Care Bill [HL]

Lord Hunt of Kings Heath Excerpts

Wednesday 12th June 2013 Lords Chamber

Moved by

[Lord Hunt of Kings Heath]

58B: Clause 98, page 81, line 25, at end insert—
“( ) the Medical Royal Colleges;”

[Lord Hunt of Kings Heath]

My Lords, Clause 98 concerns a duty of co-operation with the Health Research Authority. That is of course absolutely supported. My Amendments 58B and 58C would insert into the list of organisations,

“Medical Royal Colleges … the General Medical Council, the General Dental Council and the Nursing and Midwifery Council”.

I have no doubt that the noble Earl will warn me of the dangers of this, but in a sense his own department has provoked it by putting a list into the Bill. Inevitably, we looked at that and wondered why some organisations were missing. I realise that Clause 98(1)(i) allows flexibility by regulations to add to the list and I am sure that that flexibility is welcome, but we should get this right in the first place. I find it difficult to understand why, for instance, the medical royal colleges are not listed. They have a vital role to play in this area.

Similarly, I support the noble Baroness, Lady Emerton, in her Amendment 59. I am sure she will speak to that in a moment. If the Chief Medical Officer is named, why is the Chief Nursing Officer not? I know there has been concern over the years about the position of the Chief Nursing Officer. The last Government as well as this one have debated this issue. Given that we wish to see an extension of research into nursing and clinical areas because of the absolute importance of enhancing the quality of nursing, it is disappointing that the Chief Nursing Officer is not listed.

I also support Amendment 61 from the noble Lord, Lord Willis, which takes the responsibility in Clause 98(7) of local authorities and NHS trusts to have regard to guidance from the HRA on good practice in research and extends it to other providers, including the private sector. These are important amendments as a whole. It is important that the Bill is informed and improved.

On my Amendment 61A, I am puzzled that in Clause 98(7) the requirement is only to have regard to HRA guidance. Surely that should be strengthened, as in my amendment, which says that guidance “must” be followed,

“unless there is good reason not to do so”.

I have taken advice on this matter. The noble Earl will know that there has been a problem over the years in getting approval for multicentre trial research. I understand that the research ethics committees have improved their performance in recent years, and that is to be welcomed, but we now apparently have the problem with some NHS trusts and foundation trusts. Of course, as this is the start of another Committee day, I ought to declare my interests as the chair of a foundation trust and as a consultant and trainer with Cumberlege Connections. It is disappointing if individual NHS organisations are holding up multicentre research, for all the reasons that we know about: UK plc and the need for us to ensure that there is greater investment in research in the UK. I want some assurance that if there is undue delay, the HRA will be able to intervene and ensure that NHS organisations get on with giving the necessary approval.

On Amendment 60A, health research capacity in the UK is of course one of our strongest assets. It includes pharmaceuticals and medical devices, and takes place in our medical schools and hospitals. World-class research is undertaken here, frequently with outstanding results, yet we consistently fail to exploit that research when it comes to its translation into practice. How many other countries have exploited research undertaken in this country? I very much welcome the establishment of academic health science networks, which are responsible for encouraging much closer links between research and health service practice.

However, there is much more to be done. I would like the HRA’s objectives to include encouraging innovation and practice. It is important that the HRA is in a position to advise the department on potential policies that might have an impact on the scale of research and development in the UK. One such example is the present intention to move away from the current pharmaceutical price regulation scheme method of reimbursing pharmaceuticals. I know that the Government are committed to the introduction of value-based pricing. I always try to tempt the noble Earl to debate in your Lordships’ House the introduction of value-based pricing, principally because very few people understand what it involves. Even having been the Minister who received the original report on it, I must say that I am still in the dark as to exactly how it will unfold.

My key question is this. I know that the PPRS approach is not perfect and that at regular intervals Governments negotiate it downwards, but it has always given flexibility to the industry to price new-licence medicines as it wishes within a profit cap. The advantage of that flexibility is that many new drugs are launched in the UK rather than in other countries. I would like to hear from the noble Earl that the introduction of value-based pricing will not have an impact on the willingness and ability of pharmaceutical companies to continue launching products in the UK. I believe there is a link between the launch of products and investment in R&D in this country.

