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SANT European Parliament
Follow its sittingsRoberta Metsola
This is all progress, but there is still so much we have to do. There is still so far to go, from fixing medicines shortages to making access to care more equal across Europe. And in all of these challenges and more, our Parliament is your ally. Here we work along political lines across all political groups to come together in order for us to make your life a little bit better and a little bit more, at least less insurmountable. Because when we say that Europe is there for you, it is more than a promise, it is a mission statement.
So I'd like to wish you luck not only for today, but for all the work that we can do together in all our productive and rewarding discussions. Thank you.
Adam Jarubas
Thank you, Madam President, thank you for your special message, for your presence here and for support to people living with the cancer disorders and support for all ours health initiative, new strategies for people living with diseases. So it's a great honor have you here with us. Now I give the floor to our distinguished guests, Mrs. Loist, Mr. Dams.
You have the floor for eight minutes each. Leonore, the floor is yours first, please.
Leonore Luast
Dear Parliament, my name is Leonore, a girl that has survived the childhood cancer, and I am here today to find the names of all the children fighting cancer, dead because of it, and recovered. These days, I laugh, learn, play, and dream, but some children aren't so lucky. I find that very unfair, and today I'll tell you why. Though of course childhood cancer is less common than adult ones, it is unfair that they get treated differently and are given less valuable drugs. The medicine is much too strong for children, and lots of us suffer because of it.
These child medicines produce lifelong impacts on survivors, such as cognitive dysfunction, knee or hip replacement, amputation, organ removal, cardiac failure, secondary cancers, or even post-traumatic stress disorders. These are things that survivors have to bear with for the rest of their lives and often have an impact on their daily schedule. I, for example, is under a specific diet for my damaged kidneys. It is also extremely unfair that a child cancer survivor often gets teased or bullied at school for their differences. Lots of children die of cancer because child medicine can't cure them.
Every year, there are 35,000 new cases in Europe. In fact, it is the number one cause of death for children. And curing cancer is improving for everyone, but except for children. My wish is for you to help us children and improve the medicines, because today you can make history for all the little ones like me.
So the question I'm asking you is, do you prefer to help us or to let us suffer?
Sam Daems
Thank you very much. Good afternoon, everyone. Our daughter, Fee, was diagnosed with a brain tumor when she was just two years old, and she passed away from the disease six months after her diagnosis. I'm sitting here in front of you today primarily as her father, but beyond that, I also come as a Chief Investment Officer of a European investment firm where my job is to evaluate investments and allocate capital, and I come as a researcher working at University of Brussels who is studying innovation systems and how they work for pediatric oncology.
The slides seem to slip for a second, but I don't need to repeat the burden of pediatric cancer. Léonore has already very eloquently and very bravely introduced us to the concept of cancer. But what I would like to explain you is that despite the extraordinary progress which pediatric oncology has made in the past decades, the results today are still very uneven and as Léonore put it, very unfair. And that is because cancer is, as you probably are aware, not one single disease, but a variety and a combination of very different distinct biological indications which together are called cancer. And if we look at the survival rates and at the impact of the different diseases, we see a very big difference between the different types of cancer which we have, where some cancers have actually very good prognoses and very good survival rates and others are faced with a really dire and devastating outcome.
And in fact, it is this biology and especially the diversity in biology of cancers in children which make it very hard to make more progress for the disease. Because the cancer groups which you see on these slides are further broken down in subtypes and in molecular types which break up this 35,000 patients which Leonore referred to in very small populations, each having a different biology and each often requiring a different treatment to be effective against that biology. And beyond that, these diseases are not just pediatric indications or pediatric versions of adult cancers. These are very often completely biologically distinct indications, very different diseases, so we cannot just use the same treatments which we have for adults and hope that we can translate them without tailoring and without changing them in these children. And that creates a very strong economic problem.
And the problem is that all of these individual diseases are ultra-rare populations and are very small markets. But although the population is small, the cost to develop drugs doesn't shrink proportionally and we still need to do the same work and the same effort and the same investment to develop a drug for this population. And so despite the fact that they are small drugs, the costs to develop are the same and the risks associated to development are probably maybe even higher because there is just as much or maybe more biological uncertainty and scientific uncertainty which results in risk of failure.
And so to develop drugs, one needs to have year-long investment, year-long of effort to ultimately only be able to serve a relatively small market. And that's that is the situation which we're faced. If you look at the disease which unfortunately touched our our family, ATRT, the disease is one which across the United States and Europe together affects more or less 200, maybe a bit less patients per year. 200 patients per year spread over two entire continents. So the the market is is tiny and the effort, the burden to develop is just the same as for any other any other disease or any other cancer.
And that results in a bit the paradox which is super frustrating for for patients, which is that the slides go in the wrong direction. So the the paradox which which we're confronted with is that a therapy can have an enormous value for a child and still at the same time be a completely terrible investment. So it's not that there are no ideas, it's not that there's no science, it's not that there are no therapeutic possibilities. They exist, but these therapeutic possibilities, they need investment and they need continuous effort to be translated and developed into drugs, into therapeutics which can help our children.
But for most of those developments, the business case is just not there. The business case doesn't work and that's not bad intent from pharmaceutical industry or for a company, it is just a logical consequence of the underlying economics and of the fundamental structure of pediatric oncology. Now, that also means that we should not expect the market to come up with a solution for pediatric oncology. That will never happen. It also doesn't mean that we should all go home and accept defeat and just accept the suffering.
And as a matter of fact, I think society in general has already decided that we're not going to accept the suffering and that we're going to act. I mean, public institutions are investing, charities are gathering money, there are researchers and clinicians like Professor Vassal who spent their entire life on trying to make a difference. So society wants to act and this very meeting is probably an illustration of the fact that everyone wants to act. But the constraints will not disappear and we need to accept those constraints and recognize those constraints. And we need to, within the constraints, use the resources which we have available to make the biggest impact for the children.
And the biggest impact for the children in this environment means making choices as well. That implies that you need to have the guts to make choices. Because if you decide to fund everything and to progress everything you will probably progress nothing because nothing gets enough backing to really advance it far enough to really have an impact for the children. And so because there is no market mechanism and because there is no market system to choose where we deploy resources and to concentrate resources behind the winners, we or you probably need to design and very actively, deliberately design the pathway to reduce the hurdles, reduce the friction and try to get these therapeutics, these ideas through the pathway and into drugs, into the clinical ward. And that means a lot of things.
It means prioritization, it means choosing where to deploy the resources, it means fighting fragmentation, it means connecting the different entities in the space. And I think Europe has a unique role to play in this.
I mean, I, we cannot, unfortunately, we cannot legislate away the biological diversity in cancer, and there's nothing we can do there. But what we can do is we can really think through the entire pathway for pediatric oncology. And we can really think through end-to-end what we need to take away the friction, to connect the different dots, and to make sure that we can create progress for these children. And, and that's what I would like to, to invite you to, and that's what, what I would like to have, I would, I loved the, the introduction of the President. I would like all of us and all of you to help think through this end-to-end pathway, to see where the friction exists, where the handovers don't work, where we lose promising therapies, where we fragment resources, and try to really actively and deliberately redesign the process to remove the friction and to end up with a more, with a smoother and a less, a less problematic pathway for these children.
Because in my opinion, the, the business case will probably always fail and might not be very helpful, but that should not be the end of the line for our children. Thank you very much for your time today.
Adam Jarubas
Thank you so much, dear Leonore and Mr. Dams, for your presentation. Now I open the floor to MEPs, first coordinators and then other MEPs. Vytenis Andriukaitis as a first, please.
