Residential Care: Cost Cap

Lord Turnberg Excerpts

Thursday 10th December 2015 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I, too, am grateful to my noble friend Lady Wheeler for introducing this debate and pointing out so clearly all the difficulties we face. It is difficult not to be gloomy and I am afraid I shall not lift the gloom. Way back in 2011, we had a harbinger of what might happen to care homes when Southern Cross failed with the loss of a large number of beds. Local authorities, which are mandated to care for their needy citizens, were left to pick up the problems; they cannot refuse to do so. Now we are starting to see more of the same, as other large providers of care homes get into difficulties. The latest is Four Seasons, as we have heard, which finds that offering this type of care is increasingly non-viable financially. As my noble friend Lady Wheeler said, it is already in considerable debt, as has been laid out in stark terms in the Financial Times. We could see the loss of many more beds and Four Seasons is unlikely to be the only one so affected.

It is not difficult to see how we have got into this situation. Government funding for local authorities has been severely squeezed and the impact is clear. Since 2010 there has been a fall of 25% in the number of people receiving social care, and the fees that care homes receive from local authorities are strictly constrained. To add to their problems, they are now faced with having to pay their staff the new living wage. Quite right, so they should—these staff have been disgracefully underpaid for the critically important work that they do—but it will cost the sector some £2.3 billion over the next four years. The net result is that care home providers are hit with the double whammy of increased costs and limited income. It is little wonder that they cannot break even. Private domiciliary care providers such as Allied Health have found themselves having to face up to the extra costs due to an EU directive obliging them to pay for journey times to and from domiciliary visits, when hitherto they have been able to get away with it.

It is not only on the supply side that there are difficulties; the demand side is difficult, too. Since 2009-10, the over-75s have increased by about 500,000, a 9.5% increase. It is not simply the increase in numbers that is problematic; the elderly are living longer with disabilities. It does not help to know that in the UK the time between the onset of disability and death is now seven years. That is seven years of dependency. That compares very unfavourably with Norway, where people suffer only two years in need of support before they die.

Of course, many of the causes of dependency lie outside the remit of the Department of Health, but public health clearly does not. While lip service is paid to prevention in all the health plans that one reads about, it is sad to discover that funding for public health is to be cut—by something like £800,000, I am told. That seems an extraordinary thing to be doing when we are trying to reduce the burden of disease. I well understand that it would be difficult for the Minister to change Treasury plans, but is there anything he can do to suggest that it would mitigate the impact on public health?

All this is leaving local authorities and hospital services to pick up the tab, and neither is in a good position to do so. The fall in government support for local authorities is supposed to be bridged by permission to increase their council tax by an extra 2% a year, over the 2% that they already have the flexibility to raise, for the next four years. However, to raise a total of 4% a year across the country consistently for several years is a difficult ask, and it will be much more difficult in poorer areas of the country.

As we have heard, they will have access to the better care fund, money transferred across from the NHS, but they will not receive much, if any, for the next two years. By 2021 they will get about £1.5 billion, and it is interesting that this transfer just about matches the extra that the NHS is due to get. So there is not much relief for the next two years. Local authorities will inevitably have to raid other budgets—but they will already have been doing so for some time, and there is little slack left in the system.

I did not want to talk about the hospital sector in this debate, but it is hard not to when we know that some 30% of beds are occupied by patients who do not need to be there. Everyone knows that. If nursing homes start closing, more patients will be admitted unnecessarily to a place quite unsuited to their needs, and there they will stay for far too long. It is certainly true that the NHS received a very welcome boost in the recent CSR. We should not look this gift horse in the mouth as it is sorely needed, but I fear that it will be only a temporary relief. As the noble Lord, Lord Lansley, said, we desperately need a more basic change in the way that we provide health and social care. It seems inevitable that we will move much more rapidly to a joined-up health and social care system, the fully integrated service that is talked about so glibly. I am not sure that it will necessarily save money—indeed, it may even cost more to get it off the ground—but that must be the way to go for the patients.

Here and there across the country, efforts are being made by innovative and dedicated managers to do just that, but they are having to operate against the grain of the bureaucracy that we have set up centrally. What progress has been made since David Dalton’s report to smooth the path to integration by government, and can we expect a more rapid uptake locally? It will not solve all the problems we face—I fear that more funding for social care by one means or another will inevitably be required—but it will go some way to improving the care of a large number of our most vulnerable people who are currently being shipped around or, even worse, being neglected completely.

National Health Service (Licensing and Pricing) (Amendment) Regulations 2015

Lord Turnberg Excerpts

Tuesday 1st December 2015 Lords Chamber

[Lord Warner (Non-Afl)]

My Lords, I start by thanking the Minister for his briefing yesterday, which I found very helpful. I also declare a forthcoming interest in that I shall shortly be chairing a short-term commission to consider the approach to commissioning specialised services, which will report next April. That may well, in the light of the debate this evening, have some fairly uncomfortable things to say about the commissioning of these services in today’s financially straitened NHS. It is very difficult to argue technically with the points made by my former noble friend—still my noble friend—the noble Lord, Lord Hunt, about this set of regulations, but in a sense that misses the bigger point raised by the noble Lord, Lord Patel.

I express my sympathy for the Minister. He is, to all intents and purposes, between a rock and a very hard place. He has to operate within the extremely clunky system provided for setting the tariff for specialist services in the Health and Social Care Act 2012—which, if I may say so, is one of the less distinguished pieces of legislation passed by Parliament. Trying to set a tariff using a system of objection thresholds is a somewhat bizarre way of doing it, even by the standards of the 2012 Act. That so-called new transparent system for reconciling the needs of commissioners and providers has clearly not worked. It is very difficult to see it working, not least because we end up leaving the decision on the tariff right up close to the start of the next financial year. If we want a five-year plan for reforming the NHS, that is about the daftest way to go about setting a national tariff. I understand why no one wants to go back to the 2012 Act and revise part of it but it is pretty bizarre, in a fast-changing world, to set the detail of how you negotiate the tariff in primary legislation. That is a fundamental flaw which we are now struggling with, as a result of that legislation. That is why we are getting into this tangle over the technicalities of this set of regulations.

