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Lord Turnberg
“Provision of advice by registered medical practitioner
(1) This Act applies only to decisions made by a registered medical practitioner to advise a patient for whom he has assumed a professional responsibility for the provision of advice with regard to the choice of treatment for—
(a) a cancer which in the reasonable opinion of the practitioner is affecting the patient and is likely to cause the patient’s death without the provision of effective treatment;(b) such other conditions as may be prescribed by regulations made by the Secretary of State.(2) A condition to which this Act applies is referred to as a “relevant condition”.”
Lord Turnberg (Lab)
My Lords, this is a rather omnibus group of amendments. I will do my best to try to speak to all of those to which my name is attached as well as to serve the others.
I should say at the outset that in setting out my amendments my purpose is to try to make sure that any Act that comes out is both sufficiently safe for patients and practicable so that the innovative practice that everyone wants to see is achievable. However, I would hate to see the opening up of a bureaucratic and legal nightmare that Sir Robert Francis tells me he still has problems with.
I would also like to correct a couple of possible misapprehensions. The first of these is that I want in some way to inhibit innovation in medical practice. I find that particularly galling when I have spent much of my life in clinical practice trying to introduce innovations. In my own field of gastroenterology I constantly tried novel treatments for Crohn’s disease, for example, and, indeed, published in journals the results of the research that I carried out. I say as an aside that at that time I did not feel the need for a Bill of this sort to allow me to innovate when I already had ethics committees’ approval and the informed consent of my patients. I fear that I am not alone in wondering whether the Bill is necessary. When Action against Medical Accidents, for example, and a number of important medical bodies express doubts about the need for it, one begins to wonder. I will not reiterate the Second Reading arguments as I want to concentrate on trying to make the Bill workable. However, I reiterate that innovation has been part of my very being and I still want to do everything that I can to encourage it.
The other misapprehension seems to be that there have been no advances in the treatment of cancer since the Middle Ages. That is patently not the case for many cancers—for example breast cancer, where there have been remarkable improvements, and in the leukaemias, where many, especially in children, have been cured. Now we see remarkable possibilities emerging for melanomas and a number of other carcinomas. However, it is certainly the case that no major advances have been made in the treatment of some cancers of the pancreas or the ovary, for example. That is terribly sad but true. It is also true, however, that no one anywhere has come up with a breakthrough for any of them—not in the USA, Japan, Oxford, Cambridge or anywhere—despite enormous effort by many researchers across the world. I declare my interest as a trustee of the charity Ovarian Cancer Action. We support a fascinating range of research into potential cures and keep a very careful eye on any advances in the field through our international band of distinguished researchers and advisers, who are often mainly based in the USA, so the idea that someone somewhere has a wonder cure that we have not heard about seems somewhat remote. I fear that we may have some way to go to find a cure but we at the charity have heard recently of some fascinating research in Oxford that we are supporting. However, we have some way to go.
I have tabled these amendments as I fear that the Bill’s wording leaves open to too great a degree the potential for harm by unorthodox, unregulated practitioners. Amendment 1 seeks to make it clear that we are talking about registered medical practitioners and that for the moment we should limit the innovative treatments to patients with cancers that are likely to kill them. The idea here is that this would narrow the field of endeavour a little and give time to consider whether, after the Act is in operation and has been shown to be valuable, it could be expanded and consideration be given by the Secretary of State, taking advice from reputable sources, as to whether other conditions should be included. After all, cancers are among the most high-profile cases where patients are constantly seeking new and better treatments and are willing to try almost anything.
It is under those circumstances that my Amendment 7 is absolutely critical, as it is for precisely these vulnerable people, desperate to try anything, that we have to have in place processes and mechanisms to protect them from unethical practitioners who may take advantage of their vulnerability. We have to face the fact that there are practitioners out there using all sorts of weird and wonderful treatments that have no basis whatever. So, in Amendment 7, I set out in some detail the conditions under which a doctor may prescribe such an innovative treatment. He or she should be the doctor with responsibility for that particular patient’s care. He should have reached,
“an honest and responsible opinion”,
that it will be more effective than orthodox treatment and that it is in the patient’s best interests. He should make sure that other doctors looking after that patient who have an interest in that patient will agree with him and he should have the agreement of another expert in the field. He should have not just consulted that person but obtained their agreement—not just to take account of that person’s views, as in Amendment 12 of the noble Lord, Lord Saatchi—and it should all be put down in writing in the patient’s record. I like the way in which Amendment 14, tabled by the noble Baroness, Lady Masham, sets out the requirement for patient consent, and hope that that can be incorporated. I hope that the noble Lord, Lord Saatchi, will agree that this will make his Bill a safer Bill and that he will accept this amendment or something very like it.
My Amendment 15 also proposes, first, that all the considerations that have gone into reaching the decision to innovate, together with the type and nature of the innovation, should be recorded in the patient’s record and, secondly, that the results of such innovation should be available in some public format. Here I have suggested that it should be available within six months. I am not wedded to that time limit, only to the principle that others should be able to learn from someone else’s innovations. I know that the noble Lord, Lord Saatchi, has the agreement of Oxford University that it will act as a repository for this information. However, as I understand it, there is no compulsion on behalf of the innovating doctor to report to Oxford. We need something in the Bill that makes it not just desirable but essential. My Amendment 19 also makes that point clear.
Amendments 21 and 32 refer to research. Here I want to make the Bill absolutely clear that those engaged in research involving clinical trials will not be subject to even further stringent requirements than they already labour under. After all, these innovative treatments which we are all so desperately seeking are entirely dependent on high-quality research in clinical trials. However, there is a fear out there in the Association of Medical Research Charities—in which I express my interest as scientific adviser—the Medical Research Council, the Wellcome Trust and so on, that the stringent requirements under which researchers operate, involving clinical governance, research ethics committees, informed consent by patients and so on, will be added to by the conditions set out in the Bill. No one, least of all the noble Lord, Lord Saatchi, I suspect, wants his Bill to act as a further deterrent to clinical trials of new treatments. I therefore hope that he will find these amendments helpful.
Lord Saatchi (Con)
My Lords, I am grateful to the noble Lord, Lord Turnberg, for opening this Committee. I am greatly respectful of all he has said. In speaking to his Amendment 1, I will speak also to Amendments 8, 9, 11, 12, 16, 20, 25, 26 and 27 in my name; Amendments 7, 15, 19, 21, 24, 32 and 33 in the name of the noble Lord; Amendment 10 in the name of the noble Lord, Lord Pannick; Amendments 13, 17, 22 and 30 in the name of the noble Lord, Lord Winston; and Amendments 14, 18 and 34 in the name of the noble Baroness, Lady Masham.
In winding up the Second Reading debate—at which I was grateful, as I am today, for so many of your Lordships’ attendance, and for all that was said; it was an excellent debate—I gave an undertaking that there would be an opportunity to consider whatever amendments were suggested as a result of the study by the NHS medical director, Sir Bruce Keogh, commissioned by the Secretary of State. I suggested that it might be possible to leave those amendments to be considered in the House of Commons, but a number of your Lordships made it clear to me that there was a desire to consider these important matters in this House so that we can, I hope, send the Bill to the other place in a form that represents the consensus not just of myself and the Government but of all noble Lords who have taken such a helpful and serious interest in the Bill.
I and the Government have listened to these representations. I can testify to the seriousness with which the Government have paid attention to all that has been said. I have witnessed it with my own eyes. I am very grateful to my noble friend the Chief Whip for facilitating the Committee for the purpose of considering the amendments which were settled by Sir Bruce Keogh and which stand in my name. I hope that after today it will be possible for the Bill to make swift progress into the House of Commons so that it has a reasonable chance of becoming law before the general election. There will of course be an opportunity for the issues considered in this House, and perhaps others as well, to be considered in a Public Bill Committee in another place.
I do not propose to give a lengthy, detailed description of each amendment in the group; I have been warned not to attempt a Second Reading speech of any kind. To some extent the amendments are self-explanatory—they build on the safeguarding themes already in the Bill on introduction—but let me give a brief introduction to the purpose and effect of the amendments, which are now known as the Keogh amendments. I will do my best to answer any questions noble Lords have.
The key amendment that addresses the safeguards in the Bill is Amendment 12, which replaces Clause 1(3) of the Bill. The most significant features of the new list of safeguards are as follows. First, proposed new Clause 1(3)(a) requires the doctor to,
“obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment”.
I suggest that that must be read with Amendment 16, which inserts proposed new Clause 1(4) into the Bill, to the effect that,
“a doctor is appropriately qualified if he or she has appropriate expertise and experience in dealing with patients with the condition in question”.
Proposed new subsection (3)(b) requires a doctor to take full account of those views in a way that a responsible doctor would be expected to do. That ensures that a doctor cannot ignore views or give them minimum weight unless there are reasonable grounds for doing so. The proposed new clause provides a critical safeguard in ensuring that there is expert peer review of the doctor’s proposal and that the doctor acts responsibly in taking account of that view. We have all been concerned to ensure that the Bill cannot be seen as giving comfort to quacks or cowboys. This provision will hopefully give additional comfort to the noble Lord, Lord Turnberg, and to other noble Lords that the Bill does not do so, and, as I said at Second Reading, that it provides a statutory benchmark of good practice that will act as an effective deterrent to quacks and charlatans.
Proposed new subsection (3)(d) requires the doctor to consider a number of factors relating to the proposed treatment, including a requirement to consider,
“the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment”,
other accepted treatment,
“and not carrying out any of those treatments”.
The proposed new subsection no longer requires a doctor to notify their responsible officer about the proposed treatment. The responsible officer may not have expertise relating to the condition in question and it may be difficult for a doctor to notify them in advance in all cases.
These replacement provisions are not designed to alter the fundamental purpose of the Bill as I explained it on Second Reading, which is simply to bring forward the Bolam test to the point of treatment, so that doctors can be reassured in advance that they are innovating in a manner that the law will regard and uphold as responsible. They would not have to wait or speculate about the possibility of litigation or disciplinary proceedings before finding out whether their action is considered reasonable. By giving certainty we help doctors to innovate with confidence. We help the thousands of patients who wish to benefit from innovative treatment and do not wish the doctor to be scared off or institutionally discouraged by the mere possibility of later litigation.
A number of the amendments proposed by Sir Bruce Keogh are designed to emphasise or clarify aspects of the Bill, rather than to change its legal effect. I shall therefore mention them only briefly. Amendment 8 amends Clause 1(2) to emphasise that the protection offered by the Bill applies to the doctor’s departure from the existing range of accepted treatments for a condition, not just to his decision to do so. Amendment 9 emphasises that the Bill applies only to medical treatment. Amendment 11 amends Clause 1(2) to provide that a doctor’s departure from the existing range of accepted medical treatments for a condition is not negligent where the decision to depart is taken responsibly. This applies an objective test of responsibility to the doctor’s decision and prevents a doctor who acts irresponsibly from relying on the Bill. Amendments 20, 25, 26 and 27 are minor and consequential.
Amendment 1 would limit the Bill to terminal cancer and other conditions prescribed by the Government. I have considerable sympathy with this. As your Lordships are aware, the Bill is aimed in particular at the horror of cancer and terminal or extreme conditions. However, the principle is a general one: that doctors and patients are entitled to clarity and certainty at the point of treatment. That is its main aim and purpose. I understand completely that some Peers dislike the idea of the Bill being used for cosmetic surgery, for example. I would certainly consider an amendment later—subject to the views of the Minister, who I am sure will speak to this—either in the Lords or the Commons, to exclude cosmetic surgery if the House feels that that is important. That might well be possible, subject to discussion with the noble Lord, Lord Turnberg, and with the agreement of Sir Bruce Keogh and the Secretary of State. In the mean time, I ask the noble Lord not to press the amendment.
