 Good morning, and welcome to the 11th meeting in 2016 of the Health and Sport Committee. I would ask everyone at this time who is in the room to switch off mobile phones as they can often interfere with the sound system as well as the committee proceedings. Although those of you here will note that colleagues are using tablet devices instead of their hard copies of the papers. We have an apology this morning from Rhoda Grant and Malcolm Chisholm is still at the devolution committee and who will join us shortly. The first item on the agenda today is a decision on whether the committee will consider agenda item number 10 in private. That is consideration of the main themes arising from today's evidence session and we would normally take those considerations in private. Do you have the committee's agreement? Thank you. The second item on the agenda today is subordinate legislation, one affirmative instrument. As usual, with affirmative instruments we will have an evidence session with the Minister for Public Health and her officials on the instrument. Once we have asked her questions, we will then move to the formal debate on the motion. The instrument that we are looking at today is Public Bodies, Joint Work in Scotland, Act 2014, Consequential Modifications Order 2016, draft and can I welcome, again, the Minister for Public Health, Maureen Watt, welcome minister. The minister is accompanied today by Brian Nisbit, senior policy officer, health and social care integration directorate and Claire McKinley, a liciter from the Scottish Government and James Lane, policy officer, disclosure Scotland. Welcome to you all. Minister, do you wish to make a brief opening statement? Yes, I would like to say a few words about the draft order, convener. The order is in consequence of the establishment of integrated joint boards under the Public Bodies, Joint Working Scotland, Act 2014. The purpose of this order is to amend the Protection of Vulnerable Groups Scotland Act 2007 and the Protection of Vulnerable Groups Scotland Act 2007 prescribed services protected adults regulations 2010. Those amendments are technical in nature and are necessary to ensure that the PVG scheme continues to apply to its full extent once integrated health and social care arrangements are in place. The amendments make it clear that staff delivering health and care services to vulnerable people in Scotland that are provided or secured under the integration arrangements remain within the scope of the PVG legislation. The practical impact on health boards and councils will be minimal as staff providing these services for those organisations are already doing regulated work and so able to join the PVG scheme. Those amendments should not lead to more staff having to join the PVG scheme. The changes ensure that the integration arrangements do not have the unintended effect of removing the possibility of health boards and councils to carry out PVG scheme checks in the appropriate cases. Committee members will wish to note that this order does not take forward any new policy as it is needed simply as a result of wider legislative changes providing for integration of health and social care. I would be happy to take any questions. Thank you minister. Are there any questions for the minister? We do not have any further questions for the minister. We now move to agenda item number three, which is the formal debate on the affirmative SSI, in which we have just taken evidence. At this point, I remind the committee and others that members should not put questions to the minister during the formal debates. Officials may not speak in the debate. I invite the minister to move motion S4M-15463. Any members wish to contribute to the debate? We remain for me to put the question that motion S4M-15463 be approved. Are we all agreed? This is agreed, thank you. I can now suspend for a moment to change the panel. The fourth item on the agenda today is also subordinate legislation, another affirmative instrument. The instrument that we are now looking at is pharmacy, premises, standards, information, obligations, etc. Order 2016 and draft. We welcome again of course the minister, but the minister is now joined by a panel mayor, deputy chief pharmaceutical officer, finance, e-health and pharmaceutical director. Welcome to you. Minister, to make a brief statement. Thank you. Thank you, convener. The statement is slightly longer than the previous one. The Scottish Government and the health departments in the three other nations are committed to legislative change in healthcare regulation to enhance public protection. That is why changes are being made to the general pharmaceutical council's legislation through the disorder that is made under the Health Act 1999. That is to ensure optimal design to provide safety for users of pharmacy services, while facilitating and reducing the barriers to responsible development of practice, innovation and a systematic approach to quality in pharmacy. The general pharmaceutical council was established in 2010 with the approval of both the Scottish and UK parliaments. That order will make seven key amendments to the legislation governing the GPHC's processes. The first is to remove the requirement for the GPHC's standards for registered pharmacy premises to be set in rules. Those will now be set in a more proportionate and flexible way without requiring the use of rules that must be formalised in legislation. As a consequence of moving the premises standards out of the rules, they will no longer be included in a statutory instrument that is subject to privy council approval and laid before the UK and Scottish parliaments. Standards for individual registrants are not subject to such procedures. However, the order includes an explicit and important requirement for the GPHC to consult Scottish members as well as English and Welsh ministers on changes to pharmacy premises standards. Secondly, the proposals enable GPHC to apply the standards to associated premises that are integral to the provision of pharmaceutical services as well as registered premises. That reflects the fact that, in some respects, the traditional model of pharmacy premises being entirely self-contained operations at which all aspects of the retail pharmacy businesses are carried on is for some businesses outdated. Integral parts of their business operations, for example electronic data storage, may be elsewhere. The third amendment sets out the registration sanctions that the GPHC may use where pharmacy owners breach the standards. The general pharmaceutical council already has powers to issue improvement notices where a pharmacy owner breaches the standards for pharmacy premises. That order will mean that breaches of premises standards will be dealt with as a disciplinary matter by the Fitness to Practice Committee. Fourthly, the order will introduce the use of interim suspension orders by the GPHC when it is in the public interest prior to a disqualification decision or removal decision taking effect after a full hearing of a Fitness to Practice case. Those changes reflect the move to better align the disciplinary provisions for pharmacy owners in respect to breaches of pharmacy premises standards with those for individual registrants. As well as the changes to premises standards, the order makes some adjustments to the GPHC's powers to set rules around information gathering obligations. Should the GPHC exercise its amended powers to make rules on information obligations, those changes will be subject to further parliamentary scrutiny. The order provides for a new criminal offence to support enforcement of those rules on information obligations. That provides a backstop should a pharmacy business fail to comply with an improvement notice from the GPHC. The Crown Office and Procurator Fiscal Service have been consulted and indicate their content with that. Fifthly, the order makes changes to the GPHC's powers to gather information from pharmacy owners so that the regulator will be able to allocate resources proportionately by assessing the risk in a pharmacy. The order also clarifies when the GPHC can require pharmacy owners to provide such information through its rules and the type of information that is covered. The sixth amendment clarifies what information the GPHC may publish in reports of pharmacy premises inspections and makes clear that if a report includes personal data, it is assumed for the purposes of data protection requirements that such information can be published. Finally, the order will make a correction to terminology used in the General Pharmaceutical Council's procedure on the notification of the death of a pharmacist or pharmacy technician in Scotland. The legislation is changed to refer to a district registrar rather than the registrar general as is currently the case. The Scottish Government considers that the best way to improve consistency, create greater efficiency and simplify professional healthcare regulation would be to introduce a single UK bill covering all professional groups that builds on the work of the law commissions. I understand that the Department of Health has now confirmed that there will not be such a bill in the near future but that it has instead proposed a consultation leading to a policy paper on future regulatory policy. The Scottish Government is disappointed at the lack of a bill but is currently working with the Department of Health to understand the nature and extent of the new proposals. The order will make important changes to allow for optimal design to provide safety for users of pharmacy services while facilitating and reducing the barriers to responsible development of practice, innovation and a systematic approach to quality in pharmacy. I am happy, convener, to take any questions that members may have on the draft order. Richard Lyle? I want to ask just for clarification, premises standards. We have pharmacies standalone, we have pharmacies joined on to some doctor surgeries, we have pharmacies within boots, for example. Will that order instrument change allow pharmacies to be established in a grocery shop, a grocery shop or e-corner shop somewhere in order to encourage, we have a lot of areas where a pharmacy is not near, certain parts of the population would that be able to change that or am I going down the wrong avenue? I would like to answer that, convener. These standards apply to registered pharmacy premises. In order for a pharmacy to be established, it would still have to go through the normal procedures currently, so it does not amend that or change that or change the control of entry requirements that currently exist. Therefore, a pharmacy can still apply to be established somewhere within a locality, and that would still be under the same regulation. Yes, it would. Any other questions? Yes, sorry in the net. I apologise if I did not pick it up. Does this bring Scotland more into line with the rest of the UK rather than I would? We would like to see a more level playing field in the opening remarks. That is not good to come in the near future, but we are working closely to ensure that standards are more aligned. In terms of pharmacy standards, there are draft standards in place currently across the four countries. That would make it enforceable and the same would apply across the four countries. In terms of any future bill that you mentioned, minister, there would be now a consultation. How would Scottish Pharmacy play into that consultation and who is carrying out the consultation and who will evaluate the results of the consultation? There are two aspects of it. The first is the pharmacy standards that are in place. The GPHC recently conducted a consultation that was undertaken by an independent body on behalf of the GPHC and Community Pharmacy Scotland. Other pharmacy contractors in Scotland would be able to contribute to that consultation. GPHC have taken feedback from those comments and revised and amended to the way that they undertake the inspections. There were some concerns in terms of how any breach of set of standards would be acted on or enforced. Further consultation, do you think, is wise at this stage? I think that the consultation I understand has been undertaken quite recently and the consultation response was very positive in favour of the way that GPHC was progressing, the changes that they had made going forward. But any breaches in the standard and how they would be dealt with, there were some concerns and lack of clarity there? I think that those can be fed back to the GPHC so when the GPHC formally set their standards that would be open to people feeding back to the GPHC on that. Okay, okay. No other questions? Yes, sorry, minister. They were brought as breaches of premises standards but they would be dealt with as a disciplinary matter in relation to fitness practice. Okay. We now have exhausted questions. We will now move to agenda item number five, which is the formal debate on the affirmative SSI, which we have just taken evidence. At this point, I usually remind people that members should not put questions to the minister during the formal debates. Officials may not speak in the debate. Can I invite now the minister to move motion S4M-15458? I move that the Health and Sport Committee recommends that the pharmacy premises standards, information obligations etc, order 2016, be approved. Any member who wishes to contribute to the debate? No. I then put the question that motion S4M-15458 