Health: Medical Innovation
(11 years, 11 months ago)
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Lord Saatchi
To ask Her Majesty’s Government what steps it proposes to take to encourage best practice in medical innovation.
Lord Saatchi
My Lords, I express my gratitude to the usual channels for allowing the time for this debate. I have introduced the Medical Innovation Bill into your Lordships’ House. I will not be covering the details of that Bill in this debate; Second Reading will follow at some point in the year and we can discuss them then. However, this debate may illuminate the context of the Bill and give your Lordships’ House an opportunity to consider the whole complex question of what best practice is in innovation, particularly the application of research and knowledge to patient treatment.
In opening this debate among the judicial and medical experts in your Lordships’ House who have devoted a lifetime to this subject—compared to my own brutally short experience—a certain humility is appropriate. It will be my privilege to hear many noble Lords who are among the great innovators of our time. I particularly thank my noble friend and his team at the Department of Health for their wisdom; Dame Sally Davies, the Chief Medical Officer, for her viewpoint; the Secretary of State himself for making improved survival rates his key priority for healthcare; and the many patient groups, academics and practitioners who have contributed their thinking.
The Prime Minister himself has encouraged British medical innovation in the context of the global race, and the document on diffusion of innovation in the NHS by my noble friend, himself Minister for innovation, is, if he will allow me to say so, a model of agenda-setting by a government department.
Buoyed up by Bertrand Russell’s view that simplification is not always obfuscation and often serves to crystallise the issues, I will attempt first a simple description of the need, and then a specific suggestion of what steps your Lordships may consider to meet that need. I will concentrate on the most emotive word in the English language—cancer—and hope to draw wider conclusions from this area. To express the need, I am helped by an unexpected source, the Father of the House in another place. In his tribute to Her Majesty the Queen on the occasion of her Diamond Jubilee, he used a striking phrase:
“There is nothing more inspiriting in the whole world than a beautiful woman”.—[Official Report, 07/3/12; col. 852.]
I can amend that. There is no more distressing thing in the whole world than a beautiful woman being reduced to a sparrow.
Unfortunately, here is the status quo. A woman is told that her tests are “normal” and to come back in 12 months. She is removed from her home 12 months later and cut and drilled until she loses half her body weight. Wires and tubes are attached to her throat, nose, stomach and vagina. Drugs are given to her that cause nausea, vomiting, diarrhoea and fatigue. They open the path for fatal infections to enter the woman’s body and reduce her body’s defences against such infection. The woman is left for dead, and sooner or later the woman dies. The “process”, as it is called, involves scenes that would not be permitted in a Hollywood horror movie.
I hope that that is a fair description of the need for medical innovation. The screening techniques for such a cancer are inadequate; no reliable early detection method is available, and even if it was, it would improve the overall survival statistics but not the date of death. The treatment regimes, when provided—that is, the drugs, the cycles of their administration and the surgical procedures—are 40 years old. They are also ineffective; cancer quickly develops resistance. Not surprisingly, the survival rate for such cancers is the same as it was 40 years ago—in other words, nought; and the mortality rate is the same as it was 40 years ago—that is, 100%.
This disease is relentless, remorseless and merciless. Its treatment is medieval, degrading and ineffective. Why are we so forsaken? It is said that cancer is so complex that it is beyond the judgment and understanding of the human mind to comprehend its variables. Therefore, through ignorance, we kill people unnecessarily.
If that is true, it is not through lack of trying. Scholars in cancer have long sought general rules about the world as robust as the laws of physics and to verify statements, propositions and putative facts by the results of empirical studies. Unfortunately, it has not worked out quite like that. Instead, we find the stubborn fact that, after 2000 years of human progress, cancer is still outside Newton’s universe where physical laws govern reality.
In the natural sciences, even though, as Popper says, the closest approach to proof is just a succession of unsuccessful attempts at falsification, we can nevertheless make statements in the natural sciences, perhaps without finality but with a certain degree of probability. If I drop these papers, they will fall to the ground. Tomorrow the sun will rise. In cancer, though, the record seems to show that once we express opinions or beliefs or attempt to offer explanations, descriptions or predictions, then error, doubt and uncertainty come to the fore. In cancer you hear it said that, “Every case is different” and, “There is always hope”. Such well meaning sentiments are not science. There is no hope that if I drop my papers they will not fall. These statements are meant to bring cheer to the desperate, but instead the effect is the opposite. They bring despair—the dread revelation that cancer is a realm in which science has yet to achieve sovereignty.
In the end, all attempts to place cancer medicine within the canons of scientific objectivity have failed. There remains an irremediable tentativeness about the logically perplexing question of what is the cause or cure for cancer. Cancer science has not yet found its Newton. Why? There is a powerful deterrent to innovation at the heart of the current system. Economists would call it a systemic failure. Current law is a barrier to progress in curing cancer. Under present law, any deviation by a doctor from standard procedure is likely to result in a verdict of guilt for medical negligence. Current law defines medical negligence as deviation from standard procedure. As innovation is deviation, though, non-deviation is non-innovation. In this way, the fear of litigation for medical negligence is a roadblock to innovation in cancer treatment. The present pre-eminence in law of the standard procedure provides no inducement to progress. The self-interest of medical practitioners, as defined, for example, in doctors’ insurance policies, means that innovation—that is, deviation—is a form of self-harm.
In Clark v MacLennan, an important test case in 1983, the significance of departing from an approved mode of practice was treated by the trial judge, J Pain, as having the effect of reversing the burden of proof, so that once the plaintiff established a deviation the defendant had to disprove an inference of negligence. I quote Crawford v Board of Governors of Charing Cross Hospital, 1953:
“The practitioner who treads the well-worn path will usually be safer, as far as concerns legal liability, than the one who adopts a newly discovered method of treatment”.
In the standard Butterworth text on medical negligence, the authors Nathan and Barrowclough expressed in 1957 the following view, still applicable today, concerning deviation from accepted modes of practice and the ethics of new treatment research and experimentation:
“Medical men cannot be permitted to experiment on patients (Slater v Baker and Stapleton) (1767) ... On the other hand the courts will not press this proposition to a point where it stifles initiative and discourages advances in techniques … a line must be drawn between the reckless experimentation with a new and comparatively untried remedy or technique, and the utilization of a new advance which carries with it unforeseen dangers and difficulties”.
I hope that we can agree with Lord Diplock, who was looking for a better balance to be struck between therapeutic innovation and therapeutic conservatism. He warned of the dangers of so-called defensive medicine:
“Those members of the public who seek medical or surgical aid would be badly served by the adoption of any legal principle that would confine the doctor to some long-established, well-tried method of treatment only, although its past record of success might be small, if he wanted to be confident that he would not run the risk of being held liable in negligence simply because he tried some more modern treatment, and by some unavoidable mischance it failed to heal but did some harm to the patient. This would encourage ‘defensive medicine’”—
that is his phrase—
“with a vengeance”.
