Care Bill [HL]
(11 years, 2 months ago)
Lords ChamberRead Hansard Text Read Debate Ministerial Extracts
16:16 - Division on Amendment 168B - Ayes: 176 / Noes: 242 - Amendment 168B disagreed.
17:20 - Division on Amendment 143A - Ayes: 194 / Noes: 220 - Amendment 143A disagreed.
18:22 - Division on Amendment 144 - Ayes: 194 / Noes: 204 - Amendment 144 disagreed.
“Trust special administration: powers of administrator etc.
(1) In section 65O of the National Health Service Act 2006 (Chapter 5A of Part 2: interpretation) (the existing text of which becomes subsection (1)) at the end insert—
“(2) The references in this Chapter to taking action in relation to an NHS trust include a reference to taking action, including in relation to another NHS trust or an NHS foundation trust, which is necessary for and consequential on action taken in relation to that NHS trust.
“(3) The references in this Chapter to taking action in relation to an NHS foundation trust include a reference to taking action, including in relation to another NHS foundation trust or an NHS trust, which is necessary for and consequential on action taken in relation to that NHS foundation trust.”
(2) In section 65F of that Act (administrator’s draft report), in subsection (1), for “45 working days” substitute “65 working days”.
(3) After subsection (2C) of that section insert—
“(2D) Where the administrator recommends taking action in relation to another NHS foundation trust or an NHS trust, the references in subsection (2A) to a commissioner also include a reference to a person to which the other NHS foundation trust or the NHS trust provides services under this Act that would be affected by the action.”
(4) In section 65G of that Act (consultation plan), in subsection (2), for “30 working days” substitute “40 working days”.
(5) After subsection (6) of that section insert—
“(7) Where the administrator recommends taking action in relation to another NHS foundation trust or an NHS trust, the references in subsection (4) to a commissioner also include a reference to a person to which the other NHS foundation trust or the NHS trust provides services under this Act that would be affected by the action.”
(6) In section 65N of that Act (guidance), after subsection (1) insert—
“(1A) It must, in so far as it applies to NHS trusts, include guidance about—
(a) seeking the support of commissioners for an administrator’s recommendation;(b) involving the Board in relation to finalising an administrator’s report or draft report.”(7) In section 13Q of that Act (public involvement and consultation by NHS Commissioning Board), at the end insert—
“(4) This section does not require the Board to make arrangements in relation to matters to which a trust special administrator’s report or draft report under section 65F or 65I relates before the Secretary of State makes a decision under section 65K(1), is satisfied as mentioned in section 65KB(1) or 65KD(1) or makes a decision under section 65KD(9) (as the case may be).”
(8) In section 14Z2 of that Act (public involvement and consultation by clinical commissioning groups), at the end insert—
“(7) This section does not require a clinical commissioning group to make arrangements in relation to matters to which a trust special administrator’s report or draft report under section 65F or 65I relates before the Secretary of State makes a decision under section 65K(1), is satisfied as mentioned in section 65KB(1) or 65KD(1) or makes a decision under section 65KD(9) (as the case may be).”
(9) In section 242 of that Act (public involvement and consultation by NHS trusts and foundation trusts), in subsection (6)—
(a) for “65I, 65R or 65U” substitute “or 65I”, and(b) for the words from “the decision” to the end substitute “the Secretary of State makes a decision under section 65K(1), is satisfied as mentioned in section 65KB(1) or 65KD(1) or makes a decision under section 65KD(9) (as the case may be).”(10) In Schedule 14 to the Health and Social Care Act 2012 (abolition of NHS trusts in England: consequential amendments)—
(a) after paragraph 4 insert—“4A In section 13Q(4) (public involvement and consultation by Board), omit “makes a decision under section 65K(1),”.
4B In section 14Z2 (public involvement and consultation by clinical commissioning groups), omit “makes a decision under section 65K(1),”.”,
(b) in paragraph 15, after sub-paragraph (3) insert—“(3A) In subsection (2D), omit “or an NHS trust” and “or the NHS trust.”,
(c) in paragraph 16 (the text of which becomes sub-paragraph (1)) at the end insert—“(2) In subsection (7) of that section, omit “or an NHS trust” and “or the NHS trust”.”,
(d) in paragraph 24, after sub-paragraph (2) insert—“(2A) Omit subsection (1A).”,
(e) after that paragraph insert—“24A In section 65O (interpretation)—
(a) omit subsection (2), and(b) in subsection (3), omit “or an NHS trust”.”, and(f) in paragraph 35, omit the “and” preceding paragraph (d) and after that paragraph insert “, and(e) in subsection (6), omit “makes a decision under section 65K(1),”.””
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
This 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.
Lord Hunt of Kings Heath
“( ) Before section 65F of that Act insert—
“65ZFZF Trust special administration: measures required before powers take effect
No power under this Act for the administrator to recommend taking action in relation to another NHS foundation trust or an NHS trust, or for any such action to be taken, shall be exercised until—(a) at least 5 years have passed after the passing of the Care Act 2013;(b) the Secretary of State has reported to both Houses of Parliament on the case for the operation of such a power; and(c) an order made by statutory instrument giving effect to the recommendations of such report has been laid before and approved by a resolution of both Houses of Parliament.””
Lord Hunt of Kings Heath (Lab)
My Lords, I beg to move my Amendment 168B as an amendment to Amendment 168A moved by the noble Earl, Lord Howe.
We have just heard the noble Earl suggest that his amendment makes small changes and is a clarification of the existing law. However, it is my contention that the amendment is nothing short of a major change in policy on the reconfiguration of NHS services. Your Lordships are being asked to agree to it even though the case, or one of the cases, on which it is based—that of Lewisham hospital—is subject to an imminent Court of Appeal hearing. If it is accepted by the House, it is my view that NHS hospitals will be at risk of having services shut down without their agreement, without extensive consultation and without agreement from commissioners.
The changes made to the special administration regime by the government amendment would also extenuate the problems caused by having a different failure regime for NHS trusts compared with NHS foundation trusts—a point that my noble friend Lord Warner has consistently made.
Finally, to be effective, the changes could be construed as meaning that, for the first time, the Secretary of State has the power to issue directions to require the boards of solvent and successful clinical commissioning groups and NHS foundation trusts to take steps that they do not wish to take.
I see this not as a clarification of the law but as a major policy change that is at odds with the approach taken by the Secretary of State in the 2012 Act, when he repeatedly put his faith in local commissioning by local doctors. I make it clear that I am not opposed to changes in services: I support the major reconfiguration of services where clinical evidence supports it. Indeed, I should like to see much faster progress. When I and my noble friend Lord Warner argued this during the passage of the Health and Social Care Bill, the Government ploughed on with their extensive and fragmentary changes. The Government have belatedly come to realise that the structure they imposed is actually a barrier to progress—hence the amendment. It is also clear that, given the dire financial straits of many NHS organisations, the special administration process is likely to be used on an increasing basis. My concern is that giving so much power to trust special administrators is the wrong way to go about it. Indeed, evidence from Lewisham and Staffordshire suggests that it will often provoke widespread opposition and slow down progress.
As the noble Earl has said, the key change that the Government want to make is to ensure that the Secretary of State can act on recommendations that affect other NHS trusts, NHS foundation trusts or other providers and commissioners outwith the trust to which a special administrator has been appointed. How this would happen has been graphically illustrated in the case of Lewisham. The South London Healthcare NHS Trust was a badly performing trust with an accumulated deficit of £196 million. Consequently, a trust special administrator was appointed. In his draft report of 24 October 2012, he recommended that University Hospital Lewisham should no longer provide emergency care for critically ill patients who did not need to be admitted to hospital and that it should lose its obstetrics-led maternity unit.
The Secretary of State made some changes to those recommendations but Lewisham hospital would still have seen some significant downgrading in its services. This approach had no support locally and was blatantly unfair to the people of Lewisham. As Mr Justice Silber said when the Lewisham case came to the High Court:
“There are few issues which prompt such vociferous protest as attempts to reduce the services at a hospital which is highly regarded and which is much used by those who live in its neighbourhood”.
In the High Court, Lewisham Council and the campaign group argued that Lewisham hospital was not in the NHS trust over which the trust special administrator had been appointed and that the Secretary of State could make recommendations and decisions only in relation to the three hospitals in the South London Healthcare NHS Trust but not in relation to hospitals outside the trust area. The judge subsequently found in favour of Lewisham Council and concluded that the trust special administrator and the Secretary of State were not entitled to make recommendations and decide to reduce services at Lewisham because it was not a hospital over which the administrator had been appointed. It was situated in a totally different trust.
The appeal of the Lewisham decision by the Government will be held shortly. I find it remarkable that without hearing the outcome of the case they are seeking to amend the law in such a hasty way. The noble Earl said in his letter to us that the trust special administrator regime is,
“one way in which decisive action can be taken to deal with NHS trusts or NHS foundation trusts that are unsustainable in their current form”.
