 Good morning. I'm Richard Matias from the Center for Human Genetics in Leuven in Belgium, and I'm presenting this contribution on Belgium together with Mark Abramovich, who is the chairperson of the College for Medical Genetics in Belgium After two big countries, this is a report from a small country. So the numbers will vary accordingly but what I want to do actually is Rather than to give you a vision on what we think should happen I want to evaluate the vision of the previous generation of geneticists in Belgium who have created a framework which has allowed genetics to grow and to flourish and The point for us now is to see how we can build genomic medicine on what's available So this is why I'm taking you back to how we are organized currently in Belgium how the reimbursement system works. I Won't mention a rare disease plan. We're all working on these things. I won't mention somatic cancers I'm just keeping keeping to monogenetic Monogenic diseases and I'll give you a few examples on how we think we will be able to move Into genomics and then finally I would like to talk about what's happening in Europe But I would rather refer to Dr. Ray Norsted who is here from the European Commission I can limit myself to cherry-picking on what I think is interesting at the European level and useful useful for the nations actually So basically genetic testing in Belgium is we have a public health care system. This is a social health care system Don't be confused. It's not a socialist health care system. It's a social health care system Which means that everybody complies to the health care system, but individual doctors earn more money if they see more patients This is how it works We have eight genetic centers So all genetic testing is limited to genetic centers, which have been established by law back in 87 and that's where our Our former generation has been visionary, I believe and we have Four century in Flanders and four in Wallonia because everything in Belgium has to be dividable by two And we do have at the same by the same token We have a specific reimbursement system for the genetic tests which has been in place Since 88 as well and which I would like to present to you So here's Belgium we have as I said on the north we have the Netherlands We're at the heart of Europe with Germany and Luxembourg on the east and France in the south and just across the water There is the UK so Belgium is split into two parts Flanders and Wallonia and in total these are the yellow Sides are the ones where we have the genetic center. So there's three genetic centers in Brussels Well, two French speaking one Flemish and then the others are the sites in in Belgium And I also would like to introduce our new king because Belgium is a kingdom and the king took over last summer from his father Now politics in Belgium is complicated as you can see here. This is at the funeral of Nelson Mandela This is our king in the middle saying look guys we outnumber the American delegation And there is your former president saying who are these guys and He's right because the politics in Belgium are quite Complicated and we have lots of prime ministers and vice presidents and so on but in genetics We keep it simple and that's the message So at the national level as I mentioned we have these eight centers and they're all associated to academic hospitals Which means we do integrate research and clinics and laboratory activities Funding comes from the regions as far as it's it's about prevention It's about development and funding comes from the national health care system as far as Tests are being reimbursed and of course we have to add grant money to make it operational The reimbursement system has been very simple back in the 80s We have a reimbursement system for cytogenetics as well as for DNA tests as for biochemical tests And it includes prenatal tests as well. So for the past two decades prenatal tests have been reimbursed in Belgium The system was a bit outdated. So now we have a new system Which is stratified where we have a stratification of the different tests where we have a separate reimbursement of consultations Which wasn't the case previously and we were kind of depending on testing to also be able to offer Counseling and we do have a specific reimbursement system now for samples and brought you know in Europe A lot of samples travel and we do have a cross-border system right now And one thing I want to underline is that in Belgium labs have to be accredited according to the ISO 15189 This is unique in Europe. I think we should push hard on getting this through in all the countries This is the extract from the old law which says like a karyotype is reimbursed at 327 euros That's the latest reimbursement rate Prenatal diagnosis is possible and you see at the bottom that even before PCR was invented The law in Belgium said that anything that was about hybridization Hybridizing DNA would be reimbursed as a genetic test This was of course built on southern blotting, but it happened to also apply for PCR So all genetic tests have been reimbursed for the past 25 years Of course the system has been criticized people were blaming us that we would get 327 euros for cystic fibrosis or for factor 5 or factor 2 or hypochromatosis No one ever blamed us for offering breast cancer testing for 300 euros But it's just indicate that the system only works when you have that system in place with a limited number of laboratories who then Mix the two kind of things so the new system now which is in places this year has this Certification of the test and in total the budget for genetics in Belgium is 40 million for 11 million inhabitants This is how the budget has grown over the past 15 or 20 years It seems like we're reaching a level at about 40 million euros This is because the government is of course putting Limits on what we can expand and we'll try to push hard to get across that limit because genomic medicine will need more than classical genetics Other people also claim that they can do a lot for four euros well in Belgium We offer genetics for four euros per inhabitant per year We would of course like to see this double if genomics come in but keep that in mind four euros Per year per inhabitant. That's not a lot and that's a lot you can do if you structure that well That's the main message So what does