Medical Innovation Bill [HL]
(10 years ago)
Lords ChamberRead Hansard Text Read Debate Ministerial Extracts
Lord Winston
“( ) The provisions of this Act shall not apply where a doctor, in the pursuit of a treatment, is required to take action where time or place does not allow the required consultation.”
Lord Winston (Lab)
My Lords, in moving Amendment 1, I wish to speak also to Amendment 6. The Bill states that for the purposes of taking a responsible decision to depart from existing treatment, a doctor must,
“obtain the views of one or more … qualified doctors in relation to the proposed treatment”,
and there are a number of other issues related to that. It is very clear that it is not always possible for a doctor to do this. For example, in Committee, the noble Lord, Lord Turnberg, mentioned the case of a patient on an aircraft who had a pneumothorax. That was dealt with in a way which could not possibly have involved consultation beforehand: it was a completely unexpected event. Indeed, in my view, that would apply to any emergency treatment where there is no time to undertake consultation or the doctor is not in a place where he can consult others—for example, if he is at a bus stop, in the outer islands of the Hebrides or various other such places. That would be extremely muddling for a doctor and would increase difficulties in trying to understand the appropriate thing to do under those circumstances.
Previously, I gave the example of the unconscious patient that I dealt with when I clamped off an ectopic pregnancy without an anaesthetic because my anaesthetist refused to give an anaesthetic to the patient because he felt that she might die and he did not want to be responsible for that. That is a good example of where you can have a conflict of interest or a conflict of opinions with doctors in an emergency situation. I took the view that the anaesthetist was wrong. I opened the patient’s abdomen without an anaesthetic, immediately clamped off the bleeding point and her blood pressure became recordable. She was already, of course, having a rapid blood transfusion but the blood loss inside her abdomen was so great that her blood pressure was unrecordable until that artery was clamped. Once it had been clamped, my anaesthetist admitted that the patient needed an anaesthetic and he intubated the patient. It would be very difficult for a doctor who was cognisant of the terms of the Bill to do that.
In the case of a neonate, there is the real issue, of course, that from time to time you have fractions of a minute in which to deal with an emergency. I say to the noble Lord, Lord Saatchi, that if this Bill goes through he may have a number of brain damaged children on his conscience because of the need to give oxygen to a child in emergency circumstances using unusual procedures, perhaps when it is being delivered. Each of us has undertaken the most dangerous journey that all humans take—the four and a half inches down the birth canal. To this day, that still results in a large number of children being damaged. Indeed, in this country the commonest problem leading to babies dying or being damaged is brain damage at birth. I say to the Government that it is also a grave source of litigation. Indeed, it costs the National Health Service a large sum of money. If there is doubt about how to handle this situation in an emergency and a doctor is confused, there is a very grave risk that this could interfere with his better judgment. As I pointed out to the noble Lord, Lord Kakkar, it also applies to certain surgical procedures where there are anatomical abnormalities that require innovation—in particular, when dealing with unexpected haemorrhage.
I remember an amazing occasion when I was in training with a surgeon who had removed a kidney. He was a real surgeon, dealing with bleeding in the pelvis. He asked me, “What’s the most important instrument in the operating theatre?”. I had no idea what he was talking about. He pointed to the surgeon’s stool. He said, “That stool needs to be five metres away from the operating table and you go and sit on it”. That is not in the textbooks, but what he had done was put a pack into those bleeding vessels, leave it there, and he did not fiddle. He was, therefore, not actively involved in the consequences. That innovation by the late Dr Magri, who was my amazing teacher, helped me to understand how one could deal with haemorrhage in the pelvis, which for a gynaecologist is an important point. Therefore, I would argue that my Amendment 1 will allow a surgeon in particular, but other practitioners in general, to conduct required treatments without considering the measures proposed in the Bill, if it becomes an Act of Parliament.
Rather than detain the House for too long, I now turn to my Amendment 6. It was briefly dealt with in Committee in relation to the use of drugs. Unfortunately, we did not discuss it in any great detail. However, noble Lords will see that it is necessary—indeed, I think it is essential—to define what we mean by an innovative treatment. Innovation can mean a whole lot of different things to different people. This is not in any way a wrecking amendment. It is designed to clarify the Bill and make it rather more workable and safer. We will come back to patient safety later.
It seems to me that there are four areas where one can define innovation. The first is a medical treatment where there has not been any peer-review evidence for the benefit of that treatment or a clinical trial. In the debate on that issue, the noble Baroness, Lady O’Neill, pointed out that randomised control trials were not the only method of dealing with medical evidence—and she is, of course, absolutely right. She is the most brilliant individual and I bow to the point she made. None the less, she did not say in her argument that we should not have evidence based on some form of proper clinical appraisal. That is an important aspect.
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 Winston
Before the noble Baroness sits down, I wanted, for clarity, to speak to two amendments at a time. I will speak to Amendment 13 in due course and say exactly what I meant. If the noble Baroness wishes me to speak to those amendments now I will do so.
Baroness Garden of Frognal (LD)
To clarify for the noble Lord, the amendments are grouped together, so he is required to speak to them in the group. He will, of course, have the right to come back at the end of the group and he may wish to include them at the end.
Lord Winston
I am very happy to speak to those amendments now. They are very simple. The question of the dental practitioner is simply that dental practitioners also are involved in maxillofacial surgery and other treatments that may require innovation. With regard to other practitioners who are not medically registered, we are going to require more and more nurses and other workers with university qualifications who will be conducting treatments, and it is therefore important that we clarify whether they will be able to innovate.
Baroness Garden of Frognal
I must point out to the noble Lord that it is not in order for him to speak twice to a group of amendments at Report stage.
Lord Giddens (Lab)
I support Amendments 1 and 6 —the latter because I speak as someone who has spent much of his life studying innovation. I recognise that the backdrop to this Bill is the massive acceleration of innovation in some core areas of medicine, so the point is to try to bridge the gap between that and the time taken to test medicines. However, I will comment especially on Amendment 1, even though I cannot hope to match the rhetorical power of my noble friend Lord Winston.
I have stressed several times in the debate the crucial importance of looking for possible unintended or even perverse consequences that the Bill could have. Amendment 1 is very worth while for this reason. It would certainly be a perverse outcome of the Bill if it had the effect of inhibiting or slowing down emergency measures where they need to be taken, and I hope therefore that the noble Lord, Lord Saatchi, might be prepared to accept both the amendments, which seem to me to add strength to the Bill.
Lord Mackay of Clashfern (Con)
My Lords, as far as Amendment 1 is concerned, I think that the later amendment tabled by my noble friend Lord Saatchi has the same effect. Amendment 1 is very clear on the matter, and I think that it has been the law that emergency treatments are dealt with in a way that is suitable for the emergency. Accordingly, something of this sort in the Bill is an improvement.
I find Amendment 6 more difficult. As I said in Committee, “innovation” is an ordinary word in the English language, so to try to list all possible innovations seems to suggest a foreknowledge of what innovations may be introduced in the future. It requires unnecessary precision. As I said, “innovation” is a reasonably simple word and it is easy for a practitioner to carry it in their head. I venture to think that Amendment 6 would be somewhat more difficult to carry in your head. I have read it, of course, but I would find it quite difficult to repeat it now without reading it, so I will not attempt that test.
On the later amendments, it seems to me that emergency medicine is certainly not intended to be dealt with by the Bill. It is obviously intended to deal with a deliberate decision to administer a treatment into which has gone a degree of consultation and prior thought. I am therefore entirely of the view that innovation ought not to be covered by it. In so far as my noble friend Lord Saatchi’s amendment does not do that already, Amendment 1 is very acceptable so far as I am concerned.
Baroness Wheeler (Lab)
My Lords, as this is the first contribution from the Front Bench to the discussion of today’s amendments, perhaps I may again place on the record our support for the key principles and intent of the Bill. As we stress, Labour has always strongly supported efforts to bring innovative treatments to patients faster, and we underline the need for a major effort by government to address the barriers and bureaucracy that prevent progress being made and ensure that innovations are rapidly transcribed into practice. The noble Lord, Lord Kakkar, recently held a short debate in the Moses Room on the impact of innovation and research strategies on health improvement. It provided an excellent overview of the key issues, the progress being made, and the problems still to be addressed. We are keen to ensure that the Bill of the noble Lord, Lord Saatchi, is seen in the context of this wider, bigger picture. I know that the noble Lord accepts that his Bill will be one measure in the broader landscape of what needs to be done.
Along with my noble friend Lord Turnberg, I am also grateful to the noble Lord for the efforts he has made to address the issues and concerns raised by noble Lords across the House. In Committee we underlined our broad support for the changes—the “Sir Bruce Keogh amendments”, as they are now known—which have been made to ensure patient safety and safeguarding. We also found the round-table discussions for Peers that were organised by the noble Lord following our suggestions in Committee very valuable and useful. Again, we are broadly supportive of the new amendments he has brought forward today, which are the result of the discussions, on emergency care, on the recording of key information in the notes of the patient receiving the treatment, on excluding cosmetic surgery from the scope of the Bill, and on ensuring the preservation of the existing law about clinical trials and other forms of research.
My noble friend Lord Winston continues to express strong concerns about the Bill, and his amendments are designed to add further safeguards and limitations on the scope. He fully reflects the continuing concerns that have been voiced by a number of key stakeholders and doctors, including the BMA and the Medical Practitioners’ Union, which have issued further detailed briefs warning against the possible consequences of the Bill. At my noble friend’s instigation, I have read carefully Tuesday’s Adjournment debate in the House of Commons on patient safety and medical innovation, and in particular the contributions from Dr Sarah Wollaston MP, who expressed the strong criticisms we have heard from the noble Lord and the Bill’s critics, and the contribution from the Minister for Life Sciences, George Freeman. I thought that Dr Wollaston’s contribution well reflected the issues and concerns we have heard in this House—but also that the Minister presented a pretty balanced response as to where we are today in terms of the safeguards and workability of the Bill.
For our part, we have sought to work constructively with the noble Lord, Lord Saatchi, and other noble Lords to improve the Bill and to make it workable and safe for patients. The round-table discussions particularly focused on the outstanding areas of our concerns which we are discussing today. First, there is the issue of obtaining written consent from the appropriately qualified doctor in relation to the proposed treatment, which will come up in the next group. Secondly, we seek to ensure that the Bill does not impact on or affect the existing law on clinical trials and other forms of research. We are satisfied that Amendments 8 and 9, tabled by the noble Lord, Lord Saatchi, have the effect of reinforcing this in the Bill.
Thirdly, we desire to see a definition of “innovation” in the Bill and we have sympathy for the arguments that key areas need to be excluded from its scope, as again set out in the amendment retabled by my noble friend Lord Winston. The Department of Health has argued strongly that any definition of innovation would need to be the subject of a widespread, cross-government consultation that should include the devolved Governments. We have made a dignified retreat on our particular amendment and we accept the difficulties that would be involved at this stage in the progress of the Bill. However, my noble friend Lord Winston has made a strong case for defining innovation in respect of medical treatments and the use of drugs, and I look forward to the responses of the Minister and the noble Lord, Lord Saatchi. Like my noble friend Lord Turnberg, we think that a form of words based on that would provide a useful clarification.
