Committee on Public Health Ordinary meeting
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Speaker 6
The idea was to compare the no-base, no-action scenario with the expected benefits of coordinated action. An important aspect of the study was to make sure that it was robust. Therefore, we included stakeholder interviews, and we did our best to consult with policymakers, industry leaders, patient organizations, and other relevant stakeholders. The idea was not only to validate our findings but also to open up a discussion to understand the practicality of the proposed measures, as well as any potential gaps and challenges, which could allow us to address the fine-tuning of the proposed 31 measures that will be presented later on. And before handing over to Mariana to discuss the proposed measures, I think it's very important to take a small step back to understand what bottlenecks exist in the current state of play.
These include under-integration of European reference networks, delayed diagnosis, limited access to high-cost therapies, insufficient research scale that limits evidence generation, fragmented data and registries despite the current regulatory formats and instruments in place, as well as under-recognized social and caregiver burdens that exist. So, I think all of these together really set a baseline for which we present the measures next. Thank you. Mariana?
Speaker 4
Main findings of the study. But I think it is first important to note that the measures we assessed in the study were built from existing EU policy documents and reports that had already proposed action at the EU level to help take care of these bottlenecks. Several of these measures were also discussed at last December's high-level meeting on rare diseases, in which some of you, honorable members, participated. Also, our assessment of added value is grounded in the current multifaceted EU policy landscape. So, in our view, a potential rare disease action plan would not be a new departure or a new start, but rather a consolidation and a strategic alignment of existing EU instruments that are working, but maybe not to the level we would need or expect.
And in fact, there are currently key legal acts, such as the Health Technology Assessment regulation or the European Health Data Space, that are in early implementation. There are others forthcoming, such as the pharmaceutical reform, the Critical Medicines Act, and the Biotech Act. So we think it's important to allow time for these initiatives to mature before considering maybe more legislation. But it also seems like a good time to act to ensure that they are fully leveraged to take the momentum that this new legislation will bring to help again tackle some of the bottlenecks that Demante talked about. So, across six thematic areas that reflect the bottlenecks presented before, the measures we have proposed are mostly non-legislative.
They're mainly concerned with coordination, funding, provision of guidance, capacity building, and dissemination of best practices. So, starting from the first area on the screen in the slide: diagnosis and screening. We think that, for example, coordination could promote greater conversions in newborn screening, reducing duplication and the administrative burden. In access and affordability of therapies, we think that funding and coordination could support a more collaborative approach to pricing and, even where appropriate, some procurement, always on a voluntary basis. And the EU values improving access to high-cost therapies, particularly for smaller and lower-income member states.
At the same time, this will generate more efficiency gains and simplify procedures in this area. Next slide. Yeah. In research and innovation, funding and coordination could support a flexible EU mechanism to identify unmet needs, for example, instead of set priorities from the start, to see where the research and the evidence bring us, maximizing this way impact and knowledge generation across many rare conditions. With regards to data and registries, we think that funding could support a secure cross-border data infrastructure, fully integrating within the European health data space to build on common standards and offer cost efficiency. It would reduce duplication and enable the reuse of risk data for research, lowering transaction costs.
In social inclusion and family support, coordination at the EU level could help member states develop integrated care pathways, including social and psychosocial support as well. And your added value would come from pulling that expertise together, creating shared frameworks, and also helping reduce long-term indirect costs that are linked to carers and patients having to leave employment because of their conditions. And finally, and maybe it's a very important point here in our research, it became clear to us that European reference networks are a central driver for EU added value, but they remain underutilized. And there are already several initiatives and actions to leverage these European reference networks, but there is still room for further action through targeted funding and coordination to strengthen governance, the integration of the ERNs' international pathways, improve geographical coverage to ensure that all member states participate in reference networks, and also that there are clearer referral pathways for patients to tap into this expertise, as well as a more stable financing arrangement. So, the EU added value would derive from a better use of this EU-shared expertise, this European asset that the European Reference Networks represent.
And now, in the next ten minutes, I would like to thank you very much for your attention and for the invitation to present. It is a real honor to be here, and we would be very pleased to address any questions you may have for us. Thank you very much.
Much.
Adam Jarubas
So much for your presentation. Now I open the floor to Sandd members, first to the rapporteur and afterwards to the shadow rapporteur, Nicolas Gonzalez and Cesare Sassafras. Two minutes, please.
