Committee on Public Health Ordinary meeting
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SANT European Parliament
Follow its sittingsAdam Jarubas
Adopted, congratulations. Dear colleagues, the SANT committee has hereby approved the outcome of the interinstitutional negotiations on the Critical Medicines Act. Thank you so much. Dear colleagues, let's now move to the next point of today's meeting which is the consideration of the draft opinion on general budget of the European Union for the financial year 2027, all sections.
I will give the floor first to the rapporteur for his presentation of the draft opinion, then to the shadow rapporteurs and finally to any members who wish to take the floor based on catch the eye. If you want to take the floor, raise your hand so that the secretariat and then I can take note. Mr. Hadjipantela, you have the floor for four minutes, please.
Michalis Hadjipantela
Thank you, chair, colleagues, allow me to present the key messages of this draft opinion for the 2027 European Union budget. When preparing the report, my central objective was clear: we must focus the 2027 budget on European Union added value in public health. That means strengthening health security, tackling cancer and mental health, advancing digital health, securing critical medicines, fighting antimicrobial resistance, tackling rare diseases and investing in prevention and innovation. The report calls for public health to be treated as a priority for the Union's strategic autonomy, security and competitiveness. Underserved regions should be served better, while investment is needed for cross-border tools and better patient mobility.
Our external health spending should support preparedness, surveillance and resilient health systems in partner countries. It should help ensure access to essential medicines and vaccines, prevent cross-border health threats and reflect our humanitarian responsibilities. We also call for funding to treat patients from conflict zones on Union territory. We express concern that in the draft budget, EU4Health commitments fall from 687.9 million euro in 2026 to 635.3 million in 2027, a reduction of about 7.6%. This remains below what is needed to meet growing public health needs and demographic pressures.
We therefore call for an increase in the EU4Health allocation. The report calls for dedicated and adequately resourced EU4Health actions for critical medicines and medical devices, including manufacturing diversification, collaborative joint procurement and greater transparency on supply chains and stock levels. Another key point is the health workforce.
The report calls for stronger coordination between European Union for health, the European Union Social Fund Plus, and cohesion funding to train, upskill, and retain health professionals. On spending, we insist on clear performance indicators, transparency, and avoiding duplication between programs. The opinion highlights the need to address mental health and neurological disorders, antimicrobial resistance, and major non-communicable diseases such as cardiovascular disease, diabetes, obesity, chronic kidney disease, liver disease, rare diseases, and cancers. Very importantly, it advocates a life-course approach that supports citizens, including those on the autism spectrum, from childhood to adulthood. The report stresses that combating antimicrobial resistance requires dedicated funding for research into new antimicrobials, diagnostics, and alternatives, as well as strong infection prevention and control measures.
It calls for investment in data sharing on hospital infections to tackle this threat. The report welcomes the strengthening and adequate resourcing of the European Reference Networks for rare and complex diseases.
In a matter very close to my heart, it supports the establishment of a dedicated European Union structure, such as a European agency or center for rare diseases, to bring together research, screening, data, best practices, and treatment. This can make a real difference for patients and families living with the uncertainty of a rare disease. Finally, the opinion welcomes increased contributions to the European Centre for Disease Prevention and Control and the European Medicines Agency, while insisting that resources must match their expanded tasks. It also underlines the importance of adequate funding for the Union Civil Protection Mechanism, including rescEU, for medical evacuation, emergency stockpiles, and preparedness, with close coordination between UCPM, HERA, European Union for Health, and national authorities. Taken together, this report is a call for a more strategic and more equitable European Union health budget in 2027.
A budget that protects our citizens, supports our health workforce, and reinforces the Union's health security at home and abroad. I look forward to negotiations and to colleagues' input so that we can present a robust and complete opinion on the 2027 budget that reflects our committee's priorities.
Thank you very much.
Adam Jarubas
Thank you, Mihail. Now I open the floor to MEP Mr. Negrescu as a first, please.
Victor Negrescu
Thank you, Chair. So first of all, I would like to thank our rapporteur, Mr. Hajipandela, for his work and constructive cooperation. I believe we all have to agree on one fundamental point, that health must remain a genuine European priority. But if that is our political commitment, it is also has to be reflected in the 2027 EU budget. Our main concern is the EU4Health programme.
The issue is not only the level of payments, but above all the level of commitments, because commitments determine our capacity to finance new health actions in the years ahead. The draft budget reduces EU4Health commitments from 661 million euros in 2026 to 606 million euros in 2027, a cut of more than 8%. At a time when Europe is facing growing health challenges, it sends the wrong signal.
This is why we will table amendments to reinforce EU4Health and ensure that our financial decisions are consistent with our political priorities. We'll also propose strengthening support for health civil society organizations, in particular patient organizations. Their operating grants represent only a small share of the program, but they have an enormous impact on prevention, awareness, patient representation, and better access to healthcare. In addition, we'll table amendments reflecting key priorities supported by the Public Health Committee with regards to prevention, reducing health inequalities, strengthening the health workforce, primary care, rural, mountain, and underserved areas, mental health, rare diseases, cancer, cardiovascular health, critical medicines, HERA preparedness, and medical countermeasures. Europe cannot claim that health is a strategic priority while reducing the resources that will finance future action.
I look forward to working with everyone involved to deliver a stronger and more ambitious 2027 EU budget for health. Thank you.
Marie-Luce Brasier-Clain
Merci, Monsieur le Président. Merci au rapporteur. Quand on est confronté à une baisse de budget, il faut faire des choix, quitte à remettre en question certains fondamentaux.
C'est justement ce que la Commission a commencé à faire en recentrant les aides internationales sur les intérêts européens et en privilégiant les investissements privés à la place des dons traditionnels. C'est également une façon de responsabiliser les pays bénéficiaires pour qu'ils ne dépendent plus de fonds étrangers. La baisse dans le budget alloué au programme EU4Health est un bon exemple. Elle intervient dans un contexte de réduction générale des ressources et de la nécessité de mieux les orienter, quitte à opérer des coupes dans le domaine international, dont le financement des ONG ou dans les coûts de fonctionnement de la structure européenne. C'est la raison pour laquelle la création d'une énième agence telle que proposée par le rapporteur va à l'encontre des objectifs recherchés.
Nos priorités doivent se porter sur notre jeunesse et les intérêts européens, en mobilisant des fonds suffisamment importants pour répondre à l'urgence des problèmes de santé mentale, et cela rejoint notre discussion d'hier sur le coût de l'inaction sur ce point, et en mettant l'accent sur la transformation de la recherche et de l'innovation où l'Union dispose d'une avance réelle en force industrielle. Et pour cela, il vaut mieux coordonner les instruments existants et alléger les charges qui pèsent sur nos entreprises.
Andreas Glück
Dear colleagues, Chair, these are not my words. I read this on behalf of my Renew colleague Vlad Voiculescu. And by the way, I try to do it without reading glasses, so I hope it works out. Dear colleagues, I would like to thank the rapporteur for the constructive work on this draft opinion. It provides a solid basis for our negotiations.
We are at an important moment for the European Health Union. As we discuss the 2027 budget, we must acknowledge a worrying reality. The proposed 7.6% reduction in EU4Health commitments, following the cut of almost 1 billion in 2024, the program simply cannot withstand further reductions without affecting its capacity to deliver. My amendments aim to strengthen the report in four key areas.
First, they reinforce our public health priorities by ensuring greater attention to rare diseases, sexual and reproductive health, and women's health, while recognizing public health as a strategic investment in Europe's resilience, autonomy, and competitiveness. Second, they respond to the health workforce crisis by calling for stronger coordination between EU4Health, ESF+, and cohesion funding to train, attract, and retain health professionals, particularly in underserved regions. They also reinforce support for cross-border healthcare and the full implementation of the European Health Data Space, so that patients can access specialized care wherever it is available in the Union. Third, they seek to ensure continuity for successful EU health initiatives. As 2027 marks the final year of EU4Health as a standalone program, we cannot allow funding gaps for key initiatives such as the European Reference Network or the cancer networks established through Joint Action and EUnetCCC.
Finally, I propose to ensure predictable funding for medical evacuations under the Union Civil Protection Mechanism, so that patients, including those from conflict-affected areas, can continue to receive timely treatment. Our budget should reflect the ambitions we have collectively set for the European Health Union. I look forward to working with all of you to secure an ambitious outcome in the negotiations.
