The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, I shall now repeat a Statement made in another place yesterday by my right honourable friend the Secretary of State for Health.
“Mr Speaker, the life sciences industry is one of the most promising areas for growth in the UK economy. It has consistently shown stronger growth than the UK as a whole. It accounts for 165,000 UK jobs and totals more than £50 billion in turnover. Pharmaceuticals alone account for more than a quarter of our total industrial research and development spend. Global pharmaceutical sales are predicted to grow by up to 6 per cent a year in the coming years, and in emerging economies medical technology is achieving growth rates of more than 12 per cent. A flourishing life sciences sector is essential if we want to build a more outward-looking, export-driven economy. The partnership between industry, the NHS and our outstanding universities is not just essential to economic growth—it will benefit millions of future and current NHS patients, fuelling more rapid development of cutting-edge treatments and earlier access to those treatments for NHS patients.
Like many industries, the life sciences industry is undergoing rapid change. The old big pharma model of having thousands of highly paid researchers working on a pipeline of blockbuster drugs is declining. A new model has emerged, one that is more about collaboration, the outsourcing of research and early clinical trials on patients. Excessive regulation can mean that the uptake of new treatments and technology is slow. That is a challenge felt acutely by an industry that sometimes feels that the return is not there quickly enough to satisfy investors. It is felt even more acutely by patients, who understandably expect that they should be able to access the latest and most effective treatments and that new innovations in care should be adopted rapidly by the NHS.
We have a leading science base, four of the world’s top 10 universities and a National Health Service that is uniquely capable of understanding population health characteristics. However, those strengths alone are not enough to keep pace with what is happening. We must radically change the way we innovate and the way we collaborate. The life sciences strategy that we launched yesterday, alongside the NHS chief executive’s review on innovation, health and wealth, sets out how we will support closer collaboration between the NHS, industry and our universities, driving growth in the economy and improvements in the NHS. All the documents have been placed in the Library.
Among other key measures, we will set up a new programme between the Medical Research Council and the Technology Strategy Board to bring medical discoveries closer to commercialisation and use in the NHS. There are many medical products being developed to treat patients. The cost of developing them is high because they take a long time to develop and test. Investors want to see at least some evidence that the products might work in people and robust validation of the quality of the research and development work being undertaken, as well as of the capability of the company to bring the product to market, before they will finance the development of the products. That means that some of the best medical innovations are not making it through to patients. We are already providing investment to address that but we believe that we can do more to support the development of these products across funding organisations and the successive stages of product development, which will support the development of promising innovations and help to increase the number of treatments being made available to patients. We are therefore introducing a £180 million catalyst fund for the most promising medical treatments.
It can take more than 20 years from the first discovery of a drug until patients can be prescribed it by their doctor. We have already taken steps to address that. Through the National Institute for Health Research, we are investing £800 million in new research centres and two major translational research partnerships that will help to cut the time between the development of new treatments and their application in the NHS—from the bench to the bedside.
Now we are going further. As part of a major drive to improve innovation and access to medicines in the NHS, we are announcing proposals on a new early access scheme, which could allow thousands of the most seriously ill patients to access new cutting-edge drugs up to a year earlier than they can now. Through the early access scheme, the medicines regulator—the Medicines and Healthcare Products Regulatory Agency—will provide a scientific opinion on the emerging benefits and risks of very promising new drugs to treat patients with life-threatening or debilitating conditions for whom there are no satisfactory treatment options. That will mean that seriously ill patients of any age, who have no other hope of being treated or having their life extended, could benefit from drugs more quickly—around a year before they are licensed.
We must also ensure that we make better use of our unique NHS data capability. It is often said that the NHS is data-rich but information-poor. As a national health service, it contains more data about health than any other comparable health system in the world. However, neither the NHS itself nor scientists developing new drugs and treatments have always been able consistently to make good use of these data, or to use them to drive further scientific breakthroughs. We have seen how powerful the release of data can be. For example, South London and Maudsley NHS Trust and the Institute of Psychiatry now have access to a database covering 250,000 patients. It includes their brain scans, medical records and notes—a wealth of information, all consented to and all anonymised, that is helping them to find new answers in the fight against dementia.
We need powerful data-handling capacity and the skills to write the software to mine them. That is why we are investing in e-infrastructure, which will provide secure data services to researchers. The Clinical Practice Research Datalink is being introduced by the MHRA in partnership with NIHR and will provide a specialised service to the research and life sciences communities. Let me reassure the House that we will take all necessary steps to ensure safeguards for patient confidentiality.
