Junior Doctors: Industrial Action

Lord Willis of Knaresborough Excerpts

Monday 5th September 2016 Lords Chamber

[Lord Prior of Brampton]

My Lords, the origins of this dispute and lack of trust go back many years, to the end of the old firm structure. Many junior doctors feel a lack of support. It is easy to lob bricks at the Government, but the senior doctors and the royal colleges need to look at themselves pretty carefully and pretty hard in the mirror because they have some responsibility for this as well. I hope they will be very much part of working through some of these non-contractual issues, along the lines my noble friend suggested.

[Lord Willis of Knaresborough (LD)]

My Lords, does the Minister accept that this does not impact simply on junior doctors but that these strikes and the current chaos affect all the manpower within the NHS, particularly the registered nurses, who have to pick up a great deal of the slack in the absence of junior doctors, particularly when they are on strike? Rather than look at these issues at silos, I implore the Minister to look at the whole workforce and try to ensure that the modern workforce serving a modern NHS is one where integrated services mean integration of staff as well.

[Lord Prior of Brampton]

My Lords, the noble Lord makes a very good point. The changes that are coming upon the NHS, whether from technology or forced upon us, in a sense, by demographic change in the UK— meaning that much care that has traditionally been delivered in hospitals will need to be delivered outside hospitals in people’s homes and much care will be delivered by technology rather than directly by people—are all going to have a huge impact on a whole range of different staff levels, not just junior doctors.

National Institute for Health and Care Excellence

Lord Willis of Knaresborough Excerpts

Monday 13th July 2015 Lords Chamber

[Lord Prior of Brampton]

The noble Lord is right that the responsibility for safe staffing is now with NHS England. It will take into account any advice given by NICE, whose guidelines for acute in-patient wards and maternity services still stand. The main reason why the responsibility has been transferred to NHS England has nothing to do with funding. It has to do with the fact that the new models of care, such as the new emergency care vanguards, are much broader than just A&E; therefore, we need to take into account other factors.

[Lord Willis of Knaresborough (LD)]

My Lords, this Answer does not empower any validation at all, unless we have criteria by which all trusts could be judged. We have the safer nursing care tool, which was produced in Sheffield and London and validated by Leeds University; it has been adopted by NICE and rolled out by the Shelford Group and other major trusts. This is a tool that would give all acute trusts the ability to judge safe staffing ratios based on acuity and patient need. Can the Minister give this House an assurance that that will be mandated to all acute trusts and then rolled out elsewhere?

[Lord Prior of Brampton]

I think it might be worth while for the House if I read out four lines from the NICE guidance on safe staffing:

“There is no single nursing staff-to-patient ratio that can be applied across the whole range of wards to safely meet patients’ nursing needs. Each ward has to determine its nursing staff requirements to ensure safe patient care. This guideline therefore makes recommendations about the factors that should be systematically assessed at ward level to determine the nursing staff establishment”.

I read out that paragraph because it is important to realise that every ward is different. Where there are tools to help assess the acuity of patients in wards, those tools will be used. I do not think we are planning to mandate any particular tool at this time.

Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Willis of Knaresborough Excerpts

Tuesday 24th February 2015 Lords Chamber

[Lord Deben (Con)]

My Lords, first, I have to say that I am in favour of mitochondrial donation. I am not opposed to it in principle. I tabled this amendment because otherwise it would have passed through this House—in the Moses Room—without the kind of concern that we now have. The numbers present show it to have been right to discuss this matter very carefully. It is right because we are dealing with something of incredible importance to the families concerned: the fathers and mothers who can produce children but cannot, because those children will, almost certainly, carry this terrible disease. They deserve all the care that we have expended on them. The fact that some suggest that there are not that many of them is nothing: if there were but one we should be as concerned about this as we are.

I yield to no one in my determination to try to do what is right in this area and I do so for a personal reason, which is that I am thankful every day that my wife and I produced four children who in that sense—though perhaps in no other—are perfect. Those of us in this situation have a particular need to be concerned. We should be concerned with the parents; we should be concerned with the wider community; and we should be concerned with the children who would be born in these circumstances. My concern is that the Government have approached this in a way that is very unhappy. Because there are so many of us who would find the movement of a spindle from a non-diseased egg to a diseased egg something that we could accept, there was a basis for a commonality of understanding and support. That was there. All we needed, therefore, was to be assured that the procedure was safe and legal.

