Committee on Budgets Ordinary meeting

10 September 2026

BUDG European Parliament

Follow its sittings
00:00 - 01:14
Speaker 2
The delegation rents a total net area of around 3,000 square meters and accommodates 56 staff, as well as seven staff of our co-locators, the European Investment Bank and DG ECHO.  The current premises are well located.  They are just outside the diplomatic area and thereby therefore nearby the EU member state embassies as well as the government ministries.  The neighborhood is part of a gated area, it's secure, it's quiet, and the buildings are in a good state.  They comply with the EU criteria. 

However, as the current lease agreements do not include a clause for further renewal, a market prospection and a negotiated procedure need to be conducted in accordance with the EU financial regulation.  And this is in order to assess if there are better options in the market.  The targeted services in the range of 2,600 and 3,100 square meters.  And given the current real estate trends in New Delhi, the new annual lease may exceed the threshold of 750,000 euro, in which case the file will be submitted for approval to the budget authority.  Thank you very much. 
01:14 - 01:18
Speaker 1
Thank you, Monsieur Chastel. 
01:18 - 01:52
Speaker 4
Oui, merci Monsieur le Président.  Donc s'agit d'un early warning, j'ai pas davantage de questions à ce stade.  Je m'interroge simplement sur le calendrier, on est le 10 septembre et le bail se termine le 6 décembre.  Alors je sais qu'il y a une option privilégiée, celle du renouvellement des baux actuels.  Mais est-ce qu'on est bien dans des délais raisonnables pour un suivi administratif correct, même de renouvellement ? 

Est-ce qu'il n'y a pas un problème de calendrier dans tout cela ? 
01:52 - 01:57
Thank you, Mrs. Freiberg. 
01:57 - 02:23
Speaker 2
Okay.  Thank you, thank you Mr. Chastel.  Yes, the EEAS acknowledges that we are late with this prior information.  However, it is, we can explain it by the fact that we did not know whether the file eventually will reach the threshold, yes or no.  So the market prospection has been done in summer and now the negotiated procedure will be, will be launched. 

So apologies for any inconvenience, but we hope it will be done in time. 
02:23 - 02:28
Speaker 5
Thank you very much. 
02:28 - 02:49
Speaker 6
Thank you.  No further comments.  The point is done.  And the final building case, that is European Chemical Agency.  This time, absolutely exceptionally, the remote presentation by Mrs. McGuinness from Helsinki, if available. 

02:49 - 02:53

Janusz Lewandowski

But it should be really, yes, please.

02:53 - 04:43

Sharon McGuinness

Thank you very much, Chair. I hadn't appreciated it was an exceptional opportunity, so thank you and also to you, the honorable members of the Budget Committee. As I said, we're here today to talk about ECHA's Building 2030 project, where our current lease here in Helsinki agreement expires in January 2030. As you know, we're the agency that implements REACH, but also an expanded portfolio of other EU chemical and environmental legislation, and we require premises that support both our day-to-day operations, but also our broader scientific bodies in their decision-making. So currently we have a premise that is composed of an office area for staff and a conference center that hosts ECHA's scientific committees.

Looking ahead, our future building needs will be assessed on the basis of both current and future tasks and evolving tasks, and including those that will come to us with the new ECHA basic regulation. We will also look at developments in relation to new ways of working and the Commission guidelines on office housing, hybrid working environment concerns, etc. This early warning notice is therefore intended to ensure we are transparent and providing you with the necessary information. We hope to start the market prospection phase in this autumn, and of course a draft building contract proposal will be submitted to the budgetary authority in Q4 2027 for your approval to allow sufficient time for scrutiny and decision-making before our current lease expires in 2030. So thank you for your attention and of course I remain available for any questions you may have.

Thank you.

04:43 - 04:45

Janusz Lewandowski

Thank you. Monsieur Chastel.

04:45 - 04:56

Olivier Chastel

Voilà Monsieur le Président, je n'ai pas d'autres questions à ce stade et je propose qu'on en reparle quand nous aurons des éléments plus concrets, c'est-à-dire courant de 2027.