We will also make sure that more UK patients get the opportunity to take part in national and international clinical trials and play a much greater role in the development of cutting-edge treatments. We believe that patients should have the right to access new treatments and be involved in research to develop new medicines. We have responded to calls from research charities and clinicians for the Government to get patients more involved in supporting research. A recent Ipsos MORI poll in June found that 97 per cent of people believe it is important that the NHS should support research into new treatments. In addition, 72 per cent would like to be offered opportunities to be involved in research trials.
We will therefore consult on changing the NHS constitution so that there is an assumption, with the ability to opt out, that data collected during a patient’s care by the NHS may be used for approved research. That would make it clear that researchers and companies with new and potentially life-saving medicines could access the data of patients and could approach patients whom they feel could benefit in order to discuss their involvement in research studies. This would encourage growth in the life sciences industry as more people and more detailed data would be available for the important trials and research needed to get breakthrough treatments used more widely.
Additionally, we have set out actions to improve incentives for investment in innovation and reduce regulatory bureaucracy. With the creation of the Health Research Agency, we will streamline regulation and improve the cost-effectiveness of clinical trials. As the NHS chief executive’s review of innovation has shown, the NHS needs to be quicker and smarter in adopting new technologies and approaches to care that can both save more lives and cut costs. Sometimes, it is a question of evidence. Until recently, we could not say with certainty that telehealth could keep people out of hospital and save lives. There was understandable reluctance among parts of the NHS and councils to invest in untried technology. However, as early results from the Whole System Demonstrator pilots show, the potential of telehealth is nothing short of remarkable, with dramatic reductions in mortality, hospital admissions, emergency visits and the number of hospital bed days. To make the most of this, we will support the NHS and work in partnership with industry and councils dramatically to spread the use of telehealth over the next five years. In doing so, we are looking to transform the lives of 3 million people in this country. We will become a global leader in the management of chronic and long-term conditions, generating massive opportunities for UK companies developing this technology. It will be innovation in practice; and we will foster other proven innovations such as fluid management technology techniques that were developed for use in high-risk surgery and critical care to help clinicians administer fluids and drugs safely.
In March 2011, the National Institute for Health and Clinical Excellence published guidance recommending that this technology should be used for patients undergoing major or high-risk surgery. Currently, it is used for fewer than 5 per cent of applicable patients despite evidence showing that it could benefit 800,000 patients and save the NHS £400 million. We will launch a national drive to make sure that fluid management technology is used in appropriate settings across the NHS. That is one example of many.
The innovation review sets out how we will address all the barriers to innovation in the NHS, whether they involve culture, leadership, training, use of information or lack of incentives and investment. We will also introduce a NICE compliance regime that will mean that medicines approved by NICE will be available on the NHS much more quickly. The plans set out in today’s strategies will help to drive the development of new technologies to diagnose and treat the most complex diseases in this country for the benefit of NHS patients. This is a strong package of measures that will support economic growth and innovation in the NHS and will drive significant improvements in patient care. I commend this Statement to the House”.
My Lords, that concludes the Statement.
Earl Howe
My Lords, if I may I shall pass over that final remark. I am not sure that it is strictly relevant to the Statement. I was happy to hear from the noble Baroness of her support for the initiatives that we have taken and of her welcome for the measures. She said that the coalition Government had lost momentum in this area. From my perspective as a Research Minister, that is not the case. The Office for Life Sciences was an initiative of the previous Government that we eagerly continued. I pay tribute to the noble Lord, Lord Drayson, for his work in establishing the bridge between BIS and my own Department of Health. That relationship remains very active.
We recognised from the outset that a strong research base was vital for our future as a global knowledge economy. I refer both to basic research—curiosity-driven research—and research applied to the challenges that face business and public services. Despite enormous pressure on public spending, the BIS science budget of £4.6 billion a year has been protected; and in my own department the research and development budget is increasing year by year over the period of the spending review. In the current year it is just over £1 billion. That shows our commitment to the sector.
The noble Baroness asked several questions. The first concerned the use of patient data. There are very clear information governance rules that will protect the confidentiality of patients. We are not changing the rules. They will apply to whatever sector a researcher may come from: the public sector, a charity or the private sector. The rules are the same. All approved research is conducted to strict ethical standards. It is subject to robust regulation. Before any data are given out about a patient, the following conditions must be met. There must be confirmation that the data requested will support the health question being researched. There must be approval from an ethics committee to ensure that the research is ethically valid, including a check on the data requested. There must be information governance checks and approvals to ensure that the recipient can receive and process the data legally to conduct their research. There must be confirmation that the data are anonymised. No data will be disclosed to a researcher unless all the conditions are met.
