My Lords, I welcome the almost unanimous support for the Bill. As ever, I am indebted to your Lordships’ House for an informed and robust debate on the measures in the Bill, and I pay tribute to everybody who has contributed today. I want to take a moment to thank my right honourable friend Jeremy Hunt for his international leadership on patient safety in recent years. I also reiterate my thanks to the Joint Committee for its thorough pre-legislative scrutiny process, which has clearly been of great benefit to the Bill and has shaped our debate today. As we can see, it has created some important changes in the Bill.
I want to take a moment to reflect on why the Bill is so important. The new Health Service Safety Investigations Body will have the powers and the independence to conduct thematic investigations into patient safety incidents that occur in the NHS, in particular not to apportion blame but to spread systematic learning and establish the trust of NHS staff, patients and the public. Until now, we have not had that on a statutory basis. The noble Baroness, Lady Finlay, and the right reverend Prelate the Bishop of London rightly said that the opposite of a learning culture is a culture of fear. With that culture of fear, we cannot make the improvements in patient safety that we need. In my view and in the view of the Government, the establishment of a safe space system—which previously has been seen only in respect of transport accident investigation bodies—is a big step forward in ensuring that the NHS can go forward and learn from its mistakes, particularly by addressing the concern that, at the moment, NHS workers do not feel that they can speak out when mistakes occur. This new body will play an important role in improving patient safety and creating that vital culture of trust and learning, which will be able to prevent serious patient incidents happening across the NHS. I believe that we have the support of the whole House in achieving that.
As ever, a wide range of issues were raised in the debate, so I will do my best to respond to them as much as I can, but I will write to noble Lords where I
am not able to do so. One of the primary issues of concern was the effectiveness of the body. The best place to look for the answer to that involves looking at how well HSIB has already been performing in its pilot form within NHSI over the past year and a half. HSIB’s internal management and staff survey found that the current investigation branch was very positively received. There was an engagement rate of 91%, and 80% of staff said that they are proud to work for the organisation and want to be there in two years’ time. The responses are well above the scores of other NHS organisations, and it shows that there is more to be done and that it is progressing well.
In addition, we can measure the impact of HSIB as an organisation outside. The current investigation branch’s approach puts patients and families at the centre of its work, and I can quote from the feedback it has received. People say that they found that the “process was so supportive” in the way that it was approached and that it was,
“a great feeling that you’ve got a voice which is entirely down to the approach”,
of the current investigation branch. Another very touching response said that, “Just knowing that my mum’s death may not be in vain and may prevent similar instances from happening to other families is the best legacy that I can think of in memory of my wonderful mum. That is what she would have wanted”. That is what the HSIB has already achieved, and by putting it on a statutory footing we can ensure that it can do more and that it can do more effectively.
I want to move on to the important issue of the safe space, which was raised by a number of noble Lords, including the noble Lords, Lord Hunt of Kings Heath and Lord Turnberg, the noble Baronesses, Lady Walmsley, Lady Parminter, Lady Jolly and Lady Thornton, and my noble friends Lord O’Shaughnessy and Lady Eaton. I can do no better than to quote, as did my noble friend Lord Hunt of Wirral, from the report of the Joint Committee on the Bill:
“the primary and overriding purpose of this Bill is to put in place arrangements that will lead to learning and improvement arising from objective and comprehensive analysis of the causes of clinical mistakes and incidents, leading to better and safer outcomes for users of the healthcare system. We do not think this second principle is incompatible with obtaining justice in individual cases, which may and should be pursued by other means”.
The safe space is central to that, but it does not prevent patients and families pursuing other routes of investigation via the CQC or via the criminal courts. It is very important to understand that.
As the noble Lord, Lord Hunt of Kings Heath, said, we have to strike a balance with the safe space by including an exemption for coroners. Coroners are judicial officeholders and have an important role to play in investigating certain deaths, so we have determined that it is appropriate to allow them to access protected material where this is necessary for them to fulfil their judicial functions, but we have also determined that we should put in place tight prescriptive measures to ensure that the safe space is protected as much as possible. On that basis, if a coroner requires information under the Coroners Act 2009, they are not able to share the information without a High Court order to
do so, under Clause 19, and they can disclose only if the court makes an order after deciding, in the interests of justice, that the risk of disclosure is greater than any adverse impact on current or future investigations and the Secretary of State’s ability to improve patient safety in the NHS. In addition, Clause 14 provides for a few small exemptions where HSSIB could disclose information if it was needed to help carry out an investigation, while Clause 15 provides that if it is,
“necessary to address a serious and continuing risk to the safety of any patient or to the public”.
