Europe in Good Health: Securing EU Leadership in Life Sciences: Keynote Address

[music] Thank you very [clears throat] much for for bearing with us. And um our final speaker today is currently in the job which in theory can help to deliver much of what we have been discussing here today. As one of 27, it perhaps might not be as straightforward as it all sounds. this country in its development and potential in the life sciences sector is definitely part of her beat in one of the most challenging jobs in government. Will you please welcome Ireland's health minister Jennifer Carol. [applause] Um okay, look, thanks very much for having me. Uh and thanks to the IIA. It's an important uh it's important that you're having this conference in the middle of the Irish presidency which is here and we're nearly halfway through it and we're all still surviving and thank you to Mish and all of the teams and all of you who are doing so much work uh on it all of the time. Um I am very glad though that that you're having this conference although there's a group of different people here and of course you've got strong industry representation. You've got strong public policy and research representation and I know you've had a good and very detailed conversation about the different pieces of legislation. And I know MS from my department will have taken you through a lot of what we're doing and the stage that we're at with the different files. So I don't you know it easy to sit here and repeat that but I actually think there's probably something that's more interesting that we can chat about around the particular confluence of corporate interest, patient interest and state interest that is a particularly coming together through the expression of the files that we happen to be lucky enough to be dealing with in the department of health during the Irish presidency because I think it's very different and it happens to come this this sort of perfect triangle happens to come at a moment of extreme geopolitical uncertainty. So there's something very interesting about the state and I think that there's something for all of us in our different guises whether it's an industry or policy to understand and situate the work and situate the expression of that work in quite differently. So we might we might speak we might speak more about that. Um uh in in some in some detail um Peter Burke and I this the the files that we're dealing with in the presidency are obviously of of huge importance to Europe. They're of huge importance to Ireland. They're of huge importance to the patients of Ireland. a huge importance to the industry that is here in Ireland where so many Irish people work that has been situated here for so many so many decades. Uh we certainly feel very privileged in the department of health to have the happy accident of competitiveness European competitiveness in some ways full into our department during the Irish presidency. uh and we are as Mur would have told you working extremely hard on those different files and making good progress you know so it's important that you're aware of how wellprepared the Irish officials in Europe and in the various departments were coming into this presidency it's important to know that while we situate ourselves in it you know in between um Cyprus and Lithuania we we approached this by in a most friendly aggressive way possible as in we're starting work on the you know 1 minute past midnight on the 1st of July and you are all working until the 31st of July before August happens. But that approach we have we have made good progress and I think it's it's important to recognize that. But a but it's particularly interesting that it's happening at the same time that Peter Burke and I are trying to develop a longerterm life sciences strategy for Ireland and many of you will have been in industry at an event with us uh on Calair Street where we were talking about that in advance of the presidency and trying to get some different perspectives about where things were, where the files of the presidency would fall within that and where we were likely to go. So these are all coming together very very well uh and it's very very important to us obviously in Ireland where we've you know well over 100,000 people working in this sector and where it contributes very very strongly to our GDP but where we I suppose in the department of health are thinking really about the future of medicine the future of medical devices uh and the future of patient care in a really exciting opportunity for the future and how we're going to get access to that how we're going to get access to that physically how we're physically going to to to be able to produce manufacture that, but how we're going to get access to that in this market and in this competitive environment as opposed to being dependent on access through other markets or after access is established in other markets. Those things are very important to us. So we would like in the department of health to see a future where we're funding extraordinary research being done in public hospitals partnered with public universities driving uh innovation alongside our uh industry and that innovation being brought to market ideally within Ireland but certainly within Europe and obviously what we're trying to do now is create the conditions for that and we tried to do that and we can speak more about the role of the state in that we tried to do that for one reason and one re well actually many reasons But one reason in particular which is that we want our patients in Ireland to have access to the very best of health care whether it's through medicines or whether it's through medical devices. There is a future of health care that's quite different to what we've understood. It is a future where we will live and age longer where we will live longer and age and hopefully age well. And we want sorry the only way that we can afford for that to happen in the way that we think it's going to happen is for people to get the care that they need at home or as close to home as possible. That means personalized medicine. That means medical devices of different kinds. That means longevity uh supports of totally different kinds. And when you think about what's coming through innovation and may come to market and may come to patients, that means situating that, you know, getting rapid access to it, but also being able to afford that. And there's a couple of different things we can talk about