Committee on Public Health Ordinary meeting

13 July 2026

SANT European Parliament

Follow its sittings
07:37 - 10:04
Speaker 1
Okay, dear colleagues, ladies and gentlemen, let's get started.  Welcome to the full and substitute members of the SANT committee.  Point one, adoption of the agenda.  Can we adopt the agenda for today's meeting?  Thank you, the agenda is adopted. 

Point two, chair's announcement.  I'd like to inform you the summary of the decisions taken during the SANT coordinators' meeting on 24th of June was circulated by the secretariat on 26th of June.  Point three, adoption of minutes.  This applies to two meetings, the 3rd June and 24th June.  Can they be deemed adopted? 

Thank you.  Point four, adoption of joint meetings.  This applies to three meetings, 24th March and 3rd June SANT-EMPL, and the 3rd June joint SANT-DEVE.  Can they be deemed adopted too?  Thank you. 

Now let's move to today's meeting.  Dear colleagues, the first item on our agenda today is the reporting back from SANT delegation to Washington DC and Pittsburgh, USA, from 26th to 28th May.  The delegation chaired by MEP Ignacio Marino was composed of six members in total.  The objective of the mission to Washington DC and Pittsburgh was to build upon existing transatlantic relation and open new pathways.  The debates and the visits were enriching and fruitful and the mission was a full success. 

The meetings the SANT committee had make a significant contribution to continuous transatlantic dialogue and deepened the interparliamentary relation on which we will build.  The secretary currently looks for opportunities for a further exchange with the Center for Disease Control.  Now I would like to give the floor to chair of the delegation Mr. Marino for four minutes to report back from this mission. 
10:04 - 14:59
Speaker 9
Thank you very much, Mr. Chair.  If we had this mission as you said between May 26 and May 28 with six members of the committee from different parties.  May I have the next slide?  The main topic and the main goals of the SANT committee was to discuss about global health reflecting shifts in US global health strategy, the second healthcare workforce challenges shared on both sides of the ocean, and also as a third point engage with SANT counterparts in the US.  This was particularly important because it was the first trip of the SANT committee in the United States and we met with members of the Congress, the State Department, and all the most important federal agencies, Food and Drug Administration, Center for Disease Control, BARDA, and then the last day to a center of excellence which was the University of Pittsburgh Medical Center. 

Next slide please.  I think this is a very important message for us as a member of this committee because we were kind of surprised and kind of happy realizing that the meeting with think tanks that did a very, very diligent work, we realized that the American citizens, both Republican and Democrats, had a different vision from the administration. 

And here I want to highlight the first three histograms.  The first is about providing medicine and medical supplies to developing country, 83% of the American citizen agree with this.  Providing food and clothing to people in developing countries, 78% agree.  And about supporting economic development in developing countries, 63% of the Americans, both Republicans and Democrats, agree.  So this is a very important message how the population thinks, how the administration think. 

Next slide, we had, thank you to the people that and Julia and the other people that organized this trip, we had the meeting with top level of the two main medical association, the American Medical Association and the American Public Health Association.  The first obviously is more focusing on physicians and the second more of the access to public health for the American citizen.  And we discussed about issue that actually look very similar between the two continent: worries about workforce shortage, rural access, anti-science trends and misinformation.  If I have the next slide, this is also very important because the State Department in a very solid way they obviously as expected they supported the administration.  So the message was America first global health strategy, so walking away from the WHO and having only bilateral agreements with different countries and not, you know, with all the countries through an agency like the WHO. 

Next is about the committee in the Senate.  Again, the approach was very similar and they discussed about bilateral memorandum of understandings with different country, even if we have a current Ebola outbreak in Uganda and Congo.  Next slide, again very interesting because the Center for Disease Control and Prevention very candidly told us that they didn't feel really good because they actually went to Congo meeting with the other people from other parts of the world to discuss what should we do for the Ebola for the Ebola infection.  And they said that they had the order from the administration to sit but not to ask questions to the WHO.  They could only listen and they didn't feel very good about about that, but they had to do what the administration told them to do. 

14:59 - 16:34

Ignazio Roberto Marino

The next and next slide and then we have another one, but in Pittsburgh, Pittsburgh was the place where liver transplantation was actually developed in the in the 70 and the 80 of last century. And obviously transplantation is still very important, but they are focusing now on regenerative medicine, so in the future maybe we don't need to have organ transplant because we can treat patients with regenerative medicine. Very interesting, actually shocking to me, was the level of advanced research in the so-called electronic retina project. They are very, very close to have an electronic retina that can actually be implanted in newborns that are blind making them, you know, able to see.

The last slide is, you know, the conclusion and follow-up. The mission confirmed the importance of EU-US public health dialogue, and the US policy is shifting towards bilateral interest-based partnership, but we had the feeling from the most important stakeholders that America actually would like to be back on the global health, but at the present time they cannot because they have a clear order from their administration. Thank you very much, Mr. Chair.

16:34 - 16:47

Adam Jarubas

Thank you, Ignazio, for your presentation and leadership during the mission. Are there any questions or comments to this report? Andrus Kulia and then Stine Bos.

16:47 - 21:10

András Tivadar Kulja

Thank you very much, Chair. Dear colleagues, I would like first to express my sincere thanks to everyone who made this mission possible. In particular, I would like to thank our secretariat, our staff, and political advisors whose hard work and careful preparation ensured an excellent program for us. And also want to thank all colleagues who participated and especially to our chair, Professor Ignazio Marino, for his leadership through the mission. During the mission, we engaged with a broad range of stakeholders from American policymakers, think tanks, to public health leaders, researchers, and some of the world's leading experts in Pittsburgh.

The timing of this mission was particularly important. United States has withdrawn from the World Health Organization and global health security, but we face a significant challenge now, including emerging infectious diseases threats and like the recent Ebola outbreak. So maintaining a strong transatlantic dialogue is more important than ever because public health challenges do not stop at national borders, neither should our cooperation. And also we see other challenges in the health policy in Europe, which is related to new policies in the US. But I would like to highlight maybe one part of the mission, our visit to Pittsburgh, because it's very interesting that Pittsburgh has a remarkable transformation, economic and also social transformation, because it was once known as a center of the American steel industry and the city faced a severe decline following the collapse of the sector and losing more than half of its population.

But rather accepting decline, it reinvented itself through investment in education, research, healthcare, and innovation. So it was converted from an industrial city to a science and medical hub. And the city has 300,000 citizens and 100,000 people working for the Pittsburgh Medical Center, which is amazing.

And it's one of the world's leading academic centers in child transplantation. And it was very, very valuable to see how well recognized and appreciated is our chair, Professor Ignazio there, who used to work there as a professor. So just to one comment that as a doctor myself and politician, I was particularly inspired to see how decades of sustained investment in science and especially in medicine have transformed not only healthcare outcomes, but the entire region and the economy and development of the region. So our discussions in Washington also reminded us that despite differences between the Europe and US healthcare systems, we face many common challenges, as it was said by Professor Marino. And the workforce shortage, chronic diseases, healthy aging, preparedness for the future emergencies and ensuring that innovation remains accessible for patients.

So even where our healthcare systems differ, there is much we can learn from each other. And also in these challenging days and geopolitical situation, it is very important to continue and strengthening our cooperation. And thank you very much.

21:10 - 21:13

Adam Jarubas

Thank you. And Andreas Stine-Voss, please.

21:13 - 22:25

Stine Bosse

Yes, first of all, thank you very much for your comprehensive report and also for your further comments. I have a couple of questions. One regarding the consequences of the withdrawal from WHO. We spoke about it in this room, I mean not this room, but in ENVI Committee early in our mandate, where we also discussed that there will be consequences for us in Europe when this happens. And we see them already.

Did you bring this subject up? And how was it received, not by the sort of the NGO sector or think tank sector, but by the political environment? And second, on the same note, the most favored nation legislation that is now in place and which is really, really harming Europe, not only the pharmaceutical sector, that's bad enough, but at the end of the day, the whole thinking around the universal healthcare system is under attack in the way that they are now conduct themselves. Did you talk about this and what was their, if you did, what was their reaction to this?

22:25 - 22:28

Adam Jarubas

Thank you. Ignazio, could you comment the question?

22:28 - 24:16

Ignazio Roberto Marino

Thank you very much. Very important questions because Andreas was there, so maybe he would like to confirm or not what I'm going to say. But the feeling that we had as a committee is that unfortunately they had a clear order to walk away from WHO. But the people more involved, like the Center for Disease Control, they felt a kind of ashamed about that. And they could not say, but we could read from their body languages that they really would like to be back.

And as you said, the consequence are really dramatic because, you know, at the present time, we European, I don't think we are ready to fill the gap left by United States in international and global health. And this issue, for example, of the Ebola, could be a really dramatic. As you probably know, we already have a patient in France.

And this disease is terrible because we have no treatment, no vaccine, and actually not even treatment to support the bleeding of these people. They bleed inside of the body, outside of the body, and the only thing is to support them and see if they can survive, but it's really grim and bad. The other was about the...

24:16 - 24:24

Stine Bosse

The most favored nation legislation where they actually try to steer the pricing of our medical and medicine products.

24:24 - 25:34

Ignazio Roberto Marino

Oh, that's actually really, really bad because, and you did, it's very important that you raise this and I'm happy that we have also Tilly Metz here that worked on the critical medicines because, you know, the administration is insisting on a concept that they are paying the innovative drugs because they pay the NIH and then they give grants to the people that are developing the molecule up to the step that it can be used on human beings. And they obviously see that the same drug is sold for a much, you know, smaller price in Europe than United States. So the idea that they are trying to give to the drug company is not to sell, I mean, not to sell the drug...

25:34 - 25:39

Adam Jarubas

Okay, colleagues, because we should go further, sorry.

25:40 - 25:41

We should finish.

25:41 - 25:48

Ignazio Roberto Marino

So, and then there is the risk that we in Europe will be without some innovation in drugs.

25:48 - 27:33

Adam Jarubas

Thank you, thank you Ignazio for your report. From what I know, we received a written report to our emails, so let's go further. Our next item on the agenda is the reporting back from SANT ad hoc delegation to Geneva in the occasion of the 77th WHO from 20 to 22 May. The delegation was composed of six members in total. The objective of this mission was to meet representatives of the WHO to gain a comprehensive overview of the WHO's work and priorities, as well as the challenges it faces in the current global context and to discuss health subjects relevant to SANT's work program.

The delegation met with WHO leadership and technical experts including the EU delegation to the UN in Geneva and WHO's science division, the health systems and prevention divisions, the tobacco control unit and the pandemic agreement secretariat. They also exchanged views with the WHO regional director for the Europe, Dr. Hans Kluge. In conclusion, the mission was very successful, the debates and visits were enriching and fruitful, providing valuable insights into WHO's role in global health governance and strengthening SANT's understanding of critical health challenge.

Now I would like to give the floor to the chair of the delegation, Tilly Metz, for four minutes report back, please.

27:33 - 33:22

Tilly Metz

Yes, it remains in green hands also here. Thank you very much, dear chair, dear colleagues. This year's World Health Assembly took place in an indeed exceptionally challenging context. So it was already mentioned by Ignazio and also Stine and by others, the withdrawal of the United States from the WHO, broader also geopolitical tensions that we have, increasing pressure on multilateral institutions and financial constraint have inevitably, of course, accelerated discussions on the future of global health governance and the role of the WHO within it. If I'm not wrong, I think that in certain services of the WHO, they had to reduce human resources by nearly 25% and also they had a reorganization of the whole WHO because of the withdrawal of the United States.

So they very quickly reacted and also defined their new priorities, coming back to core business. So against this backdrop, one message emerged very clearly throughout our mission. So today, investing in health means investing in resilience, security, and preparedness. So during our meetings, it there was really a broad consensus that health can no longer be viewed solely through the lens of healthcare delivery. Health is increasingly interconnected with climate change, biodiversity loss, demographic change, digitalization, and geopolitical stability.

So the delegation had the opportunity to exchange views with WHO senior leadership, and it was already mentioned by our chair, including WHO regional director for Europe, Dr. Hans Kluge. And one recurring theme throughout our exchanges was really the preparedness. So the experience of the COVID-19 has fundamentally changed the international debate that we have. So preparedness is no longer understood simply as the ability to respond to emergencies once they occur, but should be seen as a continuous investment in resilient health system and also a well-trained health workforce, surveillance capacity, scientific cooperation, secure supply chains, and stronger international coordination. So this was particularly evident in our discussion on the implementation also of the WHO pandemic agreement.

So negotiations are currently continuing on the pathogen access benefit sharing, the so-called PABS annex, which will be essential to ensure also a rapid sharing of pathogens while promoting more equitable access to vaccines, diagnostics, and therapeutics during future health emergency. So again, international cooperation is key also here in sharing of pathogens. So our exchanges made it clear that these negotiation will remain one of the key priorities in global health over the coming months. Other discussion also focus on issues that are equally relevant to the work of this committee. For example, the antimicrobial resistance, the growing burden of non-communicable diseases, tobacco control, mental health, health workforce shortages, as well as the opportunities and challenges presented by artificial intelligence and digital health.

