Medical Innovation Bill [HL]
Lord Winston Excerpts(10 years ago)
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Lord Winston
“( ) The provisions of this Act shall not apply where a doctor, in the pursuit of a treatment, is required to take action where time or place does not allow the required consultation.”
Lord Winston (Lab)
My Lords, in moving Amendment 1, I wish to speak also to Amendment 6. The Bill states that for the purposes of taking a responsible decision to depart from existing treatment, a doctor must,
“obtain the views of one or more … qualified doctors in relation to the proposed treatment”,
and there are a number of other issues related to that. It is very clear that it is not always possible for a doctor to do this. For example, in Committee, the noble Lord, Lord Turnberg, mentioned the case of a patient on an aircraft who had a pneumothorax. That was dealt with in a way which could not possibly have involved consultation beforehand: it was a completely unexpected event. Indeed, in my view, that would apply to any emergency treatment where there is no time to undertake consultation or the doctor is not in a place where he can consult others—for example, if he is at a bus stop, in the outer islands of the Hebrides or various other such places. That would be extremely muddling for a doctor and would increase difficulties in trying to understand the appropriate thing to do under those circumstances.
Previously, I gave the example of the unconscious patient that I dealt with when I clamped off an ectopic pregnancy without an anaesthetic because my anaesthetist refused to give an anaesthetic to the patient because he felt that she might die and he did not want to be responsible for that. That is a good example of where you can have a conflict of interest or a conflict of opinions with doctors in an emergency situation. I took the view that the anaesthetist was wrong. I opened the patient’s abdomen without an anaesthetic, immediately clamped off the bleeding point and her blood pressure became recordable. She was already, of course, having a rapid blood transfusion but the blood loss inside her abdomen was so great that her blood pressure was unrecordable until that artery was clamped. Once it had been clamped, my anaesthetist admitted that the patient needed an anaesthetic and he intubated the patient. It would be very difficult for a doctor who was cognisant of the terms of the Bill to do that.
In the case of a neonate, there is the real issue, of course, that from time to time you have fractions of a minute in which to deal with an emergency. I say to the noble Lord, Lord Saatchi, that if this Bill goes through he may have a number of brain damaged children on his conscience because of the need to give oxygen to a child in emergency circumstances using unusual procedures, perhaps when it is being delivered. Each of us has undertaken the most dangerous journey that all humans take—the four and a half inches down the birth canal. To this day, that still results in a large number of children being damaged. Indeed, in this country the commonest problem leading to babies dying or being damaged is brain damage at birth. I say to the Government that it is also a grave source of litigation. Indeed, it costs the National Health Service a large sum of money. If there is doubt about how to handle this situation in an emergency and a doctor is confused, there is a very grave risk that this could interfere with his better judgment. As I pointed out to the noble Lord, Lord Kakkar, it also applies to certain surgical procedures where there are anatomical abnormalities that require innovation—in particular, when dealing with unexpected haemorrhage.
I remember an amazing occasion when I was in training with a surgeon who had removed a kidney. He was a real surgeon, dealing with bleeding in the pelvis. He asked me, “What’s the most important instrument in the operating theatre?”. I had no idea what he was talking about. He pointed to the surgeon’s stool. He said, “That stool needs to be five metres away from the operating table and you go and sit on it”. That is not in the textbooks, but what he had done was put a pack into those bleeding vessels, leave it there, and he did not fiddle. He was, therefore, not actively involved in the consequences. That innovation by the late Dr Magri, who was my amazing teacher, helped me to understand how one could deal with haemorrhage in the pelvis, which for a gynaecologist is an important point. Therefore, I would argue that my Amendment 1 will allow a surgeon in particular, but other practitioners in general, to conduct required treatments without considering the measures proposed in the Bill, if it becomes an Act of Parliament.
Rather than detain the House for too long, I now turn to my Amendment 6. It was briefly dealt with in Committee in relation to the use of drugs. Unfortunately, we did not discuss it in any great detail. However, noble Lords will see that it is necessary—indeed, I think it is essential—to define what we mean by an innovative treatment. Innovation can mean a whole lot of different things to different people. This is not in any way a wrecking amendment. It is designed to clarify the Bill and make it rather more workable and safer. We will come back to patient safety later.
It seems to me that there are four areas where one can define innovation. The first is a medical treatment where there has not been any peer-review evidence for the benefit of that treatment or a clinical trial. In the debate on that issue, the noble Baroness, Lady O’Neill, pointed out that randomised control trials were not the only method of dealing with medical evidence—and she is, of course, absolutely right. She is the most brilliant individual and I bow to the point she made. None the less, she did not say in her argument that we should not have evidence based on some form of proper clinical appraisal. That is an important aspect.
Baroness Gardner of Parkes (Con)
My Lords, I do not really understand the proceedings, in so far as the noble Lord, Lord Winston, spoke only to two of his amendments. These are all grouped together. I have just consulted with the clerk, but they should really have all been covered. I do not know whether he intends to find some way of coming back to it, but I thought we could speak only once on these things on Report. I am particularly interested in the exact meaning of his Amendment 13. I seek information on this as I read it: would Amendment 13 possibly prevent people using new innovative stem cell treatments, for example? What is the intention of Amendment 13? As he did not speak to either Amendment 12 or Amendment 13, I feel that the House should be informed as to what he means by those amendments, as this is the only opportunity to discuss the group that has been put together.
Lord Winston
Before the noble Baroness sits down, I wanted, for clarity, to speak to two amendments at a time. I will speak to Amendment 13 in due course and say exactly what I meant. If the noble Baroness wishes me to speak to those amendments now I will do so.
Baroness Garden of Frognal (LD)
To clarify for the noble Lord, the amendments are grouped together, so he is required to speak to them in the group. He will, of course, have the right to come back at the end of the group and he may wish to include them at the end.
