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Lord Collins of Highbury
“( ) The HRA shall also have the function of encouraging the translation of research into innovative practice.”
Lord Collins of Highbury
My Lords, in Amendment 58A, in addition to conducting and promoting health and social care research, we are seeking to give the Health Research Authority the ability to encourage this research to be translated into innovative practice.
On Monday, in a debate on amendments to Health Education England, many noble Lords highlighted the need to place research at the centre of what the NHS does. Under the Health and Social Care Act, Labour fully supported placing duties on the Secretary of State, the National Commissioning Board and CCGs to promote research. Indeed, my noble friends Lady Thornton and Lord Hunt supported amendments to the Bill reinforcing the importance of research.
In Monday’s debate, my noble friend Lady Wheeler reminded us of the concerns and frustration at the often painfully slow, complex and bureaucratic process of getting innovation in care and treatment adopted in the NHS. I suspect that the noble Earl shares this concern as in the debate in this House last January he reminded us that it took an estimated 17 years for only 14% of new scientific discoveries to enter day-to-day clinical practice. On Monday, too, my noble friend Lord Turnberg referred to the vision for research in the NHS contained in the recent publication of the Association of Medical Research Charities. In this vision, every patient should be offered the opportunity to be involved in research; all staff should be made aware of the importance of research; and the NHS should conduct high quality research and adopt innovation in healthcare rapidly. The purpose of the amendment is to achieve a joined-up approach in reaching these objectives so that when research is commissioned these principles are absolutely borne in mind. I look forward to hearing the Minister’s response.
With regard to Clause 97 standing part of the Bill, I should like to refer the noble Earl to paragraph 8 of the first report this Session of the Delegated Powers and Regulatory Reform Committee. The committee expressed concern over the Secretary of State’s powers to amend the main functions of the Health Research Authority. If, as suggested, they were needed to meet the obligations of an EU directive, an appropriate amendment could be made by exercising powers under Section 2(2) of the European Communities Act 1972. If that is the case, perhaps the noble Earl could explain why the Secretary of State needs these extra powers.
It is a long time since I completed my British Government A-level. I recall how Henry VIII clauses can give powers to delegated legislation to amend or repeal Acts of Parliament. However, I did a little more recent research and found reference to the 1932 Committee on Ministers’ Powers. One quote from its report is particularly relevant. A member said that, whether good or bad, delegated legislation is inevitable. It is,
“a necessary evil, inevitable … But nevertheless a tendency to be watched with misgiving”.
I look forward to the noble Earl’s further explanation as to why the Department of Health believes that these powers are necessary.
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 Collins of Highbury
I thank the Minister for that response. I agree with him that we have to see this in the round. We were trying to pick this up as an objective rather than as a specific function so that in its work the HRA could see the benefits of ensuring that research was implemented in a way so as to change practice. In relation to Clause 97 standing part of the Bill, I again hear what the Minister has said. I was rather hoping for a detailed reference to Henry VIII in his response but that was not forthcoming. We will need to watch this matter carefully. I look forward to seeing the Government’s response to the committee’s report. In the light of that, I beg leave to withdraw the amendment.
Lord Hunt of Kings Heath
“( ) the Medical Royal Colleges;”
Lord Hunt of Kings Heath
My Lords, Clause 98 concerns a duty of co-operation with the Health Research Authority. That is of course absolutely supported. My Amendments 58B and 58C would insert into the list of organisations,
“Medical Royal Colleges … the General Medical Council, the General Dental Council and the Nursing and Midwifery Council”.
I have no doubt that the noble Earl will warn me of the dangers of this, but in a sense his own department has provoked it by putting a list into the Bill. Inevitably, we looked at that and wondered why some organisations were missing. I realise that Clause 98(1)(i) allows flexibility by regulations to add to the list and I am sure that that flexibility is welcome, but we should get this right in the first place. I find it difficult to understand why, for instance, the medical royal colleges are not listed. They have a vital role to play in this area.
Similarly, I support the noble Baroness, Lady Emerton, in her Amendment 59. I am sure she will speak to that in a moment. If the Chief Medical Officer is named, why is the Chief Nursing Officer not? I know there has been concern over the years about the position of the Chief Nursing Officer. The last Government as well as this one have debated this issue. Given that we wish to see an extension of research into nursing and clinical areas because of the absolute importance of enhancing the quality of nursing, it is disappointing that the Chief Nursing Officer is not listed.
I also support Amendment 61 from the noble Lord, Lord Willis, which takes the responsibility in Clause 98(7) of local authorities and NHS trusts to have regard to guidance from the HRA on good practice in research and extends it to other providers, including the private sector. These are important amendments as a whole. It is important that the Bill is informed and improved.