04:56 - 05:43

Janusz Lewandowski

Thank you, this was so-called early warning and the last building case.

Voting time is over and thanks to Mr. Rasmussen, this was really, really very short. So we are moving to mobilization of Globalization Adjustment Funds. I think there are three cases, that is also indicating what is the climate, business climate in Europe. First case is mobilization of Globalization Adjustment Fund for displaced workers from Finland coming. And I think, yes, Mr. Andresen is to replace our rapporteur Stefano Tappia.

Please.

05:43 - 08:17

Rasmus Andresen

Yes, this I will do. The report concerns, as already outlined by the chair, the mobilization of the European Globalization Fund upon the request from Finland following displacements in the Valmet Automotive and within five subcontractors and suppliers. The downturn in the automobile industry over the last years has significantly impacted also Valmet and the situation in Finland, forcing it to cut its workforce by almost 60% since the early 2020s, leading the number of long-term unemployment in the area to the highest level in history at the end of last year.

The EGF will finance tailored measures in agreement with targeted beneficiaries, representatives, and social partners to support the reintegration in the labor market of 233 beneficiaries. In total, we are debating or discussing an amount of 410,310 euros, and they are proposed to be mobilized from the EGF, representing 60% of the total costs of the proposed actions. The measures include up- and reskilling of workers, counseling, trainings, and startup grants. The report calls on the Finnish authorities to undertake initiatives to address social disparities leading to the exclusion of workforce, such as a low level of education and age, offering them skills training to facilitate their reintegration and to strengthen their skills also regarding digitalization. It's worth mentioning that the company Valmet has signed a multi-year agreement with a national defense technology company, and there are also some other potentials of for rehiring some of the displaced workers in the region.

So hopefully the measures will be supportive with those efforts. We would, in the name of Mr. Stefanuta, I would like to also remind all members that the deadline for tabling the amendments to the draft report is Tuesday, the 15th of September at 12:00, and we encourage everyone to support the report.

08:17 - 08:26

Janusz Lewandowski

Thank you for presenting the report as for shadows. I know that Mr. Sousa Silva is to replace our shadow from EPP, please.

08:26 - 09:32

Hélder Sousa Silva

Okay, thank you chair and dear colleagues, I will take the floor on behalf of my colleague MEP Sala, and in her role as EPP shadow rapporteur, she supports the report. It is in line with the EPP priorities and it follows the typical structure of the EGF files. EGF, as you already said, aims to support displaced workers, namely in job seeking, training, and career coaching.

This fund gives the opportunity to support the displaced workers of Valmet Automotive to access training to improve their job skilling and help them with career path. MEP Sala remains at the disposal of the rapporteur and the other political groups to reach a good final agreement that facilitates the mobilization of these funds supporting the works in Finland and safeguarding the proper and responsible use. Thank you so much.

09:32 - 09:35

Janusz Lewandowski

Thank you, first and Dimosthenis Farantouris.

09:35 - 11:26

Nikolas Farantouris

Thank you, Chair. First of all, I would like to thank the rapporteur for his draft report. We fully support the proposal for the mobilization of the EGF in order to support the displaced Valmet Automotive workers. This case is another reminder that workers bear the cost of industrial restructuring and unemployment in affected regions keeps rising.

In the case of Valmet Automotive, unemployment in the region increased by nearly 15% in a single year. It is particularly concerning that 95% of the displaced workers have post-secondary education level or lower, and more than 27% are aged over 54, meaning that they would face greater barriers to re-entering the labour market. This case is added to a series of requests for the mobilisation of the EGF that are constantly increasing. This is a very strong signal that we must act. We must act to protect the industrial sector, but also to protect jobs and create new ones.

At the same time, we must keep pushing for stronger, more accessible labour market policies for workers in order to ensure full reintegration into sustainable and quality employment. For the latter, we cannot rely on the EGF mobilisation alone. The EGF is a limited, targeted and complementary mechanism that requires further action on multiple levels. Thank you.

