to be freer to develop in that growing market.
The hon. Gentleman also asked how much we would expect to raise from a sale. He will not be surprised to learn that I am not in a position to tell him today what that figure would be.
George Freeman
Proceeds will depend on how big a stake is sold, on the outcome of negotiations with investors about the value of the company and on how the company’s business plan is judged. We will need to be satisfied that any transaction represents value for money for the taxpayer, and fits with the Government’s wider policy interests and with the best interests of the bank. The hon. Gentleman would obviously not expect me to speculate this afternoon on what figure we would expect and thus undermine the process.
Importantly, the hon. Gentleman also asked me about the £1.8 billion of funding that is left. As he has highlighted, the bank can carry on for at least another year, given that it has £1.8 billion—roughly—in reserves; he suggested that after that period it could start recycling capital. The truth is that to grow its business and invest in accordance with its green business plan, the bank will need access to a much greater volume of capital from a wide range of sources.
The hon. Gentleman asked why there was urgency about this process. What we do not want is to get to a point where the bank has no reserves and badly needs capital. Anyone who has raised money knows that the time to raise it is not when there is no choice but to raise it, because money is desperately needed, but when a company is in a strong position, and has a pipeline, assets and a good track record. We think the bank is in that situation now. We are confident that we can attract private capital into the bank because of its track record and because it is operating successfully.
Graham Stuart
I am grateful to the Minister for giving way again; he is being very generous with his time. My understanding is that the funding agreement runs out in March next year, and that the steady state activity of the bank for the last couple of years is £700 million to £800 million a year. There is not clarity about what happens from 1 April 2016 onwards, and the bank will have no access to that £1.8 billion; according to my calculations, the reserves were more like £1.5 billion, but whatever the exact figure is, it will be quite a lot of hundreds of millions of pounds. Perhaps the Minister, while answering other questions, might seek advice elsewhere about this issue; I would be grateful if he could respond to me about it. I am interested to know how the bank will be taken care of between its current funding provision running out in March 2016 and whatever date it is sold, and how we ensure that there is not a chilling effect.
George Freeman
My hon. Friend makes an important point. A key part of the rationale for proceeding with this move now is that the bank’s momentum—its existing status—is a strength; it is an asset rather than a liability in the context of the bank’s fundraising. So we are actively looking at everything we can do to ensure that clarity about the bank’s status, position and momentum is provided to potential investors. It is not in our interests that there is confusion, and we are addressing that issue.
Kevin Brennan
I am still not entirely clear what the Minister meant in his answer about the £1.8 billion, in particular whether that money will remain available for use by the Green Investment Bank or is likely to be returned to the Treasury at some point. Could he just make that clear?
George Freeman
Yes, I will happily respond to the hon. Gentleman. There is a slight circularity to this process, because we want to ensure that the bank is in the strongest possible position to raise the maximum possible amount. We are currently in discussions with Her Majesty’s Treasury as part of the spending review and as part of preparing what we want to be a highly successful fundraising exercise. So the bank, the Treasury and the Department for Business, Innovation and Skills are in a conversation right now about how best to structure things, so that we maximise the chances of the bank being able to raise money successfully and to continue the momentum with existing projects, because that is a key part of the asset and of the strength of the offering that we want to put to the market.
The hon. Member for Falkirk (John Mc Nally) made an important point about Scotland. We are of course talking to the devolved Administrations; in fact, I understand that my right hon. Friend the Secretary of State is speaking to Scotland’s Deputy First Minister later today. Obviously, I will not pre-empt that conversation, but such conversations are ongoing.
I will wrap up by saying that we have had a really excellent debate this afternoon. Again, I thank my hon. Friend the Member for Beverley and Holderness—
John Mc Nally
I am very grateful to the Minister for giving way again. At yesterday’s meeting of the Environmental Audit Committee, the chief executive officer of the bank stated quite clearly that he was happy to retain its headquarters in Edinburgh, with the staff. Can the Minister give us a reassurance that he agrees with the chief executive on this issue, which is an extremely important concern for us?
George Freeman
The hon. Gentleman makes an important point. Obviously, it is for the bank to make sure that it is in the right location. We originally put it in Edinburgh because, as he well knows, Edinburgh is a great centre of finance. It is one of the great capital centres of the UK and has a great history of green energy investment.
It is ultimately for the company itself to decide where its HQ is. I will just politely point out that the best thing that the Green Investment Bank could have in terms of investor security is security about the status of the United Kingdom. If that status was clear, I think that there would be a very strong prospect of the bank remaining in Edinburgh and happily raising money as part of a country with a great devolved Administration in a strong UK.
Mr Percy, I want to highlight—
John Mc Nally
That should probably be part of the Scotland Bill; we need more powers in Scotland on our way to independence.
George Freeman
I hear what the hon. Gentleman says; I simply highlight the potential contradiction between his first intervention and his second. It is the risk of Scottish independence undermining investor confidence in a business such as this one in Edinburgh that is counterproductive. However, we will not agree on that issue this afternoon.
I will just summarise matters, as it were, at a higher level. We have heard some really important messages this afternoon, and there has been a degree of agreement about the importance of getting this bank into a position where it can take the success of its first few years and go on to the next stage, to be a pioneer in bringing private capital into this market.
I was very struck by what the hon. Member for Hartlepool said, and I thank him for his kind words about my appointment to BIS. He referred to how well the bank has been doing and applauded that. However, he said he had been concerned that when we set the bank up it should be a bank and not a fund. That is an important point. We want this bank to be able to be a proper bank and to syndicate and grow in the years ahead.
The hon. Member for East Lothian said, “If it ain’t broke, don’t fix it,” and wondered whether there was some alternative agenda. I know that conspiracy theories are popular in this House—we all indulge in them occasionally—but I again assure him that there is no conspiracy here. The Government will be held to account for the success of the bank, which we set up. We want to be able to report back at the end of this Parliament that we liberated the Green Investment Bank from the constraints of a tough public spending round and allowed it go into the private markets and lead in the burgeoning green economy.
The hon. Member for Cardiff West spoke about the success of the bank. As my hon. Friend the Member for Beverley and Holderness highlighted, it is not often that two Front Benchers sitting on opposite sides congratulate each other on the success of initiatives. The hon. Gentleman asked me a lot of questions, which I hope I have dealt with. If I have not, I will happily deal with any outstanding ones later in the day.
We had very few incidents of party politics in the debate, but I have to close with a wry smile, because at one point the Government were accused of being prisoners of public accountancy convention. That accusation could certainly not be made about the previous Labour Government: they left us borrowing one pound for every four we spent. The former Chief Secretary to the Treasury thought it was funny to leave a note saying that there was no money left. A former Leader of the Opposition said he did not think the previous Labour Government spent too much and the current shadow Chancellor is committed to the overthrow of capitalism.
I am delighted to be opposite the hon. Member for Cardiff West, who did not speak such rubbish this afternoon. We have had a good debate, in which we have all agreed that we need the Green Investment Bank to go from strength to strength.
Cancer Drugs
George Freeman Excerpts(9 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
It is a pleasure to serve under your chairmanship, Mr Hollobone, at this early hour of the morning. I know that many Members would have liked to have been here for this debate. I suspect that if the debate had been scheduled for the main Chamber, we would probably have half-filled it, given the level of interest. I am delighted to have the chance to respond.
First, I congratulate and pay tribute to my friend, the hon. Member for Strangford (Jim Shannon). He is, as a number of colleagues have observed, a tenacious campaigner on this subject, and I am glad that we have kept up our record of 100% support for each other. He is a parliamentary champion of this cause, and it is a pleasure to work with him on it. He spoke powerfully about his own family’s experience of cancer, as did the hon. Member for Denton and Reddish (Andrew Gwynne). I am sure many Members from all parts of the House have experience of cancer. My father died of throat cancer when I was 19. It is a disease that still, despite all the progress, robs families and stalks the land. I will say something in a minute about the progress that has been made, because it is stunning.
I suspect when many of us were children, that word—cancer—normally spelled a quick and tragic death. Now, more than 2 million people living in Britain have had a cancer diagnosis. Cancer Research UK and all those involved in cancer research have achieved extraordinary things, but it is still a diagnosis and treatment that people dread. Cancer is a serious cause of early death, and it was powerful to have heard such cross-party support for cancer research.
As the hon. Member for Strangford and others observed, cancer does not respect any boundaries, whether they are of geography, income or party politics, although I make the point that it heavily correlates with health inequalities. Many colleagues in the House with constituencies with particularly high incidences of cancers also have constituencies with particularly a high incidence of poverty generally. There is a strong link between life chances and poverty and health and health inequalities. I observe that the Petitions Committee has received a petition on Abraxane, which is a symptom of how widely the concern on this issue goes across the House.
I will try to deal with some of the issues that have been raised. The truth is that the field of cancer research has pioneered the model of 21st-century drug discovery and life science research that is transforming how the sector works. That is driven principally by breakthroughs in genomics, genetic science and informatics—the ability to develop treatments and diagnostics based on being able to predict which patients will respond to which drugs and which patients are likely to be predisposed to a particular disease. Such breakthroughs and the use of big data, big informatics and genomic insights into the use of genomic biomarkers are allowing us to redesign the way in which drugs are discovered and developed. Cancer has led in that field partly because cancer is itself a genetic disease and because of the extraordinary work of Cancer Research UK and various other charities. I pay tribute to their work and leadership not only in deep science, but in the policy-making framework on treatment, diagnosis and care. I will talk about the cancer strategy that CRUK has helped us to put together in a moment.
The role of charities is growing in this space. I recently opened a combined laboratory in Cambridge shared by Cancer Research UK and MedImmune, a subsidiary of AstraZeneca. We have seen partnerships and collaborations between charities and companies before, but this was a joint laboratory, jointly funded with a joint research committee. It is a sign of where this landscape is going. We will see charities become the gatekeepers of patient power, patient tissues and patient genomic information, and gatekeepers of the patient asset in this new landscape of patient-centred research. It is a very exciting time for medical research charities.
Pioneering cancer research has made many cancers diagnosable and treatable diseases. As I have said, more than 2 million people now live with cancer. Diagnosis is still poor in pancreatic and colon cancer, and in many cases there is no proper cure, but about 98% of breast cancers are treatable and curable. That is a stunning breakthrough and I am sure that over the next 20 or 30 years we will see all cancers quickly reach that point. We need to recognise the extraordinary improvements in this field. The role of genetics and informatics is welcomed by the Government. We are doing everything we can through our life sciences strategy, set out by the Prime Minister in 2011, to drive this new landscape.
We have made groundbreaking commitments with the Genomics England programme. We are the first nation to commit to sequence the genomes from 100,000 NHS patients and combine that with clinical data. We have made groundbreaking commitments to open up our data sets to drive this model of 21st-century research. It is important that all of us who understand the power of that work also support it, because our constituents worry about the use of data. We need to make sure we safeguard individual patient data, and we need to make sure we unlock the assets of the NHS throughout the United Kingdom so that we are a genuine powerhouse in the 21st-century model of patient-centred research.
