Committee on Public Health Ordinary meeting
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SANT European Parliament
Follow its sittingsAdam Jarubas
Okay. We took note. Dear colleagues, let's proceed the vote. First, we let's do a testing vote because it is roll call. I open the vote.
Testing vote. I close the vote. Okay. So we're moving to the regular roll call. I open the vote.
I close the vote. Okay. So we're moving to the regular roll call. I open the vote. I close the vote.
It is adopted. Thank you so much. Point five, laying a framework for strengthening the availability and security of supply of critical medicines products, as well as the availability and accessibility of medicinal products of common interest. Okay, let's have a very, very short break. Dear colleagues, as you know, on the 11th of May, the third and final trilogue on the CMA file took place in the Parliament, during which we reached a provisional agreement with the Council.
This deal should ensure a high level of public health protection for EU citizens by reducing dependency on non-EU countries and boosting the competitiveness of the EU pharmaceutical sector. I would like to thank the rapporteur Tomislav Sokol and shadow rapporteurs for an excellent cooperation in this file. I will give the floor to Tomislav, our rapporteur on the file, to report back on the political discussion of the trilogue. Tomislav, could you take the floor, please?
Tomislav Sokol
Thank you. Thank you very much. Thank you, Chair, for giving me the floor. I'll go straight to the point. So the agreement on the Critical Medicines Act demonstrates that when Europe's health security and strategic autonomy are at stake, EU can act decisively and deliver concrete results.
The Parliament entered these negotiations with a clear objective. The CMA had to become more than a symbolic response to shortages. It had to provide practical tools to strengthen security of supply, reinforce European manufacturing capacities, and reduce our dependencies on third countries. And I would also like to add to that also achieving or facilitating equal access to medicines, because it is unacceptable that innovative medicines get to some markets, some national markets, two or three years after some other markets in the EU, which is unacceptable, and CMA also tried to tackle that to a significant extent. I would like to highlight three key achievements secured by the Parliament during the negotiations.
So first on the scope. Parliament successfully secured the inclusion of all orphan drugs, orphan medicines, in key provisions of this act. Patients suffering from rare diseases are often among the most vulnerable and thus it was essential that they were not left behind. And I would like to mention that here specifically that 95% of patients suffering from rare diseases do not have a treatment. So facilitating and incentivizing development of new medicines for rare diseases in Europe should be one of the main strategic priorities of the EU.
So as a result, orphan medicinal products will be eligible for collaborative procurement at European level, allowing member states to join forces and improve access to these medicines. We also ensured that orphan medicinal products can benefit from the streamlined permitting procedures established under the act. Strategic projects involving these products will therefore have access to faster and more predictable authorization procedures, helping to attract investment and strengthen production capacity within the EU. So essentially this means that development of new orphan drugs will be much easier, simpler, and faster than before, and through collaborative procurement will strengthen the negotiating position of member states, which will make it easier for them to acquire these medicines faster and at a lower cost, which is extremely important in terms of ensuring equality of access for patients.
For too long, procurement of medicines has been driven almost exclusively by the lowest price. While this may have reduced costs in the short term, it also contributed to the relocation of production outside Europe and increased our dependence on fragile global supply chains, especially in combination with with having only one one winner in a tender, so combination of of lowest price and one...
Tomislav Sokol
So combination of of one winner tenders and the lowest price resulted in increased dependency on imports, especially of generic medicines from India and China, which for us from a point of view of security of supply is unacceptable. So the agreement fundamentally changes this approach. For critical medicines where there is a high level of dependency on a single or limited number of third countries, preference should be given to production based in the European Union. Price will no longer be the sole or dominant criterion in public procurement. Instead, contracting authorities will be able to favor suppliers of critical medicines and their active substances manufactured in the Union by applying a scoring system that proportionally rewards the share of manufacturing taking place within the EU.
In this context, contracting authorities may allocate additional points to manufacturers that offer 50% or more of the medicinal products and their active substances manufactured in the Union. This creates a strong incentive for companies to invest in European production capacities and supply chains. This is not about protectionism. It is about resilience, reliability and security of supply. Europe cannot continue outsourcing the production of critical medicines while expecting guaranteed access during crisis.
Strategic autonomy in healthcare is no longer optional but a necessity. The same principles will also apply to collaborative procurement conducted at European level, helping to strengthen supply supply security across the EU. And third, on solidarity and contingency stocks. So Parliament insisted that measures introduced in one member state must not create shortages in in another, which unfortunately sometimes takes place. We therefore secure a clear safeguard stating that contingency stock requirements applied in one member state must not have a negative impact on the availability of medicines in other member states.
But we went further than that. Member states will be required to inform the critical medicines coordination group of their intention to introduce or significantly modified contingency stock requirements. This will increase transparency and allow exchanges based on the principles of proportionality and solidarity. We also strengthened the link with the European voluntary solidarity mechanism. When the mechanism is activated, member states will provide information on available available stocks of critical medicines that can be relocated to countries facing shortages.
And where voluntary measures are not sufficient, recommendations may be issued inviting member states to adapt contingency stock requirements in order to facilitate the supply of medicines to member states who are experiencing shortages and ensure optimal allocation of critical medicines across the EU. So on this, this is let's I would say the only part where the Parliament was not able to achieve all of its objectives from the mandate in the sense in the sense of of adopting a mandatory redistribution mechanism, but definitely when taking into account everything that I mentioned in terms of solidarity, transparency on the European level, I think that we achieved a major major a major improvement when compared to what we have today.
So overall, this agreement strengthens Europe's ability to prevent shortages, supports investment in pharmaceutical manufacturing, modernizes procurement rules and reinforces the competitiveness of our pharmaceutical sector. So in the end, I would like to thank shadow rapporteurs, the Council Presidency and the Commission for their constructive cooperation throughout the negotiations. The result is I think a balanced and ambitious agreement that puts European patients, European resilience and European competitiveness at its center. Thank you.
Adam Jarubas
Thank you so much, Tomislav, thank you for your report and for your great work during the negotiations. Thank you all shadows as well. It's a really great moment in building of our citizens' security and European Health Union as well. Thank you so much, respect. Dear colleagues, let's move on to the sixth point, Sant mission to Warsaw and Pabianice, Poland, 30th March and 1st April.
Our delegation was composed of three members in total. The main objective of this mission was to discuss key healthcare policy issues in Poland with a particular focus on pharmaceutical policy and the state of the pharmaceutical industry in Poland. Our delegation held meetings with the Minister and Deputy Minister of Health, the chair of the Senate Committee on Health and the chair of the Senate Committee on the European Union. We have also met representatives of the Polish patients' organizations and of the pharmaceutical industry. The major topics that were discussed during these meetings covered the new pharmaceutical package and plans for its implementation in Poland, the expectations of Poland and Polish industry regarding the Critical Medicines Act, our current work on the Biotech Act, the main challenges related to reinforcing EU independence in the production of critical medicines, the challenges faced by the Polish pharmaceutical industry in the production of APIs and the EU and national financial support for pharma industry.
In addition, our delegation discussed with the representatives of patients' organization the most important topics for patients in Poland, such as availability of oncological and neurological treatments, access to treatment for rare diseases and access to diagnostics and consultation with specialists. During our mission, we had the opportunity to visit the premises of Adamed Pharma in Pabianice. This is one of the largest Polish producers of pharmaceutical products in Poland. We could observe the full process of medicine production, starting from the visit to the laboratories where new products are developed and tested and finishing on observing the packaging process and final control systems. During the mission, we have learned about the healthcare landscape in Poland and the most important challenges, for example, in accessing medicines, addressing rare diseases, workforce shortages and mental health.
We have gained insight into the practical aspects of the full cycle of production of medicines. In conclusion, the mission was very successful and the debates were enriching and fruitful. Now I would like to ask if any of other members of the delegation would like to take the floor. If not, I thank you all. Dear colleagues, now we're moving on to the point seven, exchange of views with Mrs. Pamela Rendi-Wagner, Director of the European Centre for Disease Prevention and Control on the annual activity report.
Please join to us on the podium.
I didn't know that Mrs. Pamela Rendi-Wagner couldn't join us personally, but we have you remotely, so it's great. Dear colleagues, ECDC works to prevent threats to human health from disease outbreaks and to react quickly and effectively to minimize their impact. ECDC operates dedicated surveillance networks, provides scientific opinion, operates the early warning and response system and provides scientific and technical assistance and training. I will first give the floor to Mrs. Rendi-Wagner for a maximum of 12 minutes for her initial statement. This will be followed by an intervention from Mr. Oliver Schenk, who is the European Parliament's contact point for ECDC, and the first round of reactions from the coordinators of SANT Committee.
Afterwards, we will continue with Q&A session. Mrs. Rendi-Wagner, you have the floor for 12 minutes for your introductory statement. The floor is yours, please.
Pamela Rendi-Wagner
Yes, thank you, Chair. Thank you, Chair, and dear members of the European Parliament, heartfelt good morning from Stockholm. It's indeed a pity I cannot be with you in person today due to the strike in Brussels yesterday, but thanks for providing me the opportunity to do this report today online, and I hope the technical part works. Well, as we speak right now, Europe's health security system is indeed being tested in real time. So in the past weeks, ECDC has been coordinating the response to two serious outbreaks: the ongoing Ebola outbreak in Central Africa and the recent hantavirus outbreak on a Dutch cruise ship.
So this hearing today, well, comes more than timely, I can say, and the new European health security framework, where the European Parliament indeed played a key role, has been used in global health emergency as we speak. And this framework has given us, has given ECDC more tools than we had ever before, and tools that we were able to scale up quickly and efficiently if needed. So let me start with the Ebola outbreak. According to the latest data available, we currently have 332 confirmed cases in DRC and in Uganda, 149 related deaths and 116 suspected cases. No imported case to the EU/EEA so far.
Well, after WHO declared the public health emergency on May 17, ECDC immediately stepped up its response. Within two days, we deployed our expert through the EU Health Task Force directly to Africa CDC headquarters in Addis Ababa to support the outbreak coordination and planning activities. And again, two days later, issue, we issued a rapid risk assessment where we stressed that the risk currently for the wider public in Europe is very low. Nevertheless, nevertheless, and I want to say this very clearly, this outbreak is of serious concern because, first of all, it is unfolding in an environment marked by instability and insecurity. Secondly, it involves the Bundibugyo virus, which, for which we know there is currently no licensed vaccine available or specific treatment.
Thirdly there are major challenges in surveillance, in diagnostics, in contact tracing in the affected countries. Well giving this given this very complex situation we can therefore not and this is a very important point not only rely on our experience from past Ebola outbreaks. We need to learn from the field as soon as possible for this specific outbreak and we need to adapt our response to this specific new outbreak. So the approach to protect the European Union remains threefold. First support the outbreak control at the source in the affected countries.
Second ensure rapid detection, rapid containment in the event of an imported case to the European Union by increased preparedness in the member states and ensure that all arriving passengers from affected countries receive relevant information what to do in case of any symptoms. Third point it's important that there are well-organized and functioning exit screening at the international airports in the affected countries in place. This is important to reduce the risk of importation to the EU and to minimize the risk of any transmission onboard on long distance flights through an infected symptomatic passenger. Well in order to learn more, in order to get more firsthand information as soon as possible, in order to support the affected countries and in order to assess any of these exit screenings, ECDC will increase its present in the affected regions by deploying more staff via the EU Health Task Force in the upcoming days and weeks. ECDC has also produced advice for the aviation sector to strengthen safety of passengers onboard of planes coming from these regions.