Lord Winston
I am very happy to speak to those amendments now. They are very simple. The question of the dental practitioner is simply that dental practitioners also are involved in maxillofacial surgery and other treatments that may require innovation. With regard to other practitioners who are not medically registered, we are going to require more and more nurses and other workers with university qualifications who will be conducting treatments, and it is therefore important that we clarify whether they will be able to innovate.
Baroness Garden of Frognal
I must point out to the noble Lord that it is not in order for him to speak twice to a group of amendments at Report stage.
Baroness Garden of Frognal (LD)
My Lords, I notice that the noble Baroness, Lady Wheeler, has spoken to the amendments which the noble Lord, Lord Winston, did not speak to. I will seek advice from the Clerk as to whether the noble Lord may wish to degroup the amendments to which he did not speak. I think that that would be up to the noble Lord. For the convenience of the House it might be clearer if he degrouped the amendments to which he did not speak. Does the noble Lord, Lord Winston, wish to do that?
Lord Winston
It is very kind of the Front Bench to offer that possibility. If I were to degroup an amendment, I would degroup the stem cell one and put it with Amendment 5, as it would fit better with patient safety. One of my difficulties is that the groupings are slightly odd in terms of the relevance of the different aspects of my amendments.
Lord Mackay of Clashfern
My understanding of the groupings system is that those who have views on the amendments should take the opportunity to speak when the relevant group is first dealt with, but it does not preclude a noble Lord who has tabled an amendment speaking when the amendment is called in the ordinary course of events. As your Lordships know, following a debate an amendment is often called as being not moved, but the person who tabled the amendment has the option to move it at that point. Therefore, in that sense there are two opportunities to speak. However, in order to try to make the procedure as economical as possible, the general idea of the groupings system is to enable a group of amendments to be considered as a whole on the basis that, rightly or wrongly, such consideration is facilitated in that way.
Lord Saatchi
I am sure that that will be done. I will return to Amendment 13 when I respond to a later group.
Amendment 14 relates to the preservation of the Bolam test, an extremely important point. The amendment is in my name and deals with the fact that concern was expressed in Committee about whether in emergency situations, as we discussed earlier, doctors will realise that they are not expected to follow the procedures set out in the Bill—the point made by the noble Lord, Lord Winston. Amendment 14 accordingly introduces a reference to “emergency” and makes it expressly clear that a doctor treating an emergency can and should rely on the existing law. The amendment would achieve this by giving emergencies as an express example of a situation in which the existing common-law Bolam test would apply and a doctor might not engage in the procedures of this Bill.
Amendment 15, again in my name, is a most important amendment in relation to the preservation of the general Bolam test. It deals with the principle that the Bill does not force doctors or require them to rely on its procedures, and they can simply rely on the existing Bolam test in all cases. It recasts the proposition to meet concerns expressed as to whether the intention of existing Clause 2(2)(a) was sufficiently clear. I shall return to Amendment 13 on a later group.
Lord Winston
My Lords, I apologise for my infelicity in getting the groupings wrong. I am very grateful to the Front Bench for making their proposal, which is very helpful.
I realise that I have been in your Lordships’ House since 1995 and this is the first time that I have ever proposed amendments at a Report stage. I should have learnt by now how to handle a Report stage, but I have to admit that, due partly to inexperience and partly to lack of attention to your Lordships during other Report stages of different Bills, I do not. Be that as it may, I shall not go on for long.
I was pleased to hear a degree of support for my Amendment 1, about emergencies, because I think that that approach is necessary. If the noble Lord, Lord Saatchi, is prepared to talk to me about that and see what we might do perhaps at Third Reading, I would be very happy to see how we might get more effective wording for some of these ambiguous areas in the Bill.
I am disappointed that we are not defining “innovation”. That is important because, clearly, these are issues which doctors will need to consider. It is clear from a large number of responses from doctors that there is very considerable confusion about the Bill. What is extraordinary is the number of bodies that show this confusion and say how right doctors are to be confused. Although the Royal College of Ophthalmologists is apparently worried about a particular drug—I bow to the knowledge of the noble Lord, Lord Saatchi, about this; I did not know that it was—the list of concerned bodies includes the Academy of Medical Sciences, of which I have the honour to be a fellow, the Academy for Healthcare Science, the Medical Research Council, the Wellcome Trust, the British Medical Association, the Royal College of Physicians, of which I am also a fellow and therefore I have an interest, the Royal College of General Practitioners, the Royal College of Radiologists, the Royal College of Psychiatrists, the Royal College of Surgeons of Edinburgh and, to some extent, the Royal College of Surgeons of England, the Association of Medical Research Charities, Action Against Medical Accidents, the Medical Defence Union and the Medical Protection Society. I know that it has been suggested, rather irrationally, that somehow the lawyers want to leave things as they are so that they can make more money but, in fact, the Medical Defence Union and the Medical Protection Society are most involved in litigation and they clearly want a reduction in litigation, which is why they are not in favour of the Bill.
Also concerned about the Bill are the British Pharmacological Society, the NHS Health Research Authority and the NHS Litigation Authority—I checked its website this morning to confirm that—Healthwatch and, rather importantly, Cancer Research UK, which raises about £700 million a year for the treatment of cancer in this country. Also concerned are the Motor Neurone Disease Association and, to some extent, the National Institute for Health and Care Excellence. They are mostly concerned about the confusion to doctors, but some would go further than that. They say that the Bill is unnecessary and, as I shall seek to explain, may endanger patient safety.
The reason why I tabled the two amendments about medical practitioners is that it is fair to say that, in future, the National Health Service will have to rely more and more on people who are graduates other than medical graduates. Therefore, the Bill should recognise that they will sometimes need to innovate. It may be worth clarifying their position at this stage.