Also these topics may appear diverse, they were consistently approached through a common lens, and that is prevention. Whether discussing on cardiovascular diseases, cancer, antimicrobial resistance, or future pandemic, WHO representatives repeatedly stressed that prevention remains the most effective and sustainable investment for building resilient health system.

So I would like also to draw your attention to another central issue: trust in science and in medicine. Several interlocutors, and that were also very interesting discussion we had, expressed growing concern about the spread of misinformation, declining public trust in science and increasing political pressure on evidence-based decision making. So more and more politics comes in also in medical discussion. Maintaining scientific integrity, ensuring transparent communication and strengthening multilateral cooperation were repeatedly identified as essential prerequisites for effective public health action. So dear colleague, at the time where the organization is adapting to an evolving financial and geopolitical landscape, the European Union remains one of the WHO's strongest, and even more strong now, political and financial partners.

Our presence in Geneva therefore send an important signal of the European Parliament's continued commitment to multilateral cooperation in global health. I try to resume. So let me conclude by thanking the committee secretariat and all colleagues, it was really a very, very interesting and very efficient mission, but all the people involved in the preparatory work for ensuring the success of this mission. Thank you very much.

33:22 - 33:26

Adam Jarubas

Thank you Tilly. Any comments? Stine, please shortly.

33:26 - 34:16

Stine Bosse

I promise you to be very short. I just want to thank you all again for taking that mission. I was part of it last year. I found it extremely interesting and I found your report is following exactly the same path as what we experienced. I just want to bring to our common attention one fact.

The contribution to the WHO from the EU countries, like all of us plus what we do together, is the double of what US contributed before they left. This we should all know. And that is why, I mean, they want to engage with us, I mean, because we are clever and we are nice people, but also because we are the funding fathers and mothers.

34:16 - 34:19

Adam Jarubas

Gerard Hauser please.

34:19 - 36:17

Gerald Hauser

Dankeschön. Zur Finanzierung der Weltgesundheitsorganisation muss man schon einmal feststellen, dass diese überwiegend, nämlich in etwa zu 80 % durch private Geldgeber finanziert wird und nur in etwa 20 % werden durch öffentliche Beiträge aufgebracht. Und die privaten Mittel werden verwendet im Wesentlichen so, wie das die privaten Geldgeber wollen. Der größte private Geldgeber für die WHO ist die Bill and Melinda Gates Foundation, und die hat natürlich ihr eigenes unmittelbares geschäftliches Interesse auch, die Gelder dementsprechend investiert zu haben. Und man müsste schon drauf schauen, wenn die Weltgesundheitsorganisation den Anspruch hat, tatsächlich für die Gesundheit der Menschen da zu sein, müsste man drauf schauen, dass die öffentliche Hand die Mehrheit in diesem Gremium hat und auch darüber entscheidet, was mit den Geldern der Weltgesundheitsorganisation passiert.

Noch einmal, derzeit ist es ja so, dass 80 % der Gelder durch private Geldgeber aufgebracht werden und die im Wesentlichen festlegen, was mit diesen Mitteln passiert. Und das, das ist, das ist ein, das ist ein Riesenproblem. Damit ist die WHO natürlich nicht unabhängig von diesen privaten Geldgebern. Und damit hat sie auch nicht den Anspruch, immer im Interesse der öffentlichen Gesundheit tätig zu sein. Ist ja logisch, wenn private Mittel in eine Institution reinfließen, dann entscheiden auch die privaten Geldgeber, was mit diesen Mitteln passiert.

Und so schaut vielfach die Politik der WHO aus, weil sie im Wesentlichen, und das haben die Vorredner hier festgestellt, ich höre ja nur Impfungen, ja. Es geht ja nur mehr um Impfungen. Das ist scheinbar das einzige Programm, das im Wesentlichen die WHO hat, weil die privaten Geldgeber übermächtig sind.

36:17 - 36:20

Adam Jarubas

Can you summarize shortly, please?

36:20 - 37:21

Tilly Metz

Ja, vielen Dank für die Intervention, aber das ist, das ist eben genau das, was man, was man richtigstellen muss. Ich kann Sie nur einladen, es waren auch Kollegen, Kolleginnen von Ihnen dabei in dieser Mission, und wir haben ganz genau das natürlich auch angesprochen, die Unabhängigkeit der Entscheidung, und die Basis ist die Wissenschaft und nicht irgendeine Foundation, die da mitredet. Also das, das ist nicht so. Das sind eben genau diese Desinformationen, die verbreitet werden. Ja, die WHO ist in der Hand von Bill Gates.

Come on, dann kommen Sie doch bitte mit nächstes Mal und informieren Sie sich und stellen Sie alle Ihre Fragen der WHO. Hinterfragen, kritisch sein, das sollen wir auf jeden Fall. Aber so Sachen zu verbreiten, dass die WHO in der Hand von Bill Gates oder anderen ist, das ist einfach, das ist einfach, ja, das sprengt ein bisschen aus der Kiste. Aber ja, aber trotzdem gut, dass Sie es sagen, und bitte kommen Sie nächstes Mal mit, das würde mich sehr freuen.

37:21 - 39:09

Adam Jarubas

Dear colleagues, we're running out of time, we should go further, please. Thank you. We may consider the mission report to be adopted. Dear colleagues, the next item on our agenda is the presentation of the EPRS study on mental health of young people in a digital era, cost of non-Europe report. Following the decision taken by the ENVI coordinators on 14 May 2025, the European Added Value Unit of DG EPRS was tasked with the development of a cost of non-Europe study entitled Mental Health of Young People in a Digital Era.

The study was published in July 2026 and shared with you ahead of this meeting. The study examines the societal and individual impacts of youth mental health issues in the EU, highlighting the potential benefits of coordinated actions to address this challenge and thereby reducing the cost of non-Europe. I will now give the floor to the authors of the study for their presentation, Mr. Martin Kuenemund, head of the EU evaluation at Ipsos, and Mr. Yannick Vuylsteke, associate director of the policy and evaluation unit at Ipsos. I will now give the floor to our speakers for their presentation and after to the members for the Q&A session. Mr. Kuenemund, you have, we have eight minutes for both presentations.

Mr. Kuenemund, could you start, please?

39:09 - 41:47

Martin KUENEMUND

Yes, thank you very much, Chair. Good afternoon, it's a great pleasure and privilege to be here today to briefly introduce some key highlights of our study, as just mentioned, that we've been working on for the last nine months more or less on behalf of the committee and on behalf of EPRS and with the very helpful guidance and support from in particular Filippo and Claudia, who is sitting over there. I won't go into a lot of detail, I leave it to Yannick to speak about the key findings, but just wanted to briefly, very briefly introduce what we've done. And if you can go to the next slide, please. So this is, this is only the agenda, a few points that we will talk about.

This is the one I wanted to briefly talk about. So as was mentioned this is a cost of non-Europe study. It's quite a broad-ranging study. We took a broad focus here and really began by looking at the current situation. The nature of the current mental health problems among young people the scope of those including the economic consequences.

We looked in particular and focused on the digital side of things. So the digital factors and if and how the digital environments and recent developments within it exacerbate the existing mental health problems. But then crucially we also looked at options for EU action. So we looked not only at the cost of non-Europe but also at how the EU could act to help alleviate this crisis and thereby to reduce the individual but also societal costs thereof. We based ourselves on basically three main methods.

So we did an extensive literature review. I should focus really I should emphasize that this is an evidence-based study. So we really based ourselves on the existing evidence and not on not on our personal views. We reviewed a large amount of literature both scientific and grey. We did a policy and legal mapping at the EU and the member state level including seven case studies where we looked at very specific interventions in a range of countries including a few non-EU countries.

And we also developed an economic model in order to be able to project into the future the prevalence trends and the associated economic costs of those. So that's in a nutshell what we did and I'll pass the floor to Yannick to talk you through some key findings.

41:47 - 50:59

Yannick VUYLSTEKE

Thanks Martin. Next slide please. So the first chapter of the study focused on the state of youth mental health in the EU-27. It's quite a complex picture but I'll give you some of the headline statistics which you can see here. So across Europe approximately one in five young people live with a diagnosable mental disorder.

And if you look at the bar chart here on the slide specifically the columns on the left you can see that anxiety disorders represent the highest case volume across all of age bands all the age bands. This is the latest data from 2024 but I did want to highlight as well that this is nearly doubled in recorded prevalence since 2010. This is data covering formal clinical diagnoses. If I can draw your attention to the second bullet point here you can see that subclinical distress is also highly prevalent. So beyond diagnoses recent study data shows that nearly half of all 15-year-olds reported symptoms of anxiety or depression at least once a week.

The distinction here between clinical and subclinical distress is quite important. What this does is creates quite a large volume of young people that are likely not being treated or supported effectively and the literature that we read terms this as the missing middle. There's also other data that shows almost half of young Europeans aged 15 to 24 report unmet healthcare needs. So because primary care and school provisions are under-resourced individuals with mild to moderate symptoms frequently face very long waiting lists and high clinical thresholds. This data is also quite highly gendered.

So we've seen that internalizing conditions such as anxiety and depression and eating disorders seem to be more concentrated among girls and young women as well as low-income and marginalized cohorts and externalizing conditions such as ADHD and conduct disorder are more prominent among boys.

The prevailing academic consensus in fact is that most people, most young people navigate these spaces without significant harm. So because of that we looked at the digital environment as a, as an amplifier or a mediator that interacts with pre-existing offline vulnerabilities. So how does it do that? Well, it's important to note that three quarters of lifetime mental health disorders emerge by age 24. And this is because this is a period where these young years have a critical phase of growth.

The brain regions that respond to rewards and social feedback are highly sensitive, while the areas responsible for self-regulation, impulse control are still actively maturing. So it's a biological baseline that makes it fundamentally harder for young people to regulate their engagement with highly interactive digital environments. Our analysis identified three primary pathways through which digital environments interact with this development, within this developmental phase. So the first is design-driven overuse. So persuasive features such as infinite scroll, autoplay, streaks, constant notifications, these are optimized to maximize engagement.

The second is content-driven harms. So these are algorithmic recommender systems and they can rapidly surface and concentrate self-harm material such as pro-eating disorder content, hateful or extremist content, and especially if a user lingers on such posts, on these posts. Finally we've also got AI-mediated risks, still emerging, but new AI chatbots and companions can simulate empathy and intimacy, but they have no real judgment. So early evidence points to a bit of a risk of emotional dependence, unsafe advice and confusion between simulated and real relationships. Next slide please.

I'll briefly cover what we call the double disadvantage as well. These risks don't fall on young people equally. Young people who grow up with poverty, family conflict, maltreatment, discrimination or neurodevelopmental conditions, they start with a higher baseline distress and with fewer protective adults. So they are more likely to seek escape or validation online, more exposed to things like cyberbullying or sexual solicitation, toxic communities, and they're less likely to have support to cope with what they encounter. Next slide please.

So what happens if we do nothing? Well, the impact will be seen across our health, social and economic domains. On a personal level, young people will suffer with mental ill health. As mentioned we already have quite high rates. We already have almost 1,200 youth suicides in Europe.

But digital risk pathways also affect brain development, as we've already mentioned, they affect sleep patterns. These young people affected, they're simply not fully optimized in the day to engage in the activities that a young person does, such as learning, sport and socializing. So that's the daily reality, but long-term impacts are also significant, as you can see from some of the statistics here. At the educational level, young people experiencing mental distress face a 25 to 35 percent higher probability of grade repetition, a lifetime of lost earnings as well. Now based on current data, in terms of the economic costs, we had a theoretical model and this estimates that in 2024 the total financial burden of youth mental ill health across the EU-27 was approximately 177 billion.

And if nothing is done, the cumulative 10-year cost of inaction is projected to reach about 1.68 trillion in present value. Now obviously there's a plausible uncertainty range with this. Next slide please. So what can the EU do about all of this? So first on EU competence and levers that they can use, under the treaties the EU cannot of course redesign national health or education systems, but it does have several important tools it can use to influence the determinants of youth mental health.

We group these into different types of levers. So the first are legislative and regulatory levers, so mainly in the internal market and digital space. Second are financial and program levers, so in health, education, youth cohesion, and research. And the third is soft law guidance and coordination levers. So what we did is we combined these levers across the policy domains and we looked at some policy options in those three domains.

The first is prevention and support in everyday settings, and then digital regulation and platform governance. Next slide please. I am closing shortly, Chair, sorry for running over time. But we'll close with a brief summary of where we've got to. So firstly, three short conclusions: youth mental health in Europe is common, it's rising, and it's unequal.

It's driven by an interaction of early onset offline adversity, risky digital environments, and overstretched services. If we stay on the current path, there's a very large avoidable cost. So on that basis, we proposed five priorities to look at. The first one is prevention and early help in everyday places. The problem is that prevention is patchy and there's a big missing middle between schools and doctors on the one hand and specialist psychiatry on the other.

So many young people only get help when they're already in crisis. We know that this works because we did case studies and there's several very well-evidenced interventions at country level that have done these interventions. The second priority pathway would be community pathway for the missing middle. So this would be targeting vulnerable young people that are a little bit more off the radar. In practice, this means youth-focused social prescribing, community pathways, providing trusted mentors and workers to help vulnerable young people connect to real-world offline activities such as sport, art, music, nature, youth clubs, or volunteering.

