Care Bill [HL]

Lord Warner Excerpts

Wednesday 12th June 2013 Lords Chamber

[Lord Patel]

My Lords, I rise to speak to this amendment in the name of the noble Lord, Lord Willis of Knaresborough, with some trepidation. It is not because I do not strongly support his amendment, but because I hope that I can do justice to it with the kind of passion that he would have demonstrated when presenting the argument if he had been here. However, I have no doubt that while resting in his bed, he has probably turned on BBC Parliament and is watching to see that I do the task adequately.

I think the reason why the noble Lord, Lord Willis, has demonstrated such passion is because he recognises that there is a need to reduce bureaucracy. Too many regulatory bodies mean more bureaucracy. To give an example, we have the second-highest number of competent authorities in the EU. Joint highest are Poland, Romania and Italy. However, on top of that, we have more regulatory authorities—over a dozen—than any other EU country. I see noble Lords look rather surprised, but I believe that to be true.

One issue is reducing unnecessary regulatory bodies. Another issue is reducing bureaucracy. The third issue is reducing duplication. The Human Fertilisation and Embryology Authority’s key role is to improve clinical services related to patients with fertility problems. The key reason that the authority was set up, following the birth of Louise Brown, was to reduce public anxiety about in vitro fertilisation. No such public anxiety now exists related to in vitro fertilisation.

Further functions were added to that authority in terms of embryo research. There may still be a need for that, but a reducing one. To give an example, we have enough clinical grade embryonic stem cell lines to last us a century and supply the world. I think the derivation of more embryonic stem cell lines is probably unlikely, unless there is some kind of major breakthrough. Research on embryos and embryonic stem cell lines is also now slightly superseded by induced pluripotent cells, dendritic cells and adult cells. However, I agree that there might still be a need for some embryo research and that function needs to remain.

The duplication is likely because the CQC will have a licensing role for those trusts that provide clinical services in infertility. Of course, I accept that the majority of infertility services relating to in vitro fertilisation—and I have no doubt that the noble Lord, Lord Winston, who is listening to me carefully, will correct me wherever I go wrong—are in the independent sector. Unless that service is provided for an NHS patient, the CQC does not have a role, and there must be a way of overcoming that. If we do not overcome that, the services provided within the NHS will run the risk of duplication of effort by the Human Fertilisation and Embryology Authority and the CQC.

There is also a fourth argument, and that is the reduction of cost. The noble Lord, Lord Willis, wrote a letter to the Times asking why all these regulatory authorities have a whole army of communication officers. What do they communicate? Why do they need so many? The noble Lord referred to the cost, and there are also other back office costs that are increased unless we reduce the number of regulatory authorities. His proposal is that there should be a reduction and that a body called the Human Tissue and Embryo Authority should be established rather than the HTA and the HFEA. The noble Lord lists where the changes would be required in their functions and in subsection (15) sets out the role of the Care Quality Commission to streamline all these efforts and reduce costs.

It is interesting that initially, in an attempt to reduce the number of quangos, the Government in the Health and Social Care Act decided that the HFEA and the HTA, with other quangos, would be abolished. Now, with the high profile of patient safety, we wonder whether some of the others should have been abolished. If I remember correctly, we debated the HFEA and the HTA during the passage of the Health and Social Care Bill and, in fact, we had a Division on it.

However, the Government decided to go to consultation, and I understand that Justin McCracken has been commissioned to review the operating functions of the HFEA and the HTA to see how they might deliver greater efficiencies. I think that this amendment, in the name of the noble Lord, Lord Willis of Knaresborough, would deliver those efficiencies, and I should be interested to know whether the Minister agrees that this would be a better way forward in dealing with the Human Tissue Authority and the Human Fertilisation and Embryology Authority. I beg to move.

[Lord Warner]

My Lords, I rise because I gave an assurance to the noble Lord, Lord Willis, that I would speak on this amendment as I have form, as they say, in this area.

