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.

Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Turnberg Excerpts

Tuesday 24th February 2015 Lords Chamber

[Lord Patel]

“Dangerous”, my noble friend says. It killed the other two and resulted in a premature birth. They never published this, despite being asked if there was a publication. It is wrong to say that the HFEA did not ask them; the review panel did. Professor Grifo sent a letter saying that, in his view, all the foetuses were normal but they died of prematurity. What they died of was an obstetric botch-up. It had nothing to do with what we are talking about today. It was a completely different technique. We should dismiss it completely. It would be wrong to put any credence on it and say that it is a good reason why we should not do this.

I could go on about other safety aspects that were brought up, but let me close by saying that hitherto the science has gone as far as it can in thousands of animal experiments that have resulted in normal pups. In human embryos it has gone as far as it can to produce normal embryos, which, if implanted, there is no reason to believe would not develop into normal, healthy babies who would not carry the defective mitochondria. All we are doing today is allowing the regulator henceforth to decide, on a case-by-case basis, to issue a licence to those clinics for those mothers who request this treatment, and which are allowed to use both techniques that we currently know are safe while further research goes on. None of us stops researching: the noble Lord, Lord Winston, still carries on researching; the noble Lord, Lord Kakkar, still carries on researching. If a chance was given, the noble Lord, Lord Walton, would still carry on researching. We do not stop researching; that is the nature of medicine and of academic medical science. I hope that we will pass these regulations.

[Lord Turnberg (Lab)]

My Lords, I am extremely grateful to be able to follow the noble Lord, Lord Patel. I am also grateful to the noble Earl for setting out the issues so carefully at the beginning. I listened with great attention to the eloquent and persuasive speech from the noble Lord, Lord Deben, but I am afraid I was not persuaded. I cannot go along with the idea that we should put this regulation on hold for the time being. My reason is the awful position parents find themselves in when they have a child severely affected by one of these dreadful mitochondrial diseases. They are desperate to avoid having more children with the same disease. The noble Lord, Lord Deben, started from the same position but I believe that we are now in a position to move forward.

We have all been bombarded with information about mitochondria to the extent that few of us can be entirely ignorant of what they are and what they do. Yet there is still considerable room for confusion, at least according to some of the correspondence I have received. References to GM crops and cloned animals are way out of line. Suggestions that mitochondrial transfer techniques are a form of cloning when they are nothing of the sort, or that they are on the slippery slope to genetic manipulation and designer babies when there is no conceivable link between them, are very unhelpful and not part of any reasoned discussion about the issues. I could elaborate on that but will leave it for the moment to concentrate on what I think are the more rational arguments that have been and will be made today.

The noble Earl discussed the safety issues, as did the noble Lord, Lord Patel. The suggestion has been made that the techniques may not yet be safe enough. Let me take this a little further. The basic animal experiments have been going on since the 1980s and the specifics of maternal spindle and pronuclear transfer have been very fully researched for the last seven years. We have heard about the three thorough scientific reviews by expert panels set up by the HFEA. In each, further research that needed doing was suggested and each time the research has been actively and successfully pursued. On the last occasion, in 2014, they clearly stated that there were no major safety issues remaining. It is true that they suggested some further tests—and they are all under way, as we have heard—but they pointed to the fact that at the end of the day there will be no substitute for trying it in humans who carry the abnormal mitochondria.

In vitro studies in the test tube with human embryos after mitochondrial replacement have revealed no problems, and experiments with macaque monkeys—yes, they have been done—and maternal spindle transfer are all reassuring. It is interesting that monkeys are not suitable models for pronuclear transfer techniques because research shows that pronuclear transfer in vitro fails in monkeys but works perfectly well in human studies. The only way in which safety can be finally tested is in humans since no procedure or drug can be certainly safe without that. We have gone almost as far as we possibly can before that step is taken. We have heard some issues about the China syndrome, which I believe the noble Lord, Lord Patel, has dealt with perfectly well. Clearly, that was quite something else and not relevant to our discussions today.

Equally important is that these regulations do not simply allow human trials to start now—they do not; they allow the HFEA only to examine applications made to it for full assessment. It will then decide if the science is persuasive enough, that those proposing to do it have sufficient experience and capacity, and that the patients being put forward are clearly those likely to benefit. Remember that the HFEA is no pushover. It has in its membership not just three scientists and a clinical geneticist but three patients who have gone through IVF, a barrister, a professor of philosophy, a bishop and a national security adviser. That is quite an interesting mix but not one likely to be easily moved by faulty argument. It is they and their scientific advisory panel who will be assessing applications when these regulations come into force in October.

Other anxieties have been expressed that we will be disrupting the relationship between the nuclear and mitochondrial genes: the nuclear genes carry the information that determines all the characteristics that make us human, and the mitochondrial genes provide the energy supply for cells. This argument was discussed at great length in the HFEA’s scientific report in 2014 and was found wanting, not least because half the genes in a fertilised egg are derived from the father and are therefore already foreign to the mitochondria, yet they do not interfere with each other. Furthermore, mitochondrial genes are pretty well conserved between different individuals because they perform a limited number of functions, while there are large differences between the nuclear genes of different people, each of whom is made up of a mixture of DNA from a mother and a father.

Health and Social Care (Safety and Quality) Bill

Lord Turnberg Excerpts

Friday 6th February 2015 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I, too, congratulate the noble Lord, Lord Ribeiro, on introducing this Bill in a characteristically clear and balanced way. I very much enjoyed hearing him. I find myself in the odd position of being extremely enthusiastic about the provisions of one part of the Bill and rather less than enthusiastic about other provisions, where I feel that there is a desperate need for amendment. I hope that the suggestion that we will lose the Bill if we think about amendments is not true and that we can see our way through that.

I shall begin with the bad news and say straightaway that I do not think it a good idea to try to avoid harm to patients by legislating for it. Of course, few can argue against the idea that we should do all that we can to avoid harm to patients by poor practice, neglect or abuse, least of all me, after a life in clinical practice. Certainly, after the Mid Staffs scandal, I can well understand the desire of the noble Lord, Lord Ribeiro, and the Government to be seen to be taking action, but there are three questions to be asked first. Is it necessary to enshrine this in law? Would such a law be effective? Would it have a negative effect on harm reduction?

The Health Foundation believes that the Bill might have a negative effect. It points out that if we want to avoid harm, which everyone does, the best way is through the intrinsic motivation and dedication of staff and senior leaders rather than through legal or regulatory levers. It prays in aid the Berwick advisory group, headed by Don Berwick, a significant figure in this field in anyone’s book. His group included extremely well qualified individuals whose views should at least give us reason to pause before going ahead with this legislation. It says that “zero harm”—its expression—is an impossible aspiration and to try to legislate for it is too simplistic.

Reduction in harm requires a continuing progressive process involving education, training and motivation from the top permeating through every part of an institution. Bringing the law into that at this stage is not terribly relevant and seems to be a knee-jerk response to the Mid Staffs inquiry, which is never a good basis for attempts at quick resolution. What we should be aiming at is better education and training and better supervision by those in charge. That at least has been shown to be effective in reducing harm. The Bill also talks of excluding harm that cannot be reasonably avoided, but we are then into the whole difficult business of trying to define reasonable avoidance. That needs time and expertise that is not readily available. We need to think that through more carefully.

Now for the good news: the part of the Bill that is very welcome is the desire to see a single identifier introduced for all patients in the NHS. I agree entirely with the noble Lord, Lord Willis, on this. The idea that the identifier will be used across the service so that information about a patient can be shared between all those in the NHS and social care who have to deal with that patient makes enormous sense. It makes for increased safety, too, if Doctor A knows what Doctor B has been treating his patient with. It is a common good. For example, when someone turns up in the accident and emergency department, doctors can find out rapidly what illnesses they have had and what treatment they have been given. However, there is a question about how we can include patients treated in the private sector. I hope that we will hear more about that at some point. I strongly urge that the national insurance number be used as the identifier. It makes more sense to use an existing number for the great majority of the population rather than dreaming up a new numbering system. However, of course, that does not have to be in the Bill itself.

It is of interest that the new National Information Board’s framework for action, which was published last November, states that the use of the NHS number as the primary identifier in clinical correspondence and for identifying all patient activities will be mandated in healthcare. The Independent Information Governance Oversight Panel will play a key role as national data guardian for health and care. This will ensure that proper scrutiny and challenge can be seen to be operating and will reassure those who feel that patient confidentiality will be threatened. A single patient identifier will also be extremely valuable as, hopefully, we move forward with care.data. As that gets off the ground, with the robust safeguards that we hope will be in it on patient confidentiality, the use of those data for medical research and clinical trials will be essential.

Here I declare my interest as scientific adviser to the Association of Medical Research Charities, of which my friend, the noble Lord, Lord Willis, is chairman. Our members are desperate to see research into advances in the treatment of the many diseases that they cover being aided by the use of patient data. As the noble Earl has stressed on many occasions, research is a key and central role for the NHS. There is little doubt that a single identifier, the NHS number, will be a valuable tool in achieving that desirable aim.

Returning to my concern about the difficulties of allowing the Bill to pass without amendment, I should say—in case I am seen as a maverick spoiler—that I am not alone in my view. Apart from the Health Foundation, I know that the Academy of Medical Royal Colleges, the BMA, the Medical Protection Society and, I fear, the Royal College of Surgeons have all raised aspects where amendments may be required. I know that the noble Baroness, Lady Masham, who cannot be here today, is unhappy with the Bill as it stands. I hope that we will be able to look at the Bill again and that the Government will come up with a mechanism by which we can consider amendments to the Bill. I have suggested one possible mechanism to the powers that be, but of course it is not up to me.

