Lord Walton of Detchant
My Lords, I rise briefly to express my strong support for Amendment 58A. I used to teach my medical students and my postgraduates by telling them that today’s discoveries in basic medical science bring about tomorrow’s practical developments in patient care. Surely this is what the amendment is about. If I were to be pedantic, I would prefer a change in the wording to:
“The HRA shall also have the function of,”
promoting
“the translation of research into innovative practice”.
That is preferable to simply “encouraging” it. Again, I am happy to support the amendment.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, this amendment takes us to a subject that is dear to my heart—the translation of research—and I agree very much with the tenor of what the noble Lord, Lord Collins, had to say. The Committee will know that our vision is to improve the health and wealth of the nation through research. The Government are committed to cutting the bureaucracy involved in health and social care research. We want to speed up the initiation and delivery of research so that research findings can benefit people more quickly and improve the UK’s competitiveness in the life sciences. At the same time, research involves a degree of risk, and we need to balance a desire for expediency with appropriate safeguards to protect people who participate or who may participate in research.
Clause 97 sets out the Health Research Authority’s four main functions, which are described in more detail in Clauses 98 to 104. It also sets out the authority’s main objective in performing those functions. The Health Research Authority will have functions in four main areas. These will be, first, functions relating to the co-ordination and standardisation of practice relating to the regulation of health and social care research; secondly, functions relating to research ethics committees; thirdly, functions as a member of the UK Ethics Committee Authority; and, lastly, functions relating to approvals for the exceptional processing of confidential patient information. The Health Research Authority’s main objective in carrying out its functions will be to protect participants, potential participants and the general public by encouraging safe and ethical research, and to promote their interests by facilitating the conduct of such research. This objective has been deliberately framed in a way that ensures that the interests of participants and the public are put first.
As I have said, research sometimes involves a degree of risk, so regulation provides participants, potential participants and the public with assurance that there are appropriate safeguards in which they can be confident. The Health Research Authority will meet the first part of its objective through the regulatory functions that this Bill confers on it relating to the regulation of health research and social care research in order to protect the dignity, rights, safety and well-being of research participants. The second part of the Health Research Authority’s overarching objective is to promote the interests of participants, potential participants and the general public in health research and social care research. The Health Research Authority will promote these interests by facilitating high quality and ethical research. This includes co-operating with others to create a unified approval process for research and to promote consistent and proportionate standards for compliance and inspection. To meet its objective of protecting and promoting participants, potential participants and public interest in research, we would expect the HRA to engage patients and the public in its work. For example, Schedule 7 would give it the power to set up committees or sub-committees which may include people from outside the Health Research Authority.
I turn now to the specifics of Amendment 58A, which seeks to make encouraging the translation of research into innovative practice a function of the Health Research Authority. First, I should like to reassure the noble Lord, Lord Collins, and the Committee that we are fully committed to encouraging the translation of research into practice. The Health and Social Care Act 2012 recognises the need to promote research and the use of research evidence and has created unprecedented powers and duties at all levels to meet that need. When it was passing through your Lordships’ House, we debated the duties that the Act places on the Secretary of State. Noble Lords will remember that the Act places a duty on the Secretary of State to promote the use within the health service of evidence obtained from research when exercising his functions in relation to the health service. The 2012 Act also places equivalent duties on the NHS Commissioning Board, now known as NHS England, and clinical commissioning groups when they are exercising their functions under the 2012 Act.
Lord Turnberg
My Lords, I am sorry to rise again, but I have a very brief question. In a clause dealing with promoting regulatory practice, why is the Secretary of State No. 1?
Earl Howe
My Lords, a great many points have been raised in this debate, so I may take a little time to respond. I hope that the Committee will bear with me. Amendments 58B to 62 seek to give the Health Research Authority a stronger role in streamlining the management of research, particularly in the NHS. I am the first to recognise that delays in obtaining research approvals in the NHS remain a problem for many researchers and that there is an expectation that the Health Research Authority will help to improve this situation through its relationship with the NHS.