Ten or so years ago, when one person accused me of being rather like Vlad the Impaler and we were slaughtering, as well as merging, a number of quangos, two of the candidates for merger were the Human Tissue Authority and the HFEA. Much of the argument for doing that was very similar to the argument that the noble Lord, Lord Patel, has advanced, although I did not know as much then as I know now about the number of bodies that we had compared with other countries regulating in this area. However, I assure the Committee that we had a lot more in 2003-04. Therefore, there is a case for this merger, and it has been made.

By backing away from this merger in the face of the arguments that were put forward, I ceased to be Vlad the Impaler and became Warner the Wimp. To their credit, this Government decided to have another go, but they seemed to get themselves in roughly the same position as Warner the Wimp and withdrew. Really, they withdrew because at the end of the day the savings were—certainly so far as I was concerned—not significant compared with some of the other savings that could be made. However, we have grown to appreciate more the importance of health research and the role of the life sciences in our economy, and I think that there is still a case for going the extra mile, when you can, to streamline the regulatory system in this area.

I hope that the Government will look sympathetically on this amendment, even if they do not want to accept it in its present form. I hope that some of us speaking out on this in the review will give the Government some courage to be a bit braver than they were, and than I was, in the past. Therefore, I support the spirit and the ideas behind this amendment.

[Lord Winston]

My Lords, I fear that I have to support the noble Lord, Lord Patel, on this amendment, even though I do not think it goes far enough. In my view, the case for having a Human Fertilisation and Embryology Authority at all is now quite dubious. It is 20 years or more since this treatment was established. There is no longer public anxiety about it, as there was in 1990, when the Act was introduced. It is now a regular treatment. As long as this treatment is licensed in this way, it will look like a maverick treatment to people—something extra, outside the health service.

One issue is that, sadly, these treatments are affordable only in private practice. Of course, the health service has done a good deal towards trying to supply them, but as the noble Earl knows, there are many examples where people pay very large sums in the private sector for these treatments and they are not and cannot be regulated. If one was really going to be serious about regulating in vitro fertilisation, the first thing that would be needed to prevent couples being exploited would be to find a way to reduce the massive burden of cost, which is out of proportion to the actual expense of the treatment. That is really something that needs to be looked at.

Sadly, the HFEA has not performed particularly well in the areas of research. I would like to recount briefly as an example the last licensed inspection of my own laboratory where we conduct experiments on embryos where there is no possibility of those embryos being transferred to a human patient. They are of course effectively dying in culture. It is extraordinary how stringent the last inspection was with regard to the quality of our laboratory. Why our laboratory should be seen to be more up to a particular standard than others doing cell culture work was beyond my comprehension given the fact that these cells, under no circumstances, could be used for human treatment: they were simply to investigate a phenomenon.

I could not help wondering whether in fact that particular inspection committee was being vituperative, because it had heard me speak against the HFEA at a previous debate in the House of Lords. I have no idea about that. But certainly, given that the previous year we had had a gold standard approval for our methods, I have to say that the inspection process is a patchy one. The problem really is that, currently, the HFEA licenses treatments that are practically research procedures that have not been validated and which are being charged to patients.

There are many examples of anomalies that are worrying. The noble Earl may have seen this week a full-page advertisement for egg sharing at a London private clinic. Incidentally, that clinic has been run by a member of the HFEA. One cannot help but feel that this is a shocking conflict of interest given that egg sharing is somewhat difficult to justify in certain circumstances as poor women may be persuaded to give their eggs under situations that are perhaps not ideal for them. They may in fact end up with someone else getting treatment at their mental expense—not their physical expense because they get a free treatment—and then 20 years later finding a child they do not even know about trying to trace them because of the information shown on our birth certificates. That anomaly has never been worked out.

I am really very surprised, too, that no serious attempt has been made to bar clinics that seek to send patients overseas for treatments that are not allowed in this country. There are many examples where patients are sent for various treatments where they might receive more than two embryos at a treatment, which would be against the regulations in this country, but they can come back and give birth to their triplets on the National Health Service. Clearly, that is an anomaly.

While I have absolutely no axe to grind about good private practice, there is no question that sometimes there are issues where clinics advertise wares that are unjustified. That happened two weeks ago when a clinic announced that it now had a treatment that could improve the success rate threefold. Of course, if I as a medical practitioner said that to the press, I could be held in front of the General Medical Council for advertising. But a clinic can get away with that kind of approach if it is not actually being mentioned by a medical practitioner.

