Committee on Public Health Ordinary meeting
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SANT European Parliament
Follow its sittingsOlivér Várhelyi
We are already actively working on the implementation and preparing a proposal for a Council recommendation on cardiovascular health checks. This includes a call for evidence that is open until May 19. A few other flagship initiatives of the plan foresee a dedicated program to support national cardiovascular health plans by next year. And finally, the Safe Hearts Plan also looks at the risk factors for cardiovascular diseases, including tobacco and nicotine. We recently published a comprehensive evaluation of the Tobacco Products Directive and the Tobacco Advertising Directive.
On the basis of this evaluation, the commission will now carry out an impact assessment and continue consulting widely to propose a revision of the legislative framework on tobacco control this year, as it has already been announced in the Safe Harbor's plan. Honorable members, our health system is under pressure, but I'm convinced Europe is up to the challenge. This is the purpose of the health package, which builds on the pharma reform and the Critical Medicines Act as well. So I look forward to your questions and working together on these important files. Thank you.
Adam Jarubas
Thank you, commissioner, for your presentation. Now I open the floor for questions by coordinators of Sand Committee for two minutes each. We're starting with Thomas Safakol, please.
Tomislav Sokol
Thank you very much. Thank you, commissioner. First, I would like to commend you for the work ethic, because rolling out the critical medicines act, revision of the medical devices regulation, biotech act, and the safeguards plan is definitely something that a lot of other parts of the commission could take some lessons from, because I think this really covers almost all important things that were mentioned in this mandate, at least for the first half of the mandate, obviously, for the second half. There are some other initiatives that the parliament will also call for, but this is definitely a big achievement. And I think we made great progress with all of these proposals in terms of achieving strategic autonomy of the European Union, in terms of production of medicines and medical devices, cutting red tape, enabling access to medical devices and pharmaceuticals in the EU, but also enabling equal access, which I think is also important.
And I also hope that in terms of critical medicines act, where we have these two main objectives, autonomy and equality of access, that will be able to make a breakthrough soon. I'm not saying that this will be the last trial in the next trial, but I hope that we'll at least make significant progress. On the other hand, with all of these achievements, we are shooting ourselves in the foot with the urban wastewater directive. The urban wastewater treatment directive where I the more I get into it, the more questions are being raised with and not more answers. For me, it seems completely senseless that the claim that four medicines account for 60% of toxicity in urban wastewater.
And also taking into effect that it seems that no actual measurements were carried out as part of this impact assessment definitely also raises concerns about whether this directive was based on real facts and data. So my question is what is your position on this, both in terms of measuring the actual contribution of the pharma industry to the toxicity of urban wastewater, but also the effects on the industry itself. Because if it seems that if we implement this, that this will lead to shortages of medicines in Europe, and this is not something that we want. So, what is your position on this? And what do you think should be the next steps?
And could the stop the clock be an option till we carry out a new impact assessment? Thanks.
Vytenis Povilas Andriukaitis
Thank you. Thank you. Thank you, commissioner. Also, I am happy that you are very active in your promises. I can tell you in several of your presentations, you have highlighted that achieving more in health sectors with limited resources requires a shift to a strong focus on disease prevention.
At present, the commission approaches appears to address prevention on a disease-by-disease basis, which can lead to, for once again, fragmentation and overlap. Does the commission plan to propose a comprehensive, overarching prevention, protection, and promotion strategy against main risk factors, with a broader focus on noncommunicable diseases and keeping in mind the one health concept? Second, I would also like to emphasize the importance of mental health. Is the commission considering the development of dedicated strategies supported by appropriate adequate funding for mental health? This is very important.
Empty warts is nothing. Third, when can we expect revision of tobacco legislation, I just mentioned, but do you intend to address novel tobacco products that are increasingly attractive to young people? We need to be very active initiative, you know, regulating novel tobacco. And last, my question about infectious diseases. You know, the measles outbreaks are going up.
It's very dangerous. And vaccination strategies requires permanent, you know, monitoring. You know that regarding the forthcoming council recommendations on immunization against respiratory infections, does the commission intend to propose meaningful immunization coverage targets for member states for respiratory infections, also including colds? Because vaccination is a very important issue. Thanks a lot.
Adam Jarubas
Thank you, Vietnamese. On behalf of Patriots, Margarita de la Pisa Carreon.
Margarita de la Pisa Carrión
Yes. Thank you very much, chairman, and thank you, commissioner, dear colleagues. Obviously, we're talking about strengthening the framework for incentives for innovation by looking at a possible extension of the supplementary protection certificates. In this context, how is stability going to contribute to innovation in order to create new therapeutic tools to the benefit of the patients? Do you feel that this is going to strengthen the biotechnological industry in Europe?
There are those who believe that it might delay the approval of generic medicines and biosimilar medicines. So perhaps you can say something on that.
Thank.
Ruggero Razza
you. Thank you to the commissioner for assiduous presence and dialogue with parliament, which is always very active, as well as the work which has been done until now. I would like to focus on two issues. First of all, the lack of manpower in health care. Now over the last few weeks of work, we have a resolution with which parliament and our committee and the AMF committee are fronting the issue and explained that this work has been, will be approved over the summer.
So the question is for the commissioner, what sort of time frame will the commissioner have when it comes to taking on board comments from parliament? Because if we're told that we have 1.2 million professionals missing from health care, and then over the next few years, this is going to go up to 4 million. Of course, this is going to put pressure on the health care systems in all member states. In the absence of adequate staffing, it will be impossible to even imagine collaboration. The last issue has to do with the directive that our colleague referred to before I did.
That is the collective directive. That is a problem. Today, the assembly of coordinators of this committee adopted a common position to request that the commission give thought to this. And, of course, there's the issue that most likely, not much can be expected. But on this as well, timeliness is important.
Let's recall that, otherwise, we run the risk of no longer having either the production of generic medicines in Europe or the adequate distribution of them. So time is going to make the difference. So these are the two issues I wanted to mention, but of course, there are so many others which we'll mention later. Thank you.
Heiko Lasko, renew.
Vlad Vasile-Voiculescu
Thank you. Welcome to the European Parliament again, commissioner, and thank you for your work and indeed for your leadership, balance, and dedication to European health care and European service. I have two points. The first is the European Health Data Space. This is an important achievement, but it is at its core an infrastructure primarily for professionals, less so for citizens.
Nowhere in the EHDS do we find the concrete citizen facing digital tool that empowers Europeans to proactively manage their health before illness strikes. Meanwhile, millions of European citizens are already turning to American AI platforms such as ChatGPT or Claude to ask questions about symptoms, interpret lab results, and manage their health. Every one of those conversations transfers sensitive personal health data to servers governed by US law. We are living in a paradox. The EU regulates health data more strictly than any other jurisdiction in the world, yet it offers its citizens no European alternative.
The result is that European health data flows to the United States by default, not by choice. So when will the commission develop or commission developing a European health prevention application built on EU infrastructure, compliant with EU values, and designed to keep European citizens' health data on European soil, an app that goes beyond data exchange between professionals and actually reaches citizens where they already are on their phones, asking about prevention, wellness, and early warning signs. The HDS gives us the plumbing. When will we build something that citizens can actually use? And secondly, commissioner, as we enter the next MFF cycle, parliament has fought to ensure that health retains a dedicated and visible budget line. And I'm glad, we now have a near mark 2,000,000,000 for cancer alone.
This was one of the initiatives of the Intergroup, I lead I collide. We are clearly saying that health should not disappear into a single competitiveness fund, where it risks being deprioritized. So I would therefore like to ask two things. First, can you confirm that the commission will fully commit to the continuation and strengthening of the beating cancer plan for 2028, 2034? And second, will the commission agree to present an annual implementation report to the parliament with measurable indicators so that we can fulfill our role as co-legislators and exercise meaningful scrutiny.
