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House of Lords Hansard
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Lords Chamber
12 December 2014
Volume 757

House of Lords

Friday, 12 December 2014.

Prayers—read by the Lord Bishop of Sheffield.

Retirement of a Member: Lady Saltoun of Abernethy

Announcement

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My Lords, I should like to notify the House of the retirement, with effect from today, of the noble Lady, Lady Saltoun of Abernethy, pursuant to Section 1 of the House of Lords Reform Act 2014. On behalf of the House, I should like to thank the noble Lady for her much valued service to the House.

Medical Innovation Bill [HL]

Report

Clause 1: Responsible innovation

Amendment 1

Moved by

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1: Clause 1, page 1, line 3, at end insert—

“( ) 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.”

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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.

The second area is the use of drugs. As we heard during that debate, people with disseminated sclerosis are occasionally being offered drugs that have not necessarily been tested or recommended by the manufacturer. That is perfectly reasonable if it gives those people symptomatic relief. When I was chairman of the House of Lords Select Committee on Science and Technology, we conducted an inquiry into the medical uses of cannabis. The Home Secretary at the time, I have to say, was pretty scathing about our report and refused to allow any part of it to be implemented. Eventually, of course, one recommendation in that report was included—the use of cannabis for patients with some neurological conditions, and it has proved to be quite useful. However, it was not properly effective. There are many other examples where a drug might not have been recommended by the manufacturer but its use might be justified in an innovative treatment or it may well be that in certain cases there is a therapeutic agent for which clinical trials have not been completed. That would help with vaccines as well as with drugs.

The third area is the use of devices. This may seem to be a trivial point but I must tell noble Lords that in my kind of practice, in fine surgery on the delicate tissues in the pelvis, many surgeons, without proper trials, for years put various plastic devices inside the fallopian tubes to try to keep them open. That actually caused more damage than it did good and that kind of process has now been prevented. None the less, there are times when one might want to insert a stent or plastic device that has not been fully tested. That would be justified if it is done in good faith. But, again, it would require proper definition under the Act.

The fourth area concerns the increasing use of synthetic biology and advanced monitoring equipment. We are all getting older. There will come a time when the National Health Service will require all sorts of monitors, which we will have in our homes, so that we do not need to go into hospital. Some of these are bound to be innovative and may not necessarily have been tested in the usual way. At the institution where I am proud to work, Imperial College London, we have made great advances with these devices. It would be perfectly reasonable to use them as an example of innovation, but that needs to be defined clearly in the Bill.

Those are the amendments that I wish to speak to at the moment. I will leave them for the consideration of the House. I beg to move.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

The Bill does not alleviate the situation because it could not apply in those circumstances. It is not dealing with an innovative situation because in those circumstances the safeguards in the Bill at the behest of the critics already make it clear that the machinery it provides could apply only in circumstances that were not an emergency. However, if the House thought that it was better to say that expressly in the Bill, I would find no difficulty with that. I do not think that the Bill could apply because the machinery set out in the Bill could not operate. That illustrates the problem.

Equally, it would not prejudice doctors because any protection they have in common law is not affected by the Bill, which makes that absolutely clear. The Bolam test is not written on a tablet; it is a test that has developed over the years and has needed a succession of House of Lords cases to get to where it is today. Our position is not the same as in Canada or Australia, where the law has developed to cover this. I urge the House to regard this Bill as a valuable step. It is not the end of a journey but just a step on the route to getting the balance right between innovation and protection of the patient.

Certainly, in this continuing process of improving the Bill, we should realise that its core purpose is admirable and deserves to be supported. At this stage, the development of the law must be done in the best way possible. As I indicated, the law is very much involved here, which is why, as lawyers, we have a contribution to make. As regards the two amendments with which we are primarily concerned, I find myself in exactly the situation described by the noble and learned Lord, Lord Mackay of Clashfern.

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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.

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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?

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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.

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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.

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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.

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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.

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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.

The noble Baroness, Lady Wheeler, inquired about the four tests. The answer to her question is yes. The Bill does not place an undue bureaucratic burden on the NHS. Doctors must be acting responsibly under the Bill. The Bill does not expose doctors to a risk of additional liabilities, and does nothing to deter good and responsible innovation under the current law.

The noble Lord, Lord Winston, asked whether the Bill would apply to the use of cannabis, medical devices and off-label drugs. The Bill applies to any departure from the existing range of accepted medical treatments. This would include the use of off-label drugs, cannabis and medical devices, provided that they were to be used in a way that was not established practice. Doctors are best placed to assess whether or not treatments are standard practice, meaning that the scope of the Bill will be clear to them, as well as allowing flexibility in its application. In any event, doctors can choose whether or not simply to rely on the existing Bolam test to take the steps under the Bill.

I hope that noble Lords will accept Amendments 8, 9, 10, 14 and 15 in the name of the noble Lord, Lord Saatchi, which provide useful clarification as to the scope of the Bill and the availability of the common-law Bolam test to doctors who choose to or choose not to rely on the Bill.

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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?

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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.

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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—

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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.

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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.

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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.

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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?

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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.

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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.

Amendment 1 withdrawn.

Amendment 2

Moved by

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2: Clause 1, page 1, line 5, at end insert—

“( ) 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.”

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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.

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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?

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I am speaking to both.

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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.

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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?

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

Clause 1(3)(d) requires the doctor to consider a number of factors in relation to the proposed treatment. This includes: a requirement to consider the risks and benefits that are or can reasonably be expected to be associated with the proposed treatment; other accepted treatments; and not carrying out any of those treatments. In weighing this up the doctor must apply an objective standard as to what could reasonably be expected in relation to those treatments. That provides a further safeguard for patients in ensuring that a doctor may not offer an innovative treatment in accordance with the Bill unless he has acted in an objectively responsible way.

In sum, the provisions in the Bill come as close as possible to bringing forward the Bolam test to before treatment is carried out. Under both the existing common law and the Bill, the doctor needs to show that they have acted responsibly. There is no escape for a negligent doctor under the Bill.

Amendment 2, in the name of the noble Lord, Lord Winston, seeks to require a body of responsible medical opinion to consider the treatment. It is unclear from this amendment at what point that consideration would take place. The purpose of the Bill is for doctors to have reassurance before they carry out the innovative treatment. If the consideration under this amendment is to take place in court post hoc, that would make the Bill unworkable.

Amendment 3, in the name of the noble Lord, Lord Turnberg, seeks to require that a doctor obtain the support of one of the more appropriately qualified doctors in relation to the proposed treatment. In doing so, the noble Lord seeks to replicate the language of the existing common law test. The noble Lord asked whether there is any difference between a signed agreement and a verbal agreement. It would ultimately be for a court to decide whether a doctor whose opinion has been sought was liable for any innovative treatment provided. However, to require another doctor formally to support the treatment, whether in writing or verbally, would expose the second doctor to the risk of additional litigation.

In the Government’s view that is problematic. If that countersigning doctor were sued, they would not be able to rely on the Bill directly and we would not be able to give them any certainty about their legal position. As such, doctors may be reluctant to give their agreement, which may reduce the likelihood that doctors will choose to innovate under the Bill. Instead, the Bill requires the doctor to take full account of the views of at least one appropriately qualified doctor in a way in which any responsible doctor would be expected to act. That means that a doctor will not be able to ignore those views or give them only minimal weight—such as only to note them—unless there are reasonable grounds for doing so.

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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.

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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.

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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.

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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.

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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?

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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.

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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.

In his Amendment 3, the noble Lord, Lord Turnberg, has lowered the threshold that was discussed then from formal approval to support. We are discussing linguistics here but, as I am sure noble Lords appreciate, they are terribly important. I understand and appreciate the thinking of the noble Lord, Lord Turnberg, behind that proposal, but I fear that I will have to ask him to agree with me that it does not conquer the objections that I have mentioned, which have been raised. In particular, because the notion of support could encompass something as formal and extreme as approval or something much vaguer, it would not be sufficiently certain what the amendment was achieving as a matter of law—so I have been strongly advised. I fear that one might risk argument and confusion about what amounted to support, particularly in relation to views that amounted to, or could be open to interpretation as, support subject to qualifications or conditions. For those reasons, I hope that on reflection the noble Lord feels that the aim of his amendment has been sufficiently met by the additional formality and transparency introduced by my Amendment 7, in relation to recording in patients’ notes, and that he might under those circumstances feel able not to press his amendment.

On my Amendment 7 on transparency and patients’ notes, it requires the results of the consultation, which we have just been discussing, to be recorded in the patients’ notes, together with details of the doctor’s decision to innovate. This arises because, in Committee, a number of noble Lords expressed the wish to see details of decisions to innovate to be recorded in the patients’ notes. There were also suggestions that it would be useful to see expressed in the Bill a requirement for greater transparency about the nature of responses received by the doctor when undertaking the consultation with colleagues required by Clause 1(3)(a) and (b). This amendment meets the wishes of noble Lords in that respect.

Amendment 13, in relation to cell and tissue insertion, tabled by the noble Lord, Lord Winston, would have the effect of disapplying the Bill to innovative treatments involving the insertion or injection of cells, tissues or certain other material. To take guidance from my noble friend the Minister, she expertly summed up why the Government feel that it is hard to support the amendment—and the same applies to me. I listened with great respect to what the noble Lord said on this issue today and on many other occasions. At this moment, I am not clear that the fundamental principles of the Bill in relation to what is reasonable needs to be different in relation to treatments of this kind. However, I accept that he explained a context that is most certainly a specialist one. I have understood what he said but I have also heard what my noble friend the Minister said. I have to invite noble Lords not to accept Amendment 13 and I hope that, on reflection, the noble Lord, Lord Winston, might feel able not to press the amendment.

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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.

Amendment 2 withdrawn.

