After my last visit to the accident and emergency department at Wexham Park Hospital in Slough, I left the car park and saw a huge sign on a van at the side of the main road, which said, “If you believe you’ve been a subject of medical negligence, please ring the following number”. I worry that with the way in which this whole issue is being addressed, under the conditions of the duty of candour, which in principle I would like to support, those people who put up those signs may well make rather a lot of money out of it. They will find a basis on which to start bringing more and more actions against the National Health Service. I do not know the way round it, because if that is what is happening, and there are so many people out there who are prepared to bring legal action, if they believe that they have the

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remotest chance of winning such an action, the duty of candour will be used as a means to bring about those actions.

I cannot see how we can stop it. That being the case, I believe that we are going to find that, irrespective of this duty, people will, to put it bluntly, continue not necessarily to tell the truth when responding to complaints that are being made by members of the public over their healthcare. I am sorry to dissent slightly from my own Bench on this matter, but I have a concern here and I think that the Minister, in winding his up, should be far more open in this discussion about the possibility of litigation arising out of the introduction of the duty of candour. As I say, I would like to pursue it and I support it in principle, but I am worried that it may lead to more actions.

What would I do as an alternative? In the contribution that I made on Monday, I concentrated on what I thought were the problems from which complaints arise. These are, essentially, simple complications that arise on the ward through minor negligence or lack of concentration by healthcare assistants or nurses. I think that we have to go back a stage from this whole process of candour, litigation and complaint systems, to what is actually happening on the wards so as more effectively to police the way that treatment is carried out more.

At the end of last year, I and a colleague in the Commons conducted interviews with many people involved in healthcare about the problems on wards in hospitals. I drew the conclusion that we should have on every ward a very clear set of entitlements set out on large boards whereby patients and their relatives may understand their entitlements. Instead of being hesitant about going to complain within a ward about the way that they were being treated, they would be able to point to a document and say, “Look, Sir or Madam, this says that that is my entitlement”. If we can get across the fact that people have entitlements, and that they have a right to higher standards of healthcare on wards, there will be fewer complaints in those circumstances and so less incidents of complaints that, in the responses, must rely more on this duty of candour, if it were to be introduced.

I am concerned. I think that we are looking at this problem from the wrong end. We should go right back to the ward and deal with the problem there. They say that ward problems are about leadership on the ward. I am not altogether convinced of that. You cannot have someone on the ward running around telling everyone what to do all the time. You have to have a process of accountability for those who work on the ward to the patient and to the patient’s relative, being their representative. I will not go into my idea about these signs on wards in great detail tonight, but perhaps I will at another stage in the Bill.

I will however deal in detail with one area under Clause 81. An offence is defined as follows:

“A care provider of specified description commits an offence if … the information is false or misleading in a material respect”.

So that is an offence. The care provider is defined under subsection 3(b) as,

“a body (other than a public body)”—

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in my view, that means a private body—

“which provides health services or adult social care in England pursuant to arrangements made with a public body”—

that might well be the commissioning body—

“exercising functions in connection with the provision of such services or care”.

I understand that to mean that you could have a private nursing home with an NHS contract to provide continuing care where the moment that they receive their first patient under continuing care arrangements—an NHS patient in a private nursing home—then that nursing home then falls under the provisions of subsection 3(b). Have I got that wrong? That means that the commission of an offence, if

“the information is false or misleading in a material respect”,

would apply to a nursing home where just one person is in receipt of care paid for by the National Health Service under a contractual arrangement, as against a nursing home next door where there are no NHS patients under a continuing care contract and all the patients are privately funded. There, that offence would not necessarily apply. That is how I understand what is said in that clause. I hope that the Minister will clarify the matter.

9.30 pm

Baroness Northover: My Lords, I welcome this very interesting debate which has gone in various directions. We have a number of amendments to consider here.