The NHS gives out data in anonymised form. Before they are given out, they will be checked to ensure that reidentification is not possible. The main exception is where a patient gives consent for identifiable data to be disclosed. Except in that instance, companies or other researchers who receive data in anonymised form will not be able to identify the patient. The data will be checked before they are disclosed to any company, and legal contracts for the use of the data will require all recipients to comply with strict controls on using data lawfully. The companies will be subject to spot checks.
The noble Baroness asked whether patients would be able to opt out. The answer is yes. Patients will be able to opt out of their personal electronic health record being used for research purposes in an identifiable form. Patients should tell the NHS that that is their wish. The GP will record this in the patient’s record. We have tested technical ways of delivering this and of enabling researchers to identify patients who might be able to contribute to a research project without physically searching through records. Our pilot projects have been very successful.
The noble Baroness asked how all of us can be sure that our patient data are secure. Both the clinical practice research datalink and the NHS Information Centre will hold data securely. They are governed by strict access protocols to ensure that the data are processed lawfully, including when information is disclosed to researchers. Services are subject to the highest levels of independent audit and to regular checks. The data are held in a secure data centre not connected to the internet and are managed to the highest standards of information governance. I hope that that reassures the noble Baroness.
She also mentioned the European Court of Justice ruling on human embryonic stem cell patenting. As she knows, the UK is a world leader in the research and development of stem cell therapies, and the Government will continue to support and fund this work. The judgment of the court applies only to human embryonic stem cell lines, not to other stem cell sources such as adult or induced pluripotent stem cells that are used in stem cell research and regenerative medicine. The judgment does not impact on the regulation of embryos and embryonic stem cells in the UK. However, it is a landmark judgment and we will work with BIS and the Intellectual Property Office to further explore the options on how to address the issues from the ruling. The noble Baroness will understand that the ruling is recent and it is important that we consider the implications very carefully.
Earl Attlee
My Lords, we have plenty of time but perhaps I may remind the House of the need to avoid the trap of making a detailed speech rather than asking a short question.
Lord Walton of Detchant
My Lords, I congratulate the Government on this excellent and far-sighted Statement. It was anticipated to a degree by the article in yesterday's Times by Mr David Willetts and by the Times’s first leader today that highlighted the importance of these developments. I was very glad to see that it was stressed that excellence in health service research is not entirely in the south-east of England. The leader picked out Newcastle University Medical School as another centre of excellence in this programme of research.
Some 15 years ago I chaired the House of Lords Select Committee inquiry into international investment in UK science. We found that 40 per cent of all American overseas investment in science came to the UK and 42 per cent of all Japanese investment came to the UK because of the perceived strength of the UK science base. The science base remains strong and powerful, as the Statement makes clear. However, at the time we recognised that translation of the results of the research into effective changes in patient care was inadequate. The Statement makes it clear that the Government intend to support translational research to the benefit of our community.
I will ask the Minister one or two questions. We live in an era in which genomic medicine and the results of molecular biology are being translated into new developments that may benefit patients with many severe crippling diseases and long-term conditions, not least some that are genetically determined. Genomic medicine is identifying the gene defects and medicines are beginning to be introduced that may overcome these genetic defects.
The catalyst fund is crucial. I would rather not call it a valley of death fund but a postponement of death fund, because if the drugs that are introduced as a result of this major research come to market, it is very important to recognise that in many instances the number of patients likely to benefit, particularly those suffering from rare diseases, will be small, and therefore commercial exploitation will be extremely difficult. The drugs that are now emerging are known as orphan and super-orphan drugs. The previous Government put money into a cancer drugs fund because of the expense of many of the new drugs that were being developed. Will this Government consider the possibility of developing a fund for the exploitation of these orphan and ultra-orphan drugs, because today's discovery in basic medical science will bring tomorrow's practical development in patient care?
The previous Government produced the Technology Strategy Board as a major halfway house between universities and science institutes on the one hand and commercial exploitation by companies on the other. The Statement takes that one step further with the catalyst fund. Will the Government consider funding orphan drugs for the treatment of these rare diseases?
Earl Howe
The noble Lord makes an extremely important point. He will know that the Government have already established a cancer drugs fund which is designed to enable patients to access drugs that their doctors feel they should receive but which the NHS will not otherwise fund. We are putting £200 million a year for the next three years—totalling £600 million, in other words—towards this fund. That fund is there for orphan medicines and for the treatment of rarer cancers as much as it is for more common cancer treatments. So, as a temporary device, that fund exists.