Adam Jarubas
Thank you, Vlad. Ignacio Marino, Grins please. Please try to keep two minutes, please.
Ignazio Roberto Marino
Thank you. Thank you, chair. Thank you, commissioner Varelli, to be here with us today and to have this opportunity to have an open dialogue about health care on our continent. I have two questions. One is related to an issue that was not mentioned so far, and is mental health.
And we increasingly see patients, particularly young people, teenagers struggling with anxiety, depression, isolation, and too often, we encounter a system that is not ready to respond in the 27 member states. In this context, I would like to ask, does the commission plan to launch a long-term integrated and binding EU mental health strategy as called for by the European Parliament in 2023? And I also have a question about medical devices, which is obviously a very important topic as well. The commission speaks extensively about simplifying and accelerating access to innovation. But what are the concrete innovations in this revision to strengthen patient safety and maintain high regulatory standards?
Are notified bodies sufficiently resourced and applied consistently across the member states? And will this revision effectively address the persistent delays in certification and the risk of shortage? I want to ensure that this is not driven solely by industrial consideration, but remains firmly grounded in patient safety and public health. Thank you, chair.
Catarina Martins
Thank you, chair. Commissioner, I will be speaking in Portuguese. I'd like to thank you for being here. I have to admit that I do not share the enthusiasm at your mandate with other MEPs because you're the commissioner of health of a commission that decided to withdraw health from its budget. I think that the European Parliament is doing the best it can to make sure that health is back on board in our budget, but it's not a good way to begin the mandate to be the commissioner of a commission which doesn't want to include this in its budget.
And so for this reason, I would like to ask, what do you know about the efforts that parliament is making to make sure that the commission continues to have a budget, a strengthened budget? And I heard the commissioner say how the moment, there is a tremendous amount of pressure on national systems. And so I certainly understand the need to have European solidarity. So I'd like to ask you, what do you think about the budget, and whether this parliament or this commission is going to be able to rely on your support to make sure that health has a dedicated budget? Or do you not think it's important, as does Missus Vander Leijn?
So I would also like to ask you about some issues we have here when we talk about medical devices, biotech and so forth, when it comes to the need for simplification or, to be more precise, deregulation. When I hear you speak, I have a great deal of difficulty in distinguishing what the commissioner says from what pharmaceutical lobbies say. I understand that they want deregulation, but my question is what is being done to ensure the safety of patients? And what is being done regarding accessibility, not just geographic accessibility, reaching out to the entire population, but also economic accessibility, price, because today, this exerts tremendous pressure on national health care systems and on families. And very briefly, I would also like to say that this committee approved an opinion on women's health, and, of course, there is a need for investment in this area.
For example, cardiovascular health, which is the number one cause of death among women. And as we know, there's very little research in it. And in addition, AI is completely ignoring women's bodies, and I'd like to know what you plan to do about this.
Olivér Várhelyi
I will try my best. First of all, to Mr. Sokol, thank you very much for the compliments. I will try to live up to them. First of all, on the equal access, yes, this was the trigger of creating the Critical Medicines Act to make sure that it is not only equal access when it comes to patients, but when it comes to member states because it is very clear that we have market failures that we would like to address with this proposal. We are coming to the trial with an open mind to achieve that.
So I think that on our side, all efforts are going to be done to succeed as fast as we can, if possible, already next week. The urban wastewater directive. And this is not the only topic where you try to test me whether I still align myself with the commission's line. So what I can tell you on all of these kinds of questions, like you have on, what was that, the MFF, for example, is that, of course, any commissioner is always bound by the proposal of the commission, and we're going to be bound by it as long as it remains the same. Now on the urban wastewater directive, we have had several series of discussions already in this committee.
And I think I also made my position very clear in the public, and I've made it very clear several times also in the college meetings. And probably, the best reflection of what I think about the implementation of the urban wastewater directive, because this is adopted, it needs to be implemented, is reflected best in the water strategy of the commission, which was adopted last year in June. And there is one very clear principle enshrined, which is that the implementation of the Urban Wastewater Directive will have to be designed in a way and done in a way that does not lead to shortages, market withdrawals or a significant additional cost when it comes to the pricing and reimbursement systems of the member states. We all know which are the products that are mostly debated, and those products are basic products. Basic products to treat chronic conditions, chronic conditions that people are living with.
So these are not questions. It cannot be a question of convenience. This is a question of public health, safety, and security to continue to ensure that they get the medicine that they need in order to be able to continue with their lives. So I am a partner for any solution that continues to ensure that. You mentioned one of the proposals coming from your party.
We will see how the debate in this house will go. I hope you will be able to come to a common position. And I'm happy to be a partner of yours to achieve what we have in the water strategy of the commission, but also to ensure that we meet your additional concerns when it comes to making sure that people will continue to have the necessary medicine they need. So in that, yes, I can confirm I am your partner. But it is not only me who is your partner, but the entire commission.
I can assure you of this. No one in the commission would like to see shortages or any crisis related to the supply of these very basic medicinal products. To Mr. Andrew Coitis, prevention. Yes, prevention is the name of the game.
If we want our health care system to survive as we know it now, meaning that we will always have the best available therapy and we have it on a universal basis, then we have to invest much more in prevention because we are having a population which is aging rapidly, maybe after Japan, the fastest in the world. We have also a projection that in 25 years, the chronic conditions will double. Basically, cardiovascular diseases are going to double in the population. And we also see all the budgetary limitations in the Member States when it comes to health budgets, but also when it comes to their sovereign debt level, which shows you what is their actual capacity to take on additional public funding obligations. So if we want to make more out of the same amount of money, it means that we have to start with prevention.
It means that we can then make savings on care, meaning that we would be able to serve more people out of the same budget than we do today. Whether this is disease by disease or we should have an overall strategy, for me, it was already, I think, quite a task. You remember the first discussions we have had here when I came on the criticism, why do I promote so much prevention? But now it seems accepted, so I'm very happy to hear that. But what I want to achieve is to build what has been built already and working really well in the Europe beating cancer plan.
In the Europe beating cancer plan, prevention, that's the first instrument where prevention was really put forward as a meaningful tool to address these chronic diseases. And therefore, we have built it even further in the cardiovascular plan, the Safe Heart Plan. These two plans are mutually reinforcing. There are very clear overlaps, even in terms of prevention, especially if you look at the risk factors. So what we will try to do is a holistic approach through building it sector by sector.
And this also reflects the One Health approach, I think. On mental health, this is the week of mental health. And as you know, it is not only my devotion to the fight by starting a public survey about it, a Eurobarometer survey, which we have just received the results of coming here. I still need to check it. We have sat down this week also with the young generation because it is very clear also from my mission letter that the single biggest risk we see is for the young generation.
The young generation is coming under unseen impact, let's put it this way, mildly, from social media and screen time. And this is why we are devoting maximum effort to this. And I'm also very proud and happy to tell you that it is not only me in the commission who is working on that. The president personally took engagement, creating an advisory body, and she is very much also driving these discussions internally, the commission. When it comes to adequate funding, I think this is for the budgetary debate we should have.
But certainly, we are already financing quite a number of programs from the EU Health program, something we will want to continue. But let's see how this debate evolves around the use of social media by the young generation and what additional funding needs will emerge, and then we will try to allocate the necessary funding to that. Tobacco review. As announced, it will come at the end of the year as promised in the Safe Harbor plan. You have seen that we have issued the evaluation, which is the first part.