This and much much more actually is done in close collaboration of course with the member states, with the European Commission and our international partners. I'm coming to Hantavirus outbreak because similar close collaboration was put in action for the Hantavirus outbreak only few weeks ago with the excellent cooperation and I want to say thank you for that of our Dutch and Spanish colleagues. And again within two days so very very quickly ECDC made a rapid risk assessment and we published also guidance for the member states to ensure the safety of the passengers onboard of the ship and also the passengers who left the ship earlier. Within half a day, half a day ECDC activated its European Health Task Force with an ECDC expert deployed onboard of the Dutch cruise ship and we sent also a second team of experts on the ground in Tenerife to support the disembarkment procedures with the Spanish authorities. So moreover the new EU Health Task Force was activated to ensure quick and no sorry the EU reference laboratories were activated to ensure a quick and high quality diagnostic in the member states.
So from the beginning of the outbreak ECDC was fast, we were clear and we were very strong in our advice. From the beginning ECDC adopted a precautionary approach by recommending the safe medical repatriation of all ship passengers. Well given the long incubation period we continue to closely monitor the Hantavirus situation together with the affected member states.
For both outbreaks, ECDC made use of new tools that were created following the COVID-19 pandemic, such as the EU Health Task Force to support quickly with our experts on the ground, hands-on. And second, the EU reference laboratories, which are new, and it's important for fast and modern diagnostics, including fast genomic sequencing of new viruses. These tools have allowed in these highly complex situations for a faster, strongly coordinated, and more effective response. Well, preparedness and response are very key components of ECDC's work, but we must not forget the importance of prevention of infectious diseases. In 2025, Europe recorded, and I'm sure you all know that, recorded longer and more intense transmission seasons for mosquito-borne diseases, for example, including West Nile and Chikungunya.
ECDC is therefore currently strengthening surveillance of vector-borne diseases, as well laboratory preparedness and climate-sensitive risk assessments together with the member states. Second, another challenge, sexually transmitted infections continue to rise at a worrying speed. In short, we see a doubling and a tripling of some of the STIs over the last 10 years in Europe. We are off track with the SDG targets when it comes to HIV, TB, viral hepatitis, and sexual transmitted infections. So according to our mathematical modeling, due to failure to achieve these targets, we will see 80,000 new HIV infections and over 9,000 deaths due to tuberculosis in the upcoming three years in Europe, with antimicrobial resistance contributing, of course, to these TB-related deaths.
And this brings me straight to antimicrobial resistance, which is still most, well, maybe one of the most serious public health threats we're facing in Europe, being especially dangerous for aging populations with chronic diseases. Currently, we also see more than 4 million cases per year of hospital infections, and they account for more than 70% of the burden of AMR in Europe. Well, in order to support the member states, we have strengthened genomic sequencing, we have reinforced the support for antimicrobial stewardship, and advanced One Health cooperation in this matter. Well, last but not least, vaccination remains one of the strongest investments in Europe's health. Taking HPV, human papillomavirus vaccination as an example, cervical cancer is still today the fourth most common cancer and second most common cause of death in young women.
Today, it is preventable through vaccination. Well, dear members of the European Parliament, 25 was a very intense year with lots of old and new challenges for ECDC. So last year, I'm very happy to say that we produced 170 scientific outbreaks risk assessments and actionable guidance for the member states. We conducted 12 country missions to assess in 25 the preparedness mechanisms of the member states. In total, so far, we have assessed 25 member states.
And since my start as ECDC director, I've always stressed the importance of international cooperation. So this is key to be quicker informed and to have trusted partners in the case of any crisis like the one we are in now. In 25, we signed therefore eight new international memorandums of understanding with international partners. The latest was only a few months ago with Africa CDC, and this Africa CDC memorandum is more than useful in the current situation. So until today, we have also coordinated successfully the setup of 10 new EU reference laboratories across the EU, which proved immediately useful in Hanta and the Ebola outbreaks right now, and we are working on a new one on biotoxins.
We activated the European Task Force last year 14 times.
So I'm coming to the end. 25, you know, was my first full year as ECDC director, and I would really like to thank all ECDC staff and colleagues for their great achievements in 25. And let me conclude that ECDC's work is always, always based on science and trusted partnership, including the partnership with the European Parliament. We are always ready to support you. Thank you, Chair.
Adam Jarubas
Thank you so much, Mrs. Solendi-Wagner, for your work and your presentation. And now I will give the floor to Oliver Schenk, the Parliament contact person for ECDC. Oliver, the floor is yours, please.
Oliver Schenk
Vielen Dank, Herr Vorsitzender. Frau Wagner, herzlich willkommen. Ich hatte gestern selbst größere Probleme bei der Anreise nach Brüssel, deshalb bedauere ich sehr, dass wir heute Sie nicht hier im Saal begrüßen können dort, aber ich bin sicher, wir holen das in Kürze nach. Vielen Dank, dass Sie diese beiden Themen Ebola, Hantavirus angesprochen haben. Wir haben selbst eine Debatte dazu geführt in der letzten Plenarwoche in Straßburg.
Und ich glaube, das hat uns wieder sehr deutlich vor Augen geführt, dass Gesundheitsbedrohungen heute halt zunehmend an der Schnittstelle von Mensch, Tier und Umwelt entstehen und dann noch einmal beschleunigt auch durch Klimaveränderungen, Mobilität und globale Vernetzung sie zusätzlich beschleunigt und beeinflusst werden. Das ECDC, und dafür vielen Dank für die Arbeit von Ihnen, der Kolleginnen und Kollegen, spielt aus meiner Sicht eine Schlüsselrolle bei der Früherkennung von Risiken und der Unterstützung der Mitgliedstaaten. Und ich bin sehr froh und dankbar, dass Sie dies auch zu einem Schwerpunkt Ihrer Tätigkeit gemacht haben. Mich interessieren vor allem die nächsten Schritte bei Prävention, Vorsorge und dem Einsatz neuer Technologien. Und ich weiß, dass das ECDC die Modernisierung der europäischen Surveillance-Systeme ja zu einem Schwerpunkt, zu einer besonderen Priorität erklärt hat.
Und deshalb drei Fragen von mir an der Stelle ganz konkret. Welche konkreten Anwendungen von KI sehen Sie in den kommenden Jahren für die Früherkennung neuer Ausbrüche oder zoonotischer Risiken? Und welche Voraussetzungen müssen wir auf europäischer Ebene schaffen, damit diese Instrumente auch wirklich ihr volles Potenzial und ihre Anwendungsmöglichkeiten in den Mitgliedstaaten und darüber hinaus entfalten können? Das Zweite. Bei Erkrankungen wie Hantavirus sehen wir bereits heute den Einfluss ökologischer und klimatischer Veränderungen auf Gesundheitsrisiken in Europa, man könnte auch noch andere Beispiele nennen.
Wie bewertet jetzt ECDC die künftige Entwicklung solcher zoonotischen Erkrankungen? Und welche zusätzlichen Maßnahmen sind aus Ihrer Sicht jetzt notwendig, um diesen One-Health-Ansatz in der europäischen Gesundheitsversorgung auch weiter zu stärken? Und der dritte Punkt. Wo sehen Sie die derzeit noch die größten Lücken in der europäischen Preparedness-Architektur, die wir zugegebenermaßen jetzt ja auch sagen mit den Lehren aus der Pandemie weiter aufbauen, stärken? Deshalb ist glaube ich sagen Ihr Hinweis auch noch mal auf Surveillance, Datenaustausch, Laborkapazität oder medizinische Gegenmaßnahmen wichtig.
Und wo sollten wir jetzt auch, und ich sage das auch mit Blick auf die Fragen, die wir jetzt führen, mit Blick auf den kommenden Haushalt, auch aus unserer Sicht noch mal ein besonderes Augenmerk haben, besondere Schwerpunkte setzen? Vielen Dank.
Adam Jarubas
Thank you, Oliver. We continue our discussion and Andreas Kulja as a first.
Andreas Kulja
Thank you. And thank you, Director, for being with us, even online. Last week, the SANT Committee took part in a very important mission to Washington, D.C. and Pittsburgh, where we discussed, among other issues, the importance of preparedness, surveillance, capacities, cross-border cooperation, and rapid response to emerging infectious disease threats. During our meeting with the leadership of the US CDC, the ongoing Ebola outbreak was also discussed. And in this context, they expressly underlined and highlighted the professionalism and the high quality of ECDC's work.
So we are very, very happy and honored to hear this. And in light of the ongoing Ebola disease outbreak affecting the Democratic Republic of Congo and Uganda, as well as the significant increase in the international flows linked to major global events such as the FIFA World Cup, could you please outline ECDC's current assessment on the risk to the EU, especially linked to the FIFA World Cup? And building on to what you have just outlined, could you identify what ECDC currently sees as the most important remaining vulnerability in the EU's preparedness for high-consequence infectious diseases such as Ebola? In particular, are there any areas where the Member States' capacities still differ significantly, for example, in early detection, laboratory diagnostics, hospital isolation capacity, contact tracing, or risk communication, and where further EU-level coordination would be most urgently needed? Thank you very much.
Christophe Clergeau
Thank you, Chair. Good morning, Mrs. Ammon, and congratulations for your work and the work of your team. We fully understand that it's difficult for you to be in Brussels today regarding the task you have to face. And I will have three different questions, complementary from my colleagues, more about the future and the debate we will have here in the Parliament in the next month. The first is about MFF.
And we are not discussing a lot about the budget for the agencies. So it would be useful to hear from you the vision you have of the evolution of your tasks and if you consider to have the resources corresponding to the missions, objectives that the EU is giving to you and corresponding to the difficulties, the crises you have to tackle any day that are growing, growing, growing, growing. Second question, you referred different times to One Health issues and One Health approach. And we have this One Health task force across the agencies. And if I remember well, you had the opportunity to chair, to coordinate by yourself this task force.
Perhaps you could say more to this committee about how useful it is, how it can be strengthened, and what could be the future of this cooperation between agencies on One Health.
And my third question is about the future of ECDC because we know there is an evaluation pending. When you were evoking AMR, you were evoking the interface between CDs and NCDs. And perhaps you can say more about the possibility for the future for ECDC to have more competencies in link with non-communicable diseases. Thank you.
Stine Bosse
Thank you very much. And I speak on behalf of Vlad who just arrived. So, so dear Pamela, as you very well know, these are trying times for Europe and for global health. The World Health Organization system is, you could actually call it under attack. It is being defunded and important experts are being redrawn.
That means that Europe and everyone else is now more exposed to the next pandemic, for example, avian flu. The EU institutions and member states taken together are the biggest contributors to the WHO. We must use this position and leverage it. A direct consequence of this is the fact that new pandemics for which there are no known vaccines yet, like Ebola, present even bigger threats to the world and obviously to Europe. And this is exactly why we need our ECDC and our HERA.
Strong mandates, secured funding, more Europe in ensuring our resilience and security also in the public health crisis area. So, dear Pamela, do you see yourself with everything that I mentioned here, do you see yourself funded, and this is I guess really also corresponding to my colleague's questions, well enough? Do you see yourself positioned well enough to attract attention from the countries? I mean, are they listening when you speak? And then again on, you know, could it be an idea to have an even stronger and better radar to detect new threats before they become critical?
And just one comment connecting to the funding. As we all very well know, it is much more expensive to not know. And we saw it. I mean, we've got the figures and they are devastating from, from the COVID-19. So what is your thinking about the funding and how can we put this up on the agenda?
Tilly Metz
Thank you, thank you, dear chair, and dear director, dear Pamela, thank you for your presentation and for the work of ECDC. What we are seeing across Europe is a clear structural shift in cross-border health threats. So climate change is no longer only an environmental issue, it is directly reshaping the epidemiology of infectious diseases in Europe. So we are seeing longer transmission seasons, changing geographical distribution of vectors and diseases emerging in regions where they were previously not present.
So this is not a future scenario, it is already happening now. At the same time, these developments are increasing pressure on public health systems that are already managing multiple stress factors. The line between communicable diseases and non-communicable diseases, environmental determinants of health and climate risk is becoming increasingly blurred. That requires a more integrated approach to health security at the European level. In that context, I want to underline our really strong support for the work of the ECDC and I believe it is precisely because the risk landscape is evolving that the role of ECDC becomes even more central, not only in surveillance and response but increasingly in foresight, preparedness and cross-sectoral risk analysis.