The real reason for wanting to see at least some slimming down—we may need to come back to this at the Report stage to see exactly what clauses would be eliminated; it is difficult to see the whole of this rather large amendment now—is that at some stage in the near future we should revisit the Act of Parliament to see what would be best for purpose. In the mean time, however, there is a great deal of force in agreeing to slim down the number of regulatory authorities. As everyone across the House knows, regenerative medicine is one of the great opportunities for British medicine. At the moment, one may have to apply to up to 10 different regulatory authorities to get full licensing for the sorts of procedures one might want to follow for research, particularly where animal research may have to be done in parallel. That seems to be a very inhibitory process and there is evidence that it is preventing many bright people going into this research. They need to launch their PhD projects in other ways as quickly as possible.

While the amendment of the noble Lord, Lord Patel, is not perfect, slimming it down like this is a good start and an opportunity. I am also delighted to hear that the noble Lord, Lord Willis, who would have moved this amendment with the noble Lord, Lord Patel, is on the mend. That is good news about an outstanding parliamentarian. If the amendment were to be pressed, I would wish to vote for it.

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[Lord Walton of Detchant]

I intended to say, but did not, that the two different bodies’ areas of authority collide when you deal with stem cells, because they are derived from embryo research but then become cells that are used for tissue research and transplantation and so on. That is where they collide. That does not necessarily mean that it is crucial to merge the two authorities.

[Lord Warner]

My Lords, at the risk of lowering the tone even further, perhaps I may just take us back and slightly challenge the noble Lord, Lord Walton, which I do not normally do. I also took the Human Tissue Act through this House. I am well seized of the circumstances that we faced then. At the time, I was bombarded by the research community with their concerns about setting up that body and whether it would be another obstacle to research. They recognised that this country had to do something in legislation in terms of the EU directive on human tissue. We were caught between a rock and a hard place. We had to do something about the EU directive; we had all the concerns about what had happened in Liverpool; but we were also conscious that we needed to ensure that we did not put another set of barriers in the way of medical research.

When we were considering the merger of the Human Tissue Authority and the HFEA we were very strongly of the view—which is very similar to what the noble Lord, Lord Patel, has said—that there was not a great deal of difference between the nature, if I may put it that way, of the matter being used for research under the aegis of those two regulatory bodies. In some cases, human tissues were themselves living cells being used for research, and we did not regard that as fundamentally a different type of matter from the one that is regulated for research purposes by the HFEA. I cannot even brag of an O-level in science—“Shame on you, Warner”, says Michael Gove. But in my lay view we had a situation where the advice we got from the scientists was that having two bodies was likely to be a greater impediment. There was a case on savings grounds—back-office services etc; the kind of issues that the noble Lord, Lord Willis, mentioned in his letter to the Times—but there was also a science argument for putting the two bodies together.

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[Lord Warner]

My Lords, I will speak to Amendments 65, 66 and 67 and to Clause 77 standing part. I share very much the concerns expressed by my noble friend Lord Hunt and I am not going to repeat what he said about the slightly strange situation that we are now in with the CQC having enforcement responsibilities in relation to some bodies that it registers but not in relation to others.

I want to concentrate on the missing part of this group of clauses, which is the Trust Development Authority, and go into a bit more detail on this area than my noble friend Lord Hunt had time to do. The purpose of these amendments is to try to pursue the question of whether there is parity of action required by the Trust Development Authority and Monitor, when the CQC issues a warning notice, irrespective of whether that notice applies to an NHS trust or an NHS foundation trust. There is something very curious about writing this quite complicated legislation, which, if I may say as a connoisseur of health and social security legislation, has the air of a rather rushed job. The builder was going to go off site quite quickly if we did not get the trimmings of the house finished—it has that feel to it.

