 Yn gyr Ùl, ni'n gwybod i gyfnodau yn gyfnod o ddannu cymunedig ac yn enthau'r honno yn 2017. Diolch yn ddweud, mae ein oedd yn nhw'n ysgwrdd o'i gwaith i gyd ac mae ein oedd yn y dyfyrdd o'i ffordd diwrnod. Yr Сfyrnau ym Mhwnger Cymru wedi gweld y pryd ym Mhwnger Yn Gyr Daeth mewn pryd ym Mhwnger Yn Gyr Euw Yn Gyr Daeth mewn pryd Yn Gyr Unwyd yn y Pryrwyr Ayod yn Nrwyngur Yn Gyrwyr Eyw. Ysgolwyddoedd arnyn ni'n unrhyw o busnes i ddweud i'w mewn i, ac mae'n sylwg ddim yn ddweud i 1517, a gwneud o poleg o'r gyflawni gyda'r cyffredinol, amdegwyd o Lain Homes i'w gyflawni gyda'r gyflawni gyda'r cyffredinol. wrth ddwy bitespwyd, rydyn ni oedd Wale Fynl i'r Gwylmysigol, a rydyn ni oedd yma yn Chris Cardiol o fi, ac i Gwylmysigol i'r Gwylmysigol yn� �nthunol yn dd y mi. We will hear evidence from two panels first is Tracy Gillis, chair of the independent review group, and she will be followed by the cabinet secretary for health and support and the chief medical officer. Members have a note by the clerk which provides context and background to the session four committees consideration of the petition and then addresses the content of the final report of the independent review of which members have a copy. Members also have a copy of the most recent submission from the petitioners, which sets out their concerns about the final report. Those concerns include the provision of the shared decision tables, chapter six reporting of mesh adverse events, recording of mesh procedures, the classification of mesh and the inclusion of the petitioners' input within the final report. So there are a number of areas to cover and I propose therefore to move on to the first evidence session and I welcome Tracy Gillis, chair of the independent review. I thank you for attending this morning and you have the opportunity to provide a brief opening statement after which we'll move to questions. Thank you and good morning. So I'm grateful for the opportunity to come here today to discuss the independent review and to answer the questions that you have. As people who are here today will know, the review came about because of growing public concern about the use of polypropylene mesh to treat urinary incontinence and pelvic organ prolapse and through the considerable efforts of those who have suffered complications after having surgery. You'll also be aware that Leslie Wilkie, who chaired the review from the beginning, through the publication of the interim report and beyond, resigned towards the end of last year and I was asked to take over the review at the end of last year and see it to its conclusion. Under Leslie's chairmanship, the independent review published an interim report in 2015 and a lot of work went into that report and it was well received by clinicians and patients and clearly Leslie and other members did a lot of work to produce that report. Before talking about the findings of the review, it's probably important to touch on some of the difficulties that the review faced in coming to its final publication and I think it's important to acknowledge that it is deeply disappointing that one of the clinicians and two patient members felt that they had no alternative to resign but to resign. I want to explain that I did really try very hard to find common ground and compromise so that our final report could have been produced that all members were happy with and I'm very sorry that that didn't happen. As it's often the case with the review or inquiry of this type, there were many experiences and strongly held views amongst members and in those circumstances it proved to be difficult to reach agreement and in particular consensus around some of the views around the interpretation of the evidence. But the review's final report was published at the end of March and the review, the view of the remaining group members would be that it actually strengthened the findings of the interim report. That's it, Robert. And included eight clear and ambiguous conclusions that I would want to have the opportunity to go with you through with you today. Sorry, it is really important that we conduct the proceedings as efficiently as possible, understand the level of emotional feeling in the room, but we have to take evidence, we have to ask questions and then come to conclusions. If people can, as much as possible, be streamed from commenting while we're trying to take evidence. So broadly speaking those conclusions cover the very important point that decisions around treatment and in particular in these conditions must involve patient-centred care which includes patient choice and shared decision making which is supported by robust clinical governance and to support shared decision making that should take place in the context of a multidisciplinary team. That recording and reporting of adverse events should take place in line with the GMC guidance and that we have reached a conclusion that we would include the word mandatory on that and I'm sure that you'll have some questions about that. That patient information and the consent leaflet that was previously created should be reviewed and that this should be a similar leaflet produced for those who are considering prolapse surgery, that the expert group wanted to highlight some of the gaps around the long-term impact of mesh surgery and wanted to highlight those to the research community so that further questions could be addressed to that and that there was a need to work to address the information gaps that currently exist and to make sure that information that is currently available is used as effectively as possible and that the expert group should review the training and information available to clinical teams and find ways to make sure that patient views are incorporated into the recording of the NDT outcomes and that in considering surgical treatment for stress urinary incontinence women must have the opportunity to be offered all appropriate treatments both mesh and non mesh as well as the necessary information to allow them to make informed choices and in the case of pelvic organ prolapse that mesh procedures must not be offered routinely and I'll happily return to that because I think that that is where actually there's a move in the conclusions of the final report beyond that of the interim report and in coming to those conclusions the independent review members considered the best available evidence and that one of the reasons for the gap between the interim report and the final report was that new evidence became available that evidence drew on a wide range of different sources these included patient surveys as well as stories submitted individually by women to the review or separately to the Scottish Government other evidence included the analysis of nationally available hospital record data that's carried out by the information services division and that was in chapter four and then a number of different scientific studies and those were included in chapter five so as I touched on earlier it was deeply disappointing that three members of the review felt that they had to resign but I want to make clear my gratitude to all members for their efforts in bringing the report to the place that it got to and in coming to the conclusions the remaining members of the review group did take care to consider and try to reflect the views of those members who had resigned and that I think is in part what we would see as the inclusion of the word mandatory that we knew was very important to the patient members of the group so I want to conclude by thanking those members who took part and the many women who have submitted stories and I hope and firmly believe that as the conclusions taken brought forward in the report are taken forward that the standard of care provided to women will improve because I think that there are many important lessons to learn from the events that preceded this review and from this review itself and I hope that that will improve care in the future. Thank you very much for that. If I can maybe open up the questioning, one of the issues behind the petition being brought forward was that women were not being listened to and that their experiences were not being treated with respect by clinicians. How would you respond to the views that have been expressed by the petitioners and others that the review was not fully independent and lost its transparency and integrity and can they reasonably be expected to have trust in not just the conclusions that are reached but the processes that are followed to get there and if I can give you one example I'd be interested to know your comments in this. In the interim report in chapter 6 it says that the independent review expressed serious concern that some women who had adverse events found they were not believed. In the final report that changes to the independent review expressed serious concern that some women who had adverse effects felt they were not believed. In the difference between those two reports are you not effectively saying or compounding the idea that those women were not being believed? That was not the intention of the report in any way. I suppose my question to you is if you can reflect on why there is a lack of confidence. Can you explain that change? What was the purpose of that change? It reported that people felt they were not believed rather than the earlier one. Clearly the interim draft had accepted that they were not being believed. It would be important for me to say that there was no intention in any implication. There was no intention in any implication that people had not been believed. I chaired two meetings of the group and really I went to a lot of effort to try to make sure that we were trying to listen to all the youth around the table. How do you answer this question? How do you give people confidence as the question asked you that it was when people were saying that it was not fuelfully independent and that it was not transparent? What is your response to that? I would refute the fact that it was not fully transparent. One of the issues is over the tables of evidence and it might be useful to explore that at this stage because that is what has led people to worry about the transparency of this. The tables of evidence that were included in the interim report in chapter 6 were drawn up by one of the clinicians and contained extracts from the full critical appraisal. In the discussion with the clinicians, what became clear was that there were some feelings that certain things may have been highlighted rather than others. The chapter 5 in the report is the critical appraisal of the evidence that is collected through systematic review and what I wanted to make sure was that there was really clear visibility of all parts of those systematic reviews so that is why the tables in chapter 5 can appear more difficult to read but they do contain every extract from the systematic reviews that have been undertaken. When it seemed difficult for some people that the tables from chapter 6 were being included in chapter 5, we have included those cut-down tables in front of the full tables and we have included a link to the interim report chapter 6 at the back. One of the difficulties that we have when people talk about the assessment of evidence-based medicine and how that evidence is being assessed is which parts of the evidence have been taken and looked at. I wanted to make it actually very clear that all the evidence that was involved in those systematic reviews was set out in chapter 5 and that is why that is there. In that case, did you believe that some women who had adverse effects found that they were not believed? Do you think that that was their direct experience? I think that women who have had adverse effects have not been believed and I am very sorry that they were not believed because they should have been. The final report does not reflect that for you if the interim report does not. I can only apologise for that change in wording. That is not the intention. I remind the gallery that we are trying to do through the evidence as effectively as possible. I move to Angus MacDonald. Before we move on to the report's conclusions, I would appreciate some clarification from you in relation to the process for publication of the report and the petitioners' resignations. The petitioners are clearly very angry that their names and input have been included in the report when they requested that they be removed. Can you clarify for the record when you received requests from the petitioners to remove their input and whether those requests were agreed to? For any requests that were not agreed to, can you explain why that was the case and who took that relevant decision? I have a number of letters that I would be happy to provide at a later date to the committee if that would be helpful. We will take as much information as you can provide yet. I would be happy to do that. As I understand it, following a meeting between Mrs Holmes and Mrs McElroy with the cabinet secretary, there was a request that she put to me for information to be removed. I wrote and asked for clarification about which pieces of information were to be removed. Following that, there was clarification from the minutes of the meeting of the Scottish mesh survivor women with the cabinet secretary, which stated that it was the minority report that was to be removed. I understand that you may not agree with that, but that is the information that I received. In discussion with the group, there was a very strong feeling from the remaining members of the review group that individuals after they have resigned should not be able to influence the content of the report as the review group, as it stood at the end, had agreed. The minority report was part of an appendix and had not formed the basis of discussion within the process as the review was formulated, and that is why that was removed. I had received communication asking me not to, that my letter had caused distress, which I am sorry, but following that I did feel it was necessary to actually be clear about what had been removed. I did write a further letter, but that letter was sent by post. Sorry, are you continuing? Sorry, no, I think that I have finished the end of what I have tried to answer in your question. If I have not answered any parts of it, could you just tell me the parts that I have not answered? It would certainly be helpful if you could provide the committee with the correspondence that you had, because there may be a suggestion that some of that was not received. I am not sure, but we would be obliged if you could provide that. Could you advise what correspondence you received from either the cabinet secretary