 Good morning and welcome to the ninth meeting of the Health and Sport Committee of 2018. Can I ask everyone please to ensure that mobile phones are switched off or to silent? And please ask that we respect the process of the Parliament and not record or film any of the proceedings that will be done by Parliament staff. The first item of our agenda is to hear evidence from witnesses on the impact of leaving the European Union on health and social care in Scotland. We start this morning with a session to consider the impact on research and clinical trials. May I welcome to the committee our first panel of witnesses and introduce Dema Anna Dominicic, the vice principal and head of college of medical veterinary and life sciences at the University of Glasgow, representing the Royal Society of Edinburgh, Gregor McNeill, head of external affairs for involved nations, Cancer Research UK, Dr Cat Ball, policy manager, association of medical research charities and Dr Mark Fleer, senior lecturer in law at the School of Law, Queens University of Belfast. I'm looking forward to hearing from you. We did invite University Scotland to be represented at this session but they declined as they were unable to put forward an appropriate representative but I'm delighted we have such a high quality panel from elsewhere. I begin proceedings with a question from Ivey McKee. Thank you convener and good morning panel and thanks for coming along to talk to us about this issue. I want to talk first of all or ask you first of all about common frameworks, which are clearly an issue that's much much in the news. I think there's agreement from everybody, Scottish Government, Scottish Parliament, everybody that there needs to be common frameworks and if you look specifically at this area there's a surprising number of topics that are covered in health and social care, reciprocal health, tobacco and food regulation, blood safety, there's quite a number of areas that are going to be impacted by this potentially and clearly there's differences between the way we do things in Scotland and want to continue doing things in the way things are done perhaps in the rest of the UK. So I just wanted to get your thoughts on what mechanisms you think should be in place for implementation of common frameworks and also the issue around about the importance of the Scottish Government and the Scottish Parliament having some kind of say on what was into those common frameworks. Who would like to start? If I could start and speak about research and clinical trials where the common frameworks are extremely important from variety of reasons, from the point of view of patients, the NHS, but also pharmaceutical industry and our links with industry. So I think there were early suggestions that if we're different that would be good. I think that's a very dangerous thinking because we know that in clinical trials or trials of devices we have to work with other EU countries and we alone would not be a market big enough to justify presence of these companies in this country and making a legislation on the basis of our experience in Scotland or UK alone. So I think very, very important to speak up that we do need to belong to European regulation of drugs, devices, clinical trials. If we try to be a little different we will pay for it very dearly in many levels of patient benefit. We know that patients who participate in new clinical trials whether drugs or devices do better. This is now proven by many, many bits of evidence, but we also know that we want pharmaceutical industry to come here. Scotland is famous in being the best not only in being part of clinical trials but organizing, coordinating, coming up with ideas. So I think we need to make sure that Scotland is part of the legislation in all these areas the same as the rest of Europe. I would just like to underscore what we have just heard. It is really important that if researchers here in Scotland in particular want to continue to collaborate with researchers elsewhere in the European Union, it is really important to have what we call legally speaking from a lawyer's point of view a harmonized approach. So currently as you know, that is the approach that we have. If we deviate from that then there are risks involved and we've heard what some of those are. I should just point out that my interest is in clinical trials specifically but there are of course different areas of health research but from my background in studying writing about researching on the law in relation to clinical trials, I'm sure I can say that actually maintaining a harmonized approach is in the interests of researchers here in Scotland across the United Kingdom and indeed across the European Union given the importance of the UK and Scotland within the UK then for research clinical trials in particular then across Europe, across the European Union. I think that your input is very valuable but the direction I was hoping to go on was common frameworks across the UK post Brexit because clearly there is a risk that the UK would possibly diverge from European Union which you've said obviously we all think would not be a wise direction to go on but within that context Scotland would potentially be tied into common frameworks with the rest of the UK and how would that picture play out because that could get extremely complicated at a number of levels? If I may just, I think that in terms of these common frameworks we're not quite sure what they will constitute as such at the moment so there's a lot that's unclear and that's one of the things that's unclear so I think in relation to the point that you're seeking a response to I think that there is considerable there could be a negative impact on researchers here in Scotland if there is for instance divergence UK wide then means the UK is less attractive as a place in which to carry out clinical trials that will impact on Scotland so I think that's I think that's the starting point but then I think what we need to think about if I may is if I may suggest is demanding ensuring that if there is any sort of well if there is then a common framework across the UK in respect of say clinical trials that there is not divergence or significant divergence that will undermine the carrying out the performance of clinical trials here in the UK and Scotland I think that there needs to be that effort to demand and to ensure but of course that might be difficult so we could I mean we could potentially be in a situation where I think everybody as I said at the start everybody agrees there has to be a UK common framework between Scotland and the rest of the UK everybody is clear on that the debate is about whether that is whether it's only consulted on or whether the Scottish Government Scottish parent has to consent to how that looks but we could end up with a situation potentially where a UK wide level the rest of the UK may feel that it wants to diverge from Europe but Scotland finds itself in a position of having having a say in those frameworks and Scotland is steering it back towards being more harmonised with Europe than the rest of the UK might want which could be very interesting I wonder if any of the other witnesses have comments specifically on those issues of how the development of a UK framework should be informed by stakeholders within the UK and within Scotland in order to ensure that it looks the right way Mark's language of a harmonised approach is this helpful language and common frameworks has come to be a very specific technical discussion at the moment but I think we look at outcomes of a harmonised approach and we look at a possible future of you described diving of divergence Scotland from the UK and then looking to join up with the EU the status quo is that collaboration is on as well articulated is absolutely vital for research excellence within Scotland across the UK and across the EU and when we we do these big trials and big pieces of research the first partners we look to are in the rest of the UK so it'd be extremely uncommon that you'd have a Scottish piece of research that links only with EU it would be said twice it's very important that Scotland doesn't diverge from the rest of the UK the issue is about the discussion as to what those common frameworks look like okay to answer that I'm sorry if I misunderstood that I think that this committee in the parliament therefore has a role and the Scottish Government indeed to champion a UK approach in terms of harmonised harmonisation with the EU and the the stronger that voice is in terms of championing that approach the the greater the chance of benefits for patients ultimately because and as well articulated that research when embedded in the the NHS means an excellent service and better patient outcomes so it's it's not just trials it's not just research is fundamental to the NHS as well so anything this committee to can do would be extremely welcome thank you very much thank you very much can we move on to the issue of research funding and start with David Stewart thank you conveyor good morning I'm very interested in research funding and as you all know this has been a UK success story for the UK's a net beneficiary and Scotland has more research per head than anywhere else in the EU I particularly highlight the importance of horizon 2020 what's your assessment of brexit as far as research funding is concerned I mean I think sorry just to kick off I'm from the association medical research charities just a very briefly say who that is because obviously that will make the context of my remarks more useful but we represent all the leading health and medical research charities in the UK of which cancer research UK where Gregor is from our member and we have 140 members like I said 55% of those members fund research in Scotland and our members fund more research per head of population in Scotland than any other part of the UK so the medical research landscape in Scotland is really really important for our members and as well as charities obviously EU funding is a key part of that and that largely comes from the horizon 2020 programme and I think it's obviously really important that we maintain involvement with horizon 2020 I think we've heard from the UK government we had a paper published last week that categorically states that after the conclusion of the phase one agreement negotiations in December the UK will be able to participate for the remainder of horizon 2020 of course if that agreement falls through there is an underwrite as well so I think UK and Scottish researchers can be rest assured that they can still participate in horizon 2020 I think now what's really important is ensuring association with the subsequent programme which is fp9 and the European Commission did a period of consultation on what that programme should look like and a high level group chaired by Pascal Lamy produced a key report to feed into that process and that was kind of an EU report and he called it a win-win for the UK and the EU for the UK to be involved in that the UK government also responded to that consultation so I think there is there is goodwill on on both sides of the negotiation table about a future partnership on scientific funding between the UK new panel members will be well aware that non EU members can't be full members of horizon 2020 so the danger is even if the UK remains it would be a rule taker and not a rule maker which is fundamentally very important very true but I think you know there is there is a scope for the UK to be an associated country and I think there is also an understanding that it wouldn't be an off the shelf solution so in the UK being an associated country I think there is pragmatism on both sides that that relationship would look quite different than other associated countries currently and I think obviously like you say it's not going to be as it is now I mean currently the UK get back significantly more than they put into EU programs for science but I feel that this is one area of brexit where I do feel slightly optimistic that we might be able to have a future partnership with the EU and it can assure that collaboration can continue. Yeah so I agree with everything that's been said but I think there are other additional issues there I think we need to remain an associated member that goes without saying whatever it costs because it's not just the grants and activity but the people the ability to form the networks that we now hear from researchers and consumers of research and the NHS how important these networks are and there are endless examples for example in rare diseases where one country doesn't have enough to have a framework to have a proper network and the UK has done very very well leading lots of these networks and special interest groups and there is a loss of leadership and we already see this so when we look at what happened since the vote we already see that the groupings the new networks that have been created are rarely chaired or coordinated by UK researchers and this is something that shouldn't have happened and yet happened because that's human nature and I am concerned about this and clearly as you said we would be consumers we would participate but we won't make this strategy happen if there are any ways I know I might be too optimistic but if there are any ways to pay a little more to have part of strategy to be part of coordination that would be extremely useful I believe. I could also have when other panel members are answering to perhaps answer a second question in the private sector if you were facing a loss of say a customer like Marks and Spencer's it would be on your risk register and you would analyse that within the university of Glasgow for example and the other institutions represented here is the loss of potential horizon 2020 highlighted on the risk register is a potential negativity is there a likelihood we go from net beneficiary to net contributor as far as research concern yeah so generally all these issues are on the top of our risk register every risk register at every level in our universities includes this element and broader issues that I hope we touch on of losing researchers losing talent etc. In respect of the latter point risk registers I don't have access to my university's risk register but I would be very surprised if this matter weren't really high up there so but then in terms of what we've heard so far I'd just like to add to what we've heard so far rather than repeating I underline or I agree with what we've heard so far but and one thing that's um is I think a specific concern that hasn't been highlighted thus far is um the way in which Brexit so the UK withdrawal from the EU um so impacts on yeah leadership in terms of research and so on um but then also this shaping the strategic direction of of research right so the the the sorts of things that are focused on so the sorts of it might be diseases or um you know whether we're focusing on uh high technology rather than it might just be trying to make prevention better um you know um so um actually setting strategic strategic direction is terribly important it's something that is um at risk um because of Brexit we've already heard that the UK is essentially withdrawing well not withdrawing um it's essentially facing situation where networks are forming outside of um and kind of marginal marginalising UK researchers um but then in terms of um so that's the practice so that's the actual research practice um but then in terms of setting the strategic direction um in terms of law this are the legal instruments so at at at the you know bottom of this um our legal instruments Horizon 2020 is founded on a legal instrument um actually deciding determining what's written into that in terms of strategic direction but then also um uh how that's implemented so in terms of policy the UK is essentially then because of Brexit um stepping out of that um and so that's um of great great concern I think um for research now one thing that's been highlighted by amongst others the welcome trust is the importance of um trying to and that this is underscoring the points already made um the importance then um of trying to maintain those networks trying to ensure actually um that um yes although um Brexit means the UK withdrawing from the European Union that the UK develops some sort of uh associated status um with especially the follow-up then to Horizon 2020 um that's been discussed by the welcome trust