Thank you.
Nicolás González Casares
You, chair. I would like to thank the researchers, and the reporters have done great work here and added value in terms of what we need to do now at the parliament, which is to discuss a plan for red Caesars. 28 to 36 million people suffer from rare diseases in Europe, so they're not that rare after all. They're very diverse, but many people suffer from them. So, that affects a lot of citizens, and we need to deal with this.
This is something that keeps coming up in terms of the measures we need to take to progress here. And then something struck me, which was this postcode lottery. Now, that's the case for other diseases in the EU. Depending on where you live may determine the health outcome. And here, with rare diseases, that happens too.
Right from the start, what is important is the initial diagnosis. That can't depend on where you're born in Europe, whether or not you get that diagnosis for a rare disease. As Europeans, we need to demand the same rights for everybody, at least from birth. So my first question is: now we know that health is a national competence, but here, given transparency in data protection, it's very important that all member states work together. Have you modeled the impacts of minimum principles across Europe for rare diseases?
Respecting national competencies, but being very clear about the added value that you're talking about. And then solidarity, coordinated work, and the need to move forward with the European reference network to make sure that those networks really work properly and have full support. Now, as we've said, many Europeans suffer from these diseases. There are lots of those diseases, but sometimes we're up against a situation where there aren't many people who suffer from a certain disease in a certain member state. So cooperation is essential there, and your assessment recognizes that the SRNs are the most tangible tools for cooperation for rare diseases, but you've stressed how structurally fragile they are.
This added value, do you think it would justify a more active role in the commission on the strategy, more than the current technical support and financing as it is now? Now, I didn't see a reference to something that I would like to know about. Just one more thing, chair. Have you been able to evaluate the MFF? Have you been able to identify that in terms of?
Residences? Thank you.
Elena Nevado del Campo
Thank you very much. Thank you very much for your study and presentation. Now, I think there's a big impact here, a big upshot, which is that we need a European plan for rare diseases. This is something that patients have been calling for a long time, and that needs to be flanked by an update and harmonization of governance with member states. The first issue is late diagnosis, and that is an obstacle that patients are up against in our country, in Spain: late diagnosis of these rare diseases.
It takes 5 years on average, and early detection is one of the most important things here. And this is something that the speaker was talking about: in Italy, there are 46 tests that can be carried out, and there are other member states that only have two tests. So, I think this is something that we should stress: the importance of harmonization. And then an important message is inequality in access to care and specialized care, because that depends on member states and on where you live, whether you get access to that. Now, recently in Spain, there was something very clear in terms of inequality.
People that suffer from a certain skin disorder have said that they have only just got access to cream that is freely available in other member states, and that's not right. Can the EU act in terms of price negotiations and joint purchasing of orphan medication, as Mr. Soko is looking at in the ECMA? Is that a possibility? What incentives do you think are necessary? And then, what would you do in terms of shared data for diagnosing rare diseases?
Thank you.
Marie-Luce Brasier-Clain
Thank you very much, Chair. Thank you very much to the researchers for the very interesting presentation. We need better joint research. And, by definition, rare diseases only affect a small number of people. And the fact that they are rare means that there isn't really economic interest for laboratories to get involved, which is why we need to support the public authorities.
Everybody needs to play their role: the European Union in encouraging European networks with reference centers and by authorizing the placing on the market of treatments, and states need to do their bit to ensure that diagnostics work properly. We know what the challenges are. The current fragmentation is bad news for patients, especially in terms of diagnosis, data sharing, and access to innovative therapies. This explains why the EU is not really attractive in terms of clinical trials. Last year, we had the regulation on Griggs' diseases, and that should lead to more sovereignty and more efficiency.
We need to improve the attractiveness of the EU for clinical trials and the development of laboratories of excellence. I have two questions and comments. First of all, do the solutions that you are putting forward mean more centralization, common infrastructure, and harmonization of practices? Above and beyond the principle of subsidiarity, are we not taking the risk of greater bureaucracy here? Secondly, access to treatment.
You rightly stress that there are market weaknesses and the very high prices of orphan medicines. But how can we avoid a European response that discourages the biotechnology innovation we need? Thank you. Thank you.