National Health Service

Lord Turnberg Excerpts

Thursday 8th January 2015 Lords Chamber

Moved by

[Lord Turnberg]

That this House takes note of the future of the National Health Service.

[Lord Turnberg (Lab)]

My Lords, it is a privilege to be able to open this debate on the future of the NHS. It comes at a time when we are gearing up for the election and when it seems entirely possible that the NHS will be of some interest to the electorate. I will try to set the scene with a broad brush and leave it to other noble Lords to focus on various specific aspects.

We are going through a time when the media are full of one NHS disaster after another; with reports of cancelled operations, GPs and A&E departments being overwhelmed and waiting lists rising. We have not been short of media analysis in the past few days. That this is not simply the usual media hype is pretty obvious. We have had a number of careful reports from the Nuffield Trust and the King’s Fund, for example, that make sobering reading, with titles such as Into the Red? The State of the NHS Finances and Is General Practice in Crisis? suggesting that all is not well and that we cannot continue as we are.

The Government have woken up rather belatedly, with a sudden rash of activities. We have had NHS England’s Five Year Forward View, full of interesting aspirations; the Dalton review, with some ideas about how to go about achieving some of them; a number of crisis funding rescue efforts; and the Prime Minister reportedly sending in his pre-election “hit squad” to try to sort things out. However, it is pretty clear that quick fixes are not the answer and that the nature of the difficulties we face requires much longer-term solutions. It is good to hear that my own party is making some realistic proposals that might make a difference.

The causes of the problems are pretty widely understood. A service designed largely around acute hospital care has ignored for too long the needs of people with multiple long-term illnesses, especially those of the growing band of elderly patients whose needs are much better met in the community than in hospitals. This demand is certainly rising. The number of over 80 year-olds is set to double over the next few years and, for example, the number of people on more than three different pills for their multiple illnesses is growing by the day. I dare say that there will hardly be a Member of your Lordships’ House who is not on at least two pills keeping them in the fine trim that we see today, and I fear that I am no exception.

However, it is not only the growing proportion of the elderly and the worrying rise in the number of people with dementia that is causing difficulties; it is also the pressing demand placed on acute services. We can do so much more for patients than we ever could, and the population increasingly expect that they will be given the most effective treatments available. Many of those treatments are now very expensive. Complex scanners and investigations, coupled with the development of designer drugs produced specifically in response to an understanding of the genetic make-up of smaller and smaller subsets of patients, pose severe problems for a service working within rigid financial constraints.

It is in that financial squeeze where the nub of the problem lies. The fact is that the rate of inflation in health service costs is running way ahead of general inflation rates and certainly ahead of the growth in GDP. So every year the gap between demand and the funds available is widening, and this is what is responsible for the idea so often trotted out that the NHS is a “black hole” into which money just disappears. I do not believe that for a moment, and I will explain why shortly.

You might think that a Government would try to keep pace, if not with inflation then at least with the rise in GDP, small though that might be. In fact, the slice of the national cake devoted to health has gone down from about 8.5% when Labour left office in 2010 to 7% now—that is a fall of 17% in our share of the nation’s wealth. Even worse, predictions by the King’s Fund point to a further fall to 6% of GDP by 2021, on the current Government’s projections. That, I suppose, is all part of their plan to reduce overall public expenditure to pre-1940s levels, despite their protestations about a desire to protect the NHS.

It might be asked why these problems seem to have become much more acute in the past few years. After all, we have not all suddenly become older and sicker. The fact is that when Labour left office five years ago we had managed to get rid of waiting lists, patients were seen on the same day by their GP and patient satisfaction levels were high. It is no coincidence that we had appointed some 130,000 more front-line staff to cope with demand. So what has happened that left us with our current difficulties? Certainly, the distractions of the Lansley reforms did not help, with all the redundancies and re-employment of senior managers and the loss of continuity in leadership that followed. As Maynard Keynes said:

“It is not sufficient that the state of affairs which we seek to promote should be better than the state of affairs which preceded it; it must be sufficiently better to make up for the evils of the transition”.

I fear that we are still suffering from the evils of transition.

Then we have had the Nicholson challenge and the so-called efficiency savings of no less than £20 billion over the past five years. Of course anyone working in the service knows that it is always possible to improve efficiency, but now it is clear that the pips are being made to squeak too loudly as we run out of such short-term measures as wage freezes and the like. The inevitable result is that we are failing to keep up. GPs are overwhelmed, waiting times in A&E departments are rising, waiting lists are growing, social service departments are failing to cope and many such departments are now able to deal only with those in most serious need.

So what is to be done? I shall focus on four specific areas: disease prevention by public health measures; bringing hospital and community services much closer together; focusing on some specific aspects of care where we are clearly failing, namely A&E services, general practice and mental illness; and stimulating much more research and innovation where the potential dividends in health and well-being, as well as economically, are considerable. Of course none of these sounds entirely novel, but the fact is that we have failed miserably to achieve them so far. I want to examine why that is the case and what we should do now to ensure that we do not fail again.

First, with regard to prevention with the aim of reducing demand, no one can argue with the need to try to prevent the many illnesses caused by smoking, drinking too much alcohol and eating too much food. That is why I believe that the Government must get on with the plain packaging legislation, for example. We also know that the most effective measure to reduce alcohol consumption is to increase the duty on alcohol. It is pretty clear that whenever the price of alcohol goes above the rise in the general cost of living, the incidence of death from liver disease goes down—and, let’s face it, the increased revenue generated could make a useful contribution to the Exchequer and the NHS. I will leave it to other noble Lords to go into why the Government are reluctant to use this most effective measure, but the problem here is not that these are not vitally important things to be doing—they clearly are—it is the expectation that we will see financial savings from doing them in any reasonable timespan. Any impact on costs will inevitably take time.

Secondly, I turn to the need to see much greater co-operation and collaboration—what we used to call “integration”—between community-based and hospital services. The report from Sir David Dalton provides some very helpful ideas about how this might be achieved. He, of course, has managed to show how it is possible to integrate services extremely successfully in Salford and his report describes a number of other potential models for collaboration that fit in with different local circumstances. Clearly, the removal of the barriers between hospital and community is highly desirable and the idea of pooling health and social care budgets could be a very supportive measure. However, we have to be sure that current competition laws do not get in the way, and even more importantly, we have to be clear that the funds are available to facilitate this transition. It would be naive to believe that it could be done within existing budgets, even though in the longer term that sort of joined-up service will be more efficient, and of course it will suit patients’ needs much better. But in the short to medium term, it will need transitional funding.

The idea behind the Government’s better care fund was to try to bolster community services at the expense of the NHS, which itself is pretty cash-strapped. Robbing Peter to pay Paul is never going to be popular with Peter, and we now have the lowest number of beds per head of population than anywhere in the western world. If we are to see this vitally important change in the way services are delivered, we have to accept that fresh money will have to be found from somewhere.

Thirdly, I turn to three of the biggest challenges facing the NHS at the moment: problems in general practice, gaps in mental health services, and the troubles in A&E departments. The problems in general practice have been well rehearsed. I had a letter from a young general practitioner the other day in which she encapsulated the difficulties she faced. She said she was increasingly exhausted as her workload just seemed to grow and grow. She pointed to the shortages of practice nurses and care workers, the difficulty in recruiting to those posts, the fact that many of her colleagues were retiring early and that general practice was becoming a very unpopular option for young medical graduates. It seems likely that that is the reason why it has proved difficult for the Government to encourage medical schools to get 50% of their graduates into general practice. It is striking, too, that she said that she had to spend up to 50% of her time in administration. What a waste of her valuable time, which could be much better spent in dealing with her patients.

So there is much to do there. We need to recruit and train more support staff, especially practice and district nurses, who are in such short supply; we should bring together bigger groupings of general practices into multipractices or the like so that there are economies of scale; we need to recruit and train more GPs by making the job much more attractive; and we definitely need to reduce the horrendous bureaucratic burden under which they labour. I am afraid that once again your Lordships will have noticed that none of that can be done without some additional funding.

On accident and emergency departments, which have been in the news so much of late, there is this somewhat optimistic view that once we have stopped people smoking, drinking and eating too much and once primary and community care is up to scratch, the pressures on A&E departments will disappear. But that, of course, is some considerable way off and it denies the evidence from everywhere else in the civilised world that there is a universal rise in A&E visits. So, once again, moving the deckchairs here will not solve the problem and it seems inevitable that more funds will be needed to recruit and fill posts, both medical and paramedical, in these desperate departments. We are clearly wasting far too much money on expensive locums when that money should be directed to permanent posts.

Mental illness, despite much rhetoric about parity of esteem between physical and mental illness, remains a Cinderella service. I suspect that other noble Lords will expand on this, but there can be little doubt that more resources are needed there, too.

Finally, I will say a few words about research and innovation in the NHS. The UK has been pretty successful in supporting medical research through both public funds and the research charities—and here I should express my interest as scientific adviser to the Association of Medical Research Charities. Some good things are happening here: for example, with the National Institute for Health Research, under the direction of Dame Sally Davies with the strong support of the noble Earl; the Health Research Authority is streamlining ethical approval; and the MHRA is providing quicker routes for licensing new medicines. However, there are many problems, too, because while we may be good at research, we are too often sluggish in taking up innovations. There are concerns that future funding for NIHR and its invaluable academic health science networks and centres remains uncertain, and there are also worries about the willingness of CCGs to support the Charity Research Support Fund. We are also failing to encourage and support those entering a clinical research career while their conditions of service are being neglected.