I agree, but surely not at the expense of well run trusts. Of course there need to be changes in the local health economy beyond just the trust that is failing; a trust does not fail in isolation but is part of a complex, interconnected system—change one bit and you impact on the other bits. However, the legislation was intended to deal with a simple case in which a trust had failed and was then broken up, with its assets being transferred or sold off. My contention is that this type of approach is not suited to major reconfiguration processes and should not be a back-door way to achieve unpopular changes.
I should also say that the government amendment seems to introduce a major anomaly around commissioning. A clinical commissioning group that commissions services from a failing NHS foundation trust is entitled to define and protect essential NHS services, but a clinical commissioning group that commissions services from a successful NHS trust can now see local services removed, even if that clinical commissioning group considers those services to be essential.
Further, the scheme proposed by the amendment appears to be legally ineffective. Neither a clinical commissioning group nor a foundation trust is subject to the direction-making powers of the Secretary of State—both are independent corporate bodies with boards which are responsible for making their own decisions. It is unclear to me how the boards of the clinical commissioning group and a foundation trust are supposed to be legally required to carry through any decision which is made within a special administration process relating to another body.
Nor is it clear what happens if the commissioners do not wish to commission services against the model that the special administrator has proposed. That is the case in Mid Staffordshire, where the special administrator’s proposals have not found favour with either the public or the clinical commissioning group. There appears to be no limit to how far recommendations might stretch to be “necessary” and “consequent”. It is clear that one trust could have many commissioners, and changes in services could impact upon many other trusts. The special administrator is being given a free hand to cast his net as widely as he wishes.
In conclusion, there are serious defects in the special administration process which the noble Earl’s amendment does little to resolve; indeed, it brings further anomalies and inconsistencies. However, my key concern about the amendment is that it removes the requirement to go through a properly defined and structured reconfiguration process, with extensive consultation with the local community. From all that we have learnt about successful reconfigurations, we know that they need to take a special form of open and honest leadership, a patient process of engagement and consultation, and proper consideration of the wider impact. The Government really should think again about this and my amendment gives them the opportunity to do so.
Baroness Warnock (CB)
My Lords, I have hesitated to speak before about the Lewisham situation, partly because I believe that some changes are needed in hospital provision over the whole country but mainly because, as a resident in the borough of Lewisham, I might be thought to be so biased that my opinions would carry no weight. However, the situation has radically changed with the introduction of the noble Earl’s amendment.
It is completely intolerable that the law should be changed and overturned in this hasty way, regardless of the fact that everybody admits that there is no fault to be found with the Lewisham hospital administration. It is an admirable hospital and its extensive and thorough accident and emergency section is particularly valued by a large number of people, for whom Lewisham is a centre to which they can get easily by various forms of transport, let alone by ambulance.
The contention that it would make little difference to the residents of Lewisham if this comprehensive A&E department were closed was risible. The tests to see how long on average it would take to get there were carried out at dead of night, and in various ways there was a great deal of false suggestion in the administrator’s conclusions. Above all, the clinical commissioners were by no means convinced and were not in agreement with the proposals.
The reason for speaking so strongly in favour of the amendment moved by the noble Lord, Lord Hunt, is that things have now moved far beyond Lewisham. I am speaking not only about the Lewisham situation; the proposals are perfectly general—the powers proposed for the Secretary of State could be used anywhere in the country.
What we have now is a radical change of power and, as other noble Lords have said, all hospitals are now under threat of closure, whether or not they are successful or administered with financial prudence, as Lewisham has been. It seems to me that this is an absolutely arbitrary overturning of what was found in court. Therefore, I beg noble Lords to think of this amendment in that light and not just to be concerned with the two particular trusts but with hospital provision all over the country.
Lord Warner (Lab)
My Lords, although I am Lord Warner of Brockley in the London Borough of Lewisham, I do not intend to speak about the Lewisham case.
I am conscious that this is a topic which can rapidly cause eyes to glaze over as we go into some of the processes involved here. At the heart of this there is a fundamental problem which is much deeper and more serious than when the 2006 Act was passed. That was seven years ago. This procedure of trust special administrators was set up to deal with a relatively small number of cases that might come along. It was not a system set up to deal with major overhauls of acute hospitals up and down the country.
We are now in a very different financial situation from when this earlier legislation was going through Parliament. You pays your money and you takes your choice as to who you believe about the black hole that there will be in the NHS finances at the end of this decade. If you want to believe Sir David Nicholson, the outgoing chief executive of NHS England, it will be £30 billion. A number of noble Lords may be shaking their heads because they do not wish to believe him, but he says £30 billion. If you want to believe the Nuffield Trust, it will be somewhere north of £40 billion. If you want to consider the more measured estimate last week from the chief executive of Monitor, it will be £12 billion, but that assumes a level of efficiency savings which seem somewhat like fantasy football in terms of their deliverability. It is likely to be a lot more than £12 billion.
These are numbers which no one was even thinking about when the trust special administrator system was set up. I have some sympathy with the Government’s position because there is no doubt that we have a large and growing number of clinically and financially unsustainable acute trusts. The Government have a real problem that they are trying to tackle. However, I suggest that this particular way of tackling it is not the best way, because it is trying to adapt a system which was produced for a relatively small number of cases into a whole system set of arrangements. It has some curious quirks. It seems to treat clinical commissioning groups which are commissioning from foundation trusts differently from those commissioning from non-foundation trusts. I am not going to risk eyes glazing over by talking about this, but this set of proposals does not seem to treat different clinical commissioning groups in exactly the same way.
We must also start to engage the public in the scale of changes that will have to be made to the NHS in order to make it sustainable. It is not just that black hole issue; it is the clinical sustainability of some of its services. We are already finding difficulty in staffing A&E departments. There is a set of issues around whether the manpower would be sufficient to enable us to keep 24/7 acute specialist services on the same number of sites. I would suggest to the Minister as humbly as I can that you are not going to deal with the scale of the problem with this set of arrangements. For the sorts of reasons that the noble Baroness, Lady Warnock, set out, even if you have this set of arrangements on the statute book, you are going to end up with many cases of Lewisham hospital writ large, dotted around the country. There is nothing in these provisions which really ensures that the wider public debate about the reshaping of these services takes place. They are a recipe for a very large number of one-off local rows on a major scale. The lawyers in this House must be rubbing their hands at the prospect of judicial review because a very likely outcome of all this is a large number of contested claims about the way the exercise has been done. There simply will not be the political cover for TSAs to be bold in their thinking.
The noble Earl said we want them to be able to give very effective consideration to the solutions that are needed. I suggest that if you are a trust special administrator and you think you will be kicked from Land’s End to the north-east because of the controversy around the proposals, that is not likely to produce whole-system changes. We now have to think about reviewing whether the TSA system is fit for purpose and meets the needs of the circumstances we now face. That is why, although I am not normally in favour of wrecking amendments, I agree with my noble friend Lord Hunt’s idea that we should have a pause and think again about the best way to reconfigure hospital services so that politicians and the public can engage with this issue and have the kinds of public debates that we badly need to have if we are to maintain the NHS in anything like the form it is today.
Baroness Meacher (CB)
My Lords, in part, I support the Minister because, as the noble Lord, Lord Warner, said, the Government have a problem. We know that for many years there have been attempts to close hospitals that need to be closed and it can take 15 years for that to happen. If the Government can come forward with a sensible, reasonable way of making those decisions, I will back it all the way. However, I find myself agreeing with the idea that a rather quick fix designed to achieve some solution to the Lewisham problem is not the way to do it. This is a national problem of considerable significance. I ask the Minister to take this away, think hard about it and come back with a good set of proposals to help this country close hospitals when they need to be closed. I would certainly be there behind him.
Lord Kennedy of Southwark (Lab)
My Lords, although I sit in this House as Lord Kennedy of Southwark, I actually live in Lewisham, very close to the hospital. I agree with the comments made by my noble friend Lord Hunt of Kings Heath. This is a major change of policy being sneaked through the door by the Government. I am amazed that the Minister has brought his amendment today when we are just a few days away from the case being heard in the Court of Appeal—it will be heard next week, I believe.
I live close to the hospital and I refer noble Lords to my declaration of interest that on a voluntary basis I chair a small committee in the hospital. Whatever the problems of the South London Healthcare NHS Trust, I cannot adequately describe to noble Lords the sense of injustice, unfairness and hurt about what is being imposed by the administrator. We have a good local hospital, which is supported by the local community, delivers on its targets and objectives and is financially solvent, but the administrator came along and ripped the heart out of the hospital.
I contend that the purpose of this amendment is to try to stop the campaign that we have seen in Lewisham over the past few months. The campaign has united the community like never before. We had more than 25,000 people on our march. Streets are plastered with posters to save the hospital. Any political party would be envious of the posters up in people’s windows about this campaign. Our local campaign is chaired by a local GP and has brought together health professionals and the local community.