be approved. Are we all agreed? Right. Thank you. Again, we suspend to change the panel. Item six on the agenda today is oral evidence on four Scottish statutory instruments, which, taken together, provide for the regulation of independent healthcare clinics. Don't propose to read out all of those instruments as they are listed on the agenda at item six. We welcome again this session of the Boring Wop Minister for Public Health. Minister is joined by Dr Sarah Davies, a public health consultant and Ailsa Garland solicitor, all from the Scottish Government. Minister, do you wish to make some opening remarks? I wish to thank you, convener. I thank you for the opportunity to explain the rationale behind the National Health Service Scotland Act 1978, independent clinic amendment order 2016, which, along with a commencement order, which was laid at the same time as the SSI expands the current regulation by Healthcare Improvement Scotland of independent healthcare provision to include clinics in, or from which services are provided by doctors, dentists, nurses, midwives and dental care professionals. The Scottish Government commissioned an expert group, which included a range of service providers, members of the public and industry regulators, to develop the strategy upon which the policy is based. The outcome of the expert group's work, which the cabinet secretary accepted in July last year, has been developed with stakeholder engagement into the policy to extend the regulation of independent healthcare in Scotland to specific clinics to continue our programme of improving public safety and standards of care wherever services are accessed. The policy has been welcomed by many regulatory bodies, including the British Association of Cosmetic Nurses and the General Medical Council, who will be issuing new guidance for those doctors who carry out cosmetic procedures, and that guidance will be produced in the spring of this year. Significantly, many of the service providers themselves have indicated their support. While recognising that there will be costs incurred by service providers for the purposes of registration and inspection of premises, I consider that to be a necessary burden to ensure the safety of both users and providers of the industry. To talk first about the affirmative order before the committee, the independent clinic order amends the current definition of an independent clinic in the National Health Service Scotland Act 1978 by including the additional health professions of registered nurses, registered midwives and dental care professionals. The rationale for the addition of these three groups of professionals is that, due to the changing nature of the independent healthcare market in Scotland, those professionals can now offer services that can include the provision of cosmetic procedures. The proposed change in the definition is supported by the chief medical officer, the chief nursing officer and the chief dental officer, as well as external stakeholders. The order also adds specific exemptions to the definition of an independent clinic. That reflects the policy intention that the purpose of regulation is not to regulate services that are ancillary to the purpose of an organisation, so health clinics in schools, colleges and universities or occupational health services provided solely for employees by the employer are exempted. Regulated services that are inspected by the NHS Scotland, jointly NHS and independent GP and primary dental services and three give a disproportionate regulatory burden to first aid clinics at sporting events, for example, or talking therapy clinics. There is a related commencement order, namely the Public Services Reform Scotland Act 2010 commencement number seven order 2016, which commences provisions in the 1978 act so that regulation of independent clinics goes live on 1 April 2016 with a delay in the offence not to register a clinic until 1 April 2017. This year's grace will allow clinics that are new to the area of regulation to work with his to understand the requirements of registration and ensure that their systems, policies and care are in place for the process and the following year's inspections and reports. The third instrument is the Healthcare Improvement Scotland fees regulation 2016. Those regulations set the maximum fees that can be charged by his in relation to matters such as applications for registration of independent healthcare services. This is a ceiling and, as required by the enabling powers, has been consulted on together with the actual fees that his plan to charge for the year 2016-17. Those regulations set maximum fees in relation to independent hospitals as well as clinics and revoke and replace existing fees regulations from 2011. I am aware that the fee structure has generated some interest, but, as his are providing this service on a cost recovery basis, it is intended to be self-funding. The final instrument is the protection of vulnerable groups Scotland act 27, prescribed purposes for consideration of suitability regulations 2016, and will allow his to check the suitability of a provider or manager of an independent healthcare service registered with them. In summary, the Scottish Government considers that the best way to improve patient safety in the independent healthcare clinic setting is to introduce regulation of clinics through the legislation that is described. I am happy to try to answer any questions that committee members may have for me. I know that those regulations are very much about phase one and that it is a three-phased approach towards the regulation of this industry. Can you give us any idea of a timetable for the different phases? One of the questions that came up from the round table that we had last week was that over the three phases we will end up with a situation in which some clinics have to register while some people will be regulated. I wonder how the different ways of looking at this over the three phases all come together. Phase one commenced in 2014 and we are obviously at the end of that stage now. Phase two will commence in April 2016 on the completion of phase one and then we expect that probably to last until the end of this year and then phase three will start thereafter and probably take another year. For phase two there has been preliminary discussions through the expert group but the proper work for phase two will need to be scoped and provided to the minister for it with recommendations on your other question about whether some providers will be regulated and clinics are regulated. At the moment the aim is that the clinics will be regulated because healthcare professionals are regulated under other circumstances. For phase two the idea is to try and find a way of making sure that the nonsurgical cosmetic procedures that are done by other healthcare practitioners such as beauticians or hairdressers which are a limited stock of nonsurgical cosmetic procedures such as dermal fillers are also captured. Now whether that would be through work with the environmental health officers who in licence skin piercing into two parlours is to be scoped and provided with options. Phase three would be for people such as the very few healthcare scientists who provide laser services whether their clinics would be regulated as it is phase one again has to be scoped out. That helps to get that explanation. To some extent the distinction between phase one and phase two is that phase one will be the responsibility for inspection regulation of healthcare improvement Scotland and that phase two will not be their responsibility but somebody else's. Is that partly what the distinction is based on? We would need to see what exactly the outcome would be after consultation but obviously local authorities may well have a bigger role in the second phase than they do in the first phase. So is what is proposed fundamentally what was proposed a long time ago in the regulation of care act in 2001 in terms of the inspection of independent clinics by the care commission as it was being set up then but that is now obviously the role of healthcare improvement Scotland? Yes, I was not around then obviously but I do not think that that was taken forward to regulation and then it was superseded by the Christchurch commission and the change to public services. Sarah, do you want to give a better explanation? Not all. As the minister says, absolutely there was the work from 2002. There was then the SMASAC report so the CMO had a specialist adviser group looking at cosmetic surgery in 2005-06 and again it recommended moving forward with the regulation of independent clinics but then there was a change as the minister said with moving to the work to healthcare improvement Scotland and then there was a consultation by the Scottish Government on what should be done and the block has always been this question that the regulation had because it was right at that time doctors and dentists clinics had to be regulated and what was brought forward is the result of all the consultation that it needed a wider group of healthcare professionals? There were some concerns in the evidence. We had the British Association of Aesthetic Plastic Surgeons were concerned about some situations where non-healthcare practitioners are working within independent clinics and providing cosmetic interventions, whether that was a part of phase 2 or how that will work and secondly the British Dental Association was concerned that the definition of independent clinic was on the healthcare professional providing the service rather than on the procedure and the example they gave was beauticians working in beauty salons who carry out teeth whitening without any regulation or formal training so those two situations would they be captured by phase 2 or how would they be dealt with? If I can just answer the first question if there is a beautician who's working in independent clinic providing certain services it may well be they have a nurse there because if they're doing certain types of nonsurgical cosmetic procedures they will need a prescriber so if you're providing certain prescribed medicines such as bottleining toxin and all its varieties they will need to be a prescriber so that clinic will be regulated the person who is then delegated to give the treatment may will have to be under supervision of one of those professionals if they're so that would be the first one. The second example with the British Dental Association I think is the evidence heard teeth whitening at a certain percentage of the chemicals has to be done by a dentist so I think that one of the other aspects of this work may well be that there is greater awareness of who should be doing what. Richard Lyle Can I come on Dr Sarah Davies? That's very subject. I was quite shocked actually when we heard the evidence about teeth whitening and driving by one day I noticed an advert at a tan shop that said get your teeth whitened here which quite shocked me. What would happen in regards to these premises I'm sure would have to take that out surely. The legislation is quite clear that teeth whitening is a role for dentists and I think what has happened is that this has possibly escaped people's awareness always so there are you can that's the percentage of the actual chemicals within the teeth whitening that has to be done by a dentist other can be done by different groups of people and I believe in some situations you used to be able to buy kits in certain shops to do it at home whether then so the actual level of teeth whitening that's done by dentists must only be done by dentists I'm not answering your question but the answer of the question is if there is teeth whitening that's done that should be done by dentists and isn't being done it should be reported. Richard Lyle I'll come on to my main question but you know if you actually look at adverts on the television that's advertised on the television too you can send away for these things. Anyway I'll leave that aside. Minister can I ask you in regards to fees the concern I had was I'm all for regulation I'm all you know picking up people who are outside the system and we've got to ensure that for instance that people who are going to get their teeth whitened their teeth don't fall out after they've been somewhere that's not been regulated but I'm concerned about a level of the fees some you know we're talking nearly £2,000 we have people who are independent midwights and I see that there was a strong support against a flat registration fee so why is this approach been proposed and there was also I was shocked to see that basically if you apply and you don't meet the criteria and you're refused you don't get your fee back you know has keeps the fee although I was given the assurance that they would work with the person concerned in order to ensure that they met the criteria but there still is that case now we've got independent nurses or independent midwights etc people who maybe are working with the greatest respect outside the health service and are making a living you know they're going to be faced with a fee of something like the regional nearly £2,000 in order to set up will that encourage people why don't we have it as a sliding scale why don't we have it that if they don't meet the criteria that they do get a proportion of their feedback because I certainly wouldn't like to hand you £2,000 and then for you to turn around and say no you don't meet the criteria and I