On exclusions, the briefing on the amendment of the noble Lord, Lord Saatchi, states that he has considered attempting to define the extent and scope of the Bill, but has found it impossible to do so in a way that answers more questions than it raises. However, Amendment 10 does provide the important exclusion of cosmetic surgery that was sought by noble Lords across the House, and we welcome this. At the round table there was discussion about the possibility of the scope of the Bill referring to the regulated branches of medicine to distinguish the areas it covers. My noble friend Lord Winston makes this point in Amendment 12 in relation to excluding practitioners and health workers who are not registered with the General Medical Council or the General Dental Council.
Fourthly, I turn to the very important issue of emergency situations in the treatment of patients, which is a strong area of concern for noble Lords across the House, including my noble friends Lord Turnberg and Lord Winston, and the noble Lord, Lord Kakkar. Amendments 14 and 15 tabled by the noble Lord, Lord Saatchi, address this by providing a reference to emergencies as an example of a situation in which the existing common law Bolam test would apply and a doctor might not engage in the procedures of the Bill. But if there is further clarification in respect of the issues raised by my noble friend Lord Winston, we would be grateful for that. Amendment 1 raises other issues in respect of emergency care, and again I look forward to hearing from the noble Lord, Lord Saatchi, and the Minister in response.
As I have said, we have worked constructively with the noble Lord, Lord Saatchi, to make the Bill safe and workable, and we believe that the amendments that were made in Committee—and that we hope will be made today—will make it a better Bill. It has strong support, but we know that key stakeholders still have major concerns. There needs to be strong commitment from the noble Lord, Lord Saatchi, and the Government to address these issues and ensure that there is full consultation on the regulations, guidance and codes that will enforce its implementation. The registration of innovative treatments will be crucial, and this will be picked up by my noble friend Lord Hunt under our amendment later.
Finally, I remind the House of the four key tests of what the Bill will achieve, which were set out to the House of Commons by the Health Minister, Dr Daniel Poulter. He said that the Bill must,
“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”.—[Official Report, Commons, 21/7/14; col. 999W.]
Again, I would be pleased to hear from the noble Lord, Lord Saatchi, and the Minister as to whether they consider that the Bill in its amended form will achieve this.
Lord Woolf (CB)
My Lords, I hope that I will be forgiven for not speaking before the noble Baroness, Lady Wheeler, addressed the House. Unfortunately, she responded more quickly than me in getting to her feet; thus, we have this order. The progress of the Bill has been a remarkable example of this House at its very best. The Bill has been very carefully scrutinised by people who have immense knowledge of the areas covered in the Bill. That does not mean that anything said by a particular Member of the House with undoubted expertise in this area is necessarily right in this matter. As is the case with many Bills, sometimes more than one profession can be involved. I suggest that this is an example where two professions, which in the past have been guilty at times of excessive conservatism, are involved and have been loud in some of the things that they have had to say. The other profession of which I am thinking is my own; lawyers are not always celebrated for their innovative approach. They have improved from the situation of not so long ago. They are more ready to accept change—indeed, they have been forced to accept it—than they willingly would have done in the early days when I was practising.
I have been criticised in letters I have received in a way in which I perhaps am not accustomed for my involvement in the Bill sponsored by the noble Lord, Lord Saatchi. Those who have asked me to identify cases by name and reference so that they can analyse the cases and show how they do not help any particular argument might be relieved to hear me say that if they want to know where I come from, I wrote a little book called The Pursuit of Justice. I focused on the medical profession at that time because I found that its conservatism was interfering with the pursuit of justice. As far as victims were concerned, one of the most difficult areas of litigation in this country was clinical negligence cases.
Both sides in those cases were put into great difficulty because of that conservatism. On one side were the patients who often wanted the doctors to say sorry. On the other side were the doctors who felt that they could not say sorry because if they did they would be admitting liability for negligence. So the two never met—and that, I am afraid, can happen.
I listened very carefully to the graphic examples given by the noble Lord, Lord Winston, of where he thought that the Bill could be a problem. In his first example, he said that there was a difference of opinion between his anaesthetist, who did not think that an unusual and innovative form of intervention was appropriate, and the noble Lord, who thought that it was appropriate in the circumstances. Happily, he took the initiative and acted in an innovative way. But if one pauses and thinks about what would have been the position under the Bill as it is at present, would it have made the situation more difficult or would it have alleviated the situation? I suggest it is quite clear that it would have done neither.
Baroness Farrington of Ribbleton (Lab)
My Lords, I think that it would help the House if the government Whip could advise noble Lords on whether the appropriate time for Members of your Lordships’ House to speak to all the amendments in this group is now or later. At the moment, people are unaware of whether the net result of what my noble friend Lord Winston said was to degroup or whether we are in a position where Members must speak now to any of the amendments in the group.
Baroness Garden of Frognal (LD)
My Lords, I notice that the noble Baroness, Lady Wheeler, has spoken to the amendments which the noble Lord, Lord Winston, did not speak to. I will seek advice from the Clerk as to whether the noble Lord may wish to degroup the amendments to which he did not speak. I think that that would be up to the noble Lord. For the convenience of the House it might be clearer if he degrouped the amendments to which he did not speak. Does the noble Lord, Lord Winston, wish to do that?
Lord Winston
It is very kind of the Front Bench to offer that possibility. If I were to degroup an amendment, I would degroup the stem cell one and put it with Amendment 5, as it would fit better with patient safety. One of my difficulties is that the groupings are slightly odd in terms of the relevance of the different aspects of my amendments.
Lord Mackay of Clashfern
My understanding of the groupings system is that those who have views on the amendments should take the opportunity to speak when the relevant group is first dealt with, but it does not preclude a noble Lord who has tabled an amendment speaking when the amendment is called in the ordinary course of events. As your Lordships know, following a debate an amendment is often called as being not moved, but the person who tabled the amendment has the option to move it at that point. Therefore, in that sense there are two opportunities to speak. However, in order to try to make the procedure as economical as possible, the general idea of the groupings system is to enable a group of amendments to be considered as a whole on the basis that, rightly or wrongly, such consideration is facilitated in that way.
Baroness Gardner of Parkes
Perhaps I may raise a point. When you table an amendment, you are usually sent a draft list of the groupings. You are asked whether you are happy with that or whether you want your amendment to be grouped separately. I wonder why that has not happened in this case.
Baroness Garden of Frognal
My Lords, I thank my noble and learned friend for his suggestion. I think that the noble Lord, Lord Winston, suggested moving Amendment 13 into the group which begins with Amendment 5 but leaving Amendments 11 and 12 in this group. If we proceed on that basis, then, as my noble and learned friend said, when Amendments 11 and 12 are called, he will have the opportunity to speak.
Baroness Jolly (LD)
My Lords, this group of amendments relates to the scope of the Bill. As noble Lords are aware, the Bill relates to a decision by a doctor to depart from the existing range of accepted medical treatments for a condition. I make it clear that the Bill applies not to research but only to decisions relating to individual patient treatment. My noble friend Lord Saatchi and the Government listened to concerns expressed in Committee that the conditions of the Bill might add to the requirements under which researchers operate. Amendment 8 in the name of my noble friend Lord Saatchi responds to these concerns, clarifying that the Bill does not apply to treatment carried out for the purpose of research. As such, Amendment 9 removes the existing provision on research, which is no longer necessary.
My noble friend Lord Saatchi and the Government listened to concerns expressed in Committee and at the round-table event hosted by my noble friend on 11 November that cosmetic treatment may be subject to less scrutiny than other treatments. Peers were therefore reluctant that the Bill should apply to this area of practice. Amendment 10 ensures that the Bill does not apply to treatment which is carried out solely for cosmetic purposes. Beyond this, the Government do not consider it necessary to exclude certain treatments or conditions from the Bill.
Amendment 1 from the noble Lord, Lord Winston, seeks to clarify that a doctor would not have to rely on the Bill where time or place did not allow the required consultation. The Government do not view this as a necessary amendment as the Bill already makes it clear that there is no requirement to innovate. If a doctor chooses to innovate, it is for that innovating doctor to decide whether to rely on the protection of the Bill and therefore to take the steps set out under the Bill. Clause 2, as amended in Committee, ensures that the common law test of clinical negligence is not affected by the Bill.
My noble and learned friend Lord Mackay of Clashfern suggested that Amendment 1 would be a helpful clarification to the Bill. Amendment 14 in the name of my noble friend Lord Saatchi will clarify that the Bill does not limit the circumstances in which the common law may be relied upon, and it expressly gives emergency treatment as an example. Amendment 1 is not necessary and could create confusion for doctors in determining exactly when the Bill applies. The amendment might also suggest that it is only in these limited circumstances that the Bill would not apply, whereas it is intended that doctors can choose whether to rely on the Bill, and it provides an option for them to demonstrate that they have acted responsibly. Amendment 14 proposed by my noble friend Lord Saatchi clarifies the point, confirming that the Bill does not limit the circumstances in which the common law may be relied upon, giving emergency treatment as one such example.
I want to pick up a point raised by my noble friend Lord Colwyn concerning placing GPs in a position where they are asked to innovate but are not able to do so. The Bill requires a doctor, in making a decision to innovate, to consider any opinions or requests expressed by, or in relation to, the patient in order to ensure that the decision to do so is taken responsibly. The clause in question does not confer any additional rights on patients to demand innovative treatment. However, it is crucial that, when making a decision to innovate, a doctor considers the view of that patient. As such, I hope that noble Lords will throw their support behind Amendment 14 put forward by my noble friend Lord Saatchi.
A further clarification is provided by my noble friend’s Amendment 15. In Committee, the noble and learned Lord, Lord Woolf, argued that the Bill does not offer an alternative defence to that under common law; rather, it is supplementary. The Government agree with that interpretation and also that the Bill’s current wording is not sufficiently clear on this point. Amendment 15 clarifies that a decision to innovate in accordance with the Bill does not prevent a doctor also relying on the existing common law defence under Bolam, and it would be a valuable addition to the Bill.
Amendments 11 and 12 seek to extend the application of the Bill to dentists as well as doctors. The Bill applies only to doctors, as it responds to concerns that doctors have raised concerning the fear of litigation. The Bill is aimed at reassuring doctors who feel unable to innovate due to concerns about litigation. The Department of Health’s consultation on the Medical Innovation Bill revealed that some doctors find the threat of litigation to be a block to innovation, although this view was not universally held. The consultation did not reveal the same demand for the Bill from dentists. If the Bill passes, we will consider its impact and will continue to listen to the concerns of all healthcare professionals.