or the chief medical officer in relation to the request from the patient representatives to remove the information from the report? So that was in a discussion? Well, did that discussion go along the lines of, I have met with patient representatives, they want all their information removed from the report? So yes, it did. And you did not do that? So as I have outlined before, that is what I wrote to Elaine and Olive to ask them about. No, no, no, sorry. That was the report that you received from the cabinet secretary. Verbal, she made that request to you. Yes, you have just confirmed that. And you did not remove that information. So as I have explained to you, I wrote asking that. I then took that suggestion back. You do not need to write, because the request has been made by the cabinet secretary, who you are accountable to. So she is passing on what was discussed in their meeting. She agreed at that meeting. Well, I am afraid that you would need to take that up with her. Oh, do not worry be well. But so I am trying my best to navigate a difficult process where people have different views and some of those are understandably very, very strongly felt. But the discussion about the integrity of the review and the fact that the review group have agreed the content of the review was actually, of course, I take that responsibility very seriously as chair. And I need to go back to the standing members of the group who have not resigned about any significant changes in content. It's right to listen to requests, but that doesn't mean that I would necessarily exceed to those requests. On that theme, when the interim report changed so much to the final report, did you reciprocate that arrangement and contact others in the group who may have resigned or who were members at that time and who rejected that position? So that was fully discussed at the meeting. There was a meeting held at the end of January and there was a meeting held on the 6 March, so the changes to the review were fully discussed as part of those and the agenda sets out chapter by chapter that each chapter was discussed. Okay, that will do for now. I'll come back in later. And were all members, the remaining members of the review group, would you be in attendance at both of these meetings? So all the papers were circulated to them of those who did not attend either in person or by phone. And the conversations, so if we come to the word mandatory, then that was clearly very important to those people who had suffered complications following mesh. And although the group had previously discussed the inclusion of the word mandatory and not felt that that was the way to go at the meeting on the 6 March, what we added into the review was the statement about the GMC and the GMC's expectations for individual practitioners to report complications. But when the word mandatory was still, the absence of that word was still clearly a source of deeply felt upset to individuals, I did agree to go back to the group and to check that they were all right. And at the meeting I said that I would, if you like, take chess prerogative and accept that that could be included because it seemed to me unreasonable to hold out against that. And forgive me just for the record, does the final report reflect that some of the people who are members of that group had resigned and therefore that some of the evidence that had been given and provided by them, they had asked to be withdrawn? There's no commentary on that in the final report, but I understand your position seems to be that whoever remains and is still standing at the end of the process are the review group and that's their report. But is there any commentary around it that says, well actually during the course of this we lost the two patient members and we lost the next group? In the list of people at the back it does give the dice when people lift. But it doesn't reflect in a sense what the substance of the dispute was that led to them going. So there's nothing that shows what was the bit that people might have liked to have removed but wasn't removed. It doesn't reflect even that request. I have, when members resigned, I've written to them, thanking them for their contribution and expressing my regret that they had resigned and I would be very happy for those letters to be part, to be on the website. I would be happy to reflect the comments that you've made to me today and for that to be put up on the website next to the review that actually didn't make clear what were the points of dispute about why people had resigned and what they had wanted to have removed. I think that part of the difficulty about trying to produce a report where it's written by multiple different people and we're trying to build an area of consensus is that if people choose to leave that process because they are not happy with the conclusions, it's not possible, I think, to disaggregate contributions that have been made in the course of development of the report. In extreme circumstances, if there had only been two people left writing the report, might you not have taken a view that it was unsustainable to produce a report? I wonder whether, when the two patient members said they had no confidence in the report, when another member left, you might have thought, rather than plowing on with a report that's not been able to build a consensus, we might just pause here? Was that a consideration? We did have another patient member who remained as part of the group and we had a number of other individuals who also stayed as part of the group. I think you're right, if one was left as chair of a group of two people, one would clearly have to say, this is not something that is credible to the various audiences that one would expect a report to go to, but there were still a very significant number of members of the review left, all of whom were in agreement with the content of the review. Presumably at the point when the interim report was made public, all the members of the group at that time supported the interim report, including those who subsequently felt necessary to resign. I learned something from what you said a moment ago and I'd like some clarification of it, because clearly until your predecessor resigned in November, we had a group who were supporting the conclusions of the interim report. I heard you say in relation to the tables that I felt that those excerpts were not giving the complete, I felt and I decided and I led. What I'd like to know, Dr Gillis, is it the case that it was at your instigation that the review committee's interim report was changed on the basis of what you felt having come into that review and that you led that change within the review group to the new report, or did the initiative come from elsewhere within the review committee? People who by this stage were so concerned that they had managed not to express any of these concerns when the interim review was published. In listening to the clinicians discussing how they would want to frame the conclusions of the clinical part, based on the, remember between the interim report and the final report, there is new evidence that's come forward. That's the reason for the delay. In listening to that discussion, it was very clear that there was a lack of consensus around the content of those tables that actually they were no longer agreed by the clinician members of the group. There was no longer sufficient consensus for people to feel comfortable around that. So the initiative came from you? As a way of trying to say, is there a different way that we could express this in order to continue to build consensus? Which was essentially what? To produce tables that just produced a blizzard of information which then made nothing clear at all. So it was the lowest common denominator. Nobody could disagree with anything basically. So I would absolutely refute that. I think it does come down to who is the intended audience and I have made a comment previously that actually I can understand that that level of information can be difficult to navigate. But I think what it does do is set out each of the outcomes that the systematic reviews considered rather than a selection of outcomes. Actually, for a report to be sufficiently credible to influence clinical practice, it needs to be very transparent for clinicians and for the broader clinical group to be able to read through that and to see all the different outcomes that might be considered. That becomes particularly important in the case of surgery for stress incontinence, where there is no single procedure that would provide if you like, a very, there's no single procedure that one would say was a reasonably standard choice. Each of the surgical options and I think it's important to take a step back from that and to remember that treatment may be non-surgical before it's surgical, but each of the surgical options has a range of risks, of potential benefits and of complications and those differ. So actually it's quite important to make sure that all of that subtlety is set out. I have to say I'm really struggling to understand your explanation of the tables. And your view of transparency, I have to just put that on record. I really find it very hard to understand what you've just been saying. Can I move on to my other question? The petitioners state that the interim report will integrate detail about procedures, whereas the final report covers seven procedures in less than four pages. They also argue, for example, that the suggestion that the trans-obturator mesh tape can be removed clearly contradicts what all clinicians agreed on and they updated and approved patient informationally fit. So how do you square those two? So this is not my area of technical expertise, but that particular point was expressly discussed by the clinicians and there was agreement that that was the correct wording in their surgical experience. So they— It was agreed on in the interim report, but not the final report. So what changed? So I think that what has happened in the time between the interim report and the final report is that probably surgical experience has moved on and so that was why they felt that the statement that was made in the interim report about mesh via a trans-obturator route not being fully removable, they would want that to be altered. That was a clinician-led decision in terms of the content of the report. But that's not what it says in the patient informationally fit. So there is a recommendation for that information leaflet to be reviewed. What? Reviewed as of now? Okay. Do you think that's acceptable then to put out a leaflet for patients? Is the information that's actually not valid? So it's important that all information is reviewed on a regular basis as practice changes. Okay. Moris Corry? Dr Goodis, on the issue of mesh adverse events is to be welcomed that the report recommends that it should be mandatory to report all adverse events. But I'm interested in the process of the review undertook to eventually reach that decision. Could you outline the decision making process on that specific point, including the timeline, for when the recommendation was included in the final report? So the inclusion of the word mandatory was included at the very end of the finalisation of the report. As I've previously discussed, that followed the conversation where the mesh survivors group had expressed their view to the cabinet secretary. The cabinet secretary wished to meet me to make sure that I understood the depth of feeling around those reviews. The meeting on the 6 of March, we had had discussion around the use of the word mandatory. It's really the implementation of the use of the word mandatory that the group thought could be difficult. However, at the time, it seemed unreasonable to, if that was a strongly held view, it would seem appropriate to go back and include that. I checked that back with the group and it was agreed. Okay. Thank you. Brian Whittle? Thank you, chair. Good morning, Dr Goodis. Looking at the evidence basis for frequency of adverse events, in this submission, the petitioners say that they made repeated requests for what they refer to as best study of mesh adverse events, published in the journal Nature, to be included in the report. It's stated that the study shows one in seven women experienced serious adverse incidents of mesh, yet the study is not mentioned in the report. Can you explain the evidence that the review considered and how it decided what information to be included or not included within the report? And was there a particular reason for not including the study that the petitioners refer to? Yes, I can. Sorry, I have a number of notes. That study was, as I understand it, circulated through the group by one of the clinicians prior to my arrival in the group. There was no discussion at any meeting that I attended about whether that study, people wished to include that study. In terms of the evidence that is included in chapter five, it falls into two broad groups. Those safety reviews that were included were focused on safety reviews published by agencies charged with device safety. In terms of efficacy, sorry, effectiveness, then Cochran reviews were the systematic review method that was used. The nature review doesn't follow the guidelines for a Cochran systematic review report. And so it was not considered. There were, I suppose, at least three opportunities when, if the clinicians within the group felt that there was important evidence that that paper covered that they thought was a gap from the review when it could have been discussed and included. Okay, so what we're basically saying is that there's a frequency of, the petitioners asked many times for this to be included, but you never, you were never presented with that. So any ask for that to be included with not at the time when I was the chair? Okay. The petitioners are clearly concerned by the information contained within chapter six of the final report, which they believe directs the reader to the conclusion that mesh procedures are better than non-mesh ones. They are of the view that it describes all the advantages of mesh procedures but avoids mentioning adverse events such as mesh erosion and exposure and chronic pain. It then highlights the disadvantages of non-mesh procedures but none of the advantages. How would you respond to petitioners on this point and could you outline the extent to which you consider the final report to address advantages and disadvantages with equal importance? So I would disagree with that point. I think that what chapter six does is it sets out a synthesis of how the different strands of evidence might be used by a clinician. I think