Those are important criteria because these investigations are not supposed to pose a risk to individual patients.
The noble Baroness, Lady Parminter, raised an issue regarding the PHSO. The Government’s view is that the new body’s investigations and those of the PHSO are different types of investigation and that the prohibition would be likely to have a limited impact on the ability of the ombudsman to investigate complaints about the NHS and other health bodies. The ombudsman will still be able to obtain information from the relevant trust. In addition, HSSIB will carry out only a small number of investigations—up to 30 a year—so the view is that the impact on the work of the ombudsman will be small. However, I take on board her views and we understand the position of the ombudsman.
The noble and learned Lord, Lord Judge, asked an important question about whether HSSIB has to take into consideration patient consent in order to participate in an investigation. It is required to publish its processes for ensuring that, as far as reasonable and practicable, patients and families are involved in investigations. It would be expected to be sensitive to the circumstances of patients and their families, and we would expect it to seek consent in the vast majority of cases. The current branch has developed very good working relationships with patients and their families, and we would expect the new body to continue that. However, I shall take away the point he has raised.
The noble and learned Lord similarly raised a point regarding a fine rather than a custodial sentence for a breach of information. The sanctions regime was considered following the recommendations of the Joint Committee. We believe that criminal sanctions are appropriate, regarding the seriousness placed on non-compliance with the relevant provisions in the Bill. On his point about whether it is an appropriate sanction, I will also take that away and consider the issue he has raised.
A number of noble Lords, the noble Lords, Lord Hunt of Kings Heath and Lord Scriven, my noble friend Lord O’Shaughnessy and the noble Baroness, Lady Finlay, asked questions about the scope of HSSIB to conduct investigations. HSSIB will be an independent body. It will be able to decide its own priorities and determine what it investigates based on the referrals that it achieves on its own intelligence. It is important that it should be free to do that, but those criteria will be consulted on. There will be an opportunity for patients, the public and the NHS to contribute to that consultation. The Bill is clear, however, that HSSIB may only investigate incidents that have an effect on the safety of patients which occur in the provision of the NHS and do not
involve an outcome that contributes to blame, so there are some parameters within the Bill. But the criteria of how those investigations are chosen will be set by HSSIB as an independent body.
On the question of who will be responsible for monitoring the implementation of recommendations, it is essential, if the body is to be established as effective and gain the trust of the public that it does that effectively. So the National Director for Patient Safety will chair a programme board to monitor the system response to the recommendations made by the new body. We do not believe that that needs to be set out in legislation. The Joint Committee agreed with us and agreed that HSSIB should not be responsible for enforcing its own recommendations. That is to ensure that it remains independent and does not become part of the system that is being investigated.
A number of specific questions were asked about what areas were in scope. The noble Lord, Lord Scriven, asked whether prison services were in scope. They are, providing that they are commissioned by the NHS. Indeed, HSIB has already conducted an investigation into NHS-provided prison services. The noble Baroness, Lady Hollins, asked about learning disability services, which would also remain in scope if they were funded by the NHS.
A number of noble Lords asked about staffing levels and the impact on staffing. Certainly, if the question of staffing and behavioural impact fell within the question and the terms of the investigation, that would certainly be appropriate for HSSIB to report on. The standard question is that the scope of HSSIB’s investigations and learning will extend to any patient safety incident that occurred during the provision of NHS services in England, or which occurred at a premises where such services are provided. So that would also include NHS-commissioned services in the independent sector. I will return to the independent sector in a moment.
Dentistry is also covered, which my noble friend Lord Colwyn raised, and maternity, although HSSIB does not replace the local, independent inquiries, which would be done by NHS trusts. I shall return to that in the second. On maternity services, HSSIB will focus on only a small number of thorough national investigations conducted through the safe space for maternity going forward. But we have been clear that we will allow the current investigation branch to continue to run the local maternity investigations programme for a period—the commitment is for 1,000 maternity investigations—so that we can get maximum learning for the NHS. Those will continue but they will not be part of the statutory regime.