some recommendations put forward there of course um it's for others um the EU side to decide quite what the shape of the relationship will be to it's not this for the UK to bark and uh there's to follow um you know it's it's actually a negotiation um but I think there is something to do in terms of explaining um and reminding uh EU um officials I suppose uh researchers and also UK researchers and officials about the importance of maintaining those networks and trying to develop something that um actually facilitates a strong UK voice um at the EU level and uh well the welcome trust has has suggested that um now if I can just add one more thing um and and and that's in terms of I suppose um accountability is an important issue here so um so that so we've got the follow-on to Horizon 2020 coming up um FB9 framework program nine um so um the welcome trust then highlights the importance of UK participation in that now if the UK is essentially not going to be involved in uh a more intense way than current associated members um I think there's a problem there in terms of accountability um so um essentially the UK or UK research is an ultimately patience um being beneficiaries of program programs funded research that they're not actually closely involved in shaping um I think that's problematic actually um I think that's problematic so thank you very much convener very concerning the research funding or the lack of or losing it as well um obviously um Glasgow MSP and Glasgow university is my constituency and the amount of research funding and corroboration that goes on there is absolutely fantastic heart research kidney research arthritis I've visited them all and obviously met with Anna also and I really am quite concerned it seems to be that um the UK is being left out in a limb Scotland along with it obviously and we seem to be the ones it's going to have to be asking all the time from the other countries in the EU and I just wonder when you look at that and obviously the risks that I think that are involved has already been mentioned about risk and accountability have we looked to anything that we can maintain our position in research I mean David Stewart mentioned horizon 2020 I mean the budget for that is 78 billion pounds have we looked at how we can possibly get anything like that out with the EU to continue not just for the sake of the research but the reputation that Scotland has about attracting these research grants it's fantastic and obviously we don't want to lose it have we looked at any other contingency plans Gregor McNeill? I think in relation to funding the impact of funding at the moment is on people the the long-term impacts of funding risk of yet to be played out as as is true of regulatory divergence as well the immediate here now is people is and is articulated where if you're graduating from prize university and have the choice of going anywhere in the world really and researchers are very mobile individuals then we're hearing anecdotally that people are choosing less inclined to choose the UK post-Brexit so and that's not because science has changed overnight and the quality of science has altered any it's just how people feel about things and see things and therefore I think messaging and symbolism is important at this stage just now and what can be done domestically in that front is for the UK government and the Scottish government to some extent is to be absolutely up there in terms of their commitment to science funding and commitment to research and they need to display an upward trend and a prioritisation of science and research funding to to give that global message that it's still very much a home for excellent science because if that wobbles any then we really do struggle to convince people to be to be coming here so I think that's something that can be actioned both at UK and Scottish level just to echo Gregor's points there about the importance of collaboration and the importance of people I think that the research funding is only one part of it it's what that funding catalyzes and what that funding enables and the networks it kind of links UK and Scottish researchers into and just to give some sort of evidence behind the point about the impact that the uncertainty is having on people now last summer the British Heart Foundation of which Anna is a trustee they surveyed their researchers in the UK and they found that 80 per cent of non-UK EU researchers they fund are now considering moving their career outside of the UK 80 per cent I mean that's just that is a phenomenal figure and it's just this uncertainty and the kind of unknown nature of what's going on is having a real impact on our research workforce and I think that's something that we have to be really kind of clear on the impact on. You want to add something? If I could add coming back to funding and this risk I think clearly currently UK government every year pays into EU networks a certain amount of money yes we get more out than we pay in but I think the role for you as our representatives would be to make absolutely sure that at least this amount stays and funds research here both in Scotland and the rest of the UK because I absolutely agree any messaging that things get weaker and less good would be really lethal at this stage for us because there are departures and I think as the Royal State of Edinburgh report for you said other countries take an opportunity this is for them an opportunity to poach people not only Europeans but people in UK science across the board and we know that Australian universities Irish universities and also German I have some anecdotal at this moment evidence that German universities and research institutes target our top researchers particularly if they German born to go back and I think we need to be extremely sensitive how we messaging both about finances opportunities the future the quality and our welcoming of everybody every talent from all over the world. I know that Jenny Gilruth is going to ask about basically you know what's happened the corroboration but the one point I wanted to make is the fact that yeah I mean high class research world renowned etc but if we are not within the EU and horizon 2020 we have no voting rights we have no say so is there any contingency plans apart from we talk up the fact of researchers how we will get access to monies that's the point I was trying to make we will lose out and access to these billions of pounds so anything in place that we should possibly access so as colleagues said the associate status is a must and we know that there are other countries that have associate status and do benefit but this is on the basis of paying in and not getting a penny more than you paid in. You're also right that associated countries have less of a state I say in the how the programs are steered and the UK thus far has played a really important role in shaping those European funding programs you know a key part of horizon 2020 is the European Research Council of which UK researchers do incredibly well and it's very very prestigious you know it's a really key thing for UK researchers to be able to win those awards particularly early career researchers and without the UK's influence in shaping that you could argue that it you know it may become different but they are influence it may become less excellence based you know so it is associated country status is something that I think we should definitely be aiming for but it's not without its challenges and it won't be what it is now. Thank you very much thank you to you. Just to kind of drill down on the points that Sandra White made there catbell you alluded to to workforce which obviously it's all very well and good getting the research funding but we need the people to carry out the work and in your submission you point to the fact that almost 70 per cent of the Beats and Institutes research scientists are non-UK citizens 28 per cent of academic staff in UK universities are non-UK nationals and Gregor McNeill in your submission you say that 72 per cent of UK based researchers spent time at a non-UK institution between 1996 and 2002 and in Scotland we have perhaps disproportionately higher number of EU nationals working in academia 5 per cent higher than the rest of the UK so do we have a specifically different situation in Scotland which we need a different solution to in terms of planning that workforce going forward? I'm just double checking our evidence submission on those numbers I don't think it would constitute a significant difference in terms of the the makeup of nationalities between say the Beats and Institute or the Crick Institute in London and often you point to the research and mobility so a lot of the individuals at the Beats and Institute have spent time in other parts of the UK indeed and that research and mobility is absolutely vital so we're not reading that there is a significant difference in the makeup of staff in Scotland I wouldn't think we could say that now. I agree with this our numbers that the Royal Society of Edinburgh looked at showed that we're roughly the same as the rest of UK although there would be differentials and I think the Beats and that I know very well because it's associated with the University of Glasgow is very international but that's typical of top excellent places. Crick was mentioned it's very similar these are places that that act as a magnet for top talent and we wanted them to do so. I think the messaging I have seen from the Scottish Government has been much more positive than the messaging from London that's my impression and I think we need to maintain this positive messaging and again our request to you to be as welcoming and giving this message to top talent from all over the world but unfortunately there are colleagues from who come from all European countries who are the talent we want both as PhD students, young researchers and very senior researchers and many of them are uncertain where they will be in a year or so. This is the risk I think that you pointing out and apart from being welcoming etc we should and try to have other measures to make them as safe as we can to have a negotiation that their rights for the future are as secure not only for them but for their families, their children etc and I think if we can do this we'll be winning. I think what we think about immigration in the context of science and research is not about keeping people out it's about getting people in you know for the UK to maintain it's global standing we need movement of people you know science relies on the flow of ideas and people and different ideas coming together it's not something you can do in isolation so it's just the people point is just so important I think across the research community I would say it almost seems like the most important point that it just keeps coming up again and again. Oh so it's I'm trying to think about how to weave this point in it does relate if I may just relay to you a couple of anecdotes or at least one and so a colleague walking on campus not at my university as another university actually in England and speaking in her home language so not English and being subjected to verbal abuse by a passerby and you know when you're on campus you think in a sense you're at home you're safe it's not the only example of that that I've heard people and other colleagues in London London right so an international really global city a place that actually voted to stay within the European Union however colleagues walking around the streets of London speaking again in their home language and being subjected to verbal abuse so I suppose you know brexit is supposed to be happening but I think however we feel about that it's important to try and remain as open and non exclusionary then as possible if that is possible so I think there's something there for MSPs to do for this Parliament to do for Scotland in sending those very clear signals and I think Scotland the Parliament and the government here have been more successful if I may say than at the UK level about sending positive signals about being open about I suppose this idea I think it's stemming from this idea of some sort of civic pride if I could use that word I think that kind of openness is something to be maintained and to be developed in order to send signals to people out there that it's essential that we treat everyone the same and everyone should feel at home and welcome so that they can do the best possible work they can do and then through research benefit society at large final question thank you convener with regard to the point about immigration that you made well you say in your submission we remain concerned that uncertainty about the UK's future immigration system is damaging the UK's reputation and attractiveness as a place to do research and Gregor McNeill in your submission you say the Scottish government should call on the UK government to design a future immigration system which enables us to attract recruit and to retain global scientific talent at all professional levels regardless of their nationality so picking up on Dr Mark Fleer's point then in October last year you might remember the UK government chief whip Chris Heaton Harris MP got himself into a bit of bother over the Brexit letter which he sent to UK universities regarding the teaching of Brexit asking them to name lecturers and Laura Peyton the chancellor of Oxford University described it as offensive and idiotic Leninism at the time so are we in danger then of losing our academic edge over Brexit because we can't attract the talent that we need the answer is we might but we need to do everything we can in our power and that's why I think we all here to have your help so it doesn't happen because once it happens it will be very difficult to undo it I think there is a big understanding across politicians and academics and other colleagues but we need to talk about it very broadly so there was one there was one anecdote there may I also give you my anecdote because I think it's probably relevant at this point so I lived in I've lived in Glasgow since 1982 for 36 and half years and I enjoyed enormously when my patients I'm a clinician scientist when my patients and taxi drivers and everybody used to ask and where are you from because you have such a nice accent and it was nice and friendly but when a colleague who in London who had a decision making that was important for me asked me was walking out of important meeting now that there is Brexit Anna do you do you plan to go home right that wasn't nice and I think what we need to somehow instill in population and in lawmakers and in everybody is that research researchers people who work in the NHS many of them academics who also work clinically are people we want here and that the times have changed and these sort of questions where we're really funny 10 years ago are actually now offensive and and push people away so that's my anecdote but I think Scotland is better than the rest of the UK I am a great believer that we're much more open and inviting and things happen much less here that are unpleasant but we need to be very very cautious sensitive and proactive so I am I am now on a barricade I even talk to every taxi driver please don't ask me please don't ask me where I come from I am British and come from bursden thank you very much I think it's fair to say I know my colleague Alex Cole-Hamilton and I visited the cancer research UK's research facility at the western general within the last few months and I think we were we were absolutely struck I think almost every researcher we met that day was an EU national and you know we saw in practice there the impact that this could have if it's not handled properly and sensitively I think you know in our research briefing today we were told that Scotland employs proportionally more EU and non EU staff than the UK as a whole and that's clear throughout higher education 27% of research only staff are EU nationals so you know the loss of this talented workforce who bring us much more than their work obviously socially and culturally as well would be a significant one and we've been speaking about the need to message positively because I think Scotland culturally is very welcoming on the whole and that's something that we want to emphasise but in terms of practical steps to make sure that Scotland doesn't lose out on this talent and do you believe that the significant contribution EU