that uh the government is working on h and the particularly the department of health is working on h at the moment to try to plan for that in the medium term. Um so uh that the other piece just to situate that with is our work domestically on clinical trials and I'm sure Murish will have mentioned that uh the progress that we've made with the clinical trials implementation group uh and the ambition that has been set by the chair there. Um Ireland and you will have seen this through the the public policy discourse during the summer in relation to access to medicines and some of the very you know the public stories in relation to that. uh as a small market we we sit in this difficult situation where we're a small market, we're a small country, we're part of a European system, health is a national competence. That's not realistically going to change. I don't see anybody in this room or any other room advocating for treaty change at the level of moving health from a national competence to to to an EU competence and the you know ensuing legislative and constitutional change that that might involve. We're definitely not advocating for that. But it's also the case that we're all far too much on our own as Europeans. And while we have so many different collective objectives about getting access to medicines access for our patients and creating a competitive environment within which to do that, we're still too much loan traders. And so we are actively working uh as chair of the of the of the council of the health council we are actively working on trying to work on trying to see are there ways within which member states can work in more practical ways together without the need for treaty revision. Are there ways in which without overstepping the national competence structure we can do more practical things to make it easier for ourselves a to get access to drugs but b to just understand the market environment and how we might shape some of that whether it's as a groups of small countries whether it's with particular access to you know early stage access to rare disease drugs or other drugs and how we might think about that but also how we might think as as more as collectives in terms of purchasing uh this there are so many different options that have to be on on the table because at the moment the public is not accepting the view that uh drugs are available in one country but not another country. the public is not accepting an argument that drugs should be different prices to different countries or that uh that they should be treated differently. Where we are saying where we are continuing to talk about the value of Europe as a collective where we are talking about the value of being European, the value of being active EU members and where that concept itself is challenged by different actors both internal and external to the EU. So we have a job of reconciliation around what it is to be European. the reflection of and the values of being European and the you know and the values of homogenizing systems within Europe the necessity to remain the necessity for for different reasons but most particularly because I don't want a referendum the necessity to uh remain uh keep health as a national competence very directly um and then the challenge of reconciling both of those things to patients and to advocates in very simple ways uh and that's becoming that's becoming more difficult but And fabulously and most uniquely, this particular set of le this particular set of um this particular group of of of files of legislative files give us an opportunity to do all of those things h at the same time and to generate both real benefits for industry for researchers uh but most particularly for patients while demonstrating better competence at a European level. So I think it's fantastic. Um uh I want to assure you how hard our officials are working on that through the files. We have the informal meeting of the EU health ministers here at the end of the month which I hope goes well. Um and we will be trying to show to them although you don't at those moments take you know it's it's not a formal meeting you're not dealing with the the the text of the files itself or the agreement in relation to the files you're posing questions and looking for input and looking for feedback but you're speaking around and beside the different issues. So our focus in the in the informal will be around the where we see this going, how we see that this being applied, where innovation is useful for delivering health in remote communities. So we will be showcasing some of the fantastic technology already in use in parts of North Dunny Gaul for example where we have people with COPD wearing long-term technology monitoring their device predicting exacerbations and being able to be cared for uh much much closer to home with fewer uh with fewer exacerbations and therefore fewer attendances at acute hospitals. So we will be showing that in you know Dunigola is not quite as remote as you can get in Europe but it's up there. Um, and some of our colleagues would very much like to see how some of that technology and other technology is being used and can be used in in other parts of Europe. So, we're trying to show what we're doing in Ireland that sits alongside the different legislative files uh and and and bring that to bring that to a broader audience. Um, I think one of the I know Mer as I mentioned about the clinical trials advisory group and then sorry I got distracted. Um but that work is so so very important and as a consequence we have prioritized that as Merge will have told you in our approach to the biotech act and we've made really good progress and we would hope to be in a position where we could get council conclusions on that part of the file recognizing how big the act is. But again why is that important? It's important because our patients aren't getting access to enough clinical trials at the moment and they will never while we operate as a state of 5.5 or six million euro people. it's that's just not going to happen in the way that we want it to or at the scale that we want it to. So that partnership with other jurisdictions is absolutely essential and this paves the way towards that alongside the domestic work that's already happened. So that's why we've prioritized it. Uh and also we think as a state it's the biggest contribution that we can make to moving these files along uh for the the presidencies that that will follow. And you'll be