Billy Kelleher
Thank you very much. Just to thank you for the presentations. And, obviously, I'm involved in the repertoire of an initial report on rare diseases. And I think the issue here that we really have to address is the fact that Europe is a cold place for innovation, research, and competitiveness in general, and it's something that we have to accept very quickly. I know the commission is coming forward with very omnibus and other pieces of legislation to unwind the complexities of the European regulatory architecture.
But at the same time, I don't believe that is enough to stimulate investment and innovation in the whole area of research around rare diseases. And the reason I say that is, if you look at the number of clinical trials in Europe vis-à-vis the United States and more recently in Asia, we clearly are a long way off and not an attractive place either for the initial phases of innovation and research, and ultimately the launching of medicines or therapies for rare diseases. And that is an area that I believe we have to react very quickly. So in doing that, I think we have to, first of all, ensure that the intellectual property rights are protected as was proposed. And I know that we've had long debates on this particular issue, but at least we've come to a conclusion now in Europe.
We do need to ensure that regulatory data protection and intellectual property rights are protected to incentivize companies in the whole area of research and development. From the clinical perspective as well, I think the European reference networks are functioning. I know that a lot of countries still have the obsession with oversight from a national perspective. But I believe that we have to start moving to a more integrated European Union in terms of medicinal efficacy, in terms of assessing medicines for their efficiency and efficacy, and that we should have a more centralized system for doing that. And then ultimately, the issue of reimbursement, which is a very difficult one for us to discuss in my own group and more broadly within the various political groups across the European Parliament.
But we have to get to a stage where there are actually efficiencies in the reimbursement of medicines. So, I just think that's a key area as well that should be discussed when we're talking about rare diseases. Thank you very much.
Adam Jarubas
Thank you. We've just finished the reporters' round. We're starting with the second one. Oliver Shenk is the first, please. Sorry.
Yeah. Thank you.
Oliver Schenk
Thank you very much. Thank you very much for this comprehensive report. Microphone, please, for the speaker. We've lost the microphone for Mr. Schenck.
Oliver Schenk
Start from the beginning. Yeah? So.
I have a couple of brief questions for you. First of all, when you assess the situation, where did you see measures that, in the last few years, have really been efficient and have made real progress? The centers of excellence, patents, and also better funding of research and care. Where can we make progress there? Are there any concrete footholds that we can latch onto for our future budgetary discussions?
And the second question, the big issue at present is, of course, trade policy. Are we dependent on the U.S.? S. When it comes to medical products and devices, what is the process? And what about this new trade policy?
And what do we need to be aware of on that? Thank you.
Adam Jarubas
We have Nicolas Stefanotta, a shadow reporter from Greece. Go ahead, please. Yeah. Thank you.
Martin Häusling
Thank you very much, Chair. Stéphane, unfortunately, can't be here today, so I'm speaking in his stead. Thank you very much for the presentation of the study. Very important issue, and thank you very much also to the rapporteur. We agree on many things.
I think that rare diseases might only affect a small number of people. But when you look at the EU as a whole, it's about 30 million Europeans who are affected by these rare diseases, and they include children. That's 700,000 to 2 million people with rare diseases in a certain member state, and we've said that there are issues with diagnosis and treatments. There's a lot of inequality across the EU, so we need to act. Better standards, better-qualified staff, better screening.
This is a way to save lives, ensuring access to medicines and providing support to medical staff. We can't wait any longer. Coordination at EU level: we need more money to ensure that we don't leave any patients behind, and we have a duty of care as the European Union. We need to ensure the right to treatment so that no matter where someone lives, nobody is left behind. My colleague is looking forward to working together with the rapporteur and making progress on this issue.
Thank you.
Vytenis Povilas Andriukaitis
Thank you very much indeed. I would like to raise only one question for you. You know that everyone here is repeating that health care and care systems are the national competence of member states, but no single country can solve these problems alone. No one. No one country has the capacities to diagnose and so on.
No one country can move forward alone. My question is, do you think it is time to raise questions about the necessity to propose something in shared competencies, solving problems of 36,000,000,000 patients? Can you imagine? We established European Reference Networks in 2017, but until now, they have not had stable financial support. And only 4,000 patients were consulted in those 10 years.
It's ridiculous. It's a shame on the European Union. Let's encourage the commission to be much stronger, and let's see how we can mobilize member states to understand that they are not capable of solving this problem alone.
