An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland

Chapter 1: Background and Process

1. A petition on polypropylene mesh medical devices was lodged in April 2014 to the Public Petitions Committee of the Scottish Parliament by Elaine Holmes and Olive McIIroy on behalf of the Scottish Mesh Survivors “Hear Our Voice” campaign.^[6] The petition called on the Scottish Parliament to urge the Scottish Government to:

1. Suspend use of polypropylene Transvaginal Mesh (TVM) procedures;
2. Initiate a Public Inquiry and/or comprehensive independent research to evaluate the safety of mesh devices using all evidence available, including that from across the world;
3. Introduce mandatory reporting of all adverse incidents by health professionals;
4. Set up a Scottish Transvaginal Mesh implant register with a view to linking this up with national and international registers;
5. Introduce fully Informed Consent with uniformity throughout Scotland’s Health Boards; and
6. Write to the MHRA [The Medicines and Healthcare Products Regulatory Agency] and ask that they reclassify TVM devices to heightened alert status to reflect ongoing concerns worldwide.^[7]

2. The Petition was lodged to draw attention to a number of women who had experienced serious complications following procedures to treat pelvic organ prolapse and stress urinary incontinence. This was linked with under-reporting of adverse events and a poor understanding as to why these complications had occurred.^[8] It received in excess of 1,700 signatures and 212 comments.^[9]

3. On 3 June 2014,^[10] the Public Petitions Committee took evidence from Olive Holmes and Elaine McIlroy (hereafter referred to as ‘the petitioners’) who provided more detail on what had led them to lodge the petition.

4. On June 17 2014, Alex Neil, then the Cabinet Secretary for Health and Wellbeing, informed the Committee that he intended to commission an Independent Review.^[11] The Review would not only explore the evidence that the petitioners had provided, but also consider complication rates and under-reporting of adverse events.^[12]

5. The Scottish Independent Review Group (hereafter referred to as the ‘Mesh Review Group’) held its first meeting on 25 August 2014.

6. On 27 March 2017, the Scottish Government published the Mesh Review’s Final Report entitled, The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women.^[13] This was preceded by an Interim Report which was published on 2 October 2015.^[14]

7. Prior to the publication of the Final Report, the first chair, Dr Lesley Wilkie, resigned and a second chair, Dr Tracey Gillies, was appointed. Three further members of the Mesh Review Group resigned, including the petitioners. The third resignation was a clinician member, Dr Wael Agur.

8. The publication of the Final Report generated widespread criticism over a range of concerns including the evaluation and exclusion of certain evidence, the nature and quality of the independence of the review process, and the inclusion of the petitioners’ input despite their resignation and request for their contribution to be removed.

Membership and Remit of our Investigative Review Group

9. In response to the concerns raised, on 18 May 2017, the then Cabinet Secretary for Health and Sport, Shona Robison, advised the Public Petitions Committee of the Scottish Parliament that the process by which the Mesh Review Group came to its conclusions would be examined.^[15] An Investigative Review would be commissioned to undertake this task. Professor Alison Britton was asked to lead the new Investigative Review.

10. The Membership of our Investigative Review Group was:

• Alison Britton - Professor of Healthcare & Medical Law, Glasgow School for Business and Society, Glasgow Caledonian University;
• Gerard Sinclair – Chief Executive and Principal Solicitor of the Scottish Criminal Cases Review Commission;
• Dr Ealasaid Munro – Senior Lecturer in Media and Communication, University of Stirling;
• Research – Yousaf Kanan, Fast Stream Research Officer, Health and Social Care. Scottish Government;
• Administration – Irene Brown, Administrator, Directorate of School Professional Services, Glasgow Caledonian University;
• Transcription - Alison Lockhart, Research Advisor, Glasgow Caledonian University.

11. Each member sat in a personal capacity and did not represent the views of any organisation or body.

12. The remit of our Investigative Review was:

“To consider the evidence on how to improve the investigative review process. Specific reference will be made to the Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women.^[16] This will inform recommendations for the process of establishing, managing and supporting Independent Reviews in Scotland.”