I want to pay tribute to the work of Northern Ireland scientists, academics and companies. The hon. Member for Strangford mentioned the Experimental Cancer Medicine Centre at Queen’s University. He is absolutely right that it is a world-class centre. I visited earlier in the year to commend, congratulate and support the team there. Sometimes the sector appears to be more interested in Oxford, Cambridge and London than in the extraordinary world-class centres out on the corners of the United Kingdom. I went specifically for that reason. The work there is not only world class in terms of the deep science on the cell mechanisms of cancer, but, in embracing the unified life sciences strategy research and treatment, the centre has helped to pioneer leadership in stratified medicine, pulling in inward investment and, interestingly, taking the patient catchment for the lower quartile of cancer outcomes to the upper quartile. That is a sign of how research medicine drives up clinical standards.
Jim Shannon
I visited Queen’s University in Belfast in the summer. They told me that they wished to see more partnerships and relationships with other universities, including on the mainland. The funding strand needs to be encouraged and we need to be a part of that. Will the Minister take that on board? I am sure he knows all about it, but I simply remind him.
George Freeman
The hon. Gentleman makes an important point. I will be discussing the matter with the Minister for Universities and Science and the Medical Research Council. We need to make sure that we move to a more networked and collaborative model of science funding. Traditionally, we have tended to fund established centres of excellence, which is important, but we also need to make sure we build networks. Cancer networks in research and treatment have been incredibly powerful in driving the advances that we have discussed. He makes a very good point. I was delighted to see the leadership of the Queen’s centre recently recognised by Cancer Research UK with a £3.6 million grant.
I want to talk about the wider landscape of cancer treatment and then turn to the drugs question.
Lady Hermon
I am grateful to the Minister for allowing me to intervene on him before he moves on to a different point. I am pleased that Her Majesty’s Opposition have made it clear in the debate this morning that they are going to support the Off-patent Drugs Bill, a private Member’s Bill. It would be helpful to many MPs who have had emails from constituents, as I certainly have, to find out what the Government’s attitude is to the Off-patent Drugs Bill. I encourage the Minister to say, “Yes, the Government will support it,” although I do not want to put the exact words into his mouth.
George Freeman
I will come to that important point as I deal with some of the questions that have been raised.
On the wider issue of cancer treatment, I want to highlight the announcement that the Secretary of State recently made on setting out our cancer strategy and the work of the cancer taskforce. We have set out important measures on a wider treatment regime for cancer. By 2020, NHS patients will be given a definitive cancer diagnosis or the all-clear within 28 days of being referred by a GP. This will be underpinned by an extra £300 million a year by 2020. We are launching a new national training programme that will equip another 200 staff to develop the skills and expertise to carry out endoscopies by 2018. We have a commitment from NHS England to implement the independent cancer taskforce’s recommendations on molecular diagnostics. This will mean that around 25,000 additional people a year will have their cancers genetically tested to identify the most effective treatments.
I have been absolutely insistent since day one when we launched the genomics programme that this deep science project should be embedded in NHS England. Patient recruitment for the project comes through the 11 genomic medicine centres in NHS England, and NHS England is now developing an infrastructure for doing genomic and molecular diagnostics in the mainstream NHS. We want the NHS to be the first health service in the world to launch genomic medicine for all as part of our universal 21st-century offering. A lot of work is going on at the moment on how we build the infrastructure for molecular diagnostics.
Our aim is that, by 2020, everyone diagnosed with cancer will benefit from a tailored recovery package, individually designed to help each patient. We are also committed to empowering patients and giving them much more information, so that those who choose to do so will be able to access personal health information, such as their test results, diagnosis, treatment history and their cancer recovery package, online. By 2017, there will be a new national quality of life measure to help to monitor how well people live after their treatment has ended, enabling priorities for improvements to be identified. We will continue to work with NHS England, charities and patient groups to deliver those commitments. It is important to remember that as people live with cancer—hopefully, more people will live with it—we will need to invest in the support network for how they live with it, and how we continue to monitor and support them and deliver post-treatment care.
I want to emphasise the importance of the role of NICE. Nothing I am about to say in any way undermines our commitment to its independent role and expertise in guiding and supporting decision making on drug access with the latest evidence and health economic leadership. In no way do we want to undermine its position. NICE has led the world. That is a great tribute to it and to the UK’s system. We are clear that if a drug is recommended by NICE, the NHS is legally required to fund it. Over the years, many thousands of people in England have benefited from the cancer drugs that NICE has recommended. These include Herceptin, Yervoy, and Zytiga for prostate cancer.
Most recently, hon. Members will have seen that NICE published final guidance on 7 October that recommends Keytruda, or pembrolizumab, for the treatment of advanced melanoma, after disease progression with Yervoy. I urge NICE to embrace the new technologies. I will talk about that in a moment. I am particularly pleased to be able to announce that in the early access to medicine scheme, which we launched last year as the beginning of the new landscape and which I have asked my accelerated access review to look at beefing up and developing, the first drugs have come through. They have been fast-tracked.
I am delighted to confirm to the House that NHS England has now undertaken routinely to fund the use of NICE-recommended early-access-to-medicine products within 30 days of NICE guidance being published. Colleagues will know that the scheme was established so that an innovative drug may be designated a promising, innovative medicine, and if there is no alternative mainstream therapy, the treatment can be fast-tracked into patients, with their consent, and rapid assessment carried out. The link to NHS England commissioning had not been established, but it is now in place. I am delighted that the first drug has gone through that system, and we hope that more will follow.
Mark Durkan
I welcome the Minister’s words on the progress of early access, but does he recognise that since 2011 NICE has turned down every new breast cancer medicine, while the cancer drugs fund has approved six new breast cancer treatments in NHS England? Between April 2013 and March 2015, that represented more than 2,000 extra life-years for patients coming from the CDF—life-years that NICE did not deliver.
George Freeman
The hon. Gentleman tees me up perfectly for the next section of my speech, because I want to deal with access to drugs and the Cancer Drugs Fund. We all recognise, not least the Prime Minister, that access to drugs is essential in this landscape, which is why he personally led the launch of the Cancer Drugs Fund—I thank the shadow Minister for paying tribute to that leadership. We have now committed just over £1 billion to the Cancer Drugs Fund—a substantial investment—and just under 80,000 patients have benefited from treatments that otherwise would not have been approved. They are largely treatments that NICE has turned down and the Cancer Drugs Fund has then stepped in to fund.
Because of the cancer field’s leadership in this new model of drug discovery, the rate of new drugs coming through is increasing and going to a targeted patient base. The smaller patient catchment for which industry must recover costs has driven it to raise prices and costs. In many ways, it has challenged NICE’s traditional £30,000 per quality-adjusted life-year model. It is driving huge pressure on our traditional model of health-economic reimbursement.
As Members have said, and as the National Audit Office report recently highlighted, the CDF was originally established as an interim measure to ensure that cancer patients were not denied drugs while we fixed the landscape. Although I have been in post only 15 months, I hope colleagues can see that the reviews of accelerated access and the CDF are not accidentally aligned. We are currently looking at how we make sure we support access to innovative medicines. Where cancer has led, other therapeutic areas will follow.
The genomic and informatics revolution will require NICE to change how it works. The explosion of progress in this field is what has put so much pressure on the CDF. Ever more treatments are coming online, but NICE is turning down ever more treatments on very well respected health-economic grounds. Those are difficult judgments about what represents health-economic value for the system and for patients. The CDF does not have a built-in discounting mechanism: it effectively takes the price on the basis of which NICE has rejected the drug and agrees to pay it. We want to look at whether we might use our extraordinary purchasing power to use the fund in a more productive way to get earlier access and, in return, discounts. That is what the accelerated access review is all about.
It is important to confirm that if NHS England decides to de-list a drug, any patients who have received a drug through the cancer drugs fund will continue to receive it. Where patients, particularly those with rarer cancers, are unhappy with a recommendation to de-list and their clinicians advise it, they can initiate individual cancer funding requests, an important avenue that many patients are successfully using.
I want to discuss the accelerated access review and respond to some of the questions that have been asked. I launched the review this time last year, asking and challenging the system to answer three big questions. Given the NHS’s extraordinary position as a universal, single-payer health system with leadership in genomics and informatics, the review is about asking what we can do to accelerate how we get innovation to patients. I have asked three specific questions. First, what can we do to shorten the time, cost and risk of getting innovation to that all-important moment of first use in patients? How can we make things quicker both for the patients who need it and for researchers, so that they can get those all-important human clinical data?
Secondly, what can we do to help NICE to embrace new flexibilities and pathways and to use genomics and informatics to update its systems, in order to deal with the issues raised by a number of colleagues relating to the end of the one-size-fits-all blockbuster model so that, in the 21st century, NICE has more tools at its disposal and more adaptive pathways—to use the jargon—to open up those flexibilities?
Thirdly, I have asked the accelerated access review to look at what barriers we can knock over and what incentives we can put in place to speed up the roll-out of innovative drugs and device diagnostics across the system. Unfortunately, there is great variation in the pace at which innovation is rolled out. In many ways, the CDF has pioneered on the very problems with which the system is now confronted. I am convinced that the CDF will be part of the solution. I cannot prejudice NHS England’s consultation, but I can reassure Members that, through the accelerated access review and the comprehensive spending review, we are looking at what we might be able to do to ensure that our commitment to funding innovative cancer medicines through the CDF also supports the broader landscape for innovative medicines. We will have to wait to hear the detail in the comprehensive spending review and subsequent announcements at the end of the consultation.
I want to deal quickly with one or two of the points made in the debate. The hon. Member for Upper Bann (David Simpson) made an important point about the different parts of the United Kingdom co-operating. As the UK Minister for Life Sciences, I am very conscious of leadership in Scotland, Wales and Northern Ireland, and would be interested to follow up on his point about using the broader network.
The hon. Member for Scunthorpe (Nic Dakin) asked me about NICE looking at exceptional circumstances. The accelerated access review is looking at whether we can give NICE more freedoms and flexibilities. The hon. Member for Motherwell and Wishaw (Marion Fellows) made an important point about the Scottish model—the innovative medicines fund there, the Scottish Medicines Consortium and the importance of patient voice, of which I am very conscious. She also discussed health inequalities, which are important.
Various colleagues asked about Abraxane. NICE is in the process of developing guidance on Abraxane for pancreatic cancer, which it expects to publish very shortly. The hon. Member for Strangford made an important point about data. We recognise that we need to be much better at gathering and using the data from the CDF. A data-sharing agreement between NHS England and Public Health England was signed in July.
In closing, I thank the shadow Minister for his support for the cancer drugs fund. We are intent on it remaining focused on access to drugs; we are tackling the wider treatment regime through the cancer strategy I have set out.
Access to Medical Treatments (Innovation) Bill
George Freeman Excerpts(9 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
It is a great pleasure, Madam Deputy Speaker, to serve under your stewardship today. I am usually to be found in my constituency on a Friday, unlike some colleagues who are more often here on Fridays, and it is a great pleasure to be able to debate private Members’ business and respond to this very important debate on this very important subject.
I congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris), who has had a very busy summer trying to work with the huge number of people who have taken an interest in this Bill to try to get it to a place where it can command majority support. He has been tireless in that work. He will know from this debate that there is more to do, but I know he has the appetite for it. That is not least because he and many Members across the House often see from their constituency mailboxes, as well as from their own family experiences, the great pressure there is from patients, particularly those with a diagnosis for which there is no known treatment, for us in Government to do everything we can to accelerate access to the growing range of innovations. I am privileged to be the Minister responsible for the sector that is bringing those innovations to us.
