Autism

Earl Howe Excerpts

Monday 17th June 2013 Lords Chamber

[Lord Touhig]

To ask Her Majesty’s Government what assessment they have made of the findings of the campaign by the National Autistic Society, Push for Action, launched on 14 May. I declare an interest as vice-president of the National Autistic Society.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, the National Autistic Society’s Push for Action campaign coincides with the Government’s review of the 2010 adult autism strategy. We are already taking forward some of the campaign’s recommendations, and we will consider others that fall to government during the review, the investigative stage of which is due to last until the end of October.

[Lord Touhig]

I must say that I am encouraged by the Minister’s words. Four years after Parliament passed the groundbreaking Autism Act, this National Autistic Society report reveals that despite some progress far too many autistic adults are missing out on everyday support. A shocking 70% of adults and their carers say they get no help from social services, and this is not always down to money. Indeed, economic modelling by Deloitte shows that every pound invested in services for autistic adults with moderate needs brings a return of £1.30. When the Government review the autism strategy, will they consider providing an innovation fund so that local councils can provide the cost-effective services that all autistic adults need and actually demand?

[Earl Howe]

My Lords, we will certainly consider the idea of an innovation fund during the course of the review. We have allocated some central funding already to support the implementation of the autism strategy, for example in commissioning a range of training products from expert bodies to support local areas and professionals. I hope the noble Lord will agree that the strategy and the statutory guidance that goes with it mark a great step forward for adults with autism in England. We now need to take an honest look at how it is all working and come up with further ideas and actions as necessary.

[Lord Clement-Jones]

My Lords, I declare an interest as president of Ambitious about Autism. Can my noble friend confirm that the Government’s review of the adult autism strategy will pay close attention to the kind of day support services, such as the NAS’s Horizons service, which the recent Deloitte report, Ending the Other Care Crisis, has demonstrated not only leads to increased quality of life and reduced dependency but has clear economic benefits?

[Earl Howe]

My noble friend draws attention to a very important strand of support for people with autism. Many people with this condition can benefit from small amounts of advocacy, help and support often through less formal support networks and not necessarily through the local authority. We will certainly be looking at that area.

[Baroness Browning]

I declare my autism interest in the register to the House. Does my noble friend accept that the Department of Health is the lead department on the Autism Act, but that other departments have responsibilities as part of the strategy? He will be aware of the finding of the Upper Tribunal (Administrative Appeals Chamber) in a case against the Secretary of State for Work and Pensions that the case has to be made that autism is different. Can I ask him to make sure that that case is made by his department to all other government departments involved in the care of people with autism?

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[Earl Howe]

I can give my noble friend that assurance. The autism strategy is, of course, a cross-government strategy. A number of departments will look at their role in supporting it, including the Department for Work and Pensions and the MoJ. I am hopeful that when we come out in October with some considered proposals, my noble friend will take heart from the fact that this has involved all relevant government departments.

[Baroness Howarth of Breckland]

My Lords, one of the great concerns of people with autism is the transition arrangements between young people and adults, particularly the difficulties created now that education and social care provision are separated in adult education centres for these children and young people. What is intended to ensure that this does not continue to disadvantage these young people?

[Earl Howe]

My Lords, the Children and Families Bill, which was introduced into Parliament this month, will usher in from next year new joint arrangements for assessing and planning commissioning services for children and young people with special educational needs. We realise the difficulties that young people with autism can face in making that transition to adulthood. Under the autism strategy, my department and the Department for Education funded the social policy research unit at the University of York to examine how statutory services are currently supporting young people on the autistic spectrum. Its report, published in February, points the way to some important lessons that we should take on board during the review.

[Lord Collins of Highbury]

My Lords, despite the strategy, only 63 out of 152 local authorities have a pathway to diagnosis. Will the Minister give an assurance that the department will produce a clear guide for CCGs on how to commission the right diagnosis and support services?

[Earl Howe]

My Lords, we are indeed currently supporting, along with NHS England, a practical guide for CCGs to support health professionals and others in implementing the adult autism statutory guidance, as well as the NICE guidelines on recognition, referral and diagnosis, and the management of adults on the autism spectrum. This will be published later in the summer through the Joint Commissioning Panel for Mental Health.

[Baroness Greengross]

My Lords, I was recently privileged to chair a commission that looked for the first time at the large numbers of people who grow into old age with autism. I would very much like the noble Earl to assure the House that these people will not be ignored, will also receive diagnosis, and that professionals will be trained to ensure that a preventive support system of care is introduced so that it is not always crisis-driven. Can he tell us that?

[Earl Howe]

I agree with the noble Baroness that the needs of those with autism in older age should not be forgotten. We will meet the National Autistic Society, following the publication next month of its report on autism and ageing, to see how we can support the taking forward of this work, which builds on that done by the autism and ageing commission in this House. We are also looking at the whole issue of the training of health professionals, in particular the core curricula for doctors, nurses and other clinicians.

[Lord Campbell-Savours]

Is there a connection between the MMR jab and autism?

[Earl Howe]

My Lords, no.

Care Bill [HL]

Earl Howe Excerpts

Wednesday 12th June 2013 Lords Chamber

[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.

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[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.

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[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.

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[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.

[Baroness Thornton]

Will we see the white smoke before we get to Report?

[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.

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[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.

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[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.

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Moved by

[Earl Howe]

66A: Clause 76, page 63, line 37, leave out “regulator” and insert “Secretary of State”

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Moved by

[Earl Howe]

67A: Clause 76, page 63, line 38, at end insert—
“( ) 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”.””

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Moved by

[Earl Howe]

68: Clause 77, page 64, line 8, leave out “(2A)” and insert “(5)”

Health: Children's Heart Services

Earl Howe Excerpts

Wednesday 12th June 2013 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, with the leave of the House, I shall now repeat a Statement made earlier today in another place by my right honourable friend the Secretary of State for Health on the Safe and Sustainable review of children’s heart services. The Statement is as follows.

“With permission, Mr Speaker, I would like to make a Statement on the Safe and Sustainable review of children’s congenital heart services.

On average, around 3,700 heart procedures are carried out each year on children who have been diagnosed with congenital heart conditions. The mortality rates at Bristol Royal Infirmary, identified as far back as 1989, indicated that we are not as successful as we should be in such operations. The Safe and Sustainable review began in 2008 and set out to make sure that children’s heart services are the best they can be for all children across the country. Whatever the controversy about the location of such services, we all have a responsibility to ensure the best possible outcomes for children and their families, who must always come first in any decision about service provision.

Sir Ian Kennedy, in his Bristol inquiry report in 2001, recommended the concentration of medical and nursing expertise in a smaller number of centres. Subsequent working groups and reports have endorsed that recommendation, including the Royal College of Surgeons in 2007. The public consultation on the Safe and Sustainable review received over 75,000 responses. This was the largest review of its kind, conducted independently of government by the NHS.

In July 2012, the then Joint Committee of Primary Care Trusts—the JCPCT—on behalf of local NHS commissioners, decided that children’s heart surgery networks should be formally structured around specialist surgical centres in Bristol, Birmingham, Liverpool, Newcastle and Southampton, as well as Great Ormond Street and the Evelina Children’s Hospital in London. They recommended that services should no longer be provided in Leicester, Leeds, Oxford and the Royal Brompton and Harefield in London. Following the JCPCT’s announcement, three local health overview and scrutiny committees formally referred the JCPCT’s decision for me to review and I wrote to the Independent Reconfiguration Panel—the IRP—asking them to undertake a full review of the proposals.

On 30 April 2013 I received the report. I would like to thank the IRP for producing such a comprehensive review of such a challenging topic. It strongly agrees with the case for change, specifically that congenital cardiac surgery and interventional cardiology should only be provided by specialist teams large enough to sustain a comprehensive range of interventions, round-the-clock care, specialist training and research. I agree with their analysis.

However, the report also concludes that the outcome of the Safe and Sustainable review was based on a flawed analysis of the impact of incomplete proposals, and leaves too many questions about sustainability and implementation. This is clearly a serious criticism of the Safe and Sustainable process. I therefore accept their recommendation that the proposals cannot go ahead in their current form and am suspending the review today. NHS England will also seek to withdraw its appeal against the judicial review successfully achieved by Save Our Surgery in Leeds.

None the less, the IRP is clear that the clinical case for change remains, and its report is very helpful in setting out the way forward in terms of broadening the scope of the discussion, and looking in detail at the affordability and sustainability of the proposals. The IRP says—and I agree—that this is not a mandate for the status quo or for going back over all the ground already covered during the last five years. The case for change commands widespread support and understanding and we must continue to seek every opportunity to improve services for children.

The recommendations in the report set out what the IRP considers needs to be done to bring about the desired improvements in services in a way that addresses gaps and weaknesses in the original proposals. Specifically, they include: better co-ordination with the review of adult heart surgery services; expanding the detailed work on the clinical model and associated service standards for the whole pathway of care, beyond surgery; services to be fully modelled and their affordability retested; NHS England to establish a systematic, transparent, authoritative and continuous stream of data and information about the performance of congenital heart services; NHS England and the relevant professional associations to put in place the means to continuously review the pattern of activity and optimise outcomes for the more rare, innovative and complex procedures; NHS England to reflect on the criticisms of the JCPCT’s assessment of quality and learn lessons to avoid similar situations in its future commissioning of specialist services; and NHS England to use the lessons from this review to create with its partners a more resource and time-effective process for achieving genuine involvement and engagement in its commissioning of specialist services.

NHS England now must move forward on the basis of these clear recommendations and the Leeds court judgment. I have therefore today written to NHS England, and the local overview and scrutiny committees that originally referred the JCPCT’s decision to me, to explain that the IRP’s report shows that the proposals of the Safe and Sustainable review clearly cannot go ahead in their current form. It is right to give all parties some time to reflect on the best way forward, now that the IRP report is in the public domain, so I have asked NHS England to report back to me by the end of July on how it intends to proceed. In the mean time, it is important to stress that I believe that care for children with congenital heart conditions is safe in the NHS, and that ensuring it continues to be will be the top priority for all involved in this process.

I know that many families have found the Safe and Sustainable review to be a traumatic experience. People are rightly proud of the hospitals and the staff that have saved, or tried their best to save, the lives of their children. However, there is overwhelming consensus that we cannot stick with the model of care that we have now. To do so would be a betrayal of the families who lost loved ones in Bristol and who want nothing more than for the NHS to learn the lessons from their personal tragedies. So it is right we continue with this process, but it is also essential that it is performed correctly so that any decisions, as difficult as they may ultimately be, carry the confidence of the public. I commend the report and this Statement to the House”.

My Lords, that concludes the Statement.

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[Earl Howe]

My Lords, I am grateful to the noble Lord, Lord Hunt, for his measured comments. I agree with many, if not most, of them. I certainly agree that party politics should play no part in this matter. That is one reason why in 2008 his Government decided that the Safe and Sustainable review should be a process set apart from the Department of Health and led by the NHS. We agree with that and still believe that it should be NHS-led. I also agree with what he said about the complexity of this issue being no excuse for not proceeding as fast as is safe and possible with a process designed to see a satisfactory resolution of this issue. That is certainly our view.

I also welcome what the noble Lord said about public confidence. It is clear that parts of the Safe and Sustainable process sadly did not command public confidence, not least in Leeds, but also in Leicester and other places. The noble Lord will no doubt have noticed, in the IRP’s press releases today, the emphasis on openness and transparency in the process going forward. NHS England has also made clear that whatever the process that it recommends going forward, it should involve the maximum amount of consultation with those concerned, not just the clinicians in the centres involved, who are of course very important, but also patients and their families.

The noble Lord referred to the need for greater consideration to be given to access and travel times. I noted an emphasis on that very point in recommendation 4 of the IRP’s report. They clearly matter to families, as was very much picked up by the IRP in its work engaging with stakeholders. In agreeing to address all the recommendations of the IRP report, which NHS England has done, it could not fail to address that part of the recommendation.

With regard to mortality data, I am sure that the noble Lord will understand that when we are dealing with a procedure as complicated and specialist as children’s congenital heart surgery, while transparency of data is certainly an objective, it is important that the data published are not open to misinterpretation. Mortality data are a problem that beset this kind of area because the numbers are small. They must also be presented in a way that is understandable to the public as well as to clinicians. For the most part, clinicians already have this data, but it is important going forward to ensure that when we publish data, there is genuine comparability between the various centres in terms of the outcomes denoted.

The noble Lord rightly said that, by introducing the dimension of adult cardiac surgery, the IRP had added greater complexity to the whole issue. There is no doubt that that is true. All I will say to him is that this was by far the longest and most complicated review that the IRP has undertaken in its 10-year history. It took evidence over 25 full days. That alone should indicate that the opinions that were tapped were very extensive. The IRP did not come up with this recommendation lightly. Although it adds complexity, it behoves NHS England to take that point extremely seriously.

As regards the timetable for the work going forward, my right honourable friend the Secretary of State has asked NHS England to provide him with an interim report by the end of July. NHS England’s press release states:

“We will take the time to listen before coming up with a new proposition, working with patients, clinicians and the providers of services. We intend to announce a new way forward in the autumn, with plans for implementation within 12 months”.

