 Rwyf i sutwm wrth gŷn oedd ac rathern sydd yn g йwawdd o unrhyw fyny i'r 10, yn yr edrych attitudes rwyf ar bach appointments fy f further anghofod o unf сегодня oherwydd mae'r dweud wrth fy nhu ynbrae o Moggetonçek fantai, mewn multur ac èwb draws ond â chymfer allweddolio Felly, wrth gwybod am ddasych, confer o'r colegau am arfer i gynnwysau pergol a'r ffordd. Maen nhw'n fawr i wneud cyddiadauarfer iddyntol o'r pwrdd. Ond mae hi'n du clywed i dda, ddianne, nhw, ond rhodod grunt. Felly, rhaid i ddim yn ni i'n dilyn. Rhyw bryd yw ni ynrhyw i gyd yn cwymau iddyntau ar gyfer gynghwylol y Com意ll sy'n agenda item 3, which is a consideration of the main themes arising from today's evidence to take a snapshot there. I have the committee's agreement on that, thank you. As we normally do, as we move to all 11s on the round table, I think that the normal way we would do that, Robbie Ewing, I would introduce myself then on what round there is, and we will introduce ourselves and the organisations that we come from, and then we will proceed to a general question to get us going. My name is Donkibit Neil, I am the convener of the Health and Sport Committee and the MSP for Greenock and Limerclyde. Robbie Pearson from Health Improvement Scotland, where I am the director of scrutiny and assurance and also the deputy chief executive. Fiona McLeod, MSP, the deputy convener of the Health and Sport Committee and MSP for Strathkelven and Bairstain. Hi, I'm Kevin Freeman Ferguson, I'm a senior inspector with Healthcare Improvement Scotland and I'm currently responsible for leading the work that we do regulating independent healthcare services. And good afternoon, Dennis Robertson, MSP for Aberdeenshire West. Mike Mackenzie, MSP Highlands and Highlands region. Good afternoon, David Moalsdale, chairman and chief executive of Optical Express. I'll pack up Patrick National, director for the British Dental Association in Scotland. I'll let Milne MSP for North East Scotland. MSP for the Central Region. Simon Withie, I'm a consultant plastic surgeon. I'm representing the British Association of Ascetic and Plastic Surgeons and I sat on Bruce Keogh's UK review. Malcolm Chisholm MSP for Edinburgh, Northern and Leith. Right, thank you. I should put on the record that this opportunity to discuss with you is in relation to the four statutory instruments that are before us. I don't know whether I need to read them out, but you know, in the interest of time alone, they're clear about the context that we're working on today. A general question, I think, you know that we've had the opportunity to read some of the written evidence that we have received, to get fully from you. And I think that we would, at the first stage, let me explore the consultation that took place and your views on Scotland's approach to regulating independent clinics, including taking the phased approach and how it fits in, indeed, with what's happening in the rest of the UK and across Europe. Does anyone wish to take that first question? Come on now. David, you just beat you to that, Robbie, but you'll be in next. I think that fundamentally we are in support of further regulation or new regulations as broadly as set out. I think that it's necessary for patients in terms of confidence. We have fairly, as many of our colleagues here have, a fairly extensive experience of dealing with the CQC. We also understand that HIS is very different. There are similar principles, and we think that regulation is actually good for the sector, and we're totally in support of them. Thank you, convener. Just to echo the point in terms of the position of healthcare improvement Scotland, we've obviously responded through this piece of legislation that's being brought into Parliament in direct response to the Scottish Cosmetic Interventions Expert group. What we see here is an opportunity for us in healthcare improvement Scotland to introduce our regulatory framework, which builds on the work that we've already been doing since 2011 in healthcare improvement Scotland, and the regulation of independent providers, hospitals, for instance. What we've set out in our proposals and in the consultation is a recognition that 2016-17 will be a year of transition, as best way to describe it. The point that was made in the national expert advisory group report was that this is a market that is also quite opaque. Therefore, a year ahead will be a matter of us establishing what the market looks like and understanding that better from our regulatory standpoint. So we see 2016-17 as a year of transition, and I think that that was very much reflected in the consultation exercise, convener. Anyone else? Yes, part, and then I'll take bread. Really, on behalf of the dental profession in Scotland, I think that what we are really saying is that we welcome this. This has been long needed for a long time, that private, purely private practices in Scotland have been totally unregulated and it's a source of concern to the profession at large, so we welcome it wholeheartedly. I think that that's a slightly different view. Ultimately, within the proposed regulation, there is an anomaly that sits within the non-surgical cosmetic procedures. That anomaly exists because that is an industry sector that has a wide spectrum of people that provide services within Scotland and the rest of the UK. Within this particular landscape, you've got everything from doctors, nurses, surgeons to beauticians to completely untrained individuals providing a treatment set. Fundamentally, therefore, within the current proposed regulation and the method for regulation, there are some significant flaws and contradictions. While I take Robbie's point on board, in terms of 2016 will be a learning process, you don't need a crystal ball to predict a lot of the challenges that are going to take place because of implementation in this manner. I think that we've got a number of concerns in as much as, if you look and take note of the Department of Health and what it says about regulation, ultimately it says that any regulated activity or treatment must meet the following criteria, that there's fair playing, that all types of providers must meet the same requirements and the requirements to register must be based on the risk to the people who use services and the extent to which statutory system regulation of providers can mitigate the risk. Fundamentally, if we take the fact that all providers must meet the same requirements, that has got to be one of the biggest flaws because this proposed regulation doesn't get anywhere near, including for this specific non-surgical cosmetic treatment, anywhere near holding effectively all providers to the same requirements because this does not include all providers. I think that for this to be achieved effectively, all providers should therefore be accountable to the same body, to the same standards of regulation and ultimately this regulation does fail in its current format to achieve that. Surely, for any form of regulation to be successful, it must define who is actually suitable to provide these treatments. The HIS in their response to being asked should this regulation be based on an independent clinic, i.e. providing the service rather than basic on specific procedures or cosmetic treatments, they actually said yes to this question on the guise that due to the fact that treatments change and the method of delivery changes, that regulation could be very quickly out of date if it was based on certain procedures and treatments. Ultimately, what causes the risk to the public of the treatments and the procedures? That is what causes potential damage to health and appearance. Ultimately, if you are not going to look specifically at the procedures and the treatments because you acknowledge that ultimately you would not be able to safeguard the public safety, how on earth does this safeguard public safety