 Welcome to the 12th meeting in 2016 of the Health and Sport Committee. I would ask everyone at this point, as I normally do, to switch off mobile phones that can sometimes interfere with the sound system but certainly can interfere with the committee proceedings. I would ask those present to note that colleagues and clerks are using tablet devices that are instead of their hard copies of the papers. The first item on our agenda this morning is a declaration of interest. I welcome Bob Doris back to the committee. Before I invite Mr Doris to declare any relevant interests, I want to put on record my and I'm sure the committee's thanks to Fiona Gloud who joined us in the committee for that period. Indeed, we worked with her in the past on the health committee. Mr Doris, I invite you to declare any relevant interests. I thank Fiona McLeod to take over on the committee. I was on paternal to leave in terms of any relevant interests and there is nothing outwith what is in my publicly available declaration of interest. I move to agenda item number two, which is the choice of deputy convener. The Parliament has agreed that only members of the Scottish Nationalist Party are eligible for nomination as deputy convener of the committee. That has been the case. Can I invite nominations for the position of deputy convener? Is there any other nominations? No, one nomination has been received, and therefore I ask the committee to agree that Bob Doris has been chosen as deputy convener of the committee. Are we all agreed? There is agreement, and I congratulate Bob Doris yet again on the two. Good to have you back anyway, that's good. We now move to agenda item number three, and I invite members to agree to take consideration of the evidence and social work complaints procedure at agenda item five, which is in private at this meeting. Are we all agreed? Thank you. We now then move to agenda item number four, which is oral evidence on access to new medicines. We have with us Shona Robison, Cabinet Secretary of Health and Wellbeing in Sport. Welcome, Cabinet Secretary. Dr Rosemary Parr, chief pharmaceutical officer of Scotland, Scottish Government. Angelina Foster, CBE chief executive healthcare improvement Scotland, and Professor Jonathan Fox, chairman of the Scottish Medical Consortium. Can I welcome you all this morning? I invite the cabinet secretary to make a brief statement to the committee before we move to questions. Thank you very much, convener. I am very pleased to be here this morning to talk to the committee about access to new medicines. As we enter the last few weeks of this Parliament, I think that the committee should be very proud of its work in this area and the achievements made in increasing access to new medicines in Scotland. I think that it's worth me just taking a moment to run through the main changes that have been made in the last two years, as it's quite a list. The SMC now hold their meetings in public with pharmaceutical company representatives part of those meetings. There's a new framework for considering ultra-orphan medicines. The patient and clinical engagement process has been introduced together with additional opportunities for companies to put forward a patient access scheme. SMC has seen an increase of around 40 per cent in its acceptance rate for end-of-life orphan and ultra-orphan medicines and a pilot of early dialogue with pharmaceutical companies is on-going. I've heard much-deserved praise for the public and patient engagement programme that SMC has put in place. That work is being fostered with a pilot of sharing SMC decisions and confidence with patient groups ahead of publication. We've expanded and replaced the rare conditions medicines fund with the new medicines fund. The amount available has doubled twice in consecutive years and stands at £90 million this year, meaning that the financial support has been there to implement the increase in access to new medicines. The flexibility that the committee called for in individual patient treatment requests has delivered a tenfold increase in access to end-of-life orphan and ultra-orphan medicines and there is a pilot on-going of the peer-approved clinical system. An area drug and therapeutics committee collaborative has been established and achieved some early successes in bringing together representatives from across Scotland. They have led national work to optimise medicines use, are supporting strength in public involvement and developing and testing new categorisation and communication policy for formulary decisions. The final development to note is that a formal programme of work for monitoring clinical effectiveness of cancer medicines in real-life settings has been established. Many of the changes that I have mentioned have been delivered by the Scottish Medicines Consortium and Healthcare Improvement Scotland, and they should be commended for their dedication in making the changes that the Parliament and the Scottish Government ask for. To take a phrase from you, convener, have we got more yeses? Yes, without doubt, we have, but we are not complacent and we need to continue to build on what has been achieved. There is more that needs to be done on fairer pricing of drugs for the NHS and ensuring that the patient voice is front and centre of decision making. A key next step for us is the independent new medicines review led by Dr Brian Montgomery. That will officially launch on the 21st of March with a stakeholder event in Edinburgh. Dr Montgomery will take stock of the progress to date and advise us on whether the systems that we have in place are fit for the future. Thank you, cabinet secretary. We have our first questions, which are from Nenette Mellon. Thank you very much. I think that I would share enthusiasm about the progress so far. I agree that there is more to be made. I would like to ask one or two questions, if I may, around the distribution and spending of the new medicines fund. I was under the impression—and I gather that it is not the case—that this was a fund that was held essentially that it could be applied for. I understand that it is actually distributed to NHS boards according to the NRAC formula. Can you tell me which it actually is? The new medicines fund has really ensured that boards can deliver what the Scottish Government and the Parliament's policy intentions are. Boards receive the resources. In 2014-15 NHS boards required £1.1 million to support SMC decisions and £20.5 million to support individual and group patient treatment requests from the new medicines fund. Any funding not required by NHS boards for that purpose in 2014-15 remains available in 2015-16 on top of the new allocation made in 2015-16. We keep very close to boards around making sure that we monitor the use of the fund and ensure that it is adequate to meet the needs of the board area. We will continue to do that. However, it is allocated to boards, but we keep a very close monitoring on the level of resources. There seemed to be a little lack of clarity among witnesses last week on the round table that we had. Which boards are using all their funding? NHS operator Glasgow and Clyde said that they were using all theirs and perhaps needed more. Are other boards using all theirs, or is there some still floating around that it is not used? We continue to ask boards to inform us immediately if they have any concerns about their funding allocation. I suppose that, mainly on the basis of it being sufficient to meet anticipated expenditure, no board has raised this as an issue with us. We make it clear to boards that they are expected to utilise their funds for the stated purpose over the lifetime of the fund. It might not be that they do not spend it in a particular financial year, but we would expect them to spend it over the lifetime of the fund. We think that there probably should be more transparency around how the new medicines fund has been utilised. We had planned to publish details of the number of patients treated and the relevant drugs, but the committee might be aware that there is a freedom of information request on-going to provide details of spend on the top 10 drugs, which has been an on-going complicating factor. Releasing patient numbers and spend per drug poses a risk to commercial and confidence information on pricing. Once that process is concluded, we will publish that information that we were planning to. I hope that that will provide a bit more information on how the fund is being spent. I think that that would be very welcome, because that was a point that was made that people did not know how many patients were being treated and what therapies were being provided for. That is interesting. Do you think that the fund will continue to be funded centrally? I know how it is funded at the moment from the PPRS, but do you think that it is likely to continue into the future? Obviously, what happens beyond the current PPRS agreement is an important point. The committee will be aware that it is a scheme that is negotiated between the UK Government and the ABPI, which is the Association of British Pharmaceutical Industry. The Scottish Government and the other devolved nations had asked for inclusion in the previous negotiations, and unfortunately that was refused. Since then, there has been greater involvement of the Scottish Government in the operation of the current PPRS. Of course, there are discussions on how Scotland can be included in future negotiations and decisions, whatever form it may take. We would be keen if there are changes that the UK Government wants to negotiate around that. We want to very much be involved, and I am sure that Wales and Northern Ireland do as well in what that looks like. We have the support of groups such as the Scottish Cancer Coalition on Scotland's involvement in future negotiations, because it is very important that we have a voice in those discussions, should PPRS be replaced in the future. Just some clarity to understand what a future committee will get and what timelines in terms of the breakdown of how the funds are spent, in terms of new dogs that are recommended by NICE, those that are recommended by the SMC, those that are not recommended by the SMC. We can get all those types of breakdowns. We want to furnish with as much information as possible. As I said, there has been a complicated factor around FOI, and that has delayed us putting that information out. However, we will provide as much information as we can. It is where information strays into the domain of commercial and confidence information that has obviously been negotiated with pharmaceutical companies around price. There are obviously sensitivities there, but we want to be as full and transparent as possible. Rosemary, do you want to say a little bit? To add to that, that is really important. I think that transparency, we would definitely want to give some information around that when we can. I think that that would be important. I think that the new medicines fund has been a real issue about trying to ensure that access has been increased, and I think that that is really positive. What it has done is allowed the NHS boards to deliver on the Scottish Government and the Parliament's policy intentions around increased access to new medicines. I think that that is an important area. We would certainly want to be very involved when it comes to before December 18, before this fund may change, and how that goes into the future. The Government has taken the intention to publish all of that information. I do not presume that, if we were talking about total spend on drugs that were not recommended by Nicer, SMC or whatever, that would get around the confidentiality or any business case? I think that we would want to publish as much information as possible. I suppose that where it gets into difficult territory is where there could be an association made between individual patient numbers with a specific drug and the cost of that because you could then work out price. Then there are commercially sensitive issues around the negotiation that pharmaceutical companies may have around the issue of price. Angela, do you want to say a little bit about that? Simply to endorse, I think that the issue that has been raised, which is in terms of our fundamental desire for maximum transparency, the trade-off in there is this issue around commercial and confidence. We just need to be careful not to create unintended difficulties there. From the committee's point of view, we are trying to judge what would have been available, what is now available and what is not available in the past, which gives us our more yeses. We should say at the start here that the evidence that we have had written for them and the oral session reflects what the committee feels and what the cabinet secretary feels that we are making good progress here, so we are not trying to be negative in that sense. The fact that the new medicine fund of Scotland is funded by the rebate that the industry makes with the PPRS and some evidence that we had last week from Glasgow Clyde that there was a funding issue this year. Is that a result of the rebate reducing in the shorter term? Does that give us challenges or will we anticipate that rebate will be able to fund the existing scheme and discuss what the future will look like and how that will be funded? The actual PPRS receipts are expected to be lower than was expected. That is across the whole of the UK, not just an issue for us, but across the board. In some ways, it is based on an estimate of what the receipts are that we would expect to receive. We will have to manage that. We will work very closely with boards to ensure that we manage that budget and ensure at the end of the day that the most important thing here is that patients receive the support that they require, that the fund is using the most appropriate way. As I have said, there is an ability to manage that over a number of years so that there is not such pressure in one financial year. That is what we will work with boards to ensure that that happens. I guess that this would be an issue that we want to be around the table in discussing about any schemes that would replace PPRS. At the moment, we have a system that is an estimate. We then build our fund on the basis of that. There can be issues where that is not in sync. Last year, that was not the case. That was different. We do not know what will happen in future years. Perhaps, as part of a review of PPRS, we would want to look at whether we can better match the anticipated receipts. I am not sure how we would do that, but it would be good if we could better anticipate the receipts that we are going to get and the funding that would come in when we set the budget for our new medicines fund. The shortfall this year, as was described in evidence last week from Glasgow Clyde, will not impact on patients or patient access to new medicines. We will work with boards to manage that and make sure that there is no detriment to patients. Will that mean that the Scottish Government will make up that shortfall this year? We have asked boards whether they are anticipating any problems with the resources that they have with the demand that they have. At the moment, they are telling us that they do not, but we are keeping a very close eye on that. Boards are not saying that we are not going to be able to manage the resources that we have with patient demand, but if required, that would be good. That includes Glasgow Clyde to the health board, who came along as I said last week. There is a shortfall. It is not something that will impact on patients that can be overcome by the health boards or the Scottish Government. Will forecasting in the future be any way to forecast whether that will be just a blip this year or will that impact over the next term? That is a very good point. I think that horizon scanning in this area is quite difficult, and it is difficult to predict future spread. The Scottish Government works with the HIS and the boards themselves on horizon scanning for the new medicines fund expenditure, so we work quite closely with boards to do that. That is a continuous process, so that is how we draw up our horizon scans for boards as part of their financial planning, so we work quite closely with boards to do that. That also includes some financially sensitive information and is an on-going process with estimations there, so we would want to continue to do that and improve our horizon scanning as much as possible. Does that mean that there will be increasing pressure on the money fund scheme or does it not? I think that there probably will be increasing pressure around the money for the new medicines fund, but it is definitely not at risk just now. We have information, so