Vytenis Povilas Andriukaitis
Dėkoju, pirmininke, aš kalbėsiu lietuviškai. Kolegos, aš dėkoju pranešėjui ir šešėliniams pranešėjams ir puikiai suprantu, kad situacija yra sudėtinga. Ir šis, kaip sakyt, dabar svarstomas 2025-ųjų metų biudžeto biudžeto projektas akivaizdžiai siunčia labai neteisingą signalą šalims narėms. Mes sutinkame su lėšų mažinimu. Čia gerbiamas Viktoras Negrescu labai teisingai pasakė, išvardijo labai tiksliai, kokios yra didelės problemos mažinant EU4Health programą ir ypač taip pat skriaudžiant nevyriausybinį europinį sektorių, kuris neteks galimybės gauti grantų.
Bet bendrai signalas yra štai: šalys narės, žiūrėkit, net Europos lygyje, jeigu yra iššūkiai, tai galima nukirpti lėšas sveikatos apsaugai. Čia yra signalas.
Čia yra aukščiausio lygio politinis signalas šalims narėms. Aš manau, kad mes turim suburt koaliciją ir pasipriešinti šitam ir jokiu būdu pasakyt labai aiškiai: tai ne kelias. Sveikatos investicijos yra strateginės investicijos, yra investicijos į žmogiškąjį kapitalą, į Europos konkurencingumą ir taip toliau. Tai ne kelias, mes turim pasipriešinti labai aiškiai visi kartu, padaryti bendrą visų pagrindinių koalicijų poziciją, kad sutikt su mažinimu šiemet nebegalime.
Valentina Palmisano
Thank you, chair, I will speak Italian. Innanzitutto vorrei ringraziare il relatore per aver tracciato in questo testo preliminare una panoramica che individua molte delle sfide cruciali per la resilienza sanitaria europea. Anche perché il dibattito del 2027 sul bilancio 2027 ci offre l'opportunità concreta di tradurre quelle che sono le nostre priorità in risorse finanziarie concrete per i prossimi anni.
E quindi passo subito, diciamo, ai punti che per noi sono critici, ripercorrendo quello che avete avete anche anticipato voi, ovvero ci troviamo di fronte a una proposta di bilancio il cui programma EU4Health, per noi fondamentale, subisce una riduzione di quasi l'8% rispetto all'anno precedente. Quindi per noi si tratta di qualcosa di assolutamente, diciamo, grave, soprattutto in questo contesto che stiamo vivendo, in cui rischiamo in questo modo di depotenziare delle riforme fondamentali quali, ad esempio, il Critical Medicine Act o il pacchetto farmaceutico. Facendo cosa? Lasciando poi l'Unione Europea vulnerabile rispetto a, diciamo, la carenza di medicinali critici, una dipendenza dalle catene di approvvigionamento. E noi sappiamo in quale contesto geopolitico precario e critico stiamo vivendo, in cui bisogna puntare non soltanto sulla, come dire, sulla difesa militare dei nostri confini, ma soprattutto sulla difesa della tenuta sociale e sanitaria dei nostri cittadini all'interno dei confini dei confini europei.
Un altro punto centrale che voglio a cui voglio accennare, secondo noi sarà essenziale inserire nel testo un argine politico contro la privatizzazione progressiva dei sistemi sanitari nazionali.
Noi vogliamo che il bilancio europeo riaffermi il principio secondo cui la salute deve essere promossa come un diritto fondamentale e un bene comune, escludendo ogni fine speculativo e logiche pure di mercato. Un'ultima, diciamo, anche un ultimo accenno lo voglio fare al fatto che secondo noi è fondamentale utilizzare il bilancio per stimolare un miglioramento delle, diciamo, delle condizioni strutturali, delle condizioni di lavoro, della stabilità contrattuale, degli adeguamenti salariali dei nostri medici e operatori sanitari che si trovano molto spesso a dover intervenire con, diciamo, scarsi strumenti e con condizioni di lavoro molto precarie, soprattutto nelle aree svantaggiate del nostro, del nostro Paese. Quindi io ritengo che queste siano le nostre priorità e lavoreremo insieme per rafforzare questa proposta. Grazie.
Gerald Hauser
Danke, Herr Vorsitzender. Ich höre heute laufend von allen Rednern: Wir müssen, wir müssen, wir müssen. Wissen Sie, was wir müssen? Wir müssen schauen, dass das viele Geld, das auch hier in der Europäischen Union zur Verfügung steht, endlich dort ankommt, wo es ankommen muss, nämlich beim Patienten.
Wenn Sie heute klagen, dass das Programm EU4Health reduziert wird, 635 Millionen Euro stehen für das Jahr 2027 zur Verfügung. Das ist zwar eine Reduktion von 7,6 Prozent, aber wenn man schaut, wenn man schaut, was man sinnvoll mit diesem Geld machen kann, ist das unglaublich viel Geld. Das heißt, dieses Geld muss effizient eingesetzt werden. Und das Geld muss endlich dafür verwendet werden, dass es beim Patienten ankommt. Ich habe die Diskussion über NGOs satt.
Entschuldigung, es geht nicht um NGOs. Es geht im Gesundheitswesen geht's um Patienten. Es geht um Menschen, wo das Geld ankommen muss. Und wir haben massive Probleme. Wir haben also zwei, drei große Probleme.
Das erste große Problem ist, es fehlen Mitarbeiter im Gesundheitsbereich. Sie kennen die Zahl, ich kann sie nicht genügend oft wiederholen, die hier erwähnt wurde: Bis 2030 fehlen 4,2 Millionen Mitarbeiter, Ärzte, Hebammen etc., Gesundheitspersonal. Und zweitens: Das öffentliche Gesundheitswesen innerhalb der Europäischen Union, einmal besser, einmal schlechter, wird grosso modo immer schlechter. Das heißt, dass Patienten, die auf das öffentliche Gesundheitswesen angewiesen sind, kaum Termine bekommen, lange Wartezeiten haben für Termine, die öffentlichen Kassen immer mehr Leistungen reduzieren. Das heißt, immer mehr muss auch privat finanziert werden.
Das sind doch die Probleme. Und wie wollen wir diese Probleme lösen? Sie sagen immer Digitalisierung. Aber die Menschen, der Patient möchte mit Ärzten zu tun haben, ja. Die Digitalisierung kann ja nicht des Rätsels Lösung sein.
Und wenn wir jetzt 16 Milliarden Euro bis 2027 in die Digitalisierung investieren, frage ich mich, was soll denn unterm Strich rauskommen? Das heißt, man ruft eine Nummer an, in Österreich 1450, und man weiß nicht einmal, wen man auf der anderen Leitung hat. Das heißt, mit wem spreche ich überhaupt? Und diese Person soll mir im Krankheitsfall Auskunft über meine Krankheit geben. Das ist doch eine Entmenschlichung des Gesundheitswesens.
Und diese Debatte haben wir hier zu führen, nicht das permanente Lamentieren über Kürzungen. Entschuldigung, 635 Millionen Euro, das ist so ein Haufen Geld, dass sich der Bürger da draußen gar nicht vorstellen kann, was das ist. Also mit dem Geld wüsste ich, was ich machen würde. Ich würde nicht lamentieren, würde sagen: brutal viel Geld, mit dem Geld komme ich aus und schau mal, was ich mit dem Geld sinnvoll aufführen kann.
Ondřej Dostál
Thanks, Chairman. I will speak Czech. Dámy a pánové, pokud mluvíme s voliči o tom, co z evropské politiky dává smysl, tak koordinace zdravotních systémů je jedna z mála věcí, na které všichni dávají palec nahoru. Připojuji se tedy k volání mých kolegů, aby se zde neškrtalo, aby se naopak podpořily investice do konkrétních projektů přinášejících přímý prospěch pacientům. Konkrétně Critical Medicines Act, který jsme teď hlasovali, bez přímých investic prostě nebude fungovat, protože nemůže.
Stejně tak měli jsme několik skandálů s nebezpečnými potravinami či zdravotnickými prostředky. I zde musí orgány fungovat rychleji a to vyžaduje peníze, konkrétně skandál s toxiny v kontaminované kojenecké výživě. Proto prosím zde neškrtejme. Prostoru, kde lze škrtat v evropském rozpočtu, je jinde mnohem více. Děkuji.
Ignazio Roberto Marino
Thank you, Mr. Chair. And I would like to thank the rapporteur for this really important work, because the 2027 budget should reflect the health challenges that Europe is facing today, not those of the past. Public health must remain a strategic priority of the Union and our financial commitment should match the responsibilities we continue to assign at European level. One of our priorities should be to reduce health inequalities. Equal access to high-quality healthcare is still far from being a reality across the 27 state members.
This concerns not only our geographical disparities, but also persistent inequalities linked to gender, age, socioeconomic conditions. Addressing the gender health gap and improving support for chronic disease, particularly in aging population, should therefore become an integral part of our health investment. We are aging as a continent and we need a lot of attention to people with chronic disease, particularly older people.