Now we have launched an impact assessment. What we see from the evaluation is a very clear picture. So far, the system has worked well. So far, it has helped us to reduce significantly the use of tobacco products in general in the European Union. But since new products have emerged, new marketing techniques have emerged, so the situation is changing, and the framework that we have is no longer up to date.
So we will have to bring it up to date. Your question related to the novel products is very pertinent. The devaluation makes it very clear that they are to be considered at a similar level of risk as classic products, and this is our starting point. But if you look at the proposal we made when it comes to the taxation adjustment last year already, together with the MFF program, MFF proposals, you see that we want them to be taxed at the same level. So I hope this is a clear indication of what I think about these products.
Infectious diseases and immunization targets for respiratory diseases, that is in the Safe Hearts plan. We proposed it, and now we will have to agree on a recommendation with the council, and I hope that the Member States will also take this over from us. Next question was on the SPC and how will it benefit the patients, the biotech industry? Or would it prevent the entry of generics to the market? First of all, on the patients.
Europe is now, for now, a leading innovator in biotechnology. But it is not granted that it will stay this way if we don't promote the area. This is the area, on the other hand, which is capable to bring about a completely new health treatment system or a whole new generation of therapies. For example, if you look at the cell technology, if you look at orphan products, if you look at the newest inventions in oncology, most of them are almost exclusively coming from biotech. So without biotech, basically, we are not going to be able to continue to provide state-of-the-art treatments for the European patients.
If we don't promote biotechnology, it means that we accept the fact that in a couple of years from now, Europe will become only a secondary market, a secondary health care system, compared to those where these new technologies and treatments are available. So this is a clear benefit for the patients. When it comes to the industry, the benefits are clear, I think. But our definition of the supplementary protection certificate is also very clear that we only want to honor innovation, which represents an added value when it comes to treatment. So we are not here to promote innovation, which is just a variation of existing innovative products, but we want new mechanisms, and we want clearly biological mechanisms only.
This is the guarantee that we will honor those who are really adding the next step to the development of the European health care system. And also, these are now the companies that need the most help. A very large part of them are outside the pharmaceutical industry. A very large part of them are SMEs, startups, scale-ups coming from universities supported by the Horizon program. With the creation of the SBC, we can create immediately with regulatory means a market value with which they can attract investors, which means that they can stay here to manufacture these products and do the clinical trials here.
Because if we have manufacturing in Europe and if we have clinical trials in Europe, it means that we will have access, and it means that our patients will always have access. When it comes to the generics, I think it is also clear that we have tried to promote the faster entry into the market of generic products. If you look at the BOLAAR exemption that we have agreed in the Pharma review, that will already speed up their market access. Plus, it is also very clear that we are treating biosimilars now even at an accelerated pace by facilitating even further their market entry when it comes to clinical trials. So we are balancing the interest to have the newest therapy, but also the interest of the early entry of generic products to the market.
To Mr. Radza, the lack of manpower in the health sector, this is a very touchy subject. As you know, the organization and funding of the manpower in the health sector or the health care sector as such is always national competence. So the commission has very limited competencies in this, but we have a program coordinating the best efforts of the member states from the EU health program. But maybe, the best way to make the best use of the manpower we have in the health sector is to help them through the deployment of new technologies.
Because with the new technologies, they can work much more efficiently, much more effectively. For example, telemedicine for remote regions is a new invention that more and more gets the acceptance of health care staff, but also of patients. So, for example, in the SafeHEART plan, we're trying to mainstream all the tools, all these new generation of technology tools to help the work of the health care workers so that we can also bridge the gap of some of the shortages. What is the time frame to take into account the comments? As I said, we are, of course, following very closely what the commission what the parliament has decided on this.
On the urban wastewater, I think I have already answered the question. Mr. Wojcoleskko and the European Health Data Space. Yes, I see the same trend. And what we do is that we already, in the safe arts plan, try to work out such an application.
We would want to start this year with EUR 20,000,000 allocated to the digital part of the implementation of the Safe Hearts Plan, and this is part and parcel of it. Because, of course, the Safe Hearts Plan will create a whole new generation of health care data, and we want this to stay in Europe for the benefit of our patients. So of course, we work for that. And now comes the MFF question. A number of you have raised it.
And whether I agree with the commission proposal, of course, I agree with the commission proposal because it is a collegial decision. The commissioner has no choice but to agree with any collegial decision, and this is what I do here as well. If you ask me about whether we are going to continue with all the programs that we are doing under the EU for Health program, I can say a very clear and loud yes. It is not for two years that we would like to build the Safe Hearts Plan, and the Europe Beating Cancer Plan was not built for just one mandate. No.
On the contrary, all these challenges will stay with us, and they will be reinforced even more over time. The chronic conditions, the two main causes of death in Europe, are not going to change just because the AMFF is going to be over. So I want to continue. I would push for the continuation. And of course, I'm happy to be your partner in this work.
And I'm very happy about this proposal. Of course, it will improve the negotiating position of the parliament in this. On the other hand, I must also tell you that I've been seeing a couple of MFFEs, and I know how, when, and under what conditions normally they end. But it is a very important element for the parliament to have a very clear view on what parliament wants to achieve from the health budget. But as I told you, from the commission proposal, what we tried to do is maximize all the funds that can be directed towards health.
And in that, it's not only the numbers that count, but also the new modalities that we would like to introduce. If you look at what we have put forward together with the Biotech Act, it is a whole new mechanism of funding, meaning the involvement of the EIB, trying to involve joint venture capital investors, try to involve sector investors, and try to involve also institutional investors together with EU funds. In this way, we can multiply several times the funding that we have in the EU budget. And meanwhile, and maybe even in a public session, can now confess it. Meanwhile, I try to create all the policies with which, when the discussions about what should be the actual allocation on public health programs come, we will have an even larger set of priorities, which are already under implementation, something which is always much easier to defend in a budget debate than having to explain what it is that we are going to do in the future and what we are going to develop.
We have a very solid body of public health policy by now, and we are going to push forward this as we go ahead with the budget discussions. Mental health to Mr. Marino, I think I have answered your question. We already have a mental health strategy adopted back in 2023, and we will continue to implement that. On the medical devices, and also this is a question, this is an answer to Mrs.
Martins. What have we tried to do? First of all, we have not changed any of the assessment criteria, none of it. What we have tried to do, on the other hand, is to avoid the shortages that we see in the market. Our system became completely unpredictable.
In the U. So, if you look at their system, which is, I would say, a comparable level of patient safety to ours, what you see is that there's a very clear timeline with a very clear cascade of the procedure, very much predictable for the patients, for the hospitals, but also for the producers when and how a marketing authorization can be obtained. It's a very clear system. This is what we took as a basis and as a blueprint. First time ever, I'm very happy and proud about this. First time ever, we have managed to get a timeline for these procedures in the European Union.
We have now set a deadline that in 110 days, the assessment must be done because assessments have been done in completely different and divergent level in the European Union. There have been cases where it took them the notified body less than sixty days, and we have seen other notified bodies on the same product not being able to deliver an opinion for years. And this is not fit for purpose in the single market. And this is what we like to consolidate. But on patient safety, we are not lowering the level of protection by any bit.
On the contrary, where we could increase it, we have even increased it further. To Mrs. Martin, I think I have answered your question. You said that I did the proposal. As I told you, this is a collegial proposal.
And MFF is such a big operation in the commission, and it happens basically once every seven years that I would love to create the image that I'm the one calling the shots. But normally, simple commissioners are not the ones. Yes, we are, of course, participating in providing input to the proposal. But this is a collegial proposal run by the senior management of the college, and we are all sticking by it. Medtech, am whether we are deregulating, as I told you, I don't think so. And women's health, yes, that's the last point on cardio.
