Care Bill [HL] Debate
Full Debate: Read Full DebateEarl Howe
Main Page: Earl Howe (Conservative - Excepted Hereditary)Department Debates - View all Earl Howe's debates with the Department of Health and Social Care
(11 years, 2 months ago)
Lords ChamberThis clause would clarify and make small changes to the trust special administrator’s regime in the light of our experience following its use at South London Healthcare NHS Trust and Mid Staffordshire NHS Foundation Trust.
Your Lordships will know that the regime for trust special administration was introduced by the previous Government under the Health Act 2009. The aim of the regime has always been to provide, with a tight timescale, a sustainable future for the services provided by a failed trust. The regime is only ever used as a last resort, when all other efforts by a trust and its commissioners to develop a viable model of care have been unsuccessful. There comes a point when time has to be called on local efforts to resolve the situation. Problems should not be allowed to fester, and it is not right that taxpayer resources could be diverted away from patient care to bail out failing organisations.
The regime enables a failed trust to be put into administration. The role of the trust special administrator is to take charge of the trust while the board is legally suspended and to develop and consult on recommendations in a draft report, before making recommendations in a final report that secure a sustainable future for services. The unsustainable provider regime for NHS foundation trusts was amended in 2012 to make it compatible with the extended regulatory role given to Monitor to operate the new licensing regime. The regime is used only on an exceptional basis at the most seriously challenged NHS providers, where other solutions or interventions have failed. It is time-limited, to focus efforts on delivering a sustainable solution with statutory deadlines for each stage of the process.
Use of the regime at South London and Mid Staffordshire suggests that two stages of the administration process need to be extended. The administrator would benefit from having more time to produce its draft report, and it would be better to have a longer consultation. The clause would therefore extend the time that the administrator has to complete these two key stages by giving 65, rather than 45, working days to produce the draft report and allowing 40, rather than 30, working days to undertake consultation on that report. The existing powers to extend the various stages of an administration beyond these statutory time limits will remain, as there will always be cases where an extension is appropriate.
Secondly, the clause would put beyond doubt the Government’s existing position that the remit of a trust special administrator is to make recommendations that may apply to services beyond the confines of the trust in administration and that the Secretary of State, for NHS trusts, and Monitor, for foundation trusts, have the power to take decisions based on those wider recommendations.
Where severe and prolonged problems exist, the administrator appointed must be able to propose a viable solution. It was always the Government’s intention that the interpretation of the words “in relation to” could include wider actions where necessary and consequential on primary recommendations about the trust in administration. This clarification of the scope of the administrator does not constitute a change of policy, is not retrospective, and is intended only to remove any uncertainty for the future.
NHS trusts, foundation trusts and other providers do not exist in isolation from each other. They are part of a complex, interdependent, local healthcare economy. Issues of clinical and financial sustainability nearly always cross organisational boundaries. Parliament must surely have intended originally that the legislation would enable an administrator to fix the problems that it was appointed to fix. If the only way to do this is to look beyond the confines of the failing trust then that is what it must do.
Thirdly, the clause would strengthen requirements for a trust special administrator appointed to an NHS foundation trust to seek the support of commissioners affected by their recommendations. A trust special administrator appointed to an NHS foundation trust is already required by statute to seek support for its draft and final recommendations from all commissioners of the trust in administration. This clause would extend that requirement so that the administrator would also be required to seek the support of commissioners of services affected by the administrator’s recommendations that are provided by other trust providers, with NHS England’s support being sought in the event that all commissioners did not agree.
My Lords, during the deliberations on the Health and Social Care Bill, we spent a considerable amount of time discussing the details of the trust special administration arrangements, not least because it was the first occasion on which a legal process of that kind had been in legislation. We were aware then, and perhaps even more so now, that there has to be some power to bring these decisions to a conclusion. I find it remarkable that people have demonstrated in favour of keeping open Mid Staffordshire hospital, but they have. That is the power of emotion in respect of hospital care in particular.
However, I agree with the noble Lord, Lord Warner, that this amendment is not quite what is needed, although there are some things in it which are to be welcomed. The process that needs to be gone through whenever a hospital is to be closed is to reassure the public that there will be access to alternative services. That is the absolutely critical point and it was with that in mind that I was somewhat taken aback to hear the Minister say that this procedure—and I bear in mind that, as he said, this is the last procedure in a very long process—takes away from the trust special administrator the requirement to involve the public and the patients. It seems to me that that is the very last thing that you would want to do if you were trying to have a process involving political engagement. I therefore ask him how the department came to that decision.
My Lords, the matters we have debated today are of great significance. Of course—and I need to make this clear—we do not want to see any NHS trust or foundation trust fail, but equally we cannot shirk the responsibility to take action if and when that happens. In our taxpayer-funded health system, every pound counts and every pound should be put to best use, providing high-quality, effective care. Failed organisations squander resources. I do not want to be derogatory about them in other ways, but they usually take for themselves an unfair proportion of resources in relation to the local health economy more widely. Failed organisations, if nothing is done, have to be propped up by government bail-outs. That cannot be right, particularly at a time when resources are as constrained as they are now. We need an effective regime for tackling these issues.
The House has agreed with this on two previous occasions, passing legislation in 2009, during the time of the previous Government, and again in 2012 to provide failure regimes for trusts and foundation trusts respectively. We thought that those regimes would be effective, but experience now shows that they need clarification. The noble Lord, Lord Hunt, suggested that this amendment represented a major change of policy and the noble Baroness, Lady Warnock, characterised it as an arbitrary overturning of the decision of the court in the south London case. The Government’s policy has been consistent. It is entirely unchanged. It is self-evidently not a change of policy. Had it been so, the recommendations made by the trust special administrator in south London would have been ones that we would have questioned as legally dubious in the department. On the contrary, we believe that the administrator’s recommendations fell squarely within the wording of the 2009 Act, which, as I mentioned earlier, used the phrase, “in relation to”. That was the phrase around which the judge’s ruling revolved, and it was a different interpretation of that phrase that the judge took.
The noble Lord, Lord Hunt, is very knowledgeable about the heath service, but I am afraid that on this matter he is wrong. His amendment would render the failure regime quite useless. Five years is too long for a failed hospital and the patients it serves to wait for an effective remedy, to say nothing of the cost to the public purse. One of the provisions that the noble Lord has tabled would require the Secretary of State to justify making the power operational after the end of the five-year period, but is that not the debate we should have now? In any event, the effect of accepting his amendment would lead to an incoherent muddle. Either the House believes that a trust special administrator must be able to take the action necessary to resolve serious and prolonged problems at a trust or it does not. A long wait and a report will make no difference to the issues of substance. I urge the House to be decisive on this rather than doing what is effectively kicking a can down the road.
I know that fears have been expressed that the clause we are inserting would enable the Government to make free with every hospital around the country. That is not so. In fact, I submit to your Lordships that that suggestion is scaremongering. The powers could have been used for a long time if it were the Government’s intention to close down every hospital or lots of hospitals. The regime was designed by the party opposite, lest we forget, to deal with the specific circumstances of a trust in failure. It enables an external expert to be appointed as administrator to take a fresh look at the situation and, working with the trust and its commissioners, to develop recommendations for the future.
One needs also—I say this particularly to the noble Lord, Lord Warner—to recognise that trust special administration is only ever invoked when the normal processes for agreeing a reconfiguration have hit the buffers. In normal circumstances commissioners and providers in a locality get together and very often agree about the way services should be reconfigured to make them clinically and financially sustainable. In the case of south London and in the case of Mid Staffordshire that process has been going on for a long time. It is only because we reached an intractable position that administrators were appointed in those instances.