We have taken the view that the development of a value-based pricing structure for medicines should enable us to move to a situation where drugs are assessed for value in their broadest sense and priced accordingly. In that way, if the value is computed as being high for patients, the NHS will pay the corresponding price and the patient will be able to access that drug. I would, however, say that in the case of orphan medicines the work is at an early stage. It is clear that some orphan drugs are likely to be priced very high, and it is of course necessary to ensure that the value of those drugs as reflected in the price is one that the NHS is prepared to pay. As I say, we have work to do. I can update the noble Lord as time goes on in that area. However, I can tell him that this is very much within our sights.
Baroness Sharp of Guildford
My Lords, I should like to thank my noble friend for repeating the Statement and say how much I, like other noble Lords, welcome it. In so far as the new strategy being adopted gives earlier access to new drugs and new technologies for patients, it can only be a very good thing. I have a number of questions for the Minister.
Quite a few NHS hospital data are already available to researchers. One example is the link-up between Yale University and University College, London, where data on cardiac medicine are being mined and exchanged. With the NHS we have cohorts that can be followed through, which is not available in the United States. Am I right in thinking that the difference is that GP data as well as hospital data can now be mined in the same way, enabling cohorts to be followed? If so, and if we are developing these huge computerised databases, how confident can we be that they will not go the way of Connecting for Health, the £13 billion project that hit the ground well over six years behind schedule and which the coalition decided was no longer worth pursuing?
Finally, how confident can we be that these new proposals will change the trend in clinical trials? There has been a dramatic decrease in clinical trials in the UK, from something like 6 per cent of trials done in 2000 to only 1.4 per cent today. Part of the idea behind these new developments is to bring some clinical trials back to the UK. Can the Minister explain precisely how this is expected to be done, and how confident can we be that it will reverse this trend despite the advantage of the growing markets in the Far East, in particular, in attracting clinical trials?
Earl Howe
My Lords, my noble friend has asked some extremely pertinent questions. In answer to her first one, data from GP practices as well as data from hospitals are available today. However, the clinical practice research datalink, which is the new service for researchers being established under the umbrella of the Medicines and Healthcare products Regulatory Agency, will for the first time enable researchers to access very much larger banks of information on a population basis and to target their questions appropriately at the database. I do not see that there is any risk to the technological aspects of that system. The CPRD is using existing data structures in the NHS. It is not changing systems as Connecting for Health attempted to do and has done.
Will this make a difference to clinical trials in the UK? I believe that it is one ingredient of a package that will make the UK more attractive. On its own, perhaps it is not enough. When I recently visited Japan and spoke to pharmaceutical companies there they were extremely interested in this, but of course they take into account the wider picture. That has to include the fiscal environment, where we are introducing a patent box which will protect patents, at a very advantageous rate of tax, on intellectual property invented in this country. There are various incentives aside from that including the corporation tax rate, with ours being the lowest in the G7 in a few years’ time. Also, the establishment of the Health Research Authority is designed to streamline the ethical approvals for clinical trials. The establishment of the National Institute for Health Research also is designed to streamline the all-too-slow process that we have been used to over the past few years. We are determined that, across the piece, we must make this country and the NHS, in particular, the platform of choice for clinical trials in the world. I believe that this can be done, but of course it will not happen overnight.
Lord Patel
My Lords, of course I am extremely biased but I absolutely commend the Government for bringing about this strategy. It was necessary to highlight our leadership in all these areas of stem cell therapy, regenerative medicine and other areas of drug development. Those who are concerned about the development of a clinical, practice-based research data bank need not be concerned. We have developed and used such a bank for many years and it works. The unfortunate thing about it is that it has been local. We now need a nationally based clinical-practice research data bank. Such a bank helps not only with clinical research but to improve patient care. Diabetes is an example where such a bank has been used, and where it has worked it has produced improvements in patient care. Last year, for example, it reduced peripheral limb loss by 40 per cent in diabetics. The current figures show that it will probably do the same for eye complications in diabetics. I commend the Government for this strategy.
I am biased because I am a member of the Medical Research Council. I am also a chairman of Cancer Research UK’s Dundee cancer research centre, which co-ordinates clinical research, basic research and clinical practice to deliver better research. For five years I was also chair of the Stem Cell Oversight Committee and developed the stem cell bank, which is the world's biggest stem cell bank. Other countries are envious and want access to our stem cell bank. We are the only country that has clinical-grade stem cells lodged in our bank. No other country has them. It is the clinical-grade stem cells that we will need to use for therapy, and next year we will be the first country to carry out clinical trials for age-related macular degeneration using embryonic stem cells. I do not worry about the patients ruling, either. I know that as scientists we do worry—but somehow we will overcome.
