Medical Innovation Bill [HL]
Lord Winston Excerpts(9 years, 11 months ago)
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Lord Winston (Lab)
My Lords, this is a surprisingly complex Bill, and indeed the various amendments that have been tabled in the first group conflict with each other. As a consequence I will concentrate on only a few of them in order to get some clarity. The noble Lord, Lord Saatchi, talked about clarity and certainty when he introduced the Bill, but I feel that the whole of this Bill will increase lack of clarity and promote uncertainty on the part of patients, which is something that really concerns me. I must also say that, as it stands, I believe that the Bill is quite dangerous. I say that with great respect to the noble Lord, Lord Saatchi, to whom we are grateful for introducing something of this kind.
I should say to the noble Lord at the outset that all of us who work as medical practitioners and scientists want to see innovation. No one could doubt that, as my noble friend Lord Turnberg pointed out. My entire career in the health service spanning 40 to 50 years has been a constant series of innovations, and I have to say that never once have I looked over my shoulder and thought that there might be a risk of litigation as a consequence of my innovating. That seems to be the reasoning behind the purpose of this Bill, but I believe that the noble Lord is mistaken in his view that practitioners are concerned about litigation because of innovation. They are certainly concerned about litigation, but they are not concerned because they are trying to do things which they can clearly claim are in the interests of their patients. That is a really big problem.
Had the noble Lord, Lord Saatchi, along with his noble friend the Minister of health, decided to focus on certain other aspects, I would have argued that some of the permissions for research ethics would have been a very important issue to look at. They are increasingly inhibitory. I would also cite some of the problems that have arisen out of the Human Tissue Act 2004, which was introduced by a Labour Government. There is a number of other issues that could have been looked at, such as the fitness to practise regime of the GMC, which the noble Lord mentioned.
However, let me concentrate on the Bill. I will start with Amendment 17. The noble Lord, Lord Pannick, introduced some of the questions and I want to deal with those in a bit more detail. I must suggest that anybody who has a sensitive disposition leaves the Chamber at this stage because I am going to describe personal experiences, which, I have to tell your Lordships, are unpleasant. I can give endless examples but will confine myself to two cases of maternal care. In doing so, I declare an interest as the chairman of the Genesis Research Trust at Imperial College and, of course, as a formerly practising gynaecologist.
When I was in training in a district general hospital in Essex, I was confronted in the middle of the night with a woman who started to bleed torrentially after birth. The blood went completely over the obstetric ward floor and then started to leak out under the sill of the floor into the corridor beyond. It was very clear that no matter how fast we transfused this patient with all the blood we had available, and eventually with O negative blood, this woman was going to exsanguinate and there was absolutely nothing one could do about it. I tried an innovative procedure with that uterus that was not described in the literature but had I not done so, that patient would have died.
I have to say to the noble Lord, Lord Saatchi, that, unlike him, I have tangled with innovation throughout my life. I have had sleepless nights; I have had trembling hands when facing patients who might die because I knew that I had to take a decision on the spur of the moment that might make the difference between life and death. Amendment 17 is partly concerned with that, and if we do not press it today, I think we will need to reconsider it on Report.
I will tell the noble Lord another story. This is pretty graphic as well. I was called in the middle of the afternoon to a case in the casualty department of the district general hospital where I was working as a registrar in training with about five years’ experience. There was a woman—barely a woman; a girl, really, just out of her teens—who was lying virtually unconscious on a trolley in the emergency department. There was no relative with her, there was no history with her; there was no way of knowing what was the problem.
When I examined her very quickly, I noticed that her breasts were somewhat active and her abdomen was distended, and it became likely that she might have a pregnancy but of course there was no way of verifying that. There would not be time to do a test because this woman was lapsing into unconsciousness; indeed, as I was examining her, she became unconscious and her blood pressure dropped to unrecordable levels. I put her on a trolley and ran down to the operating theatre with it. I had asked them to call an anaesthetist to help me. When the anaesthetist arrived, who was a much more senior doctor than I, he refused to have anything to do with the treatment of this patient. He was not prepared to consider anaesthesia for this woman because he felt that that would not be appropriate for somebody who was already unconscious.
I do not say this out of any sense of pride or because I am being all-powerful but this is simply how one acts in an emergency. Without scrubbing up—with unclean hands, simply with gloves on—I took a knife and opened her abdomen briskly and tied off the bleeding point. It was an ectopic pregnancy and once we had removed the bleeding point her blood pressure immediately became recordable. That woman left hospital seven days after the procedure.
Had we gone through any of the procedures that are described in the Bill, I have absolutely no doubt that that unmarried 21 year-old girl would have died there on the table, and I would have been haunted by that had I not innovated in a way that was appropriate. It was only when the abdomen was open and the blood was welling out that my anaesthetist put a tube down her throat and assisted me with the anaesthesia. He was not frightened of litigation; he just thought that the patient was going to die.