the new reimbursement system look like as I mentioned it is now stratified So we still have reimbursement of karyotites whenever we want to do it We have reimbursements for a CGH arrays, but we stratified the DNA system in a way that the cost is closer or the reimbursement rate for specific cost is closer to the Effective cost for the specific test and what these genetic centers do is put year after year Just see which test fits in which category so the flexibility is on our side now and as a result We've now been reimbursing breast cancer testing at 1300 almost 1400 euros so we're making a lot of money on breast cancer right now in our laboratories But it may well be that this test next year moves into a cheaper one But at the same time because it's an open system we can instantly insert gene panels So the gene panels have entered in our reimbursement system in that top category So no one would question whether these tests would be reimbursed. Yes or no We just put them in there and the patient will only pay what is called the ticker moderator Which is about 8.7 euros that's all the patients have to pay of course We don't have reimbursement for exomes and genomes and I personally refuse to squeeze that into this Budget because if we do the government will be very happy, but we will killing be killing ourselves So we want an extension of at least half Of the budget with at least 50% to make to be able to also cope with exomes and genomes But nevertheless, I think I'm as I said thankful to the previous generation that we have a system of Which is flexible, which is cheap, which allows us to do a lot with not too much money We work together to try and develop national guidelines and we have we're about to submit as Model for reimbursement of exomes. Of course the systems is challenged not in the least by private companies who think they can Now reap the benefits of the I would say the best part of the of things, but we'll we'll try and fight back To make sure that they don't get started in these things now One other thing is that we've have this Belgium medical genomics initiative And that's actually built on a research project project is the only left over money. We have in Belgium At the national at the federal level for research. It's small money I don't even give you the numbers, but all the genetic centers have put their forces together into a Research project to look at genomics and and and research and what we I want to just Hijack this to also make sure that we use it for standardization of how we a treat data for education of Young geneticists as well as the public So it's it's going to be added on the the initiative to deal with it at the healthcare level is Mingled with an initiative to deal with it at the research level and again It's not big money, but we'll try to make the best out of it So one way to doing this now is to put together a plan that will go to the Healthcare system to the Minister of Health where we will say, okay This is what the genetic centers commit to be doing to make sure that we introduce Genomics in the way it should be introduced and all the buzzwords that are on here are the boards that we've heard Already this morning like yes, we have to deal with ethics Yes, we have to deal with informed consent It's not a coincidence that we have divided this this into eight tasks Because there's a genetic centers and I want the eight groups to commit to the same big projects So each one of us will be in charge of one of these tasks and make sure we all move together to getting this Accepted by the Minister of Health and get the board the budget accordingly As I mentioned, I wanted to just look at the European level. There's a few things there For instance, there is that the Council of Europe as issued two years ago a recommendation That prescribes the way in which genetics should be offered in the individual countries It's a document which is not often cited and that's why I kind of refresh it here because it tells people exactly or tells Nations exactly how Europe think that the genetic healthcare should be organized Again, I won't go into details. The other thing is that together with the support of the European Commission We have been able to run a European project, which was called Eurogentist for the past Seven years or eight years and one of the things we do in Eurogentist is to try and harmonize genetic testing To try and improve the quality and the latest thing we're doing now is to issue guidelines on NGS for diagnostics They are built on the American guidelines. We're using the Dutch guidelines. We're stealing from the UK guidelines We just want to put together things which are useful and which can be used by accreditation bodies to say yes Your system fulfills those criteria most important things. There are diagnostic routing diagnostic utility We've heard this this morning and I would like to propose a scoring system as well So that people can compare the quality of exomes of gene panels between laboratories between companies So that people don't start to say mine is better because it has that hundred genes if there's no clinical utility It doesn't make sense. So these are the kind of things which we would like to propose But because I'm here now I'm not sitting down and writing the final version of that guidelines I don't blame you for that and the final thing I would like to say is and that's all too fast But we would like to lift those guidelines to the level of Erdirk and Erdirk has agreed that yes Indeed the diagnostic committee would definitely be ready to adopt the guidelines And I think we should also include Erdirk in most of the Commitments we try to make here to get this at the global level. So thank you very much for listening to the small country contributions Mark Williams geisinger I Was really impressed by this. I think it was very visionary in terms of the approach that you're taking and really like the idea of The goals that you set forward in terms of the European efforts related to some standardization I think those are going to be groundbreaking And hopefully something that this group can begin to work on I wanted to get a little additional information relating to the testing information that you presented so As I understand it the government sets a budgetary target says you have this much money to spend But