aware I hope or now I'm making you aware that there will be a a conference ministerial conference on clinical trials and medicine's access held in October just straight after the informal. So that's a really important opportunity to focus on what needs to change in practice as I said better coordination more efficient processes and stronger links between the research and patient care. Um so I think I'll sit down now because I've talked quite enough and maybe just answer questions instead. Okay. Thank you very much. [applause] start minister because the negotiations on the biotech act which is one of the central health and competitiveness file is being advanced during the presidency of the European Council. Um where are the negotiations right now? How advanced are they? >> So we started as I said with clinical trials because that's the chunkiest part of the file and it's also we we we regard that probably as the most important part for from a patient perspective. So we focused on that through July and we've made re better progress than we had hoped and we had set ourselves a fairly tough ambition. H so we've made very good progress with that and we're moving on to the different the different chapters as we speak. Um uh so that's where we are. >> So what would you regard as the best outcome from the negotiations to improve our competitiveness for example our Europe? Well, so obviously we want to agree the council position uh as far as we can or get as far as we can in this presidency, but like ultimately have an opportunity here and I know there's a member of the European Parliament here who we're working very closely with. We have I mean the outcome here is the the passing [clears throat] the passing of the legislation. Great. So what what does that mean? What that means is that companies will be able to companies and researchers will be able to bring products to the European market much more easily than they pre previously could. I have met far too many companies in Ireland who have fantastic work done and then they're going to the United States either for funding or for regulatory approval when frankly both of those things should be available in Ireland. Now we can try to help with the regulatory approval side of things. Obviously we don't have the capital market structure on a European basis that we think we should and there's you know work being done in Echoin in relation to that but uh but but that's that's what it means. It means choosing Europe as a home, as a market, as a home market, as a first market, as a bringing it to patients first market. And that does so many different things. one, we will get access to the different products much more quickly, but two, it's about the autonomy of Europe to be able to bring a product like that from idea to market and to know that that can happen and not be dependent on external actors, to not share intellectual property with external actors and to have the sort of the security and the resilience of being able to think of and produce your own things for the benefit of your own people and finance them uh all within what is a very very considerable market. So that's that's the value and it seems like a very simple thing to have to articulate but that's what's not happening um in the at the scale that it should be and I think you know you look at the theme of our presidency of all of the presidency about security and values that's that security piece for the state that security piece for the collection of states that is the EU has to be right up there. MEP Andrea Kitus was on our previous panel before you you got here and um we were talking to him about where the obstacle might be in terms of delivering the biotech act. Would would it be the commission? Would it be the council? Would it be the council? >> No. Well, he said it would be the council. [laughter] >> Come on. >> He said that essentially you're too in the council is too inward-looking. It's not global looking enough that it's too protectionist, too nationalistic. Ah now come on should we chatted [laughter] about that? No no no no I don't look I don't I don't I don't look the most important thing is the MEP group and I met this on committee um there in July and we had great harmony in our dialogue. I think it's fair to say because as I said this is the moment where on other on other files there's been division in countries there's been division in relation to more patient or maybe in in in sort of political terms within within the council or within the parliament around being more patient focused being more industry focused the there's there is a harmony in these files you know both are important both are necessary and there's a synergy and and that that comes from both of them together like the reality you have to remember the European parliament is made up of political represent representatives. So is the council. I am an elected representative. I represent the people of Dunir. That's my first job every day when I wake up. And I would like the people of Dunir to get access to medicines that the before everybody else frankly because they elect me. So um no, I'm only joking about that. Please don't repeat that. Uh but the no but but the point is that I'm a public representative. So is Regina Doerty. You know what I mean? So is the minister from um from from from Germany. So is we are all there as public representatives. And the the imperative on us on a file like this is to make as much practical progress as possible. Um sometimes those things can get lost in terms of technical groups, you know, but I think what you've seen, what I've seen from the group of ministers that happen to be the health ministers at the moment is a real drive around this, a real drive around some of the other political issues around access to medicine. Um and it's very important that that political drive gets translated into the instructions or the feeling of the instructions to their officials to make progress. But we haven't come across the speed bumps that you might expect. You know, there hasn't been that many occasions where, you know, it's been necessary for me to pick up the phone and jog things along or anything else like there has been a willingness and I think you can see, you know, an imperative from the council to try to make progress in relation >> and we think the European Parliament are great and their suggestions are going to be great as well. So, >> in relation to clinical trials specifically, there's a lot