My noble friend—and he is a noble friend; he was one of my Ministers, and we worked closely together—has carefully covered his view of the law. I think that the law is very often an ass. I am certainly not one who would demand that lawyers should decide what we should want. I say sorry to the noble Lord, Lord Pannick, who looks unhappy at that comment. However, I believe that we should obey the law and it is quite clear that there is considerable disagreement—I put it simply like that—about whether this action is legal under European law. Although my noble friend gave the best account that he could, it is worth saying that many others take a different view. What is more, the two law officers, the Attorney-General and the Lord Chancellor, voted against these regulations. The Attorney-General has said clearly that he did so on legal grounds, so it cannot be said that those of us who suggest that the legal arguments are at least uncertain have an entirely unreasonable position.

Many who are present will have been sitting through the last part of the previous debate on ticketing. I had taken a particular view on that but felt that the House had heard enough of me without intervening on that occasion. But it may be within the memory of the House that the Government fought very hard not to take action on ticketing until they were absolutely sure about the legality, under European law, of what was being proposed and that there was a proper investigation of it. I had expected my noble friend to say that he had been to outside experts and to the European Union itself to be assured that he was not going to find himself in court were this passed. He has not done so. The only legal advice that has been presented to this House is the internal advice of the Department of Health. I do not find that satisfactory.

[Lord Willis of Knaresborough (LD)]

I am grateful to my noble friend for giving way. Does he accept that the Wellcome Trust has published and given to all Members a legal position which has all the authority of its own lawyers and which backs up the position of the Minister?

[Lord Deben]

The Wellcome Trust has certainly done that but I was referring at that moment to the ministry and the Minister. However, the Wellcome Trust has not gone to experts in European law; it went to an expert that it chose. I am perfectly happy about that but it is only one of a series of opinions, which are contrary one to another.

I started with this point because of my concern about the families. It seems that it would not be a good beginning for this change if, immediately afterwards, the large number of Members of the European Parliament —from the right to the far left—who have said that they would see this as so clearly contrary to European law seek to refer it to the courts. That would not start this off very well. The real question is why the Government have not taken the steps which would enable us all to accept that this was legal. I do not understand why they have not done that, so my first questions to my noble friend are: why was that not done and why, even after we asked for it, did the ministry not go out and see that it had exterior and clear European advice, so that we would know where we were?

That is of course only the first part of it; the second is a question of safety. I have said that if we talked about transferring the spindle from one egg to another, I would not have any ethical objection. Indeed, it would be the opposite; I would want to support it. I ought to say that, because one noble Lord, who I know is going to speak later on, at an earlier meeting said, “Well, he only says all those things because he’s a Roman Catholic”. I think I will face that. Those Members of your Lordships’ House who took part in the proceedings on the Marriage (Same Sex Couples) Bill will remember that I spent a good deal of time supporting the Government’s position on that.

--- Later in debate ---

[Baroness Scotland of Asthal]

My Lords, there are two steps. I would argue that the first step is that if a Select Committee is able to deal with all these matters in the proposal currently before us in draft, and which would today go into regulations, would be the basis of the Select Committee’s examination. If that basis is found to need some minor alteration or amendment, it would be that amended version which would then come before this House and form part of the regulations. That would be the issue that would likely be tested if there was still disagreement.

My hope would be that the concerns that have properly been raised could be dealt with by the Select Committee, particularly if we were to persuade some of the noble and learned Lords who had perhaps served in the Supreme Court in the past to lend us some of their expertise on that Select Committee. One of the advantages that we have in this House is of having that level of expertise. That is why we could do this in rather a short compass. First, I do not agree with those who think that this issue should be kicked into the long grass. It should not. Secondly, I do not believe that a Government of any complexion, as has been said in this debate, who had a very well reasoned and consensual Select Committee report would hesitate from implementing it.

[Lord Willis of Knaresborough]

Does the noble and learned Baroness agree that if the regulations were agreed today, and therefore passed, the HFEA itself would have the opportunity to test the legal opinion? It certainly did that with the cytoplasmic hybrid embryos, if we go back to 2007. The HFEA then took a series of legal opinions to inform it in its opinion against the Government at that time. Why cannot that process go on at the same time?