Amendment 3

Moved by

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3: Clause 1, page 1, line 9, leave out “views” and insert “support”

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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.

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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.

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Not moved!

Amendment 3 withdrawn.

Amendment 4

Moved by

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4: Clause 1, page 1, line 15, at end insert “(based on explanation to the patient of the views and other matters considered, and steps taken, under this subsection)”

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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.

This is particularly important for people with conditions such as Parkinson’s and motor neurone disease, which are progressive and currently have no cure. Following proactive discussions with the noble Lord, Lord Saatchi, and his team, this amendment has been adapted from a similar one tabled in Committee. We are in agreement that this new amendment will not undermine the aims of the Bill to promote medical innovation. The amendment is also strongly supported by Parkinson’s UK. The charity actively promotes more innovation and its adoption into clinical practice so that new and better treatments can be developed to help people with Parkinson’s. As the UK’s largest charitable funder of Parkinson’s research, Parkinson’s UK has invested more than £65 million in developing better treatment and finding a cure. This amendment is not about restricting innovation; rather it seeks to ensure that the Bill’s provision can be exercised in a safe manner, with all patients able to make informed decisions about their own treatment. I hope that this amendment will be accepted. I beg to move.

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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.

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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.

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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.

Amendment 4 withdrawn.

Amendment 5

Moved by

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5: Clause 1, page 1, line 24, at end insert—

“( ) 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),”

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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?

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Will my noble friend accept that there are precedents in other Private Members’ Bills going back several years for such registers being set up?

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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.

Amendment 5 withdrawn.

Amendment 6 not moved.

Amendments 7 to 10

Moved by

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7: Clause 1, page 2, line 5, at end insert—

“( ) 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.”

8: Clause 1, page 2, line 6, after “section” insert—

“(a) applies in relation to treatment carried out for the purposes of medical research;”

9: Clause 1, page 2, line 6, leave out “for the purposes of research or”

10: Clause 1, page 2, line 7, at end insert—

“( ) Nothing in this section applies in relation to treatment which is carried out solely for cosmetic purposes.”

Amendments 7 to 10 agreed.

Amendment 11 not moved.

Clause 2: Effect on existing law

Amendments 12 and 13 not moved.

Amendments 14 and 15

Moved by

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14: Clause 2, page 2, line 17, at end insert “, or

(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).”

15: Clause 2, page 2, line 19, leave out paragraph (a) and insert—

“( ) 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);”

Amendments 14 and 15 agreed.

Cohabitation Rights Bill [HL]

Second Reading

Moved by

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That the Bill be read a second time.

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My Lords, more and more people now choose to live together before or instead of getting married or entering into a civil partnership. In 1996, there were fewer than 3 million people cohabiting in the United Kingdom. By 2013, the figure had almost doubled to 5.9 million. More cohabiting couples—about 38% of them—are having children. The trends are clear: people are choosing to live together and often to build families together as an alternative to getting married or entering into civil partnerships. That is a clear life choice that they make, and it is mark of a free society that we accept and indeed embrace our freedom to choose how we live and with whom we live. This Bill is designed to right injustices that have long bedevilled our law and to ensure that people who live together will not be subjected to an unfair and invidious disadvantage by so doing.

There persists widespread confusion among the public about the legal status of cohabitants. In a British Social Attitudes survey in 2006, no less than 58% of respondents thought that cohabiting couples who split up were probably or definitely in the same position as married couples. The myth of the so-called common-law marriage is widespread—but, as your Lordships are well aware, it is just that: a myth, without any foundation in law. In 2008, a further British Social Attitudes survey found that nine out of 10 people believed that cohabitants in a long-term relationship involving children, or where career sacrifice was involved, ought to have redress on the breakdown of their relationship. Yet, at present, unless they have entered into a cohabitation agreement, the protections for couples who part are extremely limited. As to the property they live in, if it is in the name of one partner, the other may secure an interest only if he or she can bring a case based on the antiquated and unwieldy law of trusts by showing that joint ownership was their joint intention. The ascertainment of the parties’ shares remains difficult, even where the property is in fact in joint names. The last major decision on the issue of intention, that of the Supreme Court in 2011 in Jones v Kernott, has made the position no easier.

Minor children are entitled to support under the Child Support Act, and the children of wealthier parents under Schedule 1 to the Children Act 1989. However, support ends when the children are older. At that stage, the caring parent may be left completely unsupported and often out of a home. Cohabitants may also secure some provision on death under the Inheritance (Provision for Family and Dependants) Act 1975, which I shall refer to as the 1975 Act. That was a welcome reform made in 1995, but the provision for cohabitants is limited to maintenance and it is necessary for the surviving party to go to court to establish a claim.

However, on separation, there are no legal rights at all for the woman who has given up her career to look after her partner’s children—or their joint children—once they are older and independent. There are no rights for the woman who gives up working to keep house for her family and then does so for many years before the relationship breaks down. There is no redress for the man who has worked for years and used up his savings to help establish his partner’s business and is then left with nothing when they break up. Then again, if one partner dies without leaving a will, the other will inherit nothing as of right from the estate—not even the home they lived in together.

The Law Commission’s proposals on separation were made, after a long and detailed consultation, in 2007, and those on intestacy in 2011. They were thorough and carefully considered. As your Lordships well know, the Law Commission was set up by Parliament to recommend necessary law reforms to government. It is an entirely independent body with a stated mission: to keep the law fair, simple and modern. Despite repeated pleas from the professions and from the judiciary at all levels to implement the commission’s proposals in this area, no action has been taken.

The Bill is limited to implementing the Law Commission’s proposals made in its two reports. I make no claim to originality in presenting these proposals. My noble friend Lord Lester of Herne Hill introduced a similar Cohabitation Bill in 2008. I pay tribute to him for his vast achievements in the area of law reform, and I am delighted that he is here and able to speak in the debate today. My noble friend’s Bill went rather further than this one, because it included provision for continuing maintenance, which the Law Commission’s proposals and this Bill do not. My noble friend also introduced a Bill incorporating the Law Commission’s proposals on intestacy in 2012.

I turn first to the proposals for relief on separation. I make it clear at the outset that the Bill’s proposals do not equate cohabitation with marriage—far from it. For many would-be reformers, the Bill is for that reason a disappointment because it proposes perpetuating what they would call a two-tier system of financial provision, with one regime for those who marry or enter a civil partnership and another for those who do not. I do not share their view. I firmly believe that when two people commit to marriage or civil partnership, they commit to full financial interdependence—a commitment which demands that there be a comprehensive range of remedies in the event of divorce. However, when people decide to live together without taking on the obligations of marriage or civil partnership, that is their choice, and they should not have those obligations thrust on them by the state.

That does not mean that where a cohabiting relationship breaks down, there should not be a mechanism to adjust the economic impact of the relationship so as to share it more fairly between the parties. Essentially, and simplifying them to the core, the Bill’s proposals aim to address economic unfairness at the end of a relationship that has enriched one party and impoverished the other in a way that demands redress.

Scotland has a cohabitation law, and has had one similar to that proposed in the Bill since 2006. Ireland introduced similar legislation in 2010. The noble and learned Baroness, Lady Hale, our one woman Supreme Court judge—how regrettable it is that she is still the only one—said in July 2012, in a significant case under the Scottish Act in the Supreme Court called Gow v Grant:

“The main lesson from this case, as also from the research so far, is that a remedy such as this is both practicable and fair. It does not impose upon unmarried couples the responsibilities of marriage but redresses the gains and losses flowing from their relationship”.

The noble and learned Baroness concluded:

“The Act has undoubtedly achieved a lot for Scottish cohabitants and their children. English and Welsh cohabitants and their children deserve no less”.

It is not just Scotland that has similar legislation. Australia, Canada, New Zealand and many other jurisdictions have strong arrangements by statute for cohabitants who separate.

Perhaps I may describe in broad terms some of the more important provisions of the Bill. By Clause 2, cohabitants are defined as a couple who either have children and live together or who have lived together as a couple for two years. By Clause 6, the parties can by agreement opt out of the financial settlement provisions of the Bill, provided that requirements for independent legal advice and other safeguards are met. By Clause 14, there would be power in the court to vary or revoke unfair opt-out agreements. Other cohabitation agreements or deeds of trust would also be honoured. So this scheme would not be compulsory; the parties could choose to make alternative arrangements. By Clause 7(3), there would be a two-year time limit for bringing a claim following separation so that such a claim would not hang over the heads of the parties indefinitely.

Clauses 8 and 9, and Schedule 1, set out the scheme of the financial settlement proposals. The starting point is for the applicant to show “qualifying contributions” to the parties’ shared lives. These could be financial or they could be in work, in care or in kind. If, as a result of such contributions, the other party had derived and retained a benefit, or the applicant had suffered or would in the future suffer “an economic disadvantage”, the court would be empowered to intervene to award a financial settlement. Such an award would first reverse any retained benefit, in full or in part. If after that exercise, the applicant would still be left with an economic disadvantage, the court could order that disadvantage to be shared between the parties. The court would be required to consider discretionary factors, the welfare of any minor children of the parties being the first consideration.

The financial position of each party would of course be crucial. Conduct which it would be inequitable to disregard would be taken into account and the circumstances in which contributions were made would be important, especially where they were discouraged rather than sought by the other party. The orders that could be made would include capital orders for lump sums, property or pension-sharing but not continuing maintenance. The lump sums could be payable by instalments. It may be argued that this would encourage litigation between former cohabitants but I would expect most cases to be settled by agreement, without coming anywhere near a court. Furthermore, mediation will play a large part in resolving such cases.