I also appreciate that noble Lords, particularly in relation to Amendments 61 and 62, seek reassurance that all providers of NHS services will be required to pay attention to the guidance that the authority is required to produce under Clause 98(6). This issue was highlighted by both the Academy of Medical Sciences and the Wellcome Trust during pre-legislative scrutiny of the Bill. The clauses in the Care Bill would give the Health Research Authority a unique, free-standing duty to promote the co-ordination and standardisation of practice in the UK relating to the regulation of health and social care research. At this point I reassure the noble Lord, Lord Turnberg, that the duty of co-ordination and standardisation necessarily involves co-ordinating and standardising the practice of NHS trust research and development committees.
In addition, the Health Research Authority will have a reciprocal duty to co-operate with other regulatory bodies or individuals that have statutory functions in the regulation of health and social care research. Statutory functions are an important point. I take this opportunity to address the three amendments listed here that are concerned with this duty. In doing so, it is important to explain why Clause 98(1) would place a duty of co-operation on the HRA and in particular the Chief Medical Officer of the Department of Health. The reason is that the Chief Medical Officer holds functions relating to research under the Abortion Regulations 1991. These require notice to be given to the Chief Medical Officer of any abortion and any information relevant to it.
The disclosure of such information is restricted, except in specific circumstances, which include disclosure for the purposes of scientific research. The Chief Medical Officer is responsible for determining whether disclosure can be made. It is because of the Chief Medical Officer’s functions in approving the disclosure of information about abortions for the purposes of scientific research that the authority, the Chief Medical Officer and the bodies and individuals listed must co-operate with one another with a view to standardising and co-ordinating practice relating to the regulation of health and social care research. Similarly, other bodies and individuals listed have functions relating to the regulation of health or social care research. So it links in those statutory functions.
I listened with great care and a great deal of understanding to the noble Lord, Lord MacKenzie, my noble friend Lady Cumberlege, the noble Baroness, Lady Emerton, and others on their wish to expand the duty of co-operation to include the Chief Nursing Officer. The Chief Nursing Officer is an NHS England role, while the Department of Health has a director of nursing. Neither of these posts has any statutory functions relating to the regulation of health or social care research. That is the key point. For this reason, Clause 98(1) does not create a duty of co-operation on the HRA either with the Chief Nursing Officer of NHS England or with the Department of Health’s director of nursing and the bodies and individuals listed in Clause 98(1). I hope that this explanation is helpful.
On Amendments 58B and 58C, the medical royal colleges, the General Medical Council, the General Dental Council and the Nursing and Midwifery Council do not have such statutory functions in this context either. The noble Lord, Lord Walton, made an important and powerful point about the GMC. However, the Health Research Authority would have powers, under paragraph 13 of Schedule 7, to work with the GMC and the other medical regulators to help and advise them in their work. That, I hope, will reassure the noble Lord that that aspect of the HRA’s work has not been forgotten about.
Amendment 60A would require the Health Research Authority to assess the impact of proposed changes to the system for setting pharmaceutical prices on health and social care research. I pay tribute to the noble Lord, Lord Hunt, for introducing this extremely interesting topic to our debates. I believe that this function is best undertaken by the National Institute for Health and Care Excellence rather than making it part of the authority’s role in promoting the co-ordination and standardisation of regulatory practice. As he will know, we have already announced that NICE will play a central role in the pharmacoeconomic evaluation of new medicines in the context of the framework for value-based pricing, once that is announced.
The noble Lord made a point about value-based pricing, in that it is important for the Government—I agree with him—to take account of the need to attract investment into this country. As set out in our plan for growth and our Strategy for UK Life Sciences, the Government are absolutely committed to ensuring that the UK continues to offer an environment that supports and encourages investment and innovation by the life sciences sector, and where the NHS is a world leader in clinical trials. However, there are some legitimate points of debate here about the impact of medicine prices on companies’ decisions on where to locate investments or conduct research. As highlighted in the 2007 NERA study, Key Factors in Attracting Internationally Mobile Investments by the Research-Based Pharmaceutical Industry, this is a global market. Companies locate where they can find the best science base at reasonable cost, taking into account other factors such as taxation, flexible labour markets and economic stability. It is not self-evident that the pricing of medicines drives decisions of this kind. It is an interesting debate to have, but perhaps it is one for another occasion.
The noble Lord also asked about the cancer drugs fund. It is very heartening that more than 30,000 patients in England have now benefited from that fund, which in total amounts to £650 million over three and a half years. We are committed to building on that success. In the context of developing new pricing arrangements for branded medicines, I can reassure the noble Lord by saying that we are exploring ways in which new patients can benefit from innovative cancer drugs at a cost that represents value to the NHS. NHS England is very much included in that discussion, and we well appreciate how important it is for patients.