For the moment, I will not divide the House on Amendment 1, but I would very much value further discussion with the noble Lord, Lord Saatchi.
Baroness Manzoor (LD)
My Lords, before the noble Lord sits down, will there be any consideration of the nursing profession and others to be included when he is thinking of medical practitioners who are not qualified?
Lord Winston
I personally think that that is very important. That is why I tabled the amendment, because I wanted discussion on the issue—in particular, for health visitors and more senior nurses, whose position means that they often have to be innovative. The real issue here concerns midwives, because midwives—particularly district midwives, when they do not have a medical practitioner with them—are often presented with horrendous situations where they have to act innovatively. We hear from the Department of Health that it would like to extend home delivery. That may be a very good thing—I do not know; although I am a qualified obstetrician, I have concerns about that—but if that extension happens, as seems likely given that the health service is strapped for income, it is important to consider other health professionals who may be confronted with those problems. At the moment, the Bill does not do that, and I think that that will cause problems in future.
Lord Saatchi
My Lords, on behalf of our team and, I am sure, that of my noble friend and the Department of Health, I greatly welcome and would appreciate the opportunity to discuss the points that he has made between now and Third Reading.
Lord Winston
“( ) This Act shall not apply where the body of responsible medical opinion considers that the innovative treatment being considered is likely seriously or unreasonably to compromise patient safety.”
Lord Winston
In another place on Tuesday evening, there was an Adjournment debate moved by the honourable Member for Totnes, who is a qualified medical practitioner. In her outstanding speech, she raised serious concerns about the issue of patient safety. In particular, she cited her concern that patients, particularly those with cancer, may be at serious risk from quack practitioners who are offering a quick-fix solution for money rather than a course of authentic treatment, and possibly entering a clinical trial. The effect of this on cancer treatment could be disastrous. First, not only might we end up endangering patients by their entering a treatment that is not valid or appropriate. Secondly, research may be inhibited because we cannot fill the clinical trials needed to prove that cancer drugs are effective.
We are now in the age of genomic medicine. Genomic medicine means, more and more, that each cancer is different. Essentially, we are understanding that there are more and more mutations. As each of us in this Chamber gets older, we develop more and more mutations, so we are more liable to get different cancers in different cells. Of course, there are the common ones, but it is worth bearing in mind that more than 50% of cancers are actually quite rare. It is important to understand that each individual rare cancer makes a massive difference to life expectancy and health in Britain. Indeed, about one-third of us in this Chamber will suffer with a cancer and, on the figure I just quoted, roughly half of those will be rare cancers.
We are beginning to understand that each of these cancers can be targeted with a specific genomic medicine which may apply only to that cancer. A classic example was the case of vemurafenib, which was used for a rather unusual form of skin cancer and resulted in metastases massively drying up—but it would not work for other cancers, because the mutations were different.
It is imperative, as Cancer Research UK clearly says, that we get patients who are able to go into trials. Apart from the fact that it would be disastrous for the safety of the patients who are being treated irrationally by illogical treatments, there is also a question of patient safety generically for our entire British population. That is the purpose of the amendment.
I have focused on one area in my Amendment 13, which is the use of cells and tissues that are biologically derived. The reason I included that is because stem cells will clearly be an important use in future. Already, we are seeing practitioners setting up quack medicine which is not proven, where they are injecting cells into patients without proper validation. That is clearly dangerous. It is being used for dementia, some forms of motor neurone disorders and other neurological disorders, such as disseminated sclerosis. A number of cancer patients have also had these horrendous treatments. That is likely to burgeon, so it must be taken very seriously by the House.
We have to be absolutely clear that whatever we do, we do not endanger patient safety. There are some interesting examples in the history of medicine. The noble Lord, Lord Walton, who comes from Newcastle, told me yesterday that he is hugely against the Bill. He is very concerned that it will damage patient safety, but for health reasons—as your Lordships know, he is now 92—he felt unable to come down from Newcastle today. He reminded me of a case which I knew of way back in the 1950s. In Oxford, where he came from at that time, there was a Dr Honor Smith. Dr Smith thought that the injection of tuberculin into the spinal cord of patients with neurological disorders—in particular, with disseminated sclerosis—might alleviate their condition. In fact, it did not.
Baroness Garden of Frognal
My Lords, I apologise for intervening, but is the noble Lord now speaking to Amendment 13 as well? Is he speaking to Amendment 13 in this group?
Baroness Garden of Frognal
No, no. We are in the second group. The noble Lord is moving Amendment 2 in the second group, but he seems to be speaking also to Amendment 13 in this group. Is that correct? If it is, then other noble Lords will want to respond to Amendment 13 as well. Perhaps the noble Lord could clarify which amendments he intends to speak to in this group.
Lord Winston
I am sorry. At the moment, I am speaking to Amendment 2 on the question of endangering patient safety, but of course the injection of stem cells is also relevant to patient safety, for the reasons that I stated. Let me continue with patient safety—or am I out of order?
Lord Cormack (Con)
May I try to help the noble Lord? He did refer to Amendment 13, because it had been suggested earlier that it would fall more happily into this group—so it seems to me that he is conforming to that suggestion.
Baroness Farrington of Ribbleton
My Lords, if it may help my noble friend, the noble and learned Lord, Lord Mackay of Clashfern, referred to the fact that my noble friend could speak to Amendment 13 in its place on the Marshalled List. Therefore we cannot reach Amendment 13 until we have gone through the others.
Lord Winston
I am now totally confused but, if I may say so with great politeness, it sounds as if I may not be the only person in the House who is confused. The key thing here, which applies to both these amendments, is the question of patient safety. Amendment 2 argues that wherever “responsible medical opinion” regards that patient safety might be compromised, that needs to be considered in the Bill. That is an important issue and would certainly include the use of stem cells in particular, for the reasons that I have stated.