Priority three would be putting mental health safeguards into current digital regulation. There is already regulation such as the Digital Services Act and the AI Act that the EU can leverage by enforcing child-friendly and incorporating the mental health-focused areas. The fourth would be raising the bar for mental health apps and online tools. Young people are increasingly turning to online tools to help with their mental health. Not all of these are regulated, and there is a lot of evidence of some of these working very well that can be scaled up into different countries.

Priority five would be better research data and joined-up governance. We really are lacking quite a lot of comparable data across countries, so we could in existing surveys include a basic set of indicators that could track better some of the issues that we're talking about. Finally, if none of these priorities have any effect on the main issues, the EU can of course commission further research into things like social media bans, which are being rolled out across several countries already. I'll stop there. Thank you.

50:59 - 51:13

Adam Jarubas

Thank you so much. Thank you for your presentation. Now I open the discussion. We starting with András Kulja.

51:13 - 53:12

András Tivadar Kulja

Thank you very much for this presentation and excellent research. And I think it is, and it is clear that it is one of the biggest challenges nowadays, and we don't have the right tools to solve this issue in one days or two days. And we have to have long-term solutions, but to have a long-term solution, we need clear data and evidences.

Thank you very much.

53:12 - 53:16

Adam Jarubas

Thank you Andreas Nikos Papandreou please.

53:16 - 54:30

Nikos Papandreou

Thank you chair very good report we got it a little bit late to read it all 200 pages in detail but I think the main ideas are there so the work is very good. I don't know if maybe I think differently because I think first of all what did this look like 30 years before before the onset of the digital era? I'm guessing it's quite different. So it's like this is an addiction and what do we do with addictions? We we try and ban them.

I mean that would be a philosophical question. Would we be better off if the kids didn't have any digital access? That's okay so you're saying yes no you're not. Question what do you think about that? And second to go into the details of your project these are mainly how to deal with someone who already has the mental health problem but then you also mention preventive.

So I'd like more what you mean. Preventive means before they get to that stage. Once they're at that stage then we're we have a health system with an aging demography we have that group of us and then we have the young ones with that and then we're going to be overwhelmed with health issues. So how do we get to the point that they don't get addicted in the first place because a lot of your recommendations are around fixing as opposed to not getting there. Thank you.

54:30 - 54:32

Adam Jarubas

Thank you Gerard Hauser please.

54:32 - 57:18

Gerald Hauser

Danke. Ich beginne mit einem Zitat zur alarmierenden psychischen Gesundheit von Kindern und Jugendlichen und dann würde ich Sie am liebsten raten lassen von wem das Zitat stammt. Psychische Symptome haben vor allem bei jüngeren Menschen Überhand genommen. Mehr als die Hälfte der bis 21 Jahre mehr als die Hälfte von ihnen sind von depressiven Symptomen betroffen knapp jeder zweite leidet an Schlafstörungen und rund ein Drittel ist von Angstsymptomen betroffen. 16 Prozent aller Jugendlichen bis 21 Jahre haben sogar Selbstmordgedanken.

Ich habe das zitiert aus der Studie Gesund aus der Krise erstellt von der österreichischen Bundesregierung in der letzten Legislaturperiode also nicht von uns von der Freiheitlichen Partei sondern von der österreichischen Bundesregierung.

Und wissen Sie, was die österreichische Bundesregierung als Grund für diese alarmierende Situation in Österreich angegeben hat? Auch da zitiere ich: Seit Beginn der COVID-19-Pandemie wurde das festgestellt. Und Sie wissen, danach wurde es ergänzt, nachdem ich das mehrmals im österreichischen Parlament zitiert habe, haben sie es ergänzt mit Krieg in der Ukraine und so weiter, weil das war die perfekte Selbstanklage. In Österreich sind mehr als die Hälfte der Kinder bis 21, das heißt 865.000 Kinder und Jugendliche mit depressiven Symptomen belastet. Das ist eine Generation.

Man hat einer Generation die Zukunft genommen durch diese fatale COVID-Politik mit Testungen, Impfungen, Schulschließungen und so weiter. Und bitte, lenken wir jetzt nicht vom Thema ab und versuchen jetzt in Richtung Social Media zu gehen und so weiter. Das ist die Studie der österreichischen Bundesregierung und ich würde Sie wirklich bitten, ich würde Sie wirklich bitten, jetzt keine Kindesweglegung zu betreiben, sondern darüber nachzudenken, wie man diesen Kindern und Jugendlichen hilft, weil hier einer Generation die Zukunft gestohlen wurde. Und da einzuschreiten. Und für diese Kinder gibt es in Österreich genau 10.000 Behandlungsplätze pro Jahr für 865.000 betroffene Kinder und Jugendliche.

Das ist das Problem und nicht, und nicht das, was Sie jetzt beschreiben mit Social Media und so weiter und so fort. Ich bin, ich bitte Sie wirklich einmal auf des Pudels Kern zu gehen und darüber nachzudenken, wie man diesen Kindern und Jugendlichen hilft, denen man über diese fatale COVID-Politik über Jahre tatsächlich die Zukunft geraubt hat. Und jetzt darf man diese Kinder nicht im Regen stehen lassen, sondern jetzt muss man tätig werden und schauen, dass man ihnen tatsächlich hilft.

57:18 - 57:23

Adam Jarubas

Sindebos, please.

57:23 - 58:41

Stine Bosse

Thank you very much. On, on the same but again a little different note, I don't think we're here to solve the, the situation in Austria, but we're here to solve and think about the whole situation in the European Union. So my question would be, and this will also show you that I haven't had time to read the full report, but I will, is there a benchmark? Because is there somewhere where we can see they have dealt with some of these issues with some kind of success so that we can share across Europe knowledge about, you know, how to deal with these issues? I'm sure that there is a government in, in place in Austria that are as interested in this subject as a government in Denmark.

Everybody can see that this is devastating and that we all need to do something. The diagnosis I do not share with, with my dear colleague here, but the fact that we should look across different countries to see how to solve this, I would love to know is there details in the report helping us here.

58:41 - 01:01:21

Christine Anderson

Thank you. Christine Anderson, please.

Yeah, thank you and, and thank you for that presentation. Uh, your study identifies indeed real problems: cyberbullying, sleep disruption, manipulative platform design and serious gaps in care. But it does not actually, in my mind, actually demonstrate that these problems require new EU action. The report itself acknowledges three important facts. First, general screen time explains less than 1% of the variation in adolescent well-being and causality is unproven.

The strongest evidence concerns specific harms in specific vulnerable groups, but not a general digital mental health crisis. Second, the headline figure of 1.68 trillion is not the cost of the absence of EU action.

It assumes hypothetical reductions in prevalence and only afterwards links them to qualitatively to possible EU measures. It does not show that the EU action would cause those reductions or that member states could not achieve them by themselves. Third, the report relies on extremely broad concept of mental ill health. It places diagnosed psychiatric disorders, ordinary distress, low self-esteem, sleep problems, difficulty concentrating, loneliness and dissatisfaction with one's appearance on the same continuum. This risks turning the normal difficulties of childhood and adolescence into symptoms of a public health crisis.

Rising self-reported distress is not automatically proof of a rising mental illness. It may also reflect changing language, greater awareness, broader screening and a growing tendency to pathologize ordinary life challenges regulars humans face in general. So my question is this: how does the study distinguish a genuine increase in psychiatric illness from an increase in reporting, diagnosis and particularly the pathologization of normal distress? And if not, if it cannot make that distinction clearly, how can it then justify presenting such a broad category of mental ill health as evidence for even further EU intervention? Thank you.

01:01:21 - 01:01:25

Speaker 20

Thank you. Ignazio Marino, please.

01:01:25 - 01:03:27

Ignazio Roberto Marino

Well, thank you very much for this discussion. I think it's very important. First of all, I'm really happy that with the proposal of the Greens, this committee agreed to launch this study because what I'm hearing here today is exactly what I was hoping to hear when I thought that the study is important. We are discussing about figures, about numbers, about scientific evidence, and this will probably help us to find a common ground as a SANT committee. I think a concept obviously was clear to me as a scientist, but a concept like the one that was discussed before, that the brain is not completely formed until the age of 21 is something that we need to consider.

It's a scientific fact, it's not an opinion. And we did an experiment that was never done in the history of human beings with, you know, the social separation of our kids during the time of the COVID. And so I think now we have the responsibility to act together. Obviously is a national problem, but is international in the meaning of European problem, and we need to face it exactly with the same energy that we faced the COVID infection because this is something that is happening and we need to work together.

01:03:27 - 01:03:31

Speaker 21

Thank you. Eulalia Pascual, please.

01:03:31 - 01:05:44

Leire Pajín

Gracias, señor presidente.

Quiero darle las gracias a los expertos por la presentación de estos informes, estos estudios que me parecen claramente oportunos y por el debate en esta comisión que me parece realmente urgente e importante. Estamos hablando de un impacto en la salud mental de los jóvenes que se ha multiplicado después del COVID. Y por tanto nos tenemos que tomar muy en serio lo que está ocurriendo. Hablamos de problemas de ansiedad, de depresión, de falta de sueño, de aislamiento, de ciberacoso y de exposición a contenidos perjudiciales que tienen un impacto evidente también en la salud emocional y sexual y afectiva de nuestros jóvenes. Por tanto no podemos mirar hacia otro lado y esto se dispara en el ámbito digital.

Ante esto creo que hay tres ámbitos de actuación muy claros, ustedes también los han dicho. En materia de prevención necesitamos impulsar programas escolares de bienestar digital y de alfabetización mediática. Necesitamos un plan de acción de salud mental concreto sobre este ámbito. En el ámbito regulatorio creo que tenemos que ser valientes para reforzar la aplicación de las normas digitales y para exigir a las plataformas herramientas seguras, transparentes y adaptadas a la edad de forma muy clara. Solo hay que ver las entrevistas que hacen muchos de los oligarcas tecnológicos sobre cómo dejan a sus hijos pocas horas de exposición a las pantallas para saber de qué estamos hablando.

Y en tercer lugar necesitamos más investigación, mejores datos, pero sobre todo implicar a los jóvenes en las políticas y en los estudios. Yo por eso les quería preguntar si existen buenas prácticas en otros países fuera de la Unión Europea que también puedan inspirarnos. Hace poco tuvimos la oportunidad de conocer a Olimpia en el seno de EuroLat, una joven mexicana que estuvo a punto de suicidarse como consecuencia de la publicación de un vídeo íntimo sin consentimiento y que dio pie a una regulación en México que ha tenido consecuencias importantes. Y por tanto qué más podríamos regular desde el Parlamento Europeo para evitar las consecuencias de esta emergencia entre nuestros jóvenes.

01:05:44 - 01:05:49

Speaker 23

Thank you, Tilly Metz, please. Go ahead, please.

01:05:49 - 01:07:18

Tilly Metz

Sorry, thank you. Thank you, Chair, and thank you to the speakers for their presentation. I will come immediately to my question. So my first question is about the balance between digital risk and the wider determinants of mental health. The report rightly highlights harmful online environments, but it also recognizes that young people's mental health is shaped also by poverty, discrimination, family circumstances, and social exclusion.

So my question is how can we ensure that future action does not become overly focused on digital harms alone, but instead also addresses the broader structural determinants of mental health through a genuine health in all policies approach? And then my second question is precisely on the inequalities that you mentioned also, because the report shows that girls and young women and also LGBTQI+ and young people, migrants, and other vulnerable groups are disproportionately affected. What would be the single most important policy recommendation to ensure that future EU action reduces these inequalities rather than providing the same solutions for everyone? Thank you.

01:07:18 - 01:07:25

Speaker 22

Thank you, and the last question from Mr. Ciccioli, please.

01:07:25 - 01:10:55

Carlo Ciccioli

Sì, ho ascoltato una parte delle relazioni in auto mentre arrivavo al Parlamento, per cui potrei aver perso qualcosa. Però mi sento di brevemente di fare una sorta di controrelazioni. Nel senso, io sono un medico psichiatra che ha lavorato 25 anni nel servizio pubblico e una parte significativa nell'area delle tossicodipendenze. Allora, oggi sembra che l'epidemiologia sia molto aumentata perché ci sono più le patologie vengono più intercettate, sono più raffinate e via di seguito. Poi dice il digitale, il Covid e anche le sostanze stupefacenti, tutto vero, però tutto relativo.

La il problema è strutturale, a mio parere, ma sull'affermazione di migliaia di ragazzi visti. Uno è un problema legato alle famiglie. Le famiglie generalmente sono meno sempre di più monogenitoriali, quindi diminuisce il contenimento del ragazzo durante la sua formazione, la sua evoluzione, la sua maturazione. C'è molto spesso l'assenza di fratelli e sorelle. Le la funzione dei fratelli e delle sorelle era molto utile perché era un meccanismo di confronto, quindi di autoconfronto eccetera.

Terzo, l'organizzazione economico-sociale. La rarefazione delle relazioni intrafamiliari, molto rarefatte. Ci si vede la mattina e qualche volta la sera. Questo cosa ha generato? Un sistema in cui i ragazzi sono intolleranti alla frustrazione, incapaci al differimento, il differimento nel tempo, tutto subito vogliono, il discontrollo delle impulsività e delle reazioni emotive molto alterne, molto alternate, un passaggio continuo da disforia, euforia e depressione.