Vytenis Povilas Andriukaitis
Thank you so much. Thank you, Leonore.
You touched my heart. It is, I think, for all of us, your presentation was brave, brilliant, and inspiring. And now it's time to think about necessity to have European pathway. And it would be good to send to European Commission proposal. In some cases, we need to have a regulation which should be covered by all means, starting from diagnostics, finishing with financial means.
Only one way, because we have, we see clearly, market is very small and we need only pan-European solution. I am medical doctor. I spent many, many years with my patients. I know what I am speaking. No one country can solve those problems being alone, no one.
And it's now up to us, time to, to say, yes, look, like, like all others, we need to ask European Commission to go with proposal, because it is, it is quite simply to propose such regulation which can cover rare cancers, rare diseases, once again repeating the same.
And then building pan-European pathway, pan-European, because in all countries we can find resources that can be joined and solve problems and address issues as you just rightly mentioned. I can't say more because it is really, it's time now to deliver our obligation.
Aurelijus Veryga
Thank you very much. It's not the question, actually. Thank you, Leonor, for your courage, for being here with us and being a real person that touched, as Vytenis mentioned, our hearts and reminded us that there are important things that politicians should do in their everyday life. And I really value the presentation that you gave about the challenges that children oncology is facing.
Actually, we are dealing with rare diseases, a very rare diseases that are rare in in both continents as you have mentioned. So what we should probably all look and do, I I believe this is not the problem here in the SANT committee, is to look for the finances in the next MFF to run the programs that are financially not very attractive as you have correctly mentioned for the pharmaceutical companies, but this should not be an excuse because the life has no, it could not be really valued in a money. And this is our responsibility as of the politicians to to provide all the all the necessary needs to finance the programs. So thank you very much for your presentation and your presence. Thank you.
Next speaker is Tineke Strik.
Stine Bosse
Thank you very much and sorry that I didn't hear your I'm sure brilliant interventions, but sometimes our calendars here in the Parliament just don't match our ambitions. Anyway, I want to let you know, you have to feel assured that in this committee we talk about the rare situations very often. And we also know that if we take all the countries in Europe and put them all together, all the kids around in Europe and we say now we don't think about it as country by country but all together, then rare disappears because there are many of you.
And that is how we need to think here. We don't need to think at this country by country but we need to see you and all other children who have, who suffers from either rare diseases or rare cancers as, as we talked about. We also spoke about this when we did the legislation for the industry, the people who do the medicine for you. So we spoke about it then and we did some better things for them. So we did push in the right direction.
We're also going to do that in the Biotech Act one. We're going to push for better solutions via the industry. But that doesn't do it all. We also need the money. And here I have two things that I want to say.
One is that in the budget that we're talking about here in the Parliament, the MFF, we need to prioritize this because it's completely right what has been said, this, this needs prioritization, otherwise it will not happen. So that is for sure something we can do. Then there is the other side of the coin and that's where it really goes wrong, the way we nowadays calculate this. Because yes, the treatment is expensive. You know this very well.
But it is also extremely expensive not to treat. Not only does it cost lives, but it also costs if the child lives long enough, it costs that mother or daddy doesn't work, it costs that siblings miss thrive, it costs that children still go to hospital frequently to have treatment, and I could carry on. So we do not calculate not treating in the right way. And this we have to fight for, all of us together. So that would be my promise to you, that we will not stop fighting for you and for all other children in Europe who suffer from cancers or rare diseases.
Thank you.
András Tivadar Kulja
Thank you very much. Dear Madam President, dear guests, dear Leonor, thank you for being here and sharing your story and the importance of this topic. And reminding us that behind every statistics, behind every number, there is a life, there is a family, there is a tragedy.
And on a paper, a rare disease, rare diseases can look rare and affecting only a few people, but those who live with those diseases or lose their child because of that particular rare disease, it's not just a number. And we in Europe, we really can show not only to our citizens, but the other parts of the world, that how important is to care about people in Europe and children, and we can improve our care, we can improve access, and we can save lives. Maybe one more aspect of this, that what we are witnessing on the struggles with children, pediatric cancers and rare diseases, it really shows us the future, because the new therapies are more and more specific, more personalized, and it means that they are becoming more and more expensive, because there is now sub-sub-subtypes of cancers what we can identify and to have a specific cure. But it really shows that we have a huge challenges in, will have huge challenges in the future, and if we can find good solutions now, the good practices, how to improve care for children cancer or rare diseases, then we can prepare Europe for the challenges of the future.
So thank you very much for for being here and and reminding us that how important is to to do more and and and to invest in healthcare in Europe. Thank you.
Ignazio Roberto Marino
Thank you, Chair, and thank you, Presidente Metsola, for being here today. Well, I would like to say to Leonor that with your tiny voice, probably you brought the strongest message today here. You asked to the members of Parliament, what are you going to do to prevent the other children will die because they do not have the same treatment that I got? And also you you actually point out to another important issue, the bulismo in school that sometimes happens and is another issue that we need to consider very seriously.
Well, I would like to make a point about the possible prevention of pediatric cancer. You, Leonor, pointed out that it's the first cause of death for children and it's actually true. But, you know, I was, I'm always thinking when I walk in my town or in other towns that when children start to walk, you know, because of their height, they breathe at the same level of the exhaust tube of the cars. And, and I always wonder, is this an issue or is not an issue? And I think it's an issue.
There are, for example, places in Europe where we know, like Saint-Pazanne in France and La Rochelle, where we know that an extra number of children, a few dozens, got cancer and, and statistically we should have had only 1.8 incidence, prevalence of cancer in those regions.
Then people, not Europe, people, individual people and organization, they test the, you know, the blood and the urine of children and they realized that many of them, dozens of them, had 45 different chemicals in their body, including pesticides. So I think it's important that as Europe we put more resources in the treatment, but we also need to put together, and that is really simple, our cancer registry with geographical, you know, location of the registry, so we can learn much more from each other.
Elena Nevado del Campo
Muchas gracias, I will be speaking in Spanish. Y en primer lugar yo quiero agradecer al presidente de la comisión, al señor Jarubas, y a la presidenta Metsola que estén liderando esta iniciativa tan importante de cara al futuro de los niños y a la investigación del cáncer, porque la presidenta Metsola siempre está plenamente comprometida con todos los problemas que afectan a los niños y es un verdadero honor.
Y efectivamente, Leonor, tú hoy nos has conmovido absolutamente a todos, porque cuando alguien recibe un diagnóstico de cáncer, entra muchísimo miedo, pero tú hoy lo que nos has demostrado es tu valentía y la superación. Y eso es un ejemplo para muchos niños y para muchos adultos, porque tú hoy nos traes también la palabra esperanza a este Parlamento. Y el señor Dance lo que nos ha pedido es que tengamos agallas, agallas como parlamentarios para conseguir fondos en la investigación del cáncer infantil, para vincular los recursos de nuestro próximo presupuesto a la investigación del cáncer infantil. Y hoy yo creo que todos los eurodiputados que formamos parte de la Comisión de Salud deberíamos asumir ese reto y tener la valentía que también nos estáis pidiendo para exigir esa financiación en el próximo marco financiero plurianual. Yo creo que la rentabilidad no debe guiar la investigación, pasa lo mismo que con las enfermedades raras, de la que yo tengo el honor de ser shadow rapporteur del informe de enfermedades raras, y que falte tiempo para que los niños puedan acceder a ensayos clínicos no puede ser un motivo para apartarlos.
I think that we had to, we cannot forget that we had to implement BECA solutions. The leading cause of death among children should be growing old. That's must be our inspiration and aspiration. In Europe, pediatric cancer is now the leading cause of death and we need to be ambitious in finding solutions for that. I would like to give you two examples for hope.