So my question: how does the ECDC see its role evolving in this changing risk environment, particularly at the intersection between climate change, infectious diseases and broader public health resilience? Thank you.
Kateřina Konečná
Děkuji, I will speak Czech if it's possible. Paní ředitelko, já vám děkuji za vaši prezentaci, nicméně není všechno tak, jak úplně vypadá. Vy tady popisujete skvělou spolupráci se Španělskem a Holandskem na záležitosti ohledně hantaviru na lodi v evropských vodách. Ale já si troufnu říct, že to vidím trošku jinak. 30 dní trvalo od prvního úmrtí, než se Komise k věci nějak koordinovaně vyjádřila.
30 dní, během nichž cestovaly stovky evropských občanů domů bez jednotné karantény, bez jasné informace, často bez ochrany. Koordinace se podle mého názoru hned v zárodku rozpadla mezi vlajkový stát lodi, přístavní stát, ECDC, WHO a národní orgány. Výsledkem byl poté zmatek ohledně podmínek vylodění na Tenerife a nejednotná karanténa v různých členských státech. HERA existuje od roku 2021, přesto jsme testovací sady dováželi z Argentiny. Nevím, jestli tady můžeme mluvit o připravenosti.
Přitom za pozdní reakci bylo ECDC i Komise kritizovány už v počátcích covidu-19. Vy nám dnes prodáváte tu aktivaci systému včasného varování jako úspěch, ale já jasně říkám, to je minimální standard, ne důvod k oslavám. Dnes zase putují jednotliví pacienti i ze třetích zemí po nemocnicích v Evropské unii, což znovu vyvolává otázku ohledně rizika rozšíření eboly v Evropské unii. Já se prostě chci zeptat, kde vidíte tu chybu v tom, že podle mě pořád ještě reagujeme s takovým zpožděním a zmatky? Co je podle vás systémově špatně?
S čím bychom vám mohli pomoct, aby k tomu nedocházelo?
Adam Jarubas
Thank you, Kateřina.
Thank you, colleagues. Mrs. Rendi-Wagner, the floor is yours to react to the question posed by MEPs, please.
Pamela Rendi-Wagner
Yes, thank you very much, dear MEPs, for the questions raised, for the interest and the appreciation of our work. I'm trying to group some of them, the answers. Well, regarding the use of artificial intelligence, this is of utmost importance for us to drive innovation in public health and to support the member states also by using innovative tools like AI. At ECDC, we have last year actually established the first AI steering group, a steering committee for an overarching cross-agency coordination and planning of all our AI strategies to drive these developments. We have been in, or we are in contact with member states regarding the use of AI, also in large-scale data for in the landscape of predictive modeling and forecasting.
This is a very interesting new and future field of work and research to be quicker in the future. We are currently also at the European level and together with the member states and at the ECDC using epidemic intelligence, where we use AI methods, which enables us for an earlier risk identification and response, because AI speeds up the processes and is able to work on much more sources and information than ever before. So this is really very important to be quicker in response and risk assessment. With regard to One Health approach, this was raised by, I think by Oliver Schenk and many others. I mean, One Health, I mentioned it in my entry statement, is a core part of ECDC's work, especially when it comes to vector-borne diseases, food-borne, climate change, water-borne diseases, and antimicrobial resistance.
So we already do together with the relevant other EU agencies, like EFSA, Food Safety and Animal Agency, joint risk assessments on the relevant diseases, which is very important. We work, as has been mentioned, also in the One Health Task Force, the European Task Force. ECDC chaired the task force, including the five relevant agencies on board. We will soon publish a rapid risk assessment actually on avian influenza. And unfortunately, determined efforts by countries, healthcare professionals, Europe is not on track, I mean, for the four of the five AMR targets set by the Council with regard to AMR and consumption of antibiotics.
But and then it was asked how do we support the member states to be also better prepared. Well, the core things are country missions, where we go directly five days to each member state and EEA to assess their state of preparedness. Then as a follow-up, together with the member states, we do actionable tailored recommendations in these various important relevant areas: prevention, preparedness, response planning, surveillance, response. A second very important pillar to improve actually the member states' preparedness is the EU Health Task Force, where we can come before an outbreak occurs, during an outbreak, or even after-action reviews after an outbreak to have the best lessons learned. And as I told you, we have been doing this 14 times last year basically.
Well, the biggest gaps in health architecture currently, I mean, we will, there are reports available regarding these missions to the member states. I would say, I mean, it's very specific from country to country. But I think where all all countries and including us, we need still to improve is the intersectoral cooperation. We see how important it is, how important One Health is. So the intersectoral cooperation when it comes to preparedness and response is a very, very decisive one, so where it needs new communication channels at the member states and at the European level.
Regarding the questions for the FIFA risk and the vulnerability, well, ECDC is indeed monitoring the situation very, very closely. And actually, what are we doing about it? I mean, the most important thing to reduce the risk for Europe, for travelers, is first to have effective exit screenings in the affected countries to avoid like infectious symptomatic individuals boarding a plane. Second, to improve the contact tracing in the affected areas. And we see that there are huge gaps, so there is the need for more international support on the ground to improve contact tracing, which reduces substantially the risk of spreading in the affected areas and spreading to other continents.
And the third is, of course, the preparedness of the EU countries, which is decisive when it comes to diagnostic preparedness, isolation, the management for such highly contagious patients. We're doing this in very close collaboration. We support the member states and they are supported first time in history, actually, by the European Reference Laboratory. And there is a survey, we know exactly which country has what needs in the current situation. So we have really very individual supports going on right now with regard to Ebola, member state to member state.
So it is important to do this as soon as possible and it's important that ECDC Task Force is as soon as possible with high number of experts on the ground to do exactly this international support and to assess also these important exit screenings. Coming to the question regarding ECDC's future, I think it was by Claire Joux asking these questions. Well, you know there is the external evaluation going on right now. We are still awaiting the replies and the draft, the report from this evaluation regarding the extension of ECDC's mandate from communicable to also non-communicable diseases. Well, as I said, from a scientific point of view, we see that the links between communicable and non-communicable diseases, this link is becoming more and more important when it comes to antimicrobial resistance, when it comes to respiratory diseases and cardiovascular patients, when it comes to also mental health and countermeasures in pandemics.
All these links are evident, or vaccine-preventable cancers. All this is evident. And this scientific link is of growing importance.
So yes, we are waiting for the results. A holistic approach from the scientific point of view makes sense to be more effective in prevention, in preparedness, and in response to any infectious disease, but also non-communicable threats. Regarding, and many of you asked the very important question about budget, I mean, there is no good work without budget and sufficient funding. Well, regarding the upcoming MFF, I want to say from an ECDC point of view, three things are maybe of most importance. First, that the budget in the future ensures continuity and consistency of our current tasks, of our current core responsibilities when it comes to surveillance, preparedness, response, prevention.
This is of utmost importance to us. Then second, I mean, everybody of you mentioned it, that public health tasks or threats are not becoming less. We see that there is a growing number of public health threats, including biotoxins and other threats being on the list. So if this is the case, I mean, if there are more responsibilities in the future because there are more threats which we need to cover, this means more tasks for ECDC. More tasks means we need more staff and more expertise in the center to cover these tasks.
Of course, this goes hand in hand with more funding, which is needed in order to cover these additional tasks in the future. And then the third one, ECDC should be sufficiently funded in the future to make use of all modern innovative tools in order to be better supportive to the member states or for quicker and better surveillance. Innovation like AI, digitalization, integration of e-health into the standardized surveillance systems in Europe are of course of utmost importance. I think I have mentioned or replied to the main, actually, yes, to the main questions asked. Well, the last question also regarding the Konečná's question regarding hantavirus and the timing.
Well, it has been a very complex outbreak involving 23 nationalities. And we have to say with regard to the timing, ECDC has reacted within two days actually after we got this information. I mean, talking about the time between the first death and the first public health steps and coordination set is a bit of, is not I think the right way to do it because we didn't know the reason for this death. There are thousands reasons for deaths on board of a cruise ship. But as soon as it was clear that this death was caused by hantavirus, which is of course a public health emergency on a cruise ship, all the actions, coordination done by the European Commission, by the member states, and by Spain, by the Netherlands, and by ECDC have been put in place within a few hours.
Adam Jarubas
Thank you so much, Director Randy-Wagner, for your clear message and response to the questions posed by MEPs. Now I will give the floor to the European Parliament representatives to the ECDC management board, Dr. Andrea Capilna in the room and Dr. Quique Bassat that is joining us online.
Dr. Capilna, the floor is yours for three minutes, please.
Andrea Capilna
Thank you, honorable president, director, and members of European Parliament. It is both a privilege and a serious responsibility to stand before you as your representative on the management board of the European Centre for Disease Prevention and Control. I address you not only as a representative, but as a physician, a specialist in infectious diseases and epidemiology, who has spent years at the bedside of patients, at the desk of a public health office, relying daily on the surveillance data, threat assessments, and technical guidance that ECDC produces. I know this institution's value in practice, under pressure, when decisions must be made and lives depend on getting them right. ECDC is one of Europe's most consequential public health assets.
Its surveillance networks, its epidemic intelligence system, and its rapid risk assessments form the backbone of how member states detect and respond to emerging threats. The recent Ebola and Hantavirus outbreaks represented an important test of the ECDC's operational preparedness and cross-border coordination mechanisms. ECDC rapidly activated its response, deploying experts from the EU Health Task Force. The agency coordinated closely with the European Commission, national public health authorities, WHO, and the Health Security Committee. These actions demonstrated that ECDC can mobilize rapidly.
Risk assessments were published within days, import risk evaluations and technical guidance reached national authorities without delay, a response that was impressive. And yet, the same episode exposed fragility in our designated treatment center networks and stockpile coordination. This brings me to governance. The management board oversees an agency that consistently punches above its weight, but whose mandate and resources must keep pace with an accelerating threat environment. ECDC needs strengthened authority for cross-border alert coordination, stronger preparedness, and clearer accountability.
My call to action is therefore clear. Support a governance framework that gives ECDC the authority to match its expertise. Invest in surveillance infrastructure, in joint rapid response capacities, and critically, in the epidemiological and infectious disease workforce across member states, because no agency, however excellent, can substitute for trained people on the ground. Our populations are only as protected as our weakest preparedness link. Hantavirus, Ebola, another pathogen we have not yet named, in an era of extensive international travel, climate change, and geopolitical instability.
The next health emergency is not a question of if, but when. Viruses do not recognize borders, and our responsibility today is to ensure that Europe is ready when it comes. Thank you so much.
Adam Jarubas
Thank you so much, Dr. Capilna. Unfortunately, we received information that Dr. Bassat had to leave our discussion, so we've just finished our discussion now.
Dear colleagues, I'd like to thank you all for the discussion. I'd like to thank our guest Director Randy Wagner, Dr. Kapilna for your excellent work in reacting to global health threats. We should strengthen, we know that we should strengthen our prevention and preparedness health systems. ECDC is essential in the center of this system, so our role, our duty is to strengthen your work from different angle also, as you said, from the budgetary as well. Thank you so much for this discussion.
Dear colleagues, we now move to the next point on the agenda which is the public hearing entitled Building Health Resilience and Ensuring Preparedness of Public Health Systems. In today's hearing we want to look into how to strengthen health resilience through cooperation, improve preparedness for crisis, health crisis, with an emphasis on preparedness, prevention and response to cross-border health emergencies. The topic is burning with the recent Hantavirus outbreak and the Ebola outbreak. We would like to hear what our experts can tell us about lessons learned from recent health crisis and about where Europe still needs to get better. To discuss this we have invited leading experts from the ground, linking experience of public institutions and academia.