In Amendment 17 I have delineated a few of the examples in medical practice where there is a real case for not innovating. I could argue—I notice the noble Lord, Lord Kakkar, is in his place and I hope he will agree with me—that every single one of your Lordships in this Chamber will have different anatomical variants in your abdomen. For example, if you are undergoing a hernia operation, the skill of the surgeon in trying to decide what the variant might be is something that he needs to tackle immediately and without consent of either an ethics committee or a group of doctors who might give him permission to do so. It is a nonsense to suggest that a surgeon needs to do that sort of thing in the process of innovating in surgical care. That is also true for neonatal care, where of course we do not have very good chances sometimes of deciding when a very small baby is on the point of death. There are many other examples. I would just argue that there is one rather exceptional case, which I have alluded to, which is in reproductive medicine.
In my view, that is a different situation. The risk is that if we encourage innovation, as we are inclined to do and as is happening in private practice at the moment for quite large fees, there is a real risk in the long term. For example, this week two companies have offered to freeze the eggs of their employees to try to delay their childbearing. It sounds a very humanitarian thing. It is not, it is a purely business proposition. What they are doing, of course, is trying to manipulate their female employees by doing this. But the doctors who are prepared to charge substantial sums of money for this freezing have not considered the real success rate that even young women who freeze their eggs have. In the United Kingdom, around 7% of patients who have had their eggs replaced actually have a pregnancy, and we do not even know how many of those pregnancies go on.
During that treatment, there are different ways of freezing eggs which are innovative, which have not been properly tested and which may, for all we know, have epigenetic effects 50 years on, when there may be a risk of high blood pressure, heart disease, osteoporosis or dementia. Indeed, we now know from some animal experiments that there are genuine incursions into the human embryo and the human egg, which in animals certainly cause very interesting but rather alarming changes in the central nervous system as a result of what is happening innovatively in humans. Of course, we cannot prove it in humans because we have to wait for a long time. I argue that Amendment 17 is essential but I suspect that more aspects of medicine will need to be covered in the Bill.
I support completely the amendment of the noble Lord, Lord Turnberg, who started the debate this morning. If he decides to press that amendment, I will certainly join him in a vote. The problem I will have, of course, is that part of that amendment, and certainly some of the implications of it, conflict with my Amendment 30, which argues that we should have clinical ethics committees. In my view, there is a strong reason to do that. I know that the Minister is very unlikely to accede to that request but there is a real issue about having better supervision of clinical treatments. We have research ethics committees but they are totally different. They do not cover routine practice. It is not a matter of simply leaving it to the General Medical Council. That is really not adequate. It needs to be dealt with locally and by the people who are concerned with the particular population with which they are involved.
I do not intend to go on at great length about the amendments in detail but there is no question that we will need to come back to some of them; others we may even wish to divide the House on this morning. But for the moment, I think I have said enough about those amendments.
Baroness Masham of Ilton (CB)
My Lords, my Amendments 14, 18 and 34, on safeguarding, are in this group.
Since the previous stage of the Bill, the deadly Ebola infection in Africa has hit the headlines and the need for fast-track innovative medicines and vaccines has become vital, as has the need for countries to come together to help support and educate suffering populations. In addition, last Tuesday the “Panorama” programme showed the innovative research being done on the spinal cord to enable paralysed people to walk. It is encouraging to see experts across countries working together.
Lord Cormack (Con)
My Lords, my noble friend Lady Gardner is right to talk about hope. It has been said that the real poor of the 21st century are those without hope, but there is a worse condition and that is to have false hopes. There was a very moving article earlier this week in the Times by Melanie Reid, writing from her wheelchair. Those of us who read her columns from time to time can only admire her courage, resilience and sense of reality. She was writing in the context of the gentleman in Poland who has been given some form of locomotion as a result of brave, innovative surgery.
We are all very conscious of the background to today’s debate, which is different from that to the Second Reading, because, since then, we have had, as has already been mentioned, the Ebola outbreak and the need for untried and untested treatments because they are the only things that might conceivably offer some hope. We have also had the extraordinary affair of the young boy taken to Prague for treatment that he was not apparently able to have in Southampton, and we had the grotesque spectacle of his parents being put in jail. It was the most dreadful story.
Those remarks are merely in preface because I strongly support the aims and objectives of my noble friend. He has done this House a service in bringing this Bill forward, but he has done more than that, because since the Second Reading, he has clearly listened. He has had long conversations with Sir Bruce Keogh, the Secretary of State and others, and has striven to make his Bill much better than it was at Second Reading. We are all very much in his debt for that.
I readily acknowledge that we have heard some powerful speeches today from people who truly know what they are talking about. I readily concede that this Bill is not perfect now. I believe that if we are to legislate on this front we need to get the best possible Bill to become an Act of Parliament and speed must not be the only criterion we take into account when we are legislating on such a complex issue.