researchers makes to Scotland's health and research workforce for example indicates the need for control over immigration for that policy to be devolved do you think that would be a helpful practical aid this is a legal question I think okay that's a big question so I'm not sure that I have an appropriate answer quite honestly um I can understand uh so I guess this is a legal response I can understand the reasons that them uh that you or one might have um to argue for a devolution of immigration um uh I think there are some good arguments and and you've uh basically outlined one uh in respect of research stuff then um however um it's the practicalities um I I I suppose there are countervailing reasons that others will put forward so um and they will have they would have to be um uh challenged or negotiated you know responded to um I yeah I'm not sure I can really say much more on on the matter of immigration I think there are other things related to uh drawing people in that are less politically charged um that will meet uh with less of a fierce response from others and that I imagine already within the powers of this parliament um so I sometimes I think it's important to focus on what can be achieved using what tools are already available and then if you know there's um there seems to be a need yes to try and go after other tools um rain it can kind of get control of them um work towards that but focus on what can be done right now because actually all of this is happening right now and um I suppose a key thing to think about is well what do we have right now and what are we going to lose or what are we at high risk of losing how do we maintain that and so I suppose the question is how does Scotland maintain that um so it's so in relation to immigration how does Scotland um ensure that it continues to attract um the best from around the world including the european union it's probably not exactly what you wanted me to say but to the end of that by just saying that you know science is inherently global it's inherently collaborative so we just need as few barriers as possible across the UK across Europe across the world you know Scotland and the UK are on the global stage and we just need no movement the barriers the movement of scientists and research talent i think that said there's um in terms of specific actions sort of scottish government can take and it is getting back to messaging rather than um more regulatory approaches um just after the EU referendum scottish government run an excellent campaign um i think it's called welcome to scotland or you're welcome in scotland um and it was put out very swiftly and very directly um after the vote um to an international audience saying that scotland is is still welcoming you and um i think a redeployment of that campaign that appropriate one would be it would be a good thing um and on on that platform and with all the evidence you hear in here in this morning hopefully scotland has a good bit of leverage within the UK to sort of set an example and and be be leading in terms of openness to to immigration and research and movement every word could be added to this i agree with everything i wonder if we can say that research particularly biomedical research that helps patients that changes the way we practice medicine is so important that we can make an exception and believe that free movement wherever you come from for talent both young and older should be maintained and if that's a position i know that important bodies such as welcome to our trust Russell group of universities have been talking about this are their exceptions from the rule thank you very much important to emphasise sorry just quickly that um the UK government should shouldn't open up the current system that's used for non ea nationals to include ea nationals i think for science and research in particular that would that would be a bit of a disaster miles briggs thank you you kind of almost answered my point there already but i wanted to look at what you just said there dr bol in terms of you know future frameworks specifically when you're talking you know global research networks and how do you currently see that working for non ea international researchers coming to the UK and where do you think that can be really improved i know you just said they're not opening that up to necessarily just include ea but where do you is there issues at the moment with people coming outside the EU to to carry out research absolutely i'd say there are definitely issues with with non ea nationals coming to to do research in the UK for example the there's a cap on the number of tier two visas so that's the kind of skilled skilled visa route and that cap has been breached twice in recent months and that means that you know research talent from outside the ea is just not getting to the UK because that that cap has been hit and the UK says no more and the social age medical research charities in the castle research UK were recently signatories on a campaign for science and engineering letter to the prime minister to highlight this very point just saying you know that the system just doesn't work for science and research and it needs to be changed like that arbitrary cap needs to be removed and if we add to this clinically qualified researchers things are even more complicated because apart from immigration rules there is also registration to practice so you've spoken to general medical council i'm sure or you're going to and for EU nationals at the moment this is quick and easy for people from all over the world outside european area this is a long process that requires hundreds of pages of evidence that they are fit to practice here and whilst that's important for safety if this is a top researcher and it takes a year to get them here this is a big big obstacle Emma Harbour i think at a question on the impact on research and innovation yeah thank you very much convener good morning everybody i'm sure the answers you're going to give me are going to be similar to previous ones but i'm interested in the impact of brexit innovation and in the cancer research UK submission it talks about thriving pharmaceutical and biotechnology sector which has developed a number of new therapies and medical technologies and 25 percent of the world's top 100 prescriptions were discovered and developed in the UK and i was reading the submission from quintiles i ms for the health select committee's inquiry into brexit and they talked about an analysis that suggests that the implications of brexit could prompt business decisions that will decelerate UK pharmaceutical market sales growth over the next three years so i'm curious about innovation and research and i am aware of collaboration with people from all over the world to develop research processes and innovation and i would like your thoughts on that i think that question kind of speaks to Anna's point earlier when she's talking about being part of a wider market and having a larger global share of the pharmaceutical market together with the EU so European Medicines Agency which is the EU body that regulates medicines across the the breadth of member states collectively that makes up 25 percent of the global sales market whereas the UK in isolation is 3 percent so i think those figures can speak for themselves on the value of collaboration on that and the value of joining together and the impact that has on the attractiveness for industry to invest in the UK which obviously has a knock-on effect on innovation as well. In terms of the immediate term and what the fallout if you like of the vote is there's a large degree of uncertainty and for a lot of these global industries they're very very mobile and already we're seeing just because of uncertainty before Brexit has actually happened that some industries are withdrawing relocating to other parts of the world so there's an issue around uncertainty and an intent from the UK Government with regard to things like joining the EMA and it would be helpful to have more certainty and have more clarity again we're getting back to the messaging point but this is the most vital aspect just now and if the UK Government could be very clear about the intent to stay within the EMA framework and very clear about how that would happen and timescales for it that would help to deal with a lot of these immediate issues we're seeing now if i can take that back to how that plays out in Scotland just as an example looking at lung cancer which is Scotland's cancer of greatest incidence i'm aware of three lung cancer drugs in the pipeline which have patient populations in Scotland of something of the order 50, 20 and 10 for a cancer that has thousands of patients every year so the patient populations for a lot of these innovative medicines are tiny and we need to be in a European on a European wide stage in that regard so this as i say the uncertainty around EMA is certainly proving harmful in the immediate term i'll just tell it the impact of that uncertainty in another way so a lot of these major pharmaceutical companies that are based in the UK they're having to do a lot of planning risk mitigation scenarios etc and where the money tends to be coming from a lot of that we've heard is from the R&D budgets because these are by definition the most flexible so when they need to suddenly source of money to put this planning because there isn't certainty it's coming from the R&D budget which obviously is going to have a knock-on effect on the development of medicines and a knock-on effect on patients and also if i could just talking about the importance of the collaboration point just really like to highlight rare diseases and less common diseases because obviously a rare disease by definition means there's less patients so it's a particular example where you really need the multinational joint EU approach just to source enough patients to be able to be involved in the trials to ensure the medicines can be licensed to come to market so I just think that's a really important angle is that the rare disease patient point very much um yes please say other word in the area where Scotland has a huge chance to lead the world but again we need collaboration and we need industry to be present and join and this area is precision medicine something we talked this morning on radio four from Glasgow so precision medicine is an area that requires health data early diagnostics and then application in the NHS and we have all the ingredients here to be the best but we do need industry because this isn't research in ivory tower this is to implement that new way of practicing medicine into the NHS it could only happen if small and big companies will want to be in Scotland so the risk and the worry as we just heard is that they are uncertain about the future and might not want to invest of course to somehow prevent this we have the industrial strategy challenge fund the life sciences sector deal all the things but Scotland needs to fight to be at the forefront of this and bring the companies with us so you absolutely right there is a risk there that we need to mitigate now because there is no time we have a chance to lead the world in this area but others are following suit. Brian Whittle, I was actually looking to maybe go back and explore this the current well established relationships and collaborative relationships you have with the EU and what impact perhaps you're currently seeing on those relationships pre-Brexit you know is there a pattern pre-Brexit you know a no sub collaborative patterns yeah yes in short we're certainly anecdotally and we've reached out to our research community around those impacts and there is a sense anecdotally that if you're putting together a European EU partnership then do you do you talk to the the British arm if you like when you know that it's going to be uncertain in the future it might just be a bit more difficult to do so and a lot of people are just although nothing's changed in a sense a lot we're here in act only a lot of people are just opting to not do that difficult bit of involving the UK and that also plays out in terms of people making decisions where to conduct the research and where to go after graduation or further on in their career we're certainly getting act don't I don't left in it's about recruitment on that front and then retention to so those are here just now and then thinking about the next step in their career might they just be that bit more incentivised to go elsewhere if they think that the UK will be an easier place to practice so all of that is playing out anecdotally in our community at least would you think that's a perception or a reality or is it both playing into that it's a reality because it's happening I mean as I say that the science has not changed yet but that's when the the bigger risk plays in if the excellence of our science starts to diminish as a result of that and it's the immediate challenges these are the human behaviors that are occurring because of the environment we're in now and it's it's how we address that quick smart really I think it's more than anecdotal already we know for example that there is nine percent less PhD applications in the Russell group of universities so two Scottish universities Glasgow and Edinburgh in the Russell group we already know that PhD students that talent for the future is not coming we also know that not only we don't lead as we discussed before don't coordinate but even the amounts of money this year are less than in the same period before Brexit was announced so although nothing yet happened although we still have the rights there are less applications going in and less money coming back to the UK and to Scotland okay I think that what the science community needs now really is is certainty you know like like I said and back back at the beginning of our discussions you know there is there is scope and there is some positivity that a good outcome could happen but unless we get knowledge of that soon there's a risk that the damage is already done and it could be too late I mean that I appreciate that sounds really alarmist but you know there is real real damage going on as a result of this uncertainty well if I could convene that that kind of leaves me on to the next question and that how do you consider the current negotiations you know and the way those current negotiations are dealt with how is there opportunities to foster new relationships you know to make stronger collaborations in the future of them I'm thinking specifically you know going back a bit bit the sort of academic science and health network that that was being established down south you know looking to push into Europe and into a more global space especially around the treatment of rare diseases and we seem to be discussing it quite rightly so because it's Brexit around the need to recruit in those rare diseases those when we're doing those studies but the reality is that recruitment in the rare diseases has to be global so there's more than more than just Europe in that sense so how do how does language or language how do from the Scottish Government and the Scottish Parliament how do we you know provide those opportunities to perhaps strengthen that sub-collaboration because I always think within health there are no real boundaries in that and I thought this was an area where you can probably make the biggest the biggest push if you like to maintain those those collaborative partnerships so I think you absolutely right there should be no boundaries there should be no borders and there has been a suggestion which has been published in times higher education supplement of global network instead of just european a global network but but clearly the cost the complexity it's not something that can happen overnight I think that would require many years of negotiation of paying into willing countries to pay and come together and also in some way the networks across Europe were very convenient for research because the systems were in some way similar the patients the way the health and the research is practiced quite similar I think it's possible to have a global have WHO I know to have a global network for health research and implementation wonderful idea but I think it would take years of planning and be very expensive you can imagine to bring it all together whilst the EU is already there it works people feel the networks that have been created the collaborations