[Baroness Scotland of Asthal]

The real issue is whether we are going to abrogate our own responsibility. Is this something which we should ask an outside agency to do? Should we make a decision where we cannot come to a fully informed and articulated decision ourselves? If we are left in the position of saying, “I am not entirely sure about the research or the sagacity of the legal principles being advanced that enable me to pass this”, surely we should wait until that is clarified. If the House believes that it wishes to abrogate that responsibility because the nature of the issues we are dealing with are such that we feel comfortable about doing that, then of course that is always a matter for us. But I simply argue that what is being asked for is what I hope to be a relatively short period for these matters to be fully considered and fully put to rest.

I am very conscious of time but there are a number of arguments that we could put forward on the law, which would help to further exemplify that this matter is not easy. It is complex. The reason I emphasise that the law officers are disagreeing is the following. All law officers are in the same position. We are not here to tell people what they want to hear; we are here to tell them what they need to know. That should be valued by the House and I am sure that the House would want to be confident that doing this, which everyone hopes would be a good thing, should be lawfully done, too.

--- Later in debate ---

[Lord Alton of Liverpool]

I am glad to hear what the noble Baroness, Lady Farrington, has said to us today. It is important that it should be on the Floor of this House, therefore we are all agreed. I contrast the 90 minutes given to the House of Commons to discuss this with the 90 hours that Parliament spent discussing fox hunting. I ask noble Lords to contrast those things. We are required to show due diligence and scrutiny, especially over controversial legislation.

It is not just the absence of the preclinical tests recommended by the HFEA that suggests that the cart has been placed before the horse, but the disingenuous decision by the clinic promoting these regulations—even before your Lordships have debated, let alone approved, these regulations—to offer women money, as we heard from my noble friend Lady O’Loan earlier on, to sell their eggs for these procedures, a practice which itself can be injurious to their health, while telling us:

“It was never about politicians voting on whether it was safe or not”.

That seems almost a contempt of Parliament, and is certainly an extraordinary dismissal of health and safety considerations, which everyone has admitted this afternoon are a consequence of what we are being asked to agree. We have a duty to satisfy ourselves about questions of public safety.

I have experienced this afternoon something of a sense of déjà vu on the arguments, which are so reminiscent of those which persuaded your Lordships to vote for animal/human hybrid embryos in 2007. Although my noble friend Lord Patel, who I think is about to intervene on me again, said earlier on that there was a significant breakthrough by Professor Shinya Yamanaka just two weeks after the Bill passed, that is not entirely accurate. The Yamanaka breakthrough came in 2006 in the journal Cell, not after the Bill passed but before it was even published. If you look back at the Hansard, as I hope Members will, I argued repeatedly that the proposal was redundant because of the Yamanaka breakthrough and that we should not have voted for it. However, despite the Yamanaka breakthrough, many argued that animal/human hybrid embryos were necessary.

Before we rush pell-mell into authorising something which the rest of the world—from the federal agency in the United States to the People’s Republic of China—has prohibited, may I ask the Minister to answer some pertinent questions? First, what regard has he had to the increasing demand for women to give up their eggs for these techniques, the failure of the HFEA to monitor the drugs and dosages used for ovarian stimulation, and published data by Newcastle indicating an incidence of hospitalisation due to such stimulation due to the frequent collection of more than 20 eggs per cycle? Does he regard it as ethical to ask women to sell their eggs for £500?

Secondly, what is the cost of these regulations, both human and financial, when pronuclear transfer—the second of the procedures that have been referred to— requires the destruction of at least two and in some cases 10 healthy embryos for every procedure? Contrast the financial cost, too, of an issue I have raised regularly on the Floor of your Lordships’ House; namely, the failure to provide vital and much needed public funding into finding a cure for diseases such as mesothelioma, which will take the lives of 60,000 British people in the next 30 years.

Thirdly, and more specifically, why have the Government not waited for the outcome of the HFEA’s recommended preclinical experiments before proceeding? Fourthly, like noble Lords today, Dame Sally Davies, the Chief Medical Officer, said at a meeting that I attended with the noble Earl:

“No one will guarantee that it is safe”.

That being so, and given the absence of safety trials, how much has the National Health Service set aside for compensation if safety fears are realised? One recent payment to the parents of a baby damaged at a hospital reached a staggering £10 million.