of focus on them because of Europe's decline in that area compared to China for example. I wonder do you think would the whole process be made easier if there was a centralized European approval body for clinical trials? >> Um look I it's not ne not necessarily not necessarily it is around the partnerships. It is around making sure that there's as many academic based clinical trials as there are you know company based clinical trials. It's really more about the partnerships and how they work and and the seamlessness seamlessness of it. Um so not Not not not necess not not necessarily it's not necessarily >> one of the other significant issues for discussion as part of the biotech act is the proposed extension of supplementary protection certificates h global nos's like medicine frontier want that extension rejected and the attachment of access conditions to public funding under the act >> many of those yeah many of those things are the subject of discussion and negotiation so it's not really you pushing for a particular conversation so at the moment I'm the chair of the health council so you know that's not something I'm going to discuss >> because it's not appropriate at this time. So all of those things are part of the discussion of the biotech act which we're taking along and that's the way that is. >> Okay. This country's national life sciences strategy is under development. H it's expected this year. Are there key developments at EU level which you would expect to shape this? >> So I mean literally the files that we're taking through at the moment are directly relevant to the life sciences strategy. Um that's that's that's that's what I said. Um They're both go together. >> Yeah. And and so what can everyone in terms from patients to researchers to industry, what can they expect to focus it on? >> So So what I just said there about making sure that we have the pathways to access that we're bringing innovation to to market. I think what you what I want to see for example from an Irish perspective is from the health side there are two things that are really important to me that that Peter and I have discussed. One is how do you test innovation at an earlier stage and how how how how we think about that and the second is as I mentioned there how we fund these things over time. Um and what I have experienced as minister for health is that the drugs budget and the demographic the population growth and the age of the population is such that our drugs budget our medicine's budget is just growing at a rate that's not sustainable on an annual basis. So it's getting close to 4 billion euros. I can't we can't plan and predict that on an annual budget structure in the way that we are used to doing. Um and that's only going to get I I use the word worse in terms of budgetary terms better because it means that we're getting more medicines to more people. So we have to think about that more in a medium-term structure and I'm working with Simon Harris and uh Jack Chambers in particular about a proposal for a longer term um fund for a longer term national fund for health technology. Uh so you will see more about that you know in the budget. You will see more dialogue around that. It will probably take us a year to to to to get further with that and to establish that. But it's the only way I think of making sure that we have a longer term uh strategic focus on making sure that those products and medicines are available in Ireland in a long-term sustainable way recognizing how much we see coming on stream. That's not to say that you're going to pay for everything at any price. So, you know, the parameters that exist will continue to exist. But nevertheless, it's just about the Irish state doing two things. one being ready for the scale of demographic change uh and the medicines that you want to get to people but two signaling a seriousness around this like I'm very conscious and we talked about this at the life sciences strategy I'm very conscious of sort of a a breach in the social contract between people who are educated here working here producing products that would benefit their health but them not being available here and again while I say you know the pharmioeconomic analysis of efficacy and cost is extremely important in those statutory processes are extremely important to us. Nevertheless, there's something a bit off about that and I think we would like to balance that a little bit. Uh and that is as much a signal to the investment in the industry as it is to expand the university places for you know PhDs in science you know so so that is it's it's another way of investing in ourselves um through that signal to industry as well. One of our earlier contributors talked about the need to for the member states, the governments of member states to emphasize the value that all of this works brings work brings rather than the cost. >> Do you agree? Is there too much emphasis on the cost of things? >> So I' I've certainly heard that from pharmaceutical companies repeatedly that language. Um I don't know if it's a it's been an industry message at the moment, but if I hear that sort of investment language again, I know I know exactly where that's coming from. I would scale it back a little bit because it's it's it's a little bit transparent. There's something there's there's a more nuanced balance. We we the state is a benign actor. The people who work for the state are there to work [clears throat] to look after the health of their people. That's what the people in the HSSE are doing all day every day. They're trying to make good decisions and get the best value for everybody. The the reality is whether you call it a cost or investment, it costs money and there's a finite amount of money and you have to to to work out what that is. what we're we continue to invest in the health service. We continue to invest in medicines. We continue to invest in drugs. We've we give this in so many different ways to the people of Ireland because we want them to be well. So we don't need to be coached by industry to use the word investment instead of cost. We know what money is, where it comes from, and how we need to use it. And we also know that it's finite. So like I hear you but yeah >> increasingly there are personalized advanced therapies you mentioned some of them earlier on the health systems needing more specialist staff diagnostic capacity artificial intelligence all of this is is Ireland preparing for that change? How