I want to pay tribute to one or two other colleagues in this House and in the other place. The noble Lord Saatchi built up the original momentum and head of steam with his Bill in the other place during the previous Parliament. My hon. Friend has sought to develop that in his Bill, which is in many ways different but trying to achieve the same ends.
My hon. Friend the Member for Tewkesbury (Mr Robertson) has been a vocal supporter of the great campaigner Les Halpin, who was diagnosed with a terminal disease and launched the Empower: Access to Medicine campaign. They have both been very vocal in supporting not only this Bill but the wider innovation agenda.
I also want to take this opportunity to pay tribute to the patients who suffer from terminal and untreated diseases, as well as their families, carers and loved ones. As the Minister for Life Sciences, it often falls to me to sign off very difficult decisions by NICE and NHS England. In the past six to nine months, I have met many people who are passionate about those of us in government and in Parliament doing everything we can to accelerate access to innovation. For all those reasons, this debate is timely and important.
An awful lot of points have been raised both this morning and in the months leading up to the Bill’s Second Reading, and I will deal as substantially as I can with the issues to which the Bill has given rise. I want to say something about the wider context in which the Bill seeks to accelerate innovation, not least the things the Government are already doing. I want to say something about the problem and, indeed, the opportunity for the UK and for patients and the NHS. Some colleagues have hinted at the ambiguity in their minds about the problem the Bill seeks to solve, so I want to shed some light on what I think the problem is that we are trying to solve. Before one legislates, it is never a bad thing to be clear about the problem.
I then want to say something about the importance of public support for and patient trust in our clinical research and medical landscape. We lead the world in medical research: the NHS in the UK is globally recognised as a leader and we set the gold standard in ethical, regulatory and other aspects of clinical research. It is absolutely vital that the Bill reinforces and supports that, and does not in any way, with or without reason, alarm or undermine public trust and confidence in our NHS and our research infrastructure. To that end, I also want to look at some of the protections proposed by the Bill and the safeguards that are already in place, to address some of the key concerns raised, to highlight where the Bill is supported and to set out the Government’s position.
I will start by addressing the context. Colleagues have touched on the UK’s glorious history in medical innovation —from amputation in the 18th and 19th centuries to penicillin, bypass surgery, transplantation, the discovery of DNA and pioneering discoveries on genomics and digital health. Barely a month goes by without this country making another significant step forward in biomedical science. On any indicator, but particularly on the numbers of patents and learned papers, we punch well above our weight. We are the global leader on medical science and research per capita.
The Government place a very high priority on the promotion of medical innovation, not least because the context of our economy and the very urgent challenges faced by our health service demand that we significantly increase the pace at which we adopt innovation. The “Five Year Forward View” by the chief executive and the management team of NHS England, which landed on the Government’s doormat a year ago, powerfully sets out the scale of that challenge.
By the end of this Parliament, demand for healthcare will be rising fast. There are 1 million more pensioners in 2015 than there were in 2010, and there will be 1 million more in 2020, while thousands of people are now living to over 85. Those who heard the piece on Radio 4 this morning will know that we now have thousands of people living to over 100. Indeed, we have the oldest citizen of the globe in Britain: she is 114 today. Such a situation is a magnificent tribute to the extraordinary advances of our biomedical, life science and medical sector, but it of course creates added pressures on our health system because in the last decades of life our health demand rises exponentially.
The NHS has set out that, as a result of that rising demand and of the obesity and dementia epidemics in our society, health will require an extra £30 billion by the end of this Parliament. NHS England has stated that it can deal with £22 billion of that through the profound adoption of innovation to change care pathways —keeping people out of hospital, diagnosing earlier, treating smarter and embracing digital, genomic and a range of other technologies—but it has also stated that the NHS will need more money. I am delighted to be a Minister in a Government who immediately said we would put in the necessary money.
We will earn some of that money, not least through our leadership in the medical innovation and life sciences space. That is why the Prime Minister, the Chancellor and leading Ministers in the former coalition Government set out in 2011 the UK’s groundbreaking life science strategy. The Prime Minister launched it in December 2011, and it is now my great privilege to be the Minister with responsibility for its implementation. At the heart of the strategy is the belief that by profoundly integrating our NHS healthcare delivery system with our research and innovation sector we can achieve a win-win-win situation: we can improve healthcare productivity by embracing new technologies; we can do so in a way that drives investment into the UK; and we can make this country as much a leading pioneer in the research, development and commercialisation of life and health science research in the 21st century as it was in the 20th century.
As the Minister for Life Sciences in the Department of Health in combination, for the first time, with the Department for Business, Innovation and Skills, my mission is clear: to accelerate the uptake of innovation in our health system and to unleash the power of our health system as a research engine. Essentially, the model is based on two cylinders of support. We have traditionally supported our life science and healthcare innovation sector through BIS, with a set of policies on investing in deep science, translational infrastructure and skills, but we have now decided that in the 21st century we must integrate that with our health service. The second cylinder is the health system, which is pumping in access to data on the genome or tissues and to our £1 billion a year clinical research infrastructure. Just as importantly—this brings us to the nub of the Bill—it is accelerating the uptake of innovation in our health service. That is my mission and that of the Department of Health’s directorate of innovation, growth and technology, which the Government created at the same time as they set up my ministerial role.
Innovation is an urgent priority for this Government and, indeed, for all western Governments tackling the profound healthcare challenges caused by growing demand. That is why, during the past five years and during this Parliament, the NHS has made it such a priority. As other colleagues have mentioned, the essence of the strategy is set out in the NHS report on “Innovation, Health and Wealth”, which captures the mission I have described and sets out a huge range of initiatives designed to drive the uptake of innovation across the system. You will be relieved to hear, Madam Deputy Speaker, that I will not list those initiatives, because there are a huge number of them, but I reassure the House that we are monitoring their delivery closely. We have launched the innovation scorecard, and through the digitisation of CCG scorecards, we will shortly build in an uptake of innovation metric, so that patients and users across the system can begin to see from heat maps which CCGs or parts of our NHS are the most innovative.
The fundamental challenge remains that to be a competitive life and health science research economy and to drive innovation into our health system in the way we need, we must take a more profound approach to tackle the challenges and barriers. That is why I launched the accelerated access review last year, which seeks to address three important questions at the heart of this agenda. There is a new landscape because the model for the development of drugs is undergoing a profound change. The 20th-century model is very silo-ed: there is deep research on a drug in universities; it is spun out to companies, if they are lucky; it is funded and acquired by a pharmaceutical company, if they are lucky; and there is a 15-year development pathway—the average drug takes more than $2 billion and 15 years to develop—before it is brought back to the oh-so-patient patient waiting at the end of the chain. Our strategy recognises that that is too long and too expensive for patients, the industry and the NHS.
That problem is also an opportunity, because the profound advances in genomics and informatics mean that we are getting to a point where we no longer have to take that amount of time to de-risk the development pathway. In an era when a genomic biomarker can predict which patient will respond to a drug and which cohorts of patients will develop certain variations of a disease, we can dramatically accelerate the development of drugs and our ability to get innovations to patients in a way that hugely reduces the cost and the risk.
We are asking three questions at the heart of the accelerated access review, which a number of colleagues have asked about. First, what can we do to make it easier and quicker for innovators outside our health system to get clinical validation in the NHS? That would unleash not only the power of our £1 billion-a-year clinical research infrastructure, but the power of our NHS, which treats millions of patients every month, to act as an innovation platform, day in, day out.
Secondly, how do the new technologies of genomics and informatics change the way in which NICE and the regulators can assess, reimburse and work out the health economics in respect of innovations in the new landscape? When a drug comes to the system with a companion diagnostic and has an absolute guarantee of working in certain patients on the back of a genomic biomarker, it profoundly changes the way in which NICE is able to assess the drug. It unlocks the possibility of targeting drugs much more quickly at the right patients and changing the way in which we reimburse. We will be able to reimburse on the basis not of an average quality of life adjusted year, a notional price or a calculation of the health economic benefit for the average patient, but of real value in our health economy for different patient groups who respond in different ways to different drugs. Just as NICE took the lead in the 20th-century model of health economics, I want it to lead in the 21st century and to embrace the new technologies.
Thirdly—and this goes to the heart of the space in which the Bill is positioned—what can we do, when we have a proven innovation, to reduce the barriers to rolling it out across the system? The NHS has a mixed track record on innovation. On the one hand, it has pioneered brilliantly, particularly in our specialist tertiary research centres, innovations that have changed global medicine, some of which I have listed. On the other hand, we have been poor at rolling out innovations in our own system across the breadth of the country. Improving that is a key ambition of the AAR.
The Bill comes in the context of our asking what we can do to incentivise the uptake of best practice across the NHS. I will say a little more about the difference between innovation and research in a moment. The Bill’s focus on supporting 21st-century medics to be more aware of what is available to them when prescribing and its insistence on their sovereignty and freedom in making clinical judgments as professionals are important and helpful.
The glorious history of medical innovation has relied on profound scientific breakthroughs, some of which I have listed, but it also contains a long-standing pattern of unpredictable and accidental innovations, many of which have been profound and have delivered substantial benefits to patients. The discovery of penicillin was an observational accident by an inquiring mind. More recently—you may well know about this, Madam Deputy Speaker—Viagra was developed as a heart treatment and the discovery of the benefit that it is now used for was completely accidental. The company in question discovered that none of the sachets of the drug that it had sent out to patients for the trial, some of which are normally returned at the end of the trial with a medical form, were returned. That was quite striking to the company and when it asked why they had not been returned, it discovered that the drug had a completely different benefit, which led to its being relicensed and becoming the popular drug that it is today. Again, that completely accidental discovery has benefited millions of patients. It is important to understand that accident and observation have always played a powerful role in our leadership of life sciences and research.
I will have a go at defining the problem and the opportunity that the Bill rightly tries to address. I do not for a minute pretend that it is simple, as has been highlighted in this debate. If the Bill goes into Committee, I suspect that this is something that the Committee will want to look at. I suggest that we should be looking at three or four issues. The first is the barriers to the uptake of innovation in our health system. There are a number of barriers and I will not delay the House with a long exposition of them all. Suffice it to say that they are in part organisational, in part financial and in part cultural.
The most profound barrier to the uptake of innovation is that innovating in our health system normally requires the permission of an awful lot of people—not always clinical permission, but purchasing permission and procurement permission. As the health service rightly seeks to drive procurement efficiencies and control spending, we often inadvertently make it harder for people to innovate with treatments.
The biggest barrier in terms of substantial innovation in care pathways tends to be that the person who is asked to make the initial investment in a preventive treatment or any new treatment is often not the person on whose budget the benefits of improved treatment or outcomes will fall. The AAR is looking at that silo-ed budgeting and other organisational, financial and cultural barriers to the uptake of innovation in the system.
Procurement is an important factor. As part of Lord Carter’s review of procurement in the NHS and the Department’s efficiency drive, we are looking at how we can use the single purchaser advantage of the NHS to drive up procurement efficiencies and at how we can make it easier for front-line clinicians to innovate by making procurement decisions that drive efficiencies into their own local health economy, at whatever scale that is.