I believe that is an ambitious aim given the added complexity, but it indicates that NHS England is conscious of the need to make progress in this area as rapidly as possible. As soon as I have further information—no doubt at the end of July or shortly after—I will ensure that the House is made aware of it.

I have seen the Royal College of Surgeons’ press release. It is impossible to disagree with it that this is a disappointing state of affairs. Everyone would like to see this issue resolved. Nevertheless, the points the college makes, which were reflected in the noble Lord’s points about the need for expedition in this area, are absolutely right. The noble Lord was also right to say that over the coming months we need to make sure that all the units, which do such a fantastic job in this very complex area of clinical delivery, are supported and feel that their work is appreciated. It is certainly important that we do not see a draining away of expertise. The clinicians in the various centres should now see this as an opportunity to present their case even more fully than they did before. I hope that they will welcome that opportunity.

As regards the tyranny of the electoral cycle, I hope that in my opening remarks I expressed my agreement that that should not play a part in this. In so far as we can divorce decisions of this clinical magnitude from politics, the better it will be. We should achieve that if this process is as consultative and open as possible, as everybody wishes it to be.

[Lord Warner]

My Lords, I take us back to Sir Ian Kennedy’s review 12 years ago in which he made it crystal clear that unless we significantly reduced the number of these centres, children would continue to die unnecessarily. That was the brutal conclusion of the Bristol inquiry. Has anything come out of the IRP review that fundamentally changes the July 2012 decision of the Joint Committee of Primary Care Trusts that seven centres, with clinical networks built around them, was the right number? As I understand it, the argument is not necessarily that seven was the wrong number of centres, but that the wrong seven were chosen. Are we not now opening up the whole issue of the relationship with adult services, which will take us back to a situation where we start to review from the beginning the appropriateness of the particular centres? Do we not need to get back to where the JCPCT was when there was a good deal of consensus around the idea that seven was the right kind of number? The issue is really about east coast versus west coast, and the danger of this report, thorough though it may be, is that it will now reopen all the issues on which we had actually made a good deal of progress by 2012.

[Earl Howe]

That is indeed the core of the disappointment felt by the clinical community and noble Lords: that we are little further forward in terms of deciding exactly where these services should be delivered. The noble Lord is also right to say that support for a philosophy of improving children’s heart services by concentrating surgical expertise to provide round-the-clock cover and develop networks of care is as strong as ever. There is a rare consensus on the clinical case for improving services on the pathway of care for children. The IRP has said that its report is not a mandate for going back over the ground of the past five years; indeed, it commends a great deal of the work done by the JCPCT. The IRP says that that work should be built upon. The JCPCT should not necessarily feel bruised by this, although I am sure that it will feel thoroughly disappointed. However, its groundwork has been publicly appreciated, and it is now for NHS England to take that work forward as swiftly as it can.

[Baroness Howarth of Breckland]

My Lords, I speak as the patron of Little Hearts Matter, the organisation that represents a large number of families who have children with heart conditions, particularly hypoplastic left heart syndrome, which is extremely serious and needs highly skilled intervention. Who does the Minister think is most disappointed about the failure of the review? I probably meet more families and children than most of your Lordships—children who await open heart surgery or extremely complex technical interventions, and whose anxiety is huge; and parents who thought that they were going to have clear answers on where their children would receive treatment and on the quality of those interventions at the end of the safe and sustainable review. I ask the Minister to take back with him all those disappointments and to look not only at safety, which is key to the families. Many of them would travel to wherever you took them if they were sure that the operation would be successful. As a woman from Yorkshire and the east of England, I understand that gap, but what the families want most is quality of service.

As the noble Lord, Lord Warner, pointed out, there is also great disappointment about the link being made with adult services because of where those services are located. Despite the review, there is a lack of understanding of the needs of children. There are certainly transitional difficulties and I ask the Minister whether it is those issues or other issues that have led to children being considered alongside adults. Will he take away with him the disappointment felt by families who are waiting longer for interventions because this has caused delay?

[Earl Howe]

My Lords, I am accountable to this House for government policy, but it is important for the noble Baroness to understand that this has been an NHS-led review. Many of her questions are for NHS England now to address. Of course there will be huge disappointment and concern among the families of those who require surgery in this area. I want to emphasise that until a decision is reached, the centres now delivering children’s heart services will continue to do so and will be fully supported in doing so.

However, we cannot ignore a series of recommendations from the IRP that has roundly criticised the methodology of the JCPCT. It concluded that the JCPCT’s way forward was flawed because the analysis was insufficiently thorough. If our aim is to improve the quality of outcomes for these children, I do not believe that it is in anyone’s interests to try to say to ourselves that we can make do with a half-good set of solutions. I do not suggest that the noble Baroness is saying that; of course she is not. We need to be thorough about this without spending another 10 years over it. I hope that I have given the sense to the House that NHS England is determined to progress this rapidly but thoroughly and, above all, in a consultative way. The families will have a chance to have their say in that process.

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[The Lord Bishop of Ripon and Leeds]

My Lords, I am grateful to the Minister and I am also grateful to the Leeds group Save our Surgery for persisting with criticisms, at least some of which seem to have been justified, as they pursued this. I am particularly grateful for the affirmation that children and their families must always come first. Will the Minister also accept that nothing about us should be done without us? Therefore, will he ensure that families, local communities and, indeed, the case for keeping cardiac and other children’s services in our hospitals are heard, in addition to the clinical professionals?

[Earl Howe]

I can readily agree with the right reverend Prelate. I think it is illustrative of the IRP’s approach that in its press release it states:

“The critical factor to consider, in the Panel’s view, is that engagement of all interested parties is the key to achieving improvements for patients and families without unnecessary delay. There is now a real opportunity to involve patients, the public and other stakeholders in taking work forward as set out in the Panel’s recommendations”.

I endorse that view wholeheartedly, and it is a point that has been directly picked up by NHS England in its press release today.

[Baroness Eaton]

My Lords, will my noble friend give an assurance that when calculating where centres should be located, account is taken not just of population numbers, but of the make-up of that population? He will know, for example, that children of Asian descent have greater need for these services than other communities, making up 23% of cases at Leeds. Their faster growing population must be taken into account.

[Earl Howe]

I hope that my noble friend will be reassured by the IRP’s recognition that the location and geography of these centres and where they are in the country are material factors in this equation. At the same time, I think it would be wrong to give the impression that one can establish a centre of expertise of this kind in every city; that is clearly not realistic. Merely because there is a certain density of a population in a location does not mean to say that there can be a children’s heart centre very close to the centre of that population. This is a highly specialised service and we must recognise that the centres that will deliver it will be few in number. Nevertheless, I am sure that the message that my noble friend has given will not be lost on NHS England.

[Baroness Jolly]

My Lords, it is critical that however NHS England proceeds, it does it openly and transparently. I welcome the Minister’s comments on that. Will he also agree that meetings of any review body should be advertised, public and make all necessary papers available to the public?

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[Earl Howe]

I agree that transparency in the process is vital, and I have no doubt that NHS England, in saying what it has today about its general approach to this, will bear that very point in mind.

[Lord Woolmer of Leeds]

My Lords, does the noble Earl recognise that in Leeds there will be a great sense of justification regarding the criticisms of the process previously followed and a welcoming of the forensic critique by the latest panel of that process? While it is certainly important that collocation of services is not essential to the provision of children’s heart surgery, does the Minister agree that, where there is outstanding and deliberately engineered collocation of high quality, that is an important factor in the future location of children’s heart surgery?

[Earl Howe]

The noble Lord makes another very good point, and Recommendation 3 of the IRP report focuses on that very issue. It says:

“Before further considering options for change, the detailed work on the clinical model and associated service standards for the whole pathway of care must be completed to demonstrate the benefits for patients and how services will be delivered across each network”.

Therefore, that point has been explicitly recognised.

[Lord Walton of Detchant]

My Lords, the noble Earl has explained with his customary clarity the reasons for this further delay. However, surely he would agree that, in the ultimate, the decision that is eventually reached must be based on quality of service and quality of outcomes. This must surely be the guiding principle throughout. I fully appreciate the concerns expressed by the people surrounding the units that were originally marked for closure, but I have to express a personal avuncular interest in Freeman Hospital in Newcastle, which, according to all international comparisons, is producing results in paediatric and adult heart surgery that stand comparison with the best cardiac centres in the world. I know that this further delay is going to cause concern and further damage morale in that unit. I only hope that in the long term it does not have any effect on the efficiency of the service. Let us hope that this review is concluded as quickly as possible.

[Earl Howe]

My Lords, I pay tribute to the work done in Newcastle in this extremely complex area of surgery. The noble Lord knows that hospital better than anyone in this House, and I understand the disappointment felt in Newcastle about this decision. Nevertheless, I would slightly qualify the comment that he made at the beginning. Although I agree that the decision must depend on outcomes and the quality of care, it must also bear in mind the sustainability of the service into the future. While we can recognise good care when we see it now, we must be sure that the service is capable of being sustained on that level into the future.

[Baroness Finlay of Llandaff]

Is the Minister able to tell us how many vacancies currently exist among highly specialised staff in children’s heart units and what NHS England is doing to monitor vacancies? During a time of uncertainty, when staff do not know what their future will be, recruitment problems can arise, and where vacancies occur at a very senior, highly specialised level, that in itself can threaten the quality of the service and indeed jeopardise long-term sustainability.

[Earl Howe]

I do not in fact have any statistics on vacancies, although if I can acquire them I shall certainly pass them on to the noble Baroness. However, the central point that she makes is of course right, and the second recommendation made by the IRP relates to the need to have sufficient staff in place to deliver a safe service. It says that patients should receive this service,

“from teams with at least four full-time consultant congenital heart surgeons and appropriate numbers of other specialist staff to sustain a comprehensive range of interventions, round the clock care”,

and, interestingly,

“training and research”.

I think that that sends a signal that will resonate with many noble Lords in the context of debates that we have had in the past about centres of excellence in the NHS.

Care Bill [HL]

Earl Howe Excerpts

Monday 10th June 2013 Lords Chamber

[Baroness Wheeler]

My Lords, I support my noble friend Lord Warner’s amendment. There will of course be further debate on integration in the wider context of the Bill, but the amendment is important because it underlines that Health Education England must have the strategic overview and understanding of the workforce requirements across the boundaries of health and social care if it is to undertake its role effectively.

Our stakeholder meetings have shown that there is considerable concern among stakeholders on that issue. They want the links between HEE and the social care sector to be more explicit. The noble Earl’s reassurances last week in that regard concerning Clause 88 were helpful, and I look forward to hearing from him further on how HEE is to work with integrated care delivery. I hope that he will concede that my noble friend’s cross-reference in his amendment to Clause 85 is necessary, because it links the HEE’s duty in Clause 88 to have regard to promoting integration to its key role of ensuring that there are sufficient skilled healthcare workers available.

The Health Education England mandate acknowledges that the future needs of the NHS, public health and care system will require a greater emphasis on community, primary and integrated health and social care. HEE is essential in that. Staff must be trained and developed in the skills that are transferable between different care settings and in working in cross-disciplinary teams in a range of different health and support settings. It must also work closely with the social care sector by developing common standards and portable qualifications across the NHS, public health and social care systems. The local LETB role, linking up with the health and well-being boards, is particularly important in that respect.

It is worth briefly mentioning two recent reports on integration, both of which, among other things, reinforce how much awareness and understanding of each other’s roles must take place for integrated services to happen and to be delivered. The shared commitment statement under the National Collaboration for Integrated Care and Support was drawn up by an impressive mix of national partner organisations, including government departments, the HEE itself, regulatory bodies, the Association of Directors of Adult Social Services, National Voices and other stakeholder groups. It pledges to help,

“local organisations work towards providing more person-centred, coordinated care for their communities”.

There is not time to go into detail, but National Voices’ A Narrative for Person-centred Coordinated (“Integrated”) Care, which sets out what integrated care and support looks like from an individual perspective, for both the cared-for and for carers, is a powerful vision for the future. It underlines how closely staff across primary, community, NHS and social care will have to work if this is to be achieved. The section of the narrative on communication describes professionals talking to each other, and patients always knowing who is co-ordinating their care, always being informed about what is going on, and having one point of contact. This in itself would be nirvana to most patients, service users and carers.

The recently published Nuffield Trust report, Evaluation of the first year of the Inner North West London Integrated Care Pilot, looks at developing new forms of care planning for people with diabetes and people over the age of 75. It underlines the importance of staff having a high level of commitment to the pilot and to the care planning process in particular. Initial results show that work on care planning and multidisciplinary groups resulted in improved collaboration across the different parts of the local health and social care system.

On public health, the HEE mandate itself states:

“The health of people in England will only improve in line with other comparable developed countries when the entire NHS, public health and social care workforce genuinely understands how their services together can improve the public’s health”.

Does the Minister accept that the HEE mandate supports the case for the Bill to include an explicit reference on the overall strategic context?

HEE’s role is to provide national leadership for workforce training, planning and development, ensuring that we have skilled, committed staff in the right place, in the right specialities and numbers. We need to meet these challenges of the future and of the changing face of healthcare provision. How to ensure an integrated approach to education and training across the NHS, public health and social care is a very strategic issue. I hope that the Minister will reassure the House on this by responding positively to the amendment.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, integration between health and social care is a strong theme of the Bill, and the Government take it very seriously. I very much agreed with a great deal of what the noble Lord, Lord Warner, and others said on that topic.