We have dedicated a research program for women-specific cardiovascular research. First time ever in the European Union. And we are also allocating funds to it already this year because, yes, indeed, and as I have promised it also in the hearing before or when nominating to be commissioner. As I promised you, we are looking into women's health aspects, especially in cardiovascular. What is very clear is that there are gender-specific differences for women. And now we will start a resource program, and we push also member states to create their own national strategies when it comes to cardio health for women.
Adam Jarubas
Thank you, Commissioner. We have a very short time for the second round. So please keep one minute each. Jessica Folfeert as first, please.
Jessica Polfjärd
Thank you, Chair, and thank you, Commissioner Vaheli. Today, tobacco use varies widely between the member states, and we all agree that we want to move away from tobacco use and protect the young generation. In the evaluation of the Tobacco Products Directive that was published a few weeks ago, the numbers are clear. Sweden has the lowest smoking rate in Europe, and it has had it for years. Among younger Swedes, less than 3% are daily smokers at the moment.
In the same evaluation, it's also made clear that Sweden has among the lowest usage rates of heated tobacco products and e-cigarettes as well. Sweden's model for lowering smoking is based on the combination of strict measures against tobacco smoking and on the availability of alternative products, mainly snus, and more recently nicotine pouches. While Sweden has an exemption from the EU rules for snus, no such exemption exists for nicotine pouches, even though the products have similar use cases. With this in mind, I want to ask the commissioner if he can elaborate on the commission's plan for the upcoming revision of the TPD. And do you intend to include nicotine pouches in the scope of the revision?
And if so, how will you learn from the Swedish experience? Thank you.
Laurent Castillo
Yes. Thank you very much, Commissioner, and thank you for coming to our meeting. And just like Mr. Sockel, I'd like to thank you for the quality of your work and for a listening ear since you took up your post. What about I'm talking about Ms.?
Climonse, who is a nurse, Jeremy, who's a firefighter, and they have lost their lives, who they were run over by somebody who was a driver who was under the influence of nitrous oxide or some kind of drug. So, obviously, we want to protect young people, do something about mental health, and improve road safety. We want to do these things, but today, we don't really know where we are, because moving on to the second part of my question, which is a cross-party question discussed in March in plenary. Is the commission going to ban the sale or import of nitrous oxide into the European Union? Apparently, yes, from February 2027. But a lot has to be done for this statement to be turned into practice.
We know that within the context of REACH, the commissioner had said that a validation would have to be carried out and be ready by April, 2025. This has not happened, so perhaps you can say something about the validation procedure. Thank you.
Martin Hausslingh, please.
Martin Häusling
Yes. I need to say. Yeah. Commissioner,
I think at one point, we agree. I think prevention, and this is really a key objective in the future, I think, and but we also have to fight is the abuse of antibiotics. And, of course, you look at the figures connected to it and the use in animal husbandry, it's been falling, but now we're starting to see that it's rising again. We see 5% more in Germany. I'm very concerned that we want to see this use of antibiotics in animal husbandry simply disappear.
So we say, oh yes. We need this for human health. But are you going to do something on this matter? Because I think you said, once again, it's simply not true that this is something that's urgently needed within animal husbandry.
Christophe Clergeau
Chair, commissioner, I won't surprise you because I will be once again asking you about the matter of support for NGOs in health and read out the text that was adopted in the context of the discharge of the EU budget by 389 against 255 votes by the European Parliament last week. The Parliament deplores the Commission's decision to not subsidize health care expenditures, which only represents 21% of the INFOF budget in 2024, and emphasizes the importance of predictable and stable support mechanisms for actors and organizations in civil society in the area of health care. It also invites the commission to make sure that operational subsidies are paid out in the context of EU and EFOF programs. So I would ask you not to hide behind the vote on the text on husbandry because, clearly, the paragraph on NGOs didn't cover health care NGOs, and rather ask you whether the commission does plan to follow the request by the European parliament or not.
Thank you, chair. I will continue in German.
Sebastian Everding
Commissioner, I would like to continue an exchange that we had already started last year. I heard said at the time that WHO and the International Agency for Research on Cancer have confirmed that consumption of meat is carcinogenic. And you had said that foodstuffs in Europe are safe, and there are no products in the trade on the market that are category one. And you said that saying that meat is carcinogenic might discredit the food legislation and provisions that apply in the EU. So this is a smaller group, but perhaps you can say what you meant.
Are you rejecting the opinions of the scientific circles? I don't know. Are you going to take meat out of circulation to protect EU consumers? What about meat and its impact on health in the EU over the next few years?
Thank you, Hefo.
Gerald Hauser
Thank you very much. No. I haven't. Commissioner, right now, we're discussing many topics: chronic illnesses, generic medicine, biotech, women's health, etcetera. That's all mentioned.
However, the health systems in the European Union are really suffering, and the health care system does not function very well for most citizens, not at all, unless there's some kind of private insurance. That can't really be the path that we're following. We have to ensure that health care supply is something that everyone can afford and is available to everyone, which is simply not the case right now. We don't have enough personnel in health care. 4,100,000 persons, in terms of nurses, doctors, midwives, was they’re simply going to be lacking.
And so I think, of course, it's a national competence. That's true. However, since we're discussing these competencies here, and I expect a solution, because right now, it's been mentioned that in emergencies, we have to be ready. And here, I've a letter from the Doctors Association in Tyrol, and they have writing to all doctors in Tyrol that with single use gloves, sterile gloves, there simply isn't enough. There's the crisis already.
They can't get these sterile gloves, and we are always they're already crying out for help. The simple banal products that you need for basic medical treatment, such as these sterile gloves, they don't have them. But these fundamental systems, we're not solving.
From Anja Hasekamp, please.
Anja Hazekamp
Thank you, chair. Do you remember the COVID pandemic and the hopelessness felt across Europe? Well, fur farms are the perfect breeding grounds for infectious diseases. Animals are cramped, stressful, and unhygienic conditions, and viruses flourish in these environments. Mink and foxes are very susceptible to SARS viruses such as COVID-19.
And more than 1.5 million people are waiting for fur free Europe. Six weeks ago, you said that you just started working on this file. How is this possible? The commission responded to the citizens' initiative in December 2023. I assume you agree with the fact that fur farming is a ticking time bomb for human and animal health.
I also assume that you don't want to start another pandemic. So my question is clear. When will you publish the European ban on the production and imports of fur?
Thank you.
Olivér Várhelyi
Yes. Yes. Let's go one by one. To snus and nicotine pouches. What I can tell you at this stage is that in the evaluation, of course, we have evaluated these products as well.
And these products, as they contain nicotine, are evaluated the same way as the other new products or novel products that contain nicotine. So our evaluation also confirms that, as I told already in response to another question, our evaluation found that products containing nicotine are capable of creating the same health risk or damage as the classic tobacco products. This is what we know from our evaluation. From here on, we are going to go one step further, and we will look into the options of how to review the legislation. How the review will going will look like, I cannot tell you at this stage, but the scope, I think, is already defined by devaluation itself.
To miss Mister Castillo, yes, I looked into this case. And, what I can tell you is that we have proposed to classify these products as reproductive toxicant category 1B under the CLP regulation, the classification, labeling and packaging of substances. And we have brought it to the REACH Committee, which is the committee to decide on the reclassification. The committee has approved our proposal on April 29 this year, and it should reclassify. The reclassification should start from 02/01/2027. It means that from here on, it cannot be sold for consumer use.