Will the Minister tell the House whether he has visited Lewisham hospital? I asked him that question earlier this year; I know that he had not been then and hope that he has been there since to see the amount of local support and what a good local hospital it is. More important, there is no support at all for what the Government propose today. I hope that the House will support the amendment of my noble friend Lord Hunt of Kings Heath and reject the amendment of the noble Earl.
Lord Patel (CB)
My Lords, I find myself in a strange position, because I agree in part with the amendment moved by the noble Earl and in part with the amendment moved by the noble Lord, Lord Hunt, although that is not a solution.
I agree with the noble Earl that we need to find a way of reconfiguring NHS services. That reconfiguration cannot just be done through dealing with failing hospitals. It must include other hospitals which currently seem to be delivering good-quality services. We have to find a way out of that. The question is therefore whether the amendment allows us to move forward with reconfiguring NHS services. This is where I find myself more in tune with the suggestion of the noble Lord, Lord Warner, that it may not and that more is required.
Another concern I have is that the commissioners may express views. I would like some explanation of why the commissioners of the NHS foundation trust are to be treated separately from those who commission services from other hospitals. Another issue is that, if the commissioners disagree, NHS England would make the decision. That means that, ipso facto, they will agree with a special administrator—or they will not. In that case, what happens?
Another issue is consultation. Clearly, none of the configuration can occur smoothly unless the public are consulted. At what point will the special administrator consult both the public served by the failing hospital and the public served by the hospital that is not failing but whose services may require reconfiguration?
In summary, therefore, there is a need for amendments that will allow us to move forward with the reconfiguration of services throughout England. In that respect, I am with the noble Earl, but I wonder if he needs to go a bit further. He might consider looking at this further and tabling more amendments at a later stage.
Lord Mackay of Clashfern (Con)
My Lords, there is of course quite a long process still to be gone through on the Bill. As the noble Lord, Lord Warner, has said, it seems clear that there is a serious problem. It occurs to me that the special administrator’s primary emphasis will be on the trust to which he or she has been appointed. It is also obvious that changes to one trust may affect neighbouring trusts. Some solution to the problems in the special administrator’s trust may rely on something done in a neighbouring trust.
On the other hand, in that situation it is extremely important that concentration on the problems of the neighbouring trust is given considerable emphasis. Otherwise, the situation may be distorted by too great an emphasis on the special administrator’s trust at the expense of neighbouring trusts brought in to try to help. I wonder whether the wise course might be for us to accept the amendment, in so far as it goes, with an undertaking that, as the Bill proceeds in the other place, that matter would be seriously considered.
This may be an opportunity for legislation that will not quickly arise again. As the noble Lord, Lord Warner, said, there is a serious problem and it might not be wise to put it off indefinitely. I can see the difficulties and understand the situation of the noble Lord, Lord Patel, but it is very difficult to see how to sort this out today. On the other hand, it might be unwise to lose the opportunity to take a step forward in the hope of improving the situation in later stages of this Bill.
Baroness Barker (LD)
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.
Earl Howe
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.
Lord Hunt of Kings Heath
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.
Earl Howe
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.
Lord Hunt of Kings Heath
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.
Lord Hunt of Kings Heath
My Lords, in view of that, I wish to test the opinion of the House.
“Chief Inspectors
After paragraph 3 of Schedule 1 to the Health and Social Care Act 2008 insert—“Chief Inspectors3A (1) The non-executive members must—
(a) appoint an executive member to be the Chief Inspector of Hospitals,(b) appoint an executive member to be the Chief Inspector of Adult Social Care, and(c) appoint an executive member to be the Chief Inspector of General Practice.(2) Each of those executive members is to exercise such functions of the Commission on its behalf as it determines.
(3) When exercising functions under sub-paragraph (2), an executive member must have regard to the importance of safeguarding and promoting the Commission’s independence from the Secretary of State.””
Earl Howe
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.
Lord Warner
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.
Baroness Greengross
My Lords, I will speak against government Amendments 145, 146 and 149, and speak at the same time to Amendment 147 in my name.
The government amendments would remove from the Bill a requirement for the CQC to conduct regular reviews of adult social care, as the noble Lord, Lord Warner, indicated. The Bill gives us an important opportunity to ensure that local government commissioning is effectively regulated. Last year’s EHRC homecare inquiry evidence pointed to serious concerns about some commissioning practices, which were found to put the human rights of older people in particular at risk. Accordingly, the EHRC’s recent review of the inquiry recommendations welcomed the fact that the Government had signalled their intention that the CQC should conduct regular reviews of adult social care commissioning.
Unamended, Clause 83 would reframe Section 46 of the Health and Social Care Act 2008 to empower the CQC to conduct periodic reviews of adult social care providers and English local authorities which provide or commission adult social care. It was very disappointing to see that the Government intend to remove clauses requiring the CQC to conduct these reviews through Amendments 145, 146 and 149, in the name of the noble Earl, Lord Howe. Taken together, these amendments would remove the proposed new requirements for the CQC to conduct regular performance assessments or periodic reviews of local authority social care commissioning, and amend existing provisions relating to special reviews and investigations by the CQC. That would leave it able to review providers and to ask the Secretary of State for permission to run special reviews when there has been a particular issue but unable to run ongoing reviews of how local authorities commission services. It seems counterproductive to be removing this power at the same time as committing to challenging bad commissioning from local authorities.
The proposals announced by Norman Lamb about CQC reviews the other day are very helpful. But, again, they seem to be focused solely on providers and what they are doing, not on the commissioners who have directed these providers. If the CQC is being made independent, should it be seeking approval for such reviews? I believe that the Government have tabled this amendment because they believe that the provisions in the Health and Social Care Act 2008 will be sufficient to keep local authority adult social care commissioning under scrutiny. However, my analysis is that the human rights of people receiving care would be better protected by retaining the requirement under the Care Bill as currently drafted so that the CQC should conduct regular periodic reviews of local authorities’ commissioning of adult social care.
Lord Low of Dalston (CB)
My Lords, I shall speak briefly against Amendments 145, 146 and 149. As the noble Baroness, Lady Greengross, has just pointed out, these will take away the requirement that the CQC conduct periodic reviews of adult social care commissioning. These amendments seem perverse, coming hard on the heels of the latest care home scandal, revealed by the coroner’s finding that neglect contributed to the deaths of five residents at Orchid View care home in West Sussex.
Last week, the Close to Home report on human rights and home care by the Equality and Human Rights Commission concluded that some commissioning practices were likely to put at risk the human rights of older people receiving care. The Leonard Cheshire report, Ending 15-Minute Care, also points to problems with commissioning. It would therefore seem to make sense to leave Clause 83 unamended so that the CQC is empowered to oversee the practices of those commissioning adult social care and not just of those providing it.
Lord Deben (Con)
My Lords, in general terms, I support the government amendments. I am sure that my noble friend will want to answer the specific issue which the noble Baroness, Lady Greengross, raised. However, I support the Government with a slight caveat. Similar parts of the localism agenda of the Government have likewise seemed to have devolved in order to encourage people to take responsibility. I agree that there is a problem of prescription—if I may use that word in the context of the health service—because we all want to add in to any freedom the particular issues about which we have a special concern. I have real sympathy with those for whom dementia is one of those issues; it certainly is for me. However, we have to guard against that because, in the end, it may produce an artificial series of priorities. In this case, it is much better for the Care Quality Commission to make its own mind up, because it is going to be responsible. I take a rather different view about the recent scandals, in that the commission has to take responsibility for the claims that have been made. If it has to take responsibility, it must have as much control over its agenda as it possibly can.
My concern is simply that the Localism Act claimed to give localities all kinds of new controls over their futures. Yet, this week, we again find the Secretary of State for DCLG calling in a locally agreed solar decision, one supported by the local authority and by the inspector, but turned down—for reasons which are extremely difficult to see—by the centre. I want an assurance from my noble friend that this is real devolution; that the powers which have been given will not be circumvented by some other mechanism within this Bill or other Bills. The purpose of such devolution is to enhance responsibility. My concern is that, often, people who are given and who claim to have responsibility find that the structures are so prescriptive that they cannot take that responsibility seriously. If the amendments are an attempt to ensure that they can carry through their responsibilities in a way which enables the country to look to them to do the job they ought to be doing, that is fine and dandy. However, I hope that we can have reassurance that this is a real change, and not something that is going to be circumvented for the convenience of some Secretary of State by other bits of this or other Bills.
Baroness Barker
My Lords, I draw to the House’s attention three questions put forward by Leonard Cheshire Disability. That organisation has worked extremely hard to support the Government in their stated objective of stopping 15-minute care appointments for older people, and its questions are worth following up.
First, why is it necessary to remove this power completely from the CQC; what will the CQC be stopped from doing by the absence of this power that otherwise it would not be? Secondly, the Government are committed to tackling poor commissioning and poor practice. If it is not going to be the role of the CQC to challenge local authorities on their commissioning practices, whose job will it be? Thirdly, is there any evidence that that power, as it exists, has been misused? Whatever one’s view about where responsibility should lie—the noble Lord, Lord Deben, made interesting points about that—those three questions are worthy of an answer when we come to formulate that view.
