Medical Innovation Bill [HL]
Lord Turnberg Excerpts(9 years, 11 months ago)
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Lord Colwyn (Con)
My Lords, I support the amendment in the name of the noble Lord, Lord Winston, providing for a number of medical treatments to be excluded from the Bill. As I said at Second Reading, I have always encouraged innovation and I listened to the examples given by the noble Lord in Committee and to the response from my noble friend the Minister, who said:
“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”.—[Official Report, 24/10/14; col. 886.]
I take the opposite view. Not to state clearly on the face of the Bill where its provisions do not extend would make innovative practice much more complicated for doctors and, I believe, be a risk to patient safety. Surely, if this House is to give its approval to a Bill where both the title and stated aim are to encourage more of something that is already being done on the front line of the medical profession, and furthermore where it actually stands to impact on current good medical practice, then there needs to be maximum clarity about where and when the Bill actually applies. On Report, it falls to the House to ensure that the Bill has clarity. We must do so to limit the potential risks created by my noble friend Lord Saatchi’s Bill and prevent it from extending into areas of treatment where it could pose a risk to the patient.
In Committee, the noble Lord, Lord Winston, gave an example of responsible innovation, describing the treatment of a young woman with a life-threatening ectopic pregnancy. From this example, as with many others, we see how potentially dangerous it would be for the Bill to extend into emergency care, operative surgery, delivery during childbirth and so forth. These areas of treatment must be excluded from the Bill. Where a doctor is in theatre and required to act quickly in a rapidly deteriorating situation, which we all know is a frequent scenario, a Bill such as this, which has the best of intentions, should not have the remotest potential to confuse that doctor about their responsibility, namely, to use their professional judgment and act quickly in the best interests of the patient.
My Lords, a recurring theme in this debate, for good reason, is that current law allows doctors acting responsibly to innovate. The Medical Protection Society, a body that remains opposed to this Bill, notes that, currently, a slight departure from NICE guidance—guidance that has been held to be the established method by which doctors gauge what procedures and drugs are standard—is done on the basis of a doctor’s professional judgment. Common law, rooted in the Bolam and the Bolitho tests for standards of care, underpins that judgment. Yet I believe that the MPS is right to say that the Bill, without greater clarity, would add,
“unnecessary bureaucracy to current good medical practice”,
creating more hurdles to treatment than there are at present. This is why the amendment is so important.
To cover briefly the exclusion of primary care from the Bill, as I understand it, the definition of an “appropriately qualified doctor” is flexible enough for it to be possible to cover treatment in a wide range of settings, including primary care. If the Bill was to reach treatment given in a primary care setting, then there are a number of concerns. In Clause 1 there is a requirement for the doctor to,
“obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment”.
There has been much debate about how effective this is as a safeguard, but in a primary care setting the risk of this requirement being open to interpretation is particularly high. Take an independent general practitioner seeking to perform an innovative treatment through the process outlined in the Bill: who would be the appropriately qualified doctor? Would it be another independent practitioner known to be in agreement? Why would a general practitioner, seeking to innovate irresponsibly, seek the advice of someone they know to be in disagreement?
While such a practitioner is absolutely in the minority of GPs, primary care must explicitly feature in the Bill as one of those areas of medical treatment excluded. Not to do so, I believe, has the potential to risk patient safety. Clinical governance in primary care looks very different to what can be seen in hospitals; GP practices tend to work in greater isolation. The concern among many in the medical community, such as the MPS, which has about 20,000 GP members, cannot be ignored. Its concern is that the Bill is placing primary care doctors in a position where treatment is demanded of them that their decision-making structures do not support them to carry out. It all comes back down to the danger of doctors being falsely reassured, and of patients being led to believe, incorrectly, that their doctor is somehow in a position to perform an innovative treatment for their condition because of the Bill.
I remain unconvinced that legislation is necessary. Continued parliamentary scrutiny is certainly needed and I give the amendment my full support as an important step towards bringing much greater clarity to the Bill and to protecting patients.
Lord Turnberg (Lab)
My Lords, I am pleased that many of the amendments that I and others proposed in Committee have now appeared in one form or another in the amendments before us. I presume that they are acceptable to the noble Lord, Lord Saatchi—many are in his name—and to the Government. May I also say how much I appreciated Daniel Greenberg’s efforts in trying to draft acceptable wording in many of the amendments?