It can only be used for professional use, either in medicine or as a substance as a food additive, but only by food producers. So I hope with this, we can also give you a reply defending the general public against this substance. To Mr. Heusling, prevention, and AMRs. First of all, I think it is very important to underline that under the veterinary medicine products regulations and rules, the use of antibiotics that are reserved for human use only are already banned to be used for animals.
It is a very important rule that we enforce with the most rigor. So in Europe, it is no longer possible to have risk coming from animal farming in terms of antimicrobial resistance to human health. Second, this is the first time I hear this figure, so I need to check what you say, that in Germany, the numbers are going up again because my figures tell me that we are safely getting to achieve this 50% reduction target by 2030. But if there are different figures, I'm more than happy to look into it. So please send it to me, and I will go for it.
Then, yeah. I think that's the answer. To Mr. Clercio, I know that you insist on this. But as I told you, my budget is extremely limited.
And compared to, for example, what you have in the Life program, it is stipulated in the regulation itself that operational costs can be or should be also paid. In the EU for Health regulation, we don't have that. And in the EU for health, last time we paid down these costs, we have spent €9,600,000 on this. I will give you a couple of examples, and then you advise me which are the programs I should cut. We are spending €11,300,000 on this new health technology assessment implementation program, basically helping to get a common assessment of the efficacy of the medicines in Europe, to promote, finally, a common assessment.
That costs us 11,300,000. We are spending on the blood tissue cell organ program, where we are also financing most of the orphan-related actions, orphan products, and rare diseases actions. We are spending EUR 10,000,000 on that. And finally, we are spending on health promotion and other programs related to the implementation of the SafeHEARS plan for prevention, €7,600,000. This is my budget reality. This is my budget reality.
And on the other hand, we have created in the budget €51,000,000 to which the NGOs can apply, and they could be our implementing partners. So we are ready to work with them, but please understand my budget constraints. €9,600,000 in this budget is a huge amount with which, if you put it into perspective, what we are financing, you will see the sheer proportions. But I'm also ready to accept your help and raise my budget. Raise the budget, and then we can rediscuss.
But I need these programs to go ahead. Please understand. To Mr. Everding, whether I contradict the WHO. The WHO, I think, but we need to check the proper wording, but the way in which I remember it says that excessive red meat consumption is considered to be a long-term risk when it comes to cancer, basically bowel cancer. This is what it says.
It doesn't say that meat consumption as such, because otherwise, we would have to revisit the whole European food safety regulations. And I don't think that our food safety regulations were overlooking any such risk. So I'm still sure that our food safety regulations are up to standards of the WHO as well, and they are not contradicting one another. To Mister Hauser and the health care system struggle, I fully agree with you. I see all these problems, but don't forget that the organization and the funding of the health care systems are national competencies, exclusive competencies in some countries with federal institutions, maybe Austria.
A large part of this falls with the lenders. So for the commission to intervene in this, it's not easy. But what we're trying to do is, for example, if you look at the Medical Devices Regulation revision, is to make life easier for the hospitals. So in hospitals where products that are meant for single use could now be easier be used several times to cut back on the costs. We will ask the producers to justify every case why they think that their product is only single use, and try to come up with solutions that are more cost effective for the public health systems.
And finally, to Mrs. Hasenkamp. I didn't say I was starting to work on this. We have been working on this. What I told you was that the internal work in the commission, meaning interservice consultation, cabinet-level consultation, started now.
We are at the very final stage of this. And still this month, I want to come forward with a very clear agenda on this. And you will hear me also announcing additional animal welfare initiatives in the livestock strategy, which is scheduled for July 7.
Adam Jarubas
Thank you. Thank you so much, commissioner. Dear colleagues, in my opinion, we had an excellent discussion with the commissioner. We appreciate your work. You're trying to have more money in the budget.
For I'd like to thank for your legal initiatives also, new strategies, I mean, cardiovascular. So I appreciate your trying, and thank you for your time today. Thank you so much. Thank you so much. Thank you.
Dear colleagues, we continue our agenda. Point 10 is exchange of views with DigiHera on priorities for financing health emergency preparedness and medical countermeasures preparedness in Europe. I invite our guests to take the place on the podium. Okay. Dear colleagues, our last point on today's agenda is exchange of views with Missus Florica Fink Hoyer, director general of DigiHera, on the priorities for financing health emergency preparedness and medical countermeasures preparedness in Europe.
I will first give the floor to Mrs. Link Heuer for her presentation for eight minutes, and after to the members for the Q and A session. If you want to take the floor, just raise your hand, please. Missus Fink Huyer, you have the floor, please.
Florika Fink-Hooijer
Thank you very much. And dear chair, dear vice chairs, and dear coordinators, it's always a bit of a challenge to speak after a structural dialogue of a commissioner, but I will do my best, hoping that you will have put all the difficult questions to him. But anyhow, it gives me a real pleasure to be here and to have the opportunity to update you on what we have done on the health emergency preparedness and response activities, which you will see are actually quite comprehensive. Indeed, when you think it's almost three years ago on the day, on May 5 that the WHO declared the end of the COVID-19 pandemic. And while we all like to forget this, the impacts of the pandemic are still in our minds and in our collective memory, and actually some are still felt today.
And we clearly drew hard lessons from it, especially for our economy as well. And therefore, one has to say we made a lot of progress, but that progress, nevertheless, is a bit fragile. And I would like to explain why. Because the global health security landscape is still marked by very profound turbulences. Actually, we have new outbreaks of infectious diseases much more and in much greater frequency since then.
We just had the hantavirus outbreak on the cruise ship, and many in Africa all the time. We have I'll just listen a bit to the exchange. Antimicrobial resistance was mentioned several times. It continues, while the drug pipeline is actually very thin. And then we had also last year here in Europe seen quite a record of numbers of chikungunya infections, which are vector-borne diseases or other vector-borne diseases, which are linked to actually warmer climate and environmental degradation.
So, and on top of that, we have a security landscape, which really is changing, and the geopolitical threats mean that our supply chains, just think about Iran now, but also cyber sector disinformation conflicts blur the line between what we would call traditional health preparedness, but then also with defense. And for me, that includes CBRN as well, and other accidents linked to that. So we have predictable known threats, which we can prepare for, but we also know that if we fail to prepare, we are preparing to fail. That's for sure. So we are working very hard on EU level and also with you, and I'm grateful for that, that we keep attention also on health, because that's not obvious with all the conflicting other priorities.
I have to say that. So since last year, we have started to put the MCM strategy, the medical countermeasure strategy, into action. We have really come forward with working with the member states, very much with industry as well, also civil society, and with you in order to advance. We adopted the health threat prioritization assessment, which is really the guiding framework. We adopted the four priority threats on which we are now looking at everything, whether we have it in place or not, as medical countermeasures.
We are also implementing much more now our EU wastewater sentinel system to rapidly detect, because the part of everything for prevention and preparedness is knowing what's coming your way, and that is the EU wastewater insight. We have 23 super sites now in Europe, but we're also rolling it out in aviation program globally and also mass gathering events detection as we did for instance in the Olympics now. We are also testing whether we are ready to respond, and we test that with our member states. And I can tell you when we had last October our first full simulation of a, let's say, large scale avian influenza outbreak like a pandemic, like a COVID-like, it was really quite eye opening for everybody. We have tools in place, but member states also have to adapt and know it, and we constantly have to test that.
And we will do in this autumn also a large another test on response capacities for radiological and nuclear incidents, and that will be linked also to a NATO exercise. Partnerships are essential. I have to say that. We reached out a lot to other regions. As I said, prevention preparedness needs to know what's happening where.
