Transvaginal Mesh Removal (Cost Reimbursement) (Scotland) Bill: fairer Scotland duty assessment

Fairer Scotland Duty - Assessment Not Required Declaration

Policy title

Transvaginal Mesh Removal (Cost Reimbursement) (Scotland) Bill

Directorate: Division: team

Health and Social Care

Chief Medical Officer's Policy Division Medical Devices and Legislation Unit

Policy lead responsible for taking the decision

David Bishop / Erin Fyfe

Rationale for decision

Background

Prior to 2014, transvaginal mesh, a medical device, was in routine use in NHS Scotland, as well as in the rest of the UK and internationally. It was implanted into persons, vaginally, in a surgical procedure that had the aim of alleviating symptoms of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The mesh is intended to reinforce weakened tissue in a person's bladder or pelvic area.

Concerns about the impact of the use of mesh began to emerge in the mid-2000s and strengthened over the years that followed. In light of concerning evidence of very painful and debilitating complications being experienced by patients who had had transvaginal mesh implanted, its use in the treatment of SUI and POP in NHS Scotland was formally halted in September 2018. This halt remains in place.

Rationale

The broad purpose of the Mesh Reimbursement Bill is to give power to the Scottish Ministers to reimburse persons who have sought private treatment and paid to have transvaginal mesh removed from their body, in relation to the costs of removal surgery and also reasonable connected expenses.

The Bill, as introduced, will only impact on those who have arranged private treatment for mesh removal in the UK or overseas, and paid for it at their own expense. As this Bill does not impact on other persons or the health system more widely, it does not constitute a strategic decision.

It should be noted that the Scottish Government is taking further steps so that, in the future, regardless of socio-economic circumstances, those who are unwilling to be treated in the NHS in Scotland or England are able to access private treatment for the removal of transvaginal mesh through a commissioned route.

It is envisaged that three distinct pathways will be available to people in the future; referral to the Complex Pelvic Mesh Removal Service in NHS Greater Glasgow and Clyde (GGC), referral to one of seven NHS England Specialist Centres, and finally, subject to the outcome of a tendering exercise, referral to an independent provider (commissioned by NHS National Services Scotland).

An assessment under the Fairer Scotland Duty is not required because the Bill does not represent a strategic decision, and its provisions should not have any direct implications for inequalities arising from socio-economic disadvantage.

I confirm that the decision to not carry out a Fairer Scotland assessment has been authorised by:

Name and job title of Deputy Director (or equivalent): Greig Chalmers - Interim Deputy Director, Chief Medical Officer's Policy Division

Date authorisation given: 20 May 2021