For hope, we can work together with public solutions, but also engaging private companies. I will switch to Spanish.
Nicolás González Casares
I would like to give you two examples for hope. For hope, we can work together with public solutions, but also engaging private companies. I will switch to Spanish. En este debate que tenemos de la competitividad en Europa, creo que no podemos olvidar una dimensión, que es la social. No hay mayor éxito de competitividad que salvar la vida de un niño con cáncer para una sociedad, no creo que lo haya mayor.
Y voy a dar dos ejemplos de lo que podemos hacer en Europa y se está haciendo. El primero es ARI-0001, la terapia CAR-T desarrollada por el Hospital Clínic de Barcelona y hoy expandida a población pediátrica a través del proyecto europeo ARI, coordinado por el Hospital Sant Joan de Déu para niños con leucemia linfoblástica aguda refractaria, una terapia nacida enteramente de la investigación hospitalaria. El segundo, menos conocido, los linfocitos infiltrantes del tumor del proyecto PRAGMA-T2. El Instituto Oncológico de los Países Bajos, junto con hospitales de Dinamarca y España, demostró en un ensayo aleatorizado de fase III que esta terapia, financiada casi íntegramente con fondos públicos, superaba a un fármaco comercial en melanoma avanzado.
Un trabajo que demuestra el potencial de la Unión Pública, de la Unión Europea trabajando con fondos públicos suficientes para abordar el cáncer infantil. Y esta es una llamada también a que tengamos un presupuesto europeo que reconozca estas necesidades. Ambos ejemplos demuestran que la inversión pública funciona porque, lo ha dicho el señor James, esto no se lo podemos dejar al mercado. Esto tenemos que hacerlo desde la iniciativa pública reconociendo las necesidades de todos esos niños y todas esas familias que sufren cada día la llegada de un cáncer. Muchas gracias.
Carlo Ciccioli
Grazie, Presidente. Nell'attuale legislazione europea, la sanità è affidata alla legislazione degli Stati nazionali e da questi talvolta, come nel caso dell'Italia, alle regioni, alle istituzioni regionali. E qui questo è il problema centrale, cioè la salute umana è una battaglia unitaria. E non è né di destra, né di sinistra, né di altrove. È un settore dove l'Unione Europea deve acquisire più ruolo, più spazio, più investimenti unitari che attualmente non ha.
Non è un caso che questa commissione è stata istituita solo recentemente.
Era sennò un'area di un'altra commissione, quella sulla sicurezza. E tra ovviamente le battaglie da fare, l'oncologia, ma aggiungerei anche le malattie degenerative, le malattie genetiche, sono aree dove conta la massa critica delle risorse che talvolta gli stati nazionali non hanno. E mi riferisco sia alla risorsa delle cure, alle persone, sia degli studi e delle ricerche scientifiche. E quindi io credo che ci debba essere un indirizzo importante che è proprio istituzionale. A questo poi segue l'altro aspetto, che è quello che oggi abbiamo ascoltato da Eleonora, la delicatezza delle neoplasie infantili.
Soprattutto le malattie degli adolescenti, dei bambini, ispirano sentimenti di angoscia anche più grandi di quelli degli adulti. E io certamente esprimo un saluto affettuoso ad Eleonora che ha presentato con molta spontaneità, determinazione, anche efficacia incredibile questa situazione sua e ovviamente di tutti gli altri bambini.
Credo che su questo dobbiamo impegnarci proprio dal punto di vista istituzionale di dare centralità alla salute nelle istituzioni e nei bilanci europei. Ovviamente ringrazio la Presidente Metsola e la Presidente della Commissione per l'impegno che spero trovino menti e spiriti aperti ad ascoltare.
Peter Liese
Yeah, thank you, Adam, thank you to Roberta and Mr. Dams, but in particular, of course, to Leonor. That was really emotional, and for us, it's important to come from emotion to action, to really do what is necessary. And it's very clear we need to do everything what we can do to help future patients and current patients much better. We cannot act alone: Member States, regions, scientists, everybody needs to work together, but we have our responsibility and we need to live up to our responsibility. I have a very close contact with the former chair of the Child Cancer Association, Professor Angelika Eggert.
She's living close to my region and I talk to her always what we can do to fight childhood cancer.
And one of the things she told me is this, this question of the different interpretation of data protection. She said to cure, to find a new cure for childhood cancer in Germany alone, either it's not possible or it takes 10 years. If we do it together in Europe, we can do it in one year. The clinical trials can be much faster. But she told me she, she needs two years to sort out the different data protection rules between Germany and France only.
So what is obliged to do in Germany is prohibited in France and the other way round. So and that's why we supported Tomislav in the Health, European Health Data Space. And my question to you, Mr. Darms, and maybe other expert is, do you see light in the end of the tunnel? Will it be easier finally to sort that out? A second question, Eleonora mentioned that still we have no obligation to, to do the cancer treatment for, for children in the same way as we do it for adults.
Now there was something in the pharma package and I would like to learn, was it enough? Is it properly implemented or what can we do on top? And what else can we do? I, these bottlenecks, I would like to listen, where are they and what do we have to do?
And last but not least, to everybody, in particular to the European Commission. We are discussing cancer here in the European Parliament now for almost eight years, definitely for seven years. And you know, the Commission is doing a lot. But when I ask them, what are the concrete results, they always tell me, we have made this workshop, we have this network, we have this body created. We need to talk about people.
Now, we have success stories with the European research, for example. We need to identify concrete success stories that every citizen can understand. When we say we created a network, people will say, okay, what does it mean for me? But when I say this guy, this young girl was cured because of an innovative therapy that Europe supported, then we can convince people to support more, to give more money and to go the way that we started. Thank you.
Tomislav Sokol
Thank you very much. I have to apologize for being late, but we have the discussion Industrial Accelerator Act, which is very important at the very same moment, so I have to run between two committees. So I apologize for that.
Dear President Metsola, dear Adam, dear guests, thank you very much for coming to discuss an extremely important topic. And I've been saying for years now, this should be the absolute priority because children are, I would say, the biggest treasure. But it's not just that. It's the area where EU can do the most because this is an area where development of new medicines is not profitable in many cases, as you already said, where in many cases you cannot get adequate treatment in your own home country. You have to go to other countries.
So in countries like Croatia, Malta, etc., in many cases you cannot get specialized treatment. You have to go to bigger countries. And EU definitely can play a major role there. First, I would like to say that we already did some things. We adopted the European Health Data Space, which should enable more interoperability of data and also much more data available for research, which I think is an extremely big potential that we have to use.
We also, we are also now changing the clinical trials regulation, which should make clinical trials much faster and development of new medicines in Europe much, much quicker and much easier.
And also we are trying to develop new rules to incentivize doing clinical trials not just in a few biggest countries, but in smaller countries as well, which I think can be definitely a big a big progress and for our children and for development of new oncological medicines crucial. In the critical medicines act that we just made an agreement on, now we we introduce so-called collaborative procurement, which will make it possible for several countries to come together to procure the most innovative medicines for for child cancer, which which will make access to these medicines much faster and much easier than it is now. We are also now pushing the Commission to revise the cross-border rules, the rules on cross-border healthcare, to make make it easier for those children who cannot get adequate specialist treatment in their own home country to go abroad to specialized centers to get treatment there. But these rules are so complicated, it is takes so much time, you have to be a health law expert to know what your rights are to get care health treatment abroad, that that we are now pushing very strongly and we are doing a report now in the Parliament to make it clear that we want these rules to be much more simplified and these procedures for accessing cross-border healthcare to be much faster and much easier than they are now. And finally on on funding, now we are discussing the new Horizon program.