then it sounds like you have the discretion to say this is how we're going to spend it. Could you talk a little bit more about the Representation of the group that makes the decisions related to the budgetary allocations Who's involved in that process? How do you manage issues that we're struggling with in this country? Like the molecular genetics community versus the pathologists for you know that everybody wants to have a little piece of the pie That's that's a lot of question or a lot of answer The first thing is if it's about going to the health care system and the government and trying to defend genetics It feels like going to the Colosseum in Rome where you know they play a little bit before they kill you eventually And this is and this is because the geneticists have no formal representation in these groups where the pathologist and the clinical chemist And the cardiologist have a seat Nevertheless, we've learned that if the if the documentation is good if you can convince the government that whatever you do is Efficient and helpful. I'm still here. I survived or at least the system survived So this is the way to go. The other thing is that the disc we do accept samples from neurologists from pediatricians, so it's not Limited in a way that only geneticist can presides genetic testing because that would be outdated But we have written in that reimbursement system that we can refuse test So the geneticist or the laboratory person says this is this is ridiculous. This is lottery testing We can say hey this we don't accept your test But basically it's on a peer review basis Which definitely only works if you if there's mutual trust and if you have piracy Commerling along a system like this is is is is that So it's based on mutual trust and also based on the fact that we shouldn't eat each other because we are eight centers If the budget is limited we should start and compete amongst us. This would kill ourselves So rather we'll try and fight together to get a bigger budget This is the only way out Bruce Cork from UAB the system of More or less centralizing the testing to a handful of centers and the reimbursement system Grew out of a kind of rare disease paradigm where it was possible to concentrate patients in these centers but as Now we move to an era where maybe everybody with cancer will have their genome or at least their cancer genome Sequenced or pharmacogenetic testing may be done on every patient. How does this scale so that it encompasses the entire health system? Well, that's the true challenge and first I think at the academic centers We try and open it up in a sense that no it's no longer the geneticist only who has access or the right to sequence a genome That's outdated. So at the academic hospital, we will make sure that anyone can use that same Framework and in Leuven we call it a hub where everybody can just use it the laboratory and say here's my data at the National level it's going to be a battle mostly between academic centers and private centers well private Again the one that work within the health care system But do it on a private basis and this is not solved yet But I hope that the nice thing about this monopoly monopolies I've never are never right and I'm one of the guys who has been fighting the breast cancer monopoly So I should not say monopolies are right, but a monopoly is right in the case You do as much as you can which has few money as possible and in that case I think from a political standpoint This is where you need monopolies This is this is where you need to limit the number of people who can offer this or this test and we will just Offer it as a service and let the interpretation be done by the experts which are the cancer geneticists Rex Chisholm north-western so you talked a little bit about the reimbursement system But can you talk a little bit about who decides which tests actually? Fall in those panels for example might be reimbursable, but I think this is the beauty of the system historically we had a system where The geneticist didn't even have to argue about which was a genetic test. Of course the government got Upset about this not the government itself, but the guys who didn't have access So that's why we have introduced this stratified system and the stratified system allows us to put as I said Different tests or different diagnosis in the different categories. This is now entirely in the hand of the genetics Ourselves, I mean, it's me together with my colleagues who draft that list handed over to the government the government Stamps it for this year and it's going to be reviewed next year The thing is if you put that in law, it takes you ages before it's changed This is true in France if you have to get something in what is called the nomenclature it takes you ages So this is a flexible system, and that's why I'm defending it It allows you to just on the side of geneticists change the list year after year and Then the discussion becomes between peers if my peers or my colleagues don't agree that yes This test is efficient, then I'll have to give in because otherwise It wouldn't work so I think it has to do with clinical utility eventually, but right now It's like a small men's club dividing the job But it's it's transparent for sure and it's flexible, and that's why I'm a strong defendant of this stratified system I want to export it actually to everybody Okay, yeah Ocru di Balling from Luxembourg just a stone throw from Belgium You made some very strong comments you partly addressed it about industry or private Companies moving in and and you use the word so we we definitely fight back I just wonder whether that's the right strategy and whether at least in in some cases an alliance might be the better way to go instead of Fighting back it sounds very strong Well, I'm a street fighter But you know the fighting back the fighting back is against the piracy of one man's companies who say okay We'll offer genomics to the public. This is where we have to fight I believe if genuine companies would come in and say we can offer on a joint basis as you said cheaper exomes cheaper genomes I think this is to be considered the fighting is against the piracy cases of Companies that say yes, we're offer a carrier testing to the whole population and then just leave the population with problems So that's a different issue