It will not always happen first in Europe. So we enlarged very much arrangements with Canada, the Pan American Health Organization, and we are now in negotiation with the other country, so Iceland, Norway and Liechtenstein, and with The UK and obviously support also the WHO as we did always. We very much put attention to, as we have a pipeline approach, to innovation and to really targeted support for innovation in order to really reach this 100 day mission. And therefore, we look very much at precommercial procurement now. This is important.
We just launched a new generation influenza vaccine with a precommercial procurement. That's exactly what Letta and Draghi always ask for. What will be in the next ECF, but we are using it now, and we are very proud of that. We also had spent just now a €30,000,000 investment to advance the development of new antibiotics. We announced that at the One Health Summit in Lyon just very recently for AMR.
We also have spent €20,000,000 on the development of new therapeutics for dengue. And already in the last work, Programme 25, we spent quite a lot of money on both AMR and dengue. Under the Herra Invest, I'm not sure how much this is known, but this is our facility with the EIB where we go for quasi-venture capital. Again, this is really a competitiveness tool where we try to support SMEs' access to finance and startups, and we are very proud to have seen that with the EAB and the French forces, we had the first antidote for a CBN threat, which is called rising threat, to which we had no antidote so far. We have it now.
In two years, we have developed this, and that is very important for us, and we will now try to stockpile that for member states. All of this is just a glimpse of what we are doing, and I'm quite sure you will have other questions. But we are working in general on what we call an industrial roadmap. We want to know what capacities we have in the member states available, how can we scale them up very quickly. It's also what we call a ramp-up system.
We also look at personal protective equipment. I understood there was a question for Mr. Hauser. Indeed, we are piloting now. We used to have EUFAP. EUFAP is a reservation contract, a reservation of capacities for the case of an emergency.
We have so far only done this for vaccines. Now we are testing, piloting whether we could do this for PPE, so also for protective equipment. Why? Because we see there might be potential shortages for member states, so we want to be prepared. It's not ready yet.
It's just something which we are launching right now. It is in our latest work program. And then this is the test case in order to see whether reservation contracts can be extended beyond vaccines. We address also the issue of mis- and disinformation, medical countermeasures where very active is used with podcast, and so on and so on. We are investing a lot in what we call civil military cooperation.
We have an umbrella, which is called Medifence Initiative, under which some parts have already been launched, others are in the pipeline. What has been launched is financing innovative financing also for new antidotes in CBN sites, but we are looking also on other parts as regards medical and mobile detection mechanisms and prepositioning of kits. But that we need to discuss with the member states. It is what member states need. It is not what we think we need.
So it really requires quite a decent analysis and also a discussion. And then we will have next week our global health resilience initiative coming out. So I think this is also a very important part where, together with others, DG Sante, of course, and DG Impa, we are contributing. You have heard that already from the commissioner before. The health budget is not necessarily on the focus everywhere, but we do need dedicated capabilities and also funding in order to do the pipeline, which starts as detection, surveillance, targeted innovation, really new innovations into our industry for ensuring autonomy, and then having response capabilities ready, potentially also to stockpile.
So this is quite important, and the MFF is, of course, a big discussion for everybody. I just want to reiterate or bring back to your attention that DG Herrera is today already using different funds, Horizon, EU for Health, and we used to use the Next Generation EU for the stockpiling. And in the proposals that are now put forward by the Commission, we still will need, in order to have this end-to-end approach, we will still need three funds: the Horizon Europe for the fundamental research, ECF for the innovation, for the procurement, for the hubs, and then the EUCPM HERE, a new instrument, where we would go more for surveillance and stockpiling in other areas, but very much also the reservation contracts for the manufacturing capacities to have them available to speed up. And of course, in the ECF, it would be very much hopefully the Hera Invest to be continued, because that has been one of the most competitiveness-driven or geared investments that we have done so far. And we are hoping that this would be continued, and are extremely keen to continue on that as well.
Honorable members, I just want to conclude by saying the economic and social case for investing in health preparedness, response, and prevention is something which we need to keep up. If we were to have any new, broader, bigger health emergencies, I think the impact on the economy, but also on the daily life is big. I count a little bit on this committee, and specifically because you are the subcommittee, but you can also count on us that we want to deliver for the citizen in this area and to be better prepared. So I would stop here. I hope I was in time.
And I now need to put on my glasses because I realize it's a very bad idea.
Thank you so.
Adam Jarubas
Thank you very much, Missus Finke Heuer, for your presentation. We're starting with the question, around, with Christopher Clajeau as the first, please.
Thank.
You, chair. Madam Director General.
Christophe Clergeau
So first, it would be very useful for us that you could come back on the budget issue because with Le Roper Jean and ECPM, we are trying to secure at least 4,000,000,000 for you, but also to strengthen what other fields we could finance with the 4,000,000,000. And on MFF ECF, this committee adopted his opinion about ECF with a lot of mention of air preparedness. So if you would be able to propose us a kind of road map of your needs indicating very completely which action could be financed by which tool you just began, it would help us to defend your vision in our future negotiation within the parliament, with our friends in its way committee who have their own vision of what should ECF be for the future. So this would be very useful. This is my first element.
My second one is about how to be prepared, because if we fail to be prepared, we are prepared to fail. I love this sentence. But I will come back to the question of the masks. Why? Because we have a list of critical medicine, and we have the critical medicine act.
If I understood well, we will have a list of critical countermeasures different from medicine, but we do not have a legislative package to promote the production in Europe of countermeasures, which are not medicines, like, for example, masks, gloves. So how do you see the specific question of not medicines, but equipment, medical equipment in the preparedness strategy and your capacity to support the development of value chains in Europe, allowing us to be independent in the access, for example, to masks or gloves. Thank you. Thank you. Gerald Houser, please.
Thank you.
Gerald Hauser
Once again, just briefly for Hera, from 2021 to 2027, has a total budget about €30,000,000,000, and six of them next generation and 24,000,000 billion are general budget. In other words, it's a huge amount of money. And HERA was created in 2027 with a decision from the parliament and the EP. So it's not an individual agency, and so it's not subject to the European Court of Auditors. And the Court of Auditors has criticized this.
Just a few remarks, they have said there is no independent auditing body to address this. I mean, it's got an enormous budget. So in a sense that they can work in a black box because they can't be independently audited. So in transparency concerning this, and I quote, the lack of structure makes it difficult to have direct parliamentary control of the HARA and their use of the budget. So I think this is quite a strong criticism.
And there have been several questions from the parliament, and it was said to me by the commissioner, said the Herod has 6,000,000,000 and only one tenth of its actual budget, 6,000,000,000. So do you have 30000000000? And you, we were told we have 6,000,000,000, and that's money. So, where are we? Are we at $630000000000?
Where are we according to the Court of Auditors? That's the figure. So there's a lack of transparency here. This isn't transparent, and there's also additional private money being used. So who is providing that money?
Ignacio Marino, please.
Ignazio Roberto Marino
Thank you very much. Thank you for your presentation and for being here so we can have an exchange of ideas on the Union Civil Protection Mechanism. As a shadow reporter, I would like to focus on a couple of practical questions. The European Union has significantly strengthened its capacity in recent years through the Union Civil Protection Mechanism, through the RESCU reserve, which is a shared European reserve of essential equipment for emergencies, and through the creation of the Health Emergency Preparedness and Response Authority. This is an important progress.
At the same time, from a public health perspective, the key issue is not only the existence of these tools, but how they function together when they're really needed. Preparedness, by definition, requires continuity. It depends on sustained investment in stockpiles, in production capacity, and in overall readiness. And now my three questions. First, how do you ensure that these capacities are maintained over time and not only strengthened in response to a crisis?
The second question, how are responsibilities organized in practice? Who identifies needs? Who takes the decision? And who ensures delivery on the ground? Finally, I have another question.
