To ask the Scottish Government, in light of it progressing the recommendation to appoint a Patient Safety Commissioner, when it plans to publish details of its plans and the timescales for the implementation of the remaining recommendations in the report of the Independent Medicines and Medical Devices Safety Review, in order to improve the lives of people impacted by sodium valproate, Primados and mesh implants.
There have been a number of points of progress in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review as they relate to devolved matters, in addition to steps taken to establish a Patient Safety Commissioner, since the Scottish Government published a delivery plan about the Cumberlege report in March 2021.
In relation to services for women who have experienced complications after the implantation of transvaginal mesh, there is now established in Glasgow a Complex Pelvic Mesh Removal Service. This service offers, where appropriate, mesh removal surgery. Women can also ask to be referred to an equivalent NHS England specialist centre or to an independent provider. All of these options are available free of charge, through the NHS.
The Transvaginal Mesh Removal (Cost Reimbursement) (Scotland) Act 2022 gained Royal Assent on 3 March. As a result women can now apply for the reimbursement of personal costs in relation to past qualifying mesh removal surgery which was arranged privately.
In relation to medical devices generally, work continues in NHS Scotland to improve the traceability of devices from manufacture to point of care, so that safety issues can be identified more quickly than is possible now and action taken to protect patients. Four Health Boards will also shortly participate in a pilot of a UK-wide Pelvic Floor Registry. This will allow the recording of all treatments for pelvic organ prolapse and stress urinary incontinence, as well as mesh removal procedures, and benefits will include rapid and efficient recall of patients in the event of an issue with a particular procedure or device.
The Government is also taking steps that seek to prevent harm as a result of sodium valproate and Primodos, and to offer those who have been impacted the care they need.
The Scottish Government is working with the Medicines and Healthcare products Regulatory Agency (MHRA) on the establishment of UK-wide medicine registries. The first of these will be an anti-epileptic medicine registry and we are working to ensure that it is accessible and transferable in a Scottish context in the first instance.
We are also funding the use of a Scottish Epilepsy Register in three Health Boards (NHS Greater Glasgow and Clyde, NHS Tayside and NHS Lanarkshire). This will help identify people taking sodium valproate, as well as any other anti-epileptic medicines which have the potential to cause harm. This work is on track to have dispensing and mortality data linked to an electronic dashboard in NHS Greater Glasgow and Clyde by summer 2022. Data on improved safety for people prescribed sodium valproate will be available to share later this year and, following this, we will look to support the adoption of this system in other Health Boards.
The Scottish Government’s Teratogenic Medicines Advisory Group, chaired by the Chief Pharmaceutical Officer, is looking specifically at what further measures can be taken to prevent wider harm as a result of sodium valproate and it will then consider other medicines with teratogenic potential. The MHRA is also currently considering the need to further strengthen regulatory measures for sodium valproate and Scottish Government officials are continuing to work closely with them on that to ensure that this is taken forward on a UK-wide basis.
Work is underway to establish specialist services for those harmed by sodium valproate in Scotland and officials are now in early discussion with Health Boards to consider what services are currently available, identify any gaps and then commission a service delivery model.
We also continue to press the UK Government on the issue of redress, which is a recommendation for the UK Government to consider due to the reserved nature of medicine regulations.