if you are not looking at the very cause of what causes the risk? That brings me back to the point that in that statement, when I read that response, I thought that this is saying that it cannot be done in terms of the delivery of regulating this industry. It can because you can change certain interpretations, you can look at what the treatments are broadly doing in terms of injecting skin, healing, et cetera, and maybe look at that a different way. To me, ultimately, the main catalyst was non-surgical treatments by the report that was published. Through that report, non-surgical treatments get referenced consistently throughout and yet it stated that this is not to regulate non-surgical cosmetic treatments. It does not seem to make sense. It singles out nurses, doctors, dentists, dental professionals, excludes certain medical professionals like prescribing pharmacists and excludes non-healthcare professionals like beauty therapists. I know that it is a phased approach, but the phased approach does not incorporate everybody within the same regulation. It eventually maybe has a licensing scheme run by multiple different boroughs implemented in London boroughs where they have got licensing schemes. It is not consistent across the board. The idea is to create public safety and lower the risk. Therefore, I think that a decision has got to be made first. Are these medical procedures that require medically trained individuals to provide them? Do they need to be provided within a medical environment and do they need to be regulated by a medically-led regulator? If the answer is yes, then it needs to be safe that who can provide the treatments. If the answer is no, then it does not need a state-run, medically-led regulator for non-surgical treatments. I can just make one final point. I will give you the opportunity to come back in, but you have raised a number of points, and I would not like to miss any of those points. I am going to take Simon now and I am going to ask for some responses from the people around about the table to what you have presented to us, seeing a discussion going on, if you are okay about that. Simon, do you agree with some of the concerns? I also agree with Mr Pearson. This is an opaque industry where no one really knows what is going on. There has to be a degree of pragmatism and a time to try to understand what is going on out there. I think that your proposal is a pragmatic approach that will allow an understanding of what is going on, but I think that it has to be done in conjunction with strong education of the public, as to how to find a safe practitioner and someone who is regulated if they choose to do so. It has to be done in conjunction with an understanding of how you are going to manage the sector that otherwise will not be regulated, given those proposals, even if it might be in stage 3. That has to be quite clear to everyone, particularly the public, as to, ultimately, will there be a difference in responsibility and regulation to the two groups, the one-regulated group and the other, partially regulated? Does anyone else want to pick up on part, please? We issue in terms of beauty therapists and dentistry, we are very concerned. That is one of the issues that we have raised in our own internal consultation, is about the number of beauty therapists doing teeth whitening and bleaching, and, obviously, that can cause considerable harm to people's teeth. It is the point that you have just made about that. The public do not understand, but it is already legislated under law that this can only be carried out by dentists, properly trained, properly qualified dentists, but it is a backstreet industry that springs up everywhere. You can see it on the internet, you can get a supplier locally. It can cause significant damage to people's teeth to the point where their dentine is completely destroyed and they have to have their teeth removed in the worst-case scenario. That is a particular issue, and it is touching on the issues that you have just raised about non-surgical cosmetic treatment, but there is an industry out there, and it is much cheaper to go to a beauty therapist who has no qualifications and who is just using a kit, but you can buy that kit on the internet. That is the difficulty, where does regulation start and stop? That is the dilemma, but we are very unhappy about that. I think that that example is in your submission from the BD. Just to be clear about what you are saying, you said that it was already against the law. Is your issue there that that sector should be regulated so that it can do it if it does it under certain circumstances, subject to inspection and so on, but you seem to be saying that it should not be doing it at all. In a way, it is not a matter of regulating that sector. As far as you are concerned, it is a matter of making sure that that does not happen. Is that not a different issue? It is, but it is perfectly legitimate for people to do it at the moment, but they might be doing a range of other things and they might be regulated for those other things. It is back to the point about the procedures and the treatments, because you are regulating the professional. You are regulating the person, but if you are regulating the procedures and the treatments, you are saying that, as a beauty therapist, this is what you can do and this is what you can do. We have it with DCPs, dental care professionals, as to what a dental therapist can do. That is clearly laid out. They cannot go around taking people's teeth out, but they can do shallow fillings and they can do a lot of periodontal work. What has happened with the GDCs? They have tried to regulate both the procedures and the professionals. It is a more robust approach and that is part of the difficulty here. Just picking up on that case example, how will the legislation make a difference in that area? Well, I think that we need to be clear in terms of this bit of legislation. This bit of legislation is here in respect of phase 1 in terms of non-surgical procedures and against the healthcare practitioners who are set out in the regulations and who are carrying out those procedures. Within the expert advisory group report, there was a recommendation that would be a phase 2, so to speak, in respect of regulation beyond this and which may involve local authority licensing. If I could go back to an earlier point and I think that it is something that the British Association of Ascetic Plastic Surgeons have said, it is not even the extent to which procedures may evolve and may change over time, which is an important point. There is a definitional difficulty at the moment in even defining how procedures are described at present. I think that the example in the submission was on chemical peels, so the important point here in making this pragmatic is a piece of legislation in the course of 16 to better understand the market is to put the regulation through and base it on individual practitioners, healthcare practitioners, and I think that that is an important point. Anyone else? Fiona? Can I ask about the phasing in reference to all this? I notice that phase 2 is for the likes of beauticians and phase 3 is for other allied health professionals. My thought to that was, is there a logic to that order in that the other allied health professionals will already be regulated through professional bodies so that they can wait to phase 3 for them because they will be caught under their professional regulations, but for the beauticians that we are talking about, we need to do that in phase 2. I was not quite sure about the teeth whitening. Is it the case that beauticians cannot under legislation do that at the moment, but they are just doing it anyway? That is not about changing regulations, that is about enforcing. Back to the phases, because you will catch certain professions under their own professional regulation. Mr