Amendment 12 also seeks to limit the application of the Bill to practitioners or health workers who are registered by the GMC or to dentists who are registered by the General Dental Council. The Government consider this amendment to be unnecessary as the Bill’s scope is already limited to doctors, who are defined under the Bill as registered medical practitioners. All registered medical practitioners are registered with the GMC.
Amendment 6 in the name of the noble Lord, Lord Winston, seeks to define the meaning of innovation under the Bill. Over the course of the debates on this Bill, a number of suggestions have been brought forward on how to approach this issue. Drafting a positive definition of innovation is a difficult task. This is revealed by the addition in this amendment of paragraph (e) relating to the application of a monitoring device or biosensor, which has been absent from prior definitions. It is crucial that the definition of innovation under the Bill is future-proof and clear for both doctors and patients.
The Bill defines innovation as a situation where a doctor decides to depart 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. Here I pick up three points, one being from the noble Lord, Lord Colwyn. I was asked about upholding the advice given by NICE and whether the Bill would allow doctors to go against NICE guidelines. The Bill does not impact on the existing legal obligation for NHS commissioners to provide funding for drugs that have been recommended in NICE technology appraisals. However, it will remain for doctors to decide on the most clinically appropriate treatment for their patients, whether or not they are innovating under the Bill.
Lord Kirkwood of Kirkhope (LD)
My noble friend has helpfully explained the Government’s position regarding the new amendments tabled by the noble Lord, Lord Saatchi. I support his amendments. What I am unclear about is whether any special provision has been made for the risks of mental health which were raised in Committee. Does the department believe that the Saatchi clutch of amendments gives sufficient protection for patients receiving innovative treatment who suffer from mental illness?
Baroness Jolly
My Lords, I am waiting for confirmation from the Box on the mental health issue. If the noble Lord will be patient, I believe something is coming. The answer is no, but under a special provision doctors can choose. I hope that is clear to the noble Lord.
Lord Saatchi (Con)
My Lords, in speaking to Amendment 1, in the name of the noble Lord, Lord Winston, I will speak also to his Amendments 6, 11, 12 and—I am advised—13, and my own Amendments 8, 9, 14, and 15.
Before I start, I will take a moment to echo what the noble and learned Lord, Lord Woolf, said. He described the discussions about the Bill at all its stages as being your Lordships’ House at its best. I so agree. I said in the debate in the Moses Room last week in the name of the noble Lord, Lord Kakkar, that the experience of watching your Lordships’ House debate and discuss the Bill is, as far as I am concerned, a tremendous privilege to be able to hear the greatest legal and medical minds in the country at work.
I thank the noble Lord, Lord Turnberg, for saying that there had been a constructive process of listening to Peers’ views as expressed in Committee. I am also grateful for the view expressed by the noble Baroness, Lady Wheeler, that the Bill team and the Department of Health have behaved constructively since Committee. I have really been only a witness to the toing and froing between Peers whose views were expressed in Committee and the Department of Health through our own Bill team. It will not come as any surprise to your Lordships that this has been a really admirable process of the officials and the legislation department in the Department of Health listening carefully and trying to respond, and I certainly have appreciated that hugely. I know your Lordships will agree. I also thank my noble friend the Minister for her clarification of the Government’s position on many of these amendments.
Amendment 1, in the name of the noble Lord, Lord Winston, would have the effect of disapplying the Bill in emergency cases. I believe and I am strongly advised that it is already clear from the terms of the Bill that doctors will be able to rely on the existing application of the Bolam test in cases where, for whatever reason, they are not able to follow the recording and other procedures set out in the Bill. Amendment 14 and the other amendments in my name have been kindly prepared by the Department of Health. Amendment 14 makes it expressly clear that emergency cases are an example of situations in which it would not be practicable for a doctor to follow the procedures set out in the Bill. Perhaps the noble Lord, Lord Winston, might agree with me that my Amendment 14 deals with the case that concerns him—emergencies—and that it does so in a clear fashion, even clearer perhaps than his Amendment 1. It also has the advantage of being less prescriptive because of the nature of the situations in which the provisions of the Bill might not apply, leaving a doctor to rely on the existing Bolam test. For that reason, I hope that the noble Lord will support my Amendment 14 and therefore not feel the need to press his Amendment 1.
Amendment 6, in the name of the noble Lord, Lord Winston, would define “innovation”. As the noble Lord said, this point was discussed in Committee. My noble and learned friend Lord Mackay of Clashfern expressed his view then, which he has repeated today, that the concept of innovation has a natural meaning in the context of the Bill and that we might do more harm than good by attempting to give it a statutory definition. That is a view with which I, as a non-lawyer, respectfully agree. In particular, I would express the fear to the noble Lord, Lord Winston, that a number of the building blocks of the definition attempted in his Amendment 6 raise more questions than they answer; for example, in paragraph (b), the question of what amounts to an “appropriate clinical trial” could give rise to considerable confusion. It is also worth saying that on 16 January 2013 he himself pointed out—and he should be in good position to know—that,
“one of the issues with true innovation is that serendipity is extremely important”.—[Official Report, 16/1/13; col. 761.]
Obviously that is true and it is certainly very hard to define.
I hope I have shown that we are open to making changes to improve the Bill wherever noble Lords or others have shown that it requires refinement. As I said, there has been a great deal of positive response to the comments and thoughts that we have received. I am not convinced that an addition of the kind proposed by the noble Lord could be welcomed in that way. I am sorry to say that but I hope that he will not feel the need to press Amendment 6.
I turn to Amendments 8 and 9. It has always been the intention of the Bill to make no change in the law relating to research. Clause 1(5) was included for that purpose. Concerns were expressed in Committee and in discussions since then that the point is not understood with the necessary clarity by all readers of the Bill and that it needs to be made even clearer. My Amendments 8 and 9 have been kindly prepared by the Department of Health for the purpose of putting the point beyond any possible doubt.
Amendment 10 relates to cosmetic surgery. In Committee, suggestions were made that the Bill should be confined expressly to the principal kinds of cases at which it is aimed; namely, relatively rare terminal cancers and other terminal conditions. In the discussions since Committee to which I referred earlier, attempts to define the intended scope of the Bill have proved unsuccessful in finding a formula that answers more questions than it raises. Much of the concern, however, has centred on the potential use of the Bill in relation to cosmetic surgery. It was suggested by Peers that it could at least be made clear that it is not the purpose of the Bill to apply to that. My Amendment 10 accordingly excludes cosmetic surgery from the Bill. However, cosmetic surgery can of course be crucial to life or quality of life, as in the case of severe burns, for example. Doctors wishing to innovate in such cases will be able to rely on the existing common-law Bolam test.
Amendment 11 in the name of the noble Lord, Lord Winston, would include dentists within the Bill’s definition of “doctor”, therefore bringing them within the scope of the Bill. The Bill is aimed at an issue on which I am aware there is a need for action: to protect health professionals from the fear of litigation or disciplinary action in relation to innovation, but neither I nor, I think, the Minister has received evidence from dentists or dentists’ patients to suggest that a similar problem arises in their context. Therefore, I do not see the need to include dental treatment in the Bill. If the noble Lord has evidence that there is a problem in the dental sector of a similar nature to the problem that I and many others have identified in the medical sector, I would be very happy to discuss that with him. In the mean time, I hope that, hearing that, he will not press his Amendment 11.
While we are speaking about a niche—perhaps that is not the appropriate term—part of the medical world, it might be interesting to refer to what the Royal College of Ophthalmologists says in a press statement on the use of a particular drug in the treatment of eyes, a drug that one would more normally use in the treatment of cancer. It states:
“Without unequivocal GMC and NICE support, ophthalmologists are understandably concerned that they may be assuming unacceptable personal liability by using an unlicensed drug when a licensed alternative exists … Consequently, patients may not be getting treatment when they need it and not getting the best results”.
Amendment 12 in the name of the noble Lord, Lord Winston, relates to the exclusion of non-registered doctors. It would prevent a non-registered doctor from relying on the provisions of the Bill. At the round-table discussion that the noble Baroness, Lady Wheeler, suggested and that we arranged after Committee—it was requested by the noble Baroness and a number of other noble Lords—the difficulty of designing helpful exclusions was carefully discussed. The exclusions suggested by the noble Lord in his Amendment 12 were discussed and difficulties of a technical nature were suggested. There might be difficulties, for example, in relation to our European Union obligations in respect of practitioners from overseas. Despite that, this is an issue with which I have sympathy for the reasons set out by the noble Lord, and I would welcome an opportunity to discuss with him whether some way could be found of achieving his objective and meeting any technical difficulties of the kind that I described.
I have been authorised by my noble friend Lord Ribeiro, who is unfortunately unable to be here today, to make a statement on his behalf about this question of registration of doctors. He says:
“I am keen to make a distinction between regulated health practice which requires surgeons to hold a licence and unregulated practices where botox and other injectables and implants are performed by unlicensed and unregulated practitioners, many of whom may not be doctors … It is important that this Bill is not seen as a charter for those in unregulated medical practice, like the cosmetic surgery industry, whose sole purpose is the enhancement of a normal appearance through the use of injectables and other materials. Surgeons who are licensed and regulated and undertake cosmetic surgery can continue to rely on the Bolam test … I make the latter point because”,
as the Bill has identified,
“reconstructive surgery is used following burns, congenital defects and as part of the restoration of limbs and the body after ablative surgery, but still perceived by some as cosmetic surgery. That is why the British Association of Plastic Surgery (BAPS) changed its name to”,
the British Association of Plastic, Reconstructive and Aesthetic Surgeons, the BAPRAS. I hope that those comments from the noble Lord, Lord Ribeiro, will help the noble Lord, Lord Winston. In the mean time, I hope that he will decide not to press his Amendment 12.
I turn to Amendment 13, which I have been advised to speak on. The amendment, in the name of the noble Lord, Lord Winston, would have the effect of disapplying the Bill—
Lord Hunt of Kings Heath (Lab)
My Lords, I thought that it had been agreed that Amendment 13 would be grouped with Amendment 5, so the noble Lord needs to respond to it then.
Lord Saatchi
I am sure that that will be done. I will return to Amendment 13 when I respond to a later group.
Amendment 14 relates to the preservation of the Bolam test, an extremely important point. The amendment is in my name and deals with the fact that concern was expressed in Committee about whether in emergency situations, as we discussed earlier, doctors will realise that they are not expected to follow the procedures set out in the Bill—the point made by the noble Lord, Lord Winston. Amendment 14 accordingly introduces a reference to “emergency” and makes it expressly clear that a doctor treating an emergency can and should rely on the existing law. The amendment would achieve this by giving emergencies as an express example of a situation in which the existing common-law Bolam test would apply and a doctor might not engage in the procedures of this Bill.
Amendment 15, again in my name, is a most important amendment in relation to the preservation of the general Bolam test. It deals with the principle that the Bill does not force doctors or require them to rely on its procedures, and they can simply rely on the existing Bolam test in all cases. It recasts the proposition to meet concerns expressed as to whether the intention of existing Clause 2(2)(a) was sufficiently clear. I shall return to Amendment 13 on a later group.