To meet the duty of co-operation in this whole area, the Health Research Authority will be required to take the lead in actively identifying ways in which to remove duplication, streamlining the regulation of health and social care research and seeking to ensure that regulation is proportionate. At this point, I reassure noble Lords that the authority must facilitate all types of high-quality ethical research, including research that is multidisciplinary in nature and research by multiprofessionals. In keeping under review matters relating to the regulation of health or social care research, the authority may provide advice to the Secretary of State and must do so on request. Such advice could include recommendations to improve the regulatory landscape for research.
The existing Health Research Authority, the Special Health Authority, has already begun an ambitious programme of work to speed up the research journey in the UK, including the creation of a unified approval process and consistent, proportionate standards for compliance and inspection. I hope that will be welcome news to the noble Lord, Lord Patel, in particular. In doing so, it is working closely with other bodies, including representation from the NHS, to identify and implement effective solutions to make it faster and easier to initiate research.
Baroness Emerton
I return to Amendment 59 and thank the Minister for explaining that there is no statutory requirement in this regard relating to the Chief Nursing Officer or the director of nursing. In the light of the comments that have been made about research and nursing this afternoon, will the Minister look at how we can take forward nursing research? If the structure is wrong for NHS England and the director of nursing for public health, where can we fit in a statutory requirement for research to be included? We cannot go on without having a means of recognising the importance of evidence-based practice based on research.
Earl Howe
My Lords, I heard very clearly a strong message from noble Lords on that point. Indeed, I recognised the noble Baroness’s strength of feeling in our earlier debates on Health Education England. Having noted that strength of feeling, I would like to engage with noble Lords between now and Report to see what avenues we can pursue in this area. I cannot make a specific commitment now, but I am very happy to talk further about these issues.
Lord Turnberg
I bring the noble Earl back to Amendment 60 on the research and development committees of NHS trusts. He made some very reassuring comments about the work that is going on in the HRA to try to unify this area. One of the difficulties at the moment is that the foundation trusts are a law unto themselves to a large extent and jealously guard their independence. I wonder whether we need to strengthen the HRA’s arm by including something about this area in the Bill.
Earl Howe
I understand the issue that the noble Lord has raised. There are a number of ways of exercising leverage on foundation trusts, if I can put it in that rather impolite way. One of them relates to the funding from the National Institute for Health Research. The noble Lord may well be aware that as from 1 April that funding is conditional on the 70-day timeline for the recruitment of the first patient into a trial. If that timeline is not met, the funding does not follow. I can tell the noble Lord that that has concentrated minds rather effectively across the health service, including in foundation trusts, towards achieving a much more efficient and effective decision-making process.
I am aware that I did not answer a question from the noble Lord, Lord Patel, about rationalising the number of research ethics committees, which may well bear upon this issue in another sense. The HRA and its predecessor have made good progress in reducing the timelines for ethical approval, something that stakeholders have recognised. The current special health authority feasibility study is looking at how to address other delays whereby trust decisions can be made based on their capacity and capability to take part in research. This is ongoing work. I come back to my point about the core function of the HRA, which is, above anything else, to protect the interests of patients and the public. It might not be advisable to load on to it too many other roles that could detract from that core function.
Lord Hunt of Kings Heath
My Lords, I am grateful to the noble Earl for that comprehensive response. I cannot help thinking that in order to protect the patient and the public there must be recognition that high-quality research is one of the best ways to enhance the quality of patient care. I remain concerned that bodies in the NHS still do not understand the importance of getting their act together in research approval. That does not mean that they do not have to go through a thorough process, because there clearly has to be a rigorous process to protect the public. I would like to see stronger language in the Bill that essentially allows the HRA to intervene if undue delays take place. I hope that we can return to that on Report.
I am grateful for the noble Earl’s comments on value-based pricing. All I would say to him is that I have been disappointed that there has been a great lack of public debate on this matter. I know that the department is shortly to publish further work. It is essential that these ideas are tested, and I am concerned that this is going to be simply a matter of negotiation between his department and the industry without there being a wider discussion of the implications. I appeal to the noble Earl for some opportunity on that.