It was very moving to hear what the noble Lord, Lord Winston, said about some of his own experiences. The account given by the noble Lord, Lord Turnberg, of the surgeon at 30,000 feet also brought home to us how incumbent it is upon those with medical and scientific knowledge to be able to react quickly. The whole purpose of science and medicine is to innovate, otherwise people are merely being repetitious, and if you are merely repetitious then you cannot make true progress.
I think that there is a way forward on the legislative front this morning. I hope that we can today accept the amendments that the noble Lord, Lord Saatchi, has thoughtfully and helpfully tabled, and I believe that there should be another stage, a Report stage, where in the light of the amended and improved Bill, people such as the noble Lord, Lord Winston, whom I admire greatly, and the noble Lord, Lord Turnberg, who has done so much himself, can sit down with the noble Lord, Lord Saatchi, and further improve the Bill, so that when it goes to another place it has the benefit of that vast reservoir of medical talent and experience which is unique to this Chamber.
If ever anything justified the existence of this Chamber, it is a debate such as we are having this morning, where people who have really achieved great things in their chosen field are able to bring the benefits of their experience to our counsels.
I hope that this morning we can accept the amendments of the noble Lord, Lord Saatchi, and that he will then consult the noble Lords, Lord Winston, Lord Turnberg, and others, so that when we have further amendments on Report, we can make the Bill as foolproof and comprehensive as possible. It can then go to another place, where I hope that they can expedite its progress to the statute book.
Lord Winston
My Lords, perhaps I may intervene briefly before the noble Lord, Lord Cormack, sits down. He refers to the Ebola virus and to proton beam or carbon beam therapy—I am not sure which it was—and the boy who eventually went to Prague, I think it was. In the case of carbon beam or proton beam therapy, there is extensive medical literature about the treatment, so it is not innovative in the context of the Bill. I suggest to the noble Lord that with regard to the Ebola virus, although a very experimental vaccine has been given that has not been tested, there has been extensive discussion in all sorts of circles, including the New England Journal of Medicine, which is one of the leading journals in the world of medical practice, of whether such plasmas or vaccines should be given. That is fundamentally different from the Bill. I thought that the subject of Ebola might well come up, and I just wanted to make it clear that that threat is a very different issue and would be outside the scope of the Medical Innovation Bill.
Lord Cormack
As that was meant to be an intervention, I suppose that I had better respond. I was merely mentioning things that had happened since Second Reading; I did not begin to suggest that they were relevant to the Bill. I mentioned them by way of background, but of course I take the graciously worded rebuke and entirely accept what the noble Lord, Lord Winston, just said about the scientific background to both those examples.
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.
Lord Winston
“( ) For the purposes of this Act, “innovation in medical treatment” means—
(a) the use of a medical procedure, treatment, therapy, device or instrument which has not been subjected to a randomised clinical trial or equivalent clinical validation, or for which there is no published evidence of its risks or benefits in peer-review medical journals;(b) the prescription of a drug which has not been licensed by the UK Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency;(c) the prescription of a licensed drug for a treatment, condition or therapy not recommended by the manufacturer; or(d) the use of a device or instrument which has not been regulated under the Medical Devices Regulations 2002 (S.I. 2002/618) for the purpose of that particular treatment.”
Lord Winston
My Lords, one issue that crops up again and again in this Bill is that we have not defined what is meant by innovation. This amendment tries to detail where something would be innovative—for example, a drug that has not been recommended by the manufacturer or a device or instrument that might be used in the course of infiltrating a patient’s body in some way. It may be a telescope or a plastic tube, or any therapy, device or instrument that has not been subjected to randomised clinical trials or published in a peer review journal. I have probably said enough about this amendment. It is very clear that, although the Minister says that we are trying to complicate the Bill unnecessarily, I think that sometimes the Bill needs more complication—it is not that simple—and certainly in my view the definitions of innovation are essential, because that is what the Bill is about.
Lord Kakkar
My Lords, I have some concerns about the wording of Amendment 6. Is it intended, for instance, to restrict the use of an agent or intervention that has been tested in a completely different situation—there may be some peer-review publication or some clinical validation in a completely different situation—but where it is proposed to use the treatment for another condition? One will recall that Gleevec was an agent developed principally for the management of patients with chronic myeloid leukaemia; it was an interesting biological compound that targeted a specific mutation in a signalling pathway in cells in that form of leukaemia. Many years later, it was noticed that that signalling pathway mutation was also seen in a particularly rare form of tumour, a gastrointestinal stromal tumour. Those who were innovating decided to use the drug because the genetic mutation appeared to be the same for treating that particular type of tumour to great effect. Would the description of innovation in the amendment have prevented that happening?
Proposed new paragraph (d) of the amendment deals with the question of devices or instruments. What happens if they have been developed and regulated for a particular intervention, and then an innovator decides to use them for a completely different condition? They will have been made available for regulated use but not for the condition in question. Would this amendment therefore restrict that type of innovation?