We have heard today that some aspects of our amendment provoke strong feelings, particularly the clarification—and it is a clarification—that a trust special administrator can make recommendations that include other providers where those recommendations are necessary for, and consequential on, his core recommendations. I bring noble Lords’ attention to those key words. Of course I recognise those views, but I do not share them. The clarification is vital for the failure regimes to be effective. It may be possible for the solution to the problems faced by a failed organisation to be found within the boundaries of that organisation, but it may not. Indeed, it is quite likely that it will not be. The health service is formed of a complex network of interdependent providers, all influencing one another. It is plain that making changes to one has a knock-on effect elsewhere. The amendment is a reflection of that reality.
I have a degree of sympathy with those who have argued that the effect of this could be unfair on the successful provider impacted by the failure of a neighbour. Such a step would, of course, be taken reluctantly. But I argue that it must be possible to take such a step if, and when, that is the only way of resolving the problem. The amendment would not apply retrospectively. The date of the court hearing in the south London case is therefore not relevant.
The rest of my amendment makes minor changes and I hope that they will be acceptable to the House. I hope more strongly that the amendment as a whole will find favour. It could be, as some noble Lords have suggested, that additional things need to be done. We do not believe that to be the case but I have heard the arguments put by a number of noble Lords that the amendment might need additions at some time in future. Our minds are open to that. But I beg noble Lords not to lose this opportunity of passing my amendment, as it matters a very great deal, not just in local areas but in the health service as a whole, in the interests of equity and fairness, which, after all, underpin the whole NHS. I believe that noble Lords should reject the amendment proposed by the noble Lord, Lord Hunt.
These are going to be rare cases and they are always difficult. The problems by their very nature are intractable and serious. We must fix them and have mechanisms to do that in order to put services back on a sustainable footing. Otherwise, I respectfully submit, we ourselves will have failed. I beg to move.
My Lords, I am grateful to the Minister and other noble Lords who have spoken in what has been an excellent debate. My feeling about the debate is that the House has conclusively come to a view that further discussion needs to take place on the matter. I will come back to that in a moment.
I agree with the noble Earl that failed organisations squander millions of pounds. He is absolutely right to say that the need for them to be propped up by others has a deleterious effect on the NHS as a whole. We know that at least 20 NHS trusts or foundation trusts are in severe financial difficulty at the moment. It is likely that that number will grow in future. That is why there is considerable doubt that the special administration provisions will apply to only a very small number of cases. There is every possibility that, over the next two or three years, it will have to be used in many cases. That is why I am concerned that the provisions that the noble Earl is asking us to agree to today will be used to lead to configuration of services in which the interests of the failing trust will be put at the heart of the process rather than interests of the health service as a whole in a given area. That is the crux of the issue and that is why Lewisham is so important. It is a very good hospital—it was minding its own business—and then, suddenly, a special administrator came along and said that to solve the problem of the trust that it was dealing with it would have to reduce Lewisham hospital services. That is the crux of the argument and why we are concerned about the provisions being put forward by the noble Earl today.
The noble and learned Lord, Lord Mackay, suggested that we should let the Government have their amendment today and it can then be dealt with in the other place. Of course, I always admire the other place’s assiduous attention to duty when scrutinising legislation, but the fact is that the other place is simply not geared up or able to do that. The noble Earl, Lord Howe, was rather rude about my amendment which was, of course, perfectly formed and correct in every way. Will the noble Earl, having listened to this debate, agree to pause and allow us to have further discussions—even between now and Third Reading in eight days’ time—to see whether it would be possible to come back with an amendment that is more suited to the circumstances he described? Is the noble Earl prepared to do that? If he were, I would welcome it.
My Lords, I am more than willing to have discussions between now and Third Reading but I suggest to the House that it is necessary to pass the government amendment now and to look at whether we need to change that amendment at a future date. Our minds are open to that but, unless we pass the government amendment, we will have missed a historic opportunity to correct a vital lacuna in the law for the benefit of the NHS as a whole.
My Lords, I am very grateful to the noble Earl. It would, however, be possible for him not to move his own amendment today, to allow for further discussions and to table a revised amendment at Third Reading. That is as far as I can go in offering the Opposition’s help in this matter.
My Lords, in view of that, I wish to test the opinion of the House.
My Lords, in moving Amendment 142, I shall speak to the other government amendments in this group, Amendments 143, 145, 146, 148, 149 and 150. This group relates to the ability of the Care Quality Commission to operate free from day-to-day intervention by Ministers. The amendments that I have tabled will place the CQC on a new footing of greater operational autonomy. They also clarify some of the arrangements for the new system of ratings to be operated by the CQC. I will outline the principle guiding the Government in tabling these amendments.
Last year we passed legislation that placed a duty on the Secretary of State to promote autonomy in the way that other bodies exercise their functions in relation to the health service. The changes that we are proposing build on this. They remove nine separate powers that the Secretary of State currently has to intervene in the day-to-day operation of the CQC. Additionally, they place the new chief inspector posts on a statutory footing, ensuring their longevity, with a specific duty to operate in a way that ensures the independence of the CQC’s judgments.
We are also introducing a new system of regular assessments of registered providers, which has no requirement for ministerial approval of the methodology. Each of these changes gives the CQC greater scope to get on with the day job without interference from Ministers. Why does this matter? The CQC has the key role in providing assurance of the quality of services provided to patients and service users. It needs to be able to inspect what it wants when it wants and to be free to report its findings as it wants. The proposed amendments and new clauses that I have tabled will see the Government relinquish a range of powers that intervene in the operational decisions of the CQC.
In addition to the amendments relating to the department’s powers to intervene in the work of the CQC and to place the chief inspectors on a statutory footing, I am also tabling a number of amendments relating to the performance assessment system operated by the CQC. The amendments clarify that the CQC will not undertake routine performance assessments of local authority commissioning but, rather, will be able to carry out special reviews of local authority commissioning under Section 48 of the Health and Social Care Act 2008. This will bring the position for commissioning by local authorities in line with that of NHS commissioning as put in place by the Health and Social Care Act 2012.
I will briefly set out two areas where the CQC’s freedom is not being enhanced and explain why. The changes that we are making will give the CQC greater freedom in its day-to-day work, as I have explained. When it comes to the CQC’s strategic role and activities, outside of its routine functions, it is appropriate that the Government maintain oversight of the commission.
The first area to which this applies is investigations of commissioning. The amendments we are making to Section 48 of the Health and Social Care Act 2008 make it clear that the CQC has the power to carry out a special review or investigation of commissioning—both of health commissioning by NHS England and NHS Clinical Commissioning Groups and of local authorities’ commissioning of adult social services. Such reviews will only be possible with the approval of the Secretary of State for Health, in the case of NHS commissioning, and the Secretaries of State for Health and Communities and Local Government in the case of local authority commissioning.
Secondly, I reassure noble Lords that we are maintaining the arrangements through which the commission is accountable to the Department of Health. We will retain a range of the conventional measures that exist to manage an arm’s-length body of the Government. The non-executive members of the CQC’s board will continue to be appointed by the Secretary of State, who will also maintain the power to intervene if the commission fails to properly discharge any of its functions. The department will also continue to hold the CQC to account for its financial and operational performance. I hope that these amendments will find favour with the House, and I beg to move.