I think for us it's crucial that that oncology and the battling cancer remains one of the priority missions and that the and that the budget of of Horizon becomes much bigger than it is now, especially since unfortunately more a lot of these a lot of research on on child cancers is not profitable, so we need public investments and Horizon is crucial in that.
And the last point, we are also pushing, the Parliament has has made a resolution that we insist on having at least 10 billion euros for the next health program in the EU budget. So to have a have a stand-alone health budget in the next MFF and to have this at the level of at least 10 billion. And I think if we are able to pull this through, to have this financial leverage as well, that we'll be able to invest much more in healthcare for children as well. So we did something, we are doing something. Of course it's not enough, but this is definitely one of the main priorities of the Parliament and we'll continue to push for this.
Thanks.
Adam Jarubas
Thank you Tomislav, thank you all for the discussion. Now, dear Leonor, dear Mr. Deems, I give you the floor to address the comments and questions posed by some members. Leonor, would you like to say something more or not? If not, Mr. Deems, could you comment please?
Sam Daems
I think I would probably like to thank you because based on the reactions I feel a lot of support for pediatric oncology and for the children and that is that's warming to feel. And I think in general nobody thinks that the Parliament is not doing anything to be clear.
I think in general we recognize that it's a complex problem and that's also I think which you recognize. It's a complex problem. We will not solve it with one individual instrument and we will not solve it with unaligned instruments. Those are two things which I think are important to recognize. We will need very a complex for a complex problem we will need a complex set of solutions and not just one silver bullet and those complex instruments need to be aligned and they need to be in my perspective I agree with what many other people said at the European level.
They will never be able to work on a national level even a big state will never have the critical mass to be able to act. And so I I probably more than want to react I want to confirm and thank you for thinking in that direction and hopefully also taking actions in that direction in the in the coming period. So thank you very much.
Adam Jarubas
Thank you so much. And now I open the second panel with Professor Vassal and Mr. Hennen. The floor is yours for eight minutes each. Professor please.
Gilles Vassal
Thank you. Dear Madam President, dear Chairman, MEPs, thank you very much for highlighting all the initiatives the parliament have already done and is doing to improve the care and results for children and adolescents with cancer. There is one thing in addition that you could do.
I would like to take one example. Medulloblastoma is a specific brain tumor occurring in children around the age of 10. In the 20th century, it was a single disease treated by chemotherapy, surgery, radiotherapy. 50% of children survive and they did suffer of long-term cognitive sequelae. In 2026, we made major progress in understanding this disease and today, it's no longer one disease, but 10 different biologically defined diseases and for each of them, there are specific alterations that can be targets for therapies.
However, in 2024, not a single medicine has been approved for the treatment of children and adolescents with medulloblastoma, despite this major progress in understanding the disease and a strong rationale to develop specific medicine to treat these children. And this is a situation where we are at the moment. In all the regulation in Europe, including the new pharma regulation that you will be voting in December, there is no incentive to incentivize biotech companies to develop specific pediatric oncology drug. You will tell me, oh, but there is orphan drug regulation, and medulloblastoma and childhood cancer is a rare disease. Well, since 2000, the orphan drug regulation did not deliver well for childhood cancer.
As an example, more than 2,700 orphan drug design have been granted in Europe for rare disease, sorry. One third for cancer in adult, only 2% for childhood cancer malignancy, which is less than 20 over more than 26 years. And if you look at the drug approved so far, only four medicine have been approved specifically for a pediatric cancer.
So the current regulation, the pharma, will address better development for adult cancer medicine into children, but will not address the development of this specific pediatric oncology medicine. So we believe that the EU Biotech Act you are working at the moment is really an opportunity to incentivize biotech to develop this medicine. But at the moment, you are working especially in Article 27 with a real question about extension of the supplementary protection certificate to incentivize the development in specific situation. And at the moment, it turns around medicine for high unmet medical need. But if there is no specific measures in the EU Biotech Act focusing on the need of pediatric, severe pediatric, life-threatening rare disease such as childhood cancer, it will not work as it did not work in the orphan drug regulation.
This is why we are really proposing that in this Article 27, you introduce a specific measures of extension of the SPC for the cases of product developed for severe life-threatening pediatric rare disease such as childhood cancer. And of course, the MFF is important.
Of course, the Article 24 on the specific support is important. And there as well, to dedicate and say in the regulation that it should be really also considering the specific needs of pediatric oncology medicines and medicine for this severe pediatric disease really would be important. And this is what we believe is important at the moment where you are building this absolutely important regulation in Europe to increase competitiveness and incentivizing company to do what they don't do at the moment because there is no incentive. Thank you.
Delphine Heenen
Dear President Roberta Metsola, honorable members of the SANT Committee. Your presence here today, President Metsola, sends a very strong signal that the European Parliament takes this cause to heart. And I would like to sincerely thank each and every one of you for the opportunity granted to Childhood Cancer International Europe to present to you the current reality of children and young patients with cancer in Europe, their needs, their hopes, and what you at the level of the European Parliament can do to make those dreams come true. I am Delphine Heenen, a member of Childhood Cancer International Europe, where I'm in charge of the European affairs here in Brussels. I didn't choose this role.
This role chose me. It chose me at the end of June 2013, but I didn't know it back then, when my son Raphael was diagnosed with cancer just a fortnight before we were to leave on a family vacation. Despite a harsh year-long treatment, which included toxic chemotherapy and the amputation of his right foot where the tumor was located, the cancer came back in Raphael's lungs just before Christmas 2015. I vividly remember the conversation we had with his oncologist for his relapse. From the careful wording she chose, we understood that his prognosis had become much bleaker.
He was offered a very toxic again combination of three drugs.
And because the chances of success seemed meager, I inquired immediately about fallback options. Silence. Clinical trials. Silence. Promising research leads.
Silence. And how can it be that we all read so much about promising advances in cancer research treatments that my son would be left out of these crumbs of hope? It tortured me. This was unfair for my son, but also deeply troubling at a societal level. Don't we all think that children should come first when it comes to curing diseases?
And this is when this role truly chose me. I resigned from my corporate career and turned to philanthropy to help cure all children with cancer. In 2017, I founded my organization in Belgium to fundraise and finance research. But as you may have understood by now, thanks to the speech of Léonore, Sam and Gio, if curing children with cancer was easy, it would have already happened. Philanthropy matters, but cannot be the only answer to a systemic problem.
The creation of a favorable environment is crucial, and we need to remove the barriers that prevent the development of medicinal products in rare pediatric populations like pediatric cancers.
Today, I would like to make the case for three changes that you can steer at the level of the Union, three reforms that hold the potential to help all future children with cancer. Firstly, as I know that you discussed the report on cross-border care this morning, we would like to ask you to ensure that the improvements to the current system will make it possible for young patients to travel for a clinical trial when they have run out of treatment, standard treatment options. In ultra-rare diseases like paediatric cancer, it is too expensive to open a clinical trial in many countries, and it is also inefficient because it slows down the opening process and it reduces the expertise in the centres. Yet, when a clinical trial is only available in five or six member states, we need to make sure that all children can access the innovation and the clinical trial. The current cross-border health system is limited to standard treatments and does not specifically include clinical trials.
This needs to change, and you have to make, you have the power to make it happen now.
