Patient Safety Commissioner for Scotland: Consultation Response

  • 9th June 2021

In this blog Patient Safety Learning outlines the key points included in its response to the consultation on a proposed Patient Safety Commissioner role for Scotland. We set out our feedback to this consultation and describe the powers and resources this role will require if it is to effectively influence change and improve patient safety.

In September 2020, the Scottish Government formally announced as part of its Programme for Government 2020-21 that it would establish a Patient Safety Commissioner for Scotland.[1] This was one of the key recommendations set out in the First Do No Harm report, published earlier that year by the Independent Medicines and Medical Devices Safety Review (more commonly known as the Cumberlege Review).[2]

Here we will briefly provide the background to this proposal before outlining the key elements of our response to the public consultation on this under the following headings:

  • Initial remit of the Patient Safety Commissioner
  • Key functions of the role
  • Independence and accountability
  • Skills, experience, and values
  • Support and patient engagement
  • Working across the UK

Finally, we will argue that the creation of a Patient Safety Commissioner for Scotland needs to go hand in hand with a step change in how we support and engage patients in patient safety and how the health care system transforms itself to put patient safety at its core.


The Cumberlege Review examined how the healthcare system in England responded to reports about harmful side effects of medicines and medical devices, focusing on three specific interventions: Hormone pregnancy tests, Sodium valproate and Pelvic mesh implants. While it was primarily concerned with England, its findings raised issues and concerns that applied to healthcare across the UK, with many Scottish patients providing evidence to this review.

Following the publication of the Review’s First Do No Harm report the Scottish Government stated that it accepted all the report’s recommendations and would implement these where it had the competence to do so.[3] This included the report’s second recommendation, which was:

“The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.”[4]

The Scottish Government subsequently set up a Patient Reference Group to discuss and provide input into developing the initial proposals in this regard and published these for public consultation on the 5 March 2021.

Initial remit of the Patient Safety Commissioner

The initial proposal in the consultation is to create a Patient Safety Commissioner for Scotland who would have a role limited to patient safety issues relating to medicines and medical devices. The consultation noted that there would be the potential to expand this in future to cover other issues. For the new Commissioner to be an effective champion for patients, encouraging health care organisations and the system to respond more effectively patient safety concerns, we believe they need a wider remit than this and from the outset.

In our response we suggested that a broader remit could be modelled on the Healthcare Safety Investigation Branch (HSIB) in England. Its rationale for looking into patient safety issues is to consider where something dangerous has happened, whether this resulted in harm or not, and investigate unsafe conditions that could cause harm.[5] They then decide whether to look at an issue further based on the following criteria:

  • Scale of risk or harm
  • Impact on individuals involved and public confidence in the healthcare system
  • Potential for learning to prevent future harm

A wider remit such as this would allow the Commissioner to investigate and make recommendations on a range of patient safety issues, such as unsafe surgical procedures, healthcare-associated infections, and diagnostic errors. This could also present more opportunities for insights and learning that could also applied to the safety of medicines and medical devices.

In our response we expressed concerns that if the remit was limited to medicines and medical devices this may create some confusion where patients want to highlight a clear patient safety issue that does not qualify under these terms. If the new Patient Safety Commissioner is not listening to these patients or patient groups concerns, who will? We suggested that there could also be value in the first Commissioner engaging in a wide-ranging survey of patients to assess what initial priority areas they may need to focus on, similar to the ‘The Big Ask’ recently conducted by the Children’s Commissioner for England.[6]

Key functions of the role

Considering what the main functions of the Patient Safety Commissioner should be, in our response we noted that we broadly agreed with the recommendations set out in First Do No Harm report. We suggested that their key functions should be as follows:

  1. Listening to voices of patients and patient groups. The Commissioner should be open to receiving and analysing reports and assessments of patient safety issues from these groups and commission surveys to gather patient views.
  2. Leading on patient safety reviews and inquiries. These may involve looking at a specific patient safety concern, patient safety performance on an issue or wider systemic reviews.
  3. Issuing patient safety advice, recommendations and share good practice. Informed from the voices of patients and its own patient reviews and inquiries.
  4. Highlight serious patient safety issues with the Scottish Government and Scottish Parliament.
  5. Building a network of stakeholders composed of patient groups and organisations to inform its work.

Independence and accountability

We believe that the Patient Safety Commissioner for Scotland needs to be able to speak their mind without fear or favour, independent of those funding and delivering healthcare.

In our consultation response we set out that this meant independence from both the NHS and the Scottish Government. This independence is crucial if they are to be trusted to hold organisations effectively to account, particularly for patients who may have lost their trust and confidence in the healthcare system because of their experience.