I turn to the proposals on the death of a cohabitant. I will deal just with the most important provisions. Clauses 16 and 17 would enable cohabitants to insure each others’ lives and write policies for the other partner’s benefit so as to fall out of the deceased’s estate for inheritance tax purposes. Clause 19 would enable the survivor of a cohabiting couple to inherit an interest in the estate of a partner who died on an intestacy. This is an important provision. The Law Commission’s research has shown that only 17% of people who are cohabiting make a will. The other 83% are vulnerable to death and intestacy. Of course if that provision is not required by a cohabiting couple, they are free to make their own wills, just like everyone else.

In relation to the home in which parties live, research has shown that most cohabiting couples would hope and expect that their partners, surviving in the house that they shared together, would be the people to whom the house would pass on their death. Clause 20 would thus ensure that a surviving cohabitant could make a claim to the parties’ joint home. By Clauses 21 and 22, and part of Schedule 2, cohabitants’ claims under the 1975 Act would no longer be limited to claims for maintenance, as they currently are under the 1995 amendment.

The previous Administration were sympathetic to the aims of the Law Commission’s 2007 report but wanted to consider how the new law was working in Scotland. As the noble and learned Baroness, Lady Hale, made clear in Gow v Grant, it is now absolutely apparent that the law in Scotland is working well. When I asked the present Government about this in 2011, they issued a Written Statement saying that they would do nothing during the term of this Parliament. However, this Parliament is nearing its end, while the need for reform in this area becomes ever stronger.

It has been a long time since the Law Commission’s two reports, particularly the 2007 report on relationship breakdown, but the trends have not changed and the injustice has not decreased. Although the noble Baroness, Lady Deech, has been a formidable campaigner against these proposals, particularly when my noble friend’s Bills have been debated—I am delighted to see that she is here to make her case again today—there is a powerful body of both professional and lay opinion in favour of these reforms: most of the family judiciary; Resolution, the body that represents family solicitors and for whose strong support I am particularly grateful; the Family Law Bar; and many others, including many in the church. I am delighted to see the right reverend Prelate the Bishop of Sheffield here today to speak in this debate. I suggest that legislation is now overdue, and this Bill attempts to redress the position. I beg to move.

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My Lords, a few months ago the Prime Minister announced that all government policies would be subject to a new family test: what impact would they have on relationship formation and breakdown? It is against those standards that I seek to assess the Bill. My conclusion is that it would reduce willingness to commit long-term and would greatly increase the stress of couple breakdown, significantly to the detriment of children.

Few of us today would argue against affording respect to all family forms. But this Bill, albeit with the best of intentions, puts a widespread choice of lifestyle—cohabitation—into lockdown. If it were to be enacted, which I sincerely hope will not come about, the outcome would be that married couples, civil partners and same-sex couples would have the free choice of union, from which they may refrain or enter, but cohabiting couples, both future and past—for the Bill has some retrospective elements, which are particularly contentious—will find that they are snared unaware in a trap of laws from which there is no escape, save for the opting-out provisions of the Bill. Almost the entire panoply of marriage law is to be lowered on to them by the Bill once they have spent two years cohabiting—two years is the average length of a cohabitation—or if they are parents of a child. People often use the phrase “bedroom tax” but, if enacted, this Bill would be the real bedroom tax: share your bedroom and you will be taxed for ever more.

Since cohabitation is so common, we are told that it must give rise to marriage-like consequences for the protection of women, although quite what that “protection” amounts to is an issue for analysis. But if the Bill is enacted, cohabitation will become as expensive and legalistic as divorce, no more attractive than marriage but bound to deter even more men from the stability that their children so badly need. It is true that some other countries have enacted recognition of cohabitation in terms of marriage law. American states, however, are rowing back from legal regimes for cohabitants. But those other countries listed by the noble Lord, Lord Marks, have already reformed their law on financial provision at the end of marriage to be less generous, less discretionary and more likely to be based on a fixed half share of matrimonial property, and they recognise nuptial agreements. It makes more sense, if any, to apply the law to cohabiting couples when it is reformed and certain, if that is what is going to happen, rather than when it remains as discretionary as ours. This Bill mimics existing matrimonial law in that it preserves too much judicial discretion with no rational principles except paternalism. That is why mediation may well not work. There will be a risk of blackmail behind the scenes because, without firm judicial principles for the assessment of property transfers, one of the couple will hassle the other for a settlement. Judges do not see this; they see only the cases that come to them, the tip of the iceberg.

Is this reform in the interests of children, children who we know, from studies of cohabitation, will do worse at school and only one-third of whom can expect to be living with both unmarried parents by the time they are 16? The damage to those children arises from their social situation, not the law. Cohabiting couples with children are more likely to break up than childless cohabitants or married couples, and they are less likely to conclude their cohabitation in marriage. Schedule 1 to the Children Act 1989 already provides for orders for the support of a parent, usually the mother, and the child, periodical payments, lump sums and the transfer of property. We also have the Child Maintenance Service, successor to the Child Support Agency. Getting child support from unmarried fathers has always been like getting blood from a stone, and nothing in this Bill will alter that sad fact.

The argument will be made that so-called wives who married in unrecognised Muslim ceremonies need financial support, but it is not a good thing to change our law in a significant way for everybody to accommodate Sharia law. It is not right for some couples to overlook or ignore our marriage law and then try to rely on it later when things go wrong, especially since I understand that there are provisions in Sharia law for alimony and something similar at the end of a union.

This Bill is a real vote loser. It is an attack on the liberty of two people who have refrained from marrying. Either they have good reasons not to—for example, preserving property from a previous relationship—or they are trying out the relationship before cementing it. It may well be that one of them would like to marry and the other holds back, but we do not have forced marriage in this country. We observe the human rights of privacy and respect for family life, which the provisions of this Bill ignore. Professor Cretney, a former law commissioner, has written that it is hard to understand why those cohabitants who express distaste for marriage and all its legal trappings should want the benefits of a comparable legal regime, with all the financial and emotional costs of litigation, and that it is possible that the scheme will become the instrument of exploitation and harassment. In fact, consultees to the Law Commission were finely divided on this.

Ordinary members of the public do not want this. Here are some quotes from the Guardian—please note, they are not from the Daily Mail:

“When is the state going to recognise that cohabiting couples are adults who choose to live their lives that way precisely because they don’t wish to have busybodies—either religious or state-sponsored—poking into their personal affairs?”.

“In an increasingly difficult world why make the very ordinary occasional experience of people choosing to live together for a while, as a test marriage or whatever, fraught with paranoia?”.

“All it will do is ensure that virtually every ended relationship will end up in court, enriching family lawyers at the expense of the cohabitees themselves”.

I am sure there are plenty of openings for legal dispute in this Bill. What does it mean to live as a couple when there are so many lifestyles today? If it means a sexual relationship, the Bill should say so. Either way, a degree of inquisition is bound to follow. The Bill implies that a sexual relationship is the key to getting financial support. It is a pity that the sexless sisters who live together for decades are still not recognised as deserving of any tax breaks, an issue I have raised before.

The Bill sends a bad message to career women. Why should the mistress of a rich man get, for example, £5 million after a couple of years of childless cohabitation? Why should two students who shared a flat find themselves exposed to legal action? Why should a woman with a good career, who is deserted by the man she had hoped would marry her, face demands from him for her money? Cohabitants know that they are not married, and they have chosen to draw back from it. There is nothing to stop them marrying, as there was years ago when divorce was difficult. If they are dissatisfied with insecurity, why not pop down to the register office and marry to get rights? Couples may be trying out a relationship and we should not impose the penalties of a failed marriage on those who thought their experimentation would preserve them from precisely that fate.

What is it about cohabitation that must be recognised? Nothing has yet replaced the traditional symbols of legal commitment: the ring, the ceremony, the contract. Today there is a general practice of not committing—relationships, rules and futures are ambiguous. A University of Denver study demonstrated that men see the moment of marriage, not cohabitation, as the assumption of responsibility, whereas women see attachment and living together as more binding. Therefore, there is an inherent clash of perspectives. Less than 4% of cohabitations last 10 years or more, and the more frequent and longer the cohabitations, the more likely the subsequent divorce, which all adds up to a bad story for children.

The intestacy provisions in the Bill are not as detrimental to the family as were those in the earlier Bill on this in 2012, the Inheritance (Cohabitants) Bill. Nevertheless, I cannot see the point of fresh provisions when cohabitants already have the capacity to bring claims under the Inheritance (Provision for Family and Dependants) Act 1975, as relaxed by the Law Reform (Succession) Act 1995 to allow a cohabitant of two years’ status to claim. Such claims, pitting the surviving cohabitant against the blood family, can be bitter, expensive and protracted.

In sum, it is illiberal to impose on couples an intrusive contractual obligation, not freely entered into, and it will encourage inherently more unstable relationships. We should encourage contracts between those who share property. The opt-out provisions of the Bill would be a good model if they were opt-in in the alternative; in other words, this proposed law should apply only if the couple had read it and signed up to accepting it. Otherwise, we should retain a corner of freedom where couples may escape family law, with all its difficulties, uncertainty and crippling expense and intrusion.

Cohabitation is not marriage, now or historically. The research by my former pupil, Professor Probert, has shown that there never was a period in the past when common law marriage was recognised. People need the freedom to try alternative forms of relationship, not to have one imposed on them. No more bedroom taxes.

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My Lords, I thank the noble Lord, Lord Marks, for giving me the opportunity to speak on this important issue—but not, I should make clear, because I welcome the introduction of this Private Member’s Bill. On the contrary, I find the whole concept of validating cohabitation deeply problematic. I want to lay out my concerns in terms of the economic implications of high cohabitation rates and the concomitant instability of the relationships that these engender; the benefits of marriage; and, finally, the need to look beyond accommodating the lifestyle choices of adults and see the repercussions for the weak and vulnerable, most notably the effects on children.

