Patient Reference Group paper - draft terms of reference: August 2021

Paper from the meeting of the Patient Safety Commissioner: Patient Reference Group on 18 August 2021.

Purpose/role of the group

The Patient Safety Commissioner (PSC) Advisory Group’s purpose is to input to, and advise, the Scottish Government (SG) on, the development of proposals, followed by legislation for the establishment of a PSC for Scotland.


Group members – whose roles are to represent the views of all users of health services in Scotland (patient representatives), or organisations that oversee or deliver health services in Scotland (professional representatives) - will work together constructively to:

  • develop a set of proposals or options that:
    • take account of the views expressed in the written responses to the consultation on the role of the PSC, as well as the outputs of other types of stakeholder engagement
    • are achievable (taking account of the existing patient safety/patient advocacy landscape in Scotland, and issues of reserved competence)

Once the proposals/options are developed, a paper setting these out will be put to the Cabinet Secretary for Health and Social Care, who will decide on how to progress the appointment of the PSC.

  • advise and support the Scottish Government in the development of the following assessments, which will both accompany and inform the proposals/options:
    • Equality Impact Assessment (EQIA)
    • Fairer Scotland Duty Assessment (FSDA)
    • Business and Regulatory Impact Assessment (BRIA)
    • Island Communities Impact Assessment (ICIA)
    • Child Rights and Wellbeing Impact Assessment (CRWIA)
    • Data Protection Impact Assessment (DPIA)
  • advise and support the Scottish Government in the development of policy instructions for the drafting of a Bill (legislation), and continue to advise and support, as required, throughout the Bill’s progress through the Scottish Parliamentary process


The Advisory Group will input to, and advise on, the establishment of a PSC for Scotland. This work stemmed from recommendation 2 of First Do No Harm: The Independent Medicines and Medical Devices Safety Review (the Cumberlege Review, 2020). Other recommendations made in the Cumberlege Review report are out of scope for this group.


The full membership list for the group can be found at annex A [to be inserted].

The group is made up of both patients who have experience of using health services in Scotland (known as ‘patient representatives’) and members of organisations involved in overseeing and/or delivering patient care in Scotland (known as ‘professional representatives’).

Patient representatives are expected to represent all patients of Scotland’s health service, rather than their own individual interests. When joining the group, patients are asked to agree to the conditions in annex B.

Relevant organisations are asked to nominate appropriate individuals, with knowledge of the systems and processes used within the organisation to support patient input and involvement, to be professional representatives.

If a patient representative member does not attend three consecutive Advisory Group meetings, a new member will be sought to replace them on the group.

Professional representative members should nominate a deputy to attend in their place if they are unable to attend a meeting.

A patient co-chair will be appointed for the group. Patient members can apply for this role using the application form at Annex C [TO BE INSERTED]. They will be involved in setting agendas and deciding the format of meetings; chairing sections of the meetings; and communicating with members outside of the meetings.


Meetings will only go ahead if there is a minimum of [insert number] people (excluding Group Secretariat) in attendance.

Meetings/working methods

The Advisory Group will meet on a monthly basis. Sub-groups may be formed to focus on particular aspects of the PSC role, if the group feel that this is necessary.

Meetings will initially be held virtually, using Microsoft Teams. In future the group may be asked whether they would prefer to meet face-to-face, virtually, or in a hybrid manner (a mixture of in-person and virtual attendance) going forward.

In between meetings the group will interact by email, via the group Secretariat (

Members of the group may contribute suggested agenda items and papers for meetings, through the group Secretariat, no later than eight working days in advance of meetings. The group Secretariat will aim to circulate agendas and papers no later than five working days ahead of meetings.

Meetings will be minuted, with minutes circulated amongst the group for comment/clearance within ten working days of the meeting taking place. However, this should be a safe space for members to speak freely, and if a member wishes to keep certain information within the confines of the group, they can request this at the meeting (e.g. if people wish to share personal stories, they can state that these are ‘not for minuting’).

Once agreed by members, papers and minutes will be published on the Scottish Government’s website.


Given political sensitivities around work to establish the PSC role in Scotland, the business of the group, including the discussions that take place during meetings, should be treated as confidential.

Annex A - membership

[To be inserted]

Annex B - patient membership agreement

Those wishing to act as patient representatives on the Patient Safety Commissioner (PSC) Advisory Group are asked to commit to/agree the following:

  • the group is expected to meet once a month for up to 18 months, with meetings expected to last 2 hours. It is also anticipated that there will be some communication in between meetings, as well as actions to be taken forward by group members. Some preparation and background reading in advance of meetings may also be required. Overall, we therefore estimate that group members will need to commit, on average, 4 hours a month to the group
  • patient representatives are to represent not only their own interests, but the interests of other users of the health service in Scotland
  • patient representatives must be respectful of the views of others, and be willing to listen, as well as to communicate their own views*
  • patient representatives must treat the business of the group, including discussions that take place during meetings, as confidential
  • patient representatives should have some knowledge, and preferably some lived experience, of using the health service in Scotland

* We wish to be as inclusive as possible. Therefore, not all communication has to take place verbally during meetings, and member’s views will be sought on their preferred methods of communication, or whether they have any special requirements to make it possible for them to participate in the group.

 Annex C - patient co-chair application form

[To be inserted]

Annex D - background

First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review (the Cumberlege Review) was published on 8 July 2020. The review examined how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices, and made recommendations on how to respond to them more quickly and effectively in the future.

A key recommendation within the report is:

Recommendation 2: 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.

In the report, Baroness Cumberlege envisaged that the Patient Safety Commissioner (PSC) would seek to address several areas for improvement in patient safety, including:

  • the need for more widespread and timely recognition by the patient safety system of issues identified by patients and public
  • the need for the patient safety system to get better at listening to, and acting on, patients’ experiences of avoidable harm
  • the need to be swifter, and for better co-ordination across and between agencies

Scottish Parliament debate on 8 September 2020

The Scottish Government has committed, through Programme for Government, to the creation of a PSC role in Scotland, and a debate was held in the Scottish Parliament on 8 September 2020, where Jeane Freeman MSP, then Cabinet Secretary for Health and Sport reaffirmed this commitment, saying that “the role must be proactive and enhance what we already have in place, with the emphasis on listening to and learning from people’s experiences and driving implementation to continually improve patient safety.”

Patient Reference Group (PRG) and Specialist Reference Group (SRG)

At the end of 2020 a PRG and an SRG were developed. The role of the PRG was to advise on the development of proposals for the appointment of a PSC, to be consulted on publically. The key aim of the SRG was to advise on whether any of the proposals put forward for consultation duplicated or crossed-over with existing processes and structures.

During the PRG meetings, many patients shared their stories and experiences, as well as their thoughts on what the role of the PSC should look like, however there was no particular consensus on this. As such, the public consultation was published in March 2021 and this did not set out specific proposals, but asked open questions about the topics discussed by the two groups, including what the scope, functions and powers of the role should be.

Following feedback from some members of the PRG that they would prefer the PRG and the SRG to work jointly, rather than as two distinct groups, and taking into account the interest from other patient groups, who had not been involved in the Cumberlege Review, in supporting the Patient Safety Commissioner work, it was decided that, following the analysis of the consultation responses, a new Advisory Group – formed of both patients and specialists – should be set up to support the development of final proposals on the PSC role.

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