Chamber and committees

I thank Jackie Baillie for her powerful words. None of us should ever forget in these discussions that the bill is about ensuring that people and their families can benefit from safer care in the future. That is at the forefront of my mind every day and I know that the same will be true for everyone around the table. I know how much of an advocate Jackie Baillie has been for patients and I thank her again for that.

We all want the patient safety commissioner to amplify the voice of patients and drive improvements in safety, and it is important that they have the freedom to do that however they see fit. I would absolutely expect that the commissioner would wish to hear from bereaved families as well as affected patients when they wished to raise an issue relating to patient safety, including in the sorts of circumstances that Jackie Baillie has mentioned.

It is critical that we do not inadvertently tie the commissioner’s hands in that respect. Everything that we are doing with the bill is intended to ensure that the commissioner has the freedom, scope and authority to set their own agenda without fear or favour, to speak up for patients and to drive improvements. Writing very specific steps for the commissioner into the bill would risk getting in the way of their doing that kind of work and working to prevent major patient safety issues from developing in the first place.

The key functions of the commissioner’s role are set out in section 2(1) of the bill. In particular, they are:

“(a) to advocate for systemic improvement in the safety of health care, and

(b) to promote the importance of the views of patients and other members of the public in relation to the safety of health care.”

I am concerned that the amendments in this group would limit the commissioner’s ability to do that. They risk clouding the public’s understanding of the commissioner’s role and would represent a significant departure from the extent of their current remit and from what was agreed at stage 1. Indeed, the committee agreed at stage 1 that it was appropriate for the commissioner not to become involved in resolving individual cases, as avenues for that already exist. It is critical to let the commissioner be guided by patients and families, not by politicians, on what action they need to take.

Following a major incident, the commissioner would have an important role in gathering information from people who were affected and investigating whether a systemic issue had led to it. There is nothing to prevent the commissioner from doing that through the powers and functions that exist in the bill. I therefore urge members not to agree to the amendments.

I am very sorry to hear that some patients have reported complications after having received a hernia mesh implant. I am grateful to Katy Clark for all her efforts in this area and to the patients who have raised concerns, including those who have petitioned the Parliament. Officials and ministers, including the former First Minister, have heard directly from patients, and we have listened carefully and taken their concerns very seriously.

In the chamber a couple of weeks ago, Katy Clark asked me for a meeting. I believe that my officials have been in touch about their meeting her. Once that has happened, we can review the situation.

As a result of what patients have told us, the Government commissioned the Scottish Health Technologies Group to produce two reports on use of hernia mesh. The reports, which are based on current published evidence, support the continued use of mesh in abdominal wall and groin hernia repairs. The reports stress the importance of shared decision making and informed consent, and they emphasise the importance of choice and the availability of alternative treatments for people who want them. We have discussed the findings with professional bodies, including the relevant royal colleges and the British Hernia Society. We will continue to work with them on this important issue.

The chief medical officer has asked medical directors to consider the development of local clinical groups and broader clinical networks for the management of complex cases. Furthermore, there is work on-going with regard to establishing registries to encourage better data collection, which will provide important surveillance and outcome information in the future.

It is therefore clear that the Government is listening and acting on the concerns that have been expressed. However, it is important that the action that we take is proportionate. There seemed to be broad consensus on that point when the Parliament debated the issue in January. The Government is thus of the opinion that further review is not warranted.

I am unable to support amendment 23, but I am happy to discuss the issue further, perhaps in the lead-up to stage 3. By legislating for a particular strand of work, the amendment risks undermining the independence of the commissioner. The commissioner should be able to decide their own priorities based on the concerns that patients raise with them. It is important that the commissioner is forward facing and uses their time to gather information and horizon scan for potential patient safety issues.

I urge members not to vote for amendment 23.

Amendments 6 to 9, in my name, are intended to ensure that the commissioner can require relevant information from all relevant health bodies, and not only those that directly provide healthcare services to patients.

I am not able to support amendment 24. The regulation of medicines and medical devices is a reserved matter, and it is complex. I agree that it would be desirable to bring manufacturers and suppliers of medicines and medical devices into information-gathering provisions. I have asked my officials to look into that further, with a view to lodging an amendment at stage 3, and to keep Paul Sweeney informed of progress. I therefore ask Paul Sweeney not to move amendment 24.

