Patient Safety Commissioner role for Scotland: consultation

Chapter 1: Introduction

On 8 July 2020 'First Do No Harm: The Report of the Independent Medicines and Medical Devices Safety Review' (the Cumberlege Review) was published.  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 concerns more quickly and effectively in the future.  

Although the report focused on England, the issues it covered relate to all four of the UK nations, and people from Scotland also gave evidence to the review.  We  accepted all of the recommendations in the report, and agreed to put them in place, if we have devolved competence to do so.

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.'

Scottish Ministers committed, in 'Protecting Scotland, Renewing Scotland: The Government's Programme for Scotland 2020-2021', to creating the role of Patient Safety Commissioner.  This consultation supports that commitment, and we would like the views of the public and other interested parties on what the role of Patient Safety Commissioner should be and who they should report to.

We have set up a Patient Reference Group, whose task will be to provide input to developing proposals to appoint the Patient Safety Commissioner, and to represent and connect with their own wider networks.  We sent an open invitation to join this group to patient and interest groups covering the following three medical interventions included in Baroness Cumberlege's review:

• Those who received hormone pregnancy tests (HPTs), such as Primodos.
• Those who were adversely affected by sodium valproate during pregnancy.
• Those who have had pelvic mesh implants. 

Legislation and supporting policies are already in place, together with a number of organisations that aim to continuously improve patient safety and make sure that  patients' voices are heard in Scotland.  The Patient Safety Commissioner role must add further benefit for patients in Scotland, rather than duplicating what already exists.  With this in mind, a Specialist Reference Group, made up of various bodies who have a role in making sure patients' voices are heard, was also formed.  Its job is to consider the roles and responsibilities of existing bodies, as well as the current policies in Scotland, to help identify any gaps.  

The work of both the Patient Reference Group and the Specialist Reference Group continues, and they will play a part in deciding the next steps once we have looked at the responses to this consultation.