I turn to Amendment 7, to which the noble Lord, Lord Turnberg, gave great importance. I believe that it is similar to my amendments in the sense that they both replace the existing conditions for the operation of the defence to negligence under the Bill with an alternative set of conditions. I understand that the noble Lord is trying to find a set of conditions that limit the opportunity for the Bill to be misused by quacks. As I have said, my amendments, proposed by Sir Bruce Keogh and the Secretary of State following consultation, have the same purpose. I hope that the noble Lord, Lord Turnberg, will therefore feel that those amendments address the fundamental concerns addressed by Amendment 7 and that he may feel able not to press it.
Amendment 10 inserts a reference to reasonableness and proportionality in the conditions for application of the test under the Bill. I agree that reasonableness and proportionality are key requirements of that test. I believe they are already provided for in the Bill as drafted and in the amendments standing in my name. In the interests of preserving a single coherent package of amendments as prepared by Sir Bruce Keogh, and on the understanding that reasonableness and proportionality are inherent to that package, I hope that the proposers will feel able not to press the amendment.
Amendment 13, in the name of the noble Lord, Lord Winston, is similar to my amendments in the group in that it replaces the existing conditions for the operation of the defence to negligence under the Bill with an alternative set. I understand that the noble Lord is trying to find a set of conditions that limit the opportunity for the Bill to be misused. My amendments were proposed by Sir Bruce Keogh and the Secretary of State for exactly the same purpose. I hope that the noble Lord will feel that those amendments address the fundamental concern of his amendment and that he will feel able not to press it.
I absolutely understand the aim of the noble Baroness, Lady Masham, in Amendment 14, which is to amplify the existing set of patient safeguards in the Bill. I hope that the noble Baroness will accept that the package of safeguards prepared in consultation with the profession by Sir Bruce Keogh and set out in my amendments deal with the concerns reflected in her amendment. I welcome the opportunity to discuss these issues with the noble Baroness in more detail. In the mean time, I hope that she will feel able not to press Amendment 14.
Amendment 15, in the name of the noble Lord, Lord Turnberg, would require the results of innovation carried out in reliance on the Bill to be registered or recorded. This is a most important amendment and I can certainly assure the House that I have great sympathy with its aim—it has been our aim from the beginning. I explained at Second Reading that we strongly believe that the Bill should be used to generate useful data about innovation. We agree completely with what the noble Lord, Lord Turnberg, said: if the Bill were successful in its aims and encouraged innovation, what would be the point if no record of the innovations was kept in an open, transparent and fully disclosable way to show that the claims that we make—that the Bill will advance scientific knowledge—were true.
Lord Pannick (CB)
My Lords, I have tabled a number of amendments in this group and I thank the noble Lord, Lord Saatchi, for his helpful responses to them. The purpose of my amendments is to ensure the protection of vulnerable and often desperate patients and their families. Amendment 10 seeks to introduce a test of reasonableness and proportionality. The noble Lord, Lord Saatchi, said in his comments that reasonableness and proportionality are central to the objectives of the Bill. Perhaps I may explain my concern.
The Bill uses the concept of “responsible” innovation. Clause 1(3), along with Amendment 12 in the name of the noble Lord, Lord Saatchi, which he has rightly described as crucial, would define responsible innovation by reference to process; that is, obtaining and taking account of the views of others, considering the risks and benefits, and securing transparency. My concern is that this is insufficient because it says nothing about the substantive content of the decision of the doctor to innovate. Amendment 10, which has the support of the noble Lords, Lord Winston and Lord Turnberg, would provide that innovation is lawful only if it is “reasonable and proportionate” in a substantive sense. It must be reasonable in the sense that the course of innovative treatment should be based on a reasoned decision, that in the light of some evidence the treatment has some prospect of success, and proportionate in the sense that in the patient’s case and taking into account the existing available treatments, the innovative treatment is not likely to cause pain and suffering that is unjustified by the prospects of success. Plainly, this is going to depend, and will necessarily depend, on the circumstances of the individual case.
At Second Reading, the noble and learned Lord, Lord Mackay of Clashfern, who I am pleased to see is in his place, said at col. 1457 that in the context of innovation, it is very difficult to see how you can assess the “reasonableness” of treatment. With respect, I do not accept that. You assess the reasonableness of an innovative treatment in a substantive sense by asking whether there is some evidence to suggest that the treatment will or may have a positive result. I think that reasonableness and proportionality are as important in the context of terminal illness as they are in any other context. Unreasonable and disproportionate medical treatment can cause pain and suffering and it can of course blight the remaining time that patients have with their families.
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 Giddens (Lab)
My Lords, I am neither a medical specialist nor a lawyer and it is pretty near impossible to follow a speech such as that given by my noble friend Lord Winston. However, I am a sociologist and we deal in unintended, or what we often call perverse, consequences. Therefore, to me it is highly important that this Bill, which itself is an innovation, covers the question of whether perverse consequences could arise and whether the Bill could therefore end up subverting some of its own intentions.
With this in mind, I ask the noble Lord, Lord Saatchi, to think again about Amendments 13, 15 and 17 and perhaps to be a bit less dismissive of them than he was in his speech, because I think they would enrich the Bill. A clinical ethics committee would be a more robust way of affirming decisions than the existing way in the Bill. Amendment 13 spells out procedure to be followed. More importantly, it also insists that written records are kept. Critics say that it would add to the bureaucracy but there is no reason why such a committee could not be quite small and have a limited brief.
I regard Amendment 17 as very important. It is crucial that if it becomes law the Bill applies to very specific and limited circumstances. Especially important in my view, and I again speak as a lay person with no direct expertise, are the clauses limiting the legislation to drug treatments and excluding surgery and conditions involving acute trauma. It is important to spell these things out and I do not think they in any way undermine the Bill. They could contribute to what I think should be a key concern of noble Lords to close any avenues to perverse consequences that could arise, especially with legislation dealing with vulnerable people. We all know the issues here are twofold—what do you do about reckless doctors and how do you make sure that vulnerable patients are not exploited? The more loopholes we can close, the better for the progress of the Bill.
Baroness Finlay of Llandaff (CB)
My Lords, I have added my name to Amendment 15 and I hope that the Minister will give it due consideration. It is really important that the process laid out in the Bill is recorded in the patient’s clinical record. That is the one way that you can verify that things have been done properly. It is also important that there is notification to the central register, as referred to by the noble Lord, Lord Saatchi.
I also hope that the Minister will be able to give due consideration to the situations already mentioned by the noble Lord, Lord Winston, and others. It is very important that we do not make it more complicated than it is already for clinicians to be able to treat patients as they feel appropriate. It is also important that patients have the appropriate safeguards in place. While quite a lot will go into guidance, there is merit in having emergency treatment actually in the Bill as a situation where the Bill would not apply and that treatment in the best interests of the patient in an emergency can proceed by whichever means appear to be best at the time.
Lord Kakkar (CB)
My Lords, I declare an interest as Professor of Surgery at University College in London and as a member of the General Medical Council. I welcome the interventions of my senior clinical colleagues, the noble Lords, Lord Turnberg and Lord Winston. They have helped us to understand that, although it is hard, this is a vitally important Bill to drive forward the practicalities of innovation in clinical practice. I hope that it will also drive forward a positive culture of putting innovation at the heart of all clinical thinking. However, there must be safeguards to ensure the protection of vulnerable patients. A number of amendments in this grouping try to address that issue. When this Bill was first made available for public comment some years ago, I was initially anxious about the fact that there were insufficient safeguards. The approach that I wished to adopt was one that I know has been considered but has been also dismissed. I have, however, become reassured by the process under the supervision of the Medical Director of the NHS, Sir Bruce Keogh. He has consulted widely among the profession and I believe that the amendments in the name of the noble Lord, Lord Saatchi, particularly Amendments 12 and 16, bring us to a place where appropriate safeguards have now been introduced. I hope that they will be judged sufficient to provide the protection that all responsible and reasonable clinical practitioners would want in a Bill of this nature.
There are two other amendments being considered in this group that I believe to be vital, Amendments 15 and 19, dealing with the registration and reporting of the results of innovation. There is no doubt that if this Bill is to achieve what it hopes to, the innovations that are provided as a result of having this provision available to us in clinical practice must be reported widely and be available for other clinical practitioners to consider. I know that, at this stage, the view is that other mechanisms are available that provide the opportunity for that reporting to be made, but I wonder whether the Minister might consider during the further passage of the Bill how very powerful a provision of the kind suggested in the two amendments would be in securing the greatest benefit for the largest number of patients.
Another question to have been raised on this group of amendments is that of being certain that the Bill does not apply to situations of emergency care and does not in any way interfere with the mechanisms available for ethical and appropriate clinical research. A strong research governance structure supported by strong legislation is available in our country, and this Bill should not be seen to impinge on that in any way. I am reassured by the noble Lord, Lord Saatchi, saying that the Bill does not relate to the conduct of research and should not be confused as doing so, nor does it in any way interfere with what are, as the noble Lord, Lord Winston, said, acute and deeply stressful decisions that have to be taken in the situation of providing emergency care. I hope that the Minister will be able to reassure us that other legislation, guidance and mechanisms exist to ensure that the Bill does not impinge on those two areas.
Baroness Gardner of Parkes (Con)
My Lords, I strongly support the Bill and hope that we will be able to reach agreement on important points today. It is essential that patients should feel safe, so all the safeguards being put forward are welcome, but patients also want to feel hope. When I think of Les Halpin, referred to by the noble Baroness, Lady Masham, I recall his rapid deterioration with motor neurone disease. When he first launched the idea of doing something, it was hard to detect that there was anything wrong with him. Within no time at all, it seemed—but probably it was about a year—he could not stand; he was in a wheelchair; and he had to have his head supported. It was unbelievable. What he wanted, not only for himself but for others, was hope.
The noble Baroness, Lady Masham, referred to Ebola, where they are trying things, irrespective of whether they know they are right, and in many cases they are probably working. It is hard to know. When I was chair of the hospital that has the Ebola clinic here in the UK, we had a case and the man recovered. In those days, there was no treatment other than just isolation and patients relying on their own strength to pull through. The noble Lord, Lord Winston, related a story about an ectopic pregnancy. It was interesting to see there how there was a conflict between two highly qualified medical practitioners. If he had not bravely taken that action, irrespective of any action that might be taken against him, that woman would not have survived. We do not want to make the procedure so enormously complicated that, by the time you have the result, it is too late for the person that you are aiming to help. On the other hand, I think that everyone agrees that the recording of the information, referred to by the noble Lord, Lord Turnberg, in speaking to his amendments, is essential. Unless it is recorded and open for use by everyone, it might help one individual, but no one will know what happens and how to help any others afterwards on a wide scale.
I think that everything that can be said on this Bill today will be said. I remember at Second Reading that the noble Lord, Lord Winston, was worried about people being sued for failure to innovate. I feel that that is only a remote prospect and should not be worried about too much. If all the safeguards are put in place, I believe that that will not happen. I strongly support the Bill and hope that the Minister will assure us that we will be able to proceed with it.
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 O’Donnell (CB)
My Lords, like the noble Lord, Lord Giddens, I am not a medic. I rise to speak because I think that this issue creates all sorts of problems and challenges in which my experience in public policy and economics can help. To me, what determines innovation is essentially economic. Economists have studied for a long time precisely how you get innovation in systems. I will not lecture noble Lords on the medical side. It is important that we operate with our heads, not our hearts, in this, so you will not get any emotional stories for me; I will be boringly analytical. I think that this is an issue about evidence-based policy.