Finally, I turn to the specific issue of pronuclear transfer. These regulations have bundled together two different procedures. As I said, pronuclear transfer—PNT—unlike maternal spindle transfer, requires the destruction of human embryos. It is a technique that has been specifically advocated by researchers at Newcastle. To date, most applications of this technique have been in mice. However, the Weatherall report of 2006, sponsored by the Academy of Medical Sciences, the Royal Society, the Wellcome Trust and the Medical Research Council, on page 85 stated the following:

“Humans and non-human primates share many features of reproductive biology that are not present in other mammals … Hence, rodents and other non-human primates have only limited usefulness as models of human reproductive physiology”.

Consistent with this, the report of the HFEA’s expert panel in April 2011 said that before the technique could be considered safe to use clinically, it was critical to undertake,

“PNT in a non-human primate model, with the demonstration that the offspring derived are normal”.

Has this been done? Nearly four years later, the answer is still no—even though most postgraduate researchers would have already completed a doctorate within this timeframe.

Strikingly, a news article for the journal Nature stated on 19 January 2012:

“The Newcastle researchers do not have plans to determine whether primates conceived through pronuclear transfer come to term and are healthy”.

Remarkably, the HFEA’s expert panel then changed its mind about preclinical experimentation in primates being critical for pronuclear transfer, in its ensuing report in 2013. The only explanation provided was exceptionally brief and far from compelling. It said that:

“Current research using PNT in Macaques has yet to be shown to be successful. From unpublished data it appears that Macaque zygotes do not survive the PNT process well”.

The panel now believes that the macaque may not be a sufficiently good model for the human. If macaque embryos do not have a good record of surviving pronuclear transfer, and human eggs are even more sensitive, are not problems with human embryos more likely? Surely this suggests the need for proceeding even more cautiously, not less.

The Joint Committee proposed by the noble Lord, Lord Deben, should reflect on the HFEA expert panel’s minutes of 12 February 2013, in which Dr Dieter Egli, of the New York Stem Cell Foundation, explains that he was,

“sceptical about the clinical application of PNT”,

because a structure known as the centrosome may be left behind, and that,

“the consequences of this need to be investigated”.

The proposed Joint Committee should also consider the minutes of the HFEA teleconference with Dr Shoukhrat Mitalipov on 30 January 2013, which reported:

“Dr Mitalipov expressed the view that development of MST or PNT embryos to blastocyst was not in itself enough to give confidence that the techniques are safe and effective”,

and the recent remarks of Professor Justin St John, a geneticist at Monash University in Australia with considerable expertise on the behaviour of mitochondria in nuclear transfer, who said:

“As well as analysing foetal development in a non-human primate model, it is essential to analyse offspring to determine that no abnormalities appear at least during early life”.

Not only have the researchers at Newcastle refused to perform such preclinical research in non-human primates, I have been unable to find evidence of their own prior experience in obtaining healthy offspring of any species following pronuclear transfer, or even in taking any such embryos past the blastocyst stage.

[Lord Willis of Knaresborough]

Clearly, I am not going to get to speak this evening, so I ask the noble Lord a very simple question. Does he have any faith at all in the HFEA to do what it actually says on this tin? If the regulations are passed today it will then have the job of deciding when it will be safe to go ahead and grant a licence. If he does not have that faith in the HFEA, will he please say that? Because I do.

[Lord Alton of Liverpool]

I serve on my own university’s ethics committee, which looks at the use of animals in experiments. Apparently, one of my roles on that committee is to be, as it were, the animals’ friend and to ask whether the experiment is repetitive, whether it is necessary to do such things and what it is going to lead to. There is no one on the HFEA who is the friend of the human embryo. That is a bizarre situation and one I would like to see rectified. But to take the noble Lord at his word, of course I think the HFEA often does a good job, and I admire many of its members.

I will simply say one other thing to the noble Lord. The HFEA is a regulator, not a legislator. That is our duty here today and that is why we are having this discussion. I am conscious that others wish to intervene and I am grateful for the patience of your Lordships’ House in allowing me to put these points. As we ponder on these serious issues revolving around public safety and questions of definition and legality, they deserve far better consideration and scrutiny than has been provided thus far. Surely we should remember the wise advice that those who legislate in haste repent at leisure. Therefore, the proposal of the noble Lord, Lord Deben, for a Joint Committee of both Houses to examine the safety and legality of these regulations deserves our support.