First, to deliver integrated care, it is important that local planning is aligned and is mutually reinforcing. That applies also to the planning of education and training. As Members of the Committee are well aware, the future needs of the NHS and the public health and social care system will require a greater emphasis on community, primary and integrated health and social care than in the past. An understanding is required of working in cross-disciplinary teams and working to break down barriers between primary and secondary care.

The mandate the Government published a couple of weeks ago gave Health Education England a clear remit to ensure that it trains and develops a workforce with skills that are transferable between these different care settings. The amendment of the noble Lord, Lord Warner, seeks to amend Clause 85 to require HEE to have,

“regard to the promotion of integration with care and support provision”,

when it performs its duty under that clause of ensuring that there are sufficient skilled healthcare workers for the purposes of the health service. As the noble Lord is well aware, Clause 88, which lists the matters that Health Education England must have regard to in exercising its functions in Clauses 85 and 87, already includes a requirement at subsection (1)(h) that Health Education England must support,

“integration of health provision with health-related provision and care and support provision”.

Subsection (1)(i) requires Health Education England to support staff to be able to work across different settings. These provisions were added to the Bill at the recommendation of the Joint Committee following pre-legislative scrutiny. Although Health Education England does not have a direct remit for the social care workforce, it will be expected to work closely with the social care sector at local and national level to ensure that workforce plans align with the training and development of the healthcare and public health workforce.

To support the development of this integrated approach, Health Education England needs to work with partners across health and care to develop common standards and portable qualifications. This must make it easier for staff to work and move between settings and should build on existing work, such as skills passports and national minimum training standards. Health Education England will work closely with the sector skills councils, Skills for Health and Skills for Care, nationally and through the local education and training boards, to ensure that workforce development is co-ordinated and integrated.

[Lord Campbell-Savours]

Let us consider a private home in the social care sector that is owned by an individual who, let us say, has 10 healthcare assistants in that home. How will this new authority be able to ensure that those people are properly trained? My noble friend’s amendment at least tries to insert into the Bill wording that would in part have covered that. How will this new body be able to ensure that those assistants are getting the necessary training?

[Earl Howe]

The noble Lord’s question relates specifically to private sector organisations, such as care homes, and the broad answer to it is exactly as I have tried to outline. Health Education England will make it its business to ensure, by working with the sector skills councils in social care, that the training that healthcare assistants and care assistants receive is fully aligned and consistent, and that it can more and more ensure that people can transfer from one sector to another. The issue of continuing professional development for somebody who is already working in such a setting is, of course, a separate issue, and we will come on to debate continuing professional development. However, that is the broad answer. As the noble Lord rightly said in his earlier contribution, all this will be increasingly important as more health training shifts into the community and into social care settings. We will see delivery of this training in a variety of settings, not just in the public sector.

To answer a question posed by the noble Baroness, Lady Pitkeathley, about what HEE will be doing to support the needs of carers, Clause 89(2)(c) means that HEE must ensure that it obtains,

“advice on the exercise of its functions from … carers”.

I hope that that gives her reassurance that the role of carers will be every bit as much in the sights of HEE as its other duties.

There is a further plank to this structure, and it is one which was mentioned by the noble Baroness, Lady Wheeler, whose contribution I listened to with great respect and agreement. The Bill places a clear duty on local education and training boards to consult health and well-being boards on their education and training plans. As the vehicle for strengthened partnership working across health and the local government and public health sectors, health and well-being boards will be well placed to reflect local priorities that need to be supported through workforce education, training and development.

The importance of multidisciplinary training was highlighted in the Government’s mandate to Health Education England. Although it will always be necessary to deliver discrete training programmes for many professions, there will be an increasing need to deliver healthcare in multidisciplinary teams, and the delivery of training should reflect this. Where appropriate it should incorporate working in multiskilled teams reflecting care pathways, rather than exclusively professional or staff groupings.

I hope that, with those remarks, the noble Lord, Lord Warner, is reassured that the Government fully support the spirit of his amendment. I hope that he has also gained a sense that, more than simply the spirit, we are pursuing the letter of what everybody wants to see: a much greater degree of integration of training and education in these sectors.

[Lord Warner]

I am grateful to the Minister for his remarks and I take them very seriously. I do not wish to be churlish, but I may be tempted along that path a little way.

Clause 85, as I understand it, is a regulation-making power. It seems to envisage that the Government of the day will from time to time make regulations that relate to very specific groups of staff. I have read the provision carefully, and it could presumably make regulations that exclude particular groups of staff. Somewhere along the way, there is a very real possibility that we will get regulations that cover particular groups of staff in a very specific manner. I am particularly interested in those groups of staff who work at the sub-professional level—the healthcare support staff. As my noble friend Lord Campbell-Savours said, these are very much the people who work across both these settings. At the moment, I cannot see why it will do harm—indeed, it is likely do some good—if we require this regulation-making power to take account of the kinds of issues which foster integration that I and other noble Lords have spoken of. The Minister mentioned the mandate. I know that mandates are extraordinarily fashionable at the moment, but mandates come and mandates go. Regulations tend to have a bit more sticking power than mandates, which might get out of date or move out of fashion.

I think that there is an issue here. I would probably be more reassured if the noble Lord could write to me, and send a copy to other Members who have spoken in this debate, on which groups the Government envisage covering in regulations under Clause 85(2).

[Earl Howe]

I would be happy to write to the noble Lord and other noble Lords on this topic. Perhaps I may add one final comment. If we were to go down the road proposed in this amendment, by providing a cross-reference to Clause 88(1)(h) in Clause 85, it could suggest that consideration of this factor alone takes priority over other factors. We want to avoid the risk of creating any perceived hierarchy in the matters to which Health Education England must have regard in the exercise of its function under Clause 85(1).

[Lord Warner]

I would like to reflect further on this. In the mean time, I beg leave to withdraw the amendment.

--- Later in debate ---

[Earl Howe]

My Lords, like my noble friend Lady Cumberlege, I pay tribute to the noble Baroness, Lady Greengross, for her very carefully crafted amendment. It seeks to extend compulsory statutory regulation to healthcare assistants and care assistants and to make further amendments to legislation to account for this. I want first to acknowledge the crucial role played by healthcare and care support workers in the delivery of high-quality care to patients and service users throughout the country. That much is a given. The vast majority of workers give the very highest quality of care and are relied on and valued for the way they improve people’s lives. However, we have all seen evidence that a minority let patients down. This is a cause for concern and it is right that there is discussion about how we can ensure consistent, high standards of care.

My noble friend Lady Cumberlege made some very compelling points on the terms of the amendment but on the wider issue of principle the Government do not believe that the case for regulation is proven. Compulsory statutory regulation is not, of itself, an effective way to assure the quality of care by these workers and it can detract from the essential responsibility of employers to ensure that any person they appoint is suitably trained and competent for the role.

There are already existing tiers of regulation that protect service users, including the standards set by the Care Quality Commission and the Disclosure and Barring Service. We also need to be clear that professional regulation is not a panacea. It is no substitute for good leadership at every level and proper management of services. It can also constrain innovation and the availability of services. Experience clearly demonstrates that a small number of those workers who are subject to compulsory statutory regulation from time to time fail to ensure that their practice is up to date and delivered to the standard that we expect. In these circumstances it is too often the case that regulation can react only after the event.

The placing of hundreds of thousands of individuals on a list would not, of itself, ensure that we never again see the appalling failings in care highlighted by the Francis report into Mid Staffordshire or, indeed, Winterbourne View. Strong and effective leadership of the workforce is where the focus for improvement should lie. Employers and managers who are closest to the point of care must take responsibility for ensuring standards.

We also recognise that we need to facilitate employers to appropriately employ, delegate to and supervise health and social care assistants. To this end, as I have previously mentioned, we commissioned Skills for Health and Skills for Care to develop a code of conduct and minimum training standards for these groups in England.

In addition, we have announced the Cavendish review to consider what can be done to ensure that all people using services are treated with care and compassion by healthcare and care assistants in NHS and social care settings. The Nursing and Care Quality Forum has been established to help all those involved in providing nursing and care in all care settings to deliver the fundamental elements of good care and achieve their ambition of providing the very highest quality of care. That is in part an answer to the point made very powerfully by the noble Baroness, Lady Masham.

The noble Lord, Lord Hunt, suggested that these workers are not being given the tools to upskill themselves. We want to ensure that all healthcare assistants provide safe, effective and compassionate care, and we have already announced a number of measures to support this, including a £13 million innovation fund for the training and education of unregulated health professionals, the publication of a code of conduct and minimum training standards for healthcare and care assistants, and a review of induction training by the CQC. This is work in progress.

Having made these points, I want to reassure in particular the noble Baroness, Lady Greengross, that we have an open mind as to the range of measures that need to be put in place. However, before we can take a rounded view of what those measures should be, we need to take account of the recommendations that flow from the Cavendish review. I suggest to the noble Baroness that that is the most sensible approach.

[Lord Hunt of Kings Heath]

My Lords, I am grateful to the noble Earl for giving way, but the terms of reference of the Cavendish review do not cover the regulation of healthcare support workers.

[Earl Howe]

No, the terms of reference encompass the core concern of the noble Baroness, Lady Greengross, which is the competence and skills of this sector of the workforce. That gets to the heart of the concerns of my noble friend Lady Browning around safety and the rest. The Cavendish review will point the way to a number of ideas that can move us in a positive direction.

[Lord Warner]

My Lords, perhaps I may ask the noble Earl a question before he sits down because I am getting increasingly puzzled by this debate. I agree with him that a list does not of itself do very much to protect the public, particularly if it is a list of apples, oranges, bananas, pears, cherries or whatever—and this is a list of people with different qualifications or experiences. However, the whole point about HEE is that it is meant to be a game-changer and to standardise some of the training for particular groups. Is it the Government’s view that the term “healthcare assistant” will start to mean the same in Cornwall as in Cumbria, because HEE has defined the training for those covered by that terminology to be the same wherever the person is trained?

[Earl Howe]

That indeed is the ambition whereby there should be consistency of standards throughout the country and people should know precisely what those standards are. The problem with this sector of the workforce is that the standards have not properly been defined until now—hence the work that Skills for Health and Skills for Care are doing. However, we will see from that work and the work of Camilla Cavendish where the gaps are and where we need to focus our attention. The noble Lord is certainly right to say that once we have these standards in place, Health Education England will be responsible for ensuring that they are properly promulgated and rolled out.

[Lord Sutherland of Houndwood]

My Lords, I thank the Minister for giving way. I appreciate his point about the responsibility of employers. They are immensely important. However, would he be prepared to extend the language of responsibility to liability, either of a fiscal, legal or right-to-practise nature? I am not asking for a detailed answer, but it would be a shift that many of us feel would be moving in the right direction.

[Earl Howe]

As a result of the Francis report, we are indeed looking at the whole question of the liability of employers in the NHS as much as anywhere else. No doubt we shall be debating those issues when we reach Part 2 of the Bill. However, I can reassure the noble Lord on that point. We have here a vital segment of our health and social care workforce. I hope that the noble Baroness, Lady Greengross—

[Lord Campbell-Savours]

I am sure the Minister will be very frank with the Committee. Is he aware of concerns being expressed about the operation of the vetting and barring scheme? Is he aware of any complaints?

[Earl Howe]

I am not aware of those concerns, and I apologise to the noble Lord as I meant to pick that up. I was slightly taken aback by his comment. Of course, I shall take advice on that point and I would be very happy to talk to the noble Lord outside the Committee on this matter. I have certainly not been made aware that that service is deficient in any material way, but that it operates effectively to protect patients and the public.

Does the noble Baroness, Lady Emerton, wish to intervene?

[Baroness Emerton]

No, my Lord.

[Earl Howe]

I conclude by saying to the noble Baroness, Lady Greengross, that I hope she takes some encouragement from the work that is in train, and that she agrees with me that it is right to take stock after we see the recommendations flowing from the Cavendish review later in the year. No doubt that can inform our deliberations on Report. I hope that, in the mean time, she will feel able to withdraw the amendment.

[Baroness Greengross]

My Lords, I thank all noble Lords who have spoken for accepting that the principle that I was arguing about is correct and that there is a need for something to be done. I think we all recognise that, too often, people receive rather poor care. It is very hard to pin down what is going on because we do not have the mechanism to do so.

I also thank the noble Baroness, Lady Cumberlege, for saying that the principle of what I said was right. I thank the noble Baroness, Lady Browning, and all noble Lords who have spoken for agreeing that something really needs to be done. In my rather simplistic way of looking at things, I think that training leads to a qualification that will lead to a registration. It is as simple as that. Getting the training right would eventually lead to a professional approach of which people could be more proud and which would give them the self-respect that they need and, in the majority of cases, deserve. That would also give us the knowledge that, when things go wrong, there is a mechanism that will stop them from getting worse.

I also agree with the Minister that the Cavendish review could be the way forward and perhaps this is pre-empting something that we will have to wait a while to achieve. I feel very strongly that this has gone on for far too long; the anxieties are really great and something must be done. I hope I can work with my noble friend Lady Emerton so that somehow we can speed things up a little. In the mean time, I thank the Minister for his comments and beg leave to withdraw the amendment.