Quindi c'è un problema proprio strutturale e le cui la cosa più importante, a mio parere, sarebbe la formazione delle relazioni. La formazione relazionale era in genere affidata alle scuole legate all'autorevolezza dei dei professori, degli insegnanti che oggi sempre meno si occupano solo di formazione delle nozioni, ma non di formazione moderna. Secondo, c'erano gli oratori, comunque le organizzazioni parrocchiali che svolgevano una funzione di relazione e anche le società sportive che svolgevano una forte insegnamento a come comportarsi dal punto di vista delle emozioni e via di che adesso sono molto orientate verso il risultato. E tutto questo ha scombinato. Cioè questi sono aspetti economici, sociali e di altra natura, anche dal punto di vista delle metropoli rispetto alle piccole comunità periferiche, no?

La popolazione si è spostata molto in centri agglomerati molto forti. Quindi noi dobbiamo innanzitutto, secondo me, dare una risposta strutturale. Poi c'è la risposta, ovviamente, l'aspetto, il contenimento dell'ansia. Quando l'aspetto più significativo è che non riescono i ragazzi a contenere gli eventi. Cioè sono molto vulnerabili di fronte a qualsiasi evento accada.

Cioè l'evento li porta a non c'è la tolleranza, non sono abituati più a tollerare qualcosa che è imprevedibile, imprevisto, perché sono più proprio più fragili, più deboli da questo punto di vista. Questa è l'area dove noi dobbiamo cercare di intervenire significativamente.

01:10:55 - 01:11:02

Adam Jarubas

Thank you so much. Now, dear experts, could you comment the question posed by MEPs, please?

01:11:02 - 01:14:01

Martin KUENEMUND

Yes, thank you very very much for the statements and for the questions. There are quite a few of them. I'll try to respond to a couple and then pass the floor to my colleague Yannick to to add to what I have to say. Two minutes, okay. First of all, it's it's it should be very clear that there's no suggestion in our study that it is only the digital environment that is leading to these mental health problems.

There are many other factors and we acknowledge them in our report. COVID is one of them, conflict is one of them, climate anxiety is another one, family breakdown is another one, so there's a number of factors. But the research and the evidence that we reviewed show suggest very clearly that there is that the digital environment can act as an as a catalyst, as a it to exacerbate and to make it more difficult to to worsen these problems or to make it more difficult for young people to deal with them. In terms of the figure we provide the 1.6 trillion, again, there's no suggestion that all of this is caused by digital digital harm and there's also no suggestion that the EU could feasibly eliminate this entirely. Instead we give this as an order of magnitude of the size of the problem and then provide some scenarios for what a three, a five, a 10% reduction in this would mean and it shows that these are significant figures.

The way our options are outlined, it would be preposterous to attach exact numbers to them. That could perhaps be the subject of a future Commission impact assessment on more specific options on the table. For the time being we've been quite broad and and and all-inclusive. And that also answers partly I think the question about prevention versus regulation etc. We have tried to be comprehensive and all-encompassing and really look at all of those.

We've looked at preventive measures, we've looked at regulation. We haven't zeroed in on a social media ban, that is covered as well to some extent in our report, but we also look at a number of other factors, some of which have to do with prevention, with digital literacy, with teaching children to to to to to better cope, some of which have to do with treatment, so better treatment for the missing middle but also for those who already suffer severe mental health conditions. So we try to cover everything. And yes just to say good in terms of good practices, yes, so maybe Yannick can say a few more words about this. We did in-depth case studies on seven countries, both within and outside of the EU, and we selected these countries specifically because there were interesting promising interventions where there's evidence that they work.

And so there's hopefully a wealth of information that can serve as inspiration at EU level but also at the national and regional level.

01:14:01 - 01:15:08

Yannick VUYLSTEKE

Yeah, that is correct. So there's there's case studies that highlight evidence of effectiveness and return on investment for specific interventions that we looked at. They also form the basis of the policy options that we provided as well. So we know that there's evidence behind those. Just very quickly touch on a couple of other questions.

You know, I mean you mentioned is it better to have no digital access at all. I think the penetration rate for smartphones is like 99.9% these days. I don't think it's possible and there's lots of benefits as well to having digital access. The most well-evidence interventions are literacy that teaching how to use these safely and how how to recognize the issues before they arise. So that's the early prevention that that came up before then as well.

I think we covered most the questions. I mean we can follow up afterwards as well for sure on time. Appreciate you haven't read the report, it's very long, but we are able to answer questions at a later stage.

01:15:08 - 01:17:19

Adam Jarubas

Thank you so much, dear expert, for your presentation, research and valuable contribution to our discussion, what additional value would be created by European approach, how to create more more efficient environment to support youth digital era.

Thank you so much for your work. Now let's move on to the next point. I'd like to welcome our expert and I'm asking Mrs. Ronja Dirschel to take the seats on the podium, please. Dear colleagues, the next item on our agenda is an exchange of view 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. As you remember, we already had several exchange of views in this series and we are continuing today with the presentation of promoting youth mental health and healthy behaviors in Europe. I welcome today Ronja Dirschel, who is the head of partnerships of Triple P Europe. I will give the floor to Mrs. Dirschel for her introductory statement and after to the members for a Q&A session. As usual, our discussion is based on catch the eye.

Okay, Mrs. Dirschel, you have the floor for eight minutes, please.

01:17:19 - 01:26:38

Ronja Dirschel

Thank you so much. Thank you for the invitation. It's a pleasure and an honor to be here today. I'm a psychologist and an ex-public health expert and I'm here for Triple P Positive Parenting Program. I'm looking very much forward to discussing with you today the role of evidence-based parenting support in promoting youth mental health and healthy digital behaviors in Europe.

Next slide, please. Here's a brief outline of my presentation. I'm going to introduce mental health as a public health issue, which we've already heard a lot about, and then talk about the role of parenting. I'll also describe the role of Triple P in supporting parents and then briefly touch upon how parents also can help children's resilience in digital environments. I'm going to conclude with consequences without consequent policy.

Next slide, please. As public health experts and advocates, you will all certainly agree with me that mental health is a highly important public health issue. While mental health is defined as the very much desirable state of mental well-being that enables people to cope with the stresses of life, realize their abilities, to learn and work productively and contribute to the community, we know that one in six people in the WHO European Union live with a mental health condition. That's 140 million people. And these conditions are ranging from mild to severe with terms of impacting their everyday life, work, education, their relationships and also physical health.

Mental disorders are the leading cause of years lived with a disability and they're producing immense economic costs. I mean, we've just heard impressive numbers about that. And this just comes on top of the social and individual burden that they're associated with. Next slide, please. So there are very good arguments to attempt to improve mental health on a public health or population level.

And when we want to do so, we need to take a look at childhood and adolescence because they are key periods for the development of mental health. 75% of mental health problems begin before the age of 24 and 50% start even before the age of 14, that means during childhood. The flip side of this is, those of us who go through a mentally healthy childhood have much higher chances of mental well-being throughout our lives. So what makes the difference? What will set up a child for mental health?

It's the family environment. I mean, don't get me wrong, there are multiple factors influencing mental health, there is no singular explanation, there will never be. But parenting competence is, I mean, there are biological factors, environmental factors, and there's definitely a difference if a child's going growing up through poverty, through times of war. But positive parenting can serve as an impressive buffer against adverse experience. So there is a large body of evidence showing that the family environment, specifically parenting behavior, the family climate, parents' mental health and their stress level, but also how much time children spend with their family and how much they feel supported.

Next slide, please.

All of these aspects of the family environment contribute to one of the strongest protective factors for children's mental health. Positive parenting practices can support the development of children's resilience and emotional regulation. So in a nutshell, the family represents the primary prevention layer for youth mental health. And that's why WHO recommends making evidence-based parenting interventions that are based on social learning theory available to all parents and caregivers globally. Next slide.

So here's one example of one of these evidence-based programs, that's Triple P Positive Parenting Program. It's one of the most effective and best-known parenting systems in the world. There's a huge body of evidence supporting it, up to date more than 430 evaluation studies, out of these more than 200 randomized control trials. And the evidence base shows consistently that the program is effective in reducing child maltreatment at a population level, in reducing emotional, social and behavioral problems in children and adolescents, in reducing stress and conflict within the family and increasing positive parenting, parental self-confidence and even the parents' own self-well mental health adjustment, let's put it that way. Many years of experience, many languages, many countries, let alone I think 223 institutions in Europe that published research on Triple P so far.

I'd like to give you a few brief examples of member states where Triple P has been implemented in. Next slide please. So one of them is Ireland, there was a widespread rollout of Triple P in two communities which led to population-wide health benefits, amongst them a 37.5% reduction of child emotional and behavioral problems in specifically vulnerable groups of children. In Germany, where I'm coming from, we've got an 18 years follow-up of the program showing that children whose parents have engaged with the program when the children were at preschool age have a number of long-term benefits, amongst these they show less bullying behavior during adolescence and they have a stronger mental health resilience during the COVID-19 pandemic. In Sweden, there was a cost-effectiveness study showing a lower long-term pressure on different systems.

And the most recent example is Greece, where Triple P has been implemented as a pillar of the national program on family and child health, supported by the Ministry of Health and UNICEF Greece and with a huge uptake of parents so far. Next slide please. Let's now take a look at the role of parents when it comes to online safety and screen use of children. Problematic screen time and social media usage patterns are key concern for parents and their children. Digital environments amplify existing vulnerabilities, we've just heard about that.

It's like with the COVID-19 pandemic, vulnerable children are at higher risk.

The flip side is, again, that parenting practices can moderate the impact of digital stressors by shaping children's self-regulation, media use, emotional coping, and help-seeking behavior. So when does parents' influence on children's online safety begin? Well, that's long before a child gets their first device. It starts when parents model healthy digital behavior in the first days of their baby. It starts when parents support the development of emotional regulation, resilience in general, and digital skills specifically as their children grow older and older.

And it's definitely happening when parents are managing everyday conflicts around screen time, healthy eating, physical activity, sleep, education, all these important matters for child development. Parents are at the front line for managing children's use of screens and social media, and this is true independently of whatever regulation will come. So we must not leave parents alone with this huge responsibility. Parents need effective support. They need accessible support.

Next slide, please. Here's one example for a puzzle piece that societies can use to support families navigating risks and chances of the digitalized world. It's an online program called Triple P Online Children and Screens. It's been developed in Australia in order to support parents to navigate the Australian social media ban for children under 16. We're just about to translate it into German thanks to funding of the Federal Ministry for Education and Family.

Next slide, please. And here's some preliminary parent results of the program. We've seen improved self-efficacy of parents, we've seen an increase in knowledge, and a reduction in screen use of children. I'm coming to some conclusions. Next slide, please.

I think we can all agree that we cannot afford not to act. Otherwise, we'll have increasing levels of violence, drug abuse, social exclusion, and suicide, which will lead to exploding costs. So what are we calling for? That's my last slide then, please. The next one.

We're calling to acknowledge the role of parents as they are at the forefront of their children's lives right from the beginning on. We're calling for recognition of evidence-based parenting programs as essential tools for prevention and early intervention within the EU mental health strategy. We're calling for support of member states in embedding parenting support into national health, education, and social service systems. And finally, to ensure that the Digital Fairness Act and any related measures on social media and mental health explicitly address parenting and family support and digital literacy within the family. Thank you so much for your time.

01:26:38 - 01:26:48

Adam Jarubas

Thank you so much, Mrs. De Reshel. And now I open the floor to MEPs, and Nikos Papandreou is first, please.

01:26:48 - 01:28:02

Nikos Papandreou

So I wish I'd seen this slide 20 years ago. Excellent presentation. It's hard not to think of what it means to be a parent if you are one when you see this presentation. And I'm haunted by a question my son asked me, I'll get to the point, when he was about seven and I punished him by taking away his cell phone for two hours. That was a big punishment.

And when he got it back, he said, "How did you know to do two hours and not four or one?" "Did you take lessons on how to be a father?" I said, "Unfortunately, I'm learning from you." But then I realized we take, we take driver's lessons for something simple, but we take no knowledge unless you happen to read books, but it really depends on the individual.

We try and follow those nice things you say, but in some countries like Greece, they don't have a program for teaching parents. That would be considered sort of intervention, but I'd really like to see how we could spread that concept. I mean, I've never seen the Triple P, obviously it's around and then you look it up, it's everywhere. It's like a new world for me, but it sounds like exactly what we need because our previous discussion was on controlling digital access, which you were here to listen to. Anyway, thank you very much for the presentation.

How do we spread this concept to parents without making them feel we're invading their privacy?

01:28:02 - 01:28:09

Speaker 29

Thank you, Margarita de la Pisa Carrión.

01:28:09 - 01:31:05

Margarita de la Pisa Carrión

Muchas gracias. Aquí voy a hablar en español. Yes. Sí. Muchísimas gracias por venir aquí y darnos la oportunidad de conocer algo que de alguna manera sospechamos, pero que el que esté plasmado en estudios pues nos da también a los padres una confianza, ¿no?