I may strain the patience of the House, but while I am talking about pharmaceuticals it is tempting to ask the noble Earl about the implications for the cancer drug fund. He knows that the intention was for that fund to become obsolete with the introduction of value-based pricing. However, cancer charities that I have met believe that value-based pricing will apply primarily to new active substance licences from 2014, and will therefore have limited impact on treatments made available through the fund. Will the noble Earl comment, or perhaps write to me, with an assurance that, before firm proposals are made on this issue, full consideration will be given to the impact of value-based pricing on the cancer drug fund, its continuation or potential substitution? I beg to move.

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[Earl Howe]

I understand the issue that the noble Lord has raised. There are a number of ways of exercising leverage on foundation trusts, if I can put it in that rather impolite way. One of them relates to the funding from the National Institute for Health Research. The noble Lord may well be aware that as from 1 April that funding is conditional on the 70-day timeline for the recruitment of the first patient into a trial. If that timeline is not met, the funding does not follow. I can tell the noble Lord that that has concentrated minds rather effectively across the health service, including in foundation trusts, towards achieving a much more efficient and effective decision-making process.

I am aware that I did not answer a question from the noble Lord, Lord Patel, about rationalising the number of research ethics committees, which may well bear upon this issue in another sense. The HRA and its predecessor have made good progress in reducing the timelines for ethical approval, something that stakeholders have recognised. The current special health authority feasibility study is looking at how to address other delays whereby trust decisions can be made based on their capacity and capability to take part in research. This is ongoing work. I come back to my point about the core function of the HRA, which is, above anything else, to protect the interests of patients and the public. It might not be advisable to load on to it too many other roles that could detract from that core function.

[Lord Hunt of Kings Heath]

My Lords, I am grateful to the noble Earl for that comprehensive response. I cannot help thinking that in order to protect the patient and the public there must be recognition that high-quality research is one of the best ways to enhance the quality of patient care. I remain concerned that bodies in the NHS still do not understand the importance of getting their act together in research approval. That does not mean that they do not have to go through a thorough process, because there clearly has to be a rigorous process to protect the public. I would like to see stronger language in the Bill that essentially allows the HRA to intervene if undue delays take place. I hope that we can return to that on Report.

I am grateful for the noble Earl’s comments on value-based pricing. All I would say to him is that I have been disappointed that there has been a great lack of public debate on this matter. I know that the department is shortly to publish further work. It is essential that these ideas are tested, and I am concerned that this is going to be simply a matter of negotiation between his department and the industry without there being a wider discussion of the implications. I appeal to the noble Earl for some opportunity on that.

Finally, the Minister has made it clear that the list in the clause represents bodies concerned with regulation, and that is now well understood. I come back to the question raised by the noble Baroness, Lady Emerton: is there not a case for another clause stating that there is a general duty of co-operation? There is an argument that while, of course, you have your statutory regulators which need to co-ordinate their efforts, you also want a lot of organisations and people to be involved, including the Chief Nursing Officer and the Director of Nursing at the department. I put that forward as a suggestion and beg leave to withdraw the amendment.

Amendment 58B withdrawn.

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Moved by

[Lord Hunt of Kings Heath]

64A: Clause 74, page 62, line 7, at end insert—
“( ) “Significant improvement” is to be defined in regulations.”

[Lord Hunt of Kings Heath]

My Lords, we now come to Part 2 of the Bill and particularly to Clauses 74 to 77, which may be described as a failure regime for NHS trusts and NHS foundation trusts. Clause 74 makes amendments to the powers of CQC to issue warning notices to those bodies. Where it appears to CQC that the quality of healthcare services provided by a trust requires significant improvement, CQC will be able to highlight those areas in a new form of warning notice. This will state the reasons for CQC’s view, and it will require improvements in the quality of services to be delivered within a specified time. At the end of that period, CQC must review whether the requirements specified in the notice have been met.

Where CQC is not satisfied, it must decide what further action needs to be taken. In the case of a foundation trust, CQC’s review must include use of its power to require Monitor to put the trust into special administration. Clause 75 extends Monitor’s powers to be able to issue additional licence conditions on foundation trusts when CQC has issued a warning notice. At present, Monitor can make use of these powers only if there is a failure in the governance of a foundation trust.

