Chamber and committees

I intend to lay an order early this year to come into effect towards the end of 2019. The later than anticipated timescale is due to a number of factors including the range of issues raised during consultation as well as a focus on FOI performance during 2018.

Patients who suspect they are experiencing complications will report concerns to their GP or other clinicians involved in their case, who will then give further treatment as appropriate. In some circumstances, clinicians may report complications to IRIC or the MHRA if considered a serious adverse event, but this does not represent the totality of complications. As such, not all complications for all medical implants are recorded centrally, and it is not therefore possible to provide a comprehensive answer.

I refer the member to the answer to question S5W-20179 on 21 December 2018. All answers to written parliamentary questions are available on the Parliament's website, the search facility for which can be found at http://www.parliament.scot/parliamentarybusiness/28877.aspx .

As set out in answer to S5W-20173 on 21 December 2018, both the Chief Medical Officer and I have written to the MHRA expressing concerns about the regulation of medical devices. In addition, Scottish Government officials participate in teleconferences with the Department of Health, the MHRA and other devolved administrations. Recently these discussions have focused mainly on EU withdrawal and transvaginal mesh. All answers to written parliamentary questions are available on the Parliament's website, the search facility for which can be found at http://www.parliament.scot/parliamentarybusiness/28877.aspx .

On 31 October, both the Chief Medical Officer and I wrote to the MHRA to express concerns about how medical devices are regulated in the UK. We questioned the degree to which the present system of regulation is fit for purpose, and the level of scrutiny given to evidence prior to the approval of a medical device.

Although some assurances were received in the agency’s response, the Chief Medical Officer has written again to the MHRA. Aside from asking the MHRA to set out the actions it has taken specifically in relation to transvaginal mesh, the Chief Medical Officer also outlined a number of more general concerns, including in relation to the governance of notified bodies, the MHRA’s relationship with industry, and public confidence in the agency and the regulatory system.

Details are provided in a Scottish Government news release of 27 November: www.gov.scot/news/regulation-of-mesh-devices .

As set out in response to S5W-20173 on 21 December 2018, I wrote to the MHRA asking it for evidence that this mesh is safe to use. Scotland’s Chief Medical Officer Dr Catherine Calderwood has also raised these concerns directly with the MHRA, and we are awaiting a substantive response to this from them.

The Chief Medical Officer wrote to Health Boards in order to highlight concerns about the use of surgical mesh in a non-transvaginal setting. Medical Directors were asked to ensure clinical colleagues discuss the use of mesh as part of acquiring informed consent, in line with guidance on that issue and the principles of the Chief Medical officer’s ‘Realistic Medicine’. Furthermore, the Chief Medical Officer has emphasised that all treatment options should be considered and discussed with the patient, including non-operative management and non-mesh surgery.

In addition, Medical Directors, and thus their colleagues, have been reminded of their obligations with regard to medical devices and adverse event reporting. Finally, the Chief Medical Officer also stressed that patients who report complications must be carefully listened to, and their concerns taken seriously. All answers to written parliamentary questions are available on the Parliament's website, the search facility for which can be found at http://www.parliament.scot/parliamentarybusiness/28877.aspx .

The European Union is presently developing EUDAMED. This system will assist European authorities to support market surveillance on medical devices through information exchange, and help to ensure that medical devices that are placed on the market and put into service comply with all of the European Union's requirements.

In addition, the Scottish Government is working with the Department of Health and devolved administrations in order to establish patient-level registries in certain specific areas, including breast and cosmetic implants, as well as stress urinary incontinence and pelvic organ prolapse procedures. With respect to the latter, an outline of an interim registry has been agreed upon and will be revealed by the Healthcare Quality Improvement Partnership next year. It is expected to become operational next spring, and officials will be considering information governance aspects in order to ensure that NHSScotland can fully participate. A bespoke registry will continue to be developed after implementation of the interim solution, with delivery expected in around two years. Both the interim and bespoke registries will record all stress urinary incontinence and pelvic organ prolapse procedures, not just those that involve mesh repair. Further, they will record patient reported outcomes in addition to clinician reports.

The annual local government finance circulars provide details of the total revenue and capital funding allocations to each local authority and can be found at the attached link: https://www.gov.scot/publications/local-government-finance-circulars-index/ .

If a member of the public believes that a crime has been committed on social media sites, they should report the incident to the police who will investigate appropriately as they would any other crime. There are a range of actions at their disposal if they view that a crime has indeed been committed and it should of course be emphasised that a modern Scotland is no place for online abuse and threatening behaviour.

The Scottish Government supports a progressive approach to industrial relations and to trade unionism and regards unions as important for building constructive employer/worker relationships and for promoting a movement for fair work, both in the workplace and in wider society. Effective voice needs effective structures through which dialogue can take place and so we believe that derecognition should be avoided.