Amendment 73A would transfer the responsibility for the National Reporting and Learning System from NHS England to the Care Quality Commission. We wish to take the opportunity to underline the importance of the data and information available through the NRLS to the work of the Care Quality Commission. Indeed, a key component of the CQC’s new three-year strategy sets out how it will make better use of intelligence to inform inspections. However, I remind noble Lords that it was only on 1 June that responsibility for the National Reporting and Learning System was transferred to NHS England. This transfer puts patient safety at the heart of the NHS—I heard what the noble Lord, Lord Hunt, said, but I think it is extremely important that it is at the heart of the NHS—and will build on the excellent work of the National Patient Safety Agency. NHS England plans to develop a responsive NRLS that will provide a one-stop shop for NHS clinicians, patients and the public.

Additionally, noble Lords may be aware of the Berwick review of safety—reference was made to it—which seeks to learn lessons from the Francis report. It will report in July on a whole system approach to ensure that there is zero tolerance of harm in the NHS. We will, of course, give full consideration to any recommendations that that review might make on the effectiveness of the NRLS. In view of these important developments and reviews, we believe that reallocating this work now would be unnecessarily disruptive.

Amendment 73B introduces a new clause which would require the CQC to have regard to guidance on staffing numbers and skills mix in carrying out all its functions. I fully understand the sentiment behind this. All noble Lords will agree that high-quality care is dependent on the people giving it. We heard from

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the noble Lord, Lord Campbell-Savours, about the problems that arise when that breaks down. Clearly, the right staffing in terms of numbers and skills is vital for good care. It therefore follows that staffing levels and skills mix are key considerations for the CQC in regulating quality of care. However, as the noble Lord, Lord Campbell-Savours, says, that is not necessarily sufficient. The CQC’s registration requirements place a clear legal duty on providers to have sufficient numbers of suitably qualified, skilled and experienced staff in place for the services provided. It is the responsibility of individual providers to be accountable for staffing levels and the skills mix of staff in their organisations. 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. However, I note what the noble Baroness, Lady Finlay, said about this being an issue which is not necessarily best placed in primary legislation. The point is to try to achieve quality, safety and efficacy.

The CQC will shortly review and consult on its registration requirements. We intend to amend the requirements so that they will include fundamental standards. These will set the basics below which standards of care must never fall. We can assure noble Lords that the new chief inspectors that we talked about previously, based within the CQC, will have the power to inspect and assess staffing numbers and the skills mix as part of examining the quality of care and will be able to take any necessary action as they consider appropriate. Noble Lords asked whether NICE might become involved in that. We believe that the current legislative arrangements already require the CQC to assess staffing levels. However, we will work with NICE, the CQC, NHS England and other partners to review the use of evidence-based guidance and tools to inform staffing decisions locally.

Amendments 76B and 77 each introduce a stand-alone duty of candour in primary legislation. We had an extremely interesting debate that demonstrated the complexity of the issue. As the noble Lord, Lord Warner, noted, it is a complicated area. The noble Baroness, Lady Finlay, illustrated that, as did my noble friend Lady Jolly and the noble Lord, Lord Campbell-Savours. He noted that there could be unintended consequences such as unwanted litigation. However, my noble friend Lady Jolly said that often all that patients and their families need is clarity and something being admitted to. All these issues show how complicated the area is. The noble Baroness, Lady Finlay, spelt that out.

The Government share the view that providers of health and care must be open in their dealings with patients and service users. Our response to Robert Francis’s report makes a clear commitment to introduce a statutory duty of candour. I therefore wish to reassure noble Lords that we are doing that. In particular, I should like to reassure the noble Baroness, Lady Masham, on that point. That is what we are doing. The route that we are taking is perhaps endorsed by the nature of this debate. We see this as something that is better taken through by secondary legislation. Let me spell that out. The Government intend to introduce an explicit duty of candour on providers as a CQC registration requirement. This will require providers to ensure that staff and clinicians are open with patients

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and service users where there are failings in care. I hear the warnings voiced by the noble Baroness, Lady Finlay. In the end, the aim has to be to improve the quality, safety and efficacy of care. I note what she said about confidentiality.