Lord Winston
My Lords, I apologise for my infelicity in getting the groupings wrong. I am very grateful to the Front Bench for making their proposal, which is very helpful.
I realise that I have been in your Lordships’ House since 1995 and this is the first time that I have ever proposed amendments at a Report stage. I should have learnt by now how to handle a Report stage, but I have to admit that, due partly to inexperience and partly to lack of attention to your Lordships during other Report stages of different Bills, I do not. Be that as it may, I shall not go on for long.
I was pleased to hear a degree of support for my Amendment 1, about emergencies, because I think that that approach is necessary. If the noble Lord, Lord Saatchi, is prepared to talk to me about that and see what we might do perhaps at Third Reading, I would be very happy to see how we might get more effective wording for some of these ambiguous areas in the Bill.
I am disappointed that we are not defining “innovation”. That is important because, clearly, these are issues which doctors will need to consider. It is clear from a large number of responses from doctors that there is very considerable confusion about the Bill. What is extraordinary is the number of bodies that show this confusion and say how right doctors are to be confused. Although the Royal College of Ophthalmologists is apparently worried about a particular drug—I bow to the knowledge of the noble Lord, Lord Saatchi, about this; I did not know that it was—the list of concerned bodies includes the Academy of Medical Sciences, of which I have the honour to be a fellow, the Academy for Healthcare Science, the Medical Research Council, the Wellcome Trust, the British Medical Association, the Royal College of Physicians, of which I am also a fellow and therefore I have an interest, the Royal College of General Practitioners, the Royal College of Radiologists, the Royal College of Psychiatrists, the Royal College of Surgeons of Edinburgh and, to some extent, the Royal College of Surgeons of England, the Association of Medical Research Charities, Action Against Medical Accidents, the Medical Defence Union and the Medical Protection Society. I know that it has been suggested, rather irrationally, that somehow the lawyers want to leave things as they are so that they can make more money but, in fact, the Medical Defence Union and the Medical Protection Society are most involved in litigation and they clearly want a reduction in litigation, which is why they are not in favour of the Bill.
Also concerned about the Bill are the British Pharmacological Society, the NHS Health Research Authority and the NHS Litigation Authority—I checked its website this morning to confirm that—Healthwatch and, rather importantly, Cancer Research UK, which raises about £700 million a year for the treatment of cancer in this country. Also concerned are the Motor Neurone Disease Association and, to some extent, the National Institute for Health and Care Excellence. They are mostly concerned about the confusion to doctors, but some would go further than that. They say that the Bill is unnecessary and, as I shall seek to explain, may endanger patient safety.
The reason why I tabled the two amendments about medical practitioners is that it is fair to say that, in future, the National Health Service will have to rely more and more on people who are graduates other than medical graduates. Therefore, the Bill should recognise that they will sometimes need to innovate. It may be worth clarifying their position at this stage.
For the moment, I will not divide the House on Amendment 1, but I would very much value further discussion with the noble Lord, Lord Saatchi.
Baroness Manzoor (LD)
My Lords, before the noble Lord sits down, will there be any consideration of the nursing profession and others to be included when he is thinking of medical practitioners who are not qualified?
Lord Winston
I personally think that that is very important. That is why I tabled the amendment, because I wanted discussion on the issue—in particular, for health visitors and more senior nurses, whose position means that they often have to be innovative. The real issue here concerns midwives, because midwives—particularly district midwives, when they do not have a medical practitioner with them—are often presented with horrendous situations where they have to act innovatively. We hear from the Department of Health that it would like to extend home delivery. That may be a very good thing—I do not know; although I am a qualified obstetrician, I have concerns about that—but if that extension happens, as seems likely given that the health service is strapped for income, it is important to consider other health professionals who may be confronted with those problems. At the moment, the Bill does not do that, and I think that that will cause problems in future.
Lord Saatchi
My Lords, on behalf of our team and, I am sure, that of my noble friend and the Department of Health, I greatly welcome and would appreciate the opportunity to discuss the points that he has made between now and Third Reading.
Lord Winston
“( ) This Act shall not apply where the body of responsible medical opinion considers that the innovative treatment being considered is likely seriously or unreasonably to compromise patient safety.”
Lord Winston
In another place on Tuesday evening, there was an Adjournment debate moved by the honourable Member for Totnes, who is a qualified medical practitioner. In her outstanding speech, she raised serious concerns about the issue of patient safety. In particular, she cited her concern that patients, particularly those with cancer, may be at serious risk from quack practitioners who are offering a quick-fix solution for money rather than a course of authentic treatment, and possibly entering a clinical trial. The effect of this on cancer treatment could be disastrous. First, not only might we end up endangering patients by their entering a treatment that is not valid or appropriate. Secondly, research may be inhibited because we cannot fill the clinical trials needed to prove that cancer drugs are effective.
We are now in the age of genomic medicine. Genomic medicine means, more and more, that each cancer is different. Essentially, we are understanding that there are more and more mutations. As each of us in this Chamber gets older, we develop more and more mutations, so we are more liable to get different cancers in different cells. Of course, there are the common ones, but it is worth bearing in mind that more than 50% of cancers are actually quite rare. It is important to understand that each individual rare cancer makes a massive difference to life expectancy and health in Britain. Indeed, about one-third of us in this Chamber will suffer with a cancer and, on the figure I just quoted, roughly half of those will be rare cancers.
We are beginning to understand that each of these cancers can be targeted with a specific genomic medicine which may apply only to that cancer. A classic example was the case of vemurafenib, which was used for a rather unusual form of skin cancer and resulted in metastases massively drying up—but it would not work for other cancers, because the mutations were different.
It is imperative, as Cancer Research UK clearly says, that we get patients who are able to go into trials. Apart from the fact that it would be disastrous for the safety of the patients who are being treated irrationally by illogical treatments, there is also a question of patient safety generically for our entire British population. That is the purpose of the amendment.
I have focused on one area in my Amendment 13, which is the use of cells and tissues that are biologically derived. The reason I included that is because stem cells will clearly be an important use in future. Already, we are seeing practitioners setting up quack medicine which is not proven, where they are injecting cells into patients without proper validation. That is clearly dangerous. It is being used for dementia, some forms of motor neurone disorders and other neurological disorders, such as disseminated sclerosis. A number of cancer patients have also had these horrendous treatments. That is likely to burgeon, so it must be taken very seriously by the House.
We have to be absolutely clear that whatever we do, we do not endanger patient safety. There are some interesting examples in the history of medicine. The noble Lord, Lord Walton, who comes from Newcastle, told me yesterday that he is hugely against the Bill. He is very concerned that it will damage patient safety, but for health reasons—as your Lordships know, he is now 92—he felt unable to come down from Newcastle today. He reminded me of a case which I knew of way back in the 1950s. In Oxford, where he came from at that time, there was a Dr Honor Smith. Dr Smith thought that the injection of tuberculin into the spinal cord of patients with neurological disorders—in particular, with disseminated sclerosis—might alleviate their condition. In fact, it did not.
Baroness Garden of Frognal
My Lords, I apologise for intervening, but is the noble Lord now speaking to Amendment 13 as well? Is he speaking to Amendment 13 in this group?
Baroness Garden of Frognal
No, no. We are in the second group. The noble Lord is moving Amendment 2 in the second group, but he seems to be speaking also to Amendment 13 in this group. Is that correct? If it is, then other noble Lords will want to respond to Amendment 13 as well. Perhaps the noble Lord could clarify which amendments he intends to speak to in this group.
Lord Winston
I am sorry. At the moment, I am speaking to Amendment 2 on the question of endangering patient safety, but of course the injection of stem cells is also relevant to patient safety, for the reasons that I stated. Let me continue with patient safety—or am I out of order?
Lord Cormack (Con)
May I try to help the noble Lord? He did refer to Amendment 13, because it had been suggested earlier that it would fall more happily into this group—so it seems to me that he is conforming to that suggestion.
Baroness Farrington of Ribbleton
My Lords, if it may help my noble friend, the noble and learned Lord, Lord Mackay of Clashfern, referred to the fact that my noble friend could speak to Amendment 13 in its place on the Marshalled List. Therefore we cannot reach Amendment 13 until we have gone through the others.
Lord Winston
I am now totally confused but, if I may say so with great politeness, it sounds as if I may not be the only person in the House who is confused. The key thing here, which applies to both these amendments, is the question of patient safety. Amendment 2 argues that wherever “responsible medical opinion” regards that patient safety might be compromised, that needs to be considered in the Bill. That is an important issue and would certainly include the use of stem cells in particular, for the reasons that I have stated.
I was going to refer to a few medical examples where in fact innovations have been done without proper scrutiny. For example, Dr Smith felt that she could inject tuberculin into the spinal cord; the result was in fact disastrous for those patients. The noble Lord, Lord Walton, thought that this was a very good example. What was reported was that the tuberculin recipient had constitutional illness with meningitis, more alarming complications from their nervous system, vomiting, retention of urine, dysphagia, dysarthria, and a whole range of other symptoms which were actually made worse. It was a scandal at the time and a very good example of where, if you have innovation which is not properly controlled, there is serious risk.
I found it quite amusing, by the way, that the lady at Oxford, Dr Honor Smith, was the daughter of a Member of this House. She was the daughter of a Baron—so, technically, she was the honourable Honor Smith. However, I do not think that she ever used that title.
This came up again in the House of Lords later on when the noble Lord, Lord Brabazon, supported a quack treatment in 1995 of a Dr William Crofton, which was also for neurological disorders and used something rather similar. One of the problems was that people with these neurological disorders, which as we know are terrifying and untreatable, flock to practitioners in the hope that they may have an unsuccessful condition successfully treated. That is still a real issue for us all in this House.
In response to the honourable Sarah Wollaston, the Member for Totnes, in the other place this week, the Under-Secretary of State for Life Sciences at BIS, who was replying on behalf of the Government, mentioned that the Government were determined—let me get the exact quotation for the record, if I can find it in Hansard. In answer to the debate on this Bill, he said:
“I reassure the House that the Government are committed in all this work to putting patient safety first and developing a landscape of evidence-based medicine”.—[Official Report, Commons, 9/12/14; col. 850.]
I suggest to your Lordships that the Bill does the reverse. It tends to risk patient safety in certain cases where patients are desperate for a treatment. It will also reduce the chance of evidence-based medicine.
I thought about this long and hard last night. I must tell the noble Lord, Lord Saatchi, that I did not sleep last night. I woke at about 1 am, having gone to bed at 12.30 am, and could not sleep for thinking about the Bill. I understand that he has been extraordinarily courteous and very gentle in introducing the Bill. He has also been very helpful in trying to ensure that the Bill is as safe as possible and very good at listening to our concerns. I understand, too, that he has had a great tragedy that has made him feel very strongly about this issue. I fully understand and deeply respect that, and I wanted to tell him something about myself, which he may not know.