There was considerable correspondence in the media after Committee stage and quite a bit of opposition voiced by the 100 oncologists who wrote to the Times expressing their concern. This was followed by a robust response by the noble Lord, Lord Saatchi, in which he accused them of being reactionary, failing to accept innovations and not wanting to move with the times. Considering that these doctors are among the most forward-looking and innovative researchers in cancer treatment, that was somewhat unfortunate and inappropriate. Their worries, and those of the BMA, the Medical Defence Union, the Medical Protection Society, the BioIndustry Association and the Academy of Medical Sciences, were about whether the Bill was really necessary, suggesting that the barriers to innovation—of which there are many—do not include a fear of litigation. Perhaps more importantly, they were worried about its safety.
These amendments go some way to help on the safety issues, even if they do not make it a necessary Bill—I will not go into that today. In this group, I am glad to see in Amendments 8 and 9 in the name of the noble Lord, Lord Saatchi, that attention has been paid to the need to clarify that the Bill will not interfere with any research or clinical trials. I am very supportive of that. There was a worry that research might be inhibited by the Bill. There is now provision in Amendment 14 to ensure that the Bill will not cut across the need to innovate in an emergency.
Amendment 1 in the name of my noble friend Lord Winston achieves a similar intent and expands on it. His amendment is excellent because it points out how it is important, in an emergency, to be able to innovate without going through this process. I believe that the clarity my noble friend Lord Winston seeks in Amendment 6 by defining “innovation” is very helpful. I hope that the noble Lord, Lord Saatchi, will see it as a helpful clarification and accept it.
Amendment 15 seems to suggest that a doctor will not be legally liable if he or she does not innovate. If it says that then I am strongly in favour of it. I hope that it does. However, there are a number of other issues that require further work. I will raise those points for clarification in a later group. They are concerned with increasing the safety of the Bill.
Baroness Gardner of Parkes (Con)
My Lords, I do not really understand the proceedings, in so far as the noble Lord, Lord Winston, spoke only to two of his amendments. These are all grouped together. I have just consulted with the clerk, but they should really have all been covered. I do not know whether he intends to find some way of coming back to it, but I thought we could speak only once on these things on Report. I am particularly interested in the exact meaning of his Amendment 13. I seek information on this as I read it: would Amendment 13 possibly prevent people using new innovative stem cell treatments, for example? What is the intention of Amendment 13? As he did not speak to either Amendment 12 or Amendment 13, I feel that the House should be informed as to what he means by those amendments, as this is the only opportunity to discuss the group that has been put together.
Lord Cormack
My Lords, I intervene very briefly. In Committee, we heard a very moving speech from my noble friend Lord Blencathra, who is not here this morning. He made it quite plain why he was supporting the Bill. As I listened to the noble Lord, Lord Winston, for whom we all have enormous respect in every possible way, I could not help but think that there really is not much difference between his aims and objectives and those of my noble friend Lord Saatchi. They are far closer together than his moving speech gave credit for.
In response to the earlier amendments that the noble Lord moved, my noble friend Lord Saatchi indicated that he was more than happy to accept the suggestion of a meeting before Third Reading. That is essential, and the points to which the noble Lord, Lord Winston, has alluded in addressing his Amendments 2 and 13 could clearly be on the agenda for such a meeting. If we can move forward in that way and not seek to divide the House this morning, we will be serving a very noble purpose.
Lord Turnberg
My Lords, it is hard not to be moved by my noble friend Lord Winston’s personal experiences and indeed those of the noble Lord, Lord Saatchi; we all have those. However, if I am correct in raising Amendment 3 in this group—I am never quite sure now—my amendment is designed specifically to improve safety. I say to the noble Baroness, Lady Gardner of Parkes, that the whole purpose of these amendments is to improve safety, not to avoid innovation. There is a distinction; you have to be safe if you are going to innovate.
My Amendment 3 is designed to ensure that a doctor who wishes to use an innovative treatment under the Bill will have not only to obtain the views of one or more appropriately qualified doctors but also to obtain their support or agreement. Otherwise, if the doctor got the view of another doctor who was not involved in innovation but who disagreed with him, he would not have to take that view into account. So he should get the support of that other expert in the field. That is an important distinction and I hope that the noble Lord, Lord Saatchi, and the Government will accept it.
On Amendment 7 in this group, I am pleased to see that everything should be recorded in the patient’s record. That is something that we were very keen on in Committee and it is now in the Bill. I think that I understand the sensitivity and reluctance about getting the written consent of the other doctor or doctors to the innovation. It is said that it might leave that doctor liable in case of legal proceedings. I had thought that the whole purpose of the Bill was to avoid legal proceedings, but there you are. It is not entirely clear whether there is a big difference between a signed agreement and the name of the doctor appearing in the notes as someone who has supported or agreed, but I think that I can safely leave that to the judges to work out.