I was going to refer to a few medical examples where in fact innovations have been done without proper scrutiny. For example, Dr Smith felt that she could inject tuberculin into the spinal cord; the result was in fact disastrous for those patients. The noble Lord, Lord Walton, thought that this was a very good example. What was reported was that the tuberculin recipient had constitutional illness with meningitis, more alarming complications from their nervous system, vomiting, retention of urine, dysphagia, dysarthria, and a whole range of other symptoms which were actually made worse. It was a scandal at the time and a very good example of where, if you have innovation which is not properly controlled, there is serious risk.
I found it quite amusing, by the way, that the lady at Oxford, Dr Honor Smith, was the daughter of a Member of this House. She was the daughter of a Baron—so, technically, she was the honourable Honor Smith. However, I do not think that she ever used that title.
This came up again in the House of Lords later on when the noble Lord, Lord Brabazon, supported a quack treatment in 1995 of a Dr William Crofton, which was also for neurological disorders and used something rather similar. One of the problems was that people with these neurological disorders, which as we know are terrifying and untreatable, flock to practitioners in the hope that they may have an unsuccessful condition successfully treated. That is still a real issue for us all in this House.
In response to the honourable Sarah Wollaston, the Member for Totnes, in the other place this week, the Under-Secretary of State for Life Sciences at BIS, who was replying on behalf of the Government, mentioned that the Government were determined—let me get the exact quotation for the record, if I can find it in Hansard. In answer to the debate on this Bill, he said:
“I reassure the House that the Government are committed in all this work to putting patient safety first and developing a landscape of evidence-based medicine”.—[Official Report, Commons, 9/12/14; col. 850.]
I suggest to your Lordships that the Bill does the reverse. It tends to risk patient safety in certain cases where patients are desperate for a treatment. It will also reduce the chance of evidence-based medicine.
I thought about this long and hard last night. I must tell the noble Lord, Lord Saatchi, that I did not sleep last night. I woke at about 1 am, having gone to bed at 12.30 am, and could not sleep for thinking about the Bill. I understand that he has been extraordinarily courteous and very gentle in introducing the Bill. He has also been very helpful in trying to ensure that the Bill is as safe as possible and very good at listening to our concerns. I understand, too, that he has had a great tragedy that has made him feel very strongly about this issue. I fully understand and deeply respect that, and I wanted to tell him something about myself, which he may not know.
When I was not yet nine, my wonderful, amazing, chess-playing, musical instrument-playing, polymath craftsman father died. He had a minor infection that was treated by an innovative antibiotic which was quite inadequate. He then had an innovative removal of a chest drain too early, so that he developed an abscess in the pleural cavity. Finally, within six months he had an innovative operation, which was not evidence-based, in which his brain was opened and an abscess removed. This man of 42 died, leaving my mother desperate and financially destitute. I was the eldest of three children; I had a sister aged four and a brother aged three. My mother was amazingly in love with my father, so I know something of the tragedy of seeing what happens when somebody is destroyed in front of you. I do not take this as an issue that leads me to oppose the Bill—that is not the case at all—but I am very concerned that we should not use innovation where we might compromise patient safety.
One of my concerns is that we often think of the National Health Service as a football. I take strong objection to my own side when it says that it is the only side that wants to support and protect the health service. That is nonsense; we all want to protect the health service and to see a health service that is efficient. Unfortunately—and I say “unfortunately” because I mean it—at the next election, I know that the health service is bound to be something of a political football. These issues are going to come up and therefore I want to make certain that we have the chance to innovate in a responsible way. Ultimately, I am not convinced by the arguments that the noble Lord, Lord Saatchi, has put forward. There are cases where treatment that is authentic and should be offered will be compromised in response to patients who are so desperate that they are prepared to try anything which has not been fully, or even partially, tested. For that reason, I beg to move Amendment 2—and I have spoken also to Amendment 13.
Baroness Gardner of Parkes
My Lords, I was particularly keen to hear the explanation of this amendment because the more I read it, the less I understood it. I would appreciate clarification from the noble Lord because I did not, and still do not, understand whether by putting this clause in on this sort of thing, we might be preventing treatment for that man who has just walked in Poland and the people who can suddenly see again because of the treatments for their eyes. If we tend to bottle this up completely, it would mean that all the marvellous advances which have changed people’s lives completely might be slowed down by this amendment. Now, if I am wrong in that, that is a different matter.
The noble Lord, Lord Winston, spoke very movingly about his own personal circumstances. However, where I disagree with him is when he talks about these desperate people who will try anything. That is one of the issues that the Bill is designed to help with. It covers only the cases of people who are already in a terminal condition. The one thing that many of these people do not have is any hope of progress, and in most cases they are willing—certainly in the cases requesting this sort of innovative treatment—to take the risk with what is only a very short piece of life remaining, in the hope that either the treatment might cure them or it might do something to advance research at a faster rate and therefore help other people in the future.
Reading this amendment, I was not clear whether it was pro-advance or anti-advance. As I say, I am still not clear. As it stands, I have grave doubts about supporting it; I think it would take away hope, which is about the last thing that remains for a lot of people.
Lord Winston
My Lords, first, let me thank the noble Lord, Lord Saatchi, for his gentle and helpful comments, which I am sure are appreciated not just by me but by the House in general. I felt great difficulty in talking personally on this issue and I debated with myself whether I should do so. I look forward to talking to the noble Lord about the amendments we have been discussing outside the House as soon as possible and I shall make arrangements to do so. I am at his disposal.
