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.