I think finally resilience depends on people. We need to invest in the health workforce, strengthen primary care, mental health services and ensure that rural, remote and underserved regions are not felt left behind. I just heard the passionate speech stressing the importance of the physicians, nurses in our continent and I think that is also a very important point because I myself don't want to call a number and have an artificial intelligence answer to my to my healthcare problems. So I think and and this is an issue in all the 27 state members, we do not have enough physician and nurses. Thank you very much.
Adam Jarubas
Thank you, Ignazio, and now I'd like to ask the rapporteur for his final remarks, please.
Michalis Hadjipantela
I would like to thank all the colleagues for their comments. We are looking forward in in receiving all the the amendments. I think the deadline is tomorrow and then we will coordinate like we do always. I don't think health there is a we are united in all health issues in this Parliament and I hope by being united we can do a good report with all of us together in order to get a good support. But I took notice of all the comments and they will be taken most of them if we can in our report.
Adam Jarubas
Thank you, Michael, thank you for this discussion. I announce now the deadline for tabling amendments that is set to 15 July at 11:00. This is like you said very short term but we are determined by budget procedure. Thank you so much. Now I'd like to ask my colleague Romana Jerković for replacing me please.
Thank you.
Romana Jerković
Thank you. Dear colleagues, our next point is the consideration of the highly anticipated draft report on the medical devices regulation. And of course, this is a vital sector to healthcare delivery and it's an important player in both European and global economy, which will strengthen the competitiveness in the medical technology. After the rapporteur, just to recall the structure of our discussion, after the rapporteur, I will give the floor to the SANT shadow rapporteurs and the rapporteurs for the opinion-giving committees, IMCO and BUDG. This will be followed by, as usually, catch-the-eye session.
If you want to take the floor, then just please raise your hand so that the secretariat and I can take a note. The Commission will be invited to take the floor at the end before the closing remarks by the rapporteur. So, Mr. Schenk, you have the floor for four minutes to present your draft report.
Oliver Schenk
Thank you very much, Chair. I would like to switch to German. Und darf Sie ganz herzlich begrüßen, liebe Kolleginnen, Kollegen, und meine Berichterstattung zu der Medical Device Regulation Ihnen mitgeben und will damit beginnen, dass die europäische Medizintechnik zu den innovativsten Branchen der Welt gehört. Etwa alle 30 Minuten, eine wie ich finde unglaubliche Zahl, wird in Europa ein neues Patent im Bereich der Medizintechnik angemeldet. Hinter jeder dieser Innovationen steht die Hoffnung auf eine bessere Diagnose, eine wirksamere Therapie und eine höhere Lebensqualität für Millionen Patientinnen und Patienten in Europa und weltweit.
Und die beste Patientensicherheit entsteht, wenn hohe Sicherheitsstandards und medizinischer Fortschritt zusammenkommen. Innovation schafft Sicherheit. Sie verbessert die Versorgung, eröffnet neue Behandlungsmöglichkeiten und gibt Menschen die Chance auf ein längeres und gesünderes Leben. Deshalb war es richtig, dass die Kommission die Revision der MDR und der IVDR auf den Weg gebracht hat.
Der Vorschlag geht aus meiner Sicht in die richtige Richtung. Mein Bericht baut darauf auf und entwickelt diesen Ansatz weiter. Er soll die Regulierung verbindlicher, risikobasierter und innovationsfreundlicher machen und der europäischen Medizintechnik zugleich wieder eine verlässliche wirtschaftliche Perspektive eröffnen, ohne Abstriche bei der Patientensicherheit. Denn wir sprechen nicht über eine Nischenbranche. Wir sprechen über rund 500.000 Medizinprodukte in Europa, fast 40.000 Unternehmen, die allermeisten KMUs, und eine Million Beschäftigte und ein Marktvolumen von 170 Milliarden Euro.
Das ist das, was die Luft- und Raumfahrt in Europa auch umsetzt. Die Medizintechnik ist eine tragende Säule unserer Gesundheitsversorgung, unserer Innovationskraft und unserer Wettbewerbsfähigkeit. Deshalb tragen wir eine doppelte Verantwortung gegenüber den Patientinnen und Patienten, die auf sichere und innovative Medizinprodukte angewiesen sind, und gegenüber den vielen Unternehmen und Beschäftigten, die diese Innovation erst möglich machen. Beides gehört in einem solchen Fall untrennbar zusammen. Mein Bericht folgt einem einfachen Grundsatz: Gute Regulierung ermöglicht Innovation und stärkt damit die Patientensicherheit.
Deshalb schlage ich sechs zentrale Reformschwerpunkte vor. Erstens: schnellere und besser planbare Verfahren mit verbindlichen Fristen.
Nur so entsteht aus unverbindlichen Vorgaben Kontrolle, Verlässlichkeit für die Antragsteller. Zweitens: Ein konsequent risikobasierter Regulierungsansatz, damit Prüfkapazitäten dort eingesetzt werden, wo sie den größten Nutzen für die Patientensicherheit bringen. Drittens: Bessere Lösungen für Breakthrough-, Orphan- und Nischenprodukte, damit gerade kleine Patientengruppen nicht zu den Verlierern unseres Regulierungssystems werden. Viertens: Weniger unnötige Bürokratie und weniger Doppelprüfungen, damit sich benannte Stellen auf ihre eigentliche Aufgabe konzentrieren können: die Sicherheitsbewertung. Fünftens: Eine gezielte Unterstützung kleiner und mittlerer Unternehmen.
Ich habe es gesagt, die meisten Unternehmen in dieser so innovativen Branche sind KMUs. Sie sind das Rückgrat der europäischen Medizintechnik und sind der Ausgangspunkt für dieses starke europäische Cluster und Ökosystem und bringen Innovation in das Gesamtsystem. Und sechstens: Wir brauchen eine sektorspezifische und effiziente Regulierung KI-gestützter Medizinprodukte. Wir sollten unnötige Doppelprüfungen zwischen AI Act und MDR vermeiden und zu einem integrierten Bewertungsverfahren kommen, ohne Abstriche bei Transparenz, klinischer Evidenz oder Sicherheit. Für mich gibt es dabei eine klare Grenze: Wo Bürokratie keinen zusätzlichen Sicherheitsgewinn schafft, sollten wir sie abbauen.
Wo Sicherheit, klinische Evidenz und Patientenrechte betroffen sind, darf es keine Kompromisse geben.
Ich verstehe diesen Bericht als eine Einladung zur Zusammenarbeit. Wir haben jetzt die Chance, eine Regulierung zu schaffen, die schneller, präziser und innovationsfreundlicher ist und zugleich den weltweit höchsten Anspruch an die Patientensicherheit wahrt. Wenn uns diese Balance gelingt, stärken wir Europas Wettbewerbsfähigkeit, sichern hochwertige Arbeitsplätze und sorgen vor allem dafür, dass Patientinnen und Patienten schneller von medizinischem Fortschritt profitieren. Ich freue mich auf die Zusammenarbeit mit Ihnen und auf die parlamentarische Debatte und danke allen, die den bisherigen Weg so konstruktiv mit unterstützt haben. Vielen Dank.
Romana Jerković
Thank you, colleague. The next is S&D Group. I will give the floor to Tiemo Wölken. You have the floor for two minutes maximum. Thank you, please.
Tiemo Wölken
Let's see. Dear Romana, thank you very much. Dear Oliver, thank you. I'll also speak in German. Ich möchte mich zunächst bedanken für den Berichtsentwurf.
Ich finde besonders wichtig ist die Klarstellung, dass Vereinfachung niemals zu Lasten der Patientensicherheit gehen darf.
Und in diesem Sinne unterstütze ich die Bemühungen des Berichterstatters für mehr Rechtssicherheit zu sorgen und die bestehenden Regelungen zur Herstellerhaftung sowie zur finanziellen Absicherung beizubehalten. Ich finde es ist auch positiv, dass die Implantatkarte wieder eingeführt wird, auch für etablierte Technologien, denn Patientinnen und Patienten sollten jederzeit Zugang zu den wesentlichen Informationen über Implantate in ihrem Körper oder Medizinprodukte in ihrem Körper haben können. Ich bin aber der Auffassung, dass wir noch weiter gehen können und müssen, um die Ziele der Verordnung zu erreichen. Das gilt zum Beispiel für die klinische Evidenz, insbesondere den Einsatz des Äquivalenzprinzips bei innovativen Breakthrough-Produkten. Ich denke, dass diese Produkte oft einen ungedeckten medizinischen Bedarf adressieren, ja, aber es liegt eben gerade deswegen nur häufig eine begrenzte Anzahl klinischer Daten vor und deswegen sollten wir bei der Äquivalenz da sehr vorsichtig sein und gucken, ob das angemessen ist.