We know that markets will not solve the issues that the noble Lord, Lord Saatchi, raises in the Bill. The incentive structures are such that the pharma companies will go for those areas where they can sell large amounts of drugs. Rare cases will be problems. One issue I have as someone who cares enormously about evidence-based policy—I gave a lecture at the Royal Statistical Society earlier this week on this, when I went on at length, which I will not repeat—is how you generate the right amount of data to handle this problem. I received a briefing from the BMA which said that there was no evidence to support such things. Of course there was no evidence; that is the whole point. We have to find ways to generate evidence.
I strongly support the Bill. In that, I am with Sir Michael Rawlins, president of the Royal Society of Medicine and former head of NICE, who knows about the analysis, so I take the medic side as given. I am very pleased that the noble Lord, Lord Saatchi, has accepted the safeguards. If you believe, as I do, that the really important part of this is the generating of evidence, we need something in the Bill to state that we will record evidence and register it correctly. That makes a lot of sense, but as a good former civil servant, I look forward to hearing the Minister’s reply and hope that he will reassure me that there is an equivalent way to do that. If that is true and is as solid, I will accept that; but in its absence, we need to make sure that we learn, that we get every innovation documented so that we build up the evidence base. That is what this is about—innovating safely and successfully.
Lord Kirkwood of Kirkhope (LD)
My Lords, I am pleased to follow the noble Lord, Lord O’Donnell, whose experience in the area of public policy is well known. I have come late to consideration of the Bill. Regrettably, I could not make the debate at Second Reading. My interest in the subject was generated by a four-year period on the General Medical Council, which ended at the end of 2012. I was deeply sceptical about the Bill when I first read that the noble Lord, Lord Saatchi, was proposing it. However, I pay tribute to those colleagues who have thought about the amendments and presented them. I am not a medical doctor; I trained as a pharmacist; but this has been a very good, easily understood, high-quality debate about the issues. I pay tribute to the noble Lord, Lord Saatchi, because he has obviously been listening very carefully. He may even win my support, subject to one or two points that I will raise in a moment.
As a former business manager, I am prepared to accept the Saatchi-Keogh package, as it were, but I would not want to take a final decision on some of the other important amendments. I might support some of them on Report, but I do not think that this morning is a good time to do anything other than take a step forward with the amendments of the noble Lord, Lord Saatchi, with the help of Bruce Keogh. That would be in the best interests of the consideration of the Bill. I warmly accept the noble Lord’s change of heart, if that is not too strong a way to put it. The Bill is much better dealt with in this House than along the Corridor, because I have been along the Corridor and I know what happens there. This is a much better context in which to get the Bill as good as it can be before we send it there. I recognise that that was a big decision for him.
I would be much happier to vote for this package in its entirety if the noble Lord paid attention to five amendments. I have listened to the careful way in which they were presented this morning. The Turnberg Amendments 15 and 19 are very important for me, and the noble Lord, Lord O’Donnell, made an important case. If we do not capture the benefits, the Bill is not worth having. At the top of my Christmas list of five amendments are Amendments 15 and 19. Given the tone of the debate in the House, the noble Lord, Lord Saatchi, may reflect that if he does not concede something in that direction he will find it difficult to persuade me that the Bill is worth having at all. Second on my list is Amendment 10, tabled by the noble Lord, Lord Pannick, because I think reasonableness and proportionality are necessary in the Bill. The noble Lord made a concise and compelling case. The noble Lord, Lord Saatchi, dismissed it rather lightly, so I ask him to think again about Amendment 10. Amendment 17 concerns restrictions. I am very nervous about the Bill being applied to mental health, and I corroborate and underscore comments made by other colleagues. Lastly, Amendment 22, in the name of the noble Lord, Lord Winston, would make it absolutely clear that there is no duty to innovate. That may seem irrelevant but it is important for the protection of doctors—and I say that as a former member of the General Medical Council.
Baroness O’Neill of Bengarve (CB)
My Lords, I am sorry to say that I am another non-medic. Indeed, I am a philosopher by trade and training but I would like to make three points. First, I was puzzled at Second Reading and again this morning by a certain divergence of vision among those of our medical colleagues with surgical experience and those who are not surgeons. It seems that, on the whole, those with surgical experience are quite happy with current legislation. They feel that they must innovate and that the non-standard anatomy, which I have learnt that we all enjoy, means that they cannot go in there with a rule book and just stick to it. I have not heard quite the same uniformity from our clinical colleagues who are non-surgeons. I hope that we could be a bit clearer about whether surgical procedures should be in here at all.
Secondly, the question of unintended consequences has already been raised by the noble Lord, Lord Giddens, and others. Some quite process-heavy amendments have been proposed which deserve rather more picking apart than they have already received. We do not wish to put in so much process that we successfully stifle the very innovation that it is the purpose of the Bill to achieve. I hope that we can come back to those amendments.
Finally, and with trepidation as I am standing right behind the noble Lord, Lord Pannick I say that, there is a bit of a difference between reasonableness and proportionality. They tend to come as twins. I am entirely in favour of reasonableness but proportionality suggests that you have at the back of your mind enough data to say what is proportionate and what is not. I fear that introducing requirements for proportionality may actually wreck the possibility of innovation in areas where part of the objective is to obtain the data, because they are not yet there. I would have thought that from a patient’s point of view it is reasonable to go for a treatment for which there are not yet complete data, and therefore no judgment of proportionality can be made, but which nevertheless is reasonable because the other options are dire.
Lord Mackay of Clashfern (Con)
My Lords, I had not intended to take much part this morning but, my name having been mentioned, I am stimulated to respond. The Bill is about innovation. Therefore, if a doctor is attacked for some failure in respect of innovation, the ordinary rules of defence that are presently available do not seem appropriate. Our colleagues who are excellent innovators have managed to avoid the necessity for litigation as a result of their innovations. However, if by any chance any of them were challenged, how would they go about their defence?
I make this basic point in answer to my colleague the noble Lord, Lord Pannick. He quoted what I said at Second Reading. It will not surprise your Lordships if I happen to hold still to what I said then. The point is that when there is an innovation, there is not much material on which to judge whether it is reasonable or proportionate. If there were in the existing practice, it would not be an innovation. The problem is therefore that the ordinary formulations of reasonable and proportionate with which lawyers are very familiar—I am enough of a lawyer to be familiar with them—are not really appropriate. I believe that the test which my noble friend Lord Saatchi’s Bill originally had, and which is preserved among all the innovations that have taken place since, is in Clause 1(4)(a):
“Nothing in this section … permits a doctor to administer treatment for the purposes of research or for any purpose other than the best interests of the patient”.
That is a simple test which the doctor must face at the time of innovation and, so far as I am concerned, elaboration with the familiar legal phrases that are very dear to lawyers is a mistake. I therefore adhere to what I said at Second Reading.
I should perhaps say that I am not entirely without experience in this area for when I was in practice in Scotland, which is now a long time ago, I did quite a lot of work in the Medical and Dental Defence Union of Scotland area. My very first appearance as a counsel in this House was in respect of a doctor’s negligence. My experience was over quite a long period; it may not have been very good but it was certainly extensive. I very much support the Bill and hope that we need not get around to voting on it today. There is plenty of scope for discussion about these matters and a good deal of substance in many of the amendments. We should discuss them further and, if necessary, have votes on Report.
Baroness Wheeler (Lab)
My Lords, on behalf of these Benches I welcome the commencement of the Committee stage of the Bill. At Second Reading we underlined the necessity for close scrutiny by this House, and we are pleased that the opportunity has been presented to us. In that debate there was both strong support for and strong reservations about the Bill, with many questions and issues to be addressed. We have moved on since then, but despite acknowledged progress made on safeguards for staff and patients contained in the amendments from the noble Lord, Lord Saatchi, there remain crucial reservations and concerns from key parts of the medical profession and from patients’ organisations, as we continue to discuss today.
We commend the work that the noble Lord has undertaken on the Bill, and feel that the changes on patient and staff safety signify improvements to it. It is reassuring that his proposed amendments have the backing of Sir Bruce Keogh, the NHS medical director, and the Government, and that the common-law Bolam test would remain unaffected by the Bill. The noble Lord, Lord Saatchi, knows that there is strong support for the principles and the intent of what he is trying to achieve. Labour has always strongly supported efforts to put innovation at the heart of the NHS and to bring innovative treatments to patients faster.
After Second Reading, the Minister for Health, Dr Daniel Poulter, responding to a Parliamentary Question in the Commons from Labour on the progress of the Bill, acknowledged the Government’s support for the principles of the Bill but emphasised that the amendments were necessary,
“to ensure it does not: put patients at risk; deter good and responsible innovation; place an undue bureaucratic burden on the National Health Service; or expose doctors to a risk of additional liabilities”.
These four key tests are what we should keep firmly in focus today, and I hope that the noble Lord, Lord Saatchi, and the Minister will address whether they consider that the tests have been met in the revised Bill in their responses to the issues that have been raised today.
I will limit myself to speaking on just some amendments in this group. Like other noble Lords, I look forward to hearing from the noble Lord, Lord Saatchi, and the Minister on the key issues raised by the many experts in this field who have spoken today. On patient safety, as I have stressed, we welcome the efforts made by the noble Lord, Lord Saatchi, in his amendments to address widespread concerns that the overall Bill would encourage reckless rather than responsible innovation and put patients at risk. We support the new emphasis on reasonable and responsible innovation contained in amendments in the next group, as well as the reference in Amendment 10 in this group from the noble Lord, Lord Pannick, and my noble friends Lord Turnberg and Lord Winston, to the doctor needing to act in a manner that is both reasonable and proportionate. The new provisions in Amendments 8 and 9 are important because we recognise that they are designed to provide that a doctor’s departure from the existing range of accepted medical treatment for a condition is not negligent where the decision to depart is taken responsibly.
We also welcome the deletion of the references in the previous Bill to the doctor’s responsible officer and appropriately qualified colleagues in respect of the staff to be consulted about the proposed treatment. These caused much confusion among both supporters and people with concerns about the Bill, and the new reference in Amendment 16 to the need to obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment is clearer—although it is a critical area that will also need to be developed under guidelines, codes and/or regulations. It needs to be clear who is an appropriate qualified doctor. The new definition of a doctor being,
“appropriately qualified if he or she has appropriate expertise and experience in dealing with patients with the condition in question”,
is also an improvement to the Bill, although the question of the independence of the doctor whose opinion is being sought is a critical one.
My noble friend Lord Turnberg addressed this earlier with much force under Amendment 7. Key stakeholders have stressed that requiring the doctor to have regard to the opinions of other professionals responsible for patients’ care, together with the requirement for written consent to be sought from at least one other doctor who is independent of the responsible doctor, would be a welcome step in providing more clarity to the process.
There is an extremely worrying potential for conflict of interest here—for example, in the supporting doctor’s involvement in the development of the drug or treatment in question—and clear guidelines and rules of engagement will be essential. Sir Robert Francis QC points to the problem that arises from the choice of the appropriate qualified doctor to consult resting entirely with the doctor wanting to offer a new treatment. He or she is free to choose someone in his own partnership or laboratory, or someone with a commercial interest in promoting or selling the treatment. It is less than clear who is the final judge of whether the individual is appropriately qualified. There is also concern among a number of stakeholder groups that pharmaceutical companies could put undue pressure on doctors to try out potentially dangerous treatments, and this concern will also need to be addressed.