My Lords, I express my concern about the provisions of subsection (4) of the Government’s new clause on the independence of the CQC. My instincts are that this will do the absolute reverse of what the Government are seeking to do in terms of the CQC’s independence, which is why my Amendment 143A seeks to remove subsection (4). I do not disagree in any way with the other provisions in this set of government amendments and will explain my thinking. Subsection (4) effectively prevents the CQC investigating, of its own mere motion, the extent to which local authority commissioning practices and decisions on adult social care damage user interests and well-being.
In effect, if the CQC considers, after looking at the results of its work on providers of services, that there is a major stumbling block to good, sound provision of services that promote the well-being of users—the provision in Clause 1 of the Bill—it has to seek the approval of the Secretary of State before it can do any kind of generalised or thematic review of local authority commissioning of services. It has to seek the approval not only of the Health Secretary but of the Secretary of State for Communities and Local Government. That seems a step backwards from the position we have now, where the CQC, as I understand it, could actually undertake these kinds of reviews. I do not see how the new subsection (4) helps the CQC to get to the root of a problem that may be affecting thousands of users of services. We have already seen that the providers were not the instigators of the policy of 15-minute home visits—it was the commissioners of services who instigated that policy. They required the providers to do that; they almost drove them along the path of not paying for the travel costs of the healthcare assistants who were making those visits. The institutional behaviour that has grown up and caused so much concern among the public and in Parliament has been driven by commissioners.
I suspect that we will have other kinds of such issues as we move through a decade of austerity in public services. It ought to be possible for the CQC to take the initiative and try to get to the bottom of those issues by carrying out a thematic review of the commissioning practices. That is why we need to take out subsection (4), which seems to be incompatible with the rest of the provisions in this set of government amendments, which I thoroughly welcome. All credit to the Government for removing these requirements on the CQC, but why are they spoiling the ship for a ha’porth of tar? Why are we pushing back on the ability of the CQC to decide that it wants to carry out a review of commissioning practices, when that is not in the best public interest? The Government should think again about this.
My Lords, I set out in my opening remarks the principle that lies behind the amendments that I tabled: namely, that the CQC should have more operational autonomy in its day-to-day activities. I sense that the principle is not inimical to many noble Lords. The amendments tabled by the noble Lord, Lord Hunt, and the noble Baroness, Lady Greengross, are in contrast to that principle and seek to tie the hands of the regulator and commit it to considering specific issues in all circumstances.
I say straightaway that the issues raised by the noble Lords are important: namely, how providers deal with the most commonly recurring conditions in specific settings, and how hospitals are implementing NICE guidance on the use of medicines. I do not argue that the CQC should not consider these issues. It has made clear in its consultation document, A New Start, that NICE guidance will play an integral role in its new performance-assessment methodology. That shows that we can trust the regulator to set its own priorities and to change them in response to new challenges. However, I submit that they should not be in the Bill.
Noble Lords questioned the CQC’s role in the oversight of commissioning of both health and adult social care. The noble Lord, Lord Warner, tabled an amendment that would have the effect of allowing the CQC to carry out a study of the efficiency of commissioning without seeking the approval of the Secretary of State.
I will explain the approach that we are taking. We are maintaining powers for the CQC to carry out reviews of commissioning in both health and social care. However, where this happens, we believe that it should be a special rather than a periodic review. My noble friend Lady Barker asked why. The main role of the CQC is to inspect and regulate service provision. The very name, CQC, reflects that. Where this leads the CQC to believe that there are problems with local commissioning, it will have the power to look into this further. However, any review of commissioning will impact on the CQC’s capacity to regulate service provision. Therefore, it is only right that this should be carefully considered and subject to ministerial agreement.
If a noble Lord were to ask me in what circumstances such agreement would be withheld, I would be in some difficulty because it is hard to imagine circumstances in which, if there were clear evidence of poor commissioning practices in an area, that agreement would not be forthcoming.
Special reviews can be tailored in all sorts of ways. They can be tailored to look at how commissioners are delivering specific policy objectives—for example, personalisation or service integration. The special review powers could be used to target the poorest performers, conduct thematic reviews across all local authorities—and I shall mention that again in a second—or perform reviews of a cross-section of local authorities. These reviews are a sophisticated power that allows the CQC to get to the heart of an issue in a way that periodic reviews cannot. If there is a good case for it conducting a review of that kind, it will not be stopped from doing so.
The noble Lord, Lord Warner, questioned the whole principle of ministerial sign-off for these special reviews. In fact, all special reviews and investigations by the CQC under Section 48 of the 2008 Act currently require the approval of the Secretary of State, so, in that sense, we are not doing anything radically new.
As I said, the CQC will be able to carry out a special review of commissioning where there is evidence that commissioning practices are contributing to the provision of poor care for patients and service users. A prime example of where the CQC could be tasked to conduct an investigation would be if it had evidence that 15-minute commissioning was taking place. That applies to any area where poor commissioning is identified as a contributory factor to the poor provision of care, either in terms of the quality of services or where access to services is raised as an issue by people who use them. I hope that that is reassuring. We are absolutely clear that the CQC will play a leading role in making sure that people receive acceptable standards of care. Indeed, only last week we announced that the CQC was considering the use of 15-minute care visits to vulnerable and elderly people. That is entirely appropriate and I emphasise that it will still have the power to carry out special reviews of that kind.
The noble Baroness, Lady Greengross, went further and said that it was counterproductive to remove the periodic review power for commissioning. She referred to statements about this made by my honourable friend, Norman Lamb, the Minister for Care and Support. I would simply say to her that retaining Section 46 functions—the periodic review functions—would offer the CQC nothing further in terms of enforcement powers against local authorities. Regardless of whether a review is undertaken under Section 46 or Section 48 in relation to an English local authority, the follow-up action remains exactly the same, with the CQC able to issue an improvement notice in the event of a local authority failing to discharge its functions and to recommend special measures to the Secretary of State in the event of substantial failings.
Our approach will allow the CQC to focus its efforts on those areas where there are concerns about commissioning, rather than on all commissioning, including commissioning where the normal oversight arrangements have revealed no overt problems. I should now like to come to those oversight arrangements, because the noble Baroness asked me who is responsible for the oversight of commissioners if it is not the CQC. We need to remember that commissioners are already regularly overseen, in a number of ways, in the new system. In the case of the commissioning of health services, the new NHS architecture has NHS England taking the central role in performance-managing the commissioning of NHS services. It ensures that clinical commissioning groups deliver the best possible services and outcomes for patients. The CCG assurance framework has been developed precisely to ensure that the CCGs are working to improve services and the quality of care for patients.
This new system is also more transparent. The CCG outcomes indicator set will support CCGs and health and well-being partners in improving health outcomes by providing comparative information on the quality of health services commissioned by CCGs and the associated health outcomes, and it will support transparency and accountability by making this information available to patients and the public. That is new. The first quarterly assurance conversations have now taken place between NHS England and CCGs. We expect that CCGs will want to make the outcome of these conversations available publicly as part of the commitment to transparency. The board will publish an annual assessment at the end of 2013-14, as required by legislation.
In addition, NHS England has its own governance processes in place, including the development of the direct commissioning assurance framework to demonstrate that it meets the standards required. As this is developed further, elements will be introduced to bring external scrutiny to its board and function. Ultimately, NHS England is held to account by the Department of Health for its commissioning activity against its delivery of the priorities set in the mandate.