I support Carol Mochan’s amendment 25. Transparency and information sharing are crucial to the success of the commissioner’s role, and I do not think that the amendment would place an unreasonable burden on the commissioner, health boards, the Common Services Agency or NHS National Services Scotland.

Amendment 10 is a technical amendment that clarifies that an offence is committed recklessly or knowingly by a person. The amendment will bring the offence into line with offences in data protection legislation, recognising that information may contain sensitive personal data relating to healthcare treatment, which must be treated with the utmost confidentiality.

I cannot support amendments 26 and 27. As my predecessor Maree Todd said in her evidence to the committee, professional regulators such as the General Medical Council are not like the patient safety commissioner, taking action against individuals instead of promoting learning and improvement. I do not want, with this bill, to create a situation that might impede healthcare professionals’ willingness to be frank and open with the commissioner. It is that spirit of openness and co-operation that I feel will drive improvement, and I do not want to risk that.

I therefore urge members not to vote for amendments 24, 26 and 27, and I move amendment 6.

I am keen to ensure that patients who are underrepresented are sought out for greater involvement. I have listened carefully to what Paul Sweeney has said about amendment 16 and about the importance of focusing the commissioner on hearing from those who, too often, are not heard from. I agree with that. I cannot support his amendment, however, because the way that it is expressed might not quite capture what is intended. Being “under-represented in health care” is not necessarily the same as being underlistened to. It is very much part of the problem that some groups are overrepresented in the amount of healthcare that they need and those are precisely the groups with the softest voices. I invite Paul Sweeney not to press amendment 16 and to work with us to bring this important issue back at stage 3.

Amendments 3 to 5 in my name will impose the same consultation requirement on the commissioner in relation to the principles as apply to the strategic plan, including in particular a requirement to consult those whom the commissioner considers appropriate, to ensure that the principles in the strategic plan reflect patients’ concerns. The amendments give effect to a recommendation in the committee’s stage 1 report. The Government agrees with the committee that it is important for stakeholders’ voices to be taken account of when formulating the principles as well as the strategic plan.

Amendment 19, in the name of Tess White, shares some common ground with my amendment 5, as Sandesh Gulhane noted, in that it would require the commissioner to consult on the statement of principles. It also adds an explicit requirement for them to consult with the relevant parliamentary committee. I cannot support amendment 19 because, if amendment 5 is agreed to—as, I hope, it will be—the bill would end up with a duplicate consultation duty. I ask Sandesh Gulhane, on behalf of Tess White, not to move amendment 19, and ask Tess White, if she is willing, to work with us to bring an amendment back at stage 3.

I am also unable to support Tess White’s amendment 17. Although I agree that, as part of investigating and monitoring potential patient safety issues, the commissioner will wish to hear from staff, they are already empowered to do so. Placing a requirement on the commissioner by way of a principle that they will seek the views of staff risks cutting across their focus on patients’ voices.

Amendment 18, in the name of Tess White, would add a number of things that the statement of principles must include. A few of the items that are listed could be described as principles, but some would more appropriately sit within the strategic plan that is required by section 5 and, indeed, already do. An example is how the issues to be investigated will be identified. The commissioner’s purview is already defined in section 2(1). Amendment 18 refers to the setting of a

“threshold for opening an investigation”.

The varied nature of concerns that the commissioner may investigate means that trying to define a threshold that would be appropriate in all cases will be difficult. The Government’s view is that the commissioner should be trusted to exercise independent judgment about when to instigate an investigation within the framework of the commissioner’s strategic plan and principles. The Parliament can then hold the commissioner to account for those decisions. Therefore, I ask members not to support amendment 18.

For a similar reason, I cannot support amendment 21 in the name of Tess White. Producing a work programme, much of the content of which is already covered in the strategic plan, would use up the commissioner’s resources. The additional requirement to set out the work that the commissioner intends to undertake in the next year would not leave adequate space for them to react to new and emerging issues of patient safety. For those reasons, I ask members not to support amendment 21.

I request that Paul Sweeney, and Sandesh Gulhane on behalf of Tess White, do not press amendment 16 or move amendment 19, and that members do not agree to amendments 17, 18 and 21.

I do not support the amendments in this group. Amendments 12 and 20 would require the commissioner to set performance standards for their own office and then to report against those standards in their annual report. Although I agree entirely that there is a need for a robust system to monitor the commissioner’s performance, I am not convinced that those amendments add anything—apart from a burden of more paperwork—to what is already in the bill.