--- Later in debate ---

[Earl Howe]

My Lords, there is no doubt that education and training can play an important role in creating a workforce that is research literate and innovative, with the skills required to diffuse the latest ideas and innovations. The noble Lord, Lord Turnberg, has focused our minds on some important goals in this area.

Through our investment in the education and training of health professionals, we must seek to ensure that our future practitioners know how to access evidence, use evidence and contribute to the national research enterprise. Developing a flexible workforce that is responsive to research and innovation is one of the key priorities that the Government have set for the Health Education England special health authority in its mandate. To answer the question posed by the noble Lord, Lord Turnberg, Section 63(1) sets out an objective for Heath Education England to support clinical academic careers.

Amendment 17 would require Health Education England to promote the use of research evidence to ensure the rapid uptake of innovations into practice. Amendment 20 would require it to exercise its functions to secure that research and innovation are incorporated into education and training. Amendment 32 would require it to have regard to the desirability of promoting research and innovation in clinical practice when performing its duties under Clause 85(1) to ensure sufficient skilled workers and Clause 87(4) when setting its objectives, priorities and outcomes for education and training.

The Government recognise very clearly the importance of promoting research and innovation. That is why Clause 86(2) of the Bill requires Health Education England, in exercising its functions, to promote research and the use of evidence from research in education and training activity. In response to stakeholder views in consultation and a recommendation from the Joint Committee that examined the draft Bill, we have strengthened the wording so that it is a duty to promote research. This has been welcomed by stakeholders such as the Academy of Medical Sciences and the Association of Medical Research Charities. It also reflects, incidentally, the equivalent duties to promote research already placed on the Secretary of State, NHS England and clinical commissioning groups by the Health and Social Care Act 2012.

The duty requires Health Education England to promote research activity in relation to its education and training functions, and the use of evidence obtained from that research, to secure continuous improvement in the quality of education and training. Those are pretty powerful provisions. I hope that noble Lords will appreciate from what I have said that Health Education England already has the necessary powers under Clause 86(2) to secure that research and innovation are fully incorporated into education and training.

I can reassure the noble Lord, Lord Turnberg, that Health Education England and the local education and training boards will work closely with research and innovation partners such as the academic health science centres and academic health science networks to deliver the duty to promote research. I can also reassure him that Health Education England will ensure that local education and training boards support this agenda and delivery of the duty to promote research. I hope that the noble Lord will feel sufficiently reassured by that to withdraw the amendment.

I shall now respond to the two other amendments to which noble Lords have spoken. Amendment 37 would add to a local education and training board’s main functions the promotion of research and the use of research evidence in the health service. Amendment 39 would require a local education and training board to support Health Education England in exercising its function to promote research into matters relating to social care services, primary care services and other health services so far as it is exercisable. I wholeheartedly agree that the local education and training boards need to take a strong interest in research and the use of research evidence when planning, commissioning and quality assuring the delivery of education and training. As noble Lords know, we have placed the primary duty to promote research on Health Education England but, as committees of Health Education England, the LETBs will be required to support the national body in delivering the duty through their workforce planning and education and training functions. Therefore, we do not see that the amendment is necessary in that sense. Health Education England will ensure that the LETBs support the delivery of key national duties, such as those in Clause 86, to promote research, support the NHS constitution and improve the quality of education and training. I also point out in this context that the appointment criteria that the Health Education England special health authority has used to appoint the existing 13 local education and training boards require the LETB to demonstrate effective mechanisms for partnership working with academic health science centres and academic health sciences networks.

I am sure that noble Lords will also be glad to know that Health Education England and the LETBs are working with the National Institute for Health Research, headed by Professor Dame Sally Davies, to ensure appropriate investment in education and training to develop clinical academic careers and increase the number of staff accessing academic careers programmes across all clinical and public health professions.

I hope that noble Lords will feel reassured that the spirit of the amendments is one which we have already grasped and which is reflected in the Bill and that they will therefore feel able not to press the amendments.

[Lord Turnberg]

My Lords, as always, the noble Earl gave some very reassuring words on this topic. I am not absolutely convinced that we do not need to strengthen the Bill a little more to reflect what he has enunciated, but, for the moment, I beg leave to withdraw the amendment.

Health: Midwives

Earl Howe Excerpts

Monday 10th June 2013 Lords Chamber

[Baroness Cumberlege]

My Lords, I beg leave to ask the Question standing in my name on the Order Paper. In doing so, I declare the interests that are on the Lords’ register and, in this instance, the unremunerative position as patron of Independent Midwives UK.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, a 12-week consultation on the legislation to require regulated healthcare professionals to hold indemnity or insurance closed on 17 May. We are now analysing the responses to assess how the issues might be addressed, including those affecting independent midwives—that is, self-employed individuals in the private sector. This includes consideration of different models of service. Officials are also facilitating meetings between NHS England and representatives of independent midwives to discuss emerging commissioning issues.

[Baroness Cumberlege]

My Lords, I thank my noble friend for that Answer. On 26 October, when the European directive comes into force, it will preclude around 170 independent midwives from practising, and this at a time when we have a burgeoning baby boom. Many of these midwives actually work within the NHS. Is my noble friend aware that many of these independent midwives are seeking a solution but they require help, advice and support from the department and, above all, a revision of the tariff for maternity services? Will my noble friend ensure that this issue is a priority for urgent action by his colleagues, the Department of Health and the other agencies involved?

[Earl Howe]

My Lords, as my noble friend knows, work has been going on for a number of years, including going back to the previous Government, to see whether there are viable ways of ensuring that this small group of independent midwives can obtain suitable indemnity or insurance cover. One of the difficulties we have had is the absence of information on the potential barriers to independent midwives moving to alternative governance and delivery practices in order to obtain that cover—hence the consultation I have spoken about. As I said, we are now analysing the responses. However, I do not agree that there is no way through. We know that some independent practitioners have opted for a corporate or social enterprise model as a way of gaining insurance cover. We are trying to understand what the barriers are to that among those who are resisting the idea.

[Lord Foulkes of Cumnock]

My Lords, why cannot these people just get employment as midwives within the NHS?

[Earl Howe]

My Lords, some of them already do. As I understand it, we are talking about 154 individuals as compared with 41,000 midwives on the register. If they work for the NHS, there is generally no issue; they will be covered by NHS indemnity in one way or another. The issue is if they wish to practise privately as individuals. That is the point of my noble friend’s Question.

[Baroness Jolly]

My Lords, there is a certain element of urgency here. A woman expecting her baby in October would be half way through her pregnancy now. What plans are in place to deal with such women under the care of these midwives and indeed the midwives themselves if, come October, the situation has not been resolved?

[Earl Howe]

My Lords, we are working hard on this. Officials from the department have been in discussion with stakeholders, including Independent Midwives UK, on an ongoing basis for at least four years with a view to identifying potential solutions to the issue. Arising in part from these discussions, independent midwives can now obtain affordable indemnity cover for the whole of the maternity care pathway either in the NHS or in the private sector. However, it is acknowledged that this is achievable only if they operate as part of some form of social enterprise or corporate entity. That is the issue that we have to get to grips with between now and October.

[Baroness Masham of Ilton]

My Lords, how independent are these midwives? Are they responsible to themselves?

[Earl Howe]

My Lords, in terms of their practice, they are responsible to themselves and of course to their patients or clients but they are registered with the Nursing and Midwifery Council as professionals.

Care Bill [HL]

Earl Howe Excerpts

Monday 10th June 2013 Lords Chamber

[Baroness Wheeler]

My Lords, we support the amendment. Our amendment on this issue relating to Health Education England’s national role in planning education and training for healthcare workers was considered last week. We were, in particular, keen to probe the role that LETBs will play in that important area.

The amendment would ensure that the annual reports of LETBs specify how they propose to support continuing professional development in that area. We strongly support that. The amendment specifies the medical professions, but it is applicable across the healthcare workforce. CPD is about ensuring that structured learning continues throughout one’s career, with clear objectives set and progress logged and regularly reviewed. CPD complements formal training and enables practitioners and other staff to acquire new knowledge and skills, as well as to maintain and improve their standards across all areas of their practice.

The HEE mandate has a small subsection on supporting the professional and personal development of the existing workforce, underlining the importance of HEE leadership and work with LETBs, but that aspect is far from being given the importance that it needs in the mandate—the point made by the noble Lord, Lord Ribeiro. There is of course emphasis elsewhere in the document on the workforce needing to be flexible and receptive to research and innovation, but CPD is wider than just keeping up to date and applies to values, behaviours and the ability to understand how one’s working role relates to the wider service, as we heard during our earlier debate on integration.

I could not see CPD addressed in any depth on the HEE website, although we join other noble Lords in welcoming the general, across-the-board progress that HEE has made in its new role so far. HEE recognises that providing leadership and ensuring greater transparency in the investment that employers make in their workforce and in supporting and championing multidisciplinary and professional CPD is a strategic priority. Does the Minister agree that HEE needs to step up and develop its CPD strategy as a major priority, and does he accept that the mandate needs better to reflect the importance of CPD?

The HEE website also mentions that it will be allocating a limited amount of central funding for LETBs to invest in CPD, particularly for staff employed at Agenda for Change bands 1 to 4 and equivalent staff employed as part of primary care teams in general practice, community pharmacy and other community-based employers.Does the Minister have any further information on how the Government expect HEE to take this forward with LETBs?

Last week I mentioned the recent member survey by the Royal College of Nursing on CPD, showing how varied the time allocated by NHS trusts is. It is worth going into the findings in a little more detail today. The survey found that in the past 12 months almost a third of respondents had received no CPD that was provided or paid for by their employer. By sector, just a third of respondents in the NHS received no training in the past 12 months, compared to just under a quarter of those working in the independent or voluntary sectors. Just over a third said that the amount of CPD provided had decreased in comparison to the previous year, while 45% said that it had stayed the same.

Interestingly, overall, members working in the NHS were more likely than those working in the independent and voluntary sectors to report that the amount of CPD undertaken had decreased. Obviously, CPD is a mix of both employer-supported and resourced training and personal development learning resourced by the individual, either in their own time or with their own money. However, the RCN survey shows a very worrying trend in the importance employers place on providing CPD. Can the Minister comment on this and on how the problem can be addressed in the future? Is he confident that HEE or LETBs will have the resources to address this problem?

Our earlier amendment was similar to the wording that the Government included in the original Bill but subsequently deleted. I am sure the Minister will explain his thinking behind this and, as the noble Lord, Lord Patel, fully expects, delight us all by announcing that he has decided to put the CPD wording back in.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, I make no apology for repeating my firm belief that the staff working in our NHS and public health system are the health service’s most precious resource. We must do all we can to ensure that staff have and continue to have the right values, training and skills to deliver the very highest quality of care for patients.

Clause 93 requires local education and training boards to publish an education and training plan for each financial year. The education and training plan must set out the local education and training board’s proposed investment in its current and future workforce for the following year. Note the word “current” in this context. In developing an education and training plan, the Bill makes clear that a local education and training board must consult with and have regard to the local priorities of, among others, the NHS and health providers and the commissioners that it represents.

The noble Lord, Lord Patel, asked what level of funding is attached to CPD in the NHS. The answer is that investment in CPD is really a decision to be taken locally. As I indicated, local providers and commissioners are best placed to decide what ongoing professional development their staff need. It will be their job to feed that in to the LETB as the local education and training plan is developed. I have already spoken in reply to an earlier group of amendments about the importance of continuing professional development, and the leadership role that Health Education England and local education and training boards can play in supporting this.

The noble Lord, Lord Patel, and the noble Baroness, Lady Wheeler, asked what happened to the reference to CPD in the draft Bill. The answer is that we widened the description in Clause 84(6) so that the Bill states that:

“HEE may, with the consent of the Secretary of State, carry out other activities relating to … education and training for health care workers”.

This still very much includes CPD. I emphasise that we consider this to be an important part of the way HEE may exercise this power. The NHS constitution sets out that staff can expect employers to invest in their development, and that all healthcare providers must take this issue seriously. Employers have a clear responsibility to provide their staff with the support and personal development they need, as well as access to appropriate training to enable them to fulfil their duties. However, Health Education England will play a crucial role in providing leadership in supporting employers in this area. The mandate sets out that Health Education England will work with LETBs and healthcare providers and commissioners to ensure that professional and personal development continues beyond the end of formal training to enable staff to deliver safe and high-quality health and public health services, for now and in the future.

--- Later in debate ---

[Lord Turnberg]

I am sorry to interrupt again. I think the noble Earl said that we should leave it to the local providers to decide what or how much CPD individuals should have. We know, however, that at the moment local providers are very variable in how far they are willing to go along that route. The problem is that leaving it where it is certainly does not give any great confidence that CPD will be uniformly available in the service. Hence the amendment of the noble Lord, Lord Patel, which tries to give a little force and pressure to local providers so that they could indeed be sure that CPD was being provided. The noble Earl is full of good intentions, quite rightly, but we need a little more than that.