That does not mean that there is no independent scrutiny of NHS commissioning. Health and well-being boards and local Healthwatch will ensure that the public voice is heard where there are concerns about the design and commissioning of services. Where local Healthwatch identifies concerns, it can raise these with Healthwatch England, which can in turn request the CQC to take action. Where the CQC has strong concerns that commissioning is having an impact on the quality and safety of provision, it can initiate—with ministerial permission—a special review or investigation. This is a much richer tapestry than perhaps some noble Lords have portrayed it.
On local authority commissioning, other measures in the Bill will strengthen the duties on local authorities in exercising their care and support functions. These include a new express duty to promote people’s well-being and a duty to shape local care markets to ensure that they are sustainable and diverse and that they offer high-quality care and support. They will not, as the noble Lord, Lord Hunt, fears, be left to themselves. To start with, the department will work with the local government and adult social care sector to produce statutory guidance on local authority commissioning of care and support. As well as this, the Government are committed to ensuring that there is a clear link between local authority commissioning and the outcomes and experiences of service users. That will be achieved through the adult social care outcomes framework, which will give local people, local Healthwatch and others robust and comparable information on councils’ performance. The Government are committed to making information on adult social care outcomes even more accessible and readily understood by people who use care and the wider public further to enhance transparency.
As with NHS commissioning, local Healthwatch and health and well-being boards will be able, through Healthwatch England, to raise concerns with the CQC about poor commissioning. This is independent, regular scrutiny that will be driven by the views of those with direct experience of service failings—the service users themselves. Although this system is in its early stages, I genuinely believe that the mechanics are in place to ensure that local authority commissioning is scrutinised regularly and in a way that it has not been before.
My noble friend Lord Deben referred to the Localism Bill and wanted assurance that the powers given to the CQC will not be circumvented in various ways. I can assure my noble friend that it is not our intention that the powers given to the CQC will be circumvented by other legislative proposals or any other means.
My noble friend Lady Barker asked why we are stopping the CQC doing what it does now, and whether there is any evidence that the power has been misused. As I am sure my noble friend will agree, the CQC plays a very important role in regulating and inspecting health and care services. It is the nation’s chief whistleblower on health, but to do its job properly it must be able to act without fear or favour from the government of the day. In a nutshell, we want to make it a stronger organisation by ensuring that it has the freedom and independence always to speak out about patient safety concerns, irrespective of who is in government. The removal of the need for the CQC to gain the approval of the Secretary of State for its programme of inspections and so on will particularly complement the role of the CQC’s new chief inspectors in providing an authoritative and independent judgment of the quality of health and social care services.
I would say to the noble Baroness, Lady Pitkeathley, that the main objective for the CQC, as set out in the 2008 Act, is centred on service provision. The objective is to protect and promote the health, safety and welfare of people who use services. It will do this, as it does at the moment, through looking at service provision and it will look at local authority commissioning when there is evidence of problems.
My Lords, I also support both amendments. It seems to me, as a nurse, to be a self-evident proposition that having safe staffing levels and the correct skill mix, taking into account dependency and acuity, is the right thing do. Anyone who has listened to the debates in this House on various Bills dealing with health and social care over the past few months knows that it is an enormously complicated issue. However, we must bring it back to this level of patient safety and the duty of providers to provide safe staffing levels and the correct skill mix. If that is not done, all the other things we talk about will be in vain and we will end up with more reports, more inquiries and more problems.
As has already been said, it is incumbent on Governments to take account of all these things: the Francis report, the review into Winterbourne View and some of the recommendations in the excellent report produced a few months ago by the noble Lord, Lord Willis. It is vital that we get this right. At a time when financial pressures will force authorities to look at diluting the numbers of trained nursing staff and trained staff in the community and replacing them with healthcare assistants or support workers with hugely varied levels of training and experience, it is absolutely right that we get the correct level. As has already been said, both of these amendments can only add to the Bill and take nothing away from it.
My Lords, I hope that I can give noble Lords considerable reassurance on the Government’s position on these important issues. It is almost axiomatic that safe, high-quality care is dependent on people and that right-staffing, in terms of numbers and skills, is vital for good care. The importance of having the right staff with the right skills and in the right numbers is central to the delivery of high-quality care. Where staff are stretched because they are too few in number, corners will be cut, with inevitable adverse consequences for patient care. Equally, where staff do not have the right skills to carry out their tasks, the quality of care will suffer.
Patient safety is the first priority, and safe staffing levels really matter. The quality of care provided to patients is ultimately the responsibility of the leadership of provider organisations. It is their responsibility to ensure that they have the right staff with the right skills in the right place at the right time in order to provide high-quality care. In the final analysis, it is for hospitals themselves to decide how many nurses they employ, and they are the best placed to do that. Nursing leaders have been clear that hospitals should determine and publish staffing details and the evidence to show that staff numbers are right for the care needs of the patients that they look after.
Although local providers are best placed to do this based on local need, we expect them to look to authoritative guidance and evidence-based tools and learn from best practice to deliver cost-effective and safe care. We recognise that there is a need for national action to ensure that local organisations meet those expectations. As a result of the national nursing and midwifery strategy and vision published in 2012, Compassion in Practice, a considerable amount of work is going on across England to ensure that providers use evidence-based tools, using acuity and dependency measures to set staffing levels, and for boards to publish these staffing levels on a regular basis.
I want to explain what we are now doing to build on that work. First, the Chief Nursing Officer, supported by the National Quality Board, is developing guidance for the system, including a set of expectations, to support provider organisations in securing the appropriate staffing capacity and capability for nursing, midwifery and care. This guidance is being developed with the intention of ensuring safe patient care and that patient outcomes are not compromised. It will include expectations on transparency and publication of information on staffing.
This guidance is being developed jointly by the statutory organisations responsible for quality across the NHS, which are brought together as part of the National Quality Board and which include the Care Quality Commission, Monitor, the NHS Trust Development Authority and NHS England. It will be published next month. I can therefore only agree with the intention behind the amendment that providers need to be open and transparent about their staffing numbers. The positive news is that action is already in place to ensure that this happens.
What my noble friend has said is incredibly encouraging. However, before he leaves that point, could he take up the very important issue raised by the noble Lord, Lord Warner? This is not just about hospitals; it is also—particularly in my case—about care homes and other community settings. Will the regulations apply to all those settings, so that we get continuity throughout the system?
My Lords, I am happy to come to that point. The short answer is that that is certainly our intention.
I turn to Amendment 159, about which I will be a little critical. We consider that requiring health or care service providers to,
“publish a report containing staffing levels based on evidence of safe staffing levels supported by acuity and dependency levels for each patient”,
is really not a viable alternative to what we are already putting in place and would not work in practice. It would be burdensome to implement in precisely that form and could detract from the ability of staff to deliver good clinical care.
I understand, of course, the thrust of the thought behind the first part of the amendment, which says that,
“the first duty that a health or care service provider must consider for any decision is patient safety”,
However, it carries the risk of unintended consequences. It could lead to other important factors, such as innovation and service improvement, not being given sufficient weight and providers becoming unduly risk averse. We need to reflect that any innovative treatment—which we want to encourage in the health service—carries some risk. That is always justified by benefits for the wider system. We do not want clinicians to become reluctant to take risks if this amendment were passed.
Also, we do not feel that specifying report requirements for provider boards is the role of the Secretary of State any more. Rather, the focus has to be to allow for local accountability and local decision-making. However, as I have said, we recognise that decision-making tools are needed and I agree with my noble friend Lord Willis about that. We are working with the CQC, NICE and others to ensure that providers have the evidence-based tools they need to make decisions to secure safe staffing levels. These decisions will then be subject to external scrutiny and challenge by commissioners, regulators and the public, and to inspection by the Chief Inspector of Hospitals.