Freeman might want to deal with the issue of the phasing. We have to distinguish about existing professional regulation, which exists irrespective of that, that people are registered and as registrants with their professional bodies are required to be competent and professional in their behaviour. That is something in respect of a regulation of a set of procedures that are currently unregulated, so there are two different things going on there in terms of professionalism and actual regulation of the quality of care. Mr Freeman Ferguson, do you wish to deal with the issue of the phasing? Yes, please. The expert group recommended the phasing approach, so we could capture a wide range of services which are potentially quite high risk, which are currently unregulated in a timely manner in phase 1. By commencing the regulation of independent clinics and adjusting the definition, we capture quite a lot of procedures and practitioners who are doing some quite significant high risk interventions in a quite efficient way, because we can do that using the existing regulatory framework and commencing that using SSIs, and it can be done quite in a timely fashion. The work that would be needed to be done in order to set up the licensing scheme is going to need some primary legislation, so that requires a little bit more work, needs a little bit more debate through the regulatory and statutory process. That would take a bit longer, so we have phased it so that we can start the regulation, we can capture some of the most high risk procedures quickly. We appreciate or it is appreciated that that will still leave some procedures and practitioners unregulated, but that will take longer to get to, so that will be wrth on through the second phase, and then the third phase for those other practitioners is, like you say, what is considered to be the lowest risk, so we will look at that at the end. Are we all agreed that we are doing the high risk first? Many of those people are already regulated under professional regulation, are they not? Am I getting that wrong? Individuals are practising doctors or nurses that are regulated by the general medical council, the nursing and midwifery council. That is a professional issue in terms of their professional competence to practice. What we are talking about here is about, in the first instance, as Mr Freeman Ferguson said, those procedures that we believe are at the higher end of risk and we need to regulate as they are currently unregulated. That is why we approve the proposal in the regulations as something that seeks to be pragmatic in that regard. I have a list here of cosmetic clinics, private GPs, private dentists, dental professionals and mobile clinics. The dental professionals are only those in the private sector, as I have read. What other regime, other than the professional standards, is there any inspection of dental practices? BDA will be able to comment that, but there is obviously cranial inspections of NHS dentistry, which is a long-standing review process that examines the quality of dental practices in Scotland. Are they subject to unannounced visits in inspection? I am not sure whether it is unannounced, but it is certainly not carried out by Health Improvement Scotland, the NHS part of it. A couple of issues are carried out by NHS boards. They have teams of inspectors who are existing, practicing dentists, and they go into practices and examine them. It is a very robust process and very detailed. It takes a lot of preparation time and time to go through. Why would not it be done by Health and... It is done by the local NHS boards who effectively give the dentists and the practice their list number. The contractual relationship is really with NHS Lothian and NHS Greater Glasgow. NHS Greater Glasgow and Clyde list number dentists are responsible for the inspection and regulation of the practice. We are pleased that this has come to the fore now because there are a large 30-odd plus. I do not think that anybody knows the exact number. I am sure that Robbie and his team know, but there are a considerable number of dental practices in Scotland, which are wholly private and do no NHS work and therefore are totally unregulated. The important point here is that I understand how the phasing will work because it is really important that they are properly regulated. Although the GDC, the General Dental Council, will require them to adhere to their own professional standards, that does not necessarily say anything about the infrastructure of a practice. In Scotland, we are very fortunate that we have the highest decontamination standards in the UK and some of the highest in Europe, which is great and is to be welcome and commended. We fully support that. If you are a private practitioner, you do not currently need to comply with that. That is a really important issue for patient safety, public safety and good quality services. It is just a consistency thing at that stage, but I have a number of bids. First of all, I will give the opportunity for any of the panel members who want to come in at this point. I have got Richard Lyle and Malcolm Chisholm for your benefit, Dennis, but I will take you after Richard because Malcolm has been in and they are doing that turn. I want to confirm that there are no other panel members wanting in at this time. My question is an entirely separate one. I could be wrong, but in reading the submissions, my understanding is that if the private clinic has one NHS patient, it would not have to go through the regulation because it would be inspected through the NHS procedure that other NHS dentists are. Is that right? They would only require one patient, so they would not have to go through the regulation. They have to register as an NHS practice, even if they only have one patient, they have to register. That is considerably advantageous to dentists to have some NHS patients. That is why we have a relatively small number of holy private practices. The 30 clinics that you are suggesting could register NHS have one patient and then they would not have to go through the regulation process that we are talking about here. I am assuming—I have not discussed this in detail with Health Improvement Scotland, but we are assuming it with the same combined practice inspection regime that the NHS goes through. What we are really doing here is bringing the rest of the dental profession up to the standards of NHS Scotland. That is why it is an important piece of legislation. That would also save them £3,500. Is that right? Well, not really, because to go through the combined practice inspection, you might not be paying the cash up front, but it can take anything between 60 to 80 hours of dental time for the teams to prepare. Also, they have to have all the investments, they have to have all the staff training. It is not an easy process, it is a very robust and detailed process, so the money issue is largely relevant, to be honest. It is just an interesting issue that they sit outside all the other inspection regimes. There is a hybrid scheme for dentists then. No, dentists are all inspected by their NHS boards. If they are NHS dentists, there is more than 1,000 NHS practices in Scotland, all inspected, all regulated, all very robustly controlled. But not as robustly as this legislation would. No, that has always been the problem. They are not subject to unannounced visits, they are not subject to taking measures and complaints, are they? Well, if I could come back on unannounced visits, there is legislation being put forward to Parliament just now to introduce unannounced visits for NHS dental practices, but they are not currently subject to that. If that legislation is likely to go forward, which I believe it will, then they will be subject to unannounced visits. That would give them parity with the private dentists who are in this scheme, who will