I am looking carefully at the time and will therefore bring these remarks to a close. Your Lordships will agree that optimal care is evidence-based care. Evidence-based medicine is therefore standard procedure for the protection of patients. However, as your Lordships are well aware, cancer is the least evidence-based disease of all. There is great uncertainty: either the evidence does not exist or, if it does, it is not clear what it means. Innovation is therefore more appropriate in cancer treatment and the consequences of not innovating are greater—poor life quality, followed by death.
I shall end with this. What can your Lordships’ House do—that is the point of this debate—to encourage the drive towards medical innovation, on which my noble friend has made such a great contribution? The advance of science depends upon the free competition of thought and thus upon freedom; that must come to an end if freedom is destroyed. Are the intellectual problems of cancer insoluble? I do not think so. What is more inspiring, apart from a beautiful woman, than the quest by scientists to explain the world; to find satisfactory explanatory theories—simple theories—and to test them? One of them will cure cancer. We should rise to our feet to applaud the great cancer doctors and scientists, many of them in this House, who are striving by their own best lights to serve the community. Let us erect statues in their honour or build bridges in their name, or parks, or avenues, or airports. Let us encourage them, not frighten them.
Lord Winston
My Lords, it is both a responsibility and a privilege to be the first speaker after the deeply moving speech from the noble Lord, Lord Saatchi. He carries the respect of the whole House for tabling this debate and has our thanks for the way that he phrased what he said. I feel that my own contribution will be paltry by comparison, but I thought that it would be interesting to look quickly at my own career and think of seven points in it where innovation was an issue. Our excellent Minister sitting on the Front Bench cannot be expected to be responsible for trying to improve innovation in the health service. This is a colossally difficult issue; I will explain why I think so.
The first thing I want to refer to briefly is my involvement in the early days of microsurgery of the fallopian tube. First, that project, which led to about 50 publications, would not have been possible today because the Medical Research Council grant that I got would not be awarded with the current competition. Secondly, it is fair to say that I would not have got an animal licence to practise a surgical procedure, rather than to do it experimentally. There is a neat difference now in how the regulation is. Throughout, there are at least eight issues that conflict to make innovation difficult. One is regulation; one is infrastructure; one is governance; one is industry and its involvement; one is the internal market, supported by both the Labour Party and the Conservative Party; one is clinical training; another is teamwork. Lastly and most importantly, there is the cultural environment. I will come to one other issue at the end, if I may.
The infrastructure for my work with the fallopian tube would not be possible now because I had access then to a workshop in a district general hospital, where Dennis Melrose was producing extracorporeal circulation pumps to improve heart surgery. That is almost unthinkable now. One of the greatest difficulties I had was in getting industrial support for making the microsurgical needles. I could not find a single industry in this country that would make the needles. We made needles with our own hands, under a microscope, that were so fine and delicate that they did not fall to the ground. Unlike the noble Lord’s papers, they actually floated on the air. Eventually, we found a German company which then captured one-third of the world’s ophthalmic market with those needles. There is a message in that innovation.
With regard to trying to translate that surgery into the female pelvis, the big problem now would be governance. What also followed was the issue of having training in teamwork around, to persuade surgeons to work as a team. That has become more difficult now because of the internal market. It is very difficult to prove that a surgical procedure works and is innovative, because it is more difficult to collect the cases together within a health service structure. We have all faced this difficulty for quite a long time. It is not the responsibility of any one Government.
The same thing applies, to some extent, to laparoscopic surgery. I think I was one of the first people to operate using a laparoscope in this country. There would now be a problem with governance; it would be considered risky and unwise, and would take much longer to innovate.
With the present regulatory system, it would also be impossible to see in vitro fertilisation—your Lordships probably know that I have certainly more than dabbled in that—on the books in the way that it is now. It would be very difficult to transfer an egg that you fertilise outside the body into a human patient. It would certainly take much longer to get permission to do that. That is one of the issues. In my own unit, we made a whole series of improvements. We improved the culture media. We demonstrated, for example, the given knowledge that glucose in the medium was poisonous to human embryos but not to any other animal that was experimented on. We could not change those media now, given the current regulatory framework. Even the little changes that one could make—the fact that tungsten light is dangerous to embryos, for example—become increasingly difficult.
I could go on and on but I do not want to spend more than a few minutes and my time is almost up. It would now take much longer to get permission for things such as embryonic detection of genetic defects. I have to declare an interest as somebody who launched a biotech company. One of the problems with that company, which might change the whole field of transplantation with the use of pigs’ kidneys, hearts and livers, and possibly pigs’ lungs, is that it took us more than a year and a quarter to get an animal licence to practise and do the work on just six pigs. It was quite difficult to get the rodent licence before that as well.
I want to say one final thing. The first experiment I ever did was as a result of fraud in my unit. I was asked to go in and troubleshoot by repeating an experiment. It was pure serendipity that we found that there was probably something wrong, with an infection in the vagina of women that might lead to the possibility of a virus being involved. We now know, of course, that the virus is very well established but I did not know what it was at the time. That was a long time ago but one of the issues with true innovation is that serendipity is extremely important. What we can perhaps best all do together is to see how we might improve the culture in which we do our medicine.
Lord Willis of Knaresborough
My Lords, I begin my remarks by echoing the comments of the noble Lord, Lord Winston. I have been a parliamentarian in both Houses for some 16 years now and I do not think I have ever heard a more moving, considerate or emotive speech than that of my noble friend Lord Saatchi. I thank him for it. In so doing, I have to say that some of the issues that he and the noble Lord, Lord Winston, have raised—and that others will raise—are ones that the Minister, with his responsibilities, can begin to address. Last night, I was responsible for hosting a reception for Children with Cancer UK, an organisation that has been running for 25 years and which began because, 25 years ago, childhood leukaemia killed eight out of 10 children who suffered from it. Now, 80% of children survive it. That happened through innovation—through the very things that the noble Lord, Lord Winston, mentioned and which others will mention—so there is hope. I would want to give my noble friend that element of hope.
My frustration is with many of our scientists’ inclinations. The means to deliver novel or experimental treatments to patients earlier exists. It is not something that does not exist and, quite frankly, it does not require further legislation. With the support of government and an excellent UK life sciences strategy, we have the means to do exactly what my noble friend wants to see. We do not need more legislation; we need action. We need regulators and funders to recognise that, while their approaches are fine for established research pathways and large populations of patients, they are hopelessly inadequate for new and experimental treatments on small, stratified populations.
There is progress. Both the conditional approval scheme and the named patient scheme are important in the toolbox of clinicians who want to try novel and untried treatments but, frankly, they are rarely used. Indeed, perhaps the Minister, when summing up, can say how often they are used and for what purpose. Perhaps, too, he could tell us what progress is being made on the early access scheme, championed in the UK Life Sciences Strategy, which would allow access to drugs earlier than the current regime permits, especially where the compounds under consideration represent possible therapies where few alternatives are available. Currently, the Government’s ambition for this scheme is two to five drugs per year. Does the Minister really feel that that should be the height of this strategy’s ambition?