I am astonished by the Government’s response. It is not adequate for quite different reasons. It is nothing to do with the noble Lord, Lord Saatchi, but the noble Baroness, Lady Jolly, does not seem to understand that the regulatory framework we have does not encompass my objections. She mentioned, in particular, the Human Fertilisation and Embryology Authority—I have no doubt we will have this debate repeatedly over the next months—but perhaps she is not aware that two weekends ago I went to the Fertility Show at Olympia, where there were a number of stands of private clinics offering their wares to patients. Offered on their big posters are treatments which are illegal or not regulated in Britain, including, for example, sex selection and some cell treatments. Practitioners who are registered with the Human Fertilisation and Embryology Authority, some of whom will be involved with stem cells, are in relationships with clinics outside this country which are not under the jurisdiction or regulation of the Government. I am happy to name but I shall not do so in the House.
The Government must understand that regulation does not cover all these issues. There are many examples where experimental treatments are being carried out in this great city of London at huge expense. This week I have received two e-mails, one concerning a woman who spent £11,000 for a single treatment and another where a woman spent £69,000 for three treatments. These treatments were not validated but would be regarded as innovative. That is why I am concerned about this. I shall not divide the House.
Lord Kakkar (CB)
My Lords, I declare my interest as professor of surgery at University College London. I also support the amendment very strongly. It comes to the very heart of innovation and sharing the results of that innovation openly, whether they are negative or positive. Therefore, the register needs to be obligatory, in which all innovation and the outcome of that innovation is properly reported. It would do much to ensure the development of an enhanced culture of innovation, but also, fundamentally, to provide very important protections.
Lord Winston
My Lords, as far as patient safety is concerned, it is clear that there is a need to keep a record so that other patients do not receive a misguided innovative treatment following an unsuccessful one. That is very important.
Baroness Jolly
My Lords, Amendment 5, moved by the noble Lord, Lord Hunt, and supported by the noble Baronesses, Lady Wheeler and Lady Masham, and the noble Lord, Lord Turnberg, seeks to require the registration of innovations that are carried out under the Bill as part of the steps that a doctor should follow when taking a responsible decision to innovate. The Government have listened carefully to the concerns expressed by noble Lords and several key stakeholders, including the Royal College of Physicians, with regard to the collection of data resulting from innovation. We agree that it is vital that doctors are able to share learning about innovation that results from the Bill. However, we do not think that a requirement to record the results of innovative treatments should be included on the face of the Bill. Requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent, as Amendment 5 would require, would impose requirements that go beyond the current Bolam test of negligence. We are reluctant to impose requirements additional to those in the existing law as this may risk deterring doctors from innovating.
A stand-alone clause that would require doctors to register the results of innovative treatment would widen the scope of the Bill to cover all innovation. This Private Member’s Bill is not the right vehicle to make provision that would relate to all innovation. Broadening its scope in this way risks the Bill becoming the receptacle for a host of measures on innovation that are unrelated to the subject of clinical negligence. What is more, such an amendment may lead to confusion as doctors associate the Bill with clinical negligence and may therefore wrongly assume that the recording of innovation is tied in with the test of clinical negligence under the Bill. This additional burden may dissuade a doctor from innovating. It would be unclear to those doctors who choose not to innovate under the Bill whether they would be required to register the details of their innovation on the registry or whether the provision applies only to those innovating under the Bill. If the provision applied only to those innovating under the Bill, this would create an anomalous position for those acting under the Bill. More importantly, the act of putting something into legislation does not guarantee that doctors will adhere to it. We need to focus on incentivising doctors to use the registry and make such a registry work for their needs. It would be unwise to put something into legislation that does not work for doctors and that they would therefore not be able to adhere to.
I am sorry, but I have lost my place.
Assisted Dying Bill [HL]
Lord Winston Excerpts(10 years, 1 month ago)
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Lord Reid of Cardowan (Lab)
My Lords, I will probably make the shortest speech that I have made in this House, and your Lordships will no doubt be relieved about that. I am not a medic or a lawyer, nor have I put in the hours that many noble Lords have obviously put in on the details of this legislation. However, we should ask of this group of amendments: “What is the essence of the subject that we are addressing?”. Surely it is the essential question of whether a decision of this nature should be based on the free will of the patient and the expertise of the medical profession or whether we ought to go further than that, whether through legislation, via the amendments of the noble Lords, Lord Carlile and Lord Pannick, or whether through the suggestions of my noble friend Lord Campbell-Savours.
I have a view based on a very banal and simple old principle. Perhaps I may paraphrase one old philosopher who said, “Yes, men and women do have free will but they don’t exercise that free will in circumstances of their own choosing”. Surely what we are essentially asking is whether there should be an examination of the circumstances in which men and women operate their free will and make a decision. I believe that, on such a profound question, there should be, and I do not believe that the medical profession is adequately equipped to do that in all aspects of the circumstances.
Therefore, I say to those who are proposing and advocating this Bill: please do not believe that those of us who think that circumstances affect a decision that people make of their own free will are somehow opposing the principle behind the Bill. It is a safeguard that recognises an eternal reality.
Lord Deben
My Lords, I speak from a position in which I must declare an interest, although it is a surprising interest and your Lordships will wonder why I am declaring it. I am chairman of the Association of Professional Financial Advisers. I declare that because the organisation has at its heart a determination to make sure that, if you advise someone on finance, you should be on their side and there should be no question over which side you are on. It is quite difficult to fight that battle because people feel that they can do both: they feel that they can be on both sides perfectly reasonably. Of course, people outside do not feel that. They want to be absolutely sure that the person advising them has only one interest, which is them and their concerns. If that is true in finance, it ought to be true in matters of life and death.
For me, at the heart of this—and, with apologies to the noble Lord, Lord Winston, it is why I wanted to follow the noble Lord, Lord Reid—is ensuring that at no point, in the mind of the patient or in the minds of the patient’s friends and relations, should doctors be equivocal. That is just as important when a patient himself is making the decision to end his life quite decently and honourably as it is when there is pressure. If the patient is making that decision, his family and friends want to feel that it is a decision in which the doctor has not played a part, for the doctor ought to be, right to the last moment, concerned only with the nature of the illness, the palliative care that can be carried through and the way in which new techniques might be applied.