Finally, the Minister has made it clear that the list in the clause represents bodies concerned with regulation, and that is now well understood. I come back to the question raised by the noble Baroness, Lady Emerton: is there not a case for another clause stating that there is a general duty of co-operation? There is an argument that while, of course, you have your statutory regulators which need to co-ordinate their efforts, you also want a lot of organisations and people to be involved, including the Chief Nursing Officer and the Director of Nursing at the department. I put that forward as a suggestion and beg leave to withdraw the amendment.
Baroness Thornton
My Lords, it is a great pleasure to be back on the Front Bench as part of my noble friend’s health team, even if it is for a short time. I join other noble Lords in sending best wishes to the noble Lord, Lord Willis, for a speedy recovery.
As noble Lords will know, I have been interested in the future of the HFEA and HTA both as a Minister and during the course, in the early days of this Government, of the slash and burn Public Bodies Act, which both these bodies survived. The idea of merging the HFEA and HTA is not new, as my noble friend Lord Warner said, and has been rejected on more than one occasion. I am puzzled by the noble Lord, Lord Patel, raising it now, especially in the middle of yet another review. What I waited to hear, particularly from noble Lords with scientific and research backgrounds, was what the public thought. The right reverend Prelate was right when he said that this is also about how people feel about these issues, not just how the great doctors and scientists think things should be done. In fact, that was how we started out with all these issues.
As my noble friend Lord Warner said, this was first raised by my Government. We proposed establishing a new arm’s-length body called RATE—the regulatory authority for tissue and embryos. According to my research, in 2007 the Government wisely decided not to proceed with that following criticism from a Joint Committee set up to scrutinise that draft Bill. The arguments advanced against RATE then were just as persuasive as they are today. Many of us have held that there is little overlap in the work of the two bodies and that the specialist expertise each provides should be maintained to ensure that regulation remains effective and public confidence is maintained. The discussion we have had so far today has not convinced me that this proposal is the best way forward at the moment. The independence of the HTA and HFEA is important for a number of reasons, not least because of the public confidence needed in both the areas they cover.
In 2010, the Government proposed as part of their bonfire of the quangos that the functions of the HFEA and the HTA should be transferred largely to the CQC. Noble Lords will remember the debate about that during the passage of the Public Bodies Act. Following an extensive public consultation, that proposal was also rejected by the Government in January this year. Once more, a clear majority of those who responded thought that the risks involved in such sensitive areas of medicine were just too great. Instead, the Government decided that an independent review of the way the HFEA and HTA carry out their functions should be undertaken by Justin McCracken. I understand that Mr McCracken’s review is complete and Ministers have yet to decide what to do. Perhaps we will have a sneak preview of that today.
Is there new evidence that there is an advantage in merging these two distinct and expert organisations? As I said, they have different roles. According to the brief I was sent, there are fewer than 10 organisations jointly regulated by both organisations. As context, around 130 organisations are regulated by the HFEA and 800 by the HTA across diverse sectors. On these Benches we are nervous that the amendment tabled by the noble Lord, Lord Patel, to merge the boards of both these organisations risks losing specialist expertise held by the HTA and HFEA and the unique roles in law that their respective boards have.
During the committee scrutiny of the Bill in its draft form—as the Care and Support Bill—the committee advised against a full merger of the boards. In its call for evidence, the committee asked for views on precisely this question. As far as I know, respondents unanimously opposed the abolition of either body or the transfer of their functions. The Academy of Medical Sciences replied:
“There is a great deal of support among our community for the HFEA and the HTA; both are perceived as having developed the experience to respond in a balanced, practical way to the changing landscape that reflects the evolving risks and benefits of research. The relatively small savings to be made through disbanding the HFEA and the HTA need to be balanced against the inevitable period of disruption and uncertainty, and any potential risk of loss of expertise, efficiency, effectiveness and coherence that could hinder research and practice and result in the loss of public and professional confidence … We therefore support retaining both the HFEA and the HTA, providing they work closely with the HRA and other regulators to further streamline the regulation, inspection and governance process for patient and public benefit”.
I accept precisely the point made by my noble friend Lord Winston and others that there are unnecessary delays and that there are clearly issues to be addressed in the way that these bodies operate.