La tecnología igual nos hace ver más claro esto, ¿no? Porque parece que últimamente a la familia o a los padres se les ha quitado un poco el protagonismo en la vida de sus hijos, ¿no? O por lo menos no se ha dado importancia al rol esencial que tiene la familia en el desarrollo de nuestros hijos y la necesidad de pasar tiempo con ellos, porque la familia hay que construirla y eso supone pasar tiempo juntos, ¿no? Llevamos unos años, unas décadas de deriva cultural donde la presencia de los padres cada vez es menor en las casas. También por una incorporación de la mujer al mundo laboral que ha restado a que uno de los miembros de la pareja esté, uno de los miembros del matrimonio esté con ellos, ¿no?

También en una necesidad económica de que los dos padres estén trabajando y no hay posibilidad de que los niños, de que las familias crezcan, haya hermanos, haya una familia más grande como era antes, ¿no? Y los niños pues pasan las tardes muchas veces solos, muchas veces llegan a casa con su llave, entran y realmente quien les está educando son las pantallas y los contenidos que llegan, ¿no? Y esto parece que lo hemos normalizado, parece que incluso a las mujeres nos tienen que proteger para que podamos seguir reincorporándonos inmediatamente a trabajar en vez de que se le dé una importancia a ese tiempo que pasamos con nuestros hijos. Parece que todas las medidas son ayudar a la mujer a que vuelva a su vida profesional y no a afianzar esos vínculos naturales tan necesarios y a que políticamente a la familia se le dé una importancia, ¿no? Para ayudar a que tanto padres como madres puedan pues dedicar menos tiempo a trabajar y más tiempo a sus hijos, ¿no?

Porque es una inversión para toda la sociedad. Tiempo que dediquen los padres a sus hijos, ese amor, ese afecto, esa estabilidad luego la van a trasladar a la sociedad. O sea, va a ser beneficioso para todos porque un niño conflictivo, un niño que tiene problemas de integración, que tiene problemas sociales luego pues también va a necesitar más apoyo también institucional y también pues también va a tener más problemas, ¿no?

01:31:05 - 01:31:21

Adam Jarubas

Thank you, Ignazio Marino. Professor, Professor Marino. No? Okay, sorry, sorry. Leila Pachín, please.

01:31:21 - 01:33:25

Leire Pajín

Gracias presidente, yo también hablaré en español. Quería darle las gracias por su estudio, sin lugar a dudas tener información precisa y recomendaciones concretas nos ayuda a orientar bien nuestro trabajo en las políticas públicas. Hemos hablado también hace unos minutos de la emergencia que supone ya la salud mental para los jóvenes, especialmente después del COVID, donde hemos visto cómo se ha aumentado en un cincuenta por ciento los problemas de salud mental de los jóvenes. Y cuando una generación entera nos está pidiendo a gritos ayuda, la sociedad no puede fallar. Y no fallar significa fortalecer los sistemas de salud, especialmente los públicos, donde hoy todavía no hay suficientes servicios de salud mental.

Por supuesto no le puede fallar la familia, como bien ha dicho el tiempo de cuidado de los hijos y también la atención a las mismas es fundamental. Debemos dar también a los padres herramientas importantes para lidiar contra este reto, especialmente en el ámbito digital. Y tenemos que fomentar la corresponsabilidad de la vida laboral y personal para garantizar que no solo esto lo ponemos o lo situamos en los hombros de las mujeres, que son quienes ocupan todo el tiempo del cuidado, sino en la responsabilidad social de todos los miembros de una sociedad. Tampoco en los hombros exclusivos de las escuelas. Siempre tenemos la tentación de decirle a las escuelas que son ellas quienes deben arreglar todos los retos, también la salud mental, y creo que ellos pueden hacer su papel y deben hacerlo, pero esto estamos hablando de un pacto social donde también los generadores de contenidos digitales, incluidos los videojuegos, las redes sociales, asuman su responsabilidad.

Por eso hablamos de pacto social, hablamos de contar con todos los actores, hablamos de prevención, hablamos de financiación suficiente y de servicios públicos y por supuesto también hablamos de regulación. Yo le quería preguntar qué medidas concretas cree que deberíamos intentar promover desde el Parlamento Europeo para responder a este reto.

01:33:25 - 01:33:31

Speaker 30

Thank you, Mr. Carlo Ciccioli.

01:33:31 - 01:35:46

Carlo Ciccioli

Grazie presidente. Allora, io tornerei brevissimamente a un intervento che suscitò molto clamore, quello di Benedetto sedicesimo nel duemila sei all'università di Ratisbona, che al di là delle valutazioni religiose o meno pose il problema dell'emergenza educativa. Oggettivamente disse un'emergenza educativa del passaggio generazionale dei valori e dei comportamenti. Questo è il tema. Si passano le generazioni trasmettono tra loro valori e comportamenti.

C'è stata una frattura, appunto la frattura nella definizione della famiglia con una serie di sostituzioni, per esempio il digitale, i telefonini. I telefonini dal punto di vista proprio diciamo dell'interpretazione psicologica diventano un io sussidiario, cioè il bambino e il ragazzino o anche l'adolescente considera un'altra parte di sé quello con cui dialoga in maniera molto semplice e spontanea il digitale, il telefonino. Poi c'è il problema delle droghe che non è da sottovalutare in età molto bassa che incidono da un punto di vista proprio biologico. Cioè le sostanze vanno ad agire nel frontale nella fase dello sviluppo. Il frontale è la regolazione di tutti i nostri comportamenti emotivi.

Si passa da zero cinque zero sei millimetri a circa un centimetro e un centimetro e sei alla fine dell'adolescenza. Lì c'è la modulazione di tutte le reazioni con il mondo esterno. La cannabis in particolare, ma non solo la cannabis, vanno a influenzare quest'area. Quindi di questo dobbiamo tenerlo molto presente. E poi c'è il problema dell'identità.

Nel mondo multipolare le identità di appartenenza si sono molto indebolite e quindi si è indebolita l'identità. Bisogna ristabilire delle identità culturali che sono appartengono a tutte le culture, non solo. Dobbiamo questi sono i punti fondamentali su cui dovremmo intraprendere, uso un termine che è detto noi in Cina, detto da uno dei miei che sta nell'area destra, una fortissima rivoluzione culturale.

01:35:46 - 01:35:49

Speaker 32

Tilly Metz.

01:35:50 - 01:35:57

Adam Jarubas

Okay, so Vytenis Andriukaitis and then Ignazio Marino.

01:35:57 - 01:37:55

Vytenis Povilas Andriukaitis

Ačiū labai, aš paklausiu jūsų lietuviškai, jeigu galima. Ačiū labai. Dėkoju už šitą visapusišką pristatymą, dovanokit šiek tiek vėlavau, bet bet bet iš dalies sekiau diskusiją, juo labiau dabar matau šias šešias pristatytas opcijas, kurių kuriomis reikėtų iš tiesų mums darbuotis, kad mes parengtumėm labai visapusišką, visaapimančią, kaip sakyti, jaunimo ir ir vaikų ir jaunimo psichikos sveikatos prevencijos strategiją, nes Europos Sąjungos mastu mes galime ypatingai daug prisidėti prie šalių narių programų, bet mano klausimas būtų: man pačiam kaip ministrui teko rengti preventyvias programas vaikams, paaugliams ir ir susijusias su tuo, kaip kaip užkirsti kelią didėjančiam skaičiui savižudybių. Kolegos, tai yra dramatiška, tai yra baisu, tai yra neišpasakytai sunku ir aš susidūriau su sunkumais, kai reikėjo įtikinti daugelį sektorių organizuoti tarpsektorinį koordinuotą darbą. Bet reikėjo ir finansų, reikėjo ir žinių, reikėjo ir įtikinti savivaldybes skirti finansinius resursus, nes prirašyti tarp socialinę paramą, ją reikia finansuoti.

Biudžeto klausimai yra labai sunkūs. Todėl mano būtų klausimas toks: ar gal jūs turite kokių šalių narių analizų tų visų minių, kurios leistų būti naudotis tais kaip geraisiais pavyzdžiais, efektyviai užkertančiais vaikų ir paauglių savižudybę?

01:37:55 - 01:38:05

Speaker 33

Thank you, Ignazio. Ignazio Marino.

01:38:05 - 01:39:09

Ignazio Roberto Marino

Thank you very much, Chair. I think that, you know, if I have tried to summarize what I am hearing here in the discussion is that we really need to focus on this issue as Europe, not as a single state, because, you know, the issues we are discussing, the the family environment, the drugs, the, you know, the use of smartphone and the consequences of the COVID epidemic, I think something that we all share. And I I don't think it will be savvy to try to give a solution by a single member states and instead is a cultural issue that needs significant intervention from the European Union. Thank you.

01:39:09 - 01:39:13

Speaker 31

Thank you, Peter Agius please.

01:39:13 - 01:41:13

Peter Agius

Thank you, Chair. I come from Malta and lately we have had a lot of suicides among young men especially reported among the youth. I believe that when I see what the situation right now, I think the European Union takes a very prescriptive approach when it comes to dealing with businesses, the operators online, when it comes to dealing with member states.

But this is an area where the question is how do we reach those mostly concerned? And as you rightly point out, education has to be in the family. This is where we must reach with our messages, with our the 250 research projects that you mentioned. Are they reaching the parents? And I can speak here also putting the hat of a father of three teenagers.

You know, it's a daily struggle. It's a daily struggle. And when you see what is reaching us as parents, you get basically TikTok advice. And how professional is that? How trustworthy is that?

But I can assure you, I mean speaking to a lot of my peers, a lot of young parents as well, this is what reaches us in the family. Not the research which we should maybe be trusting more, but the TikTok advice, which is possibly also actually harmful. So the question is this: what can Europe do in a complementary fashion to strengthen the hand of member states through national curricula, through ways of outreach to the parents to actually help the mental health of our younger generations? Thank you.

01:41:13 - 01:41:17

Adam Jarubas

Thank you. And last question from Stine Bosse, please.

01:41:17 - 01:42:53

Stine Bosse

Thank you very much. I just wanted to draw all of our attention to to what we actually voted just the other week. We are, in my opinion, really, really dragging our feet on the question of protecting our children. And and I don't want to bring up the subject of whether this is long-term or short-term. I guess we could all in this room agree it should be a long-term solution.

And it should be a solution that really protects our children and that puts up barriers to big tech and also of course protect our privacy. I mean, we don't want to sacrifice other areas that are of great importance to all of us. So I just wanted to bring up that subject. And then I just wanted also to draw your attention to the fact as much as we talk about that in some areas we talked about it at the earlier intervention about the MFF, MFN, sorry, the the US actually attacking our healthcare system. In this area, it is for example TikTok attacking our youngsters.

TikTok, Chinese TikTok is not the same in Europe as it is in China. It's two completely different experiences. And we should stop being naive and we should see this in a in a much broader perspective as part of also the geopolitical situation. And then of course come up, I can only agree with the professor that this has to be European solutions that we can work on together. Thank you.

01:42:53 - 01:43:01

Adam Jarubas

Thank you. Mrs. Dresser, let's try to to answer please, keep three max four minutes please.

01:43:01 - 01:47:09

Ronja Dirschel

Thank you so much for all your comments. There were a few different ideas and questions, so I'll try to find a common answer to at least some of them. So as a European citizen, one of the things I love when traveling through Europe is that I can trust when I open a tap, I get clear water. So what if we had a vision that the same would be true for positive parenting across Europe, right? I mean, there are voices saying that positive parenting is the clear water of mental health.

And it's a very good comparison, I think. So when we're trying to take a European approach, I think it's obvious, I've worked with governmental organizations and non-governmental organizations in different member states, and it's quite different how the different implementation goes ahead, what are the resources, etc.

So there is no one-size-fits-all approach. But if we could all agree that positive parenting is something that we need to invest in, that it's definitely worth it, and that we need evidence-based support for parents, not TikTok advice, right? Not influencers. And not only trial and error, as you said. I mean that's what many parents are going through, and it's fine to learn on the way.

It's nothing speaking against that, but you need to have a source of information that you can trust and that you can rely upon, and that you can take without having the impression that you are a bad mother or a bad father. That touches on the other question that you were having. So how can we offer this kind of support without invading their privacy? Because it's such an emotional and individual and personal experience of being a parent. I think the answer is if it's available throughout our support systems.

We've got all these support systems. We've got systems, we've got schools, we've got early education centers, we've got pediatricians or mental health or community health centers in the different member states. But if evidence-based parenting advice would be available everywhere at a very low threshold, which means that there need to be different modalities, like with Triple P we've got a multi-system approach. It's not one-size-fits-all. It's not only a parent group or a training, but we've got seminars, we've got online programs, we've got individualized training, we've got group training, just very diverse interventions in order to fit the different sectors, the different organizations, practitioners, and most important of all, to meet the very various needs of families, because families differ in a lot of things.

But we can break down what evidence knows about helpful parenting, about good relationships, and that's cross-cultural. That's valid across many different cultures. So that's what Triple P tries to do, make evidence accessible to parents. I mean parents won't read any research paper about how to be a good parent, so we need to break it down, we need to make it relevant for their everyday experience, and we need to strengthen their self-regulation. And that's a very important piece of the program.