Lord Winston
I do not think that it restricts anything at all but actually makes the Bill of the noble Lord, Lord Saatchi, workable. We need some kind of definition of what an innovation is. That is all the amendment tries to achieve. It is not in any way restrictive. Of course, if one decides to put a plastic tube that is normally used to infiltrate the trachea into another organ, this amendment will permit that to happen, when currently it would not be allowed.
Lord Giddens
My Lords, the noble Lord, Lord Saatchi, knows that I support the thrust of the Bill but there are issues around some of these amendments that the noble Lord might at least listen to.
As I have mentioned previously, one of the core things about this legislation, given its sensitive nature, is that we have to comb through it all the time for possible perverse consequences. At the risk of sounding like sociology 101, unintended consequences are different from perverse consequences. Unintended consequences can be good or bad; perverse consequences undermine good intentions and reach the opposite result of what an individual needs to achieve. For example, strong rent controls were introduced in New York City to help poor people; in fact, they adversely affected them because they could not find places to live. The noble Lord says that the Bill is crystal clear in its intent, but that is not enough because there is a massive difference between intent and consequence. I therefore feel that as a general principle we should comb through the whole Bill to try to spot possible perverse consequences.
On the whole, with the reservations that have been noted, I support Amendment 6 because it might help to block off some of those reservations. We surely must know what innovation actually means in the context of clinical practice. Without such specification, one can see that various perverse consequences could occur. What would happen, for example, if a doctor was accused in court of failing to innovate because he or she did not try some eccentric form of treatment that was available? One could block off that perverse consequence by specifying, in the way that Amendment 6 tries to do, what actually counts as innovation.
I feel strongly that as the Bill proceeds through Parliament we must tighten every loophole that could lead to a situation in which, to some degree, the Bill undermines what it is actually supposed to achieve—helping vulnerable patients in a situation in which they are often desperate by bringing innovations to them that they would not have had available before. However, I fear that some of those things could happen if one was not aware of the minefield of perverse consequences. If we do not examine it all carefully, there could be consequences that, to some degree, undermine the purest of intentions with which the legislation is introduced.
Lord Winston
My Lords, I thank noble Lords for their interventions on this amendment. In view of what has been said, I think we need to take these ideas away and think about them and consider the points made by the noble Lord, Lord Kakkar, and others. I thank the noble Lord, Lord Saatchi, for his courtesy in his reply to my amendment. For the moment, I beg leave to withdraw the amendment.
Earl Howe
My Lords, the Government support these two amendments, which ensure that the Bolam test will remain unaffected by the Bill. In practice, this will mean that it is for the innovating doctor to decide whether to take the steps set out under the Bill or to rely on the existing Bolam test. In other words, there would be no requirement for doctors to follow the Bill when innovating.
The amendments clarify that, separate to the existing Bolam test which is applied by the courts, the Bill provides doctors with an alternative option for showing that they are acting or have acted responsibly. Furthermore, subsection (2)(b) of the proposed new clause provides that doctors are not negligent, and thus will not be judged adversely if their actions are later challenged, merely because they have not followed the Bill.
My noble friend Lord Kirkwood asked how the proposed new clause affects how a regulator approaches a complaint or fitness-to-practise procedures. This Bill addresses clinical negligence law and how the courts will assess these cases, not how the regulators will process fitness-to-practise cases.
The noble Baroness, Lady Wheeler, asked whether the Bill was necessary. The Department of Health’s consultation on the Bill revealed that some doctors find the threat of litigation to be a block to innovation, although this view was not universally held. The Bill is aimed at reassuring those doctors who feel unable to innovate due to concerns about litigation. There will also be many doctors who are not afraid to innovate and for whom litigation is not a material concern. Those doctors can continue to act as they have done previously and rely on the existing law of clinical negligence, or, as I have explained, they may choose to take advantage of the Bill instead.
I hope that noble Lords will accept these two amendments, which give flexibility and choice to doctors who want to innovate.
Lord Winston
There is something troubling me here. Let us say that somebody in an emergency or other situation does not have a chance to go through the required tests stipulated by the Bill, consulting other individuals who may be confident about or more experienced in that position. I still do not understand in the context of what the Minister has just said where that individual stands in innovating without those permissions. Is that still part of the Bill? How does that work? Is there a risk of that person being irresponsible in view of his not fulfilling what is required in the Bill when he is innovating?
Earl Howe
I completely agree with the noble and learned Lord’s analysis of the situation. I hope that that has been helpful to the noble Lord, Lord Winston. Earlier, the noble Lord cited an example where a doctor was confronted by an emergency requiring innovative practice. Whether the doctor was acting responsibly or not, and the consequences, will depend on a number of factors. It will depend on the extent to which the doctor is confident in his or her judgment, based on experience in previous clinical practice and can, if necessary, show to a court that what he or she did was responsible and, at least in intent, in the best interests of the patient.