I am sincerely troubled by the reintroduction of the Bill, which, as we have heard this afternoon, echoes that of the noble Lord, Lord Lester, in the 2008-09 Session. The doubling of the number of cohabiting couples between 1996 and 2013 should be seen not as a reason to give them more rights but, rather, as a reason to sound an alarm about the negative effects of these very high rates and the correlation with markedly lower marriage rates.

Many of my days have been spent in the metal markets, so I will start with a simple economic argument against the implication of this Bill, which is the encouragement of cohabitation. This costs the country a great deal of money because of the far greater instability of this living arrangement in comparison with marriage. The annual price tag for the UK’s particularly high levels of family breakdown is a staggering £46 billion per annum. Single parent family formation is increasing at the same time as the UK’s crude divorce rates are falling, because it is far more likely to occur when children are born outside marriage. Parents raising children on their own—92% of whom are women—will struggle to provide adequately for their children, both financially and in terms of the time and attention they need to thrive. Indeed, £9 billion of the costs of family breakdown is accounted for by the additional tax credits that we provide to make up for the lack of a second breadwinner, usually a father.

Marriage, on the other hand, not only saves but also makes the country money. The interdependence within families that it engenders is an asset to the nation because those who marry, and their children, are far less likely to become dependent on the state. Also, research across many countries points to a marriage premium in wages. Employers value the behaviours and attitudes that tend to be associated with marriage. Employees who are married tend to progress further and therefore be paid more than those who are not—and, accordingly, pay more taxes.

The United States Centers for Disease Control describes how the well-being of children rests on their experiencing safe, stable and nurturing relationships. Yet they are far more likely to see their parents break up if they were not married when they were born and to be caught up in the unpleasantness this usually entails, as a result of which 1 million children have no meaningful contact with their father.

The Millennium Cohort Study found that only 9% of married couples have split up by the time their child is five, compared with 26% of cohabiting couples. Many social scientists explain this relative instability in terms of selection effects; those who are more disposed towards entering the married state are also those more likely to be able to sustain a relationship. However, I want to take a moment to explain the inadequacy of this analysis.

First, the same study found that cohabitating parents are at least twice as unstable as their married counterparts, regardless of the income group they come from or their level of education. Secondly, researchers from the respected Institute of Fiscal Studies were able to eliminate the difference in stability between married and cohabiting parents in their regression model only by controlling for relationship quality and the effect of either an unexpected or early birth. They admitted that these variables might in fact be what statisticians refer to as endogenous regressors. In other words, by trying to isolate the effect of marriage per se on stability, they controlled for factors which might themselves be affected by the thing they were trying to measure. Although they decided to take the risk that these factors were not affected by marriage, this is, in fact, the bigger leap of faith.

I shall consider each of these factors in turn. When two people stand together in public and say, “You are the one for me, above all others, whether rich or poor, in sickness and in health, till death us do part”, it is implausible that this has no effect on the quality of the relationship. We of all people believe in the importance of taking vows. Surely I was not the first of your Lordships to feel great emotion when I pledged allegiance to our Sovereign in this very House.

I made my own marriage vows a number of decades ago. Yet when I attend weddings now, it is precisely because of all the water that has gone under our own particular bridge that I gasp at the public commitment being made by two frail human beings. These awesome public promises of lifelong love and faithfulness act like essential glue, now perhaps more than ever, precisely because people in this country are no longer quite so obliged to make them. So we simply cannot encourage these default arrangements by imposing rights on couples who have not made these deliberate and intentional pledges, which are pregnant with such meaning.

Similarly, turning to the effect of either an unexpected or early birth, it is very hard to believe that the parents’ relationship status has no bearing on the likelihood that they will withstand the profound shock to their relationship that either of these events can entail. Again, if a couple have set their course from the outset, deciding to build a family together rather than sliding into parenthood, that cannot but help to strengthen their resolve.

To those who argue that adults’ lifestyle choices have to be respected and protected in law, the obvious rejoinder is that this ignores the repercussions for those who are weak and vulnerable in society, particularly the young and the old and those living in our poorest communities.

Thanks to journalists such as Fraser Nelson and others, our country is beginning to wake up to the uncomfortable realities of the marriage gap—namely, those who are more affluent are also more likely to be married and their children able to benefit from the greater reserves of time, social capital and earning power associated with having two biological parents at home.

Income-poor children, in contrast, are also much more likely to be relationally poor. Obviously, there are exceptions, and strong, close-knit extended families and communities can exist in any income bracket, but the greater informality of relationships that is such a salient feature on our poorest estates is adding to all their other disadvantages. It is a tragedy that many do not even know who their father is. Marriage ties men in, in a far more effective way than does cohabitation.

To reiterate, we should not downplay the inherent and intense struggle that is single parenthood. When I spoke recently in a debate in this House about the challenges of the digital age for families, I pointed out that keeping one step ahead of children’s internet access becomes almost impossible when there is only one person to do the surveillance.

To summarise, it would be far more beneficial to society, both economically and in order to rebuild the social fabric, to encourage marriage rather than cohabitation. We must reinforce the importance of explicit commitment rather than blur its lines by imposing on people rights and obligations they have not freely signed up to.

In conclusion, your Lordships might be surprised to know that Janet Street-Porter agrees with me on marriage. In her recent article, she questions the cult of “me” that began to take off in the 1960s and 1970s and says that politicians not willing to defend marriage are self-centred, on the grounds that, again in her words:

“Surely it’s good for most kids to grow up in stable surroundings”.

Other iconoclasts, such as Rod Liddle, are also beginning to write movingly about the effects of family breakdown, such as the greater likelihood that children affected by it will fail at school, or end up unemployed or in low-paid work or even with severe mental health problems. I would therefore recommend that this Government take note and show their concern for children’s welfare. First, they should increase the available cash benefit of transferable tax allowances for married couples, particularly those with young children.

Secondly, I am encouraged that this Government have set up a task force to improve child and adolescent mental health services. However, given the strong correlation between the prevalence of poor mental health among young people and their exposure to family fracture, surely tackling these root causes is just as important. So I propose today that all party manifestos include a commitment to launch a family stability task force. The commencement of its work should immediately follow the general election. For all the reasons I have outlined, strengthening marriage should be its overriding objective.

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My Lords, I welcome the opportunity to contribute to this debate.

From these Benches, we recognise the good intentions of the Bill. We recognise the desires to protect cohabitees in vulnerable situations and to protect children from hardship. As has been recognised, there are gaps in the law that can lead to significant financial vulnerability or disadvantage when a cohabiting relationship ends, due to either separation or the death of a partner. However, the Bill goes beyond those provisions and creates something of an opt-in blanket provision for cohabiting couples, with the very low threshold for cohabitation of a continuous period of two years as set out in Clause 2(2)(d). As we have heard, the institution of marriage is recognised in our nation and throughout the world as the bedrock of family relationships and of our wider society. Marriage brings social and economic benefits beyond the family or couple concerned, as has been described.

Like all clergy, it has been my privilege to preside at a large number of marriages over the years. The intentions of a Christian marriage are set out in the preface to the marriage service. The couple and the congregation are reminded that marriage should not be undertaken carelessly, lightly or selfishly but reverently, responsibly and after serious thought. Before witnesses the couple give their consent and make solemn vows and promises. They exchange rings and sign their names in a register. They are declared to be husband and wife, in a moment of great drama.

Marriage is therefore a public act of commitment, both a private and a public good. Rights and responsibilities are held together. The state offers protection in law to both parties and to their children once that commitment has been made. Civil partnerships offer a similar opportunity for public commitment and legal rights within that relationship. Both lawmakers and the church should be doing more to promote strong, sustainable and resilient marriages. The Church of England has recently played its part through a national weddings project.

One of the key areas for development by all, including government, is better communication by all parties of the legal protections afforded by marriage and civil partnerships, and the lack of rights afforded to those who cohabit. As the noble Lord, Lord Marks, said, there is widespread confusion. However, the answer to that confusion may be not legislation but education. One of the dangers of the present proposal is that it creates a quasi-legal matrimonial structure based on an arbitrary length of time of cohabitation—a concept which is itself very hard to define and has all kinds of unforeseen consequences, as outlined by the noble Baroness, Lady Deech. There are inequities and hardships, particularly for children, which sometimes result from the end of a cohabiting relationship. We urge that these be addressed where necessary on a case-by-case basis rather than through this kind of blanket provision.

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My Lords, it is perhaps time for someone to speak in support of the Bill. I congratulate the noble Lord, Lord Marks, on bringing it forward. Given the atmosphere that has so far been engendered since he spoke, it was brave of him to do so. I should like noble Lords to know that I have been married for 56 years. I was married in church and am a not-necessarily very good but practising Anglican. I am also a patron of the Marriage Foundation and strongly support marriage. However, I do not see the Bill as an attack on marriage.

One of the important things that has not so far been referred to is that marriage requires the consent of both parties, of an age and ability to make that consent. The freedom that is talked about is very often a freedom for one cohabitant but a sentence for the other, who is left on an inadequate income to cope with the children. Although the noble Baroness, Lady Deech, talked about the Children Act 1989 providing, where appropriate, some help for the mother or father of children, that goes only to the age of 18. I profoundly disagree with the noble Baroness, Lady Deech, the noble Lord, Lord Farmer, and, to some extent at least, with the right reverend Prelate.

It is important to remember that there is a major detriment to children from the parting of any couple. In my view, the detriment is as much from the parting of a couple who are not married as a couple who are, and, as I have already said, there is the added detriment that the mother may not have very much money and may not be able to get much from the father.