be subject to unannounced visits. That is something that we can take up. In terms of the inspection that is currently every three years pat, does that include any element looking at non-surgical treatments within that practice? Any element in terms of if I had a dentist who was getting his third year inspection and I provide dermal fillers as a treatment, for example, would that NHS inspection look at any aspect of that particular treatment or procedure set within that practice? No. Another question that I would just like to, and I know that I am getting the floor back, in terms of Richard, if I can just ask director a question to Richard. I am a little bit confused in terms of the word phasing. To me phasing is a process that is basically one entity working through a process of phasers. So then when we put in documents that this is going to be regulation via phasing, actually we are forgetting that phase two and potentially phase three are not carried out by the HIS. That is correct, is it not? In terms of the regulation of butitions, for instance, that would not fall within the responsibility of healthcare improvement Scotland. So it would not be the same regulation? It would be a different or more probably more appropriate body if we do that in the context of licensing within local authorities. Because we have not answered that. I am giving you a lot of attitude. I would not want to put you off contributing, but I cannot allow a question or answer session directly. You need to go through the chair, please. I bring you back to the original question that the Department of Health states that regulation has to include all types of provider and must meet the same requirements. Does this propose regulation meet that requirement? In terms of this piece of regulation, obviously this is a matter for the Scottish Government and the Scottish Parliament. Last, the Department of Health has said that in England there is a different regulatory regime in England and, for instance, what the Care Quality Commission does. I think that what we have got here is a problematic approach in terms of the phasing of that and the role and responsibility of healthcare improvement Scotland in looking at individual healthcare practitioners as opposed to procedures. So in Scotland, for instance, we register services. We do not register providers and that is quite different and that is again a distinctive difference between Scotland and in England. Simon, I will get you back in. I do think that it is fairly—I mean, I take some of the points made by Mr Collins. I think it would be very interesting to understand what the licensing process would be like, because I think that without that it is very difficult to know whether that would ever be effective. The other thing that I do not know whether anyone has considered the possibility that those who are non-regulated could apply for clinic status and become regulated. And if you drive the public information message clearly and strongly enough, it may be that the public are looking for regulated practitioners—certainly in the UK or in England. That is what is being proposed, that there will be a very strong public health message and regulated practitioners will—the intent is that it will mean that patients are choosing regulated practitioners rather than unregulated practitioners. So there may be an opportunity for some of that unregulated group to choose to be regulated and I do not know if the system would be in place to allow that. Kevin? The current arrangements would not allow elective regulation. If a premises does not meet the test for an independent clinic, then we would not be in a position to be able to register them because if we ended up in a situation where we were required to take sanctions to drive improvement, if the individual was electing to be part of that process and did not meet the test for a clinic, then the defence at the end of the day against the sanctions would be that the service did not need to be regulated in the first place. So it becomes very difficult for us to be able to accept voluntary registrations, but that would not stop a service that is currently a beauty salon with no registered healthcare providers within the business inviting a nurse or a doctor to join their team, which would then make their premises and their operation an independent clinic and then we could register that. Richard Lyon. I have found the discussion very interesting and the point about teeth. I am sure that I have seen the adverts elsewhere that other people offer teeth whitening and also on television, but the question that I want to come in and we touched on it and Dennis Robertson actually slightly touched on it. You have got scenarios within your papers 1-11. I will pick two of them. Scenario 7. I am a doctor and provide a range of consultation and treatment from a room or rooms in my home. Basically, you say, we only need to grant your registration if the environment you practice from meets the requirements. I am a nurse and I provide a range of consultation and treatments to my clients in their own homes. Basically, you say that you must apply to register to be a permanent independent clinic. With the greatest respect to a comment that was made earlier, the money is totally irrelevant. I will refer you to the costs. Yes, there will be a fee to pay. The registration fee for 2016-17, correct me if I am wrong, for independent clinics is £1,990. Then it gets worse. If you apply and we do not regulate you, we do not give you your money back. With the greatest respect, I am all for regulation. I want to encourage people to be regulated, but the two scenarios that I gave you, the doctor could be charging these patients £100 anewa. The nurse may be only able to charge her patients £10 anewa. How do we get the great figure of £1,999? Why do we not fund it if we do not pass you? Why do we not have a sliding scale for people who will have a nice little learner for their family and other people who, with the greatest respect to the nurse, may only earn £10, 20 anewa? That is a question that I want to pose to the community. There are a couple of issues in there. Who registers, who is business or profession? I will deal with a number of them. I will ask Mr Freeman Ferguson to deal with the issue of the refund of the fee. In terms of my very first point at the start of this session, the market is frankly very opaque. We do not know who is out there and what and what types of procedures are in different environments. What we are clear about in 2016-17 is that we have a flat registration fee in moving forward in future years when we move into actual fees and licence to operate. We will be moving to a system that is much more sophisticated and risk-based about who is doing what and what is the regulatory burden on us to oversee those procedures. There is quite a difference between a private GP having a face-to-face consultation with an individual in their own home versus another procedure being done within a more technical procedure that may have devastating long-term consequences. We have to have a better understanding of the differences in the market over the course of 2016-17. That will then arrive at a different pricing about that licence to operate fee and where the different risks are, and that will require a considerable amount of work. Inevitably, in this year for 2016-17, it is a flat registration fee, and that has allowed people to come forward and to be registered. Mr Fumon Fagas, you may wish to deal with the issue of refunds, but a key point and principle of a MAC convener is full-cost recovery for us as healthcare improvements Scotland. We have been very clear that it is up-front and transparent in the programme board that I chair about how the costs have been calculated and how there has been a portion in the construction of the fees. How would that apply to optical