Die weitgehende Abschaffung des Rezertifizierungsverfahrens sehe ich hingegen grundsätzlich positiv. Wir müssen hier klar risikobasiert abstufen, das wäre mein Ansatz. Neue innovative Produkte, für die nur begrenzte Langzeitdaten vorliegen, sollten nach ihrer Markteinführung enger überwacht werden. Ein etabliertes Produkt, das schon Jahrzehnte auf dem Markt ist und ohne Probleme benutzt wird, braucht weniger Marktüberwachung und so können wir wirklich unnötige Bürokratie abbauen, ohne Patientinnen zu gefährden.
Ein Punkt, den du auch angesprochen hast und der glaube ich noch sehr intensiver Diskussion bedarf, ist die Rolle von künstlicher Intelligenz, von KI. Mit dem AI Act haben wir ein Gesetz, das KI auch in Medizinprodukten reguliert. Und hier möchte ich ganz klar sagen, der Kommissionsansatz, KI in Medizinprodukten separat zu regulieren, reicht nicht aus. Im bisherigen Text werden jegliche Schutzstandards auf einen undefinierten delegierten Rechtsakt ausgelagert, mit potenziell gravierenden Folgen für die Patientinnensicherheit. Und das ist mit uns, mit mir nicht zu machen.
Für mich sind die Regeln des AI Acts der Mindeststandards, an denen sich auch KI im Medizinprodukt messen lassen muss. Und jetzt komme ich zum Ende, um es noch einmal ganz klar zu sagen. Einerseits möchte ich auch prüfen, wie wir Meldungen von Unsicherheitsbedenken von Gesundheitsfachkräften und Patientinnen besser berücksichtigen können. Aber am Ende steht für mich die Patientinnensicherheit immer an erster Stelle. Und dieses Leitprinzip wird meine Änderungsanträge prägen.
Vereinfachungen dürfen niemals zu Lasten der Patientinnen gehen. Und ich glaube, am Ende werden wir uns darauf gut einigen können. Ich freue mich jedenfalls auf die Zusammenarbeit und auf den regen Austausch.
Romana Jerković
Thank you, Timo. The next is Renew and I'm giving the floor to Andreas Glück. You have two minutes. Thank you.
Andreas Glück
I still work a couple of hours in a hospital as a trained surgeon every week. And I see it as my personal mission to bring those two worlds together: the world of medical device regulation and medical devices in the real world. And there are things which are bothering me. In recent years, we could see a disappearance of a lot of medical devices due to our regulation. They are gone from the European market.
Thank you, chair.
And what was meant as a contribution to patient safety turned into the opposite. It is like a screw. When you turn it, it's getting tighter and tighter until this one moment when you overdo it, then suddenly the screw holds nothing. Same with this legislation here. We went too tight with the screw and now it doesn't hold anything.
Therefore, there is the urgent need for a revision. The Commission came up with a very good proposal, and I don't only say that because you are sitting in my back right now. You really came up with a good proposal. And Oliver, I believe that your proposal, your draft report, made something good even better. You gave a lot of good input, like the abolition for the five, for the fixed five-year certificate expiry or the classification rule 11.
But we should try something now better, even better, something good even better.
Therefore, I want to go for further improvement. So for example, Article 17, when it comes to single use, it is still additional, there is still the need for additional justification for single use in a hospital. So now I'm working in a small hospital and I know the struggle. If you go for reprocessing, if you go for sterilization of medical devices, the criteria, they are so high. So at the end of the day, it is a, it can be a good decision from a small hospital to go to single use devices.
And they need to have the choice whether they want to buy single use or if they want to go for multi-use articles. Other thing is when it comes to Article 10, when it comes to supply shortages, I believe we should channel the information to Eudamed and we should not go for any further parallel structure. Dear colleagues, this discussion is also about Europe's role in the world. Now we have the chance to go for a good regulation for innovation. This is our purpose, this should be our mission.
Thank you.
Romana Jerković
Thank you. I invite now, on behalf of PFE, colleague Klon.
Please, you have the floor two minutes.
Marie-Luce Brasier-Clain
Madame la Présidente, chers collègues, je remplace Laurent Castillo qui ne peut pas être des nôtres. Notre fête nationale française et les commémorations du terrible attentat de Nice expliquent son absence. Sur les dispositifs médicaux, la proposition de la Commission était attendue, charge à notre Parlement et au Conseil de conclure rapidement ces négociations. Nous avons déjà perdu assez de temps. Ma devise a toujours été la même : garantir la sécurité des patients sans imposer aux fabricants des contraintes disproportionnées par rapport aux risques réels.
C'est le sens des amendements que je propose. Avec davantage de dialogue entre fabricants et organismes notifiés, une meilleure harmonisation et une plus grande visibilité sur les délais lorsqu'un doute existe sur la classification d'un produit. Les dispositifs médicaux sont par nature à usage unique, contrairement à ce qu'affirme la proposition de la Commission. En cas de modification d'un dispositif médical, je veux que les données déjà fournies ne soient plus redemandées, que des données autres que cliniques puissent être fournies pour un dispositif médical fondé sur une technologie éprouvée.
Et enfin, que seules les modifications véritablement majeures, susceptibles d'affecter la sécurité ou les performances d'un dispositif, justifient une nouvelle intervention de l'organisme notifié. Mon objectif est clair : concentrer les contrôles là où ils sont nécessaires et désengorger les organismes notifiés. Dans le cadre des audits et évaluations de surveillance, en l'absence de changement important, un dispositif pourrait être contrôlé tous les trois ans s'il y a absence de risque avéré ou d'alerte, notamment par les patients. Enfin, nous assumons vouloir être compétitifs avec une préférence européenne concrète qui permet une réduction de la redevance selon certains critères ou encore des procédures accélérées et de protection réglementaire pour les dispositifs de rupture, orphelins ou pédiatriques. Face aux pénuries ou aux urgences sanitaires, les dérogations doivent pouvoir concerner une catégorie entière de dispositifs afin de garantir la continuité des soins.
Les patients auront accès à la carte d'identité de chaque dispositif médical dans toutes les langues de l'Union.
Notre ligne est claire : moins de bureaucratie inutile, une réglementation proportionnée au risque, davantage d'innovation et de production en Europe au service de nos entreprises et de nos patients.
Romana Jerković
Thank you, colleague Brglez-Klang. And now I'm giving the floor to Ignazio Marino. You have the floor for two minutes.
Ignazio Roberto Marino
Thank you, Madam Chair. As a surgeon, I always consider medical devices as an integral part of patient care. They are not simply products placed on the market, they are instruments on which diagnosis, treatment, and very often patient lives depend. This is why the revision we are discussing today deserves careful consideration. I fully support the objective of making the regulatory framework more efficient and better able to respond to scientific and technological progress.
But greater efficiency should never mean lowering the level of protection the patients rightly expect. For high-risk and implantable devices, robust clinical evidence must remain the foundation of the regulatory framework. Clinical investigation should continue to be the standard because they provide the strongest guarantee of safety and performance. When we authorize a device that may remain in a patient's body for many years, the level of evidence matters. It matters for clinicians and, above all, it matters for our patients.
The same balanced approach should guide us in the use of artificial intelligence. Artificial intelligence is already transforming healthcare and offers extraordinary opportunities to improve diagnosis and clinical practice. But medicine is not only about processing data. Clinical judgment, ethical responsibility, and the relationship between the physician and the patient cannot be delegated to an algorithm. Ultimately, this revision is not about choosing between innovation and patient safety.
Europe has both the responsibility and the opportunity to deliver a regulatory framework that promotes scientific progress while maintaining the highest standards of protection. As legislators, this is the balance we should strive to achieve. Thank you, Madam Chair.
Romana Jerković
Thank you, colleague Marino. And now, on behalf of the Left, I give the floor to Valentina Palmisano.
Valentina Palmisano
Thank you. Thank you, Chair. I will speak Italian. Grazie. Innanzitutto voglio ringraziare il relatore per il lavoro svolto.
Siamo convinti che sia necessario semplificare la burocrazia sull'immissione in mercato e sull'uso dei dispositivi medici e che questo sia essenziale soprattutto per le nostre piccole imprese. Però snellire le carte, come avete detto giustamente voi, non deve mai significare abbassare la guardia sulla sicurezza dei pazienti.