I am very drawn to Amendment 13—if indeed it is in this group—about the use of stem cells. That is undoubtedly an expanding field in medicine and I can see there being a problem in deciding who should get these cells, which will be very innovative, and how they will be controlled. It is important that we have clear regulations regarding the use of stem cells. I fear that allowing it to appear that they are covered in the Bill would be a mistake, so I support Amendment 13.
Lord Turnberg
Lord Turnberg
Perhaps I may detain the House for a short moment to respond to the noble Baroness, Lady O’Neill, the noble Lord, Lord Saatchi, and the Minister about the difference between “obtaining the views of” and “obtaining the support of”. I am happy with Amendment 7, which suggests that the views of the doctors, patients and so on are recorded. However, any doctor wishing to express a view would want to know as much as he or she possibly could about the case before expressing that view. In writing in the notes the views of others from whom opinions have been sought, presumably the names of those people will appear. However, the fact that the doctor does not have to accept the views, none of which may support the doctor’s innovating, presumably gets round the issue of whether it is safe. The whole point of getting another view from another doctor in the field is to see whether there is some support for the innovation. A doctor may get three or four views, two of which may be against but one of them, at least, will be supportive.
I am not persuaded by the noble Baroness, Lady Jolly, nor, I am afraid, by the noble Lord, Lord Saatchi, who is in the hands of the lawyers on this issue. It is not a very good argument. I will reflect on what has been said and will withdraw the amendment now but the position is not entirely satisfactory.
The Deputy Speaker (Baroness Morris of Bolton) (Con)
My Lords, it might help the House if I said that, as the noble Lord has actually spoken again to Amendment 3, I have to propose it to give everybody else a chance. Now he can withdraw it.
Lord Mackay of Clashfern
My Lords, one of the purposes of the amendment, as I understand it, is as the noble Baroness has said: to record the results of an innovative treatment for the benefit of succeeding generations. If innovative treatment has been successful in a particular case, the details of that case are required to make sure of the extent to which the results might be expected to follow in another case. I regard it as important that that should happen. I understand—no doubt this will be explained later—that there are possibilities of voluntary registration systems being set up. The Government may be able to help us on that, but I regard it as essential, if the Bill is to achieve its purpose, that the innovations, particularly if they are successful, are not kept secret. If they are unsuccessful it is also wise to warn people off later attempts.
Lord Turnberg
My Lords, the purpose of the amendment is to ensure that all attempts at innovation are recorded, not simply those that are successful. A voluntary register might allow those who have some mishap with their innovation not to register. The whole point of having a more than voluntary register is important. I am very supportive of the amendment.
Baroness Finlay of Llandaff (CB)
My Lords, I hesitate to intervene, but I think the amendment is extremely important. There is a principle of audit in medical practice, of going back and looking to see whether what you think was going to happen is what happened. There is also the process of the appraisal and relicensing of doctors, and a need to report, in that process, where problems have occurred. The advantage of a properly maintained register is that it would support an audit. If there is a doctor who is overinnovating, if I could use that phrase, beyond the amount that we would expect given the patient population, it would also ensure that that would be easily and rapidly picked up.
The point made by the noble Lord, Lord Turnberg, that there is a tendency for people to record good results but not bad results, is important. There is a move, in the publishing of the results of clinical trials, to request that all results, negative and positive, are published and in the open domain. The amendment, as far as I can see, would be consistent with that move and pressure for openness. It would also provide transparency. I have not spoken to other amendments on this, but this amendment may go quite a long way to allay some people’s fears, which I think are completely understandable—in fact, the fears of all—that things could be going on under the radar in a way that is not transparent, open and properly audited.
Medical Innovation Bill [HL]
Lord Turnberg Excerpts(10 years, 4 months ago)
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Lord Turnberg (Lab)
My Lords, it is absolutely essential that we strive as hard as we can to find new cures and make them available as rapidly as possible. The principle behind this Bill is entirely in accord with that deeply felt need. I admire and respect the noble Lord, Lord Saatchi, for bringing the Bill forward in his persuasive and passionate speech. His motives are impeccable and he provided us with a valuable opportunity to debate this difficult issue.