If I was still the Minister trying to set acute hospital tariffs at a time of tight NHS finance and, at the same time, trying to prioritise community health services and mental health—as the Minister rightly suggests people are trying to do—I would probably be doing the same thing as the Minister, stuck as he is with this piece of legislation. I might even, if I was feeling particularly crotchety, go for 75% instead of 66%. But that is the fault of the system we have landed ourselves with, not because of a devious NHS England, devious Ministers or a devious Department of Health. We need to get to a different system. NHS providers have opened up some issues to talk about. It is certainly very difficult, in today’s age, to argue with the idea of a more open-book approach. But it also requires the open-book approach to take place further back down the food chain, before we get close to the beginning of the financial year. That is the only way these specialised services can look ahead.

It is true when I look back on my time as a Minister —this is where I start to part company with the noble Lord, Lord Hunt—that there is a pretty strong track record of the big NHS acute hospital providers having everything their own way. Even when, as a Minister, I said that the commissioner’s view should determine the outcome, those providers went on pushing and pushing, way up to and past the start of the new financial year. Of course, I am not talking about trusts chaired by the noble Lord, Lord Hunt—I am sure nothing like that ever happened in Birmingham. However, let us be clear, that is how some of the big London providers, in particular, behave—not in our second city, of course; heaven forbid.

There is a long history, then, of big providers pushing the envelope on the price for the job and weak commissioners being unable to stand up to them and deal with them. We now move to a situation where that problem must be tackled, and quickly. We can quibble about the technicalities of the way NHS England and Monitor have handled this episode, but it does not get away from the point that the Minister made: at the end of the day, these guys and girls have to make the decision. They have to decide on a canvas that is much bigger than that being painted by the acute hospital sector.

We should be a bit more forgiving towards the Minister on that. It takes a bit of bottle to say that we are going to put more money into community services and give more money and parity of esteem to mental health, even in a difficult financial climate. That means taking some fairly tough decisions about how much of the collective resources you put into acute hospitals and specialised services. This is where commissioning must play its part. It may mean that we want a smaller number of providers for some of those service lines; it may mean that we have to concentrate them.

NHS providers may not have realised that an open-book approach means that we start to find out more about those who are less productive or effective. I hope the Minister will listen to some of those ideas, particularly the points made by the noble Lord, Lord Hunt, at the end of his speech and by the noble Lord, Lord Patel. We have a clunky system and we need to change how we set the tariff if we really want to deliver the vision in the Five Year Forward View. I hope the Minister will respond positively to some of those ideas for a new approach.

[Lord Turnberg (Lab)]

My Lords, I must first apologise to the Minister for not appearing at his briefing yesterday and for coming late to his initial remarks. That will not stop me speaking, if I may.

The regulations are clearly designed to save money. They have little to do with correcting what is a major underlying defect in the tariff system: the perverse incentives that tariffs have introduced. My noble friend Lord Hunt has dealt pretty well with how the regulations were aimed at raising the threshold at which objections can be raised and, equally importantly, levelling the playing field to allow small providers with limited budgets to have the same voting power as very large teaching hospitals with billion-pound budgets, which provide more than 95% of the service. It is rather like non-league football clubs and those in the Premier League having the same voice in their commercial activities. The problem is that, to get 66% of all organisations, including all the small ones, puts those trusts that provide more than 90% of the service in hock to those who provide less than 10%. So it is not much wonder that the highly specialised hospitals—the Marsden and Great Ormond Street, the Institute of Neurology, the Christie hospital and so on—are voicing strong concerns about the impact on them. Of course, that is why the Government want to shackle them—to keep costs down—but that is at the risk of denying high-quality specialised care to those who need it.

All that has been well rehearsed by my noble friend Lord Hunt and other noble Lords. I really wanted to point out that the regulations do nothing to get round the unintended consequences and perverse incentives of the tariff system, which I raised with the Minister in a previous debate. That system encourages trusts to go down the route of using devices to gain higher incomes and discourages cross-referral between specialists within a hospital when a trust can gain two fees for two referrals from general practice. It discourages consultants from using phone-in follow-up out-patient clinics to save patients the need to travel in to be seen, as a visit to a hospital incurs a higher fee on the tariff. I agree with the noble Lord, Lord Warner, as he rails against the acute hospitals, but I do not necessarily agree with all his solutions.

I support my noble friend’s amendment. The regulations are unwarranted and damage those who provide the vast majority of the service, while doing nothing to get at one of the major defects in the tariff system.

[Lord Kakkar (CB)]

My Lords, I declare my interest as chairman of University College London Partners, an academic health science centre which has a number of important providers. The Minister made a very important point about the five-year forward view and the need to encourage new models of care working that ensure collaboration beyond institutional boundaries —and, indeed, to go further and look at new models of funding, including those of accountable care organisations. With a view to a potential journey towards more effective commissioning, and therefore more intuitive constructing of a tariff to support general acute services and more specialised services, will the proposals that the Minister brings to the House today aid that journey? Will looking at these regulations in the way proposed help institutions to work more effectively together, recognising the opportunity to look at tariffs that focus on pathways of care rather than individual segments of care, so ensuring the Government’s objective to ensure that valuable resources committed to the provision of healthcare are used most efficiently? There is a recognition that there will have to be greater attention to these matters as we go forward, and every opportunity should be used to ensure that that objective is achieved. One of the most important is the approach to setting the tariff and, therefore, these regulations.

Palliative Care

Lord Turnberg Excerpts

Thursday 22nd October 2015 Grand Committee

[Lord Turnberg (Lab)]

My Lords, I too congratulate the noble Lord, Lord Farmer, for his immaculate timing in having this debate and for his very wise words. There is little doubt that hospices do a wonderful job, and I for one am lost in admiration for the way they go about caring for dying patients. However, hospices care for only about 3% or 4% of dying patients, and more than 50% finish up in acute hospitals. These hospitals often do a very good job, but they have some problems. For one, they have young doctors and nurses who are ill prepared to deal with death. Too often they have not yet gained the confidence which is needed to give the care and compassion which are so vital. On top of that, they have to deal with their own sense of inadequacy when faced with dying patients. It is not easy. It is no help that they are distracted by having to rush around to deal with seriously ill patients and that they have to focus on saving someone’s life rather than helping someone else to die.

