Meeting of the Parliament (Hybrid) 08 September 2020
I start by welcoming the independent medicines and medical devices safety review—the Cumberlege report—and the opportunity in this Government debate to discuss its findings and their implementation in Scotland.
At the outset, I want to pay tribute to the many women in Scotland and across the United Kingdom who gave evidence to the review. That will have been very difficult for them to do, and I put on record my admiration of their courage and determination and their efforts in persistently raising issues over a number of years.
To all those directly harmed by mesh, sodium valproate and Primodos, I offer the Scottish Government’s sincere apology. I offer that apology to them and to those who have seen their children, family members, friends and colleagues suffer.
The review and its recommendations are of significant importance to us as we work to improve how the healthcare system responds to harm, and I am grateful to the review team for not only its work but how it has done that work.
I was pleased to be able to speak with Baroness Cumberlege and her team yesterday and to hear from her about the experience of the review’s work, the thinking behind the recommendations and her determination to see them acted on. I was able to confirm to her this Government’s commitment to implement all her recommendations where we have the power to do so, and to support her in convincing the UK Government to act on the recommendations that lie solely at its hand. I was grateful for her recognition that much of the work that we have under way is aligned to her recommendations.
Let me now set out our response to the recommendations. The independent medicines and medical devices safety review was commissioned by a former UK secretary of state for health and social care. Therefore, there are recommendations that only the UK Government, with its reserved responsibilities, can implement.
The regulation of medicines and medical devices is reserved to the UK Government, so the recommendation that says that the Medicines and Healthcare products Regulatory Agency should be subject to substantial reform is for the UK Government to implement.
However, I strongly support that recommendation. We have long argued for reform of the assessment of medicine and medical device safety. We have communicated directly with the MHRA on that and have been disappointed that the MHRA believes that its assessment systems are fit for purpose. I gave Baroness Cumberlege my assurance that we will use the avenues that are available to us to press the UK Government to act positively and swiftly to review that body, with patient safety at the heart of that.
The recommendations in relation to the General Medical Council will require consideration by that organisation, particularly around transparency of payments to clinicians and expansion of the GMC’s register. In Scotland, we have established a declarations of interest steering group that aims to formulate a common set of principles for the identification and management of declarations of interest across NHS Scotland and related sectors. The group is due to complete its work early next year, and I hope that that will help to inform the GMC’s response.
I turn to recommendations 3, 4 and 5. I understand that those who have suffered harm as a result of these treatments want redress, not only financially—although that is important—but in the form of access to appropriate, on-going care that addresses the consequences of the harm that they have experienced. That is both right and fair.
I welcome the approach taken in seeing the redress agency as independent, funded in part by the pharmaceutical and medical device manufacturers and adopting a non-adversarial approach that looks to base determinations on avoidable harm through systemic failures. That is critically important, and it is a recommendation that we support. It is important not only for the individuals involved, but for the healthcare system as a whole. That approach will allow us to learn from the determinations of that body and to apply that learning to improve patient safety.
The review recommends the establishment of specialist centres. As members know, we have invested £5.1 million over three years in a new complex pelvic mesh removal service in Glasgow, which was designated as a national service in July this year. The service will assess all a woman’s relevant health needs and, subject to fully-informed agreement, will offer vaginal mesh removal surgery for women over 16 who have mesh complications from mesh insertion, vaginally or abdominally, for urinary incontinence and prolapse.