I hope that the noble Baroness who intervened earlier will accept that there are many of us who do not approach this from a prejudiced or religious point of view. As somebody who fought very hard for same-sex marriage, I can hardly be accused of always taking the view of the church to which I belong. I take this view after 40 years as a Member of Parliament or candidate. I have seen so many people in circumstances in which they begin to doubt the advice of their doctors. Although I have no connection at all with the medical profession, I care about it so much that I do not want it to be treated with less care than the Association of Professional Financial Advisers. It should be on one side and not on the other. That is why we must have an external decision-making principle.
I am not qualified to intervene in the discussion between lawyers about what would be best. I intervene partly because I do not think that lawyers should have it all their own way in any circumstances. I agree with the noble Lord, Lord Alton, and my noble friend Lord Cormack. We have to say to lawyers that this is a situation in which getting an answer that satisfies everybody is something that we lay people would like to see. Frankly, what lawyers have to do for us, as the noble Lord who spoke previously said, is to provide us with an answer in which we feel that the decision is made outwith the medical profession so that the medical profession can do what it is there for and can never be questioned.
I finish with a comment to my noble friend Lady Wheatcroft and the noble Baroness, Lady Blackstone. It is not possible to debate this whole issue or any of the amendments unless you recognise that there is a serious issue of pressure on individuals. I am afraid that after 40 years in Parliament, seeing people at the level that you do if you are a decent Member of Parliament, you discover man’s inhumanity to man is very much further advanced than the comfortable views of many people who do not get to that level. We have to protect people and this is an essential protection.
Lord Winston
My Lords, I was delighted to give way to the noble Lord, Lord Deben, because I agree with so much of what he has just said. I want to echo something that the noble Lord, Lord Alton, said. This is an extraordinarily important Bill, which goes to the heart of our society, and it is desperately important that the Government Front Bench and Members of this Committee allow full and adequate debate on it. If this House is to survive, flourish and be respected, it is very important that it debates these issues adequately and fully and takes as much time as is necessary. If we have to come back on another day to complete Committee, we should do so. It is essential that we understand that, no matter how inconvenient it might be to come back on another Friday.
I always find myself agreeing with the noble Lord, Lord Cormack, but I feel that there is a massive difference between this Bill and the Medical Innovation Bill, which is completely unnecessary. That is why it troubles me that we should be comparing the two Bills.
Very briefly—I shall not detain the House greatly—I want to say why I disagree with my noble friend Lord Campbell-Savours. I apologise to him for disagreeing. It is essential that we have something like the amendment in the name of the noble Lord, Lord Pannick, to protect our society. The reason for that is absolutely clear. It was raised to some extent by the noble Baroness, Lady Cumberlege, in her short speech. The issue, of course, is that in our hospitals we have increasing numbers of elderly people who come into hospital, a foreign environment, and find themselves distressed and not understanding what is happening, and are seen almost as demented; certainly, they will be people who are completely out of touch with what is happening to them and they will not understand. Therefore, it is essential that we have some kind of legal process that ensures that the Bill, if it is to succeed, is properly policed. That is essential. It cannot be left to members of the medical and nursing profession to make their minds up. For that reason, I absolutely support the amendment introduced by the noble Lord, Lord Pannick.
Lord Hunt of Kings Heath (Lab)
My Lords, it is not for the Opposition Front Bench to state an official view as to what action should be taken in relation to these sets of amendments. It is up to our own individual consciences to make our own minds up. However, it is an opportunity for me to say to the Government that it is important that we have sufficient time to debate this important Bill. I hope the government Chief Whip will take to heart the comments that have been expressed—by noble Lords who have different views but who certainly think that we should have further time to discuss this.
Although the noble Baronesses, Lady Wheatcroft and Lady Hollins, and my noble friend Lord Campbell-Savours expressed doubts about bringing the courts into this process, essentially these two sets of amendments, although they differ about the role of doctors, bring the courts into the process, and can be said to respond to the debate at Second Reading about the need for safeguards. Given that, I want to put two points to the Minister, which I hope he will be able to respond to.
The first is about the capacity of courts to deal with applications in a timely manner. The noble and learned Baroness, Lady Butler-Sloss, spoke from great experience and she was clear that the courts would be able to respond very rapidly. I think she said that they would be able to deal with the process in a matter of 24 hours. Of course, we do not know how many cases are likely to be brought. I hope the Minister will be able to say a little about how the Government would respond in relation to capacity in the courts if it were needed.
The second point I want to put to the Minister is about the financial support available to persons who would go to court under the process envisaged in either set of amendments. It surely must be open to everyone to be able to go to court without fear of the financial consequences. We know that legal aid has been heavily reduced in previous years. I ask the Minister to reassure us that if either set of amendments appeared in the Bill, and it was eventually enacted, that public funds would be available to allow people to go to the courts.
It is important that the Minister clarifies these points as clearly they have an important bearing on the attitude that noble Lords may take to these amendments.
Baroness Butler-Sloss
If I may be anecdotal, as other noble Lords have been, my mother died of multiple sclerosis in her early sixties. There was a point at which I, as a young lawyer, realised that she no longer had, in my view, the capacity to make decisions. However, that was at a very late stage of her illness.
If the doctor is not satisfied because someone is a drug addict or has been an alcoholic or has, for instance, a high degree of anorexia as a young person and is saying that they want to die, those are points at which a doctor should be saying, “I’m not quite certain whether he or she has capacity”. That is why I suggest in my amendment that, unless they are satisfied, they should pass it on to someone who has the expertise, who would then, as a psychiatrist, look at whether the person actually has the capacity. Okay, we are talking about someone with three to six months to live but, if they do not have the capacity to make this incredibly important decision, they should not be allowed to do so. That is how I would see it, in answer to the noble Lord, Lord Tebbit.