When I was not yet nine, my wonderful, amazing, chess-playing, musical instrument-playing, polymath craftsman father died. He had a minor infection that was treated by an innovative antibiotic which was quite inadequate. He then had an innovative removal of a chest drain too early, so that he developed an abscess in the pleural cavity. Finally, within six months he had an innovative operation, which was not evidence-based, in which his brain was opened and an abscess removed. This man of 42 died, leaving my mother desperate and financially destitute. I was the eldest of three children; I had a sister aged four and a brother aged three. My mother was amazingly in love with my father, so I know something of the tragedy of seeing what happens when somebody is destroyed in front of you. I do not take this as an issue that leads me to oppose the Bill—that is not the case at all—but I am very concerned that we should not use innovation where we might compromise patient safety.
One of my concerns is that we often think of the National Health Service as a football. I take strong objection to my own side when it says that it is the only side that wants to support and protect the health service. That is nonsense; we all want to protect the health service and to see a health service that is efficient. Unfortunately—and I say “unfortunately” because I mean it—at the next election, I know that the health service is bound to be something of a political football. These issues are going to come up and therefore I want to make certain that we have the chance to innovate in a responsible way. Ultimately, I am not convinced by the arguments that the noble Lord, Lord Saatchi, has put forward. There are cases where treatment that is authentic and should be offered will be compromised in response to patients who are so desperate that they are prepared to try anything which has not been fully, or even partially, tested. For that reason, I beg to move Amendment 2—and I have spoken also to Amendment 13.
Baroness Gardner of Parkes
My Lords, I was particularly keen to hear the explanation of this amendment because the more I read it, the less I understood it. I would appreciate clarification from the noble Lord because I did not, and still do not, understand whether by putting this clause in on this sort of thing, we might be preventing treatment for that man who has just walked in Poland and the people who can suddenly see again because of the treatments for their eyes. If we tend to bottle this up completely, it would mean that all the marvellous advances which have changed people’s lives completely might be slowed down by this amendment. Now, if I am wrong in that, that is a different matter.
The noble Lord, Lord Winston, spoke very movingly about his own personal circumstances. However, where I disagree with him is when he talks about these desperate people who will try anything. That is one of the issues that the Bill is designed to help with. It covers only the cases of people who are already in a terminal condition. The one thing that many of these people do not have is any hope of progress, and in most cases they are willing—certainly in the cases requesting this sort of innovative treatment—to take the risk with what is only a very short piece of life remaining, in the hope that either the treatment might cure them or it might do something to advance research at a faster rate and therefore help other people in the future.
Reading this amendment, I was not clear whether it was pro-advance or anti-advance. As I say, I am still not clear. As it stands, I have grave doubts about supporting it; I think it would take away hope, which is about the last thing that remains for a lot of people.
Lord 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.
Baroness O'Neill of Bengarve (CB)
My Lords, I am not certain whether the noble Lord, Lord Turnberg, makes things easier by suggesting in Amendment 3 that one should move from views to support, for two reasons. One is that we have a later amendment that refers to views and the recording of them. The other is that I would have thought it would be important to record the spectrum of views concerned, not just the support—the negative views as well as the positive. So I have my doubts about Amendment 3.
Lord Mackay of Clashfern
My Lords, I think that we would all take the view that the last thing we want to do in any sort of legislation is endanger patient safety. However, I suggest that the honourable Honor Smith was not acting under my noble friend Lord Saatchi’s Bill; she was acting, I take it, under the law that existed at that time. Therefore, even in the best regulated circles, with no provision for innovation, something can happen. No doubt the lady thought that she was doing the right thing when she did it, but it turned out ultimately that that was not so.
With regard to the Bill, the ultimate test of the defence is whether it is in the best interests of the patient. In taking account of views from qualified people in the area, that is an important factor. It is necessary that a doctor who is going to use this treatment should be able to satisfy the court that, in the light of the available evidence at the time when the decision was taken, this decision was in the best interests of the patient. Therefore, endangering a patient strikes me as something that is already covered quite clearly by that requirement. The mention of danger must be an important aspect of the best interests of the patient, surely.
On Amendment 2 from the noble Lord, Lord Winston, he talks about the body of medical opinion. The cases that I know of talk about “a” body; lawyers certainly do not often agree one with another and I think that sometimes doctors do not agree either. Someone therefore has to make a choice from time to time.
It is perfectly clear that we all want to prevent patients from being put in danger. I have seen and listened to the programmes by the noble Lord, Lord Winston, about the injection of stem cells into people for money in different parts of the world without the promised success ensuing from that. I am sure that there is a danger in that area. Indeed, there are dangers in many areas. However, the problem for the doctor—and I am glad in a way that this responsibility is not the kind of responsibility that one has to carry generally in other professions—is that it is the life of the patient that may well be in question. Therefore, in taking an innovative step it is essential that the views which are available in relation to the matter and which are reasonably readily available to the doctor making the decision to use the treatment are taken fully into account. That is what this Bill is trying to do.
The Bill is set out as providing for responsible innovation. One of the fundamental elements of responsibility must be the patient’s safety. While I entirely agree with the view that that is an important issue, I believe that the Bill safeguards that so far as possible. The experience to which the noble Lord, Lord Walton, referred is an example of what can happen. On the other hand, you cannot make certain; nothing is infallible. I believe that from that point of view this is as good as we can achieve.
Baroness Wheeler
This is a very important group dealing with patient safety. I shall briefly intervene in support of my noble friend Lord Turnberg’s Amendment 3, which refers to seeking the support of the appropriately qualified doctor rather than his or her views, and to support Amendment 7 from the noble Lord, Lord Saatchi, on recording the treatment and consultation on the patient’s notes.
Our firm preference was for the Bill to specify the need for the written consent of the appropriately qualified doctor, but we have heard senior medical doctors’ concerns about giving formal written consent to another doctor’s proposed course of treatment for the patient without knowing their full history and other circumstances.
As my noble friend Lord Turnberg said, there is something of an irony in a Bill designed to address doctors’ fears of litigation running the risk of opening up the fear of litigation from the supporting doctor. We consider “support” to be preferable to the doctor’s “views” and I hope that the noble Lord, Lord Saatchi, can respond positively to this as a way of reassuring patients and their carers and relatives and enhancing patient safety.
My noble friend Lord Winston’s Amendment 2 seeks additional safeguards for patient safety by reference to excluding treatment where a,
“body of responsible medical opinion”,
considers that the treatment is likely seriously or unreasonably to compromise patient safety. He has raised some very important issues here, particularly in response to cancer treatment, and I look forward to hearing from the noble Lord, Lord Saatchi, or the Minister.
The clarification the noble Lord, Lord Saatchi, provides in Amendment 7 concerning the issues to be recorded in the patient’s notes provides welcome safeguards. It does not include the full range of issues, covered under Clause 1(3), which noble Lords have been concerned to see recorded in the patient’s notes, but it goes some way to providing the greater transparency and accountability that we all wish to see, particularly in recording the doctor’s decision to depart from the existing range of accepted medical treatments for the patient’s condition and the explanation of the proposed treatment.
Finally, we have considerable sympathy with Amendment 13 for the reasons ably put forward by my noble friends Lord Winston and Lord Turnberg, and I look forward to hearing from the noble Lord, Lord Saatchi, or the Minister on this issue.
Baroness Jolly
My Lords, I shall start my remarks by addressing Amendment 13. This amendment seeks to exclude from the Bill treatments that involve the insertion or injection of cells, tissues or other biologically derived material into the body of a patient. The Government do not consider this amendment to be necessary. The use of human tissue and cells is a heavily regulated area of practice. It is regulated by the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Medicines and Healthcare products Regulatory Agency. As part of making a responsible decision to innovate, the Bill requires that a doctor must consider not only the risks and benefits of the proposed treatment but how they would compare with other treatments and with not carrying out any treatment. This requirement provides a robust objective test of whether an innovative treatment should be used.
Clause 1(5) makes clear that the requirements in the law relating to best interests continue to apply in that nothing in the Bill permits a doctor to carry out treatment for any purpose other than the best interests of the patient. Further to this, the amended Bill requires doctors to act responsibly, including taking full account, in a responsible way, of the views of other appropriately qualified doctors. This 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 review. Clause 1(3)(c) requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition.
The Bill provides safeguards for patients while ensuring that doctors can use their clinical judgment and be flexible to individual patients’ circumstances.
I now move to Amendments 2, 3 and 7. It is essential that any legislation is safe for patients. That is why the Government are pleased that the package of amendments devised with advice from Sir Bruce Keogh, the medical director of NHS England, to make the Bill safe for patients was accepted in Committee in this House on 24 October. The noble Lord, Lord Winston, has tabled an amendment that seeks to ensure that a doctor cannot rely on the Bill where a body of responsible medical opinion considers the treatment to compromise patient safety. He referred to the recent debate in the other place where my honourable friend George Freeman, the Minister, asserted that the Government are dedicated to patient safety and evidence-based medicine. I should like to reassure noble Lords that the Bill does not remove any of the current safeguards in place to protect patient safety. If the innovative treatment was considered likely to compromise patient safety, it is extremely unlikely that it would be considered a responsible decision under the Bill when later judged in court. A doctor who innovated in such circumstances is highly likely to be aware that his or her decision would not be considered responsible.
The noble Lord, Lord Winston, raised a couple of points. One was about quack doctors and the other was about stem cell injection. The Bill does not remove any safeguards for patients. There is no escape for negligent doctors under the Bill. They still need to demonstrate that they have acted responsibly. Nothing in the Bill allows doctors to bypass any processes and requirements set by their trust in relation to undertaking innovative treatments in the NHS. This would include ensuring that the commissioners would fund any treatment if it is to be provided within the NHS. Individual innovation is incredibly important, but it is not a substitute for medical research, which usually tests the efficacy of treatments in a systematic way. Successful individual innovations are likely to lead to systematic research projects as evidence builds around a particular speciality. As part of their professional development, doctors should contribute to research as well as look for innovative ways to treat their patients. Noble Lords will be pleased to note that we will emphasise the importance of research in accompanying guidance to doctors on the use of the Bill.
On stem cell injection damaging patient safety, there is no reason for the Bill to damage patient safety. The decision to innovate under the Bill has to be responsible and the doctor would be negligent if he did not innovate responsibly. The Bill gives no extra leeway in respect of stem cell injection, as he suggested. Any decision to inject stem cells would have to comply with all existing safeguards and be responsible. The alarming examples given by the noble Lord are extremely unlikely to have been responsible. Quack treatments would simply not pass the hurdles of responsible decisions required by the Bill.
The amended Bill requires doctors to act responsibly, taking full account of the views of other appropriately qualified doctors. This 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 review. Clause 1(3)(c) requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition.