Health and Social Care (Safety and Quality) Bill

Lord Willis of Knaresborough Excerpts

Friday 6th February 2015 Lords Chamber

[Lord Willis of Knaresborough (LD)]

My Lords, I am conscious of the late hour and will try to keep my remarks to a minimum. The noble Baroness, Lady Pitkeathley, raised a number of issues that I should like to deal with but was not going to. I should like to thank Jeremy Lefroy for bringing the Bill into the Commons, and my noble friend Lord Ribeiro for the excellent way in which he introduced it. He introduced a number of the issues in a very balanced way, particularly those relating to Clause 1, which are clearly going to cause some concern.

I fundamentally disagree, however, with the noble Baroness. One of the things that has bedevilled us, and which Clause 5 tries to deal with, is that our regulators in particular have operated in individual silos, as indeed has the PSA. To say that the regulator—particularly, the one that I know best, the Nursing and Midwifery Council—does not have as its first priority protecting the public is to underplay not only that regulator but every other regulator. She is quite right to say that we have moved away from that mark and that the professions themselves have been the main source of the regulators’ work. I have a great deal of sympathy for that view but, as my noble friend said in his opening remarks—indeed, what was said in the other place on Clause 5 —it is clear that, following Francis, Winterbourne View et al, we have to get this back in balance and that throughout our health and care system it is the patient who comes first, second and, indeed, last. The professionals and the regulator are there to serve that interest. I hope that my noble friend the Minister will say that from the Government’s point of view that is the case. I am pretty sure that that has been the case from the Labour Front Bench. In particular, during the passage of the Health and Social Care Bill and the Care Bill, which are now Acts, in our arguments, it was very strongly the role of the Front Bench constantly to put the patients at the heart of the agenda.

I should declare some interests. I am chairman of the Association of Medical Research Charities, and our interests interface. Not one of our members has given a notification that they are unhappy with this Bill. As the noble Baroness quite rightly said, that is not to say that they would not have liked a different Bill or a government Bill or a Bill which came in on the back of the Law Commission report in 2014. Having said all that, we are not getting a particular difficulty from that. I also declare an interest as the independent chair of Shape of Caring, which has been set up by Health Education England to shape the nursing and care workforce over the next 10 to 15 years. A lot of what is in this Bill will directly affect the work of nurses and care assistants, in particular, and I will come back to that.

I do not regard this Bill as perfect. It is far from perfect. I share the concerns that we are rushing through at the fag-end of this Parliament a Bill which has significant importance in terms of patient care and public safety. Having said that, when I decided late yesterday to speak in this debate, my argument is “Is the Bill worth the effort?”. I think that it is worth the effort. Members of this House will know full well, and established Members of the other House with us today will also understand, that to try to get this sort of legislation at the beginning of any Parliament and in the first Queen’s Speech is very difficult. If there is to be a strange coalition and perhaps then another Government, we may not see legislation of this sort for some considerable time. It is better to get something on the statute book and to start working on it. There are elements of this which are very important.

The Bill has the backing of the Government and the Labour Front Bench, which I hope is still the same. I am pretty sure that it has the backing of many Cross-Benchers. The purpose of the Bill is quite simple and clear. Its first priority is to link registrations with the CQC to a statutory body to prevent avoidable harm where there are regulated health and social care services. Secondly, it has to establish a consistent identifier for patients or clients through the whole of their healthcare journey, allowing information relevant to their care or treatment to be shared appropriately. Thirdly, it has to ensure greater consistency across and between regulators of health and social care with the primary objective of public safety. I do not think that there is anyone in this House or in the broad public who would not agree that it is right and proper that Parliament addresses those three priorities.

My only questions are: does this Bill say that? Does it do what it says on the tin? Is there a reality that those three objectives can be met? I am a layman in these matters but someone who works with the nursing and care sector at the moment. I believe that the answer is yes. The Bill is proportionate, logical and deliverable but it is only one step forward. It is part of a journey to create a more dynamic rather than a stationary regulatory system. The trouble with our regulatory systems is that they are stuck in time and do not move with the times. They need to be far more dynamic.