Quindi io mi soffermerò in sintesi su due dei punti per noi critici sui quali intendiamo intervenire. Il primo riguarda la frequenza dei controlli, cioè il relatore propone di allungare i tempi delle verifiche sugli organismi di controllo portandoli a cinque anni. Noi riteniamo che specialmente per i dispositivi medici ad alto rischio, se semplifichiamo le procedure ex ante, quindi dell'immissione in mercato, almeno dobbiamo mantenere il controllo ex post almeno per cinque anni. Il secondo punto riguarda il bilancio della sanità pubblica, nel senso che la riforma introduce sconti sulle tariffe di certificazione, forti semplificazioni delle aziende, va bene. Noi crediamo però che questo risparmio debba però debba tradursi in un vantaggio collettivo secondo un principio di condizionalità sociale.
Mi spiego, cioè se le istituzioni, quindi noi, abbassiamo i costi, alleggeriamo i costi per le industrie, tutti questi, diciamo, benefici che noi introduciamo devono tornare alla collettività, ai cittadini, come direttamente, diciamo, attraverso prezzi di acquisto più bassi per i nostri sistemi sanitari nazionali.
Quindi noi riteniamo che questi siano due punti fondamentali. Concludo quindi dicendo che confido nel fatto che il testo finale potrà interpretare al meglio questa, diciamo, correlazione e quindi questo, diciamo, bilanciamento tra le esigenze del settore produttivo e i diritti fondamentali dei pazienti. Grazie.
Romana Jerković
Thank you, colleague Palmisano. And now I will give the floor to Maria Guzenina, the rapporteur for the opinion of IMCO committee. Maria, you have the floor for two minutes.
Maria Guzenina
Thank you, dear chair. From the IMCO perspective, this file is very simple for me: making sure patients have access to safe medical devices without creating unnecessary obstacles for the companies that develop them. I have four points. Firstly, about the AI medical devices, we should not fragment the AI Act, and the way it is proposed at the moment is going to cause unnecessary duplicated rules, uncertainty for the companies, for the patients.
So we should keep medical devices in the AI Act itself. Then secondly, patient safety, I support the initial validity period of five years, but after that, after that possibility of unlimited validity if there has been a successful reassessment, and also regular oversight should be included in the proposal. Unannounced audits, they are important part of patient safety and they should remain essential part of this legislation. Also thirdly, manufacturers, we need to reduce unnecessary costs for especially SMEs and developers of orphan and breakthrough devices, while ensuring that notified bodies have the resource to carry out robust conformity assessments. And then finally, transparency, safety information should be clear, accessible to patients and publicly available through Eudamed.
I think Eudamed would be the best place for this. Thank you, Chair.
Romana Jerković
Thank you, colleague Gussainina. Now I give the floor to Helder Sousa Silva, the rapporteur for the opinion of BUDG Committee.
You have the floor for two minutes, please.
Hélder Sousa Silva
Thank you, Chair, and dear colleagues. For me, it's the first time in ENVI. It's a privilege to be here. And I'm speaking, as you already said, as the rapporteur for the budgetary assessment that the Committee on the Budgets prepares on this file. Let me be clear about what that assessment is and what it is not.
The substance of the medical devices reform belongs clearly to this ENVI Committee, and our job is narrower and, I hope, useful to you. We check that the money adds up. We check that the new tasks come with the resources to carry them out, that those resources are found in an orderly way and not simply taken from other priorities, that the proposal fits within the financial framework, and that the arrangements on fees are coherent and sustainable. On this proposal, the public cost is contained and the savings for industry are very substantial, above 3 billion euros a year. And that is very welcome.
But a modest cost still deserves a careful look and three points from our point of view stands out. First, the agency takes on real new responsibilities and it is given 24 additional staff to meet them. We support that and we will make sure the resources continue to match the tasks and it's our our duty. If any new mandate is given by the committee's opinion, those should be matched with enough workspace to fulfill it. Second, the Commission itself receives 25 additional posts financed through redeployments.
We want full clarity on where those redeployments come from because new tasks should as a rule be met with fresh resources, not drawn quietly from elsewhere. Third and the last point, the fees paid for the agency's expert panel work cover only a small share of its new costs, with the Union budget carrying the rest.
The think that balance deserves scrutiny and we will propose that the principles governing these fees are set clearly and reviewed over time. We will bring forward a small number of targeted amendments in that spirit. We will stay with this file through the negotiations and to protect the budget and of course to protect the spirit of this file and to keep the financial logic coherent from the start to the finish. In conclusion, from the budget point of view, we have here a good proposal and we will propose also, as I already said, a small amendments to ensure the correct funding and the necessary scrutiny. Thank you, chair, and thank you, colleagues.
Romana Jerković
Thank you, colleague Sousa Silva. Now we move to catch the eye session and I will start with Jessica Polfjärd. Jessica, you have the floor.
Jessica Polfjärd
Thank you, chair, and thank you to Oliver for the draft report that you have presented. I think that you have done an excellent job on this very important file, and I think it's important that the Parliament also ensure that we can get this legislation in place.
I would like to highlight one issue in particular, however, where I see a need for further changes. In the proposal, the Commission proposed changes to Article 17 that would create the presumption that medical devices can be reprocessed. While I think this can be a good principle for certain sectors, I don't think it's suitable for medical devices. Many medical devices are made for single use for purposes of hygiene and patient safety, and I think that patient safety must always have the highest priority in this field. Requiring manufacturers to always justify why products are single use could also create unnecessary administrative burden, and I think that the manufacturer would know best whether their product is a single use or not.
I think the draft report goes in the right direction on this issue, but from perspective, I don't think we need any changes to Article 17 in this regulation at all. I think the current regulatory framework for this particular issue is sufficient. So I will table amendments to this effect, and I hope this will be taken into account by the rapporteurs in the upcoming negotiations. Thank you.
Romana Jerković
Thank you, Jessica. The next one is Vytenis Andriukaitis. Please, you have the floor.
Vytenis Povilas Andriukaitis
Ačiū labai, kalbėsiu lietuviškai. Pirmiausia noriu padėkoti Oliver Schienk ir pasidžiaugti, nes jis turi aplamai didelę patirtį ir aš tikiu, kad ta patirtis bus gerai panaudota, juo labiau, kad šešėliniai pranešėjai irgi, kaip čia sutampa, iš Vokietijos ir Timo Wölken ir iš žinių žinau, o kadangi Vokietija yra labai didžiulė medicininių prietaisų ir diagnostikos pramonės šalis, akivaizdu, kad jie puikiai žino didžiulę patirtį ir tai gali mums padėt. Tačiau būdamas, kaip sakyt, ministru 2013 metais Lietuvai pirmininkaujant mums teko pradėti formuoti medicininių prietaisų ir diagnostikos prietaisų reglamentą ir aš galiu pasakyti, kad ir dabar tai bus labai sudėtingi dalykai. Visų pirma norėčiau patikinti, kad būtų reikėtų žiūrėti, kad notifikavime, kituose dalykuose būtų kuo daugiau Europos. Kuo daugiau bendradarbiavimo.
Notifikuojančios firmos arba agentūros turėtų pasitikėti vienos kitomis. Mutual recognition, enhanced cooperation and open method of coordination. Šitie principai turėtų būti taip pat visur, kad mes išvengtumėm dubliavimo, nereikalingos biurokratijos ir visų kitų techninių dalykų. Dėl vienkartinių prietaisų. Nelabai norėčiau sutikti su kalbėjusia, kad jie negali būti perdirbti.
Esu kardiochirurgas su didele patirtimi. Mes implantuodavom vožtuvus, stimuliatorius ir taip toliau. Išties pritariu minčiai, kad reikėtų čia pažiūrėt labai lanksčiai. Akivaizdu, kad higiena, sauga, saugumo standartai negali būti jokiu būdu, jokiu būdu ignoruojami. Bet lankstumas vienkartinių kai kurių prietaisų atžvilgiu paliekant tai ligoninėms arba specialistams yra galimybė iš tikrųjų spręsti ir trūkumą.
Manau, kad pacientų saugos problematika ir taip pat svarbu suprasti, kad medicininiai prietaisai kainuoja. Reikia nagrinėti biudžeto ir kompensavimo išlaidas kartu ir todėl į šį procesą turi būtinai anksti būti įtrauktos šalys, nes joms teks padengti naujų inovacijų kaštus.
Romana Jerković
Thank you, Vytenis. And now I give the floor to Andre Dostal.
Please, you have the floor.