One strategy that the noble Earl did not mention was that of synthetic biology—I am also excited about that, because there was a risk that we would fall behind. The strategy states that an independent panel will be established to produce a road map for technological development in synthetic biology, which is a means of sequencing the effective things that occur in plants and other areas from which drugs can be developed. There are already examples of these in the United States, which have been used there to produce drugs. We will fall behind if we do not develop our research.
The idea of developing an independent road map for synthetic biology is commendable. I therefore ask the Minister, what is the timeline for developing that road map because, otherwise, others will leapfrog over us?
Earl Howe
My Lords, I am pleased that the noble Lord mentioned that part of our initiative. As he rightly said, we have undertaken to develop a strategic road map that will set out the timeframe and actions required to establish a world-leading synthetic biology sector. That will be published in spring 2012. To oversee the delivery of the road map, we will establish a synthetic biology leadership council, co-chaired by my ministerial colleague David Willetts, the Minister for Science and Innovation, and Dr Clarke of Shell Global Solutions. I am told that the total timeline for this is 12 months. We therefore intend to move forward on this with some speed. I share the noble Lord’s enthusiasm for its potential.
Lord Brooke of Sutton Mandeville
My Lords, first, I congratulate my noble friend on having omitted a reference in his Statement to a valley of death fund. Secondly, having picked up the reference to big pharma in this welcome Statement, I called to mind the historic and dramatic decision of the late Austin Bide of Glaxo to increase the planning horizon for research in that company from five years to 25 years. The Statement makes clear the acceleration that we shall see in drug development. Can my noble friend hazard any estimate of what effect today’s announcement will have on the planning horizon of research, in the manner of the late Mr Bide’s remarkable extension?
Earl Howe
The planning horizon for research, as my noble friend will know, has always been a long one. With the increasing cost of research, particularly in later stage clinical trials, companies end up making an extremely significant investment in order to bring one molecule to the market. What we seek to achieve for big pharma in this package of measures is a sense that we in the UK have, as it were, an unrivalled ecosystem that brings together business, researchers, clinicians and patients to translate discovery into clinical use for medical innovation within the NHS. What we want them to appreciate is that the UK provides an environment and infrastructure that supports pioneering researchers and clinicians to bring innovation to the market earlier and more easily so that this country becomes the location of choice for investment. I am thinking here particularly of our proposals for setting up academic health science networks that will span the NHS. That is our ambition. I am thinking of the early access scheme for medicines, which was mentioned in the Statement. We want to break down the regulatory barriers to speeding up clinical trials that have beset the industry. For all those reasons, I should like the industry to see this as facilitating a shorter time horizon. However, we cannot do anything to get around the essential safety and quality standards that the patient and the citizen rightly insist upon.
Lord Willis of Knaresborough
My Lords, I welcome the Statement from my noble friend. I realise that other noble Lords want to get in. I should like to ask a few brief questions. First, we have to recruit patients on to trials. It is interesting that there is a proposal automatically to opt patients in to trials—or at least have access to them. How will that be achieved? Will it be achieved through this Bill? Secondly, will the £180 million catalyst fund for the valley of death replace the Health Innovation Challenge Fund that currently operates between the Department of Health and the Wellcome Trust? If not, where will the £180 million come from?
Earl Howe
My Lords, I shall answer the second question first. The £180 million biomedical catalyst fund is a completely new fund for industry. Its object is to nurture innovative technologies from the academic or commercial sector through to companies with products or technology platforms in order to attract private equity. I shall probably need to write to my noble friend with further details of where the money is coming from. It is coming from the budget of BIS, rather than my own department, and it is therefore necessary for me to ask my colleagues in BIS precisely where the money emanates from. I am happy to let my noble friend know.
The proposal to which he referred is only a proposal. We are suggesting that the public should be asked whether the NHS constitution should be changed so that patients are aware that their data, as now, can be used in anonymised form for research. Our intention is to ask more patients whether they wish to be approached for research if that research is relevant to them. As the Statement made clear, we know that more than 70 per cent of the public wish to be informed if a piece of medical research is relevant to them. Patients are keen to be involved in this. It is important to have a public dialogue about the extent to which patients may be approached so that they may know in advance that there is a possibility of a project being relevant to them. We are formulating these proposals now and it will be some time before we issue the consultation. I shall make sure that I let my noble friend know as our proposals crystallise in this area.
I can, in fact, answer my noble friend’s earlier question as to whether the Health Innovation Challenge Fund is being replaced. No, it will continue.