Perhaps offering more promise, as the Science and Technology Select Committee heard in relation to its regenerative medicine inquiry, is the issue of adaptive licensing, an initiative that also appeared in the UK life sciences strategy. Adaptive licensing offers a flexible approach whereby regulators, clinicians, patients, the research community and industry are jointly involved in assessing the risks of a given experimental treatment so that a proportionate level of regulation can be determined for the release of novel drugs to patient groups. This proportionate approach recognises, as we move to more targeted therapies for smaller populations where traditional clinical trials will be of limited use, that this approach offers an alternative, more appropriate assessment of patient risk and benefits; but, again, where is the urgency or ambition? The expert group that was set up by the MHRA to look at adaptive licences has met only once, in October 2012. Frankly, if that is the rate of progress, it will be years before we see this opportunity realised.
Finally, I come to regulation and regulators, a topic to which I know many noble Lords will return later. When the Academy of Medical Sciences produced its report in 2011, the Government promised simplified, more unified and smarter regulation. The setting up of the Health Research Authority would herald a new dawn for those who see the regulatory burden—particularly for scientists, clinicians and SMEs working at the edge of discovery—as an obstacle to progress. Far from achieving that aim, the HRA appears to have become a very expensive national ethics service. If anything, regulation has become more complex and more bewildering. Indeed, as one expert witness revealed yesterday to our committee, “It is only accessible if you know where to look”.
Clinicians hoping to use new therapies to save the lives of cancer patients do not have the time, and often do not have the resources, to meet the demands of well meaning regulators and their plethora of never-ending hurdles set up to ensure patient safety. That is the real challenge. Without a more agile, unified and flexible regulatory system, which puts patients at its heart, all attempts to move novel and often untried treatments into patients will fail. In that case, we will fail my noble friend in his cause.
Baroness Masham of Ilton
My Lords, I thank the noble Lord, Lord Saatchi, for asking this question so movingly. I feel honoured to be taking part in this debate with such experts. Having a cousin who is research-minded and is a professor, now living in Australia, I want to raise a few points that we have discussed.
Many Britons see their clinical research careers take off after they leave the UK. Some of this is due to the internationalisation of medicine and the growing awareness of how valuable exposure to overseas best practice can be during specialist training. It is a two-way street, so some of the UK’s best specialists come from overseas.
It seems that clinical research comes a poor second after the pressing needs of an overloaded health service have been met. From clinical medical student through resident positions, specialist registrar training and on to first consultant position, it seems difficult to find the time and support for clinical research and development. Apart from a few fortunate centres, where seniors have managed to establish a strong funding stream for R&D, resulting in research fellow appointments, research support staff and so on, there seems to be a poor match between the R&D effort and the acute medical front line. More regional expert centres should be better funded. Steps seem to be needed to recognise where there is already established leadership and to make use of it.
Innovation in healthcare and innovation in clinical research have a symbiotic relationship. Without research there can be no innovation, as there will be no evidence base with which to inform clinical practice. Without that clinically proven innovation being acted on, we will see no advance in clinical practice, no improvement in patient outcomes and less incentive for clinical research to be carried out.
There seems to be frustration from some bodies involved in innovation. For example, Innovation, Health and Wealth promised to:
“launch a national drive to get full implementation of”,
oesophageal Doppler monitoring,
“or similar fluid management monitoring technology, into practice across the NHS”.
This is an admirable policy, but again reality is not living up to intention. Not only is that implementation drive delayed; it has been scaled back. The NHS is also allowing the inclusion of technologies similar to ODM that do not have adequate backing through clinical research and have not been evaluated by NICE. Allowing unproven technology to be on an equal playing field with technology that has been through the rigours of clinical research is both unfair and uncompetitive. It will also result in worse outcomes for patients, lost productivity, fewer savings for the NHS and reduced incentives for clinical research to be carried out in the UK.
Will the noble Earl look again at the ODM implementation plan to ensure that the benefits to both patients and the NHS are realised through proper consideration being given to clinical research? There are so many complicated rare conditions that need new ways of treatment. When medical innovation has come up with the answer, it is vital that patients get the correct treatment for their condition. Nothing is more frustrating for the developers of a treatment and for the patients than when commissioners will not pay, thus holding up treatment and ongoing development.
It is heartening to witness the great support that so many people give to medical research and innovation through charities.
Lord Ribeiro
My Lords, I add my thanks to my noble friend Lord Saatchi for bringing this debate on a matter that is very personal to him. I chair the research panel of the Pelican Cancer Foundation based in Basingstoke. One of our members, Professor Bill Heald, pioneered a new technique for removing rectal cancer in the early 1980s. Total mesorectal excision, or TME, reduces the incidence of a recurrent tumour in the pelvis after surgery. Despite many publications, presentations and lectures on his technique, it was not adopted in the UK. The Scandinavians, however, were more convinced of the benefits, and Professor Heald developed a national training programme with them, which was adopted in the Netherlands, Norway and Sweden in the early 1990s. It became part of routine practice, resulting in improved outcomes for rectal cancer patients. It was to take another 10 years before TME became accepted as a routine procedure and best practice in the UK, despite it having been first pioneered in England.
So how can we speed up the take-up of new procedures? How can we accelerate translational research? In 2007, the national cancer action team and the Department of Health introduced the LAPCO training programme for teaching laparoscopic colorectal surgery. The Royal College of Surgeons promoted and delivered the programme through its new skills centres and, now, through specialist hospitals throughout England. This initiative proved so successful that I was recently asked to give a keynote lecture in the United States to offer our experience of teaching and disseminating laparoscopic colorectal surgery to the surgical community, and our methodology for assessing skills and accrediting competence to practise the procedure. The invitation letter said:
“It is my understanding that the UK has done this in a more proactive and safe fashion than we have in the States”,
an acknowledgment that central direction, as occurred with TME in Scandinavia and now with LAPCO, can produce best practice and innovation.
For a national programme of laparoscopic colorectal surgery for cancer, we will need about 460 surgeons trained in the technique. This is because we have a large NHS caseload, and it is required to meet the NICE guidelines on laparoscopic bowel resection. We currently have half that number. We need to be able to release doctors and surgeons to train innovative procedures. This requires incentives, the support of the base hospital when they have to go away to learn techniques, recognition of their efforts through clinical excellence awards—which I am pleased to say have been reinstated—and other marks of recognition. These efforts definitely show that you can improve the outcome for patients, and the benefit to them is real.