across Europe in all areas whether it's disease areas or public health areas have been fantastic people learn how to work together I think it would be very very difficult to replace this with something global we can dream and yes I'm with you there should be no borders but I can't see that that would replace what we have at the moment easily I think the beginning of any exploration on that front needs to start with getting the movement of people right that underpins all of this is the mobility of researchers Good morning to the panel thanks for coming to see us today I'd like to move the discussion on to clinical trials and this touches on some topics we've already addressed it's fair to say that the EU's previous clinical trials directive from 2001 had its critics in some ways it was slightly cumbersome but that's set to be superseded by a new directive coming in at the end of this year which everyone agrees is largely an improvement however obviously we at brexit will remove us from that clinical trials directive and the represent or witnesses to the science and technology commitment committee at Westminster on this subject expressed concern about a lack of regulatory alignment and that we should continue with regulatory alignment even after we leave that directive because otherwise it means trials changing regulation while they are in mid-stream but also I think I'm touching on Emma Harper's point about the problems affecting patients who have ultra orphan conditions who might only benefit from life potentially life-saving therapies as part of a pan-European trial what steps do we need to take to either ensure that regulatory alignment allows us to buy into those trials or whether we need a new bilateral agreement with the European Union when we leave because it's legal and initially legal so actually um so the directive is going to be placed so the clinical trials directive is going to be replaced by the clinical trials regulation but that won't be until at least march 2019 after 2019 at march 2019 so that's post brexit right so so the problem there is that um it's it's well it's what's known as a well how how much to say it's a it's a regulation if if it were introduced before brexit it would just be directly applicable it would become part of UK law um it would be written into UK law then right so um it would apply to researchers um however because of uh the point at which it will become applicable falling after um brexit um there's a question there as to whether the text of that regulation is brought wholesale into uh UK law um I believe I've read that that has been one or that is one proposal that's one idea that's been um discussed um responding directly then to the point or to your query I think that that would be very wise especially in light of the submissions made by the other panel members today so I think mark please please do correct me on this but I think it's with the clinical trials regulation it's not just as simple as a as a legislative fix it's not as easy as just bringing it into our law there's underpinning infrastructure there's a clinical trials portal and a database which sort of the aim of the regulation is to make it more aligned and make trials easier to happen and those are the kind of underpinning features that would do that and it's not clear as how a country outside the EU the UK would participate in that so I think that something that needs to be included in negotiations is how the UK would participate in those two key bits of infrastructure if I could just build on what you said um so the portal and the database clinical trials portal and database so it's it's key to the actual functioning of of clinical trials um that's something brought in then by the clinical trials regulation but actually um so there's one important point I think it's article seven of the European Commission's draft withdrawal agreement it actually states very clearly that upon Brexit and I think actually after the end of the transition period the UK is not to access and or even attempt to access any EU database including that clinical trials portal and database so right even if the UK were to essentially adopt wholesale the text of sorry um you asked the question of the clinical trials regulation um that's okay something the UK is free to do however there remains a question there um and it's worthwhile underscoring around continued access to the portal to the database which provides very important information for research is ultimately ensuring patient safety um down the line um and that's something that would have to be included in the uh agreement between the EU and UK going into the future so you believe that there should be as part of the negotiations around trade around criminal justice and everything else that there should be we should be seeking a bilateral agreement a new bilateral agreement which seamlessly keeps us within that sort of pan-European clinical trials apparatus whether it's part of some sort of comprehensive agreement or something that's the sectoral you know so the specific sector of clinical trials I think that needs to happen so I don't know I think it's absolutely essential because otherwise NHS patients research everybody is losing out so I think this is absolutely essential for us to make sure that it happens I cannot even imagine how trials that are ongoing has colleagues said new trials that need to be done how UK patients Scottish patients will be excluded this is almost a criminal offence final question Emma Harper just on the clinical trials yeah it's um I was reading in the the EU newsletter about organ donation and transplants in the EU and about how there's trials going on which seems to mainly affect children because I as a former liver transplant nurse I know it's really difficult to get hearts and livers for five-year-olds so I think so far there's been 23 transplants that have taken place across many borders in the EU so obviously these regulations and requirements and common frameworks there will be a real challenge if we don't have access to that so that our veins that need livers from other areas that would be quite a challenge to set up the transplantation regulations wouldn't it be yeah I think we we we just need to agree with you that's other very similar thing but taking into account rare conditions children as you said there are no donors there are few organs and that open border policy clearly has helped many and we should do anything not to lose belonging to these organisations you used the word earlier the harp harmonisation I think it is a legal term but I think the science community has adopted it as well and I think we're very much calling for continued harmonisation with the EU on a lot of these frameworks that work for medical research and patients so can I ask a wee just a wee sup so the access to the EMA and access to all these regulatory bodies and agency it's it's going to have financial implications isn't it to pay in for access yeah absolutely yes yes but it would be every penny we'll spend absolutely very much agree with that it'll have service implications as well because where as said where NHS excellence happens research is a core ingredient and you start pulling that out you lose the talent you lose the the best people I want to teach in these hospitals and practice in these hospitals you then impact patients you impact outcomes so it's never separate from the NHS and delivery of healthcare in scotland thank you very much and can I thank all our witnesses for a very informative session it's been extremely helpful and we will now I suspend for a few moments in order to allow a change of witnesses our proceedings please and welcome to the committee our second panel of witnesses this morning order please colleagues thank you very much welcome and can I welcome old friends on you to the panel this morning can I start by introducing John Brown director of policy at the Scottish life sciences association Matt Barkley the director of operations at community pharmacy scotland and Michael Hancey director of law reform the law society of scotland welcome to you all and you will know our focus this morning is on medical regulation medical devices and I wonder if I could start with Emma Harper and Alex Cole-Hamilton who I believe both have questions around the sharing of data I'm quite happy to Alex to go first because he was a data person well thank you convener this actually follows on quite well from the line of questioning I gave the first panel which was in respect of clinical trials regulation but it also they talked quite extensively about our access to to databases not least for clinical trials when we crash out of the EU they were all of a mind that we needed some kind of bilateral agreement which was more than just regulatory alignment so that we might continue to have the advantages for Scottish patients particularly with ultra orphan conditions of pan European trials but also access to databases that that is not going to happen if we don't if we leave the European Union without a deal on this can the panel give us an idea of what kind of deal we would need what are the barriers to that and what are the implications of us not having any access to European databases yeah quite happy to kick off on that Alex yeah I think in terms of supply chain and safety of medicines to patients the whole EU setup is designed to allow pharmacovigilants throughout the whole 28 member states so adverse events happening with medicines are generally reported back on a Scottish level to the yellow card scheme which is then passed public health England which is then passed into a European database so that type of intelligence across such a broad area then allows for that data to be co-ordinated and then subsequently communicated throughout the 28 member states also areas such as antimicrobial resistance as well can be mapped across Europe which then allows for pharmacists even in community pharmacies to obtain information about prescribing patterns what should happen in a Scottish context in relation to Europe so I think certainly in that level from a safety of medicines aspect we can't lose that access to that level of data because we would lose that intelligence and I would like to think that we would obviously be part of that continued data sharing because the UK as a substantial population within that EU member 28 states obviously feeds in and benefits Europeans as well as you know patients in Scotland etc as well so there is also GDPR regulations due to come in May of this year which are European wide and I know that ICO have been lobbying for a number of years to update data protection laws as well and that is happening on a European wide level and we would like to see that maintained as well that does give safeguards and the potential for exchange of information between professionals and obviously an EU wide level but on a even professionals within your community pharmacy to a GP practice you know to a you know the safe transfer of patient data so that there is an aspect there that we would like to see maintained as well Last week we took evidence and I asked questions about the European centres for disease control because there's a lot of information shared about not just anti-microbials but antivirals, flu vaccine and looking for like pandemics for flu as well so obviously data sharing is really important not just European wide but worldwide as well to look for how do we protect people from flu virus so that would be a similar comment I suppose Yes, I mean that's hugely important and we need to stay part of that setup. I mean flu vaccines are obviously global you know that the vaccines are developed essentially from Australia in terms of whatever the flu virus that is coming there is then developed by companies for the upcoming season in the UK and Europe so yeah it's important that that level I'm sure that level of information will will be shared as well and so yeah I'd like to see that maintained. Thank you very much, can I now ask Ash Denham to open the questioning on the the wider issue of medicines regulation which I know will be of interest to all the members of the panel. Thank you convener and good morning to the panel. I wanted to turn to the European medicines agency because as we know that's quite a unique organisation in the world currently there doesn't seem to be any clarity from the UK government with regard to whether we will be maintaining membership of that and from the submissions that the committee has received it seems that that's a very serious issue so some of the comments that we had that it could destabilise the medicine supply chain a comment from the Lancet that it be very costly to taxpayers and that would be increased costs and also delays so I wonder if the panel could explain to us exactly what they see as the potential consequences of if perhaps the UK was outside the EMA. Well first of all I would comment that the prime minister said last week that the UK government would seek to attain associate membership of the EMA after Brexit and she did that in the context of a number of regulatory areas including aviation safety for example where she also said that the UK would seek to remain within the European aviation safety structure as for example Switzerland is so taking Switzerland as an example if you like in a way of the UK after Brexit Swiss Airlines do not need to ask someone else within the borders of the EU to do the tests because they have an agreement with the aviation safety regulator that Switzerland will be it's basically a mutual recognition agreement and I'm going to come back to that phrase several times I think in response to questions Switzerland has a mutual recognition agreement on aviation safety with Europe and the position of the UK government now as explained by the prime minister last week is that they will seek associate membership of the EMA but the industry view and I I represent businesses in the life sciences sector who make medicines is that the UK should have a mutual recognition agreement on health regulation now there are many of these throughout the world and that avoids the need for double testing in in the sense that I gave it in the aviation example you don't need to do all the tests and checks twice and that issue of getting a mutual recognition agreement with the EU on medicines is vitally important and one that we and other industry bodies are pressing the UK government on would you like to explain just a little the critical differences between mutual recognition and associate membership in that well associate membership of the european medicines agency would give companies the access to the expertise that that agency has at the moment but actually a large part of its expertise is british it's been in london since its inception and in fact moving it is going to be an extremely difficult thing in terms of retaining the expertise across europe if you look at the amount of regulatory and and technical expertise in medicines and medical products a large proportion more than pro rata is composed of british experts and that's one reason why the EMA was put in london so there are going to be a lot of issues for the EU in moving it but the ability to continue to have an associate membership of the EMA will allow companies for example who are thinking of new medicines to talk to them as members rather than as third parties but mutual recognition is global for example at the moment if a medicine comes from america it will be tested in america to ffd food and drug administration standards in the us when it comes into the EU it will be tested again to make sure that it's in accordance with european regulations that's what we call double testing now a mutual recognition agreement means that the recipient state accepts the efficacy of the testing in the originating state and in fact there is a mutual recognition agreement being negotiated with the us at the moment between the EU and the us and it's due to come into force next year so mutual recognition agreement is about recognising each other's testing quality if you like and not needing to check everything twice understood yes i agree with everything john said there i mean i think um from a supply point of view to patients obviously community pharmacies is probably the largest stakeholder in terms of daily transactions with patient and advice to patients in that that point i would like to think actually that