The noble Lord asked whether there was a risk of a doctor being found to be irresponsible in some emergency situations where innovative treatment is practised. Yes, there would be a risk if the process outlined in the Bill were not followed—but that situation obtains today.
Lord Winston
Both the Royal College of Surgeons of Edinburgh, of which I am a fellow, and the Royal College of Surgeons in London, absolutely support the idea that surgery should be excluded from the Bill for this very reason: they consider that there might be situations where the courts become unnecessarily involved. That involves extra expenses to the health service because of our current concern with litigation. As the noble Earl well knows, in obstetrics, for example, litigation already accounts for a huge proportion of the expenses devoted to maternal care. There are considerable knock-on effects where litigation may be started because of lack of clarity. It is possible that I am being stupid—I recognise that I am not nearly as intelligent as the noble and learned Lord, Lord Woolf—and I will have to go away to think about this, but there seems to me to be a misconstruction here which is puzzling and, I think, worrying.
Lord Saatchi
I hope that this may help my noble friend Lord Kirkwood. What we have just heard from the former Lord Chief Justice and the Minister is completely clear to me. I will try to explain it in this way: if the doctor feels completely confident that the innovation he is about to attempt will be approved when the Bolam test is applied in a subsequent trial, he will go forward with his innovation. If a trial then takes place, he either will or will not be proved right when the test is applied—that is, if he departed from standard procedure and decided to do it on the basis of his confidence that the Bolam test would make him innocent of negligence.
However, as we all know—this is fundamental to the Bill—if the doctor is obliged to speculate in advance about what might or might not happen in a trial, that raises a very high degree of uncertainty. If it is possible for a doctor to move the Bolam test forward and comply with it in advance, which is what would happen as a result of the Bill becoming an Act of Parliament, that would enable the doctor to move forward with an innovation without the fear that a subsequent trial will find him guilty. I therefore say to my noble friend Lord Kirkwood that what we have here in simple, plain language, is that the Bill is giving the doctor an option if he wants to be certain before he goes ahead with an innovation. It is not a requirement that he does that. If he is confident of the result of a subsequent application of the Bolam test, he does not need the Bill at all. It is a fundamental benefit of the Bill that it gives that option, which I think is a very simple one.
Ebola
Lord Winston Excerpts(9 years, 11 months ago)
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Earl Howe
My Lords, we are reviewing those very questions all the time. Our position at the moment is that it would be disproportionate to alert the general public to the risk of Ebola, because it remains low. As for air passengers generally, it is important to understand that the virus is transmitted only by direct contact with the blood or bodily fluids of an infected person. It is not an airborne infection. So while I do not in the least belittle the importance of a public health campaign should that prove necessary, we do not consider that it is warranted at the current time.
Lord Winston (Lab)
My Lords, I am slightly concerned—I hope the noble Earl will forgive me for not giving him advance notice of this question—about the possible risk of seeming a little complacent about saying that this is low-risk. We know that viruses mutate, for example, and we know that the Ebola virus can mutate. We know perfectly well that it is not airborne at the moment, and we know that the pharyngeal and upper respiratory tract cells are unlikely to harbour the virus. However, can the noble Earl assure us that people are looking at the risk of mutation of this virus so that we can make certain that its mode of transmission does not change and that, therefore, it will continue to be low-risk?
Earl Howe
I can give the noble Lord that assurance. There is very close monitoring of the virus itself and the way in which it mutates. I repeat that the official advice is that risk to the public in this country remains low. That advice is based on the fact that we have robust, well developed and well tested systems for managing infectious diseases when they arise, supported by a wide range of experts. The Chief Medical Officer has estimated that we should expect Ebola in the UK, but not more than a handful of cases, and we would be able to cope with those cases.
Health: Secondary Care
Lord Winston Excerpts(10 years, 3 months ago)
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Lord Winston (Lab)
My Lords, governance, early diagnosis and visits to the general practitioner are all very well but, as the noble Earl will understand, many cancers such as lung cancer, which has just been mentioned, and pancreatic cancer depend on relatively silent tumours that are not going to be diagnosed on a clinical basis anyway. Surely the need is for markers for these diseases. What are the Government planning to do to increase research in this area, to ensure that we have markers for these diseases?
Earl Howe
Cancer research is a major priority for my department. Investment in cancer research by the National Institute for Health Research has risen from £101 million in 2010-11 to £133 million in 2012-13. However, that is only what my department is doing. As I am sure he is aware, a whole range of work is going on across many different types of cancer, which we regard as a priority.
Mental Health: Parity of Esteem
Lord Winston Excerpts(10 years, 3 months ago)
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Earl Howe
My Lords, we are investing £54 million over the four-year period from 2011 to 2015 in the Children and Young People’s Improving Access to Psychological Therapies, CYP IAPT, programme. That, along with the measures that I referred to earlier, will, I hope, give a sense of the priority that we attach to children and young people’s mental health services.