A warm welcome to all speakers. Our first two speakers are Madame Elizabeth Diago-Navarro, who is the coordinator of the Preparedness Hub of Barcelona Institute for Global Health, and Andrea Gori, who is a director at the Regional Center for Infectious Diseases in Lombardy, Italy. Professor Gori is connected probably online.
I will first give the floor to the speakers of the first panel for a maximum of eight minutes each. This will be followed by a first round of reactions from MEPs. We starting with Mrs. Diago Navarro, the floor is yours for eight minutes please.
Elizabeth Diago-Navarro
Thank you so much. Honorable members, thank you for the opportunity to address this committee. We are meeting at a moment that illustrates why this hearing matters. The recent hantavirus cluster that was linked to the MV Hondius cruise ship was managed through a swift coordinated international response. And concurrently we are facing a Budibugyo Ebola virus outbreak in Central and East Africa.
And before this there was Mpox, before that it was COVID-19. So this pattern is not exceptional. It is the new normal. And yet the May 21st plenary meeting exposed a central tension. Members praised that the Hondius emergency response as a proof, a success proof that the European Health Union works.
But at the same time there was condemned cuts, they condemned cuts to the EU4Health, the very program that funds the capacities that made response the response possible. So we cannot celebrate the architecture and defund its foundations. So that is what this committee must resolve. So let me address the four themes that the hearing directly, four themes that are going to be surveillance, access to pharmaceuticals and medical devices, the important health workforce capacity and the international coordination. So first on surveillance.
The EU has made real progress, but three structural challenges persist. First, the speed. So surveillance data does not reach decision makers in actionable form quickly enough. And in addition, EU should support standing structures, scientific advisory structures and knowledge brokers pre-designed for crisis conditions and that are not improvised once that the emergency is underway. Secondly, One Health.
So One Health has to be structural, not an add-on, and it needs to move from the conceptual phase to a operational implementation. So three out of four emerging diseases originate at the human animal environment interface and climate change is accelerating this dynamic. So Europe surveillance architecture must reflect it. And third, the global surveillance system that Europe's depends on is being dismantled. The early warnings from both the hantavirus and the Ebola outbreaks are coming from outside Europe.
And yet the OECD data shows that in 2025 it was registered a massive cut of 23% of the official developmental aid back to pre-2019 levels. Also, this is affecting already to low and middle income countries.
Last year saw that the cuts had affected 70% of the countries in health emergency preparedness and 66% of them were showing public health surveillance problems. And these are not development statistics, these are European health security statistics. On the second topic, access to pharmaceutical and medical devices, as it has been shown, there is no approved vaccine or treatment for Hantavirus or the Budibugyo Ebola outbreak, and the response are a direct demonstration of what happens when the translation from a priority list organism or family in the WHO research and development blueprint is not translated to available products, and this remains an incomplete gap. To ensure equitable access, three commitments are vital. First, investment in platform technology such as mRNA, viral vectors, as a standing infrastructure, not project-by-project investments.
Regulatory flexibility from COVID-19 must also be codified, and also this requires a multi-annual financial framework and legal frameworks for the EU for health that matches this rhetoric. The second commitment is research investment. Negotiation for the next framework program, the FP10, must position health as a high-profile priority with dedicated ring-fenced funding for preparedness science. FP10 must not repeat the same mistakes and the old pattern of investing only after the crisis arrives. And finally, equity.
The countermeasures architecture that leaves the rest of the world behind is operationally self-defeating. Pathogens do not respect borders. Pathogens do not respect borders. The WHO pandemic agreement provides a framework, but the pathogen access and benefit sharing mechanism remains unsolved. The EU has the leverage to make equity structural.
And third, health workforce capacity. No preparedness system functions without the people who staff it. I support a preparedness-specific workforce, a European Health Security Corps, a standing cadre of specialists, scientists pre-identified that are deployable within 24 to 48 hours to support member states or partner countries when an emergency strikes. Speed of response is not a function of goodwill, it is a function of a standing mandate and activation protocols. And on budget, health investment is prevention.
Cutting EU for health programs contradicts the post-pandemic commitment to make health a priority. It is cheaper to train specialists in peacetime than to improvise in a crisis. And my last theme is the international coordination. The Mpox response worked because a decade of investment in multilateral institutions. That architecture now is under pressure from two different directions simultaneously: first, the erosion of the WHO's funding, and secondly, the decline of the global health infrastructure.
Sustained, predictable EU financing for the WHO is not a diplomatic gesture, it's an strategic investment. And the pandemic agreement that I mentioned before must be operationalized, including its equity provisions.
Spain, as one of the few donors that has been increasing official developmental aid, offers a model. The EU should use the next multiannual financial framework and its geopolitical leverage to ringfence global health surveillance from budget contractions. This is not a development argument, it is a security argument. So just concluding, the findings from our work at ISGlobal are clear. Preparedness requires a culture, not just plans.
Plans that are forgotten before they are needed, they are useless and offer no protection. The EU has the right framework, such as the European Preparedness Union strategy, or institutions such as HERA or the ECDC. What is required now is the political commitment to make them operational, in budget lines, in legal frameworks, in staffing, and in the willingness to protect global health surveillance and architecture. Is health security a political priority for the EU? This committee has the opportunity to provide the right answer.
The preparedness window is open, and it will not stay open indefinitely. Thank you.
Adam Jarubas
Thank you, Mr. Navarro, for your presentation. The next speaker is Mr. Andrea Gori, who is connected remotely. Mr. Gori, are you there?
Sì, vi sento, grazie. Buongiorno a tutti.
The floor is yours, please.
Andrea Gori
Grazie mille, grazie a tutti. Posso avere la prima diapositiva? Sono Andrea Gori e dirigo il centro regionale delle malattie infettive della Regione Lombardia. Come vedete dal titolo della presentazione, vorrei mostrarvi quello che è un modello realizzato in una singola regione, sebbene importante come la Lombardia, e come questo modello possa di fatto diventare una rete di preparazione per l'intera Unione Europea. Next, please.
La storia dell'uomo è fatta di storia di epidemie. Nel 1962 il premio Nobel Macfarlane, in modo molto ottimistico con l'avvento degli antibiotici, aveva detto che ci si poteva arrivare quasi a parlare di una virtuale eliminazione delle malattie infettive. Direi che la storia ha smentito in modo drammatico questa affermazione, in primis con le grandi pandemie del 1900, la peste, il colera, l'influenza del 1918. Ma direi in tempi più attuali, soprattutto con l'avvento della globalizzazione, abbiamo assistito a una serie di pandemie, l'HIV, la SARS, la MERS, l'H1N1, in qualche modo hanno infranto l'illusione di un'era post-infettiva. Ovviamente poi quando è arrivato COVID-19, questa è stata la prima vera pandemia di un mondo iperconnesso e globalizzato.
In qualche modo ha creduto di poter essere al sicuro e ogni generazione successivamente si è dovuta drammaticamente ricredere. Next slide. E qui, next slide please. E qui è arrivata appunto la lezione del COVID-19 che ci ha insegnato molto ma ma ancora non abbastanza. Difatti abbiamo quattro lezioni importanti.
La prima è il ruolo della preparazione, della preparedness fondamentale ed è fondamentale che debba esistere prima della crisi e non essere improvvisata durante una crisi. Secondo punto il coordinamento. Le crisi attraversano i confini, non hanno barriere, le chiamiamo pandemie e in questo consenso le risposte singole o frammentate costano sia vite che tempo. Altro punto è la gestione dei dati sanitari. Devono essere comparabili, condivisibili in tempo reale e sono la spina reale di ogni di ogni decisione.
Ultimo punto, io penso sia importante sottolinearlo, è la comunicazione. E qui COVID-19 ci ha insegnato davvero molto. Deve essere chiara, affidabile ed è decisiva quanto un intervento clinico. Anche perché, come ha ricordato il direttore generale dell'OMS, il COVID non sarà la nostra ultima pandemia. Next slide please.
E infatti stiamo vivendo oggi un mondo che ci dimostra chiaramente qual è la realtà. E mi riferisco al mondo dopo il COVID. Di fatto è stato un susseguirsi continuo di epidemie. Agosto 2024, Mpox clade 1b, seconda emergenza dichiarata dall'OMS, oltre 54.000 casi arrivati fino in Europa. Tra il 2024 e il 2025 l'influenza aviaria H5N1, oltre 70 casi umani con una preoccupante salto di specie verso bovini e altri mammiferi, rappresenta una delle minacce pandemiche più importanti.
Poi l'arrivo di H9N2, questo è il mio gruppo per primo ha individuato questo ceppo di aviaria arrivato in Europa, arrivato in Italia, infettato una una persona. Novembre 2025 abbiamo dovuto affrontare l'epidemia da Marburg con, ricordiamolo, una febbre emorragica che ha una letalità del 64%. E poi oggi, maggio 2026, abbiamo dovuto gestire un caso di sospetto hantavirus che ha raggiunto Milano e sempre in questi giorni l'epidemia da Ebola in Congo e Uganda. Direi che il messaggio è assolutamente chiaro. Le pandemie rappresentano una realtà quotidiana in un mondo globalizzato e allo stesso modo gli spillover zoonotici sono anch'essi una realtà ricorrente.
Quindi la preparedness non più non può più essere qualcosa di episodico. Next slide please. Dobbiamo peraltro capire che dobbiamo agire su più fronti. Oggi il concetto di salute è un concetto globale, un concetto aperto in cui giocano diversi fattori. Di fatto è l'uomo che che crea queste condizioni di emergenza.
La deforestazione, il consumo del suolo ci spingono sempre più a contatto con nuovi patogeni. L'agricoltura e l'allevamento intensivo moltiplicano le occasioni di salto di specie, così come l'utilizzo scorretto degli antibiotici alimenta il fenomeno della resistenza antimicrobica. Di fatto il cambiamento climatico ampia l'area dei vettori e l'urbanizzazione concentra le popolazioni.
Viaggi e commerci globali si diffondono sempre più spesso e noi arriviamo in poche ore dall'altra parte del mondo. Sono ambiti diversi ma un unico rischio in cui la salute umana, quella animale e quella ambientale non possono essere considerate in maniera separata. È il concetto di One Health, più fattori che richiedono però un'unica risposta integrata. La prossima diapositiva, next slide. Quindi abbiamo bisogno di sistemi sinergici.
I sistemi frammentati falliscono, questo è ormai qualcosa di chiaro e netto, mentre al contrario dei sistemi sinergici sono in grado di reagire e di reggere. Nessun ospedale, nessuna regione, nessun paese può da solo essere in grado di elaborare una risposta efficace capace di individuare, comprendere e rispondere al prossimo focolaio pandemico. La capacità di rispondere si costruisce connettendo e mettendo insieme le capacità ed essendo elaborando prima, non dopo e soprattutto non solo durante. Abbiamo tre livelli su cui dobbiamo lavorare: l'ospedale dove avvengono le diagnosi e la cura, la regione o la nazione, il centro di riferimento delle malattie infettive che dirigo penso rappresenti un ottimo esempio di questo, e l'Unione Europea. Con il progetto che presentiamo, Unity EU, questo penso sia un esempio concreto di quello che sia necessario sia necessario fare a livello di una scala che parte dal basso e sale fino al livello europeo.
Next slide. Dicevo prima del centro che abbiamo costruito, centro di riferimento delle malattie infettive, riunisce sotto un unico tetto sorveglianza, ricerca, cura e risposta. È uno sforzo importante anche dal punto di vista digitale mettere insieme, connettere gli ospedali, i sistemi di sorveglianza, le policy, l'intelligenza artificiale con metodiche di machine learning, di horizon scanning. In questo modo riusciamo e speriamo di riuscire a ottimizzare da una parte la ricerca, la clinica e la sorveglianza in modo da lavorare insieme. Porto come esempio la Lombardia perché beh, perché la Lombardia ha 10 milioni di abitanti, è uno stato di fatto.