Secondly, as you understood in Sam's presentation and as it was underlined by MEP Sokol, there is currently no commercial case for the development of new medicinal products in pediatric oncology in the system as it is designed today. When a company starts developing a new product, it will take up to 10 years before they can obtain a market authorization. During the whole development process, the company will need to generate return for its investors, which further increases its development costs. We need public funding to reduce the financial risk of the development costs in those rare pediatric life-threatening diseases, so that the industry can take over a project at a stage where it is more mature, less risky and faster to bring to the market. My ask is twofold.
First, I would like to ask you to ensure that the multiannual financial framework meaningfully finances health research in areas of high unmet medical needs like pediatric cancer. But I would like you also to use your influence to bring this message back home so that the national budgets also concentrate their efforts on high unmet medical needs like pediatric cancer.
Thirdly, I would like to address the question of uncertainty in the development of new medicinal products. Today, not only does the industry need to obtain a market authorization to sell a medicinal product, but it also needs to negotiate its reimbursement country by country. A long and costly enterprise which leads to more inequities because companies will tend to favor the wealthiest countries and the bigger markets. This is why we're advocating the creation of a joint procurement framework for rare life-threatening diseases like pediatric cancer in children. If a pharmaceutical company has the certainty to sell its medicinal product as soon as it's authorized at a pre-negotiated price, it will have three benefits: a more attractive market for the industry, a better price for the states, and a faster access for patients, all patients across the Union.
Two years and ten days ago, my son Raphael celebrated his last birthday. He turned 20 and he still had great dreams: directing films, writing novels, completing his studies in philosophy. But he passed away four days after his birthday.
So I'm standing here today in front of all of you on his behalf, but all his future companions of misfortune, the future children and young people with cancer. They really need your support and I thank you very much for your attention.
Adam Jarubas
Thank you so much. Thank you very much Delphine for your presentation. Before we start the discussion, I'd like to cordially thank our President Roberta Metsola for her presence today. Thank you Roberta. Okay colleagues, let's get started.
Tomislav Sokol as the first please.
Tomislav Sokol
Thank you very much. I will try to be very, very concrete. First on what Professor Vassal said. Yes, I try to fight as much as possible in the pharma package for to have special incentives for for pediatric medicines. Unfortunately we were not able to do it.
You know that we tried. It was a it was very hard negotiations but unfortunately we couldn't we couldn't get it through. And I'm really sorry for that and I can promise you that I will support that we try to find a specific incentive in the Biotech Act as much as possible. So I can I can give you that I can give you that promise.
I cannot promise you that we will be successful again because the problem is usually the opposition from the member states, at least some of them, and the Council, and we cannot decide anything without them, but we'll definitely try. On the second point, on cross on cross-border healthcare, for that, we need to change the legislation because the cross-border healthcare directly directive explicitly says that you can only fund treatments abroad which are covered by domestic healthcare system, which means proven treatments which have already been approved. So not which means that clinical trials, experimental treatments, unfortunately, under the current legislation cannot be covered, and we'll definitely include this in our own-initiative report to change this. So I can also promise promise you that we'll fight to change that in our initiative on-initiative report we make sure that this legislation is changed, that also access to clinical trials abroad is possible. We cannot again decide this on our own because the Commission is the one that proposes legislation, but we'll now push very hard for that, and I expect the support from other political groups to do it as well.
Peter Liese discussed this already when we were in the BECA committee, that access to cross-border clinical trials also has to be made made possible, but then but we need to change legislation for that. On the other hand, on clinical trials, I would also like to state that I personally tabled an amendment which will tie incentives, this additional protection period, for companies who provide clinical trials more diverse. So not just in biggest countries, but also in other represented countries, which means that if you provide clinical trials in countries which are now underrepresented, you can get you can get additional incentives. The idea of that is to provide to provide incentives for companies to do clinical trials in smaller countries, not just in the biggest markets. It will not solve everything, but but we'll try we are doing something concretely on that.
On public funding, I already said that, so Parliament is there, so we're pushing to have cancer as one of the priority missions still in Horizon, to to extend Horizon, to to significantly increase the funding, and I hope we'll be successful and also on the new health health budget that we have at least 10 billion euros in MFF. Again, the problem will be the Member States, the Council, but we'll fight as much as possible for that. And the last point on joint procurement, so in the Critical Medicines Act now we have that. And this covers all critical critical medicines which are problematic and all orphan drugs. So we were able to include all orphan drugs in the joint procurement under CMA, which means that now this joint procurement will be made possible for much broader number of medicines than than it is now.
It's not perfect, it doesn't cover everything, but I think it will be a major major improvement. Thanks.
Nicolás González Casares
Primero gracias, gracias por sus intervenciones y mis disculpas por no me puedo quedar a las respuestas porque tengo una reunión inmediatamente. Pero dos reflexiones. La primera es sobre la extensión del SPC en cuanto a medicamentos pediátricos en la Ley de Biotecnología, en la Biotechnology Act. Creo que es necesario, pero también creo que no va a ser la panacea. Creo que tenemos que pensar que eso es un paso adelante, pero desde luego tenemos que ver cómo solucionamos las claras fallas que el mercado tiene en estos aspectos.
El joint procurement es una posibilidad, ha sido mencionado la posibilidad de la Critical Medicines Act. Pero claro, para eso necesitamos una bolsa previa de dinero para saber con qué podemos contar para tirar hacia adelante en ese joint procurement. Es algo que la Critical Medicines Act no pretendía solucionar, pero creo que debe ser necesario. Por otro lado, ¿cómo consideran la posibilidad, y sabemos que esto es un problema paneuropeo, que son enfermedades muy raras o ultrarraras, que necesitamos compartir datos, la posibilidad de contar con un reglamento europeo de enfermedades raras para que este desafío de muchas de estas enfermedades puedan ser tenidos en cuenta desde un abordaje europeo? Muchas gracias.
Stine Bosse
Thank you very much. I indeed don't think we have done all the jobs that we need to do, but I do want to stress that we did actually in the pharmaceutical package get better conditions for development of pharmaceuticals also for pediatric diseases. So, so just to have that in the back of our minds. I also think that many spoke about the Biotech Act. I also did.
And I do hope that we with all the efforts that I can listen here in the room, that we will get that through. That we will get even better conditions through in that act. And that we will get what I call, and I think that was what many of you called for, the 28th regime, where we make it much easier, much faster to have an EMA approval and to not necessarily go to 27 different countries for next approvals. And finally, I also hope that we can agree to encourage the Commission to think about creating a fund.
Many of you spoke about also the financial side of this, and that is, very sad to say, not everybody can afford these treatments. But we could think about creating a fund also where the pharmaceutical sector can contribute, and both for the ERN systems and also for the health data space, but also for making sure that all children across Europe will be able to afford to have these very special treatments. So if we stop thinking about this as rare, if we are a bit more bold on the finances, and if we also work much more closely together cross-border, then we can do much more for these children. Thank you.
Ignazio Roberto Marino
In a way, I would like to echo what I just heard, because, and I want to make an example. I have much more knowledge in cancer in the adult population, but the example that I'm going to make is very similar for treatment of pediatric cancer. And is about, as was just said, the timing of approval of a new innovative medication to treat cancer.
And I make an example that is in front of our eyes in these weeks. In late May 2024, a new molecule was presented at the American Society of Cancer, and the name of this molecule is the daraxonsrasib, and it is capable to double the life expectancy of a patient with a deadly pancreatic cancer. So double the life expectancy. Now, in the United States, it was presented, as I said, in the last week of May at the meeting, and it's been approved two weeks ago in August by the FDA. I am pretty sure that it will be another couple of years before it will be approved by EMA, and as we just heard, then will need to be approved by the competent authorities in each of the 27 member states.
And I think this is really bad, because why our patients in Europe need to wait three or four years compared to a patient in United States to receive the best treatment?