Lord Winston (Lab)
My Lords, the Minister gave us a long list of things that the Government are doing. However, he does not mention research into mental health. Is not one of the key problems that clinicians are never able to identify the disease phenotype, and that makes further and better treatments impossible? Should there not be much more emphasis on the need to research mental ill health throughout the country?
Healthcare Professions: Regulation
Lord Winston Excerpts(10 years, 3 months ago)
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Earl Howe
My Lords, I have already said that we will introduce a Section 60 order amending the powers of the GMC, as it has requested and as we agree should happen. There is a range of changes that we hope to incorporate in that Section 60 order and I hope to have further news on that quite soon.
Lord Winston (Lab)
My Lords, I draw the Minister’s attention to the regulation provided by the Human Fertilisation and Embryology Authority, which is allowing entirely unvalidated experimental treatments, such as pre-implantation genetic screening, for patients who then have to pay to experiment on themselves. Many clinics are also advertising on the Underground and some have relationships to do work that is not allowed by British regulation in other clinics overseas. Is the noble Earl prepared to respond to that really burning issue and the exploitation of infertile women?
NHS: London
Lord Winston Excerpts(10 years, 11 months ago)
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Earl Howe
My noble friend, with her experience, asks some very pertinent questions. On the question of timescale, we believe that it will take between three and five years for the proposals to be actioned to their fullest extent. It will be necessary to take that kind of time. Some elements can happen relatively quickly, but my noble friend is absolutely right that there are important workforce issues to be taken into account. Indeed, one of the IRP recommendations was that the NHS should review its workforce programme and ensure that it has the means in place to deliver what is required. I am sure that in working through the proposals, local commissioners, as well as NHS England, will need to satisfy themselves on that point—not least with regard to the new posts to be created in the community, but also in terms of accident and emergency consultants in the A&E departments of the relevant trusts. On local communities, again I agree with my noble friend. As the Shaping a Healthier Future proposals are developed by the clinical commissioners, it will be vital that any further proposals are consulted on locally, and that there is real buy-in from patient groups and the public generally.
Lord Winston (Lab)
I declare an interest as a member of Imperial College London and a practitioner who has been a consultant in north London for a long time. It is right that the financial shortfall means that there has to be considerable reconfiguration. In this case that is a move in the right direction. However, it raises a number of questions to which I would be very grateful if the Minister would respond. One is that if you close casualty you affect the training of surgical trainees. Do the Government have a view on that issue?
The Minister also referred to obstetrics in west London. As he will almost certainly know, the neonatal paediatrics department at one of the best obstetric hospitals in the country—Queen Charlotte’s, based at Hammersmith Hospital—has always been somewhat threatened. Is that secure, given that one of the issues in north-west London is undoubtedly that of duplication in many hospitals, which is expensive? Does the Minister feel that this is the only reconfiguration that will be required, given the amount of duplication that there is?
Earl Howe
To answer the last point, it is clear from the IRP report that its authors believe that this is a comprehensive set of proposals which will stand the test of time in north-west London. It is a very thorough set of proposals which takes into account every aspect of healthcare provision. On maternity and paediatrics, I can tell the noble Lord that under these proposals there will be more obstetric consultants on duty 24/7 in labour wards. As he will know better than anyone, that, of course, is designed to reduce the number of complications during birth and to ensure one-to-one midwifery care for women during labour. Consultants in other specialties such as paediatrics will be on duty, as I mentioned, for 12 to 16 hours a day, seven days a week, providing much better cover than at present.
It was very striking in the IRP report that the first point made by the noble Lord, Lord Winston, did not elude the panel. The panel concluded that the pragmatic and explicit approach used by the NHS reflected the clarity of the aim to improve quality outcomes by implementing life-saving standards through the establishment of major hospitals. The report referred to the economic realities of the NHS and the urgency of making progress in the light of known risks to the sustainability of emergency services such as the abilities of staff, A&E and emergency surgery rotas, and the desire to minimise the negative impact on access of concentrating services. That was shorthand—as the noble Lord will see if he reads the rest of the report—for saying that the desirability of concentrating expertise in centres of excellence is a clear imperative for the quality of care that patients receive. As regards surgical experience, I think that if my noble friend Lord Ribeiro were here, he would confirm that that is absolutely the direction of travel, but that we must ensure that surgical expertise is built on a sufficient number of hours and cases for the quality of care to be maintained. That is exactly what underlies this whole set of proposals.
NHS: Health and Social Care Act 2012
Lord Winston Excerpts(10 years, 11 months ago)
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Earl Howe
My Lords, commissioners do not have to use competitive tendering for all services. First, acute elective care—which represents the vast majority of NHS services—is not secured through competitive tendering at all, and that will continue to be the case. Secondly, a single-tender action may be justified on the basis that there is only one provider able to meet the clinical quality and safety standards that the commissioner requires. There will be guidance coming out on that, and draft guidance has already been published. Any confusion that exists among commissioners should be clarified by that means.