Concerns remain that the involvement and consent of patients to untested innovative treatments are not more explicitly in the Bill. Amendment 14 from the noble Baroness, Lady Masham, addresses this issue by specifying the need to obtain informed consent in light of the aims, processes and risks. I look forward to hearing further from the noble Lord, Lord Saatchi, on how he considers the Bill can address this, as this point has been raised by a number of noble Lords in the debate.
Lord Turnberg
My Lords, I hope that I am not out of order in responding to some of the comments from the noble Lord, Lord Saatchi, about my amendments. I am grateful to him for his comments and I listened with care to what he had to say. I am also impressed by the noble Lords, Lord Cormack and Lord Kirkwood, and indeed the noble and learned Lord, Lord Mackay, that further discussions may be possible before Report, which I would very much welcome.
On Amendment 1, I note that the noble Lord, Lord Saatchi, is not very keen on the idea of limiting the scope of the Bill at the moment to cancer, but my point here was to start with that and expand cautiously in the light of experience. I note that the noble Lord, Lord Kirkwood, also urged some caution in the way in which we introduce the Bill. The amendment also impacts on Amendment 17, whose lists of exclusions, if we went along the line of limiting the Bill to cancers, would not be quite so necessary.
My Amendment 7 and Amendment 12 from the noble Lord, Lord Saatchi, overlap to a considerable extent, and I am grateful for that. The main difference is that his concentrates largely on taking account of the views of another expert, while mine suggests that we should obtain the agreement of at least one other expert, which should be recorded in the note. I think that that strengthens his amendment, and I hope he will think about that rather carefully.
On Amendment 15, a number of other noble Lords have referred to the need to have any innovations recorded in some form of register but also in the patient’s records. I listened carefully to whether the noble Lord, Lord Saatchi, had accepted the idea that the record should be in the notes as well, and I hope he will accept that too.
Amendments 21 and 32 talk about research. I am pleased that the noble Lord agrees with the principle that this Bill should not interfere with research; I do not think that anyone feels that it should. However, there are many in the research world who are concerned that the Bill might have that unexpected consequence. Something in the Bill along the lines that would exclude the possibility would therefore be extremely helpful.
Similarly with Amendment 24, which talks about emergency care, it is true that the Bill may not cover emergency care, but there are people involved in accident and emergency departments who are concerned that the Bill may somehow, in some way, inhibit them. It would be a shame if the impression left by the Bill inhibited that sort of emergency innovative practice, hence the reason to have something in the Bill.
I do not intend to divide the Committee today on any of these amendments, and I am very grateful for the informed debate on many of them. I hope we will have a chance to come back to at least some of them on Report.
Lord Winston
Does my noble friend agree that one of his amendments tends to limit the Bill almost entirely to cancer treatment? There is a problem even there, however, because, as the noble Baroness, Lady O’Neill, said, surgery is an important part of cancer treatment. It is absolutely certain—I am not a cancer surgeon but I have watched many cancer operations, and perhaps other surgeons in the Chamber will support me on this—that cancer surgery is often the most innovative surgery, and you cannot possibly take a decision with the sorts of permissions that are usually required beforehand, because you do not know exactly what you are going to encounter. There is a problem there with the structure of the Bill as it presently stands.
Lord Turnberg
I accept entirely what my noble friend has said. The surgical aspects of the Bill are quite tricky.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, this large group of amendments, all in their own separate ways, seek to ensure that patients are protected against negligent or irresponsible treatment. As we have heard, these amendments take many different approaches in seeking to achieve essentially the same goal. The Government are absolutely committed to safeguarding patients. That is why my right honourable friend the Secretary of State for Health asked Sir Bruce Keogh, the medical director of NHS England, to work with the medical profession to devise a package of amendments that would make this Bill safe for both patients and doctors. Like my noble friends Lord Kirkwood and Lord Cormack, I take this opportunity to commend my noble friend Lord Saatchi for listening to concerns and agreeing to table the amendments recommended by Sir Bruce Keogh in full.
I now address the amendments themselves. On Amendments 1, 7, 17 and 33, the Government do not feel that there is anything to be gained by restricting the scope of the Bill in the way proposed. To set out specific medical treatments or circumstances that would or would not be covered by the Bill would make it complicated for doctors to follow and less flexible to individual patients’ circumstances. That was well exemplified by the exchange that we have just heard. This might limit the Bill’s usefulness to patients and doctors alike. I say to the noble Lord, Lord Turnberg, that there is no question of the Bill applying to unregulated practitioners: it applies to doctors. In answer to the noble Baroness, Lady Wheeler, about what constitutes an appropriately qualified doctor, we believe that to define the required level of experience and expertise would create an overly burdensome requirement on doctors looking to innovate responsibly. A requirement that a doctor is appropriately qualified provides a sufficient safeguard to patients. New Clause 1(3)(b) requires the doctor to take full account of the views of an appropriately qualified doctor in a way in which a responsible doctor would be expected to do.
The provisions in Amendment 7 outlining the process that a doctor must follow to reach a responsible decision are largely addressed by my noble friend Lord Saatchi’s Amendment 12. The provisions in Amendment 7 which require doctors to consult a specified range of other doctors are too restrictive and would make the Bill complicated for doctors to follow. My noble friend’s amendment for doctors to take full account in a responsible way of the views of one or more appropriately qualified doctors in relation to the treatment is less burdensome and is a better equivalent to the existing law.
The noble Lord, Lord Pannick, raised concern that a responsible decision under the Bill is defined as relating to the process rather than the substance of the decision. I listened very carefully to that point. The steps that a doctor has to take under new Clause 1(3) include taking account of substantive factors as well as process. This includes taking full account in a responsible way of the views of one or more other doctors about the proposed treatment. In addition, the doctor must consider the risks and benefits of the proposed treatment as compared to other treatments and to not carrying out any treatments at all. This strays outside the realm of process.
The Government’s view is that it is not necessary in this Bill to require doctors to record their innovation in medical records as set out in Amendments 7 and 15. The General Medical Council’s Good Medical Practice guidance already sets out requirements on doctors to record their work clearly in clinical records, including clinical decisions made and discussions with patients. On Amendment 19 and the related Amendment 34, the Government believe that requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent is not the right approach. This is too bureaucratic and risks deterring doctors from innovating. As regards the idea put forward by the noble Lord, Lord Winston, that there should be some sort of oversight by a clinical or research ethics committee, that would add a very significant level of bureaucracy. Considering the time it would probably take to receive a response, it would act as a barrier to innovation. As the noble Lord knows, research ethics committees are specialists in considering research proposals and would not necessarily be qualified to comment on innovative clinical practice. They do not necessarily have universal coverage and they would not necessarily have the requisite knowledge to advise doctors on very specialised innovative new practices.
However, I have heard the legitimate concerns of noble Lords today, and I commit on behalf of the Government to explore this issue further and constructively with the relevant professional bodies. It will clearly be helpful to understand, should this Bill become law, what might be useful in terms of record keeping and reporting in relation to medical innovation. Furthermore, I commit to ensuring that any guidance that may be appropriate is developed and made available in a timely manner. I hope the intention to issue guidance will be of help to my noble friend Lord Kirkwood.
Amendments 12, 14, 18 and 21 seek to ensure that consent is sought and that proper consideration is given to the views of the patient. My noble friend Lord Saatchi’s Amendment 12 ensures that to fall within the Bill a doctor must obtain any consents required by law. This amendment also ensures sufficient protection for the views of the patient. Furthermore under the existing law of consent patients already have the right to information about the testing and treatment options available to them.
The noble Baroness, Lady Masham, posed questions about drugs. She asked me whether the NHS would pay for unapproved drugs or whether the patient would have to do so. It is worth noting that nothing in the Bill allows doctors to bypass any processes or requirements set by the trust that they are working for. This would include ensuring that the trust would fund any treatment if it were to be provided within the National Health Service. She was fearful that this could result in a two-tier health system in which a patient would be required to pay for innovative treatment. The Bill does nothing to alter funding arrangements for accessing innovative treatments within the NHS, as I have said. That will be governed by whatever rules apply in the trust concerned. However, the Bill also does not change the ability of patients to pay for private medical treatment, as they are able to do now.
Lord Turnberg
I am sorry to interrupt the Minister’s flow. Does he not think that that is confusing for doctors in an emergency situation, wondering which route to take and about the options at that stage, rather than just getting on with the job?
Earl Howe
Personally, no, I do not—although my noble friend may choose to address that point. I believe that what initially motivated my noble friend to introduce the Bill was a perception on his part that there are doctors out there who are afraid to innovate, and perhaps afraid to innovate even on the spur of the moment, for fear of being litigated against. If that situation were to apply, that doctor could regard the Bill as a useful way forward. I do not think that that poses any confusion, because my noble friend is proposing to bring the Bolam test forward, as he has clearly explained, so that the essence of the principle that the courts look at would apply in whichever course the doctor chose to take.
The noble Baroness, Lady Wheeler, made a point about conflict of interest. The Bill makes it clear that the doctor will be protected from a successful claim in negligence only where they have reached a responsible decision. That includes a requirement to consult with one or more appropriately qualified doctors. In choosing which doctors would be most appropriate to consult, a doctor would need to be confident that their views would enable him or her to reach a responsible decision in order to benefit from the protection offered by the Bill. Just to make the point absolutely clear, I say that the Bill does not change the law of consent in relation to children or people who lack capacity, whereby any treatment provided to them by a doctor must be in their best interests.
Amendment 10 would add a requirement on doctors to act in manner that is reasonable and proportionate. My noble friend Lord Saatchi’s Amendment 11 would ensure that a doctor must be acting responsibly in an objective sense when making a decision to depart from the existing range of accepted medical treatments for a condition. Under the law of negligence, “reasonable” and “responsible” have the same meaning. Therefore, the Government’s view is that Amendment 10 is unnecessary.
Amendment 24 would clarify that doctors would not have to follow the steps of the Bill in an emergency. My noble friend Lord Saatchi’s Amendment 29 ensures that it is for the innovating doctor to decide whether to take the steps set out in the Bill or to rely on the existing Bolam test, as I have just explained. There is no requirement to follow the Bill.
My noble friend’s package of amendments ensures that the Bill comes as close as possible to achieving the policy intent of bringing forward the Bolam test to before treatment is carried out. The amendments would do this in a non-bureaucratic way by avoiding the creation of new approval structures or alteration of the remit of existing groups such as multidisciplinary teams. They provide a critical safeguard in ensuring that there is both expert peer review of the doctor’s proposal and that the doctor acts responsibly. The Bill would not provide any protection to a doctor who carried out an operation or procedure negligently. The Government would not support any Bill that sought to prevent patients who receive negligent treatment from seeking compensation or which sought to remove the requirement of doctors to behave responsibility and in the best interests of their patient.
I will turn briefly to the questions put to me by my noble friend Lord Kirkwood. First, he asked me whether the Bill would apply to pharmacists who dispense medicines. The Bill applies to a decision by a doctor to innovate, which would include a decision to prescribe an innovative medicine. The Bill does not impact on the reliability of a pharmacist who provides a patient with a medicine in accordance with a doctor’s prescription.
My noble friend also asked whether the Bill would apply in Scotland. It would apply in England and Wales but not Scotland or Northern Ireland. Medical negligence law is within the legislative competence of Northern Ireland and Scotland, but not Wales. He also asked me whether there is a conflict between the Bill and the common law. Under both the Bill and the common law a doctor will not be negligent if they have acted responsibly. The Bill, so far as possible, brings forward the common-law Bolam test, as I have explained, to before the doctor offers treatment. There is therefore no conflict between the requirements under the Bill and the common law. The Bill simply offers doctors a way to demonstrate and be confident before providing treatment that they have acted responsibly and thus not negligently.