There is a barrier to innovation in respect of data. Information on innovative treatments and their benefits and on the improvements that different parts of the system are able to deliver is not always allowed to flow through our health system. Even today, there are huge differentials of efficiency and clinical outcome in different therapeutic areas that are not properly picked up or measured. That is part of what the programme of accountability and transparency that the Secretary of State and I are running through the CCG monitoring exercise and My NHS is intended to tackle.
Quite soon, we think that patients will want to click on My NHS and ask us the right questions, such as, “Why is my mother’s clinical outcome in Norfolk three or four times better or worse than my mother-in-law’s clinical prospects in London?” I do not for a minute seek to denigrate Norfolk’s health service—it is doing magnificently well—but my point is that there are regional variations. We want the public and patients to be aware of them and to ask their CCGs, the Government and their health professionals why they are there and what can be done to tackle them.
There have been a number of questions today about the fear of litigation. The Government’s consultation on the original Medical Innovation Bill highlighted some concerns about litigation. One difficulty is that much of the early reporting and discussion on that Bill created the impression that that was the problem that it sought to highlight. Of course, the picture is more subtle, difficult and complex than that, but it is worth highlighting that, as a number of colleagues have pointed out, the cost of clinical negligence claims to our health service is substantial. The latest figures that I have to hand state that in 2012-13, 10,000 claims were made and the payments totalled £1.2 billion. It is true that many of those claims related not to innovation, but to obstetrics and other standard procedures. However, the NHS is conscious of that bill and in most of our hospitals and other institutions, there is an acute awareness that we live in an ever more litigious society. Heaven forbid that we should ever become like America, where litigation is a daily routine in the health system, but we need to be aware of the risk. There is a legitimate fear among clinicians of doing anything that might trigger a reasonable or unreasonable claim for litigation.
Dr Wollaston
How much of the litigation cost is related to complaints about innovative treatments?
George Freeman
Most of the cases are a result of other contexts— as my hon. Friend will know, obstetrics is a big part of that—rather than innovation. I am happy to write to her with the actual figure as I do not have it to hand. My point is that the fear of litigation runs through the system.
I recently spoke to a senior paediatric consultant who is neutral about this Bill—he is neither a passionate advocate nor an opponent of it. He observed that over the past 20 or 30 years, a gradual conservatism has crept into clinical practice. When I asked what he thought drove that, he mentioned three things. First, ever tighter procurement control makes it harder to do things differently. Secondly, there is a subtly growing fear of negligence, and a lack of clear data information and guidance on what is available. Thirdly, many clinicians find it easier to stick to normal practice, and that is what the Bill seeks to tackle.
Heidi Alexander
The Minister and the hon. Member for Daventry (Chris Heaton-Harris) have referred to anecdotal remarks about fear of litigation being a barrier to medical innovation. Can the Minister set out his evidence that that is a widespread concern and genuinely prevents doctors from innovating and prescribing new treatments?
George Freeman
The hon. Lady makes an important point because it is difficult to quantify the impact of that fear. I have gone out of my way to make it clear that I do not think that issue is a primary concern, and that the organisational, cultural and financial barriers are higher concerns. That is partly what is difficult about the Bill. It gives the impression that fear of litigation is the big problem, whereas anecdotally I hear from leading clinicians—who, as I said, are not particularly for or against the Bill—that it is one of a number of issues in a complex landscape.
I am conscious of the time, so I will turn to the critical importance of patient and public trust and confidence in our clinical research infrastructure and NHS. The UK leads in clinical trials and in regulation through NICE, the Medicines and Healthcare Products Regulatory Agency, and our ethical framework. I am delighted that over the past four or five years we have made substantial improvements in recruiting more patients into trials. In 2014-15 the National Institute for Health Research—the jewel in the crown of NHS research—had 4,934 studies running, and last year we recruited 52 global first patients into trials. That is a key indicator of our leadership in the most innovative areas of medicine.
The MHRA has approved more than 80 first-in-human studies, and the NHS is becoming a leader in the forefront of that model of research, just as it was in the earlier part of the 20th century. It is also important to consider our leadership in regulation, ethics and approval, not least because those are major exports for this country. Over the next few decades, rapidly emerging economies will be looking for a lead from NICE, MHRA and our clinical trials infrastructure, and it is crucial to have a strong patient voice, and to maintain and develop patient trust. Central to my mission is to bring forward such development and put a stronger patient voice at the heart of our research landscape.
Patient empowerment through technology and access to innovation are key themes of our mission and work, and medical research charities have a huge role to play. In this new research landscape in which genomic information, patient data, records and medical histories become such key assets for research, the question is who will control that information. I think that we should build a policy landscape on the notion that such information and assets ultimately belong to the patient, and that the sovereignty of their relationship with their clinician should remain sacrosanct.
To answer an earlier question from the hon. Member for Lewisham East (Heidi Alexander), there is nothing in the Government’s plans to make such a database available to the public and drive the sort of quackery charter that I know the Chair of the Health Committee is worried about. We do not want to change the law that prevents pharmaceutical companies from talking to patients directly, and it is important that recruitment into clinical trials and access to innovation is done through patients and their clinicians.
Charities will have an increasingly important role. Cancer Research UK leads in much of this area, and many smaller charities are becoming strong advocates for their patients and collecting data. With the rise of apps and digital technologies, charities will soon create portals for patients to get involved in research communities, and work with industry and academics to drive and accelerate innovation.
Dr Wollaston
Does the Minister accept that all the bodies he has referred to, as well as the Association of Medical Research Charities, the Academy of Medical Sciences and the Academy of Medical Royal Colleges, have expressed concern that the Bill could undermine recruitment to clinical trials? That is an important point and I hope the Minister will accept that it is a genuine concern.
George Freeman
I was addressing that point to make it clear that I and the Government take strongly the need to ensure that the Bill does not undermine patient support in any way. I have heard some of those concerns, and if the Bill goes to Committee it is important to address them. It is also crucial to protect and support the sovereignty of clinicians to look after their patients, and to do as much as possible to try to liberate them from the burden of unnecessary bureaucracy and excessive targets. We must remind clinicians that they have freedoms in law and a vocational mission to do whatever they think is best for their patients.
On safeguards and protections let me make three important points about the Bill. I have taken advice from counsel, and I will respond to a number of questions raised by colleagues. As currently drafted the Bill provides no change to existing protections on medical negligence, and that is important. It sets out the power to create a database, and a mechanism to make clear to clinicians how they can demonstrate compliance with existing legal protection—the Bolam test has been referred to—and allow innovations to be recorded for the benefit of other clinicians and their patients. Importantly for the Government, that does not change existing protections on medical negligence, and it is crucial to understand that. Secondly, the Bill does not change our gold standard regulatory and ethical framework for clinical research. The Bill is not about research; it is about reinforcing freedoms for clinicians and how they prescribe. I will return to the detail of that in a minute.
Heidi Alexander
The Minister says that the Bill does not change the law on medical negligence but sets up an alternative pathway or framework. Does he accept that that could confuse matters?
George Freeman
That is an important question. The Bill does not change the legal framework on negligence; it merely seeks to clarify matters for those doctors who understand that they have the freedom to innovate but fear that current understanding in law about the test is not clear enough. It sets out an agreed, statutorily approved procedure to reassure doctors that if they follow that procedure, they will be covered by existing negligence and liability protection that the Bill does not change in any way. The hon. Lady’s second point is about whether people understand that, and whether there is a risk of the Bill inadvertently triggering fear. That is an important point, and it behoves everyone to ensure that we discuss it in the right way.
I have been shocked by some—not all—of the briefings, one of which referred to this being a “concentration camp” or a “Mengele” charter. Such unhelpful language triggers unhelpful media interest and will alarm patients completely unnecessarily. All the provisions in the Bill reinforce and endorse existing safeguards on the use of data and regulatory protection.
Time is short, but I want address the concerns that have been raised by hon. Members across the House. My hon. Friend the Member for Daventry gave a powerful speech and my hon. Friend the Member for Totnes (Dr Wollaston) made a number of interventions. There were contributions from my hon. Friends the Members for Beckenham (Bob Stewart), for Gainsborough (Sir Edward Leigh), for Bury North (Mr Nuttall) for Shipley (Philip Davies) and for Aldridge-Brownhills (Wendy Morton), and the hon. Members for Lewisham East and for Bolsover (Mr Skinner). I would like to take the opportunity to welcome the shadow Secretary of State to her post. I value hugely her offer to work on the Bill in a cross-party spirit and to deal with the issues raised. If the Bill goes to Committee, that will be an important offer. I am certainly happy to take it up and see, in a cross-party spirit, whether we can help to ensure that it does not trigger the doubts that she and other hon. Members have expressed concern about.
I want to address the specific concerns raised by my hon. Friend the Member for Totnes. She is a very distinguished Chairman of the Health Committee, as well as a doctor. For those reasons, they merit proper scrutiny and attention. I apologise to her if I am unable to deal with all of her concerns, but I will try to address them all.
The first concern is that the Bill is based on a false premise, which is that doctors are afraid to innovate because of fear of litigation. I reaffirm that the Department of Health’s consultation on the previous Medical Innovation Bill revealed that some doctors do find the threat of litigation to be a block to innovation, although that was not a universal view and I do not want to suggest in any way that it is the principal barrier. This Bill is aimed at reassuring those doctors who feel unable to innovate due to concerns about litigation. It sets out a series of steps that doctors can choose to take when innovating, to give them confidence that they have acted responsibly. I read the Bill again this morning and I am happy to highlight some of the key protections in it.
Dr Wollaston
Will the Minister clarify that the vast majority of medical bodies feel that it is not a barrier to innovation, and that there are some important points where we need to protect patients from irresponsible innovation? We have to accept that there is a risk inherent in going down a route that would make that possible.
George Freeman
My hon. Friend makes an important point about public trust, and patient safety and confidence. I do not want to detain the House by reading the relevant provisions in the Bill. I think my hon. Friend has tried, during the summer, to draft a Bill that deals with a number of those concerns. She makes the important point that if the Bill is inadvertently undermining public trust and confidence, that is in itself a problem. That is partly a function of how people discuss it and it is regrettable that the Bill has generated the level of antagonism it has, but she makes an important point that we should look at those specific measures and ensure we tackle the issues and concerns that leading doctors have raised.
Dr Wollaston
My initial point was whether the Minister would accept that the overwhelming number of respondents felt that fear of litigation was not the barrier?
George Freeman
I made the point earlier that the barriers to access of innovation are much broader than the fear of litigation, and I am happy to reinforce that.
Mr Steve Baker (Wycombe) (Con)
The Minister will know that in the treatment of wet AMD Lucentis costs £700 an injection and Avastin £60. Does he think the Bill could help clinicians use Avastin to treat wet AMD, thereby saving the NHS, I understand, some £84 million?
George Freeman
My hon. Friend is quick to leap on to a very important point. The answer is no, because in law we have an important provision to protect people who invest billions of pounds in developing new innovations. Clinicians are free to use alternative off-label drugs where there is evidence they work, but not on the basis of cost. We have a presumption in law that where a drug is licensed or on patent for a particular indagation, which is the protection for the company that has invested to bring the drug to market, we allow an alternative to be used only where there is clinical evidence, not on cost grounds. The price falls dramatically when drugs come off patent and the generics industry picks them up. There is price protection for a short period of patent life to create the incentive for people to make the extraordinary investments up front. We then get the benefit of cheap drugs through the generics sector.