don't have a £2,000 back I take your point but you know as I said in my opening statement it is his are working on full cost recovery so the same work has to be done regardless of the person making the application and this was discussed by the his board and it was judged that having a flat fee would be the fairest approach for the first year I think we need to put this in context I think we there are probably only about three independent midwives in Scotland but all providers including midwives will have a full calendar year to register and discuss the process with his I don't know if you want to add anything Sarah and if I can just add again as you heard from last week with his the registration process and as we've been hearing from his already with people putting in applications it is really quite a discursive process so it isn't providers the money we don't return it there is really a lot of consultation going on they're providing as much as possible and they can do in the way of templates of the type of policies that people are meant to have so it's quite a it's quite a long process to work through before there is a definite sort of handing over of a check and then it not being returned so if someone applies can they sit down with his and talk through what they want to do prior to paying over their money so that they can then say well what you know I don't think I'm going to meet the criteria there I'll go and do something else so yes thank you very much supplementaries on that I mean you know take your point and the evidence we had confirms that there are a few independent midwives but they are there they're doing a job they'll be affected by by by by by these measures you know it's quite a difference isn't it optical express for instance paying the same flat fee in the premises of midwives but the other aspect that's been raised with us is about what aspects of independent midwives work would be inspected you know they don't operate on the high street they operate in people's homes you know so as well as the the challenge of fairness of fees that would be levied upon them there's there's a question of how would you affect the objectives of the of the measures if I can answer that I think as we heard from his before the idea of the regulation is to review current standard current practices in a range of areas so it's the clinical governance as well as the business matters so for a midwife for instance what they would be expecting in the same way as independent nurses who are maybe providing services in a range of procedures in a range of places but just have a small clinic they would want to check record keeping decontamination of any objects how people do their complaint system so it's both the the governance and the clinical governance of the service and the financial viability that's the sort of thing that they would be wanting to look at in the place that the midwife decrease is is her probably office then the place the work that she does in people's homes would there would be a report on it so that there wouldn't be they're not inspecting individual homes where she provides those services but she wants to make sure they want to make sure that the service as an as an entity is a viable entity and meets the standards that are required for any kind of service. Implying with standards and the registration fee I presume has been a nurse and a midwife she's regulated with all of all of that so that that assures some of the quality issues how would how would someone who purchases those additional services provide ensure how would that get an outcome that's better quality or safer or whatever when they're already regularly just other than paying the thousands of pounds fees that we registered but there's a big difference between operating in a hospital or a dentist premises or even an independent hospital compared to working in a person's home and as Sarah said you know it is about decontamination nor making sure that the equipment used is properly cleaned and up standard it is in the end of the day about protection of consumers you know and in this case they're not doing it in an already regulated environment they're doing it out with that so I think it's important that standards are high. Just to be supplementary on the dentist then because there were some questions last week's committee about how they currently are inspected and the request that any inspections that would be carried out on basically private dentists would be carried out by dentists and there were some comment in the committee in regards to why dentists delivering and contacted to deliver in the health service are actually got a different inspection regime to to was this not an opportunity to bring dentistry as a whole you know into being regulated and inspected by his why do they stand separate from I think given your evidence session before recess I think many people will have been I think many people were surprised that private dentists weren't regulated at all I mean go to private dentists pay a lot of money and and there is no regulation so I think people consumers will be very pleased that there will now be regulation of dentists who operate completely out with the NHS system are completely private yeah but it will be it will be different you know yes there'll be there was an opportunity here to to there'll be right there was there'll be regulated according to um the same sort of inspection of independent hospitals so it's not quite the same as the NHS where public money is involved so you agree with the principle that dentists should be inspecting themselves which is what the majority the majority on the inspection of a dental practice within a national health service stands aside for them stand separately from from the new regime and its dentists for say that carry out those inspections qualified dentists at parry carry out those inspections they are happy with that situation of course and and the only the only the only plea that I think they made to the committee was that you know if we're going to inspect the private dentist then it should be dentists who should carry out that inspection if I can at the moment what the situate as I think you've probably heard from um the evidence gathering health boards inspect the dental practices that are under the NHS and the aim which work is his is doing at the moment with the general dental council and other dental groups is to make sure that the inspections that his will now start of purely private dentists both meets what his wants to do for independent healthcare examination and regulation but also you know ties into what the health boards are getting at the moment from other NHS dental inspections so I think as you heard from the plastic surgeon that um when there are and he was saying that his will need experts to do examinations of different types of clinics getting dentists who are independent to inspect other dental practices is what happens at the moment for the NHS you know it's like saying that doctors can only it can only inspect doctors and nurses can only expect nurses is it not absolutely it doesn't his is not staffed you know the spectres and go there i've got a speciality in inspecting a whole the general party you mentioned bookkeeping and record keeping and you know so i just i just think there's an inconsistency here which has been highlighted by by the new measures that you know that's all and you know that there is a big argument that that his itself is not independent enough from health boards and we've got health boards inspecting dentists dentists and dentists carrying out inspections you know and managing risk in hierarchy and hazard that that doesn't seem a good you know a reassuring model but I think you would expect the inspection procedures to be drawn up with with healthcare professionals whether it be doctors dentists in the mix into drawing up the procedures they might not necessarily carry out the inspection but at least they've had an input into the procedures that are followed while during the inspection inspect them against standards but the idea that you know we've we must have more dentists than we had 10 years ago and they're running about carrying out inspections i put we can only be in the net uncanny knack of answering the questions that i'm going to ask but don't worry about it now to get back to the independent minimise I have to I was quite surprised to see that particular group of people included in this because I understand they are pretty heavily regulated by the nursing midwifery council anyway and I just wondered what can his do that's actually better than their current regulators as far as inspecting them it just it seemed a bit odd to me that they were included yes I mean the the reason that they were included was to cover the two areas one is the midwifery and one is if they are any midwives who are also taking additional training and involved in cosmetic procedures so that was why they were included because the expert group advised that there are some windwives who are also doing cosmetic procedures out with their midwifery practice so it was to make sure that there was no gaps in the healthcare professionals who are providing those type of services on the issue of the midwifery service I think they are very well regulated at the moment whether the actual clinic organisation in the sense of the total services they're providing is looked at is not clear because they are regulated for parts of the services that they provide but not the totality that's helpful I actually haven't picked up about the cosmetic side and I say I mean are you confident that his seems to be involved in awful lot meridies in many what areas of health inspection if you're confident that his will be able to get the appropriate people to do this his have been provided with extra resources to deal with this extra work no other questions Richard no other questions no just just to pick up on one of of Richard's questions earlier in terms of professionals offering services you know on I think you mentioned online or you know on TV or whatever whatever that online providing services in Scotland but where the business itself is registered out with Scotland or where there's no fixed business premise or a PO box or whatever whatever will companies like that be required to register? Were those services that are provided from a base in England they will obviously be being regulated by the Care Quality Commission where there is services that are provided in Scotland where at all possible they will be regulated under this regulation it's quite difficult with a PO box or a website but his is going and it's already looking into how they can track that down to make sure there's some type of reason it could be a loophole for teeth whitening I think it's more that it's a question of how easy is it going to be how practical can his do the regulation of those types of services but they will be saying to people with websites if you're providing services in Scotland you must be regulated so they will be telling the basic requirement whether they will or not how we make them but will be a challenge for people in Scotland the services to people in Scotland must be registered through his okay no other questions thanks very much for that we now move to agenda item number seven which is a formal debate on the affirmative ssi which we have just taken taken evidence and again I remind the committee and others that members should not put questions to ministers during formal debates our officials may not speak in the debate I invite the minister to move motion s4m 15452 I would certainly agree to this regulation at the end of the day I know we'll tighten up the situation you know as I said earlier I was quite concerned two weeks ago when we're told that teeth whitening can be done anywhere and I saw it and I noticed outside the shop the only concern I have and I've but again I've sought the assurance and I'm sure that it will be as the cost and that if someone applies it they don't get their funding back but again I've sought the assurance and we'll be given the assurance that people will be allowed to sit down discuss with us and ensure that they're not paying over for them to come back a couple of weeks later to say sorry you don't make the criteria so with that regard I'm certainly support this amendment no other member no um minister i want to get some up okay and then put the question that is motion s4m 15452 be approved are we all agreed thank you um as it's suspend for a moment thank you minister and your colleagues who have accompanied you this morning thank you very much I'll just take a moment well we we now move to agenda item number eight and more support legislation we have two negative instruments before us both of which were part of the evidence we have taken on regularly in independent clinics the first instrument is healthcare improvement scotland fees regulations 2016 ssi 2016 backslash 26 there has been no motion to annul and the delegated powers and law reform committee haven't made any comments on the instrument do any of the committee members have comment if not is the committee agreed to make no recommendations on the thanks that is agreed thank you the second instrument before us is the protection of vulnerable groups scotland act 2007 prescribed purposes for consideration of suitability regulation 2016 ssi 2016 backslash 27 there has again been no motion to annul and the delegated