Lord Avebury (LD)
My Lords, I wonder whether a doctor who is asked by a patient about alternative therapies is obliged to tell the patient that these treatments have not been approved and that he does not recommend that the patient use them. Many patients, when they are desperate, will go for those alternative therapies even if that means paying for them themselves. I would therefore like an assurance that the doctor would dissuade the patient from taking that course of action.
Baroness Jolly
I am sorry; I do not have a note on that here, but I will write to the noble Lord and place a copy in the Library.
Amendment 7, in the name of the noble Lord, Lord Saatchi, adds to the steps that a doctor must take for the purposes of evidencing a responsible decision to innovate. The amendment requires doctors to record in the patient’s notes details relating to the views they have obtained from one or more appropriately qualified doctors, their decision to innovate and the proposed treatment.
As noble Lords may be aware, the NHS constitution is clear that patients have the right to access their own health records. The Government have gone further, setting the clear expectation in the first two mandates to the NHS that by 2015, everybody who wishes to get online access to their own health records, which are held by their GP, will be able to do so. Furthermore, we would fully expect doctors to have an honest and open conversation with their patients about treatment decisions. The GMC’s guidance Consent: Patients and Doctors Making Decisions Together sets out a model for a constructive dialogue between doctors and patients about treatment options.
I can now answer my noble friend’s question about complementary and alternative medicine and whether doctors who practise those forms of medicine will be able to experiment with untested procedures under the Bill. Under both the existing common law and the Bill the doctor needs to show that they have acted responsibly when deciding to offer a patient innovative treatment in order not to be negligent. Doctors are able to offer patients innovative, complementary and alternative medicine under the current law. If the innovative treatment were a medical treatment provided by a doctor, they could seek to take the steps under the Bill to evidence that they had acted responsibly in so doing. The amendments made to the Bill in Committee apply an objective test of responsibility to the doctor’s decision to innovate and would prevent a doctor who acts irresponsibly from relying on the Bill. The guidance is clear that doctors should set out in an honest and open way what is known and not known about the benefits and risks of innovative treatment and why it is being proposed.
I therefore hope that noble Lords will join me in accepting Amendment 7 from this group, which is a welcome amendment that requires doctors to record the details of innovative treatment in patients’ records.
Lord Avebury
My Lords, my question was whether the doctor has a positive obligation to say to the patient who asks about an alternative therapy that it is not approved by medical opinion, and that they should positively advise the patient not to go in for these alternative or complementary therapies, knowing that they are unable to help patients.
Baroness Jolly
Perhaps I can help my noble friend. The Bill is about the doctor making a decision about treatments for patients that are innovative and untested. If a doctor has a conversation with a patient about something that is complementary or alternative, that is a slightly different situation, and not the sort of situation that the Bill addresses.
Lord Davies of Stamford (Lab)
Before the noble Baroness sits down, the word “responsible” has played a key part in the debates on the Bill, and she has used that term herself about a dozen times this morning. Do the Government consider that Clause 1(3) adequately defines that word; or, otherwise, that the word “responsible” in a medical context is adequately defined in the existing jurisprudence—which it may be; I am not a lawyer and am not familiar with that jurisprudence? Or do the Government think that the Bill might gain from a specific definition of “responsible” at some point in the Bill?
Baroness Jolly
My Lords, to put a definition of an abstract term such as “responsible” in the Bill would be quite a considerable challenge. I think that the Government have covered the issue through the first clause.
Lord Saatchi
My Lords, in speaking to Amendment 2 in the name of the noble Lord, Lord Winston, I will also speak to Amendment 3 in the name of the noble Lord, Lord Turnberg, to my Amendment 7, and to Amendment 13 in the name of the noble Lord, Lord Winston. I am therefore starting with Amendment 2.
To say that it was touching to hear what the noble Lord, Lord Winston, said, would be a considerable understatement. We share the experience of witnessing a terrible event. However, I know that he will share with me the view that, although we have that experience in common, it has not led to an agreement between the two of us about the merit of the Bill, for which I am very sorry. I hope that, in the course of the wide-ranging discussions that he has happily said that we will have before Third Reading, we can arrive at a happy synthesis—perhaps above all for the reason of the two stories that we have to tell. We have a great deal in common.
All these notes are about patient safety. I would like to reassure the House that at a certain crucial moment—probably the crucial moment in the legislative journey of this Bill—the Secretary of State for Health called a meeting in his office of all the great representative bodies and all the great figures in the medical world. I know that he will not mind me saying this. There was a discussion and views were sought by the Secretary of State, after which he said, as an accurate summary of the meeting, that he thought that there was a consensus to move forward with the Bill. However, he said that he wanted reassurance that the safeguards in the Bill in relation to patient safety were adequate. He said that he had decided therefore to formally ask the NHS medical director, Sir Bruce Keogh, to formally advise the Secretary of State on that one question. As we know, this resulted in Sir Bruce widely consulting and producing what are now famously known as the Keogh amendments, as the noble Baroness, Lady Wheeler, said, which were passed in my name in Committee. Therefore, I would like to reassure the House that the Government have taken the greatest possible interest, even at the cost of significant delay to the passage of the Bill, to be sure that the clauses reflected that concern and those concerns expressed in this group about patient safety.
I come to Amendment 2, in the name of the noble Lord, Lord Winston, which would disapply the Bill to cases where the body of responsible medical opinion considers that the innovation proposed is likely to compromise patient safety. As I have just said, everyone—not least of all the Government—want to ensure that patient safety is paramount. I am confident that the Bill already makes that clear in a number of ways, which my noble friend the Minister recited, including in the safeguards added in response to the concerns expressed by the Keogh amendments. Perhaps the noble Lord would allow me to say that the formula suggested in the amendment does not bring an additional clarity to the Bill, for the reasons given by my noble friend the Minister. When there is a requirement to take account of the views of appropriately qualified and experienced colleagues, it means that when there is a general consensus against the proposed innovation, on safety grounds or otherwise, the doctor would not be safe in relying on the Bill to innovate. Nor would I want a doctor to be able to rely on the Bill in those circumstances. My fear is that in attempting to add clarity on the point, the noble Lord might be introducing a number of concepts that could add a high degree of uncertainty, particularly in relation to what amounts to sufficient consensus for the purpose of his new provision, and what amounts to a serious or trivial compromise of patient safety. For those reasons, I hope that the noble Lord will accept that the point at which his amendment is very sensibly aimed is already covered by the terms of the Bill and that perhaps he might agree that his amendment could cause some uncertainty on that point. Therefore, he may agree with me that he will not want to press Amendment 2.
Amendment 3 deals with the question of “views” versus “support”. I would like to reflect in these comments, perhaps in a more long-winded way, on what my noble and learned friend Lord Mackay said, and on what the noble Baroness, Lady O’Neill, said on this subject, on the use of the words “views” versus the words “support”. We have heard that the amendment proposed by the noble Lord, Lord Turnberg, would replace the requirement to obtain the “views” of “appropriately qualified” colleagues with the requirement to obtain their “support”, which sounds perfectly straightforward. However, in Committee there were suggestions that the requirement to consult colleagues should become a requirement to obtain their formal approval. We all thought very hard about whether we could meet those suggestions; several senior doctors were consulted on the point and it was discussed at a round-table event suggested by the noble Baroness, Lady Wheeler, last month, which we arranged following Committee. At that meeting and elsewhere, a number of doctors expressed concern about giving formal approval to another doctor’s proposed course of treatment without knowing the full history and other circumstances, while they were clear that they would be relaxed about expressing a view, orally or in writing, of the soundness of a doctor’s proposal as described to them. Senior lawyers also consulted were concerned, as my noble friend the Minister said, about a possible new form of legal liability for doctors giving approval. We certainly would not want that, for just the reasons that she gave. That is why my Amendment 7 would require doctors to record views expressed by colleagues in the patients’ notes, in the hope of introducing the necessary formality, transparency and accountability, while avoiding the problems that doctors and lawyers have expressed in relation to introducing a requirement for formal approval of colleagues.
Lord Winston
My Lords, first, let me thank the noble Lord, Lord Saatchi, for his gentle and helpful comments, which I am sure are appreciated not just by me but by the House in general. I felt great difficulty in talking personally on this issue and I debated with myself whether I should do so. I look forward to talking to the noble Lord about the amendments we have been discussing outside the House as soon as possible and I shall make arrangements to do so. I am at his disposal.
I am astonished by the Government’s response. It is not adequate for quite different reasons. It is nothing to do with the noble Lord, Lord Saatchi, but the noble Baroness, Lady Jolly, does not seem to understand that the regulatory framework we have does not encompass my objections. She mentioned, in particular, the Human Fertilisation and Embryology Authority—I have no doubt we will have this debate repeatedly over the next months—but perhaps she is not aware that two weekends ago I went to the Fertility Show at Olympia, where there were a number of stands of private clinics offering their wares to patients. Offered on their big posters are treatments which are illegal or not regulated in Britain, including, for example, sex selection and some cell treatments. Practitioners who are registered with the Human Fertilisation and Embryology Authority, some of whom will be involved with stem cells, are in relationships with clinics outside this country which are not under the jurisdiction or regulation of the Government. I am happy to name but I shall not do so in the House.
The Government must understand that regulation does not cover all these issues. There are many examples where experimental treatments are being carried out in this great city of London at huge expense. This week I have received two e-mails, one concerning a woman who spent £11,000 for a single treatment and another where a woman spent £69,000 for three treatments. These treatments were not validated but would be regarded as innovative. That is why I am concerned about this. I shall not divide the House.
Lord 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.
Baroness Masham of Ilton
Baroness Masham of Ilton
My Lords, as medical innovation stands, any doctor providing an innovative treatment—for instance, departing from the existing range of accepted medical treatments for the patient’s condition—must consider a range of factors, including the views of at least one other appropriately qualified doctor about the proposed treatment, the risks and benefits associated with the proposed treatment, the risks and benefits associated with existing treatments, and the consequences of not providing these treatments. Amendment 4 will require doctors to explain these factors to the patient so that they are able to make a fully informed decision.
This is important because people have the right to a clear understanding of any innovative treatment, including how it is intended to work, and all the associated risks. Without robust safeguards there is a danger that people could undergo potentially risky treatments without a full appreciation of what they involve. Clause 1(3)(d) already requires doctors to take account of,
“any opinions or requests expressed by or in relation to the patient”,
a welcome and necessary provision. However, this relies on the patient or their carer proactively questioning or commenting on the proposed treatment. Given the complexity of innovative treatments and comparisons to existing treatments, it is unrealistic to expect that a patient or carer will be able to properly form opinion and requests without first receiving an explanation of the views, risks and benefits that have been considered by the doctor. The amendment will therefore strengthen Clause 1(3)(d) and ensure that this provision is able to fulfil its intended purpose.
Clause 1(3)(c) requires doctors to,
“obtain any consents required by law to the carrying out of the proposed treatment”.