In a report in 2001, From theory to theatre: Overcoming barriers to innovation in surgery, the Royal College of Surgeons recommended that surgical trainees should be encouraged to participate in ongoing research and to work with multidisciplinary teams. With the support of CMO Dame Sally Davies, who was mentioned earlier, the Royal College of Surgeons has committed to funding five surgical trial centres from 2013, with the aim of recruiting thousands of patients for these trials. As surgeons, we are often criticised for not getting involved in randomised control trials; the comic opera referred to as “surgeons trying to do research” perhaps refers to this.
It is necessary today for us to carry out these trials because the number of trials carried out in surgical discipline comprises less than 10% of those done in cardiology. The trials units will provide expertise to develop multi-centre surgical trials, offer technical support and speed up the delivery of clinical trials. As surgeons, we are trying.
In order to speed up the process, from theory to theatre, it is vital that we involve patients in decisions about innovative treatment. Patients must understand the potential risks so that they are able to give full, informed consent. The process for doing this is in place—we have study design, ethical approval and patient involvement—but it needs to be expedited. We all know how long it takes to get approval to start a new trial. It is important that we do not have to wait the length of time that Professor Heald in Basingstoke did to introduce a procedure which has clearly saved many patients’ lives.
Lord Rennard
My Lords, I first declare my interest through the work that I do with the British Healthcare Trades Association, as in the register. However, the issue that I was asked to raise in this debate is specifically about the provision of insulin pumps.
I am one of the 2.9 million people in this country already diagnosed with diabetes. As a type 2 diabetic, I was first told that my treatment would only be in the form of tablets, but in common with many people who are diagnosed at a relatively early age with what they used to call “mature onset diabetes”, I found that after 10 years or so I also needed insulin injections every day. Now, as our understanding of dealing with diabetes grows, I am advised by my excellent diabetes specialist nurse that I may well need an insulin pump in another 10 years or so in order to be able to maintain good control of my condition.
The prevalence of diabetes is growing, and the period of time over which people need treatment is growing substantially. I am, therefore, concerned that many people with diabetes, who might benefit considerably from the provision of insulin pumps, do not currently find them available on the NHS. A survey not very long ago showed that the average rate of insulin pump provision for people with type 1 diabetes in this country was 3.7%, compared with the then 12% benchmark recommended by NICE and in comparison with other countries, such as the USA, where such provision is estimated at 35%, and Sweden, France and Germany, where it is estimated at 15-20%.
Good diabetes management is, of course, crucial to reducing diabetes-related complications, such as hypoglycaemic episodes and potentially fatal conditions such as heart disease and strokes. Greater use of technologies such as insulin pump therapy can deliver much better outcomes for patients. It can also help to reduce cost savings for the NHS by improving diabetes control, reducing primary care contacts, and reducing hospital admissions and hospital outpatient contacts.
However, the provision of insulin pumps is very patchy and inconsistent. Many healthcare professionals are not trained in supporting patients on insulin pump therapy and, as a consequence, are reluctant to recommend it as a treatment option. The position seems much better in Scotland. The Scottish Government announced in February 2012 that they would invest over £1 million to deliver insulin pumps to patients with diabetes. Over the next three years, their NHS boards will increase the number of insulin pumps available to under-18s, in addition to tripling the number of pumps available across Scotland.
Patients must of course be given accurate information about self-managing their condition, which should include advice on insulin pumps as a treatment option. It is imperative that healthcare professionals are trained in supporting patients to use insulin pump therapy.
Baroness Morgan of Drefelin
My Lords, I congratulate the noble Lord, Lord Saatchi, on securing this debate. I, too, found his introduction moving, so I thank him for that.
I declare an interest as chief executive of the medical research charity Breast Cancer Campaign and, perhaps more importantly for this debate, honorary president of Cancer52, an alliance of more than 60 organisations—many of which are very small and unstaffed—working to address the issues faced by those with less common cancers who make up 52% of UK cancer deaths, including ovarian cancer.
The promotion of a vibrant research environment is absolutely essential for the development, evaluation and take-up of new medical innovations in our NHS. Research and innovation are vital if we are to ensure better outcomes for cancer patients, which is why I am so proud that we in this House worked hard and successfully to ensure that duties to promote research and innovation were included in the Health and Social Care Act 2012. It is now equally essential to make sure that these duties are embraced by the new NHS structures as they take up their responsibilities in the coming months. I know that there is much debate about how that will happen.
I turn to an issue that is of concern to many patients: the use of drugs which are off-patent and not licensed for a particular indication, but which could be helpful in new and innovative ways. This is a little related to concerns that the noble Lord, Lord Saatchi, has raised through his Private Member’s Bill. Many noble Lords will have seen the news yesterday about proposals from the National Institute for Health and Clinical Excellence to recommend the use of the drugs tamoxifen and raloxifene for the prevention of breast cancer in high-risk patients. The barrier to using tamoxifen for chemoprevention in the UK arises from the fact that the drug is now off-patent and its original licence does not cover the use of tamoxifen for chemopreventive purposes, despite the drug being licensed for this indication in the United States for a number of years. Because existing UK legislation only allows the original owner of the drug to seek to change the indication—even when a drug is off-patent and there is therefore no incentive for the drug company to seek a change at this stage—this means that medical professionals who may wish to prescribe the drug for their patients must do so outside the existing licensing agreement. This is a significant disincentive and we could argue that it is stifling innovation.
Indeed, the draft guidelines issued by NICE yesterday are clear. They state that the prescriber of these drugs should follow the General Medical Council’s good practice in prescribing medicines and take full responsibility for their decision. This means that medical professionals must clearly document that the patient, or whoever has the authority to give consent on the patient’s behalf, has provided informed consent to receive the drugs for chemopreventive purposes.
Although the NICE guidelines are designed to circumvent this problem and make health professionals more comfortable with prescribing these particular drugs for chemoprevention, the best way to eliminate any remaining doubts for prescribers would be for a new avenue to obtain licences for new indications for drugs where there is a clear evidence base of clinical benefit and when they are off-patent. Therefore, would the Minister tell us what avenues the Government are exploring for closing this existing shortfall in the current legislation? Have the Government perhaps explored any possibilities for public bodies such as NICE to seek new licences for off-patent drugs where the manufacturer has no incentive to do so? He might want to write to me on this, but it would be very interesting to hear how this kind of innovation—which is looking at existing medicines and discovering how they might be used in different ways in different conditions —could be made a more nimble, innovative process.
Baroness Finlay of Llandaff
My Lords, I, too, congratulate the noble Lord, Lord Saatchi, for having described, in a very moving and clear speech, the reality and the horror for patients of illness and treatment, and the difficulty that many patients and their families face while in the shock of realising that life is not as they hoped it would be and has changed in an instant.
The noble Lord, Lord Saatchi, has highlighted the push and pull of the dilemma of innovation in medicine. We have a push from research councils to innovate; we have a push in academic medicine, principally in secondary care in specialist services, to innovate, to think and to instigate new trials; and we have a push from industry to come up with developments. However, we have a pull, which is a risk-averse system that is frightened of taking the decision to go with something that looks as if it might be high-risk or to go with the unknown. It is that tension between the push and pull that I think we are caught in the middle of today. Perhaps this debate is really timely, because we need to think about how we should handle that.