On my Amendment 61A, I am puzzled that in Clause 98(7) the requirement is only to have regard to HRA guidance. Surely that should be strengthened, as in my amendment, which says that guidance “must” be followed,
“unless there is good reason not to do so”.
I have taken advice on this matter. The noble Earl will know that there has been a problem over the years in getting approval for multicentre trial research. I understand that the research ethics committees have improved their performance in recent years, and that is to be welcomed, but we now apparently have the problem with some NHS trusts and foundation trusts. Of course, as this is the start of another Committee day, I ought to declare my interests as the chair of a foundation trust and as a consultant and trainer with Cumberlege Connections. It is disappointing if individual NHS organisations are holding up multicentre research, for all the reasons that we know about: UK plc and the need for us to ensure that there is greater investment in research in the UK. I want some assurance that if there is undue delay, the HRA will be able to intervene and ensure that NHS organisations get on with giving the necessary approval.
On Amendment 60A, health research capacity in the UK is of course one of our strongest assets. It includes pharmaceuticals and medical devices, and takes place in our medical schools and hospitals. World-class research is undertaken here, frequently with outstanding results, yet we consistently fail to exploit that research when it comes to its translation into practice. How many other countries have exploited research undertaken in this country? I very much welcome the establishment of academic health science networks, which are responsible for encouraging much closer links between research and health service practice.
However, there is much more to be done. I would like the HRA’s objectives to include encouraging innovation and practice. It is important that the HRA is in a position to advise the department on potential policies that might have an impact on the scale of research and development in the UK. One such example is the present intention to move away from the current pharmaceutical price regulation scheme method of reimbursing pharmaceuticals. I know that the Government are committed to the introduction of value-based pricing. I always try to tempt the noble Earl to debate in your Lordships’ House the introduction of value-based pricing, principally because very few people understand what it involves. Even having been the Minister who received the original report on it, I must say that I am still in the dark as to exactly how it will unfold.
My key question is this. I know that the PPRS approach is not perfect and that at regular intervals Governments negotiate it downwards, but it has always given flexibility to the industry to price new-licence medicines as it wishes within a profit cap. The advantage of that flexibility is that many new drugs are launched in the UK rather than in other countries. I would like to hear from the noble Earl that the introduction of value-based pricing will not have an impact on the willingness and ability of pharmaceutical companies to continue launching products in the UK. I believe there is a link between the launch of products and investment in R&D in this country.
I may strain the patience of the House, but while I am talking about pharmaceuticals it is tempting to ask the noble Earl about the implications for the cancer drug fund. He knows that the intention was for that fund to become obsolete with the introduction of value-based pricing. However, cancer charities that I have met believe that value-based pricing will apply primarily to new active substance licences from 2014, and will therefore have limited impact on treatments made available through the fund. Will the noble Earl comment, or perhaps write to me, with an assurance that, before firm proposals are made on this issue, full consideration will be given to the impact of value-based pricing on the cancer drug fund, its continuation or potential substitution? I beg to move.
Lord Turnberg
My Lords, I strongly support my noble friend in Amendments 58B, 58C and 59. This clause is about taking note of the regulation and the regulation of research activities, but not of people who are engaged in research. It is important to involve those who regulate the professions—the General Medical Council, the General Dental Council, the Nursing and Midwifery Council—as well as the nurses. I agree entirely with the statement that the nurses should be included. In saying this I should also mention the pharmacists, who play an important part in research. I have been approached by those involved in pharmacy regulation to indicate that they also have an interest here.
I wish to speak particularly to Amendment 60, which is in my name, and to Amendments 61 and 62. On Amendment 60, I emphasise the important part played by the local R&D committees of NHS trusts, which the noble Lord, Lord Hunt, mentioned. We now have the Health Research Authority, which is doing a really remarkable job in speeding up the process for approval of research by bringing together the different research ethics committees and the special ethical approval for research, using data where patients are no longer able to give consent. It has developed a single portal of entry and a single application, which is having an enormously helpful effect, but there remains one major hurdle in the way of those trying to carry out multicentre clinical trials: the local R&D committees of NHS trusts. Some are good and speedy while others are slow and capricious, and the whole clinical trial is determined by the slowest and most capricious of those who have to give approval.
When the Academy of Medical Sciences reviewed research regulation, it identified the local R&D committees as the most difficult and time-consuming concerned, with delays of almost a year in too many instances, so in Amendment 60 we are trying to give the HRA the responsibility of rationalising and improving the approval processes in R&D committees. If it can get the approval of all trust R&D committees to rely on and accept a single robust assessment, covering all their various concerns, it will not only relieve them of that burden but give them the confidence that the review has been properly performed. It will also speed up the process for researchers. I hope that we can include this message in the Bill at a time when I know that the HRA itself is working hard to achieve it. The amendment is simply intended to offer it the support that it needs for its efforts.