11:26 - 11:28

Janusz Lewandowski

Thank you, Madame Pyre.

11:28 - 11:38

Angéline Furet

I ask if I can do just one intervention for the whole three files as it is all FEM, if you don't mind, President.

11:38 - 11:44

Janusz Lewandowski

Let's, let's try this experiment because they are so different, but please go on.

11:44 - 11:51

Angéline Furet

Thank you very much. I will, I will wait until the end of the three files.

11:51 - 12:23

Janusz Lewandowski

Mrs. Filipkova would like to comment or not on this case?

So, vote to take place on 28th of September. So far everybody was in favor of this case. Second case for globalization fund is unfortunately again automotive industry. This one is coming from Spain and I think again Mr. Usakovs is to replace rapporteur.

12:23 - 13:53

Nils Ušakovs

Thank you, Chair, on behalf of Sandra Gómez López. This report concerns the mobilization of the European Globalization Adjustment Fund in support of 671 workers made redundant in Galicia's automotive industry following a process which was driven by weaker European demand and significant disruptions in the trade and supply chains. Within the region, the most affected area by these redundancies was Vigo, where unemployment is close to double the EU average. The profile of the displaced workers highlights the urgency of this intervention, as eight out of ten displaced workers have a post-secondary education level or lower, while one in four is over the age of 54.

These characteristics can constitute significant barriers for re-entry into the labour market, and most importantly, this is not an isolated case. This is a similar pattern reflected also in other applications to the European Globalisation Fund. A coordinated approach with trade unions, regional authorities and social partners is essential for the mobilisation of the EGF, proposed to ensure that support is tailored to the needs of workers. On this basis, we recommend the approval of the Commission's proposal and the financial contribution of 2,725,000 euros for Spain. Thank you.

13:53 - 13:58

Janusz Lewandowski

Thank you. Yes, Mr. Silva, you have the floor.

13:58 - 15:18

Hélder Sousa Silva

Thank you, Chair. In this file, I'm replacing and speaking on behalf of MEP Benjumea, the EPP shadow rapporteur. Today we are discussing the mobilisation of European Globalisation Adjustment Fund in Spain and more specifically in the region of Galicia.

We welcome the fact that this report highlights the importance of assessing how these funds are used and their actual impact. We also welcome the specific measures to which the funding will be allocated: training and career guidance for workers, I mean many of whom are over 50, incentives, reskilling, entrepreneurship training and job search assistance. These are all important priorities for the EPP group on which we regularly table amendments and we are pleased to see that they are already included in the report. MEP Benjumea remains at the disposal of the rapporteur and the other political groups to reach a good final agreement that facilitates the mobilization of these funds for Galicia and ensures that they are used for the purposes for which they were created. Thank you so much.

15:18 - 16:00

Janusz Lewandowski

Thank you. Madame Fritzon now of S&D. Okay. Any shadow? Yeah, so now what rests for me is to recall that the deadline for amendments, as it was with previous file, is 15 September at 12:00.

We are to vote again as in the previous file on 28th of September. Final mobilization of Globalization Adjustment Fund is coming from Belgium.

And I think again we have replacement by Mr. Sousa Silva. Yeah.

16:00 - 18:09

Hélder Sousa Silva

Thank you, chair. It's the first intervention related with the same fund and, of course, dear colleagues, the supermarket chain Cora has been passing through a period of restructuring which led to a progressive downsizing and successive waves of collective redundancies affected 1,257 workers in Belgium, mainly in the region of Wallonia. Behind these numbers, there are workers and families facing uncertainty. It is on such occasions that Europe must continue to show its solidarity. Commission proposes to mobilize 3.82 million euros from the European Globalization Adjustment Fund, covering 85% of the total costs to finance targeted and personalized reintegration measures with a clear goal: to support and reintegrate these workers into the labor market as quickly as possible.

However, this fund remains a limited and complementary instrument.