A tortuous funding approval process also gets in the way. It may come as some surprise to learn that to get the approval of NHS England for a new medicine to treat a rare disease there are no fewer than eight committees through which it has to go. It has been said that if you want to avoid making a decision, set up a committee. If you want never to make a decision, set up eight committees. That is a case where NHS England needs to look at its own efficiency, and if it is just an example of its committee structures, it has some way to go.

In the pressure for ever more efficiencies, we must avoid being so short-sighted as to leave research and innovation to wither away. The dividends we will lose are just too great. I believe we know what should be done—there is a growing consensus on that. However, it is increasingly clear that without an input of more resources we will not be able to rescue the NHS from this downward spiral. Even Simon Stevens, the chief executive of NHS England, has said as much. The next Government will have to face up to this issue and square with the public about how they intend to protect an NHS and a social service system that is so precious to them and to focus on the sources of the increased funds that are needed. I look forward to the speeches of other noble Lords and to the Minister’s response.

[Baroness Jolly (LD)]

I remind the House that time is very tight, so I ask noble Lords to keep their remarks to six minutes. When the clock shows six, your time is up.

--- Later in debate ---

[Lord Turnberg]

My Lords, I thank all noble Lords for their wide-ranging and well informed contributions. I have learnt a lot. I clearly cannot comment on every noble Lord’s contribution, but I particularly wanted to say how pleased I was to hear from the noble Baroness, Lady Wilkins, who is back in her place and in fine voice.

Clearly, we were never going to solve all the problems of the NHS today, but I believe that this debate has been a useful contribution as we ease our way into the next election. The next Government will have to level with the public, who are very supportive of the NHS, and grapple with the issue of how we might cope with the conundrum of paying for a service that becomes more complex as every day goes by.

Of course we should become more efficient, but I am reminded that Aneurin Bevan, when the NHS began, thought that as we cured and prevented more diseases the service would get cheaper. However, every year it seems to have got more expensive, and as we cure one disease, another disease pops up. It is an unfortunate fact that the mortality rate among humans is almost 100%—exactly 100%. On that happy note, once again I thank all noble Lords for their contributions and look forward to the next Government’s actions as a result.

Motion agreed.

NHS: Medical Competence and Skill

Lord Turnberg Excerpts

Wednesday 7th January 2015 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I, too, thank the noble Lord, Lord Parekh, for introducing this debate in his usual erudite manner. Many years ago I had the privilege of being president of the Medical Protection Society, a mutual assurance society that provides indemnity for doctors accused of negligence and misbehaviour. It provides recompense for patients who were harmed by their negligent practice. It was there that I was brought face to face with the poor behaviour of too many doctors. I was surprised and discomforted by that because until then I had done my level best to instil high standards of practice in my students, when I was dean of a medical school, and in my trainees, when I was a consultant and president of the Royal College of Physicians. To say the least, I was somewhat disappointed when I came to the Medical Protection Society.

However, I soon realised that in a busy day-to-day practice, doctors are only human. They can make occasional honest mistakes or errors of judgment. I do not for a moment excuse any of that but I thanked my lucky stars that there but for the grace of God went I. Among the millions of patients seen every day, there are bound to be occasional mistakes. Those are much more likely where doctors are rushed and under the sometimes intolerable pressure that is too common now. Much more worrying were the fortunately less common doctors whose behaviour and practice were poor, who were unfeeling and lacking in empathy or who were just substandard. They clearly have to be weeded out by one means or another. They have to be retrained or prevented from practice, which is where the General Medical Council comes in.

Something I noticed when I was training young doctors was that it was hard to distinguish between those who had qualified from different medical schools around the country. Their skills and practice seemed very similar, no matter where they had graduated. That made me realise that most of their skills and attitudes were being gained after they had qualified and that it was their postgraduate training that really mattered. Here, too, there are problems that might be relevant. Training has certainly suffered as a result of the EU working time directive and the imposition of rotas of care. Both have had an impact on continuity of care and have fragmented the learning experience of many. Some training programmes have been so structured and rigid that they have seen trainees rotate at bewildering speed from one experience to another, again interfering in that continuity of the relationship between trainee and trainer that is so important. These are not easy problems. We must, however, try to correct them. I would be interested to know whether the Minister has any ideas about how we might do this.

Finally, I shall follow the noble Viscount, Lord Bridgeman, and say a few words about the EU directive under which doctors trained in other member states can come to practice in the UK without any assessment here of their competence and skills. It is only in the past couple of years that the GMC has been allowed under EU law to test the language skills of EU doctors. I fear that we are still not in a position to assess the training of a cardiologist, for example, from Greece, Spain, Holland or France or that of a neurosurgeon from Germay, Luxemburg or Belgium. They may be perfectly competent and capable, but the problem is that in the UK we have no information about what their training comprised and we are not allowed to make any assessment of it. That would interfere with EU manpower laws that encourage free movement of workers around the Community.

I tried to fill this gap several years ago when I was chairman of the Specialist Training Authority of the Medical Royal Colleges. Even though it would have been possible to do this then by a simple change in the directives that were available to us, as with many others of my efforts, I am afraid that I failed miserably. I would be very interested to hear from the Minister whether there is any hope that we may now be able to correct this anomaly.

NHS: Health Improvements

Lord Turnberg Excerpts

Wednesday 26th November 2014 Grand Committee

[Lord Turnberg (Lab)]

My Lords, it is about two years since I last stood in for the Opposition Front Bench, so I reckon that I have been forgiven for my previous appearance. It is a pleasure to speak after what has been a fascinating debate, and of course I am grateful to the noble Lord, Lord Kakkar, for introducing it in his usual erudite manner. If anyone is an expert in innovation, he is. I declare my interest as a scientific adviser to the Association of Medical Research Charities.

The noble Lord, Lord Kakkar, is surely correct in asking the question in the title of this debate about what impact innovation has had on the NHS. Of course, we need to know much more about how helpful all the innovations that we are introducing into medical practice really are, but it is easier said than done. It is rather like trying to measure the productivity of services like nursing or medicine. Economists tell me that it is easy to measure the productivity of material goods, but what do you measure in services? Is it the number of patients seen, the number cured, patient satisfaction or other intangibles? It is not straightforward. Furthermore, we may know that something works under the carefully controlled conditions of a clinical trial, but we do not know how effective it might be in the hurly-burly of clinical practice. It may take many years before an innovative treatment is widely taken up. Even when it is, it may take a long time before we see its impact on a reasonably representative number of patients. So, although it is essential that we try our best to trace the relationship between innovation and improved care, it is not straightforward. Despite those difficulties, it is clear that the UK is really pretty good at innovation and we are doing well from advances in medicine. We are all living longer than ever before, gaining about two years of life expectancy for every 10 years that go by, and at least half of that improvement has been shown to be due to advances in medical treatment. So we must be doing something right.

When I look back—if noble Lords will forgive me for looking back—at what medical practice was like when I started as a young doctor more than 50 years ago, the transformations have been remarkable. In 1957, there were few effective treatments for cardiovascular disease. Heart attacks had a high mortality rate. There was no angioplasty or bypass surgery. There was nothing for childhood leukaemia—uniformly fatal then, but now mostly cured. Hip replacement surgery was hazardous and rarely successful; that was before John Charnley, who the noble Lord, Lord Selsdon, mentioned. There were no knee replacements or cochlear implants and there was no organ transplantation. I remember going round the wards and seeing rows of polio victims lying immobile in iron lungs. Thankfully, all that has gone.

Medical innovation has been a constant during my lifetime, and patients are infinitely better off, even in the absence of a good system for monitoring its impact. Now we are on the cusp of an even more dramatic change in medical care, with remarkable advances in genomics, digital health and regenerative medicine, and the UK is at the forefront in most of these fields. As the noble Lord, Lord Kakkar, said, the Government, to their credit, are supportive in a number of ways. They set the scene with their Innovation, Health and Wealth report a couple of years ago. The NIHR, under Dame Sally Davies’s direction, is producing results, not least through its very successful academic health science networks and centres, as the noble Baroness, Lady Brinton, emphasised. The various innovation initiatives are also very helpful. The recent rationalisation of ethical approval processes and regulation by the HRA is bearing fruit, and the moves now afoot to reduce the time taken for regulatory approval by the MHRA and the EMA are very welcome. They should help bring much needed drugs to market more quickly for patients and, at the same time, encourage the pharmaceutical industry to invest.

Of course, not everything in the garden is rosy. For example, there are still things to be done by NHS England to speed up its approval of drugs for rare diseases. The recent report from Genetic Alliance UK found that there are no fewer than eight committees involved in assessing these innovative drugs and no fewer than 11 stages to be gone through before approval. Clearly that cannot be right. Perhaps most important is the thorny problem of the woefully slow dissemination into clinical practice of all the fruits of our excellence in innovation. This resonates very much with the remarks of the noble Lord, Lord Mawson. It is here that the Government need to focus much more effort. The barriers to spread and to practice are multiple and well known. They include not simply a medical profession that is not always eager to accept change—although there is some of that, particularly in general practice, where pressures to provide the service are high and distracting—and a lack of tools and expertise to be able to take up innovation. Even more importantly, there is a lack of continuity at trust chief executive level, where few stay in post longer than two years. Introducing change and innovation in a hospital takes years of planning and the winning of hearts and minds not only in the hospital but in the community, but managers are too often taken up with immediate fire-fighting pressures and only just begin to think about the longer term before they are moved on.