I think that that is reasonable. Is that an issue that needs to be looked at in the review? We would certainly want to get the independent review to take stock of all that progress to date, and I think that that would be a really positive thing to do for Dr Montgomery. I think that the other key area that we would like to look at in the other aspect is to look at commercial negotiation on price as well, so that under our current system potentially we could do better to get a better price, and we want to look at those improvements there as well. The new medicines fund is very important and it has allowed boards, I think, to increase access to new medicines, and that is shown by an increase of around 40 per cent of acceptance rate by SMC across those areas for end-of-life orphan and ultra-orphan conditions. However, we would definitely want to negotiate better on price so that Scotland gets better value for the price of that new medicines fund. Two of the issues that were prominent in the oral evidence, which you may have seen and also in the written evidence for the PACE and the IPTR. In terms of PACE, I think that people really appreciated the extent of patient and clinician involvement, but two questions arose from our evidence in relation to PACE. First, it was good to have, as it were, pre-meetings, but there was concern that there was no possibility for patients or clinicians to be questioned at the final SMC meeting, and quite a few submissions and evidence last week suggested that that would be beneficial. The second issue was an issue about the evaluation of the decision-making by the SMC and, in particular, the impact of PACE on that. Therefore, I do not know whether we have any information on that or whether there are any proposals to evaluate it, but I would say that those were the two main issues that came up in relation to PACE, but it was obviously very positive in terms of what PACE has achieved so far. I think that, like you have said, we have received pretty full positive feedback from patient groups about how their views are being taken on board and into account through PACE. One of the specific areas that I have asked Dr Montgomery to look at is the very point about whether there is more that needs to be done around that. You have mentioned one specifically around the end point of decision-making. That is why we have made huge progress, but we know that there is always more that can be done and there are further improvements that I am sure that can be made. Dr Montgomery will look at that, and if there are recommendations that he thinks could further improve the system, I am sure that he will make those recommendations. I will kick off on the IPTR. I am sure that colleagues will want to follow up on it, but I suppose that the key issues around IPTR were to do with consistency and transparency. I think that people have various comments about how those issues might be addressed, but, again, while welcoming the extent to which IPTR had delivered more positive results for patients, there was concern about consistency between different boards in their decision-making process and the transparency of the process. I do not know whether there are any proposals to deal with that or to what extent it packs when it gets rolled out and will address those issues. As you have recognised, the extension to the flexibility that the committee called for has led to the tenfold inquiries from the time of the committee's inquiry. We can think about specific examples of where that has worked. I know that you have heard evidence directly from those who have benefited. We have been clear from the outset that there should be a reduction in the reliance on the route to access medicines as a result of changes made at SMC. The forthcoming review will test how that has worked as part of Dr Montgomery's review. If a system of packs in which there is intended to be much less reliance than for IPTR had been rolled out in May 2014, it would have been ahead of a body of decisions by SMC under its new process. As we have said, the extension to flexibility has allowed 500 patients to access ultra-orphan drugs in 2014 that, at the time, were not recommended by SMC. In terms of the rolling out of packs, that has coloured our view of how that should be done, which is why we went to the pilot. We recognised that something was working quite well, and we did not want to jeopardise that by moving too quickly to a new system. That is why we have the pilot in Glasgow and Clyde. It is also fair to say that boards have adapted their decision making. They have applied the flexibility in a way that we have seen the number, so the evidence is there to show that they have. Obviously, the new Medicines Fund has supported that change of approach, which has been very important. There will always be individual decisions and individual circumstances. I do not think that any system can wholly get away from that. Whether it is IPTR or whether it is packs, there will always be that element. Guidance to boards states that they should share best practice. We have encouraged that. We are, as I say, keeping a very close eye on decisions that are made either way. We are in a better place. We are moving forward with caution around the pilot and moving to that new system over time. We want to make sure that we continue with the positive improvements that we have seen. Amongst all that, there will still sometimes be decisions, whether it is under IPTR or whether it is under the new pack system that will be unpopular and difficult. I do not believe that no system will ever perfectly address that. However, we are in a much better place than we were previously. Can you explain to us the main ways in which packs are different from IPTR, or to what extent it is being piloted? Is that really about the detail or are there still some fundamental questions that you are exploring about packs? The changes that are being tested through the pilot are the focus on capturing measurable clinical benefit and monitoring the outcomes and adverse events. That is a key part of it. The approach of the prescribing clinician, leading on seeking peer support on an individual patient basis, is the use of a panel of clinicians to provide oversight of the cases that are put forward and the consistency that delivers. The focus of packs is the clinician being at the centre of it, but with oversight of that. There is nothing in the pilot so far that would cause any alarm in any way. We think that there is some good information that will come out of the pilot, not least trying to capture more and measure clinical benefit. The thing that we are less good at is seeing what happens when a drug is out there with a patient. Is it delivering what it was supposed to deliver? Is it delivering more? Is it delivering less? How do we capture some of that information and feed that back, potentially, into the SMC for future reference? Perhaps trying to complete the circle of real-time information? I think that that is right. We are being cautious on the pilot for this roll-out, for a peer-approved clinical system, and I think that that is the right approach. We want to look at the outcomes of that. That will be very important in going forward, involving more of the clinician as well on an individual basis. Those systems, such as IPTR and packs, hopefully in the longer term, we would want to see less reliance on those systems, so that SMC decisions would really be the ones that we would want to stick with on that kind of national basis. However, I think that in going forward, seeing what will happen with a pilot and any roll-out of that, we will look at that through the independent review, and I think that we are open to and prepared to make further changes if necessary. I think that, as the cabinet secretary has said, that this is a really interesting and difficult area for some people, so I think that that is really helpful that we do it with caution. I think that we want to see the main route for access to pharmaceutical companies, which is putting a good case through SMC and putting forward that good quality submission with a fair price and offering at SMC for the first time and really not by any other route, so I think that that is what we would like to see most. We will take all of those routes into account. I would like to offer a couple of extra comments in relation to the first part of Mr Chisholm's question about PACE. Mr Chisholm, you were asking, might it be desirable for patients and clinicians who have been part of PACE to also be present at the SMC meeting? I just wanted to mention that one of the bits of organisational arrangements that we have very deliberately put in place has been a thing called the patient involvement network. That is a support mechanism and a consultative mechanism whereby we are looking at how the current arrangements may evolve over time in a spirit of continuous improvement. My sense is that from the point of view of our internally driven, so to speak, continuous improvement, the patient involvement network may well be the place where proposals such as that may come from and then be looked at and mature. Your second aspect of your PACE point was around the impact. My observation would be simply that the figures that I genuinely believe to speak for themselves there in terms of the outcomes of the SMC decisions before and after the introduction of PACE. Lastly, I am sure that Professor Fox will wish to speak for himself, but I know that he is always very clear with his committee members about the importance that they ought to place around the output from the PACE meetings as a really crucial part of the deliberations of his committee. Rhoda, a supplementary on that question and any others who wish to pursue some of those points in the process? Just around the IPTR system and how it operates currently, we are still getting people expressing concerns that some people are getting access to medicines that others are not. That looks a bit starker if you are both being treated by the same clinicians but come from different health boards. One then imagines that it is not about whether the treatment can actually make a difference, because one would imagine that the information coming from the same clinicians is the same. I am wondering what health boards are basing their decisions on those requests currently, how transparent is that and how that will change going forward? Ultimately, the clinical decision might be that one patient may benefit from that treatment, but another patient may not or the side effects may be such that that patient's clinical condition could not tolerate. We do not know what clinical discussions are with the clinical needs of the patient, so although it might appear that a clinician has made a different decision in two patient's cases about the same drug or that two health boards have made a different decision about a drug and a patient, what we do not know is what are the different circumstances of the patient, and they might be quite different. However, having said that, we keep a very close eye on making sure that if we were to become aware of what we would see as a process that raises questions, we would look at that and we would ask pertinent questions about that. However, overall, we have seen a different approach. Across all health boards, the numbers speak for themselves and would not be such if that was not the case. Ultimately, as I said to Malcolm Chisholm, there will be occasions when difficult decisions are made. We would expect that those decisions are based on clinical judgments and that there is a fair process around the boards that would use the best practice and guidance in how they approach whether it is IPTR or, indeed, in the future, a PAC system. However, if you are aware of any cases that you think are stand-out ones that you would want us to look at, and if you think that that has not been the case, then, by all means, you should either preferably let myself know and we will have a look at that. I mean, how much work have you carried out with clinicians who would be in that situation, who would see a difference between, for instance, taking the weights and, for example, do you speak to them? Do you listen to what they say about different health boards giving the okay for different drugs because they would be the people that would know, because they are treating the patients and they would know the information that they are feeding back to the health boards and they would know if they were getting different outcomes? It seems to me, and I do not have a case, but certainly anecdotally what seems to be coming back is that if you are in a different health board, you treat that slightly differently. Yeah, we do. Rosemary, do you want to say a bit more about it? Absolutely, yeah. I mean, it is an interesting area and I think what we have to say is that patient numbers in these areas are quite small, so it is actually quite difficult to interrogate the data, but the data that we have to date does not give any evidence of a postcode lottery, so there is something there about, I think, people perhaps having that impression, but I think that what we are seeing is that individual decisions are for individual patients and I think that it is right and proper that sometimes these decisions are different. I think that what we can point to is the fact that before the policy changes were made, around 50 patients accessed orphan-altern and end-of-life medicines through the IPTR route, and by 1415 that had increased to over 500 patients. I think that we are seeing increased access, even though those numbers are actually quite small, and we only really have anecdotal evidence of any postcode lottery and we do not think that that really does back up those claims. I think that what we can do in Scottish Government would absolutely help and want to bring forward is that sharing of boards' information, and you have heard that last week, I think, from some of the clinicians that, for some of those very small areas that clinicians sharing that information together is a really good thing, so we would absolutely encourage that to happen. Thanks for that. I think that you will have been aware and others have written the evidence that we have had in some of these issues and the oral evidence that we had last week, and most people are making the point that it is evolution that we are talking about here, but it is not a criticism of the progress that has been made. I think that it is worth just putting that on at the end again, you know that. Bob. Thanks, convener. I was going to return a little bit to the subject of price. I listened carefully. Rose-Marie Parr said that he wanted to get a better negotiate better in price for the NHS, and the cabinet secretary said that he wanted to get the best deal for the NHS. If I quote from Angelina Foster's submission to the committee ahead of this evidence session, it says that healthcare improvement Scotland believes that the assessment process is best served by pharmaceutical companies offering a competitive price from the outset. The price considered is the assessment, and the assessment may involve a patient access scheme. Throughout all that woven between it, of course, is the fact that we have commercial confidentiality as well, but the theme that I am getting again and again and again is that we can do better on price. That can only mean that pharmaceutical companies are charging more than we would expect to pay for medicines. The obvious benchmark for myself would be are we getting as good a deal as they are getting in England in relation to this? I would be keen to know are we negotiating as hard as we can on price? Are the pharmaceutical companies coming to the table to give the best possible deal? I spend much of my time working constructively with pharmaceutical companies as key stakeholders, but they are also private companies at the same time and getting that balance between maximising shareholder profit and their corporate and social responsibilities and the balances that they have there can be quite tricky. Given that prices have come up repeatedly in relation to the evidence this morning, are we getting the best deal on what more can we do and how does it compare to elsewhere in the UK? I think that this is a really important area that has been already very important. We have been monitoring this issue very closely, not just in relation to those medicines that fall within SMCs—a new approach, but generally. The short answer is that we do not always get to the company's best price first time around or even at all. I should be clear that I am not all of the pharmaceutical industry that it behaves in the same way when it comes to pricing. However, companies