It cannot be replaced the national responsibilities or substitutes competitiveness. Kora's difficulties reflect changing consumers' habit, digital transformation, rising costs, and competition from non-EU online retailers. Europe needs a business-friendly environment that promotes innovation, that reduces unnecessary regulatory burdens, and that helps companies to adapt, remaining competitive and sustaining quality jobs. Nevertheless, solidarity must therefore go hand in hand with responsibility. Effective monitoring and evaluations must ensure that funding delivers real results for workers.

For these reasons, we support this proposal and we call for its rapid, effective, and responsible implementation. Thank you very much.

18:09 - 18:30

Janusz Lewandowski

Thank you, and I'm sorry, you are a right rapporteur, you are on so many occasions today as a substitute or replacement, that is justifying my mistake, but Mr. Sousa Silva is rapporteur on this file. Mr. Farantouris would like perhaps to...

18:29 - 20:05

Nikolas Farantouris

Unfortunately our shadow Mr. Giuseppe Lupo could not be here today due to overlapping obligations but he asked me to share a few points on his behalf. Mr. Lupo would like to thank the rapporteur for their work on the EGF file. S&D we support this proposal and the more than 3 million financial contribution to the displaced retail workers in Wallonia. This case illustrates the human cost of structural retail sector changes with 1,257 workers displaced driven by e-commerce growth and unfair competition from non-EU platforms which are not operating according to the EU regulatory and production standards. It is particularly concerning that the majority of displaced workers have upper secondary education level or lower and are aged more than 54 meaning that they would face barriers to re-entering the labor market.

Sure. Thank you, Chair.

Targeted tailored support will be essential to their sustainable reintegration. We must not lose sight of the workers who are at the core of this file.

The EGF alone is not enough. We must keep pushing for stronger, more accessible labor market policies to ensure workers' full and lasting reintegration into the labor market with sustainable and quality employment conditions. Thank you.

20:05 - 20:09

Janusz Lewandowski

Thank you. Now time for Madame Furet.

20:09 - 21:21

Angéline Furet

Merci beaucoup, Monsieur le Président. Aujourd'hui, l'Union européenne joue les pompiers après avoir elle-même allumé l'incendie. Derrière ces trois dossiers, ce sont 2 200 pères et mères de famille qui se retrouvent brutalement sur le carreau en Belgique, en Finlande et en Espagne. Arrêtons le jargon et l'excuse des changements structurels. Ces gens perdent leur emploi à cause de vos décisions.

En Belgique, notre commerce de proximité se fait écraser par la concurrence déloyale des géants étrangers du net. En Finlande et en Galice, c'est toute notre industrie automobile que vous tuez à petit feu, sacrifiée sur l'autel de l'écologie punitive et du tout-électrique forcé. Nous voterons ces aides, car c'est l'argent de nos impôts et il doit servir à nos concitoyens dans la détresse. Mais notre ligne rouge est non négociable. L'enveloppe de ce fonds doit aller à 100 % dans la poche des travailleurs licenciés.

Pas un seul euro ne doit être détourné par la Commission européenne pour payer ses propres frais administratifs, financer ses petits séminaires de mise en réseau ou s'offrir des campagnes de pub. Cessez de détruire notre travail d'un côté pour nous faire la charité de l'autre. Je vous remercie.

21:21 - 21:31

Janusz Lewandowski

Thank you, this was a really horizontal remark on three cases discussed today. Mr. Geisel, yes.

21:31 - 23:21

Thomas Geisel

Thank you, Chairman, I'm going to speak German again. Ich habe in dem Zusammenhang drei Fragen an die Kommission. Es liegt erneut ein Antrag aus Belgien vor. Ich habe mir mal die Mühe gemacht zu überprüfen, welche Anträge in dieser Legislaturperiode gestellt wurden. Wenn ich es richtig recherchiert habe, waren zehn von 17 Anträgen aus Belgien.

Gibt es aus Sicht der Kommission irgendeinen Grund, weshalb Belgien so überproportional bei Anträgen aus diesem Fonds berücksichtigt wird oder Anträge stellt? Das Zweite, der Antragsteller, es geht um eine Supermarktkette. Beim Globalization Adjustment Fund geht es ja in erster Linie darum, von Entlassung betroffene Arbeitnehmer, die letztlich als Folgen der Globalisierung entlassen werden, diese Arbeitnehmer zu unterstützen.