Why has such strong opposition to the Bill been expressed by some significant bodies and respected individuals who cannot be easily dismissed? What does the General Medical Council have against it? We cannot really discard its fear of a rise in the number of cases of reckless and damaging practice. What do the Academy of Medical Sciences, the Wellcome Trust and Cancer Research UK have against it? CRUK says that the Bill is unnecessary because it can find no evidence that the doctors it supports are put off by a fear of litigation. What do the Patients Association and the charity Action against Medical Accidents have a problem with? Again, it is uncertainty about opening up patients to potentially damaging practices. Why is Sir Robert Francis still anxious about the Bill before us? A very respected medical litigation lawyer, he remains worried about the wording and safeguards in the Bill, and suggests that in any case it is unnecessary. These are significant anxieties from responsible people. At the very least they give us reason to be cautious about how we view the current Bill.
I hope your Lordships will forgive me if I spend a moment discussing the barriers to innovative practice. I fear that there are many. First, delays are imposed by an overly bureaucratic regulatory environment. The myriad regulatory bodies pose a major hurdle and there is much to do there. Then there are the funding issues. We still need much more money for research. There is the issue of affordability by hospital trusts and CCGs. Too often they find it difficult to provide the resources for very expensive treatments, even with the Cancer Drugs Fund, and because of that doctors are prevented from prescribing what they think their patients need.
Of course, we also have the natural conservatism of some doctors who seem unwilling to try anything new. However, the reasons for that seem more to do with a reluctance to try something of which they have had little experience rather than a fear of litigation. There is certainly need for guidance on good innovative practice, as described in the Association of Medical Research Charities publication, Our Vision for Research in the NHS. I declare my employment by the AMRC as a scientific adviser.
There are many targets at which we should aim if we are to improve access to novel treatments. Of course, the Bill is not designed to influence any of those. It is designed specifically to try to remove a fear of litigation by doctors wishing to use novel treatments. However that does not appear to be a problem in the major centres. For example, in the case of cancer treatments the Royal Marsden Hospital in London constantly tries novel treatments well before they have been approved or licensed. Oncologists working there say they do not need any help to innovate and are doing it all the time. They do the basic research, often with the involvement of the pharmaceutical industry, to produce new drugs and test them on their patients well before they have been approved and licensed.
Indeed, the whole personalised medicines agenda is one in which drugs are designed for very specific individual patients based on their own or their cancer’s genetic make-up. Clearly, the usual process of prolonged regulatory approval is inappropriate for these types of treatment. It is the case, too, that the majority of cancer patients are now in one type of clinical trial or another, where the possibility of litigation is not a barrier. Indeed, Mr Greenberg, Parliamentary Counsel, told me that the Bill is not intended for those situations.
Who is it intended for? Who might be put off trying something new on their patients for fear of litigation? Perhaps it might be an isolated doctor, outside one of the main specialist centres; a physician in private practice, general practice or a small district general hospital; or perhaps a surgeon wanting to try out a new procedure not tested elsewhere. These are the doctors we should certainly encourage to take up all the latest developments that have been shown to be effective at least somewhere or—preferably—refer patients desperate to try the latest possible treatment to a major centre that is trying them out in proper trials.
One can imagine the situation in which a new drug was being tried in America, Japan or Israel but not yet here and a doctor wanted to try it on his or her patient. Doctors can prescribe such drugs now on what is called a “named patient basis”, with all the safeguards of patient consent and a rational basis for the treatment to back them up. Certainly, better guidance on what doctors can and should do would be enormously helpful—the opportunity for debate that the Bill is giving us is invaluable in that regard—but the idea that someone working in isolation will come up with an entirely new treatment de novo seems inherently unlikely. Where will it have come from? What underlying research will have been done? What toxicity studies and tests will have been done to make it a reasonable option? Such innovation is far too risky.
Forgive me for going on for so long, but I wanted to explain why I have some difficulty with the Bill as it stands. Those working at the cutting edge of research and application of new treatments say that they do not need it; they have no fear of litigation. Those not working in the major specialised centres need better guidance, not a weakening of the law that might open opportunities for them to be more reckless than they are now.
I have read with interest and, I have to say, some confusion the legal opinions expressed by lawyers on both sides on the wording of the Bill. They have certainly made me realise why I am not a lawyer. I have also listened carefully to the wise words of the noble and learned Lord, Lord Mackay, but I also recognise that one has to be very cautious about accepting a Bill where there is room for disagreement among lawyers. Although the noble Lord, Lord Saatchi, for whom I have particular regard, has given us an extremely valuable opportunity to open up the whole subject of innovative practice—we certainly need that—and it may be possible to amend the Bill to make it more acceptable, we will have to look at that very carefully in this House. Meanwhile, I am sorry to say that I remain to be convinced that the Bill is the answer to the problem it seeks to solve.