Clause 1 appears to have caused some problems with the BMA, certainly with the Berwick advisory group—or some members of it—and with the Health Foundation. I know that the noble Lord, Lord Turnberg, will address some of those concerns in his contribution so I will leave him to do it. While I fully accept the concerns which have been raised about Clause 1, there is, as the noble Lord, Lord Ribeiro, said, some exaggeration of what the Bill is trying to do.

The Bill, rightly in my view, seeks to make it a duty of the Secretary of State to require the CQC to impose regulations which cause no avoidable harm to patients. The Bill states just that; what it does not state, nor do the Explanatory Notes, is that we are trying to go for a legalisation of zero harm. There is no healthcare system in the world that could have zero harm framed within legislation—that is impossible. I hope that my noble friend will make it clear that that is not the intention. I hope, too, that he will go on to say that the current regulations from the CQC, which if I am not mistaken are about to come before the House—perhaps they have already gone through the House and I have missed them—have already put into statute exactly what we want to see happen in this Bill. So I do not think that there is a problem from the CQC either.

Clauses 2, 3 and 4, although again eminently sensible in their changes, cause one or two issues which I hope the Minister will be able to respond to. The idea of a common identifier is so obvious that you wonder why we did not put it into the Health and Social Care Act in the form that it is in. The idea of using of one’s national insurance number to deliver that seems sensible, but I am delighted that the Bill does not have it on its face because modern technology is moving so fast that there may well be within a very short time a totally different concept of a common identifier. The Bill will allow that to come in very effectively. Who knows? In future, babies might be chipped at birth so that there is a way of barcoding them as they go along their journey. Before the noble Lord, Lord Hunt, puts out a tweet somewhere, I should say that that is not a Liberal Democrat idea for the next election.

On data sharing, the latest response from Fiona Caldicott is right. The duty to share important information is as important as the duty to protect it. Getting that balance right is important. The fiasco over our attempts to share research data, which nearly derailed that important initiative, is in our minds. The fact that we constantly hear reports of data being lost or put in the post to somebody is something else that we have to take care of.

The area of the Bill that I am particularly concerned about and want to see through is Clause 5. I want to devote the last few moments of my speech to the work of the Nursing and Midwifery Council, which is faced with an impossible task at the moment. It spends an inordinate amount of its time dealing with disputes about people who have reported nurses or midwives for unprofessional conduct; it is mired in a morass of cases. The difference is this: the GMC has roughly 10,000 complaints about doctors each year. In 2013-14, 2,371 of them were investigated, and only 241—about 2.4%—were brought to full hearings. Compare that with the NMC where there were roughly 4,000 referrals last year, 75% of which have gone to full hearings. The NMC is spending an inordinate amount of time dealing with hearings, no matter how important or trivial they are, simply because that is the way the legislation is formed. Clause 5 allows us not only to have a comprehensive framework across all the regulators but gives them powers to streamline the way in which they deal with complaints. It is far more important to deal with the key point of keeping patients safe than with the huge amount of trivia which comes through the regulators.

All in all, this is not a perfect Bill, but is a Bill well worth putting on the statute book, and I hope that noble Lords will support it and give it a Second Reading.

NHS: Clinical Negligence

Lord Willis of Knaresborough Excerpts

Tuesday 20th January 2015 Lords Chamber

[Earl Howe]

My Lords, we are looking at that proposal, but there are currently no plans to repeal that particular piece of legislation.

[Lord Willis of Knaresborough (LD)]

My Lords, following the passage of the Health and Social Care Act, there are now some 350 other qualified providers. Will my noble friend confirm that they all get support through the Department of Health for any clinical negligence claims? If that is so, how much was paid out in 2013? Further to the point made by the noble Lord, Lord Hunt, if a claim is made within the private sector or third sector, will such providers be prevented from providing that claim within their organisations if negligence was proven?

[Earl Howe]

My Lords, potentially, independent sector providers may elect to be members of the negligence scheme, although only in respect of their NHS services. Therefore, only NHS-related liabilities would be covered in those circumstances. It is a pay-as-you-go pooled scheme, and I do not therefore have the figure that my noble friend requested. If I can get the figure disaggregated for him, I would be happy to write. In answer to his last question, I take it that he is asking whether the provider would be allowed to continue treatment, having been found to be negligent or having admitted negligence. That decision would be clinically led, with the patient exercising choice in each individual case.