that, importantly, it considers non-surgical options around treatment and tries to place an important emphasis that surgery is not the only way for these conditions to be treated. It's really a view from the clinicians of the group. I guess my role as chair is to draw those views together in what has been set up as a multi-author review rather than to pass judgment on the technical views that are contained within that. The report also says that this chapter is now used to explore some of the nuances of clinical interpretation of the evidence presented earlier. Can you explain to me what exactly that means? That's why I was trying to say in the beginning, in the opening statement, the review contains different types of evidence. Some of those are quantitative results from research trials where different trials select a narrow group of the population, randomise them between different treatments, and then those trials are put together like different layers in a cochran review. I'm trying to see, from looking at the way to that narrow perspective for randomised trial evidence, whether there is a particular benefit or a particular risk profile related to a particular treatment. There is also the type of evidence that comes from the study that was produced by ISD, which takes routinely collected hospital inpatient day case activity data, which is, if you like, taking outcomes from a much broader population, it's a much more pragmatic way to look at what the outcomes are. Then the review also contains qualitative evidence, which is based on people's experience. Can we just again ask people—I do understand the scale of feeling in the room, but we really do want to try to proceed as efficiently as possible. Neil Findlay, you're indicating that you want to come back. I cannot get my head around the dismissal of that report on adverse incidents that was published in the journal Nature. Do you find that strange that such an up-to-date report on adverse incidents was not included in such a review? I find that remarkable. I have come in at the end of— I know that. I know all of that. Actually, you've asked me here to answer the questions, and I think it's important that I'm allowed to make a comment that I have come in at the end of a process, which has been set up in a particular way. If I had started the process, I may not have chosen to approach it as a chair in this particular way. That's not to imply any criticism of the previous chair, but the review has obviously run for quite a considerable length of time. Where things come forward, if they don't necessarily neatly fit into one of the chapters that has been set out, then I can understand why people might think, why didn't they consider that. There were opportunities when, if any individual member of the group or people who are far more steeped in the current evidence around this particular area of practice had felt that it was important for that review to be included, then I am quite confident that there were opportunities for them to raise that. So, do you find it remarkable that it wasn't? I don't have that clear review, actually, because I wouldn't want to make a comment on the actual technical validity of the way the study was done. Sorry, sorry, sorry. More questions briefly, and we're going to move on. What about the FDA's alert on counterfeiting in the US, and what about the European Union's change of mesh from medium to high risk, and the fact that the report still concludes that it's medium risk? My very, very final point is, Dr Gillis, and I've always been reluctant to ask this question to any of the women involved in this. I would find it much more easy to ask this question if I was a woman. Given what you know about mesh, given what you know, if you suffered the same condition as many of the women behind you, would you have such a procedure done? I am rather unclear about the validity of asking me a personal question about my own health in this setting. Or would you recommend it for someone else? No, you don't have to answer that question if you don't want to. So, if you could answer the first point that was made to you, then you can choose to answer the second point if you want. Sorry, in terms of thinking about the second point, I've slightly lost track of the first point. Sorry, the counterfeiting warning by the FDA and the EU's classification. The MHRA are the regulatory body for devices in the UK, and they were part of the group, and they attended, and those particular points were expressly discussed on 6 March, and that's the input that has gone into the final review. The regulatory body in the UK has been part of the group and has been, if you like, responsible for that content, and that's clearly set out. The FDA are not the regulatory body in the UK. In terms of the second question, I think it is important to really say that one of the difficulties around this is that we're at the forefront of what is a necessary and important change in surgical practice, and that is a change from a more professionally led view about what might be the right procedure for somebody to a much more participatory equal relationship between professional and patient, and that is a difficult thing to navigate, but it's a very important change that we need to make, and it then becomes the role of the professional not to say what they think should be done for an individual, but to find out enough about for that individual what are the things that are important to them, and to then provide them with information that allows them to navigate and come to a shared decision about what is the right decision for them to have in terms of a surgical procedure or not. That requires far more skills from professionals than we currently necessarily provide them with in terms of being comfortable about asking some of those questions and not providing the normal professional response. So in answer to your question in terms of if that was me, I would want to make sure that the professional that I was dealing with was able to give me an explanation about the different risks and benefits of the different options, and to also find out from me about the things that would be important to me and to come to a joint decision with me. I have to say to you that I have considered that question myself. I don't think it's appropriate for me to give you the answer, but I think that what we have tried very, very hard to do in conclusions 7 and 8 in particular is to set out that surgical options for stress, urinary incontinence, none of them are, if you like, a clear option to choose. Each one of them has different risks, benefits and complications, and actually it's not possible to look at the evidence and say choose this one or choose that one, and that is what makes it complicated to understand. The thing that we have actually, and I realised that this did not go down well when I said it at the beginning, but actually the thing that we think that the final report has strengthened is actually around the use of mesh in prolapse. There is now clear evidence of no benefit for the use of mesh in prolapse, and that is the thing that has changed between the interim report and the final report, because it is based on the evidence that the final report was waiting for, and all that available evidence points in the same direction. I think that it's an important but subtle difference to point out that evidence of no benefit is stronger and clearer than no evidence of benefit, and so actually that is the thing that we have tried to move forward in the final conclusion. Maurice Corry On the issue of the mandatory reporting of mesh adverse events to the non-mandatory reporting of mesh procedures, I note the figures that say that currently only 27 per cent of surgeons record mesh procedures. Systems are dependent on whether information is being input and on the quality of the information that goes in. I will simply ask you to respond to the questions raised by the petitioners in this regard, and how would it be possible to obtain accurate information on adverse event rates if the recording of procedures is not made mandatory, and how, if recording is not made mandatory, will more surgeons use the current recording database? Those are important questions. The purpose of the review is not to provide an implementation mechanism. One thing that we have highlighted is that what was previously the expert group, as it moves to an oversight group, needs to be very clear about how they wish recording to happen and to make sure that our systems are there to support that, but I completely agree with the point that it is not possible to understand about the instance of adverse events if denominator information isn't clear. It is important to make sure that those are recorded. Can I just clarify how many members of the review group signed off the final report? I cannot give you an absolute number, but we were quite careful, given the difficulties, to make sure that every member who remained at the end signed off the report. So, in terms of the number of people that are listed in the appendix of the members, each one of them signed off the report. How many were in the review group? So, it's between 12 and 15. It's a number of that order. And they were happy to sign off the final report, even with all the changes that have been involved in the interim. Can you say honestly now that you feel in this final report that the views and feelings, you came into this as a new chair. You must have been aware of the controversy surrounding these procedures. Are you happy that the views have been reflected in this final report? So, I am aware that, particularly of the people in the room, based on their very real experience, they have very strongly held views. There are many other people whose voices are less audible. And the report does try to acknowledge that. So, I wanted to make sure that the review actually came out into the light of day, because there are actually many women who are unsure of what they should do. And there are many clinicians who are actually far less clear now about, prior to the review being published about what was or wasn't the right thing to do. So, actually, in terms of the totality of people for whom this is important, it seemed to me that the right thing to do was to try to bring the review to publication. I understand that, but can I put it to you that the people in the room, it's not their views, it's their experience? Yes, I'm sorry, I'm sorry that if I phrase that incorrectly, that's not at all what I meant to imply. I absolutely understand that it's their experience. And you feel that their experience, as severe as it has been, has been reflected well enough in the report? Well, I'm sorry that that is felt to be the case. I think that that also reflects the views of the whole group about why they would not want to see pieces of the review removed at the final stage, because people had resigned. It's almost mission impossible from the beginning. I think what's important is that one should always reflect and think, could I have done things differently. Actually, I do think that what we have produced is a report that has tried to look at all the available evidence and has tried to assimilate that, and that actually from the quite respected clinicians who participated from Scotland and from elsewhere and from the professional bodies who participated, they have signed off a report that they feel is balanced and that reflects the current state of the evidence. Just ask when you said it was mission impossible. Do you mean you had a mission impossible coming in at the point that you did, or that having this review at all was a mission impossible? No, sorry, that's a personal view around my... So, as you said quite correctly, it was clear that there were strongly held views of difference at the point that I came in. So, one could say more for me for agreeing to chair this. This is not something that most people would have welcomed to be the wrong word, but it's clearly going to be a very difficult thing. And I personally have reflected and feel disappointed that I have not achieved what I would have set out to do, which would have bring this in consensus. And I hear the voices from behind me, and I feel very sorry. No, I feel sorry that I have not achieved something which brought something together where people felt they were able to stay as part of that at the end. And I am personally sorry that that has not happened. And if that is any fault of mine, then I would want to acknowledge that. But I think that the reason why I accepted what I might describe as mission impossible, and that's my personal view, is because actually for the totality of women who may face this problem, I thought it was important to try to bring the final report to a conclusion so that there can be the necessary improvements to information and clinical governance and discussions around treatment options. Okay, thanks very much. Can I welcome Alec Neill, MSP, to the meeting and ask Angus MacDonald to ask his question? Okay, thanks, convener. Obviously, this isn't an issue that's been looked at in Scotland alone, as Neil Findlay has already alluded to. And the risk classification of mesh is an issue that's been brought up by the petitioners. Indeed, the previous committee in session 4 took the opportunity to raise the issue during a visit to the European Commission in Brussels, which is on record. The final report anticipates the reclassification of mesh devices as class 3, the highest risk category. This is clearly an issue that's been raised by the petitioners. Looking at the timeline, the date of reclassification, as published online, was the 8 March, and the final report was published on the 27 March. Can you clarify whether there was an opportunity to update the final report? The final meeting was held on 6 March, in between other agreements around wording that was not one of the things that was raised and discussed. But I would again point out that we did obtain individual sign-off from each constituent member about whether they were happy with the content of the report. So it was not raised as that's something that we could have amended. So why exactly was that not raised? Do you know why? It's the reason of omission rather than commission. It's not deliberate in any way. Okay, can I go back to my previous question at the start of the session with the indulgence of the convener? Um, just for the record, was a guide to the issue when the petitioners resigned, as I understand it, the petitioners resigned on the 4 March. So can you confirm what was added to the report following the meeting on the 6 March, and was that referred? I think you said there was