Elena Nevado del Campo
Muchas gracias presidente I will speak in Spanish. Y en primer lugar yo también quiero dar las gracias a ambos intervinientes por su exposición y decirle también a la señora Gerin que ella también nos ha emocionado mucho con sus palabras. Hoy su hijo estará orgulloso probablemente de usted allá donde le esté escuchando que estoy segura que así será. Yo tengo un par de preguntas si pudieran responderla y es en concreto qué incentivos concretos consideran que serían necesarios para que las empresas farmacéuticas pudieran tener interés en investigar los medicamentos pediátricos y qué extensión consideran que sería razonable para motivarlas en este sentido. Y en segundo lugar les pregunto por el papel de la EMA.
¿Consideran que habría que modificar en algún sentido, desde la reducción administrativa, la función de la EMA en concreto en la investigación pediátrica del cáncer pediátrico? Gracias.
Ondřej Dostál
Thank you, Chairman. Being from Czech Republic, I would like to add that sometimes the marketing authorization is not the biggest hurdle. The biggest hurdle is reimbursement. In my country, healthcare is mostly reimbursed publicly, but it sometimes takes two, three years before patients can get the free of charge pharmaceutical which was already approved. EU has passed ten years ago the so-called Transparency Directive, which says that the decisions on listing the medicine onto the reimbursed list should take no longer than half a year.
It should be based on objective and concrete criteria, and there should be a possibility of court review. It does not happen, and I think not only passing a new legislation, but also enforcing the existing very diligently is very necessary. Now we will have the advantage of health data space, so we would be able to see very quickly which medicines are actually helping and what is also their cost-effectiveness, so the listing procedure for reimbursement should be much more quick. So also this problem should be tackled.
Thank you very much.
Adam Jarubas
Thank you, dear Professor Vassal, dear Mrs. Delphine Heenen. I will give the floor back to comment that question posed by MEPs.
Gilles Vassal
Sure, thank you very much for your comment and suggestion. I would like to address a few points that you raised. Indeed, the change in the pharma legislation that will be voted in December makes improvement in the development of adult cancer medicine in children by saying a drug for lung cancer, targeted drug, should be developed in neuroblastoma, in a pediatric disease, if the target is relevant. That was not the case in the previous regulation because lung cancer does not exist in children, the drug should not be developed. Now it will be possible.
And this will be an important change in how the medicine in adults should be considered as relevant or not for a pediatric development. You are absolutely right, Mme. Mažylis.
However, there is no in the pharma package, no incentive on the specific pediatric drug development that I mentioned before. And this is why we believe, no, no, there is no specific incentive for a drug developed only for children with the first marketing authorization in children, which is exactly the question that we are raising here. If the target is in an adult cancer drug is relevant for children, this is under the pharma regulation. If this is a specific pediatric target, not existing in an adult cancer, then there is no incentive at the moment because it doesn't fall under the EU legislation on pharma package. So this is why we are proposing and asking for specific incentive for companies to develop this specific pediatric medicine that would be first authorized in children, because at the moment there is no such incentive.
And regarding your point about heterogeneity of HTA evaluation and delays across Europe for all drugs, including anti-cancer medicine, including the RAS inhibitor that really at the time is a very first drug with hope for patients with pancreatic cancer, you are absolutely right. But then, we do need medicine approved for children. And this is what we don't have.
If we look at how many of these drugs have been approved since the pharma regulation, the pediatric regulation 2007, it's no more than 22. So indeed, there are issues in accessing innovation for patients across Europe, heterogeneity, reimbursement and so on. But so far, the point is that we don't have enough medicine approved for children with cancer. Thanks with the new pharma package, there may be more of these adult drugs developed in children. But in addition, we need to have incentive for companies to embark on the development of what we call specific pediatric oncology drugs.
And this is why we are proposing that in the Biotech Act, the Article 27 on SPC would, could include a specific measures for this life-threatening pediatric rare disease such as childhood cancer, with 12 months extension if they are first marketing in children. It will be an additional things, it will not solve everything as mentioned by one of you, but clearly in the package there will be a new incentive in the European regulations to favor the development of these specific pediatric oncology drugs.
Delphine Heenen
Thank you very much everyone for your questions and comments. I would like to reiterate Sam's comment that it's heartwarming to see that you're also committed to supporting children and young patients with cancer. And I really appreciate your question about what we should do to remove barriers or make sure that more drugs can be developed specifically for children with cancer. And I think as you may have understood by now, it's an very complicated complex question to tackle and there is not a single thing that we need to do and we have to work step by step. One thing that definitely needs to happen is to lower the barriers for the industry or to develop academic industry, non-for-profit industry, however you call it.
We need to make sure that it becomes possible despite the small market in pediatric oncology and in many other rare life-threatening pediatric diseases. And so anything that can be done at the level of regulations to simplify drug development, and I know it's ongoing in the framework of the Biotech Act, lowering the barriers in clinical trial regulations, health technology assessment that takes place at the European level, because the first way to recoup your investment is to get money from the states when they reimburse the drugs. So the faster this happened, the better it is to incentivize drug development. European health data space and the European Medicines Agency's currently reviewing how they are reviewing, yes, evaluating files for new drugs. All these measures really help to make sure that we lower the complexity of drug development.
The less complexity, the more attraction for the industry to go in that field. And then I really like Mrs. Boss's idea about the fund that would be nourished by the industry, and I think that's maybe something we have to bear in mind. Definitely we need affirmative investment in the budget, because when we do that, we can make sure that we are selective on certain disease areas. Sam spoke about prioritization. We need to make sure that we don't sort of fund everything and end up being effective nowhere.
We need to be very focused and aligned in what we fund. And the further we can push research at an academic level before it moves to the industry, the better the odds to end up with a medicinal product. We know that the chances that academia alone develops new drugs is more complex anyway, because the know-how, the expertise is in the industry today. But we need to make sure that the further we go, the more knowledge we develop in academia, so that we have good leads for the development of new products is higher. And so we could have a non-for-profit company, a joint venture between industry and academia and with funds from the industry.
I think that would be great. If you can set this up, I'm signing for it tomorrow. Thank you so much.
Adam Jarubas
Thank you so much, Delphine. Thank you all for this fruitful discussion, remarkable exchange. Especially I'd like to thank our expert, dear Leonor. Thank you for your courage.
Thank you all for what you are doing for people living and fighting with the cancer. As you can see, our discussion proved that Parliament, our committee, are doing a lot in this area, but still a great work is ahead of us. We need more collaboration. We need more money for fighting with the cancer and we should create more effective system within national competence and European institutions. You can count on us.
Thank you so much for your time, for your great presentation. Thank you.
Please colleagues, don't leave the room because we have one point yet. We're going to the next point, exchange of views in the series Excellence in Health Science on TechBio, the AI-enabled future of drug discovery. Dear colleagues, we continue our meeting with another exchange of views in the series Excellence in Health Science.
By developing this series of exchange of views, I wanted to put more focus on science and innovation in health, and for this purpose, we are inviting representatives of excellence in health science. Okay, today we are continuing today with the presentation of TechBio, the AI-enabled future of drug discovery. I welcome today Mrs. Liesbet Lagae, who is the R&D fellow and program director for life science technologies at IMEC Health. I will give the floor to Mrs. Lagae for her introductory statement and after to the members for the Q&A session. Mrs. Lagae, you have the floor for eight minutes, please.
Liesbet Lagae
Thank you, Mr. Chairman, dear members of the Parliament, dear ladies and gentlemen, I would like to explain to you briefly today what TechBio is and how TechBio enables the future of drug discovery. So where do I come from?