Ondřej Dostál
Thanks, Chair, I will speak Czech. Po dvaceti letech praxe ve zdravotnickém právu jsem se na toto pokusil trochu soustředit a bohužel po rozhovorech s výrobci i s notifikovanými osobami zde stále problémy zůstávají. Zaprvé, z tisícistránkových složek se často skutečné kvality týká jen zlomek a zbytek se dělá draze a zbytečně. Větší problém z hlediska vlády práva zůstává, že se divoce liší praxe notifikovaných osob v různých státech, co se týká přísnosti i četnosti kontrol, případně opakovaných kontrol, čímž vzniká motivace, nehezká motivace pro takzvaný forum shopping při vstupu na trh Evropské unie, kde ať domácí či zahraniční výrobce, který vstupuje, tak by měl dobře zvážit, přes kterou zemi a přes kterou notifikovanou osobu, aby si nepřidělal problémy.
Toto je špatně a možná je načase začít přemýšlet, jestli léková regulace není v tomto lépe řešená než regulace zdravotnických prostředků. Samostatný problém je financování notifikovaných osob, které na jednu stranu omezuje možnost dělat jejich práci řádně, na druhou stranu vytváří pokřivené motivace, na co se soustředit a na co ne, aby z toho vyšly finančně dobře. Toto vše dosud bohužel nebylo odstraněno, pokusíme se přes pozměňovací návrhy, ale je to i dobrý podnět pro práci na příštích revizích. Děkuji.
András Tivadar Kulja
Thank you very much, Chair, and dear Oliver, thank you for your presentation of the report. The Commission's proposal was already good, but you provide some very important and necessary improvements. And I especially support that any simplification of regulatory procedures must continue to safeguard a high level of patient protection by maintaining the safety and performance of medical devices. Simplification should make the system more efficient, but it should never weaken the standards that European patients rightly expect.
I also welcome the emphasis on providing greater legal certainty by introducing clearer timelines and specific deadlines for regulatory procedures. And another important part, the recognition of cybersecurity and interoperability as essential components for the regulatory framework. As medical devices become increasingly digital and connected, these are no longer technical considerations but fundamental requirements for patient safety and high-quality healthcare. So, and maybe one comment in response to our colleague from IMCO concerns the interaction between the AI Act and the MDR, IVDR. In my view, we should avoid unnecessary duplication while ensuring the legal certainty and predictability for manufacturers.
The Commission's original proposal, so to simplify the framework by removing overlapping requirements for AI-enabled medical devices already regulated under the MDR and IVDR.
The compromise reached through the digital omnibus strikes a balanced approach. It empowers the Commission through implementing acts to limit the application of certain AI requirements where the MDR and IVDR already provide an equivalent level of protection. And this helps reduce regulatory burden without compromising patient safety. And maybe one comment for a single-use device. I'm in favor of that position that the manufacturers should provide information why their devices should be considered as single-use because we see in the medical field in surgical operating rooms that many staplers in maybe in rural hospitals or mostly in rural hospitals are used many times and they are sterilized even the manufacturer says that it is a single-use device or only two or three times usable.
But it is clear that it is possible to use even eight times if it is necessary and sterilization is properly managed.
So I am in favor of of some administrative space for the manufacturers to to actually prove that why why are those devices single use, but of course we have other devices, for example blood bags which are obviously not multi-use devices or products. But overall, thank you very much for for your work and and thank you very much for the time.
Romana Jerković
Thank you, András, and finally Peter Liese, please, you have the floor.
Peter Liese
Thank you very much and I was really impatiently working for this day for more than three years. And I'm grateful to the Commission that we have this proposal and very grateful to Oliver Schenk that he even improved the proposal. The current MDR is just not fit for purpose. You know, when when you put a screw too tight it broke it breaks. So there's a saying in English: tight is right, but too tight is broke.
We need tight rules for medical devices, but the current rules are so tight that it just doesn't work.
And we have a medical problem. My colleagues from pediatric, for example, tell me that specific devices for pediatricians for heart disease with children are not available because the rules are so complicated and so expensive that they just don't produce this anymore. And that's why it's not only a question for the companies, for the business, for the jobs, but also for the patients. We need to change the rules and I'm grateful that we have a very good report on the table now because it also hints at the very few weak points from the Commission proposal. The Commission proposal is rather good, but there are some issues where Oliver even improved the text and the main point is unannounced inspections.
You know, the scandals that we had, for example, with PIP breast implants, they wouldn't have happened if we had unannounced inspections. And that's why unannounced inspection is maybe the core of the learning: not bureaucracy, not paperwork, not recertification, but unannounced inspections. And that's why this must survive and that's why I'm happy that Oliver put it in his draft report. Thank you very much.
Romana Jerković
Thank you for all your interventions. Now I invite Commission to take the floor for four minutes. And we have here Ms. Flora Giorgio. She is the head of the Medical Devices Unit in the DG SANTE. Please, the floor is yours.
Thank you, Peter.
Flora Giorgio
Thanks a lot. Thanks, Madam Chair. Thanks to the rapporteur, thanks to the honorable member, to the shadow rapporteur, and also to the other committee that are working actually on the opinion for this report. First of all, yes, a big thank you because I think you recognized and you share, and in the rapporteur in primis, the objective of the proposal, the objective of the Commission proposal that aims indeed, it is a simplification initiative, but is a simplification that is not and cannot be at the expense of patient safety. I think nobody has the interest in doing that, and is simply not acceptable.
We have some of practitioners here, and you all underlined the key role of medical device in clinical practice. And that's can only be the starting point of this, of this discussion. Having said that, it was mentioned this screw going too tight, and that's exactly where we are ending up and where we are today.
There is no patient safety without devices in the hospital for our patients. And that's where we came from. And where we came from in this proposal is also the extensive feedback we have received in the preparation of it and also the extensive experience in implementing a framework since almost ten years that we are, you know, my colleagues and myself are struggling every day to ensure that these regulations are actually applied in a consistent and proportionate way. And that's where probably I take the, let's say, the praise from several of you that recognize the balanced approach of the proposal. And it's not because the Commission is good, but it's because the Commission has listened and has also learned from the practice.
And that's really the way forward in the co-legislative process going in the same direction. The rapporteur said that his report is an invitation to cooperation and I think that's also from the Commission we are just there to take up on this invitation. You made a couple of points, I will briefly refer to that. You underlined and you also mentioned it in the report the importance of timelines and predictability.
That's for us is a given and you may recall we have already now through the adoption of an implementing act for the timelines on the conformity assessment process improved significantly the predictability. I mean the act will be will be applicable in January or February next year, but we have already a plan to actually give this predictability. At the same time we understand the importance to put times and days in the legal act, we also should balance this with the need for flexibility and adaptability. It's a framework that has to adjust to the very fast technological development and empowerment, we like it or not, institutionally there are different positions as well, they are important tools that maybe can be framed, maybe should be further clarified, but are important tool to ensure that the framework is agile and responds to the technological development. You mentioned the pace of patent that are actually are, you know, medical device is still the second sector filing patent every day, that shows it's an innovative sector and needs flexibility.
You mentioned also and several of you actually the risk-based approach and this is exactly even a more risk-based approach because the current framework are based on risk-based, but we need to focus resources where needed. And that's where unannounced audit, which are not exam, which are not abolished, I want to make the facts right, there is a lot of discussion. Unannounced audit are a key tools, but when needed that should make in take into account the safety history, the track records of the manufacturer, the notified bodies. There are a number of provision goes in that direction and that's where we believe it is important. Last point, mindful of of the time, the interaction MDR AI.
I think that's another important point, again clarifying the Commission does not aim at undermine the AI Act, the Commission the Commission proposal come from the AI Act, the Commission agreed on a digital omnibus on the AI Act. The Commission is simply making the AI Act requirement more fit for purpose and targeted to the very special sector that is the medical device, which has already a very developed framework to certify those device, which is already certifying these device and integrating those requirement in the MDR directly with the of course clarity and reassurance that human oversight, data integrity, bias, these are all element which are currently not covered by MDR, but of course needs to be properly addressed in order to keep the trust of the of the physician that will need to use AI because AI is there and we should and healthcare system should be able to have the trust to use it more.
So, reusable and single use and refurbished, this is point taken. There is a lot of discussion there and the Commission again is happy to engage to find a pragmatic solution. I think the objective is to improve the current framework, make it proportionate, more harmonized, and there are a number of elements where we also consider that keep the harmonization element of this of this regulatory framework is essential. This was one of the things that have been highly reported in the targeted evaluation. Over 446 responses out of 575 that we received really pointed to the fragmentation of the sector of the sector as something to be addressed.
And that's why we have a number of provisions in the regulation for joint monitoring, for exchange of views with the Member States and stronger coordination. I think that's all there. Last, very last point, just to give justice on one of the most important element, everything works if the money is there. So we welcome also the approach of the colleagues from the the opinion from the BUDG Committee.
We have made a very careful assessment to secure that there are sufficient resources at EU level for this in the agency and the Commission. Obviously, this is also a message to the national authority because a good system costs and we all need to make effort to ensure that is well resourced to achieve the ambitious objectives. So thanks a lot and looking forward to continue the cooperation.