I do not see “the panoply of family law” as an appropriate phrase for the very modest proposals that the noble Lord, Lord Marks, has put forward, particularly in Clause 8 of the Bill. These are modest proposals: you have to show either a benefit acquired or an economic detriment. I wonder whether two years is right; I would have thought this more likely to be an economic detriment over a much longer period. If the Bill went forward—as I fear it may not, but I would like to see it do so—I would be likely to table an amendment that would require a rather longer period of cohabitation. However, that is perhaps a minor thing compared with the good that I think the Bill would do.

This modest adjustment on the economic disadvantage would affect two groups of people, about whom I would like to speak briefly. The first has been referred to: generally it is the woman, but could be the man, who has been living with the other partner sometimes for 25 or 30 years. I was a family judge; I saw these cases. That woman very often either did not have a job because her partner was well-to-do and wanted her to stay at home, or she had a modest job that was not compatible with her considerable abilities. When she is left by that man, who, after 25 or 30 years, looks for a younger woman—that is quite a usual situation to happen for those whose relationships continue beyond the rather shorter period of many—she is absolutely stuck. She has no house because the house is very often in his name and she did not suggest that it should be in both names. That is particularly the case with older women; I suspect that younger women are savvier about this than women in their fifties and sixties. They are left on their own with the children growing up; they are not required to have maintenance; they are homeless and without a proper job, and they have to find something to be able to keep themselves, or live off benefits. Of course, they also have no pension.

The other group—which was briefly referred to by the noble Baroness, Lady Deech, I thought in a rather unfair way—are the women in this country who are Muslim and who marry under Sharia law. Many of them have little English and most of them have no knowledge whatever of English law. Recently I went to the London-based Islamic Sharia Council. Its representatives said that they spend a lot of time trying to help these women. They have married under Sharia law without any knowledge of the fact that there should be a registration of that marriage by a registrar at the registry office. They are completely stuck because they are not married. Sharia law is not the law of the land. It is all very well for the noble Baroness, Lady Deech, to say that the Sharia court can make a money payment for the Muslim wife, but that has absolutely no position in English law. If the man chooses not to pay, there are no enforcement proceedings in the Sharia court—quite rightly, in my view, because the English court should be dealing with English people and English financial matters that relate to a couple. However, in no way can one say that the Sharia court can do anything very useful.

If the parties have not yet separated, the London Sharia council offers mediation, but I heard many sad stories of women in this country who are either English or living with someone they are permitted to be with under our immigration laws and who, as I say, are completely stuck. That is the second group. The fact that they are a minority group and that they are Muslim women should not lead us to say that they should be less regarded and less interest taken in them. They are being equally unfairly treated under our English law.

Perhaps I may add that these women are unlike the first group where the noble Baroness, Lady Deech, says that both sides have the right to suggest marriage, but they both choose not to. Perhaps I have not said this, but I meant to do so. Quite often one half of the couple does want to marry, but the other half does not. You cannot force a marriage. Again, regarding the woman, if she loves the man and has had children by him, what is she to do? Should she leave him and become a single mother, or should she stay with him, hoping that the relationship will continue? However, she lives in fear that when it ends, she will not have any of the rights, however limited, that this Bill would provide.

I also want to mention that support after death on intestacy is an excellent measure for the reasons that have already been given. So, as the first voice in support of the noble Lord, Lord Marks, I would like to see the Bill go further and for the House to reflect on the fact that it is not all one way. There are women and some men out there who are seriously disadvantaged in a financial way. We cannot brush that aside and say that it does not matter. It is actually wrong and something should be done.

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My Lords, it is an enormous pleasure to follow the noble and learned Baroness, Lady Butler-Sloss, who knows far more about this subject than I could hope to learn and speaks with great authority as, among other things, a former senior family judge. Like her, I should say straightaway that I am married. I have been married for 42 years and my wife has put up with me throughout that time. I am a very strong supporter of marriage. If I thought that this Bill would deter people from marrying, I would oppose it, and if I thought that it would coerce people into cohabiting relationships, I would find that inappropriate for the state. It does no such thing.

I should begin by expressing my gratitude to my noble friend Lord Marks of Henley-on-Thames for introducing a Bill that is more modest than mine, except in relation to a two-year rather than a five-year period. As I say, in other respects it is more modest and probably more realistic and in accordance with what the Law Commission has recommended. We have to live a very long time and we have to be very patient to achieve social reform in this country. Governments lack the imagination and energy to do it themselves, so we have to stimulate them, unfortunately, with Private Members’ Bills—or perhaps fortunately, since otherwise nothing would happen.

My noble friend Lord Marks got history slightly wrong. The first time I engaged with this was in 2002 at Second Reading of my Civil Partnerships Bill. In that Bill, I provided for opposite-sex couples as well as same-sex couples to be able to enter into civil partnerships. I did that because I was advised to do so by Stonewall, which thought that it might make the Bill more acceptable. Curiously, there was complete agreement about the need for gay and lesbian couples to be civil partners, but some of the more conservative and orthodox Bishops opposed the stuff about opposite-sex couples because they thought that it would threaten marriage. It does seem to worry people but there is no evidence from any country, including this country, that the existence of civil partnership schemes, as in Ireland or something more modest such as my noble friend’s Bill, in any way discourages marriage.

On the contrary, as Resolution has pointed out in its submissions and as the Royal Commission has observed, the evidence is that it does not in any way discourage marriage. It provides a safety net in order that, instead of the state having to bail out through public finance the consequences of irresponsible men abandoning the women and children they have been involved with and putting the women—the mother—on social security, it makes the bad men pay instead of us as taxpayers, which I hope that the noble Lord, Lord Farmer, understands. If one looks at this Bill through the eyes of an economist or someone concerned with money, the effect is to transfer some of the burden away from the state on to irresponsible common-law husbands and fathers.

The noble Baroness, Lady Deech, is the most doughty, indefatigable campaigner against everything that I have just said. I hope she will not mind my saying that, if I put in the scales her views and the views of the Law Commission, the noble and learned Baroness, Lady Butler-Sloss, the Supreme Court of the United Kingdom and Resolution, they and their evidence seem to me to be more persuasive.

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Perhaps the noble Lord will allow me an intervention. On one side of the scales we have lawyers, not the public. The consultees who responded to the Law Commission who were members of the public were largely against this. Even the Supreme Court has a variety of views. On my side of the scales, I offer the public.

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I am grateful for the intervention, but it does not match the facts. Resolution, for example, indicated what it called,

“strong public support for change: almost 90% think that a cohabiting partner should have a right to financial provision on separation if the relationship has been either long-term, involved children, or has involved prioritising one partner’s career over the other’s”.

It gives other evidence as well, in which I am sure the noble Baroness would be interested.

Going back to the judiciary and the Supreme Court, my noble friend Lord Marks referred to the noble and learned Baroness, Lady Hale. Although she is outstanding in all respects, what was impressive about the Gow case was that the three English members of the Supreme Court—Lord Carnwath, Lord Wilson and the noble and learned Baroness, Lady Hale—all said the same thing. They all referred to Professor Elizabeth Cooke, the Law Commissioner who leads the commission’s work on this. They quoted her as saying:

“‘We hope that implementation will not be delayed beyond the early days of the next Parliament, in view of the hardship and injustice caused by the current law. The prevalence of cohabitation, and of the birth of children to couples who live together, means that the need for reform of the law can only become more pressing over time’”.

The other two members of the Supreme Court were Scots. Since it was a Scottish case, they dealt with the Scottish issues. However, these were the three English Supreme Court judges speaking as one. They said:

“As Prof Cooke also pointed out, the ‘existing law is uncertain and expensive to apply and … often gives rise to results that are unjust’ ... There was no need to wait for experience north of the border to make the case for reform”.

I know perfectly well, because the coalition Government have said so, that they have no intention of doing anything about this during the lifetime of this Government. I also know perfectly well that the Conservative part of the coalition is deeply opposed to such a measure because it is considered to undermine marriage in exactly the way that the right reverend Prelate was worrying about. I repeat that there is no evidence whatever for that. I think that having a modest safety net, which is all that this Bill is, is better than saying to couples who do not understand the law or understand the limits of being in a so-called common law marriage, “It is better to marry than to burn”. That was said by St Paul, but I do not regard it as a guiding principle for legislation.

This being Liberal Democrat core policy, I can only say that I am delighted to await the views of the Official Opposition on this, as the only hope that I can see for such a measure being adopted is a change of government. It will not happen under a Conservative Government and it probably will not happen under a Conservative coalition Government; it can happen only if there is a Labour Government or a Labour coalition Government. I am sorry that that is the position because I would have hoped that the issue could transcend party politics. I am sure that there must be some within the Conservative Party who understand that this is a conservative measure doing limited justice to a very vulnerable group.

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My Lords, I am only intervening here to make sure that I understand what is going on, having heard the noble Lord’s expectation that the Labour Party is likely to take this through. If I remember correctly, when I was on the opposition Benches speaking for my side on the Civil Partnership Bill and we discussed this matter, the Labour Party, which was putting the Civil Partnership Bill through, did not agree with this.

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That is absolutely right, but it was not this measure; it was civil partnership applying to both kinds of couples. The Government did not agree with that. I tried to press them and I failed. These provisions—

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My Lords—

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Perhaps I may just finish. These provisions relate not to civil partnership but to limited cohabitation rights. During the lifetime of the Labour Government, we discussed my Bill and it was indicated to me by Labour that the Bill had come very late in the Session and was therefore unrealistic as a measure at that time.

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I was not referring to the Bill that the noble Lord was trying to put through. I was referring to the Civil Partnership Bill, in which the cohabitation question had come up. At that time, the Labour Party had said no. It then said no to you when it said that there was only a small amount of time and it could not do it. But that is twice Labour has said no, so before the noble Lord tells the House that it would be only under a Labour Government that this would come through, I suggest that he votes for and returns to the side that he came from in the first place.