Amendment 61, in the name of the noble Lord, Lord Willis, who unfortunately still cannot be with us, gets at the problem of ensuring that all providers of services for the NHS, including the private sector, should have the same responsibilities for research and innovation as the rest of the NHS. The HRA should have a role in ensuring that they do. It is important that their staff have opportunities to engage in research; certainly, they should be encouraged to introduce innovation into their practice.
Amendment 62 is also in the name of the noble Lord, Lord Willis. We welcome the explicit mention of the responsibilities of NHS trusts in the Bill. However, there is further need to ensure that trusts not only have regard to guidance issued by the HRA but actively comply with such guidance. I would welcome further clarification of how the requirement to have regard to such guidance will be ensured and how trusts’ compliance with such guidance might be strengthened.
Lord Walton of Detchant
My Lords, I was uncertain whether to speak on these amendments in the presence of two past presidents of medical royal colleges, the noble Lords, Lord Turnberg and Lord Patel. I feel unable to support Amendment 58B because the medical royal colleges are not regulatory bodies. They are essentially educational bodies. They play a role in producing and monitoring the standards of qualifying examinations for those seeking to be specialists, but they are essentially educational and do not have a regulatory role, although, of course, they play an important part in advising on a whole range of health service issues.
However, I believe it is right that Amendment 58C should be inserted, because the bodies mentioned are regulatory authorities. The General Medical Council, for instance, can play a crucial and important role in disciplining doctors who have been found guilty of fraud and misconduct in medical research. This is very relevant to the qualities and responsibilities of the HRA, and for that reason I believe it right for this amendment to be included in the Bill.
Baroness Emerton
I rise to speak to Amendment 59 which includes the Chief Nursing Officer in the list of those participating in the authority. I thank the noble Lord, Lord Hunt, for his words on this point. I have raised the issue of the importance of evidence-based practice and the need for us to be able to develop research within the nursing profession where, to date, it has not been at the forefront of progress. Having the Chief Nursing Officer taking part in the work of the research authority, although perhaps not in its detailed content, will assist in raising the profile of the importance of research. It may well be delegated from the CCGs to the health trusts, where we may see professors of research, which will then encourage research throughout. The nursing profession is the largest single workforce within the NHS. It is important that we promote the idea and development of research by having the Chief Nursing Officer in the list.
While on this subject, it is encouraging to see the list in the Bill. When the Health Bill was introduced, health education was not included and the membership of Health Education England was not clearly set out. Although it does not relate to research, I would like to mention the importance of having an executive nurse on the health education board, because there is an executive doctor, but not an executive nurse. Perhaps I can return to this when we come to Report.
Lord MacKenzie of Culkein
My Lords, I rise briefly to speak to Amendments 58C and 59. The noble Lord, Lord Hunt, and the noble Baroness, Lady Emerton, rightly referred to including nursing in the Bill.
As the noble Baroness, Lady Emerton, said, the practice of nursing these days is underpinned by research. Of necessity, nurses are involved in research, and it must be right to include the Nursing and Midwifery Council and the Chief Nursing Officer in the Bill.
In debates on the Bill, we have heard a number of times that it is all too easy to exclude nurses. Whatever body they should be represented on, they so often are not there. I can go back, probably the better part of 40 years, maybe more, to when I once had the temerity to ask my matron to raise something at the hospital management committee. She said to me, “I’m sorry, nurse, I can’t, because I only attend by invitation of the group secretary”.
There have probably been about 20 reorganisations—I forget how many—since those days. However, all too often the situation has not changed and nurses remain excluded. The reason for excluding them, very often, is that the legislation does not cover it and therefore it is not necessary for nurses to be included. We now have the opportunity. Let us have nursing in the Bill. If we are going to have lists, as the noble Lord, Lord Hunt, said, I want to see nurses in it. I hope that the Committee will support that.
Baroness Cumberlege
My Lords, I strongly support the amendment tabled by the noble Baroness, Lady Emerton, and am very interested in what the noble Lord, Lord MacKenzie, said. It seems that, over the years, nursing has been the poor relation when it comes to promoting the medical profession. Both are so important, and they have to work together. If the Francis report tells us anything, it is that we need to ensure that both are of a very high quality.
I asked the Royal College of Nursing today to give me some examples of research that nurses are doing. I will not try the patience of the Committee by going through them, but it gave me three extremely good examples which undoubtedly improve the quality of patients’ experiences and recovery rates. This work is going on, but it really should be of a higher profile. It should be applauded and used. I appreciate very much what the noble Lord, Lord Hunt, said about lists, which are a trap that I remember falling into on occasions when I was a Minister. I suspect that the noble Earl will tell us that we want to have it both ways: sometimes we want things in regulations because that is more flexible and at other times we want them in the Bill. This is something of a dilemma, but if the medical profession is in the Bill, nursing certainly should be as well.