to patients accessing medicines and receiving advice from pharmacists on a daily basis that process is essentially seamless but the whole us supply chain is extremely complex behind that from the manufacture of the products which can quite often cross many borders in the EU and as john explained globally to the wholesalers who then take that on and distribute medicines to the pharmacy so it's extremely complex i mean at the minute we import 90 percent of our medicines into the UK about 50 percent of that is imported from the EU so in terms of that the mutual recognition would be very beneficial to allow that frictionless trade to occur so that i and my pharmacy can obtain the medicines without any extra additional barriers and then supply it on so that that process of a GP rank prescription may receive the prescription and being able to order or just to actually provide a medication to patients is as seamless as possible within that as well there are if that mutual recognition that john can i explained or alignment of regulations is quite often the term that's used within that there are potential if that's not there that there are increased costs born across the piece there because of course manufacturers have to make money from medicines wholesalers make money on margin from the distribution of the medicines and partly my members in terms of our financial package to meet their cost base are allowed in agreement with the certainly in scotland the the scottish government to make a degree of margin which which forces and encourages our members to purchase very efficiently and keep the price low for the nhs who is the ultimate consumer of these medicines and keep that price extremely low and in the UK it's recognized that we're one of the the lowest in terms of costs of medicines costs that i mean john mentioned america it's extremely much more costly to be providing medicines in america than it is in the UK for example so for that system to be maintained and supported it needs to be as aligned or as john said mutually reciprocal as possible aglokrancy thank you can be none of course the prime minister in making that speech was went on to say after she said that she would want to have associate membership of the EMA and these other agencies which included the european chemicals agency and the aviation safety agency which john has referred to she said this would we this would of course accept that we this would mean abiding by the rules of those agencies and making an appropriate financial contribution and she then went on to say that associate membership of these agencies is the only way to meet our objective of ensuring that these products only need to undergo one set the series of approvals in one country and i think that that's quite an important objective for the prime minister to have set out that there should be one series of approvals in one country and then of course she would want to negotiate so that the UK could continue to provide technical expertise and suddenly that this would permit UK firms to resolve certain challenges related to the agencies through UK courts rather than at the CGEU as it should be heard to more modernly now of course that's fine for the prime minister to want that to happen but if you take a look at the european councils publication on the 7th of march of draft guidelines for these negotiations it's quite clear the european council takes a different view in paragraph 6 european council further reiterates that the union will preserve its autonomy as regards its decision making which excludes participation of the united kingdom as a third country to EU institutions agencies or bodies so i don't know if that is back to you prime minister in the negotiation flow but it certainly seems to be quite a difficult negotiation coming up to be able to persuade the EU to relax that approach or perhaps for the EU to ask the prime minister to think again and then turning to Switzerland in our submission to the committee we talked about the confidentiality agreement which the swiss have with the the the EMA and the EU's director general for health health and food safety and that includes the swiss agency for therapeutic products or swiss medic and the swiss federal department for home affairs now in that there is no automatic recognition of marketing authorisations granted by the EU so therefore the the prime minister's aspiration of having one series of of checks may not actually be the way that we end up going if a swiss type agreement is where we finally arrive that's something different from being an associate member yeah that's the point i was going to raise actually on the back of the comments from john brown that in canada and switzerland obviously they do have a separate approval system but in that situation medicines are typically reaching the market about six months later than they currently do for the EU so i suppose my question to the panel would be is there a risk here that if the UK government is not able to get agreement such as we all might wish with the EU that you know potentially new cancer medications for instance might be quite delayed to the UK do you do the panel see that as being a risk yes i i do there are 82 million packs of drugs across the EU UK boundary every month that's a lot of drugs and at the moment it's to use the popular term frictionless if it becomes encumbered by the need to do double testing and also something which i'll refer to as double batch release sign-off then that will slow down the supply of drugs to patients and the pharmaceutical industry in the UK is pressing the government that that will become a patient safety issue now if i could just very quickly convener expand on what i've said medical devices are only tested once when they're designed and they begin to be manufactured and i know that your scope includes medical devices but for medical device manufacturers of which there are a huge number in scotland we have far more medical device medical technology companies in scotland than we have pharmaceutical companies so looking at it from an economic point of view we don't see a big impact of brexit the device once tested and accredited can then be sold and there is some regulatory overview of its use for instance if something explodes then there is a it's the equivalent of the pharmacovigilants there is a report goes back but by and large once approved the device is available for sale wherever but with medicines even after initial clinical studies every batch of medicines or rather i should say continue there is continuous safety testing in laboratories of medicines and under EU regulations that for a drug supplied in the EU that must be done within the borders so for drugs manufactured in britain that means double safety testing if we don't get some sort of mutual recognition but then every batch of drugs that's released to patients has to be signed off in a regulated process by people who are called qualified persons and that's a term of regulatory art every batch has to be signed off and that too has to be done within the borders of the EU so without an mra it will be probable that medicines made in the UK will have to be tested in the UK and then tested again and each batch that's released will have to be released in the UK and then someone will have to do the same thing again in Europe and that becomes a patient safety issue for the reason that you said miss denim it it will slow things down in good morning panel i think mr brown alluded to the prime ministers looking to have this sort of relationship associated relationship with the ema in medicines and that's the one we'd all hope but as mr clancy has then pointed out you know that that's not necessarily the current position of the EU negotiators so then i suppose it boils down to what's likely to happen and of the likelihood of that relationship to be to be made and then that spins back to me the relationship the current relationship between the mhre and the ema and the likely and what would the impact on the ema if the mhre or they're not part of that associated relationship because it's my understanding that the mhre have a significant input into the to the the ema so in the likelihood is of the two parties coming closer together as we get closer to the need for it for an agreement in reality the ema would want the mhre to maintain a part of that that whole process would would i be correcting if i could just comment on that i've been working now for seven years in this with this industry and after the fda in america i believe it's true to say that the mhre is the best regarded medical regulatory agency in the world it's certainly up there with the fda in terms of the quality of its work and the expertise that it has so it's a huge contributor to the work of the european medicines agency and that won't stop the mhre will still be a very well respected regulator so i think that the question is then if we cut through all the rhetoric that that seems to be following the EU negotiations the reality is both sides would prefer to maintain some sort of close relationship i i have to choose my words carefully but the pharmaceutical industry is quite a powerful lobby it's well funded and it's very good at lobbying national governments not just in britain and that industry is very alive to the threat of double testing and double everything and it would be foolish to say what's going to happen but there is still a degree of optimism that the the european council's response is just part of the negotiation the prime minister says she would like to do this europe says that's cherry picking and we're not going to allow cherry picking but i'm not going to say how it's going to end up i think as well i've certainly heard in some quarters that there possible is a small opportunity here i don't know quite how likely it is because certainly the swiss canadian australian models and going through there they do get their medicines 60 12 months or new medicines 60 12 months later but if we were to align so closely to the eu that basically there was sign of it of the marketing authorization at the EU level there is a role potentially for the mhre within the UK i believe to then speed up the process in the UK to allow that medicine to come in potentially even quicker than the EU but i'm not quite sure how likely that is but i have heard and spoken to people in the industry that have said that that is unlikely but is a potential positive Mr Duggan, you cannot predict all negotiations we'll know more shortly i mean the european council's meeting at the end of this month will have a better vista of the approach which they're actually taking i think the point which john brown makes that that this is a negotiation talk but a negotiation talk lasts a long time although in fact it's only 381 days today until the 29th of march 2019 as i checked it on my brexit countdown calendar this morning so you know time is running out for us to be to be getting to the stage where the positioning has to give way to actual agreement what's a brief supplementary from Sandra White very much convener i'm so glad that michael counted down the days i couldn't correct it and i can see cherry picking if i like because i think that's what it's about but i'm interested in how it's affecting the patience of people at the end of the day when it's going to be more expensive but i'm also worried about you know counterfeit drugs as well getting into the system how is that going to work how are we going to stop that if we're not member in the mae yeah i mean sorry john yeah yeah i think at the minute with there is a there is a good system among the 28 countries i mean at the minute the 28 countries obviously marketing authorisation goes round that 28 countries we operate a wholesale dealer licenseeism in the in the same way through the wholesale chain and there is a high guarantee of authentic medicines although there is a new piece of legislation coming in ironically the month before brexit is due in febru 2019 called the falsified medicines directive and that is a significant undertaking by every single EU country basically to have an electronic database and mapping electronically so on a community pharmacy for example come next march we should have special scanners which allow us to scan medicines for patients and if it is signalled as a counterfeit medicine it will come through now the amount of counterfeit medicine which is in the UK supply chain at the minute has been relatively small over the last 20 years or so the risk is if we were to reverse and not take on the falsified medicines directive and to be fair there's no sign of that certainly the UK Government and you know my own organisation have been involved in the community pharmacy subgroup that's working on FMD there's no indication that we're not going to be part of that system but if we were to fall out at any point in the future it could potentially mean that the UK could become a dumping ground for counterfeit medicines because we don't have the same I suppose safeguards that the other EU member states would have so that's a potential risk the whole system for me is a patient safety issue in terms of I know when I'm supplying medicines and the pharmacies are working as a locum clinician that actually you know in general they're safe and the the falsified medicines directive is a new addition to that which is seen as very important we currently have legislation in place which protects us against fraudulent drugs I think though the important point to remember is that as this new directive comes into effect in March next year the European Union withdrawal bill is designed to transpose that from EU law into UK law so we will carry forward that subject to the reciprocal elements which are involved in the database arrangements and now that I have no doubt is exactly the kind of area where the United Kingdom government will want to negotiate and if not access to the database then access to the information in the database in much the same way as is used in criminal justice areas where there are databases like ECRIS and and Euro DAC and things like that and so so I think that that we ought not to get into a position where we are fearful that we are going to be flooded with counterfeit drugs all over the place that there will be mechanisms albeit not as smoothly running as we expect them to be which will protect people from that kind of criminal activity. Thank you very much. Can we move on to some questions regarding medical isotopes on your atom and start with David Stewart. Thank you for being a good morning panel. I've been very interested in looking at medical isotopes of the last few months and one of the little known aspects of Brexit is the withdrawal of your atom which I suspect is not the most popular body or well-known body across the country. As the panel will know, your atom monitor the supply of medical isotopes which again the panel will know that we don't produce any within the UK. What's the panel's assessment of this? As the panel will know, medical isotopes are used in Ghana cameras, pet scans and therapeutic use and are very important in treatment of cancer. What assessment have the panel made of the withdrawal from your atom on the supply of medical isotopes, particularly for those suffering from cancer? It so happens that I should declare a kind of aged interest here. I was a member of the Scottish Government's working party on positron emission tomography or PET, scanning from 2003 until about 2011, I think. I'm glad you didn't ask me what PET stood for, by the way. Well, just wait. What's an isotope for then, Mr Stewart? No, no, no, we won't do that game, shall we not? I have an interest in this personally and professionally, but if one rolls back to the beginning of this particular aspect of leaving the EU, when the notification was given by the Prime Minister almost a year ago to the European Commission on Council that we were withdrawing, it included that withdrawal from your atom, which is the European Atomic Energy Community, just to make sure that we're all on one page here. That withdrawal was, I think, no real rationale given. In the notification bill explanatory notes, it simply said that this was going to be a consequence of what was happening. Therefore, if one tries to identify why it is the case that the UK has withdrawn from this particular treaty, then you've got to look at things like the fact that your atom as a