Gibt es aus Sicht der Kommission irgendeine besondere Betroffenheit von Supermarktketten, also vom Einzelhandel mit Lebensmitteln und Dingen des täglichen Bedarfs, die im Zusammenhang mit den Folgen der Globalisierung steht? Die dritte Frage: Bei den vorgeschlagenen Maßnahmen geht's in erster Linie um Trainings- und Qualifizierungsmaßnahmen, die, so nehme ich an, von externen Dienstleistern erbracht wurden. Unmittelbar den betroffenen Arbeitnehmern kommen, wenn ich die Unterlage richtig gelesen habe, lediglich sogenannte Incentives und Allowances und gegebenenfalls Startkapital für den Einstieg in die Selbstständigkeit zur Verfügung. Hat die Kommission einmal untersucht, wie viel der Mittel des Globalization Adjustment Fund unmittelbar den betroffenen Arbeitnehmern zugutekommen und welcher Anteil der Mittel externen Dienstleistern zufließt? Vielen Dank.

23:21 - 23:31

Janusz Lewandowski

Vielen Dank. Es waren drei Fragen an die Kommission. Mrs. Lenka Filipkova ready to answer.

23:31 - 25:04

Lenka Filipkova

Thank you very much and thank you for the questions.

So indeed it is true that Belgium presented most of the cases compared to the submission from other member states. I don't think it is, or we also looked at it, it is necessarily disproportionate impact of globalization. It's just maybe the willingness and knowledge of the authorities to actually submit the request for the EGF, while other member states or other regions might simply decide to cover the costs themselves rather than go through the administration and necessarily also the delays on receiving the money. Core and globalization, I can also pass the floor to my colleagues, but I think it respects the rules and indeed the impact for the hypermarket is the fact that many people simply buy online and probably don't go so often to a hypermarket. So it is a globalization and impact of the trade patterns and trade habits of the people.

Indeed, again, the EGF measures are meant to provide training and help requalify the workers so that they can work or get self-employed.

But I don't know if it is not unemployment benefits as such. I think that are different active market measures than that, but I can also pass the floor to my colleague.

25:04 - 28:41

Speaker 22

On the first question, why there is apparently many more Belgium cases, in the past two years the number of bankruptcies in Belgium have increased heavily, and that reflect to the increase in the applications. The EGF is a support that comes on top of what is available at national or regional level. So this increase in bankruptcies has put pressure on the resources available at national level, and Belgium has increased their applications. But if we check the historical data, we see that not every time are the same Member State, but reflect impact in particular Member State. So it's not that Belgium is behaving in a different way.

Regarding the remark about that retail cannot be fully linked to globalization, I wish to recall that in the current regulation, the trigger of the fund was moved from the causes causing the displacement to the effect of such displacement. And a huge effect was considered to be reached the moment there is at least 200 redundancies. It's clear that online retailers outside of the EU are having an impact on the EU retail sector, but nevertheless, the case is eligible not because of that, that is a cause, but not the only one. As I said, the case is eligible because of the huge impact of the redundancies on the territory.

And regarding how much money should go to workers or not, I wish to recall that the let's call it shortly cash payment, that's allowances and financial incentives, are capped by the regulation at 35% of the total cost of the package. In this 35%, we include contribution to commuting cost, to pay the cost of carers of dependent persons, and also to pay hiring benefits. That means that if such payments are capped at 35%, 65% goes mainly to counseling and upskilling and reskilling. That is how the co-legislators defined a basic EGF package, and therefore the package is eligible because it's down aligned the line settled by the regulation. Thank you very much.

28:41 - 29:21

Janusz Lewandowski

Thank you, and if other comments? No. So again, amendments until 15th of September 12:00, voting of three cases on 28th of September, and this is the end of globalization cases. Final point to make the very long description short, this is about simplifying rules on medical devices and support for European Medicines Agency.