Then there are the funding issues that bedevil the introduction of new treatments. CCGs and trusts are too often reluctant to fund new drugs because of costs. This is especially true of the high-cost so-called personalised medicines that are being developed to treat smaller and smaller subgroups of patients. None of this is helped, of course, by the uncertainty surrounding the future of the Cancer Drugs Fund or the continuation of funding for the academic health science networks. Some clarity there would be helpful.

The UK does extraordinarily well at innovation and has a health service in which a million patients are seen every 36 hours, and they are patients that we have in our care for the whole of their lives. What a marvellous opportunity that provides to innovate for the good of everyone. However, if we are to take full advantage of these wonderful resources, we must place much more emphasis on overcoming the multiple barriers to dissemination that are getting in the way. I hope that the noble Earl will comment on how the Government will address them and the many other issues raised by other noble Lords.

Medical Innovation Bill [HL]

Lord Turnberg Excerpts

Friday 24th October 2014 Lords Chamber

Moved by

[Lord Turnberg]

1: Before Clause 1, insert the following new Clause—
“Provision of advice by registered medical practitioner
(1) This Act applies only to decisions made by a registered medical practitioner to advise a patient for whom he has assumed a professional responsibility for the provision of advice with regard to the choice of treatment for—
(a) a cancer which in the reasonable opinion of the practitioner is affecting the patient and is likely to cause the patient’s death without the provision of effective treatment;(b) such other conditions as may be prescribed by regulations made by the Secretary of State.(2) A condition to which this Act applies is referred to as a “relevant condition”.”

[Lord Turnberg (Lab)]

My Lords, this is a rather omnibus group of amendments. I will do my best to try to speak to all of those to which my name is attached as well as to serve the others.

I should say at the outset that in setting out my amendments my purpose is to try to make sure that any Act that comes out is both sufficiently safe for patients and practicable so that the innovative practice that everyone wants to see is achievable. However, I would hate to see the opening up of a bureaucratic and legal nightmare that Sir Robert Francis tells me he still has problems with.

I would also like to correct a couple of possible misapprehensions. The first of these is that I want in some way to inhibit innovation in medical practice. I find that particularly galling when I have spent much of my life in clinical practice trying to introduce innovations. In my own field of gastroenterology I constantly tried novel treatments for Crohn’s disease, for example, and, indeed, published in journals the results of the research that I carried out. I say as an aside that at that time I did not feel the need for a Bill of this sort to allow me to innovate when I already had ethics committees’ approval and the informed consent of my patients. I fear that I am not alone in wondering whether the Bill is necessary. When Action against Medical Accidents, for example, and a number of important medical bodies express doubts about the need for it, one begins to wonder. I will not reiterate the Second Reading arguments as I want to concentrate on trying to make the Bill workable. However, I reiterate that innovation has been part of my very being and I still want to do everything that I can to encourage it.

The other misapprehension seems to be that there have been no advances in the treatment of cancer since the Middle Ages. That is patently not the case for many cancers—for example breast cancer, where there have been remarkable improvements, and in the leukaemias, where many, especially in children, have been cured. Now we see remarkable possibilities emerging for melanomas and a number of other carcinomas. However, it is certainly the case that no major advances have been made in the treatment of some cancers of the pancreas or the ovary, for example. That is terribly sad but true. It is also true, however, that no one anywhere has come up with a breakthrough for any of them—not in the USA, Japan, Oxford, Cambridge or anywhere—despite enormous effort by many researchers across the world. I declare my interest as a trustee of the charity Ovarian Cancer Action. We support a fascinating range of research into potential cures and keep a very careful eye on any advances in the field through our international band of distinguished researchers and advisers, who are often mainly based in the USA, so the idea that someone somewhere has a wonder cure that we have not heard about seems somewhat remote. I fear that we may have some way to go to find a cure but we at the charity have heard recently of some fascinating research in Oxford that we are supporting. However, we have some way to go.

I have tabled these amendments as I fear that the Bill’s wording leaves open to too great a degree the potential for harm by unorthodox, unregulated practitioners. Amendment 1 seeks to make it clear that we are talking about registered medical practitioners and that for the moment we should limit the innovative treatments to patients with cancers that are likely to kill them. The idea here is that this would narrow the field of endeavour a little and give time to consider whether, after the Act is in operation and has been shown to be valuable, it could be expanded and consideration be given by the Secretary of State, taking advice from reputable sources, as to whether other conditions should be included. After all, cancers are among the most high-profile cases where patients are constantly seeking new and better treatments and are willing to try almost anything.

It is under those circumstances that my Amendment 7 is absolutely critical, as it is for precisely these vulnerable people, desperate to try anything, that we have to have in place processes and mechanisms to protect them from unethical practitioners who may take advantage of their vulnerability. We have to face the fact that there are practitioners out there using all sorts of weird and wonderful treatments that have no basis whatever. So, in Amendment 7, I set out in some detail the conditions under which a doctor may prescribe such an innovative treatment. He or she should be the doctor with responsibility for that particular patient’s care. He should have reached,

“an honest and responsible opinion”,

that it will be more effective than orthodox treatment and that it is in the patient’s best interests. He should make sure that other doctors looking after that patient who have an interest in that patient will agree with him and he should have the agreement of another expert in the field. He should have not just consulted that person but obtained their agreement—not just to take account of that person’s views, as in Amendment 12 of the noble Lord, Lord Saatchi—and it should all be put down in writing in the patient’s record. I like the way in which Amendment 14, tabled by the noble Baroness, Lady Masham, sets out the requirement for patient consent, and hope that that can be incorporated. I hope that the noble Lord, Lord Saatchi, will agree that this will make his Bill a safer Bill and that he will accept this amendment or something very like it.

My Amendment 15 also proposes, first, that all the considerations that have gone into reaching the decision to innovate, together with the type and nature of the innovation, should be recorded in the patient’s record and, secondly, that the results of such innovation should be available in some public format. Here I have suggested that it should be available within six months. I am not wedded to that time limit, only to the principle that others should be able to learn from someone else’s innovations. I know that the noble Lord, Lord Saatchi, has the agreement of Oxford University that it will act as a repository for this information. However, as I understand it, there is no compulsion on behalf of the innovating doctor to report to Oxford. We need something in the Bill that makes it not just desirable but essential. My Amendment 19 also makes that point clear.

Amendments 21 and 32 refer to research. Here I want to make the Bill absolutely clear that those engaged in research involving clinical trials will not be subject to even further stringent requirements than they already labour under. After all, these innovative treatments which we are all so desperately seeking are entirely dependent on high-quality research in clinical trials. However, there is a fear out there in the Association of Medical Research Charities—in which I express my interest as scientific adviser—the Medical Research Council, the Wellcome Trust and so on, that the stringent requirements under which researchers operate, involving clinical governance, research ethics committees, informed consent by patients and so on, will be added to by the conditions set out in the Bill. No one, least of all the noble Lord, Lord Saatchi, I suspect, wants his Bill to act as a further deterrent to clinical trials of new treatments. I therefore hope that he will find these amendments helpful.

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We have heard in today’s important debate that noble Lords want dialogue and discussion with the noble Lord, Lord Saatchi, and indeed he has said that himself. Is he prepared to consider hosting a round-table discussion with all those Peers who have an interest in the matters before us today? That would be a very helpful way forward.

[Lord Turnberg]

My Lords, I hope that I am not out of order in responding to some of the comments from the noble Lord, Lord Saatchi, about my amendments. I am grateful to him for his comments and I listened with care to what he had to say. I am also impressed by the noble Lords, Lord Cormack and Lord Kirkwood, and indeed the noble and learned Lord, Lord Mackay, that further discussions may be possible before Report, which I would very much welcome.

On Amendment 1, I note that the noble Lord, Lord Saatchi, is not very keen on the idea of limiting the scope of the Bill at the moment to cancer, but my point here was to start with that and expand cautiously in the light of experience. I note that the noble Lord, Lord Kirkwood, also urged some caution in the way in which we introduce the Bill. The amendment also impacts on Amendment 17, whose lists of exclusions, if we went along the line of limiting the Bill to cancers, would not be quite so necessary.

My Amendment 7 and Amendment 12 from the noble Lord, Lord Saatchi, overlap to a considerable extent, and I am grateful for that. The main difference is that his concentrates largely on taking account of the views of another expert, while mine suggests that we should obtain the agreement of at least one other expert, which should be recorded in the note. I think that that strengthens his amendment, and I hope he will think about that rather carefully.

On Amendment 15, a number of other noble Lords have referred to the need to have any innovations recorded in some form of register but also in the patient’s records. I listened carefully to whether the noble Lord, Lord Saatchi, had accepted the idea that the record should be in the notes as well, and I hope he will accept that too.

Amendments 21 and 32 talk about research. I am pleased that the noble Lord agrees with the principle that this Bill should not interfere with research; I do not think that anyone feels that it should. However, there are many in the research world who are concerned that the Bill might have that unexpected consequence. Something in the Bill along the lines that would exclude the possibility would therefore be extremely helpful.

Similarly with Amendment 24, which talks about emergency care, it is true that the Bill may not cover emergency care, but there are people involved in accident and emergency departments who are concerned that the Bill may somehow, in some way, inhibit them. It would be a shame if the impression left by the Bill inhibited that sort of emergency innovative practice, hence the reason to have something in the Bill.