express? Would that be a fee for each location? So, in registering actual services, Mr Fumon Fagas, do you want to actually do that? Thank you. In terms of the registration process, the registration process is a fairly well-defined process that requires the examination of all the arrangements, the business arrangements and the clinical governance arrangements for the service. The experience that we've got from registering hospitals is that that is a fairly defined process and the amount of work taken to register a service is fairly fixed and it doesn't vary much regardless of how big or small the service is. So, if you look at the fees that are set out for an independent hospital, you'll see that there's a fixed flat fee for the registration of a hospital regardless of the size of it, and then as we move into the continuation fees for that hospital, the fee that we charge for a hospital is per place. So, if a hospital has got four places, then they would pay the amount of money times four. And if they've got 122, which is the largest hospital we've got, then obviously their annual continuation fee is considerably bigger. And so, we've looked at the work that we already do and that combined with the fact that the market's very opaque has led us to the most pragmatic approach at the moment is a fixed fee, a fixed flat fee for registration. With regard to refunds, we don't, it's not, it's not, you submit the application then we make an arbitrary decision as to whether or not you're registered. The registration process is quite an extensive dialogue from before the forms are submitted to get a good understanding about the service and whether or not the kind of service and the arrangements that they've got in place would actually meet the requirements. So, if we think that someone's proposing to submit a registration form and we don't think that they would meet the requirements, then we would have those discussions in advance to make sure that they could either do the work that they needed to do to be more sure of getting a registration or decide that that's not something that they want to do. Once the registration form's submitted and that process begins, we're committed to doing quite a large piece of work around evaluating the information that's submitted and making the assessments around whether or not the provider and the service that they're proposing is appropriate to be granted access to the market and we have to do that work and at the end of the day we're working towards granting everyone's registration and it isn't our intent not to register anybody and it would only be, and a registration would only be refused in what I would consider to be exceptional circumstances that the provider really couldn't demonstrate that they were meeting the necessary standards. But if we find that there are issues that need to be improved, then that's a dialogue during the registration process and we would be working towards granting registrations. So, at the end of the day you've got a nurse who's only going to maybe have 10 clients and you've got a doctor who's got 20, 30, 40 clients and the variations of timing. So, why didn't you decide, and I get your point, and I'm pleased that you've just answered the last question, was basically that if you will have discussions with the person first to ensure they're going to pass before you take their check, cash it and then turn around and say, sorry, you didn't pass. So, I'm very pleased about that and that's answered that question. But why not having very different fees in order to encourage people? I'm concerned about the fact, I've just been told about Keith Whiting, I'm concerned about backstreet practices, which may be going on. Why don't we encourage people to register based on a big hospital? I can understand, Harley Street or whatever, Harley Street is known in Scotland but somebody like that in Scotland. Fine, but we missies McSuegel who's looking after some of our local clients £1,990, I think that's a bit OTT. Just my follow-up question about what does it mean for optical express who already comply with high standards being a UK company and don't see any burden, what would happen in an optical express situation? Day one registration or register a rebremise? No, it would be, so for optical express they would be required to register each of their four treatment clinics that would meet the test, so that would be each clinic would have to register. Simon's been one again. I support this pragmatic approach but my sense is that at the moment we're looking as if we're going to or you're looking as if you're going to end up with a registered sector and a licence sector, one of which at the moment it's fairly clear what the regulation will look like and it's pretty robust. You've got another system where it remains very unclear and I'm just not convinced that it would be interesting to know whether you've exhausted the possibility of ultimately in phase 2 producing the same system to govern both sets of practitioners. It does sound as if you're saying you can't do that. I think that the important point is in terms of the expert advisory group report and obviously presented to ministers and ministers have taken the view that the process should be a two-stage, a two-step approach in terms of healthcare improvement in Scotland. I think that that's perhaps more a matter for officials from the Scottish Government to comment upon. It's something that we can raise with them. Mal, part sorry, I'll let part in and then directly to Malcolm. I mean in response to the point that you made about money, I'm not saying that that's not a big fee, it's a big fee. In terms of the regulation of dentistry, that's really important, so we've stated that and we think that's important. In relation to the fee, I agree with you, because even within dentistry we don't represent DCPs, we don't represent hygienists as a trade union, as a professional association, but you can see that there is the legal ability to set up. I could set up if I was a dental nurse or dental therapist, my own private practice, and I could just do periodontal disease, lots of scaling, cleaning, polish, minor fillings, solve that preventative treatment with patients. I would not be earning anything similar to what a dentist would be earning, so I do agree with you about the sliding scale. I think that we are also concerned that in a year where the registration fees for individual dentists went up from about £450 to £980 per year, that there is a considerable on-going burden of cost of regulation. A sliding scale that looked at income turnover and maybe the number of patients that you were seeing and trying to give some sensitivity to the cost, I think, would be a really good idea. I support that. I think that Simon Withers' distinction there was interesting between regulation and licensing, and I wonder to what extent that is based on phase 1 is what healthcare improvement Scotland is going to do and phase 2 will be what somebody else is going to do, but that is really just an opening thought. I am interested in lots of things like that. When I read this, I am surprised that we are where we are, because 15 years ago, I was the minister who took through the Regulation of Care Act, which has provision for the inspection of independent clinics. My understanding is that the Care Commission of the time developed standards for independent clinics, so why none of that was ever implemented if anyone knows the answer, that would be interesting. I suppose that my question to Ronnie Pearson is just to go into a bit more detail about what will be involved in terms of these private clinics. For example, will standards be developed for them, and will the inspection regime just be similar as for all other bodies that it inspects? However, I suppose that it is related to that. My final point is that Simon Withers, in his paper, made