Patient Safety Commissioner for Scotland Bill - Advisory Group: terms of reference

Terms of reference for the Patient Safety Commissioner for Scotland Bill: Advisory Group.

Purpose/role of the group

To advise on the establishment of a Patient Safety Commissioner for Scotland (PSC). 


Group members – whose roles are to represent the views of 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:

  • advise and support in the development of the following assessments, which will both accompany and inform the proposals/options:
  • Equality Impact Assessment (EQIA)
  • Health Inequalities Impact Assessment (HIIA)
  • Fairer Scotland Duty Assessment (FSDA)


The Advisory Group will input to, and advise on, the establishment of a PSC for Scotland, including during the legislative process, although ultimate decisions on policy will be taken by the Cabinet Secretary for Health and Social Care. 

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 on the group page.

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

Patient representatives are expected to represent the interests of patients in Scotland. 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. All represenatives are asked to agree to the membership conditions at Annex A.

If a patient representative does not attend group meetings, the Secretariat will approach the member in the first instance to keep them up-to-date on meetings missed and to establish whether they will be able to attend future meetings. If the member feels they still cannot continue in the role, for example due to ill health, a new patient representative 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. If a professional representative does not attend group meetings, and does not send a deputy in their place, the Secretariat will approach them in the first instance to establish whether they will be able to attend future meetings. If they are not able to do this and are unable to nominate a deputy to take their place, a new professional representative will be sought to replace them on the group.

A patient co-chair has now been appointed for the group, 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 be quorate with a minimum five attendees in attendance, not including Scottish Government representatives.

Working methods

Meetings will be held using Microsoft Teams.

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

Members of the group may suggest agenda items to the Secretariat, no later than eight working days in advance of meetings. The Secretariat will 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 within ten working days of the meeting taking place. The meetings will be a safe space for members to speak freely, and members can request that certain information is not minuted (for example, 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 business of the group, including the discussions that take place during meetings, should be treated as confidential.


A background note can be found at Annex B.

Annex A


Membership agreement

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

  1. The group is expected to meet at least twice between June 2022 and October 2022, 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.
  2. Representatives are to represent not only their own interests, but the interests of other users of the health service in Scotland (if they are a patient representative) or the interests of the professional organisation which they represent (if they are a professional representative).
  3. Representatives must be respectful of the views of others, and be willing to listen, as well as to communicate their own views (We wish to be as inclusive as possible.  Members’ 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).
  4. Representatives must treat the business of the group, including discussions that take place during meetings, as confidential not to be discussed out with the members of the Advisory Group.

Annex B


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; and
  • 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 and Specialist Reference Group

At the end of 2020 a Patient Reference Group (PRG) and a Specialist Reference Group (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 overarching 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 could 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.

We are currently drafting policy instructions to help lawyers form the structure of the Bill. We are also working on impact assessments to understand how our proposals may affect various groups in Scotland: children and young people, island communities, people from lower socio-economic backgrounds and people with protected characteristics as defined by the 2010 Equality Act.

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