I do not intend to divide the Committee today on any of these amendments, and I am very grateful for the informed debate on many of them. I hope we will have a chance to come back to at least some of them on Report.

[Lord Winston]

Does my noble friend agree that one of his amendments tends to limit the Bill almost entirely to cancer treatment? There is a problem even there, however, because, as the noble Baroness, Lady O’Neill, said, surgery is an important part of cancer treatment. It is absolutely certain—I am not a cancer surgeon but I have watched many cancer operations, and perhaps other surgeons in the Chamber will support me on this—that cancer surgery is often the most innovative surgery, and you cannot possibly take a decision with the sorts of permissions that are usually required beforehand, because you do not know exactly what you are going to encounter. There is a problem there with the structure of the Bill as it presently stands.

[Lord Turnberg]

I accept entirely what my noble friend has said. The surgical aspects of the Bill are quite tricky.

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

My Lords, this large group of amendments, all in their own separate ways, seek to ensure that patients are protected against negligent or irresponsible treatment. As we have heard, these amendments take many different approaches in seeking to achieve essentially the same goal. The Government are absolutely committed to safeguarding patients. That is why my right honourable friend the Secretary of State for Health asked Sir Bruce Keogh, the medical director of NHS England, to work with the medical profession to devise a package of amendments that would make this Bill safe for both patients and doctors. Like my noble friends Lord Kirkwood and Lord Cormack, I take this opportunity to commend my noble friend Lord Saatchi for listening to concerns and agreeing to table the amendments recommended by Sir Bruce Keogh in full.

I now address the amendments themselves. On Amendments 1, 7, 17 and 33, the Government do not feel that there is anything to be gained by restricting the scope of the Bill in the way proposed. To set out specific medical treatments or circumstances that would or would not be covered by the Bill would make it complicated for doctors to follow and less flexible to individual patients’ circumstances. That was well exemplified by the exchange that we have just heard. This might limit the Bill’s usefulness to patients and doctors alike. I say to the noble Lord, Lord Turnberg, that there is no question of the Bill applying to unregulated practitioners: it applies to doctors. In answer to the noble Baroness, Lady Wheeler, about what constitutes an appropriately qualified doctor, we believe that to define the required level of experience and expertise would create an overly burdensome requirement on doctors looking to innovate responsibly. A requirement that a doctor is appropriately qualified provides a sufficient safeguard to patients. New Clause 1(3)(b) requires the doctor to take full account of the views of an appropriately qualified doctor in a way in which a responsible doctor would be expected to do.

The provisions in Amendment 7 outlining the process that a doctor must follow to reach a responsible decision are largely addressed by my noble friend Lord Saatchi’s Amendment 12. The provisions in Amendment 7 which require doctors to consult a specified range of other doctors are too restrictive and would make the Bill complicated for doctors to follow. My noble friend’s amendment for doctors to take full account in a responsible way of the views of one or more appropriately qualified doctors in relation to the treatment is less burdensome and is a better equivalent to the existing law.

The noble Lord, Lord Pannick, raised concern that a responsible decision under the Bill is defined as relating to the process rather than the substance of the decision. I listened very carefully to that point. The steps that a doctor has to take under new Clause 1(3) include taking account of substantive factors as well as process. This includes taking full account in a responsible way of the views of one or more other doctors about the proposed treatment. In addition, the doctor must consider the risks and benefits of the proposed treatment as compared to other treatments and to not carrying out any treatments at all. This strays outside the realm of process.

The Government’s view is that it is not necessary in this Bill to require doctors to record their innovation in medical records as set out in Amendments 7 and 15. The General Medical Council’s Good Medical Practice guidance already sets out requirements on doctors to record their work clearly in clinical records, including clinical decisions made and discussions with patients. On Amendment 19 and the related Amendment 34, the Government believe that requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent is not the right approach. This is too bureaucratic and risks deterring doctors from innovating. As regards the idea put forward by the noble Lord, Lord Winston, that there should be some sort of oversight by a clinical or research ethics committee, that would add a very significant level of bureaucracy. Considering the time it would probably take to receive a response, it would act as a barrier to innovation. As the noble Lord knows, research ethics committees are specialists in considering research proposals and would not necessarily be qualified to comment on innovative clinical practice. They do not necessarily have universal coverage and they would not necessarily have the requisite knowledge to advise doctors on very specialised innovative new practices.

However, I have heard the legitimate concerns of noble Lords today, and I commit on behalf of the Government to explore this issue further and constructively with the relevant professional bodies. It will clearly be helpful to understand, should this Bill become law, what might be useful in terms of record keeping and reporting in relation to medical innovation. Furthermore, I commit to ensuring that any guidance that may be appropriate is developed and made available in a timely manner. I hope the intention to issue guidance will be of help to my noble friend Lord Kirkwood.

Amendments 12, 14, 18 and 21 seek to ensure that consent is sought and that proper consideration is given to the views of the patient. My noble friend Lord Saatchi’s Amendment 12 ensures that to fall within the Bill a doctor must obtain any consents required by law. This amendment also ensures sufficient protection for the views of the patient. Furthermore under the existing law of consent patients already have the right to information about the testing and treatment options available to them.

The noble Baroness, Lady Masham, posed questions about drugs. She asked me whether the NHS would pay for unapproved drugs or whether the patient would have to do so. It is worth noting that nothing in the Bill allows doctors to bypass any processes or requirements set by the trust that they are working for. This would include ensuring that the trust would fund any treatment if it were to be provided within the National Health Service. She was fearful that this could result in a two-tier health system in which a patient would be required to pay for innovative treatment. The Bill does nothing to alter funding arrangements for accessing innovative treatments within the NHS, as I have said. That will be governed by whatever rules apply in the trust concerned. However, the Bill also does not change the ability of patients to pay for private medical treatment, as they are able to do now.

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As regards emergency situations, as I have said, the Bill does not need to be used in all situations. The existing law remains. That route can be used where the doctor does not want to follow the Bill, or where it is not appropriate to do so. That, indeed, could include an emergency.

[Lord Turnberg]

I am sorry to interrupt the Minister’s flow. Does he not think that that is confusing for doctors in an emergency situation, wondering which route to take and about the options at that stage, rather than just getting on with the job?

[Earl Howe]

Personally, no, I do not—although my noble friend may choose to address that point. I believe that what initially motivated my noble friend to introduce the Bill was a perception on his part that there are doctors out there who are afraid to innovate, and perhaps afraid to innovate even on the spur of the moment, for fear of being litigated against. If that situation were to apply, that doctor could regard the Bill as a useful way forward. I do not think that that poses any confusion, because my noble friend is proposing to bring the Bolam test forward, as he has clearly explained, so that the essence of the principle that the courts look at would apply in whichever course the doctor chose to take.

The noble Baroness, Lady Wheeler, made a point about conflict of interest. The Bill makes it clear that the doctor will be protected from a successful claim in negligence only where they have reached a responsible decision. That includes a requirement to consult with one or more appropriately qualified doctors. In choosing which doctors would be most appropriate to consult, a doctor would need to be confident that their views would enable him or her to reach a responsible decision in order to benefit from the protection offered by the Bill. Just to make the point absolutely clear, I say that the Bill does not change the law of consent in relation to children or people who lack capacity, whereby any treatment provided to them by a doctor must be in their best interests.

Amendment 10 would add a requirement on doctors to act in manner that is reasonable and proportionate. My noble friend Lord Saatchi’s Amendment 11 would ensure that a doctor must be acting responsibly in an objective sense when making a decision to depart from the existing range of accepted medical treatments for a condition. Under the law of negligence, “reasonable” and “responsible” have the same meaning. Therefore, the Government’s view is that Amendment 10 is unnecessary.

Amendment 24 would clarify that doctors would not have to follow the steps of the Bill in an emergency. My noble friend Lord Saatchi’s Amendment 29 ensures that it is for the innovating doctor to decide whether to take the steps set out in the Bill or to rely on the existing Bolam test, as I have just explained. There is no requirement to follow the Bill.

My noble friend’s package of amendments ensures that the Bill comes as close as possible to achieving the policy intent of bringing forward the Bolam test to before treatment is carried out. The amendments would do this in a non-bureaucratic way by avoiding the creation of new approval structures or alteration of the remit of existing groups such as multidisciplinary teams. They provide a critical safeguard in ensuring that there is both expert peer review of the doctor’s proposal and that the doctor acts responsibly. The Bill would not provide any protection to a doctor who carried out an operation or procedure negligently. The Government would not support any Bill that sought to prevent patients who receive negligent treatment from seeking compensation or which sought to remove the requirement of doctors to behave responsibility and in the best interests of their patient.

I will turn briefly to the questions put to me by my noble friend Lord Kirkwood. First, he asked me whether the Bill would apply to pharmacists who dispense medicines. The Bill applies to a decision by a doctor to innovate, which would include a decision to prescribe an innovative medicine. The Bill does not impact on the reliability of a pharmacist who provides a patient with a medicine in accordance with a doctor’s prescription.

My noble friend also asked whether the Bill would apply in Scotland. It would apply in England and Wales but not Scotland or Northern Ireland. Medical negligence law is within the legislative competence of Northern Ireland and Scotland, but not Wales. He also asked me whether there is a conflict between the Bill and the common law. Under both the Bill and the common law a doctor will not be negligent if they have acted responsibly. The Bill, so far as possible, brings forward the common-law Bolam test, as I have explained, to before the doctor offers treatment. There is therefore no conflict between the requirements under the Bill and the common law. The Bill simply offers doctors a way to demonstrate and be confident before providing treatment that they have acted responsibly and thus not negligently.