I also strongly support Amendment 60, in the name of the noble Lord, Lord Turnberg. I was very interested to read about the delays that occur through not getting together all the different organisations that are going to be involved in a single trial. According to Kidney Research UK, the time taken in one trail to receive R&D permission varied from around five weeks to 29 weeks. A study of stroke survivors took between one week and 35 weeks to receive permission from the NHS trusts involved. The time taken between submission of site-specific information and NHS approval ranged from five weeks to 50 weeks for a multi-centre trial comparing two types of emergency intervention for ruptured aortic aneurysm. This is totally unacceptable. Those who are promoting the research, and are the leaders in it, must get so frustrated when the bureaucracy will not allow them to go ahead. We need good research. It makes a huge improvement to patients’ lives, especially, of course, when it is translated to the patient in the bed, as it were. Anything that we can do to speed this up and to put pressure on to ensure that the time lags are not as long as this would be very much welcomed.
Lord Patel
My Lords, I rise to support Amendments 59, 60, 61 and 62, to which I have put my name. It was very clever of the noble Lord, Lord Hunt of Kings Heath, to have an amendment about the medical royal colleges lead to a discussion on value-based pricing and the cancer drugs fund. I am tempted to have that debate because it may be much more interesting; it is an issue that we should debate at some stage. In responding to the previous amendment, the noble Earl highlighted the Government’s strong backing for life sciences. When we talk about value-based pricing, we must consider how we could reimburse cell-based therapy, which is not drug therapy, at what stage in the development of cell-based therapy reimbursement should kick in and what value would be put on different stages. That would be a good debate to have.
Moving on from that, I strongly support the amendment tabled by the noble Baroness, Lady Emerton, on the inclusion of the Chief Nursing Officer. I also support her in asking why Health Education England does not have a nurse education director. If the nursing workforce is the largest health workforce in the NHS and does not have a nurse education directive, something is missing and needs to be replaced.
Baroness Jolly
I will speak briefly in support of Amendments 59, 61 and 62. We have had this debate about lists—sometimes they are good, and sometimes not. There is no way of knowing when they are good and when they are not. However, I welcome the additions suggested in the amendments, in particular the amendment in the name of the noble Baroness, Lady Emerton, on the Chief Nursing Officer. That is absolutely critical. Everybody knows about doctors, but the amendment sends out the key message that nurses play a role in collecting an evidence base to improve care for patients. That is very important. I have seen some very nice research done by nurses, who work in the community, about care. That really makes a difference and, of course, it is then shared among their colleagues.
I will also speak briefly to Amendments 61 and 62, in the name of my noble friend Lord Willis. These are about the guidance that the HRA produces and who should pay heed to it. Here we have a mini-list, but the not-for-profit and private sectors were missing from it. Anybody who does work for the NHS should be included. The wording should be strengthened from “have regard” to “comply with”. It currently makes no sense whatever. I would be grateful if the Minister can confirm that.
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.
Lord Patel
“Human Tissue and Embryo Authority
(1) There shall be a body corporate called the Human Tissue and Embryo Authority.
(2) The Authority shall consist of—
(a) a chairman and deputy chairman, and(b) such number of other members as the Secretary of State appoints.(3) The Authority shall keep proper accounts and proper records in relation to the accounts and shall prepare for each accounting year a statement of accounts.
(4) The annual statement of accounts shall comply with any direction given by the Secretary of State, with the approval of the Treasury, as to the information to be contained in the statement, the way in which the information is to be presented or the methods and principles according to which the statement is to be prepared.
(5) Not later than five months after the end of an accounting year, the Authority shall send a copy of the statement of accounts for that year to the Secretary of State and to the Comptroller and Auditor General.
(6) The Comptroller and Auditor General shall examine, certify and report on every statement of accounts received by him under subsection (5) and shall lay a copy of the statement and of his report before each House of Parliament.
(7) The Secretary of State and the Comptroller and Auditor General may inspect any records relating to the accounts.
(8) In this section “accounting year” means the period beginning with the day when the Authority is established and ending with the following 31st March, or any later period of twelve months ending with the 31st March; and Schedule 1 to this Act (which deals with the membership of the Authority, etc) shall have effect.
(9) The Authority shall prepare—
(a) a report for the period beginning with the 1st August preceding the day when the Authority is established (or if that date is a 1st August, beginning with that date) and ending with the next 31st March, and(b) a report for each succeeding period of 12 months ending with 31st March.(10) The Authority shall send each report to the Secretary of State as soon as practicable after the end of the period for which it is prepared.