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I am grateful for the advice about how I should vote. Since I will not have a vote, it does not make much difference.

I want to say something about British Muslims. It is a very important subject. There are 2.7 million British Muslims, I believe, in this country. There are 300,000 British Jews in this country. Because of the injustice of British Jewish orthodoxy about the so-called chained wives, I and others introduced a Private Member’s Bill, which was supported by the noble and learned Lord, Lord Mackay of Clashfern, to enable an injustice done to a very small number of orthodox Jewish women to be remedied. How did we—the noble and learned Lord, Lord Mackay, and the rest of us—do it? We did it by saying to orthodox Jewish men, “If you want to leave your wife for somebody else without getting a get”—a written consent—“you will not be able to get a civil divorce and you will therefore not be able to remarry”. We put that in a Bill because the Chief Rabbi and a small number of Jewish victims needed it.

I was then told that my Bill was discriminatory because we did not give the same benefit to Muslims, so we amended it to give the same benefit to Muslims if they asked for it to be applied to them. The male-dominated hierarchy of British Muslims did not do so and the position is exactly as the noble and learned Baroness, Lady Butler-Sloss, said: many Muslim women are now extremely vulnerable because they do not have registered civil marriages; instead, they have unsatisfactory arrangements that give them no protection if the men treat them very badly. I am not suggesting that the whole of this Bill is designed to deal with that—not at all—but I am suggesting that it is not something that we can ignore on the grounds that this is a small minority, if that is what the noble Baroness, Lady Deech, meant to say.

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My Lords, I think that is a rather unfair comparison. Jewish marriages are carried out according to the law of this land. In fact, as far as I understand it, the Jewish orthodoxy insists that a couple get married according to the law of this land. I disapprove of the way men use get just as much as the noble Lord does. That provision was only to try to put pressure on the men to give a get, and it does not necessarily work. What we are talking about is people complying—at least, they ought to comply—with the law of this land. We ought to be encouraging, as a matter of integration and the rule of law, that Muslim marriages are carried out according to the law of this land. That is what Jewish marriages do. They are registered civilly, like any other—100% kosher. Muslim marriages should not be allowed to escape under the net. We must help people by insisting somehow that they get married properly.

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I do not disagree with that as an aim, but I think I am more in favour of choice than the noble Baroness. The thing about the Bill—and about Jewish marriage law—is to encourage choice and protect vulnerable people. This does not force people into cohabitation. It does not force people into marriage. It does not force Muslims into having to register their marriages as civil marriages. It does not do any of those things—it simply provides a basic safety net, and that safety net should apply to everyone, including British Muslims. I am sure that is common ground.

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My Lords, it is a great pleasure to follow the noble Lord, Lord Lester, and the noble and learned Baroness, Lady Butler-Sloss. I congratulate other noble Lords who have spoken in this debate, although I have to confess that I had a few moments of same-sex marriage déjà-vu, particularly during the remarks of the noble Baroness, Lady Deech, and the noble Lord, Lord Farmer. I congratulate also the noble Lord, Lord Marks, on bringing forward the Bill on behalf of the rights of cohabiting couples and on his comprehensive description of it.

As noble Lords have said, in its publication, Families and Households, 2013, the Office for National Statistics published data on the estimated number of cohabiting couples and noted:

“The number of opposite sex cohabiting couple families has increased significantly, from 2.2 million in 2003 to 2.9 million in 2013”.

As noble Lords have said, this issue goes back to July 2007, when the Law Commission published a report on cohabitation. It focused on people who were living together as a couple but were unmarried, or who had not formed a civil partnership. The report made recommendations concerning the law in relation to cohabitants’ property and finances. The noble Lord, Lord Lester, picked this up—as he put it, he stimulates Governments—and introduced his Private Member’s Bill the following year. It did not make progress at the time, although the then Government were very sympathetic and, indeed, we on these Benches still are.

In its 2007 report, the Law Commission recommended reform and described the current law relating to cohabitation as,

“unsatisfactory … complex, uncertain, expensive to rely on and, as it was not designed for family circumstances, often gives rise to outcomes that are unjust”.

Members of the judiciary have added their voice for change in recent years, with Lord Justice Wall saying in 2011:

“I am in favour of cohabitees having rights because of the injustice of the present situation”.

Noble Lords are right to say that it is of concern that surveys show that more than half of those who cohabit still believe in the myth of common law marriage, assuming that when they split they have automatic rights similar to those available on divorce, even though I understand that this concept has not existed since 1753.

The harsh reality under current English law is that unmarried couples have no financial rights for themselves arising from their relationship, be it long or short and whether or not they have children together. Unless the home is jointly owned, it can be difficult as well as inordinately costly for cohabitants to argue that they have a share in the other’s property. Claims of this nature are determined by reference to complex and esoteric principles of trust law. Financial provision for children will inevitably be limited in duration and, unless the paying parent is very wealthy, limited in amount, too. I say to the noble Baroness, Lady Deech, and the noble Lord, Lord Farmer, that their remarks say, “Tough”. I do not think that it is good enough to say, “Tough”, to those children.

I appreciate that the Bill is based on the Law Commission’s recommendations for reform made in 2007. Under those proposals, financial claims by cohabitants on separation would be more limited in scope than those available to their married counterparts on divorce. The objective would be to redress the economic disadvantage suffered as a result of the relationship—for example, giving up a career to have children—or to rebalance the retention of a benefit from the relationship by the other party, such as a contribution by one towards the other’s property. The Law Commission’s subsequent report in 2011 proposed reform of intestacy law to enable provision to be made for the survivor in the event of death of the other cohabitant. Very sensibly, the noble Lord, Lord Marks, has put those two together.

These proposals for reform are not pioneering. Australia introduced cohabitation legislation more than 25 years ago and other European countries also offer protection to their cohabitees, with recent notable additions to the list being Scotland and Ireland. However, as has already been said, in September 2011, four years after the Law Commission’s 2007 report, there was a Written Ministerial Statement that there would be no action taken by the Government in this Parliament to implement the Law Commission’s proposals.

As has been said, reform of the law relating to cohabitation enjoys widespread judicial support. The cohabitation law in Scotland is working very well. Ireland introduced similar legislation in 2010. Of the Scottish legislation, the noble and learned Baroness, Lady Hale, quoted researchers as saying:

“‘The Act has undoubtedly achieved a lot for Scottish cohabitants and their children’”.

She then said:

“English and Welsh cohabitants and their children deserve no less”.

I think that right-thinking people would agree that the time has come to take up the Law Commission’s proposals on separation, consider a way forward and stop kicking this into the long grass. It is for Parliament to determine what proposals it will implement when the Law Commission reports, but the point of having a Law Commission is to achieve reform in the law, and this law is clearly in need of reform.

Both noble Lords who have spoken from the Liberal Democrat Benches are passionate advocates of this reform. I wondered whether they might not have tried to get it into the coalition agreement. The Liberal Democrats have been part of this Government for five years. The noble Lord, Lord McNally, was number two in the Ministry of Justice. I think that Simon Hughes is the Minister responsible for this area of policy. I ask the Minister why, as the Government took such a progressive line on equal marriage, they failed to consider the impact of the lack of protection for children and partners in cohabiting relationships. They should also take a sensible line on that. It is not a threat to marriage.

Do the Government agree with the Law Commission, the Supreme Court and all the other bodies cited by the noble Lord, Lord Lester? What is the Government’s policy, or are there two policies here? It would help the House to know exactly what the Government’s policy is in this area.

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My Lords, I, too, thank my noble friend Lord Marks for bringing forward the Cohabitation Rights Bill and providing a further opportunity to debate this important subject. As a novice in these issues—and in marriage itself, with only 27 years under my belt, just over half the number of the noble and learned Baroness, Lady Butler-Sloss—I have learnt much listening to the contributions of noble Lords, many of whom have long experience of these matters and have been debating them in this House for many years. I pay tribute to my noble friend Lord Lester of Herne Hill, who introduced previous Bills on this subject.

The Bill addresses the issue of what rights individual cohabitants should have against each other. At present, when a couple break up, those rights are decided by applying a patchwork of legal rules that sometimes provide one cohabitant with an interest in the other’s property, and by the statutory intestacy and family provision rules when one of the couple dies without making a valid will.

The Bill would, in broad terms, implement recommendations in two Law Commission reports. The first is the report, Cohabitation: The Financial Consequences of Relationship Breakdown, published in July 2007. The Bill would implement most of the recommendations in that report. The second is the report, Intestacy and Family Provision Claims on Death, which was published in December 2011. The Bill would implement the recommendations in that report relating to cohabitants. The Government have already implemented the other recommendations in this report in the Inheritance and Trustees’ Powers Act 2014, which came into force on 1 October.

Here, I mention my noble friend Lord Lester’s comments about the way that Governments in general approach legal reform—in particular, Law Commission reforms. He will of course have realised that this Government are in fact implementing the Law Commission’s proposals under the insurance Act.

The overall effect of the Bill and the Law Commission’s recommendations in those two reports would be to create a scheme of legal rights and obligations for cohabiting couples. I should say at the outset that while the Government will not oppose the Motion to give the Bill a Second Reading, the Government have reservations about the Bill. It deals with serious personal and family issues on which very different views may be genuinely and firmly held—and, I may say, courteously debated. Today’s debate is testament to that fact, as were our previous debates on these matters. In our debate today, the numbers of speakers for and against—which is obviously not a scientific survey—were equally matched: or rather, virtually equally, given that there were seven speakers.

The Government have consistently taken the view that major changes relating to the rights of cohabitants must be fully considered. The speeches of the noble Baroness, Lady Deech, and the noble Lord, Lord Marks, alone would demonstrate the wisdom of proper consideration.