The committee concluded that Ministers should not have the power to abolish the HFEA or HTA and recommended that the relevant clause should be deleted. While its conclusions were about abolition, these same points apply to the merger of the boards: expertise would be lost, there would be huge disruption and all for relatively tiny cost savings at the moment. The work of the HTA and HFEA is of enormous scientific and ethical importance. We accept entirely that there is always room for improvement and we should never be complacent. The review led by Justin McCracken will no doubt make recommendations for further efficiencies. We would be jumping ahead of his proposals by agreeing this amendment at this time.
Earl Howe
My Lords, this has been a very instructive debate and one to which I have listened with enormous care and interest. It takes us back to a well-worn area, as noble Lords have been keen to point out. The amendment proposed by the noble Lord, Lord Patel, would abolish the HFEA and HTA and replace them with a new regulatory body, the human tissue and embryo authority. It would also transfer responsibility for the regulation of infertility treatment involving embryos, sperm and eggs to the CQC.
I listened with great care, as I always do, to the noble Lord, Lord Patel, when he moved the amendment. As has been amply demonstrated in the course of this debate, the prospect of the merger of the HFEA and HTA, or of the transfer of their functions elsewhere and the subsequent abolition of the two bodies, is by no means a new one. It has been considered carefully and consulted on on a number of occasions over recent years, including by Members of this House.
In 2007, as we were reminded, a Joint Committee of both Houses of Parliament, chaired by my noble friend Lord Willis, considered a proposal to replace the HFEA and HTA by the regulatory authority for tissue and embryos—RATE. The committee roundly rejected that proposal. It recognised concerns expressed by stakeholders about the risk of losing the specialist expertise that the HFEA and HTA individually hold and the small extent to which the two bodies actually cover common ground. That point was made very powerfully by the noble Lord, Lord Walton, today.
The Government are as keen as anybody to minimise the number of arm’s-length bodies when we possibly can. A substantial exercise was undertaken across government when the coalition was new to do exactly that and a great number of bodies were abolished. Within that framework, last year the Department of Health undertook a public consultation on a proposal to transfer the functions of the HFEA and HTA to the Care Quality Commission and the Health Research Authority, as part of our review of the arm’s-length bodies. Across the full range of respondents, a majority of three-quarters disagreed with the proposal. The main reason cited was that the HFEA and the HTA have developed considerable expertise in their highly specialised fields. They were said to be trusted and respected by the regulated sectors. Respondents believed that this expertise and trust would be lost were a transfer of functions to take place. That point was well made by the noble Baroness, Lady Thornton, who I am delighted to see on the Front Bench opposite. The noble Lord, Lord Patel, indicated that in his view it was unnecessary to have two separate organisations, but that was not the view of those who responded to the consultation.
Respondents also said that they did not believe that the CQC was well-placed at the time to take on the functions of the two bodies and they feared that those functions would be subsumed by the CQC’s other responsibilities. Another strong message from the consultation was that the small size of the two bodies and the small overall anticipated savings did not warrant the risks involved in abolishing them and transferring their functions. I recall that the noble Lord, Lord Warner, made that very point when we debated these issues during the passage of the Public Bodies Bill. The Government listened to the responses and decided not to proceed with the transfer and abolition. However, we also recognised the clear message from the consultation that there is scope for the HFEA and the HTA to achieve further efficiencies in the way that they operate. That much, I hope, all noble Lords agree on.
The noble Baroness, Lady Thornton, asked whether there was any new evidence about the value of a merger. It was with that very question in mind that we commissioned an independent review of the two bodies by Justin McCracken, former chief executive of the Health Protection Agency, in January this year. The review included looking at the scope for shared membership and leadership of the HFEA and HTA and for their merger. The report of the review was submitted to Ministers in April and is currently under consideration, so I am afraid that I am not in a position to share any conclusions quite yet. I will give way.
Earl Howe
I sincerely hope and anticipate that we will, but I am afraid I do not have a particular date in my brief. If I am able to supply the noble Baroness with that information, I will be happy to do so. The noble Lords, Lord Winston and Lord Patel, cited the number of different regulators involved in the organisational arrangements and the regulation of regenerative medicine in the UK and pointed to the complexity of these arrangements. I understand that point of view, but we are now in a world where the regulators in this area work very closely together to provide regulatory clarity to the sector and to ensure that the system actually works. I know, for example, that the MHRA and the HTA work closely together and have carried out joint inspections.