To ensure this independence, we suggested that the Patient Safety Commissioner should be nominated and report to the Scottish Parliament. This model of accountability was suggested by Alex Neil MSP in the Scottish Parliament debate on the Cumberlege Report last year.[7] There is existing precedent for such a structure in the arrangements for the Children’s and Young People’s Commissioner Scotland, which is nominated and funded by Scottish Parliament and cannot be removed from their post without a two-thirds majority vote in Parliament.[8]

Skills, experience, and values

The consultation posed a question around the skills and expertise that would be required by the new Patient Safety Commissioner. In our response, we suggested that the following would be of particular importance:

  • Co-production: Strong commitment to an ethos of involving members of staff, patients, and the public working together, sharing power and responsibility. We feel it is of particular importance that the Commissioner takes this approach when working with patients and patient groups and healthcare leaders and professionals.
  • Just culture: Advocate of principles of an open and fair culture, that we should focus on learning and action for improvement, less focused on blame, considering the wider systemic issues of when things go wrong.
  • Personal insight: A strong understanding of patient safety, the impact of avoidable harm on patients and families and of the challenges/opportunities in ensuring that the patient voice is heard and acted upon.

Support and patient engagement

For the Patient Safety Commissioner to be able to perform the key functions we outlined earlier, we believe that it is important that they have a small office of staff to support their work. In our response we also set out the importance of them seeking advice and expertise in a voluntary capacity and engaging with patient groups and campaigners.

The Cumberlege Review clearly demonstrated the vital role that patient groups can play in highlighting systemic safety failings.[9] At Patient Safety Learning we are currently working closely with patient groups to highlight patient safety concerns impacting people living with Long Covid and women who have experienced painful hysteroscopy procedures in the NHS. We believe there is a significant opportunity for insights from such groups to help inform the Commissioner’s work and that such groups would be key stakeholders and partners in striving to reduce avoidable harm.

Working across the UK

One issue that the questions in this consultation did not touch on was the wider UK context. In addition to these proposals there are also plans afoot to establish a Patient Safety Commissioner for England.[10]

As we set out in a previous blog on this issue, there is likely to be significant common ground between Patient Safety Commissioners operating in different parts of the UK, resulting from similarities between the respective healthcare systems.[11] We think there would be value in the Patient Safety Commissioners in Scotland and England establishing a strong working relationship. This would enable them to coordinate on emerging patient safety concerns and share examples of good practice.

In our consultation response we also noted the importance of this in cases where Patient Safety Commissioner for Scotland identifies an issue but is unable to place duties on an organisation to act, due to the limits on its competencies within devolved arrangements, but where the Patient Safety Commissioner for England may be able to do so. An example of this would be a safety issue that required action to be taken by the Medicines and Healthcare products Regulatory Agency (MHRA).

The need for system-wide change

Patient Safety Learning believes that a Patient Safety Commissioner could play a vital role in improving patient safety in Scotland. To do this however they must have the resources and powers they need to influence change. It will not be sufficient for them to raise patients’ concerns if the healthcare system is not committed to or compelled to listen and respond.

However, a Patient Safety Commissioner alone will not be able to bring about the fundamental change that is required to tackle unsafe care and empower patients. What is required is a step change in how we support and engage patients in patient safety and how the health care system transforms itself to put patient safety at its core.

We believe that the key to this is patient safety being treated as a core purpose of health and social care, not one of several competing priorities to be traded off against each other. In our report, A Blueprint for Action, we set out an evidence-based analysis of why harm is so persistent and what is needed to deliver a patient-safe future, identifying six foundations of safer care.[12] The work of the new Patient Safety Commissioner needs to be considered in this wider context, as part of a transformation in our approach to patient safety.

[1] Scottish Government, Protecting Scotland, Renewing Scotland: the Government’s Programme for Scotland 2020-21, 1 September 2020.

[2] The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020.

[3] Scottish Government, Consultation on a Patient Safety Commissioner Role for Scotland, Last Accessed 2 June 2021.

[4] The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020.

[5] HSIB, Tell us about a patient safety concern, Last Accessed 27 May 2021.

[6] Children’s Commissioner, The Big Ask, Last Accessed 27 May 2021.

[7] The Scottish Parliament, Meeting of the Parliament (Hybrid): Tuesday 8 September 2020, Last Accessed 2 June 2021.

[8] The Children and Young People’s Commissioner Scotland, Who is the Commissioner?, Last Accessed 3 June 2021.

[9] The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020.

[10] Department of Health and Social Care, Factsheet: Patient Safety Commissioner, 25 January 2021.

[11] Patient Safety Learning, Early thoughts on a Patient Safety Commissioner for England (a blog by Helen Hughes, Chief Executive of Patient Safety Learning, 23 December 2020.

[12] Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019.

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