how how are we preparing? What do you mean >> in terms of just the technological developments that are upon us that are with us in the in the health and life sciences sector? >> Are we training our younger people the education workforces? >> Yeah. I mean like I think about 25% of our PhD graduates work in this industry you know. Uh yeah. Yes. Absolutely. And we continue to expand that access. And I think I was just saying there about preparing for it in relation to a health technology fund which would [clears throat] be a very direct expression of a sort of a sovereign fund, a national fund which not identifies the issues that that you're describing. But we've already done that through the future Ireland fund which is a fund specifically to plan for and manage how this population is growing and aging in different ways. I don't think it's not that that's not going to be enough. I just think it's distinct from the need for something that's more specific in relation to medicines and medical technology because so much of what's coming will have such a huge investment will have such a a huge investment in making doing what we want to do and the only thing that we can afford to do which is care closer to home and we have to remove this idea in Ireland that care can only provided in a model for hospital when that's clearly not the case and it's a dialogue that comes from the acute hospitals and from our own socialization of how we've understood care in the cost. It is much better, cheaper and more effective to get appropriate care in the community h rather than in a hospital setting and to get out of a hospital setting as quickly as possible. And I think that medicines and medical devices of the future, sort of more personalized medicine, the the wearable technology, all of the different things is going to contribute to that and contribute to thinking in that alongside the different types of virtual care that exist and that are going to exist uh more and more. you know now you can get triage for you know on your way into Cork University Hospital you can there's a virtual triage before you ever before you ever get there that's just fantastic and in some ways it's about giving confidence to the other decision maker the GP to say well that person doesn't really need to come here or they very much do need to come here but we're using virtual care in so many different ways you know we will you will see more virtual clinics for outpatient appointments we saw we learned that during co but there's so much more that can be done with that we have virtual wards where we're creating additional beds 157 new beds last here that are virtual beds because it just get to the point of your care where you still need to be sort of under the clinical care of a hospital but you don't need to be in a physical bed in the hospital with the infection risk for example and so you can be discharged to a virtual ward where you're at home on your couch with your technology and um looked after perfectly well there except for the one guy who did go to the pub. [laughter] >> We couldn't find him. >> Okay, >> he was fine. He's fine. >> Minister, thank you very much indeed for joining us and for being with us here today. Thank [applause] you speakers from the very start of today and thank you for coming today as well. Thanks my thanks to everyone here at the institute for making my job so easy today. And before we go I'd like to invite the to the stage the director of research with the IEA Barry Culfur. [applause] Thank you. Thank you very much everybody. I won't detain you much longer. It's just my job to to thank a few people and to provide a couple of short remarks. So first of all, obviously thank you to Minister K McNeel and her team for her leadership, for her remarks and her cander. I think it was a great way to end the discussion today to our speakers for their clarity and their accessibility. All speakers are equal. But just to mention Mr. Rainer Becker who came here via parachute from a moving aircraft notwithstanding all the challenges we say that Gelick and Association says nothing beats being here. So you're here for a bit of time and I'm sure you can chat to people afterward. So thanks for making the effort to you and to all the speakers. Audrey, you'd learn how to navigate conversations by observing somebody like Audrey. I know I do. And just thanks for uh thanks for your grace and for making it look so easy. It's been great. We've squeezed every bit out of the discussion. So thank you Audrey. And to all of our attendees, of course, given so generously your time. Time is precious. Just to acknowledge J&J. The IIA is a membership based organization. We exist due to the support of our members, members like J&J, and we really support uh we really appreciate your support and thank you for it. If anyone isn't a member and would like to consider being a member of the institute, please grab me or any of the colleagues before we leave. And just to thank indeed the IIA team and the staff here at the Alex for uh pulling off the event today. Just to to really conclude, or or Quinn at the outset uh mentioned that this is a presidency associated event and we're really honored and pleased to be part of the official presidency program. The minister and the speakers rightly identify the some of the key files that Irish officials, Irish ministers, Irish leaders, we will be pursuing over the next couple of months for the betterment of Irish citizens, for the European citizenry indeed, for the European way of life. That's really really important um to to pull off a good presidency. Ireland always does and Ireland will. But everyone in this room knows as well that the presidency really presents a special opportunity to present Ireland as a credible and a reliable partner as a serious venue for research, for investment, for innovation, and for creativity. And I think this sort of engagement is so important to highlight Ireland's role as a leader in this sector and in adjacent sectors. And we're just so proud as the IAA to be part of those discussions and to be able to convene people from all sectors and none leaders, thinkers, patients, civil servants, and more. And we're just really pleased to be part of that. And thank you again for for giving us your time. Thanks for being here. I hope you learned something. Hope you'll continue to think about what you've learned over uh over the uh over the half day and see us next time. Thanks very much. [music]