Skip to main content

Commissioner for Patient Safety (Appointment and Operation) (England) Regulations 2022

Volume 820: debated on Monday 21 March 2022

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Commissioner for Patient Safety (Appointment and Operation) (England) Regulations 2022.

My Lords, patient safety remains a top priority for the Government, and we continue to place enormous emphasis on making our NHS safer and as safe as possible for patients. This builds on earlier measures including, for example, the first ever patient safety strategy launched by NHS England in 2019. This aims to improve the way the NHS learns from avoidable harm and to create a safety and learning culture across the NHS. However, we know that more work needs to be done.

The First Do No Harm report by my noble friend Lady Cumberlege highlighted and effectively exposed a healthcare system that failed to listen to and disregarded the experiences of women. In my noble friend’s absence, I pay tribute to her for the work and to the review team for their diligence and dedication in conducting the review. I should put on record that my noble friend Lady Cumberlege cannot be with us today but did send her apologies.

The Government published their formal response to the Independent Medicines and Medical Devices Safety Review’s recommendations in July last year, setting out an ambitious programme of change. This included accepting the recommendation to appoint a patient safety commissioner with a remit covering medicines and medical devices. We are making progress towards fulfilling this important commitment. We included provisions in the Medicines and Medical Devices Act 2021 to establish the commissioner and set out their core duties. We also held a public consultation between June and August last year on the detail of the commissioner’s appointment and operation. In January, we started the process to recruit the very first patient safety commissioner. The job advert closed on 1 February and we hope to make an appointment this spring.

As well as establishing the patient safety commissioner, the Medicines and Medical Devices Act allows the Government to make legislative provisions about the appointment and operation of the role. Our public consultation set out nine proposals, covering details such as term of office, reappointment arrangements and remuneration. We are grateful to all those who took the time to engage with our proposals and share their views.

I can inform noble Lords that each proposal was supported by more than half of those who responded, ranging from 59% to 91% of respondents being in agreement. Having considered all the responses carefully, we have laid before the House this statutory instrument that will implement the proposals put forward in our consultation. This instrument will enable the patient safety commissioner to function effectively by providing a clear legislative framework within which they can operate. It allows for the commissioner to serve an initial term of three years. This received strong support during our public consultation, and we believe it provides sufficient time for the postholder to become established and develop the role.

I am aware that some respondents were concerned that this would provide too short a period for the commissioner to establish himself. I should stress, however, that the regulations also allow for the commissioner to be reappointed for an additional three years, in effect giving them up to six years in office. We believe that this provides the right balance between those who were concerned that a longer initial term would make it difficult to remove an ineffective commissioner, and those who were concerned about the premature removal of an effective commissioner.

The regulations also set out a range of other details about the role of the patient safety commissioner, including producing a business plan covering a period of at least 12 months; receiving the commission’s funding from the Government; keeping proper accounts each financial year; remuneration; publishing and laying in Parliament an annual report; and allowing staff to exercise any of the commissioner’s functions so far as they have been authorised to do so by the commissioner. The regulations also require the commissioner to appoint an advisory panel to provide advice and assistance to the commissioner.

The Government believe that we need to have a more patient-focused system of healthcare. The patient safety commissioner will play a vital role in promoting the safety of patients in relation to medicines and medical devices. We believe that these regulations provide appropriate arrangements to enable the commissioner to function and operate effectively once appointed. I beg to move.

My Lords, the noble Baroness, Lady Brinton, is taking part remotely. She speaks as the Front-Bench Liberal Democrat spokesman but as there are no Back-Benchers, I invite her to speak.

My Lords, I thank the Minister for his introduction. He will know that across the House there have been considerable discussions, not just in recent months but recent years, on the role of the commissioner for patient safety in various Questions, debates and Statements since the First Do No Harm report of the noble Baroness, Lady Cumberlege, was published in 2020. I join the Minister in paying tribute to her, not just for her report but for her absolute persistence in holding the Government to account to deliver as many of her recommendations as possible. I too am sorry that she cannot be with us today but I know that she is pleased that this SI has been published.

This SI specifically covers the appointment of the commissioner but, once again, government actions are happening before Parliament has had a chance to scrutinise this SI. This SI sets up the role of commissioner, but the Minister has just told us that not only is the advert out, but it is closed and an imminent announcement is due. I do not think that there is anyone who does not want the commissioner to be put in place, but once again, this seems to be putting the cart before the horse in that the SI is being dealt with after the advertisement has gone out.

However, for the first time there will be an independent commissioner whose role is to stand up for the rights of patients when they have suffered avoidable harm. The three main parts of the report of the noble Baroness, Lady Cumberlege, covered HPTs, sodium valproate and vaginal mesh but there are other issues as well, and unfortunately there will be more in the future. That is why the Minister is right to say that the creation of a learning and safety culture is absolutely vital, as is an environment in which people working inside the NHS and other organisations associated with delivering medicines and medical devices can speak without fear. That is why some of us had concerns over the initial period of appointment. While the possibility of a second term is welcome, the concerns related to that first period of setting up the commission. This is not just somebody who will walk into the job and everything will be ready to go. The difficulty is that, having established themselves in the post, they will then have to gain the confidence of everybody who they might be investigating, which can take a while. It will be quite difficult to judge whether it is appropriate to appoint them for a second term if they have had probably only about 18 months when they have been able to do the job properly.