Health and Social Care in England
Lord Turnberg Excerpts(11 years, 4 months ago)
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Lord Turnberg
My Lords, this debate is extremely timely and I congratulate the noble Lord on introducing it so well and on stealing some of my best lines. It is hard to get away from the fact that we are in for a rather prolonged period of constraint on public spending that will inevitably impact on funding for health and social care. It cannot be denied that we are falling behind as inflation in medical care runs ahead of general inflation.
There is a commonly held assumption that the NHS is a bottomless pit but that is just too simplistic. During the years of relative plenty, when the Labour Government dramatically increased funding, we saw a remarkable improvement in care: waiting lists virtually disappeared; GPs could be seen on the same day in most places; waits in A&E departments came down; patient satisfaction levels rose; and productivity, despite views to the contrary, rose too. The number of operations and other procedures rose by 50% during the decade starting in 2000 and hospital lengths of stay fell by 27% from an average of 10.5 days to 7.7 days. So money did talk but now, as we deal with the Nicholson challenge, we are failing to keep up. We are seeing a rise in waiting lists and a fall in staff numbers. The pips are squeaking and we are beginning to see a fall in standards.
So how do we fill this funding gap? The Wanless report of a few years ago suggested that we would need to find 10.6% of our GDP by 2021, while John Appleby, in his report for the Nuffield Trust, suggested that in 50 years’ time we would need to put 20% of our GDP into the NHS. Fifty-year predictions are just a little fraught but he said it would be affordable—that is an important point—if our total GDP increased threefold, illustrating the point that the better off a country is, the bigger proportion of its GDP it can afford to put into healthcare. We have not been short of ideas about how we might fill the looming gap but few are free of problems. Doing nothing is clearly not an option as we will just see a steady deterioration in standards and quality with a public backlash, voter disillusionment and a change of government, whoever is in office.
That leaves us with three options: become more efficient, find more money or ration what we provide for patients. First, there are always efficiencies in a system as huge as the NHS but there are limits and we are pretty close to them now. So-called reconfiguration of hospitals is a popular idea at the moment. Close a few and the community services will pick up the bill for caring for the patients. I am all for focusing specialised services in a few places, as it certainly saves lives, but, unfortunately, it does not save money. I am all for closing small, inefficient hospitals and moving money into community services, but simply redistributing funds does not give us any gain.
I agree here with my noble friend Lord Filkin but, in the face of the enormous pressures building up, I really cannot see that even more efficiency savings are sustainable for very long. As regards finding more government money, I cannot see much prospect of that either, at least in the short to medium term. It would mean taking a bigger slice of the cake and leaving less for everything else, which would not be very popular. Only when we manage to increase our GDP and reduce our debt would we be able to consider taking a bigger slice of the cake. Then we could look at limiting what we provide in the NHS; that is, we could define a basic package of care but stop funding some types of treatments. Again, that is not likely to be very popular and defining which treatments should not be available in the NHS will always raise hackles. As a way of controlling costs it was found to be pretty ineffective in Oregon a few years ago.
Then there is the possibility of co-payments by patients—we have heard about that. We have already broached that principle in the UK, but experience elsewhere is not encouraging. When they tried it in Germany, they saw a rise in the number of patients who avoided visiting their doctors when they were ill or who failed to fill their prescription. The impact of charges for care will have to be examined very carefully if we are not to see a fall in the number of patients who need care but who avoid getting it for financial reasons.
At the end of the day, we will have to choose between a number of unappealing and potentially unpopular options, but one thing is absolutely clear: doing nothing is not one of those options. It is essential that we have a more open debate with the public about these possibilities. A cross-party discussion is desperately needed, as many noble Lords have said. We certainly cannot keep our heads down for much longer.
Financial Services Bill
Lord Turnberg Excerpts(12 years, 5 months ago)
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Lord Eatwell
My Lords, if new Section 3A covers the point, and we want to avoid ambiguity, why not simply delete subsection (4) of proposed new Section 9B? What does it do?
Lord Turnberg
This amendment has been put in the wrong group. New Clause 9B(4) is about the Financial Policy Committee, not the oversight committee.
Lord Eatwell
The point is that the oversight committee is supposed to keep the activities of the Financial Policy Committee under review. There is an amendment among the amendments tabled by the noble Lord, Lord Sassoon, that changes “court of directors” in new Section 9B(4) to the “oversight committee”. So if we accepted his amendment, it would read that the oversight committee,
“must keep the procedures followed by the Committee under review”.
Why do we have that when we have new Section 3A doing all the work for us?