community is subject to the European Court of Justice at the EU, and brings with it some movement of people in terms of research experts across the EU. If one looks at the treaty, you can see why the Government might have taken that view because membership or being subject to the EU is one of the Government's red lines, and free movement of people is one of the Government's red lines. Now, if one were to then look at the agreement of December last year between the UK and the EU, you can see there in terms of citizens' rights, the CJEU has been given the opportunity to take referrals from UK courts for a further eight years until after the leaving date. I think that one has to press the Government on this particular point about how that red line is capable of being massaged a little in terms of citizens' rights, but it still holds good with your atom. Could I raise just two other issues while I've still got the facts on my head? The scale of this is quite phenomenal. I looked something up for the UK figure. The 700,000 medical isotope procedures were used in the UK last year, which is approximately 70,000 for Scotland. On the supply side, in a nontechnical sense, the raw ingredient for medical isotopes is 99 mO, but six of the world's countries have 90 per cent of that supply. Four of them happen to be in the EU, so you can do the maths. We know that the demand is great, but we know that the EU has not quite a monopoly, but a massive supply base for new radioactive isotopes. We know that Hinkley Point, in theory, is capable of producing this when that comes to stream as another argument for another day, but that is 2027. I am very concerned about the future supply for cancer treatment of medical isotopes. You are absolutely correct, Mr Stewart. There is no UK producer of those isotopes. The three countries in Europe—Belgium, the Netherlands and France—have reactors that can produce mollabdenum 99 mO. Therefore, the supply chain, which is quite a complex one, needs to be maintained. We found this when there was the fire in the channel tunnel in 2008. There was an interruption to the supply chain of these isotopes, and that meant that procedures were postponed or put off for some time until things got back on an even keel. It is essential for both diagnostic and therapeutic applications that we have a consistent supply. If you troll the evidence that has been given to the UK Parliament's health and social care committee, you will see their memorandum from the Department of Health, which talks about the extent to which the Euratum Treaty restricts export. According to the Department of Health and Social Care, it does not restrict the export, but it is the security of the supply that it provides. Because those isotopes are not ffisial material, the EU can allow them to pass across borders, but we want them to be—we all want that supply to be secure so that, on occasion, when one of us or people we know and love requires that kind of treatment, that material is there to provide it. You might not be surprised to hear that we do not deal with radioisotocs and community pharmacy very often, but we cite it in our evidence as one of the big impacts potential in patients. A briefly building Michael's point is that, without the frictionless efficient movement of those products, there is an element where they decay. You could buy 100 per cent at the minute and have 100 per cent available for use with patients in the UK and Scotland, but if there is any delay at customs in any future arrangement, then there could be an element of decay of those products, which would mean, of course, increased costs and less available use for patients. That is just a slightly building Michael's point. Could I make a linked point that is not about medical isotopes and it is about their shelf life, as it were? The way that modern medicine is going is towards cell and gene therapies, and those, by their nature, are not long-lived tablets that you can keep in a cupboard for three years like an aspirin and take and it still works. The move towards cell and gene therapy is slow because they are very expensive, but I think that it is fair to say that many medical experts regard those kinds of medicines as, at least in part, the future. One of the issues that we have spotted, as it were, is that it has nothing to do with medical regulations and the terms of trade and customs arrangements. If you have customs arrangements that do not allow products like that to pass quickly from one country to another, they will degrade and, in fact, they may become useless. Some cell therapies have to be used within hours of manufacture and there is a whole network of suppliers that exist to make sure that that is possible. On new UK-EU customs arrangements, which slow down the transfer of material across customs borders, could have an impact on patient safety, where new therapies were being used. It is a parallel to the isotopes losing their efficacy. Jenny Gilruth Ashley-Davies, you have covered the points. Can we move on then and talk about regulation of medical devices? Michael, I think that you have asked a small point. Just one small point, convener, because I think that the idea of projecting information about this is quite important to the UK Government. If the CJEU is being used as a reason for coming out of Euratom and for having special arrangements in the associate membership of the EMA, we have to remember that in the 48 cases that have been to the CJEU dealing with Euratom matters, only eight have been related to the United Kingdom in all the time that the Euratom treaty has been in place. In those instances, only two were found in the commission's favour. The United Kingdom has a good record of compliance with the treaty. We have to be alive to the fact that the anxiety about the CJEU is not as forthright and real as it might be. Excellent. We have already heard about the importance of medical devices in the Scottish sector, and I wonder if Alison Johnstone would like to answer that question. Thank you, convener, and good morning, panel. As you will know, medical devices are regulated on an EU-wide basis. I think that we have concerns that medical companies, medical technology companies in the UK may be incentivised to relocate. Obviously, something that we want to avoid, because 94,000 people apparently are employed in the sector. It has a £17 billion turnover, so any loss could have a large impact on the UK economy. Obviously, by leaving the EU, the UK loses influence on shaping policy, legislation, procedures and so on. I would be interested to hear your views of the risks of the UK losing that full membership of Senolik and how those risks might be mitigated if they can be. Medicines, for obvious reasons, have always been extremely rigorously regulated. Until a few years ago, it would be true to say that devices were not so heavily regulated, because the definition of medical devices does not go inside your body. Or, if it does, it does not interfere with your physiology. It might be a hip joint, but it is not a medicine. However, in the wake of the PIP implant scandal, the European medical regulators, including the MHRA, did a lot of work over the last five years to bring the standard of regulation of medical devices up quite a lot. Now, I am not going to make comparisons, but it is true to say that medical devices are now regulated much more stringently than they were. Those regulations are coming into force now. Just as we have already heard about the fraudulent medicines directive being transported into EU law by the UK Parliament, so will those regulations be brought into UK law. Now, the position of life science companies in every sector—medicines, medical devices, diagnostic tests—is that they very much want UK regulation to stay completely consistent with EU regulation for the foreseeable future, otherwise they just lose markets. The UK regulatory arrangements for medical devices are at the moment consistent, and I believe that they will stay that way. Having just had what I might call a very big upgrade to their rigor, we are in a good place, as it were. Nearly half of the Scottish life sciences sector is composed of medical technology and diagnostic testing companies, and I have not heard from one that is even thinking of relocating, because once they get their product tested and they can show that it conforms with the regulations, they can sell it anywhere in the world. They do not need to keep on testing it. The potential threat that you have highlighted is not something that our members are at the moment concerned about. Is that a view that was shared by other witnesses this morning? I have no view on that. I think that I would probably agree with John. He is probably much closer to it than I am. I think that, going back to a brief point that John made earlier, the MHRA took a huge role in this, but my understanding is that up to 50 per cent of the testing and processes occurred through the MHRA. Again, that would benefit the EU as well. The MHRA being that international recognised as a close partner in global health is very helpful here probably. Thank you, thank you, convener. Thank you very much, Brian Whittle. Thank you again. I was quite interested, and we did quite a lot of work around digital health and the adoption of digital technology into the health service. I wondered pre-depedicated by asking what state we think the health service is currently in within the adoption of digital health and what impact of Brexit might be on that adoption. Well, again, as a trade body, we have many digital health members who are seeking to do business with the NHS. Now, I will leave aside the economic and health issues in your previous inquiry. In fact, you were looking into the adoption of new technology by the NHS, but as far as the impact of Brexit is concerned, we see no impact. The ability to trade in software is pretty much free of boundaries. For example, one of our member companies in Edinburgh called Crainware supplies quarter of US hospitals with their billing software. They do that without reference to borders. One issue that I will touch on because it comes back to regulation is that much medical software at the moment is not regulated. That is a risk from a patient safety point of view because there are more and more medical people using apps on their phones. How do you know that the programme in that phone has not got a bug in it that could kill a patient? There is a slowly building move by digital health companies to think about the need to have their software regulated. That means meeting standards of efficacy. It is a huge issue for software companies. How can you prove that a massive piece of software has no mistakes in it that could kill a patient? Those issues are just emerging. The MHRA does not have any published regulations on that issue but recently introduced draft guidelines. That is a small first step towards the regulation of medical software in the UK, but it is a pretty much unregulated area at the moment, which is an issue in terms of health. We do not see a Brexit impact in that area at the moment at all. I am aware of Craneware and the fact that the MHRA companies supply such a huge amount of technology to the US but not in Scotland. They do not supply anybody in Scotland. Hospitals do not build their patients in Scotland. They have gone for a US market that only exists in the US and they have been very successful. When you talk about the beginning of the story for the regulation of medical software, does that mean that there are potentially going to be three strands in the UK, the EU and the US of the regulation being developed separately because of the timing of this area of regulation? Again, convener, it is at its very early stages. However, drawing on my earlier comment about the respect with which the MHRA is held globally in terms of its regulatory clout, the fact that the MHRA is starting down this track by issuing draft guidelines will be studied by those other regulators. I would not be surprised if they fall in line, because the issues are the same wherever you are. Thank you very much. Can I now ask Ivan McKee to come in? There are a number of areas that I know Ivan wants to go. Thank you, convener. It is barely still good morning at one minute to 12. It has been a long morning to the panel. I would like to ask about common frameworks and trade agreements as well in the back of that. Clearly, we have talked extensively about the relationship between the UK and the EU, which may or may not be in place going forward, but clearly how the UK as a whole operates in that environment is something of discussion at the moment. I think that everybody agrees that there should be common frameworks across a number of areas where it is relevant, and there are hundreds of other areas where there are previously several of them in the health arena. I suppose that the question is to what extent, clearly, Scotland's health service has been different in many, many respects. To what extent do you think that your organisation, between Scottish organisations, should have some input to that through the Scottish Parliament and the Scottish Government and able to be able to influence the direction of UK common frameworks? I suppose that, if there was a threat of divergence of those frameworks from EU standards, is there a situation where Scotland would have had a significant say in the generation of those frameworks that could help to influence that and keep it more aligned to EU standards going forward as well? Thank you, convener. The whole issue rises out of the European Union withdrawal bill, Clause 11, which seeks at the moment to effectively withdraw from the Scottish Parliament competence in connection with EU law. As it happens, Lord Callan and the Government Minister tabled amendments yesterday that were published this morning to the bill, which I have not had the chance to analyse, but, from what Mr Lidington was saying last week, we can assume that they are completely changing the orientation of Clause 11 in many respects, but we can come back to that at a later time. It is quite interesting that the UK Government published the common frameworks document on Friday. If you look at that document, which identifies the breakdown of the areas of EU law that intersect with devolved law, you can see that there are a couple of things in the interests of this committee that the UK Government says will take no further action on, or no further action is to be taken. That includes social security co-ordination and cross-border healthcare rights. There are a few things that are subject to non-legislative common frameworks—blood safety and quality, regulation of tobacco, organs, public health cross-border issues and tissues and cells. There are 24 policy areas in which the UK Government believes that it has the issue, and the two in that area relate to reciprocal healthcare and nutritional health claims. Lastly, in the area of which the UK Government believes to be reserved in any event, the one that applies is medical devices, which we have just been talking about. I searched schedule 5 of the Scotland Act 1998, which lists all the reservations quite closely. I could not see medical devices mentioned, but I think that this is in the context of consumer protection, which is a reserved matter, and some aspects of medicines and medical products, which is a reserved matter. I could not find a precise phrase for someone who has read it more closely and will be able to identify it for me. The issue is that those are the proposals for the frameworks, which are the point of negotiation between the UK Government and the Scottish Government. I think that we have got to find out now what the Scottish Government is going to say about the amendment that is being proposed in the House of Lords Committee, which will come up next week. If there is a fast-moving area in legislation, this is it. You may want to revisit it when it is just a bit clearer. Yes, but if it is a happening thing at the moment, surely that is the point at which we should be making an input to try and influence its direction? Indeed, but until we have had the chance to look at the amendments, it is difficult to be able to say at the moment, from my point of view. I understand that. I want to make an input as to where you think the common frameworks or what influence you think you should have in terms of how those common frameworks shape