[Earl Howe]

I probably expressed the position less than well because I was seeking to indicate that CPD is inescapable. There are a whole host of reasons why providers and the LETBs cannot avoid a focus on continuing professional development. Equally, we do not want to prescribe any kind of ring-fenced budget for CPD, for the reasons we debated earlier: we are clear that we must leave it to LETBs to exercise autonomy in the way that they work out their local education and training plans. They will have to prioritise, inevitably, in certain cases and from year to year. It may be that they will have to make hard choices. The great thing about Health Education England is that, as a non-departmental public body separate from NHS England, it will have a dedicated budget which cannot be eroded by those who might wish to siphon money off to patient care, for example. I hope that, in that sense, the noble Lord, Lord Turnberg, can take some comfort. We are very clear that the prescription is there and that local providers cannot avoid addressing the needs of their employees for CPD, but at the same time we do not want to dictate to them how much to spend on this in any one year.

[Lord Patel]

My Lords, I thank the Minister for his reply. I have no doubt whatever that he speaks with conviction and is full of good intentions. However, the way in which he spoke makes me feel that he, too, has some doubt that local providers and employers will deliver on this. If LETBs do not have any duty even to collect information about continuing professional development, local providers may not take any notice of the issue; there will be that variability in their reactions to which the noble Lord, Lord Turnberg, referred. However, I have no doubt that the Minister and the department have the intention that this will be delivered. We will reflect on that. In the mean time, I beg leave to withdraw the amendment.

--- Later in debate ---

[Lord Campbell-Savours]

As a layman among all these very professional people, I raise a very simple point. Returning to the private care home paying workers something like £7 an hour, I presume that that care home, if it so wished, could use the LETB.

[Earl Howe]

No, that is not the case, because the LETB is only responsible for healthcare staff, not adult social care staff.

[Lord Campbell-Savours]

Perhaps that answers the question, but from the way in which the Bill is written I understood that it went wider than that and included care home staff. What about nursing homes? Nursing home workers are healthcare workers, are they not? I suppose that they are covered by both areas.

[Earl Howe]

My Lords, in so far as nursing homes are staffed by healthcare staff, those staff are certainly eligible to benefit from the education and training budget. Indeed, I should have clarified that in privately run care homes you might well find a nurse who is healthcare trained, and therefore is in a position to receive the benefit of the healthcare budget if they are an employee funded by the NHS.

[Lord Campbell-Savours]

Then let us take it to the next statement. What about the healthcare assistant working in a nursing home—in other words, in this particular sector, where I presume the LETB applies? Would that worker also be trainable under the system established under the Bill, or does that nursing home healthcare assistant also have access to other training facilities outside the provision being made here? In other words, does the employer have the option?

[Earl Howe]

My Lords, training can be delivered in a variety of ways. It can be delivered onsite and on the job within the healthcare or care setting. It can be delivered outside as part of a higher education course. Who funds that will depend on the status of the worker. If he or she is a healthcare worker, it is possible, as I said, that they are funded by the NHS. It is also possible that he or she is privately employed by the organisation concerned, and that organisation will therefore fund the course of education. So it depends. I suggest that in a care home it is more likely that the person would be designated as a care worker rather than a healthcare worker if they do not have a recognised qualification to their name. I do not think that there is any generic answer to the noble Lord’s question. I hope that I have been helpful in explaining the various situations that can arise.

[Lord Hunt of Kings Heath]

There are various definitions relating to LETBs. For instance, Clause 90(3) says:

“In carrying out its main function, an LETB must represent the interests of all the persons who provide health services in the area for which the LETB is appointed”.

However, the general interpretation on page 89 defines not “health services” but rather “the health service” as,

“the comprehensive health service in England continued under section 1(1) of the National Health Service Act 2006”.

My question is: does “health services” in Clause 90 equate to “the health service” in Clause 110, or is “health services” in Clause 90 a wider interpretation that embraces the argument of my noble friend Lord Campbell-Savours?

[Earl Howe]

It may be convenient for the Committee if I take together the questions of the noble Lords, Lord Campbell-Savours and Lord Hunt, because the noble Lord, Lord Hunt, asked me about the role of the independent sector in participating in training and indeed in funding it. Perhaps I may clarify that.

The Health and Social Care Act 2012 placed a duty on the Secretary of State to ensure an effective education and training system, as I mentioned earlier. The Act also placed a duty on commissioners of health services to ensure that providers support the Secretary of State in this duty when contracting with them. The Government have already put into place measures to deliver the Secretary of State’s education and training duty by amending the commissioning contracts and supporting regulations for the delivery of services, so they now require co-operation on education and training. This means that all providers of NHS services are expected to co-operate and, where appropriate, this co-operation will involve them providing education and training.

--- Later in debate ---

[Lord Campbell-Savours]

I have one final question. How can a person placing a relative in a care home know that the standard of care provided in that home by presumably trained healthcare assistants will be of a similar standard to that available under the arrangements proposed in the Bill for those who work directly in the healthcare sector of the National Health Service?

[Earl Howe]

The answer is twofold. First, the Care Quality Commission inspects every care home to a uniform standard. One of its duties is to ensure that the staff in a care home are sufficiently capable and trained to deliver care in the right way to the patients and service users who live there, taking into account the acuity of need of those people. Secondly, as the noble Lord may be aware, the Government have proposed that a system of star ratings should be reintroduced for both healthcare settings and adult social care settings. In that way the general public may have a much closer and more detailed sense of the quality of care provided in the care home, as assessed by the Care Quality Commission. Again, this is work in progress. The Care Quality Commission is working out its methodologies for delivering those star ratings, but if we get this right, I believe it will take us several steps forward in transparency of quality and the ability of members of the public to choose, in a much more meaningful way, the setting that they wish to see either themselves or their families benefiting from.

[Lord Hunt of Kings Heath]

My Lords, that has been extremely useful. The intervention of my noble friend Lord Campbell-Savours has been particularly useful. Reading Clause 86 (5) together with Clause 93 and the interpretation in Clause 110, it becomes clear that many nursing homes will receive some funding from the NHS in providing continuing healthcare for some residents. That seems to me to be very helpful indeed because, given that there is a great deal of concern about the quality of staff in nursing homes and the training of those staff, it gives local education and training boards a clear remit to concern themselves with the staff in a lot of nursing homes in their area. I hope that it will be possible for a message to be sent to Health Education England from this debate that, if it is looking at the most vulnerable areas in terms of vulnerable people, that ought to be where the priority should be. My noble friend has teased out a very important indicator of the way in which LETBs should work in future. I hope we will see in their plans that a major effort will be devoted to the staff in those homes.

On the more general question, I noted that the Minister had been urged to be cautious by various bodies in relation to whether there should be a levy on private sector providers. It is a bit rich of the Future Forum to worry about the third sector contribution since it is the Future Forum that has tried to open the door to a competitive market in the NHS. The third sector and Sir Stephen Bubb cannot have it all ways. If he wants to have a competitive market, as he seems to, then the third sector can jolly well make a contribution alongside the NHS. They cannot have it both ways.

[Earl Howe]

My Lords, I hear what the noble Lord has said on this. In practice, as he knows, most education and training take place in the public sector, but we expect Health Education England and the LETBs to seek advice from a range of stakeholders. Indeed, HEE has reinforced the importance of this in the appointment criteria that it has set for LETBs which state that they should demonstrate meaningful collaborative working relationships with stakeholders, including third and independent sector providers. This will help to establish stronger links with the independent sector so that it can deliver clinical placements and perhaps also postgraduate training programmes where appropriate.

Clause 95 agreed.

--- Later in debate ---

Moved by

[Earl Howe]

53: Schedule 7, page 118, line 27, at beginning insert—
“(A1) The HRA must appoint a committee for the purpose of giving advice—
(a) to the HRA in connection with the exercise of the HRA’s function under regulation 5(1)(a) of the Health Service (Control of Patient Information) Regulations 2002 (S.I. 2002/1438) (approval for processing confidential patient information);(b) to the Secretary of State in connection with the exercise of the Secretary of State’s functions under regulations 2, 3(4) and 5 of those Regulations (processing of confidential patient information).”

[Earl Howe]

My Lords, I beg to move Amendment 53, and at this point it will be convenient to consider government Amendments 54 to 57 as well.

The importance of balancing a person’s right to confidentiality with the benefits of using information to improve the current and future health and care of the population cannot be underestimated. The NHS constitution sets out a number of rights and commitments in this regard.

Section 251 of the NHS Act 2006 provides the Secretary of State with a power to make regulations that modify the common law obligations of confidentiality so as to allow researchers, public health staff and other medical practitioners to access information where there is no reasonably practicable way of obtaining consent to use such information for the purposes of medical research; that is, in the interest of improving patient care or in the public interest.

The Health Service (Control of Patient Information) Regulations 2002 made under Section 251 of the NHS Act make provision for public health surveillance and risk management, work associated with cancer registration and approvals for the processing of confidential patient information for medical purposes in certain circumstances, provided that the processing has been approved by the Secretary of State.

These amendments provide continuity for the functions of advising on the approval of processing of confidential patient information for medical purposes, other than direct patient care. These functions were previously carried out by the national information governance board and its ethics and confidentiality committee. The special health authority has been directed to undertake these functions since 1 April this year, and so the provisions would ensure continuity.

I turn to the detail of this group of amendments. The amendments would require the Health Research Authority to appoint an independent committee to provide advice on applications to process confidential patient information. The committee would advise on approvals to process confidential patient information for medical research purposes and for other medical purposes. As the Bill is currently drafted, the Health Research Authority would have the power to appoint such a committee under its proposed functions in Schedule 7 to the Bill, but this would be discretionary.

This group of amendments would ensure that such a committee is established and that it is independent. This is important to ensure that the arrangements that are currently in place will continue, maintaining public confidence in the decisions made. In the interests of consistency across the system, these amendments would require a single, independent committee to advise both the Health Research Authority itself on approval for medical research purposes, and the Secretary of State on all other approvals for medical purposes.

The Health Research Authority special health authority has established an independent committee, known as the Confidentiality Advisory Group, to advise the existing Health Research Authority and the Secretary of State on approvals. The provision of transparent, expert and independent advice to support approvals for processing of confidential patient information is vital. It protects and promotes the interests of the patient while facilitating the appropriate use of confidential patient information beyond direct patient care. It ensures that each application for approval is carefully considered and that there is consistent, expert advice to inform approval decisions.

I hope noble Lords will accept that these amendments will ensure that there continues to be independent advice on applications to process confidential patient information for medical purposes. I beg to move.

[Lord Hunt of Kings Heath]

My Lords, I am sure that the amendments will be welcome, and that access to confidential patient information needs to be accompanied by full safeguards for the protection of individual patient privacy. However, will the noble Earl also confirm the importance of access to this information for the purposes of legitimate research? Can he also confirm that by transferring these functions to the HRA, we can look forward to a more transparent, consistent and streamlined process in the future?

[Earl Howe]

My Lords, as I indicated, we have always needed to strike a balance—reflected in the 2002 regulations which the noble Lord brought forward in that year—between protecting the rights of the individual and ensuring that ethical approved research can take place using confidential patient data only where appropriate. I agree with the noble Lord that we should not place any undue barriers in the way of research, but there are clear rules around this which we need to honour and protect. We will be reaching a group of amendments around the issue of transparency, and if the noble Lord will allow it, I will reserve my remarks on that until we reach that group of amendments.

Amendment 53 agreed.

Moved by

[Earl Howe]

54: Schedule 7, page 118, line 27, after “appoint” insert “other”

--- Later in debate ---

[Lord Warner]

Perhaps I may respond to my noble friend. I was arguing the case on behalf of the Joint Committee as much as anything else. The committee heard a lot of evidence on this, and across the parties, and across the Commons and the Lords, the conclusions were drawn up in its report to the Government.

I say to my noble friend that most of these clinical trials look at a product which is being tried for a particular purpose. If that product happens to fulfil some other purpose, a different set of issues arises. Seroxat was actually trialled as an anti-depressant, but it failed that test in so far as it was applied in a dangerous way to juveniles. The information about it failing that test was concealed from the public and the regulator. My wording might not be perfect but I am not arguing for my wording. I am trying to get the Government to engage with the issue so that they can find a wording that meets my concerns—and, I suspect, those of my noble friend Lord Turnberg—in the way that the Joint Committee proposed, to engage the HRA in ensuring proper transparency when there are downsides to research. That is in no way stopping a pharmaceutical company from using a drug or trialling a drug for a different set of purposes from that for which it was originally constructed.

[Earl Howe]

My Lords, I say straight away that I sympathise with the intention behind the noble Lords’ amendments. These two amendments seek to make an explicit statement about the Health Research Authority’s role in encouraging transparency in health and social care research findings and clinical trial results.

We are all keenly aware of how topical the issue of transparency in health research is. The House of Commons Science and Technology Select Committee is currently undertaking an inquiry into clinical trials. Last week I gave evidence to that committee along with my right honourable friend the Minister of State for Universities and Science. I look forward with interest to the committee’s report. As the noble Lord, Lord Turnberg, and the noble Baroness, Lady Wheeler, rightly pointed out, maintaining trust in research is crucial to its success, and the way in which we respond to the mounting calls for greater transparency has consequences for how the integrity of research conducted in this country is perceived not just on a national level but on the international stage.