Baroness Pitkeathley
My Lords, I, too, am troubled by the seeming perversity of government Amendments 145, 146 and 149. The effect of the amendments seems to be to make it harder for the CQC to conduct investigations into local authority practices, particularly of commissioning. My understanding, from my hazy memory of when the CQC was set up, was that that was a particularly important function. Surely it has become more so, given the commitment to integration between services provided by the health service and those provided by local authorities. Was that not a key feature of establishing the CQC? The timing of this seems to be very odd—perverse, as the noble Lord, Lord Low, said—given the current huge concern about the way in which services are commissioned, the so-called 15-minute care visits, and so on.
Do the Government see a continuing role for the CQC in working with local authorities to improve the way that they commission services, or is this a retreat from the way the Government view the CQC? I was very involved in the discussions before the CQC’s relaunch, and understood that to be an important part of its function. The amendments appear to reduce the CQC’s power to help improve local authority commissioning and, because of that, its oversight of care quality. That is a great concern to us all, particularly when we are so concerned about the quality of the services which are commissioned.
Lord Hunt of Kings Heath
My Lords, first, I welcome the amendments in relation to CQC independence. I would like assurance that it does what it says on the tin. I assume that the CQC will be regarded as independent. Perhaps it will be making fewer visits to the Secretary of State than it does at the moment. If there are weekly meetings, as is suggested, between the Secretary of State, the CQC, Monitor and NHS England, it is very difficult to believe that it is going to be truly independent. The proof of the pudding will be in the eating; but it is very difficult to know why the Secretary of State needs to see the CQC on such a regular basis if it is really an independent organisation.
Like other noble Lords, I am puzzled why the periodic reviews of local authority performance in commissioning adult social services have been removed from the Bill. I am surprised at the current policy, which is that, as part of wider moves to devolve responsibility for improvement in the sector, local authority commissioning performance and assessment will be led by councils. Presumably that means that it is government policy that the performance of the commissioning function of local authorities in adult social care will be reviewed by local authorities.
With the greatest respect for the noble Earl, Lord Howe, he knows that I am a great admirer of local authorities; I have served on two. However, like the noble Lord who spoke so eloquently earlier about solar decisions being called in by DCLG—to which, no doubt, the noble Earl will have a detailed response—I would not have thought that the commissioning performance of local authorities was thought to be so excellent that they can be left to themselves to police their performance in future.
Earl Howe
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.
“Independence of the Care Quality Commission
(1) Part 1 of the Health and Social Care Act 2008 (the Care Quality Commission) is amended as follows.
(2) In section 48 (special reviews or investigations), omit subsection (7) (Secretary of State’s power to make regulations as to procedure for representations before publication of report).
(3) In section 54 (studies as to economy, efficiency etc), in subsections (1) and (3), omit “, with the approval of the Secretary of State,”.
(4) After subsection (2) of that section, insert—
“(2A) The Commission may not exercise the power under subsection (1)(a), so far as it relates to the activity mentioned in subsection (2)(d), without the approval of the Secretary of State.”
(5) In section 55 (publication of results of studies under section 54), omit subsection (2) (Secretary of State’s power to make regulations as to procedure for representations before publication of report).
(6) In section 57 (reviews of data, studies and research), in subsection (1), omit “, with the approval of the Secretary of State,”.
(7) In section 61 (inspections carried out for registration purposes), omit—
(a) subsection (1) (Secretary of State’s power to make regulations specifying frequency etc. of inspections), and(b) subsection (4) (Secretary of State’s power to make regulations as to procedure for representations before publication of report).(8) In section 83 (annual reports), omit subsection (3) (Secretary of State’s power to direct preparation of separate reports).
(9) In paragraph 5 of Schedule 4 (inspection programmes etc.), omit—
(a) in sub-paragraph (1) (preparation of programme etc.), “, or at such times as the Secretary of State may specify by order,”, and(b) sub-paragraph (3) (Secretary of State’s power to specify form of programme etc.).(10) In consequence of subsections (3) and (6), omit section 293(3) and (4) of the Health and Social Care Act 2012.”
Lord Warner
Lord Warner
My Lords, I listened carefully to the points made in this debate, particularly those made by the noble Earl, Lord Howe. I find this brave new world that we are moving into—of which he painted such an attractive picture—a bit puzzling. In the previous debate on the trust special administrator, we heard that the trust special administrator comes into play when this wonderful piece of architecture around commissioning has failed to deal with the job. The CCGs, supervised by NHS England, have simply not been able to deliver the changes that are required through the commissioning arrangements. In that area, the fall-back position which the Government insist that we have, is a trust special administrator, often to make good the deficiencies of an unsatisfactory commissioning set-up. The Government do not seem to have quite as much confidence in their new architecture for commissioning as the noble Earl suggested.
I turn to my amendment, which in effect maintains the status quo and the ability of the CQC to decide, in the light of the evidence it has had from its reviews of performance by providers, that there is a systemic problem with commissioning, the making of arrangements for adult social services. It seems odd that we should just leave this, in effect, to all 152 local authorities and put in place another hurdle to be got over, which is the approval of two Secretaries of State, before the CQC can actually act in the area of commissioning. We have to bear in mind that in the good old days, when I was a director of social services in local government, I had to look over my shoulder at the Audit Commission as to how we were behaving and making our arrangements. The Audit Commission, however, has gone the way of all flesh, so that is the end of another watchdog that was there to make sure, without being too obtrusive, that there could be thematic reviews of the way local authorities carried out their commissioning behaviour. I do not think that this architecture is robust enough to safeguard patients, and I wish to test the opinion of the House.
Lord Hunt of Kings Heath
“Staffing numbers and skills mix
The Care Quality Commission shall, in carrying out its functions, have regard to any official guidance on staffing numbers and skills mix.”
Lord Hunt of Kings Heath
My Lords, we come to an important amendment that relates essentially to staff ratios and guidance. I refer back to the Francis report, which focused very much, among many other serious matters, on staffing ratios and appropriate staffing numbers employed by NHS trusts.
We know very well that given the financial strain currently on the health service there is a large concern about whether there are enough staff on the wards to give appropriate care. Much of the concern around the quality of nursing care and the quality of care by healthcare assistants has related to essential aspects of care, including feeding, caring and all those things associated with what we would regard as appropriate caring. Underlining those things has been a concern as to whether enough staff are employed on the wards.
The noble Earl will know that the Francis report recommended that NICE should benchmark issues around appropriate staffing levels. He will also know that since the Francis report came out we have had the Keogh report into 14 trusts with outline mortality rates. It is interesting that one of the important conclusions of the Keogh review was the need to look seriously at staffing numbers. There seems to be a direct relationship between outline mortality rates and staffing levels on the wards and in clinical areas. We have also had the Berwick review, which the Government established, looking more generally at staffing levels within the health service. The review identified staffing levels as being one of the most important areas on which to focus when it comes to reviewing quality of care.
My amendment relates to ensuring that in its responsibilities the CQC has sufficient focus on staffing levels. This is a very important matter at a time when the health service is being presented with an increase in the number of patients and an increase in technology and complexity at the same time as having to operate on a budget that is just above a level budget. Things are very difficult indeed in the health service. Roughly 70% of the budget of NHS organisations is spent on staffing and expenditure on nursing and healthcare assistants forms perhaps the most important element of the staffing budget. Therefore, in some way we need to protect staffing levels in such circumstances. My amendment suggests that this is a very important role for the CQC to play and I hope that the Minister will be sympathetic to it. I beg to move.
Baroness Gardner of Parkes
My Lords, I do not want to speak before whoever supports the noble Lord, Lord Hunt, in his amendment, so I will sit down and speak after the noble Baroness.
Baroness Wall of New Barnet
My Lords, I did not intend for that to happen. Noble Lords may find this quite tedious, but I want to follow both the theme and the specifics of the amendment moved by the noble Lord, Lord Hunt. As to the theme, his statement that things are difficult out there today is quite an understatement. Things are hugely difficult. I spent the morning with the TDA in my trust and heard very difficult messages around performance and, more importantly, around finance.
On the specific point about the suggested skill mix and the way of dealing with it in the Care Quality Commission, when we had our Care Quality Commission representative for Barnet and Chase Farm with us a couple of months ago—on a routine visit rather than an impromptu one—she set aside a session to talk to people about healthcare assistants. She got the same message that I have tried to impart to noble Lords on several occasions that the regulation of these people is hugely important. She was trying to understand what difference it would make. Patients who came in to listen at the event could not understand why healthcare assistants were not regulated in that way—although some thought that they were. There is also confusion about who they are and what role they play.