However, at the end of the day we come back to the fundamental point, that it is the responsibility of individual providers to be accountable for staffing levels in their organisations. The existing registration requirements, which are enforced and monitored by the CQC, already recognise the importance of that. That is my response to Amendment 144. The requirements state that providers must take steps to ensure that at all times there are sufficient numbers of suitable staff to carry on the regulated activities that the organisation provides. Additionally, the Chief Inspector of Hospitals has also made it clear that appropriate staffing levels are part of the requirements of registration for the CQC.
In assessing whether a provider meets the registration requirement on staffing, the CQC refers to relevant guidance about staffing levels and skills mix published by professional councils and relevant expert and professional bodies. These include the Department of Health, Skills for Care, Skills for Health, the NHS and the Royal College of Nursing. Where a provider does not meet the staffing registration requirement, the CQC is able to use its enforcement powers to protect patients and service users from the risks of unsafe care associated with inadequate and/or poorly trained staff.
In its consultation document A New Start, published in June this year, the CQC stated that the focus of its new inspection methodology would be on five key domains. Are services safe, effective, caring, responsive to people’s needs, and well led? These domains will cut across all areas of activity, including levels of staffing and skill mix.
How easy will it be for members of the public to see this material when they are trying to be sure that they are going to a safe place?
The answer to that question is the rating system, which the chief inspectors are planning to bring in. Proposals for that will be announced very shortly. We attach great importance to that kind of transparency, not only in the NHS but in the care sector. On my noble friend’s question about whether all this would cover the care sector as well as the NHS, as he will know, the CQC issues sector-specific guidance on how to meet staffing registration requirements. Obviously NHS England would only provide guidance that relates to the NHS. As I already said, the Chief Inspector of, say, Adult Social Care would inspect regularly against CQC guidance. The plan is to consult in April 2014 on the CQC guidance on social care.
My noble friend spoke about an emerging consensus on a minimum level of staffing below which care is unsafe. I understand his point, but I am sure he will acknowledge—and did, implicitly, in his remarks—that staffing is not simply about crude numbers; it is not just about nurses. Healthcare assistants and other members of the team all have a key role to play. My noble friend Lady Gardner was absolutely right to point out that the skill mix is relevant in these circumstances. Patient safety experts agree that safe staffing levels should be set locally. It is not for Whitehall to set one-size-fits-all staffing rules. That is exactly why we have asked NICE and other nursing experts to review the evidence, to help organisations to make the right decisions on staff numbers at a local level and then, essentially, to govern themselves. I make it absolutely clear that we fully agree that safe staffing should apply in all settings and that point will be taken into account as we develop our plans.
I hope noble Lords are reassured that action is already being undertaken in a combination of ways, through Compassion in Practice, the CQC registration process, and, shortly, through the role of the Chief Inspector of Hospitals. That will ensure that providers are open and transparent about their staffing numbers and that they assess these staffing levels, not just on the day of an inspection but on a regular basis, using evidence-based tools, and by taking into account local factors that relate to local patient needs and outcomes. I therefore hope that noble Lords will be content to take stock of what I have said and will not press their amendments.
My Lords, I am grateful to all noble Lords who have spoken. I will say at once that I very much support Amendment 159. I agree with my noble friend Lord Warner that the two amendments run in parallel very well indeed.
I know that the noble Baroness, Lady Gardner, thinks that my amendment may be a little too modest. Perhaps it is a start. I assume that the noble Baroness was not chair of the Royal Free when the “poaching” that she described took place. The point was well made.
The noble Earl, Lord Howe, has listed a number of ways in which we could be assured that staffing numbers and skill mix will be okay both in the NHS and the care sector. The fact is that, however much information is published and however much this might be part of the licensing regime of CQC, these organisations have been around for some time. There is consistent evidence that staffing levels are not sufficient. We have already had the Francis report, which said that NICE should undertake benchmarking on staffing levels. The Keogh report on the 14 hospital trusts said:
“The review teams found inadequate numbers of nursing staff in a number of ward areas, particularly out of hours—at night and at the weekend. This was compounded by an over-reliance on unregistered support staff and temporary staff”.
The Berwick report goes over the same ground. At the end of the day, I do not think there is enough beef in the system to ensure that we have adequate support staff. If NICE is going to carry out the benchmarking, which is a very good thing, we need to make sure that the regulator actually has some beef in terms of ensuring that we get adequate staff levels in clinical areas. I think that my Amendment 144 ensures that that will happen. I should like to test the opinion of the House.
My Lords, I shall speak also to Amendments 152B to 152F. These are amendments to the clauses that establish a new offence and penalties where care providers provide certain false or misleading information. Together with the new duty of candour on providers that we considered last Wednesday, this measure is key to supporting openness and transparency among care providers.
We are making two substantive amendments. First, Amendment 152F extends the offence to directors and other senior individuals who consent to or connive in an offence committed by the care provider, as well as to cases where the negligence of senior individuals has led to the offence by the care provider. This amendment brings the offence into line with a number of other offences that are committed by organisations, such as Health and Safety at Work etc. Act offences and offences under the CQC legislation, where senior individuals are also liable for the offence. This will encourage directors and other senior individuals leading organisations to take greater ownership of the provision of information.
Secondly, since Committee, the Government have reflected on the penalties for this offence. The provision of accurate information is central to the safe functioning of the health and social care system as it provides the intelligence on which commissioners and regulators form judgments about the quality of care. Where that information is wrong, it can result in delays in taking action to protect patients and service users. Falsifying such information is a serious matter that can frustrate attempts to provide safe care for patients and service users. In the light of this, we believe that a custodial sentence is warranted in the most serious cases. I am therefore bringing forward Amendment 152E, which introduces a maximum penalty on indictment of two years’ imprisonment. I emphasise that the Government are not of the view that the custodial penalty will be used with any frequency. The aim of the offence is not to punish directors and other senior individuals but, rather, to drive improvement and performance.
The amendments also address a number of concerns that were raised in Committee. There was some debate about the scope of the false or misleading information offence. I should like to make it as clear as possible that the false or misleading information offence will apply only to the provision of publicly funded care. We will specify in regulations—a preliminary draft of which we have shared with noble Lords ahead of the debate—which information this will relate to, starting with information provided by hospitals. We are making a small number of amendments to clarify the scope of the offence. First, we are amending the definition of a care provider to make it clear that this does not include commissioners or regulators. We are also amending the wording so that the offence could apply to sole traders and all types of partnerships, such as GP practices, and to care providers who are funded by service users under direct payment arrangements. I beg to move.
My Lords, I want to ask the noble Earl just one question. Why does it not apply to commissioners? We know from events that have happened in the past few years that in many cases commissioners have been responsible for issues by sins of omission or by not being completely open. It is a puzzle to me why all the emphasis is on providing and not on the way that commissioners actually operate. There is evidence, for instance, that the way some commissioners operate can have a direct impact on the quality of provision. We have already discussed this in relation to 15-minute visits. I am puzzled as to why so little attention is being paid to the way that commissioners themselves should operate.
That is a perfectly reasonable question. The short answer is that, in determining the scope of this offence, our focus was and is on information that is closest to patient care, where inaccurate statements can allow poor and dangerous care to continue. That approach responds directly to the Francis report concerns about the manipulation of patient safety information. We believe, therefore, that the proposals are focused and proportionate. We are targeting this offence on the key patient safety and quality data that commissioners and regulators use to assess performance. We think that we have the balance right.
