At its meeting on 15 November 2022, the Delegated Powers and Law Reform Committee considered the delegated powers contained in the Patient Safety Commissioner for Scotland Bill (“the Bill”) at Stage 1.

The Committee submits this report to the lead Committee for the Bill under Rule 9.6.2 of Standing Orders.

The Scottish Government Bill was introduced by the Cabinet Secretary for Health and Social Care on 6 October 2022. The lead committee is the Health, Social Care and Sport Committee.

An independent review into how the healthcare system in England responded to reports about harmful side effects from the use of medicines and medical devices began in February 2018. The Cumberledge Report, although focused on England, was recognised by healthcare practitioners to apply to all four UK nations, made a number of recommendations to improve healthcare, including the appointment of a Patient Safety Commissioner. This review followed a number of instances where patients raised concerns about the safety of medical interventions which were not heeded by healthcare professionals, resulting in harm. Examples included transvaginal mesh used for organ prolapse and sodium valproate to treat epilepsy in women capable of childbearing, both of which resulted in patients suffering harm as a result of these treatments and damaged trust in the healthcare system.

The Bill is intended to implement the recommendations from the Cumberledge report in Scotland with it establishing a new Patient Safety Commissioner for Scotland to promote and improve patient safety across healthcare in Scotland, to advocate for systematic improvement in the safety of health care and promote the importance of the views of patients and other members of the public in relation to the safety of health care. The remit of the Patient Safety Commissioner will cover all aspects of the safety of health care in Scotland. In carrying out this function, the Patient Safety Commissioner will produce a statement of principles, set up an advisory group, carry out formal investigations, prepare and publicise a strategic plan to be reviewed regularly as well as complying with reporting and accounting requirements.

The Bill contains 25 sections and 2 schedules:

• Section 1 establishes the office of the Patient Safety Commissioner for Scotland, supplemented by the specific requirements outlined in schedule 1, with the principles and functions of the office being outlined in sections 2-4.

• Sections 5-7 provide for strategic planning in relation to the office.

• Sections 8-11 outline the process for the Patient Safety Commissioner when conducting formal investigations and the reporting requirements relating to those investigations.

• Sections 12-15 detail what powers the Patient Safety Commissioner has to gather and use information when carrying out their functions.

The Bill confers three powers to make subordinate legislation on the Scottish Ministers.

The Scottish Government has prepared a Delegated Powers Memorandum (“DPM”) which sets out its reasons for taking the delegated powers in the Bill and for the procedure chosen.

The Committee considered each of the delegated powers in the Bill at its meeting on 15 November. It determined that it did not need to draw the attention of the Parliament to the delegated powers in any of the three provisions:

• Section 22 - Ancillary provision

• Section 24(2) - Commencement

• Paragraph 21(2), Schedule 1 - Accounts and audit