I come from IMEC. IMEC is a world-renowned hub in semiconductor R and D with a very large infrastructure, partially funded through Europe. But what is maybe less known is that we also have about 1,500 people working on AI, both hardware and software, and about 300 people working on health. And that is where I'm coming from, that's the group that I'm leading. So let me show you the promise where biopharma and many AI researchers are dreaming of to build the ChatGPT for biology, the model that can explain and can decode and understand biology in depth.
Now that is much more difficult than human language. Human language, you can find all the information on internet, but for biology, you actually need to get access to not only the clinical data, but also to the biology data, which are in the labs. And where the CEO of NVIDIA, Jensen Huang, in 2023 claimed that digital biology will be the biggest revolution ever, I think today is getting challenged by, for example, the CEO of Eli Lilly saying, well, we cannot get very far if the data is not there. So the data is too thin and the models hence will not be good enough in order to be able to predict biology.
And that's exactly what we want to talk about. So why should we talk about this? Because first of all, it is what pharma wants. They want to reduce development time and costs for new drugs. They're spending a lot of money in doing clinical trials, but in fact, if we are able to do our drug discovery better through AI, we will spare a lot of cost.
They dream about drugs that can be developed in one year. And they dream about this because actually the COVID mRNA vaccine took one year to develop from the sequence of the virus until the first authorization. So why should Europe care? Well, I think Europe needs to care about competitiveness and we need to make sure that the biotech intelligence remains in Europe. And that is why we need to care about AI innovation in biotech.
So where are we today? Today, on one hand, we see that there is a number of AI foundational models in biology that are maturing, but are not yet trustworthy, are not yet good enough.
What we also see is that the very first AI-designed drugs are starting to show clinical successes. So there's about 173 AI programs today, about 63 in clinical development, and the frontrunner is actually this Insilico Medicine, who actually developed with AI a drug for lung fibrosis and has a deal now with Eli Lilly to basically go for commercialization. And so what we also see is that the big tech players are positioning themselves to enter the biotech space. For example, Anthropic actually took over a company because they had very good biological AI models. So there is the possibility that all the biological intelligence will be with the tech companies rather with the pharma companies.
And that is something that we have to be aware of and that we have to also deal with in Europe. I'm going to give you now a few examples on how IMEC is actually in a good position to help in this evolution, giving you a few examples where we actually are together already supporting that industry. So one example comes from the DNA sequencing world. So I already told you that the sequence of the COVID-19 virus actually was known one month, it was sequenced one month after taking the first sample.
So end of January we already knew the sequence and that was actually the start of the race for pharma to develop the best mRNA vaccine. Now sequencing is possible because there's a number of companies that actually developed sequencing infrastructure and have helped to reduce the cost per genome. One of those is PacBio, a company in the US that we're working with. So in 2015 we launched a sequencing chip together with them. Today that same sequencing chip is being used to sequence a trillion species and build the largest Atlas trillion genome Atlas in the world.
So it's a collaboration between PacBio, Anthropic and NVIDIA. Another example, IMEC developed a neuropixel. It allows to record from animal brains at scale. We have actually distributed those neuropixels to about 1500 neurolabs in the world who are making a lot of publications with this. But by doing that have built the largest database in the world of, you know, brain functional information.
And now we're actually starting a project with Stanford University called Enigma Project to build a trustworthy digital twin of the brain by aligning all the Neuropixel data with AI modeling. So these are two projects which are already in existence, but we're also building the next generation of projects in that, in this area. One deals with NAMs and we basically build together with Merck and MilliporeSigma an MPS platform for gut toxicity based on a chip to basically bring together the data and make sure that we have a gut toxicity digital twin model that can, you know, inform us without sacrificing animals. And then a fourth project, I think, is very strategic to Europe. We believe that Europe should not only think about AI models in order to understand and decode biology, but also to build the next generation of biology by building programmable therapies, cell and gene therapies, for example.
It requires us to build a tech bio foundry that can modify cells, and that all starts with DNA synthesis. And what we try to do here is to build the next generation DNA synthesis machine that can build enormous DNA libraries that can actually be the basis of a new set of engineered therapies.
So we think this is very strategic. Synthetic biology is put as a top US strategic national priority, but also in China a lot of millions go to synthetic, billions go to synthetic biology as is phrased here by Mark Rutte who sees it as a potential threat as well. So we believe that Europe should think about how to deal with synthetic biology and how we can build the infrastructure. So how would it look like, zooming out a little bit, so the AI biologist working within a tech bio foundry will see the AI models, but in the back are running a very big set of experimental experiments that actually create the datasets, the biological processing units that actually create the datasets in order to train the models and to make the models much more trustworthy. So in summary, and that is my last slide, we think Europe should not only consider European Health Data Space, which is about the data which is in the clinic, should not only consider AI factory, which is about the infrastructure that is needed in order to do all those AI models, but also needs to think about the tech bio layer that helps to create the vast amount of biological data that accelerates the AI core.
Adam Jarubas
Thank you so much, Mrs. Lagae. Is there anyone who wants to take the floor and ask? Ondřej Dostál.
Ondřej Dostál
Thank you, Chairman, and thank you also for the presentation. I have a legal question. Well, AI at this point is not like generating, but rather analyzing data. And the data are a necessary part of it. So from patent point of view, it is rather an invention or rather a discovery?
I ask this because at some point it will be necessary, or somebody will want to commercialize the results of these research. And perhaps those who provided their population's data should have some rebate, let's say, right?
Liesbet Lagae
Yeah. I think it's a very relevant question. So I think the models that are created can be inventions.
Can be inventions, and then what comes out of those models actually might be, yeah, might be, you know, patentable in terms of protecting your product because it is created through a patented model. So the data itself not, the data of course is what comes out. But the models are patentable and could be inventions.
Adam Jarubas
If I may ask Mrs. Lagae, let me speak in Polish. Ja miałem niedawno przyjemność zwiedzić państwa ośrodek. Sądzę, że miałem okazję zwiedzić ośrodek IMEC, który znajduje się niedaleko od Brukseli. Jestem pod olbrzymim wrażeniem tego, co państwo robicie, tworząc taką unikalną infrastrukturę wykorzystującą chipy najnowszej generacji, tworząc takie zaplecze dla nauki, dla również środowiska firm tworzących czy oferujących technologie w obszarze ochrony zdrowia.
I chciałem zapytać, jak pani postrzega szanse związane z wykorzystaniem czy z wdrożeniem europejskiej przestrzeni danych zdrowotnych. Na ile to może być taki akcelerator dla nowych technologii w zdrowiu, w leczeniu, w nowych terapiach? I też zapytać o ten model, który państwo stworzyliście, bo jesteście swoistym takim połąceniem energii żywiołów naukowych, uniwersytetów też funkcjonujących w różnych częściach Europy. Jak Europa mogłaby wspierać jeszcze bardziej skutecznie takie właśnie projekty jak wasz? Dziękuję.
Liesbet Lagae
Okay, thank you for this very valuable question. I'm gonna try to answer in two parts. One is about the infrastructure that we are building and all the chips that we are building do generate data. And that data is complementary to the patient data which comes out of the clinic and is needed to understand biology, but also to help pharma to develop the right drugs, not spend ages and a lot of money to develop the wrong drugs, but develop the right drugs, the one that will be effective to treat the diseases.
So yes, this is what we do and what we want to do. The ecosystem that we today are building is an ecosystem in which we try to align tech partners and pharmaceutical partners and biotech partners and startups to basically find the right synergies in the ecosystem and combine expertise to work with us on this tech-bio future. We've done that in the context of the chip research and the Chips Act. We've basically shown that we can bring an ecosystem around us and we are doing this today to enable the future of tech-bio. So we believe that Europe can help us.