The Bill is very focused on the enforcement action by Monitor, but is pretty much silent on what the TDA does. Like my noble friend Lord Hunt, this strikes me as extremely odd, because, as a general rule, the weaker trusts—I exempt my noble friend Lady Wall and her skilful chairmanship of her trust—are tucked away in the Trust Development Authority. You have to remember that they have all had the best part of 10 years to convince people that they could be given the autonomy of NHS foundation trust status.

I seem to recall that since its inception the TDA has not made a great deal of progress in getting over the hurdle trusts for which it has responsibility. My recollection, and the noble Earl will be able to correct me if I am wrong, is that there is only one trust in the past 18 months, Kingston, which has made it to FT status. There is hardly a queue of candidates in Monitor’s FT pipeline. Indeed, there is a real danger—if I may say so, slightly pessimistically—that the Trust Development Authority will struggle to live up to the middle word in its title.

What seems likely to happen, as we move forward into the next few years, is that as the money gets tighter we start to see increasing failure among some of the TDA trusts and a greater flow under this new legislation of warning notices from CQC. I have therefore become rather intrigued as to what should happen when the warning notices thud on to the desks of NHS trust boards and they fail to respond adequately.

Under this Bill, it is relatively clear, even with the reservations my noble friend Lord Hunt made, what happens with FT boards and Monitor. Far less clear, indeed totally unclear on the basis of the legislation, is what happens with TDA trusts, which after all account for about £30 billion a year of public sector expenditure, so there are quite a lot of patients going through their beds and doors.

In my search for further enlightenment, I have taken the trouble to read the document that the Trust Development Authority published last December with the rather upbeat title, Delivering High Quality Care for People, the accountability framework. This is a model of Department of Health speak—I am something of an expert on this, as is the Minister. It makes clear that trust boards will have to comply with some of the licence conditions set by Monitor, but it is rather uncertain which ones it will have to satisfy. It has set a lot of operational performance standards which look uncannily like the evil Labour targets imposed from time to time. It promises more details on the Trust Development Authority’s oversight model. I have yet to see very much of that further detail, but nowhere in this document is it clear what happens to these trusts that fail to live up to the expectations of that accountability document published about six months ago.

Continuing my search for enlightenment, I have moved on to read the May Department of Health document entitled, The Regulation and Oversight of NHS Trusts and NHS Foundation Trusts. It claims to throw light on the Bill’s quality of services clause. The first nine pages are pretty clear. We start to get into a bit of difficulty when we get to page 10, which is headed “Intervention”. That is when I became really puzzled. It says—I am not quoting, but this is pretty much what it says—that the TDA can request recovery plans, increase engagement with the trust, commission an independent and rather exciting thing called a deep dive, review the skills and competencies of the board and executives, and commission an interim report.

The noble Lord, Lord Hunt, and I are veterans of debating the regulations setting up the Trust Development Authority. Many of us thought it would be doing that anyway. We did not think this was some kind of new regime. This looks like a bit of a rehash of what it should have been doing in order to get the trusts for which it was responsible to pass the foundation trust tests set by Monitor. When it was set up, it was supposed to have that responsibility for quite a short period of time. It hardly looks like some new, sexy enforcement set of procedures which we would expect it to take when the CQC warning notices come to its attention. It looks as if the enforcement procedure for the trusts in the TDA remit is that they have to be given further chances. It is not explicit but—dare I suggest, as my noble friend Lord Hunt I think implied? —we could be heading back down the road of money being taken away from the successful trusts to buttress people in organisations who are not cutting the mustard in terms of the quality of services or the financial management that is required not only to be an effective foundation trust but to be an effective trust.

It is not at all clear to me how the Government are going to tackle the fact that the weaker brethren are within the responsibility of the Trust Development Authority but there is nothing in the Bill which actually says what the TDA will do. I am sure that the noble Earl will tell me about other bits of legislation, but it seems to me that if we want to convince the public that there is a new show in town for real enforcement when things continue to fail in a trust, whether it is an FT or an NHS trust, it would be sensible to put these provisions in the same Bill, particularly when we all know that the weaker trusts are under the TDA.