My Lords, in Committee noble Lords were rightly concerned about the way that healthcare assistants and social care support workers are trained and supported to carry out the crucial tasks assigned to them. Amendments were also tabled concerning the regulation of this group of workers. I sought then to reassure noble Lords that the Government were determined to ensure that this important part of the workforce received high-quality and consistent training to deliver the best standards of support and care to patients and service users. Having listened very carefully to the views expressed in Committee, I have reflected a great deal on this important issue and today I am able to go further than I was able to do on that occasion.
First, however, I shall provide a short recap. What we are now doing will mean building on what we have been putting in place since your Lordships’ House last discussed this issue during the passage of the Health and Social Care Act 2012. Common induction standards have been in place in social care since 2005, but the sector skills councils jointly published a code of conduct and national minimum training standards in March 2013. The standards place dignity and respect at the centre of the knowledge required to provide safe and effective care. The sector skills councils engaged comprehensively in the development of both the NMTS and the code of conduct across the health and social care sectors, including NHS and social care providers, the Health and Care Professions Council, the Royal College of Nursing, the Royal College of Midwives, the Nursing and Midwifery Council, and patient representative groups.
We know that we need to build on these standards. The department is investing £130 million in training and developing the social care workforce this year. Working through Skills for Care, the Department of Health provides funding of some £12 million each year to social care employers to train and develop their workforce. Health Education England is also investing £13 million in the training and development of healthcare assistants.
My Lords, I am very pleased that noble Lords have recognised the announcement I made today about the development of the care certificate, led by Health Education England working with professional bodies and the sector skills councils. It goes a long way to ensuring that we address training and quality standards for this part of the workforce.
I shall do my best to answer the questions that have been put to me. First, I pay tribute to my noble friend Lord Willis who has made a very important contribution to the debate on healthcare assistants in the Willis Commission on Nursing Education. I acknowledge his long-standing interest and expertise in this area. While the government position on a recommendation such as regulation is different from his—I will come on to regulation in a moment—we share his concern that healthcare assistants and social care support workers need to have the training to do the tasks that they are asked to do. I am well aware of the recommendations that he has made in that area and we will not lose sight of them.
My noble friend asked about government Amendment 153 and why it does not say “must” instead of “may”. First, I can confirm that we will make regulations in this area. The amendment provides an expressed power to delegate the standard-setting function to another body if we so choose. It is in the Secretary of State’s power to delegate. The amendment states “may” because the Secretary of State may in the future wish to set the training standards which he would be able to do under his existing powers. The Secretary of State would not be able to do that if regulations had been made that delegated this function to another body.
The noble Lord, Lord Warner, asked what the care certificate will look like. It is a little too soon for me to answer that in any detail. Health Education England is still considering that issue because of the range of settings in which healthcare assistants and social care support workers operate. We have asked Health Education England to ensure that the approach to the care certificate is flexible so that it is meaningful in every setting. As Camilla Cavendish recommends, they will need to build on the best of the training and development practice which is out there, and the good work that is being done on the code of conduct and the national minimum training standards. A key requirement is to ensure that the skills and behaviours are taught so that we move away from the tick-box approach identified in some instances in the Cavendish review. I know that that is a particular concern—rightly—of the noble Baroness, Lady Emerton. Equally, the noble Lord, Lord Warner, was right to say that we have to think about the mechanisms which would allow, in appropriate cases, the withdrawal of a certificate where an individual had been found wanting in their caring skills.
The noble Baroness, Lady Emerton, asked who will be involved in the development of the certificate. As I have said, Health Education England has been asked to lead this work. It will engage with sectoral bodies, including the sector skills councils, but also more particularly the NMC, the RCN and providers of care. The department will be involved as well. I can reassure her that the code of conduct and the national minimum trading standards were not solely the product of the sector skills councils but were very much the result of consultation and cross-sector working with a number of professional bodies.
My noble friend Lord Willis asked whether there would be an advanced certificate. An advanced certificate, bridging into nursing qualifications, certainly needs to be considered as part of the wider response to Camilla Cavendish’s report and we may have more to say about that when we make our official response. However, we agree that any work done by Health Education England must look at the broader picture and the other recommendations made by Camilla Cavendish.
My noble friend also asked about recognising existing high standards of training, where those pertain. He is absolutely right that we need to build on the best training that is out there and to recognise the tasks that people are called upon to do. The Cavendish review makes recommendations on better quality assurance which we are also considering.
The noble Baroness, Lady Wall, asked what we do about healthcare assistants and social care support workers who are already working in the field. That is a point of detail which is still to be worked through but, in principle, if someone is already working as a healthcare assistant or social care support worker and meets the standards there should be some way for them to demonstrate this without having to undergo unnecessary repeat training.
The noble Lord, Lord Hunt, suggested that, if we have gone this far, it is almost inevitable that we should proceed to regulate this sector of the workforce. I do not agree with him, but, in answer to the noble Lord, Lord MacKenzie, our minds are still open to the possibility of regulation at some time in the future. However, we need to bear in mind that statutory regulation is not just about training: it is a much broader process and we do not currently view it as appropriate or proportionate for healthcare assistants and social care workers. Statutory regulation involves setting standards of conduct required within a scope of practice; protecting commonly recognised professional titles; establishing a list of registered practitioners, which is quite an onerous process; providing a way in which complaints can be dealt with fairly and appropriately and allowing a regulator to strike off an individual from a register. We must make no mistake about how complex a business this is. I emphasise that we will continue to review this whole question as we go along but we do not think it is appropriate at present.
The noble Lord, Lord Patel, asked what sanctions there will be for people who do not meet the standards described in the certificate and the noble Lord, Lord Warner, asked a similar question. Unfortunately, I do not have a detailed answer for him today. However, it is a pertinent point that, as the development of the certificate continues, we will need to bottom out. Managers and the CQC will play a big role and are important in ensuring that the certificate is an effective way of evidencing people’s skills.
The noble Lord, Lord Warner, asked a related question about who an employer tells if they fire someone with the certificate. The process operated by employers under the existing system should include checks on various matters, including qualifications. However, the disclosure and barring service also provides a further layer of assurance by helping employers make safer recruitment decisions and prevent unsuitable people working with vulnerable groups.
The noble Lord asked what level the certificate would be set at. It is, at this stage, basic training but full details have not been finalised and I hope noble Lords will understand that if I go any further on this point I am in danger of pre-empting our formal response to the Cavendish report. Currently, the national minimum training standards cover issues such as how to communicate effectively with stakeholders, how to ensure that care is person-centred, how to handle patients, and infection control and prevention. However, no doubt those issues will be looked at and, if appropriate, built on.
I stress that I recognise how much of an issue of concern this is. I will take the opportunity to reassure noble Lords that, while what I am describing is the right course of action, we will continue to keep under review further measures as necessary. With that, I hope that noble Lords will feel reassured that there is already in place a proportionate system and process to provide public assurance, and that these measures, in addition to the commitments that I made today in relation to the training and development of the workforce, will in their totality be sufficient to enable them to feel comfortable in not pressing their amendments.
My Lords, I will speak also to Amendments 155, 156, 157, 161, 162, 163 and 164.