some reference to the GMC. Yep. Can you perhaps clarify that please, just for the record? I can clarify that. It is the statement that says that it's the statement that references the obligations on a professional to report adverse events to the necessary regulatory body who in this case would be MHRA. So if you wait, I'll find it. So it's in chapter 8 from memory. It's on page 91. It's under the summary. It says the reporting of adverse events is therefore mandatory, and that's the part that was added in later, as we've already discussed several times, that word was added in. But the part that was added in after the 6, following the discussion, was the reporting of adverse events in line with a good medical practice, a good medical, the general medical council's good medical practice, which states that, to help keep patients safe, clinicians must report adverse incidents involving medical devices that put or have the potential to put the safety of a patient or another person at risk. It gives the link to that part in good medical practice, and then sets out that the MHRA is the organisation that should be informed. Okay. Thank you. Can I just ask, in your response to Angus MacDonald, that there was a reclassification that was reported on 8 March, and the final report was published on 27 March? No one thought that this report, this reclassification, merited—was it not something that you were waiting for? Was it not something that you were aware was going to happen? I mean, I get that something might have happened in the world and nobody noticed, but this is the thing that this report was focusing on. Their job was to look at this. It was reclassified, and no one thought, wait a minute, does this have any impact on the report that we were going to issue on 27 March? In terms of how it would change practice, it would not have any other implications in terms of the way that the mesh is currently used. If my understanding as a new person is acknowledging a higher level of risk, it is moving from medium to high risk, is that not significant in a report that is reflecting on the risk involved in this procedure? That point was explicitly discussed at previous meetings with the MHRA, and if you would wish I could provide you with an extract to the minute that outlined that discussion. Would you not think that it would be extraordinary that nobody was keeping an eye on what this reclassification conclusion was going to be? My colleague here has said that this was something that was raised with the European Commission. It was something that would have been in the minds of people who know a great deal more about it than I do. In the same way that the interim report was waiting for a report to inform its findings, would that not be one of those lists of things to take a note of before you sign off the report? Yes. I understand that point of view, and I will happily come back to you with a written view about that and to provide you with the extract of the minute. To say that it is an omission, I think that what we would be interested in is to know how nearth could it have been in the committee? Yes, and I would say that that is the fair point. Thank you very much. Can I just final question here, unless Alex or Neil? Thank you very much indeed, convener, for allowing me to participate in the committee. Can I just explore the relationship with the MHRA, because we are told that that is a regulatory body for devices? There are a number of issues here. First of all, in my view, the MHRA has totally failed in its responsibility to the people across the UK, not just in Scotland, in terms of what it has not done in this area. Leaving that aside, that is not the responsibility of you or the Scottish Government. Have you checked out whether the Scottish Parliament, particularly under the new powers, now has the ability to transfer responsibility in Scotland for regulation from the MHRA to the Scottish Government? Was that checked out as part of the committee's work? No. Why was it not checked out? That is not something that was… So, when I came in as the chair, then, essentially, it was this review is pretty much concluded, and we need to now try to move that on. It was not to start unpicking other opportunities to explore… Well, that's a fairly fundamental issue, because clearly, many of the changes that were taking place—and I'm not a lawyer, I'm not saying that it has been changed—I just think that the committee surely should have checked whether there was any scope at all for the regulatory function in this to be transferred from the MHRA to the Scottish Government. You're saying that the committee didn't look at that. My understanding of what the review was set up to do with it did not include that as a question to be answered by the review? I'm sure that if you'd asked the cabinet secretary to extend the review, she would have allowed you to do that. The second point is that the MHRA is the regulatory body for devices, but the control of what can be funded through the national health service in Scotland is controlled by the Scottish Government. Therefore, despite the MHRA failing in its responsibility to properly regulate devices, the Scottish Government surely has the power—and certainly I did, as Cabinet Secretary for Health, because I exercised the power—not to allow procedures that may be using devices that may be unsafe. The national health services in Scotland has the power to say that that will not be done. Was that explored by the committee? I think that that's a question that's not for me as the chair of the review. Did the committee look at that issue? The opportunity to make a recommendation for the Scottish Government to exercise powers about not undertaking procedures through regulation is not my understanding of what the review had been set up to do. I set it up and I certainly would have intended that. I can only apologise that message. That's not the brief that I received. Certainly, if you look at the terms of reference, there was nothing in the terms of reference to stop the committee asking these fairly basic questions, given the concerns that were around about these devices. Although the regulation of the devices is apparently still with the MHRA, although that should be checked, the issue of whether, even if the devices are legal, whether the national health service in Scotland actually allows the devices to be used because we are funding the procedures is a separate question. That clearly lies within the responsibility of the national health service. Before you arrived, I had commented about the previous chair, who had obviously undertaken an awful lot of hard work and had set up the review in a particular way. I do not know her. I have not spoken to her. Her reasons for resignation are not known to me, so I would need to respect that. I have taken the review from the point where it was at the end of November in 2016. Obviously, if you establish the review, you know what you had in mind, but I do think that those questions are probably more reasonably addressed to the previous chair than to me if they were questions that you wish to see explored in the beginning of the review. I think that the questions for the whole committee, and clearly, since you had taken over the chairmanship of the committee, would have been reasonable for the committee, particularly given that, at the same time as the committee was reviewing the whole issue, simultaneously there was legislation going through the UK Parliament and this Parliament to transfer substantial additional powers across a wide range of areas. It seems to be that it would have been logical and sensible to double-check the scope for taking back regulation of the devices from the MHRA, which, as I say, is not an impressive organisation, in my view, to put it mildly, back into the Scottish Government's remit. I suppose that you had no conversation with the previous chair, is that correct? Correct. There was a report that came out from the European Union, changing it from medium-risk to high-risk, and the report does not reflect that. We had members of the report, granted before you joined it, who went 10 months without meeting, were excluded from sub-committee meetings, could not access the minutes or the agenda of those sub-committee meetings, and we have a number of members of the committee who it has been suggested to have conflicts of interest, and much more. Are you surprised, therefore, that people see this as being a report that has become a whitewash? I can only reiterate what I said previously, and that is that I have done my best from the place that I started in to try to include the views as I heard them, and to try to make sure that we produced a report that considered the evidence as we had been asked to do, and that actually produced a report that was credible and tried to set out as much of the evidence as possible. I am conscious of time when we need to move on. You have said that you found this to be mission impossible, and there are a number of issues. I think that people are surprised that the committee did not investigate that, and that might have been prior to your time. They did not respond to the question of reclassification. Personally, I am surprised that you did not have a conversation with the previous chair, but there may have been personal reasons on behalf of the other chair. It would be interesting to know if there was any attempt to have that conversation, at least to have a hand-over point at that point, which does not seem to have happened. There is now going to be a review of the process involving independent review work, rather than asking you to outline all of those now. I wonder if you are prepared to make an input into that independent review from your place, coming into the process late, particularly about the dilemma about when a point, when a body is broken because so many people walked away from it? Do you think that, if a report is trying to bring together the views of practitioners, clinicians and those of an experience, if those of an experience have walked away, then the argument with just simply the clinicians, is that not diminished in some way? I think it would be important to remember that we did have another individual who had experience who did remain in the group. In answer to your first question, I would very much welcome the opportunity to speak to somebody undertaking a review of this particular process in order for future processes to be improved. Thank you very much for coming along today. If there are things that you want to add to your evidence, and there are a number of things that you have highlighted, please contact the committee and we will be more than happy to receive either what you have already committed to or any other further evidence or comment that you want to add. That has been a fairly long session. I appreciate that you have been on your own doing that, and I know how difficult that can be. Thank you very much for your attendance. Can I suspend to change witnesses? Can I remind everyone that we are constrained in time because we have to be finished by 12 o'clock. We have already been given permission by the Parliament to extend beyond the normal time, so I appreciate that we are under pressure. I appreciate just how important those issues are, particularly for people who are visiting the Parliament today. It is important that we manage to get through, as I said earlier, as efficiently as possible. I am hoping to finish questioning by about half past 11 o'clock in order that the committee can consider what we have heard. We can extend slightly beyond that, but I just hope that everybody can cooperate with that because I do not want any opportunity to get evidence to be missed. I recognise the level of interest in that, but I also recognise the time constraints that are placed on us by issues beyond our own control. If we can move on to the next part of the meeting, I welcome to Shona Robison, Cabinet Secretary for Health and Sport, and Catherine Calderwood, the chief medical officer of the Scottish Government. I thank you both for attending this morning, and I invite you to provide a brief opening statement before we move to questions. I welcome this further opportunity to speak to the committee and members of Parliament on this important topic following the statement that I made in the chamber at the end of March. The independent review came about as a result of the efforts of many of those affected and who strove to make their voices heard. Indeed, two of those women Elaine Holmes and all of McElroy, who submitted the petition to this committee, later directly took part in the independent review. Before I outline the Scottish Government's response to the review's recommendations, I would like to inform the committee, and I have written to the convener about this, that I have commissioned Professor Alison Britton, who is a professor of healthcare and medical law, as an independent expert to examine and report on the process of the independent review. Professor Britton currently works in Glasgow Caledonian University and is a specialist in public healthcare, clinical negligence, mental health law and professional ethics. Professor Britton will produce a report on how the independent review process was undertaken and, importantly, what lessons can be learned in the future. I turn to the report. Upon the report's publication, the chief medical officer wrote to the chief executives and medical directors of all health boards about the review's conclusions. In particular, the chief medical officer highlighted the conclusions around the circumstances in which mesh procedures should and should not be offered in the case of both pelvic organ, prolapse and stress urinary incontinence and also made clear the importance of health boards ensuring that detailed and patient-friendly information is available to all women. That information must be provided so that women can make careful, fully informed decisions on the best treatment in their case. In addition, the CMO has also instructed all health boards to limit the number of surgeons that carry out mesh procedures and to ensure the mandatory reporting of adverse events. The Scottish Government will establish an oversight group that will be expected to work with health boards in taking forward the conclusions of the review. That will include working on guidance for nationally agreed pathways, publishing patient-centred versions of sections of the independent review's report and producing leaflets on pelvic organ prolapse and post-operative information and expect patients to be involved in the oversight group's work. I can also confirm that Scottish Government