NHS: Five Year Forward View

Lord Willis of Knaresborough Excerpts

Monday 1st December 2014 Lords Chamber

[Lord Willis of Knaresborough (LD)]

I thank my noble friend for repeating the Statement. I echo the point that, while many of us on all sides of the House may have disagreed with some of the structural changes in the Health and Social Care Act, the last thing the health service wants is another structural reorganisation. The plan by the party opposite to scrap the Health and Social Care Act is a real worry to many professionals. I say to my noble friend that no matter how much money the Chancellor promised today, it will not be enough to meet the demands of a changing healthcare system, where we are seeing, year on year, because of the success of the NHS, people living longer and with lots of different comorbidities.

I have a concern about the Statement. I actually think that Simon Stevens’s report is an excellent report and one that should have united this House rather than dividing us. After all, his pedigree comes from working with the Labour Party on the early reforms in the last Parliament. What really worries me is that neither in Simon Stevens’s report, nor in the Statement, is there a mention of the other crucial element, which is the workforce. The workforce and, indeed, the work of Health Education England, is not even worth a mention in the Statement—yet it is the 500,000 nurses and the 1.4 million care workers who bind the health and care system together and who will deliver the integrated health and social care which all of us in this House want to see.

Will my noble friend make it clear today that no savings will be made by reducing Health Education England’s budget? Will he state clearly that there will be investment in the skills of our staff in order that Simon Stevens’s plan actually works and that we can make it a realisation rather than a hope?

[Earl Howe]

My noble friend is absolutely right. One of the critical elements of the Five Year Forward View is to ensure that we have the right number of staff with the right qualifications in the right places. While Health Education England is the body charged with ensuring that that happens, it is up to us in government to ensure that there is adequate funding to enable it to do that. I can assure my noble friend that Ministers are very clear that Health Education England should be fully supported to deliver the programme that it has mapped out for itself. That programme is an exciting one. It involves more doctors and nurses in training over the next few years. Our ambition is to see by 2020 an extra 10,000 people working in primary care, for example—and that is only one detail.

As a result of the Government’s reforms to the health service, we have been able to afford a large number of extra posts in front-line care, including doctors and nurses in both primary and secondary care. We have done that by reducing the number of administrators in the system—20,000 fewer than there were in 2010. My noble friend is right to draw attention to this issue; it is one that is very much in our focus.

Health: Polypill

Lord Willis of Knaresborough 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.

--- Later in debate ---

[Lord Willis of Knaresborough]

My Lords, perhaps in the time we have I might make a very short intervention because I agree with my noble friend in her analysis. I feel that there is a real issue not simply with the polypill but with the research, which needs to take place where there are combinations of drugs being given anyhow. You can give a combination of drugs without having serious clinical research and that is okay, but if you combine them into a single dose, you need a complete clinical trial. That issue has to be addressed.

Health: Patient Safety

Lord Willis of Knaresborough Excerpts

Tuesday 24th June 2014 Lords Chamber

[Earl Howe]

It was only recently that the Nursing and Midwifery Council revised the curriculum for the training of nurses. I am sure that the noble Lord will be pleased to know that that curriculum is broadly divided 50:50 into practical training and training in the classroom, which was the balance historically. I believe that nurse training is now set fair for the future. The noble Lord is right to raise concerns about Project 2000, which many people felt did not quite address the needs of nurse training. However, that programme is substantially different now from what it was in 2000.

[Lord Willis of Knaresborough (LD)]

My Lords, I am delighted to follow the arch-moderniser, the noble Lord, Lord Pearson. In the whole of my noble friend’s Statement, and indeed until the noble Lord raised his question, not a word was mentioned about the training of the staff who actually care for our patients. We have a situation in which, unless you are a medic, you are not entitled, even if you are a qualified nurse, to have resources spent on you in order to continually update your professional development. In terms of preceptorship, there are no resources; in terms of mentorship, there are little additional resources; and there is virtually no resource to train healthcare assistants. Will my noble friend agree that although the move to have 9,000 more nurses is incredibly welcome, we need to put training at the very heart of the safety agenda, because unless we train we will not get high-quality staff?

[Earl Howe]

I agree with my noble friend; it would be difficult to disagree with him. Training is essential if we are to have high-quality staff. That is why we have protected the training budget, which is now hosted by Health Education England, whose job it is to ensure not just that there are adequate numbers of each type of professional in the health service but that the quality of the training is as we would all wish. It is the task of the local education and training boards to assess the position at a local level and, informed by the NHS providers that are under their wing, to respond to the needs of those providers.