Mr Baker
The Minister raises a critical point. I am concerned that cost grounds do matter and that some people might be going without early treatment for wet AMD, because they cannot, for a range of reasons, access Avastin. My concern is that people might be going untreated for wet AMD at a point when the relevant drug, Avastin, might help them more than Lucentis at a later stage.
George Freeman
My hon. Friend makes an important point. The NICE clinical guidance to NHS England, after carrying out a health technology appraisal, is binding. NHS England has a duty to implement it across the system. There is an issue about how quickly different parts of the NHS implement guidance and how quickly innovative drugs are rolled out. Another Bill going through the House will be looking at what can be done to support the use of off-label drugs. My position on that is that the most profound barrier to the adoption of off-label drugs is in fact information for clinicians on the clinical benefits of an off-label indagation. It is the clinical evidence that provides the basis on which they are perfectly free at the moment to use alternative drugs.
Let me address the other points raised by my hon. Friend the Member for Totnes, the Chairman of the Select Committee. She expressed concern that the Bill would undermine research and clinical trials. That is an important point. I stress that the Bill, as drafted, does not cover clinical trials, which are regulated by the MHRA and the HRA from a scientific, safety and ethical viewpoint. Rightly, the Bill does not stray into that regulatory environment. I confirm that we would be concerned if it did. It does not relate to formal clinical research, only to clinicians’ duties to their care of individual patients. If the database is got right, we think it could contribute to the sum of healthcare knowledge by collecting information on innovations and their success or not.
My hon. Friend said that she fears the Bill would do more harm than good. I merely point out that the chief medical officer for England supported the final version of the Medical Innovation Bill, which ran out of time in the House of Lords at the end of the previous Parliament. The national clinical director for NHS England confirmed that he had no concerns about patients’ safety with regard to that Bill. Hon. Members may debate whether the Bill is needed, but it is really important to understand that we are clear that the Bill in no way damages patient safety. The test of responsibility under the Bill is intended to reflect absolutely the requirement of the Bolam test, which has been the gold standard for decades. I highlight that a doctor has to obtain any consents required by law when taking a decision to part from the existing range of medical treatments. The Bill expressly provides that a doctor must have regard in particular to the requirements of patient safety. Under both existing common law and the Bill, the doctor would need to show that they had acted responsibly. There is absolutely no escape for a negligent doctor under the Bill. The Bill seeks to give doctors access to the database as a source of learning—doctors, not patients. We hope that if the database has got right it could help to drive both innovation and information through the system.
My hon. Friend set out some concerns about safeguards for patients. I reiterate that the Government are clear that the negligence provisions in the Bill do not provide any immunity to irresponsible doctors. It would be irresponsible for anyone to suggest that they do. I want to make that point very clearly from the Dispatch Box and to reassure her that in our view the Bill does not remove any of the current safeguards in place to protect patients’ safety. Our view is that the Bill does not apply a weaker test to a doctor’s decision to innovate than the existing law on clinical negligence.
My hon. Friend raised points about the rigour of the database, which I will come on to in a moment. A number of other concerns have been raised. I want to run quickly through, in two batches, the concerns about the database and about negligence and legal protections. Colleagues have asked whether there is really a need for legislation for a database. I confirm that the Bill gives power to the Secretary of State to confer functions on the Health and Social Care Information Centre in relation to the establishment of a database. Legislation enables provision to be made for the disclosure of information from the databases, ensuring that the HSCIC has the necessary powers to disclose information and that appropriate safeguards are in place. Were the Bill to become law, we would obviously consult on regulations setting out the detail of how the database would be constructed.
Heidi Alexander
Does that power not exist under section 254 of the Health and Social Care Act 2012?
George Freeman
The hon. Lady might be surprised to know I do not have that section right in front of me, but I will happily come back to her. The Bill would allow a database to be created for specific purposes. It is not for me to judge the merits of the wording of different private Members’ Bills, but this would not be the first such Bill to command the authority of the House and then to be rewritten to put into effect the ambitions it sets out. I think, however, that the Bill goes a lot further than the existing powers in requiring us to consider a database with specific functions linked to providing a mechanism of statutory protections for clinicians under existing law. We understand what it is trying to achieve, although it is complex in that it does not change the legal protections but merely sets out a particular runway in which clinicians can have confidence.
Questions have been asked about how the database will work. As I have said, if the Bill becomes law, we will want to consult on regulations, but it is intended to be principally for the use of medical practitioners, not patients. We would not support the Bill if it were to be a database—my hon. Friend the Chair of the Select Committee expressed concern about that point—providing support for companies, quacks and unregulated providers to contact patients directly and to validate illegitimate innovations. It is for clinicians to record the innovations that they, in their professional judgment, have decided to adopt. We would envisage the database being used to flag a treatment as innovative, meaning it would be coded and picked up by the HSCIC, allowing us to form a national database.
Questions have been asked about who would submit information to the database. As with all data provisions, patient confidentiality will absolutely be protected. I would envisage the detail of who could access information, and in what circumstances, being a source of substantial discussion, if and when we came to pass regulations. I stress, however, that it would not be used by patients. We could not support that.
Questions have also been asked about who would determine which groups could get information. It is designed for clinicians, the HSCIC and regulators. At the moment, a doctor passing information to the HSCIC is bound by the common law duty of confidentiality and their professional obligations. The HSCIC would need to be satisfied that any disclosure was in accordance with the law, including the Data Protection Act 1998.
Hon. Members asked about funding. The exact level of grant in aid required would be subject to additional scoping by the HSCIC, and if the House decided to proceed, we would need to come back with the details. Hon. Members also asked whether the treatments in the database would be flagged with some kitemark or advert. The Government would oppose this being used as a marketing tool. Such flagging by means of kitemarks, being regulated differently, would not be appropriate. We want a database focused on helping doctors to see what other clinicians have decided is an appropriate treatment. We would see the database not as a process of quality assurance, but as a way for doctors to learn from and see transparently what other doctors have decided is an appropriate treatment.
I turn quickly to the negligence and regulatory questions. Colleagues have asked whether the negligence provisions provide another way for doctors to carry out research, circumventing the usual safeguards. The answer is an emphatic no. The Bill would apply not to research, but only to individual treatment decisions, as clarified in clause 5(2). Research is highly regulated—rightly so—by the Health Research Authority and the MHRA. Research studies cannot go ahead without ethical approval overseen by the HRA, and research that involves clinical trials and the investigation of medicinal products must be thus authorised. The Bill is concerned with innovations in individual treatments by clinicians. The results of an innovation might trigger further research—I think my hon. Friend the Member for Daventry envisages the database triggering questions such as, “Well, if one or two clinicians think this is an appropriate innovation, shouldn’t we look at whether it might be more widely applicable?”—but that would then take it into the more formal jurisdiction of a research application.
Hon. Members asked whether the Bill would relate to clinical trials. It is important to note that it does not cover clinical trials, which are regulated by the MHRA and the HRA. We would not want the Bill to stray into that territory and risk undermining that international gold mark of UK clinical trials infrastructure. It has been asked whether innovation is just the same as research. I strongly believe they are not the same thing, although they are often confused. They are closely related, but they are not the same thing. Research is highly regulated; innovation is the application of different ways of practising medicine, which clinicians have always done. That is partly what makes it hard to regulate and why the Bill has raised the questions it has.
Hon. Members asked whether patients would be asked for their consent before being given an innovative treatment. Yes, patients would have to give their consent. There is no change to the law of consent, which requires patients to provide informed and voluntary consent to any treatment offered. Colleagues have also asked whether the Government support the Bill in the light of the concerns raised by the medical profession about its impact on patient safety. I will confirm the Government’s position in a moment, but we believe it is an important and timely debate for the reasons I have set out, and we support the intentions behind the Bill. My hon. Friend has engaged with those who have raised concerns, and if the Bill goes to Committee, issues raised today would need to be tackled, but in the view of the Government and parliamentary counsel it does not undermine the current law on clinical negligence.
It has been asked in the House this morning and in the run-up to the debate whether the Bill is safe for patients. I again repeat that the Bill does not remove any of the current safeguards on patient safety. The test of responsibility in the Bill is intended to be the nearest possible equivalent to the Bolam test. It simply seeks to provide clarity via a mechanism by which doctors can be sure they are complying with that test.
Heidi Alexander
As I understand it, the current test requires a doctor to seek the advice and medical opinion of a responsible body, while the arrangements in the Bill require them to seek someone else’s view on whether such a responsible body holds an opinion about the safety of treatment. I think those two things are slightly different. Does the Minister share that concern?
George Freeman
The hon. Lady raises an interesting point. I am just looking at clause 3(2):
“For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, a doctor must in particular—
(a) obtain the views of one or more appropriately qualified doctors in relation to the proposed medical treatment, with a view to ascertaining whether the treatment would have the support of a responsible body of medical opinion,
(b)take full account of the views obtained…(and do so in a way in which any responsible doctor would be expected to take account of…),
(c) obtain any consents required by law”,
including
(d)(i) any opinions or requests expressed by or in relation to the patient,
(ii) the risks and benefits”
and to
(e) take such other steps as are necessary to secure that the decision is made in a way that is accountable and transparent.”
Let me repeat that we would not even countenance supporting the Bill if its intention were in any way to change the basic test of clinical professionalism to which every clinician is subject. They remain subject to all the professional safeguards of the GMC and other regulatory bodies and clinical negligence law. The Bill merely seeks to put in place one particular mechanism on which doctors can rely to be clear that the innovation they propose is in accordance with the law. There is a danger of thinking of that if this Bill ever became law, it would be the last and final word on the area of medical innovation. It would absolutely not be; it is a small contribution to a vast canon of common law and practice that—importantly for the Government—does not change.
Counsel’s advice to us has been very clear that the negligence provisions provide no immunity to irresponsible doctors. Under both existing common law and this Bill’s provisions, doctors will need to show that they have acted responsibly. There will be no escape for a negligent doctor.
Members have asked whether the Bill will allow doctors to prescribe untested medicines. It is important to make it clear that the Bill does not change existing medicines legislation, which permits the use of unlicensed medicines —tested or untested—prescribed by physicians on their own responsibility, subject to all their own professional tests, regulatory conditions and the law. This will be based on what they believe, in their own professional clinical judgment, is right for their patients. If there is an unmet medical need, there is clearly more scope for clinicians to innovate.
Finally, I was asked whether the Bill will prevent patients from making a claim if they receive negligent treatment. No. I want to be clear that this Bill in no way changes patients’ rights to claim for negligent treatment. We are completely committed to ensuring that patients are safe and protected. On the occasions when, regrettably, things go wrong and treatment has been given negligently, it is absolutely right that patients are entitled to seek compensation. It is essential that any new legislation or any amendments to the Bill do not put patients at risk in any way. If a doctor carries out a procedure negligently, they would not be protected by this Bill, as is made clear in clause 4(3).