Paragraph 27 of the May document I mentioned is pretty elusive. Commissioners can have a go at reconfiguring if there is failure but that may not work. Eventually, the trust is unsustainable and becomes the responsibility of the TDA. Guess what the TDA can do? The TDA has absolute discretion as to whether it advises the Secretary of State. It can advise the Secretary of State to appoint a trust special administrator but is not required to. Under the current guidance, which only came out a month ago, the most the TDA is required to do is to consider doing that. If it chooses not to, it need not. We therefore have a situation in which the TDA seems to be operating under a different regime from Monitor. This is a really serious situation to be considered, and I suggest to the Minister that it will become a public confidence issue. I am not making a party political speech—this is all about getting legislation which is fit for purpose to restore public confidence after the Mid Staffordshire debacle.

Why does this Bill not provide for a much sharper set of actions from the TDA when the CQC issues a warning notice to a trust? The notice is a clear signal that the TDA’s efforts to rehabilitate the trust are simply not working. I suggest this with a bit of nervousness, but should the Government not consider withdrawing these clauses and provide a clear set of rules and requirements that protect patients effectively, whether or not they are in NHS trusts or FTs? I do not think that the Bill, as drafted, does the job of protecting patients. I do think that the TDA needs to be brought into this part of the Bill on a basis of parity and equivalence with the requirements that will be made of foundation trusts through the enforcement panels of Monitor.

[Baroness Wall of New Barnet]

My Lords, unlike my noble friend Lord Warner, I am not a connoisseur, other than about what happens in my trust. Maybe I can share our experiences in response to the questions on which my noble friend Lord Warner has been seeking clarification. I think it will answer some of them, although not all.

As many noble Lords will know, 18 months ago Barnet and Chase Farm Hospitals NHS Trust took the decision that it could not comply with Monitor’s requirements, primarily the financial aspects, and brought in Deloitte to do a complete survey of all our services. We met the benchmark for clinical services but, because of the historic debt, we did not meet the financial benchmarks. We went up to two for Monitor’s rating on finances, but it goes up to four, and so we were two—two and a bit—for one period. Although we sought support through the SHA at the time, from a body that offers trusts opportunities to apply for funding, we were unsuccessful. This is where I may not be able to assist my noble friend Lord Warner, because we decided ourselves, as a trust, that we would not be fit for purpose in that sense. There is a process, and people who have been involved in it much more than I have will know what that process is. We notified Monitor that we would not be able to do that.

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I could not agree more with my noble friends Lord Hunt and Lord Warner that reconfiguration has to happen. We had brave words about it from the previous Government, but we did not do it. We now have brave words from the Secretary of State, who is doing a perfect job, from what I have seen—he is going out and seeing how it really works in a trust: rolling up your sleeves and making beds. My plea to the noble Earl is that the Government stick to the fact that reconfiguration has to happen. Politically, closing hospitals is dynamite. I have said that more times from these Benches and from the Benches opposite than I can remember. However, unless it happens, failing trusts will continue to fail. The financial aspects of failure are awful, but the performance of some of those trusts is not good enough for patients to be on the receiving end of it. I thought it would be helpful to share that. I am not sure whether I support the amendment, but I am sure I will come to a decision on that.

[Lord Warner]

My Lords, I clarify that I did not seek to attack the TDA. What my noble friend has said has made me more worried. What happens if these trusts do not make it to FT and people get fed up with the TDA and decide to try something different? We would still have these trusts, which would be providing services, still on the receiving end of CQCs, so why does the Bill not provide for some of these eventualities—which again, could happen in the real world?

[Lord Campbell-Savours]

My Lords, I will intervene only briefly, unlike yesterday when I went on at length on a couple of the amendments. My noble friend Lord Warner referred to the absence of a new force in town. I suspect that in some ways he is referring in part to the confusion referred to by my noble friend Lord Hunt. I will deal with paragraphs 60 and 61 of the Francis report, where two recommendations are made. Will the Minister, in his response to this debate, just tell us why the Government are refusing to implement those recommendations? I will not read those paragraphs in their entirety, but just the key points. The report states:

“The Secretary of State should consider transferring the functions of regulating governance of healthcare providers and the fitness of persons to be directors, governors or equivalent persons from Monitor to the Care Quality Commission. A merger of system regulatory functions between Monitor and the Care Quality Commission should be undertaken incrementally and after thorough planning”.