However, in reaching answers to these pressing questions, we must be careful not to create perverse incentives that simply result in people choosing not to carry out research in the UK and invest elsewhere. Promoting transparency in research is a core part of facilitating the conduct of safe, ethical research. People enrol in trials because they want to contribute to medical knowledge and advances. In considering the ethics of research proposals, ethics committees have to be assured that any anticipated risks, burdens or intrusions will be minimised for the people taking part in research and will be justified by the expected benefits for participants, or for science and society. Knowing what research has already been undertaken or is under way and the results of that research is therefore essential in order to minimise risks and burdens by not repeating research that has already been conducted.

Here, I come to the answer to the question asked by the noble Lord, Lord Hunt, in debate on the previous group of amendments. Promoting transparency in research is inextricably part of facilitating the conduct of safe and ethical research, which is the Health Research Authority’s main objective in Clause 97(2)(b). As Dr Wisely, the Health Research Authority chief executive, said in evidence to the Joint Committee which scrutinised the draft Bill, promoting transparency is absolutely fundamental to protecting patients and the public in health research. As a special health authority, the Health Research Authority is already doing a number of things with regard to transparency in research. First, research ethics committees already consider an applicant’s proposals for the registration and publication of research, for dissemination of its findings, including to those who took part, and for making available any data or tissue collected as part of the research.

Secondly, since April 2013, the Health Research Authority has been undertaking checks of research ethics committee applicants’ end-of-study reports to see whether they registered and published research as they declared they would to the ethics committee. Thirdly, as noble Lords may be aware, the Health Research Authority recently published a position statement setting out its plans for promoting transparency in research. This statement has received widespread support from stakeholders, including the AllTrials campaign, the James Lind initiative, the Association of the British Pharmaceutical Industry and INVOLVE.

I turn specifically to Amendment 63, which would specify that one way in which the Health Research Authority, the bodies listed in Clause 98(1)—for example, the Human Tissue Authority—and the devolved Administrations would be able to fulfil their respective duties to co-operate would be through encouraging transparency in the reporting of clinical trials results. The intention behind these duties of co-operation is to encourage co-ordination and standardisation of practice so as to streamline regulation and remove duplication. The aim is that through these duties the people and bodies listed will work collaboratively with the Health Research Authority to create a unified approval process for research applications and to put in place consistent and proportionate standards for compliance and inspection. Streamlining the approval process for research will make initiating research faster for researchers, funders and sponsors, and ultimately enable people who use health and care services to benefit from research more quickly.

Noble Lords will be aware that clinical trials in this country are governed by EU law. The EU Commission’s current proposals for a new clinical trials regulation look likely to enshrine the principle of transparency in the rules governing clinical trials at every stage, including, as the current proposals set out, mandatory publication of clinical trials summaries, not only in their technical form but in a form that ordinary members of the public will understand. We believe that that is the right direction of travel.

Given the focus of these duties on streamlining the regulatory system that the HRA has, I hope that noble Lords understand why it is not necessary to make encouraging transparency in reporting clinical trials a fundamental part of co-ordinating and standardising the regulatory practices of the persons and bodies listed and the devolved authorities. I hope that noble Lords are reassured by the fact that promoting transparency is a core part of the Health Research Authority’s main objective in facilitating safe and ethical research.

The noble Baroness, Lady Wheeler, asked about discussions with the national advisory council on health improvement drugs. Perhaps I may write to her on that topic. I hope she will forgive me for not answering now.

The noble Lord, Lord Campbell-Savours, asked about the patient information leaflet that is now mandatory within packs of medicines. The risks that are set out typically on the patient information leaflets can be derived in several ways: first, from the original clinical trials data—the noble Lord is quite right about that—but also from any data that may have subsequently arisen from the reporting system that exists. Pharmacovigilance legislation, which came into force last year, now enables the Medicines and Health products Regulatory Authority to require pharmaceutical manufacturers to report safety and efficacy data where either concerns arise or where the evidence for a medicine was perhaps less than it might have been in the first instance. So transparency can be promoted in that sense as well. The noble Lord may already be aware that the MHRA regards its pharmacovigilance responsibilities extremely seriously.

[Lord Campbell-Savours]

Is the Minister therefore saying that, in the event that adverse effects arose during the course of the clinical trial, there is now a requirement that the risk factors, as set out in the leaflet to which he referred, will reflect those adverse effects?

[Earl Howe]

There is a requirement that the patient information leaflet should contain warnings about the possible adverse side-effects of the medicine. The noble Lord is quite right that data may well have arisen from the clinical trials, but also from the yellow card reporting system, as it is called, and any other data that emerge from across the world. The point is to ensure that the patient is properly informed. No medicine is risk-free. All medicines carry some kind of risk of a side-effect and one has to recognise that that is part and parcel of the benefit that we get from medicines. The benefit-risk equation has of course to be positive, but these things need to be kept under scrutiny.

[Lord Campbell-Savours]

The noble Earl said that it “may well reflect”, which is different from “shall reflect”.

[Earl Howe]

The MHRA, in granting a marketing authorisation to any medicine will have access to all the clinical trial data that the company has at its disposal. That is mandatory. Therefore, if the MHRA decides to issue a licence for a medicine, it will require that the full range of adverse effects is reflected in the patient information leaflet. The answer to the noble Lord’s question is yes, but he will not necessarily see a whole lot of technical data in the patient information leaflet. It will be translated into language that the ordinary patient can understand.

I believe that the Bill as drafted already gives the HRA a clear objective which requires it to take an active role in promoting transparency in research. I hope that I have given enough reassurance on these issues to all noble Lords to enable the proposers of Amendments 58 and 63 not to press them.

[Lord Warner]

My Lords, that was an interesting and rather complicated set of assurances from the noble Earl. I would like to consider it carefully and talk to my noble friend Lord Turnberg and the noble Lord, Lord Patel, before considering whether to go any further.

As an observation, if the EU directives are going in the direction of this amendment and there is a lot of concern to make sure that patients are left in no doubt that a full, frank publication of reports including the adverse consequences of that research is a prime consideration, I still cannot see why we cannot put something—whether my wording or something equivalent to my noble friend's wording—on the face of the Bill. I would like to think about that a little further and I certainly do not promise not to bring this issue back after talking to my noble friends. In the mean time, I beg leave to withdraw the amendment.

Care Bill [HL]

Earl Howe Excerpts

Monday 10th June 2013 Lords Chamber

[Lord Patel]

My Lords, I support Amendments 38 and 41 in the name of the noble Lord, Lord Turnberg. I slightly disagree, which is difficult to do, with the noble Baroness, Lady Cumberlege. In the new world, postgraduate deans are responsible not just for medical education, but for the whole of health education. If Health Education England is to be a body that influences education and training from the beginning to the end—we will come to another amendment relating to continuous professional development—postgraduate deans and deans of medical and nursing schools are crucial. If they are not to be represented on the local education and training boards, Health Education England cannot, through its committee, influence any of the innovations in education and training. That would be wrong.

There are examples where postgraduate deans and deans of medical and nursing schools are represented on education and training boards and they work fantastically well. I cannot see any reason why postgraduate deans and deans of nursing and medical schools could not be represented on local education and training boards, no matter what their size. I support the amendment.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, this is a really useful short debate. I begin by saying that members of the Committee should not feel anxious; I feel that there is a degree of anxiety which needs to be allayed.

Local health providers and their clinical leaders have told us that they are well placed to understand the changing shape of services and the way in which their workforce must respond to deliver high-quality services to patients. They are able to link workforce planning to service and financial planning, something that has not always been done well in the past and which has contributed to failings in workforce planning.

Following consultation, we have chosen to give local education and training boards a statutory basis as committees of Health Education England. But the policy intent, reflected in the Bill, is that they are not mere local delivery arms of a national body. Rather, they are a key part of decentralising power, so for the first time, the providers of health services will have clear responsibility and accountability for the planning, commissioning and quality management of education and training for their workforce.

The mandate to the Health Education England special health authority includes a clear objective to support more autonomous local decision-making on behalf of local communities. A critical measure of the success of Health Education England at national level will be the effectiveness with which its engagement with the LETBs and employers results in greater responsibility and accountability for workforce development being taken by employers at local level.

At the same time, with localism comes accountability. HEE will need to hold LETBs to account for their investment in education and training and delivery against key priorities. Of course, there needs to be co-ordination in the approach to planning and delivering education and training. That is why the Government, and the vast majority of stakeholders, believe that we have got the balance right in establishing Health Education England as a national leadership organisation for education and training, with local providers securing greater autonomy and accountability through the LETBs. There will always be national level priorities and objectives for workforce development and, rightly, Ministers want reassurance through Health Education England that they are being addressed, but the policy intent is to do that in a way that strikes a balance between the national and the more local perspectives.

Amendment 22 is intended to ensure that duties under Clause 86 extend to the LETBs. I appreciated the balanced comments of the noble Lord, Lord Hunt of Kings Heath, and wholeheartedly agree that local education and training boards, given a statutory basis as committees of Health Education England, should support Health Education England in the delivery of key national duties, including those in Clause 86. As commissioners of education and training, Health Education England and the LETBs will work with education partners, service providers and professional regulators to ensure that the education and training that is provided in education institutions and in health service settings continually improves and delivers health professionals who are fit for purpose and who meet the needs of employers, patients and service users.

We have already discussed the importance of research and the role that local education and training boards can play in supporting the diffusion of research and innovation. By promoting the NHS constitution through its workforce planning and education and training activities, HEE and the LETBs will help to ensure that staff develop the correct values and behaviours to practise in the NHS and the public health system.

Amendment 47 would amend Clause 92 to place an obligation on Health Education England to provide guidance on how it will ensure that providers of health services co-operate with local education and training boards. Clause 92 builds on an existing duty introduced by the Health and Social Care Act 2012, which places a legal obligation on commissioners to make arrangements with providers to secure their co-operation with the Secretary of State on education and training. The purpose of that duty is to ensure co-operation with the local education and training board to support workforce planning activities, the provision of workforce information and the delivery of education and training to healthcare workers. That is an important step in ensuring that the system is well integrated and that all providers play their part in supporting essential education and training activity.

To emphasise that, and in answer to a question put to me by the noble Lord, Lord Hunt, Clause 92 provides that regulations,

“must require specified commissioners ... to include in the arrangements under the National Health Service Act 2006 ... terms to ensure that”,

providers co-operate with the LETB.

The Government have already put in place measures to deliver the duty in the Health and Social Care Act 2012, which came into effect on 1 April 2013, by amending the commissioning contracts and supporting regulations for the delivery of services, so that they now require co-operation on education and training.

It will be the regulations rather than any guidance which will set out how the duty is to be implemented. The level of co-operation, the information requested and the obligations required may vary over time. It is therefore more appropriate to enable this level of administrative and procedural detail to be set by regulations rather than in the Bill.

Turning next to Amendments 38, 41 and 50, as we have previously discussed, it is important that Health Education England and the LETBs have access to people with expertise and knowledge on education and training matters. The postgraduate deans have great knowledge and expertise and, through the local education and training boards, they are now an integral part of the new system, working alongside other colleagues to strengthen the multidisciplinary approach to planning and developing the workforce. It is important to remember here that Health Education England and the LETBs have responsibility for the education and training of all the professions. Although medical training is a very important element of their functions, the LETBs have a much broader focus.

--- Later in debate ---

[Lord Turnberg]

The problem is that I suspect there to be a conflict. There is a desire to devolve responsibility for education to local education and training boards, which are dominated, of course quite reasonably, by local providers. Their desire is to see a trained workforce in the right numbers, and they will be very interested in workforce planning. There is also a drive at the centre to maintain standards across the country, and so there is tension between the two. The noble Earl set out a number of provisions which will help. The amendments we put down were meant to strengthen that capacity in order for the LETBs to inspire confidence that they fully take account of educational standards and all that sort of thing, as well as the need to provide numbers of doctors, nurses, trainees and everything else.

[Earl Howe]

My Lords, I would rather have a creative tension than a disconnect. If we get this right the tension will be there but it will be mutually reinforcing. You will have accountabilities running in both directions, essentially, from the national to the local and from the local to the national. In the past this has been a notoriously difficult area to get right. We hope and believe that the structure we are putting in place, in which the LETBs are committees of the national body but which have their own autonomy to a certain degree, will ensure that the tension that the noble Lord referred to really is creative, rather than the reverse.

[Lord Hunt of Kings Heath]

My Lords, that was a very useful exchange. I do not disagree with this architecture, in which national leadership comes from HEE but considerable autonomy is given to LETBs. When looking back at the history of the NHS I remain concerned, as does my noble friend, about failure to implement national strategies in relation to the workforce. This is because decisions are being taken locally which do not fit into the national strategy, particularly over training commissions. This afternoon the noble Earl said that HEE has enough powers to intervene if that were to happen. I think the question is whether HEE has enough national leadership and confidence to actually ensure that a national strategy is implemented. Of course, we will have to see.

On membership, I note the noble Earl’s statement about the number of different professional groups that will have to be covered by LETBs, which is why postgraduate deans are not listed on the face of the Bill. I think that my noble friend really was persuasive on this point. Doctors may not be the only profession, but they are a very important profession. I would have thought it quite extraordinary not to have a postgraduate dean among those around the table of the LETB. Equally, I do not think that the patient advisory forum is sufficient at national level. Considering the NHS record over the last few years, one of the areas causing most concern has been whether trained staff are fit for purpose when it comes to clinical areas. To have a representative of a patient or carer around the table at a LETB would have been very important. However, this has been a good debate, and I beg leave to withdraw my amendment.