Stine Bosse
Thank you very much. And I guess a little on that note. I do agree that the financing of the EIN systems and even the health data space building should be at the core of our minds. And I hope that all members of this committee will put mild pressure, or even a bit more than that, on colleagues in the batch, colleagues working with the next MFF, and colleagues working with the ECF to make sure that we actually get not just words around this, but actual action, and that we invest together because this is what we need. And for nations to see that the EU comes up with finance for this area, that is what we actually can do.
And then, of course, we can also talk to our member states at home. Then, I just want to draw your attention to something else here: the theme two on access and affordability is that patient access will likely come under even greater threats due to the most favored nation policy adopted by the US administration. Drug launches in Europe will be staggered or canceled, and I fear that orphan drugs will be especially strongly impacted. Have you looked into this, especially? And I just want all of us to know that this is a real threat for all countries, but especially for countries that we know even now have less or worse access than others.
Thank you very much.
Thank you. Catarina Martins.
Catarina Martins
Thank you very much, Chair. Good morning, everybody. I would like to thank the panelists for their report back this morning. Thank you very much for being with us. We're talking here about the best way we can innovate medicines in the European Union so we can meet the needs of people affected by rare diseases.
We know this is complex. We know it's multifaceted. We have also been looking at critical medicines. We have the Critical Medicines Act. We've reached the trial of that, and that will, of course, have ramifications for rare diseases.
So, my questions are the following: What already exists? And how can we ensure that patients have better access to the medicines that already exist and the solutions that are already out there? That's a very important point. And if I correctly understood you, you said that we need a better framework for cooperation more than new legislation. So, my question is: how can we ensure that across different countries of different sizes, where you have different critical masses when it comes to the number of people suffering from rare diseases?
And, you know, some health systems are more fragile than others. But how can we ensure a framework that enables everyone to have access to what already exists? Have you taken this aspect into account during your study? How can the EU play a more significant role? Of course, we are currently discussing the MFF.
How can we best use the financial tools at our disposal to ensure that we promote more solidarity on rare diseases? I think that is the only real solution to ensure that everybody has access to the best possible therapy. Thank you.
Kateřina Konečná
Thank you very much for the presentation. I just wanted to ask a simple question. Why are we still not succeeding? Why is there still success? These things, we've been hearing for the past 5 years as we've been discussing the action plan.
I understand that it has not been fully approved and that member states are still discussing it. But all the problems that you've alluded to, including the proposed solutions, are things that I have personally heard at least 20 times over the past five years. Why do you think it is not a success yet? Why are we not moving it forward? Sitting here, say, 3 years from now, I'd be worried that I'd be hearing the same.
Of course, it is in our hands as politicians and policymakers, but I believe there are many technical and legal barriers. I'd like to hear more about that. Hmm.
Sirpa Pietikäinen
Thank you very much. Most of us are on board and realizing the same problems at the moment. We are severely lagging behind the USA and practically China in the development of treatments for rare diseases. The member states cannot do it alone. It is the research and development.
It is about orphan medicines. It is the care model for the patients. And we would need to have a package to act. And this is, of course, the funding for R&D in different fields on the MFF. It means justified access for patients to seek therapies and treatment in other member states because it is rare.
You can't have all the knowledge in all of the member states. It means the joint procurement of medicines and, yes, indeed, the reimbursement. That means that when it is accepted and funded by the joint procurement fund, everybody all over Europe should have it. It's a big change. Not only plans, strategies, white papers, or whatever won't deliver it.
So, the next step is that we should be pushing the commission to act on this, with the direction to pressure the member states.
Adam Jarubas
Thank you, Silpa. And the last question is from Margarita Della Pisa Carreon, please.
Thank you.
Margarita de la Pisa Carrión
Thank you very much, ladies and gentlemen. Chair, thank you for the studies from the European Parliament because it's quite astounding. This study shows that it is important to strengthen research and innovation, particularly in biotechnology and advanced therapies, to provide a true response to rare diseases and guarantee our autonomy in this area. But the reality is that Europe is losing leadership to other regions partly because of the regulatory framework that is increasingly uncertain, which puts a break on SMEs innovating and means that lots of projects are outside the EU. Many rare diseases have a genetic basis, so progress means hope for early diagnosis and treatment.