officials continue to work with colleagues across the UK to explore a mesh registry pilot and the development of e-learning packages that are being considered for use in general practice. What I want to be absolutely clear about is the key safeguards that are to be put in place as a result of this review must be implemented before any procedures using mesh are reintroduced routinely to healthcare services in Scotland. The chief medical officer has met with the medical directors of the health boards to gain assurance that those measures will be in place. As those here today know, during the concluding stages of the independent review, three members felt that they had no choice but to resign from it. This was, of course, deeply disappointing and it caused me a great deal of concern. I met with all of McElroy and Elaine Holmes after their resignation, because I was very keen to hear directly about their concerns and, indeed, to put those to the chair of the independent review when I met her, which I did. Turning to the original petition that was presented to the committee in 2014, it is worth briefly considering the demands contained within it and what progress has been made towards meeting them. First of all, the petition called for the suspension of the use of polypropylene transvaginal mesh procedures. Of course, the Scottish Government requested that health boards suspend the use of mesh until the independent review published its final report. As I have said, routine service provision will only recommence once the medical directors and chief executives are assured that the recommendations have been implemented. Secondly, the calls to initiate a public inquiry and or comprehensive independent research to evaluate the safety of mesh devices using all of the evidence available, including that from across the world. Of course, the independent review was initiated to fulfil that request and that has now published its final report. Thirdly, the introduction of mandatory reporting of all adverse incidents by health professionals and, of course, the final report makes clear that this is mandatory. Fourthly, the setting up of a Scottish transvaginal mesh implant register with view to linking this up with national and international registers. The Scottish Government officials are exploring this with colleagues in NHS England. Fifthly, the introduction of fully informed consent with uniformity throughout Scotland's health boards. Health boards will be required to make every woman fully aware of all of the options available to her in her case. Sixthly, to write to the MHRA and ask that they reclassify mesh devices, the reclassification of surgical mesh has been under consideration by the European Commission and it was adopted by the European Parliament on 5 April of this year. So, just in conclusion, convener, despite the concerns raised, which I understand fully, I believe that there has been some progress made on the issues raised in the original petition that is before the committee. I am happy to take questions. Thank you very much for that. Obviously, we did receive information from you last night about this review of the review. Do you not think that the fact that you are having a review of the review might suggest that there may be a lack of confidence in the final report? I wonder whether, in those circumstances, there is a possibility that you would revisit the independent review itself? I accept that, particularly from the point of view of the women who came to see me and expressed this very directly to me, that I know how they feel about the final report. They feel very strongly indeed about that. One of the reasons I wanted to get an external expert to look at the independent review process was because of those concerns and the fact that members resigned, the fact that a clinician resigned, none of which is the way that we would want independent reviews to be conducted. Without looking at the reasons in detail of that, I think that it would be a missed opportunity to look at—this is not about looking and revisiting the evidence, it is about looking at the concerns that are raised about the process, what lessons can be learned about independent reviews in general, about understanding the roles and responsibilities that are taking part in independent reviews and, indeed, looking at the way that the evidence was presented and the decision making around that and the governance around that. I think that the right person to look at that, which I hope will give us recommendations that will help us to make sure that independent reviews going forward, of which there will be more, I am sure that the lessons are learned and we can hopefully avoid some of the issues that happened within this independent review process. If the process was wrong, if we got the balance of evidence between the professionals and those who had suffered as a consequence of those procedures, if we got that balance wrong, if that is what the professor established, what does that say about the final report? We need to see what Professor Britton says about the process of the independent review, and we will have to wait for her to undertake that work. She will meet with everybody who took part in that independent review process. It is without a doubt been a very complex and difficult process for all involved, dealing with a lot of very complex clinical information. What I want to do is—I have asked Professor Britton to focus on—during that process, are there things that could have been done better? If so, what are those recommendations for going forward in the future so that, if possible, we avoid some of the difficulties that this independent review faced over the time that it was established? I do not want to labour the point, but if the professor looking at the review establishes that the process had an effect on what the final conclusions were and the capacity of those conclusions to have a consensus and agreement around them, surely that would take you to the place where you would then have to go back and revisit that review itself and look again at what those conclusions were and what that would then inform practice in Scotland? I am not going to prejudge what Professor Britton comes up with. I think that we need to wait for her to do that work. Obviously, I would not have asked her to do the work around this independent review if I did not have concerns about the independent review and where we ended up with it. Clearly, there were well-established concerns. I think that we need to wait to see what Professor Britton says about that. She will speak to everybody involved in the independent review and she will bring forward recommendations. I am not going to ignore those recommendations, so let's see what recommendations she brings forward and what analysis she brings to the process. Can you confirm, then, that the moratorium will remain in place until the conclusion of Professor Britton's work and her response to it? It is very important that the recommendations from the final report are implemented, not least. If you look at some of those recommendations, for example, on the mesh for prolapse, it says that that should not be routinely offered to women. That is an important recommendation. If we were not to implement that, that would not be— I asked you if the moratorium would remain in place until Professor Britton. That is a pretty substantial point. That moratorium, which matters a lot to people, will remain in place until such time as you have received and responded to that report? As the chief medical officer has made clear, the suspension will not be lifted until the recommendations of this report are implemented. The recommendations are important, not least, as I have said, that mesh for prolapse is stated in the final report that that should not be routinely offered. We have to accept that, even during the suspension that we called for health boards to not have these procedures going ahead, because it is not a banned procedure, many procedures still went ahead, because it was down to the choice of women in the full knowledge in discussion with their clinicians whether or not, in the light of the concerns raised, whether they still wanted to go ahead. Even during the process of suspension, because this is not a banned procedure, only the MHRA can ban this procedure, and they have not done so. Therefore, it is important that the recommendations that tighten up the procedures are put in place, not least the mandatory reporting. That is something that the women have called for. If we were to do nothing and not implement this report, then the mandatory reporting would not be implemented. There are elements of this report in the recommendations that are very important. The moratorium will remain in place. The suspension will not be lifted until the medical director can assure the CMO that those recommendations are in place, like the mandatory reporting, like making sure that the recommendations that are clear have to be put in place, and the CMO has been very clear with medical directors that all of that has to be in place before those procedures are offered on a routine basis. That is very important. I think that we will be coming back to mandatory reporting before the close of the session. However, I refer to the petitioner's submission dated 8 May to this committee. Following the resignation of the ex-chair Dr Laisley Wilkie in November 2016 and the appointment of Dr Tracy Gillis, a serving medical director, that became a Government review rather than an independent inquiry. The review has simply lost its independence. The current final report is clearly a whitewash, and the recommendations expose women to unnecessary harm. What reassurances can you offer to the committee, the Parliament and, most importantly, the petitioners that this report is the conclusion of a wholly independent process and that women can be assured that their experiences have been listened to and that they can have trust in the conclusions of the report and also the processes that led to those conclusions and recommendations? First of all, Laisley Wilkie's resignation was unfortunate. It was for personal reasons, as she is confirmed to me in writing. Of course, Tracy Gillis was taken over. It was a very difficult position to take over. It is a very complex issue and one where there were very strong differing views, not least within the clinical group within the independent review. It is not unusual for clinicians to disagree and within the independent review process they did disagree. That has been one of the issues that has been discussed on a number of occasions. In terms of Tracy Gillis and her position, I will let the CMO say a little bit more about that, but it is important to note that Tracy Gillis, in the time that she took over within NHS Lothian, was actually after—do you want to say a little bit about the time frame? Tracy Gillis had been medical director in 4th valley, which has not done any procedures using mesh since June 2016. She has then taken up a new position as medical director in NHS Lothian on 1 February. She was in a health board, which was not performing the procedures at the time that she was appointed to be the chair of the group. That still does not give us an assurance, at least the petitioners, that they have been listened to. Given that you have mentioned Tracy Gillis, there is some concern at the earlier evidence session that Tracy Gillis had made no attempt to contact the previous chair. Clearly there may have been personal reasons for that with regard to the previous chair, but have you expected at least an attempt to have been made to contact the previous chair? That would be a judgment for Tracy Gillis about whether or not she should contact the previous chair. The previous chair did resign for personal reasons. It is not for me to go into what those personal reasons were, but clearly she could not commit the time to the process in terms of whether there should have been a handover. Those are matters that the chair would have had to have judged in terms of whether she felt it was necessary to make that contact or not. In terms of continuity, perhaps there would have been some advantage to doing that. In terms of your question about whether or not the women felt that the independent review process has been a positive one or, indeed, has come to the conclusions that they would have liked the independent review to come to the conclusions, clearly that that is not the case. The independent review has not come to the conclusions that the women wanted. In fact, for most of the correspondence that I have had from women who have been adversely affected by mesh, the conclusion that they wanted the independent review to come out with was a ban on mesh. Unfortunately, that could never have been the case because only the MHRA can ban mesh. Indeed, it is a procedure that is approved for use within the UK. I believe that the MHRA, in the evidence that is given here, I know that there have been criticisms of that evidence. I have written to Jeremy Hunt to ask him what his view is of the way that MHRA goes about its business and whether there are lessons there in terms of whether they can improve their communication and the way that they take evidence. I am not in charge of the MHRA. That lies elsewhere, but they are a key organisation within the process. They are the only organisation that can ban a procedure. I cannot ban that procedure. That is why, during the suspension, women were still able to have the procedure if they consented to that and were fully informed about the risks. We know that that happened during the process of the suspension. I very specifically want to come in on this, cabinet secretary. I was a member of this committee in 2015 when we heard evidence from the MHRA. It was some of the most deeply unimpressive evidence that I have heard in my lifetime, frankly. Never mind my political career. It was patronising. It was arrogant. Much more fundamentally, it was crassly superficial. I do not think that this should have been part of the review committee, but that is neither here nor there. Here comes the point. I have heard you say—I have spoken to the First Minister, asked the First Minister in the chamber. I have asked questions of you about the MHRA. The responses you have been received remind me of when I was a boy of a programme called Hogan's Heroes that used to have a Sergeant Shultz on it, whose response to everything was, I see nothing. That has been the MHRA's response. I am concerned that this is a skirt, cabinet secretary, that you are hiding behind. Let me ask you. You say that the MHRA is the only body that has the power to ban this