Lord Winston
I thank the noble and learned Baroness for giving way, but would she not agree that sometimes people who have capacity and say that they wish to die, as indeed my mother did, may then change their mind some months later, quite unexpectedly?
Baroness Butler-Sloss
Yes, that seems to me to present one of the problems with the Bill.
Medical Innovation Bill [HL]
Lord Winston Excerpts(10 years, 5 months ago)
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Lord Newby
My Lords, perhaps I may remind the House of what I said at the start of the debate; namely, that it is a firm convention that the House should rise at around three o’clock on sitting Fridays.
Lord Winston (Lab)
This is a Bill of colossal importance and to truncate speeches to six minutes, even though it is a Friday, seems to be highly undesirable. It needs to be discussed because there are many implications behind this piece of possible legislation.
Lord Newby
My Lords, I am not in any sense trying to curtail the debate. I am reminding noble Lords of the conventions of the House. My experience of listening to debates is that those in which the speeches last for six minutes can be among the best we have.
Lord Winston
My Lords, when I first read the Bill I was deeply impressed and thought how important it was. I congratulate the noble Lord, Lord Saatchi on introducing it. It is a hugely welcome discussion; I am very pleased that we are having it today, albeit in a truncated fashion. When we come to Committee, we will need to tease out a number of issues that the Bill raises. As I think more and more about the Bill, I have increasing misgivings, which I must explain to the noble Lord, Lord Saatchi, whom I deeply respect; I think he has acted with huge dignity and great compassion throughout his speeches on this issue, including on this occasion.
I am not against innovation in any way. In fact, innovation—if I may dare to be so pompous—has really been my entire life. For 40 years in surgery, I have innovated. I produced the finest microsurgical needles, which were not made by manufacturers—we made them on the bench ourselves because we needed them. I designed my own instruments, which subsequently became a general standard throughout the world and were finally designed by a German company. They were not standard in Britain. I swung a microscope over the abdomen of a patient for the first time anywhere in the world—something which most people thought was actually risky because it might introduce infection. It transformed pelvic surgery. I have to say that when laparoscopy came along, I think I was probably the first person to operate down a laparoscope, well before any general surgeon did so. Indeed, it was only with subsequent experience that we realised that laparoscopic surgery—fortunately, not in my hands as a gynaecologist but in the hands of general surgeons—actually caused a number of very serious accidents and even a few deaths. Of course, it took experience to find out that that innovation actually had all sorts of complications which might not have been recognised by any committee assessing the situation to start with.
Also, in the field of in vitro fertilisation, we have clearly been innovative in this country. We introduced hormone treatments, which could not be assessed by a randomised controlled trial initially—one of the points that Onora, the noble Baroness, Lady O’Neill, made was that there are many ways of assessing research. Programmed dosing of drugs in IVF, which transformed that treatment and made it possible to perform retrievals without laparoscopy at all, without a surgical procedure, were started in my unit and are now used world wide. There is also the example of ultrasound replacement of the embryo.
One trial that we did that was not truly randomised was to give patients alcohol at the time of the embryo transfer, because we thought that alcohol might calm the uterus down and therefore stop it contracting. Of course, that was not something you could really submit to an ethics committee, but it is the sort of thing that a woman might take during treatment. We found that white Loire wine had no proven benefit, but a good red from Pauillac was really quite effective.
Subsequently, genetic diagnosis, which was important in how legislation was formed in this House, could not easily be assessed, except by an ethics committee. There was a whole range of innovative procedures there that did not need this Bill. Neither did sperm microinjection nor endometrial abrasion. We now find, for example, that if you make a deliberate injury in the lining of the uterus before in vitro fertilisation, you can improve the success rate. That is completely counterintuitive and might be quite difficult to get through a committee without very difficult scrutiny. We also introduced what is called sham transfer, which prevented a lot of patients having unnecessary embryo transfers.
I feel a little like the noble Earl, Lord Howe, who is sitting on the Front Bench. I do not think that he was in his place during Prayers this morning, when we heard from the right reverend Prelate the Bishop of Birmingham:
“I will lift up mine eyes unto the hills, from whence cometh my help”.
I suspect that he feels that quite often when he is besieged by doctors protesting against legislation or improvements in governance. However, this issue really is causing increasing concern among many practitioners, as the noble Lord, Lord Turnberg, said. It is not quite as simple as was originally thought and we need to be very well aware of that, because it has the possibility of untold consequences. I want to explain what I think those are in just one minute or so.
We can see very well that in the practice of in vitro fertilisation now being carried on, all the governance in the world, including a regulatory framework, does not prevent innovative treatments which risk damaging patients. Let me give just two examples. One of them is embryo biopsy, which is substantially to try to understand which embryo might be better for transfer. What we actually know now, after various meta-analyses of a number of randomised trials, is that this procedure not only decreases the chance of a pregnancy by about 50% but is ineffective in understanding whether an embryo is truly suitable for transfer. Moreover, animal experiments now being done are showing that some mice show changes in their central nervous system, which lead to cognitive impairment when they are adults. Some of them are showing demyelination of nerve fibres in the brain. This potential innovation is one example of in vitro fertilisation—but not the only one—that might cause untold circumstances without all sorts of issues which innovation might risk. Not the least of those is blastocyst transfer, which we know causes changes in gene expression in humans in some cases.