In conclusion, let me highlight that although substantial concerns have been raised—my hon. Friend the Member for Totnes has expressed some of them this morning—it is true to say that there has been support for the Bill. The “Empower: Access to Medicine” campaign has said:
“This new Bill provides a real opportunity to renew the focus on patients’ rights to try innovative medicines within a reasonable risk framework. Empower: Access to Medicine has long advocated appropriate access, for some patients, to certain medicines earlier in the clinical trials process. Chris Heaton-Harris’ new Bill provides a real opportunity to make that ambition a reality.”
It is particularly supportive of the accelerated access review that I am running. A number of colleagues have suggested that we look at the Bill in the context of those recommendations that will shortly arrive on my desk.
The Royal College of Physicians has said that it
“generally welcomes the first part of the Bill to enable the secretary of state…to establish a database of medical treatments. However, the RCP strongly recommends that the medical and research communities should lead in developing the database.”
If the Bill becomes law, it is very important for that to happen. I understand that the RCP has particular concerns about the second half of the Bill.
Let me also highlight what was said in the extensive discussion of the Medical Innovation Bill, which was launched in the other place. The chief medical officer, Dame Sally Davies, said that she was
“confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”
She was referring to the provisions in the second half of the Bill. Sir Bruce Keogh, clinical director of NHS England said, in connection with the same provisions in the former Bill:
“Encouraging innovation in medicine and protecting patients are both of vital importance. This 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 Medical Innovation Bill would
“allow responsible innovation in treatment...I believe that 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.”
I appreciate that there are real issues of contention and debate, but I wanted to highlight the views of eminent people on both sides of the debate, of which the House should be cognisant.
I was particularly struck by the comments of the hon. Member for Lewisham East. At the end of the last Parliament, her predecessor as shadow Health Secretary said, interestingly, that he was “disappointed” that the Liberal Democrats had withdrawn their support for the Bill. He said that
“there should at least have been some cross-party talks about this”,
and I was glad to hear the hon. Lady echo that view this morning. He went on to say:
“The Bill was heavily amended and extra safeguards put in, and I worry a little bit that those who are opposed to it don’t realise that it is actually quite a different Bill now.”
He said that for parents whose children suffered from untreatable diseases and had no hope, the Bill was “about opening up hope”, and added:
“It is often parents who struggle to get their voice heard”.
In the other place, although some peers had concerns about the Bill, a number of others supported it. I have a list in front of me, which shows that the numbers were equal on both sides. It also shows that some pretty eminent peers supported the Bill: Lord Kakkar, Lord Patel, Lord Ribeiro, Lord Mackay, Lord Woolf, Baroness Gardner, Lord O’Donnell, Baroness Butler-Sloss and Lord Blencathra. Those are all eminent people in their fields. I am not suggesting for a minute that there is not a debate, but I think it is a genuine debate, which is, after all, what the House is here to provide.
The Government support the intention of the Bill to promote innovation, to reinforce existing medical negligence law, to promote the dissemination of information on innovations, to protect and reinforce the sovereignty and the freedom of clinicians to vary and innovate treatment in the interests of their patients, and to promote the use of identification and data on innovation as critical to 21st-century healthcare. We are—and I am— very concerned to ensure that the Bill promotes, rather than undermines, patients’ and doctors’ trust in the legal and regulatory framework for innovation, to ensure that it fits into the wider landscape and framework for innovation that I—along with various bodies—am putting in place, and to ensure that it reflects and supports the growing discussion about research medicine and innovation.
The House has many and varied ways of improving the lot of our citizens, and private Members' Bills are one important way. As you well know, Madam Deputy Speaker, we Ministers are normally sceptical about the virtues of private Members' Bills, and jealously guard our, and the Government’s, unique monopoly on legislative virtue and competence; but I believe that when a Bill—such as this Bill—seeks to do something that we support, even if the mechanics proposed may not yet be perfect, there is a strong argument for it to proceed to a Committee stage and be subjected to detailed scrutiny. I hope that the Bill is given such a hearing in Committee. The hon. Member for Lewisham East has signalled her willingness to work on a cross-party basis to try to get the Bill into a shape that will address the concerns that have been expressed, and I was delighted to hear my hon. Friend the Member for Totnes make a similar offer.
Heidi Alexander
I am slightly worried that the Minister is ascribing to me words that I have not used. I have indicated a willingness to work on a cross-party basis to address the barriers to innovation, but, as the Minister will have heard me say in my speech, I have very serious reservations about the Bill, and I intend to oppose it today.
Dr Wollaston
Perhaps the Minister will give me an opportunity to clarify my position as well. I shall robustly oppose the Bill’s Second Reading. As the Minister has said, we all support the principles and aims of the Bill, but many of us robustly reject the notion that this is the way in which to achieve them.
The Minister has quoted two bodies that he says support the Bill, one of which disagrees with half of it. Does he accept that the Association of Medical Research Charities, the Academy of Medical Sciences, the Academy of Medical Royal Colleges, the British Medical Association, the General Medical Council, the Patients Association, Action against Medical Accidents, and even the Association of the British Pharmaceutical Industry—as well as legal experts such as Sir Robert Francis—all oppose the Bill? It reads like an A to Z of opposition. All those bodies would work with the Government if the Bill were given a Second Reading, but they robustly reject the notion that this is the right way in which to achieve its aims. Does the Minister accept that list, and does he accept that, according to the vast majority of opinion, this is the wrong way forward?
George Freeman
I well accept that views on the merits of this Bill are divided, not least for the reasons I have highlighted in my speech. Some of the commentary on it, referring to it as the Mengele Bill for example, has played a very damaging part in misrepresenting—[Interruption.] I can show the hon. Member for Lewisham East the briefing after the debate if she would be interested.
It is important that colleagues decide for themselves whether to vote for this Bill. My own view, and the Government’s view, is that it is seeking to address a matter of public policy that we share in terms of promoting access to innovation. The measures in the Bill may not be quite perfect; it would not be the first Bill to be in that situation, and I dare say many of our proudest legislative breakthroughs going right back to the 18th and 19th centuries started in a format that possibly did not command unanimous support. I would have thought it is worth us debating this further in Committee, but I reiterate that if we cannot get a Bill into a position where it clearly has, and reinforces, public and clinician support from our world-leading expertise in research medicine and clinical practice, and if it any way undermines patient trust and confidence, it would be retrograde.
I think this Bill is trying to do something laudable, however; I think my hon. Friend the Member for Daventry is trying to do something laudable. This is a complex field, and the Government are trying to put in place the right measures, and I thank him for raising it—and I thank you, Madam Deputy Speaker, for allowing me to respond in full.
Oral Answers to Questions
George Freeman Excerpts(9 years, 1 month ago)
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Paul Maynard (Blackpool North and Cleveleys) (Con)
10. What plans he has to review renewal arrangements for the issuing of NHS medical exemption certificates.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
Medical exemption certificates excluding patients with long-term conditions have been in place since the 1960s. The requirement to renew the certificate every five years has been in place since at least 2002 and we have no plans to review it.
Paul Maynard
The Minister will be aware that, over the summer, there has been media coverage of patients with ongoing and exempt conditions being penalised for not having an up-to-date exemption certificate. Because the renewal period is five years long, the NHS Business Services Authority’s address database gets out of date very quickly and many people have been penalised for inadvertently not renewing their certificate because the database held an out-of-date address for them. What more can be done to assist the authority and the patients, perhaps by introducing a shorter renewal period, and to ensure that this stops occurring?
George Freeman
I pay tribute to my hon. Friend, who has first-hand experience of this matter. It is true that people who are responsible for ensuring that they hold a certificate when claiming the exemption could be subject to genuine mistakes. That is why we responded to the feedback this summer and put measures in place so that if someone submits a valid medical exemption certificate within 60 days of a penalty charge notice, the penalty charge will be cancelled. It is also worth remembering that all patients on benefits or on the NHS low income scheme are exempt anyway, and that patients who require frequent prescriptions can enrol for a pre-payment certificate, which costs no more than £100 a year.
Keith Vaz (Leicester East) (Lab)
There are 3.3 million diabetics in this country, including myself, who are entitled to these certificates. This is not special pleading, but the issue is that when they come to renew they do need help. As the hon. Member for Blackpool North and Cleveleys (Paul Maynard) has said, it is difficult for them to fill in some of these forms. Will the Minister ensure that local GP practices are able to help people if they need assistance in filling in these forms?
George Freeman
I will happily look into that specific issue, discuss it with the right hon. Gentleman and see whether there is anything we need to do.
Christina Rees (Neath) (Lab)
11. What steps he is taking to improve support for carers.
Tom Pursglove (Corby) (Con)
14. What steps he is taking to ensure consistency in services and treatment throughout the NHS.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
The mandate for NHS England sets out our national ambitions for the health service across England. NHS England and the clinical commissioning groups are responsible for working with local providers. To ensure quality and consistency, the Care Quality Commission has developed a set of fundamental standards. The National Institute for Health and Care Excellence also provides a range of guidance and quality standards, and the Department of Health has established the MyNHS website to highlight regional variations and use transparency to drive improvement across the system.
Tom Pursglove
I thank the Minister for that answer, but earlier this year figures published by Public Health England showed that more people under the age of 75 die from cancer in Corby than anywhere else in England. What steps are Ministers taking to help to improve those rates? They are stubbornly high, and we need to stop the higher prevalence of cancer in our area.
George Freeman
My hon. Friend makes an important point. The Government are absolutely committed to world-class cancer care, which is why we put £1 billion into the cancer drugs fund. We have seen a huge 71% increase in cancer referrals, with 40,000 more patients treated, and a new cancer strategy has just been set out. It is true that the incidence of cancer in my hon. Friend’s constituency is regrettably high, and Corby CCG has significantly worse cancer outcomes. That has been recognised and the 2015-16 commissioning plan puts in place a series of measures on cancer, including improving earlier diagnosis, providing treatment within 62-day referral targets and implementing the national cancer survivorship programme.
Mr Dennis Skinner (Bolsover) (Lab)
Creswell in my constituency of Bolsover has been trying to get a health service centre, but that small ex-pit village has been unable to get it because NHS Property Services has been arguing with the CCG and others within the national health service. Despite efforts and letters to Ministers, the village is still waiting for the health service that it has been trying to get ever since this Secretary of State got his job under the coalition. If Ministers want some consistency throughout the land, they should give that deprived ex-pit village a new health service: knock some heads together and get it done.
George Freeman
It is a pleasure to take my first question from the hon. Gentleman. I thought I needed my ears cleaning, but I clearly do not. I will happily talk to him about the issue in his constituency, but the truth is that local CCGs are responsible for commissioning local services. I will happily, as a Health Minister, talk to him about what needs to be done.
Adult Stem Cells and Life Sciences
George Freeman Excerpts(9 years, 2 months ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
I congratulate my hon. Friend the Member for Enfield, Southgate (Mr Burrowes) on securing this Adjournment debate on this crucial topic. I also thank Members from across the House—the hon. Members for Torfaen (Nick Thomas-Symonds), for Strangford (Jim Shannon) and for Alyn and Deeside (Mark Tami), my hon. Friend the Member for Congleton (Fiona Bruce) and the hon. Member for North Tyneside (Mary Glindon)—for staying late to raise and support this important issue. Let me take the opportunity to pay tribute to the Anthony Nolan trust, and to the work of the many volunteers who support its work around the country and the partnership it has established with the NHS and with the National Institute for Health Research. I have been invited by them twice to visit the facilities and I am very keen to do that. I want to put on the record that the only reason those two visits had to be rearranged was the intrusion of the general election, and I look forward to visiting as soon as I can.