Lord Winston (Lab)
My Lords, would it be fair to say that the noble Earl is somewhat between Scylla and Charybdis on this issue? On the one hand tendering is certainly more expensive but, on the other, if tendering does not take place, is there not a real risk that services will be offered at the price that the market will bear rather than the one that it really costs the health service? The health service has not always managed to cost out its treatments effectively.
Earl Howe
The noble Lord makes a good point. There is, I think, a desire on everybody’s part not to see competition result in a race to the bottom on price. That is why we have specified that commissioners must make clear what standards they expect and apply those consistently to whoever is tendering for the service in question at a price which reflects a fair value. We believe that the current rules protect the NHS but also protect those bidding. I emphasise that competition will not be pursued as an end in itself; it will be pursued as a means to drive up quality.
Care Bill [HL]
Lord Winston Excerpts(11 years, 3 months ago)
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Lord Warner
My Lords, I rise because I gave an assurance to the noble Lord, Lord Willis, that I would speak on this amendment as I have form, as they say, in this area.
Ten or so years ago, when one person accused me of being rather like Vlad the Impaler and we were slaughtering, as well as merging, a number of quangos, two of the candidates for merger were the Human Tissue Authority and the HFEA. Much of the argument for doing that was very similar to the argument that the noble Lord, Lord Patel, has advanced, although I did not know as much then as I know now about the number of bodies that we had compared with other countries regulating in this area. However, I assure the Committee that we had a lot more in 2003-04. Therefore, there is a case for this merger, and it has been made.
By backing away from this merger in the face of the arguments that were put forward, I ceased to be Vlad the Impaler and became Warner the Wimp. To their credit, this Government decided to have another go, but they seemed to get themselves in roughly the same position as Warner the Wimp and withdrew. Really, they withdrew because at the end of the day the savings were—certainly so far as I was concerned—not significant compared with some of the other savings that could be made. However, we have grown to appreciate more the importance of health research and the role of the life sciences in our economy, and I think that there is still a case for going the extra mile, when you can, to streamline the regulatory system in this area.
I hope that the Government will look sympathetically on this amendment, even if they do not want to accept it in its present form. I hope that some of us speaking out on this in the review will give the Government some courage to be a bit braver than they were, and than I was, in the past. Therefore, I support the spirit and the ideas behind this amendment.
Lord Winston
My Lords, I fear that I have to support the noble Lord, Lord Patel, on this amendment, even though I do not think it goes far enough. In my view, the case for having a Human Fertilisation and Embryology Authority at all is now quite dubious. It is 20 years or more since this treatment was established. There is no longer public anxiety about it, as there was in 1990, when the Act was introduced. It is now a regular treatment. As long as this treatment is licensed in this way, it will look like a maverick treatment to people—something extra, outside the health service.
One issue is that, sadly, these treatments are affordable only in private practice. Of course, the health service has done a good deal towards trying to supply them, but as the noble Earl knows, there are many examples where people pay very large sums in the private sector for these treatments and they are not and cannot be regulated. If one was really going to be serious about regulating in vitro fertilisation, the first thing that would be needed to prevent couples being exploited would be to find a way to reduce the massive burden of cost, which is out of proportion to the actual expense of the treatment. That is really something that needs to be looked at.
Sadly, the HFEA has not performed particularly well in the areas of research. I would like to recount briefly as an example the last licensed inspection of my own laboratory where we conduct experiments on embryos where there is no possibility of those embryos being transferred to a human patient. They are of course effectively dying in culture. It is extraordinary how stringent the last inspection was with regard to the quality of our laboratory. Why our laboratory should be seen to be more up to a particular standard than others doing cell culture work was beyond my comprehension given the fact that these cells, under no circumstances, could be used for human treatment: they were simply to investigate a phenomenon.
I could not help wondering whether in fact that particular inspection committee was being vituperative, because it had heard me speak against the HFEA at a previous debate in the House of Lords. I have no idea about that. But certainly, given that the previous year we had had a gold standard approval for our methods, I have to say that the inspection process is a patchy one. The problem really is that, currently, the HFEA licenses treatments that are practically research procedures that have not been validated and which are being charged to patients.
There are many examples of anomalies that are worrying. The noble Earl may have seen this week a full-page advertisement for egg sharing at a London private clinic. Incidentally, that clinic has been run by a member of the HFEA. One cannot help but feel that this is a shocking conflict of interest given that egg sharing is somewhat difficult to justify in certain circumstances as poor women may be persuaded to give their eggs under situations that are perhaps not ideal for them. They may in fact end up with someone else getting treatment at their mental expense—not their physical expense because they get a free treatment—and then 20 years later finding a child they do not even know about trying to trace them because of the information shown on our birth certificates. That anomaly has never been worked out.