I was involved in some of the early trials to which the noble Lord, Lord Willis, referred, of children with leukaemia. I remember some of the children who were in the arms of the failing drugs; I remember them as if it were yesterday. I can see in my mind’s eye the room and the face of the child who then died and having to talk to those parents. However, it was through those trials, through every child taking part, that the face of childhood leukaemia has completely changed. I sincerely say, thank God that it has, because there was a terrible toll before those trials were properly instigated.
Another problem for patients, when they are faced with a disease for which there does not seem to be a conventional treatment on offer, is that in desperation they go off and try to find their own treatment and therapy. It is worth remembering that about half, or possibly more than half, of patients with malignant disease of any type seek help and treatments outside of conventional medicine, going for complementary or alternative medicine—often taking treatments for which there is no evaluation. Some years ago, it was a great difficulty for my team to cope with people who were coming in and saying that they were taking shark’s fin. The ecological disaster, the cruelty to sharks and the total lack of evidence of any efficacy made us come up with a form of words that we could use to dissuade patients from ever even thinking along those lines and discuss with them their use of alternative therapies or medicines. Some things that they pinned great hope on really had no benefit.
I also congratulate the noble Lord, Lord Saatchi, on having focused our minds on the patient in the context of themselves as a person and their whole family. He put me in mind of a patient I had at one time who was in exactly that situation. She was a young woman with a rare disease who was clearly dying. We discovered that her children had been fundraising at the school gate for a treatment that they had found on the internet. This treatment had been shipped over from America and she wanted it given to her. There was no evidence base that I could find for it, and I discussed it at length with her and her family, documenting everything—pages and pages of documentation of those conversations. She knew she was dying but she wanted to try it because she knew that her family could live afterwards if she tried it; but if she had not done so, they would not have been able to. Therefore, I undertook to take the whole responsibility on myself for administering it, equipped myself with drugs for every adverse event that might occur, and gave her one dose. There was no adverse effect but there was no benefit either, but after her death her children, who had fund-raised at the school gate, were able to cope better and were glad that she had at least tried it.
We have a system in medicine called the N of 1 trial, which is underused and should be used, particularly where we have rare conditions and genetic disorders, and where we could document and should be documenting what we do. There is a problem, though, for those who instigate such trials in getting them published. I would like to address the publication difficulty in my closing remarks—the difficulty of pooling all the little bits of information that can come from different aspects of medicine.
I think that the N of 1 trial will have an increasing place as we get further into rare genetic conditions and personalised medicine, but the NHS, with its push to embrace research as a core component, is going to have to look at a kind of buffer zone for funding the additional bits of work that need to go along with doing that properly. We also need to have good publication of negative results and we need to publish all the results, including all the adverse effects, when trials fail. Unless all of those emerge, we really will not know the full picture and what we are dealing with.
I make a plea that in this push-pull with which we are faced in medical innovation, there is a real push to have a repository for the results of some of these N of 1-type studies, and a repository for negative results and those that are currently going unpublished.
Lord Ryder of Wensum
My Lords, I congratulate my noble friend on the clarity and strength of his speech. I am conscious of the medical distinction of many noble Lords here tonight; I participate as a layman.
For the past eight years I have chaired the Institute of Cancer Research, an organisation driven by innovation. The institute, a college of the University of London, employs about 800 scientists from more than 40 countries. According to the Times Higher, we came top of the most recent research assessment exercise. We prize a global-leading drug discovery unit and are proud that over the past six years alone, 16 of our drugs have been nominated as candidates for development. Two months ago, an innovation debate took place at the Royal Society. Professor Paul Workman, head of cancer therapeutics at the institute and the RSC’s entrepreneur of the year, was a speaker. He argued that, although we are making strides against cancer, we are failing to convert our knowledge into outcomes. To be precise, our knowledge of the genomes of cancer cells should be allowing us to develop targeted therapies for patients—what is known as personalised medicine.
There are many reasons why we are not advancing at greater speed. Biotech companies are diminishing because venture capitalists demand profits in three years, when in our sphere it is often a struggle to achieve results within a decade. Pharmaceutical companies should be switching from blockbuster drugs to personalised medicines targeted on small patient groups based on cancer genes, but we suffer from the fact that these pharmaceutical companies are also enduring an era of change, which is typified by the theme of next month’s Pharma Summit in London—namely, “Should pharma cut its losses and get out of R&D?”.
How can we turn our knowledge into targeted drugs? How can we bridge this innovation chasm? The commendable Strategy for UK Life Sciences, which was produced by the Government, urged us to develop infrastructures that connect academics, industry, investors, clinicians and the NHS. Thanks partly to a long-standing relationship with our sister organisation, the Royal Marsden Hospital, that is our model. It has worked well for years in terms of innovation and outcomes. It is vital for it to be taken up in as many places and as many fields as possible.
We also require more investment in drug discovery and development carried out by non-profit groups, especially early-stage drug projects that are too risky for industry and can be advanced quickly only in the lab and with patients. In addition, we require further re-evaluation of regulations and pricing. Patients must have earlier access to drugs. I am told by institute clinicians working in the Royal Marsden that the European clinical trials directive handicaps their work and impedes innovation. The Minister will know that, unfortunately, clinical trials carried out in the UK, as a percentage of the world total, have fallen from 6% to 1.4% during the past 10 years.
Drug discovery and development is the UK’s leading innovation-based business. It is the UK’s most successful manufacturing industry in terms of the surplus it provides for the balance of payments. However, expenditure does not necessarily correlate with inventiveness. I have always upheld the Schumpeter line that innovation is the critical part of economic change, yet Governments have a duty to create the right climate for innovators, and they have plenty yet to do.
Baroness Warwick of Undercliffe
My Lords, when I read just before Christmas the cri de coeur of the noble Lord, Lord Saatchi, about the lack of progress in finding cutting-edge treatments for cancer, I had huge sympathy, which has been reinforced by his passionate speech today. I remember a similar sense of anger, frustration and bewilderment at the lack of speedy diagnosis and then effective treatment of my mother’s cancer, albeit some years ago now.
I hoped that the science would move on. I knew how good our scientists and our clinical researchers were, so there was no question in my mind that our scientists could produce results so long as they were given the means and the encouragement to do so. Sadly, the improvements have been patchy and, in some cases, stubbornly resistant. A few months ago, I noted in a debate on pancreatic cancer that there had been virtually no change in treatments over the past 20 years, although it is about not just drugs but early diagnosis and access to surgery.
There are many reasons why progress has been less speedy than we might have hoped. The noble Lord, Lord Saatchi, has identified one important area—the effect of medical negligence claims and the risk-averse culture that they generate—and I wish him good speed with his Private Member’s Bill.