None of that is an excuse for the failing standards, and it is not possible to read the ombudsman’s report with any degree of equanimity. Indeed, as someone who has spent much of his life trying to educate medical students and train post-graduates in the proper practice of medicine, I feel deeply ashamed. As an aside, I should say that there is a peculiar fear that giving adequate doses of morphine for pain relief is somehow dangerous. The correct dose of morphine is that which relieves a patient’s pain, and there is no excuse for withholding it when it is needed. I feel some sympathy for Woody Allen, who said, “I don’t mind dying, but I don’t want to be there when it happens”.

Despite the fact that there is absolutely no shortage of guidelines on how to care for the dying, there is still a huge gap between what we can do and know should be done, and what is actually achieved in too many places. First, it is clear that many patients would prefer to die at home, as many have said. It is obvious that too few social services and primary care facilities can cope with the heavy demand that this sort of care puts on them. Hospices at home can be very successful—as they are in several places, as the noble Lord, Lord Farmer, and my noble friend Lord Judd mentioned—but we need to provide more resources to spread that good practice.

Secondly, we must face an obvious lack of the leadership that is needed in hospitals to ensure that palliative care services are provided in a timely and effective way. We need someone with clout to take responsibility to oversee this service, somebody everyone knows and can turn to when needed. Thirdly, we must place much more emphasis on education and training. This is an area of clinical practice which you cannot just pick up as you go along. You need high-quality training by experts, and it is good to see that tomorrow’s Bill emphasises this. Finally, we have to make sure that CCGs, trusts and those with the money take responsibility for these services being funded, delivered and monitored. Are the tariffs for palliative care adequate? Are these services monitored, and by whom? Many questions are being raised in this debate, and we have to answer them if we are to be judged to be a society that cares for its most vulnerable citizens. I very much look forward to the Minister’s response.

NHS: Reform

Lord Turnberg Excerpts

Thursday 16th July 2015 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I, too, welcome the Statement and many of the things in it. We accept that higher mortality rates at weekends in hospital are unacceptable, so we have to try to think of ways of reducing them. Seven-day working for consultants is just one element. Consultants are important, of course. The Minister is probably aware of Brian Jarman’s publication some years ago which showed that there was an inverse correlation between the number of doctors in a hospital and the mortality rate; that is, a hospital with more doctors had a lower mortality rate. There are lessons to be learned there, especially as we in the UK seem to have fewer doctors per head of population than almost any other OECD country, and fewer beds come to that—so we are starting from a low ebb, and the points made by noble Lords about where we are going to get the extra people from are important.

However, the consultant element is just one part. The noble Baroness, Lady Finlay, made a very good point about the need for radiologists, physiotherapists and pathology laboratories. All the machinery of the hospital has to be there. Equally, there is the whole business of general practice and community care. Primary care at the weekend is poor, by and large; that is one of the major problems. Patients are not getting into hospital until they are in greater extremis, so they are more ill when they get there: then they require more service, and once they are there, they cannot get home because there is no one to see them home. Concentrating on consultants is just one element. What is the Minister’s response?

[Lord Prior of Brampton]

The noble Lord, Lord Turnberg, knows the situation on the ground as well as anybody in this House and, of course, he and the noble Baroness, Lady Finlay, are absolutely right that this will not be solved just by having more consultants in acute hospitals. We have to look right the way across social care, primary care, community care, mental health care and acute care. We are talking about a system. In many ways, one of the reasons why we find ourselves in the position we find ourselves in today is that we have not had a system for some time. We have deliberately broken up the system for good reason.

I was very much in favour of foundation trusts having their own balance sheet and their own profit and loss account because of increased accountability, but disadvantages have flowed from that. Chief executives in acute hospitals look after their own. They have treated themselves as an island. We are not part of an island. Rebuilding the system will take some time. It is not going to happen tomorrow, and there is no silver bullet. All I can say is that the Government are committed to the five-year forward view, the new models of care and joined-up care. We are committed to experimenting with accountable care organisations, integrated care organisations and all kinds of joined-up models. We are seeing exciting developments in Manchester and possibly, in time to come, in Cornwall and other parts of the country where we will have pooled budgets between social care and healthcare. I am confident that over the next five years we will if not solve these problems, at least go a long way to doing so.

Local Authorities: Public Health Budget

Lord Turnberg Excerpts

Wednesday 15th July 2015 Lords Chamber

[Lord Prior of Brampton]

The noble Lord makes a good point that goes considerably broader than the Question. I accept that many of these things are inextricably linked.

[Lord Turnberg (Lab)]

My Lords, does the noble Lord accept the report from NICE, which showed that investment in public health improves not only the health of individuals but the economy? Can I tempt him to agree that cutting funding by as much as—I think—7.5% is counterproductive in trying to improve the nation’s health?

[Lord Prior of Brampton]

The noble Lord may be interested to know that the McKinsey institute assessed that the cost of obesity to the British economy was some £46 billion. I am under no illusion about the importance of proper prevention.

National Health Service: Sustainability

Lord Turnberg Excerpts

Thursday 9th July 2015 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I, too, congratulate the noble Lord, Lord Patel, on introducing this important debate in such a powerful and impressive way. I, too, resonate very much with the idea of a royal commission. Indeed, I suggested it some time ago in a previous debate.

When the noble Earl, Lord Howe, was Health Minister he must have got used to me banging on about the parlous state of NHS finances, so I see no reason why I should not continue that theme with his esteemed successor, the noble Lord, Lord Prior. But I say at the outset that I do not go along with the “black hole” or the “bottomless pit” theory that we will never be able to fund the NHS adequately. The bottomless pit argument is faulty because, while we may not be able to afford everything that everyone wants, we can and should afford what they need. That is, we can afford a service that is widely regarded as satisfactory and which can meet all reasonable expectations at a reasonable level. Indeed, many countries manage to do this very well.

However, it is clear to virtually all observers that we are not in that position now. We are falling behind. I look back to the halcyon days of the previous Labour Government, when, by 2010, we were putting in almost 9% of GDP, we had got rid of the waiting lists, accident and emergency waits were down, GPs could be seen on the same day and patient satisfaction was high. Now we have problems in all those areas. We have cut the share of the national cake from more than 9% to around 7%. I understand the need for austerity measures, but may I ask the Minister: what is the justification for reducing the proportion of GDP spent on health? Bringing the share of GDP up to a reasonable level is something a country with as high a GDP as ours, and more billionaires per square inch, can afford. All the problems due to these stringencies have, of course, been spelt out in reports from the King’s Fund, the Nuffield Trust and the health service managers who are heading for huge deficits this year. I fear that these are just the conditions in which research and innovation are squeezed out. As the scientific adviser of the Association of Medical Research Charities, I find that particularly disheartening.