Innovation undoubtedly has risks and we really have to understand that. If this Bill goes through to Committee, as I hope it will, we will clearly need to look at it very carefully to make sure that a number of amendments are made to it. I notice that the noble Baroness, Lady Bakewell, is now not in her place. Sadly, and in spite of what the noble Baroness said, litigation might increase as a result of the Bill as patients might decide to litigate because a doctor has not tried innovation in an unusual circumstance. Whether we like it or not, the problem really is that litigation under any circumstances is extraordinarily damaging to all parties concerned, even when a patient wins the case. It should be avoided not least because of that psychological damage, leaving aside the cost to the national purse.
The massive correspondence which I have received is very concerning. I conclude with the words of Michael Baum, one of the leading innovative surgeons in cancer in this country, whose contribution to breast cancer is second to none. He has said to me that in his view, “Their Lordships are walking over a precipice if they pass this Bill”. We have to listen to that very carefully. Of course I really want to demonstrate my absolute sympathy for what the noble Lord, Lord Saatchi, has said. I congratulate him on bringing forward the Bill but we need to consider it very carefully on the Floor of the House in due course.
Lord Woolf (CB)
My Lords, like those who have gone before me, I congratulate the noble Lord, Lord Saatchi, on his Bill and endorse the view of the law as it is at present, so clearly enunciated by the noble and learned Lord, Lord Mackay. What is important to appreciate—and, possibly, this may not have come through clearly in some of the speeches delivered today, although all of them were carefully considered and moderate in their tone—is the fact that the Bolam test, good as it is in the courts for determining questions of negligence, is not designed to deal with the question of innovation, although it has been tempered so that it does not prevent innovation, as it might otherwise.
Some time ago now, I had the task, given to me by the noble and learned Lord, Lord Mackay, of looking at civil justice and proposing reforms to it. The area in which there was the greatest need for reform was with regard to medical negligence and how such cases were conducted. There was a remarkable situation whereby doctors and patients were unable to speak to each other and had no confidence in what would be the consequence of doing so. The doctors on the one hand said, “We are threatened by these actions, which can ruin our lives and our careers”, and the patients on the other hand said, “All I wished was for somebody to say sorry for what happened, and no doctor came and said that to me”. The reason for that was that the doctors were worried that, if they did say sorry, it would be interpreted as an admission of negligence, whereas no sensible court would ever take that view.
I stress these matters because, at present, doctors do what I would regard as vital work, taking their courage in their hands and doing what they think is in the best interests of their patient, even though it involves innovation, while having no way of telling beforehand whether they can successfully comply with the Bolam test. The other thing that the law does not do at present is to require doctors to do what is necessary if they are going to innovate in a responsible way—that is, to be open about what they are doing, to make it clear that what they are doing is innovating and to take carefully thought-out steps to see that the cleansing effect of openness that we have heard about applies to what they do. One very important effect of this Bill is to set out a course that must be taken by a doctor if he is going to innovate. Those steps have been gone through in turn by the noble and learned Lord, Lord Mackay; they speak for themselves, and I do not propose to say any more about them than this.
In a Bill of this sort, you can try to find a balance between the dangers involved in innovation and the protections necessary in the interests of the patients, albeit that the patient may not be appreciative of that fact, and may be desperate for something to be done, while no responsible doctor should do what an irresponsible doctor would do. There is always going to be a danger, but there can be a balance. That is a word that really has to be applied with regard to consideration of the Bill. I suggest to the House that it draws a proper balance and takes into account the need to encourage innovation and remove barriers to innovation, while at the same time taking into account the risks by doing so.
The final thing that I would say about this Bill is that it is nonsense to suggest that the culture of litigation that now exists does not have a dampening effect on doctors. The doctors with whom I spoke when I conducted my inquiry made that clear, and doctors whom I have met in the course of my social life have equally made that clear. It is something that hangs over them. At the moment, the problem with the Bolam test is that it may provide them with protection when they get to court, but that is little comfort to doctors who have litigation going from stage to stage through the process to the courts, and whose lives are cast into the shadows by what is happening to them. It will be a great benefit that comes from this Bill, if that is removed by the open and transparent steps that it recommends.
Lord Winston
I apologise for intervening, as I understand that this is a time-limited debate, but this seems to me a very important issue. Every surgical operation in a sense is innovatory because anatomy varies from patient to patient, and many emergencies are highly innovatory when a patient is bleeding. Is the noble and learned Lord convinced that litigation may not be a problem in those circumstances where a surgeon decides not to innovate to try to save a patient’s life when they are bleeding? That seems a very difficult issue under law.
Lord Woolf
Of course, I fully accept that there is a problem in that situation and that not all doctors will be as brave as the noble Lord, given the innovations he told us about in his speech. Other doctors will take the less courageous course and, if faced with an emergency, will take what they feel is essentially the safe route, even though it may not be the best one.
Coins
Lord Winston Excerpts(12 years, 10 months ago)
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Lord Winston
My Lords, is the Minister aware that the change to copper-plated steel is very difficult when I am doing electrical experiments with my three and a half year-old grandchild?
Lord Sassoon
My Lords, I am not sure what we can do about that, but I can assure the noble Lord that, based on the experience with the 1p and 2p coins, there will be many cupronickel 5p and 10p coins still in existence for many years to come.
Comprehensive Spending Review
Lord Winston Excerpts(14 years, 2 months ago)
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Lord Winston
My Lords, would the Minister be kind enough to answer my noble friend Lord Eatwell’s question about universities? Does he agree that the Browne review can in no way cover the costs of teaching, which we need, in the universities which contribute so much to our economy beyond the STEM subjects and so much to our civilised society?
Lord Sassoon
I am very happy to endorse absolutely that sentiment of how critical it is to support the finest universities in the world, which stand up with the universities of the US at the top of all the league tables. While we preserve critical elements of science spending, there needs to be a fundamental rebalancing—that is exactly what the noble Lord, Lord Browne, proposed in his report—between what the state can afford to pay and the contributions paid by those who benefited from a university education. That is what we are proposing.