Medical Innovation Bill [HL]

Lord Winston Excerpts

Friday 24th October 2014 Lords Chamber

Further, I would mention Amendment 22 which seeks to protect the interests of doctors by making it clear in the Bill that the doctor has no duty to institute an innovative treatment when he or she does not consider it to be in the best interests of the patient. The noble Lord, Lord Saatchi, said that this is covered by existing law. No doubt it is, but if the Bill is designed to provide clarity for doctors as well as patients, it needs to address this point.

[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.

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[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.

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[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.

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Moved by

[Lord Winston]

6: Clause 1, page 1, line 3, at end insert—
“( ) 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.

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[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.

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We have heard that my noble friend the Minister has difficulties with a new statutory duty. He has expressed his view very clearly. He may be able to persuade the noble Lord, Lord Hunt, the noble Baroness, Lady Wheeler, and your Lordships generally that this amendment is, as he says, unnecessary. I greatly support what the authors of this amendment are trying to do. It is clear to us all that the important thing about Amendment 28 is that it shows that all sides of this House are united in seeking to use the Bill as an opportunity to drive medical innovation forward in a safe and responsible way.

[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.

Amendment 6 withdrawn.

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[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?

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[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.