If we don't make the environment more attractive, then the risk is that we won't have these therapeutic tools, which are sometimes available outside. So the BAERITA CAT study is important because it looks at orphan medications and so on being produced in Europe and accessible to patients. There's been an analysis of other legislative bottlenecks that affect medication in other areas, which are factors to achieving those goals. So, you need incentives, but at the same time, there are big obstacles, such as the directive on water residue, which makes it harder to get access to medication in Europe.
Adam Jarubas
Now, I will give the floor to our experts. Could you please answer the question? Keep the total time to ten minutes. Okay? Let's try.
Speaker 4
Thank you, sir. Thank you, everybody, for your questions. Well, there were a lot of questions, so let's try to keep it to ten minutes. But starting with the first references to the postcode lottery, issues with diagnosis, screening, and so on. I would like to draw your attention to the fact that, in our study, we focused on the issue of newborn screening and how it could be expanded and further harmonized in a dedicated case study that contains a lot of information on that.
And there is, in our view, room for further coordination in this area. And we suggested some measures there, including, for example, the setup of an expert panel for coordinating newer screening across the EU. So, even within the existing framework, there is room for that. Also, I would like to explain again that we conducted an in-depth legal analysis as part of the study. So, we have been careful in respecting the competencies and the existing legal framework.
And having said that, we've considered that there are still a lot of things that could be done at the EU level using the existing framework. So, we are respectful of national competencies in what we have proposed. In terms of joint procurement or joint negotiation of medicines, we think that in the current framework, there is space for that, but on a voluntary basis. Having said that, it could take different shapes and forms. It could be something more elaborate in terms of buying certain medicines together, but it could also be something lighter, such as sharing suggestions and ideas on how to tackle these issues on pricing. We haven't looked at reimbursement specifically because that is not something that you can act on.
Again, I think, sorry. I'm trying to go through the list. Demente, do.
Speaker 6
Do you have it? I would just like to add on the second question about joint procurement and voluntary sharing that Mariana was reflecting on. And, as we said, it's very important that this is voluntary and that we propose these recommendations within the EU's legal mandate. So what we are essentially stressing is competence sensitivity and measure specificity, and these voluntary information exchanges and price sharing discussions do not necessarily have to happen at the European level. There could be options for regional cooperation and information exchange to ensure that there is mobility in place, discussions are open, and patients are informed about their potential pathways.
So, just to add to that.
Speaker 4
Yes. Thank you, Deimante. Then there was also a question about measures that have already been efficient. I mean, I think it looks like, you know, because there is this need for patients with rare diseases. So it does look like there hasn't been enough action, or not all the measures have been sufficient.
But we think that there are some efficiencies in terms of, for example, funding for research. The EU has invested an important amount of money in research. There's also, again, the issue of the European reference networks. As it was referenced before, they existed in 2017. It's been a long time, but I think, in the great scheme of things, they're fairly recent, and they show the potential for collaboration. They have achieved a lot in a short time.
So, the issue with this is probably that they are underutilized, and there is a lot more that can be done. And in a way, us with rare diseases, we see that the landscape, or the current ecosystem for tackling rare diseases at your level, is a bit heterogeneous and scattered. Sorry. But they could, through initiatives like the ERNs, be connectors in this ecosystem and help tackle these bottlenecks jointly. So, yeah, there is already some efficiency, but more efficiency can be gained.
On the issue of trade, I have to say that we have not looked at that specifically. Our study was based on, as we said, a literature review. It was a rapid review because the time frame we had for the study was quite short. So, we had to focus a lot on what has already been assessed and established as evidence-based. And we were conscious that things were moving on; we also wanted to consult key stakeholders on the ground.
But this issue didn't come up as clearly in what we assessed. But I think it's an interesting point. I know that it came up in other questions, and it is something to consider. But as the work for the EU action plan of rare diseases evolves, maybe it's something that could be considered in more detail. Again, Demanti, if you...
Speaker 6
I want to. Thank you very much. I also wanted to reflect on the questions relating to innovation and attractiveness, especially in light of the competition and, of course, abroad. So, we didn't look at these differences, but what really stood out is that we shouldn't be looking at cooperation, collaboration, and innovation as opposites. It's very important to look at them as reinforcing pillars of one another.