and that it is a UK reserve body. I understand that. If you had the power, would you ban the procedure? If the MHRA were a devolved organisation that reported to me, and they said that this is a medical device that should not be used, then, of course, I would accept that evidence, but I am not a clinician. I cannot decide what medical devices and procedures should be banned or not banned. Actually, the fact that it is reserved is irrelevant. What you are saying is that, because the body, which I believe has fundamentally failed in its analysis and its contribution, but it does not really matter whether it is reserved, if the body was reporting to you, you still would not be here today implementing a ban. If you are saying to me that a body that is designed to say whether or not a medical device or procedure should be banned or not banned, and they tell me that it should not be banned, and I was to say as a politician, while I am going to ignore that and ban it anyway, that would be irresponsible of me as a politician. I am not a clinician. I rely on those organisations and bodies to give advice about whether or not a procedure should be banned, and they have said that it should not. Now, where I do agree with you is that the way that they have gone about their communication and their evidence session, I understand that, and I saw it as well. I think that there is absolutely a need for the MHRA to look into all that. I have written to Jeremy Hunt asking for his view, because obviously there is a report coming to NHS England in the summer about mesh that will be of further importance in terms of what that says for NHS England. However, in terms of what the MHRA's position is in all of this, whether they were devolved or reserved, if their recommendation about a medical device to me as a Cabinet Secretary is to ban or not to ban, I would have to follow that, because on what basis would I not? I can understand that. On what basis would I not? I come back to the evidence that you have given, which has been that no ban was possible because the MHRA is a reserved body. That is a convenience, because what you are saying is that the fact that it is reserved is irrelevant. If that body had not made that recommendation to you, you would not implement the ban. That is the point that I am getting to. I want to ask you, Cabinet Secretary, given how dissatisfied there has been expressed the whole conduct of the MHRA in all of this, and even the reservations that you have expressed, what steps have you taken to have these matters devolved to the Scottish Parliament? We want all matters devolved to the Scottish Parliament. I would be very happy for the powers of the MHRA to be devolved, and we will continue to make those arguments about that and many other matters, but we have to separate out the conduct of the MHRA and the recommendations that they make. Whether or not we think that the conduct of the MHRA is right or wrong, their recommendation determines whether or not a medical procedure can go ahead or not. Whether that is devolved or reserved as a politician, on what basis would I reject that recommendation? I think that we would be into very serious territory if I was deciding what procedures were to go ahead or not, what medicines we have or do not have in use in the NHS. Those are matters that we rely on clinical expertise to determine, and I would hope that you would accept that limitation in terms of the power I would have. I accept it to this extent, but surely as politicians, if we see a body that we feel is not acting appropriately and whose conduct of an investigation we believe not to have been comprehensive in a way that inspires confidence as politicians, that is something on which we should then intervene and we have it. Every time those concerns were raised about the MHRA, I have communicated those concerns in the strongest terms about the evidence session and about concerns that you yourself raised within Parliament. Each and every time I raise those concerns with the body directly. Can I just ask if the logic of your position is then that if you had been Cabinet Secretary for Health at the time when this issue emerged, you would not have called for an independent review because you cannot second guess the work of the regulatory body? The independent review was to look at a number of issues surrounding mesh, it was to look at what the guidance would be to health boards, what it is we are asking clinicians to do in terms of following the best evidence and guidance, but I think to say that in some way the independent review could have banned a procedure that is not a banned procedure across the UK is it could not have done that. It could have said with respect possibly they wouldn't spend public money on it. The clinical evidence that has been gathered as part of the independent review process is the clinical evidence. What I'm saying is it was probably never going to meet the understandable expectations that many of the women had that have written to me saying that we wanted a ban. All I'm saying is that that was probably never going to be the expectation that was going to be met through the independent review process because what the independent review process was really going to look at was the evidence of when mesh should and should not be used within the NHS here in Scotland. Rona Mackay. Thank you, convener. Good morning, cabinet secretary. At topical questions on 7 March, you said that at the end of all this, we must make sure that whatever guidance is given to the NHS and clinicians, it's based on the most robust evidence. I wonder if you could tell us what constitutes the most robust evidence and how will that evidence-based review to ensure that it reflects the most up-to-date information? I'll ask Catherine to come in with some of the detail around the evidence, but whether it's from the interim report to the final report, obviously a lot of evidence has been looked at through the independent review process. Some of that evidence was external reports that became into the public domain in between the interim and the final reports and all of that has been looked at by the independent review process. It's fair to say that there were clinical disagreements around that, and I think that those have been well aired in terms of the view of one clinician being different from the view of the other clinicians. As I've said previously, that's not necessarily unusual, but given the controversy and the strong feeling around that issue, it has taken on additional significance. If I could maybe ask Catherine just to say a little bit about the evidence and how that has been handled by the independent review and, importantly, what then happens with that in terms of the guidance to boards? One of the reasons for the delay between the interim review and the final publication was waiting for several very large pieces of evidence, a European study that was looking at the safety of the use of mesh and the prospect trial, which has a long-term follow-up of the use of mesh in prolapse. It's the evidence from that prospect trial, which has led the conclusion about the use of mesh in vaginal prolapse, not to be used, except—and the full text in the chapter actually says that it must not be used routinely, may only be used in complex situations and then only with the agreement of the full multidisciplinary team. That evidence, which was well worth waiting for, led us in the clinical community to completely change the way we would talk to women about having mesh for vaginal prolapse so that we will not discuss the use of mesh except in very complicated examples of prolapse. We will only use native tissue to repair prolapse when women are coming forward with symptoms. As for stress, urinary incontinence, the evidence again, we've waited to collate as much evidence as possible because we know these trials are going to be published. We have publication dates, again well worth waiting for those because we now have a much broader body of evidence, where the complication rates can be discussed with women with the most up-to-date evidence. What I have asked is that our current information for patients is completely reviewed. We do have a standard leaflet at the moment for stress, urinary incontinence, but of course that now needs to be updated. We have the instruction to medical directors about the mesh not to be used for vaginal prolapse. We would expect the oversight group to keep reviewing the evidence that comes forward, but also to review the data that ISD is collecting for us. We have new codes, so again, after the women bringing the petition forward, we have made changes because we realised that our coding for these procedures was not adequate. It did not reflect the complications, as the women will affirm. It did not talk about removal properly. It did not talk about the number of procedures that women were having. Those codes have now been revised. Those will be used in ISD to collect all of our data going forward. I expect the oversight group to look at the data of mesh use, but also for procedures that are not using mesh across Scotland. Does that mean that you agree with the petitioners that the final review, which you are saying is going to be progressively updated, does not strike the right balance and does not reflect their experience of the procedure as much as it should? Absolutely not. I have met women since all of this process started. I have listened to their stories, and their stories clearly are. You can hear them from them themselves, but they are very clearly documented. We know that there are women who have had mesh inserted into them because they were not properly consented. They did not have a full description of what might happen in the worst-case scenario to them. For that, I have already apologised because no one intends, as a clinician, to harm patients and women. We have moved from that situation to needing to find out more about exactly what this mesh was doing to women. At the time that some of the women had the procedures done, the full evidence was not available. The clinicians were working on the evidence that they had, but some of it was very short-term. Mesh has only been used for around 10 to 15 years. The evidence that we now have is partly because of the brave efforts of the women in flagging this up, the need for more research, and the need for long-term complications to be followed up. We have changed the way that we are talking to women who come forward. We must remember that around 50 per cent of all women will have incontinence at some stage in their lives. This is an extremely common condition. In some cases, it is very life-limiting. It restricts people, so they come forward. What I am trying to get at is that, given the level of risk that is involved, we have now moved to a state of category 3. Would it not have been safer just to say, let's not do this? When women are coming forward, as I said, this is common, so a lot of women come forward. Those with particularly severe symptoms will be referred up to hospital to either a gynaecologist or a urologist to discuss their symptoms. In some cases, those women will have such severe symptoms that they want to have something done. Reading that they have laid out in this review is that all options must be offered. For some women, they will have no treatment at all, their decision, a shared decision between them and their clinician, but for other women what we want is that there are all the options, with all the complications, all the risks, all those things that those women were not fully aware of. At that time, they did not have what we would not see as fully informed consent. Can we move on in modest recording? With regard to the shared decision tables, are you content that all the relevant information is clear, reliable and easily accessible for all those who need to use it in considering the treatment options? Also, does it sufficiently support informed decision making on the part of the person seeking treatment? I understand a lot of the discussion that was had at the previous session around the way that information has been presented within the report and the changes between the internal report and the final report. I understand that all the information is there in some form, but it is there in a different way than was initially there in the interim report. The chair has explained the rationale behind that. I understand the complexity of it. I think that it is not particularly an easy report to read, which is why there is a commitment to produce an easier version of the report. That is the right thing to do. That is something that Professor Britton should look at in terms of the type of information. When it is complex information, some of it is clinically complex, and the way that it is translated into a public-facing report is something that we should look at through Professor Britton's work. Catherine, do you want to say a little bit about the evidence team? I think that the way that the review is in the interests of time, if you have a particular view on that, we could maybe write us about that. I think that the points that the cabinet secretary probably covered it. Yes. My reason for asking this question to the cabinet secretary and Dr Colwood is that, if it has been reported, there are only 27 per cent of the mess procedures, and therefore I have a concern about the reliability based on that low rate of the information that you are basing some of your decisions on. I am also very concerned about that. My letter, which was followed immediately after the publication of the review, I wrote to the medical directors. I have provided a copy for the committee for you to see afterwards. I have said that the report provides clear guidance on the use of mesh for the two clinical indications. At all times, information must be shared with patients and mandatory reporting by clinicians of procedures to a recognised database. In accordance with the general medical council guidance, adverse events involving mesh as a medical device must be reported. I have spoken personally to all medical directors. They received my letter and have welcomed it, and they have since been asked to confirm with me their arrangements for starting to audit all of these procedures on a recognised database, so that a surgeon will not be able to do the procedures unless they are recording their outcomes, including complications on a recognised database. Medical directors have all said that they will support that. I have no doubt that suffering from incontinence or prolapse is a completely miserable experience, but it does not lead to the loss of your job, your home, your career, your