As regards the cost of implementing the Bill, which my noble friend also asked me about, my reply to him at this stage is that there is not sufficient evidence for us to arrive at a cost figure. The impact of the Bill is by its very nature hard to predict.
I hope that noble Lords will accept my noble friend’s package of amendments in this group—that is to say, Amendments 8, 9, 11, 12, 16, 20, 25, 26 and 27. It is the Government’s view, based on medical and legal advice, that together these amendments do all that is necessary to protect patients, while freeing doctors to innovate responsibly without undue bureaucratic burden.
Lord Saatchi
My Lords, I thank all noble Lords who have spoken on this group, which was initiated by the noble Lord, Lord Turnberg. Many interesting points have been made on ethics, law, science and medicine. I am sure that we will all agree that the Minister has dealt with them all admirably. He certainly put the points better than I could have myself, and I hope that he has covered most of what was said.
What can I add to what my noble friend has said? I do not want to descend into anecdotage, but if any noble Lord sensed a reluctance on my part in relation to these amendments, perhaps this will help. I was taught the importance of what the noble and learned Lord, Lord Mackay, and the noble Baroness, Lady O’Neill, said as regards trying to maintain the simplicity of the Bill in an exchange with the noble and learned Baroness, Lady Butler-Sloss. At an early stage Daniel Greenberg, the Parliamentary Counsel, who has been the draftsman of the Bill throughout, showed her the first or second draft and said, in effect, “What do you think?”. She replied, “Make it shorter”.
Over the course of the last two years we have tried very hard to keep the Bill in a state which I think the noble and learned Baroness and the noble and learned Lord, Lord Mackay, would approve of. I learnt from her that the courts want to have an Act of Parliament that is absolutely crystal clear in its intent, so that there is no doubt and confusion at all in the mind of the court about what Parliament intended with this or that clause, phrase or wording. We have tried very hard to do that. I reassure your Lordships that if that has in any way given the appearance of reluctance on my part, I am deeply apologetic.
I would certainly welcome following up the suggestion of the noble Baroness, Lady Wheeler, and those of many other noble Lords. The noble Lord, Lord Kirkwood, had an excellent wish list of following up Committee today—with your Lordships’ approval—with discussion between now and Report to see where we can get to. I am trying only to deliver to the noble and learned Baroness, Lady Butler-Sloss, and her fellow judges in the courts, an Act of Parliament that is simple, completely straightforward and totally clear, and which does what it is supposed to: provide clarity and certainty at the point of treatment both to the doctor and the patient. As noble Lords can see, I am resisting the enormous temptation to revert to a Second Reading speech, so I will now sit down, after a long group of amendments, so that we can go on to the next group.
Lord Turnberg
My Lords, I am very grateful to the noble Lord, Lord Saatchi, and to the Minister for their comments and their acceptance of many of the points that we made in these amendments and in Amendment 1. I commented earlier on many of the points that have been made. I am somewhat disappointed that the Minister does not like the idea of ensuring that agreement in writing is put into the patient’s record—I thought that that would be quite a useful thing to have. However, perhaps we can talk about that at a later date. Meanwhile, I beg leave to withdraw my amendment.
Lord Pannick
Lord Pannick
My Lords, Amendment 2 refers again to the concept of “reasonable” innovative treatment. I will be very brief on this. First, I am reassured by the comments just made by the Minister that as a matter of law, “responsible” and “reasonable” in this context have the same meaning. Secondly, I am persuaded by the noble Baroness, Lady O’Neill of Bengarve, that we do not also need a criterion of proportionality in this context.
Thirdly and finally, the noble and learned Lord, Lord Mackay of Clashfern, pointed out that in this context of innovation there is of course by definition a limited amount of information already available. That is why innovation is required. My concern is that to justify the innovative treatment, especially if it causes further pain and suffering, it needs to be based on some evidence or at least on a rational judgment that there are some prospects of success. I should also mention Amendment 4, which would leave out the concept of “reckless” treatment. I note that the noble Lord, Lord Saatchi, has added his name to a similar amendment: Amendment 5. I beg to move.
Lord Saatchi
My Lords, I think that the Minister has answered this point, and I do not know what I can add. The Bill at the moment focuses on “responsible” and “irresponsible”, and it is very pleasing to hear that the noble Lord, Lord Pannick, might accept that the Bill concentrates on that distinction, and that to introduce a reference to “reasonableness” or “proportionality” might risk causing confusion. Therefore, perhaps this is a topic on which he can satisfy himself in the discussions that follow Committee.
Lord Turnberg
My Lords, I strongly support Amendment 2 in the name of the noble Lord, Lord Pannick, for inserting the word “reasonable” for all the cogent reasons that he has given. Amendment 3 follows on from my earlier Amendment 1, which defines “relevant condition” and does not need further discussion here. I am very pleased to see that we have the agreement of the noble Lord, Lord Saatchi, that the word “reckless” will disappear from the Bill.
Baroness Butler-Sloss (CB)
My Lords, I strongly support the Bill as it is drafted. I am relieved that the noble Lord, Lord Saatchi, produced a short Bill; I hope that the House does not think that it was a bad idea to suggest that a short Bill might be more attractive than a longer one. For that reason I am not at all happy about the various amendments that were in the first part of our discussions today.
I do have reservations about the words in brackets in Clause 1(1), and I take the view that the noble Lord, Lord Pannick, is probably right to say that they should be excluded.
Baroness Finlay of Llandaff
My Lords, I added my name to the amendment deleting “reckless” because I felt quite strongly that it detracted from the overall intention of the Bill. This is not about reckless innovation; it certainly must deter irresponsible innovation, but it is about encouraging responsible innovation. I also added my name to Amendment 3, on treatment for the “relevant conditions”, because many of these patients who are seriously ill will have multiple co-morbidities and may have many things happening to them. This Bill is aimed, as far as I have understood, at the principal condition—the condition for which patients are often desperate for some innovative treatment. It should not inadvertently allow lots of other strange things to be presented to patients to cope with many of the other co-morbidities that they may have.
My feeling about that comes particularly from my own specialty, which the House knows is palliative medicine, where we see time and again patients who are very emotionally vulnerable, psychologically fragile and potentially in despair, so they are unable to make sense of what is going on. In that state, they are quite vulnerable to people presenting all kinds of strange treatments with false claims. I will give a specific example from my own practice. We came across a group of patients on a ward who all had small crystals by their bed, and we discovered that a member of staff strongly believed that holding on to these crystals would shrink the patients’ cancers. The evidence for it was absolutely zilch; I think that the patients had paid to have the crystals given to them. That type of so-called experimentation is completely outside the scope of the Bill—and must be outside its scope. That is why it struck me that the wording about the relevant medical condition should feature in the Bill, because of the potential for exploitation otherwise.
Earl Howe
My Lords, this group of amendments seeks to alter the purpose clause of the Bill. Under the law of negligence, the words “reasonable” and “responsible” have the same meaning, as the noble Lord, Lord Pannick, reminded us. As such, the addition of “reasonable” is not necessary and risks creating confusion. Existing clinical negligence law commonly refers to a responsible body of professional opinion. The addition of “reasonable” may suggest that the test under this Bill differs from the existing Bolam test.
The noble Lord, Lord Pannick, asked me whether the Bill required a rational judgment of success. Proposed new subsection (3)(d) in Amendment 12 requires the doctor to consider a number of factors in relation to the proposed treatment. This includes a requirement to consider,
“the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment”,
other accepted treatments, or,
“not carrying out any of those treatments”.
In weighing this up, the doctor must apply an objective standard as to what could reasonably be expected in relation to those treatments. This provides a further safeguard for patients in ensuring that a doctor may not offer an innovative treatment in accordance with the Bill unless he has acted in an objectively responsible way. I hope that that helps the noble Lord, Lord Pannick.
My noble friend’s Amendment 11 seeks to ensure that a doctor must be acting responsibly in an objective sense when deciding to depart from the existing range of accepted medical treatments.
On Amendment 3, the Government do not feel that there is anything to be gained by restricting the scope of the Bill in this way. To set out specific medical treatments or circumstances that would or would not be covered by the Bill would make the Bill complicated for doctors to follow and less flexible to individual patients’ circumstances. This might limit the Bill’s usefulness to patients and doctors alike.
On Amendments 4 and 5, the Government support the amendment to remove the reference to deterring “reckless irresponsible innovation” from the purpose clause. Recklessness has a very specific meaning in criminal law, and the term is out of place in a Bill about the law of negligence. Furthermore, the substantive provisions of the Bill focus on how a doctor can demonstrate that he has acted responsibly. This amendment therefore ensures that the purpose clause better reflects the focus of the Bill. I hope that noble Lords will accept Amendment 4, which brings clarity to the purpose of the Bill.
Lord Saatchi
My Lords, I thank my noble friend the Minister for what he said. I think that there is a consensus on Amendment 5 in my name, that of the noble Lord, Lord Turnberg, and that of the noble Baroness, Lady Finlay, to remove the word “reckless”. I think that we are agreed on that. My noble friend dealt with the point under Amendment 3 from the noble Baroness and the noble Lord. We understand the wish to exclude certain treatments and types of surgery, and perhaps that is something that we can discuss between now and Report.
I share the Minister’s wish to accept Amendment 4 from the noble Lord, Lord Pannick, which removes the reference to deterring quackery from the purpose clause. We are agreed on the view that, if the noble Lord, Lord Pannick, believes that it is important to confine the purpose clause to the positive, we should not insist on the inclusion of both limbs—positive and negative—since as a matter of law the negative flows naturally from the positive in any event. If the noble Lord, Lord Pannick, presses that amendment, I shall support it.
Lord Pannick
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 Blencathra (Con)
My Lords, I say, for the record, that I have been here throughout but below the Bar of the House, so I am not suddenly intervening in the debate.
Inevitably, the Bill of my noble friend Lord Saatchi has been driven by terminal cancer care, and we understand the motivation. As regards the discussions on the first group of amendments, I agree with the noble Baroness, Lady O’Neill, that we have heard from some of Britain’s most distinguished “scalpel” experts but we need to hear a bit more from physicians who have responsibility for long-term and chronic care. That is why I totally support my noble friend’s Bill and the amendments he has proposed but I also support Amendment 6 proposed by the noble Lord, Lord Winston. I support it but I hope that it may not be necessary and that my noble friend Lord Saatchi will see that it is already taken care of in the Bill. However, I would like to flag up in this debate that it is important that the Bill covers innovative drug treatments, including drugs which are not necessarily authorised or approved in this country.
One does not want to get into describing personal medical things—it is a bit grubby. However, as an enthusiast for the Bill, who has experience of innovation approved by medical authorities in this country and has participated in some innovative treatments not approved in this country, I think that the House should hear from the users at the sharp end, so to speak.
I was diagnosed with MS in 1996. It is slow, progressive and each year it slightly tightens its grip. I would say to our distinguished lawyers, as I said at Second Reading, that when one goes to see one’s consultant, one does not go with a lawyer in hand to see whether the consultant makes mistakes and one can sue him. I suspect that, like me, a hundred thousand other MS sufferers and those with Parkinson’s and motor neurone disease all go along to ask, “What is new? Have you seen the latest research? What have you got? Is there anything that will work?”. We know that at the moment there is no cure for MS, although I think that researchers are getting pretty close to finding one, but we want to get palliative care.