È la regione più popolosa e densa in Italia, tre aeroporti, traffici internazionali, ha la migliore rete di ospedali, di istituti di ricerca e di università. Da sola genera più del 22% del PIL italiano. E la regione ha impegnato in questo centro 15 milioni di euro in tre anni e non è un centro che è qualcosa che arriverà, ma è un centro operativo. Di fatto nel, come ho detto, nel maggio 2023 ha coordinato la risposta lombarda rispetto a un sospetto caso di hantavirus a Milano. La prossima diapositiva.
Come come come deve funzionare, come funziona questo centro? Abbiamo due modalità: prima della crisi in termini di preparedness, di preparazione, quindi che si concretizza in una ricerca con approccio One Health su zoonosi e resistenza antimicrobica e lo sviluppo e la prova dei piani prevenzione di risposta, sorveglianza digitale. E invece durante la crisi il centro deve lavorare come centro di risposta, quindi un centro di ricerca d'emergenza avanzata, sperimentazioni e linee guida cliniche rapide, attivazione dei piani su una rete di supporto alle decisioni che vengono prese a livello di sanità pubblica. Quindi deve esserci la capacità di passare rapidamente da un modo all'altro in modo tale da trasformare la preparazione in risposta.
Next slide. Da qui la proposta... Next slide. Prossima diapositiva. Ok.
Da qui la proposta del progetto Unity EU che rappresenta una rete europea. Il passo successivo proprio è quello di portare questo modello a livello europeo. Quindi il progetto si concretizza in una rete sostenibile di 15-20 ospedali europei che hanno dimostrato di poter lavorare insieme in modo coordinato e sinergico, quindi in grado di raccogliere dati clinici, microbiologici, biologici, armonizzandoli e mettendoli a disposizione di tutta Europa. Tre i pilastri del progetto. Primo: dati a livello di paziente.
Sono dati che devono essere standardizzati attraverso procedure comuni e una piattaforma sicura. Una rete pronta per la ricerca multicentrica anche dal punto di vista di creare una biobanca e soprattutto una condivisione di dati conformi al GDPR in grado di in qualche modo di superare quelli che sono i blocchi oggi normativi a livello europeo. Una rete che si possa anche collegare a quello che già esiste a livello europeo come appunto la proposta che si sta elaborando sulla gestione dei dati sanitari e che possa essere sinergico con altri progetti. Cito uno tra tutti l'European Vaccine Hub for Pandemic Readiness. In questo caso c'è una perfetta sinergia tra i due i due progetti.
La prossima diapositiva. Quindi concludo per quello che sono le tre richieste all'Europa. Il primo: finanziare la preparazione, non solo la risposta. Dobbiamo arrivare prima, non possiamo arrivare impreparati e soprattutto non possiamo arrivare dopo. Quindi creare e sostenere una rete di centri di riferimento come quello che vi ho illustrato a livello lombardo ed italiano.
Secondo: connettere la rete oltre i confini nazionali sostenendo Unity EU. Terzo: far circolare i dati in sicurezza raccolti in maniera comune con obiettivi comuni, con un quadro comune perché i dati possano essere condivisi in giorni e non in anni come succede oggi in Europa. Quindi dall'ospedale alla regione, alla nazione fino ad arrivare all'Unione Europea. Anche perché abbiamo visto che la prossima pandemia metterà di nuovo alla prova tutte le nostre connessioni, tutti i nostri ospedali, tutti i nostri centri di sorveglianza. Penso che questo progetto debba essere costruito insieme per costruire insieme un futuro più sicuro.
Vi ringrazio per l'attenzione.
Adam Jarubas
Thank you so much, Professor Gori, for your interesting presentation. Now I open the discussion, we starting with Tomislav Sokol, please.
Tomislav Sokol
Thank you very much. Thank you for very interesting presentation on a topic which should definitely not be underestimated, even though I have to say we saw that several years ago during the COVID pandemic and right after, the resilience was definitely a big a big focus, a big priority of the EU, but I'm seeing that we are kind of losing the momentum and that is definitely not a good development because all of these threats are still here.
Some of them have been mentioned, that we had several cases of outbreaks of different diseases which could potentially threaten Europe. So definitely it's important that we do not forget the lessons we learned from COVID and that we need to still make a considerable effort in strengthening our health security, from improving surveillance and crisis response mechanism to reinforcing supply chains and preparedness planning. So resilience is not only about responding to the next crisis. It's also about ensuring that our health systems can withstand long-term pressures such as demographic change, workforce shortages, increasing chronic diseases, antimicrobial resistance, and emerging health threats. And we have tried to tackle a lot of these things through legislation, for instance through providing different incentives for development of new antibiotics, also through Critical Medicines Act to strengthen our supply chains and security and decrease the dependence of our medicines supply.
So definitely these long-term projects are also and long-term efforts are very important. So preparedness must move from strategy papers to practical implementation. Citizens expect public authorities not only to anticipate risks, but also to guarantee continuity of care and equitable access to health services when crises occur. So I have a very concrete question. What do you see as the single most critical gap that still prevents European public health systems from being truly resilient in crisis threat?
And what concrete actions should EU and Member States prioritize over the next five years to address this gap while ensuring efficient use of public resources and avoiding unnecessary duplication of structures? Or in other words, what do you see as still the main problem that we need to tackle? Thanks.
Christophe Clergeau
Merci Monsieur le Président, merci pour vos interventions. Je crois qu'il y a effectivement beaucoup à faire en termes de recherche, de dispositifs de monitoring, de coordination, de capacité à répondre rapidement, et ce que vous avez montré montre que ces enjeux sont très bien identifiés. Mais je voudrais aller dans le sens de ce que vient de dire mon collègue Sokol sur deux points. Le premier, c'est que quand on parle de résilience en termes de santé, on ne parle pas simplement de préparation à des épidémies. Une catastrophe naturelle avec un impact majeur sur une zone donnée est aussi un enjeu majeur de santé auquel il faut se préparer, et je ne vois pas vraiment évoquée dans vos présentations la question de ce que j'appelle moi les vulnérabilités, c'est-à-dire la capacité à comprendre comment un événement extérieur, quel qu'il soit, va avoir un impact différent suivant les territoires, suivant les populations, qui va nécessiter des prises en charge différenciées en termes de santé.
On pense toujours aux populations vulnérables, mais il y a aussi les territoires moins bien équipés où l'accès aux soins est plus difficile, où la communication est plus difficile. Et derrière ça, mon deuxième point est le même que celui de Monsieur Sokol, c'est : est-ce qu'on est capable de se dire, bah si on doit être prêt à assurer la continuité des soins et la qualité de prise en charge des patients à n'importe quel moment, bah il nous faut 10 %, 20 % de capacités hospitalières de plus, ou une capacité de déploiement rapide d'hôpitaux de campagne, ou des réseaux très fins d'identification et d'accompagnement des personnes vulnérables pour qu'elles ne soient pas oubliées dans les périodes de crise ? Et cette dimension de la gestion de l'impact des événements, quels qu'ils soient, sur l'état de santé des populations, et si on fait le lien avec ce qu'a dit Madame Redig-Wagner avant sur notamment les conséquences sur les gens qui sont déjà dans des situations de maladies chroniques par exemple, est relativement peu présente dans le débat public. Donc j'aimerais peut-être vous entendre réagir aussi sur ces points.
Aurelijus Veryga
Thank you very much, Chair, and I would like to thank for the presentations. I have two questions. One is very much associated to the just recent report that we voted in the committee regarding health workforce. And to be prepared, we need an experts and specialists. Especially when we speak about the pandemics, we need epidemiologists and infectologists.
What happened during the COVID, what we found out that we really are lacking them. But that is a problem because the pandemics doesn't happen every day or every year, they come as a waves. So it creates a natural problem that you cannot over-prepare, you know, the specialists. But my question would be how to find the right balance, the healthy balance, how to keep the sufficient level of epidemiologists and infectologists, and how to create motivation for young people to choose those professions, how to keep the attractiveness of those professions for the situations that doesn't happen every day. That's the first question.
And the second question is related to communication. During every crisis, communication is one of the key elements because if the communication fails, we can have a lot of problems that would not be associated directly with the health workforce or the facilities we need or medications, but the communication problems might create a crisis itself. So I believe we did communicational mistakes during the COVID pandemic. But from your perspective, as an experts, what do you see as the biggest communicational mistakes that we did and how we can learn from them? Now we have a lot of problems associated with trust, trust to vaccines, trust to the health workforce, trust to experts.
So how we can change and learn from it? Thank you very much.
Oliver Schenk
Ja, von mir auch ein ganz großes Dankeschön für die beiden interessanten Vorträge und auch ein Dankeschön an die Regie heute, dass wir erst ECDC hatten und jetzt dieses Hearing, das baut gut aufeinander auf. Wir haben mit Frau Rendi-Wagner über die Frage gesprochen, was brauchen wir auf der europäischen Ebene, um uns besser vorzubereiten: Laborkapazitäten, Datenaustausch, Surveillance. Meine Frage an unsere Experten, Sie haben das auch angesprochen, wir brauchen es auch in der Breite. Sie haben das Forschungsprogramm angesprochen, Sie haben Personal angesprochen, Sie haben Ausrüstung angesprochen. Wie schätzen Sie die Situation tatsächlich ein auch in den Regionen, um auf diese Aufgabe vorbereitet zu sein?
Theoretisch ist es, glaube ich, vielen von uns klar, aber die praktische Frage, und das ist, was die Kolleginnen und Kollegen ja auch angesprochen haben, wie sind wir in den Mitgliedstaaten darauf vorbereitet? Auch um dieses Netzwerk, was Sie eben angesprochen haben, der 10 bis 12 Krankenhäuser, haben wir diese identifiziert? Haben wir eine Form der Zusammenarbeit, wo heute schon ein solcher Datenaustausch, solche eine Kooperation praktiziert wird, damit wir diese Synergien auch wirklich entwickeln und dass wir sie auch im Krisenfall dann parat haben und dann mit ihnen arbeiten können.
Nicolás González Casares
Gracias a todos los intervinientes y coincido en algunas cosas de las que se han dicho, algo una fundamental que ha dicho la señora Diago Navarro y que y que está en el ambiente y es que la salud global es en sí misma seguridad y Europa debe ser consciente de estas prioridades. Hace apenas 10 días miembros de este comité estábamos en la OMS en una misión de la Asamblea General y vimos la necesidad de de contribuir de verdad a la gobernanza y a la sostenibilidad de los organismos multilaterales. No olvidemos que el multilateralismo es fundamental para tener una respuesta eficaz ante la crisis. Yo me voy a centrar en una cuestión, en una propuesta que ha defendido desde el Instituto Salud Global la señora Diago Navarro, que es la la Workforce, es decir, la el equipo europeo de salud para la respuesta ante emergencias. ¿De qué manera cree que estos equipos deberían estar estructurados?
¿Cuál sería la gobernanza de un equipo de salud europea para respuesta a las situaciones de emergencia y y cómo podríamos apoyarlo desde aquí más allá de de este file? Y luego una reflexión general. Creo que es el momento de que hemos visto que que esto son cuestiones donde la salud del planeta afecta también a la salud humana. Y yo creo que la evaluación de salud planetaria, la dimensión de evaluación de salud planetaria debería estar presente cada vez más en las políticas que aquí hacemos, introducir esto dentro de las evidencias científicas que usamos para hacer la mejor regulación. No sé también cómo lo ven los ponentes.
Muchas gracias.
Adam Jarubas
Thank you. Now I give back the floor to the speakers to address the question posed by MEPs for three minutes each, we starting with Mrs. Diago Navarro, please.
Elizabeth Diago-Navarro
Hi. Okay, thank you. There are many questions, so I will try to address some of them. So I think for the resilience, for the main challenges to be prepared, I think plans and coordination, those plans should be already that people should know what to do, but also that those things cannot be on a paper. They need to be exercised and all the members they need to be that are take stakeholders that are taking part on there, they need to exercise and to be familiar on what to do during the health emergencies.