(11) A report prepared under subsection (9) for any period shall deal with the activities of the Authority in the period and the activities the Authority proposes to undertake in the succeeding period of twelve months.
(12) The Secretary of State shall lay before each House of Parliament a copy of every report received by him under subsection (10).
(13) The following provisions of the Human Fertilisation and Embryology Act 1990 are repealed—
(a) sections 5 to 10, and(b) section 11(1)(a) and (aa).(14) Save for the provision in subsection (13), references in the Human Fertilisation and Embryology Act 1990 to “the Authority” shall be taken to be references to the Human Tissue and Embryo Authority.
(15) The Care Quality Commission may grant the following licences—
(a) licences under paragraph 1 of Schedule 2 to the Human Fertilisation and Embryology Act 1990 authorising activities in the course of providing treatment services,(b) licences under paragraph 1A of that Schedule authorising activities in the course of providing non-medical fertility services.(16) Sections 12, 13 and 13A of, and paragraph 4 of Schedule 2 to, the Human Fertilisation and Embryology Act 1990 have effect in the case of all licences granted under subsection (15) as they would do for licences granted under that Act.
(17) Section 13 of the Human Tissue Act 2004 is repealed.
(18) Save for the provision in subsection (17), references in the Human Tissue Act 2004 to “the Authority” shall be taken to be references to the Human Tissue and Embryo Authority.
(19) In Schedule 5 (power to modify or transfer functions) to the Public Bodies Act 2011 omit—
(a) the entry for the Human Fertilisation and Embryology Authority, and(b) the entry for the Human Tissue Authority.”
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.
Lord Walton of Detchant
My Lords, it pains me to oppose this amendment because the noble Lords, Lord Willis, Lord Patel and Lord Winston, are people for whom I have the highest possible regard. Each in their own way has made outstanding contributions to issues relating to medicine and science in your Lordships’ House. Almost invariably, we have found ourselves singing the same tune, if perhaps sometimes in slightly different keys. Having said that, however, I am opposed to the amendment because I thought that this battle had been won two years ago. Admittedly, when this Government came into office, they embarked on what they called the “bonfire of the quangos”. A huge number of quangos were abolished, but after careful consideration and an attempt to merge these two bodies, the decision was made that they should continue to function independently.
Let me give my reasons for taking this view. When I came to this House in 1989, my baptism of fire was the Human Fertilisation and Embryology Bill that later became an Act. It was based upon the Warnock report. The function of the Bill was to create a Human Fertilisation and Embryology Authority that would license bodies and scientists working on research into the human embryo up to 14 days after fertilisation with, first, the objective of improving the treatment of infertility and, secondly, of helping in the prevention of inherited diseases. The noble Lord, Lord Winston, and others were among those who were eventually extraordinarily successful in carrying out the procedure known as pre-implantation diagnosis in order to detect embryos which were likely to cause serious human diseases. That was a very important development.
Subsequently, several other amendments were introduced—and I was deeply involved in those debates in your Lordships’ House—so that the licence could allow people to embark on research with these objectives and to address the important and crucial issue of carrying out research into the treatment of human disease. That in turn led to the development of the mechanism for creating stem cells for the treatment of human disease. There has been a series of progressive amendments that have been fully debated in your Lordships’ House. Now we are faced with the very exciting prospect, following an extensive period of consultation, whereby embryos can be created by pronuclear transfer derived from women who are likely to pass on devastating mitochondrial genetic mutations to all of their children of both sexes. The consultation is now complete and we can look with hope towards the prospect of the regulations to allow those embryos to be implanted being introduced into your Lordships’ House. This is a crucial development. I agree entirely with certain things that the noble Lord, Lord Winston, has said—the Human Fertilisation and Embryology Authority has not functioned as effectively as it might. However, his criticisms were largely concerned not with the potential merger but with the actual performance of the body as an authority.
I was also heavily involved in the debates in your Lordships’ House on the formation of the Human Tissue Authority. This body arose as a result of the so-called Alder Hey scandal where a huge number of human brains and other organs were kept in the hospital without the permission of the families. Of course, it was not recognised in many debates at the time that certain members of the medical profession held a widespread, ill-founded belief that once permission was given by a family for a post mortem examination it was proper to retain organs. That belief was partly based on the fact that to establish a diagnosis after a post mortem examination it is essential that certain organs are fixed in formalin before they can be studied and before the diagnosis can be confirmed. This is crucial. As a result of the so-called Alder Hey scandal the Human Tissue Authority was established. It has the authority to license anatomy departments to handle human organs and pathology departments to study human samples, both full organs and biopsy specimens. It has the authority to license organs being used for transplantation purposes and many similar functions. These departments in universities and hospitals are licensed by the HTA.