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, like my noble friend Lord Campbell-Savours, I remain puzzled by the Government’s approach. I am grateful to the noble Baroness, Lady Emerton, for setting out a number of persuasive arguments for why there ought to be mandatory training for health and care support workers. There seems to be a general consensus around the House and no doubt the Minister will agree with it. My reason for supporting the amendment is that mandatory training is clearly very important, but it is inevitable that if you have mandatory training you have regulation; the two run together. Those who are proposing these amendments ought to recognise that there is an inevitability that if you have training then you must have a list of people who are trained; action has to be taken against those people who have been trained but are then found to be unsafe in dealing with vulnerable people; and there has to be a way of removing them from the list of those who have been trained that has been published. If you go down this route, one way or another you are clearly signing up to mandatory regulation, and a jolly good thing too.

Amendment 23A puts forward an eminently sensible suggestion for healthcare support workers to be certified to show that they have been trained in basic standards, with employers to register individuals who hold such certificates. We need to go back to the Francis report. Mr Francis is widely reported to be disappointed with the Government’s response to his report, and it is not hard to see why. His report commented on the absence of minimum standards in training and competence. This is compounded by huge variations in the approach of employers to job specifications, supervision and training requirements. That is why my noble friend Lord Campbell-Savours has come across so many instances of poor-quality healthcare support.

The Prime Minister’s Commission on the Future of Nursing and Midwifery noted that training for support workers was very variable and recommended that they should be better trained. In response, as the noble Earl told us earlier, the Government have commissioned Skills for Health and Skills for Care to work together to develop a code of conduct and minimum induction and training standards. We now know from the mandate issued by the Secretary of State to Health Education England that it is obliged to establish minimum training standards for healthcare assistants by spring 2014. At this point, I ask the noble Earl: how far does that go? Will it be mandatory for all entrants to the role of healthcare assistant to undertake such training? If that is so, will this extend to care assistants? What about existing health and care support workers? Will this training extend to them, or will it apply only to new people coming into the healthcare profession?

Under the proposals, how will employers know if their support workers have undertaken the minimum standard of training? Will a nationally recognised certificate be issued? Will a national list be established, indicating those who have undertaken such training? If there is not a list, does that not leave a big burden on employers seeking to check whether prospective staff have undertaken the minimum training requirement under the mandate? I come back to the point I made at the beginning: if a list is established, would that, in essence, not amount to a register? If there is such a list or register and it becomes clear that a support worker is unsuitable to care for vulnerable people, is there a way in which an organisation or employer could then apply to have such an individual removed from the list of people who have received the minimum level of training?

Having a certificate showing that someone has achieved a minimum level of training will be generally regarded as a certificate of an ability to practise. If there is such a certificate, there must be a way to remove that certificate if people are found to be wanting. In effect, once one begins to lay down minimum standards and to specify mandatory training, will there not be an inevitable step towards regulation? Amendment 23A poses those questions to the noble Earl. I hope that he will answer sympathetically.

[Earl Howe]

My Lords, I first thank the noble Baroness, Lady Emerton, for an interesting set of proposals and I am grateful for her thoughtful introductory remarks. I agree that ensuring the capability of the health and care support workforce is vital to delivering high-quality care to patients and service users across both health and social care settings. The issue is how we achieve this. Key requirements for delivering high-quality care can best be achieved by providers having the right processes in place to ensure they have the right staff with the right skills and the right training to deliver the right care in the right way to patients and service users.

The idea of statutory requirements can seem an attractive means of ensuring patient safety, yet Robert Francis’s report demonstrates amply that this in itself does not prevent poor care. I confess that I was a little surprised by the vehement support of the noble Lord, Lord Hunt, for the idea of statutory regulation because it was an idea that his Government resisted for some time. I suggest that they resisted it for a number of reasons and they came to the conclusion that it is not as self-evident as some like to make out. That is certainly this Government’s position. This is not, as the noble Lord, Lord Campbell-Savours, suggested, a laissez-faire attitude on the part of the Government. As we made clear in Patients First and Foremost, the initial response to the Francis inquiry, the Chief Inspector of Hospitals will ensure that all hospitals act to make sure that all healthcare assistants are properly trained and inducted before they care for people. I suggest that this is an important step forward.

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[Lord Campbell-Savours]

Has anyone in the department ever sat down to work out the annual cost to the health service of paying for litigation defence and compensation to people who have made complaints successfully? What proportion of those complaints stem from failures on wards arising simply from a lack of training? Would that not be a useful exercise for the department? Although I know it is difficult to introduce this principle of candour, it might well be that if someone were to look at this and some honest assessments were made in hospitals, we might find out that a lot of it has to do with people simply not being trained properly.

[Earl Howe]

I agree with the noble Lord. It would be an interesting exercise. If I can glean relevant facts from the National Health Service Litigation Authority, which is the holder of the corpus of information in this area, I would be glad to share it with noble Lords. We do not dispute that skills are an issue. They clearly are. That is why we have instigated the Cavendish review, but it is important that we set about this in the right way.

The Secretary of State has clearly stated in his mandate to Health Education England that it should work with employers to improve the capability of healthcare assistants. That will include the standards of training that they receive. In developing a strategy and implementation plan to achieve this, Health Education England will build on the Cavendish review, when it is before us, and the work of Skills for Health and Skills for Care on minimum training standards for health and care support workers.

The Government accept that the arrangements for induction, training and performance management of this workforce vary between providers. We do not duck the importance of training and I want to stress that. The Cavendish review has been tasked with reviewing how the training and support of healthcare and care assistants can be strengthened so that they provide safe and compassionate care to all people using health and social care services. The noble Lord, Lord Patel, is right that Amendment 23A and whatever recommendations emerge from the Cavendish review may not necessarily be mutually exclusive. At the same time, it surely makes sense for the Government to look at all these issues in the round before pronouncing one way or the other on prescribing specific arrangements around certification, new criminal offences or whatever the case may be.

I hope the noble Baroness will agree that the Government should be afforded the time to consider any recommendations from the Cavendish review and the respective roles of employers, commissioners, regulators and other bodies before taking further steps. At the same time, I hope that she will feel reassured by what I have said today and that Health Education England and the Government have taken sufficient steps in committing to the training and development of this workforce, and that she will feel able to withdraw her amendment.

[Baroness Emerton]

My Lords, I thank the Minister for his summary and noble Lords who have taken part in this debate. I think there is no doubt in anybody’s mind that this is a very important subject, which we cannot ignore. In his summary, the Minister suggested that the Government need to take this away and look at it. I think that we, too, need to take it away and look at it, and at what the Minister said. Will the Minister tell us when the Cavendish report is to be published? We understood that it was signed off two or three weeks ago, and we need to understand where it fits into the picture with the CQC. I thank the Minister for his comments. I will withdraw the amendment tonight on the basis that I will return to it later in the passage of the Bill. I beg leave to withdraw the amendment.

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[Baroness Wheeler]

My Lords, I shall make a brief intervention in support of the desire of my noble friend Lord Rea to draw our attention to the importance of interprofessional education if we are to develop health and social care staff’s mutual respect, understanding and knowledge of each other’s professions that will bring about the collaboration, joint working and integration of care and support that we need. My noble friend describes this as staff knowing “how the other half lives”—in other words, staff knowing about each other’s services and how they operate, and being aware of boundaries, interdependence on achieving outcomes and competing agendas. He commends IPE because it provides an established model of collaboration and co-operation on the ground.

The amendment refers back to our earlier debate on integration and the need for multidisciplinary teamworking, and it will also be relevant to the debate that we will come to shortly on the importance of continuing professional development for healthcare workers. It adds promoting the use of joint IPE for clinical and social care staff as a matter that HEE must have regard to in relation to its responsibility for promoting the integration of healthcare and health-related provision.

My noble friend helpfully sent me a considerable amount of background information on his amendment in which, as a former HR professional, I was genuinely interested. It included extensive research by the Centre for the Advancement of Interprofessional Education, which my noble friend referred to, supporting the effectiveness of interprofessional education and training. My noble friend also referred to discussions between CAIPE and Health Education England to explore HEE’s role in taking IPE forward and embedding it in professional curricula. This is to be welcomed. Two-thirds of UK universities with two or more undergraduate programmes in health and social care include IPE, so these discussions will be helpful. These programmes cover a wide range of professions, including nursing, social work, physiotherapy, pharmacy, clinical psychology and radiography—all professions that are increasingly required to work flexibly across different care settings as part of multidisciplinary teams.

The Nuffield Trust evaluation of the first year of the inner north-west London integrated pilot that I referred to earlier underlined the importance of staff in multiprofessional teams having a high level of commitment to the pilot as a key factor in improving collaboration across different parts of the local health and care system. However, the evaluation also reminds us of the international evidence that integrated care takes years to develop and that a minimum of three to five years is needed to show impact in relation to patient experience and outcomes. Culture change, moving from silo to collaborative working among professionals, is a slow process, however committed we are to trying to make it work. I look forward to the Minister’s response to my noble friend’s amendment.

[Earl Howe]

My Lords, if I may say so, the noble Lord, Lord Rea, has explained his amendment in a very compelling way. Amendment 31 seeks to amend Clause 88(1)(h) so that Health Education England must have regard to the promotion of joint interprofessional education of clinical and social care staff where appropriate. As he is aware, much of the ground on these issues was covered in our earlier debates, when I hope I was able to reassure noble Lords that the Government take this issue very seriously. Clause 88 of the Bill, in listing the matters that Health Education England must have regard to in exercising its functions, is clear that Health Education England must support integration between health and care, and support staff so that they are able to work across different settings in health and social care.

In establishing Health Education England with a multiprofessional remit with responsibility for the development of all the professions, the Government have reinforced the importance of planning and developing staff in an interprofessional manner. As I mentioned, this approach is reinforced further in the Government’s mandate to Health Education England, which places a clear requirement on Health Education England, where appropriate, to develop multidisciplinary education and training programmes. I hope the noble Lord will agree that that is very much consonant with the principles that he was propounding in his contribution.

We entirely appreciate the importance of close working between the professions. I am sure that that is something Health Education England will consider carefully. I will write to the noble Lord if I can add any useful detail once I have had a chance to investigate further the issues that he raised and once I have discussed them with my officials.

However, I point out, as the noble Baroness, Lady Wheeler, did in our earlier debate, the importance of the recent commitment entered into by 12 of the national leaders of health and care, who signed up to a series of undertakings on how they will help local areas to integrate services. This was the document Integrated Care and Support: Our Shared Commitment—the first ever system-wide shared commitment. That document set out how local areas can use existing structures such as health and well-being boards to bring together local authorities, the NHS, social care providers, education, housing services, public health and others to make further steps towards integration. The ambition here is to make joined-up and co-ordinated health and care the norm. It works towards the first ever agreed definition of what people say good integrated care and support looks and feels like. That will be developed by national voices. There will be new pioneer areas around the country, to be announced in September of this year. One of the 12 partners of that shared commitment is Health Education England.

I hope that the noble Lord will be reassured by what I have said. I am entirely in tune with the spirit of his remarks. I will be happy to write to him if I have further and better particulars to impart, but for now I hope that he will feel able to withdraw his amendment.

[Lord Rea]

My Lords, I thank the noble Earl for a very full reply and for the sentiments that he expressed. I shall read with interest his reply in Hansard, and I look forward to any further information that he may send me. I am sure that CAIPE will be very interested to read his remarks, too. I thank the Minister very much. I beg leave to withdraw the amendment.

Medicine: Experimental Drugs

Earl Howe Excerpts

Monday 10th June 2013 Lords Chamber

[Baroness Gardner of Parkes]

To ask Her Majesty’s Government whether they will enable the use of new experimental drugs by terminally ill patients who are prepared to waive their right to sue pharmaceutical companies in order to assist the development of new drugs and ease their own condition.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, there are existing provisions under medicines legislation for access to unlicensed medicines without requiring changes to the law. The Government are committed to ensuring access to new and promising medicines for patients while ensuring that medicines continue to meet high standards of safety, efficacy and quality. This is why the Government have been taking forward work on an early access scheme, adaptive licensing and promotion of clinical trials in the UK.

[Baroness Gardner of Parkes]

I welcome that Answer as it means that many valuable drugs might come to the market much earlier and be available for patients. Does the Minister agree that many elderly patients with a terminal condition will definitely get treatment that they may not particularly want themselves but that hope is terribly important in all our lives? Any of the new, experimental drugs can provide this valuable ingredient of hope to such patients.

[Earl Howe]

My Lords, I agree with my noble friend, and it is one of the reasons why the NHS constitution contains a pledge to inform patients of research studies in which they may be eligible to participate if there is a promising new medicine in the pipeline.

[Baroness Finlay of Llandaff]

My Lords, in light of the proposed EU directive that is being led by MEP Glenis Willmott to facilitate clinical trials and the work done by Empower: Access to Medicine, led by Les Halpin, are the Government working with the Halpin protocol, which aims to overcome the legal barriers—real or perceived—to early access to, and development of, medicine in the UK?