are absolutely entitled to take commercial decisions on how they wish to price their drugs. It is incumbent on all of us to ensure that the NHS has systems in place so that the best value is achieved and that the need for, for example, time-consuming resubmissions to SMC is avoided. We take the review that there should be external commercial negotiations linked with the SMC process. I think that the pharmaceutical industry could also do better on fairer pricing without unduly impacting on the returns for its shareholders. If we get that into a better place, it means that things such as the new medicines fund can go further, supporting more people in Scotland. We would expect that a pharmaceutical company is able to offer a better price elsewhere and that there is no reason for it not to offer that better price to the NHS in Scotland. This is an area that we have—again, I have asked Brian Montgomery—to look at how we can make those improvements. There are potential ways within the systems of trying to get an earlier discussion to avoid getting to the position at the end of the process where a better price is then offered on resubmission that could have been offered in the first place, and yet sometimes months have elapsed within that period. There are definitely some process issues that can be improved to get to that better position. However, as I have said, we think that there should be external commercial negotiations linked with the SFC process that can drive towards a fairer price, and that is something that we are very keen to pursue. I do not know whether— Absolutely. I think that the only thing to add to that is that the Scottish Government can monitor price very closely because we have access to commercial and confidence information, so that allows us to do that. That is how we can say that, in going forward, we think that there could be definitely some areas of improvement there. I think that that would help us to allow areas such as the new medicine fund to be used and to go further. I think that we would like to see that as part of what may come out of the review to see how we can do that better. I do not know if any other witnesses want to add to that. Yes, just to make it clear, I agree with everything that has been said, but the SFC itself does not negotiate on price. It would be a conflict with its role in medicine's assessment. Just one additional point about getting the best deal is that the new pace process, as well as the pace meeting, allows the companies to come back with a new or improved patient access scheme or confidential discount. That has helped on a number of occasions to improve the cost-effectiveness of the medicines. We have had about seven of those occurrences and the four of which have resulted in eventual acceptance. That has helped the ability to get the medicine at the best price, I would say. That is very helpful. I should point out that I have met pharmaceutical companies frequently and often. I should point out that I have never been paid to meet them, and it is done in a constructive, collegiate way in my role on this committee. However, the point that I would make is an important one. I have never met a company yet that does not say that they are in this for the best interests of the patients and for the people they serve. Therefore, if there are better deals being struck elsewhere in the UK, I am sure that they would want to look at that carefully and work constructively for the Scottish Government to make sure that Scotland is a better deal than we are currently doing. I am sure that they are listening to the exchange that we have just had. We are also hoping to develop a Scottish model of value, something that the committee was keen to see during evidence that we had on value-based pricing back in the day when we were doing our initial inquiry and access to new medicines. We are quite keen to hear about any update in relation to that. In particular, my interest has always been on clinical evidence from trials, which might not be as mature as it could be. There is not longevity to that evidence. I apologise if my terminology lets me down here, but I suppose that what I mean is that it is results-based reimbursement for lack of a better description and maybe even reimbursement in instalments. One of the things about whether someone consists of an employment for longer because of getting a medicine or their social care needs are less because of getting a pharmaceutical intervention. That is time-release savings to the health and social care sector and its upfront costs to NHS for medicines. In that context, I would view any Scottish model of value. I have to say that pharmaceutical companies would be key stakeholders to working in partnership to develop that. Is there any progress on that? Can we hope to see something in the near future? We said from the outset that the new approach adopted by SMC would be the first step in developing a Scottish model of value. The independent review under Dr Montgomery will consider whether the progress that is made to date provides a solid base for developing that concept further. I think that some of the points that you make are very fair. I agree. There will be a lot of interest, both from patient groups and the industry, to see how we build on that model of value as we go forward. I would absolutely say that the new approach is part of that. When we say that we have a new framework for end-of-life medicines, ultra-orphan and orphan drugs, they include modifiers and how that type of value can be taken forward as well. The patient and public involvement and the PACE process and the pilot packs can all be added to that model and how we take things forward. That would be a solid movement on the way forward. I think that there are issues about trying to look at evidence and outcomes. I would agree with your points that sometimes the narrative is not just always about access to new drugs, it is how they are used and what the outcomes we get from that, too. We will definitely be looking at aspects of the context of looking at new medicines and what evidence they have and what they deliver, both for the patient and for the NHS. We expect the review to look at the type of real-time health technology assessment that you were referring to. That would definitely need further consideration for policy and practising it into the future, but we want to look at that as part of the wider group. To see what nationally and internationally companies and countries are doing around health technology assessment, I think that that would be very positive to go into that view, too. Professor Fox, one of the issues that was raised is that the SMC does not negotiate in price, but one of the issues that has been raised by people with access to new medicines is that sometimes nothing very much changes other than the price and then the new medicine that is made available. What we are getting in evidence is that the principle that price does not really matter when in the process itself, if the price changes, then the drug that has been tightly accessed does become available. That process is important to people who have been heard and written evidence in last week. There is also the issue about the openness, and pharmaceutical companies are saying, well, if we knew more about the initial discussion, whether that is right or wrong, if we knew more about why that new dog or medicine was refused, we would be able to respond quicker. The process itself has been criticised by all sides. The Government is not working for them in terms of price. The patient who has denied access and it takes longer time to access that medicine sometimes too late because of the process, the negotiation is rightly or wrongly that takes place. Let us hear what you have got to say. We might be able to offer you, so it is important that there is a negotiation there. The process has been highlighted as one of the issues that are causing problems. Will those type of issues be addressed by the review and how? That is a key issue that Dr Montgomery's review will consider about how we get to the nub of the issue of the best prices early on and the process as possible to avoid the scenario that you have described. How can we have an external process that is linked to the SMC process but is driving that discussion at an early enough stage that can result in a—what do we want out of that? We want the best price, the fairest price at the earliest stage of the process as possible to avoid what you have described at the end of the process or a resubmission coming back with a different offer. That is one of the key issues that Dr Montgomery has been asked to look at so that we can focus on getting the right set of procedures in place. Some of that will no doubt be external to the SMC, but we will have to feed in to the SMC in the right way. That is a key ask of Dr Montgomery to take that forward. We are more likely to get a better price from pharmaceutical companies if we work with the UK Government or the European Government, so they are all competing. That is the market. If I can sell a drug in Italy that they are prepared to pay twice the money for, how do we circumvent that market? How do we get with our population size and our demand and spend to get a better price than our next-door neighbours with £60 million? Is there opportunities for Governments to work together to ensure better pricing rather than seeking a Scottish solution to taking on global companies? If it is helpful, I sense that there are three distinct concepts that we are wrestling with here. The first is the pursuit of the best possible price for Scotland in a commercial context. The point that you are rightly flagging, convener, is that it is a global marketplace and therefore any improvement in the processes that Scotland deploys for commercial negotiation will need to recognise the global nature of that marketplace. That is concept one, if you will. That is the commercial issues. Number two for me is the question of the overall affordability of the drugs bill for Scotland's NHS. That is quite distinct and it is clearly a policy and value issue. The third concept is one of cost and clinical cost effectiveness. It is that third area and only that third area is the business of SMC's professional and public deliberations. I do not know if you want to say more than that, Jonathan, but if it is helpful, those are three things that clearly interplay but the mechanisms and the possible maturing of each of those three things may take separate routes. Depending on what system is devised and developed for price negotiation and depending on whereabouts in the process it happens, SMC's expertise can be valuable in informing that without taking part in it specifically. That is undeniable. As far as how to get the best price is concerned, having a health technology appraisal system like SMC has helped that. Without it, it would be a market that was far less controlled. Also, you talked about how price might still be a factor. Clearly, access to new medicines cannot come at any price. That has been stated many times, even by patient groups. What we have done very deliberately is increased flexibility after the advice of this committee and the instruction of the Cabinet Secretary a few years ago, so there is no question that increased flexibility has increased access to these medicines. In the case of ultra-orphan medicines, we have downgraded the importance of the cost-effectiveness information, but overall cost-effectiveness, value for money, still has to play some part in drug decision making. Is the current procedure for dealing with that, the quality and all that, do you still consider that the appropriate way to evaluate these? For the great majority of medicines, we deal with a lot of medicines that are not for end-of-life and not for very rare conditions. For the great majority of medicines, that is an appropriate way to deal with them. That is outside my personal domain, and it is an interesting argument. You heard evidence three years ago about what the true cost of the quality might be in the NHS. We have conventional ways of assessing these medicines, and they are not strict thresholds. There are various issues that can be considered, as well as the strict cost per quality. Clearly, as I say, the flexibility that we have now given to some kinds of medicines has much increased. Yes, it is a proper way or a way. We have also offered the opportunity with the very rare conditions of the ultra-orphans of using other kinds of argument, let us say, but that is still in quite an early stage. Is that something that needs to be developed? Yes, we are continually trying to develop that. It is again a question of our relationship with the pharmaceutical companies and getting to understand what may be acceptable in those unusual circumstances. Is that something that will be dealt with with the reviewer's welcome that is set to the cost per quality and the rare and orphan diseases? Good. Do you want supplementary on that? Apologies, Richard. Just in terms of cost per quality, we have to be slightly careful, because I remember, and I apologise if I now get the numbers wrong, but a rule of thumb again, back in the day when we did the initial inquiry, was for a bog standard drug, but 25,000 to 35,000, depending on the clinical evidence and that would be affordable. By having such a rigid crib sheet, if you are a pharmaceutical company and you might be prepared to settle for £20,000, if you know the cost per quality threshold 35,000, why would you not put a bid in at 35,000 at the top end? I know that Mr Fox does not deal with those pricing and negotiations, but is there a real politic in those discussions in relation to you have to be slightly careful and setting out a rigid crib sheet on what cost per quality is, because why would not a company just go into the top end of it and maximise a profit if it can do so? Is there a little health one that comes with the cost per quality chart also? Yes. The fact is that in the real world competition also helps. Remember that after the SMC, there is scope for tendering and price-cost negotiations. In the case of some medicines, even after they have been accepted at a certain cost, because of course that can include the confidential discount, it is not the list price necessarily, then there are opportunities at national or local level for some further negotiation. I guess this is the difference between what might be regarded as a price that allows cost-effectiveness and the best price, which the cabinet secretary mentioned in her opening statement. Is that where the independent commercial discussions could take place in tandem with, but not as part of that SMC process? I mean, it would obviously have to relate to the SMC process and it would have to provide an input and it would have to work out how that would happen, but yes. That is what I have asked Dr Montgomery to look at, how might that work, what synergy would it have, and just the practicalities of how it would sit alongside who would do it, how it would work in practice. I am very clear, as the cabinet secretary, that getting the best price, which will be a fair price, but getting the best price for Scottish patients and Scottish taxpayers, is very important. We believe that there is room for improvement there and we want to make sure that we get the best deal. I ask about co-payments, where patients decide themselves to fund their own access to medicine. Has this declined with the new system because that was one of the major issues of the old system where some patients could afford and did go on to access new medicines but others couldn't? There is some extant CMO guidance from 2009 that covers more than medicines but was introduced to allow work on access to medicines in a previous Parliament. That remains in place, although we are not aware that the provisions have been widely used. The Scottish Government does not hold that information centrally, so that would be information held at boards. However, we do not think that, although that is in place, we are not aware that the provisions have been widely used around that. I think that there is something there that patients, if they are, are paying significant amounts of money for treatments that do not give a great deal of benefit. I think that we would be quite concerned about that. Leading on to that, I suppose, going through and into the review, the CMO's work on realistic medicine and that area around how we want to speak to patients about shared decision making might be an opportunity to discuss that further. There might be that shared decision making between the clinician and the patient themselves to look at some of those areas. Some of those drugs