As with all requirements for registration with the CQC, the Government intend that the duty of candour should be set in secondary not primary legislation. There are very strong reasons for that. Using secondary legislation will enable us to expedite the introduction of this duty and provide a degree of flexibility to get the design of the duty right. I am sure that the department and my noble friend Lord Howe will welcome noble Lords’ engagement, bringing their own wet towels if they wish to, as we take this forward. Secondary legislation will still allow for full parliamentary scrutiny, given that the changes to the regulations that set CQC registration requirements will be subject to the affirmative procedure in both Houses. The duty itself will have the same legal power in secondary legislation as it would in primary legislation. There is also the additional advantage that in such a new and important area we can refine this new duty over time, if noble Lords’ warnings prove to be significant. That is why I commend the Government’s preferred approach of setting the new statutory duty of candour through secondary legislation.

Amendment 77A has the effect of removing the power to specify the type of information and the type of care provider within scope of the new false or misleading information offence. This is a different but obviously related area. This would mean that we have a criminal sanction that applies to all information required by legal obligation, including under contract, which would be disproportionate. It is important that the offence does not inhibit providers from sharing information voluntarily, but we also need to keep the flexibility to respond to new information or different priorities for information over time.

We appreciate that noble Lords will be interested in understanding more about the types of providers to which this offence will apply. The Government are still considering the scope of the offence and I am absolutely certain that my noble friend Lord Howe will be happy to discuss this further with noble Lords.

We start from the issues raised in the Francis inquiry. We are therefore clear that the offence will apply to providers of NHS secondary care. This includes NHS trusts, foundation trusts and independent sector providers of NHS secondary care. We are giving further thought to whether the offence should also apply to other types of providers. We will consider whether, for example, there is a case for extending the offence to providers of adult social care, general practice and mental health services. We will consider this, working together with our stakeholders, and we will of course keep noble Lords informed as to our thinking as this moves forward.

Lord Warner: I am sorry to interrupt the noble Baroness’s flow, but could I just get her to expand a little bit on the approach on the issue I raised about protecting the employer? I was pleased to hear what she was saying about using the registration process to impose the duty of candour on the employer, but there

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remains the concern, which I think a number of us have, about how the employee who blows the whistle actually gets protected under the arrangements that she is talking about.

Baroness Northover: My noble friend says that they have protection under the NHS constitution. I hope that that clarifies it for the noble Lord but, given the time, I am happy, if necessary, to write to cover that further.

There were a number of questions, but I am well aware that time is pressing and that we are almost at the end of this part, so I will just come to one or two of them. In terms of the individual statutory liabilities in Patients First and Foremost, the Government stated that:

“before we introduce criminal sanctions at an individual level…we would want to ensure that this does not unintentionally create a culture of fear”.

The noble Baroness, Lady Finlay, spoke about that. We are, of course, waiting at the moment for the Berwick review, and no doubt we will be addressing this further in the light of it.

The noble Lord, Lord Hunt, asked about various points in relation to Francis. Francis himself made clear that many of his changes can be taken forward within the existing legislative framework and, as the noble Lord, Lord Campbell-Savours, indicated, they are, at heart, about changing behaviours in organisational cultures. The responsibility is therefore with each and every person serving patients to take action to make the changes needed.

However, we have these reviews coming forward, and we will obviously review what else we need to do. This has been an ongoing, long-standing problem, as noble Lords will be aware. I have listened to many debates in your Lordships’ House where these issues have been addressed, and people are endlessly frustrated in terms of trying to make sure that the quality and safety that you see in certain parts of the NHS is replicated in all parts of the NHS.

I am scurrying on through. If there are issues which I have not addressed, I am sure that—

Lord Campbell-Savours: I asked about the circumstances in which a private home took in a single National Health Service patient on a continuing care basis, paid for by the National Health Service. Does that home then come under the provisions of Clause 81? I am talking about one patient. Could that be an impediment to that home being prepared to take on NHS patients? I shall wait for the response to that.

9.45 pm

Baroness Northover: The noble Lord may wish to bear in mind that his Government extended the inspection to private providers. The scope of the offence is wide enough to capture such providers, and it would first be necessary for such providers to be specified in the regulations made under Clause 81. I hope that that helps to clarify the matter for him but, if it does not, we will be happy to fill in any further details.