the interesting point that the Care and Quality Commission in England already inspect private clinics, so it is always useful to compare what is happening in Scotland and in England. My general question would be, in a couple of years' time, will the inspection of private clinics be the same in Scotland as in England, or will there be differences that we can learn from, or not, as the case may be? In terms of the detail around how we inspect and regulate those services, if we take what we do at the moment in terms of independent hospitals and hospitals, we use the national care standards as a basis in which we inspect against those services. Those national care standards, as a committee will be aware, are now under redevelopment, and I am very much thinking in the context of human rights, and we are working closely with a range of stakeholders, including the care inspectorate on the redevelopment of those national standards. As regards what it will look like on the ground in terms of inspection and how we apply it, Kevin May will be able to answer that. Just going back to the Care and Quality Commission, the regulatory regime for the Care and Quality Commission in England is quite different in Scotland, but in respect of the private provision, we are converging here in respect of moving to a regulation similar to what the Care and Quality Commission does, with the only distinctive difference that it regulates providers and services. As regards the actual standards and how we apply them, Kevin May will be able to answer that. Thank you. With regard to the national care standards that are currently under review, but we do have national care standards in place for independent specialist clinics and GP practices, so they were developed along with the rest of the suite of the national care standards and have been available, and we will continue to use those in the relevant services as the basis for our inspections and along with the legislation until the new standards are developed and the independent healthcare team are involved in the development of the new standards to make sure that we get coverage for independent healthcare services within the new national care standards. In terms of what an inspection would look like in an independent clinic, what we are trying to achieve is consistency for all independent healthcare services, so we will endeavour to use the same self-assessment process, we will be endeavouring to use the same grading process, but there will be the inevitable adjustments and tweaks, so I suppose what we are looking for is consistency across the piece, but with appropriate adjustments to make sure that when we cross the threshold at a clinic, the intervention on a day-to-day level inside the premises is appropriate, we spend currently around two days in a hospital or a hospice, I wouldn't be anticipating that we would be spending two days in a clinic, so we will adjust that, but on the broad scheme of things we will be looking for consistency and we will also, specifically with regard to dentists, be looking to try and get consistency across with the triennial health board practice inspections as well, and we are working with colleagues who are involved in that work to make sure that they marry up as well. Malcolm Ew, what a quick point to Robbie Pearson. Would it be right to say that everything on phase one will be your responsibility and do you envisage that anything in phase two will be your responsibility as well, or do you assume that that will be somebody else's responsibility? In regards to phase one, our responsibility, phase two, is entirely different, and Kevin who has an experience of local government and local authority licensing, I think that that would be the most appropriate vehicle in terms of phase two. There is a couple of options written within phase two. One is local government licensing, but there is also an option to prescribe a number of treatments that should only be delivered in an independent clinic, so there is potential if we can get to the point where you can prescribe or define specific treatments, then there may be that list of prescribed treatments that should only take place in a clinic, which will obviously move that to us. Just a quick one. In terms of the reason for including midwifes in the proposed legislation and some of the obvious difficulties, not many of those midwifes work out there, but there are questions that arise about why they were included, how that sort of service would be inspected, what aspects of their work would be inspected, given the delivery of their services in people's homes and things like that, and the extent to which you have had consultation with the midwifes about those proposals? In terms of the actual introduction of midwifes in the legislation, I was obviously a matter for officials in the Scottish Government, but clearly there was a gap in terms of the regulation of a healthcare provider, a healthcare professional that wasn't currently regulated, so there was a natural requirement and proposal to put that within the legislation. We have been very open and transparent in setting out, through the consultation exercise, what fell within the scope and obviously we have received information to the submission as well in terms of the view of the Royal College of Midwives and independent midwife practitioners. It is a very small number of independent midwives that operate in Scotland, but Kevin may be all tired in terms of any other points. We have got the midwives as a group to engage with and we do recognise that obviously they are not unique, but the majority of the services they provide are in people's homes and delivering services in people's homes is one of the things that we are going to be looking at as we ramp up to moving towards inspection. Currently we only regulate hospitals and hospitals deliver all of their services within the bricks and mortar of the building, private GPs, occupational health services potentially and travel clinics as well as some cosmetic practitioners all potentially deliver services in people's homes, so that is something that we are very aware of and looking to how we can sensibly regulate that and what our approach might be. Before I call and make my case, will you break up my eye there and Simon? In terms of the objective, it is to ultimately reduce risk for members of the public who have these treatments and therefore I guess in terms of how that landscape looks in terms of the effectiveness of the regulation. If I can just give a few examples, I do not believe that there is any budget put aside to raise awareness of actually the regulation and people who are part of that regulation and there will not be a resource that a member of the public will be able to go on, i.e. a register, that they will be able to search for a regulated practitioner by treatment and procedure, so if you ultimately promote, find a regulated practitioner for example, I will not have anywhere to be able to go and do it, so to give you a real example and I am just wondering in terms of how this could be addressed through the phases, if in 2017 when this regulation is put in place I am on a street in Scotland and on that street you have got a doctor who previously has done quite a lot of NHS work but now that only constitutes 10% of his practice and 90% is actually private work, they will not need to be regulated. On the same street you have got a doctor who does work in NHS hospital 50% of his time and is invested in a private clinic where he treats his private patients, that doctor will be regulated. Then on you have got a nurse who rents a room in a beauty salon, she will be regulated and she does that through three rooms in the city, three times the cost if she wants to maintain that business. You have then got a prescribing pharmacist who rents the same room in the same salon who is not regulated, you