I call it the heart piece maybe, not imposing things to parents, but just providing them with evidence-based information and supporting them along the way, maybe like a midwife supporting a woman giving birth, supporting them setting their own goals, thinking about what changes they want to make in their family, what's really concerning them, what matters to them, what's kind of their own values, and supporting them with evidence-based pieces of information, supporting their self-efficacy by helping them understand the crucial role they are playing for their children, independently of the very important role of early education, school, peers, social media, etc. But parents are there for a lifespan, hopefully. So supporting them with self-efficacy, helping them understand what important aspect they are of their children's life, and giving them evidence-based information and helping them finding their own way. Was it most of the questions?

01:47:09 - 01:49:30

Adam Jarubas

Thank you so much, Mrs. Deloschelle, for your great, impressive presentation. We know that mental well-being is composed of many aspects: family, digital culture, school conditions, like you said.

Thank you for your recommendation what we can do at European level. Thank you so much. Dear colleagues, let's move on to the next point, presentation of the priorities of the Irish presidency. I'd like to welcome cordially Madam Jennifer Carroll MacNeill, Minister for Health of Ireland. Please join us.

Thank you so much. Okay, colleagues, on the 1st of July, Ireland started its presidency of the Council of the European Union. Today I have the pleasure to welcome Mrs. Jennifer Carroll MacNeill, Irish Minister for Health, who will present the priorities of the Irish presidency in the field of public health. I will first give the floor to Minister Carroll MacNeill and after her intervention, I will open the floor to members, first to coordinators and then to MEPs who want to take the floor. Dear Minister, you have the floor for eight minutes, please.

01:49:30 - 01:59:16

Jennifer Carroll MacNeill

Thank you. Thank you, dear Adam, members of the committee. Thank you so much for having me here today to present the priorities of the Irish presidency, and we so look forward to working with you. I'm a member of the Irish Parliament and I've huge respect and regard for the work of the Parliament and the members within it, and I'm so looking forward to working with you so constructively over the next number of months. It's a particular pleasure to be here at the SANT committee, the standalone committee, in recognition of the importance of health to Europe and most importantly to our people.

As the co-legislator, of course, you bring extremely important perspectives and, as I said, I had the opportunity to meet with many of you, as many as I as many as we could, members of the committee in Strasbourg in April, and again I look forward to our continued engagement. I think at a time of geopolitical uncertainty, regional conflicts, health security threats, demographic challenge, and indeed complex public finances, European cooperation on health matters has not been so important for some time. We know, of course, that the management and the delivery of health services is, of course, a national competence, but we also know that European legislation underpins so many important elements of health, including the authorization of medicines, medical devices, clinical trials, tobacco products, blood and organs, cross-border healthcare, the management of health data and health security. And even in the areas that still remain that are the that do remain a national competence, cooperation at a European level, as we've seen, enhances national and regional efforts to address some of the major challenges, such as cancer or how we treat patients with endometriosis, emerging different issues.

We will listen carefully, we will build work together, we will build bridges where positions differ, we will try to bring everybody as close together to drive ahead what is a shared European agenda to really deliver both for competitiveness, but most importantly for patients through delivering in competitiveness, and a very, very focused focus on delivery. Our program will focus on delivering a secure, competitive, and sustainable European Union that works for our citizens. And we're going to prioritize strengthening Europe's economic resilience and competitiveness. We really want to support innovation, to support skills, and the single market while also advancing more broadly the green and digital transitions in a fair way. We will work to reinforce the EU's global role through steadfast support for Ukraine, commitment to enlargement, and deepened international partnerships.

And also the Irish presidency will at the same time champion social cohesion, protect our democratic values, the rule of law, and promote practical cooperation on security, migration, and climate action. Our approach will be one of unity, one of delivery, one of pragmatism, and ensuring that Europe remains strong and open to the challenges ahead. We believe in Ireland, we believe in multilateralism, we are strong supporters of the World Health Organization and the valuable work that it does in partnership with European Union and with so many others. So our health program in the presidency is framed through this lens of values, security, and competitiveness. We will take forward the theme of investing in health to enable competitiveness, to enable access to medicines and to medical devices for our people.

Healthier people, resilient health systems, predictable regulation, and improved innovation are foundations of Europe's economic and social strength. And what that means for the presidency period is that we will progress as quickly as possible the legislation on the Biotech Act and aim to reach a Council general approach on the simplification of the medical devices and in vitro diagnostics regulation. Our priority in progressing the legislative files is to show that health resilience and competitiveness are not competing objectives in any way, but very, very much one and the same thing. It means smarter regulation. It means better access to patients.

It means stronger preparedness for the things that can happen, the crises that can happen. It means sustainable innovation, and it means continued protection both of public health and patents, those two things working together to support each other all of the time. The Biotech Act regulation is a timely and it's an ambitious response to the challenges and opportunities facing Europe's life sciences and biotechnology sectors. And I believe in supporting that it provides real benefit to citizens. We want our citizens to have access to the most innovative and effective medicines and medical devices that are out there.

We need to move quickly on this file, and I know I share that ambition with the different rapporteurs. I know I share that ambition with members generally because we want to deliver for our people together. Accordingly, the Irish presidency will initially focus on the amendments to the clinical trials regulations. We of course want people in Europe to have access, much, much better access to clinical trials. We want those trials to occur in Europe, and we've decided to prioritize that part of the regulation to make sure that we can make as much progress as we reasonably can.

So we will try to progress that, we are progressing that this month before opening other chapters and making as much progress throughout the year as possible. The other major legislative file is the simplification of the medical devices regulation. That is a priority again for the Irish presidency, and we really do welcome the opportunity to advance the revision to ensure availability, to ensure a high level of patient safety, crucially, but also reducing the administrative burden, improving predictability, and supporting innovation in Europe.

It's just as big a problem for patients not to have access to medical devices as some of the changes that we need to make. And I know that colleagues in the European Parliament representing those people very directly will share that ambition and want to make, as you have expressed to me in Strasbourg, rapid ambition on this file as well. Our objective is to reach a Council general approach in December. Last month, as you're aware, the Council agreed its general approach for the biotech directive on genetically modified microorganisms and the processing of organs. I know that Parliament is still formulating its position on that file, and we look forward to constructive engagement with you on and whenever you are ready to proceed on those negotiations.

The Irish presidency then, I'm grateful of course to the work of my Cypriot colleagues in advancing that as far as they did. Our presidency, the Irish presidency, also intends to progress the proposed Council recommendation on health checks for cardiovascular disease when it is published later this year. We know that it's an important public health initiative. We know that it's one of the first deliverables of the Safe Heart Plan. Cardiovascular disease leads to 1.7 million deaths across the EU each year.

And we think that in addition to health checks, we've got to step up our prevention efforts more broadly. In that regard, we hope that the Commission will publish a proposal for revision of the tobacco products legislation towards the end of the year. We would be keen to work on that, but I think it may be towards the end of the year. We also expect to engage with other ongoing files, as you're aware, such as the PABS annex of the WHO pandemic agreement and the Union Civil Protection Mechanism reform, which does of course have a significant health dimension. Alongside the legislative agenda, our presidency program will bring together in a series of meetings welcoming delegates to Ireland.

Our non-legislative program will focus on areas we believe are strategic importance, largely around prevention strategies, around how technology and innovation can help with preventative health and address health inequality. So we'll be focusing on early detection, integrated care, aging and dementia. We'll be focusing on endometriosis and women's health. We'll be focusing on mental health. And we will also support implementation of the European Health Data Space, promoting secure data use, interoperability, and digital trust.

And that's essential for better care. It's essential for how we think about AI and bring that to people. The Irish presidency as well will overall in all of the different pieces that we're doing, we want to champion mental health, of course. My excellent colleague, Minister Mary Butler, is a dedicated minister for mental health driving that in Ireland. And we are making big improvements, but we want to place a focus on that for all colleagues in Europe.

I know that Poland had a special emphasis on that in their presidency also, and it's important to highlight that. But overall, our agenda is trying to drive competitiveness, drive sustainability, and why? So that we can drive improved outcomes for patients right across Europe. So that we can protect health innovation in Europe, not just for industry, not just for competitiveness, but most importantly to get those innovations, medicines, and medical devices to our people as quickly as possible. That is we will approach this presidency as we have past presidencies, committed to constructive engagement, committed to dialogue, committed to listening.

And we hope that we can bring our experience in the past and our experience with some of these industries to a benefit of everybody in advancing these files as quickly as we may. Thank you, Chair. I appreciate I went over slightly. Thank you.

01:59:16 - 02:00:33

Adam Jarubas

Thank you so much, Minister, for your presentation. Before I give the floor to my colleagues, I would like to pose a question to you on the health funding in the context of annual budget for 2027 and then more broadly in the context of upcoming MFF. As regards the annual budget, we have concerns on the health funding, in particular EU4Health program and its allocation.

Could you please elaborate the position of the Irish presidency on the 2027 budget for health? And the second question on the upcoming MFF and the proposed new structure of health funding, how do you plan to ensure sufficient funding for health in general and more specifically health in crisis preparedness and response? I'm concerned that the proposed MFF architecture where health no longer has a dedicated budget line, it might not meet the citizens' expectations in terms of lessons learned from the crisis 19 pandemic and in light of the recent health crises. Next speaker is Andras Kulja.

02:00:33 - 02:02:59

András Tivadar Kulja

Thank you, chair. Dear minister, it's a pleasure to welcome you to our committee today. Following our meeting during the April plenary session, we are pleased to see Ireland taking over the presidency of the Council and thank you very much for your presentation and presenting your priorities. Indeed, the Biotech Act and the review of the medical device regulation and in vitro diagnostic regulation will also be among the key priorities for this committee. Biotechnology is increasingly recognized as a strategic sector for Europe's competitiveness while ensuring timely patient access to safe and innovative medicines and medical technologies remains a shared priority across all member states.

To achieve this, the EU needs a regulatory framework that provides predictability, simplifies procedures and avoids unnecessary fragmentation. At our last SANT committee meeting, we discussed the draft of the Biotech Act and tomorrow we will begin discussing the Commission's proposal on the MDR revision. I'm glad you mentioned the clinical trials because improving access to medical trials for our Europeans and across the EU is very important and can open new treatments and possibilities for our patients and I'm also glad to hear your intervention to revise and simplify quickly the MDR regulation. In that regard, my question would be that what assurances can the Irish presidency provide that the negotiations on both MDR review and Biotech Act will deliver a more efficient regulatory framework, reduce unnecessary delays and strengthen Europe's attractiveness as a place to invest, innovate and bring new health technologies to patients? Do you plan to adopt a Council position and have a kick-off trilogue?

Thank you very much.

02:02:59 - 02:06:24

Vytenis Povilas Andriukaitis

Thank you, Andras. Vytenis Andriukaitis, please. Thank you so much. Thank you so much. Welcome to our committee meeting.

Thanks a lot for your very clear lines presenting your presidency priority. I know after you, Lithuania will be and then Greece, we are all in one boat, in one trio.

But of course, as just, you know, Adam Jarubas raised questions about MFF and about EU for Health budget, we can repeat once again, you know, it is our common goal to achieve ring-fenced EU for Health budget in line with Parliament's call for a dedicated 10.05 billion euro envelope in keeping in the program, public health focus. You know, we need to defend standalone program. Otherwise, it would be very difficult to you, to Lithuania, to Greece, to explain to people that health is disappearing from radars of European Union policy. I fully in line with Adam's question about, you know, the necessity to joint our forces. And of course, also you just rightly mentioned about Biotech Act.

One, we are doing our best. I think I count on, on, you know, on Ireland move forward with because we are from European Parliament side, we are keen to finish our job in December. It would be good to align Council efforts and Parliament efforts to see how can we really achieve better results. But please keep in mind, we are not treating only Biotech as competitiveness. We are treating Biotech Act as health-driven ecosystem which can address patients' needs.

Accessibility, affordability of medicines, especially orphan medicines, so huge, so big file. And we can ask Ireland once again to champion defending patients' need, orphan drugs, rare diseases and so on. And of course, finally, it would be good to also to know about your efforts to move forward, you know, mental health issues, especially keeping in mind young generation. You know, we listened your, you know, activists here in the Parliament presenting, you know, a necessity to strengthen European Union activities in mental health. We will be more than happy to, to see prevention and health equity in mental health.

It would be very valuable, you know, priority which should be supported from all countries. And finally, I can remember you about Dublin Declaration. You know, social inequalities, you know, health inequalities, they are so high on the agenda. And it would be good to see your efforts to renew Dublin Declaration. We will be more than happy to support you to move in this direction.

Thank you very much.

Muchas gracias. Margarita de la Pisa Carrión, please.

02:06:24 - 02:07:29

Margarita de la Pisa Carrión

Muchas gracias por estar hoy aquí con nosotros en la Comisión de Salud y gracias por ver que una de las prioridades de esta comisión, como es el Reglamento de Biotech Act y el de productos sanitarios, es también una de las prioridades para la presidencia. Sabemos que Irlanda ha acertado en la apuesta por este tipo de empresas y por el desarrollo también de otras tecnologías. ¿Qué elementos creen que han sido la causa de este éxito? Elementos que de alguna manera también podamos recoger nosotros en la regulación, ¿no? Se han impulsado ideas sobre acceso a la financiación, sobre ayudas al tema fiscal.