Under existing legislation and case law, doctors must explain the risks associated with the treatment and ensure that the patients have the necessary support to help them understand relevant information. However, as the Bill stands, there is not any explicit legal requirement for doctors to provide patients with information on the specific new factors that they are required to take into account under Clause 1, such as the views of other doctors on the proposed innovative treatment.
The amendment will not require doctors to obtain any extra information over and above that already necessitated by Clause 1. It will simply mean that this information is shared with the person being offered the treatment.
In addition to facilitating informed choices, the amendment is also necessary to help ensure that patients have realistic expectations about the likelihood that an innovative treatment will improve their condition. Through receiving an explanation of the various assessments and views obtained by their doctor, patients will have a better understanding of how effective any treatment may be.
Baroness Jolly
My Lords, Amendment 4 of the noble Baroness, Lady Masham, supported by the noble Baronesses, Lady Gale and Lady Wheeler, seeks to require doctors to explain the steps they have taken under the Bill, including the views they have obtained from other doctors, as part of the process of obtaining consent from the patient.
The noble Baroness inquired whether the Bill should specify the need to obtain informed consent in the light of the aims, processes and risks involved in untested treatments. The Bill requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition. The Bill does not change the law of consent, whereby a patient must still provide an informed and voluntary consent to any treatment offered to them. This would include the need to ensure that patients have sufficient understanding of the treatments being provided. Nor does the Bill change the law of consent in relation to children and people who lack capacity, whereby any treatment provided to them by a doctor must be in their best interests.
The Government are reluctant to set out in the Bill the factors that are needed to meet the existing law of consent. To do so might imply that the requirements listed in the Bill are all that are needed to obtain consent under the existing law. We think that a more sensible approach is to make clear that all the existing requirements under the law of consent will continue to apply to doctors who act under this Bill.
In addition, the Government do not consider this amendment to be necessary as Amendment 7 of the noble Lord, Lord Saatchi, will ensure that the steps the doctor has taken in following the Bill are recorded in an accountable and transparent way. I hope that noble Lords will take into account the Government’s view that it is best to rely on the existing law of consent, and not accept Amendment 4.
Lord Saatchi
My Lords, this amendment in the names of the noble Baronesses, Lady Masham, Lady Gale and Lady Wheeler, would add a proposition to the provision that requires innovating doctors to ensure that they obtain all the necessary consents required by law. The amendment would add a qualification to ensure that the patient’s consent must, in particular, have been based on a process in the course of which the innovating doctor explains to the patient what steps the doctor has taken to comply with the reasonableness, transparency and accountability requirements of Clause 1. The doctor must explain the steps taken generally, and in particular must tell the patient what views have been sought from the doctor’s colleagues and what those views were.
I do not claim for this Bill the status of our great poetry, usually best defined as the only possible words in the only possible order. I can quite see why the noble Baronesses think that this specific requirement would add clarity and certainty without changing the essence of what the Bill already requires. Although I think that what the noble Baroness proposes would already be a necessary part of any reasonable reliance on Clause 1(1), I can absolutely appreciate—we have spoken about this, obviously—why she thinks that express provision on this point would help readers to understand how the Bill is intended to work. However, my noble friend the Minister has explained why the Government do not consider this amendment necessary, and will therefore not invite the House to support it.
I hope that the noble Baroness will consider the relevance to this amendment of my Amendment 7, which seeks to do exactly what she is describing. Therefore, although I have considerable sympathy with the intentions behind this amendment, I know that she will appreciate that I am bound to follow the lead of my noble friend the Minister on this matter. However, I hope she will feel reassured by the fact that her amendment has enabled both the Minister and myself to place on record that our understanding of how Clause 1 would be applied in practice is absolutely in accordance with the noble Baroness’s own understanding, as set out in her amendment, of how it ought to work.
Baroness Masham of Ilton
My Lords, I thank the noble Lord, Lord Saatchi, and I thank his team for its very helpful intervention. However, I must say that patients need very clear explanations of what is going to happen. I will take the amendment away again—we have one more stage—and continue the advice from many patient groups. Today on the “Today” programme it was said that in the other place there was considerable worry about patient safety. The Government, therefore, should emphasise this clearly if they want the Bill to go through. I beg leave to withdraw the amendment.
Lord Hunt of Kings Heath
“( ) comply with any professional requirements as to registration of the innovation with a scheme for capturing the results of innovative treatment (including positive and negative results and information about small-scale treatments and patients’ experiences),”
Lord Hunt of Kings Heath
My Lords, before speaking expressly to the terms of the amendment, perhaps I may ask a question of the noble Lord, Lord Saatchi. He knows that we have enormous sympathy for the intent behind his Bill and have put forward what I regard as constructive amendments. He has been gracious and constructive in his response.
However, I am still left uneasy that a substantial body of medical opinion—noble Lords have read out the list of organisations—is concerned about the impact of the Bill. The noble Lord may well decide just to plough on. Clearly, we will have a Third Reading, which, I assume, will be in the new year because we could hardly have a Third Reading, say, next Wednesday because it would not give enough time for noble Lords to table amendments properly. That must at least put some doubt as to whether the Bill can get through the other place, particularly in view of the intervention of the chair of the Health Select Committee, although I may be wrong about that. However, even more importantly, what has become clear, in the light of the arguments that have come from medical bodies and clinicians at the forefront of innovation, is that we know that before the Bill comes into effect, various guidance will be issued by the Minister’s department and the General Medical Council—and probably by the defence organisations to their members. My assessment at the moment is that the Bill is unlikely to be used by doctors because of the advice that will come from these different bodies.
The point I wish to put to the noble Lord is this: the arguments that we have heard have been between lawyers and doctors. The lawyers—two distinguished noble and learned Lords have spoken—are saying that, by and large, the law is okay in relation to the Bill, and I fully accept that. However, doctors are saying that there will be greater confusion as a result of the Bill and, therefore, they will not use it in the way in which the noble Lord, Lord Saatchi, wants it to be used. There is no meeting of minds. The noble Lord has said that he will talk to my noble friend Lord Winston between now and Third Reading, which I very much welcome, but he surely has to engage again with the bodies he met with the Secretary of State to try to find a way through. We support what the noble Lord wants to do and the need for innovation, but my judgment at the moment is that even if he gets his Bill it will not be used, except by the kind of doctors my noble friend Lord Winston referred to—the kind we do not want to use the provisions.
As far as my amendment is concerned, I will say just this: a number of noble Lords felt that it would be a good idea if there were a register on the use of the Act—if it is used—which could then be followed up by research and regulatory agencies. There was general sympathy for that. I thought the noble Earl, Lord Howe, was, up to a point, sympathetic and said:
“The Government’s view is that it is not necessary in this Bill to require doctors to record their innovation in medical records … The General Medical Council’s Good Medical Practice guidance already sets out requirements on doctors to record their work clearly in clinical records”.
However, the noble Earl then said that he had,
“heard the legitimate concerns of noble Lords today, and I commit on behalf of the Government to explore this issue further”.—[Official Report, 24/10/14; col. 887.]
My amendment essentially seeks to embrace that, to ascertain from the noble Baroness where those discussions have got to, and embrace the requirements likely to come from the GMC over the Bill. That would provide considerable reassurance to noble Lords who raised this matter in Committee. I beg to move.
Lord Cormack
My Lords, the noble Lord, Lord Hunt, as he so often does, put his case succinctly and elegantly in what is essentially a probing amendment. It is important that we reflect on the points he made because the whole purpose is to get something on the statute book that will be accepted and used. Two things are essential if that is to happen. First, the notes for guidance on and interpretation of the Bill must be written in the clearest possible English. Sir Ernest Gowers’s Plain Words comes to mind. Also, there must be a version that is designed specifically for patients. In all our discussions this morning—we have heard some fascinating speeches—the word “patient” has not occurred often as it should have done. The Bill is designed, above all—as I understand my noble friend’s intentions—to help patients and their loved ones who are concerned, and who do not wish to fall into the clutches of the quacks but to be treated by sympathetic, empathetic, well trained and qualified medical practitioners.
If the Bill goes on the statute book—I hope it will—I should also like there to be a major conference on the Bill. That must be not only in London, which will of course be necessary, but around the country, in all the great regional capitals of the kingdom, so that doctors and patients will have the opportunity—I am delighted to see the noble Lord, Lord Hunt, nodding assent—to have the Bill explained to them. The Bill does not really pose a threat to any doctor or patient. If it did, it would completely negate its own purpose. Clear explanations are essential. When my noble friends the Minister and Lord Saatchi comment, I hope that they will recognise that there is some validity in the points I seek to make.
Baroness Masham of Ilton
My Lords, I support the amendment, as do many organisations. They say that it is essential that provision is made for collecting and sharing data to ensure that information, both on beneficial and harmful effects of treatment, is captured for the benefit and subsequent use of patients. We should be much better at collecting data than we are at present. This is important for research, but also for safeguarding patients. I hope that the amendment will be accepted.
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.
Lord Kakkar (CB)
My Lords, I declare my interest as professor of surgery at University College London. I also support the amendment very strongly. It comes to the very heart of innovation and sharing the results of that innovation openly, whether they are negative or positive. Therefore, the register needs to be obligatory, in which all innovation and the outcome of that innovation is properly reported. It would do much to ensure the development of an enhanced culture of innovation, but also, fundamentally, to provide very important protections.
Lord Winston
My Lords, as far as patient safety is concerned, it is clear that there is a need to keep a record so that other patients do not receive a misguided innovative treatment following an unsuccessful one. That is very important.
Baroness Jolly
My Lords, Amendment 5, moved by the noble Lord, Lord Hunt, and supported by the noble Baronesses, Lady Wheeler and Lady Masham, and the noble Lord, Lord Turnberg, seeks to require the registration of innovations that are carried out under the Bill as part of the steps that a doctor should follow when taking a responsible decision to innovate. The Government have listened carefully to the concerns expressed by noble Lords and several key stakeholders, including the Royal College of Physicians, with regard to the collection of data resulting from innovation. We agree that it is vital that doctors are able to share learning about innovation that results from the Bill. However, we do not think that a requirement to record the results of innovative treatments should be included on the face of the Bill. Requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent, as Amendment 5 would require, would impose requirements that go beyond the current Bolam test of negligence. We are reluctant to impose requirements additional to those in the existing law as this may risk deterring doctors from innovating.
A stand-alone clause that would require doctors to register the results of innovative treatment would widen the scope of the Bill to cover all innovation. This Private Member’s Bill is not the right vehicle to make provision that would relate to all innovation. Broadening its scope in this way risks the Bill becoming the receptacle for a host of measures on innovation that are unrelated to the subject of clinical negligence. What is more, such an amendment may lead to confusion as doctors associate the Bill with clinical negligence and may therefore wrongly assume that the recording of innovation is tied in with the test of clinical negligence under the Bill. This additional burden may dissuade a doctor from innovating. It would be unclear to those doctors who choose not to innovate under the Bill whether they would be required to register the details of their innovation on the registry or whether the provision applies only to those innovating under the Bill. If the provision applied only to those innovating under the Bill, this would create an anomalous position for those acting under the Bill. More importantly, the act of putting something into legislation does not guarantee that doctors will adhere to it. We need to focus on incentivising doctors to use the registry and make such a registry work for their needs. It would be unwise to put something into legislation that does not work for doctors and that they would therefore not be able to adhere to.