have got a dental practice who is 50% NHS, 50% private, that dental practice does not need to register, however he has got a good friend who is a doctor who rents a room in his dental practice, guess what? That doctor has to be regulated, I have got a beauty therapist on that street who does not need to be regulated and won't be visited and we do not really know what the landscape looks like in terms of the licensing because it will be done by somebody else and then you have got the icing on the cake, I have got a friend who is on the same street who has a flat above the doctors who does the treatments in his kitchen with his kids and his cats running round, I want him to be regulated and the idea is to reduce the risk for members of the public and I am on that street and do you know what I am probably going to be driven by because I have no resource to identify who actually is regulated. So out of the eight examples I have given, three will be regulated and five won't and I have still got the same chance of walking in to somebody who has not been affected by this regulation and my final point is I feel really sorry for the nurse who actually outside of her NHS job she actually provides sports massage and she does it one day a week and it costs brings in limited revenue but she does it because her salary she's topping it up because the the pressures that we know are on the NHS and junior doctors and she will have to regulate because she provides sports massage so she stops doing it. Yeah we've got your written response as well as your written evidence Kevin do you want to respond to that and then I'm going directly to Simon because the clock's running down fast now. Sorry convener just specifically with regard to a resource for being able to find out whether or not services are registered the purpose of applying to be registered is to go on a register and we have a register of independent healthcare services and the independent clinics will be added to that register once they are registered and that register is a we are required to have that register publicly available it's available on our website and and anybody can can go on to that website and they can search for a service provider search for a service by the type of service that they provide and they can also search on location so that's available it currently isn't particularly well marketed I would concede because the amount of services that are actually on there are quite limited and if you're looking for an independent hospital it's well known that they're regulated and that you can go and find information about that I think that that that we can that we will be able to do some work to promote that going forward but just just for clarity there is a register the services will be on a register because that's the purpose of applying to be on the register and that register is publicly available Simon in terms of inspection I just wanted to comment that the Care Quality Commission have had quite a lot of problem recruiting expert advisors for their inspections that they do and I think it's an important thing to understand particularly if there are anomalies like dental practices being being inspected in other ways I think it's important that you both systems have equally expert people going in because it was one of the weaknesses the Care Quality Commission identified when it was going around doing inspections that it didn't have people who are adequately trained to do the inspection capacity to carry out these responsibilities and then parts absolutely so be a core of inspectors that we're recruiting to but we're also budgeting for clinical expertise advice to support those inspections as well because that would be crucial it's got to be self-financing and there's been a question in the written evidence that you're underestimating the number of people that would need to be registered and I think you was at 400 so in terms of your calculation about costing there was a number of practitioners and clinics and things that needed to be registered and I think at least one person was saying that you know that's an underestimation so if that business plan isn't right something's got to give either you've not got enough inspectors enough quality to do your job or fees we need to get up or whatever so what would what would happen there how confident you are about those estimates on those figures well with the caveat that is said at the very start this is a very opaque and in some extent quite invisible market obviously we can see a hospice we can see a private hospital but in terms of people's individual procedures that they do in people's homes it's not as visible we are counting every day in terms of the numbers that are coming forward to seek to register with us or to seek advice in that dialogue and Kevin May wish to see what the latest figures are on that. So currently there are we're in conversation with 150 services where where both parties agree that they will need to move forward and register next year we've got 100 I'm sorry 348 on on our research list of services that we think would need to be registered that we are communicating with that we're writing to but but we've not heard back from yet. How many you've communicated just on that 350 45 48 list that's who you've communicated we're communicating we're we're now in a position where we're sending different communications out to the different groups so we're we're still sending out more general information to the 350 but now once for the 150 that have been in touch with us and we know what they're doing and and who they are then they get much more targeted communications part. A couple of things one is Mr Collins I've made a fundamental misinterpretation NHS dental practices are very very heavily regulated it is a very detailed robust time consuming and expensive process but they are well regulated there is absolutely no question that everybody in this room should understand that and all that we're seeing here is that you're bringing the private sector the holy private sector who treat no NHS patients into line with the existing regulatory system. The second point that I would like to clarify with Robbie is in the comprehensive practice inspections system which is that robust regulation which is done at health board level all the inspection work is done by trained qualified and experienced dentists and we would like to see that same parity we would like to see that same consistency and that same level of professional inspection and the third point really is again we don't represent dental care professionals but we work very closely with them as part the dental team and I think from a professional point of view we'd like to know who's going to inspect them how that be set up and you know that's an important element which has really not been understood in Scotland. I think the point was made earlier that it sits out all of the other regimes that's been set up and we're just wondering why that would be not that you weren't being regulated not that you're providing good quality and safe care is why dentists would be different in that regime I think. I mean Mike Mackenzie has been very patient and I'm wanting in I'm sorry we've got you know difficult time because the chamber we're not allowed to go beyond that but we have all the written evidence and we'll be meeting the minister on the 25th so we'll be taking all that in the accounts. Mike. Thank you. I'm very glad I don't live in the street that was described by Mr Collins. The very thought of it makes me feel unwell it sounds like a set for one of these dreadful health soaps but I'm seeking reassurance convener you know and from health improvement Scotland essentially because I've got a concern and it's a growing concern listening to what I've heard this afternoon about the possibility of this driving those practitioners that are not up