In the event of healthcare services provided by the trust requiring significant improvement, Monitor will as a result be able to take timely action to make changes to leadership or governance with the intention of securing improvements to those services. Clause 76 will enable Monitor to make an audit to authorise the appointment of a trust special administrator in cases where it or CQC is satisfied that there is a serious failure by an NHS foundation trust to provide healthcare services of sufficient quality and that it is appropriate to make the order. At present, Monitor is able to authorise the appointment of a trust special administrator only in cases of insolvency. Monitor may make an order when it is so satisfied, but must make the order when required to do so by CQC.

Let me say at once that the Opposition support the intention of giving greater emphasis to safety and quality and enhancing CQC’s powers in this area. Of course, we are very much influenced by the report of Robert Francis on Mid Staffordshire. We also welcome the introduction of a single failure regime, focused on quality as well as financial failure. However, I suspect that I am not the only noble Lord to have been confused by the respective roles of CQC and Monitor when reading this Bill. Indeed, I was surprised that the Department of Health boldly claimed in its factsheet that the new failure regime will give regulators clear roles in tackling failure. I must say that I found it anything but clear. The factsheet says:

“The Care Quality Commission … will focus on exposing problems and requiring action while Monitor and the NHS Trust Development Authority … will focus on intervening if a poor-performing provider is unable to resolve the situation working with commissioners”.

To confuse matters further, CQC retains enforcement powers for social care, general practice and independent sector providers. That is going to be very confusing. I also pose the question as to whether there are not going to be significant risks associated with these changes. As Robert Francis made clear, regulatory complexity can contribute to system failings. It is important that we get this right, so there are a number of matters which I would like to put to the noble Earl, Lord Howe.

Does the Minister consider that with this level of complexity, there is a risk of slowdown in the action required to address failures? How will Monitor, CQC and the NHS Trust Development Authority work together to ensure that problems are acted upon? Will Monitor and the NHS Trust Development Authority be able to question CQC’s findings and recommendations? What happens if those three august bodies disagree about whether action is needed? Will Monitor and the NHSTDA be equipped to come to their own views on quality, or do they have to take the view of CQC on trust?

The noble Earl will know that the potential confusion has been examined recently by the Health Select Committee. Indeed, the Secretary of State explained to the Commons Health Committee that the change in the arrangements so that CQC in essence has to refer concerns to Monitor, which then takes enforcement action, is devoid, as he put it, of conflict of interest when an inspector identifies a fault then later feels obliged to say that there is no longer a fault, simply to avoid the enforcement action appearing ineffective. However, that does not apply to the other sectors. It does not apply to social care provision, general practice or the independent sector. I do not understand why there is deemed to be a conflict of interest in relation to NHS foundation trusts and NHS trusts but not the other bodies. Nor does it apply to other sector regulators, such as the Health and Safety Executive or the Civil Aviation Authority. There are plenty of examples of regulators that monitor and also take the enforcement action.

I also do not understand why, when it comes to healthcare, the NHS has a different regulatory regime from that of the private sector. Surely, there ought to be consistency in approach. The noble Earl will know that we have had the fair playing field work undertaken by Monitor, as a result of discussions on the previous Bill. It does not seem that there is a fair playing field when it comes to regulatory machinery in relation to, say, the independent sector and to the NHS, even though they are both providing services under NHS contracts. I very much welcome Amendments 65, 66 and 67, tabled by my noble friend Lord Warner, and I would add to them my Amendment 66ZA, which would ensure that the NHS is dealt with equivalently.

On the NHSTDA and the NHS trusts, there is a puzzle regarding what appears from the architecture. I think it is generally accepted that those trusts which have not yet reached foundation trust status are generally considered to be the weaker organisations, given that NHS foundation trusts were introduced quite a number of years ago now. What is puzzling is that the weaker organisations seem to come under a weaker regulatory system. I will be interested to hear my noble friend Lord Warner’s remarks concerning his amendments, but it appears to be a puzzle and an inconsistent approach.

This also takes us back to the recommendations of Robert Francis concerning the merger of regulatory functions, which he suggested in his report that the Government should consider. On the fact that the Government have got themselves into such a tangle on the respective roles of CQC and Monitor, while I can well understand nervousness about having yet another restructuring in relation, for instance, to CQC—given the number of changes that have occurred to the care regulator over the years—I worry that they have come up with such a complex solution that I wonder whether merger might not come to be seen as the easier option.