As a transplant surgeon, I would like to know how transplantation fits within the union civil protection mechanism as a vital medical logistics system. In Europe, we are losing every year 7,000 lives. They die on the waiting list. And I don't know how to explain to my friends, in The United States where they have one system. So, if an organ is compatible with the patient in Ohio, the donor from Pennsylvania will give that organ to Ohio.
We in Europe behave like we have borders between France and Germany, or Germany and Poland. And so a number of organs that could be used are wasted just because we don't understand that the organs need to be compatible with the recipient. We need to not have borders for this. Thank you very much.
Leire Pajín
Thank you very much, chairman. I'll speak in Spanish. I do agree with what you've said on the need to answer the question as to what we learned from the pandemic and how we can make sure that we are better prepared in the face of future outbreaks of epidemics. You've talked about some of the latent threats and risks that we're facing, and I would like to add the hantavirus because I'd like to take the opportunity that you're here because we do need to strengthen our vigilance. But I would like to ask you about three issues.
I'm the rapporteur for the self-protection mechanism, and you have said that we need to have an appropriate budgetary reserve for health but also for the integrated knowledge networks. So I would like to know what kind of elements we do have to guarantee through the financing. Secondly, we know that in order to be able to better prepare and respond to future global health risks, we do have to focus on the Southern Hemisphere countries, focus on prevention mechanisms, epidemiological surveillance and vigilance, increased knowledge. So I would like to know what kind of coordination exists. E, between DG INTPA and the Commissioner for Development, to guarantee that this work is going to be done.
Finally, I would like to ask about the need for guaranteeing the synergies, the necessary synergies within the commission to ensure that these strategic reserves are effective. I would like to know what kind of specific work you're doing in that area. Thank you.
Laurent Castillo
Merci, madam. Thank.
you. Thank you, madam. This was mentioned a few days ago. Our teams began technical negotiations on civil protection mechanisms, and Era Herat will be part of this new regulation, where what is new is to include a health component. HERA will be in charge of preparation and reaction to health emergencies.
So madam, just a couple of questions on this. So how exactly do you see DG Herrera's role with respect to the RCC, the emergency reaction and coordination center? Do you think that the current legal framework is sufficiently clear to avoid any overlap of competence and to ensure effective coordination should a crisis situation arise? And what medical countermeasures do you have in mind for her to take a determinant place regarding a member state that's acting alone? And one final question.
In your view, is protection and preparation, does that represent about 80 people in Herau? Because the text says that you're going to have to beef up the staff numbers. So, do you have some sort of estimate of your needs? And then I'd like to finish with a topical question, hantavirus, which will arrive in Spain in a couple of days. Could you please keep us abreast of what's happening with that virus?
Thank you.
Florika Fink-Hooijer
Thank you very much, first of all, for all the questions. I will take them one by one, but some are a little bit limit linked because many are related to the UCPM slash Herr. I have to admit, this is not just a civil protection instrument. It's also a health emergency and response instrument. So it has two different parts.
And I would like to really point out that while this is a bit what MEP Clajo asked, but also MEP Castillo in the end asked as well. I put that together now. Sorry. Is the UCPM part? It's one instrument, and it's about preparedness.
This is true, and we are all working together under the preparedness commissioner. And as you remember, there was also the European preparedness strategy last year, and the first deliverable under this strategy was actually our MCM strategy and our stockpiling assessment and our threat assessment. So you can see that, yes, we work extremely closely and well together. But when it comes to the financing instrument, it is a bit confusing perhaps for some to see that while the UCPM part is not just a financing instrument, it also revises the decision that is underlining the civil protection mechanism. Whereas in our part, the health part, it is a pure funding instrument.
The only instruments and the regulations that govern the health emergency part for us on prevention and preparedness are the serious cross border health threat regulation, and, of course, also the European framework regulation, the four increase. We have a real crisis which gives Hera specific responsibilities but also possibilities to act, especially vis-à-vis the industry. That's why it might be appearing a bit confusing, but for us, it is a financing instrument pure and sure. And we have enumerated, now I come back to your first question. We have enumerated now in the latest draft that is put forward by the presidency, the type of presidency, in the annex, very clearly, the list of action that would fall only under that part, which would be, as I said, the surveillance mechanisms.
So wastewater surveillance, for instance, the threat analysis that we will do, the mechanisms that we would need for that, the reservation contracts, so the capacity and the manufacturing capacity that we want to keep in Europe always warm in order to be able to scale them up. And, of course, also issues like stockpiling because that was where initially the link with the rescue stockpiling was made. Whereas in the ECF, we would really only concentrate on the innovation ongoing for the development of new medicine. It can be therapeutics, it can be devices, it can be everything, but it has to be linked to innovation. And the Hera Invest, which is now, I think it's 100,000,000.
We would like to have that beefed up to 200000000 and more. This is where we really could innovate very much with industry, especially start ups and small and medium sized industry. When we go on the Horizon Europe, you didn't mention it, but that is also a part where we would need to continue being receiver. That would be for fundamental research such as, for instance, we have gene therapy now being put forward under Horizon Europe. We have, for the moment, a specific window which is really for Hera under this instrument.
Why are these three instruments important? The majority, perhaps, of our day-to-day operations will probably be under the UCPM here. But the other two are parts of the pipeline. As I said, the response cannot be ensured if I don't also have the innovation, the detection, all of this. We have an end-to-end approach, which goes not just in one single instrument, and that is probably the most important feature of the way we are acting.
But I'm happy also to come back and share with you the list that was now put forward both in the UCPM but also in the ECF, and that hopefully will be making it a bit clearer. But if it stays with you that we would need all of that, that would be already important, because this is all fine. It's all as important as the pipeline. How to prepare? That was the second question for the mask, for instance, and why is it not on the CMA, because indeed it is more a medical countermeasure.
We have no specific dedicated legislative act for MCMs. I would be very interested in hearing your ideas, but perhaps we can have that bilaterally. For the time being, we, as I said, have only the two regulations, which are really our foundation, which I just mentioned. But when we look at mask or, as I mentioned before, on gloves and other MCMs, of course, we look at the EUFAP mechanism. This is how we ensure, for the moment, reservations.
Mister Hauser, indeed, I know that you have put several questions forward, and I would love to have the 30,000,000,000. I mean, I would really love to. I would be, I mean, teaming up with you on that. The reality is I'm very afraid to say that, and I can really say it because we only, it's enough. It's good.
It was very appreciated. It was 6,000,000 billion at the beginning of the MFF period. Then came the midterm review, and it was decided to cut by 1,000,000,000, so we have 5. I also appreciate it, nevertheless, that the parliament came forward already this year and last year to ask even to at least not cut us further. But this is really the amounts that we have, and we are coming to the end of our pipeline, and we have used it up quite extensively for the different areas I mentioned.
Now we are not an agency. We are a commission service. And as a commission service, we are, of course, subject to multiple audits by the court of auditor, our internal audit because the budget that we are spending obviously has to be transparently checked. And that is where the court of order does it very regular, especially for those contracts where it was actually before with another entity. It's our legacy contracts from the COVID time.
But I can assure you that is what we also accept, and we, of course, have to continue on that. So the answer is really what you have received from commissioner Labid is, I can only confirm. We don't have private funds. We only have public money, the money that the two budgetary authorities entrusted us with for the member states. We worked with the EIB, and the EIB can leverage up funding, but that's the EIB as a bank.
So that is how they can themselves leverage funds. We sometimes co-finance other institutions or other actors who then can leverage themselves, like CP or Gavi. But then our funding is always earmarked, very clearly indicated what we want to fund, and they can't, let's say, deviate from it. So we don't have any private funding. A difference is if we were to act from private for joint procurement for member states, then we act for member states with member states' funds, public funds again.