powers and law reform committee has not made any comments on the instrument do the committee members have any comment there's no comment are therefore the committee agreed to make no recommendations thank you that is agreed thank you and I'll suspend now until 10 30 when we expect our witnesses to be with us thank you we now move to agenda item nine which is oral evidence session on access to new medicines progress and update round table so it's time for everybody to introduce themselves we've been here before many of us as a look round the table but my name's Duncan McNeill I'm the MSP for Greenock and Inverclyde and convener of the health and sport committee my name's Leslie Lollager and I'm the chair of the charity PNH Scotland good morning Dennis Robertson SMP member for Aberdeenshire west Malcolm Trism MSP for Edinburgh Northern and Leith Leith Smith from Melanoma Action and Sport Scotland but representing the health and social care alliance here today Mike Mackenzie MSP and I represent the Highlands and Islands Natalie Frankish development officer for Scotland for genetic alliance UK and rare disease UK good morning Colin Keir Edinburgh western MSP good morning Mark White director of finance from NHS Greater Glasgow and Clyde good morning Richard Lyle MSP for central region hi Aileen Muir lead pharmacist for governance for Greater Glasgow and Clyde and the net mill MSP for north east Scotland Rob Jones I'm a medical oncologist at the Beats and in Glasgow Fiona McLeod I'm the MSP for Strathkelman and Beardsden and the deputy convener of the committee good morning I'm Sandra Old I'm director of VBPI in Scotland good morning I'm Meryl Katrina McMahon and I'm the lead SMC member for industry working with ABPI and other companies and I'm also an Edinburgh trained physician great thank you for that those introductions we're going to go directly to Nanette Millan who's going to start us off Nanette thank you thank you convener I'm very interested in hearing how things are progressing with with the access to new medicines because as you know the committee has done quite a lot of work on this over the years. How do you think access to new medicines has improved since we did all our investigations have there been any change in particular that have been successful in improving access to these drugs and where does progress still need to be made and I'm particularly interested in the uptake of the new medicines fund how that's going okay well I think that sets the scene Nanette who's who's who's first we have had the written evidence which eluces some of that but there is an opportunity to have some of that on the record here today who's first Leslie go on thank you I was very fortunate two weeks ago to take part in the new pace meetings that have been taking place in SMC I just wanted to say what an amazing opportunity it was to have the chance as a patient to speak about my condition to speak about the the costs that are in existence other than just the basic costs of the actual drug to have clinicians that can speak on behalf of the drug people that are experts in my condition and experts in my drug I also wanted to say that before the pace meeting I was given the most amazing help and support by the SMC in preparation for it one-to-one preparation and help that was just second to none now you said what things could be improved obviously there are things that can my drug is also used for another condition called atypical hemolytic ureic syndrome AHS they also had a pace meeting in december by all accounts it went very well they've been turned down for the drug now it makes perfect sense to me that not every drug can be accepted that's not what we were looking for in this process however the wording of the rejection slightly concerned me because it did seem to still imply that we're looking at the bottom line cost of drugs and expensive drugs and I completely understand that but I still feel we're slightly missing on the understanding of the overall cost the difference that this makes to people's lives the extra things that would have to be in position like dialysis etc so I still think we need a little bit of clarity on how the decisions are made and also if there's a rejection because a drug is far too expensive which I completely understand I would like some sort of clarity in what negotiations go on after that stage where a drug company can be kind of brought to task and these things maybe happen but if it was something that a patient or a clinician could have more sight of then we'd have more faith in the system and we'd also have a bit of hope that we've got a path of care still available to us thank you thanks anyone else yes so I try to represent the views of my colleagues at the Beats and we've noticed a significant luring of the threshold for acceptance of drugs by the SMC and that's the bottom line I think. By and large we're very enthusiastic about the PACE scheme those of me and my colleagues who've taken part and I've taken part myself because it gives an opportunity to give information over and above what can come out in a written submission. There is a little bit of perplexity we do accept that even when a PACE group warmly supports the use of a drug it won't always be accepted but I think there is a feeling that we would like a clearer explanation particularly where the PACE group has given a very resounding support to a drug when it is then rejected a clearer explanation from the SMC is to specifically why the PACE groups recommendations have been rejected so I think as far as the SMC goes yes there's tangible improvements because the other aspect to access to medicines is the individual patient treatment request and I think there have been some concerns amongst colleagues that this has led to different thresholds being set for acceptance of the same medicine in what would be the same clinical circumstances from one region of Scotland to another and that's something none of us are keen to support and the PACE system can't actually remember what it stands for now and none of us have seen any evidence of this in action yet and I think we feel that that's an opportunity to try and level the interregional variability in individual patient treatment request we are also keen that even with a sort of an overarching agreement on access this is about access to medicines where the SMC have not accepted the use that there should there should still be retained an individual patient treatment pathway though whatever process comes in place with PACE trying to encourage I see the MSPs up they can put their hands up all day but we're trying we've got this panel here we're going to we're going to give them a voice Lee I would hope that everyone has read Dr Andrew Walker's submission Andrew is an academic you could say poacher turned gamekeeper gamekeeper turned poacher hard to say from his record but he has laid out quite clearly in his submission exactly how many drugs have been accepted and there is a definite improvement but I would have to echo what Dr Jones has said I've been to four PACE meetings and on each occasion we felt that a really strong well supported by SMC staff plea was made for a drug both by ourselves a patient and the consultant who deals with melanopent patients at the Beatson and we came away from the PACE meeting feeling that we had done our best it had been accepted and all would be well but then you go along to the full meeting and watch the result of that and what comes across very strongly and it's part of the transparency you can see very clearly that really the place for the clinician would have been at the full meeting to answer any questions that are still unanswered to allow the committee to make a properly informed decision and I was dreadfully disappointed to find that one of the drugs that we pleaded for was accepted for first line use and then because of questions which were unanswered in the final meeting we we lost out on the second line use and we have a whole batch of patients who have done well on a first line immunotherapy treatment who will in time start to fail on that or will not respond to it and they desperately need to have the second line therapy and it does mean it's going to have to be go to a resubmission and that takes even more time and I really feel that clinicians time is desperately important we are very very short of clinician time for melanoma patients and we can't afford to pick up any more of it to bureaucracy. I would just agree exactly with what Leah has said there I think one of the real strengths of the new system is the way patients and clinicians are involved in the pace process and the pace process has certainly been an excellent step forward and the patient involvement team in particular with SMC do an absolutely fantastic job in raising awareness of what the SMC does and how patients can be involved in it but I think where there is a glaring omission is when it comes to that final decision meeting and there's not a patient or a clinician around the table to answer those questions and sometimes things can get lost in the discussion or tangents be taken which would benefit from the ability I think of a clinician or a patient to clarify a point and I think that's the necessary next step to take there's certainly room now for the pharmaceutical industry to sit round the table and answer questions that same courtesy I think should be extended to patients and clinicians. ABPI would like to commend the change in process that SMC have gone through it has been substantial and they have worked very very hard to pull through the changes in process. If the intention was to have more acceptances then that is what has happened quite dramatically. What continues to need to happen is that the system continues to need to evolve to deal with the continuing new medicines and the types of new medicines that are coming through and will continue to be presented to SMC. If SMC wants to stay at the forefront and be the world recognised organisation that they are there will need to be a continued evolution. Dr Jones mentioned IPTRs and the PAC system. It has become clear that there needs to be a safety net for medicines that are not recommended. We are waiting to see what the replacement for IPTRs is and I'm not clear of what the pilot. I know that there has been discussion around a pilot in Glasgow. I'm not clear of any of the detail of that but it has become clear that there is absolutely a need for a safety net for these medicines. From the written evidence and from what people have said here that genuine progress has been made. The committee is looking for more yeses in the system. There's clearly more yeses in the system. People appreciate the engagement and the involvement and the opportunity to give that greater detail. I think that all that was coming out there at Nevins as well. They also do the listening, I suppose. I'm always going to be down to, I'm looking at Mark here because he's the man with the balance sheet. I'm referring to your written submission in terms of the cost and diversion of resources, etc. What limits have I got? There's not much more to add. The new medicines fund has been excellent in terms of allowing us to allocate resources to what would be rare and orphan drugs without the virtual resources from other areas of our healthcare provision. We are very supportive and we hope that we will continue. What level of funding comes down to the likes of Glasgow and Glasgow Klein? In 2015-16, the new medicines fund, the total pot, was £90 million for Scotland, of which our NRAC share for NHS Glasgow equates to around about £22-23 million of that. That's the level of funding we get. Initial numbers for 16-17 are down on that. We're still trying to finalise them and walk through with our Scottish Government colleagues, but that's the level of funding that equates to a board the size of Glasgow. The 20th is down, so there's a gap this. Likely there will be. We're still finalising those numbers. Have you been spending your allocation at suppose? Absolutely, yes. I've been spending more on allocation. It does contribute, but it's still not enough. We've got to find funding from other sources to fully fund, but it's very helpful. Does anyone want to pick up on—I think we've got somebody here from Glasgow. We've not got other boards representing it, but the issue of the regional application of some of this, I think that Rob mentioned that in terms of the submission from Beatson as well, and that in some other areas the progress is not as great or that some don't want to use the postcode prescribing. It would be helpful if one of the questions that the committee asked was, has this improved access to new medicines? We are able to say that it's certainly the approval rate has improved, but whether that has translated into patients being able to access those new medicines were not clear. It would be helpful to have, for example, perhaps Healthcare Improvement Scotland identified as an organisation to monitor the implementation of SMC decisions moving forward, and then it would be clear throughout the health boards what was happening Can somebody give—you might want to come back Sunday and give us a full explanation of that, because in my simple mind, more money, more patients overall, how there's a contradiction between patient accessing. Yes, please, Leslie, help me. What I was going to say was that we were trying to get rid of the IPTR system. That was one of the