Of course, I recognise that there are more efficiency gains to be made. I want to provide one or two examples where the system under which the NHS labours is causing a terrible waste of money, and where efficiency has gone out of the window. I have a friend who is a distinguished gastroenterologist and who is desperately trying to do his best for his patients and at the same time save money for the NHS. Here, I must express my interest as a one-time gastroenterologist way back in the dark ages. My friend was trying hard to fulfil one of the major requirements of NHS England—to move much more care out into the community and reduce the cost of hospital care—so he started running out-patient consultations by telephone instead of bringing the patients up to the hospital. That saved them much time and effort, and they loved it. He also knew that the tariff paid by the CCG for each out-patient consultation was around £150, while a telephone or face-time consultation cost £29. That is a considerable saving to the NHS and a win-win situation. However, noble Lords might imagine how that was perceived in his trust. He was called in to meet a middle manager, who told him in no uncertain terms that he must stop this because the trust could not afford to lose the funding that his activities were causing, so he stopped for a while but has reintroduced the practice surreptitiously and is waiting for the trust to call.

My friend also wanted to set up a one-stop clinic for patients needing endoscopies, seeing them in the morning, treating them the same day and giving them their results later the same day. This saved patients waiting 12 weeks for an endoscopy and three more weeks for the results—just what the NHS should be about: efficient, convenient service. But again, the incentives for the trust got in the way. Trusts lose money when patients attend only once instead of three times.

I doubt whether this is a unique phenomenon, and it is a clear result of the disincentives we have set up in the internal market. So long as providers are desperate for funds from purchasers, we will run into this type of problem. So my question for the Minister is: is the internal market broken and counterproductive, and, especially when we are under such financial constraints, would not an integrated budgetary system be more suited to our needs? How do the Government envisage achieving their objectives of integrating community and hospital care, hitting savings targets and improving the care of patients while we have this dysfunctional internal market? The question is not whether we can afford a health service free at the point of delivery but whether we can afford one that is hidebound by disincentives in the way I have described. I look forward to his response.

NHS: Innovation

Lord Turnberg Excerpts

Thursday 11th June 2015 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I am very grateful to my noble friend Lord Wills for introducing this debate in his usual eloquent and powerful way and for emphasising the importance of giant cell arteritis, which is such a devastating condition, but potentially treatable if it is diagnosed early enough. It is a particular pleasure to know that the noble Lord, Lord Prior, is at the Dispatch Box for the first time and giving his maiden speech. I know that he is extremely knowledgeable about the NHS, so I am sure he will have no trouble at all in answering all our questions.

The topic of innovation is very close to my heart. How could it not be, as someone who spent his life—rather a long time ago—as an academic physician and constantly tried to innovate in my practice, and who is now scientific adviser to the Association of Medical Research Charities, which produced that very far-sighted document a couple of years ago, Our Vision for Research in the NHS? In that vision, we wanted to see, first, every patient being offered the opportunity to be involved in research, for example in clinical trials. It is clear that most patients want to be involved. Perhaps they know that there is good evidence that patients who are in trials do better than those who are not. Secondly, we wanted research to be embedded in the NHS and every healthcare worker—doctors, nurses and others—to know that they can contribute to research. They should be motivated to engage in understanding the benefits of research for their patients. Thirdly, we wanted the NHS itself—the CCGs and trusts—to ensure that there is a research culture in its organisations.

How far have we come since then? Of course, some things have got better, but I fear that others have become worse. On the positive side, we have a very strong basic science sector. We are very good in the UK at innovation. We punch way above our weight in our research outputs internationally—citation indices, Nobel prizes and the like. We are being overtaken by China and Singapore, and India is coming up fast on the outside, but we are still pretty good.

Also on the positive side is the investment that the Department of Health is putting in through NIHR, under Sally Davies’s direction. The academic health science networks and centres are doing very important work in encouraging clinical research around the country—long may that continue. My first question for the Minister is about what plans the Government have for the longer-term funding of AHSNs. The last Government were rather cagey about that. Then, again on the positive side, we have the Health Research Authority, under Jonathan Montgomery’s chairmanship, which is doing good things in easing the regulatory burden on clinical researchers. There is more rapid approval through ethics committees and through local trust research committees.

However, of particular importance and value has been the rapid licensing of new drugs by the European Medicines Agency and the MHRA. That will prove invaluable in getting drugs through regulation and into practice. Yet too many hurdles still interfere with the uptake of innovations in clinical practice, and there are too many delays before patients begin to gain the benefits of innovation. Some of these were brought out in the Lords Select Committee report on regenerative medicine. I had the privilege of sitting on that committee a year or so ago. The report suggested that, first, funding for research was problematic. We found that although many original discoveries were made in the UK, lack of research funding and in particular venture capital investment prevented us from keeping ahead of the game. Researchers in other countries capitalised on our inventions—a very familiar story. We now hear that funding for universities might be cut back in the Chancellor’s proposed new austerity measures. What assessment have the Government made of the cuts to universities on research outputs, particularly medical research outputs?

Then there is the problem of how we can encourage doctors to engage in research at a time when clinical pressures on them increase all the time. That is certainly true of hospital doctors but even truer of GPs. Here, there is much greater resistance to engage in or contribute to research activities—clinical trials and the like. When I speak to GPs it is very clear why: they are simply rushed off their feet and overwhelmed by their clinical and administrative load. They just do not have the time. Are the Government doing anything to ease that burden? How can they even contemplate seven-day working and at the same time think about research?

The workload of GPs has another effect too. It impinges on their willingness to take up novel treatments as they come along. I am afraid that a natural antipathy to accepting something new is made worse when they do not have the time to even look at the evidence. If we are to achieve our ambitions for research in the NHS we need GPs to be much more involved. Do the Government have any ideas about getting round this serious difficulty?

Then there is the problem of access by researchers to data about patients. Clinical and other data are vital to the research endeavour and, indeed, for good clinical care. However, the care.data fiasco last year put that back far too far. What is being done now to untangle that mess? When will the planned pilot studies take place? What care is being taken to reassure the public and patients that their confidentiality will be protected, while at the same time explaining how vitally important it is that their data are made accessible to legitimate researchers?