As I say, I do not want to go into details but some of the side-effects of increasing MS are pretty nasty and, frankly, life is not worth living unless those side-effects are dealt with. For many MS sufferers, as the nerve endings die, particularly in the legs and feet, the feet drag. No problem there, as one loses some strength in the legs, one can have a wheelchair. But many people suffer a complete loss of bladder control. If one has to go to the loo every 10 minutes, life is just not worth living. An innovative treatment was developed by the Swiss, which was then experimented by the National Hospital in London. Those Botox injections directly into the bladder were not a life-saver but they made life worth living again. Without going into details, I fought my way through to become patient No. 51 in the clinical trials. That treatment has now been approved by NICE after all these years.
I am not saying that I am typical of patients with this sort of slow, progressive disease but I suspect that I am typical of many who will try any innovative treatment. I am 16 days into a treatment with a new drug, Fampridine, which is approved for use in this country but only, I think, in the national neurological hospital in the wonderful Queen Square. I believe that in clinical trials of the drug, 40% of people experienced a 40% improvement in their ability to lift their feet a tiny bit. However, lifting one’s feet a quarter of an inch when one is walking is very beneficial as it stops one tripping over every dead fly on the carpet.
As I say, at the moment there is no cure for MS but these innovative treatments are making life better. After just 16 days of my experimental treatment, I certainly feel a marginal improvement—at least I am not declining further. That may be the only hope one can offer many people—not that we can fix them but we will make the quality of their lives better for the long term and we will try to hold the disease at bay. Therefore, the provisions of Amendment 6 are absolutely apposite.
In October or November of last year, an American research institute, the Scripps Institute, reviewed about 10,000 drugs currently approved in the United States for various conditions and treatments. The staff there discovered, partly by accident, that there was one drug prescribed for Parkinson’s which seemed to repair the myelin sheath, certainly in their laboratory animals suffering from MS. I understand from my research that American doctors have slightly more power to prescribe off-label treatments than do British doctors. If it is in the patient’s best interests, they are entitled to prescribe a medicine which is not authorised or approved for that condition. British doctors do not seem to have that same flexibility or freedom, except perhaps if a drug is prescribed for adults and a child has those same symptoms, they may off-label prescribe a quarter of a pill or half a pill, like half an aspirin given to children with an illness. As I say, British doctors do not seem to have that freedom or flexibility.
The vast majority of people do not have the benefits I have of contacting an American doctor and managing to get my hands on some of those pills. They are prescribed in this country for a certain condition but no doctor can prescribe them for MS patients at present. It will be another five or 10 years by the time all the trials are conducted. I appreciate that this Bill is not about laboratory experiments or turning us into lab rats, although I am happy to go much further than the terms of my noble friend’s Bill and be a lab rat for some of these things. However, unless physicians treating long-term chronic illnesses can prescribe off-label treatments, which they think are in the best interests of the patients, this Bill will have failed. I hope that we can include off-label treatments.
I am obviously not an expert but I am deeply interested—I declare that interest as a patient—in the cocktails of drugs that seem to be available. For many treatments—it is the same for HIV and many others— there is no magic pill about to come on the market that will fix them. However, doctors have discovered that a combination of drugs, cocktails of various things, may have palliative or curative effects. I am on various cocktails of drugs, involving daily injections, weekly pills and various tablets. I can say that most of these are approved in this country but some are not. I am not taking illegal drugs but tablets and pills that have not been approved by NICE but which I, unlike the vast majority of patients in this country, can acquire from abroad. So I hope that if the Bill goes through and if the treatments mentioned in Amendment 6 are automatically included I will, one day soon, able to try those drugs without having to acquire them from doctors in New York. I hope that that would apply to many other patients in this country.
I am supportive of all the contents of Amendment 6 but if my noble friend says that it is not necessary, I am happy to go along with that.
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 Pannick
My Lords, I added my name to Amendment 6 because I agree with the noble Lord, Lord Winston, that it would improve the Bill to provide a definition of the core concept of innovation. As the object of the Bill is to provide greater clarity for medical practitioners, it is surely perverse not to include any definition of that core concept in the Bill. No doubt Amendment 6 needs improvement, perhaps for the reasons given by my noble friend Lord Kakkar, but I could not be persuaded that it is beyond the very considerable skills of the draftsman of the Bill, Daniel Greenberg, to provide a definition of innovation.
Lord Mackay of Clashfern
My Lords, the word “innovation” is a straightforward word in the English language. I am not sure that clarity is necessarily brought by multiplying it by how many in this amendment. Apart from anything else, one of the possibilities of innovation is for a doctor to say, “The standard treatment for this is a particular course of operation and chemotherapy. My belief is that that would not ultimately save you; it would subject you to a lot of pain and suffering and so on. The best thing, as far as I am concerned, is that you should not have any further treatment”. I am not sure whether that comes under the definition in Amendment 6, but if we want simplicity, we should go for perfectly clear English words. “Innovation” is one of them.
Baroness Masham of Ilton
My Lords, I support what the noble Lord, Lord Blencathra, has said. The use of drugs seems much more flexible in the private sector than in the National Health Service. I ask the Minister to look very closely at the funding of these drugs if they are to be accepted in the Bill.
Baroness Wheeler
My Lords, I am pleased that Amendment 28 has been grouped with the amendment of my noble friend Lord Winston and the noble Lord, Lord Pannick, as we have considerable sympathy with their attempts to define innovation. I understand that it is a probing amendment. We consider that the Bill would benefit from a clearer understanding of what we mean by innovation and indeed of some of the exclusions that would apply that were referenced in the earlier comments on Amendment 19. I am grateful to my noble friend Lord Giddens. His perspective on that was helpful. I look forward to the response on that.
Amendment 28 is also a probing amendment and underlines that medical innovation and the adoption of new treatments require the whole NHS to make both research and innovation its business. The Secretary of State, the NHS regulators and all the key NHS bodies have a clear responsibility and the authority that they need; they need to use it. We have had many debates in this House that recognise the scale and pace of innovation taking place across the NHS and the frustrating barriers that prevent innovative treatments being adopted.
The noble Lord, Lord Saatchi, considers that doctors’ fear of medical litigation or disciplinary proceedings is a key factor that,
“reinforces a culture of fear and defensive medicine in the NHS”.
Whether medical litigation evidence supports that or not, we need to keep emphasising that it is just one of a number of barriers that have to be overcome. I know that the noble Lord recognises this as the context for his Bill. As Sir Robert Francis QC puts it:
“The real obstacles to responsible innovation are not to be found in the Bolam test but in the minefield of regulation and bureaucratic inertia which doctors presumably have to surmount, not to mention the reluctance to fund innovative treatment”.
The contribution of the noble Lord, Lord Blencathra, underlines that we are far too slow in this country to introduce new treatments.
The Health Research Authority is still yet to make a real impact on speeding up the painfully slow, complex and bureaucratic process of getting innovation in care and treatment adopted in the NHS. There is huge frustration across the NHS that existing pathways and mechanisms are not being fully used, such as the single portal of entry and single application procedures for clinical trials. NHS trusts’ slow implementation of the UK life sciences strategy, Innovation, Health and Wealth, and the very low level of awareness and action that they have taken on that strategy are continuing causes for concern.
Most important too is the role of Health Education England in ensuring that innovation and research are incorporated into the education and training of key medical and other health staff. The excellent vision report from the Association of Medical Research Charities, which my noble friend Lord Turnberg takes every opportunity to raise and endorse, showed the huge challenges we face in building support among doctors and patients for participating in research that leads to innovation.
As research and innovation go hand in hand, we were keen to include reference to research and innovation in our amendment, but I hear what has been said by the noble Lord, Lord Saatchi, and the Minister on this. I note that the Medical Defence Union, while now supporting the changes the noble Lord, Lord Saatchi, has made to the Bill, also makes the point about the importance of research being included because that is where most innovation takes place. It is concerned on this issue because it feels that many doctors are likely to be uncertain about whether the Bill would apply to innovation they are contemplating. This may hold up a proposed treatment or procedure while they check the position. In most cases, the Bill will not apply. Even where innovation arises out of a research project, doctors are likely to want to ensure that information gathered in treating the patient contributes to overall research in that area, and the MDU is concerned that the wording of the Bill may prevent that. I would be grateful for comments on this point from either the noble Lord, Lord Saatchi, or the Minister.
Our amendment seeks to place the Bill in the context of the duty of the Secretary of State and the key bodies of the NHS to support responsible innovation in medical treatment and makes it clear that that is the overall purpose of the Bill. I would welcome a response from the noble Lord, Lord Saatchi, on whether, despite his desire to keep the Bill short, he considers that a clear definition of the core concept of innovation, as the noble Lord, Lord Pannick, said, could be incorporated into the Bill as a reference to its overarching purpose. I would also appreciate the Minister’s comments on this.
Baroness O'Neill of Bengarve
My Lords, before the noble Earl responds, I would like to know whether other noble Lords think that this attempted definition of “innovation” does not perhaps inadvertently classify some entirely traditional medical treatments as innovations simply because they have been around for much longer than randomised clinical trials with equivalent clinical validation, and there will be no published evidence of their risks and benefits in peer-reviewed medical journals. I have in mind such homely treatments as prescribing the drinking of a lot of water, taking the waters or dietary advice. Many such things seem to be medical treatments but have probably not been documented in the journals.
Baroness Butler-Sloss
It seems to me that if one is going to have Amendment 6, instead of saying that it “means”, it should say that it “includes”. That would then leave open everything else that might come in as medical innovation.
Earl Howe
This group of amendments seeks to define innovation and the scope of the Bill. This is a uniquely difficult task as innovation is, in essence, about constant improvement, change and progression. It is essential that in the act of defining we do not inadvertently limit responsible innovation. I ask the Committee to take on board the point neatly made by my noble and learned friend Lord Mackay.
Amendment 8 to Clause 1(2) in the name of my noble friend Lord Saatchi limits the scope of the Bill to situations where a doctor departs from,
“the existing range of accepted”,
medical treatments for a condition. This will be well understood by doctors, who are best placed to know whether they are following accepted treatments. This amendment also ensures that the Bill applies only to medical treatment.
A further provision, Clause 1(4)(a), ensures that the Bill applies not to research but only to the care of individuals. This exclusion of research is sufficient to achieve the same effect as Amendment 6 in the name of the noble Lord, Lord Winston. I hope that that clarifies that point for the noble Baroness, Lady Wheeler.
The Bill’s definition of innovation allows for situations in which doctors choose to carry out no treatment in the best interests of the patient. The definition of innovation in medical treatment proposed by the noble Lord, Lord Winston, would exclude that. I hope that that point, if no other, will give him pause when he decides what to do with Amendment 6.
There is another basic point to make here. Defining innovation on the face of the Bill would restrict the application of the Bill and could risk uncertainty for doctors as to whether the protection offered by the Bill would extend to the treatment that they are proposing. It is important that the scope of the Bill is clear to the medical profession.
Moving on to Amendment 28, the Government do not believe this to be necessary. The Government are already fully committed to promoting innovation which can save and improve lives. The Committee may be aware that NHS England has a full programme of initiatives to unblock innovation and disseminate the benefits to the NHS and beyond—something that the Government fully support. These include Innovation Connect, a programme to help innovators in the health service and industry to realise their ideas, embed them into clinical practice and exploit new opportunities in international markets, NHS innovation challenge prizes to encourage, recognise and reward front-line innovation and drive the spread and adoption of these innovations across the NHS, and the NICE Implementation Collaborative, which supports work streams by providing essential support to overcome identified barriers to innovation. Those are just some examples.