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Lord Campbell-Savours: But does the noble Baroness recognise that that might then determine the policy of nursing homes concerning whether they are prepared to take on the responsibility of carrying NHS patients? They will then be chargeable with an offence which otherwise—if they were not to take on those patients—they would not be subject to.

Lord Hunt of Kings Heath: Perhaps I may ask my noble friend whether that then comes to the point that the noble Baroness raised earlier about needing to extend this duty to GPs and social care providers. The reality is that if the duty were extended to social care providers, most of those homes would not be viable unless they accepted either local authority-funded clients or clients from the health service. Is not the answer to extend the duty to make sure that we cover GPs, community health and so on?

Baroness Northover: In terms of the division that the noble Lord pointed to, if a provider decides that it does not want to take on NHS patients because it will have to reach higher standards than for private patients—which appeared to be part of what he was saying—once that is publicised and becomes apparent, that will not exactly encourage people to use those providers.

Lord Campbell-Savours: No. My case is that they could be prosecuted in circumstances where they might otherwise not be prosecuted because they would not fall under the provisions of Clause 81(1)(c).

Baroness Northover: It might be better if my noble friend answered. However, I think that it would be best if we wrote to the noble Lord and explained the detail in this regard.

Perhaps I may conclude so that we can move on. I hope that it will reassure noble Lords that the draft regulations will be available for them to consider on Report, giving full details and specifying the type of information supplied or published by providers of NHS secondary care that will fall within the offence that I have just been talking about. Regulations will, again, be subject to full parliamentary scrutiny of both Houses using the affirmative procedure. I hope that that provides reassurance to noble Lords.

The Government place great importance on ensuring that the public, regulators and commissioners have an accurate picture of a provider’s performance and can have confidence in the information supplied or published by providers.

I trust that noble Lords will find some reassurance in regard to the actions that the Government are taking, particularly on the duty of candour, the complexity of that, the importance of putting it into secondary regulations and the involvement that they may wish to have as that is taken forward. Even if I need to clarify the specific points that the noble Lord, Lord Campbell-Savours—

Lord Campbell-Savours: I have one other point to make. When the reply comes, it might deal with whether that provision applies only to that individual patient who is subject to NHS support, as against the balance of residents in a nursing home.

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Baroness Northover: My noble friend says no. I can see that the van advertising litigation probably does not want to encounter the noble Lord, Lord Campbell-Savours, as he comes out of whichever hospital it is.

In the light of what I have said, and anything else that we need to clarify, I encourage noble Lords not to press their amendments.

Lord Hunt of Kings Heath: My Lords, we are extremely grateful to the noble Baroness for that reply. There are obviously a lot of issues that we may want to return to, but clearly the main debate is about the duty of candour. It has been a good debate because noble Lords have identified the problems of a statutory duty on individuals. This presents some real challenges, which clearly need to be thought out with great care and attention. I very much accept that there is a real risk of perverse incentives and discouraging staff doing the right thing because of the fear of prosecution.

However, I am puzzled about the duty of candour. I do not understand why the Government have included this offence of supplying false or misleading information in the Bill when the duty of candour, which is clearly much more important, will be relegated to secondary legislation. From the debate and the comments of all

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noble Lords who spoke, clearly this is not easy. It has to be got right. The best way to get it right is through primary legislation.

The problem with secondary legislation is that, at best, we will have an hour and a half of debate and we are not allowed to amend it. This issue is so complex and important that it warrants more. I strongly recommend that the Government to look at this again and bring back an amendment on Report in the light of Professor Donald Berwick’s recommendation. I think that they will find that the duty of candour is the flagship of the Francis report. Not to have it included in the Bill means that we are missing something. I suspect that patients will miss out in the end.

Having said that, this is a good way to conclude our discussions tonight and I beg leave to withdraw my amendment.

Amendment 73A withdrawn.

Amendment 73B not moved.

House resumed.

House adjourned at 9.52 pm.