[Earl Howe]

My Lords, the Medicine and Healthcare Products Regulatory Agency is at the forefront of the negotiations at European level to ensure that the new clinical trials regulation, which will replace the current directive, is much more conducive to companies directing their clinical trials towards Europe, in particular, we hope, the United Kingdom. This needs to happen. The trend over the past 10 years has been in the wrong direction and we want our own market share to increase; there are already signs that it is doing so.

[Lord Taverne]

The Minister’s Answer is encouraging. Does he agree that if one looks at the possible benefits to patients and the public from avoiding delays and extra costs, to press on with it is a no-brainer?

--- Later in debate ---

[Earl Howe]

I do agree. There are two reasons to press on with it: the first is the benefit to patients, as my noble friend rightly emphasises; and the other is the benefit to UK plc if we can get more investment in research in this country.

[Lord Campbell-Savours]

The Question refers to waiving the right to sue pharmaceutical companies. What is the Minister’s response to that?

[Earl Howe]

My Lords, there is no need to think in those terms. There are many routes by which patients can access medicines lawfully and maintain their legal rights. We want to make sure that ethics and patient protection continue to be at the forefront of drug development. It would be wrong to give an indication to drug companies that they can throw caution to the winds in that sense.

[Baroness Oppenheim-Barnes]

It often takes as long as five or six years to develop a new drug. Sometimes, even after that period, when permission has been given, something is found late in the day. Therefore, does the Minister agree that we need to know what sort of period he is thinking of in accepting drugs that have not yet been approved?

[Earl Howe]

My Lords, this will very much depend on a case-by-case analysis of the drug in question. If there is a very promising new drug that is a breakthrough medicine, where there is no alternative treatment, there may be a case for considering that more favourably than a drug for which there is a readily suitable alternative. As I mentioned earlier, the menu of options available to us, such as an early access scheme for unlicensed medicines and an adaptive licensing scheme within European Union rules for licensed medicines, can perhaps be tailor-made to suit the drug in question.

[Lord Patel]

Does the Minister agree that there are two separate issues: one is doctors’ and nurses’ ability to prescribe off-label drugs, which is allowed, and for which the doctor takes responsibility; and the second is using a drug that might be promising for treatment and doing research on it, which requires research protocol to be followed? Neither is permissible under current regulations.

[Earl Howe]

My Lords, the noble Lord is right that the two issues are distinct. It has always been the case that a doctor can, under his or her own professional responsibility, in certain circumstances, prescribe an unlicensed medicine. However, he is also correct that clinical trials need to take place within a framework of proper ethical and organisational approval.

[Lord Hunt of Kings Heath]

My Lords, I refer to my health interests in the register. Will the introduction of value-based pricing inhibit or encourage early access to new medicines?

[Earl Howe]

My Lords, the noble Lord will have to wait, I am afraid, for the results of the current discussions that are going on with the pharmaceutical industry about what value-based pricing will look like in the end. Certainly, it is our ambition that the price of a medicine should more fairly reflect its benefit to the patient and society. Therefore, if doctors have greater confidence that those two things apply when they are made aware of the price of the medicine, we certainly hope that uptake will follow.

Abortion

Earl Howe Excerpts

Thursday 6th June 2013 Lords Chamber

[Baroness Knight of Collingtree]

To ask Her Majesty’s Government what steps they have taken to cease the practice of terminations of pregnancy in NHS hospitals that are not compliant with the Abortion Act 1967.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, in 2012 the Secretary of State instructed the Care Quality Commission to inspect NHS and independent abortion providers to ensure compliance with the Abortion Act 1967. The Chief Medical Officer also wrote to all providers of abortion services, reminding them of their obligations under the Act. All allegations of illegal abortions are taken very seriously and should be reported to the police, who will, if appropriate, conduct a criminal investigation.

[Baroness Knight of Collingtree]

My Lords, is it not the case that early last year the Government’s own care quality inspectors found, in a number of abortion clinics, piles of forms signed by doctors authorising abortions for women they had never seen, let alone examined? Was it not also reported that other abortions were being done for non-medical reasons such as that the child coming was a girl? Why has so little been done to stop these happenings when they are so blatantly against the law of the land?

[Earl Howe]

My Lords, the Care Quality Commission has put in place procedures to identify pre-signing or other instances of non-compliance, and they are confident that these would now be picked up during inspections. However, my noble friend is right; there was a concern early last year that this pre-signing was happening. Since then, however, the CQC has been working directly with providers who are registered to provide termination of pregnancy services to ensure that they are complying with the requirements of the Act. It is beginning to explore how it can strengthen the registration process alongside its regular inspection activities. I therefore suggest to my noble friend that it is not a case of nothing having happened.

On sex selection, we have no evidence at all of gender-related abortions in the UK. Again, concerns were expressed about this in the press, but analysis has been done that shows that the UK birth ratio is within normal limits.

[Lord Alton of Liverpool]

My Lords, does the noble Earl accept that some cases were referred to the police last year where gender abortions were identified? Will he welcome the decision of Ranjit Bilkhu and a group of Asian women in this country to set up an organisation to challenge the attitude that it is permissible to take the life of an unborn child merely because of its gender? Has he noted the Private Member’s Bill of the Member of Parliament for Congleton, Mrs Fiona Bruce, and the Early Day Motion, signed by more than 50 Members of another place, drawing attention to the need at least to collect the data where the gender of a child is known so that we can truly know whether or not this phenomenon is occurring in this country as it does in many other parts of the world, where the three most dangerous words are, “It’s a girl.”?

[Earl Howe]

My Lords, I am aware of all the initiatives mentioned by the noble Lord. The issue of the sex selection of foetuses is, of course, extremely serious. However, as I mentioned in my earlier Answer, following extensive investigation and analysis we do not believe that there is any evidence that this is happening in the UK. That is the prime reason why we do not agree with the noble Lord that measures should be put in place to collect data regularly on the sex of the aborted foetus. Were we to do that it would require changes to legislation. It would also require changes to clinical practice, and it has ethical implications. I hope the noble Lord will understand that we have thought about this very carefully.

[Lord Mawhinney]

Will my noble friend tell us how many prosecutions have taken place in the last year for terminations that fell outside the Act?

[Earl Howe]

I am not aware of any prosecutions in the last 12 months. The Crown Prosecution Service reviewed the evidence of the pre-signing of HSA1 forms and decided not to take further action against some individuals, but other investigations are continuing.

[Lord Steel of Aikwood]

I thank the Minister for the steps that have been taken to stop abuses of the 1967 Act. Will he confirm that there has been a welcome drop in the total number of abortions recently, but that there is still a problem of what are called repeat abortions, where women present who are clearly using abortion as a form of contraception, which is thoroughly undesirable?

[Earl Howe]

My noble friend is right. The abortion rate across England and Wales has been static since 2009. The good news is that the abortion rate for women under 18 has gone down. There was a 9.6% decrease in the rate between 2010 and 2011. On repeat abortions, the news is not so good. The proportion of repeat abortions for women who had abortions in 2011 was 36%. The figure was higher than it had been the previous year, which is a matter for concern.

[Baroness Royall of Blaisdon]

My Lords, I very much welcome the figures that the Minister gave on the number of abortions going down for younger women, and regret the figure for repeat abortions. Naturally, we must do everything possible to stop illegal abortions. However, will the Minister confirm that it is important that women who need abortions should not be impeded in any way, and that sex education and education about relationships are terribly important? I hope that the Government will be open to accepting amendments to the forthcoming education Bill on that issue.

[Earl Howe]

I am sure that those issues should be discussed very thoroughly. I agree that young people should be taught about relationships. However, I also believe that access to contraception is very important. Our data show that there has been no decrease in the number of women using contraception, and that more women are turning to extremely effective measures such as long-acting contraception. It is encouraging that the abortion rate for the under-18s is coming down.

[Baroness Masham of Ilton]

My Lords, how many late abortions have there been for babies who may have had a handicap?

[Earl Howe]

The vast majority of abortions are performed at under 13 weeks. The figure was 91% in 2011. There has been a continuing increase in the proportion of abortions that are performed under 10 weeks. Again, that is positive news. I do not have detailed information on the issue which the noble Baroness asked about, but I will write to her.

Health and Social Care

Earl Howe Excerpts

Wednesday 5th June 2013 Lords Chamber

[Baroness Tyler of Enfield]

To ask Her Majesty’s Government whether they will consider linking the separate outcomes frameworks for health and social care.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, we will improve outcomes only if all parts of the system work together with a common purpose. The three outcomes frameworks have been and continue to be increasingly aligned, reflecting the joint contribution of health, public health and adult social care to improving outcomes. The frameworks form the basis for integrated working locally. They support local partners across the health and care system to identify shared responsibilities, pursue shared goals and improve outcomes for their communities.

[Baroness Tyler of Enfield]

I thank the Minister for that helpful reply. I certainly welcome the efforts that have been made to align more closely the various outcome frameworks, in particular the sharing of particular outcome indicators on premature mortality. Given the new duties that are now on the Secretary of State, the NHS Commissioning Board and clinical commissioning groups to reduce health inequalities, and indeed the current inequalities in the incidence of conditions such as cancer and survival rates among deprived groups, what evidence is there that using these common outcome indicators will result in more integrated services such as smoking cessation, leading to real reductions in health inequalities?

[Earl Howe]

The essence of the answer to that is that improved outcomes will be achieved only when all parts of the system work together. If you have shared measures within the outcomes frameworks and measures that are complementary to each other, you will shine a light on areas of inequality and inform local and national action to advance equality. This focus on outcomes rather than processes enables an innovative approach to health and care services that is driven essentially by the needs of the local population. I will just add that local Healthwatch has a role to play in working with partners to make sure that the views of vulnerable and seldom heard groups in the population are heard.

[Baroness Pitkeathley]

My Lords, is any work being done on the outcomes of preventive work? I speak, for example, of installing a handrail to prevent a fall that results in an unnecessary and expensive hospital admission. These are often overlooked in terms of outcomes. Will the Minister tell the House if any work is being done on preventive work?

--- Later in debate ---

[Earl Howe]

There are a number of indicators in the NHS Outcomes Framework and, indeed, in the public health outcomes framework and the adult social care outcomes framework relating to the vulnerable elderly groups in our population. I shall need to write to the noble Lady with a specific answer to her question. However, her question is extremely pertinent to the issues that have been very high profile recently, the resolution of which depend, in part, on ensuring that we can avoid unplanned admissions to hospital and keep people securely in their own homes.

[Lord Laming]

My Lords, will the Minister assure the House that when the separate inspectorates are established they will reinforce integrated working rather than operate in separate identities?

[Earl Howe]

I can indeed, and I can do so with confidence because the three chief inspectors that we propose to create—one of whom, the Chief Inspector of Hospitals, has already been appointed—will be working as part of the Care Quality Commission. They will be senior employees of the CQC and their job will certainly be to align the methodology that they use to assess good and poor care.

[Lord Kakkar]

My Lords, I declare my interest as professor of surgery and consultant surgery at University College London Hospital. During the passage of the Health and Social Care Act 2012, there was a discussion about the need to ensure that there was an ongoing focus on integrated care between community hospitals and tertiary services. This needed to be attended by a focus on the development of metrics that would describe whole pathways of care outcomes for patients. What progress has been made with regard to the development of those whole pathway metrics?

[Earl Howe]

The noble Lord hits upon a point of central importance. The outcomes framework clearly sets out where the different parts of the health and care system share responsibility for outcomes and support joint working in the way that I have described. However, we are committed to developing a measure of people’s experience of integrated care for use in the outcomes frameworks. That is a work in progress. Meanwhile, a place holder was included within both the NHS and adult social care outcomes frameworks when they were refreshed in November last year. We have highlighted the development of this measure in the public health outcomes framework, so I hope to give the noble Lord further news in a few months’ time.

[Baroness Jolly]

My Lords, within local authorities, public health is responsible for reducing local health inequalities, particularly in areas of non-communicable disease. For those, the solutions are often long term, so would my noble friend explain how success can be measured and incentivised in the short term?

[Earl Howe]

Again, my noble friend asks an extremely good question. The year-on-year success of public health interventions to address non-communicable diseases, for example, will be measured through the public health outcomes framework. The department will incentivise some of the indicators in the public health outcomes framework through the health premium incentive scheme. Some of the indicators that will be selected may contribute to prevention of non-communicable diseases.

[Baroness Wheeler]

My Lords, on social care, the charity Mind has pointed out that many people with mental health problems are never properly assessed to see if they need social services, such as having somebody to help with admin or household tasks, or with washing, dressing or something meaningful to do during the day. Is the Minister confident that the outcomes framework is robust enough to measure this problem, and how does he think that local councils will be able to address this issue in the light of the £2.7 billion cuts that they will have had to their adult social care budgets by the end of this spending round?

[Earl Howe]

My Lords, the adult social care outcomes framework was put together with a great deal of help and support from local authorities, so we hope that there will be a great deal of buy-in to it. It has as its focus high-quality care and promoting people’s independence and well-being, and it enables councils to make comparisons, assess scope for improvement and measure progress against their own local priorities in adult social care. Therefore, the virtue of the outcomes frameworks is, above all, transparency and accountability, leading to improved quality of care as defined locally by councils.