Structure of this Report

13. This Report presents our findings. Our Report comprises 10 chapters. It takes a chronological approach, from the commissioning of the Mesh Review until its publication. The balance of this chapter introduces key information about the composition of this Investigative Review Group and our methodology. Each subsequent chapter discusses key areas in which we have identified failures or, mistakes as well as lessons which can usefully be learned from the Mesh Review for the establishment, management and support of future independent reviews.

14. Chapter 2 considers the importance of clarity and shared understandings in formulating the title, remit and terms of reference of any review and finds that the Mesh Review lacked many of these essential characteristics. This lack of clarity about the aims, object and purpose of the Mesh Review, continued to follow the review process through the long and increasingly dysfunctional months of its operation.

15. Chapter 3 examines the issues of independence, and conflicts and declarations of interest in the independent Review process. We identify a series of inadequacies in the approach adopted by, and record-keeping of, the Mesh Review. Chapter 4 considers the selection and responsibilities of the Chair, while Chapter 5 looks at important considerations in the selection and composition of members of a review.

16. Chapter 6 examines the role and responsibilities of the chair and members in an independent review. Chapter 7 considers the management and evaluation of the evidence in the course of the Mesh Review process.

17. Chapter 8 focuses on the composition and production of a review report, highlighting a number of limitations in the Mesh Review’s approach. Chapter 9 considers the timeframe, administration and budget of a review, and the problems characterising the Mesh Review on all three elements.

18. Finally, Chapter 10 considers the management of external influences on independent Review processes, and the impact which the publication and subsequent public and media scrutiny had on many of its members.

Intended Audience

19. Although our report was commissioned by the office of the Cabinet Secretary for Health and Sport, we anticipate that it will have a wide and diverse reading audience. It has therefore been written with that diversity of interests in mind. Where technical terms have to be used, an explanation or links to further explanation can be found in the endnotes. If we have made reference to other literature, a reference to this can also be found in the endnotes.

Legal Context

20. The focus of our investigation is a non-statutory, ad hoc^[17] review as opposed to a statutory inquiry which has been established under the Inquiries Act 2005. There is, however, a wealth of information which has been written in relation to the latter and we have drawn freely upon that literature. Both forms share certain core principles – subject to some differences in form and procedure^[18]– which raise common themes and pose similar questions.^[19] Reviews are commissioned for a wide variety of reasons. Generally, they aim to provide a public account on what has occurred and why it has occurred. A successful review aims to restore public confidence and provide reflection and lessons to reduce the likelihood of the event or circumstances occurring again in the future.^[20]

21. The nature of the commission and the remit and terms of reference means that each review will have its own unique characteristics and requirements,^[21] and a rigid set of processes may not suit all reviews. There is no presumption that a statutory inquiry will be commissioned in preference to its non-statutory ad hoc counterpart.^[22] Each has its own purpose and place.

22. There are three main distinctions to be made between a statutory inquiry and a non- statutory review. The latter will usually be conducted in private. Those who are called to give evidence are not required to do so under oath. Non-statutory investigations cannot compel attendance of any witnesses.

23. Under section 28 of the Inquiries Act 2005, the Scottish Government has the power to commission a public inquiry but only where the matter concerned is devolved.^[23] Transvaginal mesh products are classed as medical devices whose regulation is a matter reserved to the United Kingdom Parliament.^[24]

Evidence gathering process

24. In carrying out our remit, we first read the Interim and Final Reports of the Mesh Review Group to gain an initial understanding and context of the Review. Once this was complete, our main focus was to speak with those who were directly involved as members of the Review. We contacted everyone who appeared on the membership list contained in the Final Report of the Mesh Review, inviting them to meet with us.^[25] 17 out of 24 members listed in the Final Report met with us or submitted written evidence.

25. A short, Plain Language Statement, containing our terms of reference and remit was made available to those with whom we wished to meet. Meetings were recorded and transcribed. All interviewees had the opportunity to review their own transcripts. The transcripts were then read by us and themes identified. Occasionally, interviewees provided additional information which had not been part of the original discussion. We have recognised these as additions which informed our work, but they have not been included in the thematic review of the transcripts. Where it was not possible to meet with members of the Mesh Review in person, we spoke on the telephone.