can be very difficult to take and quite toxic, and that end-of-life discussion is very important. I think of a wide-scale issue. I would have known about it and people would be raising it with me on a regular basis. That is just not being the case. Obviously, it is something that we need to keep a close eye on, but I am certainly not aware of issues that have been raised with me that this is something that is a common occurrence. I do not think that it is a common occurrence, but I think that it occurs. We had evidence going back to where we were looking at the system previously, where there were issues around people who were paying for their own medicines, and then, for treatment, they would have received free on the NHS because they were already paying for medicines. Some of the treatment they would have been entitled to for free for their condition scans, blood, deaths and the like. They then had to pay for it. My understanding is that that has now changed, in that they would pay for the drug separately, but they would receive the treatment on the NHS. There are some concerns about delays around who pays for what, and I am just looking for some information on that as to how that could be speeded up to make sure that there were no delays in treatment. One of the examples that were given was that someone actually only got access to the drug treatment that they were looking for weeks before their death, where, had the co-payments been sorted out sooner, they would have had treatment of that drug sooner. I am certainly happy to look into particular cases like that. I think that you have said quite rightly that there has been the CMO's guidance to change that, to make sure that those issues that you cited about the other aspects of someone's treatment other than drugs were resolved. As I said, those are such small numbers of cases that we need to have permission to look into any individual cases, but I am certainly happy to do that if there are still issues around timing. I understand that we are talking about very small numbers of cases here, and, ultimately, it still has to be a clinical judgment about whether or not someone would be well-harmed, potentially, by deciding to go ahead with treatment if the clinician is of a different view. The clinical judgment in those matters is still very important, but I will look into the circumstances that you raise. That would be useful, because one assumes that if the system were working right and the clinician thought that that drug treatment was going to be beneficial, then surely there would be access in some form, if it was going to be greatly… People would not have to look at funding that treatment themselves. That was also an issue historically where those who could afford access treatment and those who could not could not. It would be good to look at all of that around and see whether NHS treatment is being provided free and quickly and what circumstances that is happening and whether the system should not be picking up on it. I have several questions. One of which, within the islands, we have the context of the United Kingdom to distinct—made up of several countries but to distinct countries—Scotland and England. In England we have NICE and in Scotland we have SMC. One of the comments that is always made to me by patients is that down in England, NICE accepts a drug and it is then brought to SMC and SMC does not. Why is that? Should we not be working together where either we have accepted a drug or they have accepted a drug, the work that has been done on that acceptance should then be taken on board by the other organisation or vice versa? It works both ways. There are drugs that are approved by NICE. There is a different view taken by SMC, but there are similarly drugs approved by SMC that NICE takes a different view of. I will hand over to Angelina II, but, interestingly, I think that the decision has just been made, for example, to bring the cancer drugs fund into NICE. There have obviously been various views expressed about that. However, our approach has been different in that we believed that it was important to have a sustainable position. In our view around the cancer drugs fund, we had concerns that this was going to be pretty short-term and then what. The then what is now that the cancer drugs fund is going into NICE and essentially will be absorbed through NICE processes and concerns are being raised because, until that happened, there was a different process. We have taken a more sustainable view of making the improvements incrementally and not putting all our eggs in one basket, if you like, with all the difficulties that have now followed for the cancer drugs fund, Angelina. Thank you, cabinet secretary. It is a good challenge, may I say, but I am going to ask Professor Fox to give you a more detailed explanation. SMC started about 14 years ago now, and its mission role was to assess all new medicines or significant new indications for medicines. We have done that and we continue to do that. NICE has never had quite that remit, so there have been differences from the beginning. NICE selects medicines to appraise. Given the philosophy that Scotland should have a system that appraises all new medicines, that is one of the answers, I guess. The next one, of course, is the notion of the population perhaps in Scotland or the circumstances of the population in Scotland being different to those in the whole of the United Kingdom. Increasingly, there is the fact that the NHS in Scotland is rather different from the NHS in England. I am giving you a number of reasons why I believe that the SMC should continue to exist. I would say that, of course, but I think that they are relevant. Now, do we co-operate with NICE? We certainly do, because one thing that NICE can do—incidentally, NICE produces excellent output. I have no question about that. The process has traditionally been very much slower than ours. We have tried to get our decisions quickly so that we can shape future practice rather than having to change established practice. As well as being comprehensive, we have also been rapid—and still are rather rapid—even with the small increased times related to the pace process. I was going to tell you where we do co-operate. We obviously talk to each other and discuss each other or read each other's output and co-operate on more levels. In particular, there is a thing called the multiple technology appraisal, where NICE is able to compare many existing medicines or other treatments within a specific disease area. That is something that we do not do and that can be very useful. It is often not of brand new medicines, clearly. It is a market or an area, a therapeutic area, where there are many or several medicines. We usually do adopt those via Healthcare Improvement Scotland. We have a mechanism for accepting those for use in Scotland and superseding if we accept them, previous SMC advice. We do work closely in that respect. Can I say that I am not suggesting that SMC would be done away with and taken over by NICE? In regards to—but quite the reverse—the point that I was making is that people are saying to me why is it that I can get it in it? People can get it in England but we can't get it in Scotland. I know that we are taking steps. In some ways, I think that you let the cat out of the bag earlier by suggesting, Professor Jonathan Fox, that the eventual acceptance of a drug is based on price. I know that, last week, several people were suggesting that we should have a hard negotiator that should go in and negotiate the price. Is a drug eventually accepted in Scotland if the drugs company comes back and says, well, we made a mistake or we can negotiate or whatever, is that a real—and I'll give notice that I've got another question afterwards. I think that we should distinguish first between the bulk of medicines that we deal with that are not in the end-of-life or very rare conditions categories. In those cases, although we don't state a specific threshold, clearly the cost per quality of which cost, not the list price but the cost that it represents to the NHS Scotland in Scotland compared to the benefits it brings, is a specific factor, a major factor. I do want to correct something from the last meeting, which is this business of it's just the cost. It isn't. It's not just the price or the cost of the medicine. We take into account all the healthcare-related costs in the conventional process even for the new medicine compared to the comparator medicine, the previous medicine. So it's not by any means just the price of the medicine. It's all costs. That includes the costs of not using the medicine. That is, if there are consequences of not using the new medicine, that's all taken into account. As I've said, in the new process we've a lot more flexibility and that's been shown by the increased acceptance rates that we've had and indeed in the ultra orphan medicines, these are medicines for people with very few under 100 or thereabouts people affected in Scotland. It's even less important but I have to say it is difficult to sustain an argument that access to medicines can come at any price, given the enormous price of some of the new medicines that are coming to market. I, like Bob Doris, have had meetings with certain companies and the first thing that I've said to him is that your medicines are too dear. I think that I'll go back to a point that you made, let's live in the real world. The real world is we want the best for the people in Scotland but we also want it at the best price and I agree with you. Can I move on to something that I don't know and you may wish to liken this on? How the membership of SMC or the members who sit on the SMC and the comments made about patient representative being on it or not, who makes up, I'm not asking you to name them individually, but how are these people, the people who sit on the SMC, how are they appointed and the other comment was made that there's not worse that you've allowed people into public meetings and more meetings have been held and it's getting more transparent that the votes that are taken by the SMC are not made public. Could you maybe explain that? On the first point, SMC has really from the beginning led the way in terms of involving public partners and the industry as full voting members of the committee. So the committee includes three public partners and three members of representatives of the pharmaceutical industry, nominated by the appropriate groups as well as managers, finance, chief executives and a range of clinicians, doctors, pharmacists, nurses. So it is a very diverse group with, I believe, all the appropriate stakeholders. The other factor we take into account of course is that we want representation from all the health boards in Scotland so we try hard to make sure that the committee covers the whole of Scotland in terms of the territorial health boards wherever possible. So we try to balance it that way. The SMC is a consortium of area, drug and therapeutics committees so the representatives, the clinical representatives are nominated by them. We don't go out and pick people, we ask for nominations and then try to choose the nominations that best fit the necessary mix of both skills and geographical representation. So that's your first point. The second point is about voting. Now this point was raised by, I've looked through all the written submissions here to see, but effectively this clearly has been raised by a few of the pharmaceutical companies and I have some understanding of why and also by the ABPI. We changed to a system of paper ballots for the votes, paper votes, when we moved to meeting in public and that decision was made by a committee which included representatives of the pharmaceutical industry. We were told quite clearly that we could not reveal the result on the day because of possible effects on the share price both locally and internationally and other commercial and maybe some other considerations as well. So we could not use the previous method of either an obvious consensus or a show of hands. We've moved to this method which I think is the most appropriate both on practical grounds and on the grounds of transparency because we can assure the public that they have seen every bit of the discussion of that medicine. We have the entire discussion to the end and then we ask for a vote. The votes are taken away, they're counted and then they are announced to the committee in a very short private session afterwards. We do not discuss the medicines again because that would not be in the spirit of full transparency. The only exceptions to this are sometimes in a very few cases, seven out of the first 125 submissions, where we had to have a short private session to discuss commercial and confidence information. We handle that by referring members to the paperwork rather than speaking the figures in order to allow the whole discussion to take place in public. I could go on, but I suspect you don't want me to, about why it would be very difficult to change. The one point you haven't answered me, is there a patient? I know it's harder right across the border, different organisations, patient representatives, is there intention or is there a patient representative on SMC? There are three public partners who have, as it happens, extensive experience both personal and in the healthcare context. I think you may be referring to whether or not we should have the patients presenting the PACE statement and that's something we will consider. That was not recommended by the task and finish group which was the basis of our new process, but I think it's something that will be considered in the review. Malcolm Chisholm on this team. To be reminded of the origins of the SMC and how it was set up to be different from nice, but there were problems in the past in terms of making sure that boards that might be a question for the cabinet secretary, implemented the decisions of the SMC. Is that a problem that no longer exists? Do you audit the extent to which boards follow and implement the decisions of the SMC or are there still time-synch problems? I am not aware of any systemic problems with boards implementing the decisions. I think that the numbers wouldn't be as they are if that was the case. We are not seeing any stand-outs that are running counter to the direction of travel of other boards, so I am certainly not aware of any particular issue. In many ways, this has been one of the real success stories of boards speaking to each other and there has been a new collaborative around boards speaking to each other around our area of drug and therapeutics committee, hosted by his as well, so they may want to comment on it. That has had successes in sharing that best practice. The current timeframe in which Government expects boards to take decisions on SMC advice is still within 60 days of publication, and boards are reaching that, and I think that that is important as well. However, the wider issue around a collaboration is that more consistent communication of board decisions should happen across Scotland, and I think that that would be important going forward. We definitely want to see that collaboration between boards, the area of drug and therapeutics committees continuing, and I think that that has been one of the success stories of the Kena new framework. Thank you, and simply to add to that that one of the mechanisms that healthcare improvement Scotland has again very deliberately put in place to support this is the collaborative, and the reason for that is to address any perceived inconsistencies or differences in timeframe between the SMC decision and its implementation on the ground. Our sense is that a number of the perceived differences are to do with inconsistencies of language, right down to issues of vocabulary and the way the process locally is being described, so on one level it may sound a little mundane or trivial. We are finding that the material that we are providing to the collaborative and shaping with its members around consistent use of words and description of the activity on the ground is beginning to help to dispel any perception of inconsistency or failure to implement. Over time, we think that the greater consistency will help to do that enormously. 