As regards the cost of implementing the Bill, which my noble friend also asked me about, my reply to him at this stage is that there is not sufficient evidence for us to arrive at a cost figure. The impact of the Bill is by its very nature hard to predict.

I hope that noble Lords will accept my noble friend’s package of amendments in this group—that is to say, Amendments 8, 9, 11, 12, 16, 20, 25, 26 and 27. It is the Government’s view, based on medical and legal advice, that together these amendments do all that is necessary to protect patients, while freeing doctors to innovate responsibly without undue bureaucratic burden.

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[Lord Turnberg]

My Lords, I am very grateful to the noble Lord, Lord Saatchi, and to the Minister for their comments and their acceptance of many of the points that we made in these amendments and in Amendment 1. I commented earlier on many of the points that have been made. I am somewhat disappointed that the Minister does not like the idea of ensuring that agreement in writing is put into the patient’s record—I thought that that would be quite a useful thing to have. However, perhaps we can talk about that at a later date. Meanwhile, I beg leave to withdraw my amendment.

Amendment 1 withdrawn.

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[Lord Saatchi]

My Lords, I think that the Minister has answered this point, and I do not know what I can add. The Bill at the moment focuses on “responsible” and “irresponsible”, and it is very pleasing to hear that the noble Lord, Lord Pannick, might accept that the Bill concentrates on that distinction, and that to introduce a reference to “reasonableness” or “proportionality” might risk causing confusion. Therefore, perhaps this is a topic on which he can satisfy himself in the discussions that follow Committee.

[Lord Turnberg]

My Lords, I strongly support Amendment 2 in the name of the noble Lord, Lord Pannick, for inserting the word “reasonable” for all the cogent reasons that he has given. Amendment 3 follows on from my earlier Amendment 1, which defines “relevant condition” and does not need further discussion here. I am very pleased to see that we have the agreement of the noble Lord, Lord Saatchi, that the word “reckless” will disappear from the Bill.

[Baroness Butler-Sloss (CB)]

My Lords, I strongly support the Bill as it is drafted. I am relieved that the noble Lord, Lord Saatchi, produced a short Bill; I hope that the House does not think that it was a bad idea to suggest that a short Bill might be more attractive than a longer one. For that reason I am not at all happy about the various amendments that were in the first part of our discussions today.

I do have reservations about the words in brackets in Clause 1(1), and I take the view that the noble Lord, Lord Pannick, is probably right to say that they should be excluded.

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[Lord Saatchi]

My Lords, in moving Amendment 23 I will speak also to Amendment 29 in my name.

Amendment 23 is a paving amendment. The substantive amendment in this group is Amendment 29, which inserts a new clause into the Bill after Clause 1, expanding the existing provision that states that the Bolam test is unaffected by the Bill. It is for the innovating doctor to decide whether to take the steps set out in the Bill or to rely on the Bolam test as at present. The new clause also includes express provision that doctors are not negligent merely because they have not followed the Bill. I beg to move.

[Lord Turnberg]

My Lords, I am very pleased to see Amendment 29 in the name of the noble Lord, Lord Saatchi. I support it because it allows doctors to continue to rely on the current common-law arrangements based on the Bolam principle and on a body of reasonable medical opinion. It means, however, that there are now three options open to an innovating doctor. He or she can engage in a research clinical trial in which ethics committee approval has been given, the patient has given consent and all the regulatory approvals have been given, he or she can rely on the Bolam principle and take all the precautions that that entails or he or she can go through the processes outlined in this Bill in the belief that this will somehow avoid the fear of litigation under the common law. I just wonder whether that might lead to a little confusion and lead doctors simply to use and rely on the current common-law principle. However, I am happy for this amendment to be approved. I see that it would be a useful amendment to the Bill because it gives the doctors the opportunity to use what they always have done.

[Lord Kirkwood of Kirkhope]

Perhaps I may expand on the point I made on the first group of amendments. I am grateful for the comment from the Minister, which I understood as far as it went. I agree with what the noble Lord, Lord Turnberg, has just said. This changes how the regulator approaches a complaint, as far as I can see. It would not change the way that the regulator decides whether there is a case to answer but it seems that this clause—which I think I welcome—gives the doctor an option of which defence he uses against the allegations in front of him.

As I know from previous experience, the General Medical Council has very clear, long-established systems for determining how complaints are lodged and how fitness-to-practise procedures are put in hand. It is very carefully controlled. Do I understand that the proposed new clause in Amendment 29 would merely—if I can put it that way—give the doctor against whom the complaint was alleged the choice of one of these channels of defence in relation to any complaint made against him by the regulator? I am still not clear as to whether I understand this properly. I think I am in favour of this amendment but I am not too sure. If anybody can help me understand it better, I will be really pleased.

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Moved by

[Lord Turnberg]

31: After Clause 1, insert the following new Clause—
“Code of practice
(1) The Secretary of State may issue one or more codes of practice in connection with—
(a) the process to be undertaken by a doctor before giving advice under this Act;(b) the form in which the agreement required under section 1(2)(d) is to be recorded;(c) the factors which the doctor should take into account in deciding to offer advice under this Act;(d) requirements for making and keeping records required by the Act;(e) such other matters relating to the operation of the Act as the Secretary of State thinks fit.(2) Before issuing a code under this section, the Secretary of State shall consult such persons as he thinks appropriate.”

[Lord Turnberg]

As we have heard, my Lords, there is a degree of uncertainty surrounding certain aspects of the Bill that we have been trying to clarify. It is on that account that I have tabled Amendment 31, which sets out the need for a code of practice in which the Secretary of State describes in somewhat more detail what the Bill is about and how it should be enacted. I hope that it will be helpful to have that in the Bill.

[Lord Hunt of Kings Heath (Lab)]

My Lords, this has been a fascinating debate, both in Committee and at Second Reading. We are all very grateful to the noble Lord, Lord Saatchi, for listening carefully and bringing the amendments that he has today, and for agreeing to a roundtable discussion between Committee and Report, which is a very constructive response to some of the issues that have been raised.

I say at once that I am absolutely with the noble Lord on the need to encourage innovation in our NHS, but the more that I have listened to the debate, the more convinced I am that it is not so much a question of the law but more one of actual practice within our NHS. I am afraid that we have to face up to the fact that there is a culture of regulatory processes and funding procedures that often get in the way of introducing innovation. For me, the Act that the Bill will become will be a signal to the NHS.

The noble Lord, Lord Blencathra, raised some interesting points about some of the problems that we have at the moment. He talked about off-label medicines. The Minister responded by saying that the Government are committed to innovation and gave a number of examples, which were welcome, but the point that I would put to him is that we now have a situation where NICE produces technology appraisals of new innovative procedures and drugs that clinical commissioning groups are essentially breaking the law by not implementing. He knows that they are under a requirement to fund the use of those procedures and medicines within three months of the technology appraisal being issued, yet we know from research by patient groups that the actual implementation is patchy. We could do an awful lot in relation to innovation if we insisted that people locally did what they were required to do.

My second point relates to the drug budget, an issue that the noble Lord raised. A few months ago the Government concluded an extremely interesting agreement with the branded drug companies, so that for five years the cost of branded drugs in England, apart from modest rises in inflation, will be fully met by the pharmaceutical industry. This is a very good agreement and one that I very much welcome. We still hear people in the NHS saying that they cannot afford the new drugs, yet the industry has promised to pay back any increase in the cost of those drugs over what they are paying now plus a modest increase in inflation. Here is a wonderful opportunity at last for the NHS to move quickly in widely adopting new medicines, but somewhere in the system someone is stopping it. I have read the NHS England five-year plan and it says nothing about the introduction of innovative new medicines.

I am sorry that this is a little outside the noble Lord’s Bill and I hope that he will forgive me, but this is about innovation. I am genuinely puzzled, and we will come back to this point, about why the Government did not rush to insist that the NHS took advantage of the agreement. In fact very few people in the NHS know about the agreement. My concern is that the rebates that the drug industry is going to give will be used for other purposes, which would be a very big mistake.

I hope that the Minister will agree to the amendment; I strongly advise him to do so, or at least to consider it. It is clear from the speeches that have been made that there is some confusion about the circumstances in which the noble Lord’s provisions are going to be made. Earlier in our debates, the noble Earl essentially said that doctors would have a choice when it came to whether, in relation to a given medical treatment, they would use this Bill’s provisions or rely on the traditional approach, the Bolam test. The noble and learned Lord, Lord Woolf, said that they are not alternatives and, in the circumstances raised by one noble Lord where there was not time to get the advice of the clinicians that is provided for in the noble Lord’s Bill, you would rely on the Bolam test. I am only a lay person, but I suspect that there is a risk of doctors not catching the nuance of that distinction. It is clear from the various letters that we have had from many of the medical bodies that there is some concern about this. I know that the noble Lord will speak and I strongly endorse his amendment on the regulation-making power, but I strongly advise the Government to agree to issuing guidance to the medical profession in this regard. There is a danger of some confusion and such guidance would be useful. If the noble Lord is not able to accept this amendment today, perhaps he will give it some further consideration.

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[Lord Saatchi]

My Lords, perhaps we could add this point to the discussions that we are going to have before Report. My noble friend the Minister expresses a modest view of what the Government should and should not do and wants to leave it to the regulatory bodies to make this happen.