As my hon. Friend the Member for Enfield, Southgate has made clear, stem cell transplantation is a life-saving treatment that plays a key role in the treatment of leukaemia and some other diseases. Almost 4,000 patients a year receive this type of treatment. Many patients are fortunate to have a closely related family member who can donate stem cells, but the treatment of more than 1,000 patients depends on stem cells from a suitable unrelated donor. The Department of Health has invested significantly in this area and since 2011 will have provided a total of £19 million in funding to establish and staff a series of donor centres around the country. Earlier in the year, I was delighted to announce the latest £3 million of funding, and just this week we have seen the formal opening of the £3 million blood and transplant research unit down in Bristol, where red blood cells are being manufactured from stem cells. It is based in Filton and is the world’s largest blood bank. It is one of four new NIHR-funded blood and transplant units—part of the £15 million programme the NIHR is putting in place. The latest analysis by the UK stem cell strategy oversight committee is that this funding has directly led to approximately 130 additional patients each year receiving a transplant.
That great achievement relies on not only the dedicated clinical teams working in hospitals across the UK, but the effective partnership between NHS Blood and Transplant and the charity Anthony Nolan. I want to take this opportunity to pay tribute to Professor Charlie Craddock and the work that he and all those involved in the trials acceleration programme are doing. They are, in many ways, trailblazers for the wider programme of accelerated access that I am leading through the accelerated access review. The Institute of Translational Medicine in Birmingham is breaking new ground on how we can take science into NHS practice.
The Government have also directly funded the creation of a unified registry—the Anthony Nolan and NHS stem cell registry—that ties together the different databases across the UK, making searching for a suitable donor quicker and easier. The number of registered donors continues to grow, and I am delighted that last year the registry passed the 1 million mark.
As hon. Members have highlighted, this is not just about the quantity; it is also about the quality. In response to the recommendations from the oversight committee, the funding from the Department of Health has specifically been used to create a panel of young male donors, who are much more likely to be able to donate. That panel now exceeds 70,000 and continues to grow. The data clearly show that that has been an effective strategy and that those young men are several times more likely to be asked to donate than others on the registry.
Finding a suitable donor is not the same for all patients. There is a global shortage of donors for patients from minority groups and those with diverse origins. To address that, the Government supported the targeted recruitment of donors from the black, Asian and minority ethnic community, which has now increased the chance of a patient finding a suitable well-matched donor from only 40% in 2010 to 60% today. It should be noted that our work with minority communities is supported by a number of partners in the charitable sector, such as the African Caribbean Leukaemia Trust, and more widely the Department continues to work with NBTA—the National BAME Transplant Alliance—which co-ordinates the work of those organisations on all forms of donation, including bone marrow.
It is an unfortunate fact that for many patients, finding a suitably matched donor will remain very difficult if not impossible, and in those situations umbilical cord blood might offer an alternative source of stem cells. Cells isolated from the umbilical cord are much more tolerant of slight mismatches and can be just as clinically effective as adult bone marrow and, unsurprisingly, BAME patients are almost six times more likely than Caucasian patients to receive stem cells from the umbilical cord. That is why funding from the Department has supported the targeted collection of high-quality cord blood samples. Both NHS Blood and Transplant and Anthony Nolan run dedicated units to collect cord blood and they have a specific target of collecting 40% of samples from BAME parents. The NHS cord blood bank now has more than 12,000 high-quality samples and, as a consequence, many more patients are now receiving cord blood samples obtained in the UK, making transplantation quicker and easier.
We continue to explore how transplantation can be improved, including clinical outcomes. I am aware that the NIHR Office for Clinical Research Infrastructure, NOCRI, has been in discussion with the University Hospitals Birmingham NHS Foundation Trust and other stakeholders to explore how it might be possible further to build on the NIHR national clinical research networks. The NIHR welcomes applications on any aspect of research related to stem cell transplantation and those applications are subject in the normal way to peer review and judged on the basis of scientific quality and the importance of the subject to patients and the healthcare service. The collection of clinical outcome data, which has been mentioned by a number of colleagues, remains an important issue within stem cell transplantation, which is why some of this year’s stem cell improvement funding of £3 million has been earmarked specifically to support data collection. That is an issue that the hon. Member for Torfaen has highlighted.
Such initiatives complement at every level the broader work we are doing to support the new life science landscape in which genomics and informatics drive better targeted treatments. When we are thinking of the future of stem cell transplantation in the UK, it is important to see it as part of a much wider strategy for the development of regenerative medicine. When we identified regenerative medicine as one of the eight great technologies in 2012 in the Department for Business, Innovation and Skills, it was largely on the basis of its theoretical potential to develop into a significant sector, but in the past few years we have seen an explosion of activity in this field, justifying that investment. Much of the work is, of course, for small and medium-sized enterprises.
We have not only established through the work of Innovate UK the Cell Therapy Catapult but have provided £55 million of funding to build the cell therapy manufacturing centre in Stevenage. That centre will enable UK and global companies that are looking to scale up to phase 3 manufacturing, solving a key barrier identified in the translation of research into commercially viable products. When that facility opens in 2017, it alone will support the creation of up to 150 new jobs on the Stevenage campus.
The creation of such centres of excellence attracts further inward investment and current estimates are that the sector will grow within the next 10 years to be worth £1.2 billion here in the UK. The Government have worked to co-ordinate funding across the regenerative medicine sector through initiatives such as the UK regenerative medicine platform, driven by Innovate UK. The unique role played by NHSBT is notable in this respect. It already has experience in cell processing, storage and delivery of living cell-based therapies from its work with blood supply and it will have a key role in the development of the logistics systems to respond to the specific requirements for regenerative medicine. In the coming years, the number of cell therapies and their clinical impact will expand far beyond their current use in transplantation, but will none the less rely on this key foundation. NHSBT is more than just a specialist logistics organisation; it has the ambition and potential to play an important role in the development and adoption of a wide range of novel therapies. It has already set in place a number of regenerative medicine projects, working in partnership with universities and the commercial sector.
Preparing the NHS for the novel regenerative therapies was a key aim of the regenerative medicine expert group, and am I pleased to say that the excellent report published in March this year contained a number of clear recommendations. To ensure that those recommendations are acted upon, I have asked the chief executive officers of the key delivery organisations to take them forward. I look forward to receiving their update in due course.
My hon. Friend asked whether I would be prepared to meet the all-party group on stem cell transplantation. I would be delighted to meet the group. In fact, I want to take this opportunity to announce that, in order to facilitate the process of submitting applications to the National Institute for Health Research, I am in the process of organising an NIHR parliamentary moment—I hope that it will become a parliamentary day—at which that great institution, which spends £1 billion a year on front-line clinical research at the heart of the NHS, can come to Parliament and set out for colleagues across the House the different programmes that we are running in the different disease areas and how applications can be made. I hope that the all-party group, along with the Anthony Nolan trust and clinicians such as Charlie Craddock, will play a role in making applications to the NIHR.
I echo my hon. Friend’s call for donor volunteers to come forward. I congratulate those, such as my hon. Friend the Member for Salisbury (John Glen), who have already led the way by donating. The truth is that progress in biomedical science, cell therapy, genomics, informatics and the development of autologous stem cells—stem cells that do not require donation—is moving at an incredible pace. I recently visited the Berlin institute for stem cell therapy, and the extraordinary advances across Europe are bringing within our range a whole new world of regenerative medicines based on autologous, manufactured stem cells that do not require donation. There is a whole new class of therapeutics, with the T cell and the immunotherapy drugs, which we hope will mean that in due course we can treat some of these cancers without that therapy being necessary. For now, however, it is our line of last resort, so it is crucial that we support that work and encourage and support donors to come forward.
Mr Burrowes
I welcome the Minister’s call for donors. I want to return to the point about trying to get the life sciences industry more involved. The Minister mentioned that it was largely SME-based. Although there has been public sector and charity involvement in the early stage of development, industry investment has been moderate. What does he put that down to, and how can we try to encourage the bigger life sciences industry to get involved?
George Freeman
My hon. Friend makes a good point. As in some other sectors, such as malaria, where the commercial models are not as well developed or as clear, there is a role for the Government, which is why we have set up the strategy and the partnerships. By de-risking and supporting the deep science in the early stages and bringing forward these partnerships of support, we hope to make it a sector in which more and more companies are beginning to see a return, and then they will start to invest their own money. All the indications are that that is beginning to happen here in the UK.
Mary Glindon
Will the Minister therefore ensure that the Government will continue to support the science budget in the years ahead?
George Freeman
Much as I would like to, I cannot take on the role of my right hon. Friend the Chancellor and announce the results of the autumn statement. I hope that the hon. Lady will see that our commitment to, and support for, the sector is clear. I am confident that we will see a continuation of that support for science in the autumn statement. We all know that funding is tight. The key is to demonstrate clinical impact and partnerships of support with companies.
I think that this is a great success story. I pay tribute once again to the Anthony Nolan trust, whose partnership with the NHS is genuinely changing outcomes for patients.
Question put and agreed to.
Arm's Length Bodies
George Freeman Excerpts(9 years, 4 months ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
The Department of Health has completed its triennial reviews of the Advisory Committee on Clinical Excellence Awards (ACCEA), the Medicines and Healthcare Products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the NHS Litigation Authority (NHSLA), and is today publishing the associated review reports.
The four reviews, which commenced on 15 January 2015 (ACCEA), 30 October 2014 (MHRA and NICE) and 16 October 2014 (NHSLA), consulted with a wide range of stakeholders. Their key conclusions are that all the organisations perform necessary functions. However, all the review reports make a number of recommendations— primarily around communications and engagement, efficiency and governance—that aim to improve performance further.
Copies of all four reports and associated annexes can be viewed online at: http://www.parliament.uk/writtenstatements
[HCWS170]
Oral Answers to Questions
George Freeman Excerpts(9 years, 4 months ago)
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Harry Harpham (Sheffield, Brightside and Hillsborough) (Lab)
3. What steps he is taking to ensure that clinical commissioning groups routinely fund cough-assist machines for people with muscle-wasting conditions when a clinical need has been identified.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
Muscle-wasting conditions associated with neurodegenerative disorders affect about 60,000 people in England at the moment. The Government are supporting research through the National Institute for Health Research, totalling £39 million. NHS England, CCGs and Muscular Dystrophy UK have come together and are jointly working on the “Bridging the Gap” report to improve neuromuscular disease, and the Department of Health is supporting this work with funding of £600,000. Decisions on the funding of cough-assist machines are rightly the responsibility of CCGs on a case-by-case basis.