Romana Jerković
Now I'm back to you, colleague Schreinemacher, you have two minutes for concluding remarks, please.
Oliver Schenk
Ja, ganz herzlichen Dank, Frau Vorsitzende. Vielen Dank für die Stellungnahmen und Einreichungen der Kolleginnen und Kollegen als Schattenberichterstatter, aber auch der opiniongebenden Ausschüsse. Ich habe den Eindruck, dass wir hier eine sehr konstruktive Zusammenarbeit entwickeln werden über dieses Gesetz. Ich habe viele Stichworte aufgenommen, um die herum wir sehr stark inhaltlich miteinander diskutieren werden: das Äquivalenzprinzip, die Fragen von KI natürlich, die Frage von Wiederverwendung, aber auch das Thema Bürokratieabbau.
Und das, was uns alle miteinander, glaube ich, in diesem Raum verbindet, dass wir das tun immer mit der Gewissheit, es geht um die Patientensicherheit. Dafür arbeiten wir daran, dafür brauchen wir Innovationen, aber sie muss auch in einem sehr geordneten Rahmen stattfinden dort. Und deshalb will ich mich ganz herzlich bedanken. Ich freue mich auf die Zusammenarbeit. Wir haben einen Punkt gar nicht erwähnt.
Er findet statt. Das ist die Rolle der EMA, die auch eine Rolle in diesem neuen, in diesem Fall bekommen wird. Und deshalb freue ich mich auf den nächsten Tagesordnungspunkt, wenn wir dann jetzt gleich auch in die Diskussion mit Frau Cooke einsteigen dort und vielleicht dann auch noch mal auf diesen Fall zurückkommen. Vielen Dank.
Romana Jerković
Thank you, dear colleagues, thank you all for the excellent debate. I announce now that the deadline for tabling amendments is set for 20 July at 11 o'clock. So we look forward to continue work together on this important file. And I will move immediately to the next item: exchange of views with Emer Cooke, Executive Director of the European Medicines Agency, on the annual report.
And invite all our speakers to come to the stage. Okay, I will continue. Yeah, because we are already late.
Dear colleagues, we are pleased to have Ms. Emer Cooke, the Executive Director, as I said, of European Medicines Agency with us today to present their report, annual report for 2023 and exchange views with members. As you know, the mission of the EMA is to foster scientific excellence in the evaluation and supervision of the medicines for the benefit of public and animal health in the European Union. I will first give the floor to Ms. Cooke for her initial statement. This will be followed by interventions from Mr. Tomislav Sokol, who is the European Parliament's contact point for EMA, and a first round of reactions from the coordinators of the SANT committee or their replacement. Afterwards, we will continue with the Q&A session with the members in the room using the catch-the-eye, I mean, you know everything.
And we will finish with interventions by the European Parliament representatives to the EMA Management Board. So, Ms. Cooke, please, you have the floor and maximum eight minutes. Please.
Emer COOKE
Um, so, dear Mrs. Jarckovich, dear honorable members, thank you very much for the invitation today and the opportunity to report on EMA's activities. Many of you know that it's my last exchange with this committee because my mandate will end in April and I'm very grateful to the committee for the great collaboration over the past years. Now today I'm going to look back at some key highlights from our 2025 report. I will update you on some preparations for our new pharmaceutical framework. I will touch on our work on competitiveness and also on women's health.
Okay.
And then finally I want to share a few personal reflections and important achievements over the past six years. So let's start with the highlights from 2025. EMA delivered 104 positive recommendations on new medicines for human use and many of these addressed unmet medical needs. And some notable approvals include a medicine to treat early Alzheimer's, a medicine to delay the progression of type 1 diabetes and an important new medicine to prevent HIV infection which needs only to be administered twice a year, so that's a game changer. In the area of veterinary medicines, we issued 30 recommendations for new medicines and seven of these were vaccines that strengthen our response to public health, sorry, to animal health emergencies.
And this is the highest number of positive opinions in the veterinary area since the agency opened its doors in 1995. Now, given that we're on the cusp of a new pharmaceutical framework, I want to talk a little bit about what we're doing here. It's the most significant transformation of our regulatory framework in over two decades, and it will allow us to deliver a more efficient environment that supports innovation, competitiveness, and the needs of patients, which is most important. And this legislation, in combination with the health technology assessment regulation, the Biotech Act, the Critical Medicines Act, and the review of the medical devices legislation that you've just heard about, also the European Health Data Space, provides us with additional opportunities, conditions, and regulatory tools, which means that we can now reshape how we deliver medicines for patients across Europe, building on a more responsive, agile, and patient-centered regulatory framework. Supply chains for critical medicines will be strengthened through more proactive approach based on collection and analysis of better data.
And we will have targeted incentives to address unmet medical needs, as well as shortened evaluation timelines and reinforced provisions to improve access and availability of medicines across member states.
So it's also an opportunity to reduce fragmentation and complexity, creating a more predictable environment for developers so that patients in the EU can benefit more quickly from scientific advances, and this is a time where there are lots of scientific advances. Now, let me say a few words about some of the activities we're doing to improve the health of women, and we know that improving women's health remains a priority for the European Parliament, and it's also one of my personal priorities. I'm keenly aware that important gaps remain in our understanding of sex-related differences in disease and treatment responses, and in the development of medicines for conditions that are specific to women. We're already doing quite a lot. We're monitoring clinical trial representation, we're requiring tailored dosages and warnings where necessary, and we're stepping up work on the safe use of medicines during pregnancy and lactation, and we're doing this on an international level.
We're also making better use of real-world data to help us understand medicine use and disease patterns specifically in women, and we're strengthening our dialogue with stakeholders and our international collaboration. But there's a lot more we can do, and in September, the European Medicines Agency and our European regulatory network will host a women's health workshop to identify gaps, share lessons learned, and set up a plan for further action. Now, as I approach the end of my mandate, I find myself reflecting a lot about the future of EMA and the EU medicines regulatory network. And I want to leave you with three things that I have learned and that I strongly believe. I strongly believe that we must use the power of Europe to serve our patients and animals better.
And we saw this on full display during the COVID-19 crisis. The Commission's vaccine strategy was really a game changer, and we at EMA were able to mobilize our scientific network at unprecedented speed, pooling expertise, reviewing evidence, leading to the rapid authorization of safe new vaccines, which saved millions of lives.
The Commission's joint procurement of vaccines was another example of European solidarity in action, helping to support to secure the availability and successful rollout of vaccines to citizens in all 27 member states at the same time. A population of 450 million gives us access to stronger, more representative data, and the European Health Data Space will enable better use of this data across EU. So that same spirit of European cooperation must continue to guide us, so that all people and animals can benefit from safe and effective innovations. The second thing I want to stress is that even though medicines regulation is our bread and butter, it's only one part of a bigger picture. To make a real difference for patients, all stakeholders need to work together in an end-to-end way, from research and development to authorization to access to use in healthcare systems and post-authorization monitoring.
Health is at the core of Europe's prosperity and competitiveness and must continue to be considered as a strategic investment in Europe's future. We are truly stronger together. And finally, we should never stop investing in transparency and promoting trust and confidence. Public trust is essential to our work, yet it is steadily declining, and we have to find new ways to engage audience audiences and to champion science.
At EMA we're doing this in different ways, we're trying to reach younger generations through podcasts, social media ambassadors, also partnerships with content creators. And we have established a new vaccine confidence expert group with international experts from around the globe. We cannot do this alone. Rebuilding and safeguarding trust in science and public institutions requires a broad and collective effort. Now, to conclude, let me end with a couple more highlights.
During my mandate, we have played an important role in the European Union's response to four public health emergencies: COVID-19, mpox, hantavirus and now Ebola, and we're still working on Ebola at the moment. We're actively supporting this through the emergency task force that was created by new legislation that you supported. We are now much better equipped than before to responding to crisis with new structures and coordination mechanisms such as the emergency task force, the medicines shortage steering group, and we are grateful to you together with the Commission and the Council for helping to cement these in legislation. This means that we can act more rapidly and effectively.
On clinical trials, we've processed more than 14,000 new trials through the clinical trials information system since it went live four years ago. The trials are in a publicly accessible database and we've made available an interactive clinical trial map which provides real-time information for patients and healthcare professionals. And in parallel, the accelerating clinical trials in the EU initiative is helping to transform how trials are initiated, designed and run. I'm also very proud that the EMA serves as an international reference point. Many medicines regulators worldwide rely on our scientific work and through our partnership with the African Medicines Agency, we are sharing our expertise to build a strong regional regulatory network on the African continent.