It is important that Health Education England, through its education and training functions, is able to develop a workforce that is informed by, and responsive to, the needs of patients and service users. Robert Francis QC highlighted the importance of embedding a culture of listening to, and engaging with, patients in his report of the Mid Staffordshire NHS Foundation Trust public inquiry. The report included a recommendation that Health Education England should include a lay patient representative on its board. The Government supported that recommendation and tabled Amendment 154 to require the Health Education England board to include a non-executive member who will represent the interests of patients. Indeed, we have already taken steps to recruit such a non-executive member to the board of the Health Education England Special Health Authority. However, it is our intention to go further. Amendment 162 would require local education and training boards to include a person who will represent the interests of patients.
Amendments 163 and 164 reflect minor changes to the drafting of Clause 94. Together, they clarify that the regulations requiring clinical expertise on LETBs relate to the provision in subsection (3)(b) of Clause 94.
In setting Health Education England up as a non-departmental public body, it is important that we give it the appropriate levels of autonomy and flexibility to determine how it organises itself and performs its functions. Amendment 155 seeks to enable Health Education England to arrange for any of its committees, sub-committees, members or any other person to exercise its functions on its behalf. Linked to Amendment 155, Amendment 156 seeks to enable Health Education England to make payments to any of its committees, sub-committees or members, or to any other person to whom it delegates functions. These amendments bring Health Education England into line with other bodies established under the Health and Social Care Act 2012 that have powers enabling functions to be exercised by their committees and by their non-executive and executive members. It is also consistent with Amendment 165, which covers the Health Research Authority.
Amendment 157 seeks to amend the Bill to clarify that Health Education England may not delegate the functions of a local education and training board to any other committee, sub-committee, member or any other person. The functions of the LETB will continue to be the sole responsibility of those committees established as local education and training boards. This is important and reflects the discrete role of the local education and training boards and the separation in the Bill of responsibilities for national and local education and training functions.
We had an excellent debate in Committee on the important role that education and training can play in supporting research. I know we are all in agreement that it is vital to create a workforce in the health service that is innovative and research-literate, with the skills required to diffuse the latest ideas and innovations.
The noble Lords, Lord Turnberg and Lord Patel, and my noble friend Lord Willis sought reassurance that the duty placed in Clause 89 on Health Education England to promote research would be equally applicable to LETBs when exercising their local workforce planning, education and training functions. As I set out in Committee, our view is that local education and training boards are obliged to support Health Education England in delivery of its primary duties. However, I have given this some thought and agree that it is important to reinforce the Bill to make this clearer. Amendment 161 not only seeks to clarify that the duty to promote research applies equally to LETBs but makes it clear in the Bill that Health Education England’s duties relating to continuous quality improvement and promotion of the NHS Constitution apply also at a local level.
These amendments will strengthen the patient voice within Health Education England and the local education and training boards, provide greater autonomy and flexibility, and ensure a strong research duty. I hope that noble Lords feel able to give these amendments their support. I beg to move.
My Lords, we very much welcome this important group of amendments. If one reads back over the debates on the Bill in Committee, there can be little doubt that the provisions for HEE and LETBs have been considerably strengthened and improved by your Lordships’ detailed scrutiny and deliberations. These amendments consolidate that work.
We have also been encouraged by the progress that HEE has been making under the leadership of Sir Keith Pearson. The website demonstrates this, and the HEE leadership team has been highly visible at conferences and forums, setting out its proposed strategic priorities and consulting on the way forward. In particular, HEE seems to have taken up the key message that, in educating and training staff for NHS and public health, it must have a strategic understanding of the workforce requirements across the boundaries of health and social care and of the need for staff to work in an integrated way. This has been a major concern. I was pleased, for example, to hear the HEE medical director, Wendy Reid, emphasise this at a recent Westminster Health Forum workforce conference that I chaired.
These amendments strengthen the role of LETBs by emphasising that HEE duties under Clause 89 to ensure that quality improvement in education and training, promotion of research—as the Minister has stated—and the NHS Constitution all apply to LETBs. This is an important provision and reflects concerns expressed in Committee that LETBs must pay attention to the maintenance of standards and quality in education and training, as well as ensuring that sufficient numbers of staff are trained locally. This was a point made by my noble friend Lord Turnberg and which the Minister addressed earlier.
Amendments explicitly providing HEE with authority to delegate its functions to its committees, sub-committees, members or other persons are important in allowing HEE the flexibility that it needs to deliver its priorities and functions, and we strongly support them.
On HEE board and LETB representation, we join other noble Lords in expressing our relief at the government amendments, which ensure that people with clinical expertise are appointed to both bodies. This was a serious omission and its inclusion now greatly strengthens the Bill, as does the Government’s commitment that regulations will place a specific requirement on HEE and LETBs to include a nurse and a doctor. It is particularly important, as my noble friend Lord Hunt underlined in Committee, for the people in the driving seat on education and training requirements, standards and future needs at local level to be those who provide the services. HEE and LETBs must understand the pressures that the service is under in relation to staffing and to ensuring that education and training is flexible and responsive to the rapidly changing face and needs of health and social care. The implementation of the Francis recommendations for a lay patient representative on the HEE board and LETBs is also a key change to the Bill, which we strongly welcome and which will only enhance the work and effectiveness of those bodies.
Finally, as supportive of HEE as we are, it is hard to see in HEE work to date a clear strategy for developing the vital cadre of NHS managers that is needed to lead the NHS in the coming months and decades. There was a strong concern about this in Committee and the need for close working with HEE and the NHS Leadership Academy was acknowledged by the Minister. The Joint Committee wanted to see a statutory commitment for HEE to work in partnership with the academy, to ensure that managers in training work alongside their clinical colleagues and to increase the number of managers in the future who have clinical experience. Does the Minister not agree that this needs to be an explicit, upfront priority for HEE, which translates through to the work of LETBs? How will the Government ensure that this vital issue is addressed?
My Lords, I turn first to the amendment in the name of the noble Lord, Lord Aberdare. He has, of course, raised a very important matter. I think that it would be too ambitious for me to offer him complete comfort on this issue at the Dispatch Box, but I hope that I can give him some. It is essential that patients have their conditions diagnosed promptly and effectively. Both Health Education England and the other responsible bodies, such as the professional regulators and royal colleges that are involved in setting the standards and content of education and training, must work together to ensure that the latest best practice is followed to deliver the best possible outcomes for patients. That is fundamental.
Going further, I reassure the noble Lord that in delivering its education and training functions, Health Education England will be very focused on doing so in a manner that supports the efficient delivery of NHS and public health services and the achievement of the best possible outcomes for patients. Health Education England has a clear duty in Clause 89 to exercise its education and training functions with a view to securing continuous improvement in the quality of health services. Those are not idle words; they are significant.
It is also important to remember that the NHS Constitution includes pledges on access to NHS services, including the right to access services within maximum waiting times. The Government are clear that bodies in the new health system must support the NHS constitution, which is why in Clause 89 there is a clear duty for Health Education England to promote the NHS constitution.
Finally, the list in Clause 91 of matters that Health Education England must have regard to includes the Government’s mandate to NHS England. I reassure the noble Lord in that context that the mandate already contains an explicit objective for NHS England to make progress in supporting the earlier diagnosis of illness as part of preventing people from dying prematurely. I acknowledge that this is a very important matter. I hope that for the reasons I have set out the noble Lord will feel somewhat comforted and reassured, at least enough not to press his amendment. I have no doubt that this is a debate that we will continue to have at reasonably regular intervals.
The noble Baroness, Lady Wheeler, asked what role Health Education England will play in developing NHS managers and whether it should be a priority for it. Health Education England is working closely with the Leadership Academy to support the development of the next generation of managers and clinical leaders. The Government included this as an objective in Health Education England’s mandate.