Healthcare assistants and nursing assistants are hugely important to the skill mix, but what they do and what they are able to do is paramount to being able to understand how their contribution to the skill mix really fits. I support the amendment. It can ensure that we once and for all deal with what it really means to be a healthcare assistant, what they can do and how they are regulated.
Baroness Emerton (CB)
My Lords, I rise to speak to Amendment 159 standing in my name and in the names of the noble Lords, Lord Willis and Lord Warner, and of my noble friend Lord Patel. Amendment 159 is about safeguarding patients. I championed safe staffing levels during the proceedings on the Health and Social Care Bill and during the proceedings on the Care Bill to date but failed to get my amendments accepted following a firm rebuttal by the Minister. Therefore, it was with a slightly doubtful mind that on 29 July, before we left for the Summer Recess, I put my name to the amendment before us today.
I then began nine weeks of reflection on whether I should or should not withdraw my name. I want to share the experiences of those nine weeks that have left my name on the amendment. I resolved to try to convince the Minister and noble Lords that if we wish to meet the challenges of high-quality, safe care acceptable to patients and their families in hospitals, we cannot ignore the contents of this amendment, set out under four headings. It recognises that it is only a small part of a very comprehensive Bill focusing on the acute hospital provider but it is nevertheless important that patients should be assured that all the measures that are taken will ensure their safety and the high quality of delivery of care to their satisfaction, resulting in a short length of stay, less likelihood of infection, reduced readmission rates and lower mortality rates.
Surely there is a cost-effective and care-effective way forward, despite the challenges it brings with it. The need to consider staffing levels in the community is equally important if we are to achieve an integrated service from primary healthcare and community care as well as from the acute providers in hospitals. Before the Recess I was involved in discussions about staffing levels with a number of very senior nurses, academics, the Royal College of Nursing and other organisations. The Bruce Keogh report focused on the seriousness of the situation, identifying 14 hospitals with high mortality rates and low staffing levels. That was quickly followed by the publication of the report by Professor Don Berwick, also just mentioned, on the safety of patients, which again referred to low levels of nursing staff as being a problem, but not measured against an evidence-based level.
The group of senior nurses formed themselves into the Safe Staffing Alliance, chaired by Elizabeth Robb, the chief executive of the Florence Nightingale Foundation, who had personally experienced introducing care bundles for five long-term conditions, which led to a dramatic reduction in mortality rates, and who was a member of the Keogh commission. The alliance busily engaged itself in examining the research evidence available internationally, and within the UK, on staffing levels. Its statement says:
“Under no circumstances is it safe to care for patients in need of hospital treatment with a ratio of more than 8 patients per registered nurse during the day time on general acute wards including those specialising in care for older people”.
Very soon after that, Robert Francis spoke to the CQC and referred to his original recommendation on staffing levels. He said, “So much of what went wrong in our hospitals is likely and indeed was in many regards the case in Stafford, due to there being inadequate numbers of staff either in terms of numbers or skills. The evidence given to my inquiry however was not sufficient to persuade me that there should be a minimum across the board staffing level, and I know not everyone agrees with that conclusion. But I could only act on the evidence I had and I was after all only dealing with the event arising out of a particular hospital so the inquiry for all the breadth in the end had limitations. However, evidence has been put forward to me since from the Safe Staffing Alliance to suggest there is a level below which it should be regarded a service is not safe, not that’s the adequate level of staffing but the level below which you cannot be safe. It does seem to me that it’s evidence that is worth consideration and therefore ought to be considered somewhere with regard to whether there is some sort of benchmark which at least is a bit like mortality rates an alarm bell which should require at least questions to be asked about whether it is possible for a service to be safe given whatever the staffing situation is. I just ask you to consider that as being a potential way to show real support for staff, some of whom are working in really challenging circumstances”.
In an interview reported in the press on 8 October, Robert Francis discussed the possibility of services being shut down if insufficient staffing levels were evident.
During September, I met directors of nursing from the teaching hospitals called the Shelford Group, who were grappling with staffing problems but in slightly different circumstances from those in other NHS trusts and NHS foundation trusts. I also discussed the issue with the director of nursing at Salford Royal NHS Foundation Trust, Elaine Inglesby, who gave evidence to the Health Select Committee that demonstrated clearly that the whole hospital was engaged in the safe staffing project. She had been able to implement the suggested staffing levels by using the acuity and dependency tools supplied by the Association of UK University Hospitals and using the ratio of one registered nurse to eight patients as a minimum, based on the evidence from Southampton University, King’s College London and the National Nursing Research Unit. Evidence suggested that there was a need for three registered nurses on night duty.
In this hospital there is a safe staffing steering group to support ongoing development. The introduction of a white board on every ward or department indicates the number of nurses and grades on each shift. This is posted so the patients and visitors can immediately identify how many staff at what grade are on duty at any time. There is a daily safe-staffing teleconference on daily rotas meeting each morning at 8.30. This looks at the morning, late and night shift and presents a true picture of ward and department nurse staffing. Obviously this is an ongoing development project involving the board members and the staff of the whole hospital. To date it is working to the satisfaction of patients, families and, above all, the staff involved.
During this time, I also noted the media and varying reports of events demonstrating failings in service delivery because of low staffing levels, including the reports of warning signs from the Royal College of Nursing and other organisations. I also listened to patients’ experiences, where shortage of staff appeared to be a major concern. The need for so many trusts to seek overseas recruits because of shortage was reported last week. There are also records from the Patients Association, which has received many complaints on staff shortages during this time.
I then went on holiday myself and reflected back over the eight weeks. I came to the conclusion, while declaring that I am a long-retired nurse not on the NMC register, that I could do nothing but support the amendment and continue campaigning for the future safety of patients. I hope I have persuaded the Minister. Although this amendment is only a very small part of this large Bill, because of the ramifications for the safety of patients in hospitals who rely on 80% of their care being given by nurses, we owe it to the nurses and to the patients they serve at least to acknowledge and accept the words of the amendment so framed to allow the flexibility required to meet patient need but avoid high risk to the delivery of care. I trust the Minister will respond accordingly to the amendment.
Lord Willis of Knaresborough (LD)
My Lords, I am delighted to follow the noble Baroness, Lady Emerton. May I say—not as an aside but as genuine comment—that we are all in awe of her commitment to nursing and the care profession? It is not just eight weeks, but a lifetime of commitment. I think the whole House is enormously grateful for the contribution she makes.
I rise to support Amendment 144 in the name of the noble Lord, Lord Hunt, having first thought that it was not required. It seems fairly obvious that the Care Quality Commission shall, in carrying out its functions,
“have regard to any official guidance on staffing numbers and skills mix”.
The idea that any inspector or regulator would look at the guidance and then apply that as criteria would seem an absolutely normal process. Yet on reflection, having read the Francis report and the Winterbourne View report, one suddenly realises that, certainly from 2009 but far back in time as well, the department under successive Governments has offered guidance about safe staffing levels. It has done that in everything, but particularly in acute settings, I appreciate that. The fact that that was not taken into consideration makes the noble Lord’s amendment absolutely appropriate. I cannot see for the life of me why my noble friend would not accept it as a very sensible addition for making sure that the CQC, when it carries out inspections, takes that into consideration.
I would like to spend a little more time on Amendment 159, which has been so superbly introduced by the noble Baroness, Lady Emerton. Amendment 159 covers a lot of the same ground but goes further in spelling out the direct link between staffing and patient safety. It is important for my noble friend to understand what it does not do; nobody on either side of the House has sought to impose statutory staffing limits in legislation. That would be counterproductive in getting the sorts of outcomes that we want.
I prefer, as I am sure colleagues on all sides of the House do, to have strong statutory guidance with good inspection, which is what we have had in the past. The amendment of the noble Lord, Lord Hunt, does this—it completes the circle. I am very concerned that this House and the department spend too little time addressing the question of safe staffing. What does that actually mean? I declare an interest as an honorary fellow of the Royal College of Nursing. The RCN associates safe staffing with nursing because nurses, together with healthcare assistants under their supervision, do most of the care. But safe staffing is about the total product, not simply about nursing. It is also about the ward managers and everything else that goes into ensuring that when patients go into any setting, whether it is domiciliary, a care home or an acute hospital, there is an appropriate level of staffing.
When I was writing the Willis Commission report last year, one of the things that came up over and over again was a demand for mandatory staffing levels. I spent some time looking at the literature on safe staffing levels to see whether there was a correlation between having the right number of staff—registered nurses, care assistants, doctors or consultants—and outcomes. Frankly, it is very difficult to find empirical evidence to support it one way or another, simply because nobody in the healthcare system works in isolation from their colleagues. You are only as good as the team that works around you and their skills and training mix. I looked up what was happening in California where for more than 10 years they have had mandatory staffing levels for registered nurses. No other state has followed that. In April Senator Barbara Boxer introduced a Bill in the Senate to try to establish a federal system of ensuring that all hospitals had particular staff levels but nobody has followed that through.