I am really very surprised, too, that no serious attempt has been made to bar clinics that seek to send patients overseas for treatments that are not allowed in this country. There are many examples where patients are sent for various treatments where they might receive more than two embryos at a treatment, which would be against the regulations in this country, but they can come back and give birth to their triplets on the National Health Service. Clearly, that is an anomaly.
While I have absolutely no axe to grind about good private practice, there is no question that sometimes there are issues where clinics advertise wares that are unjustified. That happened two weeks ago when a clinic announced that it now had a treatment that could improve the success rate threefold. Of course, if I as a medical practitioner said that to the press, I could be held in front of the General Medical Council for advertising. But a clinic can get away with that kind of approach if it is not actually being mentioned by a medical practitioner.
The real reason for wanting to see at least some slimming down—we may need to come back to this at the Report stage to see exactly what clauses would be eliminated; it is difficult to see the whole of this rather large amendment now—is that at some stage in the near future we should revisit the Act of Parliament to see what would be best for purpose. In the mean time, however, there is a great deal of force in agreeing to slim down the number of regulatory authorities. As everyone across the House knows, regenerative medicine is one of the great opportunities for British medicine. At the moment, one may have to apply to up to 10 different regulatory authorities to get full licensing for the sorts of procedures one might want to follow for research, particularly where animal research may have to be done in parallel. That seems to be a very inhibitory process and there is evidence that it is preventing many bright people going into this research. They need to launch their PhD projects in other ways as quickly as possible.
While the amendment of the noble Lord, Lord Patel, is not perfect, slimming it down like this is a good start and an opportunity. I am also delighted to hear that the noble Lord, Lord Willis, who would have moved this amendment with the noble Lord, Lord Patel, is on the mend. That is good news about an outstanding parliamentarian. If the amendment were to be pressed, I would wish to vote for it.
Care Bill [HL]
Lord Winston Excerpts(11 years, 3 months ago)
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Lord Winston
My Lords, I entered the Chamber expecting to speak not to this amendment but, as the Minister may recognise, on the issue of human fertilisation. However, I am feeling drawn into the argument. I find it difficult to agree with my noble friends on this side of the House. The wording of the amendment would not really fulfil the laudable purpose set out by my noble friends. There are many examples where this information would be very important. The case of Seroxat is a fine example of where there was a real need to have better regulation of the negative results of a drug trial.
There are many examples where the negative effects of a drug trial may not be of relevance in the same sort of way. In the area of reproductive medicine, for example, clomiphene citrate was first given as a contraceptive. The surprise was that people got pregnant on it, so the drug was shelved as a contraceptive. A great deal later, however, a drug company suddenly recognised that it had something that might stimulate pregnancy in women who had been infertile. The problem is that a drug company sponsors, pays for and organises research, so to some extent it has a commercial value in that research. We have to strike a very careful balance between when there is an important commercial angle which requires proper legislation and, equally, when there is a chance for drug companies to do a good job—as they did eventually with clomiphene citrate when it was launched as one of the most successful drugs in my area of medicine.
With all due respect to my noble friend Lord Warner, that makes the wording of this amendment difficult. I do not think that frank and fair reporting of a drug trial would be sufficient to meet the needs of what he is arguing in this case.
Lord Warner
Perhaps I may respond to my noble friend. I was arguing the case on behalf of the Joint Committee as much as anything else. The committee heard a lot of evidence on this, and across the parties, and across the Commons and the Lords, the conclusions were drawn up in its report to the Government.
I say to my noble friend that most of these clinical trials look at a product which is being tried for a particular purpose. If that product happens to fulfil some other purpose, a different set of issues arises. Seroxat was actually trialled as an anti-depressant, but it failed that test in so far as it was applied in a dangerous way to juveniles. The information about it failing that test was concealed from the public and the regulator. My wording might not be perfect but I am not arguing for my wording. I am trying to get the Government to engage with the issue so that they can find a wording that meets my concerns—and, I suspect, those of my noble friend Lord Turnberg—in the way that the Joint Committee proposed, to engage the HRA in ensuring proper transparency when there are downsides to research. That is in no way stopping a pharmaceutical company from using a drug or trialling a drug for a different set of purposes from that for which it was originally constructed.
Homeopathy
Lord Winston Excerpts(11 years, 6 months ago)
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Earl Howe
My Lords, we have been consistently clear that no treatments should be arbitrarily rationed on cost grounds. The NHS constitution sets out that patients have a right to expect local decisions on the funding of drugs and treatments to be made rationally following a proper consideration of the evidence. More importantly in this context, it is the responsibility of the NHS to make decisions about commissioning and funding of healthcare treatments and not for Ministers to second-guess that process.
Lord Winston
My Lords, perhaps I may be permitted to help the Minister. Many years ago, there was a very interesting study in Wales of a placebo-controlled trial that showed that, whatever was given, the best chance of a treatment working, placebo or not, was whether the doctor who was giving the medicine actually believed in it. Does the same apply for homeopathy and the Secretary of State?