Healthcare Professions: Regulation

Lord Willis of Knaresborough Excerpts

Tuesday 10th June 2014 Lords Chamber

[Earl Howe]

No, my Lords. We understand the frustration felt by the regulators that this has not been taken forward yet, but other government priorities have had to take precedence. That is the reality that we must accept. As I have said, we are committed to legislating on this important issue when time allows. With that in mind, we are currently working hard in consultation with key partners, including the professional regulators and patient and professional representatives, on our response to the Law Commission’s work. The complexity of that exercise cannot be overemphasised.

[Lord Willis of Knaresborough (LD)]

Would my noble friend agree that, after the very challenging Bills that went through the House in the first two Sessions, this Bill would have support right across the Chamber, across both Houses and across all the professions in terms of patient safety? Would my noble friend also agree that this would be a wonderful opportunity for us to tackle the appalling situation whereby 1.3 million healthcare support workers are not regulated and do not have standards, and no one can judge fitness to practise? A draft Bill would at least give us an opportunity to frame that legislation.

[Earl Howe]

My Lords, as my noble friend will know, we have debated the regulation of healthcare assistants on a number of occasions. The Government’s view is well known. However, I agree with him that the content of the Law Commission’s draft Bill is welcome to many parties—indeed, the Government are keen to see it progress. Much of the proposed legislation is already law in one form or another. The review is about pulling together all the different bits of legislation, introducing consistency across the professional regulators where practicable, making sure legislation is fit for purpose and, importantly, introducing flexibility for the regulators to respond to changing situations.

Elderly People: Abuse

Lord Willis of Knaresborough Excerpts

Wednesday 14th May 2014 Lords Chamber

[Lord Willis of Knaresborough (LD)]

My Lords, I congratulate my noble friend Lady Cumberlege on this debate and on not only highlighting the issue of abuse but putting forward a raft of suggestions as to how the Government can take a positive stance. That is important. My contribution is unashamedly a return to the question of how we train those staff who are caring for the vulnerable elderly. Unless we create a culture where those working with vulnerable patients see it as part of their caring role to protect and care for those people, and they are properly trained and empowered to deal with abuse, we will not get much further.

Is it not ironic that, in the heath and care sector, the personnel with the greatest levels of contact with the most vulnerable patients, particularly the elderly, receive the lowest levels of training? Medics are not only well trained at the start of their careers but are required to engage in continuous training in order to continue practising with high levels of safe professional care. However, the thousands of health and social care assistants, who are often left to deal with the most challenging needs of elderly and confused patients, receive little training and have no test of fitness to practise or opportunity to engage in continuous upskilling—nor, of course, are they registered and regulated.

Fortunately, thanks to Members on all sides of the House and, in particular, the efforts of my noble friend Lord Howe during the passage of the Care Bill, we now have the opportunity to address this. The promise of basic training and certification of healthcare support workers, as recommended by Francis, Cavendish and, indeed, my own report, are already under way, with the new care certificate being piloted.

Tomorrow, Health Education England and the Nursing and Midwifery Council launch a major review of the training of the whole of the caring workforce, from healthcare support workers to postgraduate nurses. The review, entitled the “Shape of Caring”, brings together key professional groups—including Health Education England, the Nursing and Midwifery Council, the Council of Deans of Health, the Royal College of Nursing, Unison, employers, the Department of Health, NHS England and, crucially, a wide range of patient forums—with the sole aim of creating an integrated training pathway for all who, day to day, care for patients, in whatever setting they are in. The aim is to ensure that patient care is the golden thread that runs through the whole of training and that continuous professional development is guaranteed for everyone who comes into contact with patients or clients.

All staff should have a grounding in what good care looks like; all should have an understanding of other people’s skills and competences; and all should recognise that care is dependent on a team, no matter how important an individual member might be at a particular time. I am enormously privileged, and declare an interest, that I have been asked to chair the review and to report at the end of February to Health Education England. It is my hope that, if we could get the framework and standards right, and if we could get agreement across this House and the other place that those proposals should be taken forward, we would have for the very first time an integrated pathway of training, qualifications and care right throughout the profession. That would be something that was worth striving for.