And for this we have standing rapporteur for EU agencies, Mr. Sousa Silva, please.

29:21 - 33:29

Hélder Sousa Silva

Thank you, Chair, and dear colleagues. I'm presenting today the budgetary assessment on the revision of the rules of medical devices and on the role of European Medicines Agency. The proposal is above all a simplification of the rules for medical devices and in vitro diagnostics. Most of it concerns authorization and monitoring procedures that belong to lead committee, the Committee on Public Health. And of course, I would like to congratulate the presence here of the rapporteur of this file, our colleague Oliver Schenk.

Only a small part touches the Budget Committee, and that is why this assessment is deliberately shorter and more focused than others we have seen on agencies. It covers what falls within our remit. And speaking about our remit, the budgetary picture is contained.

The estimated impact for the period 28-34 is around 42 million euros under Heading 2 and around 20 million euros under Heading 4. The agency receives 24 additional posts and the Commission's home department receives 25, financed through redeployment. We support these resources, and our first insistence is a simple one: the tasks and the resources must match now and as the file evolves. Three points guided our works. First, resources, as usual, must follow tasks.

We support the 24 posts for the agency and we note its strong recruitment performance with an occupancy rate close to 100%. It's not, I mean, usual. New tasks for agencies should be met with fresh appropriations and redeployments should stay limited and be examined with care. That applies to the Commission's posts as much as the agency's. Second, the balance between fees and the Union's contribution.

The agency's new work is financed almost entirely by the Union budget, 88.7%, while fees cover only 11.3%. We do not object to that starting point, but we do ask for clarity on it and we recommend that if the broadened mandate brings in more fee revenue, the split between the budget and the fees is revised during the annual budgetary procedure. We have also asked the Commission for fuller explanations in the financial statement itself. Third and the last one, we welcome the reductions in notified body fees for micro and small manufacturers and for orphan devices. These are reductions granted by private bodies, not by the agency, so they carry no cost for our budget and they help exactly the smaller companies this reform is meant to support.

Dear colleagues, I have shared these points with the shadow rapporteurs and I have proposed that we keep this a concise and a consensual assessment.

Given this limited budgetary scope, I believe that is the right approach and I would welcome your support for it. Let me close by thanking the secretariat and the advisories for their support throughout all this work, and I look forward to our exchange and remain available for any questions. Thank you so much.

33:29 - 33:45

Janusz Lewandowski

Thank you. As usual, interpreters asking for slowing down, but this was not, and I don't think this was the case with you, this was more the case with me. But floor is for shadow rapporteur, Mr. Oliver Schenk.

33:45 - 35:28

Oliver Schenk

Thank you very much, chair. I would like to switch to German, so please use your headphones. Liebe Kolleginnen und Kollegen, herzlichen Dank erst einmal für die Gelegenheit heute hier auch Stellung zu nehmen. Herzlicher Dank an den Kollegen Sousa Silva für Ihre Arbeit und die wirklich konstruktive Begleitung der wichtigen Überarbeitung der MDR und IVDR Regularien. Ihr Entwurf gibt uns wichtigen Rückenwind für die praktische Umsetzung dieser Reform.

Sie bewerten die vorgesehenen Mittel zum jetzigen Stand als ausreichend und unterstützen die wichtige personelle Verstärkung der EMA. Das ist für uns insgesamt ganz wichtig. Wir wollen verlässlichere Verfahren, weniger unnötige Bürokratie und einen besseren Zugang zu sicheren Medizinprodukten.

Dafür müssen auch die wissenschaftliche Unterstützung und die Koordinierung auf der europäischen Ebene funktionieren. Wir werden in der kommenden Woche in Straßburg beginnen unsere politischen Verhandlungen mit den Schattenberichterstattern, um tragfähige Kompromisse zu erarbeiten. Mein Ziel ist, die Verhandlungen zügig voranzubringen und dabei die hohen Sicherheitsstandards zu wahren. Die erfolgreiche Umsetzung dieser Reform ist eine gemeinsame Aufgabe. Ihre Arbeit leistet dazu einen ganz wichtigen Beitrag, indem sie die notwendigen finanziellen und personellen Ausstattungen in den Blick nimmt, und deshalb will ich mich dafür nochmal ganz, ganz herzlich bedanken.