up. Michael Russell answered that quite comprehensively. We mentioned a couple of things in our submission on reciprocal healthcare and public health. We have been able to because health is devolved, as you rightly say, that we should be maintaining an element of divergence there and should be allowed. We would like to see that maintained, essentially, because the community pharmacy contract, for example, is very different in Scotland than it is in south of the border, so that happens in stay evolution. If there were any common frameworks that impacted on our ability to do that, we would be worried about that. I understand that. I want to talk about trade agreements, which intersect, and that is something that came up in the committee last week when you mentioned the area of public health, which could be the tobacco regulation. We have had minimum pricing, and we are talking about food standards in relation to tackling obesity, etc. Clearly, some of those areas could potentially be pulled in by the UK Government as a bargaining chip, if you like, in negotiating trade agreements with third parties post Brexit. Is that an area that you have given any thought to? Not on a large scale, I have to say. Do you see risks there, if that were to be the situation? It is not an issue for businesses. The T-Tip negotiations raised certain anxieties in the negotiation of the treaty between the EU and the USA about healthcare providers being allowed to operate within the EU to the perceived detriment of EU citizens, but that, of course, did not proceed. We do not know. Clearly, if there were suggestions in the trade negotiations that there would be detrimental effects across a whole range of issues, people would want to know. However, I fear that the same strictures that apply to the T-Tip negotiations of confidentiality would apply to the negotiations of any trade agreement between the UK and other third countries. The difficulty will be being able to find out. The issue could be not only would the UK Government be able to trade access to the Scottish NHS without the Scottish Government stopping doing that, but we would not even know what was happening. I could not go that far, because I do not know what would be the parameters of the negotiation. That is the possibility. You may say that. I think that that is what you just said prior, was not it? You said that we would not know what was happening. I said that we would not know what was happening. That is true. Just last question. We have talked quite a bit about the problems with Brexit. It is going to make things more expensive. It is going to make security supply more difficult. It is going to make access and skilled labour more difficult. It is going to make access to research more difficult in several other areas that we have talked about. Do you see any advantages? Yes. If double testing is needed, and I hope that it is not, that will be a business opportunity for companies in the UK that can do testing that is at present done elsewhere. There is also a view that has been put forward by some of our members that, in terms of the value of, say, a batch of medicine, which can be extremely high, the cost of double testing will not be large. I think that if double testing and double backs release sign-off were imposed because we cannot get a mutual recognition agreement, there would be an impact on the cost of medicines, but it might not be as large as some people might fear. I am not in a position to say how large or what proportion it could be, but there are some businesses that are quite relaxed. You take iCuvia out at Livingston with 1,000 people. It used to be called quintiles. It brings in samples every morning, a whole plane load of them to Edinburgh Airport and analyses them and sends the results back. iCuvia, as a global business, treats Brexit as one of the business risks that it takes wherever it is in the world. Charles River out at Trenent is another one. It does a lot of work in clinical studies and is used to operating across boundaries because they are big globals. In fact, one of Scotland's greatest strengths in life sciences is in clinical contract research for clinical studies. Those two big companies are doing a lot of business. They have increased their staffing levels over the past five years by about 25 per cent, and they are bringing in work from all over the world to Scotland. They are doing that in the knowledge of what might happen, but they see it as a business risk that they just manage. I fully understand that, but what you are giving there is an example of companies that may not find things worse but would not have an advantage and are showing also that it is possible to generate business with third countries, even though they are part of the EU, which means that there is no advantage in that sense to Brexit. The one example that you gave, given that I have understood you correctly, was companies that may be able to profit from the fact that everyone else has to pay more for their medicine because of double testing. They may profit from the fact that there is a new business there. Sure, but that still has to be paid by the health service, the public post office. In fact, there has recently been an inward investment by a company that operates in the medicines testing area to Scotland. It is a big global company, and it has moved in. I cannot say why they moved in, but it is interesting that they did it at the moment. It just happened in the last few months, and they are a testing company. That is a fascinating aspect in which to end our session. Thank you very much to all our witnesses for some very useful evidence. We will now suspend briefly to allow a change of witnesses. Thank you very much. We will now resume business and move in a moment to agenda item 2, which is in relation to the community care, personal care and nursing care Scotland amendment regulations 2018, in draft. We had a discussion with colleagues before the formal commencement of this meeting in relation to a report that I know has been drawn to the minister's attention this morning, which is in relation to the report on sport for everyone, which we completed on 28 November last year. We were expecting a response from the Government in January, and the minister will recall that I wrote to her in February to ask her about that response. I wonder if she would like to tell us this morning—take the opportunity this morning—to tell us when we should expect that response. Thank you, convener, and I understand and appreciate the timescales that you are setting out. We would expect you to have that very soon. It is with me before we issue it to you, so it will be imminent. There was a lot within the requirement of the letter. It required us to engage with a lot of different departments, a lot of different agencies. We want to make sure that we furnish the committee with the right level of detail and make sure that we do justice to the work that the committee has put into this. It will be with you shortly. I apologise for the delay, but it is in order to try to make sure that we give you the best response that we can, because of the importance of the topic. It is well topical, given the ongoing interests that members have around diet and obesity strategy and the whole host of other public health developments that are happening. I can only apologise for the delay, but it is because of the attempt to make sure that we get you the right information and the engagement that has had to go on across many different parts of the Government. I hope that that is met with an understanding, but I also understand the requirement to get you this as soon as we can, and it will be with you. I am very grateful, minister. That is very helpful. Having sat at the ministerial desk, I know that, once it is on the desk, you have taken that responsibility. It is now over to you. It is over to me. I hope that you turn gamekeeper, Mr McDonald. I look forward to hearing more very, very soon, as you say. We will now have, as with all the affirmative instruments, an evidence-taking session with the minister and her officials on the instrument. During that evidence-taking session, there will be an opportunity for members of the committee to ask any questions that they may have of the minister and her officials on the personal care and nursing care regulations and drafts. As well as the minister, Eileen Campbell, is also welcome for this session, Mike Liddle, from adult social care policy and Emma Stevenson from the Government solicitors. I invite the minister to make a brief opening statement. Thank you, convener. As you say, I am joined today by Emma Stevenson and Mike Liddle. The draft affirmative regulations before the committee today reflect our continued intention to increase free personal and nursing care payments in line with inflation. The regulations, if approved, will continue to benefit vulnerable people aged 65 and over. The rates are calculated using the inflation prediction tool, the GDP inflator. The regulations will increase the personal and nursing care payments for self-funding residents in care homes in line with inflation, which this year is an increase of 1.56%. The weekly payment for personal care will rise from £171 to £174 per week. The nursing care component of the payment will rise by £1 up to £79 per week. It is estimated that this rise will cost approximately £2.1 million. Funding of £66 million was allocated to local authorities for social care in the 2018-19 budget, taking this proposed increase into account. The free personal and nursing care policy continues to command strong support and, as you will be aware, we are taking forward the extension of free personal care to those aged 65 by April next year, so I am happy to take questions on those regs. Thank you very much and can I see Alex Cole-Hamilton first question? Thank you very much, convener. Welcome to the minister and officials. Thank you for joining us today. This government, to some degree of fanfare at the most recent budget, announced a 3 per cent public sector pay increase across the board for public sector workers. I am just interested in why the payments for personal and nursing care have only gone up by 1.56 per cent. Obviously, a lot of care and nursing professionals will be in public sector employees, so who is expected to meet the shortfall of the increase between 1.56 and the public sector pay increase of 3 per cent? The approach that has been taken over a number of years is not unusual to make sure that we use the GDP deflator to ensure that that level of payment is increased. The council budget has been increased to reflect the wider social care needs. Aside from that, the wider local government settlement also takes into account some of the wider pressures around staffing. The workers who will be delivering this care will all be receiving a 3 per cent pay increase, and that is to be funded entirely through an increase in uplift in the local government settlement, but it is not reflected in the payments that we told them about. That is around the free personal care element. Again, that is not unusual. That is the approach that we have taken over a number of years. That increase is a regular thing that happens that we have come in and we have presented to the committee. I am just making the point that, within the wider parts of the Government, there has been a reflection of the wider social care needs that have been met within the Government's budget. I accept that the model that the Government has used for uplifting those payments before, but I imagine that the majority of those payments—the £174 for personal care and the £79 for nursing care—are largely staff costs and pay staff salaries. Obviously, there are overheads included in that, too. However, if we have come to a national decision that the public sector workers require a 3 per cent pay increase and, by extension, want to ensure that private sector workforce and private sector social care workforce are also keeping pace with that level, then, if that is the value that we are putting on staff costs, why is the uplift only 1.56 per cent? That is due to the being around free personal care and the commitment around ensuring that it increases by inflation. That is the regular attendance appearance at the committee because of the way in which we have increased free personal care, which is around using the GDP deflator model. If you would like to engage on that issue, that is absolutely fair. However, we were also committed to extending free personal care to under 65s. I am happy to have a conversation with you and the committee if that is something that you want to revisit, but that is around the regular increase through the GDP deflator model to ensure that free personal care increases in line with inflation. I do not mind. Do you want to add anything? That is the payment rate that is going to the self-funders within residential care. It is actually providing an uplift to the people who are funding their own care in the amount of public money that is paid towards their care. There has been additional money put into the budget over the last couple of years to enable payment of the living wage for social care staff. If I am making a final question on this, I am not trying to be difficult. Is that for the self-funders? However, if the cost of their care is going to increase more than the amount of the payment that we are offering, is that not a problem? It is about the simple matter of increasing free personal care for over 65s, which had not been increased until 2007 until we came into post. There had been no increase then, so we came into post and decided that the right thing to do was to make sure that it increased by at least in failure inflation. If there are ways in which, on other things that you want us to do to alter how that approach is, we are then happy to have that discussion and that dialogue. However, that is a fairly regular thing that we do to ensure that it is keeping up pace with inflation. There is a wider look that the Government is doing across the piece and across a number of different policy areas to ensure that adult social care is keeping pace with the change of need. We can look at that if that is something that the committee or yourself so desires. There has also been agreement between COSLA and the care providers on an uplift to the national care home contract for this year. That will find its way through to putting extra money into the pockets of those care workers as well. I just wanted to, as it was mentioned within your statement, minister, ask you if you could give us an update with regards to Frank's law and the regulations that would come to extend free personal care. Do you envisage those to be in April, brought to the committee then? Any update you have on that would be useful. I know that that would be a timescale that we have publicly set out. At least April would be the deadline for that. I think that there is work on going to the care. The group that is looking at that has met twice. They meet again next week and Amanda Cappell is due to present it as well. There is engagement work on going to keep up with the pace that we need to work at to make sure that we make good on that commitment. In that regard, you expect local authorities to deliver that from April next year. Are there any further questions for members of the committee? If not, we now move on to the next item on the agenda, which is the formal debate on the affirmative instrument on which we have just taken evidence. Can I remind members of the committee that there is no opportunity at this stage for further questions? It is simply a case that I will ask the minister in a moment to move the motion and then we will simply, you may of course offer debating points, but there will be no questions as such and we will then move to conclusions. So, may I now invite the minister to move motion S5M-10338? Thank you very much. Other members who wish to contribute to the debate on this item. If not, the question is that the motion S5M-10338 be approved. Are we all agreed? That is agreed. Thank you very much. Very brief suspension to allow a change of witnesses. Colleagues, we now move to agenda item number four, which is a further session on subordinate legislation. I welcome Peter Stapleton from Carers Policy and Ruth Lannu from the Scottish Government to support the minister and welcome Eileen Campbell again on this item. That relates