¿Qué ha hecho Irlanda para haber conseguido ser atractivo y haber conseguido generar tantos hubs de desarrollo de tecnologías, no solamente biotecnología, sino también otro tipo, para que podamos también nosotros trabajar en esta dirección? Gracias.

Thank you. Stine Bosse, please.

02:07:29 - 02:10:25

Stine Bosse

Thank you very much and thank you very much for coming here, Minister. It is a pleasure to meet you. For me, it's for the first time. So first of all, I'm very pleased with all the time you spent on the Biotech Act.

It is obviously a very, very important piece of legislation and also happy to hear that you are going to focus on cross-border trials especially. I want you to also pay attention to the most favored nation legislation and the pressure that this is putting not only on our pharmaceutical industry here in Europe but also on our universal healthcare system. And this is spreading now across Europe also for nations to be very, very worried about and we need to have your full attention on this matter and we will of course as negotiators pay full attention. It translates into many areas but one of them is the SPCs where we need also to have a clear signal to our industry that we want them here and that we appreciate them. Second, I'm very happy to hear that you will also focus on women's health, an obvious area, and I know for sure that you have very interesting experiences from many years back now in Ireland and for that to be shared across Europe is absolutely excellent.

So no question there but more a comment. And then also on the EU's health data space, there we also need funding. And you are so right to focus on this area because this is also an area where if we get it right we have a huge opportunity. We have all the data that we need for ourselves as patients but also to actually support our industry in developing the right and the relevant drugs. So if we get this right we have a huge asset and we should treat it as such.

That brings me on to the MFF, so pushing there also for health as a prioritized area. We are at the moment negotiating the Parliament's position on the ECF and here I am especially pushing together with others obviously but I am shadowing for Renew on the health area. There I'm pushing for that we really have finance in there for the health area. We might be finished with the MFF at the end of this year but if we are not please bear in mind that health needs funding, it needs public funding, otherwise all the things that we can really do together becomes very, very difficult and much more expensive by the way.

Thank you, Tilly Metz.

02:10:25 - 02:12:29

Tilly Metz

Yeah, here, thank you, thank you very much for being with us, it's a pleasure to meet you. And also for your presentation where you addressed a lot of different topics. But three topics I want to address and two mainly that I maybe missed in your presentation nevertheless. First of all is the idea of the One Health concept that you did not mention explicitly. So also the impact of the environmental pollution on human health, also the issue of antimicrobial resistance which is also due to all the antibiotics we give in intensive farming for example.

So that is one point I wanted to address, what's your position and how we can force and push more for the One Health concept. And then another point that I did maybe not hear, maybe you mentioned it, we work also in this committee on the healthcare workforce shortages and that is very important that as member states in the European Union we work together based on solidarity and not on competitiveness in order not to push brain drain or so.

So that's another point. And then working also on the third point I wanted to address, working also on the Omnibus on food and feed in the ENVI committee, which has and will have a huge impact on human health if we allow a prolongation, unlimited prolongations of pesticides that we know are toxic, or also the prolongation of grace periods not basing on scientific from different universities coming from member states but only on EU European approvals and studies. So what is your point on that? Are you not worried because me as a member of the SANT committee and working on this file, I must say obviously on the Omnibus food and feed I'm very worried on the impact on human health that this risked to have. Thank you.

Thank you, Kristian Vigenin.

02:12:29 - 02:14:26

Kristian Vigenin

Thank you, Chair. Thank you, Minister, for your impressive presentation. I wish you successful presidency even more because your slogan, Strength with Unity, resembles very much the Bulgarian one 80 years ago, which was Unity Makes Strength. So I hope you will achieve this strength and the unity of the European Union. Your presidency rightly presents health not only as a social responsibility but also as a foundation of Europe's competitiveness, resilience and security.

But competitiveness in health must be measured not only by innovation but also by whether patients can access it. Major inequalities remain between member states, especially in Central and Eastern Europe and in rural and border regions. This is why health cannot be treated as an optional component of the next multiannual financial framework. Now the presidency will have an important responsibility to ensure that the negotiations on the European Competitiveness Fund and the next EU budget provide a clear, identifiable and adequately financed health component. Since my colleague Vytenis Andriukaitis asked the question on the health fund, I would ask my second question that I have prepared.

Would you, taking into account what I have said, rather focus on ensuring that Biotech Act, the pharmaceutical package and the European Health Data Space reduce inequalities between member states rather than further concentrate investment, clinical trials and innovation in the strongest markets? I know it's a difficult task, but it very much depends how we address these challenges. So of what I know and what I've heard from you, maybe this is one of the elements where your presidency can make a difference. Thank you.

Thank you, Gerald Hauser, please.

02:14:26 - 02:16:38

Gerald Hauser

Danke, Herr Vorsitzender. Geschätzte Frau Minister, Sie haben richtigerweise angesprochen, dass auch Sie ein wettbewerbsfähiges Europa benötigen. Übrigens war das auch ein Wunsch der zypriotischen Präsidentschaft, das wiederholt sich jetzt laufend. Das Problem ist nur, mit den Worten alleine werden wir nicht wettbewerbsfähig. Wir haben in Europa mittlerweile ein Riesenproblem, die Wirtschaft ist im Niedergang und mit einer stagnierenden, rezessiven Volkswirtschaft wird man auch nicht die Steuereinnahmen lukrieren, um all die Wünsche, die heute und hier auch in diesem Rahmen auch für die Gesundheit erwähnt wurden, zu finanzieren.

Fakt ist, dass das Zugpferd der europäischen Wirtschaft, die deutsche Wirtschaft, stottert, wenn nicht Deutschland deindustrialisiert wird. Das heißt, erst jüngst Hiobsbotschaft, VW wird möglicherweise weitere hunderttausend Stellen abbauen müssen, das ist ein Desaster für unsere Wirtschaft. Und wenn ich heute rein zufällig nur mir ein deutsches Medium gekrallt habe, die Münchner Merkur, und hier getitelt wird, die Wirtschaft will neue Klimaziele, ist das mehr oder weniger auf den Punkt gebracht.

Das heißt, der Wirtschaftsstandort Europa ist nicht konkurrenzfähig, weil wir zu teure Energie haben. Der ganze CO2-Wahnsinn, die ganzen Klimaziele sollen die Europäische Union, soll Europa meistern, während die restliche Welt munter drauf los produziert. Das heißt, wir werden nicht mehr konkurrenzfähig. Was werden Sie ganz konkret, was werden Sie tatsächlich unternehmen, um das von Ihnen angesprochene wettbewerbsfähige Europa tatsächlich zu erreichen? Das soll ja kein Schlagwort bleiben.

Ich möchte konkrete, konkrete Vorschläge hören, und das wollen ja auch die Menschen draußen hören, die Angst um die Arbeitsplätze haben. Und wenn Sie das wettbewerbsfähige Europa ansprechen und im nächsten Satz vom digitalen Übergang sprechen, ist das mit Sicherheit keine Lösung. Also, was schwebt Ihnen vor?

Carlo Ciccioli, please.

02:16:38 - 02:19:03

Carlo Ciccioli

Grazie. Innanzitutto un saluto affettuoso al nuovo presidente, ministro di turno, e che spero abbia la possibilità di interferire su alcune cose che secondo me negli ultimi anni non hanno avuto un'accelerazione. Parto da un fatto, che siamo in una fase fortunata della salute perché ci sono nuovi farmaci molto avanzati, sia quelli chimici che quelli biologici. Abbiamo nuove risorse strumentali, soprattutto radiologiche, che non avevamo mai avuto la possibilità di avere. Abbiamo nuovi accertamenti dal punto di vista dei sieri biologici e genetici.

Quindi tutte buone notizie. Il problema è che tutto questo costa tantissimo ed è difficile poi spalmarlo nella popolazione. Praticamente rimane soprattutto un'acquisizione di alcune fasce più economicamente che hanno più risorse e possibilità. Quindi dobbiamo puntare molto a questo punto, perché il personale per gestire tutte queste cose, ed è la spesa più importante della sanità, costa moltissimo, sulla possibilità dell'innovazione tecnologica con la digitalizzazione. Cioè la stessa persona o lo stesso gruppo di medici, di professionisti o operatori sanitari, riesce a fare più cose dislocate in aree geografiche anche a distanza e monitorare anche gli aspetti di seguiti a domicilio e via di seguito.

Quindi, poiché il bilancio c'è un bilancio ordinario, si sa tutti che la salute è delegata agli stati nazionali, c'è un bilancio ordinario che è sempre stretto dalle disponibilità di cassa, dalla spesa corrente. Noi dobbiamo intervenire in quella fascia più modesta, se vogliamo, di bilancio straordinario, di investimenti straordinari, che ci permettono di finanziare questo passaggio dalla sanità come è stata erogata finora all'utilizzo di risorse straordinarie che sono legate alla digitalizzazione e all'intelligenza artificiale. Io spero che questa fase sia gestita a livello europeo, perché è lì dove non disperdiamo i soldi, dove l'Europa può fare un salto di qualità alla salute negli stati.

Mr. Kelleher, please.

02:19:03 - 02:22:55

Billy Kelleher

Gabh mo leithscéal, a Chathaoirligh, it is deas a bheith anseo arís i bh bhur dteannta, agus táim cinnte go ndéanfaidh tú sár-jab de do chuid oibre anseo, so go n-éirí an t-ádh leat agus do roinn. Minister, first and foremost you're very welcome, and you highlighted a very ambitious program and I want to wish you well in that.

We've been advocating for some time in certain key areas and I'm delighted that you have highlighted the the necessity to address the clinical trials regulation, the medical devices and obviously the Biotech Act as well. I mean Europe has been a cold place for many years for innovation and research and for clinical trials and we need to address that very very quickly. Primarily due to the need to make sure that we have high tech medicines available to our citizens but equally from a geopolitical perspective as well to be completely dependent on others for essentials is certainly something that's would be very undesirable. So I very much appreciate the need and the urgency around the clinical trials as well. Just an issue that has brought to our attention, I'm on the FEMM committee and we're working on gender inequalities in healthcare at the moment.

And there's an inherent bias minister in in certain areas but primarily in health and healthcare, the education, the academic side of it and a bias against certain cohorts of female population. So for example breastfeeding, menstruation, pregnancy as well. And in that it is clearly evident that we don't have a full picture when it comes to assessing medicines for the entire population base. And it is something that our report is identified very very obviously that needs to be addressed. And that means probably regulation but equally it also means changing culture with with academia, clinical trials themselves and the companies that are engaged in the clinical trials and the development of medicines and therapies.

There's just a second area as well minister that we've a keen interest as well. I'm currently working on the rare diseases action plan which will be voted on later in the in the autumn. And the number of people in the European Union with rare diseases is something between 29 and 35 million people. And over my lifetime in politics we've often seen and we've witnessed outside Leinster House from time to time patient advocacy groups campaigning for medicine to be made available. And surely at this stage we must do better to make sure that we have the high tech medicines available as quickly as possible.

And one area that I think we should look at is the idea that we have 27 health technology assessments across 27 member states for the same medicine and for the genetically the same people in my view makes no sense. And I think that there should be some way of us being able to mutually recognize health technology assessments carried out in one member state which would mean effectively conferring approval on all member states. And I just think it's an issue that might be addressed otherwise we have a situation as highlighted earlier by previous speakers where medicines are available to citizens based on your postcode, based on where you live, where you're from. And I certainly believe if we're to develop a deep union in the issue of healthcare that making medicines available, recognizing them through mutual recognition and then having quick reimbursement to ensure that we complete the cycle of innovative medicines being made available to people, stimulating innovative and creative developments in medicines and medical devices and then having closing that that circle to make it efficient and effective both for patients, also for public health, member states and for the pharmaceutical and the medical devices sector as well. Go raibh maith agat.

02:22:55 - 02:23:03

Adam Jarubas

Thank you Mr. Kelleher and last question from Kateřina Konečná please.

02:23:03 - 02:25:26

Kateřina Konečná

Děkuji pane předsedo. Vítám vás tady paní ministryně. A dvě otázky. Zaprvé jedno poděkování. Velké poděkování Irsku, protože vy jste nedávno přijali jako jedenáctý členský stát právo být zapomenut pro pacienty s rakovinou.

Je to legislativa, na které jsme tady pracovali v Evropském parlamentu, já jsem byla zpravodajka.

Jste bohužel teprve jedenáctým státem v celé Evropské unii, které tuto možnost dává pacientům s rakovinou. Z druhé strany ale máte jen pětileté období po remisi, což je velmi krátký čas. Například moje země má deset až patnáct let a je to podle mě velká chyba. Takže můj dotaz zní, jestli využijete jako předsednictví své funkční období k prosazení práva být zapomenut jako priority na úrovni Evropské unie pro zbývající členské státy, zejména v oblasti hypoték. A druhý můj dotaz je ten, který asi tady řekli už všichni kolegové.

Tento výbor přijal v dubnu velmi silný nadstranický postoj k víceletému finančnímu rámci, včetně výzvy vyčlenit deset miliard eur na zdravotnictví. Zatím, když se podíváme do rozpočtu, jak je projednáván členskými státy, tak to nevypadá nadějně. A proto se vás chci zeptat, jestli irské předsednictví využije té příležitosti a odpovědnosti napravit to, co bohužel udělal Kypr a jeho předsednictví na Evropské radě dne patnáctého října, a jestli zajistíte a pomůžete nám zajistit, aby se o zdravotnictví jen nemluvilo, nebylo na papíře, ale aby tam ty peníze opravdu byly. Děkuju.