I would have thought that the Bill was the opportunity to do that. If that is the case, will the Minister tell us precisely what the objection is, and why we are not taking up that particular recommendation from the Francis report?

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The Bill does not mention NHS trusts and the TDA because the latter is a special health authority established under secondary legislation. The NHS Trust Development Authority Directions 2013 delegate the Secretary of State’s extensive powers in relation to NHS trusts to the TDA. They include appointing directors and terminating their appointment, power to give directions to NHS trusts in relation to quality and recommending trust special administration. We have tried to place the regime on an absolutely equal footing with the regime that we are creating in the Bill for foundation trusts.

[Lord Warner]

My Lords, I am sorry to interrupt, but I have here a document that the noble Earl’s department sent out in May, signed up to by the TDA, Monitor and the CQC. I want to direct his attention to paragraph 27 of that document, which I mentioned in my remarks. As I understand it, this sets out the Government’s policy on the relative difference between TDA and Monitor. It makes it very clear. I shall quote from it, because this is absolutely the nub of the issue:

“Monitor can also place a foundation trust into special administration directly, following consultation with the Secretary of State and the CQC, on the grounds that it has, or is likely to become, financially unsustainable. The changes proposed in the Care Bill will enable it also to do this where it is apparent that a provider is clinically unsustainable”.

The initiative lies with Monitor. It can do this in relation to the trust of my noble friend Lord Hunt or to any other foundation trust when it has had a warning notice from the CQC and thinks change has not taken place. Hold that thought in the head and look at what the document says about NHS trusts that are in the maw of the TDA. It states:

“Managing the process of reconfiguring local services to provide sustainable, high quality healthcare that meets patient expectations and needs is primarily a role for local commissioners, supported by NHS England. In the event that an NHS trust or foundation trust has failed to make improvements and commissioner-led efforts to resolve the issue have not succeeded, special administration may, as a last resort, provide a mechanism for dealing with NHS trusts and foundation trusts which have become either clinically and/or financially unsustainable. Where the TDA considers it is in the interests of the health service, it can already advise the Secretary of State to place an NHS trust which it considers to be either clinically and/or financially unsustainable into special administration”.

Monitor can simply take that decision itself when it has the evidence. The TDA has to go through a series of hoops with commissioners before it can advise the Secretary of State. That is what this document seems to say. If it is wrong we need to be clear that it does not say what the Government mean it to say.

[Earl Howe]

I think the noble Lord has misled himself. The way in which we envisage the system working for both trusts and foundation trusts, where we have a provider that looks as though it might be clinically unsustainable, is to encourage commissioners and the provider concerned to come together and have a grown-up conversation about the configuration of services. That is the first resort and it is the normal course of action that we would expect, whether it is an NHS trust or an NHS foundation trust. In either case, trust special administration is going to be a last resort.

The noble Lord is right that, while we envisage the process of trust special administration to be broadly the same in both instances, there has to be a difference. The difference arises from the fact that foundation trusts are, in statute, much more autonomous bodies than NHS trusts. NHS trusts are still subject to directions from the Secretary of State. What the TDA does is act as the Secretary of State’s proxy in overseeing their quality, sustainability and governance. That is why there is a process around referral to the Secretary of State before a trust special administration can take place for an NHS trust, whereas that is not the case with a foundation trust. That is because Monitor is the independent regulator for FTs charged with doing that.

The noble Lord does not need to make too much of the differences that he has purported to identify in that document, which I will, of course, re-read in case we have inadvertently misled the Committee. The point I sought to make was that in no way do we envisage a material difference in the process which will ensue from a clinically unsustainable provider, or one whose quality is in question.

