I thank Jackie Baillie for lodging amendments 3 and 4. She is deeply committed to patient safety and has campaigned on the issue for many years. I am grateful for her continued work within and outwith the Parliament to ensure that those who have suffered harm and their loved ones remain at the heart of the bill.

I am delighted that Jackie Baillie and I have been able to work together to find common ground and bring those important amendments to stage 3. Together, amendments 3 and 4 will place on the commissioner a duty to produce a charter that will set out what the commissioner considers to be best practice and appropriate standards expected of all healthcare providers. The commissioner will be required to take into account the expectations that are set out in the charter when considering a healthcare provider’s handling of an incident. The charter will send a powerful signal to healthcare providers that the requirement to act is on them, and not on patients and families. I share Jackie Baillie’s determination that those who have been harmed or bereaved should not have to push for answers from healthcare providers.

Amendments 3 and 4 will underscore the need for meaningful engagement with patients and families. That means much more than just the passing on of information, although that in itself is important. The commissioner will be able to use the charter to set out what is expected of healthcare providers when they engage with patients and families. That emphasises the importance of healthcare providers listening carefully to what patients and families say and of using the insights that are gained from that dialogue to strengthen patient safety and continuously improve their services.

Jackie Baillie has spoken powerfully, and we have heard her. I know that we share the same goal, and I am very grateful that we have been able to work together to get here. I urge members to support amendments 3 and 4.

However, I cannot support amendment 3A, because, after careful consideration, I believe that Jackie Baillie’s amendment 3, which I fully support, will be more effective without further amendment. Amendment 3 already provides that the commissioner is required to look at a healthcare provider’s actions against the expectations that are set out in the charter when considering how the provider has handled an incident, and it does so in stronger terms, setting out that the commissioner

“must take the expectations set out in the charter into account when considering a health care provider’s handling of an incident.”

We can expect that the commissioner will consider the extent to which healthcare providers have met the expectations of standards and good practice, and they can cover that in their reports on an investigation.

Amendment 3A is weaker by comparison, stating only that the commissioner

“may prepare and publish a report on the compliance of a health care provider with the charter insofar as such compliance impacts on the safety of health care.”

The second reason why I cannot support amendment 3A is more closely connected with our shared aim of ensuring that healthcare providers engage meaningfully with patients and their representatives. The amendment states that reports could cover compliance with the charter only

“insofar as such compliance impacts on the safety of health care.”

Arguably, that would include scrutiny of the quality of a healthcare provider’s engagement with patients and families in the report. That is because engagement is a step removed from the actual provision of healthcare where safety issues might arise. That is covered by amendment 3, and Jackie Baillie and I both recognise it as an important element of the commissioner’s role. I do not see the merit of a further amendment that cannot be relied on to allow the commissioner to report on issues of poor communication and inadequate engagement. Therefore, I urge members not to support amendment 3A on the basis that its broad aims are achieved more effectively in Jackie Baillie’s amendment 3.

I am not able to support amendment 19. Members will recall that, in its stage 1 report, the Health, Social Care and Sport Committee called on the Scottish Government to confirm that the commissioner would be able to address matters arising at the intersection of health and social care. At stage 2, I was very happy to confirm that the commissioner could look at patient safety issues wherever healthcare was being provided, including in social care settings.

I reiterate that in the chamber today. The commissioner’s role is about safety in healthcare. I make it absolutely clear that there is nothing in the bill that would prevent the commissioner from dealing with healthcare provided in a social care setting or any other setting. I therefore urge members not to support amendment 19, which, rather than clarifying that point, risks creating doubt over whether the reference to healthcare includes healthcare that is provided in contexts other than social care, such as schools, prisons or, indeed, anywhere.

I do not support amendment 14, which would allow the commissioner to make a special report on any recommendations from a previous report that they felt

“have not been, or will not be, implemented”.

As I said at stage 2, the bill expressly gives the commissioner power to publish information on a person’s response to recommendations that the commissioner has made in an investigation report or, indeed, on any failure to respond. Amendment 14 is therefore unnecessary.

At stage 2, I noted my concern that requiring the commissioner to lay before Parliament a report about actions that

“it appears to the Commissioner ... will not be ... implemented”

could leave them open to defamation actions, because it anticipates or speculates about wrongdoing by others. Therefore, I ask members not to vote for amendment 14.