My Lords, the first thing I did when preparing for this debate was to ask the noble Baroness, Lady Cumberlege, if she was content—of course I did. Since her shocking and moving report First Do No Harm, mentioned by the Minister and the noble Baroness, Lady Brinton, and during the passage of the Medicines and Medical Devices Act, there has been active cross-party support for the recommendations in that report and a determination in this House to bring about change. This SI is another step along that path.

As one would expect, the noble Baroness, Lady Cumberlege, is involved in the appointment—and will, I suspect, be involved in the work—of the new commissioner. I join the noble Baroness, Lady Brinton, in asking why we are discussing this SI when action has already been taken. The reason this SI and the commissioner’s job are important is that when people, often at their most vulnerable, put their trust in the hands of healthcare professionals they do so in the expectation, quite rightly, that their safety will be of paramount concern. Sadly, that is sometimes not the case. Even worse, sometimes the patient is not heard. Where those incidents have taken place, patients have been made to jump through hoop after hoop in their fight for recognition and voice. The independent patient safety commissioner will take steps to ensure that patient safety is a top priority and will act as a voice for patients.

There is no question that the noble Baroness’s report was a landmark in the fight to improve patient safety, so I praise her but also honourable and noble Members of both Houses for their work, whether on sodium valproate, Primodos or surgical mesh, who have stood up for the thousands who have suffered because patient safety was not taken seriously enough. My honourable friend Sharon Hodgson MP, for example, was at the forefront of championing these women.

Despite this, there remain several outstanding ways in which this Government could further improve patient safety. I welcome that, in this instance, the Government have taken on board the recommendation to provide an independent patient safety commissioner, but I would like to know from the Minister what progress has been made on the remaining recommendations in the review. I think all are agreed that that full package of reforms is essential.

I would also like the Minister to explain why the tenure is only three rather than five years. I realise that it is allowed to roll over for another term but, when you are setting up a new office with a new role and getting an organisation up and running, three years is too short a time. The Children’s Commissioner has five years. I would be grateful if the Minister could outline how and why that decision was taken.

We welcome the obligation on the commissioner to lay an annual report before each House of Parliament. There is an additional obligation for the commissioner to publish a business plan at the start of each year, which is not mentioned in the SI. What is the point of the commissioner providing a business plan if they are not held accountable for its contents?

Finally, I draw the attention of the Committee to the advisory panel that

“must consist of persons who (taken together) represent a broad range of interests which are relevant to the Commissioner’s functions.”

Will that include the patient voice? Will patients have representation on this board?

Of course, this SI has our support and we welcome it, but the Government should see it as a beginning, not an end.

I am grateful to the noble Baronesses who spoke today. Once again, I would like to echo their gratitude to my noble friend Lady Cumberlege, but I also agree with the noble Baroness, Lady Thornton, that a number of politicians in both places across parties raised a number of these issues. We have read some horrifying stories about some of the victims of the three issues that were raised. They are really heartbreaking in many ways.

My Lords, we are determined to deliver meaningful change in our response to the Independent Medicines and Medical Devices Safety Review. We see the safety commissioner playing a key role in that change. I know there are concerns about the three-year and three-year-plus extension. When I was asking questions, right at the beginning of my awareness of this when I first became a Minister, I was told that three years is standard for a number of offices. So I was interested to hear the noble Baroness, Lady Thornton, talk about the term of the Children’s Commissioner being five years. The initial advice I was given was that three years is standard. There were also some concerns from other quarters about what happens if we appoint an ineffective commissioner; do we then have to wait five years to get rid of them? We think three years is the right balance, but it continues to be a subject of debate and I completely understand that.

I also take on board the point made by the noble Baroness, Lady Brinton, that it is not only about women who have had mesh complications or valproate or the other issue; there will be other issues we come across, but this was set up as a result of the Independent Medicines and Medical Devices Safety Review. We completely agree that patient safety must remain a top priority and we hope that this will not be the only way to improve safety. There is a statutory duty of candour, regulated by the CQC, which requires a trust to tell patients if their safety has been compromised and to apologise. There are protections for whistleblowers and “freedom to speak up” guardians; provisions in the Bill to establish, as the noble Baroness will be aware, the Health Services Safety Investigations Body; the implementation of the first-ever NHS patient safety strategy in 2019 with substantial programmes under way to create safety and learning; the implementation of medical examiners across the NHS as a critical reform, so that all deaths not involving a coroner are scrutinised by an independent medical practitioner; and of course legislation for the patient safety commissioner.

I am also in conversations directly with my noble friend Lady Cumberlege who, quite rightly, keeps pressing the department on the issues of valproate, vaginal mesh and the other issue, where we need some form of redress. I have mentioned to my noble friend where the concerns are and that, if we continue those conversations, I hope to close that gap as much as I can. I make no promises, but I hope noble Lords recognise that I do try to close the gap whenever I can, and I am in constant conversation with my noble friend Lady Cumberlege on that.

On top of this, we hope the patient safety commissioner will play a key role in that change, championing the view of patients in relation to medicines and medical devices. It is not particularly party political; this is important across the House. When the NHS performs brilliantly, of course it should be praised, but when things go wrong, we should find out. That then clearly makes it a patient-centred NHS, but it also means we can learn to make sure we have a better health service in the future. These things should not be swept under the carpet.

We hope the regulations before us will help us support the success of this new role, providing a sensible and clear legal framework within which to operate. In case I have not answered any of the questions, I will read Hansard and try to sweep them up and write to the noble Baronesses. Before that, I commend these regulations to the Committee.

Motion agreed.

Committee adjourned at 5.58 pm.