to one affirmative instrument, the Carers Scotland Act 2016, adult carers and young carers identification of outcomes and needs for support regulations 2018 and then five negative instruments, which are SSIs 29, 31, 32, 33 and 34 of 2018. Once again, may I invite the minister to make a brief opening statement in relation to the affirmative and the other instruments? Thank you very much, convener. I do not think that I will be as brief as the last one, because there are a number of regulations to refer to. As you have mentioned, I am joined by Peter Stapleton and Ruth Lannu. It is just over two years since the Parliament passed the Carers Scotland Act 2016 with unanimous support to put in place an important new approach to supporting carers. The 2018-19 budget includes an additional £66 million to support additional expenditure by local government on social care, including for implementation of the Carers Act. We expect the full amount to be transferred to IJBs in line with their delegated responsibilities for those purposes. This batch of six statutory instruments are the final ones that are required to enable implementation from the start of April. I would like to just say a few words about our approach to each of those regs. The transitional regulations provide for carers who receive support under the existing system to move to the new system under the Carers Act. They require local authorities to continue providing support to existing carers and continue to waive charges until they move to the new system or cease to need carer support. Local authorities must also keep the support under review until the carers move to the new system. The regulations allow this transition to the new system to be phased in within three years or a year for young carers. Those carers must be offered an adult carer support plan or young carer statement sooner where there is a change that has a material impact on the care that they provide. They have a right to request an adult carer support plan or a young carer statement at any stage. Those transitional arrangements are designed with three principles in mind, to provide continuity of support during the transition process for carers already receiving support, to allow a managed transition so that existing carers move into support under the Carers Act on a phased basis and over a reasonable timescale, and to be responsive to the circumstances of individual carers. The short break service statement regulations add further requirements to the Carers Act duty for local authorities to prepare these statements of short break services available in Scotland. In particular, they require local authorities to consider the views of carers and carer representatives when preparing the short break service statement and to provide contact details for the responsible department on publication. This will help to ensure that statements are appropriate to the needs of local carers and that they know who to contact for further information. Following last year's consultation, the regulations also require the first statements to be published by the end of December to allow adequate time for the information to be assembled and for local discussions to ensure that statements are as useful as possible. The amendment regulations on waving of charges and direct payments simply update legal references in 2014 regulations so that they refer to carer support under the Carers Act. When the new duty to support carers takes effect from 1 April, those amendments will maintain the existing requirements for local authorities to wave charges in relation to carer support and not mean test carer support delivered via a direct payment. The review regulations set out circumstances in which young carer statements and adult carer support plans must be reviewed, in particular when the carer or carer for person moves or another change which the authority decides has or could have a material impact on care provided by the carer. Examples of such circumstances will be discussed and outlined in guidance. Finally, the affirmative procedure regulations on identification of carers needs and personal outcomes set out requirements that align those responsibilities with those for preparation of young carer statements and adult carer support plans. As discussed in the policy note, those regs are essential to the definition of identified personal outcomes and identified needs under the Carers Act. The key duties in relation to adult carer support plans and young carer statements and carer support can work as intended. In summary, supporting those changes will enable the Carers Act to be implemented from the start of April, putting in place important new rights for carers as part of the structured, personalised approach to carer support envisaged under the act. I am happy to take questions on those suite of regulations. Thank you very much and I remind colleagues again that we are in a two-stage process that there is an opportunity now for questions to the minister or to our officials. When we move to the formal debate, there will be no such opportunity. If there are questions, this is the time to ask them. I have had a number of constituents call me about carers assessments and the requirements for assessments. I am interested to know what instruments cover lay out and how an assessment should be undertaken. Is that part of the process? There will be a lot of local work happening to ensure that design and local circumstances are reflected in how the assessments are taking place. Peter, would you like to offer some ideas on how that is happening in a practical sense for Ms Harper? There is quite a lot on the face of the act and the content of adult carers support plans and young carers statements. There is a lot in there detailing what they need to cover, emergency planning, identifying needs, personal outcomes and so on. We have supplemented that in the guidance that is due to issue very shortly. It has been out in draft for a while for local areas. We are really focusing on the conversational approach with carers understanding their needs, what is important to them and the personal outcomes that should be focused on in the adult carers support plans and young carers statements. There is not in these instruments, but certainly in the act and the supporting guidance, there is a lot on the content and the approach to developing those plans. It is fairly fair to see as well a lot of attention because of the young carer element to make sure that that is done in a way that is appropriate, age-appropriate and understandable for the young people who are in need of that support. I have seen a lot of engagement. Different local authorities are doing different things to make sure that the engagement is happening, that it is inclusive and as facilitative as it can possibly be, depending on the age of that young carer. Generally, if the minister could respond to concerns that she too will have received from carers organisations and COSLA, for example, on overall funding for implementation of the carers act, it is fair to say that there is a view from those involved in the provision of care that the act has not been adequately resourced with some people believing that there is a potential shortfall of tens of millions of pounds by the end of year 5. If the minister could address those concerns, I appreciate that the minister said that local authorities have a duty to provide support, but I would like to hear her views on what the Scottish Government could be doing to help and to allay those concerns around the financing of the act. The £18.19 budget includes an additional £66 million to support that expenditure by local governments on social care, and part of that includes the pressures around implementation of the carers act. It is important to note that that will take the overall package of additional direct investment into social care integration to over £550 million in 2018-19. However, there is ongoing dialogue and conversation that is taking place around the financial implications of the carers act. That is why we have the carers act finance group, which is populated by ourselves and led by ourselves. The Government has COSLA, local government services and NCOs, so it includes the suite of people who have an interest in making sure that the implementation of the act happens in as good a way as it possibly can. There is also a bit of work around the uncertainty of future demand, so part of that work will be looking at assessing the true impact. As the act is implemented, there is preparatory work happening now to get a much more accurate baseline of what support might be, but we will also work on going to make sure that we can have a much more detailed level of understanding about impact, and that will allow the carers act finance group to look at that and understand what the financial impact might be, if that is higher or lower or about right on the money as it is set out within the financial memorandum. It is also important to recognise that the year 1, 2, 3, 4, 5 also understood that there would be an increased need to reflect the implementation of the act. There is money in the system, and there is a recognition that we need to continue to monitor it. There is work there to ensure that we understand that adequately, and we have set out the anticipated costs within the financial memorandum, which will take into account additional requirements. I think that it is worth highlighting COSLA's specific concern around waiver of charges and short-term and replacement care. You have made no allocation for those directly in the sense that you have assumed that that is something that will be picked up by local government through flexibilities. If that proves not to be the case, will you revisit that matter before next year's regulations are brought to the committee? I think that that is why there is benefit in having the carers act finance group that brings together COSLA and NCOs who have expressed some concerns. That group allows us and the monitoring that we have put in place to ensure that we can have a better understanding about the impact of the bill. Of course, that will include the waiver element. The whole act and its totality is well, so we can look at those. However, it is important to say that the waiver was not part of the act that was already in place before the carers act came into being. Local authorities are already spending around £200 million on that part of it on respite and the waiver that that includes. We can continue to look at that and continue to have the dialogue. The finance group offers an opportunity for us to have that on-going dialogue. Thank you very much. My other question is more of a technical nature, but it is still important in relation to negative instrument number 33, which is the review of adult carer support plan and young carer statement regulations, where there is a drafting error that has been drawn to the attention of the Government by the Delegated Powers and Law Reform Committee. However, I understand with the instrument before us today that the Government currently has no plan to introduce a further instrument to correct that error. I wonder if either the minister or her officials could explain their reasoning for not offering an immediate amendment regulation, as we have seen with other errors in drafting in recent weeks. Will the minister understand why we have used a correction slip, as opposed to revoking? As I said, sadly, we had another drafting error in our previous regulation before us recently, in which the Government then issued a second instrument to cover the same territory, which immediately replaced the one that was in our office. The correction slips are appropriate to use when it is deemed to be a minor change that needs to happen. There has been discussion between the Government and the Queen's printer, who did not take any issue with us using that approach. From our perspective, it would seem to be a proportionate to the correction that needed to happen, which was essentially a bullet point number change. It did not change anything fundamental within the legislation. It was a simple typo. We think that this is a proportionate way to make that change, particularly when we have the pressing deadline of 1 April to implement the act. I do not know, Ruth, whether you want to add any more, but we think that it is a proportionate response to the error that was made. Given the timing that we need to make sure that the regs are granted, we need to make sure that we have your agreement. However, if they have passed, that enables us to move on to implementing the act, as agreed, in 2016. I echo the minister's comments on that. It was regarded as a minor error that did not affect the ability to interpret the instrument as it is meant to be interpreted. There has been no issue taking with the printers as far as progressing in that way, and I believe that that is in progress at the moment. I appreciate the explanation. I think that it is important, clearly, for this committee and for Parliament to have correctly drafted instruments coming before us and that every measure should be taken to ensure that errors of that kind do not happen. We have had, I think, now three in the past few weeks where we have had issues of that kind, and, clearly, we are very keen to see that address. Okay. Convener, we will certainly take that point on board, because I think that nobody wants there to be mistakes in legislation, regardless of whether it is a simple typo error or whether there is something more fundamental. I will take that point on board, because that is something that will certainly make sure that the wider Government understands that it needs to be looked at. I am grateful. Thank you very much. We now move on to agenda item 5, which is the debate on those items. As before, simply an opportunity to take part in the debate, but no further questions will be permitted. Can I invite the minister to move the motion S5M-10889? That formally moved. Thank you very much. Can I invite any members who wish to contribute to the debate on that motion and on the negative instruments that are associated with them? There are being none. Can I therefore put the question to the committee? My apologies. Sorry, just to clarify, convener, we are debating the affirmative instrument as well. It is the affirmative instrument that is not due to the debate. I would like to make a brief comment about May. I will not vote against the passage of these affirmative instruments, if it were to come to vote, because I do not want to unnecessarily uphold the uplift of payments. However, I want to put a marker down that I think that when, whilst I accept that there is a standard model for increasing these payments along a line with inflation, I think that that is a good thing. But when there is an exceptional shift. Excuse me, sorry, Mike. Is that relating to the deflator? That is what I am asking about. Because that was the previous one? Yes. Do we have… Oh, I have missed the bill on that. I am grateful for your vigilance, minister. I failed to notice that the member was repeating that. Alex, that is fine. Yes. This item, to be clear, the motion the minister has just moved relates to the adult carers and young carers identification of outcomes and need for sport regulations 2018 in draft that they be approved. If there are no further contributions on that specific piece of legislation, can I now ask whether the motion S5M-10889 from the minister is approved? Are we all agreed? Thank you very much. We now have the negative instruments, which the minister made comment on, but which are negative instruments and where I simply need to seek your approval. Can I say on each of these instruments that there has been no motion to annull and in four of the five cases there has been no comment from the Delegated Power and Law Reform Committee, with exception being regulation 33 of 2018, which I mentioned in my final question to the minister and you have heard the minister's response to the comments made by the committee on that. Can I invite any comments from members of the committee? If there are no comments, are we agreed that the committee should make no recommendations on any of these instruments? That is agreed. Thank you very much. I think that that concludes that item of the agenda. I thank the minister and her officials for their attendance. I move into private session. We have two brief items to discuss.