Und ich bin zuversichtlich, dass wir auch mit Ihrer Unterstützung diese wichtige Reform auf den Weg bringen können, die für viele Menschen auf diesem Kontinent einen Zugang zu Innovationen, zu moderner Medizintechnik öffnet. Vielen Dank.

35:28 - 35:34

Janusz Lewandowski

Thank you, Mr. Ferantouris.

35:34 - 36:55

Nikolas Farantouris

Thank you, Chair, again, on behalf of Mr. Giuseppe Lupo, a few points on his behalf. We would like to thank the standing rapporteur for the drafting report dealing with this important decentralized agency.

The issue at stake, medical and in vitro medical devices rules, are a major pillar of public health and patient safety in Europe. We must ensure that the agency has sufficient staff and funding to execute its responsibilities in this regard. It is the long-standing position of the Parliament that new responsibilities and tasks must be accompanied by new resources. We see this will in part be achieved by redeployments, and we reiterate that this approach has its limits. We will take a close look at the rapporteur's proposed approach on fees, which is one of the central points of this report, and if needed, table amendments.

Finally, when dealing with EMA, it is worthwhile to remind ourselves that the unresolved issue of the former headquarters building in London will be a burden on the financial resources of the agency and the EU budget for years to come. Thank you.

36:55 - 37:01

Janusz Lewandowski

Thank you, Madame Furet.

37:01 - 38:11

Angéline Furet

Merci, Monsieur le Président. Sous prétexte de simplifier la réglementation en matière de santé, la Commission nous présente un dossier qui cumule deux scandales : une dérive budgétaire et une violation de la souveraineté de nos États.

D'abord le budget. L'Agence européenne des médicaments est normalement financée à 92 % par l'industrie. Pourtant, on nous réclame ici plus de 62 millions d'euros d'argent public, payés à près de 89 % par les contribuables, pour recruter 49 nouveaux bureaucrates. Ensuite la méthode. Comme vient de le dénoncer officiellement le Sénat français, ce texte est présenté sans aucune analyse d'impact.

Pire, Bruxelles profite de cette proposition pour forcer les États membres à transférer leurs bases de données nationales vers la base européenne centralisée Eudamed, en violation totale du principe de subsidiarité. Enfin, la Commission s'octroie le droit de modifier les règles essentielles par de simples actes délégués, contournant ainsi le contrôle des parlements nationaux. Faire payer le contribuable à la place de l'industrie pour mieux confisquer les prérogatives de nos nations, c'est inacceptable. Je vous remercie.

38:11 - 38:14

Janusz Lewandowski

Thank you, Mr. Geisel.

38:14 - 39:37

Thomas Geisel

Thank you, Chairman. I can speak in German again. Ich habe zwei Fragen an die Kommission und vielleicht auch an den Kollegen Schenk als Schattenberichterstatter.

Wenn ich die Unterlagen richtig verstanden habe, dient die Überarbeitung der einschlägigen Verordnung ja in erster Linie dem Bürokratieabbau. Es ist darin zu lesen, dass anwendbare Regeln vereinfacht, der administrative Aufwand verringert und die Kosteneffizienz des Zertifizierungsverfahrens erhöht werden soll. Vor dem Hintergrund vermag ich nicht ganz zu verstehen, weshalb letztlich 24 zusätzliche Stellen mit erheblichem finanziellen Aufwand zusätzlich geschaffen werden müssen. Zweite Frage: Die Zertifizierung medizinischer Geräte durch die Europäische Arzneimittelbehörde erfolgt gegen Gebühren. Nach der Unterlage können Gebühren von der Arzneimittelagentur auch erhoben werden, nicht nur von den Herstellern für die Zertifizierung, sondern sowohl von den Herstellern wie von den nationalen Gesundheitsbehörden für Beratung und Stellungnahmen dieses neu einzurichtenden Expert Panels.