to standard further underground. I'm quite sure that the reputable people this won't pose many problems to them picking up the points that Richard White was making about the cost of fees and so on and I wonder how much perhaps has there been too much concern with the idea of this being self-financing full cost recovery and fees and not enough to about the effectiveness. We've already heard from Miss Kilpatrick that despite the fact that teeth whitening is not legal it goes on day in and daily in kind of backstreet outlets and my final part of my question would be that if a business then becomes regulated and I walk in their door looking for a Simon Kyle smile and I walk back out again with no teeth who's going to pay for the reconstructive surgery or whatever it costs to remedy that situation. Right, who's going to take that? Who's going to reduce the risk or cause different behaviours to take place? Well if it may convener. I think at the moment the risk is sitting with individuals who are accessing these procedures at the moment without any regulation so what we're doing is seeking people who are undertaking these procedures to come forward and would expect and I think that the widespread feedback we've had from the consultation is that people who are reputable professionals are very happy to engage in this because they want their work to be registered, they want because of the quality of the service that they deliver to be acknowledged and recognised on the register so I think that's been a very strong point. As regards the issue of the compensation, procedures that go wrong, I'll leave that to Kevin to answer that but I'm not sure what the legal basis is but it is a private individual to a commercial entity relationship but that will be a much better relationship if individual providers, services rather, are regulated and have nothing to fear and put themselves on the register and demonstrating through inspection regulation that they deliver a high quality service. Obviously we'll be the body for receiving complaints about independent health care services we are the body for receiving complaints about independent health care services and clinics will fall to that. We'll take complaints about services and we will investigate complaints in respect of the service delivery and whether or not the service delivered met the standards that were within our remit and we will be looking at whether or not the service complies with the national care standards and the legislation essentially. If there was a matter in respect of clinical decision making with regard to whether or not it was the right decision to take the teeth out or not then we would refer that as a matter for the general dental council because that would have been a clinical decision with regard to the dentist that made that and then with regard compensation that would be a civil matter between the patient and the dentist. I suppose I should rephrase that then because I'm not particular absolutely sure that you understood the thrust of it. The thrust of my questions is that we can talk and we've had a bit of discussion about how the regulation will be implemented and so on and so forth. What my question is is how sure are we that this regulatory framework will actually be effective in driving forward better standards and giving protection to the public? My personal view is that it's an important step forward in the sense that individuals won't be practising in the dark but will actually be visible to everybody that we require to be registered. The quality of the service will actually be inspected. We will be publishing reports as regards the quality of those services, which individuals can access. Ultimately, it will be an offence to proceed to operate without a licence, without a registration, and again, boss, that's the stick. The carrot must be that everybody's raising standards and raising the quality of the procedures that are undertaken. Currently, we have no—what route do we take with those unregulated services now if we've got a complaint? There isn't any route, is there? No, there isn't. It's completely a regional professional basis to the professional regulatory body. Apart from that, practice of behaviour. How does the ombudsman fit into this, for instance, in the future? The public service ombudsman wouldn't have a remit for this because these are not public services. Currently, for independent hospitals, we are usually at the end stage for a complaint about an independent hospital. Normally, a service user would complain to the hospital to begin with, and they would go through a number of processes with that service, and if they still weren't satisfied, although they could come to us at any time, they would normally come to us at the end of that, in the same way that a patient of the NHS would complain to the board, and once they got to the end of the process with the board, they would go to the ombudsman. Simon, I see your hand, but what I'm going to do is take a net issue out. Independent, mid-wise, but you got in first. Right, okay, okay, Simon. Sorry, did you say it would be an offence to practice without being on the register at some point? That would be very, very complicated, wouldn't it? If it was an offence for a doctor who was qualified and could show qualifications to do something which someone else is already, someone who is completely untrained, is doing without the similar position on a register, it would be very complicated to mean that was... Tell us a clarification. Kevin may help me on terms of the language, but you would actually not be permitted on law to actually carry out that procedure. So it is an offence to operate an unregistered independent healthcare service. So within the legislative framework that we have, if the legislation has been commenced, so in terms of independent hospitals currently, if you operate an independent hospital and you are not registered, that's an offence. So Ergo, once the regulations around clinics these commence, it would be an offence to operate an unlicensed clinic. I see your hand, Brett, but I'm going to give the people the three-second pitch right at the end here. It's got to be three seconds, and I'm conscious that others haven't had the same opportunity. Brett, if you've got three seconds, you can do this in three seconds. Ready, steady, go. If I'm a beautician, just pushing back on Simon's comment, and I cannot be prosecuted, but a nurse or a doctor or a dentist could be. I think that that was the question in terms of this. It's the fact that a nurse can be prosecuted, but a beautician can't under the same regulation for doing the same treatment. Do you wish to make any final points, leave us with any final point? We welcome regulation, but we would like inspection to be done by dentists. The lot said that clearly there is a need for increased regulation. There's a big difference between qualified private practices and unqualified practitioners providing procedures. I think there's a bigger risk in the latter group. I think that most qualified medical professionals have a responsibility and a duty of care to their patients and they're worried about getting struck off, so there's almost self-regulation with the qualified and registered medical professionals. I think that the bigger issue is in the unqualified practitioners who are performing these procedures in the back street, where there's no real control, there's no real penalty for getting it wrong, and I think that that's something that needs to be probably explored beyond this meeting. I thank you all on behalf of the committee for your attendance, your written evidence. As I said, it's been very useful for us rather than just having the written evidence to have you here with us today. We're meeting, as I said, the minister on 23 February and we'll reflect on some of this evidence and that'll shape our questions.