There is some research being done in the UK, such as Anne Marie Rafferty’s 2007 study, with which Members are familiar. It was a really good piece of work which showed a 26% higher mortality rate in the cases of very high patient to nursing ratios. Kane’s meta-analysis in 2007 of all the literature indicated an emerging consensus that there are particular staffing levels beyond which the situation becomes dangerous. It is an issue for the department to constantly keep that under review. The amendment does not go over that ground but makes it clear in terms of safe staffing that there would be a duty on the provider, such as the hospital or the care home or those providing domiciliary care, to ensure that staff levels were appropriate and that staff competence is such to carry out safe care. After all, there is nobody in this House who does not want to see safe staffing within all NHS and other providers of health and care. That seems to be a basic starting point for a high-quality health and care system. We need to be able to ensure that that is the case. You will only find out what safe staffing levels are in a particular scenario and setting if you monitor them. That is why there is a requirement in the amendment to report on it. We are not talking about a report every three or five years, but there should be a continuous report so that when the CQC goes into a setting, it can look at the correlation between safe staffing levels, acuity and mortality rates and other factors, to see whether outcomes are dependent on particular mixes of staff.
Nor is the amendment saying that there should be annual reports. The Secretary of State would decide how often the department should be able to look at those reports. In essence, however, we are trying to establish that ensuring that the staffing mix is appropriate to the setting and to the patients who are being cared for is fundamental to healthcare. I hope that the Minister can give us some serious comfort on that. If we can get that right, we will have a good healthcare system.
Baroness Gardner of Parkes (Con)
My Lords, I am of course impressed by what has been said by the noble Baroness, Lady Emerton, who always knows so much about this subject. We have benefited from her great expertise over time. I am also interested in what the noble Lord, Lord Willis, has just said on the same amendment; he cited Amendment 159 but I thought it was Amendment 158.
Baroness Gardner of Parkes
I leave it to the department to work out whether it was Amendment 158 or 159, but that is not too important.
In many ways Amendment 144 does not go far enough. I am sure that the point of the noble Lord, Lord Willis—that the Care Quality Commission should be capable of thinking of these things for itself in any case—is right. However, the phrase “the skills mix” concerns me. There can be huge differences in the skills mix. I was concerned that the Chelsea and Westminster Hospital, having waited for perhaps as long as 10 years, at last got a specialist nurse for neurological conditions. The hospital was delighted because it had had huge demand for such a service. I am a great supporter of specialist nurse services.
The Royal Free then came along and poached that nurse from the Chelsea and Westminster, which then looked at what it could do. I was informed by word of mouth that there was no question or even thought of a replacement because there was a long list, and it was a case of “the first cab on the rank” as to who was deemed to be most needed. It could have been an ordinary nurse, it could have been a surgical nurse or anyone. You moved on and did not replace the person with the skills that you needed and wanted. You had to replace your missing person with whatever the next thing on the waiting list was. That seemed to be a serious cause for concern.
It is essential to know what skills mix is needed. The amendment mentions “official guidance”. It would have to go much wider than official guidance. It has to be attributable to the particular hospital or service that is involved. Although the amendment covers many of the important points, it does not cover the need for every facility to have cover within that department and not to then find that they have lost it because someone left—they could have gone off on maternity leave, they could have left for any reason, but in this instance they were poached by another NHS hospital.
Whatever the answer, it is important. The relationship between the staffing levels is hard to assess and has to be individually done. The Care Quality Commission should be capable of having an indication of what it should be looking at, and needs to be aware of all these problems. Of course, not one of us could oppose having enough staff on the wards, which the noble Lord, Lord Hunt, said was necessary. However, we are now faced with positions where budgets are limited and they have to look at and work out what they need most. I do not agree at all that it should be just a progression from whoever has been waiting the longest; it should be whatever the hospital, or a particular department, needs the most. Although I support the principle, perhaps it needs more than this. I am hoping that the Minister will be able to assure us that he can incorporate some words within those he already has to make it clear that there must be this obligation. I strongly support Amendment 144 and I am open to conviction about Amendment 158 or 159.
Lord Warner
My Lords, I support both the amendments. They are not alternatives but complementary. I want to start briefly from where we are. The issue of staffing numbers, ratios and skill mixes is just a black box as far as the public are concerned. It is something that goes on within the NHS. This has some relationship to our earlier debate about failure. It is often very difficult for outsiders—and I include regulators as outsiders—to understand what is going on in institutions, particularly acute hospitals. This issue is not peculiar to hospitals; it is even more of an issue for community services, in some ways.
I would like briefly to share my experience as the chairman of the provider agency in London. If your Lordships think that things are bad in some hospital services, try the community services. When we started to poke around in the community services, we found huge variations in the staffing levels for populations with particular conditions. There were massive variations in the face time that clinical staff spent with their patients. We have issues in community services which are often probably more dangerous and less reassuring than we have in some of our hospitals. If we are to have such amendments to the Bill, it is clear that they must relate not just to acute hospital services.
We are not going to get public understanding about when hospitals are failing or unsustainable without a better sense of public education about what a safe level of staffing is to give the reassurance that you are going into a facility which is safe. I added my name to Amendment 159 because it opens up the issue of putting into the public arena some data and reassurance about what a safe level of staffing is for some of these services. It can then be prayed in aid by both commissioners and providers when there are issues about whether a unit is sustainable. We often talk about unsustainability as a financial issue, but it is often about staffing issues—the sheer inability to get a safe group of staff together to run the institution. One acid test of why a place is unsafe is the number of bank or agency staff in a unit, who come and go at ever-increasing frequencies. Public understanding of what is going on in these hospitals seems critical to public reassurance.
Nobody wants to put staff numbers into the Bill, but we need something better than we have now to give the public some idea about the staffing levels and skill mix in what are, at the end of the day, relatively closed institutions. It is difficult for the public to understand what is and is not safe without more data, and that would make it much easier to hold boards to account. Amendment 159 would make it clear that the boards of trusts need to come back continually to what they are providing to the public in the safety of their staffing levels. Amendments 144 and 159 certainly do no damage to the Bill. They strengthen it and it is much more in the interests of the public to have this data available locally, as the noble Baroness, Lady Gardner of Parkes, has said, relating to specific establishments and institutions.
Lord MacKenzie of Culkein (Lab)
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.
Earl Howe
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.
Lord Willis of Knaresborough
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?
Earl Howe
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.
Baroness Emerton
My Lords, on what evidence would the CQC base the answers to those questions?
Lord Warner
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?
Earl Howe
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.
Lord Hunt of Kings Heath
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.
“(13) Consultation undertaken before the commencement of this section is as effective for the purposes of subsection (9) as consultation undertaken after that commencement.”
“( ) In section 48 (special reviews and investigations), in subsection (1)—
(a) omit “, with the approval of the Secretary of State,”, and(b) at the end insert “; but the Commission may not conduct a review or investigation under subsection (2)(ba) or (bb) without the approval of the Secretary of State.”( ) Omit subsection (1A) of that section.
( ) In subsection (2) of that section, for “a periodic review” substitute “a review under section 46”.
( ) In that subsection, after paragraph (ba) (but before the following “or”) insert—
“(bb) the exercise of the functions of English local authorities in arranging for the provision of adult social services,”.( ) After subsection (3) of that section insert—
“(3A) A review or investigation under subsection (2)(b), in so far as it involves a review or investigation into the arrangements made for the provision of the adult social services in question, is to be treated as a review under subsection (2)(bb) (and the requirement for approval under subsection (1) is accordingly to apply).””
“( ) in section 293 of the Health and Social Care Act 2012, omit subsections (1) and (2);”
Earl Howe
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.
Lord Hunt of Kings Heath
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.
Earl Howe
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.
(c) a person who provides health services or adult social care in England all or part of the cost of which is paid for by means of a direct payment under section 12A of the National Health Service Act 2006 or under Part 1 of this Act.”
(a) on summary conviction, to a fine;(b) on conviction on indictment, to imprisonment for not more than two years or a fine (or both).”
“Offences by bodies
(1) Subsection (2) applies where an offence under section 84(1) is committed by a body corporate and it is proved that the offence is committed by, or with the consent or connivance of, or is attributable to neglect on the part of—
(a) a director, manager or secretary of the body, or(b) a person purporting to act in such a capacity.(2) The director, manager, secretary or person purporting to act as such (as well as the body) is guilty of the offence and liable to be proceeded against and punished accordingly (but section 85(2) does not apply).
(3) The reference in subsection (2) to a director, manager or secretary of a body corporate includes a reference—
(a) to any other similar officer of the body, and(b) where the body is a local authority, to a member of the authority.(4) Proceedings for an offence under section 84(1) alleged to have been committed by an unincorporated association are to be brought in the name of the association (and not in that of any of the members); and rules of court relating to the service of documents have effect as if the unincorporated association were a body corporate.
(5) In proceedings for an offence under section 84(1) brought against an unincorporated association, section 33 of the Criminal Justice Act 1925 and Schedule 3 to the Magistrates’ Courts Act 1980 apply as they apply in relation to a body corporate.