marriage, your ability to walk or enjoy a life. The report simply does not cut it. The chairs did not meet each other. I find that absolutely remarkable that the people heading up the inquiry did not meet each other. For whatever reason, we have members of the committee, the review group, who did not attend meetings for 10 months, were never included in agendas or minutes, asked for them and were not received. The nature published report into the adverse incidents omitted. We have the EU reclassification omitted, the FDA advice note omitted, and the original report completely changed when the final report was published. We have FOIs that I have put into your department that have still not been released to tell us what has been going on. That is going to be the biggest litigation against the NHS in Scotland's history. That review simply does not cut it, cabinet secretary, and I think that you need to act, and you need to act now to do something about that, because all of that information about EU classification, new information that has come forward since the review and before it was published, has been omitted. That is not good enough. I say to Neil Findlay that, obviously, since the report, there has been the reclassification on 5 April, which has obviously been something that was in the offing and anticipated, but actually happened on 5 April. The fifth of 8 April, the European Parliament reclassified mesh. Cabinet secretary, can I just say that the date that we were given as a committee was the eighth of March, and Trace Gillis confirmed the eighth of March that that was the date? I have seen the paper from the European Parliament and it is the fifth of April. Can I ask if it was a surprise to you that the independent review did not reflect that movement at all? As I understand, the independent review talked about the anticipation of that, but obviously it had not been confirmed. Would there have been any issue if they had come to you and said, we want to delay publication post whatever the date was that the reclassification was going to be announced by the European Commission? Could they have said to you, you know what, this is coming up, this might affect what we want to say in our report. It is quite a significant issue, you had to reflect on it yourself. We would not expect to report to clearly the interim report, the final report was delayed until the prospect report was concluded, so this would have been a reasonable thing. If they had asked you that, would you have acceded to that request? If the chair had asked for more time in the light of that or any other report that was coming out, then of course. Could it have been reasonable for you informed by the chief medical officer to say that this report has come out ahead of this announcement? Could you now reflect and add it into your recommendations and reconvene for one meeting to see if that was significant? I understand that the report does refer and reflect to what they anticipate was going to be the change in classification. Catherine, I do not know whether the expectation was that it would be reclassified to class 3, and the report reflects that it was in draft consideration with the European Parliament. We did not have that date. We can provide you with the European Parliament decision to the committee. Sorry, I do not want to talk this. Is the decision of the European Commission material to this question? I think it was anticipated, as Catherine is saying, by the independent review that this would be happening, that this would be reclassified. It is just the fact that it had not actually happened, so the report is written from the point of view of recognising that was likely to happen, as I understand it. It is important also to realise that reclassification of all surgical mesh is not just vaginal mesh. We will send you the information that we have about the European Parliament. On the FOIs, as you will understand, there was a great number of FOIs, and that involves a lot of information. Just to reassure you that we will be responding to that as quickly as possible, but it obviously is a great deal of information that has been requested from your office, and that will take time to gather that information, but that will be issued to you as quickly as possible. Brian Whittle In the report, conclusion 8 says that, in cases of pelvic organ prolapse, mesh procedures must not be offered routinely. Cabinet Secretary, during your statement to Parliament on 30 March, you referred to those recommendations as clear, unambiguous and incredibly important. I wonder, then, if you can make it clear and unambiguous what is meant by must not be offered routinely, because surely that phrase is open to interpretation. The full wording is that the use of polypropylene mesh or biological graft should not be offered routinely, but it may be considered in complex conditions only after discussion at an appropriate constituted MDT. Catherine Calderwood earlier on alluded to that there may be exceptional cases where there is absolutely no other treatment available to the women who, in the full knowledge of and explanation of what those risks are, decide to go ahead because there is no other treatment available, so it will be exceptional circumstances. The MDT is really important here because it is then not just about that clinician's view, it would be the multidisciplinary team that would discuss it. We would only anticipate that in a very few cases in Scotland. It would usually be a case of procedentia. That is where the whole womb is outside the body. There is no other way of keeping that tissue from being outside the woman's body. We can do a hysterectomy where we remove the womb, but then sometimes what happens is that the vaginal vault prolapses. It is extremely uncomfortable. It causes terrible urinary problems. The only treatment that will suspend that tissue inside the woman's body in exceptional circumstances would be mesh. That would be the circumstances under which I would expect it to be used. Other forms of prolapse we have also read in the full chapter that it must only be native tissue used, no mesh. My point is that the phrase is not open to interpretation. That is the point. It is not absolutely original and clear. That is why the work that Catherine is doing with medical directors is making it very clear about the exceptional cases and when that would be used. In terms of the reduction in the number of surgeons who would carry out those procedures, all of which is about tightening up on making sure that the procedures are only used, first of all, with the full consent and understanding of the woman in terms of the risks and looking at all the other options. In that case, as Catherine said, we are talking about very specific circumstances where no other treatment is available and that the woman must fully understand the risks. Tightening up on all of that will be very, very important. Catherine is taking that work forward with the medical directors. If I could go back briefly to the issue of mandatory reporting, Dr Calderwood mentioned your letter to medical directors and health boards dated 27 March, which we have a copy of. We just got it during the meeting. I believe that that was cascaded. There was an instruction to cascade that down to GP practices as well. It sets out your expectation of clinicians stating at all times mandatory reporting of procedures that must be made to a recognised database. When do you expect the IRIC procedure to be in place with regard to mandatory reporting? Will there be a consistency with regard to the level of information that is recorded? The IRIC has been in place. It is our Scottish way of reporting any kind of adverse incident, not only for mesh. We have evidence of that. Again, due to the women drawing this to our attention, they were able to give a number of complications—a great many women—who had complications. When we looked at the IRIC data, there were tiny numbers being reported through that system. What we know is that clinicians do not report when they should, and there is not a full understanding of the types of complications they should be reporting. Again, I am taking this forward with medical directors. We are going to have many fewer surgeons performing these procedures because you will also see that I have said that each surgeon must perform a minimum of 20 procedures a year. Each medical director will know by name who is performing those procedures. We will have the data on the database that I have described already so that we know the numbers and the complications will also be recorded. Those clinicians will then need to further report those complications to IRIC to an external adverse review. We will then use those data in the oversight group as we monitor what is happening and what complications are happening in Scotland in the future. What is the timeline? Is it in place now? It has been in place. It is already in place. I have met all the medical directors who have cascaded the instructions into their health boards and staff who are discussing the procedures that are being performed, not only ones with mesh but the other procedures, so that they have heightened awareness of the need to report any complications to IRIC. Is there any procedure or sanction if they do not report? We have the GMC revalidation, which is based on yearly appraisals. I have also discussed with the medical directors that they will discuss the data for these surgical procedures so that each surgeon is bringing the number of procedures that I have performed. Those were the complications and then they would be asked, did you report those complications as per the IRIC criteria for reporting of adverse incidents? Through a yearly appraisal, which every five years is necessary to have a doctor revalidated so that we can have a licence to practice. I think that the heart of the concerns about this report are the perception that it may not have been as independent or independent. The second one is the issue of the ban. I think that these are the two core concerns that people have. On the first one, I will go back to the original question by Angus MacDonald, because I think that this is something that Professor Britton needs to look at. When Leslie Wilkie resigned and was replaced by Tracy Gillis, with all due respect to Catherine, I do not think that it really matters whether she was medical director of a health board that did or did not do meshes, the point was that at the time she was an employee of the national health service. Therefore, the perception is that this is an inside job, not an independent report. One of the lessons for the future is how do you define what an independent report is and who are independent members. Looking back, the MHRA should not have been on the committee review for the same reason, so I do think that there is an issue there. That leads me to the question, who actually sat down at the computer and drafted the report? Let me take the first, but I agree that sometimes perception can be everything. It is very difficult once a perception is there to change that in any way. I could sit here all day and the perception is the perception. We absolutely have to learn the lessons that, as you have pointed out, who sat on the review, who was invited to take part in the review, what were their expectations, what was the remit, what were the roles and responsibilities of each and every one within that independent review. I think that Professor Britton should look at all of that. If there are lessons to be learned around how, even though people still might disagree with future independent review conclusions, we might end up with a different subject in the same place because people disagree with the conclusions. If they feel that everything has been done in the right way in terms of process, I think that it would be very helpful in countering the perception and allegations that have been made around this review. Professor Britton absolutely needs to do that, and I think that is going to be very, very important going forward. In terms of the drafting of the report, Catherine, I understood that that was through the chair and the review group. I understand that I was not there on the clinical section. The draft was not written by civil servant or written by somebody like that. It was written by the members of the committee. Is that right? Well, that is my understanding. Certainly, the chair, as I understood, wrote the kind of overview part because I think that she wanted, well, there was obviously the lead-in and recognising some of the difficulties. As I understand that, that was very much her reflection. The clinicians wrote the clinical bit. I think that different people drafted different parts of the report. I think that it would be useful to get a breakdown of that and find out who were the authors of the various bits of this report. I think that that would answer some questions or not about the reliability and people's minds of the report. I will ask because, obviously, I do not think that he has spoken publicly, but what were the stated reasons as well as Oliver and Elaine resigning from the committee? Obviously, a consultant resigned from the committee. Why did he resign from the committee? Obviously, the person has not been named in the public domain. Let's talk about the clinician. As I understand, the main reason for his resignation was a disagreement with the other clinicians about the evidence. In his view, his preference was for a procedure called... Culpo suspension. He felt that that should be the main procedure offered to women. The other clinicians disagreed and said that that should be one of the options, but the other options should be offered to women. I think that if you boil it down, there are probably other issues, but to me, looking at it from what I understand, that has been the main issue. There was a fundamental disagreement around that issue and that led to his resignation. That leads me on to the next issue of the ban, because my understanding is that, in some jurisdictions, particularly in Australia and parts of North America, there has been a ban imposed. Is that right? I think that it is a restriction on use, which is much as the recommendations are here. There is nowhere where there is a total ban. Is that what you are saying? Yes. That is my understanding. It is not a total ban. Are you sure about that? I can certainly clarify that for you. Right. I have been told that there had been parts of Australia where there had been a total ban, but I think that information is quite useful, convener. We would certainly look into that, but, obviously, they will have their own regulatory regime that is