From my experience at the New York City Department of Health where I managed the high consequence infectious disease preparedness program for the hospitals in the city, this was really capacity building for the health workforce and later exercises and drills in order to make sure that continuously those capabilities are being tested and all the lessons learned were incorporated already in the new plans to make them better on what to do when a an emergency arise.
For the communication, I think, as it was pointed, trust right now we are having is the main challenge. So we are having really problems with the population to trust health authorities and this is something that we really need to focus and to work with the communities. Not make them passive receivers of the information, but create co-creation of the strategies for prevention and for preparedness with them already that they are not. And also how to address, we really need risk communication experts that are able to address the uncertainties and how we communicate those uncertainties to the population so they understand what are the risks but also what they can do in order to be prepared. And that means that, as it was pointed, this is not a one recipe for all.
There would be populations that are more exposed, more vulnerable, or the hazards that they are being affected with. So we need to take into account that it's going to be a diverse strategies, but work with the communities. And from Dr. Casares, what he was saying about the public health workforce, the governance, I think this should be a mechanism that ECDC and HERA should be working and in trying to identify these specialists and having them ready in each of the countries of the Union that they are able to get responses outside. And those plans should be, I think it would be having an allocated budget for all of them. So I imagine them as firefighters that they are training even when there are no fires.
This is something that it's built into the culture of prevention. So they should be receiving money only for being prepared and trained to when to go to the response for a health emergency. And I think more or less I covered. Thank you.
Adam Jarubas
Thank you so much, Mrs. Navarro, and the floor is going to Professor Gori. Dear Professor, are you there?
Andrea Gori
Sì, sono qua, grazie. Allora, innanzitutto volevo ribadire quello che è già stato ribadito, e cioè il concetto di resilienza si è un po' perso in questi anni dopo il COVID e confermo anche da clinico proprio questa percezione. Questa percezione che in parte va di pari passo con quali sono i problemi che sono stati evidenziati, cioè che cosa è mancato durante COVID-19 e dove si deve lavorare, a mio avviso, rispetto alla risoluzione di questi problemi. E due sono, secondo me, le parole più importanti. La prima parola è la frammentazione.
La comunità ha troppa frammentazione tra gli Stati, per cui gli Stati agiscono in maniera molto diversa su scala nazionale e ciò porta a poca sinergia e soprattutto una diversità di comportamenti che sicuramente non è efficace. Quindi eliminare la frammentazione e avere un approccio sinergico, questo è sicuramente, a mio avviso, una delle chiavi per poter arrivare a una risposta più efficace. Si è parlato di anche però altri problemi oltre ai problemi epidemici, quindi dover affrontare altre problematiche della salute.
Allora qui vorrei dire che però problemi specifici richiedono soluzioni specifiche, che non possiamo mettere tutti insieme. Questo è un argomento estremamente specifico che richiede personalità, professionalità estremamente specifiche. È vero che non possiamo focalizzarci però in maniera così stretta su quello che è la pandemia. E qui nella mia presentazione ho cercato di far emergere due concetti: uno, l'approccio One Health, che quindi va molto al di là di quello che è la pandemia e va a intaccare un po' quelle che sono le problematiche che poi potrebbero favorire eventuali pandemie, ma che hanno interessi molto diversi. Quindi un approccio multidisciplinare anche qua è assolutamente necessario.
La seconda cosa è che io penso sia necessario lavorare in maniera duale, cioè un conto è la risposta alla crisi ed essere pronti a rispondere in maniera attiva, veloce e professionale al momento specifico. Ma come si è detto, queste crisi non avvengono tutti i giorni ed è necessario quindi che questi centri partecipino alla vita quotidiana non solo nel momento di crisi, ma anche nel momento di non crisi. In questo senso la lotta all'antimicrobico resistenza o alle altre problematiche che non sono prettamente pandemiche, ma che rappresentano una delle grandi, come dire, grandi challenge futuri, questo è qualche cosa che deve essere messo sul banco. Quindi lavorare durante la crisi, ma lavorare anche fuori dalla crisi. Questo permetterebbe anche di avere una maggiore attrattività rispetto alle persone, alle professionalità da poter coinvolgere in queste problematiche.
Rispetto alla comunicazione, anche qui ritorno al tema della frammentazione: troppe persone che parlano, troppe teorie e soprattutto troppe opinioni di esperti o troppe opinioni in generale. Io penso che la comunicazione debba perlopiù focalizzarsi sull'informazione, soprattutto quando parlano gli esperti. Questi non devono parlare, a mio avviso, di teorie, ma devono parlare fondamentalmente di fatti e di informazioni. In ultimo, rispetto all'ultima domanda, ritorno sull'uniformità dei comportamenti. È necessario che i centri collaborino nello stesso modo.
È stato posto la domanda se questi centri sono già stati evidenziati e questi centri a livello europeo la risposta è sì, a livello europeo questi centri lavorano già da tempo e hanno dimostrato estrema qualità nel loro operato. Alcuni di questi centri già collaborano molto attivamente insieme. Volevo concludere dicendo solo che è importante che si parta non solo da quelle che sono le autorità sanitarie, ma che si parta da chi operativamente è direttamente coinvolto. Quindi gli ospedali di riferimento sono fondamentali in questa fase. Sono fondamentali perché il lavoro non rimanga sulla carta, non rimangano solo policies, ma che il lavoro diventi concreto e che coinvolga le persone che sono operativamente coinvolte nelle risposte.
Quindi ribadisco il bisogno che oltre alla uniformità abbiamo bisogno assolutamente di concretezza. Grazie.
Adam Jarubas
Grazie, professor. Thank you all for a mindful discussion on the first panel, especially to our great expert for your impressive presentation and excellent work. Okay, thank you so much. We will now move directly to the second panel of the public hearing. I'd like to ask our guest speaker to take the seats on the podium.
Okay, colleagues, for this panel we welcome Dr. Fabio Ciciliano, head of the Italian Civil Protection Department, and François Lannoy, who is the head of the Belgian Walloon Agency for Health, Welfare, Handicap and Family. As for the first panel, I invite colleagues who would like to take the floor to indicate it to me and the secretariat. Now I would like to give the floor to our first speaker of the second panel, Dr. Ciciliano, you have the floor for eight minutes, please.
Fabio Ciciliano
Thank you, thank you Mr. President, thank you dear members for this kind invitation. I hold this brief speech in in Italian just to share with you also the nuance of my thinking. So, grazie, per me è un grande onore essere essere qui oggi e condividere con voi il mio pensiero su un tema che considero centrale per il futuro dell'Unione: la gestione delle emergenze e la costruzione di una vera resilienza europea in ambito sanitario. Vi parlo non solo in termini teorici, ma soprattutto da operativo. La mia esperienza nasce sul campo prima come medico e chirurgo d'urgenza e successivamente in ruoli manageriali nella gestione delle crisi, e non solo sanitarie.
Le riflessioni che porto oggi, quindi, non sono astratte, ma derivano da situazioni vissute direttamente spesso in contesti complessi ad alta criticità. Oggi l'Europa si trova ad un punto di svolta. Viviamo in un contesto caratterizzato da shock climatici sempre più frequenti, da tensioni geopolitiche e di stabilità che possono emergere improvvisamente e diffondersi con rapidità. A ciò si aggiunge un cambiamento profondo della tipologia delle minacce. Ora non siamo soltanto di fronte a crisi isolate, ma ad eventi complessi, interconnessi e spesso simultanei.
Sono convinto che l'Unione Europea possa essere tanto più efficace quanto più i suoi stati membri saranno forti e performanti. Ogni paese ha le proprie regole i propri modelli organizzativi e le proprie tradizioni. Bisogna investire su queste diversità come punti di forza. Se ciascuno migliora le proprie capacità interne l'intero sistema europeo ne beneficia. Allo stesso tempo è indispensabile rafforzare la capacità di lavorare insieme e questo richiede un elemento chiave il linguaggio condiviso.
Bisogna costruire standard comuni procedure interoperabili e principi di riferimento che consentano una reale cooperazione transfrontaliera. Se vogliamo costruire una vera Unione Europea della salute questa cooperazione deve essere integrata lungo l'intero ciclo della gestione delle emergenze dalla preparazione alla prevenzione alla risposta. La preparazione si fonda su una sorveglianza robusta e sui sistemi di allerta rapida che debbono rimanere ed essere efficienti. Una preparazione efficace è prima di tutto una preparazione basata sui dati. L'Europa non può difendersi da ciò che non è in grado di vedere e quindi di conoscere.
I dati però da soli non bastano debbono essere accompagnati da esercitazioni complete e concrete. Ritengo fondamentale introdurre il concetto delle simulazioni transfrontaliere obbligatorie e periodiche tra stati membri. Queste simulazioni consentono di individuare in anticipo colli di bottiglia nelle comunicazioni nelle capacità ospedaliere di risposta e nelle catene di approvvigionamento. Allo stesso modo è necessario investire nella formazione congiunta del personale sanitario. Il futuro della sanità europea dipende dalla nostra capacità di operare come un unico sistema e ciò può essere garantito solo se vi è alla base una chiara conoscenza dell'organizzazione sanitaria dei paesi membri.
L'esperienza ci dimostra che mappare in anticipo le vulnerabilità dei territori e delle strutture sanitarie riduce drasticamente l'impatto delle crisi. Su queste basi debbono essere costruiti piani di intervento dettagliati sviluppati a livello locale dove la conoscenza del territorio è insostituibile e la responsabilità delle autorità è diretta. Prevenire significa soprattutto evitare il collasso del sistema sanitario sotto pressione improvvisa. E in questo contesto il fattore più critico è il personale. L'Unione Europea affronta oggi una carenza strutturale di professionisti sanitari aggravata dal burnout e dai flussi migratori sia verso l'interno che verso l'esterno.
È necessario intervenire con decisione esplorando strumenti di finanziamento coordinati in maniera tale che il mercato dei professionisti delle discipline STEM possa cambiare in questi anni. Basta ragionare con una delle più semplici regole economiche che viene utilizzata da millenni. Più sono pochi più sono preziosi. Più sono preziosi più costano e quindi il costo deve essere sostenuto. Esiste però un corollario potenzialmente negativo che è legato alla carenza e alla necessità.
I professionisti sono pochi ci si accontenta di ciò che il mercato offre si riduce la qualità e riduco i costi. Questo in sanità non è concepibile.
Quando prevenzione e preparazione non sono sufficienti, entra in gioco la capacità di risposta. In questo ambito, la rapidità e l'equità nell'accesso alle contromisure mediche fanno la differenza. Il meccanismo unionale di protezione civile ha dimostrato il suo valore operativo. In particolare, però, esistono ancora dei margini di miglioramento. Appare però necessario affrontare la potenziale duplicazione tra UCPM e HERA, l'autorità per la preparazione e la risposta delle emergenze sanitarie.
HERA svolge un ruolo molto importante nel rapporto con l'industria, ma appare meno definita sul piano operativo dei stockpile e della distribuzione, funzioni a forte caratterizzazione logistica, ambito in cui continua ad operare l'UCPM. Una riflessione su una maggiore integrazione o razionalizzazione di queste competenze appare opportuna. Bisogna valutare l'espansione delle riserve includendo i principi attivi farmaceutici critici, i dispositivi di protezione individuale, le attrezzature mediche specialistiche come ventilatori e kit diagnostici. L'Unione Europea non può essere sicura se agisce da sola. La resilienza sanitaria richiede una politica estera integrata nel settore della salute a partire dalla sinergia con l'Organizzazione Mondiale della Sanità.