Wieso plant die Kommission dann zusätzliche Kosten in Höhe von über 60 Millionen, die aus dem Haushalt zu decken sind, wenn tatsächlich praktisch sämtliche Ausgaben der Behörde auch durch Gebühren gedeckt werden könnten? Vielen Dank.

39:37 - 39:53

Janusz Lewandowski

Thank you, so we have questions and any of the rapporteurs would like to react, Sousa Silva or Mr. Schenk? No? If not, again, Mrs. Filipkova. Mr. Schenk would like to, yeah.

39:53 - 41:19

Oliver Schenk

Ja, ich wollte nur wissen, wer von uns beiden beginnt. Vielen Dank für das Interesse daran. Als Antwort auf den Kollegen Geisel der Frage der Bürokratie. Ich würde nicht sagen, dass der Abbau der Bürokratie im Vordergrund steht. Es ist ein notwendiges Mittel, damit wir bei der Zulassung insgesamt von Medizinprodukten besser werden.

Wir sehen, welche Innovationskraft diese Branche hat. Wir sehen, wie wichtig Innovation in diesem Feld ist, weil sie Therapiemöglichkeiten, Behandlungsmöglichkeiten für die Menschen verbessert. Wir sehen, wie die vorherige Regelung dazu geführt hat, dass durch ein Aufwuchs von Regeln Zulassungsverfahren behindert worden sind, dass teilweise bestimmte Verfahren in Europa gar nicht mehr zugelassen worden sind, sondern im Ausland. Und dass wir vor diesem Hintergrund auch schnellere Verfahren brauchen und auch ein Abbau von Verfahren und zu schnelleren Verfahren kommen. Diesem Ziel dient auch die Einbindung der EMA, die sehr viel Erfahrung hat bei der Zulassung von Arzneimitteln heute schon.

Diesem Ziel dient auch die Einbindung der EMA, die sehr viel Erfahrung hat bei der Zulassung von Arzneimitteln heute schon, und durch diese Konzentration auch von bestimmten Verfahren an dieser Stelle wir die Erwartung haben, dass wir auch bei dem Thema Medizinprodukte wieder zur Wettbewerbsfähigkeit zurückkehren, die wir in den letzten Jahren verloren haben.

41:19 - 41:25

Janusz Lewandowski

Thank you. Comments from Commission, please.

41:25 - 43:23

Lenka Filipkova

Yes, thank you very much. First of all, many thanks to the rapporteur for the support of the proposal and indeed the reassurance that the principle that if the agency gets more tasks, that they also should get sufficient resources. So we believe that for the task included in our proposals, the reinforcement for the agency is justified and correct. Also, we will have to see how we manage additional task within the Commission, but as proposed by redeployment. In principle, I think what we want to see, and the LFS also included assessment of the fees, but it is at this stage a forecast.

We will obviously then look at the implementation every year and then, depending on how much fees we can collect, the contribution from the budget is a balancing contribution. So if we indeed can collect more fees for this task, then indeed the impact or the contribution from the budget can decrease.

And it is unfortunately the case that the EU budget contribution also includes the cost of the building that EMA had to abandon in London after Brexit. But that we have discussed, I think, many times in this committee. And I think there was, and obviously as we will follow up also the negotiation with our colleagues that lead from DG SANTE, but if there are any evolution in the tasks or the evolution or more information on the fees, then we will be very, very happy in the process to update the legislative and financial statements, also follow the usual procedure when there are changes to the agencies and we then discuss in the trilogue before the final budgetary impact is assessed and then every year during the annual budget negotiation where you will have a say as usual. Thank you very much.

43:23 - 43:47

Janusz Lewandowski

Thank you. So far for budgetary assessment. Deadline for amendments is on 18th of September, 12:00. Voting is voting on 4th of November. This is the end of our session.

We are to resume on 28th of September, voting also these three mentioned already Globalisation Adjustment Fund cases. Thank you for your presence.

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