equivalent to the MHRA, although we would expect all of them to be drawing from similar evidence bases in terms of the recommendations that they need. That was my point. If there is evidence that there is a ban, why did they do it, and we are not doing it, what lessons can we learn from them? That is what they can write to you. I think that the whole committee action is probably… I think that they can write to the convener. I think that the whole committee action is probably… Thanks very much, now. Are there any final, very brief questions from the committee? Brian? Thank you, chair. The gathering of evidence is crucial in any review and how that is gathered. I think that there are concerns that are raised today about the consistency across NHS boards of reporting of adverse events and also questioning the consistency and the guidelines of what constitutes an adverse event. Is that something that could be better addressed? Well, we have already been working with boards around the reporting of adverse events in relation to something completely unrelated to mesh, but around the adverse event reporting regarding maternity service. The issue that emerged with the nation and iron has brought to my attention that there needed to be the implementation of what is clear guidance to boards around adverse events, but they needed to implement that. Work is going on with boards around making sure that what they classify as an adverse event is the same and that how they report that adverse event is the same. That will be strengthened by the duty of Canada legislation that is coming in next year, which will be a requirement in law around the information that is put into the public domain around adverse event reporting. Catherine, do you want to add in? We know that it has not been adequate and has not been standardised. In this particular topic, we will have the oversight group, which will then produce guidance that is standardised and will scrutinise those adverse event reports. In the wider adverse event reporting, Healthcare Improvement Scotland has done a lot of work recently to try to improve both the level of reporting and to standardise that. More important, of course, is to use those adverse events to look at those and to learn lessons so that we can improve the services. At the meeting that Elaine Holmes and Olive McElroy had with the cabinet secretary following their resignation, they drew to your attention the fact that there was still out-of-date information residing in a number of NHS facilities and GP surgeries. You gave an assurance at that point that you would take steps to have that removed and updated. Are you able to give an assurance today that that has now happened and that no out-of-date literature is still being circulated? I can assure you that when there are discussions occurring, as per my letter, which Angus MacDonald has pointed out, it was cascaded right through the system to GP practices as well, so that when there are discussions, everybody has received this letter and should be talking to women using the up-to-date information from the review. I cannot say that there won't be an out-of-date leaflet that is sitting in a GP surgery. There are out-of-date okay magazines and all sorts sitting in it. Sorry, I did not mean that to sound as it has been interpreted. I would not want to assure this committee that you wouldn't find an out-of-date information leaflet in a GP surgery or a hospital. What I do know is that we have made sure that the information is available to those who will be discussing the women's problems with them. We are striving to make sure that that is not the case, but I think that you would appreciate that it would be difficult for me to give assurance that there may not be an out-of-date leaflet somewhere in a GP surgery, but we are working hard with health boards trying to disseminate through to GP practices to avoid that happening where at all possible, but it is working in progress. I am happy to keep you updated about that. I will just ask two very brief points at the end. First of all, and if we don't have time for you to respond in full, are you concerned that there was full sign-up to the interim review and then the final reports clearly not being able to gather that? Secondly, there was some discussion at the earlier session with the chair about your reporting and request that the information that the women had provided to the report be removed. I am understanding that you asked for that to be done and it was not done, and I wonder whether it may be that you want to reflect on what Tracy Gillis has said to us, but it would be good if you could come back to that, because I think that that was something that we were concerned about. The request made to you that you then pursued with the chair, which did not seem to be accepted as quite significant, that what they had contributed to the report should be removed because—not to put words into their mouth, but the sense that having participated—to their participation—was almost then being used as a means of them having part of a process that they then did not agree with? I understand that, and we talked at length about this when I met with the women on the 16th of March. We talked in detail around a number of those issues. They also mentioned their support for the interim report compared to the final report. I understand that it is still important to recognise that there are recommendations in the final report, not least the one that we have talked about around mesh for prolapse, which is important. The mandatory reporting was not in the interim report, but was not in the final report. I understand and heard what the women said about their support for the interim report compared to the final report. When I met with the chair on 22 March, I relayed to her all of the concerns that the women had raised. She then contacted the women to ask about a number of pieces of information and to seek clarity about what should be removed. The women then responded on 23 March with a list of information that they wanted to remove, and it was then ultimately the chair's decision about whether or not to accede to that request. She has clearly agreed with some of that and agreed to remove, for example, the minority report. She gave her reasons earlier about why she did not remove the other material. It is not my report that was an independent report, and it was for the chair to make that decision. I relayed to the chair the concerns that the women had raised. It may be that we will have to write to you about that, because I think that there is a sense that people thought that you were going to be at least indicating your support for the material being removed. I appreciate it. I think that it will be useful for you to look at the exchange committee, and we can also pursue that further. I am genuinely concerned about time, and I appreciate that it is such a significant issue for so many people that we do not want to lose the opportunity to get it absolutely right. Given that we are nearly 10 minutes away from having to stop altogether, thank you, cabinet secretary, and the chief medical officer for your evidence. What we will now do is look at how we think that it should be taken forward. I would say to you that there are further things that you want to feed into the committee in the next period. I think that that would be helpful. My sense is that the difference between the interim report and the final report getting agreement is so significant. I think that we should be asking the petitioners to come back and give oral evidence. It would be worth while asking everyone who was on the review group whether they resigned or not to take the opportunity to give us the evidence about how they feel the conclusions were reached and, to the extent that they want to do that, that would be a matter for them. I think that that would be useful. Are there other suggestions that people have? I think that, firstly, we should reflect on the evidence that we have heard today, a great deal of extra additional information. Clearly, the view of the petitioners should be sought, however, in the meantime, I would be keen to instruct our committee clerks to seek time for a debate on the serious issue in the chamber of the Parliament, to allow other members of the Parliament to raise issues that they no doubt have. We have had a ministerial statement on the 30th of March, however, I feel that a parliamentary debate is justified. I am not sure if that can be diverted before recess or not, but I think that a full debate in the chamber is long overdue and should be explored further. We can certainly explore that with the convener's committee, but there are a limited number of slots for committee debates. However, I am sure that the Scottish Government will also be aware that we think that there is a good and important debate, so it may be that they can, through the cabinet secretary, be something that can be flagged up to the business manager. Are there anything else that we think—I think that we have agreed that this is certainly an optition—that we want to close? I think that there is further information for other concerns that need to be addressed, and some of those are the ones that I have suggested. I support the debate in the chamber. I think that what we have said is that to get more evidence, I would be keen to hear from the members of the group. I think that we have already heard from them. I suppose that one thing that we do want to ask the class bearing the mind that the comment that was made by Alex Eil was whether those regulatory powers are coming to the Parliament or not, and if they are, it would be something that we can then ask the Scottish Government what it might want to do. In my sense, there are so many of those issues. Where is the authority to the clinician's stop? It is very difficult when somebody says that it is a clinical decision. We all have to say fair enough, but at the same time, I was highlighted by Alex Neil other questions about even though there is a clinical or that it exists in regulatory terms, does that mean that the national health service has to sanction it? We are just trying to understand how that works would be useful. If there are any waiver powers, I mean a parallel example, I am not saying parallel in the sense that I do not know now what the up-to-date position is with the regulatory given the new powers, but if you take housing, for example, we did not have the power to licence the PRS sector, I understand that we now have that power if we want to use it. None of us would know that from the way that legislation is presented at Westminster, so I think that it would be useful just to get a legal advisory update on what the scope there is for repatriating the MHRE powers under the new legislation if there is any. For me, convener, there have been more questions than answers today, and I think that listening to the testimony today, especially in the first round, there were so many blank spots that I certainly would need time to reflect on everything that we have heard today. Without doubt, we need to hear from the petitioners again to hear their views on the review and what happened between the interim and the final review. I have got to say that I do support Angus MacDonald's call for a debate in the chamber, because, as I said, some of her hour we have got to bring this to some kind of conclusion. We want to take more evidence from petitioners, other stakeholders that we have identified, including people who were part of that review. While the chair changed, there is a group of people who remained, and what is their view on the way in which the thing changed, and those who resigned. We will recognise their privacy if they do not want to say anything publicly or to the committee, but I think that it would be worthwhile to seek that information from them. Convener, I am also getting an understanding of—and maybe this is more for Professor Britton—the members of the committee were drafting different sections of the report rather than one person pulling the draft together based on committee discussions, then I think that that would be a recipe for a lot of things to happen that necessarily—wasn't necessarily sort of endorsed by the entire committee or without realising what they were actually writing up. I think that that process is a highly unusual one for an independent review. There is one example where the difference between the—and it was before you came in—where the interim report says that, basically, some women who had adverse effects found that they were not believed, and it is an independent review that is expressing its concern, but at the time of the final one comes, it says that adverse effects felt that they were not believed. Now, this is clearly the same report with different versions. It is not as if it was a new report that went to the final version. It has not started again. They have been working on the interim report, and, in my view, they are softening up on that. When you end up with more than one author who is drafting the thing, I think that it is wide open to being problematic. I have never heard of that before, where the members of the committee actually draft sections of the report. There is usually a secretariat—I am pretty sure that we had agreed a secretariat to be independent to do that. We are not having a dialogue—sorry. It is okay. Everybody has been extremely well-behaved. It is just five minutes before the bell, so we know that everybody starts getting jumpy. Just to say that it would be useful for us to find that information, but I note that, from the cabinet secretary's letter, I think that Professor Britten will probably be looking at it because it says that the management and presentation of evidence, so it may be that we can both pursue it but recognise it as something that the independent review would do. I think that there are substantial things there that we can pursue, work for the clerks to do and an opportunity for people who may have an interest with voices not being heard yet to take that opportunity. Obviously, we will keep people informed about progress, particularly to petitioners who may wish to respond to this session. There was more information, but we will also be calling for evidence from you. I am sorry for keeping you there, cabinet secretary. For your attendance today, I recognise the scale of interest among the people who are in the audience. I thank you for abiding by the general constraints of the committee. That was very much appreciated by me and I am sure by other committee members. I also thank those non-committee members, MSPs, who are also attending today. I close the meeting.