Another area often cited as a brake on innovation is regulation. I declare an interest as chair of the Human Tissue Authority. I want to offer some thoughts on how regulation might be a force for good and need not stifle innovation. It is vital that all bodies involved in the health service do all that they can to facilitate high quality medical innovation. Innovation in medicine leads to improved healthcare and quality of life, and can have significant economic benefits.
Sir David Nicholson’s recent report, Innovation, Health and Wealth, provides us with a clear picture of what needs to change if we are to encourage further innovation in medicine and healthcare. In his report, Sir David makes a passing reference to regulation as a “top-down pressure” on innovation but, importantly, he does not identify regulation as one of his six,
“barriers to innovation in the NHS”.
No one doubts that regulation has value in providing assurance for quality, safety and efficacy, and regulation can sometimes be a driver of innovation. None the less, and notwithstanding the exclusion of regulation from Sir David’s six barriers, it is clear that some regulation, if it is excessive, complex, unclear or inflexible, can impede innovation. I believe that we should review all healthcare regulation in terms of design, implementation and enforcement, to ensure that unnecessary barriers are removed. The regulators should be challenged and, just as importantly, should challenge themselves to ensure that they are not creating barriers to innovation.
I shall finish with a few words about the approach to regulation used by the Human Tissue Authority. Of particular relevance to this debate is our remit relating to the use of human tissue for patient treatment and the development of regenerative medicines, where we work very closely with the Medicines and Healthcare products Regulatory Agency. The HTA is very supportive of research and ensures that effective regulation supports good practice and high-quality science which, in turn, leads to improved healthcare.
There is no doubt that some of the regulation in this area is complex, primarily because the science itself is complex, as is the legislation underpinning that regulation. Complex does not have to mean burdensome, however. At the HTA we believe that a key role of a regulator is to provide clarity and to support organisations in working through the quality and safety regulations. I urge the Minister to reinforce the point that, if done well, regulation can yield significant benefits. It provides assurances about quality and that products can be used safely for patient treatment. It promotes faith in the efficacy of products. Will the Minister confirm that regulators should be committed to doing all that they can to support innovation in medicine? This is certainly true at the HTA, and I hope that the Minister will encourage all regulators in the sector to have such an enabling approach.
In my last few seconds, I should like to raise a related topic. I learnt this morning of a proposal in the European Parliament that the minimum duration of a medical training programme should be increased to six years. This could have serious consequences for graduate-entry programmes in the UK. Medical schools will probably not be able to recruit arts graduates, and surely we need creative people in the profession if we want to be more innovative, especially when evidence shows that they make as good doctors as do science graduates. Will the Minister take this back to his colleagues and ask them to do all that they can to prevent the requirement being increased in this way before the vote on 24 January?
Lord Patel
My Lords, I thank the noble Lord, Lord Saatchi, for initiating this debate and for presenting it so movingly. This ought to be the start of such debates. It ought not to be the last debate we have on this subject. I hope he will remain committed to leading us in future debates.
Some of the treatments the noble Lord described, particularly for some cancers, are medieval and this continues to be the situation for some cancers. Treatment for pancreatic cancer, to which the noble Baroness referred and of which both my mother and my mother-in-law died, remains the same. However, there is hope. Some novel and innovative treatments are now being tried out, such as molecular tagging of drugs to get at cancers that are not amenable to conventional treatment. There is also nanomedicine for targeting tumours that are not responsive to current treatments. There are other technologies that I will come to which could be used to target tumours that are not receptive to radiotherapy.
We should also be slightly more optimistic in this country about where our science is today compared with 10 years ago. For instance, we have had 12 Nobel Prize winners in medicine and physiology since 2001. We have to go back to 1998 for the previous one. Not only that, we have Nobel Prize winners in allied disciplines, such as Sir Venkatraman Ramakrishnan who won the chemistry prize in 2009 for his isolation of the structure of life science-related diseases.
We now have a commitment from the Government to investing in science and having strategies in life sciences and other fields. We should give credit for that. We hope that innovations will come but we must also ensure that regulation is proportionate and is not bureaucratic. We must always keep an eye on that.
There is also the question of investment in translational medicine. One example is in the field not of drug therapy but in cell therapy where big pharma will not invest and small countries do not have the money to do early translational research. There are many examples. One is the use of embryonic stem cells as a therapy for age-related macular degeneration. Currently, the first-phase translation of that is being funded through research councils and charities. The Government should be funding early-phase translation. What plans do the Government have to help with this?
I come now to technological advances and I use the example of focused radiotherapy which is often referred to as “cyberknife”. Of course it is not a knife: it is focused radiotherapy. You cannot use conventional radiotherapy for targeting tumours because you will do more harm to normal cells. Currently, to make that available to a patient who is not amenable to conventional treatment, the doctor will have to ask for finances from commissioners or PCTs. They do not have the expertise to know whether that is indicated for that patient or not, and they may or may not fund it. The Government should be commended for accepting in the Health and Social Care Act that all NHS organisations must have an awareness of research, but it is difficult to find money to fund an expensive, one-off treatment. However, that is sometimes the only thing that is available to the patient. We should support such technologies and make sure that whenever we find that they are not supported, we do something about supporting them. Will the Minister confirm that he will expect commissioners to look at such treatments and innovations in a more favourable way and provide the funding that individual patients require? These treatments are expensive.
I again thank the noble Lord, Lord Saatchi, for initiating this debate. We should debate some of these issues at length at the Second Reading of his Bill and I wish him luck with that.
Lord Kakkar
My Lords, I, too, thank the noble Lord, Lord Saatchi, for having introduced this important debate with so much courage and with such intellectual power. In doing so, I declare my interests as Professor of Surgery at University College London, as Chair for Clinical Quality in our academic health sciences centre, UCL Partners, and as an active clinical researcher.
Innovation is absolutely at the heart of improving clinical practice and outcomes for our patients. It is only right that patients, their relatives and the public expect the profession and government to do all they can to ensure, first, that the research necessary to develop innovative treatments and diagnostic strategies is promoted at national and local levels, and that, once we become aware of innovation—be it through research in our own country or anywhere else in the world—it is quickly identified, adopted and placed in clinical practice. Her Majesty’s Government have placed a particular emphasis on this. Driving a research commitment in the Health and Social Care Bill for the first time, ensuring an obligation on the Secretary of State for Health to promote research and development in the NHS, was an important statutory development. We have the commitment of funding through the National Institute for Health Research, the biomedical research centres and their associated units, and the academic health science centres, which all promote early-phase, experimental and clinical research in our healthcare system.
However, Her Majesty’s Government have also recognised the problem of adopting the findings of that innovation and diffusing it more broadly across the healthcare system and across larger proportions and populations of patients. The recent report, Innovation, Health and Wealth, has identified the need for the development of academic health science networks with a clear obligation to ensure that high-impact innovation is quickly adopted and diffused across populations and healthcare systems, and that the recognised therapies that have been shown to have important clinical benefit and are approved by NICE through its guidance mechanisms are applied more broadly across populations for which we are responsible.