14 area drug and therapeutics committees, glad to hear that there is a collaborative now, that is a heck of a lot of area drug and therapeutics committees for a nation of 5.25 million people, is the review going to be looking at how they can work closer together and start to integrate a lot more of what they do, understanding with managed clinical networks as well. A lot of that is already starting to take place, so will that be part of the review as well? We have been encouraging more regional working and regional planning of services more generally, and in this area that would apply as well, and we have worked under way. There is, and I think that BORS themselves are exploring how more regional structures might operate in practice. We see that already in clinical practice in some areas across Scotland. I think that that helps the communication and the collaborative that Angelina Foster referred to earlier will help that as well, and that consistency of information. A couple of brief questions, just to follow up on the, I think that Richard Lyle covered the issue of voting, and we have allowed a good response on record that gives some balance to what we have heard. Beyond the pharmaceuticals, there was a discussion that was taken place by practitioners and some of the patient's groups that there was a need for greater clarity. They could go to these meetings, and they got a good hearing in some cases, and when they were mystified, that had been turned down because there was no indication. They were asking themselves, are they being listened to? I think that there was a call for greater clarity behind the decisions that were taken in explanation. Is that something that you accept, and is it something that will be addressed by the review or indeed addressed? Professor Fox? Yes. We do accept that it is something that we should certainly look into and see if we can provide better explanations. We accept that. It is also true, though, that it is sometimes quite hard to provide a full explanation because of the amount of material, particularly about cost, that is declared to be commercially in confidence. There is a problem with giving a really full explanation. That is only part of it. However, I think that this is something that we will try harder to address in the review process. I think that that is probably all that I should say on that point. I think that what we are trying to do is reflect the written and all the evidence that we are hiding. Demonstrate that we are listening, I suppose. The other point is that the pay statements are always presented very powerfully to the committee. As Angelina said earlier, I always remind the committee of the powerful influence that they should have on decision making. Of course, even a powerful pay statement accepted does not necessarily mean that the committee is going to accept the medicine for all the reasons that we have discussed before. However, there is no question of the power. I think that the call was for great clarity in and out of those things. In our previous work, it needs to be said that we recognise that some of the work of the SMC was at the forefront, not just here in the United Kingdom, but as an exemplar to other similar organisations struggling with the issues that you have been struggling with. Bob Doris mentioned earlier that we need to get some clarity on that, because we are hearing evidence in terms of whether the whole process is fit for the future, that we have got medicines now being given breakthrough status by regulators. If the SMC continues to be at the forefront of the work, what will we do to address the issue of breakthrough, where the evidence that we have heard from the oncologists is not as good as you would expect with other types of medicines and new drugs? How do we ensure that the SMC is fit for the future on that? That is a very good point, it has to be said. One of the major challenges that will face the SMC over the coming years is that we have discussed with similar international groups around the world that are all facing the same kind of issue. First of all, it is something that we are working on and we will have to come up with some mechanism in the future for dealing with the relative immaturity of the data that you referred to, because medicines are coming to market earlier. Let us say that they are getting their approvals earlier. The SMC, as a one-off process, albeit with the possibility of fairly early resubmission, may not be applicable to all of those medicines. We may have to look at some kind of conditional acceptance with a review based on the kind of real world data that we have been talking about that needs to be collected about the benefits of the medicines when they are used in NHS Scotland. The answer is yes, it is something that we are seriously considering. It is difficult to use patient data presently in a systematic way to allow those health economic assumptions. That is in the real-life situation, I suppose. The Scottish Government is providing some investment to Greater Glasgow Health Board to work with FAR Institute and others to look at the clinical effectiveness of cancer medicines in the real-life setting, not just about access, but about how they are used. That will give us some information on medicines that are accepted by the SMC and perhaps what that might point to in the future. The concept of investing in new medicines on the basis of little evidence so early on access to medicines is definitely going to be a major decision in terms of what we do in going forward, as with other HTA organisations as well. We expect that those types of suggestions will be put forward as part of the independent review, and we would wish to see evidence around that both nationally and internationally. Thank you, Cabinet Secretary, and the colleagues that are with us here this morning for the evidence given and the time that you spent with us. Last week, the patient groups and all of those stakeholders were engaged with us. I showed an appreciation for the progress that has been made by the Scottish Government and the committee. There is an element of satisfaction that we can take from that. The committee worked with the Scottish Government and others have made some progress here, but evolution was the word that was being used. The cabinet secretary reaffirmed that today. More to be done, but progress has been made. Thank you very much for your input this morning. We now move to the fifth item on the agenda today, which is subordinate legislation, one affirmative instrument. As usual, with affirmative instruments, we will have an evidence taken session with the Cabinet Secretary for Health and Wellbeing and Sport and our officials on the instrument. Once we have asked our questions, we will have the formal debate on the motion and the instrument. The instrument that we are looking at today is public services reform, social work complaints procedure, Scotland Order 2016 draft. Before I introduce the panel on the record, I want to acknowledge that the committee has reached a milestone today at this meeting. We welcome our thousandth witness this session. I am sure that members agree that witnesses play a vital role in the committee's work of committees of the gateway to this Parliament. We are nothing without those who are prepared to engage in it, give us oral and written evidence and inform all of our work. We are very proud of the level of engagement. Anything that we have achieved in terms of our reports is to the credit of those who have engaged with the committee's system in the Scottish Parliament. We welcome this session here today. Our thousandth witness is Fiona Collie policy and public affairs manager, carers Scotland. I am not going to go with a thousand and one or a thousand and two of it. Beth Hall, policy manager at health and social care team Cozzler, Paul McFadden, head of complaint standards, complaint standards authority Scottish public service ombudsman and Ian Smith, policy and parliamentary officer including Scotland and Marie Allison, director of fitness to practice Scottish social services council. Welcome you all here this morning. Given the time, we are going to go directly to questions and the first question is from Malcolm Chesham. I would like to thank all the witnesses for their evidence, which was very interesting to read. If I could just start with a general question. I suppose that the paper from the ombudsman explains that this is going to align the procedure with the health procedure, which they already deal with. Perhaps the ombudsman representative can confirm that. Will the two processes now be identical, which seems to make sense in an era of integration? For those who have concerns, it would also be interesting to know if the ombudsman process will lose anything. Will it consider all the range of issues that are currently considered by the complaints review committees? Will a more centralised procedure result in any loss through losing the locality dimension of the current situation? Just as a general background, we have raised concerns over a number of years since the Synchro report on complaints handling around the areas of social work and social care more generally, where there have been multiple complex routes to complain in different statutory processes in place, and with integration a feeling as that was approaching, that there may have always been a missed opportunity to align these. Over a number of years, we have been aligning complaints handling processes within the public sector into a standard model procedure of two stages with timescales and standard requirements around governance and how they should be handled. The exceptions to that were in the area of social work and relation to health, and that is because there were separate statutory schemes in place under the Patients Rights Act and the Social Work Act and Directions. We have been commissioned by the Scottish Government. We have been working on the back of a health council report to bring the NHS complaints process into line with what is now the standard practice across the rest of the public sector, and we are well under way in that process. That procedure will be in place for the NHS from April 2017. That is one element of this area that we have raised as complexity. The other area will, of course, be the social work process, which will align. There will be the same process and the same standards within that. I think that, crucially, from the complainants point of view, there will be one single process point of entry, one joined up response, key requirements in there to make sure that they are not having to engage with different agencies on a complaint that spans over different services. That is something that we feel will bring a very clear, simple and consistent process for people complaining about services in that area. In relation to the second part of the order of the complainants review committee, that also dates back to 2008, when the single report recommended that the SPSO take on the role of the existing complainants review committees. It is almost universally from what we can see accepted that the complainants review committee system is not something that has been operating effectively. The proposals to give the OMSM professional judgment on top of the wider mal-administration role that we have in relation to our standard role would be the role that is currently undertaken by complainants review committees, so we would have the same roles of complainants review committees in that regard. Clearly, that is an extension of our remit as it stands. The benefits of giving the OMSM professional judgment role is that it aligns with what we have had in relation to health complaints for a number of years, where we do investigate on the basis of clinical judgment. At the moment, we would see complaints that might cross over both areas and decisions are made by joint agencies. At the moment, we can all look at judgment in relation to those elements that are made by the health board. We cannot look at that in terms of local authority. The proposals that are outlined will mean that we can now look at those types of complaints holistically. There is a clear alignment with the integration agenda. Any other witnesses who concur or have a slightly different view? There is a question about whether it might lose some of the locality issues from the CRC. I think that the general view of users is that the CRC system just did not work and did not deliver for service users who wanted a review. What we have seen over the past few years and the committee has been heavily involved in that work is a number of pieces of legislation that have come through for social care that provide a background of rights that should be defined on a national basis. Therefore, it makes more sense for those to be addressed through a national complaint system so that there is some consistency in how complaints are dealt with. There are issues such as the social services self-directed support act, the public bodies joint working act and the carers bill, which has just been passed. All of those set certain principles and guidance as to what levels of service people should expect should be based on the rights and dignity of service users, given them choices and control about participation in public life. All those things are national guidance delivered locally, but if that fails to be delivered at where people's choices aren't properly respected or their dignity is not respected, we feel that that should be a nationally based complaints procedure that looks at those things to ensure that the national principles that should be agreed by this Parliament, by this committee, are delivered to individuals. I would just like to agree wholeheartedly with what Ian has just said. Seeing the SPSO role in isolation, it would not be clear, but the involvement of the model complaints handling process, the two parts of it, to make an aligned system that is very clear to people who use services and carers about how they make a complaint, how that complaint can be resolved, the timescales for that and that they have exactly the same route to make a complaint about health and social care or an integrated service. I think that that's a significant step forward and I think that it will reduce confusion and enhance clarity for people who are making complaints. Our members were broadly supportive of the recommendations of the short-life working group that looked at this originally and made some recommendations in January 2014. Obviously, the nature of the statutory instrument that we've got before us today doesn't go into a level of detail around how some of this would work. Our members had a couple of concerns with the proposed changes. Initially, it's around the alignment with the model complaints handling procedure that is in operation across other areas of local government services and which Mr McFadden has just said that there will be further work to bring the health system closer towards that. Although we would welcome that in terms of the consistency that Ms Collie has just highlighted, we were concerned that the current social work complaints procedure allows 15 days for the initial front line resolution stage, that first stage, whereas it's just five within the model complaints handling procedure. One of the things that we would want to see is that that 15 days remains. The reasons for that are that in terms of social work, when you think of it in comparison to other local authority service areas, you can see that just by its very nature it's more complex than those other areas. We're looking at very often relationships which can have been beginning to go wrong by the time it gets to this stage. Secondly, cases that lead to a complaint are often the more complex ones. We would be looking for assurances that those 15 days would be maintained. Secondly, in terms of the extension of the SPSO's role to consider not just my administration but professional judgment, our members were broadly supportive but did have some queries or concerns around what professional expertise would be drawn on in fulfilling that role and also how the interface with SPSO would work. Currently, SPSO has the role in relation to looking at professional judgment and indeed malpractice. Those were a couple of points of clarification. Finally, just to pick up on the issue around the local versus national focus, certainly I'm aware that the Sinclair report did highlight the need for providers to be able to resolve complaints more locally, not less. Where we would want there to be some clear thinking is around what would that look like on the ground, especially for more vulnerable groups if we had a centralised process? Would people have the opportunity to have a face-to-face hearing, perhaps with the support of advocacy services? Is it proposed that this would all be done as a paper exercise? Or, indeed, if it was going to be a centralised face-to-face approach, what supports would be there for people to participate in that? That was just a couple of thoughts on the issues that have come up so far. As the professional regulator of the social service workforce, we consider any issues in relation to the professional