And one additional question from Michael McNamara, please.

02:25:26 - 02:26:47

Michael McNamara

Thank you very much and welcome, Minister, and good luck to you in your role. Obviously, the issue of medical data and what to do with it, how to protect it, the extent to which it can be used under what circumstances for training of AI, etc., is a live one and one that will undoubtedly cross your desk in the duration of this presidency. However, I suppose it's one that doesn't affect the Department of Health very much because people are still running around with paper records in Ireland. I congratulate you on being the minister who's actually tackling this as you are with other issues and moving it along, but it'll be 2032 by the time Ireland has a full digital record in our public hospitals and that paper records are replaced with digital records. By then, will we be the only country in the European Union, even by now are we the only country in the European Union using paper records, because it beggars belief in a country with one of the biggest tech sectors in Europe that that is the case?

And it's, you know, but again, I congratulate you on moving that along, but do you have any reasons why, could you explain how government has failed so miserably to put a proper system in place before your tenure in the Department of Health?

Thank you. So many questions, Madam Minister. Could you try comment?

02:26:47 - 02:42:33

Jennifer Carroll MacNeill

Thank you. Thank you so much and thank you for all your questions, which I have written down in the backwards order, so forgive me as I try to answer them in the best and most appropriate way that I can. In relation to just very quickly on electronic health records, I think all European countries are at different stages of their evolution in relation to that and it's certainly true to say that we're mid-table. But I think the value of the European Health Data Space and data generally is the population health benefit that can be accrued from sharing data just differently across such a major market, against such a huge great group of people. And as Mr. Kelleher said, the access to the patient improvements that can be achieved by collaborating and working slightly differently, most importantly from data, the opportunities that are created from that are really without parallel.

There isn't another block that has that opportunity, and the way in which we use that intelligently now will form the basis for how we innovate for patients for the future. On the right to be forgotten, thank you so much, Madame Concha, for your observation on that. That is a domestic issue, of course, and we're pleased to have been able to advance it in relation to cancer for cancer survivors, but it's not one for the full presidency. It is more of a national competence how insurance is treated and how mortgages are treated, if you'll forgive me on that, though I do see the importance of raising it at European level. Mr. Kelleher, thank you for your series of questions in relation to clinical trials, medical devices, and high-tech medicines.

I think the way that you've framed it brings everything together. This is a geopolitical imperative that Europe can protect its own people. It's a geopolitical imperative that health delivers for its people as well as driving innovation for the future, as well as driving health as an economic driver in itself. All of these things are, they build on each other, they reinforce each other, and both innovation and universities and research institutes benefit from this focus, but more importantly than anything else, patients sitting alongside and living beside those research institutes benefit. I want, as Europe wants, clinical trials for people in Ireland, for people in Bulgaria, for people in small countries and countries at the edges of Europe as much as for large markets at the center of Europe.

This is what we want. We want all people in Europe to have access to clinical trials, to medical devices, and to medicines. And we have brought ourselves to a place where that access isn't what it should be. And that's not good for innovation. It's not good for bringing products to market, but more than anything else, that's not good for public health.

And it's not good for the future of public health. It's not good for how we think about budgets, for the sustainability of national budgets for medicines, because unless we're producing our own, unless we're driving innovation ourselves, unless health becomes so much bigger as an economic entity within the European Union, we will never ever ever be able to deliver for our patients in a financially sustainable way. And quite remarkably, the Health Committee, the Irish presidency on the health side, has this opportunity through these files, though they are rooted in competitiveness, are simply essential for the future of patient health. And this one opportunity where they all sit together and reinforce each other, and while there are different perspectives at the edges in relation to patient safety or the speed or the times, everything is about driving a single outcome, which is that Europeans, people in Europe, can make sure that they have access to the medicines of the future, the medical devices of the future, and the preventative health measures for the future that we are all going to need in a growing and aging population. This is a unique opportunity, and I certainly am committed to driving as quickly as possible these different files.

Again, you're so right to highlight the rare disease element of this, because while a rare disease is rare in itself, the group of people who have rare diseases is not rare at all, as advocates say better than I do. And again, how we make those medicines available, those orphan drugs or those very, very rare drugs that have been funded differently to get to that point of innovation, is a crucial task for all of us. And again, we come to that balance of rewarding innovation so that medicines can get access, so that patients can get access to those medicines. Thank you also for highlighting gender inequalities, you're not the only member to do so, of course. We will have a particular focus on menstrual health during our presidency.

We will have a dedicated conference to endometriosis, endometriosis being a whole system disease for women, not a menstrual disease, but a whole system disease that has been under-researched and under-understood, not sufficiently understood, both in medicine and in society more broadly.

It is a deeply painful debilitating disease that impacts potentially one in seven women. It's very, very common and we don't have the surgical capacity or the radiology and imaging capacity nor the education and awareness in workplaces, schools, to be able to support those women, those many women that do have it, particularly at an acute stage. So we are dedicating one of our conferences specifically to that to try to drive awareness and research in Ireland and on that element of gender inequality. Now, forgive me. Thank you, Mr. Hausen, who again you recognize this challenge around competitiveness, economy struggling to compete.

But again, I may go back to the answer that I gave to Mr. Kelleher. All of these things reinforce each other. And to drive health as an industrial driver is important for the Union. It is important, I believe, that medicines and medical devices are made in Europe, both for our own autonomy, for our own protection, to make sure that we have access to these things at a time of, you know, very difficult and changing geopolitical circumstances as we have seen. It is important, I believe, that the people in Europe can access the medicines that come from the innovation that happens in Europe, that is often funded in Europe.

And what we have to do with these two pieces of legislation, and you know, I welcome the broad support for the impetus behind these pieces of legislation, we must make sure that we make progress so that we can drive the economic advantages of it, so that we make sure that products are being brought to market in Europe as opposed to the innovation happening in European universities and then being brought to market in other in other in other jurisdictions. That doesn't work for us. That doesn't work for patients. So we must make sure that we take the steps that we need to take to make it easier to bring innovation from the university to the market to the patient because that is the only thing that that will work. And that in itself has an ancillary advantage of making Europe competitive.

So what I will do to try to make Europe more competitive is try to advance these files as efficiently as we possibly can in the in the during the presidency. Forgive me. I don't want to mix up my notes. Mr. excuse me. Again, Mr. excuse me, forgive me, oh he's gone, Giglio.

Giglio, forgive me. Yes, again the same point about health inequalities arises for depending on where where we are. I mean, look, we are Ireland is a small nation, a small country that makes many medicines historically over time. We've had pharmaceutical companies there for 40 and 50 years historically and I'll come to Madame de la Casse's question related to that. But we struggle from time to time to get access to medicines as other countries do in different ways.

And there is a better synergy that is possible between us, as Mr. Kelleher alluded to, for example, harmonizing the health technology assessments, the other elements that are not necessarily national competences, are not part of the delivery of healthcare, but are about the synergy of healthcare right across from a technical perspective right across Europe. There are challenges, the you know, the MFN has thrown into question some of the the challenges that we have to make sure we're making the best collective decisions about health, access to medicine, and how we organize ourselves in relation to that. So I think the health inequalities piece, the the a big the new pharmacies, the biologics, the fact that they can be hugely expensive, their broad availability, it is about funding issue, but it is but it is more about the access issue and making sure that we're streamlining those processes as best we can to the advantage of the of the member states and not to anybody else's advantage.

On the MFN question which I think a number of of members raised, and forgive me because quite a number raised it together and not to speak across it, but it is a huge priority. It's really important of course to the ministers for health. It did come up again in a very in a detailed way at the Council meeting in Luxembourg in the summer. We know that the Commission is reflecting on the very strong positions that health ministers have taken in relation to it and we do expect a a paper from the Commission in due course over the next number of of weeks. You know, it's July, I'm not sure, but but it is it is a key priority for us and that geopolitical impact on pricing, access and the certainty of medicines is is very sharply felt.

Again I would refer to this question of how we have organized health as a national competence. It's very very important the delivery and yet we can see that there is possibly a better way of organizing how we think about medicines and and how where that situ where that's situated for the benefit of member states and therefore the benefit of of people more broadly. But I will just leave it in that that space for the moment. Of course it's a broader trade perspective trade issue as well which is very important to not to confuse. In relation to the on clinical trials, I'm sorry Mr. Vilgeña, I'm sorry I don't know you all individually, please forgive me Mr. Vilgeña.

Again it's not so you were about reducing inequalities, it's not just about stronger markets but access to clinical trials. And again I think the huge advantage of the Biotech Act is how quickly can we make that's why we've prioritized clinical trials within the Biotech Act. How quickly can we get to a point where the size of the market is not what's attractive, but it's about the efficiency and availability of researchers and clinicians to engage with clinical trials in a cooperative way so that everybody is on an equal playing field. Every member states wants their citizens to have access to the medicines that may be possible through clinical trials and I do believe we have not had that opportunity until the opportunity that comes from the Biotech Act. And that is why the Irish presidency has prioritized that part of the Biotech Act.

Yes for the benefit of European citizens more broadly, but it's also true to say that we have understood that perspective as a smaller country notwithstanding many of those medicines being made in Ireland. So it's a we we understand that perspective and I appreciate those perspectives are very different in different member states and for different populations. I do believe the Biotech Act measures will help smooth and manage many of of those different issues. Mrs. Metz in relation to one health and AMR the health workforce shortages, we are having a specific event in relation to innovating for resilience on health workforce shortages. It is a a dedicated event in relation with our joint chief medical officer, our chief nursing officer and one of the themes is around pivoting to prevention, reshaping the workforce to respond to the population needs and preventative health, but recognizing the need for a sustainable health workforce across Europe and not at the detriment of other of the global south and how we do that sustainably.

And there are some very good proposals within the World Health Organization that help respect and balance those needs for a growing health workforce in Europe and in the the north more generally and how we balance that with the human rights obligations of not of of making sure that we're doing that respectfully and sustainably. So I think it's very very important to highlight that. Thank you Mr. Andriukaitis, thank you so much for for your question. I again and I reference your own work of course on rare diseases for the past which has advanced so much and I know there's so much more that that you want to do in that space.

Thank you for referencing mental health where again we will have a dedicated event during our presidency led by our minister for mental health. Again, I think many of the points that you made balance this need for access for patients and competitiveness. And I very, very much see them as the same thing. The quicker that we bring ideas from the university to the markets in Europe, funded through Europe, not to other jurisdictions in Europe, that's how we get it to patients. So this is the unique moment where those things sit together very, very beautifully, where we get to do competitiveness and patient care together.

And I think there's a huge opportunity in relation to that. You did ask about MFF, indeed a number of colleagues asked about MFF, of course yourself, Chair, and others. And I'm very conscious that that is being negotiated at the General Affairs Council. Of course, as a domestic minister for health, I would always advocate for bigger and bigger budget for health specifically, but that's not what the presidency of the Council of the European Union and health. There is, of course, a very definite call, sorry, a call for a more definite allocation of funds and it has been raised across other instruments too.

But it is, of course, subject to the more horizontal discussions that are happening at the General Affairs Council. And I don't want to step across my colleagues either at the General Affairs Council or at ECOFIN in relation to that, if you'll forgive me on that point. And Mr. Kulja, again, thank you for your questions in relation in particular to MDR, to Medical Device Regulation. And again, what I think we have an opportunity to do here is to have a much, much more efficient framework for how products are registered, but more than anything else, the predictability for industry. We need industry to know that when they bring devices to market in Europe, they need to know when, how, and how quickly their products will be registered or re-registered as the case may be in due course.

That attractiveness to the European market is something that we may have lost over time and that we're trying to re-establish. And these again, happily, these are things that benefit both patients and industry at the same time. And it means, I mean, what is our goal here? What is our vision for the future of health for Europe? It's preventative health.

How do we best do preventative health? Through innovation and medical devices that allow us to live at home while managing different conditions. How do we have a more sustainable health budget? It's preventative health and it's medicines and medical devices that help us live better, longer, at home and away from acute hospital care. How do we do that?

We make it a more attractive place. These products are being developed anyway. We want them to be developed in Europe. We want them to be funded in Europe. We want them to come to market in Europe.

And we want that for the benefit of ourselves, for health as an economic driver, but more than anything else, for all of us and for all of the people that we represent across all of our different areas and constituencies to make sure that they have the best health opportunities for long, safe, healthy lives for the future. And I think this work, the work of this committee alongside the Council as co-legislators, we have a special opportunity to progress this work as far as possible.

02:42:33 - 02:43:21

Adam Jarubas

Thank you, thank you, Madam Minister, for your energetic, very energetic presentation and valuable contribution to our work. Thank you so much. We count on you. The cooperation between Parliament and the Council is very important and I believe that our exchange of views will help to make it successful. We want to strengthen European Health Union.

So it is our common interest. Thank you so much for your work. We're keeping the fingers crossed for you. Dear colleagues, I close today's meeting. We will meet again tomorrow morning at 10 o'clock in the same room.

At 9:00, we will start coordinators' meeting. Thank you.