Finally, we have the knotty problem of approval for funding of new treatments, particularly those for patients with cancers and rare diseases. These are often very expensive and must go through specialised NICE or NHS England assessment processes. There is the rub, because these are extremely slow and tortuous. Even though drugs may get a licence quickly through the new systems offered by the EMA and MHRA, they must then jump through the hoop of NICE for funding in the NHS. However, NICE can deal with only three of these requests a year and usually takes well over a year to approve any one of them. It is even worse for those drugs that it cannot take on. It can deal with only three; any more it must pass on to be examined by NHS England. Here, they must be considered by no less than seven serial committees—that is, seven committees in series. If you wanted to invent a system to avoid making a decision, then this is it. What can be done in NICE and in particular in NHS England to reduce this bureaucratic nightmare, set up to approve funding of these new treatments? Is there anything that can be done to rationalise the number of committees employed in NHS England that are needed to do this work?

It has been repeatedly stated by Ministers, including the Chancellor and the Prime Minister, that the Government give high priority to research and, in particular, to medical research. Indeed, the Health and Social Care Act made it mandatory for CCGs and trusts to include clinical research in their strategies, but it is equally clear that these ideals are being frustrated. There are other reasons, but funding for the service is going to be important—funding for GPs; funding for expensive drugs; and funding simply for the service—which makes it even harder for it to engage in the research agenda. But it is not just a question of funding, as I have said, and I look forward with interest to the response from the noble Lord, Lord Prior, and wish him well in facing the difficult times ahead.

Health and Social Care (Safety and Quality) Bill

Lord Turnberg Excerpts

Wednesday 18th March 2015 Lords Chamber

[Lord Ribeiro (Con)]

My Lords, I beg to move.

[Lord Turnberg (Lab)]

My Lords, I hope your Lordships will allow me just one minute. I do not intend to oppose this Bill, but in Committee I expressed some concerns about the possible unintended consequences of Clause 1. In fact, I have withdrawn an amendment I had intended to move that would have tried to mitigate some of these consequences by pointing to a rather better way of avoiding harm to patients by proper education, training and supervision within hospitals and care homes which would lead to a continuing, progressive reduction in harm but without stifling innovation. I withdrew my amendment because I was told that I would cause the Bill to fall and I have no intention of doing that. But I do hope, at least, that the noble Earl will be able to offer some reassurances on the points that I have raised.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, I understand concerns that noble Lords have raised about the Bill potentially stifling innovation and openness. I assure noble Lords that this is in no way the intention of the Bill. Indeed, the Bill does not place any requirements on providers of healthcare and adult social care registered with the Care Quality Commission. This is achieved through regulations and the associated guidance issued by the CQC. My officials have been in contact with the Chief Inspector of Hospitals, who would be very happy to meet noble Lords to discuss the content of the guidance to ensure that the CQC’s approach to inspection supports continuing reductions in avoidable harm, innovation and supervision and training of staff.

Health and Social Care (Safety and Quality) Bill

Lord Turnberg Excerpts

Friday 13th March 2015 Lords Chamber

Moved by

[Lord Turnberg]

1: Clause 1, page 1, line 7, leave out from “that” to “avoidable” in line 8 and insert “service providers carrying out regulated activities take steps to reduce”

[Lord Turnberg (Lab)]

My Lords, I am grateful to the noble Lord, Lord Ribeiro, and to the Minister and his team for spending some time last week discussing the Bill with us. That was helpful but I fear that I am still very concerned about the potential impact of the Bill in its current form.

I say at the outset that I will not be arguing against the case that we should be doing everything we possibly can to avoid harming patients; nor am I arguing against the underlying purpose of the Bill, which I am convinced is meant with the best possible motives in mind. But we know that even in the best hospitals occasional mistakes will be made and someone will be harmed, and the question we have to face is whether legislating for mistakes never to be made is the best way of achieving that purpose.

During our discussions it was helpful to hear that the new regulations will apply only to institutions, such as hospital trusts and care homes, and not to individual healthcare workers—nurses, doctors and other carers. They, as we know, are regulated by other bodies and held to account by them if they cause harm. But it is not at all clear that that is the intention of the Bill as it is currently written. Indeed, it was pretty obvious at Second Reading that much of the debate focused on individual surgeons who operated on the wrong leg—regrettable and devastating though that may be—but now we are told that that is not what the Bill is about. We even heard from one noble Lord details about which hernia he was having operated on and you cannot get much more personal than that.

We now know that the Bill is about ensuring that all the precautions necessary to avoid harm are taken by institutions. It is obvious that that is where we should be aiming our efforts to try to avoid those terrible stories that we hear about of neglect and abuse, particularly of elderly people, in hospitals and care homes. These are far too common for comfort. They are largely due to institutional failings and that is where we need to aim the Bill. But the problem is that it is not clear in the wording of the Bill that it applies to institutions and not individual care workers. I fear it is not much clearer in the proposed regulations, which I have now had a chance to look at.

My anxieties are increased, rather than the reverse, when I read those regulations, where there is much reference to individual persons providing the care—for example,

“the things which a registered person must do to comply”;

there is then a long list of things they must do “to mitigate such risks”. The regulations also,

“make provision as to the persons who are fit to carry on a regulated activity”.

I have been told that “a registered person” refers to a trust manager or chief executive, not someone registered with the GMC, for example. But I fear if that is the case the room for misinterpretation is too great.

My first amendment tries to make it absolutely clear that the Secretary of State’s duty applies to institutional service providers as a whole, not individual healthcare workers. I have also included in the amendment the proposal that the responsibility of institutions is not to produce zero harm but to aim at a continuing reduction in harm over time. That at least is in the realm of the possible, which is what legislation should be about. My second amendment is designed to ensure that institutions take this responsibility very seriously by regularly monitoring the effectiveness of the systems of harm reduction that they have put in place.

There is yet another problem with the current wording of the Bill, and that is the possibility of the harm that the Bill itself could cause if it is not amended. Let us suppose that we can be convinced by the noble Earl that the Secretary of State’s duty applies to institutions, not individuals. We can then easily imagine that fearful hospital trusts, with the Secretary of State and CQC breathing down their necks and trying to ensure that absolutely no avoidable harm is ever inflicted on a patient, will place a severe burden on their doctors and nurses. They in turn will be very cautious indeed about any medical innovation they might consider offering to their patients. The whole atmosphere that we are desperate to introduce into the NHS of an innovative service keen to take up new ideas and treatments will be frustrated.