things that was meant to happen. We were moving to PAX, which was alluded to, and that obviously hasn't happened. In the interim, we still have a situation that each health board has their own IPTR protocol, which they are following. I went in and printed out most of the protocols that I could find IPTR protocols from the different regions, and they still are asking for patients to have significant difference in their clinical circumstances and to have a significant difference in the way that a drug would affect them. As you know from my condition, we have 15 in Scotland on the drug, and it's very hard to be different amongst a cohort of 15 people. The issue that we're having is that the practice is an IPTR form that still requests exceptionality, by another word, by clinical difference, and that's an issue. We need to see PAX in place. Rob, I'm the guilty person for using the term postcode prescribing. I did qualify it with the low level. This concerns clinicians, and it concerns patients as well. When it's an SMC acceptance, we have no tangible concerns about differences in implementation. I'm not saying there aren't any, but I have no evidence for that, but it is about the non-accepted. That may be prior to an SMC review, of course, so it may be something that is ultimately accepted by the SMC. Prior to July 2013, there were reasonably clear definitions of when an IPTR should be accepted, and by and large it meant that it wouldn't be accepted. Clearly, we have seen a dramatic lowering of the threshold, but the problem is that there are now no clear criteria by which an IPTR should be accepted. The same patient submitted to different parts of Scotland may get a different answer, and that's the problem. A national agreed system would be good, but I would reiterate that we are very keen to retain the process by which individual patients' needs can still be met. Notably, in England, there is virtually no process by which an individual patient needs can be assessed, and that causes a lot of problems for patients in England. I don't think that we want to see that happening in Scotland. Yeah, you're in the bottom of a long list, Richard. Dennis Robertson, thank you for being here. No, and it really is to continue the discussion on the IPTR, unless he says that he wanted to abolish it, basically. The cabinet secretary, in her evidence, suggested that there had been a substantial increase to medicines. The IPTR has been reviewed. Do you agree with that submission from the cabinet secretary? It's in access to medicines. Yeah, a substantial increase, basically. Yeah, no, I didn't want to get rid of the IPTR, I mean in the access to new medicines. That was one of the things that was discussed as basically an overhaul of the IPTR system. I would say that the new medicines fund has increased access to medicines quite considerably, and I know that all the patients that have my condition all have the drug, so without a doubt something is working. I guess the point here is to try and make sure that we fill in those gaps that still need to be looked at. It's where it would be unfair. I still find myself in my patient group when a new patient comes in. I'll ask them which area they come from in Scotland, and I want to get rid of that. I don't want to have to keep asking that, so I want it to be fair throughout the country. Sandra, you want to respond to Dennis's question? We understand that there has been a specific issue with IPTRs once a medicine has not been recommended by SMC that medicines that had been approved for once a medicine is not recommended by SMC may be subject in the gap between that and a resubmission. That there has been a sharp decline and maybe a complete cessation of approval of IPTRs. Again, those are patients who are no longer able to access a medicine, and that's a real concern for us. From a patient organisation perspective, our member groups come to us and we have had much less criticism of the IPTR system and fewer people coming to us with real, tangible problems that aren't down to communication from clinicians. I think that there's a little bit of a difficulty, because we can say for sure that there has been an increase in the number of people accessing medicines through this route, but we don't really know why. I think that that comes down to the lack of guidance that is available. The interim guidance for the IPTR says that there is no exceptionality, but the forms suggest that there still is. It's a little bit inconsistent, I think, with the message that's coming on what is actually happening on the ground. The PAC system was definitely something that we were really supportive behind in our patient groups, which we are very keen to see moving forward. Understandably, there has to be a pilot, and we need to know that that transition will be smooth for patients and that patients don't then end up getting lost in the system. However, the lack of communication on that has been slightly disappointing, because it would be good to know and be able to tell patient groups what's happening, when it's going to happen, and to have an understanding of the system before it comes in place. We have not had anyone apply through IPTR to have a drug for melanoma have it accepted. Because of the changes in the system and companies seeing an opportunity to perhaps be re-heard by the SMC, it appears that the SMC's workload has increased substantially. The time gap between a drug being licenced and it being heard by the SMC appears to be growing, as if perhaps there just isn't enough time or enough staff to process it, and we have patients in desperate need of new drugs at this time, which are licenced, are accepted in England and have not been accepted in Scotland because they haven't been tried yet, or we haven't got it for second blind use and not at IPTR either. A lot has improved. I was delighted to read the GGHB submission where it says that patients with cystic fibrosis and renal disease have benefited from the new medicines fund, but equally it's very disconcerting to read that the Beatson people have not seen any of this money and they haven't benefited at all, despite the fact that the Beatson is in Glasgow where the pilot scheme is. I hope that I haven't misunderstood that. None of the consultants at the Beatson are aware of that, but the assumption is that the money takes place behind the scenes. It was one of the specific questions that was asked, and we've just seen no evidence of it, but I don't think that there's a suggestion that it's not happening. Correct. Behind the scenes, we look at what medicines have been prescribed by the consultants and we would then submit that list to the Scottish Government to access the new medicines fund. I don't think that it's unexpected that the consultants themselves wouldn't have anything to do with that in particular, because that's been data that comes out of the system. It has been accessed widely for the appropriate medicines. Dennis, you wish. Lesley mentioned different protocols from different areas in Dr Jones. You've said that perhaps a national guidance would be maybe more effective, although you still look for the individuality aspect of it as well. Who would write this national guidance yourself? I'm not sure that necessarily guidance is the way forward, because it's very difficult to formulate guidance. What we want to see is greater consistency across the country, and there are a variety of mechanisms by which you could generate that. One of my concerns about the PACS is that, of course, we want to move away from exceptionality, and yes, we do, but what do we move to? Clearly, it can't be blanket acceptance, because that's the SMC's job. It's very difficult, but there may well be systems by which clinicians can get together to at least try and find processes to minimise inequalities of access. This may not be the place to put these forwards. I think there are a couple of potential ways in which this could be done, one of which could be to meet and try and agree as specialist groups. For example, I treat prostate cancer. While there are only about a dozen of us in Scotland who will prescribe these drugs, we do meet regularly. We all know each other, and we could at least get together—indeed, we've tried to do this—to try and at least define what our wishes would be there, but even that's quite difficult. A second approach would be some form of process by which IPTRs, or whatever replaces them, are at least reviewed on a national basis. I don't actually know what happens to an IPTR in Lothian. I know what happens to all the ones in the west of Scotland within the four member health boards there. There are a number of ways that you could do this. Is there anyone else who has a solution to some of those problems? I wish to make some comment. I think that we come back to the thing that I raised originally when we first started talking about this, which is the fact that, for very, very rare conditions, you have very few specialists in that condition. For me, for example, I have one recognised expert in Scotland, so we come down to the fact that we need a centre of excellence for different conditions. I know that that wouldn't necessarily be possible for every condition. From my point of view, I'm very grateful that I have my recognised expert close by, but that isn't the same for every patient throughout the country. They deserve to have the same expertise when their drug regime is being considered. The other issue that was mentioned by Lee is the unintended consequences, delays and potential negotiation. I think that there was some of the written evidence that said, well, if we are creating a system that the pharmaceuticals are going with a bid to provide these drugs and medicines, then you expect to be sent back with that, then that distorts the system as well. Mark, I'm looking at you because it was your written evidence. I'm just looking for delays in the system because, in a lot of this, we're talking about small numbers of people, individuals that you're trying to help. That process becomes burdensome for the people who you're trying to administer and get those processed as well as a negotiation process and whatever. That's got an implication that's disproportionate with the people that we're dealing with at the end of life. We need to have some discussion about that. Eileen, I'll get back to you. In our submission from Greater Glasgow Clyde, what we were saying was that we would rather see the pharmaceutical industry come forward with their best price right at the beginning of the process rather than have to go back or wait for a patient access scheme in the middle of the process for SMC. That would be a much more efficient way forward, rather than expecting to have some price reduction in the middle of the process. It's for efficiency, and everyone's time, we would prefer to see that. Nothing more to add by the fact that I reiterate that comment. I think that some of the discounts we subsequently get are sizeable and they can be very beneficial, but it's almost after the event, if you like, so that level of negotiation in the process would be more helpful. How would you know that that's the best price that we can get around in anyway? That could come in. I can't help but think that a great deal of expertise is used at the various meetings where perhaps the best people to negotiate a price with a pharmaceutical company would someone who is a skilled negotiator, dealing with a skilled negotiator from the pharma industry, because that's certainly what you're going to get. In the past, it would fall to the principal pharmacist to work out a deal on drugs and the cost that they would pay. They were in very close contact with each other, and if somebody got a penny off a pack more than someone else, believe me, the pharma people got to know about it very quickly. I can't help but think that the place of the SMC might be to ignore the price and the negotiation side of things, decide on whether or not we need this drug in Scotland, how much of it we're going to need and feed that to someone who is a negotiator and get them to screw down the pharmaceutical company to get the very best price from them. That is repeated by Andrew Walker in his submission. I would like the committee to focus on the value of medicines rather than the price and looking at the medicines that are going to be coming through for very small patient populations and how the system that we have in place can be adapted to be able to deal with those medicines so that patients in Scotland can access them. There is a real opportunity in Scotland because of the way in which our NHS and academic centres are designed, but we can really lead the way here. It is an opportunity that we need to be making most of. I think that we're just trying to establish whether it's an issue here when we look as a committee to recommend evolution of this process. Is it an issue or is it not? There could be a more efficient way of doing things. We do have within Scotland national procurement who are the body that looks at negotiating on prices. However, when a new medicine comes to the market, that is often not the time that that happens, although it is up to the pharmaceutical industry to come forward with a patient access scheme at that point. The onus is on the industry at that point, the way that it stands just now. I suppose that I am interested in seeing where there is agreement so that we can know what to push