Europe can help us because it's not only about the chips, it's about getting out the data and getting together the ecosystem.
And we in Europe have been historically much better in building consortia around new technologies and sharing data than, for example, in the US where everything is commercial. So we believe that in order to keep a competitive edge in Europe, we should try to build an ecosystem around tech bio. And IMEC for sure is willing to help there with our knowledge in chips and in AI.
Elena Nevado del Campo
Muchas gracias. Yo voy a hablar en español. Yo le voy a hacer una pregunta concreta en relación con lo que ha dicho. Gracias por su exposición porque la verdad es que es más que interesante. Le pregunto sobre el poder de los datos sanitarios, el poder sobre todo económico.
Y la pregunta es qué incidencia puede tener en la industria farmacéutica que los datos sanitarios estén en manos de las tecnológicas.
Tiene, tenemos que crear un ecosistema común o qué contrapesos o qué riesgos en ese contrapeso pueden existir a la larga en el ecosistema de salud.
Liesbet Lagae
So I understood half of the question, I think you were broken up at some point, but I will comment already on health statistics and then if you have further questions, please ask again. So health statistics is about data, right? So AI is actually the next level of health statistics, right, because it is not only, it starts to become much more predictive because it actually improves the models by training it on much larger datasets. So what was called statistics 20 years ago is today called AI. So I think this is very relevant for health.
It is super relevant because we will learn what works and what doesn't work through data and through statistics. What I think today is lacking is the vast amount of data that is needed to build the best AI models, because the data is locked up in hospitals, in academic labs, in closed pharma organizations. So it's all small pieces of the puzzle.
And we cannot bring the entire picture together unless we do something on the societal level. European Health Data Space is one aspect where we force clinics, hospitals to make patient data more available for R&D. But we believe tech biofoundry is the second part because biology is not only about patients, it's also about DNA and proteins and tissues and cells and a lot of research information that today is also not available. So the second part we believe tech biofoundry can help to solve.
Elena Nevado del Campo
Y la pregunta siguiente sería: ¿quién debe tener esos datos que fundamentalmente van a ser públicos? ¿A quién hay que ofrecérselo? ¿A las tecnológicas para que a través de la inteligencia artificial podamos llegar a soluciones o a las farmacéuticas?
Liesbet Lagae
I think that's a very relevant question. What we see is that in the US the tech companies are starting to take a big position. Google holds a lot of health data for everybody. Anthropic is building a Claude for life sciences and for healthcare. So we see that the people holding the data might actually hold the intelligence.
And in America, it looks like the tech, the big tech is actually getting a very big footprint. And that's exactly what I want you to realize, and we need to think about what that means for Europe. And I don't know whether it's pharma or tech that will need to hold the European data. But I do think that the government should care and should find who is the best, how, you know, what is best for the patient, what is best for the future of the citizen. To hold it in private companies or to hold it in the public is something that we should worry about.
András Tivadar Kulja
Thank you, Chair, and thank you for this very interesting and important presentation here, because the world is changing and has been changing in the last few years in a very, very quick way. And it's even difficult to follow in everyday life, not only, but the clinical research is a bit lagging behind, and maybe that can be a new tool. And my question would be that, because many times we see that the data is not so clear.
And my question would be that, because many times we see that the data is not so clear, and for example, in different healthcare systems, the data is a bit biased because the hospitals are getting the reimbursement after the, you know, the diagnosis code, and because it pays more for the hospital, there are tendencies, and it happened in the last 16 years in my country, that hospitals and doctors sometimes or very often use the more severe codes, and because of it, the whole data is biased. That how can we use AI to clear this data, or the AI research based on this data, how can we be sure that it's not biased?
And also the speed and it is always the dilemma, the speed and the safety, that if the AI can reduce the the time for research, how can we be sure that we know the long-term effects or or those side effects? And I'm not talking as a I'm a medical doctor and I really believe that that for example the new treatments, the vaccines are the biggest inventions in healthcare system, but many times in this world full of misinformation these are the main critics and how can be sure that we have a good answers for this misinformation or criticism? Thank you very much.
Liesbet Lagae
Thank you, very relevant questions indeed. So the fact that hospitals are keeping their data as an as an asset and trying to make money out of it and and you know biasing the system in order to get more money is something that we believe can be overcome if the the models and the data are not hospital specific so that we can train models which are trained on bigger sets of data, right, all the hospitals together. European Health Data Space is a very good proposal in in that direction in making sure that the data can be assessed on a larger scale because then you can do proper statistics and then you can also get out some of those biases, I believe.
But I'm not an expert in hospitals, so that's just my opinion. I think the second part is that indeed AI drugs, they go much faster in discovery, but this is not a plea to let them go faster through approval. I think we need to have exactly the same safety measures as before, right? But what we believe is that because if the models are well trained and are very accurate and very predictive, the drugs that will be created are going to be better, better for individuals, you know, better, more precise, precision medicine. And hence it will become easier to get them approved, not because we are less stringent.
I think the same safety measures should be in place, maybe they should even become stringent in to cover some aspects that are less well covered and that are important for these AI drugs. But the drugs themselves are going to go to approval because they are better designed. They're more predictive. And that means we're wasting less money, but we're not releasing, you know, we're not making it less safe, you know, the criteria should be as stringent as before.
Adam Jarubas
Is there anyone who wants to take the floor? If not, I'd like to thank Mrs. Lagare for your presence here, for your presentation. You represent the leading European AI center utilizing the best AI and chips technologies across the world. AI really seems to be a big chance for accelerating treatment and creating better equipment for devices, medical devices. So we keep the fingers crossed for your success and your partners collaborated with your center.
Thank you so much for your presence. Thank you. Dear colleagues, I close today's meeting. Our next meeting will take place on 7th September. Thank you all.
I invite coordinators... probably... yeah, yeah, we are going to meet for the coordinators' meeting at 5:15 in this room. Thank you so much.
Okay, dear colleagues, let's get started punctually. Unfortunately, I have time only until six, so let's try to do our agenda. Dear colleagues, I trust you have taken note of the list of the decision we took at our last coordinators' meeting. Point one, modalities for cooperation. Dear colleagues, no further points regarding the modalities for cooperation today.
Point two, allocation of files. Colleagues, the INI on mental health strategy is up for allocation according to our usual rules.
The allocation is for one point minimum. We start the bidding procedure with the EPP.
One point.
Adam Jarubas
S&D? No points. Okay, Patriots? No. ECR?
No. Renew?
With two points, it still goes to the Greens. You need a bit more. Yes, it's not enough to beat, yeah. Oh, sorry, sorry about the mistake, yeah. Three.
Three. Greens. Three and a half. Okay. No bid.
Okay, so the file goes to Greens. For three and a half points. For three and a half points. Okay, congratulations. Point three, appointment of rapporteurs.
We have no new appointment of rapporteur. You can ask if Mr. Marino knows already the rapporteur, then the point is done. For this? You could ask whether they already... Ah, okay.
Ignazio, you are prepared to appoint the person who will be responsible for this? The rapporteur will be me. Okay. Okay. Point four, SANT INI's work program.
Colleagues, in the coordinators' meeting on 14th May 2025, coordinators decided on the first and second batch of INIs and INLs. The first and two reports from the second batch are currently in preparation, together with a joint SANT-EMPL INI requested in 2024, which has been adopted. Following the launch of a call for proposals for new INIs early this year, coordinators took a decision to postpone the request of authorization of further INIs. You can find in Annex 1 the proposals.
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