The function of these two bodies is entirely different and I do not believe that it is sensible—even in the attempt to create another quango which brings together two quangos—to merge them. The new body would undoubtedly have to create two sub-committees, one to look at human fertilisation and embryology and another to look at the issues of human tissue and the retention of it. I therefore do not support this amendment.
Lord Patel
I disagree with my noble, respected and even revered friend Lord Walton of Detchant. He fundamentally fails to understand this amendment. It does not remove the research functions of the Human Fertilisation and Embryology Authority. I have spoken strongly in the past about embryo research, including cell nuclear transfer and mitochondrial research. It is the authority that has held up for so long the progress in mitochondrial research. We should have been doing something about it at least 18 months ago. This amendment does not remove that function, nor does it remove the functions of the Human Tissue Authority, but by amalgamating these functions we can better promote research. The authority and functions of the Human Fertilisation and Embryology Authority—and now we are entering into a science debate, which is not the purpose of the Bill—stop once it gives a licence to do specific research on an embryo. Once the embryonic stem cells are created it has no authority over how those cells are used. Once the cells are used to create a tissue for research it does not have any authority, but the Human Tissue Authority may do. By amalgamating the two you are co-ordinating this research function and maybe improving it. I hope that my noble and revered friend accepts that explanation.
The Lord Bishop of Chester
My Lords, having listened to these distinguished doctors taking different points of view on this subject, I fear that I might lower the tone of the debate. However, I think that my money is with the noble Lord, Lord Walton of Detchant. There is a world of difference morally between research carried out on tissue taken from a dead body and research taking place on living tissue which has the potential to be a human being in one way or another. People will argue about when life begins and those arguments can be very sensitive and very divisive. That is why there is separate legislation on research and on therapeutic techniques involving eggs fertilised outside the womb. Whether one likes it or not, if you put together the Human Tissue Authority and the HFEA you will create an impression that you are just dealing with dead matter or whatever, just a lump of cells. That is the impression that will certainly be given psychologically, even if in practice one could construct the unified authority in a way that had the two legs.
It may well be that one needs to revisit this area. The noble Lord, Lord Winston, speaks with such authority that I am very reluctant to take a different view. However, he seemed almost to be arguing for greater regulation rather than no regulation. I would be very reluctant to see a free market in implanting more than two embryos into women in this country, for example. The 14-day rule, which may be an irritant to researchers, was fought over and discussed at great length. To those of us who have quite a few reservations in this area, that is at least a line in the sand. I think that this area needs to be considered on its own merits and, notwithstanding the arguments quite rightly put by the noble Lord, Lord Patel, I am with the noble Lord, Lord Walton.
Lord Patel
Stem cells are not dead cells: they are immortal cell lines, such as the HeLa cells on which scientists have been doing research for decades. These cells were taken in 1951 from a woman called Henrietta Lacks—that is why they are called HeLa cells—and they are still alive. Most cancer research is done, and many drugs produced, using HeLa cells. They are immortal, living cells.
The Lord Bishop of Chester
My Lords, as St Paul once said, I speak as a fool. However, is there not a difference between stem cells that are alive in that sense and a fertilised egg that is alive in a different sense?
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.
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 Patel
I thank the Minister for his comments. Of course, I feel satisfied that the matter has been fully explored. No doubt the noble Lord, Lord Willis of Knaresborough, will take note of all the comments made. I thank all the other noble Lords who took part in the debate. I say to the noble Baroness, Lady Thornton, that I look forward to the day when her party brings forward an amendment again to burn the quangos, including the HTA and the HFEA. I look forward to the Minister then being on my side and arguing the point. Until then, I beg leave to withdraw the amendment.
Lord Hunt of Kings Heath
“( ) “Significant improvement” is to be defined in regulations.”
Lord Hunt of Kings Heath
My Lords, we now come to Part 2 of the Bill and particularly to Clauses 74 to 77, which may be described as a failure regime for NHS trusts and NHS foundation trusts. Clause 74 makes amendments to the powers of CQC to issue warning notices to those bodies. Where it appears to CQC that the quality of healthcare services provided by a trust requires significant improvement, CQC will be able to highlight those areas in a new form of warning notice. This will state the reasons for CQC’s view, and it will require improvements in the quality of services to be delivered within a specified time. At the end of that period, CQC must review whether the requirements specified in the notice have been met.
Where CQC is not satisfied, it must decide what further action needs to be taken. In the case of a foundation trust, CQC’s review must include use of its power to require Monitor to put the trust into special administration. Clause 75 extends Monitor’s powers to be able to issue additional licence conditions on foundation trusts when CQC has issued a warning notice. At present, Monitor can make use of these powers only if there is a failure in the governance of a foundation trust.