for in terms of change. I was struck at the beginning just by the emphasis on the PACE process, because it is a genetic alliance in the UK. The Beatson seems to be saying much the same thing, and I have been supported in this campaign by Breast Cancer now who are saying the same thing about why patients and clinicians are not available at SMC meetings. There seems to be agreement on that. I suppose that one area that I would be interested in a bit more on is just the IPTR process. Again, for example, Breast Cancer now would welcome consideration of a national decision making system. I wonder whether, in fact, we should be trying to establish some improvement now to the IPTR system, whether it is that or some other one, or whether, in fact, we should just be looking to get the PAC system introduced as soon as possible, although it seems clear from what Professor Jones said that that will not necessarily solve all the problems. I have not really got a sense of any consensus around what we should do for the situations that are covered currently by the IPTR system. I think that it is quite difficult to answer that question until we know the outcome of the pilot that is happening in Glasgow. Whilst we are unsure what that is actually going to look like, I think that it is important to remember that PACS was developed through a real multi-stakeholder consultation on what should be the best system. As a result, you would hope that that would have some positive impact, but until the pilot is communicated and what has actually happened there, I think that it is hard to know how that will look in practice. For me and for the patient organisations that we consult with, there is a frustration that PACS has not come into place yet and a real keenness to see that develop quickly now that there is a pilot, but until we know the results of what that pilot looks like, it is hard to know exactly how that will work in practice. I think that there is a natural tension in the system whereby we are looking for being able to identify what is the best treatment for the individual patient who is in front of us on that day as a consequence of their clinical need versus the national perspective of having a proposal that would manage the majority of requests that might come through. As Professor Jones says, individuality is very important and it is SMC's job to give the blanket positioning on a medicine where it is possible to do so. For me, as Natalie says, it is very much about consultation, it is about working through the pros and cons and it is about testing the system to identify where the best answer sits. My own feeling is that it would be very difficult to put a solution in place that would be national and would cover all disease processes. In actual fact, what would probably end up with a best case scenario is something that is very individual for each disease process. Every patient group has its own system because it needs very much according to what the presenting issues of the patients are. I would love to be able to say that there is a one-stop answer to that, but there is a very natural tension in the system that is going to make it very difficult. There could be some national criteria for individual diseases, that is what Professor Jones was saying about prostate cancer. I am trying not to speak specifically about prostate cancer. There are some opportunities where you could say that this particular group of patients defined by X, Y and Z should be able to access this drug, which is not accepted by the SMC. The problem is that that will probably, first of all, it will be disease indication specific. I suspect that it will not deal with the majority of situations where a patient's individual needs are for a drug that is not accepted by the SMC. It cannot deal with the whole problem. That is where I think the opportunity sits around process rather than specific guidance or specific decision. How do we ensure that the processes that we put in place actually reduce the confusion and the complexity, rather than having definitive decisions? I do not want to concentrate too much on my own disease area, but with melanoma, there are only four or five clinicians in Scotland who I would like to be using the sorts of drugs that we are discussing. Scotland is a small country. We have 1,200 roughly new cases of melanoma each year, of which only maybe 200 at most will go on to need this sort of drug. Following up what actually happens to those patients when they are given a new drug over a certain threshold, would provide so much more evidence—a post-marketing surveillance—of what happens with those drugs when they are used in Dramson's Barrens instead of patients who are carefully selected for drug trials for a variety of reasons. If we then fed back to the pharmaceutical industry the results of real-life, everyday usage of their drugs, we might well be able to negotiate an even better price for the information that we could sell them, which would then be used throughout the rest of the world. We are just an ideal size for this kind of research. We are in dire need of knowing exactly how much benefit we get from the huge spend that we make on those very expensive drugs. It is not impossible that there are computer programmes available that can have patient input about their everyday side effects, for instance. Every time someone gets a side effect, that means an intervention, perhaps a hospital visit, perhaps another drug, and it all adds to the cost. We really need the global cost of treating those diseases, not just the price of the drug. I completely agree with that statement. The wider view of what the value is is definitely something that needs to continue to be discussed and taken forward with the SNC. In terms of the SNC decisions, although we have seen an increase across the board really since the changes have taken place, it is difficult to know the reasons why those changes have happened. Is it because of pace? Is it because of the patient access scheme? Is it because of cost? What is the contributory decision-making factor? I think that there needs to be a process for a constant evaluation of those decisions going forward so that we can pinpoint the point in the process that the decision-making is being made on. That would give us some scope for making the process available for the future. I think that we are talking very similarly here. When we are looking at what we need to be doing in the future, we are looking at a significant change in the regulatory structures that are happening, whereby medicines are now being approved on the evidence that is more immature than healthcare systems have been used to date. Also, when we are looking at rare diseases or ultra rare diseases, we are looking at evidence-based, which is not at all aligned with the gold standard that clinicians are used to using when making evidence-based decisions. The industry is also very interested in what can be done to be looking at earlier HTA approvals, earlier agreements for medicines that can be used within the Scottish healthcare system, but conditionally. Is there an opportunity to be doing exactly what Lee is talking about—collecting the evidence as the medicines are being used actively in patients, with people who are experiencing both the condition and the medicines and the consequences, both good and bad of the medicines, and being able to play that back into what the true value of the medicine is? It plays into other aspects. When we talk about patient access schemes, more or less we are talking at the moment about simple discounts, but there are many other ways to be truly looking at the value of the medicine rather than the modification of the price of the medicine. There are some medicines that are going to be coming through in the next few years, but if you made the medicine free, it would still have a cost per quality that would be above £50,000 to £60,000, purely as a consequence of the way that the medicine could be introduced. The cost of the medicine, per se, is not the only aspect that we should be looking at, and the industry is very interested, as patient groups are, in terms of working out how we could be making that part of our reality. Other views on that? When you put it like that, it plays into some of the other evaluation of the justification that I spend at the health board. Indeed, what is the best treatment for patients, because sometimes access to those drugs and new drugs is not always the best treatment. I will look into some recent comments from the chief medical officer in terms of woman medication and what is best for the patient here. What is going on out there to evaluate the benefits and justify the costs? Is there any body or groups that come together to do any of this work that Lee suggested? I can only speak with limited knowledge here, but there has certainly been quite a large exercise. With cancer drugs, all cancer drugs are prescribed by a computerised system, which uses the same database throughout Scotland. The idea is that that will give us the opportunity to draw together all information for every patient who has prescribed these drugs within the NHS in Scotland. There is work on going. I do not know, Lee may have a bit more information. There is work on going to try and harmonise those systems so that we can deliver more data. I think, though, that it is really important to manage at this point the expectations because it is actually very difficult to quantify the benefit that a drug gives to an individual patient. I am not saying that we should not do it. It is important, but I would not want to raise expectations that we can say that this drug delivered so many quality of life years gained. How difficult would it do to get an exercise of the ground? Is it a level of work that is taken? I agree with Rob, but there is certainly work on going to try and bring together reporting mechanisms out of a prescribing system. This is sometimes the challenge that we have got an IT system that is brought into use for one reason and then we try to use it for another reason at the end. That inevitably makes it more difficult, so we are trying to use a prescribing system that might be used slightly differently in different boards to get out similar data. We do, within GCC, try to do some small-scale work around individual medicines and how the patients respond in a real-life situation. At the moment, that is a very long-hand, laborious methodology because it has to be done by people in a long-hand way. Perhaps once work moves forward in reporting out of the prescribing systems, we would be in a better position to do that. We might be able to do some small-scale work around that, but to have something that would be a large-scale post-marketing exercise seems to me a bit out-of-reach at the moment. Sander would be able to tell us how much a robust clinical trial costs, while post-marketing pieces of work to get robust data would also have a cost attached to it that would be, I imagine, quite large. Sander? Certainly what was coming to mind, as you were speaking, is that this is something that industry would be really willing to collaborate on. We see that this should be a collaborative venture and we would be willing to work with the NHS in putting systems in place. Lee? There is a system that has been presented and accepted by the IT systems people, whoever they may be, within the Scottish Government. It is so defined that a patient with an iPhone can input their own data on a side effect or whatever as it happens. It has been used in some disease areas, some health boards are interested in it and, hopefully, it will evolve and will happen for all of us. We have also got the problem that medicine is evolving at such a stage 2 and we have stratified medicine coming along. The system is going to have to be constantly evolving because we might have a situation in which we have three patients in the whole of Scotland in need of a particular stratified drug. From the health boards point of view, they want to use this evaluation and all sorts of procedures but there might be a good argument for that looking at the outcome. It is not just cancer drugs, I do not think, but we are talking about drugs for rare diseases. Richard Lyle? Can I say that the point that Lizael Rowlinger said earlier on that I totally agree with at the end of the day if you could try and keep people in their home and look at the cost. You might say that you could lengthen the person's life and save. The cost, as far as I am concerned, is a politician and should not come into it. I know that it does for my Mark White. Can I turn to some of the evidence that we have given? Cross-border differences are fewer now than earlier in 2013. Indeed, there are some drugs that are accepted for use in NHS Scotland but which are not accessible in NHS England. Why is that? The concern that I have is that there are drugs that are accepted in England and that SMC is not accepted in Scotland. Why cannot we have nice and SMC working together if they evaluate a drug? Professor Rob Jones would want to answer that. One of the agencies that accept a drug, why should the other agency accept their findings and both have a running? Throughout the United Kingdom, if I want to use that word, we can ensure that we are evaluating it. Again, can someone correct me? I thought that nice decides the price and we have to follow. I would love the point that we could get a strong arm person and cut a