I would also like to raise some issues about the process under which the failure regime takes place. I start with my Amendment 64A, in relation to the Section 29A warning notice under Clause 74(3). Can the noble Earl give some indication of how the significant improvement required is to be defined and assessed? Can he also say how proportionate CQC will be? Under proposed new Section 29A(2)(a) of the Health and Social Care Act 2008, which is introduced in Clause 74(3), a warning notice will state,

“that the Commission has formed the view that the quality of health care provided by the trust requires significant improvement”.

Is there not a need to clarify either in the Bill or in secondary legislation how “significant improvement” is to be defined and assessed and, specifically, how and where the warning notice applies given the number of multisite trusts offering a wide range of services?

In Clause 75, reference is made to Monitor’s imposition of licence conditions. What criteria will impact on Monitor’s decision to impose those licence conditions? Should they not be subject to statutory guidance, given the serious impact of their imposition? In view of the service implications for NHS trusts and NHS foundation trusts of CQC and Monitor interventions, ought there not to be a clear appeals process for providers, given the potential serious consequences for an individual trust or a local health economy of a warning notice or a “failure to comply” administration, both for the provider concerned and the other providers that may be affected by that decision?

My Amendment 66ZB deals with the multisite issue by requiring CQC to define how this is to be assessed. My Amendments 66ZD and 66ZE seek to have published the Monitor criteria under which a licence condition is issued following a warning notice. When such a warning notice is issued, a foundation trust should have the right to appeal under my Amendment 66ZC, which is consequential on Amendment 66ZE. The same principles apply to Clause 76 in relation to the regulator. CQC must surely publish criteria on following a transparent process in making judgments on trust special administration, where there also ought to be an appeals procedure.

It seems that there is a lot of work to be done to make sure that the health service and other providers fully understand the new regulatory apparatus that is to be brought into being. I remain concerned that there could be confusion between the two roles of Monitor and CQC and that the NHS Trust Development Authority’s role is rather mysterious. It is hard to understand why NHS trusts are not in fact subject to a much more robust process than other providers because, as far as I can see, apart from a number of community trusts which are likely to get foundation trust status, the intention is that we simply roll on for years to come with these unviable organisations. Money is clearly top-sliced in order to keep them going, and we know that the real issue is, in many cases, a failure to tackle reconfiguration. It is a worry that almost a limbo situation is being created in which no progress at all is going to be made. There is also a very clear need for due process as to how these licensing provisions are to operate and an appeal process for any organisation that is affected by them.

If the noble Earl, Lord Howe, would agree to the principle of that, I think he could look forward to general support within the health service and outside and, of course, public confidence. The overriding principle of making sure that quality and safety are considered at the same level, or even a higher level, than that of financial viability is one that we certainly support from these Benches. I beg to move.

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I hope that noble Lords are content with my assessment of the failure regime in the light of the amendments tabled and that I have been able to provide reassurance that the approach that we have taken is correct. As I said, these clauses are a direct response to the report of the public inquiry led by Robert Francis, which sets out how regulators, commissioners, professional bodies and the Department of Health failed to secure high-quality care. The single failure regime will ensure that when quality is found to be lacking, a prompt and robust approach will be taken.

[Lord Hunt of Kings Heath]

My Lords, I will not detain the Committee other than to say that the noble Earl’s response bears careful reading. I am still confused about the role of the CQC. If it is able to enforce action against non-NHS social care providers, I do not understand why it is unable to enforce action against NHS providers. I hear what the noble Earl says about the better working relationship between Monitor and the CQC and I am sure that is right. I pay tribute to the new leadership of the CQC and to the appointment of Sir Mike Richards. However, I believe that the architecture still allows for confusion. I would like further clarification on when Monitor and the CQC can take a different view on quality issues. Perhaps we will come back to this on Report. I cannot believe that Monitor will simply accept the CQC’s judgment at face value. Surely its board will have to come to its own view on those issues. That is an area I would like to explore further.

The noble Earl was reassuring about the issue of non-foundation trusts raised by my noble friend Lord Warner. None the less, it does not feel quite like that on the ground. It does not feel as though immediate action is being taken with the many trusts that are clearly nowhere near achieving foundation trust status. I may encourage my noble friend to come back to that point. Having said that, I am grateful to the noble Earl for his comments, and I beg leave to withdraw the amendment.

Amendment 64A withdrawn.