judgment of social workers. Although we are absolutely broadly welcome to the simplification and streamlining of complaints procedures, it is important that we have to work closely with the SPSO to try and avoid duplication or unnecessary lengthening of investigation times, both for the person bringing in the complaint but also for the worker whose professional judgment may be called into question. Is there any stats on the length of investigations that has been mentioned a couple of times? How many are resolved within the 15 days? Are we going to have any stats on that? Malcolm, do you want to fill up? That is useful and interesting. To summarise what has been said, on the one hand, Paul McPadden said that he has got to bring the health one into line with the rest, but not. Basically, it will be the issue of professional judgment that distinguishes social work or health from everything else. Is my understanding right or will there be other differences from that? In terms of the omidgen zone, that will be the key difference. In terms of the local process, there will be a number of main institutions. In terms of Ian Smith, in a way, I was surprised when I was comparing it with your written submission, you seemed to be more positive because you did have this concern in your written submission that the SPSO's decisions are not binding, so in a way you would like it to go further. I was answering the question that you had asked rather than necessarily what was in our submission. Our view is that for certain aspects of the decision-making that the SPSO should have the right to overturn the local authority decision. Does that not be beyond any powers that the ombudsman will have over the Scottish Welfare Fund that will be able to change a decision and impose an alternative decision? Our concern is that, for many of the issues that we have highlighted in things like social work packages, for example, that if the ombudsman's investigation determines that perhaps the social worker has decided that X is required but the local authority has decided that the only other resources to provide Y, the ombudsman says that he should provide X. He goes back to the local authority and says that he can only afford Y. The service user is not any better off, so we feel that in certain circumstances the ombudsman should have the right to say, no, you must deliver service X, otherwise you are not meeting these national criteria that have been established. For example, in terms of social care charges, for example, if a local authority is not taking account of disability or the expenditure in determining the contribution that a person has to make towards social care charges, the ombudsman disagrees with what is happening, how does that actually change things if the local authority just does not decide not to accept the recommendation of the ombudsman to change it? It does not give a right of appeal and therefore we do not think that it is actually ECHR compliant. It does not meet the requirements to have a right of appeal on that. There are many other areas where that is a case of self-directed support packages, for example, portability when you move from one local authority area to another area, where you may find that you are having difficulty getting your package transferred. There is a whole area where we think that the powers that are proposed here do not go far enough. That is interesting to the point of ECHR. I do not want to enter this conversation, but it is pretty interesting. Beth has been trying to get in for a wee while as well. She might add to some of it as well. It is okay, I said that it was okay. It is just to pick up on three things that our colleague mentioned, the welfare fund and the fact that the ombudsman can overturn decisions in that context. It is really to highlight that the welfare fund is very different. It is a national fund, which local government simply administers. We do not set the budget and the money is ring-fenced. We have to follow national guidelines in doing that, including on eligibility. In terms of social work services, local government sets the budget and is accountable to communities for how that is managed. Those decisions are subject to local eligibility criteria. As you can imagine, we would see any ability for the ombudsman to overturn those decisions as interfering with the local democratic accountability that councils have. The fact that that equates to the fact that there being no appeal is mentioned. People are able to appeal decisions, for example, around SDS resource allocation. Yes, that is an internal process, but in the wider context of this complaints process, you still have the judicial review available to people, which I understand is absolutely the last resort. To my mind, I do not have any legal advice on whether the judicial review element of that is compliant with the HRC, but I would imagine that Scottish Government colleagues might be able to advise on that. Anyone else who wants to contribute to this point before I let my staff come back in. I think that I'm a little bit concerned that we're trying to put in place something that we want to be able to seek resolution for people, whether that be a complaint about the allocation of a budget or about a service that's not working effectively or about someone's professional judgment. What we don't want is people to have to go to judicial review. Not only is it expensive, but it adds an additional layer of stress to carers and people who use services. Whatever direction we go with this, we need to make sure that within it, we focus completely on seeking resolution. Seeking resolution is one at the earliest stage if we possibly can. However, when it gets to the point of the SPSO, we can seek a resolution that's appropriate to everybody. That might be a compromise. I think that that's the most important point. We have in place processes that allow someone to take their dissatisfaction with a decision to an independent body for a review of that decision as to whether it was reasonable. The discussions so far since 2008 in various consultations have been around fixing a broken complaint system. If Government and Parliament wanted to look at an appeal system, then there's a whole different discussion that would need to be had. We've said before that in taking on this role, which we think will give people an administrative justice route to challenge decisions that have been made in terms of their social care assessments. When we have that role and we start to see that there is a need for something more than that, that's something that we would report to Government and Parliament if there is that need identified. We're not aware of anything that's there that would suggest that there is that need at the moment. Clearly, that is not a decision for the ombudsman to decide whether it's an appeal or a complaint route. However, we do feel that the proposals as outlined will maintain people's administrative justice rights and give them a right to approach an independent body to assess whether the decisions were reasonable. I would agree in relation to the Scottish Welfare Fund that it is a very different scheme. The Welfare Fund is essentially an appeal route. The role that we have will be replacing a previous role that the independent review service at the DWP had, which had this role. It's a national scheme, as was highlighted in my colleague, with clear national guidance that is applied. There is clarity at a national level that might not exist in relation to social work, so there are differences there. I think that Ian Smith wants to come back again. In response to the best point about local discretion, we understand that the social work departments have discretion and it's therefore more difficult to have an appeal around discretionary decisions, but what I'm stressing is that the national legislation now sends a framework that sets certain rights and principles behind social work legislation, which those social work authorities have to abide by. It's in those cases where they are failing to abide by that people should have a right to review and an appeal. If their right to dignity has been not delivered because a local authority has decided that they cannot afford to provide overnight care for someone, that is something that they should be able to challenge without having to go through a judicial review route, which is very cumbersome, expensive and requires a very, very high level of failure in order to reach success. A review through the ombudsman of whatever body does that, which allows them to say, in this case, that the local authority has got it wrong and must change that decision, is what we are seeking, not necessarily a judicial review process. I suppose the question then is how does that square with Beth and indeed the policy of these? That these policies are set locally in local democracy and there isn't an emergency decision somewhere else that will overturn that. I suppose that's what we're wrestling with Ian? I think that's what we're wrestling with, but the issue is that the legislation, as I've said, about health and social care, social self-directed support, carers, the national care standards are coming through, all set principles which give rights to dignity, choice, control, public participation, et cetera, to service users and they ought to have a system which they can ensure that those rights are being respected by the local authorities at providing the services. I think that this is quite an interesting and important area and if I understand the ombudsman's written evidence, the suggestion was that you would not take up a policy issue or a local policy issue unless it related directly to the person affected's complaint and unless that person specifically related their individual problem to the policy area. I just wonder how realistic that is, first of all to an individual who is making a complaint to be aware of local policy, to understand the connection between the policy and their specific complaint and whether or not you can reserve the right. If, for instance, you were to notice a similarity or a multiplicity of complaints arising in a certain area because of particular policy decisions, then whether or not you would, as the ombudsman, reserve the right to take up to challenge that policy position or can it only be triggered if a member of the Republic makes the connection on your behalf and draws it to your attention? The way that we do look at complaints and will look at complaints in relation to this is in terms of the impact on the individual, the impact on an individual of how their carers have been assessed within all of the framework that has been talked about, such as legislation, national policy and local policy in terms of their entitlement. The sense of what we are looking at is whether they are getting access to their rights and have the judgments that have been made in assessing their needs taking account of those rights. The element in our evidence around the wider resource decisions was designed to answer the question that the committee had raised or certainly had been raised in evidence. That was whether larger resource decisions by accounts or whether we would have an ability to comment on those. An example might be where, for example, a decision is taken to close at day centre. There may be elements of professional judgment that may contribute towards that decision. We feel that the way that the order is drafted would be the lowest to look at that. Of course, those decisions are made in context of a whole wider range of factors, including user input, including local discretion and local democracy and resource concerns. What we are trying to highlight was that it is probably quite unlikely in our experience in relation to healthcare judgment that it is unlikely that we could look at any specific judgments that were made there in comment on those, if the person was able to demonstrate that they were impacted or if there was an injustice or potential injustice on them. With the greatest of respect, you have just kind of almost repeated back to me what my question was. The point is that if the person making the complaint to you can make that suggestion, what I am suggesting in general terms is that it is fairly unrealistic. If I were to go out into the street and take a straw pole and ask people about local authority policies for the sake of argument, very many of them would not be able to give a coherent account of local policy. What I am suggesting is that it is a bit of a far stretch to assume that those complaints will necessarily be made in that kind of coherent fashion, in an ideal world perhaps. If, for instance, you were to receive a number of complaints in a particular locality that led you to believe that there was a policy problem, would you then be able to analyse that overall situation and then make recommendations with regard to the policy? Given what we have heard from Mr Smith about certain rights being pretty well described and inalienable? In terms of the person bringing the complaint to us, they will bring a general description of the circumstances and the way they have been affected. They would not necessarily identify a particular policy that has the reason for the impact. We would go through a full process of speaking to the person to try to understand what they are trying to say. That is something that we would do as a matter of course. We would try to unpick what are the underlying reasons. We would look at the information given by the local authority in relation to that case and try to unpick whether there were issues there. In terms of the wider question of whether there were a range of complaints in one locality or about one policy, that is certainly something that we would see in terms of the intelligence that we are getting or the learning that we are identifying and that we would feed back to a particular authority on that. In terms of the way the legislation is laid out, we are anomism in which we are looking at impact on an individual. That is just the role of the anomism. Recommendations on the individual case will relate to that, but we could make recommendations related to the wider policy, which would of course have to respect local decision making and discretion that exists there. I think that it is useful just to be clear that the purpose of the social work complaints procedure is exactly that. It is about individuals and their families' experience of services and where that has not gone as everyone would want. They have some kind of redress. What it is not about is examining local government's policy and budgetary decisions at the macro level, if you like. The local authority is there through the elected members who have been democratically elected to scrutinise that budget and its implementation. That is obviously subject to further scrutiny through bodies such as Audit Scotland, which can be escalated all the way up to the Accounts Commission, which can have significant powers in terms of the penalties that they can seek on local authorities if that is not going as it should. For me, it is just about remembering that this is a complaints process that needs to be responsive to individuals. I accept that there are patterns emerging in those individual complaints that there needs to be further discussion and connections made, but I think that, as my colleague out from the SPSO outlined, there is the ability to do that. Bob Doris is the next question for my Rhoda Grant. I thought that Beth Hall's questionnaire was really quite helpful because it is almost as if we have been discussing two different things. A complaints process and an appeals process for resource allocation at a local level are two very different things. I understand from this that the SPSO will step in and take on the powers in the responsibility of the local authority. It previously had to make sure that, within the resource allocation set at a local level, within the structures established for care at a local level, the SPSO will make sure that individual complainants have their cases handled appropriately through that process. I guess that some of our witnesses may wish it to go further than that, and some of the submissions clearly make that argument, but I think that what we are scrutinising for today is in terms of the handling of that complaints process. Where I would see the crossover for the SPSO would be—a good example for myself—complaints that I have had over service delivery issues with Cordia and Glasgow, which I hope that they are improving. I hope that that is work in progress and I will be kind to them there. However, if a number of what I would see as service failures occurred and vulnerable constituents were complaining to the