I refer once again to anecdote. The noble Lord, Lord Turnberg, said to me at an early stage in this process, in which he has been a great inspiration, “What are you going to do after the Bill becomes law?”. I said, “I am going to go on a very long vacation”. He said, “Oh no you’re not”. I said, “Why not?”. He said, “Your work is only just beginning”. His point, and he speaks as an expert, is that a culture change is contained in this Bill. “Culture change” is a phrase that my noble friend just used, and it was used by Dame Sally Davies, the Chief Medical Officer, many months ago. A culture change is being sought, but it will not happen overnight. It will follow, exactly as the noble Lord, Lord Hunt, says, a great deal of education and discussion in the medical profession.

Not to go on, but the noble Lord, Lord Turnberg, said that this will fall largely not just on the regulatory bodies, such as the GMC and NICE, but on the royal colleges. They will have to be involved in the process of educating people about what this means. This is the beginning of the process and I am rather with my noble friend in not wanting to have the Government set out the rules. I hope that that is acceptable to the noble Lord, Lord Hunt.

[Lord Turnberg]

My Lords, I am slightly reassured by the noble Earl’s comments that the Government’s intention is to produce some guidance with help from the relevant bodies. I am sorry that he does not think it necessary to have that in the Bill. I wonder why not. He has not explained why the amendment should not be there, because it sets out the need for such a code of practice. Meanwhile, however, I beg leave to withdraw the amendment.

Amendment 31 withdrawn.

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[Lord Kirkwood of Kirkhope]

Not to prolong events, I support Amendment 35, which I think is sensible. It is necessary to make sure that steps are taken so that practitioners are fully advised and informed in England and Wales about the provisions in the Bill. I assume that the answer to my question is yes, but can I have an assurance that the regulators have the full Section 60 power that they would need to implement this? If there is any doubt about the regulators not having complete legal cover, will the department make sure that any Section 60 provisions for those powers are put in place before these statutory instruments are brought forward, to avoid any confusion?

[Lord Turnberg]

My Amendment 36 has a similar effect to that of Amendment 35. Mine seems somewhat simpler, but I am quite happy to bow to Amendment 35 in the name of the noble Lord, Lord Saatchi.

[Earl Howe]

My Lords, this group of amendments addresses how the Bill would come into force. My noble friend Lord Saatchi’s Amendment 35 would ensure that the Bill came into force in accordance with regulations made by the Secretary of State rather than on Royal Assent as under the Bill as introduced. This would allow the Government and the medical profession time to prepare for the changes to the law made by the Bill—for example, to produce any guidance that might be helpful. This amendment also enables transitional and saving provision to be made if necessary. My noble friend’s Amendment 35 achieves the same objective as Amendment 36, which the Government therefore do not consider necessary.

The Government also support minor technical Amendments 37 and 38, which clarify that the section in question comes into force on the day on which the Act is passed. I urge noble Lords to accept Amendments 35, 37 and 38, which would ensure a smooth commencement of the Bill, and I hope that my noble friend Lord Kirkwood will allow me to write to him on the question that he posed a minute ago.

NHS: Hospital Waiting Times

Lord Turnberg Excerpts

Thursday 10th July 2014 Lords Chamber

[Earl Howe]

Up to now, mental health has been omitted from the waiting time standards. However, we are looking actively at what might be possible within the bounds of affordability.

[Lord Turnberg (Lab)]

My Lords, there seems to be little doubt that waiting lists will grow. Is the noble Earl aware of the recent King’s Fund report, The NHS Productivity Challenge, which shows that the share of the national cake for the NHS, which was above 8% in 2009, is now about 7% and is set to fall to around 6% by 2021. Is there any justification for reducing the share of GDP for health services?

[Earl Howe]

My Lords, the noble Lord knows of the economic constraints that this country has to contend with at the moment. Despite that, the Government are increasing the NHS budget over the course of this Parliament by £12.7 billion. That should indicate to the noble Lord the priority that we are giving to the NHS.

Health: Polypill

Lord Turnberg Excerpts

Monday 7th July 2014 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I too am grateful to my noble friend Lord Hunt for introducing this debate. It is pretty obvious that he, like me, has been briefed by Sir Nick Wald—and I suspect that the noble Earl may have heard a little from him too—so if what I say sounds a little familiar, I hope he will forgive me. Heart attacks and strokes remain among the biggest killers, despite the improvements in mortality rates in recent years. We know many of the risk factors—smoking, alcohol, obesity, salt and lack of exercise—and we must not be distracted, as the noble Baroness, Lady Brinton, says, from dealing with these public health issues. They are not mutually exclusive, of course.

We know that we should do more to detect and treat high blood pressure and raised blood cholesterol levels, but there is one important risk factor that we can do little about. That is age. There is a straight-line relationship between age and the incidence of heart attacks and stroke. The older you are, the higher the risk. The most striking thing about this is that about half of those getting one of these killers do not have one or other of the conventional risk factors—they have normal cholesterol and normal blood pressure. They come as a surprise in people thought to be fit, and it is in these unsuspected and unsuspecting individuals where the polypill may play a role.

The rationale for the polypill relies on a number of basic principles and here I rely specifically on Sir Nick Wald’s briefing, so what I say, as I pointed out, may not be entirely novel. First, we know that using drugs to lower a raised serum LDL cholesterol reduces the rate of heart attacks, and lowering the raised blood pressure reduces the incidence of strokes, but the intriguing observation is that the same drugs reduce even normal levels of cholesterol or blood pressure to a similar proportion as in those with raised values.

Furthermore—and here is the nub of the argument—lowering even normal levels reduces the risk of heart attacks and stroke. For example, Nick Wald calculates that a fall in blood pressure of 10 millimetres of mercury reduces the risk of stroke by about 60% and reducing serum LDL by 1 millimole per litre lowers the risk of coronary artery disease by 40%. The fact is that there does not appear to be a lower limit below which reducing blood pressure or cholesterol is not effective in reducing risk.

The second principle is that you can achieve as good or better effect in reducing blood pressure from a combination of two or more hypotensive drugs given in half or lower doses than a single drug given in a normal dose, and in this way markedly reduce the incidence of side effects. You get the same impact on blood pressure with many fewer side effects from a combination of half doses.

Therefore, combining these pieces of evidence—risk increasing with age, lowering risk factors even when they are seemingly in the normal range, and combining low doses of drugs to reduce side effects—leads to a conclusion that points to a need to give polypills as a preventive measure to those at risk, namely all the population over the age of 55, say, regardless of their conventional risk profile. Indeed, if they have other more obvious risk factors they are likely to be treated for them by one means or another already. It is the unsuspecting population where a polypill is most likely to be effective. In these, it lowers cholesterol and blood pressure as well as risk.

Nick Wald has suggested that one in three individuals taking a polypill containing small doses of simvastatin, losartan, amlodipine and hydrochlorothiazide would live an extra eight years than they would have done without the pill. It could reasonably be concluded that we should be giving everyone over 55 a polypill of this type, and it would help those harbouring unsuspected coronary artery disease or strokes. If this were a preventive programme like vaccination, as my noble friend suggested, we probably would not hesitate, but of course it is not a one-off, single shot like a vaccine. It is to be taken life long, every day, as a prophylactic treatment, more like the contraceptive pill to prevent pregnancy, although of course for rather longer.

So many issues would have to be overcome, and a number of critics of the mass medication that such a programme would entail have to be answered. There is the question of regulation. Although all the constituents of the pill have been through all the regulators and are in fact well out of patent, the MHRA and MEA may well need convincing that the combinations do not need further appraisal and approval. There is the question of side-effects. Although doses are low, there are undoubted side-effects with all the constituents of the pill, even in the low doses used here. They may well become significant when trying to reach whole populations.

Some say that we are already an overmedicalised society and we do not need yet more pills for everyone. I am not sure that that is a terribly good argument, because we rely quite heavily for our longevity on many of the medicines we take. I am one of the few, it seems, who is on simvastatin without side-effects, out of a huge population who are similar to me. In any case, no one is forced to take drugs if they do not want to. Nevertheless, those are views that we cannot easily dismiss and are to be taken seriously.

We come to the question of whether the polypill should be available for prescription on the NHS or simply over the counter at pharmacists. It is probably very cheap, and the economic value of preventing those diseases is a strong argument for prescription. It would at least allow us to get a clear angle on the number and incidence of side-effects, which free availability would not. It would allow doctors the opportunity to assess their patients for other preventable risk factors at the same time, which we have to do something about. On the other hand, an approach in which people simply decide whether to buy the pill over the counter is certainly more libertarian, but would probably not make a great impact on the epidemiology of those diseases, nor on the health of the nation.

There are certainly interesting debates to be had, and I am very grateful to the noble Lord, Lord Hunt, for starting us off on this topic.

[Lord Willis of Knaresborough (LD)]

I am grateful to the noble Lord for giving way. One issue raised earlier was about the dosage and combining those dosages in relation to particular side-effects. It was only 12 months ago, I think, that NICE advised against giving particular doses of simvastatin together with a modifier. When doses are given separately, you can take the evidence and change them. When they are combined in a polypill, that goes out of the window and you are left with all the elements at the dosages that have been agreed. Is that not an argument for retaining the current position of giving separate dosages rather than combining them all?