Furthermore, it is not too difficult to imagine that a culture and oppression could follow—I cannot believe that that is the intention of the noble Lord, Lord Ribeiro, or of the Minister. We need a culture of openness and willingness to admit mistakes and those errors of judgment that are bound to be made, so that lessons can be learnt. I am afraid that errors are inevitable even in the most safety-aware trusts and care homes, yet fearful employees may feel that they are better off covering up rather than admitting to their mistakes.

--- Later in debate ---

[Earl Howe]

Not for the first time, my noble friend Lord Elton comes to my aid. That is exactly right.

[Lord Turnberg]

My Lords, I listened extremely carefully to what the noble Earl has just said and I am grateful to him for clarifying what a registered person is—I think that it is the word “person” that gets very personal here. I remain somewhat concerned about whether legislation to stop avoidable harm is a feasible proposition.

[Lord Hunt of Kings Heath]

Perhaps I may say to my noble friend that I think that the noble Lord, Lord Ribeiro, should wind up first and then he should come back.

--- Later in debate ---

[Lord Turnberg]

My Lords, I apologise to the House and to the noble Lord, Lord Ribeiro, for leaping to my feet in my eagerness to respond.

I listened very carefully to the noble Earl and to the noble Lord, Lord Ribeiro, both of whom were able to reassure me to an extent about the meaning of the term “registered persons” and to whom that refers, so I am happy about that. Incidentally, I am also happy that there should be a duty that the Secretary of State “must” put forward regulations.

However, the question remains, is legislation to stop avoidable harm a feasible proposition? I remain unhappy about the possibility that this will result in excessive caution, lack of will to innovate in clinical practice and the potential to drive underground the bad behaviour of some doctors who may not wish to admit to it. Therefore, there is still some worry there.

I am particularly concerned after having spent some time going through that rather weighty document, the CQC’s guidance notes, which are particularly heavy-handed. They are extremely clear and dogmatic, and rather light on how to achieve what it wants to do. They seem designed to inhibit any innovative practice, and I fear that the document itself, following on from this legislation, will be unacceptable to people in the field.

I take the point, incidentally, about not having training, education and supervision in the Bill, even though I know that that is critical to the way in which this whole programme—what we all want—can be delivered. That is entirely dependent at the local level on people who will oversee and ensure high standards of care in their institutions. Therefore, clearly this is an important element which comes out in the CQC guidance, but not as strongly as one would wish. I noted that the noble Earl said that he would take away the possibility of looking at the CQC guidance—I am not sure whether I understood that correctly, but I hope that that is the case.

For the moment, as I have expressed, I am still somewhat unhappy about the nature of this bit of the legislation. I will ponder further on what has said. I beg leave to withdraw my amendment.

Amendment 1 withdrawn.

Health: Rare Diseases

Lord Turnberg Excerpts

Tuesday 3rd March 2015 Lords Chamber

Asked by

[Lord Turnberg]

To ask Her Majesty’s Government what action they are taking to improve access to treatments for patients with rare diseases.

[Lord Turnberg (Lab)]

My Lords, many rare diseases can be severe and life threatening, and the problem for patients unlucky enough to suffer from them is that there are few really effective treatments for most. So among the small number for whom a new treatment seems to hold out some promise, there is intense interest and renewed hope. Of course, it is reasonable that new treatments should be evaluated for their effectiveness and that they should be prioritised before they can be commissioned. But therein lies the rub—because, although these diseases each affect a small number of patients, there are more than 8,000 individual rare and ultra-rare diseases in existence. Although there are no treatments for most, more than 100 drugs licensed by the European Medicines Agency are awaiting approval for funding by NHS England, and many of them are very expensive.

It is not surprising that companies that develop such drugs for very small numbers of patients find it difficult to recoup their investment without a high charge; and it is hardly surprising that NHS England, which foots the bill for specialised services, is pretty cautious about what it can afford to pay. This budget is already overspent by £900,000. So we can no longer avoid recognising the dilemma of how to pay for these expensive drugs. My first question to the noble Earl is: what effort are the Government making to face up to this problem? We clearly now need to have the open discussion and thorough review that the topic deserves. The consultation exercise that NHS England is currently conducting is interesting but limited in scope, and the whole issue of affordability of expensive drugs is one that should be opened with the public by the Department of Health itself.

Leaving aside that issue for the moment, nothing can provide an excuse for the enormous delays in decisions being taken by the bureaucratic systems that we have set up. They are not only complex but so completely opaque that clinicians and the pharmaceutical industry despair, and the poor patients are completely bewildered and perplexed. I have spent a considerable amount of time trying to understand the ways in which these treatments are assessed, and here I have relied heavily on advice from the Rare Disease UK alliance, whose members represent a large number of patient groups.

The problems begin when anyone who is proposing that a new treatment should be centrally funded is faced with no fewer than seven possible routes to take. The first three are through NICE—although only one of these, the HST or highly specialised technology route, is really capable of assessing these types of treatment. The problem here is that the HST can manage to deal with only three proposals a year. It does not have the capacity to cope with more. It has, in fact, so far approved only one treatment—eculizumab, for atypical haemolytic uraemic syndrome—since it took over responsibility for rare disease treatments more than a year ago. Yet we know that the EMA is licensing many more new treatments for rare diseases, and that many of these, at least 10 a year, have to be redirected to NHS England itself. However, the rationale behind which three treatments NICE will take on itself and which it will hand on is clouded in mystery. Even worse, it seems that a few drugs have to go through an assessment by both organisations. Can the Minister say how NICE decides which treatments to examine itself and which to hand on—and, more importantly, why on earth we need two separate systems of appraisal? Would it not save a lot of time and money if we had one well resourced and efficient system?

Then we come to the remarkable apparatus set up by NHS England, where we also have several possible entry routes that I will not bore noble Lords with. The main route is through the clinical reference groups, of which there are 75, each assessing different types of potential treatments. Their views are then transmitted to one of five programme of care boards—and that is just the beginning. Approval is then sought from the clinical effectiveness team and the finance group, before the matter is sent on to the clinical priorities advisory group, which in turn passes it on to the specialised commissioning oversight group and the directly commissioned services committee. I hope that noble Lords are keeping up. If it gets through that lot, it is sent out for public consultation and, if approved, has to wait until the beginning of the next financial year for funding.