I note the strength of feeling in the House about the independent sector and I will take that issue away with me. I answered the question in my opening remarks so I will not go into too much depth now. At the moment, the independent sector is not covered, but I take the point on board and will take it away. In addition, I note the point raised by the noble Lord, Lord Scriven, regarding social care. However, it was the Joint Committee’s recommendation that the new body should not be tasked or expected to be an investigatory body for social care. But it should be able to investigate all
aspects of the healthcare pathway relating to patient safety investigation, so people should not fall through the cracks. I hope that that reassures him.
On the question of the independence of the body, which will also be critical, and responding particularly to the questions raised by my noble friends Lord O’Shaughnessy and Lord Ribeiro and the noble Lord, Lord Hunt of Kings Heath, the new body is modelled on some features of the AAIB. It will have statutory powers and carry out impartial investigations. But the AAIB sits within a department and we wanted to make sure that the new body was more independent than that and given a statutory, stand-alone role, which is why we are setting it up as a non-departmental body. It will have the powers to conduct impartial investigations and the Secretary of State may request but cannot direct the body to conduct a particular investigation. This is similar to the CQC set-up, and we think it is appropriate.
The chair and the non-executive directors will be public appointments subject to open competition. The process follows a published governance code which is independently regulated by the Commissioner for Public Appointments. This is in line with other public bodies, as is the process for the appointment of the chief investigator, which is in line with NHS England, Monitor, NICE and ALBs. The chief investigator would be appointed by the board, but would then be subject to the consent of the Secretary of State.
We are clear that the HSSIB would need to integrate and work closely with similar regulators in the space so that there is no question of duplication, which was a point of concern raised by the noble Lords, Lord Faulks and Lord Turnberg. We are reassured that that would not be the case given that the effectiveness of the HSSIB has already been demonstrated. We will make sure that it works effectively through the mutual duty of co-operation which has been set out in the Bill, a number of MoUs and the demonstration of the effective working of the body as it stands. It does not duplicate other bodies.
The National Patient Safety Agency was in many ways a forerunner, as noted by the noble Baroness, Lady Thornton, and the noble Lord, Lord Patel. I pay tribute to it for its work in that way. As noble Lords will be aware, in 2012 the decision was made to transfer the main functions of the NPSA to NHS England. Those functions now sit with NHS Improvement under Aidan Fowler. Unlike the NPSA, the new body will focus on only a small number of thematically based investigations that offer systemic learning without any blame attached and will have a statutory footing. I hope it is recognised by those who were involved in the NPSA that this is a step in the right direction.
In answer to the noble Baroness, Lady Thornton, and the noble Lord, Lord Turnberg, I say that these investigations do not replace very important local investigations. There is no intent to replace them in any way. However, there is value in national learning, as sometimes investigations which happen at trust level do not share best practice nationally. This is not a duplication on that basis.
I shall quickly move to the end of my speech, but I want to answer the question regarding the devolved Administrations asked by the noble and learned Lord, Lord Hope, and the noble Baroness, Lady Finlay. Currently the investigative branch has had positive interactions with the devolved Administrations in Scotland and Wales and has worked closely with trusts in Wales in recent investigations involving cross-border care. We think that more formal plans will be developed with the new body which will mean that other Administrations will be able to ensure that effective working can go forward. However, I take on board the concerns that were raised by the noble and learned Lord regarding Clause 25 and will ensure that it is fully tested.
There are a number of issues that I would like to go forward and raise, but I am aware that time is ticking on, that we are at the end of the day and that tomorrow may end differently. I thank everybody who has contributed today. There are some important questions that need to be resolved. As we have a little bit of time to go through it, I am sure we will be robustly tested, but ultimately the Bill is destined to play a key role in helping to prevent the recurrence of patient safety incidents and fulfilling the Government’s commitment to ensure that the NHS provides high-quality, safe care. We expect the new body outlined in the Bill and
the medical examiner system to be operational from April 2021, subject to the passage of the Bill through Parliament. I heard the support of this House very loudly today.