I have discussed with Tess White the basis for the Scottish Government’s opposition to amendment 22. It seeks to create a duty for the patient safety commissioner to consider whether it would be effective for resources to be shared with other parliamentary commissioners. I hope that members will agree that requiring the commissioner to proactively consider resource sharing in that way would not be an effective use of their time.

I am strongly of the view that the commissioner should be focused solely on patient safety. Resourcing for parliamentary commissioners is, as has been pointed out, a matter for the Scottish Parliamentary Corporate Body. Section 19 provides that

“The Commissioner must comply with any direction given to the Commissioner by the Parliamentary corporation in relation to ... the sharing of premises, staff, services or other resources.”

The amendment is therefore unnecessary and it would create a distraction. I appreciate Tess White’s intention to withdraw it.

Amendments 5 and 8, in my name, relate to wording that was inserted into the bill at stage 2 by Carol Mochan. Following stage 2, the provision in section 12A sits among provisions about investigations by the commissioner. The provision relates instead to amending the Health and Care (Staffing) (Scotland) Act 2019 to require health boards and the Common Services Agency—or, as it is more widely known, NHS National Services Scotland—to provide information to the patient safety commissioner as well as to the Scottish ministers, about the steps that they have taken to comply with the guiding principles for health and care staffing.

Amendment 5 removes the provision in section 12A from the bill, and amendment 8 inserts it into schedule 2, which deals with similar modifications to other legislation. The substantive effect of the wording inserted by Carol Mochan’s amendment at stage 2 is unchanged by that. Amendments 5 and 8 simply move the provision to a more appropriate part of the bill, for the benefit of those using the legislation. I have advised Carol Mochan of those changes, and I thank her for her contribution to the bill. I urge members to support amendments 5 and 8.

I turn to amendment 15, in Paul Sweeney’s name. At stage 2, I was unable to support a similar amendment that Paul Sweeney lodged. As I indicated then, medicines and medical devices are a reserved matter, and the situation is complex. The reservation includes matters relating to the regulation and control of medicines, such as their manufacture, distribution, importation, licensing and marketing. I undertook that my officials would look into that further, and we have carefully reconsidered the information gathering powers in the bill.

Our conclusion is that amendment 15 is not required. Section 12 of the bill contains a general power to seek information, and section 13 contains a wider power for more focused inquiries as part of a formal investigation. The general power to seek information from healthcare providers that is allowed by section 12 is appropriate, because the role of the patient safety commissioner is fundamentally about the safety of healthcare being provided to patients by those providers.

The healthcare providers are the direct interface with patients. Pharmaceutical companies and a range of others are one step removed from that, so it is appropriate that they are covered by the power in section 13, so that information can be compelled from them if and when it becomes necessary during the course of an investigation. If, for example, the commissioner were to instigate a formal investigation into hernia mesh—a subject that I know is of particular interest to Katy Clark—she or he would be able to require information from manufacturers and suppliers of hernia mesh if that information would be relevant to the investigation. Amendment to section 12 is not required.

The commissioner’s power under section 13 to require information that might be relevant to a formal investigation extends to any person, including manufacturers and suppliers of medicines or medical devices, subject to the general limitations contained in the reservation of medicines and medical supplies. We consider that, as part of a formal investigation, the power in section 13 is the appropriate context in which to empower the commissioner to require information that might be relevant to a formal investigation from such manufacturers and suppliers. The bill already provides that, so the amendment is not required. I therefore urge members not to support amendment 15.

I am also unable to support amendment 6, in the name of Carol Mochan. As my predecessor, Maree Todd, said in her evidence to the committee, professional regulators such as the General Medical Council do not have the same purpose as the patient safety commissioner. It upholds professional standards and will, when needed, take action against individuals, rather than focusing primarily on promoting learning and systemic improvement. I do not want to create a situation in which the bill might impede the willingness of healthcare professionals to be frank and open with the commissioner, and I believe that amendment 6 risks doing just that. It is also important to note that nothing in the bill prevents the commissioner from working with regulators for the benefit of patient safety. I urge members not to support amendment 6.

I begin by acknowledging the voices of patients who have been harmed while in the care of the NHS or any other healthcare provider, as well as those of their families and loved ones. I can only begin to imagine the grief of those families who have been bereaved, and my heart goes out to them for the devastating loss that they have suffered. Families have spoken clearly and powerfully about how the healthcare system has let them down. In Jackie Baillie’s words, they have had to battle. The best thing that any of us can do now—in fact, the only thing that we can do—is to take every step that is possible to make sure that other families do not suffer the same thing in the future. I record my thanks to Jackie Baillie for her continued support and advocacy for those patients and their families and for working with us towards our common aim of making the bill and the patient safety commissioner as strong as possible.