L'esperienza recente, quella dell'outbreak di Ebola nell'Africa centrale, ci insegna proprio questo. L'Italia è l'unico paese europeo ad aver raggiunto la Repubblica Democratica del Congo dove ha inviato un team di esperti coordinato dal Dipartimento della Protezione Civile Nazionale per dare supporto alla gestione dell'emergenza sanitaria sostenuta da Ebola attraverso il rafforzamento della sorveglianza epidemiologica, l'assistenza tecnica e scientifica, la fornitura di farmaci e materiale sanitario utile al contrasto dell'epidemia. Ed è molto giusto a riguardo il fatto che dopodomani, il 5 giugno, ci sarà una riunione di coordinamento tra ministri della salute per la che ha voluto convocare il 5 giugno, anche su sollecitazione italiana, la riunione dei ministri della salute. In sintesi, rafforzare la resilienza sanitaria europea significa trovare un equilibrio tra gli Stati membri che è complesso ma assolutamente necessario. Bisogna rispettare le competenze nazionali sulla gestione della sanità locale.
Bisogna rafforzare il coordinamento a livello europeo. Bisogna integrare la dimensione internazionale. La salute del futuro non si costruisce solo potenziando la medicina ordinaria, ma blindando la resilienza dei sistemi sanitari attraverso la prevenzione territoriale, la formazione per le emergenze e la governance multidisciplinare. Solo adottando questo approccio possiamo rafforzare veramente la nostra capacità collettiva di proteggere i cittadini europei. Vi ringrazio.
Adam Jarubas
Thank you so much, Dr. Siciliano. I will now give the floor to Mrs. Lannoy for eight minutes, please.
Speaker 33
Merci, Monsieur le Président, Mesdames et Messieurs les députés. La crise du COVID-19 a profondément transformé notre compréhension de la résilience sanitaire.
Elle nous a appris une chose fondamentale : aucun système de santé ne peut être résilient seul. Face aux risques désormais globaux, la résilience repose sur une capacité collective à analyser et anticiper les risques, détecter précocement les signaux, coordonner rapidement les décisions, déployer efficacement les réponses. C'est pourquoi nous devons penser la résilience non pas comme une somme de systèmes nationaux, mais comme un système européen intégré fondé sur des territoires forts au sein d'une gouvernance multiniveau fluide et opérationnelle. Et donc la gouvernance multiniveau est en effet la clé. N'étant pas médecin de formation, d'ailleurs ma communication est essentiellement liée à la coordination et la gouvernance.
Au niveau fédéral belge, cette gouvernance s'exerce à différents niveaux. La gestion des risques sanitaires repose sur une architecture qui peut sembler complexe au vu de ce schéma, mais qui est très cohérente. Le niveau scientifique est assumé par un Risk Assessment Group, le RAG, qui est un organe d'avis dont les missions sont d'évaluer les signaux, examiner les risques pour la santé publique, formuler des recommandations. Celles-ci sont portées au niveau stratégique au sein du Risk Management Group qui assure la fonction de Chief Medical Officer. Il évalue les risques sanitaires en se fondant sur les organes d'avis scientifique, particulièrement le RAG dont je viens de parler, mais aussi le Conseil Supérieur de la Santé.
C'est ce groupe qui détermine les mesures nécessaires pour protéger la santé publique et saisit l'autorité politique. Enfin, l'autorité politique, c'est la Conférence interministérielle Santé. Dans un pays comme le nôtre où plusieurs ministres sont en charge de la santé, c'est cette conférence qui prend des décisions politiques majeures en prévision de ou en période de crise sanitaire et fait office de forum pour la mise en œuvre des accords. Les entités fédérées, puisque je représente moi la Région wallonne au sein de cette organisation, les entités fédérées siègent autant au sein du RAG, organe scientifique, qu'au sein du RMG, organe stratégique. Leurs représentants sont considérés comme des points focaux, ils doivent être mobilisables en cas d'urgence.
Ce dispositif garantit une remontée rapide d'informations, une analyse scientifique consolidée, une décision coordonnée, un déploiement opérationnel au plus proche des citoyens. Complémentairement, la planification d'urgence en Belgique est un système structuré et territorial qui joue un rôle complémentaire et coordonné avec un niveau communal, provincial et fédéral qui va permettre d'assurer une réponse rapide et proportionnée adaptée aux réalités de terrain. Une crise mal gérée est souvent une crise où le mauvais niveau a agi au mauvais moment ou le mauvais niveau a communiqué aussi au mauvais moment. En phase aiguë, la Région wallonne n'a pas de rôle à part entière qui est déterminé par la législation. Cependant, ses ressources peuvent et doivent être allouées aux services acteurs de la phase aiguë.
Dans le même ordre d'idée, pour ce qui relève de la gestion de crise au niveau d'une crise sanitaire, ce sont les acteurs de la planification d'urgence qui sont les leviers de la mise en œuvre des décisions régionales. Ainsi, au niveau de la Wallonie, nous avons décidé de renforcer notre capacité d'action au travers un plan régional de gestion de crise qui permet d'organiser la réponse selon différents niveaux de gravité et d'activer progressivement les structures adaptées en coordonnant les acteurs dans une logique intégrée. Elle s'appuie, le schéma ici est un peu compliqué mais c'est le carré jaune, sur une cellule de crise, particulièrement l'AVIQ en matière sanitaire, une coordination pluridisciplinaire et une articulation avec les dispositifs fédéraux et européens. C'est ainsi que dans le cadre par exemple des inondations, nous avons pu mobiliser l'ensemble des services régionaux qui sont appelés à gérer ces risques de manière coordonnée.
Je parle bien entendu de la surveillance des cours d'eau, mais la gestion des infrastructures, de la mobilité, de la distribution d'eau potable, de la communication vers les collectivités et aussi de la gestion des risques épidémiques dans de telles circonstances. La planification au niveau régional est donc de décrire et comprendre les principes généraux d'une organisation, d'une coordination et d'une communication de crise en cohérence avec la gestion interfédérale et européenne en matière épidémique et planification d'urgence. L'enjeu pour la Wallonie n'était pas d'ajouter un niveau supplémentaire, mais plutôt d'être là pour fluidifier les interfaces entre eux. Pour renforcer la résilience et la préparation des systèmes de santé publique, et c'est la question qui m'a été posée, je me permettrai de relever quatre priorités stratégiques et je me réjouis que les précédents experts qui se sont exprimés vont dans le même sens. Bien entendu, il faut renforcer la préparation et la gestion des crises pour dépasser la fragmentation du système de santé, particulièrement fragmenté en Belgique en effet.
Pour dépasser cette fragmentation, cela passe par l'écriture et les tests sur des plans intégrés qui englobent des dimensions sanitaires, environnementales, mais aussi et surtout sociales. Une organisation territoriale de première ligne de soins et d'accompagnement forte et des stratégies de prévention qui sont cohérentes aux différents niveaux. Le deuxième axe d'amélioration, c'est la surveillance et les données de santé. Ça implique de disposer d'un système de surveillance épidémiologique en temps réel. En Wallonie, on a mis en place un système de déclaration en temps réel avec une communication des données directes vers les autorités, des publications de données très régulières vers les professionnels de la santé, ainsi qu'une communication très structurée dans les situations critiques.
La surveillance et les données de santé impliquent de développer l'interopérabilité des données entre régions vers d'autres niveaux de pouvoir. C'est essentiel sur des données de vaccination, mais aussi sur des épisodes infectieux par exemple ou des opérations de tracing. Enfin, d'exploiter ces données pour une détection précoce et une prise de décision rapide et ne pas avoir peur d'utiliser toutes les sources de détection précoce. Je pense par exemple à l'analyse des eaux usées. Se fonder sur l'evidence-based, notamment en terme de vaccination, et investir davantage dans des systèmes de données qui nous permettent de mieux comprendre les comportements et donc de mieux construire nos stratégies.
Troisième axe d'amélioration, c'est renforcer nos ressources humaines en santé et les compétences et les connaissances. Il est primordial de lutter contre la pénurie de personnel, améliorer l'attractivité des métiers et la rétention, développer des réserves sanitaires mobilisables en cas de crise. Et ne vous inquiétez pas, ces réserves ont tous aussi du travail hors des périodes de crise. Le quatrième axe est de sécuriser l'accès aux médicaments et aux dispositifs médicaux. On l'a vu, c'était fondamental.
Il convient de réduire notre dépendance aux chaînes d'approvisionnement, développer des stocks stratégiques au niveau local et au niveau national, soutenir la relocalisation d'une certaine production en Europe. Ce dernier sujet appelle clairement des réponses européennes coordonnées. Mesdames et messieurs les députés, la résilience des systèmes de santé européens repose donc sur des systèmes régionaux et locaux solides, une gouvernance coordonnée et évidemment des moyens suffisamment financiers pour anticiper, absorber et s'adapter aux crises. Mais surtout, elle repose sur une conviction que nous devons passer d'une logique de silo à une vision intégrée où la coordination est concrète. La résilience européenne doit s'inscrire dans un continuum d'anticipation, de coordination et de déploiement opérationnel.
C'est collectivement que nous pourrons la construire. Je vous remercie pour votre attention.
Adam Jarubas
Thank you so much, Mrs. Lannoy, for your presentation. Now I open the discussion, starting with Mr. Clouzet, please.
Christophe Clergeau
Bonjour, merci à tous les deux pour vos présentations. Je voudrais revenir à la question que j'ai posée tout à l'heure sur les vulnérabilités puisque Monsieur Ciciliano, vous avez insisté sur la nécessité, j'ai noté, de réduire l'impact des crises et le risque d'effondrement du système sanitaire. Donc ma question c'est : est-ce qu'on investit dans la connaissance des vulnérabilités du système de santé et des populations et dans l'anticipation de l'impact des crises sur les populations et sur les territoires au même niveau que l'on investit sur la construction des scénarios de réponse de santé publique aux différentes épidémies ou risques que l'on peut identifier ? Ensuite, nous sommes en train de faire l'exercice sur la législation sur la protection civile. Et dans cette législation, si vous vous êtes penché dessus, il n'y a pas de coordination entre la législation protection civile et la législation sur les soins transfrontaliers.
Et quand vous parlez l'un d'exercices de simulation transfrontaliers obligatoires et réguliers ou l'autre de gouvernance multi-niveaux forte s'appuyant notamment sur des territoires de santé forts, est-ce que vous considérez que ces notions sont aujourd'hui correctement prises en compte par la loi européenne ? Et la loi sur les soins transfrontaliers était censée être révisée pour la fin de l'année 2025. Pour le moment, ce n'est pas le cas et nous n'avons pas de visibilité. Est-ce que vous considérez qu'il serait utile de réviser la loi sur les soins transfrontaliers pour aller dans le sens de cette gouvernance plus robuste de la préparation aux crises ?
Ruggero Razza
Grazie per entrambe le relazioni e io vorrei affrontare alcuni temi che sono relativi più alla strategia preparedness in genere perché poi dopo di me c'è certamente il collega Verheyen che è relatore sul regolamento di protezione civile e che è relatore ombra sul Critical Medicine Act vorrà intervenire sui temi specifici dell'approvvigionamento e delle modifiche al regolamento di protezione civile. La nostra commissione è reduce da una importante missione negli Stati Uniti d'America nella quale abbiamo avuto la possibilità di uno scambio di opinioni con due delle agenzie che si occupano della strategia di preparazione negli Stati Uniti: BARDA per quanto riguarda l'approvvigionamento e il CDC per tutto quello che riguarda la valutazione epidemiologica e il monitoraggio dello stato del Global Health e della strategia di cooperazione degli Stati Uniti anche con gli stati più deboli. Quello che mi viene da chiedere e mi rivolgo soprattutto al dottore Ciciliano per la sua ampia esperienza anche durante la pandemia in Italia, noi abbiamo potuto cogliere una resilienza che ci è sembrata più forte rispetto a quella messa in campo dalla Commissione Europea. Penso allo stoccaggio di materiali, penso all'interfacciarsi con il mondo dell'industria per le tecnologie elettromedicali e per l'approvvigionamento farmaceutico, ma soprattutto quello che ci ha colpito moltissimo è l'investimento che viene compiuto su un settore strategico come quello della manifattura in sanità.