The process of consideration of the recommendations in the Law Commission’s 2007 report of course began under the previous Administration, as the noble Baroness, Lady Thornton, mentioned, but had not been concluded when this Government took office. This Government’s priority in family law matters has been to improve the family justice system. The detail of the work that has taken place to date is clearly set out in the Government’s report A Brighter Future for Family Justice: a round up of what’s happened since the Family Justice Review, published in August this year. Examples include: the introduction of the Single Family Court in April; a legal requirement for all separating couples to consider mediation before they can go to court over children and financial matters; and the introduction of a 26-week limit for care and supervision cases.

Our work to improve the family justice system continues, with current priorities including the implementation of measures to improve support for separating parents, taking forward the recent recommendations of the mediation task force and continuing to reduce the length of care cases, in line with the new statutory time limit of 26 weeks. Faced with this programme of work, we knew that we could not do justice with the resource available to the complex and far-reaching recommendations made for the reform of the law relating to cohabitants. We therefore announced in September 2011 that we would not take forward the recommendations set out in the 2007 report in this parliamentary term. We further announced in March last year that, due to the continuing priority of these family justice reforms, the recommendations contained within the 2011 report relating to inheritance rights for cohabitants would not be implemented during this Parliament.

This remains the coalition Government’s position and, as the noble Baroness, Lady Thornton, mentioned, that includes the Minister responsible for this area, my right honourable friend Simon Hughes. We do not consider that the matters raised by my noble friend’s Bill and by the Law Commission have yet been properly and fully considered to the extent that they ought to be. We therefore take the view that consideration of the question of rights for cohabitants is properly for the new Parliament. We do not think that taking forward this Bill now, in the limited time that we have in this Parliament, would be the correct approach.

Although we have not reformed the law relating to cohabitants, this does not mean that cohabitants are unable to protect their interests against the legal effect of the ending of their relationship. Cohabitants may, for example, choose the terms on which they jointly own property. This can then provide a basis for distribution on separation or death. Alternatively, cohabitants may create contracts or deeds of trust to make provision for each other. Importantly, cohabitants can also make wills, as my noble friend Lord Marks mentioned, to ensure that their property goes to the person they wish it to go to after their death. We are currently considering what steps we can take to raise awareness of the importance of making a will.

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My noble friend the Minister said that at this stage, the Government think that further work needs to be done. What does he have in mind, given that the Law Commission has given two reports and that the matter was first raised, I think, 12 years ago? We have had all these experts giving their views, including Supreme Court judges. What further work is needed before the Government can reach a conclusion?

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We consider that the next Government, whoever they are, should undertake consultation and pre-legislative scrutiny to decide exactly where they want to go forward. We have not made any commitment on this matter. As far as the Bill is concerned, we do not consider that proper consideration has taken place.

It is for those reasons that, while the Government will not oppose the Motion to give the Bill a Second Reading, we have reservations about the changes to the law proposed in the Cohabitation Rights Bill. Accordingly we maintain our position, outlined in 2011 and 2013, not to support the reform of cohabitation law during this Parliament.

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My Lords, I thank all noble Lords who have spoken in this interesting and serious debate, which, as the Minister said, has been conducted with great courtesy. However, I would like to respond to a number of points, particularly those made by the noble Baroness, Lady Deech, and the noble Lord, Lord Farmer, who opposed the Bill, and, to a lesser extent, to those made by the right reverend Prelate the Bishop of Sheffield, who, if I may gently chide him, recognised the injustices that were caused by the existing law on cohabitation but, frankly, opposed the measures in the Bill designed to right them.

My central position is that it is simply no answer to the injustice inherent in our arrangements at present—they were rightly described by the Minister as a patchwork, and I think he implied that they were unsatisfactory—to say that cohabiting couples could just get married. My noble friend Lord Wallace is indicating that I should speed up, so I will.

Along with almost all noble Lords who have spoken, I believe that we should support marriage. I have been a great supporter of marriage and have been married for many years, although not as long as some noble Lords who have spoken. I agree with and accept the point that this is a very public and important long-term commitment, and am in awe of all those who make it. However, we cannot deny the point that many couples simply choose not to get married, and their numbers are increasing. I say to the noble Lord, Lord Farmer, that we are not going to turn the clock back simply by refusing to help to relieve the injustice that cohabiting couples suffer—many of them unknowingly, as has been pointed out—under the present system. We are not going to persuade cohabiting couples to marry by denying relief on breakdown. While I fully support marriage, I start from the position that people should be free to make the choice to cohabit if they wish, and that if they make that choice they should at least be offered some protection by the law against unfairness.

The other point that I suggest was extremely well made by the noble and learned Baroness, Lady Butler-Sloss, was that it is not a case of couples choosing to marry; in many cases one partner, in love and wishing to continue the relationship, wants to get married but the other is not willing to do so. I am very grateful for the distinguished support of the noble and learned Baroness, who has more experience in this field than probably anyone else around. The position of the noble Baroness, Lady Deech, would be to tell the partner who wished to marry that she or he must leave the relationship or accept the imbalance—or, as the noble Baroness, Lady Thornton, put it succinctly, accept that the other partner can simply say: “That’s tough”. I suggest that it is entirely wrong to perpetuate a system that has as its default position the notion that the unwilling partner may take advantage of the other and, while doing so, take advantage of any children that they have together.

The further point is that the Bill does not force anyone into the Bill’s scheme for redress on separation, nor does it require inheritance to pass to the surviving partner on death. The Bill provides for a default position that would apply where couples had chosen not to make alternative arrangements. That default position is nothing like the arrangements that follow from marriage. There is no continuing obligation of maintenance, as there is on divorce. There is no division of property, as there is on divorce; so the £5 million demand by the undeserving cohabitant mentioned by the noble Baroness, Lady Deech, is simply a figment of her imagination, or at least a forensic exaggeration. The opt-out provisions in the Bill are sensible. They give couples the power to take their future into their own hands, after consideration. No doubt most who opt out would do so with the additional help and certainty of a cohabitation agreement. The requirement for legal advice in connection with opt-outs is there as a safeguard. Yes, it would cost some money, but that is to be balanced against the protection, security and avoidance of future battles that such money would buy. The overwhelming points are that there are many cases where the present lack of protection gives rise to real injustice when a relationship ends with one party in a weakened position and the other having taken substantial benefits.

The noble and learned Baroness, Lady Butler-Sloss, mentioned the period of two years which I have chosen. The Law Commission suggested a period of between two and five years and suggested that if a longer period were chosen, couples would be able to get dispensation from the court so that the minimum duration requirement in an appropriate case would go down to the two-year position. I accept that that is a perfectly workable alternative. I chose two years because two years is the average length of a cohabitation that breaks down.

The unfairness is exaggerated, as has been pointed out, by the prevailing myth that cohabitants in a long relationship are protected, when that is simply not the case. The position is even worse where children are involved, and it gets worse every year. I am very grateful to my noble friend Lord Lester for pointing out what was said in Gow v Grant about Professor Elizabeth Cooke’s views on this point. Professor Cooke has been a leading proponent of family law reform within the Law Commission and her views are worthy of respect. However, children are the innocent victims of these breakdowns. The central question is therefore where you draw the line between the need to protect and what the noble Baroness, Lady Deech, calls unwarranted interference by the state. This Bill draws the line by giving limited protection against injustice to long-term cohabitants and those with children as a default position while permitting parties of full capacity to opt out of the scheme if they wish.

As for provision on death, there is no need for anyone to die intestate. The remedy if couples do not want a surviving partner to inherit is to make a will. No one should forget the point, which has been made, that in the absence of provision, former cohabitants and their children tend to be forced to turn to the state for support on separation or bereavement. The noble Lord, Lord Farmer, pointed that out as a reason against supporting the Bill. I regard the opposite as the reality: the expense for the state is to be avoided. It is not only the expense for the state that is to be avoided by the provisions in the Bill, it is also the unwelcome dependence of abandoned parties on benefits, which has the effect of draining their confidence, draining hope and having a seriously damaging effect on their children. It is not compassionate to force people into state dependency and a complete lack of freedom in the name of a spurious freedom to cohabit without responsibility. This Bill places obligations on parties who part and have benefited from a relationship to offer some redress in respect of the benefit that they have gained.

I am very grateful for the support from the noble Baroness, Lady Thornton, on behalf of the opposition Benches. Unlike my noble friend Lord Lester, I do not see this so much as a party-political opportunity. I believe that there are many in the Conservative Party who support the provisions that I am proposing and that the Law Commission has proposed. Although the Minister was not enthusiastic about the Bill and thinks that a great deal of further work needs to be done, I did not sense an innate opposition to these proposals.

As it happens, I totally disagree that a great deal of further work needs to be done. I accept the position, although it was a cautious one, put by the noble and learned Baroness, Lady Scotland, when answering a Question on this matter in the previous Parliament: that the then Labour Government wished to wait until the experience in Scotland made the day a little clearer. The position now is that the Scottish legislation has worked and is working, and it has been applauded by the Supreme Court of the United Kingdom.

The Law Commission’s reports were thorough and well researched, and the position has not changed. The demand as well as the need for the Bill has increased, not reduced. I expect the Labour Party to support the Bill in accordance with what was said by the previous Government, and I am very grateful to the noble Baroness, Lady Thornton, for making that clear. I believe that, on consideration, if they form part of the next Government, Conservatives might also accept that position.

The Bill is about responsibility. It involves recognising that when people live together they take on a responsibility to consider each other, not to take advantage of each other, and at least to consider their positions in the event that things go wrong by separation or death. The Bill enables the law to recognise that responsibility and give some meaning to it. However, it is also about compassion. The Law Commission has recognised that millions of couples are in cohabiting relationships and need protection under the law. It is about compassion for those who do not form cohabitation agreements or write a will. The Law Commission rejects the harsh view that if those people do not marry, they must take the consequences of staying outside marriage. The Bill recognises the realities of our society and tries to address them in a balanced and compassionate way. I ask the House to give the Bill a Second Reading.