SPSO, that might be an issue for the SPSO in terms of the process and structure of that complaint. However, would the partner agency not be the care inspector at perhaps to look and actually see if the quality of service was fit for purpose more generally? For me, I do not have any concerns at all about this passing to the SPSO. I think that that has to happen under health and social care integration. It would be crazy to only look at one part of the picture for the SPSO and then go on elsewhere for the other part of the picture. That just has to happen. It is the links with the quality of service more generally across the local authority or an integration board area. What would you see the links being in the future with the care inspector and the more general strategic level of care, where they would have a democratic responsibility to hold local authorities to account for a third breach of the level of care that they should be providing? In terms of social work, we are looking at assessment and broad-term assessment of care needs. In relation to what you are talking about, in terms of registered care providers and the delivery of that care, the complaints would go to the care inspector who is the national body responsible for that, and they would continue to be so. In terms of that linked up learning or looking at the assessment of what we are seeing and how that links up with what the care inspector is seeing in terms of delivery, you will see that the order also contains provisions to allow us to share information both with the care inspector and the Scottish Social Services Council, which will help to facilitate us in providing information. We work with regulators at the moment in terms of our role, but we have restrictions in that and what information we can share in terms of individual cases. The provisions in here will make that a lot easier, and that is something that we have been quite keen on from an early stage that we are able to make as easy as possible for us to feed back into that national regulator. Are there other bodies that you should be sharing with? We have a triple SC, a care inspector, and who else is out there that perhaps would have an interest in having that information and taking that? There are checks and balances in the system. I get the fact that local authorities are democratically elected and democratically accountable, but there are checks and balances in the system. We have mentioned two organisations that are part of that check and balance in the system. Are there any others that we should perhaps be adding to that more generally, or have we got the balance right? I think that the role of the mental welfare commission, which certainly looks at individual issues and how the two bodies will link together and with the care inspector as well, because I think that at the moment it can be quite confusing for carers and people using services about who it is that they complain to and who it is that they get support from if things are going wrong. I think that there is some clarity around the role of the mental welfare commission in relation to the SPSO that would be useful. Can I just ask a question for clarity as much as anything else to start with? I am going back to previous questions about professional judgment. I am assuming that it is the local authorities collective professional judgment that will be reviewed, because if it was an individual's professional judgment, that would have been picked up earlier in the complaints process. If somebody's professional judgment was way off, that would have been an issue for the SSC, rather than the SPSO. Is that correct? What generally is that we are looking at the judgment of the organisations, we are looking at the actions of the organisations and we report decisions against the organisations. Clearly, individuals are making judgments, but we are quick to emphasise that it has been the collective organisation. The interaction with the SSC is one that we have already committed with the SSC to explore further in developing the existing MOU a bit further and so forth, understanding exactly when we may want to cross-reffare where that higher threshold has been met in the actions of the individual. We have experienced in other areas of working with regulators. The GMC would be the most obvious example of the general dental council and others as well, and we have in place arrangements there that have worked very well since we have had these powers in relation to health. However, if something will work very closely with the partners to make sure that we get it right. We would certainly hope and expect that employers will make referrals to us at an early stage if they were identifying any issues with professional judgment of individual social workers coming out of the complaints process at an early stage. However, we anticipate that it is likely that there may be cases where the ombudsman may be at a later stage identifying issues and, if so, we will be hoping and expecting that there will be close working between the two bodies to try and ensure that that was dealt with as effectively as possible. Can I ask about hearings where they take place? I would imagine some of this I know currently with the SPSO that some of this is kind of a paper-based exercise where there aren't hearings, but if there are hearings where would those be held? I know certainly with SSC, I have had concerns from constituents about having to travel quite a distance to access those. If we are talking about people who are requiring care services and quite vulnerable people having to travel to access hearings, that would surely put pressure on them to withdraw their complaint, because they might not be able to access that. What support would be available to them to attend that as well? We won't be undertaking hearings as a matter of course, and that's not something we think is necessary in relation to the other complaints. We're quite clear that we have the power to undertake that. We actually have the power to go as far as putting people on their oath, although we've never had to use that. We will undertake hearings where we think that it is necessary to understand the circumstances of the case and, to be honest, in the interests of fairness. I think that in terms of how we will carry those out, we're going to have to speak to Ian and other third sector organisations and users as to how we carry that out. We have been having some discussions on this in relation to the Scottish Welfare Fund role, which is about to come in for the first of April. We've had some helpful feedback from Inclusion Scotland members and users on that system, which we'll transfer over to this. Assuming that the order goes ahead, this is a start of a process of discussing how that should be put in place and taking account of the needs and respecting the dignity, for example, of individuals in that context. I'm just about to do that. Ian, you've got a quick moment to cover issues that you feel you want to put on the record as well as your written evidence, and I offer that opportunity to the others. A quick brief round-up, because I've just sent for the cabinet secretary who we're meeting next. Ian? It was just to follow up on the point that Paul has just made. It's important that recognition is made by local authorities and the Government that there will need to be advocacy support available to service users. We wish to raise complaints. I'm not sure that that's been recognised in the financial memorandum behind this particular order, and I think that that needs to be recognised that there will be costs associated with having an effective complaint system both for health and social care, so that is quite important. One other point that I want to make is that we are aware from anecdotal evidence that many service users do not wish to make a complaint about assessments that they've received in terms of the social care packages, because they are frightened that if they do so, their packages may be cut further. It's important to bear in mind that they need that support, the advocacy support, to give them the confidence to challenge decisions that they think are wrong, because at the moment there is anecdotal evidence out there that people are very concerned about SDS assessments, for example, resulting in cuts in the packages, and that they challenge them, so that they may get cut further. On that point, are there any other witnesses who want to put anything else on the record? I think that I would like to re-emphasise the point about advocacy, but also to emphasise that there is a real need for advocacy for carers, that there is a reduction in services across Scotland, and certainly there is new guidance coming out about developing new services, and advocacy for carers and people who use services is vital, and we really need to look at how we build a network across Scotland to support making complaints, but also resolving issues in the first instance. In relation to the costs that have been mentioned, we would want to see further work done to look at what the costs of the new system might be, and in part that will depend on the choices that SPS will make around having physical hearings and where they would be, so it's just to flag that issue. Secondly, we would be looking for guidance around the new system to be co-produced with organisations such as Inclusion Scotland and Carers Organisations, the SPSO and COSLA. That would be an opportunity to pick up on some of the issues around advocacy and how vulnerable people can be supported that we've been discussing today. Have you done any work on the costs associated with reducing the 15-day time limit to five? No, we haven't, and we think that, firstly, sorry, it's to extend it. Sorry, I'll start again. No, we haven't. We think that as it's currently 15 days with social work complaints procedures, what we're looking for is it to be maintained at that when the new system comes in, so it would be the same at that stage. I suppose the costs that I was referring to were more around stage 3, which is the part that's changing significantly, and we've talked today about it perhaps being a more centralised approach, so it's specifically that part. I was just trying to get a waiting about the benefit to the person making the complaints as against the impact of just doing that in five days as 15 days, whether it be a resource application error for yourself or whether it be an additional cost. I presume that the five days were taken because that is part of a model that we expect public services to respond in the first instance within five days. Scotland is unique in that it has one standard process across the public sector, and the aim of the five days is to enable empowerment of staff to resolve things very quickly, close to the point of service. We've achieved that, and the service is 80 per cent of local authority complaints are resolved at that stage. We have flexibility in there because we recognise that some judgments might take a little bit longer, and we need to enable people to make those without having to escalate unnecessarily. That flexibility exists already in relation to the CHP. There were minor suggestions in terms of the working group, which we fully understand in terms of the context of vulnerable social work users that we will take account of. On the cost point, it is important that the independent services resource is to be an effective service. One of the key things in there will be recruiting advisers, which we do in relation to health. If we are making decisions on the judgments, it is important that we have access to solid professional advice. That will be part of the cost. That is something that will work closely with the Government of our zone. Thanks for that. No other... Can I thank you all for your attendance today and your written evidence and your oral evidence today? Thank you very much. We appreciate that. Suspend at this point where we change the panel. We now welcome, for the second time today, the Cabinet Secretary for Health and Well-being and Sport and her officials, John R. Robinson, the Cabinet Secretary for Health and Well-being and Sport, Mike Little, policy manager, integration and reshaping care division and Victoria McDonald, senior principal, legal officer from the Scottish Government. We are expecting, Cabinet Secretary, a brief opening statement. Thank you, convener, for inviting me to give evidence to the committee on the public services reform social work complaints procedure Scotland order. There is a long history of discussion around the current system for social work complaints going back to the Crerar review in 2007 and the Sinclair report in 2008, which called for the streamlining of the complaint system for social work. What our draft order proposes is fully in line with the recommendations in the Sinclair report. Our intention is that the changes will make, will shorten the time scales that a service user faces when making a complaint and brings the procedure for making a complaint about social work into line with those procedures for health and other local authority complaints. In all of those cases, the Scottish Public Services Ombudsman is the appropriate external body to investigate if necessary following internal consideration of the complaint. The order extends the ability of the SPSO to consider discretionary decisions taken in the exercise of the professional judgment of social work staff. During the course of our consultation on the draft order, some respondents raised concerns that there may be an overlap of functions between the SPSO and the SPSC, which is the regulatory body for social work staff. The SPSO and the SPSC already have a memorandum of understanding between the two organisations, and that will be updated to ensure that there is a clear delineation of the roles of the two bodies. The order also allows the sharing of information between the SPSO and the care inspectorate and the SPSC where appropriate should something important come to light in the handling of a complaint. During the consultation and responses to the committee's call for evidence, some respondents highlighted the need for the SPSO to ensure that they have appropriate independent social work advice in reaching decisions around professional judgment. I can confirm that in the same way that the SPSO receives professional medical advice in its investigation of complaints into health services, it will ensure that it has professional social work advice in its investigations into social work complaints. If the draft order is approved by the Parliament, the SPSO will work with stakeholders, including service user representatives, to produce a model complaints handling procedure, which will be published before the SPSO takes on the function for social work complaints in April 2017. Thank you, cabinet secretary. We now move directly to questions and our first question is Malcolm Chisholm. There it brings the social work complaints procedure into line with health and other local authority complaints. More specifically, it brings it into line with health. It is that right because of the professional judgment factor. I think that most people would say that this is a good idea in an era of integration, but one concern that was raised was that it might not be in the oral evidence. We have just heard that it might not be a CHR complaint in the sense that the ombudsman could not direct a local authority to follow the decision that he or she had arrived at. Have you considered that dimension of it or is that not something that you would agree with presumably? I recognise the importance of ensuring that complaints are joined up from the perspective of the complainants. Health boards and local authorities have to agree and set out within their integration schemes their arrangements for managing complaints that relate to the delivery of services that are within the scope of integration. I hope that that gives some reassurance that there will be a synergy and coherence in relation to the CHR issue that you raised. It is important to remember that SPSO is fully independent of local authority. The criticisms that have been previously made about the links between complaints review committees and local authorities are being dealt with in those reforms. Ultimately, in the same way as judgments around health, it is for the public body in a very public way to then implement the recommendations. That is how it works for health and other services and how it will work for social work. It would be unusual to say the least if a public organisation was determined to say that that is the recommendation and that the complaint has been upheld, but we are going to ignore it anyway. In reality, that does not happen. Mike, I