[Lord Turnberg]

Those are very good points. The doses used in polypills are very low, in fact—20 milligrams of simvastatin, when the normal dose is 40 to 80 milligrams. The other drugs in the polypill are half doses. The point is that, if you have raised LDL cholesterol or raised blood pressure, you should certainly be on the treatments; they have been shown to be effective. It is people who do not have raised cholesterol or raised blood pressure who we are aiming to treat—or to prevent their diseases—so it is a different situation. The point about safety is important. It is clear that we need and should have proper clinical trials of those doses, but the impact of such doses, from what we know about them in this combination, is that they are likely to be safe in the vast majority of cases. What we do not know is the number who will get side-effects.

[Lord Hunt of Kings Heath (Lab)]

My noble friend, and other noble Lords, mentioned the importance of clinical trials, which I am sure is absolutely right. Is not the problem here that in fact no pharmaceutical company will conduct a clinical trial because all the drugs used in combination in the polypill are off-patent, so there can be no protection of that research by any company taking it forward? So there is, if you like, a block here, although people can see the potential benefits. Rightly, noble Lords are asking for clinical research, but there is no possibility of that happening unless the Government take a hand themselves, which is why the debate on antibiotics is interesting. They are completely separate subjects, but the Government had to step in there because, at the moment, the market simply cannot respond to the issue.

[Lord Turnberg]

I agree entirely. I think that it will be difficult for the drug firms themselves to conduct trials because these are generics and they are manufactured by a number of companies. The only way forward, I suspect, if we are to have a clinical trial, is through NHS funding—that sort of trial. My final remark is that I very much 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 thank the noble Lord, Lord Hunt, for giving us the opportunity to debate a particularly interesting subject and for having elicited a number of very well informed speeches. In calling for this debate, he has done the House a considerable service by enabling noble Lords, including myself, to bring ourselves up to date on what progress has been made in the development of the polypill concept. As has been said, heart attacks and strokes are major health issues in the western world and a growing issue in the developing world. Reducing mortality for people with cardiovascular disease and improving their outcomes is a key priority for the Government. We have made it clear, through the NHS and public health outcome frameworks and the Government’s mandate to NHS England, that we want to see action taken across the health system to reduce avoidable premature mortality from cardiovascular disease.

The 2013 call to action on premature mortality set out the Government’s ambition for England to be among the best in Europe in tackling the leading causes of early death, including cardiovascular disease. In April this year, we published Living Well for Longer, which brings together what the health and care system will do to meet this challenge.

There has been a great deal of interest in the polypill and its potential for reducing the risk of heart disease over the years. It may surprise some noble Lords that the concept was first introduced into the scientific and public domain as far back as 2003. It was proposed in an article in the British Medical Journal by two people whose names have been mentioned already, Professors Nicholas Wald and Malcolm Law of the Wolfson Institute of Preventive Medicine. Using mathematical modelling, they estimated that a polypill comprising a statin, aspirin, a combination of three blood pressure lowering drugs and folic acid, could reduce heart disease events by 88% and stroke by 80%. Their article concluded that their proposed polypill could,

“largely prevent heart attacks and stroke if taken by everyone aged 55 and older and everyone with existing cardiovascular disease.”

Although the effectiveness of the combined drug and any possible side-effects had yet to be evidenced though patient trials, this captured the imagination of the public health research community, particularly for the prevention of non-communicable diseases such as cardiovascular disease.

Essentially, the polypill is a combination of multiple medicines which aims to prevent or reduce the risk of cardiovascular disease: that is, strokes and heart attacks. Each of the constituent medicines is either at the current recommended dose or at lower doses. The premise is that these combinations should be used in preference to using the same medicines separately. In practice, the polypill can refer to either the fixed-dose combination medicine to reduce cardiovascular risk, patented as the polypill, or any other fixed-dose combination medicine, such as the red heart pill. However, any discussion of polypills is complicated by the huge range of drugs which might be included in any combination.

Polypill active ingredients are licensed separately as medicines and well established in their own right; their use together in fixed combination is what is novel. Just like any other medicine, any application for a marketing authorisation for a polypill needs to be supported by data demonstrating that its quality, safety and efficacy are satisfactory and that the risk-to-benefit profile is favourable for the proposed treatment before such an authorisation or licence can be granted.

My noble friend Lady Brinton drew attention to the side-effects of polypills and statins. She was absolutely right to do so. My information is that the evidence is not yet there on the side-effects of the polypill. Patient safety must of course be paramount in that context.

No polypills are currently licensed for use in the UK for the prevention of heart attack or stroke. I understand that the Medicines and Healthcare products Regulatory Agency has provided scientific advice to a number of sponsors and companies for combination products of this type. However, no application has yet been made to the licensing authorities. In the event that a marketing authorisation proposal is submitted, the data supporting any claims for benefit in the stated patient population, together with any evidence of adverse events, will be carefully reviewed. Only if the overall balance of benefits versus risks is favourable will a marketing authorisation be granted.

Without a marketing authorisation, as the noble Lord will know, doctors can prescribe an unlicensed medicine under their own professional responsibility. That addresses one question raised by the noble Lord, Lord Turnberg, as to whether it is in theory available on the NHS. The answer would be yes, in those circumstances, but any national action to promote the use of a drug that is not licensed is out of the question, as I am sure he is aware. I understand that there are several clinical trials of polypill products in progress in various countries and it will be interesting to see the results.

The noble Lord, Lord Hunt, questioned whether it was the fear of additional workload that was deterring doctors in the context of the polypill. My information is that the evidence on that front is as yet unavailable one way or the other, as regards the primary prevention setting, but that clinical studies are now under way. Indeed, I have in front of me the details of three polypill phase 3 clinical trials which had either completed or were close to completion as of May 2014. I can let the noble Lord have details of those trials if he would like me to do so.

The noble Lord, Lord Turnberg, raised the possibility that the polypill could be prescribed to those people who do not fall into the risk group. That is, of course, the primary prevention group. I am advised, though, that as age advances, the risk of side-effects also increases proportionally. I suggest that before embarking on a course of this nature, we would need evidence that the polypill influences benefit more than risk. We therefore come back to the issue of clinical trials in order to demonstrate that.

Having said that, to answer another of the noble Lord’s questions, I accept that the polypill could be more convenient for some patients and could help them to adhere to their medicines. Whether it would prove cost-effective is something that NICE might in due course consider.

I know that not everyone is convinced by the polypill. There are, for instance, concerns about the medicalisation of otherwise healthy people. Even by its proponents it is seen as secondary to other forms of prevention. Professor Wald himself is quoted as saying:

“This is not the solution for primary prevention … Primary prevention requires education of the public. As a priority this is much more important than any polypill”.

There is a range of population-based interventions that could be put in place to reduce the risk of cardiovascular disease. Each has its pros and cons and may be suitable for some patients and in different circumstances. We know that many premature deaths and illnesses could be avoided by improving lifestyles. The Government’s public health programme includes national ambitions to reduce smoking, obesity, physical inactivity and the harmful use of alcohol—all with appropriate metrics included in the public health outcomes framework.

In addition, through the NHS Health Check programme people between the ages of 40 and 74 are offered a range of tests that include measuring their cholesterol and blood pressure levels. The check has been designed primarily to help healthcare professionals identify cardiovascular risk in the adult population earlier so that steps can be taken to reduce it, but it is worth emphasising that it is also targeted at a range of other conditions.

All 152 local authorities are now offering the NHS Health Check programme, which is a significant milestone in the programme’s evolution. In 2013-14 a total of 2.8 million people—almost 20% of the eligible population—were offered an NHS health check, and just over 1.4 million of them received one, giving a take-up rate of 50%. This is the greatest number of NHS health checks offered and accepted in one year since the programme began.

[Lord Turnberg]

That is all extremely credible. However, the polypill is aimed at those who have passed the health check with flying colours—that is, they have normal cholesterol and blood pressure, do not smoke and are not overweight. It is with this group of individuals, who are not suspected of having the liability to develop a heart attack or stroke, where it seems to have its place.

[Earl Howe]

Again, that is the primary prevention group, and the point that I was seeking to convey earlier was that we would need evidence that the benefit-to-risk ratio was sufficiently positive before proceeding down that course. That is not to say that it is not, but there is work to be done to prove it.

In March 2013 the Cardiovascular Disease Outcomes Strategy was published. This set out possible actions within the current legislative framework, systems architecture and financial settlement to deliver improved outcomes for people with CVD. It set out a framework for 10 actions that would make a real difference in improving outcomes for patients and their families. While I could expatiate on that subject, I am told that my time is drawing to a close, so suffice it to say that I hope that noble Lords have found today’s debate as interesting as I have.

The polypill is certainly an interesting concept. It may be that this type of approach would be more suitable in developing countries, where the real epidemics of cardiovascular disease are building up and where clinical trials are taking place, rather than in a more sophisticated healthcare system such as ours, where prevention and tailored therapy are more the norm. Time will tell.

On the issue of market failure, which was introduced by the noble Lord, Lord Hunt, I am not convinced that the same arguments apply to the polypill as apply to antimicrobials. For one thing, there are a number of clinical trials of polypills in progress, as I mentioned, and the MHRA has provided scientific advice to a number of companies, so clearly there is commercial interest out there. We do, however, welcome any technologies that contribute to providing the best treatment for people with cardiovascular disease.

In answer to the main question of the noble Lord, Lord Hunt, of whether the Government will consider playing a more active role in this debate, I would certainly be interested in looking at the noble Lord’s proposals in more detail and would be happy to discuss the matter with him at a suitable moment. With that, I thank him once again for introducing this extremely interesting topic for our consideration.