The bill already obliges the commissioner to produce a strategic plan of activity and to include a review of their activities in their annual report. It seems right to me that it is against that plan of activity, as well as against feedback from patients and from this committee, that the commissioner’s performance should be assessed. I find the idea that the commissioner should have to come up with a separate set of performance standards to be assessed against to be an odd one, which is likely only to muddy the waters regarding what the true expectations of the commissioner should be.

It seems to me that the time and resource that the commissioner would have to spend coming up with further standards and then consulting on them, as amendment 20 would require, would be better spent in getting on with the job of speaking up for patient safety. The bill as drafted already contains an element of annual reporting, but it must be remembered that some of the commissioner’s work will take time to achieve and might become apparent only outwith an annual reporting cycle.

Amendment 13 would require the committee to propose a debate in Parliament, about the commissioner’s annual report, every year. The committee is already free to propose a debate about the commissioner at any time. There is no requirement for legislation to create that right and using the law to tell Parliament, ourselves and our successors what to spend time on risks setting an unwelcome precedent. We should trust those who are elected to this place to know which issues matter to their constituents.

The same point can be made about amendment 32, which would require Parliament to arrange a review of the commissioner within three years. If dissatisfied with the commissioner, the committee would be able to carry out an investigation into their work and to report on that to Parliament. However, Parliament already has scope to review the commissioner’s work and role in whichever way we deem appropriate, which includes looking at the commissioner’s place in the pre-existing patient safety landscape. It seems to me that amendment 32 would serve only to tie the commissioner’s hands regarding the approach that they might want to take and might break the golden thread that Dr Gulhane spoke about. I therefore urge members not to agree to the amendments in the group.

I have lodged amendment 1 in response to calls from stakeholders, and an emphasis by the committee in its stage 1 report, on the need for a co-operative approach to patient safety. I whole-heartedly agree with that principle, and therefore I am keen to clarify, with this amendment, that we expect such a co-operative spirit to extend to all public authorities that have functions relating to healthcare, as well as to healthcare providers.

I do not feel able to support Carol Mochan’s amendment 28, because, although we are all hopeful and expectant that a spirit of collegiate working to improve patient safety will extend as far as possible, I am mindful that we cannot propose to Parliament an amendment that is outside its competence. We are just not able to impose a duty on the Patient Safety Commissioner for England.

I move amendment 1.

In respect of amendment 1, our aspiration for the patient safety commissioner is that they work in a co-operative way as much as possible. Although I am unable to support Carol Mochan’s amendment 28, due to its seeking to impose a duty that is outwith our competence, I do not disagree with the spirit in which it has, I think, been lodged. In the event that the member moves the amendment, though, I urge members not to support it, on account of the competence issues that it presents.

Amendment 1 agreed to.

Although I have moved an amendment to drop section 4, recognising that there is existing legislative provision in the Equality Act 2010, I whole-heartedly encourage any steps by the commissioner to embrace the spirit of such communication in their public-facing activity.

Amendment 2 agreed to.

Section 5 agreed to.

Section 6—The planning process

Amendment 3 moved—[Jenni Minto]—and agreed to.

Section 7—Frequency of planning

Amendment 4 moved—[Jenni Minto]—and agreed to.

Section 7, as amended, agreed to.

After section 7

Amendment 5 moved—[Jenni Minto]—and agreed to.

Amendment 21 moved—[Sandesh Gulhane].

I am not able to support the amendment. The committee, in its stage 1 report, called on the Government to confirm that the commissioner will be able to address matters arising at the intersection of health and social care. I am happy to confirm on the record today that the commissioner’s role is about safety in healthcare, and there is nothing in the bill that would prevent the commissioner from dealing with healthcare that is provided in a social care context or any other context.

I hope that Paul Sweeney will accept that confirmation and will not press amendment 33, which, rather than clarifying matters, might create some doubt about whether the bill’s reference to “health care” includes healthcare that is provided in contexts other than social care. I therefore ask Paul Sweeney not to press amendment 33.

In moving my amendments, I want to ensure that the commissioner can access the data that is needed to do their job. Where I oppose amendments, that is so that we can try to protect the spirit of openness and frankness and not threaten the improvements that we all strive for.

Amendment 6 agreed to.

Amendments 7, 8 and 9 moved—[Jenni Minto]—and agreed to.

Amendment 24 moved—[Paul Sweeney].