do not know if you want to add in. I understand the point that you are making, because in practice that is what happens. Obviously, that was a concern that was raised. Your first point there was really interesting because I think that this has come up in a different session that we had because that is really about what the ombudsman is going to do, but I assumed when the integration boards were set up that they would deal with complaints, but are they still going to be dealt with separately, as they were, by local authorities and health? That is what you were touching on in your first part of your answer there. The integration scheme has to set out the process by which a service user and anyone else complaining on behalf of a service user may make a complaint, and the arrangements that are set out in the integration scheme do not alter the underlying position that complaints are to be dealt with under existing health and social work complaints procedures, but the health board and local authority must ensure that the arrangements that they have jointly agreed are clearly explained, that they are well publicised, that they are accessible and that they allow for timely recourse. Of course, they have to also ensure that people are signposted to independent advocacy services. At the end of the day, if you are a service user, all you want to know is that your complaint is going to be dealt with the way that is dealt with behind the scenes needs to be consistent and it needs to be joined up by both bodies working together and ensuring that there is something that perhaps spans the services of both organisations. In the world of integration, you can envisage how those services might be services going into someone's home, for example, that are delivered jointly by both organisations. There has to be a synergy in the way that it is dealt with, but it will be legally dealt with under the auspices of both organisations that are set out in legislation. I will pick up some of the evidence that we heard in the last session. One of the concerns that was certainly raised by COSLA was the 15-day window that it currently has in relation to complaints at the most local level and the national consistency. Five days ago, we were told that there could be discretion in relation to that. How would we make sure that, in practice, appropriate discretion was shown, I suppose? An opportunity to roll a couple of questions together in relation to that is again when you have people without social work expertise making professional judgments on those with it. We heard again from the SPS that they would be looking to recruit people from that context, but I suppose it is just to make sure that what oversight government would have to make sure that that happened. Those were two concerns from groups that obviously support the reform, but I hope that, just to get on record, there is some reassurance that you can give in relation to that. In terms of the question of 5 or 15 days for the timescales at the front-line resolution stage, during the working group that Reverend Graham Forbes shared, that was one of the issues that was raised as we were going back to 2013 on that. We did listen to that. One of the things that we have committed to in producing the model complaints handling procedure, which SPSO will do in collaboration with the service users, with other organisations, they will be looking at that at that stage. It is an issue that has been raised consistently, and we would expect that to be addressed in that model complaints handling procedure. Officials from the Scottish Government will be working with SPSO and those organisations to ensure that that guidance is appropriate for service users, as well as for local authorities in producing a good complaints handling procedure for social work. There would be relevant SPSO employees with substantial support. The resources that will be provided to the SPSO to enable them to take on the functions will ensure that they can take on social work professionals to ensure that there is good professional oversight of any of the issues that are raised to them. There will be social work professionals working with SPSO. One of the questions that was asked in the earlier session was not for the first time. Whenever a complaints process comes up, the theme quickly turns around to appealing decisions that local authorities have made. In various other SPSO legislation, that settles in so much the lobbying that MSPs get. There are financial decisions that local authorities make that I may or may not always agree with. There is also an allocation towards meeting service and addressing need. The complaints process will look at how people go through that system rather than the overall allocation. However, where there is a service failure for individuals, because not enough care is provided, SPSO might have something to say about that, the care inspector might have something to say about that and I am pleased that there is information sharing arrangements in place. It would be suggested if you want to call it, maybe the mental welfare foundation might be a relevant body as well. I am just wondering whether you will keep that under review about how we can share that information as much as possible to put those really important checks and balances in the system. Yes. One of the most important aspects of a complaint is how the organisation learns from that in terms of improving practice in the way that things are done. You are right that it is really important that the dots are joined up with the SPSO, the care inspectorate and the mental welfare commission. If there is information that comes to light during a complaint that might have wider implications, whether that is for the conduct of individuals or whether it is about the service more widely, it is appropriate that other organisations are able to take that. We use a number of routes to that in the health service. For example, patient opinion, if something is raised there, that could be of particular concern. We would expect that that would be looked into, particularly if there were issues of concern for individual welfare. One of the most important aspects of the change is to bring it together. At the moment, as I understand it, it is not allowed to share any information unless there is a threshold that has to be met before the ombudsman is able to provide information to other organisations such as the triple SC or the care inspectorate. The purpose of the amendment that is made in this order, adding it to the schedule, is to allow them to do so in a wider range of circumstances, where it would be relevant to those bodies' functions. Just to check, it is not the mental welfare commission, not the foundation, of course. I got that wrong. You will take a view, maybe, going forward whether that is an organisation that should maybe get a greater degree of information sharing as appropriate. That is something that we will have to consider. It is not explicitly listed under those provisions, but it is something that we would want to give some consideration. From the work that we have done on it, I do not think that it is to come up in any of the consultation responses to the quite extensive work that has been done. I suspect, but I am talking off the top of my head, that it is to do with the nature of exactly what role the mental welfare commission has in individual cases, as compared with the role of the care inspectorate and the triple SC. There is nothing to stop if it is appropriate that being done in a subsequent order, but I am not aware that it is to come up in any of the consultation to date. I am sure that that was my last question, but it was going to be when I was in relation to just making sure that, with the guidance and regulations, this is the kind of thing where you keep a weather eye on it and update it as appropriate. This is not job done, this is the transition made and followed through the on-going basis. I will definitely continue to monitor. Just a couple on the detail, but one maybe on the strategic, the national care standards, how important they are in providing points of reference about how service is delivering. I am going to say it anyway. It was 2011-12 that the committee recommended the review of the national care standards. When will they be in place? Will they be in place before 2017, when this is in operation, and how important will they be to what people can expect in terms of their delivery on the ground? Yes, they are very important. My understanding is that they will be at the time frame. There is synergy there from recollection, but I will confirm that, I am sure that it is. That backdrop of the standards that are expected will be an important reference point for service users and the SPSO. What I will do is get a note back to the committee just to confirm in the time frame on that. On the detail in terms of the five or the 15 days in terms of complaint handling, and I think we are focusing on timely resolution. The five days meets that requirement, and I think that we know as MSPs that that can be very, very important indeed to ensure that it does not become a full-blown complaint that issues are satisfied, etc., so it is an important element over. The next stage is what meaningfully can be done to ensure that in that five days advocacy can be put in place, that the individual is fully aware of their rights, the local council policy in regards to the complaint and be supported in that complaint. Is it realistic that all of that can be put in place in that five days and that complaint can be handled and dispatched efficiently? Will that become a problem in itself if we are setting an unrealistic five days, then we are going to get breaches and people are going to be complaining that they have not been here within the five days. The detail and the practicalities there, I suppose, and I have one final question in that might as well do that, is how do we ensure, for instance, if it is a question on a social work person's professional opinion, how do we ensure that we can get the appropriate person involved at that very early stage to have the skills to review that professional opinion that is cause for complaint? On the last point, there is good experience of doing that in the health service, so when it is a health service complaint, the ombudsman is well experienced now of being able to bring in the right expertise that can provide the level of advice that they need, so essentially it will be the same. It may take a little bit of time to build up those contacts but I would imagine that there is a good template there of being able to apply that to social work services, which, of course, are. There is a big range there from services to children, older people, people with learning disabilities. The expertise that is required there in terms of giving advice will be a bit different, but I would assume that the ombudsman, Michael, might say a bit more about this, would have that bank of expertise that they would then draw up on? I understand your concern there. If it is a case of someone, perhaps, with additional support needs who may need quite an intensive advocacy input in order to be able to take the complaint forward, that may be a challenge within five days. It should certainly still be the aim, but there is also an issue about doing it properly and making sure that the person's concerns are expressed fully. It is that balance of trying to deliver that within five days, but losing the ability for the person to have the opportunity to express or complain properly. I suppose that that would be the balance. I was going to say that it is important to be clear as well that the five day period is really just for the front line resolution. There is the stage after that where it would be a senior manager who would look at the complaint, so it is really focusing on getting it right and getting that change made at the very first stage. We will be providing SPSO with sufficient funding to ensure that they are able to… I know that that is more for the local authority side of things, but we will provide SPSO with enough funding to ensure that they have the advocacy support for people coming into them. To meet the requirement in the legislation in the five days, we just need to acknowledge the complaint and say that it has been investigated. That would meet the requirement, is that what we are saying? What we are looking at is to try and resolve a complaint at the first stage wherever possible. What we are talking about in terms of the five and 15 days is that we aim to try and resolve a complaint within five days to start with, but with the possibility of extending that to 15 days, should either the local authority or the complainant need additional time to do that? In the circumstances where it might be somebody with quite profound additional support needs, it may be more appropriate to take that little bit of extra time, but, ultimately, those judgments will be made. Just on the point of advocacy, I pick you up that people with additional support needs would get advocacy, but it may be that people putting in a complaint are quite vulnerable. I mean, people receiving support services would probably require advocacy as well, and is that built into the whole process, both within the appeals process to the council itself and onward to the SPSO, that they would have access to advocacy, taking that forward? My understanding is that advocacy is there for anybody to use who requires it. I do not think it is for defined cases. My understanding is that, in some ways, that is self-selecting. If someone asks for advocacy in helping to make a complaint, I do not think that you have to fit into a particular person who feels that they need support in making the complaint. They determine that themselves, if they require that advocacy. We will have to monitor to make sure that it is adequate to meet the needs, and I am sure that the SPSO will be keeping us fully informed about whether it feels that the resources are meeting the demand. Those are things that we will have to monitor as we go along, but that is my understanding that it is self-selecting. Another issue that might require more resources is that if hearings are required, getting the hearings to go out to the people rather than have them travel, it can be quite distressing if people have to go a long way from home, stay overnight and go through the process as well. I am sure that those things will be judged by the SPSO on the needs of the individual concerned. If someone has very limited mobility, for example, it may be absolutely right that people would go to the service user rather than the service user being expected to go to a central point of the SPSO's office or whatever. That would be my understanding. We now move to our next item on the agenda, which is agenda item number six, which is now the formal debate on the affirmative SSI, which we have just taken evidence. I remind the committee and others at this point that members can discuss issues with the cabinet secretary, but should not put direct questions to her during the formal debate. Of course, officials may not speak in the debate. I now invite the minister to move motion S4M-15465. Is there any member who wishes to contribute to the debate? No. No member wishes to contribute to the debate. Is there anything else that you want to add? I put the question, which is that motion S4M-15465 be approved. Are we all agreed? We are agreed, thank you. I now suspend at this point and thank the cabinet secretary and his colleagues for being with us. Agenda item number seven, which is subordinate legislation. We have two negative instruments before us today. The first instrument is the national health service general dental services Scotland amendment regulations 2016, SSI 2016, backslash 53. There has been no motion to approve at all. Members will be aware that the Delegated Powers and Law Reform Committee has commented on the drafting errors in the SSI, and the Scottish Government has confirmed that it intends to lay a correcting instrument early in the new session. I invite any comments from members. If there are no comments, I put the question that committee are we agreed that we make no recommendation? We are agreed that the second instrument before us is personal injuries and NHS charges among Scotland amendment regulations SSI 2016, backslash 59. Again, there has been no motion to approve at all, and the Delegated Powers and Law Reform Committee has not made any comments on the instrument. Any comments from members? No comments. I take it from that that the committee agreed to make no recommendations. That is agreed then, thank you. And as previously agreed, we now move into private session.