In the event of healthcare services provided by the trust requiring significant improvement, Monitor will as a result be able to take timely action to make changes to leadership or governance with the intention of securing improvements to those services. Clause 76 will enable Monitor to make an audit to authorise the appointment of a trust special administrator in cases where it or CQC is satisfied that there is a serious failure by an NHS foundation trust to provide healthcare services of sufficient quality and that it is appropriate to make the order. At present, Monitor is able to authorise the appointment of a trust special administrator only in cases of insolvency. Monitor may make an order when it is so satisfied, but must make the order when required to do so by CQC.
Let me say at once that the Opposition support the intention of giving greater emphasis to safety and quality and enhancing CQC’s powers in this area. Of course, we are very much influenced by the report of Robert Francis on Mid Staffordshire. We also welcome the introduction of a single failure regime, focused on quality as well as financial failure. However, I suspect that I am not the only noble Lord to have been confused by the respective roles of CQC and Monitor when reading this Bill. Indeed, I was surprised that the Department of Health boldly claimed in its factsheet that the new failure regime will give regulators clear roles in tackling failure. I must say that I found it anything but clear. The factsheet says:
“The Care Quality Commission … will focus on exposing problems and requiring action while Monitor and the NHS Trust Development Authority … will focus on intervening if a poor-performing provider is unable to resolve the situation working with commissioners”.
To confuse matters further, CQC retains enforcement powers for social care, general practice and independent sector providers. That is going to be very confusing. I also pose the question as to whether there are not going to be significant risks associated with these changes. As Robert Francis made clear, regulatory complexity can contribute to system failings. It is important that we get this right, so there are a number of matters which I would like to put to the noble Earl, Lord Howe.
Does the Minister consider that with this level of complexity, there is a risk of slowdown in the action required to address failures? How will Monitor, CQC and the NHS Trust Development Authority work together to ensure that problems are acted upon? Will Monitor and the NHS Trust Development Authority be able to question CQC’s findings and recommendations? What happens if those three august bodies disagree about whether action is needed? Will Monitor and the NHSTDA be equipped to come to their own views on quality, or do they have to take the view of CQC on trust?
The noble Earl will know that the potential confusion has been examined recently by the Health Select Committee. Indeed, the Secretary of State explained to the Commons Health Committee that the change in the arrangements so that CQC in essence has to refer concerns to Monitor, which then takes enforcement action, is devoid, as he put it, of conflict of interest when an inspector identifies a fault then later feels obliged to say that there is no longer a fault, simply to avoid the enforcement action appearing ineffective. However, that does not apply to the other sectors. It does not apply to social care provision, general practice or the independent sector. I do not understand why there is deemed to be a conflict of interest in relation to NHS foundation trusts and NHS trusts but not the other bodies. Nor does it apply to other sector regulators, such as the Health and Safety Executive or the Civil Aviation Authority. There are plenty of examples of regulators that monitor and also take the enforcement action.
I also do not understand why, when it comes to healthcare, the NHS has a different regulatory regime from that of the private sector. Surely, there ought to be consistency in approach. The noble Earl will know that we have had the fair playing field work undertaken by Monitor, as a result of discussions on the previous Bill. It does not seem that there is a fair playing field when it comes to regulatory machinery in relation to, say, the independent sector and to the NHS, even though they are both providing services under NHS contracts. I very much welcome Amendments 65, 66 and 67, tabled by my noble friend Lord Warner, and I would add to them my Amendment 66ZA, which would ensure that the NHS is dealt with equivalently.
On the NHSTDA and the NHS trusts, there is a puzzle regarding what appears from the architecture. I think it is generally accepted that those trusts which have not yet reached foundation trust status are generally considered to be the weaker organisations, given that NHS foundation trusts were introduced quite a number of years ago now. What is puzzling is that the weaker organisations seem to come under a weaker regulatory system. I will be interested to hear my noble friend Lord Warner’s remarks concerning his amendments, but it appears to be a puzzle and an inconsistent approach.
This also takes us back to the recommendations of Robert Francis concerning the merger of regulatory functions, which he suggested in his report that the Government should consider. On the fact that the Government have got themselves into such a tangle on the respective roles of CQC and Monitor, while I can well understand nervousness about having yet another restructuring in relation, for instance, to CQC—given the number of changes that have occurred to the care regulator over the years—I worry that they have come up with such a complex solution that I wonder whether merger might not come to be seen as the easier option.