Mister Marino, you asked us for the rescue. This is indeed, you said, a shared reserve for emergencies. And from the public health perspective, you asked what is the perspective on the stockpiles. The reserves were put forward at the time after COVID, based on member state wishes. I have to say that very clearly.
We exchanged, at the time, what you would need in the lessons learned from COVID in the stockpiles. And that's how the COG stockpiles were created. There are CBI n things. There are ventilators. There are respirators.
There are gloves. There are the full range of medical countermeasures. This health part, health emergency MCMs, it's distinct from what is under the civil protection mechanism because the civil protection mechanism in the EU your rescue has other a clinic in a box or something else, which they would deploy as civil protection actors in an emergency. Because if you have a refugee crisis, a flood, or whatever, you always will have a health implication. So they would deploy that, but it's not an MCM.
This is a classical part. The MCMs were really created according to member states' wishes. Now we are having a compendium and a joint action ongoing with member states to identify when we want to replenish under the next MFF, with what and how, and what would be the most cost effective. Could it be more reservation contracts? Could it be more joint procurement?
Or could it be for certain niche products, especially probably also in the CBN area, very much probably stockpiling and what type. So we are mic piling now, but we are discussing with member states again what would be needed in complementarity, what they should have in their own national stockpiles so that we not duplicate but complement. So that's extremely important. But I would like to clarify that the way that we use the MCM stockpiles is not the classical setting in a civil protection mechanism where somebody asks and first come, first served, it is sent. No.
Here, it is specific because this is a reserve that is put up for the member states as a last resort. So just to hopefully clarify that better. So who delivers and who decides? How do we infight the needs? I think I explained that.
The delivery often is up to the last mile by member states because who hold the member stockpiles. But then we make use in particular of the civil protection mechanism, because they have the logistical capacity to then transport. And they can even transport it within five variable rates, or in an emergency situation. So this is again why you see civil protection and health emergency sometimes come very close together, but we work hand in hand with them on that. Now, on your questions on transplantation, and you are absolutely right.
I think this is an important topic, which, however, I'm afraid is not falling neither on the civil protection nor under the MCMS. This is not something where I would be able to give you any reassuring measures. The only thing that we have and which could be used in an operation would be ventilators, respirators, but this is what normally, in that case, a member state would have available. Madam Parhein, you asked again what lessons learned we drew from the pandemics, how best to prepare, and also again on the UCPM here, what would be needed and what not. You know that the commission proposal is going for full flexibility for various reasons, and the whole idea was also to simplify.
This is also why certain parts, like from the EU for Health, were now put in parts into the UCPM slash care. So that is clear. So you know the position at the commission. What I note, however, is that parliament, member states, court of auditors, they are asking for more predictability because often it's long time investments. They ask for more clarity on the budget allocation.
They also have asked for more different types of cometology, which is not foreseen for the moment, and other things to clarify how the health community and the civil protection community would act in which area. Therefore, also, they ask for a certain split in the committees. I note that, but you know our position as the commission is a different one. We have put forward amounts for the UCPM help. I think of the cover, I think it's around 10,000,000,000.
If that would be coming, we would be already happy, depending, of course, on the split. We have also amounts foreseen, and the commission put that forward for the ECF and for Horizon Europe. However, these are very crowded windows, and it's not a window only for health emergencies but for many other things. If we were to get some funding, that would be extremely helpful. So how to guarantee synergies to using the strategic reserve and how to coordinate, for instance, with INPA.
I have to say this is excellently working as this is a classic commission internal corporation, interservice, and everything else. You will see that reflected, I hope, and in a reassuring way also in the global health resilience initiative that comes out and hopefully is adopted then next Wednesday. Because here, we work very much hand in hand with DG Inpa, because we also have, from the preparedness side, this regional approach. We also fund certain genomic sequencing capacities and other capacities, whereas then Inpa comes from the manufacturing capacity outside Europe. So I think there, we work super clearly together.
And also on if there were any strategic reserve to be used, we discussed that, of course, within the commission, including also with our civil protection questions. Now on the role of the ESCC, was Mr. Castillo, you asked for that. Again, the ESCC is a hub to identify needs and then dispatch that as far as civil protection is concerned. And they also provide there are certain rules, IPCR rules, where they would do the reporting and the monitoring fed by all the commission services. It can be energy.
It can be transport. It can be so, move or it can be us depending on the crisis. But we so it was a coordination hub. But as I said already in the beginning, our legislative framework is completely distinct, as it would be for energy or for transport. So that would stay irrespective of the new instrument, because for us, it's just a financing instrument.
Protection preparedness, how to beef up staff members on this, I cannot say much because, again, this is always for the budgetary authorities to decide. But I would like to say a few words on the hunter virus, because I think that's something which is alarming for everybody. And I think it also is perhaps a quick reminder of how quickly something can occur when, out of the blue, we wouldn't expect it. Now here, I have to say we all, you know, it. I mean, I can definitely say that we immediately had coordination meetings, with several, especially with ECDC, SANTE, but also EES, but also the WHO and also, ECHO and us, obviously.
But, it is also clear that for the moment, it is so that you know that the most affected were evacuated already out by the member state concerned. And now, the Spain, who might be the one receiving the boat with the not acute, but still we don't know patient, they have now asked the civil protection mechanism for evacuation because that's a classical disaster risk management action. They have evacuation teams. They have planes or they can get the planes in order to evacuate them and contain patients and also to have extra medical emergency teams for that. Now from the MCM perspective, I have to say just a few words because I think it's important.
What would be needed for member states would be, in the current context, again, ventilators, gloves, and all of this, and they would definitely need that. But they have not asked for anything because this is sufficiently available so far as to our knowledge. If they were to ask, we would see. But for the moment, nobody has asked for this, and they say they can handle it. They have specialized, wherever it is now, ten hospitals who have the required MCM's medical countermeasures.
The only thing that I could say is, obviously, we are monitoring this very closely because we see when you look at what would be available as an antidote for that hantavirus, which is a very seldom one, which is, unfortunately, as it is seen, transmittable from human to human, or it seems to be from human to human, and that could be the Andes virus, but one has to see and double check that. There are investigational vaccines available, but they are not authorized here, and they can only be administered before something happens. So they would not be relevant now because they are not, how do you say, they are not functioning when the antivirus outbreak has already occurred. The only thing that we will reflect, discuss with member states is would we want to stockpile some of these investigational non authorized medication somewhere here in case of? But that depends on how this will develop.
But it's a very rare occurrence. The WHO has also said it's a very low risk. It is unfortunate that it happened in a very closed environment, and therefore the human to human spread probably was a little bit, we don't know. We will have to see. I can assure you that we are not only us, but also all the other commission services and ECDC and WHO have very close coordination and contact, and look at that.
But from the MCM perspective, for the moment, there are no specific needs on which we could become active. Thank you.
Adam Jarubas
Thank you so much, Missus Fink Hayer, for your very concrete professional presentation. You represent a crucial institution responsible for resilience and readiness to present and future health crisis. We learned many lessons from past experience, and we know that we need more collaboration, European Commission, institution with member states as well. As you can hear from our discussion, you can count on support from the parliament. We want to ensure enough money in the MFF for the action under your responsibility.
Thank you for being with us today.
Florika Fink-Hooijer
Thank you. Thank you for the questions, and thank you for having me.
Adam Jarubas
Thank you, dear colleagues. Any other business? None foreseen. The colleagues are closed today. Meeting. Our next Sunday meeting will take place in June.
Thank you all.
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