26. We also received a joint written submission from the petitioners. This was treated in the same way as the transcripts arising from the ‘face to face’ discussions that we had with members of the Mesh Review. We included what we considered to be pertinent sections of their submission in our Report. The evaluation of what was a pertinent section was based upon the questions that we asked those with whom we met. The petitioners’ written submission can be found in Annex 2 of this document.

27. A call for evidence was made and a Focus Group was held. The Focus Group comprised of representatives from academia, law and public policy as well as a previous chair of a Scottish Independent Review. The Focus Group was invited to discuss themes that had arisen from our interviews. We also considered some of the more general issues that had arisen as the Mesh Review progressed. The outcome of our discussions helped us as a Group to shape our thinking and test our conclusions. The Focus Group made a significant contribution to our recommendations.

28. We met with the Convener and Deputy Convener of the Public Petitions Committee of the Scottish Parliament. We also met with Alex Neil MSP, as former Cabinet Secretary for Health and Wellbeing and with Jackson Carlaw MSP and Neil Findlay MSP.

29. We considered literature which touched upon issues of relevance to our remit and we have been able to draw upon their content during our deliberations.^[26]

30. One of our initial tasks was to ascertain the frequency and type of investigations that are commissioned and conducted in Scotland. We asked the Scottish Government to provide data on how many reviews had been commissioned over the last 5 years and the subject of their investigation. This data is not available. It is complicated by the fact that reviews are called different things. The area of the Scottish Government’s website which details “Commissioning Inquiries, Reviews and Panels” provides a list of investigations which are current and those which have been closed and archived.^[27] Whilst some may include the words ‘commission’ ‘review’ or ‘panel’, others do not and there are no definitions on what these are nor how, they ought to, or if they should be, distinguished.

We recommend that appropriate data on the frequency and nature of ‘Commissioning Inquiries, Reviews and Panels’ is collected, recorded and reported. This will help provide an understanding of the review process more generally and inform best practice for future reviews.

We recommend that a distinction is made between those which have been established within a statutory framework and those which have not. Including this detail on a website will inform the public understanding

31. We considered evidence given to the Public Petitions Committee of the Scottish Parliament and parliamentary questions and debate. We recognize that the majority of that evidence was submitted after the publication of the Final Report of the Mesh Review; however we believe it would have been an omission on our part not to consider those questions and the evidence that was presented.

32. Those who participated as members of the Mesh Review often expressed strong views in our meetings with them and we wanted to reflect that in our Report. We have therefore included quotations and, where possible, have anonymised these. All quotations appear in italics. We took a thematic approach to the questions posed which were shaped by the interests, experience and professional representation of the members of the Mesh Review.

33. Finally, throughout our work, we were struck by the fact that there are no established procedures or guidance on how to establish, progress and publish outputs of a commissioned review. Guidance tends to be piecemeal, relying on goodwill from those who may have had some previous involvement or whoever happens to have some time to spare. Detailed guidance on running reviews would also have value for investigations more generally since statutory inquires similarly have no such guidance. The call for such guidance and some way to pull, currently disparate, strands of knowledge together has been enduring^[28] and broad.^[29]

34. A dedicated centre for public investigation^[30] would bring together experience and expertise that can be drawn upon when a review or other investigation is being commissioned. It could provide a common knowledge base and be a repository for best practice. It could advise on the most effective way to ensure appropriate administrative support and IT equipment.^[31] It could provide guidance on how to appoint and recruit members of a review. It could provide templates to assist with the title and remit of a review; these could also be used to help scope and draft terms of reference. It could introduce novice chairs and members to those who have previous experience and would be willing act as mentors. It could provide guidance for members on how to cope with intense public and media scrutiny. It could also provide a mechanism for a review to share methodologies, conclusions and recommendations^[32]. Looking forward, it could monitor the implementation of the recommendations arising from a concluded review.

We recommend that there would be merit in setting up a dedicated unit to support commissioned reviews. This unit could provide a common knowledge base for both non- statutory and statutory reviews. It could keep records of previous reviews and collate data on their conclusions and outputs. It could provide guidance and templates for establishment of a review and for scoping terms of reference. These documents could be updated to reflect best practice and experience.

35. We would like to thank all the individuals who contributed to our work by sharing their thoughts, experience and knowledge. For some, this was a difficult and emotional experience. A list of those individuals with whom we met or received evidence is set out at Annex 1.