Perché dico questo? Perché ancora oggi l'Europa approvvigiona quasi tutto il proprio manifatturiero sanitario in Asia, tra la Cina e l'India. Questo ci fa capire che probabilmente, ed è la domanda che io rivolgo, la nostra strategia industriale è ancora lenta rispetto alle necessità. E soprattutto mi viene da chiedere se rispetto ad alcune cose che ci sembrano banali oggi, ma che non lo sono state durante la pandemia, i dispositivi di protezione individuale, i ventilatori polmonari, la possibilità di approvvigionare personale adeguato alla risposta della crisi, alcuni anni dopo il Covid la sua sensazione è che questa criticità che si è manifestata in maniera così evidente durante la pandemia è in qualche modo superata o ancora c'è una certa lentezza, un certo timore ad affrontare i grandi stock e la necessità di essere pronti ad un'eventualità che comunque si potrà ripresentare nel futuro. Dopodiché voglio anche io riconoscere il grande lavoro che la Protezione Civile italiana svolge in ogni ambito delle crisi internazionali.
Il direttore Siciliano ha parlato prima dell'intervento in Ebola nella Repubblica Democratica del Congo, un grande lavoro in maniera sanitaria la Protezione Civile italiana lo ha fatto a Gaza e lo ha fatto in quel territorio di crisi, un grande lavoro lo sta facendo in Ucraina e quindi sento di approfittare dell'occasione per dare ampio riconoscimento di questa leadership nel settore della Protezione Civile sanitaria. Grazie.
Aurelijus Veryga
Thank you very much. I would like to thank experts for their very good presentations. And as colleague Ruggero mentioned, I'm one of the rapporteurs on UCPM. And I have a question to you because we have some debate, let's say, with the Commission and some different points of views or disagreement, let's say. And my question would be how would you see if the civil protection and health crisis management should be treated at the same level, both organizational and financial?
And where we have a disagreement or debate with the Commission is on specific allocation of the finances because as a co-rapporteurs we have proposed to allocate specific percentages of the potential money allocated to UCPM, let's say 40% to civil protection and 40% to health sector crisis management and preparedness. And the Commission's point of view is that there should be no such proposal because we have to have a maximum flexibility. So from your as an expert's point of view, how would you see this situation? Because from my personal experience working as a Minister of Health in my own country, I know that health is always lacking resources, always lacking investments. And only when something happens, then we spend money on health.
But if we are serious about preparedness, how would you see the money allocation to that? And how you see the role of HERA in this? Thank you very much.
Adam Jarubas
Thank you, Aurelius. Now I give the floor back to our speakers to address the question posed by MEPs. Dr. Siciliano, could you start, please?
Fabio Ciciliano
Grazie, Mr. President. Rispondo in anche qui in italiano. Allora, domande molto molto complesse, però cerco di dare una risposta sintetica. Allora, prima di tutto, le lezioni apprese dalla pandemia da COVID-19 ci insegnano una verità semplice, però fondamentale. Cioè che le minacce sanitarie non conoscono confini amministrativi.
Mentre invece i confini amministrativi possono peggiorare le minacce sanitarie sia dei paesi membri, sia dell'intera Unione Europea. Questo è un elemento che ritengo essere fondamentale perché con questo ragionamento possiamo fare la differenza tra l'aumento della vulnerabilità e la riduzione della vulnerabilità per i rischi sanitari. È importante perché la gestione sanitaria deve essere una gestione incentrata un po' meno all'ideologia e un po' più alla scienza. Spesso quando ci si muove in questa direzione l'ideologia prende il sopravvento e quindi indirizza anche quelle che sono le politiche dei paesi membri e anche le politiche ovviamente europee. Questo è un aspetto che secondo me dovrebbe essere tenuto al di fuori della porta di questo tipo di valutazione.
Per quanto riguarda l'EUSPM, la gestione delle crisi sanitarie è un elemento fondante di quella che dovrebbe essere l'attività di supporto tra i paesi membri, ma anche all'esterno dell'Unione Europea. Io non so, perché è una valutazione di carattere politico, quindi io mi astengo da questo tipo di valutazione, se il budget è da indirizzare in un modo o nell'altro. Quello che però tengo a sottolineare è che la gestione dell'emergenza e della contingenza non può aspettare. Non può aspettare soldi. Non può aspettare organizzazione.
I soldi ci debbono essere già. L'organizzazione deve essere già predisposta prima dell'emergenza, perché nell'emergenza si segue ciò che si è imparato, fatto e che si è fatto prima. Dopodiché chi si occupa di emergenza sa che il ciclo termina e si ricomincia daccapo per fare tutto quello che è il nuovo il nuovo assessment. Penso che se questo aspetto pragmatico di approccio venga portato anche nei confronti di coloro i quali sono rappresentanti del nostro Parlamento Europeo che però magari non hanno questo tipo di esperienza, diciamo, concreta di carattere personale, possa dare sicuramente un contributo maggiore per l'efficacia pragmatica di questo tipo di di situazione. Dopodiché, e finisco, la riduzione della vulnerabilità significa fondamentalmente aumentare la conoscenza.
E per aumentare la conoscenza è necessario spendere soldi. Un ultimo elemento. Se si spendono i soldi per la preparedness si risparmiano i soldi per l'emergenza e alla fine si risparmiano i soldi in generale. La preparedness costa molto meno dell'emergenza. Non so se ho risposto.
Adam Jarubas
Thank you so much, Dr. Siciliano. Mrs. Lannoy, could you comment the question?
Speaker 33
Oui, merci. Je n'aurais pas grand-chose à ajouter à ce qu'a dit le professeur Siciliano parce qu'effectivement, je pense que la science doit être primordialement mise en avant dans notre démarche. Et c'est pour ça aussi que j'insiste sur la nécessité de travailler sur les données et sur ce partage des données, notamment en matière de vulnérabilité.
Donc en Wallonie, on tente de déployer des réseaux territoriaux très forts pour soutenir les premières lignes d'intervention, tant d'aide que d'accompagnement des personnes les plus vulnérables, mais pas que, de manière à pouvoir leur fournir toute une série d'informations et de connaissances de leur territoire pour mieux guider leur action locale. Et ça, ce management populationnel, il est fondamental aussi que l'on parle de période de paix comme de période de crise. Pour nous, c'est vraiment un développement que nous devons mettre au-dessus de dans toutes nos priorités. Pour ce qui relève de la coopération transfrontalière, elle est complexe. Je ne peux pas me prononcer sur l'opportunité de réviser la loi, mais par contre sur la nécessité d'exercices.
Nous comprenons de mieux en mieux nos systèmes, nous comprenons de mieux en mieux notre gouvernance et notre réactivité par l'ensemble des exercices que l'on mène. Et ces exercices, on doit les faire au niveau local, au niveau national et dans des perspectives transfrontalières. Pour moi, ça me semble évident qu'on comprendra mieux nos systèmes une fois qu'on les aura testés dans la par des exercices de crise.
Adam Jarubas
Thank you so much, Mrs. Lannoy. Thank you all for this fruitful discussion. I would like to thank especially to our speakers for their presentation and for being with us today. Dear colleagues, I close this morning meeting. We will meet again here in this room in the afternoon at three.
Thank you so much.
Et enfin, nous aborderons la question de la santé mentale, qui est devenue une priorité majeure suite à la pandémie. Avant de commencer, je voudrais savoir s'il y a des commentaires sur l'ordre du jour.
Merci, Monsieur le Président. Je voudrais simplement souligner l'importance du point sur les dispositifs médicaux. De nombreux acteurs du secteur nous ont fait part de leurs inquiétudes concernant les délais de certification. Il est crucial que nous puissions garantir la sécurité des patients tout en évitant les pénuries de dispositifs essentiels. J'espère que nous pourrons avoir un échange constructif sur ce sujet.
Merci pour cette intervention. C'est effectivement un point critique. Nous allons maintenant passer au premier point de l'ordre du jour. Je donne la parole au représentant de la Commission pour nous faire un point de situation sur les dispositifs médicaux.
Speaker 39
Merci, Monsieur le Président, Mesdames et Messieurs les députés. La Commission est pleinement consciente des défis liés à la transition vers le nouveau règlement. Nous travaillons en étroite collaboration avec les États membres et les organismes notifiés pour accélérer les processus. Plusieurs mesures ont déjà été prises, notamment l'extension des périodes de transition pour certains dispositifs. Notre objectif reste le même : assurer un niveau élevé de protection de la santé tout en soutenant l'innovation.
Nous suivons la situation de très près et nous sommes prêts à envisager d'autres mesures si nécessaire.
Merci pour ces précisions. Y a-t-il des questions de la part des membres de la commission ?
Oui, merci. Je voudrais savoir si la Commission a une estimation du nombre de dispositifs qui risquent de disparaître du marché faute de certification à temps. C'est une préoccupation majeure pour les hôpitaux et les patients.
C'est une question difficile car les données évoluent constamment. Cependant, nous avons mis en place un système de surveillance pour identifier les produits critiques. Nous encourageons les fabricants à soumettre leurs demandes le plus tôt possible.
Bien, nous reviendrons sur ce sujet lors de nos prochaines réunions. Passons maintenant au deuxième point : la stratégie pharmaceutique pour l'Europe. Cette stratégie vise à garantir l'accès à des médicaments abordables et à renforcer la résilience de nos chaînes d'approvisionnement. Je laisse à nouveau la parole à la Commission.
Speaker 38
Merci. La stratégie pharmaceutique est un pilier de l'Union européenne de la santé. Elle repose sur quatre piliers principaux. Premièrement, assurer l'accès à des médicaments abordables pour les patients. Deuxièmement, soutenir la compétitivité et l'innovation de l'industrie pharmaceutique européenne.
Troisièmement, renforcer la préparation et la réponse aux crises. Et enfin, assurer une voix forte de l'UE sur la scène mondiale. Nous travaillons actuellement sur la révision de la législation pharmaceutique de base pour atteindre ces objectifs.
Merci. C'est un vaste chantier qui nous occupera pendant de longs mois. Nous arrivons au dernier point de notre ordre du jour : la santé mentale. La pandémie a mis en lumière les lacunes de nos systèmes de soins en la matière. Il est temps d'agir de manière coordonnée au niveau européen.
Je donne la parole à Mme la députée pour introduire ce sujet.
Speaker 37
Merci, Monsieur le Président. La santé mentale ne doit plus être le parent pauvre des politiques de santé. Nous voyons une augmentation alarmante des cas de dépression et d'anxiété, en particulier chez les jeunes. Nous avons besoin d'une approche globale qui intègre la prévention, le diagnostic précoce et l'accès aux soins. L'UE peut apporter une valeur ajoutée en favorisant l'échange de bonnes pratiques et en finançant des projets de recherche.
Il est essentiel de déstigmatiser les troubles mentaux et de garantir que personne ne soit laissé pour compte.
Je vous remercie pour ce plaidoyer. Je pense que nous sommes tous d'accord sur l'urgence de la situation. Nous allons poursuivre nos travaux sur ces différents dossiers. La séance est levée. Merci à tous pour votre participation.
Speaker 40
Good morning, everyone. Welcome to the meeting of the Subcommittee on Public Health. I would like to start by reminding you that the meeting is being webstreamed and that interpretation is available in German, English, French, Italian, Dutch, Danish, Greek, Spanish, Portuguese, Finnish, Swedish, Czech, Estonian, Latvian, Lithuanian, Hungarian, Maltese, Polish, Slovak, Slovenian, Bulgarian, Romanian, and Croatian. I would also like to remind you that the meeting is being held in a hybrid format, with some members present in the room and others participating remotely. I would like to ask all participants to ensure that their microphones are turned off when they are not speaking and to use the "raise hand" function if they wish to take the floor.
The first item on our agenda is the adoption of the agenda.
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