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.
Amendment 24 in the names of the noble Baroness, Lady Masham, and myself raises the issue of what a doctor may or may not be able to do when faced with an unusual or unexpected situation in an emergency, where there is little or no time to consult anyone else. I remember, for instance, the case of a colleague of mine, an orthopaedic surgeon, on an aeroplane when a patient suddenly became extremely breathless and lost consciousness. He had developed an acute tension pneumothorax, a serious condition in which a lung ruptures and air becomes trapped outside the lung in the chest cavity, where it compresses the lung and the heart. The only treatment is to get the air out of the cavity fast. My surgical colleague on the aeroplane, with no instruments, got hold of a wire coat-hanger, opened it up, plunged a sharp end through the chest wall and followed it up with a small tube from the end of a ball point pen. Air rushed out, the patient recovered consciousness and no one sued the doctor for using an unorthodox treatment. I am also aware of some novel, untried treatments recently used on Ebola victims, without anyone fearing litigation. So Amendment 24 is to make sure that doctors do not feel more constrained than they are already from acting in an emergency. I hope that the noble Lord will agree that this will be a valuable addition to his Bill.
Finally in this group, Amendment 33 brings up the point that regulations made under the Act should be exercisable by statutory instruments. We may return to this later in our debates on some other relevant amendments. I hope that the noble Lord, Lord Saatchi, will recognise that in raising my amendments my intention is to support him as strongly as I can in making innovation in medicine an important part of practice that is safe and practicable, and I hope that he will find these amendments helpful. I beg to move.