In these discussions, none of us will ever forget that we all want to make healthcare safer. That has been at the forefront of my mind since I started working on the bill and I know that the same is true for all members in the chamber.

As I noted at stage 2, the patient safety commissioner’s role is to amplify the voice of patients and to drive improvements in safety, however they see fit. The commissioner will have powers to investigate any healthcare safety issue, and listening to patients and their families is a fundamental element of their role. I know from my discussions with her that Jackie Baillie’s amendments seek to strengthen the commissioner even further, to ensure that the voices of those harmed in major healthcare incidents and families who have lost loved ones are heard.

The patient safety commissioner will undoubtedly wish to hear the voices of bereaved families as well as affected patients when they wish to raise an issue relating to patient safety that stems from the sort of incident that Jackie Baillie has described. That is already provided for in the bill. Indeed, as a Government, our key consideration when developing the bill has been to give the patient safety commissioner as much independence as possible, so that they have the most freedom possible to examine any healthcare issue that affects patients and their families.

The most important thing that we can do now is to do our best to ensure that no families see loved ones harmed while in the care of the healthcare system. That is why it is so important that the bill improves patient safety by encouraging openness, learning and co-operation within the healthcare system, so that, when things go wrong, lessons are learned and families do not go through the same things again.

Although I understand the intent behind amendment 10, it is likely to detract from the vital function that I have just described, which is to encourage openness, to ensure that lessons are learned and to prevent the same harms from happening again. Adding to the commissioner’s role a function of providing or assisting with redress for patients and bereaved families, and giving their opinions on the actions that others should take in light of past incidents, risks putting the commissioner into an adversarial role and may encourage healthcare providers to believe that they have to be defensive, as opposed to open, in their dealings with the commissioner.

Focusing the commissioner on openness and learning rather than on redress for past incidents will be the best way of ensuring that, when they look into any healthcare safety issues that are connected to a major incident in which many patients are harmed, lessons are learned and those harms are not repeated.

Similarly, amendment 21 provides an extensive list of definitions of what constitutes family, which I know Jackie Baillie has drafted with the sole intention of ensuring that no family member is excluded from being able to speak to the commissioner or to receive support. However, family means different things to different people, and the family connections that are important to one person will not necessarily be the same as to the next. In addition, some of the language in the amendment on whole-blood and half-blood relationships is outdated. It is more effective not to tie the commissioner up with lengthy definitions of who they should or should not consider in the context of their work. That is a matter for the commissioner’s discretion.

We all share the desire for the patient safety commissioner to be able to look into healthcare safety issues arising from major incidents in which multiple patients are harmed. I have considered carefully how best to achieve that. My view remains that it is more effective to allow the commissioner to be guided by patients on the issues that they look into and the actions that they take. I do not wish to inadvertently tie the commissioner’s hands with regard to the circumstances that they can look into, and I worry that this group of amendments, by adding very specific steps for the commissioner to take in relation to a certain group of incidents, would unintentionally undermine the commissioner’s vital ability to set their own agenda and to look into the issues of most concern to patients.

It remains the case that, following a major incident relating to healthcare safety, the commissioner would have an important role in hearing from those who are affected and considering whether a systemic problem has caused it. I must emphasise again, as this point is very important, that there is nothing in the powers and functions that are already in the bill preventing the commissioner from doing that. I therefore urge members not to support the amendments.

Amendments 7 and 16 from Carol Mochan seek to add a duty on certain organisations to co-operate with the commissioner in the exercise of their functions and for the commissioner to reciprocate.

As I explained during the bill’s stage 2 debate, this Parliament does not have legislative competence to impose a statutory duty on the Patient Safety Commissioner for England, and that is still the case. When viewed in conjunction with Ms Mochan’s amendment 6 in group 6, amendment 7 also poses a legislative competence risk, since the Health and Safety Executive is reserved and we cannot impose a duty on it. For that reason I cannot support amendment 7.

With regard to amendment 16, which appears to be an evolution of amendment 7—I thank Carol Mochan for explaining that—I consider that specifying certain bodies carries a risk of limiting the current intentionally broad expectation that all public authorities with responsibilities and functions relating to the delivery of healthcare in Scotland will co-operate in the exercise of the commissioner’s functions. I believe that amendment 16 risks creating confusion rather than clarity.