Harry Harpham
As revealed in Muscular Dystrophy UK’s “Right to breathe” report published in February 2015, in some areas of the country patients have access to cough-assist machines which the local clinical commissioning group will not fund in other areas, despite a clinical need being clearly identified. These machines can help to prevent potentially fatal respiratory problems and to reduce costs and lengthy, unplanned hospital visits. A cough-assist machine costs £4,500, whereas a long stay in an intensive care unit can cost more than £13,000. [Interruption.] Will the Minister meet me and representatives of Muscular Dystrophy UK to discuss how better consistency in provision of vital respiratory equipment—
George Freeman
My answer of a few moments ago stands. Decisions on the commissioning of those machines are taken on a case-by-case basis locally. The National Institute for Health and Care Excellence has set out in guidance that cough-assist machines may be appropriate for some patients, but not in every area.
Richard Harrington (Watford) (Con)
4. For what reasons his Department categorises corrective refractive eye surgery for medical purposes as cosmetic surgery.
Mr Speaker
They do not need my help, but they might need that of the Minister.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
I can confirm that the Minister for Community and Social Care will be delighted to meet my hon. Friend. NHS England is looking into how the fair funding formula works between different clinical commissioning groups, which is the reason for the uncertainty, and I, too, would be happy to meet my hon. Friend and confirm the process.
Richard Burgon (Leeds East) (Lab)
T8. Millions of people are worried about the privatisation of our national health service, so it is a real concern that the health sector remains part of the negotiations on the Transatlantic Trade and Investment Partnership. Tomorrow the European Parliament votes on TTIP, but the European Commission has already said it will not remove health from those negotiations, so can the Government confirm that they will defend the NHS and support the removal of health and other public services from future TTIP negotiations?
Fibromyalgia
George Freeman Excerpts(9 years, 4 months ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
I congratulate my hon. Friend the Member for Reading West (Alok Sharma) on securing a debate on this important issue. In his constituency, he has shown great support for his local fibromyalgia patient group by advocating on its behalf, raising money and raising the profile of the disease, which is so debilitating for its sufferers. He has helped the group to continue its important work of improving awareness of the condition and providing advice to patients and their families. I pay tribute to the work of FMA UK, other fibromyalgia charities and the many patient support groups around the country who work tirelessly to raise the profile of the disease and support those who are affected by it. I welcome today’s merger of FMA UK and FibroAction, which will help to give a stronger patient voice to those who are affected.
Fibromyalgia is an incurable musculoskeletal condition of unknown cause that can have a debilitating impact on those who are affected. Although no exact figures are available, research suggests that fibromyalgia affects around 2.5 million patients in the UK, the majority of whom are women over the age of 40. Fibromyalgia symptoms affect the soft tissues, muscles, tendons and ligaments of the body and result in widespread and variable pain throughout the body. Poor-quality, non-refreshing sleep contributes to an ongoing cycle of chronic pain and fatigue, and, in some cases, poor concentration and short-term memory problems. Irritable bowel syndrome, restless legs, head and neck pain and sensitivity to temperature change are also associated symptoms of fibromyalgia. The symptoms and their severity differ from patient to patient.
Diagnosing the symptoms of fibromyalgia can be challenging for GPs. Some 20% of the general population consult their GP about a musculoskeletal problem each year, which amounts to more than 100,000 consultations a day. The symptoms of fibromyalgia are common to other conditions such as rheumatoid arthritis, lupus and chronic fatigue syndrome. In addition, patients with fibromyalgia can often visibly appear well, despite their symptoms. GPs face a further obstacle because there is no diagnostic test that accurately identifies the condition. A diagnosis is usually made via a process of diagnostic investigation to exclude other potential causes of the patient’s ill health. It is, therefore, important that clinicians have the training, tools and resources to help them identify fibromyalgia symptoms when a patient presents.
Musculoskeletal conditions are a key part of the generalist undergraduate MBBS medical curriculum. The General Medical Council requires that the MBBS curriculum provide enough structured clinical placements to enable students to demonstrate the outcomes for graduates across a range of clinical specialties, including musculoskeletal health. Musculoskeletal health is also a key component of GP training, and the Royal College of General Practitioners’ curriculum statement on musculoskeletal conditions sets it out that GPs should be able to diagnose and manage common regional pain syndromes such as fibromyalgia.
In addition to clinical training and experience, GPs have at their disposal a number of tools and resources. They include: the Map of Medicine, an online evidence-based guide and clinical decision support tool available to GPs and other healthcare professionals in the NHS, which has a fibromyalgia and chronic pain pathway, and helps clinicians to identify the symptoms and make the right referral; a free e-learning course on musculoskeletal care, including fibromyalgia, developed by the RCGP and Arthritis Research UK, which aims to improve skills in diagnosing and managing musculoskeletal conditions; NHS evidence services, which provide access to a vast online repository of clinical knowledge and guidance covering a wide range of conditions, including fibromyalgia; and a fibromyalgia medical guide for health professionals developed by FMA UK.
Once a patient is diagnosed with fibromyalgia, a number of treatment options are available to them. In the absence of a cure, relieving pain and restoring quality of life are the primary clinical goals. Treatment options include pain relieving medication, physiotherapy, dietary and exercise advice, counselling or cognitive behavioural therapy, and self-management programmes to give patients the skills and confidence to manage their condition. The routine assessment and management of pain is a required competency of all health professionals. Many patients can have their fibromyalgia successfully managed through routine access to locally commissioned services via GPs, and community and secondary care services. I will turn to my hon. Friend’s point about specialist clinics in a moment.
Jim Shannon
The hon. Member for Reading West (Alok Sharma) and I asked how we can raise awareness within the GP profession to ensure that GPs understand the symptoms of fibromyalgia and diagnose it earlier. As I pointed out in my intervention, only 3% of people in Northern Ireland have been diagnosed with the condition, but the number of people who suffer from it is far larger. There seems to be a gap between those who have been diagnosed and those who have not. Is that because GPs are not really aware of the condition? How can we make them more aware?
George Freeman
The hon. Gentleman makes an excellent point, and he is helping to raise awareness today. I will pass on the points made today to the team at NHS England with responsibility for this issue. The answer to the question on awareness is to support debates such as this, and to promote the work of the charity and the patient advocacy groups.
The routine assessment of pain is a required competency for all healthcare professionals. However, patients who remain in high levels of pain after conventional approaches to treatment have failed are able to access specialised pain services, which are nationally commissioned by NHS England. Patients referred to such services receive multidisciplinary team care from clinicians with expertise in pain management.
Mr David Jones
The Minister heard my earlier intervention, and he now mentions specialised pain relief centres, most of which are located in England. He also heard my points about the bureaucratic difficulties experienced by patients living in Wales when accessing such centres in England. Will he liaise with his colleagues in the Welsh Government on whether a smoother path can be achieved for patients from Wales?
George Freeman
My right hon. Friend is an outspoken advocate for addressing such needs in Wales, in health as in other issues. He will know that pain centres in England are distributed evenly, but they are a devolved matter in Wales and the other devolved Administrations. I will happily write to the relevant people in Wales to highlight the importance of this condition and what we are trying to do in England, and to encourage them to adopt similar best practice. I cannot vouch for their response and, as in other areas, it is a matter for the local Assembly, but I will happily pick that up.
In addition to the specialised pain services that are available, a number of NHS trusts provide dedicated fibromyalgia clinics, such as that at the Royal National hospital for rheumatic diseases in Bath. That clinic offers expert support and advice, as well as a fibromyalgia coping skills programme to facilitate self-management. Some constituents of my hon. Friend the Member for Reading West have raised concerns about the co-ordination of their care; I reassure him and them that improving care and support for people with long-term conditions, and improving the co-ordination of that care, is a central ambition of this Government, as reflected in our mandate to the NHS.
Nick Thomas-Symonds
Is there not also a social aspect to this—the issue of sufferers being able to support each other? I am delighted to hear the Minister’s point about co-ordination, because improving co-ordination is crucial to such support being more widely and more consistently available across the UK.
George Freeman
The hon. Gentleman makes an important point. Such co-ordination is happening across different therapeutic areas. Charities have a role in providing a strong voice for patient empowerment. Patient networks, increasingly including social media, allow us to advance the voice of disease sufferers in research, treatment and patient support. I am delighted by the news of today’s amalgamation of the two charities, which can only be a good thing for developing wider understanding and a patient voice in new treatment pathways.
We want everyone with a long-term condition— around 15 million people—to be offered a personalised care plan that sets out their needs and preferences for care. Martin McShane, who is responsible at NHS England for improving outcomes for long-term conditions, and Peter Kay, the national clinical director for musculoskeletal care, are working hard to make that happen. I will ensure that the points raised today are passed on to them as part of that work.
My hon. Friend the Member for Reading West mentioned research. Nationally, the Department of Health has substantially increased overall medical research investment from £885 million a year in 2010 to the more than £1 billion allocated for 2015-16. The usual practice of the Department’s National Institute for Health Research, for which I am responsible, is not to ring-fence funds for expenditure on particular topics but to invite and assess research proposals in all areas. Although no fibromyalgia projects are currently funded by the NIHR, the European Commission is contributing nearly €6 million to a project seeking better ways of treating chronic pain, including fibromyalgia. I look forward to the results after the project ends in 2018, and I urge hon. and right hon. Members who are present, FMA UK and the patients it represents to feed their comments into that project and to welcome the results.
We are considering further ways to showcase the world-class research funded by the NIHR, and we are working in this place, and with the public and charities, to drive accountability. I am working with the NIHR to put together a parliamentary open day to allow Members such as those who have spoken today to see where the £1 billion a year is spent, and to work with charities and patient groups on making applications.
A number of colleagues on both sides of the House have talked about discrimination in the workplace, which is a serious concern for people both in my hon. Friend’s constituency and in local fibromyalgia support groups. It is completely unacceptable if patients with long-term conditions are misrepresented as malingerers at work. Historically, we have seen that happen with other conditions, and as research and understanding of the disease develop, we need to be aware that people who present with conditions that are not well understood may be suffering from diseases that have yet to be properly diagnosed. People with long-term disabling conditions are rightly protected from discrimination in the workplace under the Equality Act 2010. Where a disability, such as one arising from a long-term condition, has been established, the Act requires employers to make reasonable adjustments to ensure that the disabled are not placed at a substantial disadvantage compared with their non-disabled colleagues. Failure of an employer in that regard could amount to direct disability discrimination under the Act.
My hon. Friend and a number of others spoke about the establishment of a network of specialist fibromyalgia clinics. We are aware of a number of dedicated fibromyalgia clinics across the UK, including the UK’s leading centre at the Royal National hospital for rheumatic diseases in Bath, but I will write to Martin McShane, the head of long-term conditions at NHS England, to ask whether more formal networks can be established and whether, with the support of active patients and charities, there is more we can do to develop such groups and to help them to support research on developing new treatments and pathways.
I genuinely thank my hon. Friend for his tireless constituency work to raise this issue, and I congratulate him on securing this debate. So much medicine begins with the small voice of misunderstood patients who get together through charities to promote research, raise the profile of a disease in this place and elsewhere, build a head of steam, bid for research projects—the NIHR stands open and ready to receive bids—and build cross-party support. I have no doubt that, in the years to come, this work, this discussion and this topic will come to be seen as one of those occasions when the more we come to understand a condition, the more we drive research on cure and diagnosis and the more we improve treatment across the NHS. I warmly welcome his leadership in bringing fibromyalgia to the House’s attention today.
Question put and agreed to.