You can imagine the frustration and angst that all this creates among patient groups who feel alienated by the whole prolonged and tortuous process, which is made worse by the fact that the way in which these committees go about their business seems quite opaque. No minutes seem to be available, decisions are hard to come by and patient involvement is tangential to say the least. The noble Earl, in a response to my Written Question on 1 December, tried to reassure me that patients were involved in a number of advisory committees, but I have to tell him that many patient groups feel quite ostracised by the systems that have been set up. There are no less than seven serial committees, and a cynic might think that this complicated system has been devised to avoid having to make any funding decision. You might well think that; I couldn’t possibly comment.

As if that is not enough, the whole apparatus has now ground to a halt after a legal challenge to CPAG on behalf of a child with Morquio’s syndrome. No new treatments have been examined since December and there is no end in sight until at least next June. There is now a backlog of some 80 treatments awaiting a decision. Can the Minister say when we might expect this matter to be resolved?

With such a complicated system, it is little wonder that there are inconsistencies in the decisions that have been taken. For example, why has funding been agreed for patients with tuberous sclerosis who have brain tumours but not for those with kidney tumours that are equally life threatening? How come treatments have been approved for a very small and specific subgroup of patients with cystic fibrosis but not for a small specific subgroup of patients with gastrointestinal stromal tumours? The numbers affected are similar and the treatments equally effective for each of these rare subgroups, but there is no consistency in the decisions taken. Will the noble Earl press NHS England to rethink this problem of inconsistency?

On another issue, can the noble Earl say why the commissioning through evaluation system, set up in 2013, has apparently not yet approved any drugs brought to it—that is, zero drugs—despite having an available budget of some £16.9 million? Why has this innovative scheme not been activated?

Then there is the question of the high costs that drug companies have in developing new treatments for these very small markets. There is a need here for negotiation between government and industry on price—and there is clearly room for negotiation where industry could be asked to justify its high charges when it has such small patient groups to test and can avoid the very high costs of large-scale phase 3 trials. In practice I understand that companies find that, despite the price access scheme, it is extremely difficult to fix up a meeting even to begin negotiations. Can the noble Earl explain why there seems to be this reluctance to negotiate?

There is also a particular problem when a clinical trial of a new innovative treatment is coming to an end and patients are seen to be benefiting from it. Industry funds the trial but expects to be able to hand on the costs of continuing the treatment after a successful trial has finished. This area of negotiation is particularly fraught since many patients who have benefited are desperate to continue the treatment yet find themselves in limbo because of a reluctance to reach a decision on who pays. Can the Minister clarify what engagement the Government are having with companies and patients who find themselves in this position?

Finally, there is a mind-blowing system of committees and advisory groups set up in NHS England. Can all the CRGs, PoCs, CPAGs, SCOGs, DCSCs and RDAGs be justified? I doubt it. Is it not time for NHS England to get a grip and radically prune this morass of committees? Will it take advantage of its current consultation exercise to think again, and will it kick-start some interim measure to get past the logjam while it is cogitating? I hope that the noble Earl will exert some pressure on it to provide a simple, clear and transparent system of appraisal in a timely way that takes full account of patients’ views. We clearly do not have that now and it is desperately needed.

I return, finally, to my plea for a thorough and open inquiry into the ways in which it might be possible to cover the costs of expensive drugs for rare diseases in an equitable way. That is something that the department itself can hardly avoid tackling. I look forward to the noble Earl’s response.

--- Later in debate ---

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, I congratulate the noble Lord, Lord Turnberg, on securing the debate and raising this issue. I am acutely aware that access to treatments for patients with a rare disease is of great importance to him and many others. We have had some excellent contributions from noble Lords this evening.

The Government are committed to improving the life of all those affected by rare disease. The UK is a recognised leader in research, treatment and care for rare diseases. We are at the forefront of the genomics revolution, which has the potential to radically transform the way that we diagnose and treat people with rare conditions. The UK strategy for rare diseases, which my noble friend Lady Bottomley kindly mentioned, is a high-level framework that sets out our strategic vision. I am sure she will know that raising awareness of rare diseases is a key aim of the strategy. To that end, the department has worked with Health Education England to produce two videos: one aimed at parents and patients, the other aimed at healthcare professionals, particularly GPs. These were launched last week at the Rare Disease Day event, which the noble Lord, Lord Walton, referred to.

I was interested to hear about lymphangioleiomyomatosis, or LAM. Access to treatment for that condition, as for others, is based strictly on clinical need, as set out in NHS England’s published clinical policies, irrespective of tariff arrangements. The key in so many cases such as this is what is often referred to as the diagnostic odyssey—the delay that patients experience before getting a diagnosis.

I listened with huge interest to the noble Lord, Lord Rogan, talking about ITP. The UK Strategy for Rare Diseases sets out our strategic vision for improving the lives of all those affected by rare diseases, including ITP, the autoimmune disease. He will be impressed to know that my officials furnished me with an extensive note on ITP as he was speaking.

NHS England has been charged with taking forward many of the strategy’s commitments and in the Five Year Forward View it sets out a contextual backdrop for the strategic work during the next few years. Due to their rarity and their low patient populations, services for rare conditions in England are directly commissioned nationally by NHS England as specialised services. I am sure that the noble Lord, Lord Patel, will agree that commissioning these services nationally means that NHS England can commission each service to a single national standard with single national access criteria. It ensures that patients have the same access to specialised services regardless of where they live in England. NHS England has made significant progress in developing a set of nationally consistent service specifications and commissioning policies which ensure equity of access to high-quality services across the country.

Since April 2013, the National Institute for Health and Care Excellence, or NICE, has been responsible for the evaluation of selected high-cost, low-volume drugs under its highly specialised technologies programme, as has been mentioned. This plays an important role in ensuring that commissioning decisions are based on a robust and thorough assessment of the available evidence. NHS commissioners are legally required to fund treatments recommended by NICE in its highly specialised technologies guidance. Until NICE’s guidance is available, commissioners make their funding decisions based on the available evidence.