Bill read a second time and committed to a Committee of the Whole House.

House of Lords (Expulsion and Suspension) Bill [HL]

Report

Clause 1: Expulsion and suspension of members of the House of Lords

Amendment 1

Moved by

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1: Clause 1, page 1, line 15, leave out subsection (4) and insert—

“(4) A resolution passed by virtue of subsection (1) must state that, in the opinion of the House of Lords, the conduct giving rise to the resolution—

(a) occurred after the coming into force of this Act, or(b) occurred before the coming into force of this Act and was not public knowledge before that time.”

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My Lords, I will speak also to Amendments 2 and 3 in my name. I hope that I will not need to detain the House for very long.

At the outset, I will record my gratitude to the Minister and his officials—and I am delighted to see the Leader of the House in her place today. There have been a number of useful conversations—certainly useful from my point of view—which I hope have allowed us to end up with drafting in the Bill that meets the need for a more robust sanctions regime for the House but which also takes into account the necessity for this to be fair and balanced.

I also reiterate what I said about the Bill at Second Reading. This is an enabling Bill. The House will have the opportunity, when drafting standing orders under the Bill, to look very carefully at the processes that it wishes to put into place, were there to be, first, an investigations, then a report, and then a Motion in the House to bring sanctions against a Member under the terms of the Bill. So there are plenty of opportunities for ensuring that we get those processes absolutely right—but the original problem remains, unless we pass this Bill.

I turn to Amendment 1. In Committee, we debated and passed an amendment that dealt with the issue of retrospectivity in a blanket way. Many noble Lords would have been concerned that we could run the risk of double jeopardy and of reopening issues of conduct that had already been through the disciplinary processes of the House and been adjudicated on. However, there was a concern that, in so doing, we should not tie the hands of the House in circumstances where, for example, wrongdoing occurred today but did not come to public notice until after the passage of this Bill. We did not want to be left in the position of having no sanctions regime available at all to the House.

I have therefore taken the wording in the 2012 House of Lords Reform Bill, which had to consider exactly the same issues of retrospectivity. In this amendment, we would put those provisions into my Bill and ensure that any conduct that gave rise to proceedings under this Bill had either to take place after the Bill’s passage or to deal with issues that preceded the Bill’s coming into force but were not in any way in the public domain. That was considered to be an appropriate approach in the Bill on major House of Lords reform that did not proceed, and I hope that it will be considered appropriate in this Bill.

The other two amendments are of a technical nature. I am particularly grateful for the conversations that I had with officials, because I am not sure that I would have got there myself in understanding, in Amendment 2, the need to ensure that the interaction between the entitlement to receive the writ of summons, which is obviously a very important issue and one that stopped the House in the past being able to suspend Members beyond the lifetime of a single Parliament, and the House of Lords Reform Act 2014 should be made clear. Amendment 2, I am reliably informed, achieves that end and ensures that there is no lacuna between my Bill and the Act.

Equally, I attempted in my drafting to ensure that the effects of ceasing to be a Member in the case of expulsion should be the same under these provisions as they would be for expulsion under the provisions of the 2014 Act. I believe that the wording that we now have in Amendment 3 achieves that.

I hope that, if the House is minded to approve the amendments, we have now got the Bill into a form that is watertight and acceptable to the House and that achieves the ends for which there was so much support. I think that the Leader of the House recognised that in the strength of the contributions made from all over the House at Second Reading and in Committee.

As I said at the beginning, this is not a House of Lords reform Bill. It is not called that and it is not that in any way. It does not deal with composition. It deals with our internal disciplinary processes and, in that sense, may seem very minor. However, as I have said before, it also deals with a situation that those among the general public who are aware of it already find unacceptable and that, were it to come into the spotlight because a case arose, even more of them would find totally unacceptable. In my view, this issue concerns the reputation of this House and of Parliament more widely. That is why I hope very much that the Bill will make rapid progress not just today but in another place. I beg to move.

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My Lords, very briefly, I thank the noble Baroness, Lady Hayman, for taking up the standard. I hope, as I know she does, that this Bill, when it becomes an Act, will never be needed. However, if it does not become an Act of Parliament, that would be very difficult to explain to anyone outside Parliament.

I am greatly comforted by the presence of my noble friend the Leader of the House on the Front Bench. I sincerely hope that the Bill can go through its remaining stage in this House and through another place in good time for the Dissolution of this Parliament, so that it is fully operational when we come back. There is no reason why that should not happen from the point of view of parliamentary timetables. I made that point at Second Reading and again in Committee. We are enormously indebted to the noble Baroness, Lady Hayman, as we are to the noble Lord, Lord Steel of Aikwood. The Bill perfectly dovetails with, and in effect completes, what he and Mr Dan Byles sought to do. It has my total and complete support.

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My Lords, until now we have had a regime that partly dealt with the problems that this Bill deals with. However, as the noble Baroness, Lady Hayman, explained, the statutory framework under which this House has worked hitherto did not enable us to exercise the full powers that the House would have wished to exercise in some circumstances because of the need to curtail any sentence of suspension to the period of the next issue of writs of summons. I do not think that anybody thought that was an entirely satisfactory system. On the other hand, I thought—and I think this was generally agreed—that it was the best that we could achieve without statutory intervention.

Now we have the opportunity to introduce statutory intervention. It is extremely important that from now on we should have a system that completely replaces what was in place before without the impediment involved in the previous arrangements. This Bill does exactly that, covering in full the situation where someone, unfortunately, transgresses the Code of Conduct of the House, and allows it to be properly dealt with.

I am extremely grateful to the noble Baroness, Lady Hayman, for taking this on. I am also grateful for the progress that has been made in the consideration of the Bill, which has made it, in my view, as perfect a statutory framework as we can have, while leaving the detail of what should happen to the decisions of this House through the making of Standing Orders, as the noble Baroness said. That has the important advantage that, if the initial Standing Orders prove to be somewhat in need of improvement, that improvement can be made. That is an important feature of the Bill in bringing in a completely new regime to replace the regime, with its unsatisfactory features, we hitherto have used. I hope that the Government feel—I imagine that they do—that this would be an improvement, and I hope that the Bill will speedily pass into law.

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My Lords, I should like to say a few words from a selfish point of view. The last time we had three expulsions, all three, unfortunately, were Asian. The amount of backlash one received was enormous. People said, “What have you done? You have done nothing; these people have done this and that, and you do nothing to them”. If they were working for some company they would not be there any more. This approach is long overdue and I am really grateful to the noble Baroness, Lady Hayman, for bringing it forward. It is hard to say, “Look, there are people in this House who do not follow the rules they should follow”. They are not honourable and should not be in this House.

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My Lords, I should like to put on record my support. I had the honour to serve as the chairman of the Conduct Sub-Committee of the Privileges and Conduct Committee. At Second Reading, I gave strong and firm support to, and welcomed, the Bill. As the noble and learned Lord, Lord Mackay, has made plain, it would fill the present, most concerning lacuna in our sanctioning powers. Again, I echo the hope that it will never be necessary to exercise these increased powers.

I welcome all the amendments. The first meets the concern expressed by the noble Lord, Lord Finkelstein, in Committee. In its original form, this provision was too narrow and confined only to what is now in proposed paragraph (a) of the amendment. As the noble Lord pointed out, it would fail, for example, to deal with someone who committed perjury in a libel case and it took four years for that perjury to be revealed. That problem is now cured by the amendment. I strongly welcome it and the other two amendments, too.

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My Lords, on behalf of the Opposition, I agree with the noble Baroness, Lady Flather, that this is timely and long overdue. We support all three amendments. How good it is to know that something survives from the 2012 House of Lords Reform Bill and goes forward in this Bill. We support it.

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My Lords, the important thing is to get all stages of the Bill through the House in good order. We entirely accept that the Bill is about Lords’ conduct and therefore their reputation. As such, it is a useful addition to the procedures available to the House, although—to repeat what has been said—we all hope that the powers will rarely, if ever, be needed.

The question of what happens in another place will, of course, have to be discussed. I have assurances that the Leader will be discussing that matter with others but, meanwhile, we welcome the clarity of these amendments. The Bill is now in good order and we should accept this as the Report stage.

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My Lords, I am extremely grateful to everyone who has spoken for their support for the amendments, which I believe have now struck the right balance, particularly on the issue of retrospectivity. I am very grateful to the Minister. He said that the important thing is to get the Bill through this House. That is an important thing. I think that the most important thing is now to get the Bill through another House. I know that the Government have made very clear that they will not stand in the way of the Bill. I hope that in willing the ends they may be able to move towards willing the means as well. I know that there has been real good faith from the Government Front Bench on this issue. I hope that we will see the fruits of that in the new year and that this small but important measure will become law before the general election.

Amendment 1 agreed.

Amendment 2

Moved by

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2: After Clause 1, insert the following new Clause—

“Entitlement to receive writs of summons to attend House of Lords

In section 6 of the House of Lords Reform Act 2014 (interpretation), after subsection (2)(c) insert—“(d) section 1(3) of the House of Lords (Expulsion and Suspension) Act 2015.””

Amendment 2 agreed.

Clause 2: Effect of ceasing to be a member

Amendment 3

Moved by

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3: Clause 2, leave out Clause 2 and insert the following new Clause—

“Effect of ceasing to be a member

A person expelled in accordance with section 1 is to be treated as if that person had ceased to be a member in accordance with the House of Lords Reform Act 2014, for the purposes of section 4(2) to (8) of that Act.”

Amendment 3 agreed.

House adjourned at 3.05 pm.