The noble Lord, Lord Warner, asked what will happen to NHS trusts that do not meet expectations of the accountability framework published last December. The accountability framework covers clinical and operational metrics, governance, leadership and finance. If the TDA judges that a trust is failing the accountability framework, it has a number of options. It can request recovery plans—Monitor is also in a position to do that with FTs; it will increase the frequency of its engagement with the trust; it can commission an independent investigation; it can review the skills and competence of board members. Again that is something that Monitor can do with FTs. It can commission interim support to provide additional management capacity—again that is something that in theory Monitor could do under its licensing arrangements. Ultimately, the TDA can exercise the Secretary of State’s functions and terminate appointments. Monitor has similar powers. I want to reassure the noble Lord, Lord Warner, that there is not such a gap as he has made out in this area.

Incidentally, the noble Lord called into question the speed of progress of the foundation trust pipeline. I can assure him that the pipeline is moving. It may look rather glacial from his perspective, and I can understand why. However, even though the TDA was established only on 1 April, two foundation trusts have been authorised since then—Kingston on 1 May and Western Sussex, which was announced today.

The noble Lord, Lord Warner, sounded a warning that this kind of arrangement posed a risk that money could end up being taken away from successful trusts to bolster poorer performers. It is precisely to avoid that that we need to grasp the nettle in some cases as we had to do in south London to ensure that one part of the NHS did not drain the resources that should be shared out more equitably among the rest of the health service. Certainly, this is not the intention of our policy. In fact, the purpose of special administration, if it is deemed necessary, is to ensure both clinical and financial sustainability. When it is clear that a hospital cannot resolve quality failures in its current form, we will no longer have to wait until a trust fails financially before action is taken. That is why I shall talk about special administration in more detail in a second.

In future, issuing a warning notice to a trust or foundation trust will be a sign that there is a serious quality issue at that trust and that significant improvements are required. I fully agree with the noble Lord, Lord Hunt, that it will be important to determine what significant improvements could encompass, as proposed by Amendment 64A. We have been clear that the new warning notices are designed to highlight serious failings, such as a systematic failure to meet fundamental standards. As noble Lords will remember, the fundamental standards are a concept that Robert Francis put forward, whereby treatment or practices in a trust could be said to be absolutely unacceptable by anyone’s measure. The fundamental standards themselves have not yet been defined; that process will be taken forward in the coming months with full consultation with the public, and we need to get that right. That is the issue underlying the provision around significant improvements. Under the 2008 Act, the CQC is already required to publish guidance to detail its approach to issuing warning notices. This will be revised in light of this Bill to include its interpretation of “significant improvement”. That is a flexible and proportionate approach.

When a trust receives a warning notice, just as happens now, it will be published and the CQC will send a copy either to the TDA or to Monitor, depending upon whether they relate to an NHS trust or foundation trust, as proposed by Amendment 65. Clause 74 amends Section 39 of the 2008 Act, which requires that a copy of the notice be sent to Monitor and any other persons whom the CQC considers appropriate. When the notice relates to an NHS trust, this would include the TDA.

I have listened carefully to the noble Lord’s arguments in favour of Amendment 66ZB regarding large providers spread over many sites. This is not a new issue; having a regulatory system that is flexible enough to cope with such organisations has always been critical. At present, the CQC has to ensure that they can take a differentiated approach and can deal appropriately with providers, ranging from large multisite hospital trusts to care homes. This will continue to be the case, so I feel that this amendment, while I sympathise with its intent, is unnecessary.

Clause 75 introduces changes to ensure that when failures are identified, there is a prompt and firm response. We have been clear that when a provider receives a warning notice, the responsibility to resolve problems will remain with the provider in conjunction with the local commissioners, as I referred to earlier. However, serious failures in the quality of care must not be allowed to be endure, so Clause 75 makes changes to ensure that, when quality of care at a foundation trust requires significant improvement, Monitor can take timely action to make changes to leadership or governance to secure improvements in those services. It amends Monitor’s powers under Section 111 of the 2012 Act to enable it to impose additional licence conditions on foundation trusts when the Care Quality Commission has issued a warning notice to that trust. At present, Monitor can make use of these powers only if there is a failure in governance. If the foundation trust breaches those additional licence conditions, Monitor will be able to use its powers to suspend or remove directors or governors. The NHS Trust Development Authority already has powers to intervene in NHS trusts or to remove or suspend boards, as appropriate.