My noble friend Lord Blencathra asked in particular about off-label treatments. Without repeating the answer that I gave earlier to the noble Baroness, Lady Masham, on a similar issue, the Bill sets out a series of steps which doctors can choose to take when innovating to give them confidence that they have acted responsibly and with the intention of reducing the risk to doctors of successful claims of clinical negligence. With that threat diminished, the intended effect is that doctors will be confident to innovate appropriately and responsibly. That applies in full measure to off-label treatments. I would say as an aside that the cancer drugs fund, which has enabled access to a number of novel medicines, including off-label treatments, has benefited more than 55,000 patients since September 2010. So the decision on whether to prescribe unlicensed or off-label medicines will remain a matter for the doctor or prescriber who has clinical responsibility for the patient’s care, taking into account their individual clinical circumstances.
In response to the noble Baroness, Lady Masham, about funding, I should make the simple point that the Bill does not add any extra funding for drugs. Funding may be a consideration in certain circumstances, but the Bill does not affect the situation one way or the other.
I hope that noble Lords will take into account the Government’s view that innovation is best defined as a departure from the standard range of existing medical treatments, and that on reflection the Committee will not accept Amendments 6 and 28.
Lord Saatchi
My Lords, as we have just heard, Amendment 6 attempts to make a definition of “innovation”. I myself think that that is quite difficult to do, even though the noble Lords, Lord Pannick and Lord Winston, made it clear that they are trying to provide a definition in order to assist the purposes of the Bill. I find it difficult to do for the reasons given by my noble and learned friend Lord Mackay. The word is clear and the Minister has just defined it even more clearly, which is that innovation is a departure from the standard procedure. I am advised that that definition of the concept is sufficiently clear for doctors, patients and the courts to be able to judge in the light of the circumstances of each case. I am told that the proposed definition also refers to some procedures, so that the legislation may become outdated at some point.
The main point in plain English is that the noble Lord, Lord Winston, himself described innovation elsewhere as being serendipitous; in other words, the term has in it the concept that what is about to happen is unheard of and unknown, and therefore it is a true innovation because it has not been conceived of. It is quite difficult to make a definition, but perhaps that is something we can talk about with the noble Baroness, Lady Wheeler, when we meet before the Report stage.
I wish I could say something more encouraging to the noble Baroness, Lady Masham, about funding. Many people have said to me over the course of the long journey of this Bill that, “This is all very well, but what we actually need is more money. If we had more money, we could have more innovation for every disease”. I really do not know whether that is true because there are completely different views about it. However, the one thing that is certain is that this Bill, as my noble friend the Minister said, does not do anything to increase the UK GDP, nor does it increase the percentage of UK GDP that is spent on health, nor does it increase the percentage of UK health spending that is spent on innovation. As my noble friend has just said, it has no impact on what the noble Baroness is interested in hearing, which is on the subject of funding. It is completely neutral.
I will come to Amendment 28 in a moment. Perhaps at this point I could say that it is wonderful to hear my noble friend Lord Blencathra speak because we are hearing the true voice of the patient, as I understand it. We all say that what we do in this House and in the Department of Health is putting patients first. If that is what we are doing, your Lordships have just heard the true voice of the patient and nobody has ever expressed it better.
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.
Lord Saatchi
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I must inform your Lordships that if Amendments 11 and 12 are agreed to, I cannot call Amendment 13 on grounds of pre-emption.
Amendments 11 and 12
Lord Saatchi
“(3) For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, the doctor must in particular—
(a) obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment,(b) take full account of the views obtained under paragraph (a) (and do so in a way in which any responsible doctor would be expected to take account of such views),(c) obtain any consents required by law to the carrying out of the proposed treatment,(d) consider—(i) any opinions or requests expressed by or in relation to the patient,(ii) the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment, the treatments that fall within the existing range of accepted medical treatments for the condition, and not carrying out any of those treatments, and(iii) any other matter that it is necessary for the doctor to consider in order to reach a clinical judgement, and(e) take such other steps as are necessary to secure that the decision is made in a way which is accountable and transparent.”
Lord Saatchi
“( ) For the purposes of subsection (3)(a), a doctor is appropriately qualified if he or she has appropriate expertise and experience in dealing with patients with the condition in question.”
Lord Saatchi
Lord Saatchi
Lord Saatchi
My Lords, in moving Amendment 23 I will speak also to Amendment 29 in my name.
Amendment 23 is a paving amendment. The substantive amendment in this group is Amendment 29, which inserts a new clause into the Bill after Clause 1, expanding the existing provision that states that the Bolam test is unaffected by the Bill. It is for the innovating doctor to decide whether to take the steps set out in the Bill or to rely on the Bolam test as at present. The new clause also includes express provision that doctors are not negligent merely because they have not followed the Bill. I beg to move.
Lord Turnberg
My Lords, I am very pleased to see Amendment 29 in the name of the noble Lord, Lord Saatchi. I support it because it allows doctors to continue to rely on the current common-law arrangements based on the Bolam principle and on a body of reasonable medical opinion. It means, however, that there are now three options open to an innovating doctor. He or she can engage in a research clinical trial in which ethics committee approval has been given, the patient has given consent and all the regulatory approvals have been given, he or she can rely on the Bolam principle and take all the precautions that that entails or he or she can go through the processes outlined in this Bill in the belief that this will somehow avoid the fear of litigation under the common law. I just wonder whether that might lead to a little confusion and lead doctors simply to use and rely on the current common-law principle. However, I am happy for this amendment to be approved. I see that it would be a useful amendment to the Bill because it gives the doctors the opportunity to use what they always have done.
Lord Kirkwood of Kirkhope
Perhaps I may expand on the point I made on the first group of amendments. I am grateful for the comment from the Minister, which I understood as far as it went. I agree with what the noble Lord, Lord Turnberg, has just said. This changes how the regulator approaches a complaint, as far as I can see. It would not change the way that the regulator decides whether there is a case to answer but it seems that this clause—which I think I welcome—gives the doctor an option of which defence he uses against the allegations in front of him.
As I know from previous experience, the General Medical Council has very clear, long-established systems for determining how complaints are lodged and how fitness-to-practise procedures are put in hand. It is very carefully controlled. Do I understand that the proposed new clause in Amendment 29 would merely—if I can put it that way—give the doctor against whom the complaint was alleged the choice of one of these channels of defence in relation to any complaint made against him by the regulator? I am still not clear as to whether I understand this properly. I think I am in favour of this amendment but I am not too sure. If anybody can help me understand it better, I will be really pleased.
Baroness Wheeler
My Lords, we have had a very authoritative and detailed contribution on the issues raised by Amendment 29 from the noble Lord, Lord Saatchi. Opinion among noble Lords and indeed the stakeholder medical and patients’ organisations is still divided on: first, whether a change to the law is required or whether the existing law and professional ethics arrangements will allow responsible innovation; and secondly, whether the potential two options/processes—or three as my noble friend now makes it clear will be available if the Bill becomes law—will improve and speed up the administering of innovative treatments or will cause considerable confusion among doctors about which system they should use, lead to more bureaucracy and deter them from embarking on the course?
As we said earlier, we welcome the attempts of the noble Lord, Lord Saatchi, to ensure that with this amendment the Bill does not affect the common-law Bolam test. On the overall Bill he has led a powerful campaign and is reported to have won the support of patients responding to the consultation and the publicity from Cancer Research UK, Marie Curie Cancer Care and other patient organisations. I was pleased that the noble Baroness, Lady Masham, raised a number of questions from Marie Curie about palliative care and the use of drugs arising from issues in the Bill, and I was grateful for the Minister’s very helpful response.
The General Medical Council has now given its support to the amended Bill and the Medical Defence Union has said that the amendments cover the main objections to the previous Bill. However, we have to acknowledge that some key stakeholders maintain that the Bill is not necessary because the existing law already ensures protection for doctors to innovate, and the current law and ethical guidance from the General Medical Council are clear. The Royal College of Surgeons still has strong reservations about the Bill, particularly about it applying to surgery, as we have heard. The Medical Protection Society still believes that it confuses rather than clarifies the law. The Association of Personal Injury Lawyers says that the amendments make a confusing Bill even vaguer. The BMA still strongly questions the necessity and desirability of clarifying or changing the law. Action Against Medical Accidents, one of the leading patient organisations, still says that the Bill is fraught with unintended and dangerous consequences and will create a more bureaucratic system. Sir Robert Francis QC, while considering that the amendments have produced an improvement in safeguards over what was originally proposed, has said that serious problems remain. In particular, he is concerned, as my noble friend Lord Turnberg pointed out earlier, that the Bolam amendment, while restoring a level of safeguard, also has the disadvantage of restating Bolam in different language, leading to a real risk of confusion. His question is: why not just stick to Bolam? I would be grateful for the noble Lord’s comments on that.
Will the noble Lord, Lord Saatchi, and the Minister tell the Committee whether they consider that the amended Bill now meets Dr Dan Poulter’s key test that I referred to earlier; namely, of not placing an undue bureaucratic burden on the NHS or not exposing doctors to a risk of additional liabilities?
I welcome the response of the noble Lord, Lord Saatchi, on the question of convening a round table, which I think will be a very helpful way of going forward. Obviously, it will never be possible to satisfy everybody’s concerns but, if the Bill is to be further supported, what steps will be taken by the Government to engage with stakeholder concerns?
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?
Lord Woolf (CB)
My Lords, before the Minister replies, perhaps I could just make a comment. I have resisted getting involved in the various excellent speeches that have been made so far. While I am on my feet, I make it clear that I strongly support the noble and learned Lord, Lord Mackay. There is a danger in looking at these as alternatives. If the matter comes before the court—of course, one hopes that it will not—the court’s approach would be to say that there is nothing in the Bill, because of the amendment we are now considering, which prevents the Bolam test being relied upon as it is today, without the Bill.
On the other hand, if the situation is one that enables the Bill to be relied on, that is another matter that the person can rely on. In some situations, such as a state of emergency, it may not be possible to rely on the Bill, but that does not prejudice the doctor involved in any way, because the Bill leaves the Bolam test intact. It is supplementing the Bolam test, and the importance of the fact that it is supplementing it is apparent in the fact that it states that if the doctor can comply with the Bill, he knows that he is safe and does not have to wait until the Bolam test has been applied to find out whether he is in danger. I think that that is understood. Does the Minister agree with my approach, which is that these are not alternatives?
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.
Baroness Gardner of Parkes
Can I seek some clarification? I wonder whether anyone could make clear for the Committee whether, if the doctor says that he does not want to do the innovative treatment, there is a defence in court on the grounds that he thought that it would be unwise or unsatisfactory. I say this because everyone seems concerned about the effect of not doing something innovatory.
Earl Howe
I can reassure my noble friend on that score that a doctor’s clinical judgment not to go ahead with something innovative would be something that the doctor would be able to cite in court, if necessary, as being the most reasonable course to take in the circumstances.
Lord Saatchi
Lord Saatchi
“Effect on existing law
(1) Nothing in section 1 affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion.
(2) Accordingly—
(a) where a doctor departs from the existing range of accepted medical treatments for a condition, it is for the doctor to decide whether to do so in accordance with section 1 or in reliance on any rule of the common law referred to in subsection (1);(b) a departure from the existing range of accepted medical treatments for a condition is not negligent merely because the decision to depart from that range of treatments was taken otherwise than in accordance with section 1.”