Therefore, I ask members not to support the amendments.

I am grateful to members for their contributions to this afternoon’s debate, which has been thoughtful and constructive, and I am pleased that there is support for the bill across the chamber. It has been clear that the bill’s overall purpose—the establishment of a patient safety commissioner for Scotland—has enjoyed strong cross-party support from the start. Members on all sides of the chamber share the common goal of making Scotland’s healthcare system as safe for patients as it can be. That is only right, given the challenges that the NHS has faced in recent times, and it will continue to be of the utmost importance as we continue to recover from the pandemic.

We have had a useful debate today, and it has explored a range of issues. I would like to reflect on a couple of visits and events that I have attended in the past 24 hours. One was today at Children’s Hospice Association Scotland’s Rachel house, in Kinross, and the other was the neuroblastoma event last night in Parliament.

There are important issues for us to consider when we are in this chamber. I have met—we have all met—brave parents and families who have shared their experiences. We all draw on such occasions to put the people of Scotland at the heart of what we do and to work together to improve healthcare in Scotland. I believe that, as a number of members have said, the introduction of the patient safety commissioner is a key part of that.

I note that a number of members used the words “trust” and “confidence”. That is absolutely the nub of where we have to get to, so I appreciate those comments. With the fantastic role of commissioner, we also need to achieve openness, learning and co-operation.

Jackson Carlaw commented on the latitude and power to make decisions. I believe that the commissioner will have that under the statutory powers in the bill. Carol Mochan said that patient safety is paramount to the survival of the NHS, and I agree. She recognised that the bill is a step on the path and she also recognised the importance of staff being involved.

Gillian Mackay commented on system-wide improvements, and she mentioned the importance of our being clear about the commissioner’s role. I agree that we need to ensure that the people of Scotland understand the roles and responsibilities of the commissioner.

Evelyn Tweed commented that if we get it right for the most vulnerable, we get it right for us all. That is why I reflected back to the neuroblastoma event that I was at last night.

Kenneth Gibson raised the importance of the strategic approach. From the Scottish Government’s perspective, we would always be willing to talk to the corporate body, and I think that he raised some important points.

As Tess White mentioned, she and I discussed the intention behind amendment 12 when we met on 4 September. I explained then that I do not believe that it adds value to the role of the commissioner. The commissioner’s role is, first and foremost, for patients and their representatives.

The current wording of the bill already provides for the commissioner to consult and engage widely on the draft statement of principles and the strategic plan. In doing so, the commissioner is to have

“regard to the importance of”

those documents

“reflecting patients’ concerns”.

If it is considered “appropriate”, consultees “may” include committees of the Scottish Parliament.

Of course, I recognise that health committee members have a deep understanding of the healthcare system and that, as representatives of their constituents, they might hear of experiences relating to safety from patients and families, both of which could be helpful to the commissioner’s work. However, the commissioner's consultation powers are already set out and are broad enough to enable consultation of those whom the commissioner deems to be “appropriate”.

It is also worth noting that a duty to consult a relevant committee is not placed on other commissioners in Scotland. I remain strongly committed to the independence of the commissioner: that they should be independent was the clear message during the consultation on the bill, and I do not want to compromise that independence by specifying that the commissioner must, in the course of their work, consult specific parliamentary committees. For those reasons I do not support amendment 12.

However, I support Paul Sweeney’s amendment 13, which is on ensuring that underrepresented groups are heard. A similar amendment was lodged at stage 2, which I supported in principle, so I am pleased to have been able to work with Paul Sweeney since then on the wording of the amendment. I am content that it will now have the intended effect, on which we all agree, of ensuring that the commissioner gives particular consideration to groups whose perspectives are often less heard or not given sufficient weight in discourse on healthcare.

First, on Jackie Baillie’s point, paragraph 5 of schedule 1 still excludes the persons to whom Ms Baillie referred.

I thank Emma Harper for working with me on the amendments. As she has said, it is critical that we do not, in haste, disqualify any otherwise suitable individual based on a minimal financial interest, such as shares in a pension plan. The amendments put forward a more sensible approach and would not lead to an individual’s automatic exclusion; instead, they would, importantly and rightly, allow the Parliament to exercise its judgment on suitable candidates. I fully support the amendments, and I urge members to do the same.