few pence off some of the prices, but most of the drug companies say to me that it costs millions to develop these drugs, so we need to recoup our money back. Professor Jones could inform me why we do not have an acceptance of both sides of the border. I raised this point about cross-border differences simply because that is what causes patients a lot of anxiety if they are perceived that they cannot access a drug which they know they could access if they had an English postcode. The NHS is very different between Scotland and England and we have to have our own processes. It is not for me to decide how things differ across the English border, but it seems to me very difficult to see how we could entirely have an independent healthcare system where we would have to follow decisions entirely made by another country. I would hope that they would follow our decisions. Sometimes the Scottish decision comes before the nice decision. Remember that England has had this cancer drugs fund, which has enabled more rapid access prior to a nice decision, but I do not think that we debated this at the time. There was no appetite in Scotland that I could detect for anybody to want an English cancer drugs fund in Scotland. If you see where it is going, I think that we were right. First question. Some of the differentiation does sit with the definitions that we use in Scotland particularly. For example, around the end of life, our end of life definition is three years or less, whereas in England the end of life definition is two years or less. The other thing in Scotland is that we do not set a threshold per se. As a committee member, we have thoughts on the cost per quality and the implications of that, but there are no set numbers that define our decisions, whereas in nice there is much more definition that sits behind the process. Those I suggest are the major differentiators as to why we get stuff through in Scotland, whereas in England you might actually not necessarily see medicines getting through. With regard to the second question, if I may, it is that nice do not set a price either. Nice are purely—they are an HTA body, so very similar to Scotland to use a different process, but their job is to determine the value in terms of the cost effectiveness of that medicine. The price is actually defined or it is set in collaboration with the UK Government. It is a defined responsibility of the UK Government. What companies then do is offer discounts on those prices. The price is set because it has international implications at a level and then it is discounted from that point onward, but it is nice to do the same as SMC does—the cost effectiveness. Strong concerns have been expressed regarding the number of submission deferrals that have been experienced by companies. What appears to be a limited factor regarding the throughput of three-pace submissions per month? The SMC process does evolve. Does it have the right resources and skills in the right place? Does SMC have the correct support that it requires in order to basically adhere to the decisions that we are making? One of the pleasures of the role that I do is that I get to see it from both the industry perspective and the SMC perspective. From the industry perspective, my answer is that over the past 12 to 18 months what we have seen as a significant number of new medicines coming through is a consequence of company pipelines starting to deliver. We have seen companies become much more efficient and much more effective in developing their medicines. The consequence of that is that new medicines get licensed, more medicines get licensed and they come through to health technology bodies such as SMC. SMC has got an embrace all medicines strategy, which means that virtually all new medicines have to be considered by SMC in one way or another. My own feeling on that is that we are now at a stage where we are seeing the pipeline of medicines and the number of medicines and, critically, the complexity of those medicines just continuing to grow, grow and grow with an SMC structure that is fully cognisant of the transitions that are happening. The conversations that I have with the SMC know that this is happening, but the resources are actually behind the pipeline delivery. I think that SMC will need more resources and we are going to see more complex medicines, probably more paced medicines, more complex decisions having to be made by the infrastructure of SMC in the committees. Are there any other responses? Are there any other comments on that? Yes. There are also resource implications as far as PACE is concerned with health board representatives and patient groups and charities. It is not just specifically SMC resources, it is the resources that PACE puts on to those other organisations as well in enabling them to attend and contribute to the meetings. Is that impact mark in terms of the wider cost with the processes and the involvement on the health board? It just contributes to the bottom line and we are going to then try to manage it, certainly. It is as simple as that, really. There is a cost but it is not being defined? Yes, effectively. Will you have to work back and try to establish what it will be and build it into your budget and manage it in the best way that you can? Yes, not only. There can be a real impact on patient organisations, particularly those for very small-disease areas, where maybe it is just one person who heads up an organisation UK-wide, perhaps somebody who just provides peer support to other patients and does not perhaps get involved in those processes. There is a real capacity issue for a lot of patient groups to be involved. I think that the patient and public involvement team at SMC have been absolutely excellent in providing as much support and advice as they can to help those smaller groups in the process, but there will be times when patient groups just will not be there. I think that it is recognising how you adapt in those situations as well. Dr Jones wants to say about the clinical input to pace and the demands that that puts on the system as far as clinic time and patient facing time. Certainly clinicians have a number of calls on their time. I would like to think that clinicians would prioritise that kind of activity, however, because we do perceive that we put our very high value on it, and that was very clear when I discussed it with my colleagues. We are maybe a bit luckier in Glasgow because the meetings are held in Glasgow and there are difficulties getting people in from the other areas. I was just going to follow up on that and suggest that that is true. The physical aspect of attending a meeting can be difficult, but I know that a lot of clinicians from other health board areas do try and teleconference in, or videoconference in, so they certainly do try and make efforts to take part in a process. As you say, it is extra dialogue that they seem to value. I was just going to say yes as somebody who runs charity on their own. Obviously it is financial impact to go to these meetings, but I have to say that attending the pace meeting was incredibly important and very valuable. From my clinician's perspective, it was time out obviously of a very busy work schedule, but she also said how amazingly valuable it was to attend. I will just always come back to the fact that the whole wish that I had for this whole process when we started was that we would have a clearer understanding of exactly what you were saying about the overall cost, not just the bottom line cost of the drug, and as Richard very kindly brought up again, if we had some kind of mechanism, even like a price per each individual thing that can happen to a patient that is over and above the drug in question, something that you could say, look, this is what it would cost for a person with this ultra orphan condition if they did not have the drug, then I think that that is something that would make the pace system a lot better. I am sorry to repeat it, but the pace system is brilliant and we are well supported to do it, but I am very concerned about the clinician time. We have one part-time clinician in the west of Scotland looking after melanoma patients. One of the advantages of the new drugs has been that the clinics have grown because people are surviving longer and the numbers of people going along to clinics on a regular basis have multiplied. One part-time clinician's workload has grown enormously and she is having to take time out to go to pace meetings and it just so happens that we have had four of them in the past since the pace meeting started. I really feel that the clinician's place needs to be at the final meeting. I feel that it would be a better use of the time because there is an impact on patients. If people have to wait longer because their clinic timing might be due today and their clinic visit will be put back for two weeks because there is no one to see them, there is constant add-on of the system and the bureaucracy. We have to use the clinician where they can be of most value and that is either at new drugs where the first decisions are made or at the final stage rather than bringing them in at pace. We have to make sure that in future there is a clear division between what is happening in that phase between the new drugs committee deciding that a drug is too expensive and it is going to pace because that is the time when the pass comes into play. If the final decision is made on the drug discount, it is such a waste of time of not just the small charities but of the clinician going along to a pace meeting and taking up everyone's time when the difference has been made by the fact that the cost has been dropped. I am sure that everybody with any experience of this would agree with me. We need to have that separated out. Any other members? The on-going thing is that we are looking at some of the evidence in terms of how the new medicine fund is funded now. Based on the share of the rebate, Andrew Walker points out that there is a new agreement due in 2018. Is the rebate going to be as generous if it is not? How do you sustain this? Are the boards themselves able to sustain this? Or is there more cost-effective treatments that are being used elsewhere that should play into some of this? Anyone want to take any of that? I think that you started to answer that mark in terms of you are in a good position now because the Scottish Government is through this system. That money flows to the boards to deal with that. Is it the best way to use it? Are there other cost-effective treatments that could be giving us similar results? It would be an idea that it would be worth looking at more. The new medicine fund, as I mentioned before, has been a very welcome source of funding and it has enabled boards at the front line to be able to devote resources to the drugs that we have talked about today. In terms of the renegotiation going forward, I am not excited on that at the moment. I do not know how that will pan out. Those things are determined very much at a UK level, as much as the Scottish Government level. I would hope that it would result in similar funding sources that we have seen in the past 23 years, but I am not sure how that will pan out. In terms of other cost-effective methods, our pharmacists are continuing to look at that and reviewing that. That is a challenging area that we need the expertise that is brought to the table. Does anyone else have any insights into that? It is a bit early, but if you are running a scheme and a £90 million budget, £23 million goes into Glasgow, there is a renegotiation in 2018. We should be starting to have an appreciation about what is going to happen. It may be more appropriate to ask the Cabinet Secretary or whatever, but there are no insights about that. From a pharmaceutical industry point of view, I am not able to shed any light on that. What I would do is to continue to applaud the Scottish Government's stance on allocation of the payback from the current PPRS, which has left Scotland being lauded by other nations or being invaded by other nations. I would also suggest that they are moving forward. Would it be reasonable for other interventions to be afforded the same scrutiny as medicines are? Other interventions so that medicines are not looked at in the singular way that they are? That would be something to look at moving forward. It is a fair challenge. If you look at the whole healthcare system and the patient's journey, there are not many other areas that are scrutinised as much as medicines. We have debated today and the wider costs around the added value and the knock-on effects and the wider implications. It is true that there are many other ways of system at that level of rigor that is not applied upon which it is not applied. It is maybe a debate for another time as to whether that should be a further development of the process. It is not unique to the Scottish healthcare system and, by any means, it is very much adding new to the system and not decommissioning the old. There might be some opportunity and I think that it is very much aligned with what Mark is saying. It is about being able to identify the old that can be stripped out to be able to find funding potentially. The other one that I have got here is the threshold and the quality of the £30,000. Is that too high? Could it be harming? I am sure that people, given that drugs are made available above the £30,000 threshold. In terms of my understanding of