Topics are referred to that programme by Ministers, following a topic selection process that is overseen by NICE. At the core of the topic selection process is a set of prioritisation criteria that are used to determine whether a topic is suitable. These criteria are published on NICE’s website. The process for deciding which topics to refer to NICE is carried out with as much transparency as possible and includes consultation with stakeholders once a topic has passed the early stages of the process. However, it must be recognised that some degree of confidentiality is required, particularly early on in the process, as information on new drugs can be commercially sensitive before they are licensed. The noble Lord, Lord Turnberg, might be interested to know—as he was asking me about this—that NICE has recently taken steps to improve the level of transparency in the topic selection process, and has begun to publish more detailed information about the rationale for its topic selection decisions.

NHS England’s Clinical Priorities Advisory Group formulates recommendations on commissioning of new treatments for rare diseases in England. In order to ensure that the maximum number of patients benefit from innovative treatments coming on stream, hard choices need to be made about which of these to fund routinely. Patient groups asked NHS England to consult on changes to the principles and processes by which it makes these decisions. At its board meeting on 17 December, NHS England decided that a 90-day consultation would be carried out on the prioritisation framework and decision-making process that NHS England should use to make commissioning decisions on new treatments and interventions. The length of that consultation period reflects the importance of these decisions and the advice received from patient groups. The decisions on prioritisation will not be completed until the consultation has closed and the responses have had due consideration. The consultation was launched on 27 January, and it is open for responses until 27 April.

In carrying out its public consultation, NHS England will ensure that the principles and processes for making these decisions are well informed, evidence-led and in line with the expectations of patients and the public. I am sure that the noble Lord, Lord Turnberg, will agree that it is important that NHS England has a robust decision-making process in place and that that process must be followed to ensure that NHS England is treating all patients with rare diseases fairly.

[Lord Turnberg]

My Lords, will the Minister give way?

[Earl Howe]

I will give way, but I am sure that the noble Lord understands that we are time-limited.

[Lord Turnberg]

I just wanted to check that the Minister is aware that there are no fewer than seven serial committees that it has to go through. That does not seem very efficient.

[Earl Howe]

I note that point, my Lords, and I will reflect carefully on it. If NHS England has a comment to make, I shall be glad to write to the noble Lord about that process.

Clearly, once the prioritisation consultation finishes, and in the light of NICE assessments, NHS England will take stock of its position in relation to new treatments.

Our priority must always be to ensure that patients with rare conditions have access to new and effective treatments on terms that represent value to the NHS and the taxpayer. I am sure noble Lords will agree that it is very important that NHS England has a robust decision-making process in place and that, as I have described, it makes sure that all patients with rare diseases are treated equitably.

I also recognise that it is vital that we speed up the discovery, design and take-up of new, innovative 21st-century medicines and treatments in the NHS. We will continue to work with industry and our European partners to increase access to these innovative medicines for patients with rare conditions. In April last year, we launched the early access to medicines scheme, which aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, or licence, when there is a clear, unmet medical need. More generally, our Strategy for UK Life Sciences sets out an ambitious, long-term programme of action to improve the wider environment for health life-sciences companies and overcome the barriers that prevent discoveries being translated into commercial opportunities and new treatments with real benefits for patients.

The noble Lord, Lord Rogan, stressed the importance of research. Undertaking research into rare diseases requires effective partnerships between patients, their families, clinicians, researchers and industry. Of course, health research holds the promise for breakthroughs and improvements in the way that we diagnose and treat people with rare diseases. For example, the NIHR’s world-class Rare Diseases Translational Research Collaboration, launched in parallel with the UK rare diseases strategy, is just about to start 14 new projects. We also want to make it faster to start rare disease research in the NHS. That is why we asked the Health Research Authority to bring in a new single approvals process. This will speed up access for patients to new and effective treatments.

I will cover as many questions as I can in the time available. My noble friend Lady Thomas referred, very powerfully, to the value of hydrotherapy and the importance of appropriate equipment being commissioned by CCGs. As she will know, CCGs are autonomous statutory bodies. Decisions are made locally but I am happy to look into the matters she raised and will write to her on what I fully agree is a very important issue.

The noble Lord, Lord Patel, asked about the successor arrangements to AGNSS. Responsibility for evaluating the use of new and existing highly specialised medicines and treatments within the NHS in England transferred from the Advisory Group for National Specialised Services—AGNSS—to the National Institute for Health and Care Excellence in April 2013. So far, that is working satisfactorily. However, there is the other group—the Rare Diseases Advisory Group—which was referred to by the noble Lord, Lord Walton. Where does that fit it? In terms of rare diseases and highly specialised services, the RDAG makes recommendations to NHS England and the devolved Administrations on issues related to highly specialised services. Its further role is to have an overview across the four countries on the development and implementation of the UK strategy for rare diseases and highly specialised services. It makes recommendations to the Clinical Priorities Advisory Group about how highly specialised services should be commissioned.

The noble Lord mentioned the cancer drugs fund, which has helped more than 60,000 people with cancer to get life-extending drugs that would not otherwise have been available to them. NHS England is now responsible for the operational management of the fund. It is currently working to ensure the very latest, most clinically effective drugs can be made available to patients. We will carefully consider with NHS England what arrangements should be put in place for the fund in the longer term.

The noble Lord, Lord Turnberg, questioned the inconsistency in funding arrangements for different conditions. He mentioned tuberous sclerosis and kidney tumours. Over the next few weeks, the six programmes of care responsible for advising NHS England on specialised services will draw up the work programme for 2015-16, which will include developing a number of policies. Two policies—one for the provision of everolimus for tuberous sclerosis complex-related renal angiomyolipoma and the other for subependymal giant cell astrocytoma or SEGA—will be considered for inclusion in this process.

The noble Lord asked about commissioning through evaluation. That programme was established by NHS England in 2013 as an innovative mechanism to capture further evaluative data and I will write to him further about progress on that front. As regards negotiation on patient access schemes, companies that are members of the pharmaceutical price regulation scheme have the opportunity to propose a patient access scheme to improve the cost effectiveness of their drug, as part of a NICE appraisal. Departmental officials stand ready to meet with any company that wishes to discuss its options.

Time has run out. I conclude by saying that I am committed—indeed, the Government are committed—to ensuring that patients with rare conditions get the same quality, safety and efficacy in medicines and other treatments as those who have more common conditions.