We have also heard in this debate that there are important hurdles to innovation in our healthcare system. These hurdles are regulatory, they are potentially legal and they are cultural in terms of the way that clinical practitioners and others work in the National Health Service and healthcare systems more broadly.
With regard to regulation, I should like to ask the Minister about one particular problem that we have heard about today—the European clinical trials directive. I know that Her Majesty’s Government are involved in negotiations at the European level to overcome some of the problems associated with this directive, which has been damaging to clinical research in our country. Is the noble Earl able to give an update on the progress that has been made there and on what changes might be made to this regulation in the future?
With regard to the legal problem, the noble Lord, Lord Saatchi, identified case law which suggests that there may be anxiety in clinicians’ minds about innovating when it comes to the individual patient in front of them. This may indeed be a very important problem and something that needs to be addressed. As we have heard in this debate, it needs to be addressed in a sensitive and careful way to ensure appropriate innovation and to ensure that clinicians who are in a position to innovate do so effectively but that any deleterious effect is not allowed to take place.
Then there is the question of culture. This is particularly important because much of the debate today has focused on what the views of clinicians and researchers, the healthcare system and indeed the Government may be on innovation. However, we must also look at innovation from the patients’ point of view, as well as that of their relatives. They are right to expect that when they need it most, innovation, wherever it is, is responsibly applied to the management of their case. In all the important work to drive innovation, and the research and development of biomedicine that has been achieved in our country so far, we must be sensitive to the fact that we may not be meeting the expectations of patients—our fellow human beings—when they are at their most vulnerable, and therefore more may need to be done to drive an improved culture for the adoption of innovation and the improvement of practice in our country.
Lord Turnberg
My Lords, it is clear that we are all enormously grateful to the noble Lord, Lord Saatchi, for introducing this very timely debate. It was impossible not to be moved by his remarkable personal story, and I respect and admire the motivation that lies behind his desire to see the best possible treatments being made rapidly available for patients. He has certainly stimulated a wide-ranging debate.
I declare an interest as a trustee of the charity Ovarian Cancer Action and as a one-time practising clinician. We have heard from a number of noble Lords about the time-consuming, bureaucratic regulatory pathway that new drugs have to go through, and we should do something about that—I hope that the noble Earl might comment. However, I want to concentrate on how it might be possible to bypass this normal route to approval, and to give patients a drug that has just come out of research. I shall limit myself to cancer patients.
We know that the Government are committed to embedding research in the NHS, although we are a little way off delivering fully on that holy grail across the whole of the NHS as yet. However, it is the case that novel candidate drugs for cancers are being developed all the time, and are being used for patients in many major centres around the country. At the Cancer Research laboratories that we heard about, the Christie hospital in Manchester, the Beatson Institute in Glasgow and centres in most other cities new drugs are being developed all the time. The £200 million cancer fund has been invaluable in making them available for patients. What will happen to this funding when the source dries up, as I believe it might? It is a tragic fact that, despite some remarkable advances, there remain many cancers that have proved terribly resistant. Ovarian and pancreatic cancer, for example, creep up on patients with vague symptoms or none at all, so that diagnosis is often made too late.
The point is, however, that as novel treatments become available, they can be and are being tried. Of course, there are strict conditions. Novel treatments can be given to individual patients only during clinical trials or on a named patient basis, where patients are made fully aware of the risks and dangers as well as the fact that the treatment may or may not help them. They must give their informed consent. Then, the best conditions for giving the treatment must be available. Those involved in the research, who understand the possibility of adverse side effects, should be available, as should the laboratory facilities to monitor the patient’s response. These are the conditions under which it is reasonable to give novel treatments, and they are just the ones that are provided by the NHS in our major cancer centres around the country.
It should be clear, too, from all of this that it is difficult to provide these conditions outside major centres, particularly in private hospitals where the expertise may not be available. Consultants there are often on their own, and do not have the full back-up that would give them confidence. They may feel vulnerable and unwilling to take the risks to which they would be exposed. Furthermore, private funders may be quite unwilling to fund untried treatments or the extra tests needed to monitor the patients.
I come to the problem described by the noble Lord, Lord Saatchi. It is clear that we do not currently lack the ability to try out novel treatments within the NHS, and I have described the best conditions under which they should be and are being given. However, there are problems of continuing funding, with particular difficulty in private hospitals and in some district general hospitals which lack the facilities. In those hospitals, doctors and their patients need to be made aware of the limitations that exist. When the possibility of a novel treatment arises, patients should be offered the prospect of transfer to a centre where the relevant research is going on and the treatment is being given.
This debate has been invaluable in setting out a set of problems that really deserve our attention. The need to be able to speed through the availability of novel therapies is vitally important, and we must do something about the regulatory burden. However, so far as the use of innovative treatments is concerned, I am not yet convinced that we need a new law to achieve what we want. We should concentrate on spreading information about what novel treatments are emerging across the whole of the service, what treatments are available in our cancer centres, and ensuring the rapid transfer of patients to those centres.
I very much look forward to the noble Earl’s response and I hope that he will say something about many of the other problems mentioned today, such as streamlining regulation, availability of cancer funds and replacement of those funds by some other source. I believe that we owe an enormous debt of gratitude to the noble Lord, Lord Saatchi, for raising the debate, and for giving me my moment in the sun on the Front Bench.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, my noble friend Lord Saatchi introduced this debate most compellingly and very movingly, and I thank him for bringing a subject of such importance to us and one on which your Lordships have considerable expertise, as this debate has amply shown.
Let me start, as many speakers have done, by focusing on the NHS. The unique and integrated nature of the health service has brought many advantages. Since the NHS was established in 1948, innovation has brought incalculable benefits for patients. Treatments have been improved, as has health policy. Inequalities have been reduced. Productivity has been increased. However, while the NHS is recognised as a world leader at invention, the spread of those inventions within the NHS has often been too slow, and sometimes even the best of them fail to achieve widespread use. It still takes an estimated average of 17 years for only 14% of new scientific discoveries to enter day-to-day clinical practice. This is not acceptable. Patients have the right to expect better health, better care and better value from their NHS.
We need to make sure that our staff can get the best, transformative, most innovative ideas, products and clinical practice spread at pace and at scale so that every patient benefits. That cannot happen without innovative minds working with the best resources in a creative and supportive environment. As the noble Lord, Lord Winston, reminded us so powerfully, research is an essential part of the innovation pathway. The Government’s investment in basic health research through the Medical Research Council underpins invention, and our investment in applied health research through the NIHR underpins evaluation. Translation of research is also vital for innovation to progress along the pathway. I hope that the noble Lord, Lord Patel, will be pleased to know that the Government are investing a record £800 million over five years in a series of NIHR biomedical research centres and units. These are translating scientific breakthroughs into better treatments for patients.
