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  • Consultation Analysis Report: on the Role of a Patient Safety Commissioner for Scotland (2 December 2021)

    • UK
    • Data, research and analysis
    • Pre-existing
    • Public domain
    • No
    • Scottish Government
    • 02/12/21
    • Everyone


    In the Scottish Government’s Programme for Government 2020-21 it committed to establishing a Patient Safety Commissioner for Scotland. The decision to create this role came about as a result of a specific recommendation in the First Do No Harm: The Report of the Independent Medicines and Medical Devices Safety Review (also known as the Cumberlege Review), published in July 2020.

    The Scottish Government held a consultation process seeking views on a range of issues relating to the creation of a new Patient Safety Commissioner role between 5 March 2021 and 28 May 2021. This report analyses responses from the public and other interested parties.


    Below is a summary of the main responses and themes from the report:

    Should the initial focus of the Patient Safety Commissioner (PSC) be on medicines and medical devices? And in the future?

    • Most respondents agreed that the PSC role should initially focus only on medicines and medical devices, as recommended in the Cumberlege review. However, it is clear that there is support for the role expanding at some point.
    • When the role does expand, it was suggested that the PSC should cover communication, policies, processes and systems such as adverse event reviews, learning and accountability.
    • Specific topics were also mentioned, such as ensuring the safety of healthcare products, or specific conditions such as mesh complications.
    • Other suggestions were that the PSC should focus on patient safety in general terms, or that the PSC once established should determine their own priorities.

    Independence and accountability

    • There was strong support for the role being independent of both the Scottish Government and the NHS, and accountable to the Scottish Parliament.

    Existing processes and policies

    • A list was provided within the consultation document setting out some of the policies, processes and pieces of legislation that are already in place to support the patient voice within the healthcare system. The narrative highlighted that it will be important that the PSC does not duplicate what already exists.

    There is a varying level of awareness of existing processes, and respondents also highlighted the challenges of engaging with these, including:

    • inaccessibility and complexity and/or time consuming nature of many of the processes.
    • lack of awareness or promotion of options for feeding back/complaining.
    • trust issues - patients being dismissed or not believed and a lack of trust or confidence in current systems and processes as not independent.
    • concern about reprisals/anonymity.
    • systems and processes are seen as tokenistic with no action taken, or patients are not given feedback on actions that are taken.
    • agencies not being joined up, so patients have to give the same feedback to numerous agencies.

    Main functions and skills of and support for the PSC?

    • In terms of functions, the PSC should provide a clear route for patients to express concerns and should listen to and act upon the patients' voice, as well as ensuring learning and change happens as an outcome of patients raising concerns. Investigating or intervening in the care and treatment of patients (including holding organisations to account, scrutiny, reporting and monitoring) was also seen as important. There was also an emphasis on the PSC acting quickly, as some of the existing processes are seen as taking a long time.
    • Some of the skills highlighted were compassion, caring, empathy, lived experience, political acumen, knowledge of the NHS, self-confidence and ability to lead.
    • In terms of support, responses highlighted the need for an office system to support the role as well as different kinds of expertise, including analytical, communications, IT, professional, clinical, legal, safety, ethics, equalities and human rights experts.
    • Alongside these the PSC will need support and input from other organisations and individuals, particularly patients, as well as sufficient financial resources to ensure that they are able to carry out their role.

    Should the PSC role be established in legislation?

    • There was strong support for the role being set out in legislation. Reasons given included: to ensure that the PSC has the necessary powers, to protect the role and ensure independence, to provide assurance to patients and because this is what was recommended in the Cumberlege Review.

    You can read the full consultation analysis report here.

    Related reading

    Consultation Analysis Report: on the Role of a Patient Safety Commissioner for Scotland (2 December 2021) https://www.gov.scot/publications/patient-safety-commissioner-consultation-analysis-report/
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