(6) A fine imposed on an unincorporated association on its conviction for an offence under section 84(1) is to be paid out of the funds of the association.
(7) Subsection (8) applies if an offence under section 84(1) is proved—
(a) to have been committed by, or with the consent or connivance of, an officer of the association or a member of its governing body, or(b) to be attributable to neglect on the part of such an officer or member.(8) The officer or member (as well as the association) is guilty of the offence and liable to be proceeded against accordingly (but section 85(2) does not apply).”
“Training for persons working in regulated activity
In section 20 of the Health and Social Care Act 2008 (regulation of regulated activities), after subsection (4) insert—“(4A) Regulations made under this section by virtue of subsection (3)(d) may in particular include provision for a specified person to set the standards which persons undergoing the training in question must attain.””
Earl Howe
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.
Lord Willis of Knaresborough
My Lords, I rise, somewhat gobsmacked, as they say in Yorkshire, at the launching by my noble friend of what has been a major breakthrough in the training of healthcare support workers. I notice that the noble Baroness, Lady Gibson, is nodding in approval as this is an area with which she too has been very closely concerned. I thank my noble friend for making that commitment. It makes most of my speech totally irrelevant but, nevertheless, I will add one or two bits just for good measure.
There is no doubt that there is an overwhelming case for appropriately training the 1.3 million healthcare support workers who do such a fantastic job in care homes and domiciliary settings, as well as in hospitals. This has been a national scandal so far. These people are a hugely valuable part of the workforce and it is important to recognise them as such.
I should like to ask some brief questions. Camilla Cavendish recommended that the certificate of fundamental care be a baseline on which there would be an advanced certificate. That would lead directly into nurse training so that there would be no glass ceiling for healthcare support workers, particularly since nursing has moved on to being an all-graduate profession. When the Minister responds, I hope that he will be able to say whether that is within the psyche. The idea of having student nurses working alongside healthcare support workers, particularly those training for the advanced level, is a good one, so that you know the skills mix that you are working with.
In Amendment 153, I railed at the word “may”. The amendment states:
“Regulations made under this section by virtue of subsection (3)(d) may in particular include provision for a specified person”.
Surely, the Minister could go one step further and say that, at Third Reading, it will become a “must” and not a “may”. The one thing we must not have—there are a lot of musts—is a situation where people can move away from this need to be able to make sure that within a short period the whole of our social, health and care workforce will be properly trained to a standard approved by the sector skills council and the Nursing and Midwifery Council. That is a major breakthrough.
My noble friend is right that there are some excellent training programmes. I have seen many of them. I remember one for healthcare support workers at John Radcliffe Hospital in Oxford within the hospital setting. I know that many care homes give superb training to their staff because that leads to good patient outcomes which sell the product. Has any thought gone into existing training being recognised so that people do not have to go through another hoop for the sake of getting their certificate? Perhaps Health Education England can do that with this. I hope other noble Lords will comment on our amendment.
Amendment 160 remains a thorny issue. A mandatory regulatory system for healthcare support workers has been on the table. Francis himself made it clear that this workforce should be regulated. Until now, my problem with that has been that there has been very little to regulate because if people are not trained to approved standards, how on earth do you have a regulatory system by which you can judge their competence? Now that we are getting one, I hope that the Minister will look again at regulation so that we get the complete package and, my goodness, this will be a Care Bill that we can really celebrate.
Lord Hunt of Kings Heath
My Lords, the noble Lord, Lord Willis, has just referred to my Amendment 160. It relates to the regulation of health and care support workers. I have long thought that the regulation of support workers is necessary, desirable and inevitable because they play such an important role in caring for so many people. I pay tribute to the noble Lord, Lord Willis, for the outstanding work he did for the RCN’s independent commission which has informed this debate about standards of care workers.
I very much welcome what the Minister said about the development of a certificate of fundamental care. My noble friend Lord Young reminded me that I ought to ask the Minister at what level that is going to be because anyone who understands these issues will know that the level of a certificate is very important.
I want to draw together Amendments 153, 158 and 160. Given that in future when employers wish to take on care workers they will expect a certificate of fundamental care, does the Minister not think it inevitable that there will be a list of people who have been awarded the certificate? Does he not also think it inevitable that once you have that list, if you then have a person with a certificate and they transgress and there is concern about the way they care for people, there will inevitability be a drive to ask how you get that certificate off them? I believe regulation is inevitable now. There is no way away from the fact that once you have a certificate like this, there will have to be a list or a register and people will have to be evaluated. I for one very much welcome what the Minister has announced because it is a very important step along the road of regulation.
Baroness Wall of New Barnet
My Lords, I, too, welcome the announcement, and I am sure that the noble Earl is not surprised at the depth of feeling I have in welcoming it. I see this as a step towards regulation. He might baulk at that but, as the noble Lord, Lord Willis, said, regulation is important for us, and I have been asking for it for a long time. However, I also have felt: what is it we are regulating in the sense of the absolute ultimate? So I think this gives us a very clear and descriptive way in which that can be measured.
I echo what the noble Lord, Lord Willis, said about “may”. That must be “must”, please, because “may” gives such a lot of flexibility that we may go back to exactly where we are right now if people are not required to carry this out. I very much agree that regulation helps in bringing value into the skill mix. My noble friend Lord Hunt referred to an aside by his colleague sitting alongside him. As somebody who is involved in skills heavily, whether it is NVQ level 1, 2 or 3—which I am sure my noble friend Lord Young was referring to—I know from the work that I have done with Skills for Care that the aim is that between level 2 and 3 will be competent level because obviously it depends very much on what people start with.
A final point, which the noble Lord, Lord Willis, picked up on and which we have in industry as well, is how we measure the skills and experience that people already have when we try to ascertain where they fit in. One of the dispiriting things that we find elsewhere is that, when people are asked to take a level 2 or 3, no recognition is made of what they have already gained while they have been doing the job. Skills for Care knows how to cope with that in the way that the skills levels are drawn up.
I thank the noble Earl very much. I spoke before about being tedious. I am sure that the way in which he has pursued this issue has nothing to do with me or other people being tedious; it is because he has a belief in it.
Baroness Emerton
My Lords, I, too, thank the noble Earl the Minister for what he has said. I think I have probably been more of a pain than anybody on this subject. I thank the noble Earl very much for the assurances that he has given.
I have one or two very quick questions. He knows that I have a thing about Skills for Care and Skills for Health. Who is going to decide the membership of those groups? I am concerned that in teaching skills each individual care worker will want to have the background knowledge to support their skill. It is no good just teaching someone a simple skill without having the knowledge behind it. It reminded me that 63 years ago I was a St John Ambulance cadet. I did an elementary first-aid course where a doctor taught elementary anatomy, physiology and treatment of first aid. I then went on to home nursing and was taught by a registered nurse how to look after patients in the home, provide good nutrition and prevent bed sores. I think probably what I knew at the age of 11 is more than what some of our healthcare professionals know today. What will be the professional input into Skills for Health and Skills for Care? Who will do the syllabus, the curriculum and the teaching? Presumably Health Education England and the NMC will give the backing to that. If we could have that assurance, it would keep me quiet for a little longer.
Lord Warner
My Lords, I also thank the Minister for his persistence within Whitehall in actually getting progress in this area. I think we all feel that he has put a lot of personal effort into it and deserves a great deal of credit.
If I may, I will ask a couple of slightly nerdy questions. I think that the issue of where this stands in the pecking order is vital. Is it down at NVQ levels 1 and 2? Is it up at level 3? How far away is it from the degree-level professional qualifications? In some ways, the title that has been given to this rather diminishes its standing up the food chain, so to speak. A certificate of fundamental care sounds a bit basic, and I am not quite sure what signals are given about the level that Health Education England should strive for in overseeing this particular work. A lot more work needs to be done on that.
Perhaps I may also pick up the point that my noble friend Lord Hunt hinted at. At the end of the day, if employers are to make this operate, they need some kind of register of who has the certificate. They also need to know what happens when they fire somebody and take disciplinary action against someone who has this certificate. Who do they tell? That seems a quite critical issue, because this is a very large workforce and it would be quite surprising if each year we did not get a steady flow of bad cases where an employer has fired someone for a breach of good practice of one kind or another. This would all be set to nought if there was no record of where these cases of disciplinary action have been taken, and people with a certificate were still floating around the system when they have actually been released by an employer for poor practice.
Lord Patel
My Lords, I have put my name to Amendment 158. I also thank the Minister for pulling a rabbit out of the hat, so to speak. However, I am not as gobsmacked as the noble Lord, Lord Willis of Knaresborough, because I have lost count of the number of times and days in this Chamber that we have debated the need for training healthcare support workers. I am at least glad that it has now paid some dividends.