I would also like to raise some issues about the process under which the failure regime takes place. I start with my Amendment 64A, in relation to the Section 29A warning notice under Clause 74(3). Can the noble Earl give some indication of how the significant improvement required is to be defined and assessed? Can he also say how proportionate CQC will be? Under proposed new Section 29A(2)(a) of the Health and Social Care Act 2008, which is introduced in Clause 74(3), a warning notice will state,
“that the Commission has formed the view that the quality of health care provided by the trust requires significant improvement”.
Is there not a need to clarify either in the Bill or in secondary legislation how “significant improvement” is to be defined and assessed and, specifically, how and where the warning notice applies given the number of multisite trusts offering a wide range of services?
In Clause 75, reference is made to Monitor’s imposition of licence conditions. What criteria will impact on Monitor’s decision to impose those licence conditions? Should they not be subject to statutory guidance, given the serious impact of their imposition? In view of the service implications for NHS trusts and NHS foundation trusts of CQC and Monitor interventions, ought there not to be a clear appeals process for providers, given the potential serious consequences for an individual trust or a local health economy of a warning notice or a “failure to comply” administration, both for the provider concerned and the other providers that may be affected by that decision?
My Amendment 66ZB deals with the multisite issue by requiring CQC to define how this is to be assessed. My Amendments 66ZD and 66ZE seek to have published the Monitor criteria under which a licence condition is issued following a warning notice. When such a warning notice is issued, a foundation trust should have the right to appeal under my Amendment 66ZC, which is consequential on Amendment 66ZE. The same principles apply to Clause 76 in relation to the regulator. CQC must surely publish criteria on following a transparent process in making judgments on trust special administration, where there also ought to be an appeals procedure.
It seems that there is a lot of work to be done to make sure that the health service and other providers fully understand the new regulatory apparatus that is to be brought into being. I remain concerned that there could be confusion between the two roles of Monitor and CQC and that the NHS Trust Development Authority’s role is rather mysterious. It is hard to understand why NHS trusts are not in fact subject to a much more robust process than other providers because, as far as I can see, apart from a number of community trusts which are likely to get foundation trust status, the intention is that we simply roll on for years to come with these unviable organisations. Money is clearly top-sliced in order to keep them going, and we know that the real issue is, in many cases, a failure to tackle reconfiguration. It is a worry that almost a limbo situation is being created in which no progress at all is going to be made. There is also a very clear need for due process as to how these licensing provisions are to operate and an appeal process for any organisation that is affected by them.
If the noble Earl, Lord Howe, would agree to the principle of that, I think he could look forward to general support within the health service and outside and, of course, public confidence. The overriding principle of making sure that quality and safety are considered at the same level, or even a higher level, than that of financial viability is one that we certainly support from these Benches. I beg to move.
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.
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?
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.
Lord Hunt of Kings Heath
My Lords, I will not detain the Committee other than to say that the noble Earl’s response bears careful reading. I am still confused about the role of the CQC. If it is able to enforce action against non-NHS social care providers, I do not understand why it is unable to enforce action against NHS providers. I hear what the noble Earl says about the better working relationship between Monitor and the CQC and I am sure that is right. I pay tribute to the new leadership of the CQC and to the appointment of Sir Mike Richards. However, I believe that the architecture still allows for confusion. I would like further clarification on when Monitor and the CQC can take a different view on quality issues. Perhaps we will come back to this on Report. I cannot believe that Monitor will simply accept the CQC’s judgment at face value. Surely its board will have to come to its own view on those issues. That is an area I would like to explore further.
The noble Earl was reassuring about the issue of non-foundation trusts raised by my noble friend Lord Warner. None the less, it does not feel quite like that on the ground. It does not feel as though immediate action is being taken with the many trusts that are clearly nowhere near achieving foundation trust status. I may encourage my noble friend to come back to that point. Having said that, I am grateful to the noble Earl for his comments, and I beg leave to withdraw the amendment.
“( ) 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”.””
“( ) In paragraph 15(4) of Schedule 14 to the Health and Social Care Act 2012 (abolition of NHS trusts in England: consequential amendments to section 65F of the National Health Service Act 2006)—
(a) in the new subsection (2A) to be inserted by paragraph 15(4), in paragraph (a), for “65DA” substitute “65DA(1)(a)”,(b) after that new subsection, insert—“(2AA) Nor may the administrator provide the draft report to the regulator under subsection (1) without having obtained from the Care Quality Commission a statement that it considers that the recommendation in the draft report would achieve that part of the objective set out in section 65DA(1)(aa).”, and
(c) in the new subsection (2B) to be inserted by paragraph 15(4)—(i) after “Where the Board” insert “or the Care Quality Commission”,(ii) for “to that effect” substitute “to the effect mentioned in subsection (2A) or (2AA)”, and(iii) after “, the Board” insert “or (as the case may be) the Commission”.”