the system and working in it as well, there is no actual threshold. The new drugs committee works to a very tight process and therefore they apply a threshold. My understanding is that it is £20,000. If you are under that, you will get an approval through the NDC as long as other parameters are defined. If you are over that, you will get an automatic rejection by the NDC. That is because they work within a very tight process of ensuring that the analysis and assessments are done to very high quality and very high rigor. It is thereafter at the SNC that modifiers can be applied. People can draw their own conclusions as a consequence of the value of a medicine. At the SNC, there is no defined threshold per se as to what is approvable and what is not. That is what you are seeing. There is a reflection of that within the different range of the cospiricollies and the icers that come through the system. I think that we could talk about whether 30 is enough or not enough or too high, but in actual fact it is a number that is not actually applied to any massive degree in the system. That is a trigger. I can trigger a bureaucratic process if it was at a different level. It might reduce some of the burden on that. One of the conversations that we are having in industry is whether there is a possibility for decisions to be fast tracked as a consequence of the threshold that is being achieved. We are very early in conversations on those opportunities. I am sorry to say this but it deals with the medicines that are not much of a problem to us. The conversations that we are having around this table today are probably not the medicines that would fall into those easier decision frameworks. It is being able to meet the needs of the future by giving capacity rather than assisting the decisions of the medicines around the table. I think that, although there is no defined threshold within the SNC, it does not mean that one does not necessarily exist. I think that there were some statistics on one of the submissions that I read that suggested that a medicine that is at the 60,000 to 70,000 threshold is not likely to get through the system. Although there is not a defined threshold, it does not mean that it can be prohibitive. That is where we could have to step back to looking at how future proof is going forward, because no doubt that more medicines that are more complex will come through and they will command a higher price. It is making sure that the process is robust enough to assess those medicines and whether that is to do it with quali plus something else or no qualis at all. That is what really has to be the next step on what we look at. When you are talking about looking at other systems than drugs and perhaps decommissioning things that are not cost effective, I think that that was something that the health committee did. I will agonise over a bit when we were doing our original inquiry. I just wonder if that is something that maybe a future health committee could be encouraged to actually look at and take some evidence on. I was wondering about the current uptake of the new medicines fund. You spoke about what might happen in the future. We know what Glasgow and Clyde is getting from the fund. Do we know if other health boards are actually using up their allocations from the fund? Is there any money-going spare, you might say? If so, should there be a fairer way of perhaps sorting it out? I don't think that there's anyone here who can give us those figures, but we can't request them. It's quite useful to know, I think. Richard? One question that hasn't been asked and I want to touch on it. First of all, I want to thank everyone who, I know that you are very committed in order to help people and patients. At the end of the day, Liz was talking about earlier, our first priority is to help patients. We're reminded that there's a need for an increase of the number and type of patient voice on all decision-making panels of SMC. Every witness supports that view. Again, I know that it's impossible to target each person on to a particular panel who may be interested in a particular disease, but should we have more patients who are driving for patients, what should be the best for patients? The answer is absolutely. Having a patient perspective on any panel or any decision-making body is really important, regardless of whether they have a personal interest or not. The perspective that a patient can give is really unique, and we can lend that to discussions from other patients as well and provide an aspect to that discussion that is maybe missing at the moment. Sandra, I'm sorry, Liz, but you're on my blindside. You're the line of vision. The SMC user group forum has been working and has produced some work just now, where companies have made available information to go to patient organisations to help them with what they can contribute to their patient group submission. The industry is working quite hard, along with the SMC, to try to help to improve the quality of information so that the ultimate submissions are better. Although each rare condition has its own set of issues, there is a lot of commonality between them, so having as many patient representatives wherever possible is excellent. The patient involvement network, which is a subgroup that the SMC's public involvement team has set up, has been a really positive step as well. It has brought together representatives mostly of our Marella organisations, but also patient groups that have been through the process. It's been a really good opportunity to feedback on what is working and where some issues could be improved, certainly around things such as guidance for patient groups going through the process. That's been a really positive step going forward, and I would hope that that would continue to grow as the SMC does. Thank you for that. Just to complete the questions, in 2009, the Scottish Government issued guidance, and I think that this is basically to our board representatives here, which clarified that patients could privately fund part of their treatment while still being treated by the NHS. If they wanted to pay to access a drug that wasn't available or had not been recommended by the SMC, do you keep track of that? Yes, Aileen. That advice is still extant and so patients can still utilise that route. It's a very rare occurrence, I have to say, but it does occasionally happen. I suppose that we're looking at it as a rarer now. Do you keep track of it? How many patients within Glasgow Clyde take advantage of that mechanism? I can't tell you the figure for that over a certain period, but it's only been used very occasionally. But we don't really keep track of it. We would keep track of it, but I just couldn't tell you what the figure from the past year was, but we would be able to have information on that. We've had one patient who paid £90,000 for her treatment because it wasn't available at the IPTR or any other way. The process took about three months. The first price that was given was £75,000, then we discovered that it was plus fat, and it was a long, arduous process for the patient and her family. They had to give up a great deal to achieve that. At the end of the day, it didn't make a blind bit of difference. By the time she got the drug, she had a brain secondary and died within weeks of having started the treatment. Yes, by all means, people should be allowed to make up their own mind about how they want to spend money that they've earned and no doubt pay tax on, but the process has to be very much faster or else, with cancer, it's growing all the time and they're just going to be throwing their money away. I think that it would be, beholden, on drug companies to at least offer patients who go down this route the best price that they've made available to the SMC rather than the full cost plus the fat. We're just trying to establish complete the questions here today about whether it's been affected or not, whether there's still a current use of it, whether it's declined or whatever, so we'll take whatever information is available when it was a key question this morning. We've come to that point that there's no other questions, but on the way home, we don't want you to be saying, oh, I should have said this, so now's your chance. I'm happy to go round the table if there's one thing that you want to leave with the committee and our considerations for our more legacy work at this stage, but Leslie, do you want to have one or two? Just want to say, I think that the changes that have been made have been remarkable. I think that the SMC has really picked up the most amazing amount of work that's been remarkable. I just would ask for increased transparency at every level. My clinician doesn't always know what's happening and she can't give a response to patients and that can be very hard, so just transparency for me is the big thing. You're not compelled to do this, but have you got something in your head, Lee? I wanted to reiterate the GGHB point that there's no encouragement for the industry to quote its best price up front, which delays access and requires more NHS time revisiting cost efficiency mid-process. Lastly, I would like to thank the SMC staff who have been involved in this evolving process. The PACE process has been of great assistance and we especially value the kindness that they have shown when patients are attending and for the clinicians who have given evidence and therefore have to catch up with their clinical work at some other stage, probably meaning going home late to their families night after night. Obviously, to the Health and Sports Committee, for all the work that you've put in, it must have been very onerous and we really do appreciate it very much. I think that we'll just stop at that. Natalie? I definitely commend the work of the committee on this. It has been an ongoing and long piece of work. We're drilling down to the real bedrock of the issues now and I think that that's testament to the commitment that this committee has had. I would also really commend the SMC for taking forward the changes in such a positive manner and through such engagement with patient organisations as well. For me, there are two key points to look at going forward that really will drill down how we move forward. The first is evaluating exactly how decisions are being made at SMC and what really is the impact of PACE. Transparency around the IPTR and PAX transition is incredibly important as well. Anyone else? Sandra? Not surprisingly. I echo the thanks to the committee for undertaking this evidence session previously. One area that I wanted to highlight the industry had as I continued concerning and also one that was raised by a couple of other submissions to the committee was around the voting process within the SMC committee. There is some feeling that voting doesn't allow the same transparency as is aimed for. There have been occasions where the decision reached hasn't necessarily been mirrored by the discussion that's gone beforehand. The knock-on effect to that has been on a couple of occasions where companies can go back to SMC having had and not recommended, not accepted, looking for some guidance as to how they might tailor a new submission, and the information that SMC has been able to give the company has been a personal view rather than based on the view of the committee because it's not known how individuals voted. That hasn't been helpful as far as the company is moving forward. Catriona, do you want to add anything on that issue? With regard to the voting, it's to be able to ensure that the first resubmission doesn't transition to the second and doesn't transition to the third. It's really important that companies get the message very clearly as to the basis of a non-recommended position, and at the moment that just doesn't exist. It just fits into the overarching call of greater transparency across different aspects. The other piece that I would like to add is another aspect of your examination was around the Scottish model of value. At this point in time, whilst we have improvements in the SMC process in defining what a Scottish model of value is, I personally am not necessarily seeing it as tightly defined or as shaped as perhaps would be of great assistance both to patients, patient groups, industry and SMC in terms of defining what we need to be doing. We talk about the quality threshold, price and other things, but the essence is value. I don't think that we have defined what we value and therefore what should be fitting into the value equations, so they've not been done yet. I see a lot of nodding at that point. It might be an omission on the other part, but if people want to say something on that issue of value, we're okay. Thank you all for being with us again. Thank you for your kind comments on the committee's work. It wasn't the committee that did it, it was the people who participated in those committee hearings, gave evidence, written submissions and it's heartening to learn that some progress is made. The evidence is small and a good model in place, so of course it can be improved. Hopefully, we can work together with future committees to ensure that future proofing and we maintain what's good in the system that we possibly have and improve it. Thank you all very much for being here this morning and giving me a precious time. I'm going to suspend at this point and go into private session, as we previously agreed. Thank you all very much.