Lord Turnberg
“Code of practice
(1) The Secretary of State may issue one or more codes of practice in connection with—
(a) the process to be undertaken by a doctor before giving advice under this Act;(b) the form in which the agreement required under section 1(2)(d) is to be recorded;(c) the factors which the doctor should take into account in deciding to offer advice under this Act;(d) requirements for making and keeping records required by the Act;(e) such other matters relating to the operation of the Act as the Secretary of State thinks fit.(2) Before issuing a code under this section, the Secretary of State shall consult such persons as he thinks appropriate.”
Lord Turnberg
As we have heard, my Lords, there is a degree of uncertainty surrounding certain aspects of the Bill that we have been trying to clarify. It is on that account that I have tabled Amendment 31, which sets out the need for a code of practice in which the Secretary of State describes in somewhat more detail what the Bill is about and how it should be enacted. I hope that it will be helpful to have that in the Bill.
Lord Hunt of Kings Heath (Lab)
My Lords, this has been a fascinating debate, both in Committee and at Second Reading. We are all very grateful to the noble Lord, Lord Saatchi, for listening carefully and bringing the amendments that he has today, and for agreeing to a roundtable discussion between Committee and Report, which is a very constructive response to some of the issues that have been raised.
I say at once that I am absolutely with the noble Lord on the need to encourage innovation in our NHS, but the more that I have listened to the debate, the more convinced I am that it is not so much a question of the law but more one of actual practice within our NHS. I am afraid that we have to face up to the fact that there is a culture of regulatory processes and funding procedures that often get in the way of introducing innovation. For me, the Act that the Bill will become will be a signal to the NHS.
The noble Lord, Lord Blencathra, raised some interesting points about some of the problems that we have at the moment. He talked about off-label medicines. The Minister responded by saying that the Government are committed to innovation and gave a number of examples, which were welcome, but the point that I would put to him is that we now have a situation where NICE produces technology appraisals of new innovative procedures and drugs that clinical commissioning groups are essentially breaking the law by not implementing. He knows that they are under a requirement to fund the use of those procedures and medicines within three months of the technology appraisal being issued, yet we know from research by patient groups that the actual implementation is patchy. We could do an awful lot in relation to innovation if we insisted that people locally did what they were required to do.
My second point relates to the drug budget, an issue that the noble Lord raised. A few months ago the Government concluded an extremely interesting agreement with the branded drug companies, so that for five years the cost of branded drugs in England, apart from modest rises in inflation, will be fully met by the pharmaceutical industry. This is a very good agreement and one that I very much welcome. We still hear people in the NHS saying that they cannot afford the new drugs, yet the industry has promised to pay back any increase in the cost of those drugs over what they are paying now plus a modest increase in inflation. Here is a wonderful opportunity at last for the NHS to move quickly in widely adopting new medicines, but somewhere in the system someone is stopping it. I have read the NHS England five-year plan and it says nothing about the introduction of innovative new medicines.
I am sorry that this is a little outside the noble Lord’s Bill and I hope that he will forgive me, but this is about innovation. I am genuinely puzzled, and we will come back to this point, about why the Government did not rush to insist that the NHS took advantage of the agreement. In fact very few people in the NHS know about the agreement. My concern is that the rebates that the drug industry is going to give will be used for other purposes, which would be a very big mistake.
I hope that the Minister will agree to the amendment; I strongly advise him to do so, or at least to consider it. It is clear from the speeches that have been made that there is some confusion about the circumstances in which the noble Lord’s provisions are going to be made. Earlier in our debates, the noble Earl essentially said that doctors would have a choice when it came to whether, in relation to a given medical treatment, they would use this Bill’s provisions or rely on the traditional approach, the Bolam test. The noble and learned Lord, Lord Woolf, said that they are not alternatives and, in the circumstances raised by one noble Lord where there was not time to get the advice of the clinicians that is provided for in the noble Lord’s Bill, you would rely on the Bolam test. I am only a lay person, but I suspect that there is a risk of doctors not catching the nuance of that distinction. It is clear from the various letters that we have had from many of the medical bodies that there is some concern about this. I know that the noble Lord will speak and I strongly endorse his amendment on the regulation-making power, but I strongly advise the Government to agree to issuing guidance to the medical profession in this regard. There is a danger of some confusion and such guidance would be useful. If the noble Lord is not able to accept this amendment today, perhaps he will give it some further consideration.
Earl Howe
My Lords, the Government’s view is that it is not necessary to include in the Bill a provision for the Secretary of State to issue codes of practice about the Bill, but I hope that I can reassure the noble Lord, Lord Hunt, on the last point that he made. If the Bill is passed, the Government will work closely with the professional bodies, including the General Medical Council, to help doctors to prepare for the changes to the law. This will include producing any guidance that may be helpful.
I listened carefully to the points that the noble Lord made about the adoption of innovative treatments in the National Health Service. He knows from his experience as a Minister that this issue has been with us for quite a long time. We have silos of innovation and forward-thinking practice throughout the health service. The challenge has been to spread that innovative behaviour more widely and for the diffusion of innovative treatments to become second nature to the health service. It is a cultural issue.
The noble Lord is right to say that in many cases the non-adoption of NICE-approved drugs is a particular feature in parts of the NHS. That is exactly why the document Innovation, Health and Wealth was published some time ago. It is why we now have the NICE implementation collaborative, which is designed to bring together the key players in the system to ensure that NICE-approved medicines are adopted. There is the innovation score card, which helps in this regard. The academic health science networks are there to shine a spotlight on promising new innovative devices and medicines and to spread them at pace and scale throughout the health service. The early access to medicines scheme is another example of where we are trying to give patients access to innovative treatments, even before they have been licensed.
There is on occasion a good reason why a NICE-approved medicine may not be adopted by a particular trust. That is quite simply that for a given condition there are many alternative treatments, many of which have been endorsed by NICE. The Government cannot mandate clinical decision-making by individual doctors. Where there is a choice between one and another NICE-approved medicine available to a doctor, it is open to the doctor to make that choice. Nevertheless, the noble Lord’s basic point is well made and I hope that he will accept that the Government are taking a number of measures in conjunction with NHS England to ameliorate the situation.
I hope that, with the remarks that I made earlier about producing guidance, the noble Lord will be reassured and the noble Lord, Lord Turnberg, will not press his amendment.
Lord Saatchi
My Lords, perhaps we could add this point to the discussions that we are going to have before Report. My noble friend the Minister expresses a modest view of what the Government should and should not do and wants to leave it to the regulatory bodies to make this happen.
I refer once again to anecdote. The noble Lord, Lord Turnberg, said to me at an early stage in this process, in which he has been a great inspiration, “What are you going to do after the Bill becomes law?”. I said, “I am going to go on a very long vacation”. He said, “Oh no you’re not”. I said, “Why not?”. He said, “Your work is only just beginning”. His point, and he speaks as an expert, is that a culture change is contained in this Bill. “Culture change” is a phrase that my noble friend just used, and it was used by Dame Sally Davies, the Chief Medical Officer, many months ago. A culture change is being sought, but it will not happen overnight. It will follow, exactly as the noble Lord, Lord Hunt, says, a great deal of education and discussion in the medical profession.
Not to go on, but the noble Lord, Lord Turnberg, said that this will fall largely not just on the regulatory bodies, such as the GMC and NICE, but on the royal colleges. They will have to be involved in the process of educating people about what this means. This is the beginning of the process and I am rather with my noble friend in not wanting to have the Government set out the rules. I hope that that is acceptable to the noble Lord, Lord Hunt.
Lord Turnberg
My Lords, I am slightly reassured by the noble Earl’s comments that the Government’s intention is to produce some guidance with help from the relevant bodies. I am sorry that he does not think it necessary to have that in the Bill. I wonder why not. He has not explained why the amendment should not be there, because it sets out the need for such a code of practice. Meanwhile, however, I beg leave to withdraw the amendment.
Lord Saatchi
“(1A) Sections 1 and (Effect on existing law) come into force on such day or days as the Secretary of State may by regulations made by statutory instrument appoint.
(1B) Regulations under subsection (1A) may—
(a) appoint different days for different purposes;(b) make transitional or saving provision.”
Lord Saatchi
My Lords, I also speak to Amendments 37 and 38 in my name and Amendment 36 in the name of the noble Lord, Lord Turnberg. Amendments 35, 37 and 38 amend Clause 2 of the Bill on commencement and provide for the Bill to be brought into force by the Secretary of State. I am content with this change proposed by my noble friend, on the basis that it will allow time for the Department of Health and professional bodies to produce any guidance that may be helpful. Amendment 36 would stop the Bill coming into force on Royal Assent and would allow the Government to control commencement. The amendment has essentially the same effect as my amendment and I hope that the noble Lord, Lord Turnberg, will be content not to press it. I beg to move.
Lord Kirkwood of Kirkhope
Not to prolong events, I support Amendment 35, which I think is sensible. It is necessary to make sure that steps are taken so that practitioners are fully advised and informed in England and Wales about the provisions in the Bill. I assume that the answer to my question is yes, but can I have an assurance that the regulators have the full Section 60 power that they would need to implement this? If there is any doubt about the regulators not having complete legal cover, will the department make sure that any Section 60 provisions for those powers are put in place before these statutory instruments are brought forward, to avoid any confusion?
Lord Turnberg
My Amendment 36 has a similar effect to that of Amendment 35. Mine seems somewhat simpler, but I am quite happy to bow to Amendment 35 in the name of the noble Lord, Lord Saatchi.
Earl Howe
My Lords, this group of amendments addresses how the Bill would come into force. My noble friend Lord Saatchi’s Amendment 35 would ensure that the Bill came into force in accordance with regulations made by the Secretary of State rather than on Royal Assent as under the Bill as introduced. This would allow the Government and the medical profession time to prepare for the changes to the law made by the Bill—for example, to produce any guidance that might be helpful. This amendment also enables transitional and saving provision to be made if necessary. My noble friend’s Amendment 35 achieves the same objective as Amendment 36, which the Government therefore do not consider necessary.
The Government also support minor technical Amendments 37 and 38, which clarify that the section in question comes into force on the day on which the Act is passed. I urge noble Lords to accept Amendments 35, 37 and 38, which would ensure a smooth commencement of the Bill, and I hope that my noble friend Lord Kirkwood will allow me to write to him on the question that he posed a minute ago.
Lord Saatchi
Baroness Finlay of Llandaff
My Lords, I will be brief; this will probably turn out to be a probing amendment. We have an interesting situation in Wales because health and healthcare provision is completely devolved. The experience of patients under the Welsh NHS falls completely within the legislative competence of the Assembly. However, if I am right, this relates to the law of negligence, and the Ministry of Justice does not have any devolved functions. The concern expressed to me within Wales has been about the use of resources and the possibility of practitioners being answerable as regards legislation that covers England and Wales, when the provision of healthcare is something for which they are answerable to the National Assembly. I tabled this amendment with a view to seeking clarification over that.
Sadly, we have had experience of extremely strange medical practices sometimes being put forward in the past. The Assembly is particularly concerned that, with its move toward prudent healthcare, which is a whole policy direction for NHS Wales, the Bill should not inadvertently cut across the principles of prudent healthcare, the first of which is, of course, to do no harm. I tabled the amendment with that in mind.
Earl Howe
My Lords, this amendment seeks to ensure the Bill would not apply in Wales unless a legislative consent Motion had been passed. The operative provisions of the Bill relate entirely to modifying the law of tort, which is a reserved matter. The Bill can fairly and realistically be classified as relating to a non-devolved subject, and therefore not within the competence of the National Assembly for Wales. The Government cannot accept this amendment, and I urge noble Lords to resist it.
Baroness Finlay of Llandaff
I am grateful to the Minister for the clarification. I expected that answer, but it is important to have it on the record. I beg leave to withdraw the amendment.