The department, along with the UK regulators, worked together to produce a regulatory map for stem cell research and manufacture, and I think that too has been helpful. I fully understand and appreciate the interest of noble Lords in this matter and their desire to streamline regulation. We all welcome that aim. I hope that noble Lords will appreciate that the Government have given this matter consideration in some depth, including through public consultations. The strong message we have consistently received from stakeholders is that the HFEA and the HTA should not be abolished or merged or their functions transferred elsewhere. Our latest consideration of this is the scope for regulatory streamlining that the McCracken review looked at, including the scope for regulators to work closely together. That consideration is currently taking place. As soon as the Government’s position on it is determined I will ensure that noble Lords are informed. I am additionally told by a most reliable source that we do not yet have a confirmed date for that announcement.
I am always loath to disappoint the noble Lord, Lord Patel, but I hope he will understand that we did not reach this position without due deliberation and indeed without taking extensive soundings among the stakeholders who are most concerned in this area. I hope he will feel, if not exactly comfortable in withdrawing his amendment, at least satisfied that the matter has been fully debated.
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?
Earl Howe
My Lords, in addressing this complex and very important topic, I begin by thanking all noble Lords who have spoken in this debate, not least those who have introduced the amendments they have tabled. I welcome the opportunity to debate these clauses as they form a key part of our response to the issues raised by Robert Francis QC. They deal with difficult issues and I recognise the critical importance of getting this right. I particularly welcome the support of the noble Lord, Lord Hunt, for the principles, which I can assure him have governed the Government’s work in this area.
The intention of the changes we are making is to deliver a strong but flexible process for tackling quality failures to ensure that all NHS trusts adopt a rigorous approach to maintaining high quality care. I hope that noble Lords have had an opportunity to familiarise themselves with the document my department published, in collaboration with CQC, Monitor, the Trust Development Authority and NHS England, copies of which can be found in the Library. In my response to the amendments, it may help if I summarise the key elements of our proposals and why we feel that the approach we have taken is appropriate.
The Francis report made a strong case that the regulation of NHS trusts and foundation trusts needed to change so that greater emphasis is placed on addressing failures of quality. We agree. In future, roles within the regulatory system will be simpler and clearer. The Care Quality Commission will focus on assessing and reporting on quality, and Monitor and the NHS Trust Development Authority—the TDA—will be responsible for using their enforcement powers to address quality problems. To free up time to care, the overall regulatory burden on providers will be radically reduced. I remember that that concern was raised from the Benches opposite when I made a Statement to your Lordships on the Francis report. However, where there are failings in the quality of care, there will be a stronger response.
The CQC, through its new Chief Inspector of Hospitals, will become the authoritative voice on the quality of care provided. It will take the lead in developing a methodology for assessing the overall performance of organisations in meeting the needs of patients and the public. In doing so, the CQC will consult a range of bodies, including Monitor, the TDA and NHS England, to ensure that national organisations are working to a common definition of quality. The idea here is to arrive at, if I can put it this way, a single version of the truth: a single, national definition of quality that brings together information and intelligence from commissioners, regulators and local Healthwatch, as well as from the other bodies I mentioned. This new approach to assessment and inspection will form the basis of a new system of ratings to provide a fair, balanced and easy to understand assessment of how each provider is performing relative to its peers. It will also provide the basis for identifying where improvements are needed. We will, of course, debate the provisions on ratings later on.
The noble Lord, Lord Hunt, has tabled a number of amendments—Amendments 64A, 66ZB, 66ZD and 66ZF—relating to the consistency of CQC’s judgment. I understand the concern to ensure that there is transparency and consistency over how decisions to intervene are reached, but I am not sure that it can be defined through legislation. In part, it will be for the CQC, Monitor and the TDA to agree and set out in guidance—something, incidentally, they have all committed to doing. However, ultimately they must be matters of judgment rather than the tick-box mentality that allowed the failures uncovered in Mid Staffordshire to go unnoticed for so long.
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.
“( ) In subsection (4) of that section, for “the reference in subsection (1) to the Secretary of State is to be read as a reference” substitute “the references in subsections (1) and (3A) to the Secretary of State are to be read as references”.
( ) In paragraph 24 of Schedule 14 to the Health and Social Care Act 2012 (abolition of NHS trusts in England: consequential amendments to section 65N of the National Health Service Act 2006), after sub-paragraph (2) insert—
“(2A) In subsection (3A), for “the Secretary of State” substitute “the regulator”.””