I am sorry, but I have lost my place.
Lord Forsyth of Drumlean (Con)
I am trying to be helpful to my noble friend while she finds her place. I have been listening to her words, but surely from the point of view of the intention of the Bill, which is to encourage innovation so that people can benefit from it, it is rather extraordinary to argue that there should not be some record of success or failure.
Baroness Jolly
My noble friend is right. The Government are suggesting that there should be a registry because it would make no sense not to record innovations. It could otherwise not be replicated. The Government’s preferred approach is to set up a registry but not to put that on the face of the Bill.
In Committee, my noble friend Lord Howe committed on behalf of the Government to explore constructively what might be useful in terms of record-keeping and reporting in relation to medical innovation. The Government have begun engaging with partners in the health system to discuss how to achieve this goal and will continue to do so as the Bill progresses. This mechanism should be developed with a sufficiently light touch so that clinicians see it as being facilitative of good practice rather than burdensomely bureaucratic. It is also important to consider the efficiency of the data-collection mechanism and how it can be developed in the most cost-effective way.
In response to my noble friend Lord Cormack, once we have a Bill, the Government will work closely with the professional bodies and all other organisations to help the health system and patients understand and prepare for the changes to the law made by the Bill, including producing any guidance that might be helpful.
Lord O'Donnell (CB)
As a strong supporter of this Bill, I back the idea that we must learn from the innovation. To be honest, I worry not about the successes but about the failures not being recorded. Therefore, I am grateful that a register will be set up. However, will it be compulsory? If it is not, that would not meet the requirements.
Baroness Jolly
At the moment, it is not the intention that it should be compulsory, but it should be such that doctors would not dream of not recording on the register. In that way innovation is spread but failures are disseminated, if that makes sense.
Lord Cormack
The noble Lord has made a very important point. My noble friend clearly is very sympathetic. At Third Reading there will be an opportunity for a suitable amendment. It would reassure people throughout the House and, more important, throughout the country if there were such an amendment.
Baroness Jolly
As I have said, the Government are very sympathetic to the idea of a registry. On Monday, I have a meeting with the noble Earl, Lord Howe, when I shall pass the views of the House to him. Third Reading will be in the new year.
Baroness Masham of Ilton
My Lords, surely patients have a right to know what works and what does not work and surely the noble Lord, Lord Saatchi, wants his Bill to be positive rather than negative.
Baroness Jolly
I have said that the Government are very supportive of a registry. Of course, patients would want to know what does and does not work, as would all doctors. I have said that I will take this issue back and discuss it with the noble Earl, Lord Howe.
Baroness O'Neill of Bengarve
My Lords, in so doing, it would be valuable if the Minister could go back to the central theme of today’s debate, which is patient safety, not the protection of doctors from clinical negligence claims. If we are focused on patient safety, any failure to collect valuable information, whether positive or negative, would compromise patient safety—not perhaps the safety of that individual patient at that moment but patient safety generally. The collection of data here is of fundamental importance. I cannot see the reasons why it should not be compulsory.
Lord Mackay of Clashfern
Do I understand that the position that the Government are taking is a technical one on the scope of this Private Member’s Bill and that it would be improper in a Private Member’s Bill to set up a register that would go beyond the scope of this Bill as to the innovations that it covers? The idea is to set up a register that would be wider in its scope than the mere innovations that take place under this Bill, assuming that it becomes an Act. Is that the difficulty?
Baroness Jolly
I thank my noble and learned friend for helping me out. I thought that I said at the onset that this was felt by the Government to be outside the scope of the Private Member’s Bill. But they are very sympathetic to the idea and have already started to have conversations. The noble Baroness, Lady O’Neill, talked about safety and, as the noble Lord, Lord Davies, said, responsibility is another thing. The Government see it as the responsibility of doctors to enter on to the registry. In the mean time, I ask the noble Lord to consider withdrawing his amendment.
Baroness Warnock (CB)
Surely it is important that this register should be compulsory. The obvious point is that if you innovate and it fails and then you do not register, that would destroy the whole point of having a register.
Lord O'Donnell
Perhaps I may come back on whether it is relevant for this Bill. As I understand it, the Minister said that the Government were deciding to set up this register and therefore it is not a question of what is in the Bill. We were asking whether the Government can make the register compulsory and how they would do that.
Lord Newby (LD)
My Lords, I remind noble Lords that this is Report and that, under the rules of the House, noble Lords are normally supposed to speak only once.
Lord Brown of Eaton-under-Heywood (CB)
My Lords, as I am speaking just the once, perhaps I may draw attention to Clause 2(2)(b), which contemplates innovation in the sense of,
“a departure from the existing range of accepted medical treatments for a condition”,
not—I repeat, not—within the scope of the Bill. Surely that innovation, too, should be included within the register, because it is important that its effects should be recorded. It should not be confined only to those who seek to invoke the provisions of this Bill.
Lord Newby
My Lords, I also remind noble Lords that, under the rules of the House, it is not permitted for noble Lords to speak after the Minister.
Baroness Butler-Sloss (CB)
But it is permitted for noble Lords to ask the Minister a question before she technically sits down. I should just like to reiterate what has already been said: it seems to me that making the register compulsory ought to be on the face of the Bill.
Lord Saatchi
I am going to put my notes to one side, probably to the horror of parliamentary counsel. On this amendment I find myself in complete agreement with every word that has been said by every Peer who has spoken on the subject. The reason is that it has been my fundamental position on the Bill from the beginning that, without a register that records both positive and negative results of innovation, it is very hard to explain to a man from Mars what the point of the Bill is. The Bill is designed to move science forward. If it does not do that, I can only say that I do not know quite what it does. That is its purpose.
I do not speak as an expert on the subject, but at least I can read. The standard text on the subject of science and scientific discovery was written by Professor Popper some years ago—noble Lords will all be familiar with it. In it, he describes the logic of scientific discovery as “reputation by application”. If no record is kept of a case in which a hypothesis has been refuted, then science will not advance in the way that the logic of scientific discovery requires. Therefore, it is, in the words of my noble and learned friend Lord Mackay of Clashfern, absolutely essential that there is a register that records both the successful and the unsuccessful results of innovation. In that way, science will advance and the wonderful result will be, as is the purpose of the Bill, to speed up the discovery of cures for horrific diseases.
I also want to reflect on what my noble friend Lord Cormack said. It has been pointed out to me that the work on the Bill will really only start on the day it receives Royal Assent. My noble friend the Minister and the Department of Health will have to hold some kind of conference and undertake some kind of educational programme with the royal colleges in order to achieve the purpose of the Bill, which, as described by the Chief Medical Officer of the United Kingdom, is a culture change. It is designed to change the culture slightly towards innovation and to provide doctors with a relief from the fear of litigation that some doctors have. None of those things will be possible or logical without the register.
I remind your Lordships that Oxford University has offered to maintain the register. It regards it, as I do and as we all do, as an essential part of the Bill. Therefore, it is reassuring to hear from the Minister today that the Government are not saying that the register is something that they are going to review or consider, or that it is something that they regard as perhaps having a benefit. The Minister has said today, for all of us to hear, that the Government commit to the creation of a register that does exactly what Members of your Lordships’ House have said. I am satisfied by what my noble friend the Minister has said because she has said flat-out in Hansard that the Government intend this register to be created—by Oxford, NICE, the Government themselves or whomever—and that the Government intend to bring the relevant people together during the passage of the Bill through the House of Commons in order to resolve the question of how and by whom that register is going to be compiled. I have certainly heard the Minister say that the Government are committed to the register. That is very reassuring to me.
Lord Forsyth of Drumlean
Will my noble friend deal with the issue of compulsion? You can create a register, but it might be a voluntary register, not a compulsory one.
Lord Saatchi
That is an important point and many have made it. The discussion that has to be had is whether this can be achieved by regulation, as I think my noble friend the Minister believes, or by GMC guidance. It is possible that there are other ways to achieve what is in effect compulsion without putting it in the statute.
Lord Ryder of Wensum (Con)
Will my noble friend accept that there are precedents in other Private Members’ Bills going back several years for such registers being set up?
Lord Hunt of Kings Heath
My Lords, I thank all noble Lords for taking part in this short but interesting debate. I say to the noble Lord, Lord Saatchi, about the conference that his noble friends suggest, that it is all well and good to have a conference after a Bill has been enacted, but in my judgment that is too late in relation to his Bill. He needs to engage with the professional medical bodies before the Bill goes to the other House; otherwise, he risks enacting a Bill, if he is able to do so, that will start with a huge defect—all the main medical bodies are opposed to it. I urge him to try to reach consensus with those bodies as the Bill goes through.
On the question of registration, all noble Lords agree that for any treatment that took place under the provisions of the Bill there should be a register—for patient safety concerns, research concerns and audit concerns. The question is how to ensure that that happens. I am disappointed by the Government’s response. This was meant to be a constructive amendment, which I think meets the needs. The Minister is not in favour of compulsion. She said at one stage that she thought that, even if you enacted a provision, there is no guarantee that doctors would use it, but she said later that she wanted a position where doctors would not dream of not registering with a scheme. That seems inconsistent.
On the question of the technical scope of the Bill, the noble Lord has already pointed to other Private Members’ Bills, which is a relevant point. But my amendment relates to the circumstances under this Bill. It says:
“Page 1, line 24, at end insert—”,
so I am very clear that the circumstances of a register relate only to interventions that take place under the auspices of the noble Lord’s Bill. I am not seeking to create a wide-ranging register for other aspects of legislation; I am seeking to give statutory underpinning to a register that one hopes the General Medical Council or a similar body would undertake.
I hear that the Government will consider this again. I will bring this back at Third Reading and I will press it unless we get an absolute assurance that there will be a compulsory register. I beg leave to withdraw the amendment.
Lord Saatchi
“( ) The steps that must be taken by virtue of subsection (3)(e) include the recording in the patient’s notes of details relating to—
(a) the views obtained under subsection (3)(a),(b) the doctor’s decision to depart from the existing range of accepted medical treatments for the patient’s condition, and(c) the proposed treatment.”
“(a) applies in relation to treatment carried out for the purposes of medical research;”
“( ) Nothing in this section applies in relation to treatment which is carried out solely for cosmetic purposes.”
Lord Saatchi
(b) is to be read as limiting the circumstances in which any such rule of the common law may be relied on (including, for example, where emergency treatment is required).”
“( ) any decision by a doctor to depart from the existing range of accepted medical treatments for a condition in accordance with section 1 does not prejudice the doctor’s ability, in relation to the departure, to rely on any rule of the common law referred to in subsection (1)(a);”