So what our measures really understood is that access and innovation are linked, and it is important to focus on reducing fragmentation, improving post-launch evidence gathering, and making pathways more predictable rather than weakening incentives. So, it's very much interlinked. And by improving collaboration and cooperation, you are ultimately providing better tools for that innovation to foster. Thank you.
Adam Jarubas
Thank you very much. Thank you for your work and your presentation today. The fight against rare diseases is a big work. We know that we have great work ahead of us. Your work, your presentation, and your report are very helpful for our work.
We need more money. We need more friend-friendly legislation. So, it was, I think, a good discussion today. Thank you very much. Okay, colleague.
The next point is to vote on the guidelines for the 2027 budget. Let's have a one-minute break to prepare well for that. Thank you, of course. Thank you very much.
Guests.
Adam Jarubas
Dear colleagues, please take your seats. We will start the vote in a moment. As I said, our next point is a vote on the opinion on guidelines for the 2027 budget. On 18th December, coordinators of Sun decided that the committee's contribution to the guidelines for the 2027 budget, section three, should be in the form of a letter from the Sandd chair addressed to the budget chair. The vote on this opinion will take the form of a single roll call vote.
Let's now proceed to the vote. At the beginning, we will try.
Test.
Adam Jarubas
Testing vote. Of course, I open the vote. We close the vote. There are too many voters. No?
It's okay. I close the vote. Yeah. Thank you.
Test vote. Yeah. Yeah. Yeah. Yeah.
Adam Jarubas
It was a test vote, of course. Yeah. As I said. Okay. Let's go to the regular vote.
I open the vote. I close the vote. Adopted. Thank you. Dear colleagues, our next point is the report back to the committee on the trial of the Critical Medicines Act.
On February 2, the first trial of CMA took place, during which we exchanged views with the council presidency on key political points and our negotiation position. During the meeting, we agreed to use the four-column documents as a basis for the negotiations. We also agreed to mandate the technical level to prepare the negotiations and work on technical issues. The meeting was conducted in a very good atmosphere. I would like to thank the rapporteur and shadow rapporteur for excellent cooperation.
Now I will give the floor to Tomislav Sokol, our rapporteur on this file, to report back on the trilogue. Tomislav, the floor is yours, please.
Tomislav Sokol
Thank you, Chair. So, I will skip right to the point. As you know, the kickoff political trial took place on February 2nd. And, first, I would like to thank you and the secretariat for the strong support in organizing and hosting this first political trial. The council is represented by Minister Nefitos Haralambidis, I hope I pronounced it correctly, and the commission by the Director General of Digi Centre, Madame Galina.
Following the council's introductory remarks, we presented Parliament's mandate. During this first trial, we approved the four-column document, and all three institutions agreed to mandate the technical level to begin discussions on the positions of the Parliament and the Council across all issues reflected in that document. More specifically, the technical discussions will aim to, first, identify areas where the positions of the two co-legislators converge. Such points may be considered provisionally agreed upon, on the clear understanding that nothing is agreed until everything is agreed. Second, to overcome differences between the Parliament and the Council and address provisions of a technical nature.
Three, where agreement cannot be found at the technical level, refer those issues back to the political level and explore possible solutions to political issues in order to prepare future negotiations and facilitate agreement at forthcoming trials. In parallel, negotiations at the technical level are already advancing, which I'm very glad about, and we are now preparing the second political trial, which is expected to take place on March 16. This structured approach should allow us to make efficient progress while fully safeguarding Parliament's mandate and political priorities. So, essentially, as usual, the first trial log was about stating the positions of both co-legislators and also the Commission by giving a mandate to the technical level to proceed with negotiations. Of course, we didn't agree on anything substantial in the first trial log because that's just the procedure.
And now we are already working strongly on the technical level to come to the first trial in March, with some concrete things to discuss on the political level. Again, I would like to thank all of you for your support. We have a very strong mandate from the parliament, with more than 500 votes in favor, and this gives us a strong incentive to fight for our main political priorities. So, thank you very much.
Adam Jarubas
Thank you, Tomisla, for your work and your report. Is there anyone who wants to ask or comment? If not, okay. Thank you. Dear colleagues, I close this morning's meeting.
We'll meet again this afternoon at 2:30 in the same room. Now you are all invited to attend the special plenary session that marks 4 years since the Russian war of aggression against Ukraine. It will start at 10:15. Thank you all.
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