I am also glad that the noble Earl said that Health Education England would take the lead on this, and will involve the NMC in devising the standardised training programmes, because it has the expertise to do it. I agree with the noble Lord, Lord Hunt, and others that this inevitably means there will need to be some sanctions for those who do not fulfil the requirements for training and therefore fail to be regulated. I am not sure whether that is for this Bill or subsequently, but it will inevitably lead to that. However, I thank the noble Earl for his amendment.
Lord MacKenzie of Culkein
My Lords, I join in the congratulations to the Minister on his words this afternoon. For a long time I have felt that trying to get some movement on this issue of education and training for healthcare assistants was rather like the sufferings of Sisyphus pushing that stone uphill. Fortunately, I was wrong and the debates that we have had on this issue over the past few months have clearly borne fruit.
I join the noble Lord, Lord Willis, in saying that the permissive “may” in Amendment 153 should be changed to “must”. It is extremely important that that happens if at all possible. For me, regulating healthcare assistants has been an issue since the long preparation for Project 2000 and the eventual demise of the enrolled nurse, leaving the gap which has now had to be addressed in this way.
The Minister has always been careful to say that the Government do not have a closed mind on regulation. I hope that that remains the position because, given the position we have now arrived at, it is inevitable, for the reasons that my noble friends Lord Hunt and Lord Warner have given, that regulation will come some day. To coin the current phrase, it is a can that has been kicked down the road long enough. We ought to stop kicking it and get there sooner rather than later.
I heard the Minister say in the past that regulation is not a guarantor of good care. That, as far as it goes, is true, because if it was a guarantor, there would be no poor practice or misconduct in any profession. That is not an argument against regulation for all the professions that are properly regulated to safeguard the public. I hope that an open mind will be kept on this and that we can come back to the issue of regulation, which is now inevitable. Having said that, I am grateful and delighted that we have made the progress that we have today and again I thank the Minister for his persistence in this matter.
Earl Howe
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.
“(0 ) The non-executive members of HEE must include a person who will represent the interests of patients.”
Earl Howe
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.
Lord Aberdare (CB)
My Lords, I shall speak to Amendment 160A, which is sandwiched in the middle of this group of government amendments. My amendment seeks to add an additional matter to which Health Education England must have regard when publishing its objectives and priorities—namely,
“the needs of patients to have their conditions diagnosed promptly”.
This is intended to promote the interests of patients suffering from diseases that are hard to diagnose but where early diagnosis can be critical. There are, of course, a number of such conditions, but the Minister may not be surprised to learn that the particular condition on which I shall focus is pancreatic cancer, for which early diagnosis is often literally a matter of life and death. This amendment is based on my work with the charity Pancreatic Cancer UK. I am also a member of the All-Party Parliamentary Group on Pancreatic Cancer, chaired by my noble friend Lord Patel, which has been conducting an inquiry into how survival rates can be improved. Speed of diagnosis is critical and depends largely on the level of awareness of pancreatic cancer and its symptoms in primary care.
The 2010 National Cancer Patient Experience Survey found that 40% of pancreatic cancer patients visit their GP three times or more before being referred to hospital for investigation. The National Cancer Intelligence Network has found that half of all pancreatic cancer patients are diagnosed only as a result of an emergency admission to hospital. Patients diagnosed via this route have far lower one-year survival rates—only 9%, compared to 26% for patients diagnosed as a result of GP referral. A 2012 survey of GPs found that half said that they were not confident that they could identify the signs and symptoms of possible pancreatic cancer in a patient. Education and training are needed to give them enhanced skills and tools in order to improve their ability to recognise and diagnose the symptoms of conditions such as pancreatic cancer, and to help prevent the sort of shuttling between GPs and a range of different secondary care providers that some patients undergo before a firm diagnosis is made. That needs to be a clear part of Health Education England’s brief.
The aim of this amendment, therefore, is simply to ensure that such a responsibility is formally included among matters to which Health Education England must have regard. It would require it specifically to recognise that time is of the essence in diseases such as pancreatic cancer, and encourage HEE to identify, share and promote best practice in achieving earlier diagnosis. It might, for example, lead to initiatives such as conducting case reviews with experts from the Royal College of General Practitioners to determine why cases identified through emergency admission could not have been diagnosed earlier. I hope that such initiatives would help to close the gap between the UK and other leading countries that do significantly better in terms of survival rates and other outcomes.
My amendment may not be the best way to achieve these goals but it is important that they should be achieved, and I look forward to hearing the Minister’s response as to how this can and will be done.
Lord Patel
My Lords, I rise to support the amendment in the name of the noble Lord, Lord Aberdare. He is extremely knowledgeable about issues relating to pancreatic cancer. While the principles of early diagnosis and related outcomes are important for all diseases, this is particularly so for cancers and especially for certain cancers, such as pancreatic cancer. I have spoken before in this House about how two members of my family—my mother and my mother-in-law—both died of pancreatic cancer. Emphasising the need for early diagnosis of any disease is important in the training of doctors and nurses.
Baroness Wheeler (Lab)
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?
Earl Howe
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.
“(1A) HEE may arrange for any of its committees, sub-committees or members or any other person to exercise any of its functions on its behalf (but see sub-paragraph (4)).”
“( ) Subsections (1), (2) and (4) of section 89 (quality improvement in education and training etc.) apply to an LETB in the exercise of its functions as they apply to HEE in the exercise of its functions.”
( ) a person who will represent the interests of patients.”
Earl Howe
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.
Lord Willis of Knaresborough
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.
Lord Patel
I concur with what the noble Lord, Lord Willis of Knaresborough, just said. All of the research councils and charities support these amendments. There are the caveats to which he referred, particularly related to clinical trials and data. There is another important issue about the summary given at the conclusion of the research, which not only has to protect the confidentiality of the patients but also needs to be brief, because otherwise it is too cumbersome. On the whole, these amendments that we debated long and hard are most welcome.
Lord Mackay of Clashfern
I also agree with the view that these are important headings. The precise detail has been mentioned by the noble Lord. Regarding paragraph (c) of Amendment 167, I think that access to the data is quite important although it requires consideration. It is important that the experiment or trial can be repeated. One of the difficulties in the past has sometimes been the announcement of research findings. When those in the same area tried to find out exactly what the findings were based on, there was some difficulty in repeating the experiment and occasionally there was something seriously wrong with the research. Therefore, access to the data certainly has to be kept in view if one is going to have proper transparency. However, I accept that, like paragraph (c) of Amendment 167 and the other paragraphs, it requires an amount of restriction in certain cases.
Baroness Wheeler
My Lords, I welcome the Government’s decision in Amendment 167 to support the recommendation of the Joint Committee on promoting transparency in research and ensuring full publication of the results of research consistent with patient confidentiality. It is right that this should be a statutory objective of the Health Research Authority. The arguments in support of this at the Committee stage from noble Lords were very compelling and, since then, have been strongly reinforced by the House of Commons Science and Technology Committee report into clinical trials and, indeed, the strategy and ongoing work undertaken by HRA itself.
In particular, HRA’s September announcement requiring registration of clinical trials in a publicly accessible database as a condition of ethical acceptance—taking up a longstanding recommendation of the Association of Medical Research Charities—recognises the overwhelming support for this agenda. The HRA has much to do in the coming months to develop its guidance into practical measures, but the Bill now gives clear and explicit direction to its work. The HRA has stressed that it expects the vast majority of researchers, sponsors and funders to embrace the plans to realise greater openness, responsible data sharing and publication of all results, and this is very welcome news.
It is so important for patients and the public to have confidence that the research they have been involved in will be used in the best way to improve understanding and health outcomes for the groups involved. Improved transparency is vital if more patients are to be encouraged to become involved in clinical research—one of the key ambitions of AMRC’s excellent vision for research in the NHS. The noble Lord, Lord Willis, referred to reservations. I was going to raise them and I am glad he did. I look forward to the Minister’s response. He may need to write to us in detail about those reservations and his response to that, or there might be a need for some small rewording of the draft provisions before Third Reading.
Finally, we recognise that the HRA is strongly committed to working with other bodies to overcome the barriers to transparency and create a culture of openness. Changing culture is, however, a tough call in the NHS. We also know from the AMRC research survey covering both doctors and nurses that we have a long way to go to get NHS staff to take part in research in the first place, let alone sign up to the transparency agenda. GPs are an important gateway for getting patients involved in research. However, although a majority of GPs surveyed believed it very important for the NHS to support research and treatment for their patients, only 32% of those surveyed felt it was very important for them to be personally involved. Will the Government ensure that HRA and HEE work closely on this very important issue of buy-in to research and transparency by NHS staff? How will they ensure that the CCGs fully engage in this agenda?
Earl Howe
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.
“( ) Promoting transparency in research includes promoting—
(a) the registration of research;(b) the publication and dissemination of research findings and conclusions;(c) the provision of access to data on which research findings or conclusions are based; (d) the provision of information at the end of research to participants in the research;(e) the provision of access to tissue used in research, for use in future research.”