Demands on healthcare continue to rise for now and the foreseeable future. We must meet those demands from within our current real-terms funding, while at the same time improve quality. Accelerated change is not so much a goal as an absolute necessity. This means that doing more of what we have always done is no longer an option. We need to radically transform the way in which we deliver services. Innovation is the only way in which we can meet these demands. Spreading innovations in large disaggregated organisations is notoriously difficult. It is one of the biggest challenges facing the NHS. Systematic bottlenecks come with the territory. To make things harder still, technology adoption can be very complex, often requiring significant and disruptive reorganisation. New methods can require different expertise and mean new training, while care pathways have to be overhauled and existing procedures decommissioned. There can be financial barriers or issues of silo-budgeting. Of course, if we are to change this there have to be effective and efficient ways for innovations to reach the patients who need them. This must be across the NHS. That is why implementing the recommendations in Sir David Nicholson’s report, Innovation, Health and Wealth, is crucial. It set out a delivery agenda for spreading innovation at pace and scale throughout the NHS. Its programme is designed as an integrated set of measures that will together support the NHS in achieving a systematic and profound change in the way in which services are delivered.
The innovation landscape before the publication of IHW lacked transparency and accountability; there was variable compliance with NICE technology appraisals, and the picture was confused and cluttered with layers of organisations seeking to serve as gateways for interaction between the NHS, academia and industry partners. Value for money for patients, the NHS, UK plc and healthcare partners was, I have to say, doubtful and innovation was not a central priority throughout the system. IHW seeks to overcome barriers to innovation that have built up over decades, and aims to deliver long-term, sustainable change embedded right at the heart of the NHS. To do that, we need not only to change structures and process but, as the noble Lord, Lord Kakkar, reminded us, to change culture and behaviour—and this takes time.
Innovation is a top priority for the new NHS. This was most recently illustrated by the publication of its planning guidance on 18 December which clearly stated:
“All NHS organisations should demonstrate how they are driving innovation and developing delivery mechanisms for long-term success and sustainability of innovation in their health economy”.
To spread ideas right across the NHS means working collaboratively with all those who have an interest. I am completely in agreement with my noble friend Lord Ribeiro on this. This is why we want to see a more systematic delivery mechanism so that innovation spreads quickly and successfully through the NHS. This can happen in a number of ways, in particular through Academic Health Science Networks, or AHSNs. The NHS needs a stronger relationship with the scientific and academic communities and industry to develop solutions to healthcare problems and get existing solutions spread at pace and scale. AHSNs present a unique opportunity to align clinical research, informatics, innovation, training and education and healthcare delivery—exactly the issues highlighted by the noble Lord, Lord Winston. They will improve patient and population outcomes by translating research into practice, developing and implementing integrated healthcare services. My noble friend Lord Saatchi will be glad to know that our ambition is for every NHS hospital to be part of an AHSN.
The noble Baroness, Lady Masham, expressed her view that clinical research was somewhat of a poor relation in comparison to delivery of services. We have done a great deal to turn that situation around. Through its integrated academic training programme, the NIHR has taken a lead in reversing the decline in clinical academic careers. Around 250 NIHR academic clinical fellowships and 100 NIHR clinical lectureships are now available annually for medics. Last month we announced the award of five new NIHR research professorships in the second competition for these awards, and a third round is under way.
The noble Lord, Lord Winston, my noble friend Lord Willis and the noble Baroness, Lady Warwick, focused on regulation and the varying degree to which it can be a force for good. I listened with concern to what my noble friend Lord Willis had to say about the Health Research Authority. He is so up to date that I probably do not need to tell him this, but the House may be interested to hear that the HRA is collaborating with other regulatory and advisory bodies, for example the MHRA, to create a unified approval process for the approval of health research and to promote consistent and proportionate standards for compliance and inspection. This should reduce the impact of regulation on research-active businesses, universities and NHS trusts; it will improve the timeliness of decisions about research projects and hence improve the cost-effectiveness of their delivery; and it has the clear support of the Academy of Medical Sciences’ review of health regulation and governance.
My noble friend Lord Ryder rightly focused on earlier access to drugs. That is one of the reasons why we have introduced the cancer drugs fund, as the noble Lord, Lord Turnberg, was kind enough to mention, of £600 million over three years. Clinicians can now proscribe the cancer drugs that they feel their patients will benefit from, and 23,000 patients have already benefited from it. I will write to him on the future of the fund.
My noble friend Lord Willis referred to adaptive licensing. This is a subject in which I have taken a personal interest. It is an important area but, I would say, one in which there are many complexities. He is quite right that the MHRA has convened an expert advisory group to consider matters such as this, and I attended its meeting last October. However, we need pharmaceutical companies to come forward and nominate candidates for adaptive licensing. So far, despite asking, no such candidates have been proposed, but we are pressing forward in that area as fast as we can.
My noble friend Lord Ryder also referred to genomic and personalised medicine, an area of major importance in the delivery of personalised medicine, as he said. My right honourable friend the Prime Minister announced on 10 December that the ambition of the UK is to achieve a paradigm shift in the development of high throughput genome sequencing. Our ambition is to sequence 100,000 patients and have a small number of contracts in place to deliver this from 2014. From a standing start, I think that is going to be an impressive achievement, and we are on track to deliver it.
My noble friend Lord Saatchi took us very movingly to the subject of cancer, and a number of other noble Lords have also spoken about it. I fully recognise that, with cancer, screening and the identification of symptoms are vital, and perhaps the single most important thing that will improve outcomes. I will write to my noble friend about this, because all is not lost in this area. We have cause for hope, contrary to what he said, not least in ovarian cancer, where there has been a slow but steady improvement in one and five-year survival rates over the past few years.
My noble friend Lord Ribeiro rightly focused on the slowness of adoption of techniques developed in the UK. I agree that that is the problem. It is one that we are trying to address, but it is a matter of culture, which, as I have said, takes time to change. In addressing long-term culture change, we are seeking to make innovation at pace and scale everybody’s business in the NHS. People throughout the service have to feel ownership of the agenda. The IHW programme is bringing together a community of leaders at different levels in the system who will work together over the next few months to build commitment and ownership in the NHS, to ensure that innovation really is at the heart of the way the NHS does business.
As so often, time is my enemy. I have a number of other things that I would like to have said if I had had more time, not least to my noble friend Lord Rennard, the noble Baronesses, Lady Masham, Lady Finlay and Lady Morgan, and, indeed, others. If they will allow, I will write to them all and to other noble Lords whose questions I have not answered.
I believe we can point to a great deal of progress being made at a time of great change in the NHS, but much more needs to be done to deliver the improvements we need. We must not be complacent, and I am not. We owe it to patients, the public and our stakeholders to achieve that systematic adoption and diffusion of innovation that I have referred to. We are committed to a future in which innovation is a core function of the NHS. That will help us achieve our overall aim, which is to have health outcomes as good as any in the world.