My Lords, at this point it will be convenient to consider also Amendments 166, 167 and 168. We have previously had some valuable debates about the Health Research Authority’s role in promoting transparency in research. I thank the Joint Committee that scrutinised the draft Bill and the Science and Technology Select Committee in the other place for their reports, which have informed Amendments 166 and 167.
In previous stages of the Bill’s passage, the noble Lords, Lord Patel, Lord Turnberg, Lord Warner and Lord Winston, the noble Baroness, Lady Wheeler, and my noble friend Lord Phillips of Sudbury have made particularly valuable contributions to the debate on this issue, which I have listened to with considerable interest. The Government have also discussed the Health Research Authority’s role in promoting transparency with stakeholders and with the existing special health authority.
The life sciences industry plays a key role in the Government’s strategy for economic growth and makes a valuable contribution to both the health and wealth of our nation. The Government agree that there is a powerful case for increasing transparency in clinical trials. Ensuring that research is registered and published and that data, information and tissue are available where relevant will help to make the best use of research, thereby maximising the health benefits for patients and the public from research undertaken and thus maximising the return on our investment in research. Amendment 166 makes it explicit that the Health Research Authority’s objective of facilitating the conduct of safe and ethical research includes promoting transparency in research. Amendment 167 lists some of the ways in which the HRA must promote transparency.
The existing special health authority is already making great strides in promoting transparency in research. The Health Research Authority published an action plan in May 2013, which received widespread support from a range of stakeholders including researchers, research sponsors, funders, professional bodies, stakeholders and members of the public with an interest in transparent research. Since 30 September, registration of clinical trials in a publicly accessible database has been a condition of favourable ethical approval from a research ethics committee.
These amendments will ensure that the Health Research Authority continues to promote greater transparency in research when it becomes a non-departmental public body. By doing so, that authority will continue to reassure people who participate in research that research is not duplicated unnecessarily and that unnecessary risks and burdens continue to be avoided. As promoting transparency in research is specifically included within its objective under Amendment 166, the Government would expect that the annual report would cover the authority’s measures to meet this section of its objective. While there is more to be done in this area, including by research funders, I hope that I have been able to reassure noble Lords that great strides are being taken and will continue to be taken.
Amendment 165 clarifies that the Health Research Authority may delegate any of its functions to any of its committees, sub-committees, members or any other person. The amendment mirrors a similar amendment that we have already debated with respect to Health Education England in Schedule 5—it was Amendment 157.
Finally, I would like to explain briefly Amendment 168, which corrects an oversight in the drafting of the Bill. It ensures that an appropriate body under the Mental Capacity Act (Appropriate Body) (England) Regulations 2006 is a research ethics committee recognised or established by or on behalf of the Health Research Authority, rather than a research ethics committee recognised by the Secretary of State.
I thank noble Lords and others for the contributions that have informed the amendments on the HRA’s role in promoting transparency in research. I hope that they will be welcomed. I beg to move.
My Lords, first, I declare an interest as the chair of the Association of Medical Research Charities. The brief comments that I am about to make are an amalgam of those made with the Academy of Medical Sciences, Cancer Research UK and the Wellcome Trust. On behalf of all those organisations, I can say how much we welcome these amendments and the way in which the HRA has so quickly become embedded into the research psyche. The work that it is doing ensures that on each of the major obstacles—of which ethics was the first, particularly in local ethics committees, but going right through to the regulation that it is starting to streamline, particularly with the Human Tissue Authority—we are really seeing a march forward. Frankly, the progress that has been made has staggered me. I congratulate not only the chairman and chief executive of that organisation but the Minister himself.
My Lords, I am very grateful to noble Lords for their questions and comments. Without spending too much time, I shall try to cover the questions raised. Anything I do not cover, I undertake to answer in a letter. My noble friend Lord Willis asked a number of questions about how he should interpret the provisions in Amendment 167 in particular. Incidentally, it is important to point out that the way Amendment 167 is framed means that the HRA may do other things to promote transparency and research, not just the things that are listed in the amendment. The HRA should do what is set out in paragraphs (a) to (e), but it is not an exclusive list.
My noble friend asked me whether we should not be talking about registration of clinical trials instead of research. The amendment requires the HRA to promote the registration of research because we want to encourage transparency in all health and social care research. Greater knowledge about what research is under way or has already been undertaken is essential, so that new research can build on it, minimising the risks, intrusions and burdens for patients. We think that that applies to all research, not just clinical trials. The amendment requires the HRA to promote registration of research; it does not create a requirement for all research to be registered. I hope that that will ease my noble friend’s mind a little.
In delivering its objective of facilitating safe and ethical research, I would expect the HRA to take into account what databases are available for the registration of research, any existing requirements to register research, the need for requirements on registration to be proportionate and practical, and what is happening internationally. In doing so, presumably the HRA would consult stakeholders on achieving this part of its objective.
My noble friend asked me what is meant by,
“promoting … the provision of access to data on which research findings or conclusions are based”.
It is important that the data generated during research are made available to others, where possible, while protecting patient confidentiality. That helps to ensure that we maximise the benefit from investment in research. The Health Research Authority special health authority is currently planning to strengthen the research ethics committee review of researcher intentions, to make findings, data and tissue available. It is undertaking a pilot to consider whether the introduction of ethics officers will increase the proportion of favourable opinions at first review, improve the timelines of review and reduce the administrative burden on research ethics committees. That includes a review of researcher intentions to make findings, data and tissue available.
My noble friend referred to patient confidentiality. I stress, as I have on previous occasions, that in promoting the provision of access to data on which findings or conclusions are based, the common law duty of confidentiality and the Data Protection Act 1998 apply. The HRA will need to take account of these in delivering this part of its objective. We do not believe that it is necessary to state this explicitly in paragraph (c) of Amendment 167.
The noble Lord asked what is meant by,
“promoting … the provision of information at the end of research to participants in the research”.
Participants who take part in research have said that they want to be able to access the results of the research, and that was confirmed by recent HRA public engagement work. The HRA is working with others to set standards and provide guidance on how information should be provided to participants. Consideration of these plans against agreed standards will continue to be an issue for research ethics committees to review at approval. That work will continue through the HRA’s involvement work stream.
My noble friend questioned whether the results should be released to every participant, perhaps in aggregated form. It will be for the HRA, as an NDPB, to set out in its guidance for researchers its expectations as to the information they should provide to research participants at the end of the study. We would expect the HRA to develop its expectations, not only with stakeholders but with research participants themselves. We do not think that it is necessary to state explicitly that information should be in aggregated form.
As regards access to tissues, my noble friend made a good point. Human tissue is a valuable resource for research. Disposal should be a last resort. Making tissue available at the end of a study allows other researchers to make use of material already collected. Maximising potential for research from tissue collected helps to reduce the risks, burdens and intrusions placed on people by minimising the need to collect further tissue. Making tissue available at the end of a research study might involve the tissue being transferred to an appropriately licensed tissue bank, for example. We recognise that tissue has a limited life, and, through quality and assurance systems, tissue that should be disposed of is identified by either the tissue bank or the researcher. I can expand on that for my noble friend if he would like me to.
The noble Baroness, Lady Wheeler, asked whether the Government would ensure that CCGs and NHS staff engage in research. I am pleased to remind her that CCGs have a duty to promote research under the Health and Social Care Act 2012. I hope that that has covered at least the majority of the questions.