It has been the privilege of my life to serve in this role as EMA and to work side by side with my fellow scientists, with colleagues and friends. I have to commend my own EMA staff, the staff at DG SANTE, the heads of medicines agency across the network and the thousands of scientific experts in our in our regulatory network because it's their hard work and dedication that makes an extraordinary benefit to public health.
To this committee, thank you for standing up for EMA's valuable work during very challenging times. Thank you for the many health and medicines related recommendations that you've put forward. Sincere and special thanks to some of the key rapporteurs affecting our work, Mr. González Casares who is rapporteur for the EMA's extended mandate, Madame Montserrat and Timo Völken, rapporteurs for the pharma package, Tomislav Sokol, rapporteur for EHDS, critical medicines act and now EMA contact point in SANT. And let me also acknowledge MEPs in SANT working on some ongoing files, Mr. Andriukaitis, rapporteur for the biotech act, Mr. Schied, we've just heard about on the the medical devices legislation and of course the EP representatives in EMA's management board for their valuable contributions, Christian Bușoi, who's on my left, former MEP and EMA contact point and also the rapporteur in EMA's fees and Cristina Gherasimov, who's on my right. So as always, thank you all very much and I'm very happy to answer any questions you may have.
Romana Jerković
Thank you, Ms. Cooke, not only for being here today, but also for your support and collaborative approach over last years. I'm sure I can tell this on behalf of everyone that your expertise and your guidance have made a lasting difference. So thank you once again. Now I'm giving the floor to Tomislav Sokol. You have the floor for two minutes, please.
Tomislav Sokol
Thank you very much. Thank you, Director, for coming again to the Parliament, which is again the proof of a very good collaboration and I also want to commend you, thank you for the very great collaboration that we had over the years. Also on important files, but also in the work of the committee and as the contact person of EMA I can only say the best words about this collaboration. So thank you. So concrete question.
So you know that today the ENVI committee approved the provisional political agreement on the Critical Medicines Act, which we reached with the Council in May. This is an important milestone towards strengthening Europe's resilience against medicine shortages and reducing strategic dependencies in pharmaceutical supply chains.
The Act gives the EMA an important role. Beyond its existing work on shortages, the EMA will contribute through vulnerability assessments, scientific and regulatory support for strategic projects, coordination with the MSSG, and by supporting transparency and cooperation between Member States. The success of this legislation will therefore depend not only on the legal framework itself, but also on how effectively it is implemented in practice. So my question is, from the EMA's perspective, what will be the biggest implementation challenges once the CMA enters into force, and what should policymakers in the European Parliament and the Member States do to ensure that the agency has the tools, resources, and cooperation it needs to make this legislation deliver real improvements for patients across Europe? And furthermore, that's the second question, EMA's mandate was significantly strengthened, giving the agency new responsibilities in monitoring and coordinating the management of medicine shortages across the EU.
Looking back, what difference has this made in practice? How has the management of shortages at EU level evolved during your mandate, and can you share some concrete examples where EMA's coordination has actually improved outcomes for patients in the Member States? Thanks.
Romana Jerković
Thank you. And now I will open the round of questions by coordinators, and I will start with Vytenis Andriukaitis. Please, you have the floor.
Vytenis Povilas Andriukaitis
Thank you so much. First of all, thank you, dear Emer, for your very excellent now presentation, absolutely broad picture. You know, I am big fan to see EMA much stronger. I remember when I visited, you know, Food and Drug Administration and then tried to to convince our colleagues that we need to to have much more stronger EMA capacities. Now I am think that we in right direction, especially as just Sokol mentioned that your mandate what what extended, and now speaking about Biotech Act, about medical devices revision and so on, I think that we need move forward, you know, guaranteeing much more strongest role of EMA in in in fields, especially in biotechnologies and so on.
Of course, knowing that we need to guarantee very strong cooperation between Member States notifying bodies and and notifying authorities and EMA, creating much more strongest capacities on clinical trials information systems, inviting much more experts and so on and doing much more that we can of course raise also.
My question is very simple. How can you, you know, see possibilities to attract much more expert capacities at EMA level, because without expertise we have no chance to move forward. It is simple question because I know that we are all facing big, you know, health expertise shortage. Thank you.
Romana Jerković
Thank you. And now I invite Gerald Hauser, please, you have the floor.
Gerald Hauser
Danke schön. Ich habe der Wortmeldung von Dr. Cooke gespannt zugehört. Sie haben als, Frau Dr. Cooke, Sie haben als einen Ihrer Zukunftspfeiler erwähnt, dass die EMA zukünftig mehr in Transparenz investieren sollte, gerade von Ihnen als einer der drei Punkte erwähnt, um das Vertrauen der Bürger zurückzugewinnen. Da kann ich Ihnen voll beipflichten. Aber wie ist es mir ergangen?
Sie wissen, ich habe am 25. Juni 25 eine schriftliche Anfrage an Sie gerichtet im Rahmen der Transparency for Safety Initiative, also im Rahmen der Transparenzinitiative, weil ich schriftlich von Ihnen wissen wollte, welche Daten den von Ihnen zugelassenen sieben COVID-19-Impfstoffen zugrunde liegen. Ist eine normale Frage, weil diese Daten einer unabhängigen wissenschaftlichen Prüfung unterzogen werden sollten, was auch üblich ist. Sie behaupten ja, die Impfstoffe sind wirksam und sicher. Die WHO hat auf ihrer Homepage heute noch den Hinweis auf die sicheren und wirksamen Impfstoffe. Aber wir wissen auch, dass in den Impfstoffen möglicherweise Stoffe enthalten sind, die nicht passen, zum Beispiel das SV40-Promotor-Gen, das möglicherweise krebserregend ist, wie auch Fremd-DNA.
Um das auf den Punkt zu bringen, so eine Anfrage im Rahmen der Transparenzinitiative von mir an Sie gestellt. Ich habe ein Antwortschreiben erhalten und in diesem Antwortschreiben haben Sie auf eine Homepage verwiesen, wo Sie diese Daten offenlegen. Geschätzte Kollegen, schauen Sie sich diese Homepage an. Auf dieser Homepage stehen geschwärzte Dokumente. Beispiele: Das haben Sie auf die Homepage gestellt.
Jetzt frage ich Sie, Frau Dr. Cooke, welchen Informationsgehalt hat so ein Informationsschreiben? Seitenweise, seitenweise geschwärzte Schreiben.
Ich verstehe das nicht. Das ist doch eine Beleidigung für jeden Bürger, ist eine Beleidigung für einen EU-Mandatar, der im Rahmen einer Transparenzinitiative eine Anfrage an Sie stellt und solche Dokumente werden veröffentlicht, geschwärzt. Frage ich Sie, welchen Inhalt, welche Botschaft wollen Sie damit transportieren? Wissen Sie, der Volksmund in Tirol sagt Folgendes: Wenn ich etwas zu verbergen habe, dann muss es wohl stinken. Frau Dr. Cooke, erste Frage: Wieso machen Sie sowas?
Wieso tun Sie sowas? Es gibt eine Transparenzinitiative. Das sieht doch jeder, ist vollkommen sinnlos, schade um die Zeit, schade um das Engagement. Zweitens, werden Sie, nachdem Sie das heute erwähnt haben, werden Sie der Aufforderung nachkommen und werden Sie die Daten veröffentlichen? Wenn Sie der Meinung sind, dass die Impfstoffe wirksam und sicher sind, vor was fürchten Sie sich?
Dann veröffentlichen Sie die Daten einfach. Das ist doch das Mindeste. Wenn wir in dieses Haus reingehen, lesen wir Demokratie in Aktion. Die Europäische Union definiert sich als die größte Demokratie der Welt. Transparenz wird großgeschrieben.
Transparenz kann aber so, Frau Dr. Cooke, so nicht ausschauen. Das ist keine Transparenz.
Also wann und werden Sie die Daten endlich veröffentlichen? Und drittens, ich habe aus Expertenprotokollen in Österreich, von Regierungsprotokollen, nicht von uns, nicht von mir, gelesen, dass dort Experten festgestellt haben, dass Sie, die EMA, vor der Zulassung, vor der bedingten Zulassung der COVID-19-Impfstoffe massiv unter Druck gesetzt wurden, um die bedingte Zulassung der COVID-19-Impfstoffe zu ermöglichen. Stimmt diese Aussage, die in Expertenprotokollen in Österreich der österreichischen Regierung so protokolliert ist?
Romana Jerković
Thank you, colleague. Now I give floor to Ignazio Marino. Please, you have the floor.
Ignazio Roberto Marino
Thank you, Madam Chair, and thank you to the Director of the European Medicine Agency, Dr. Cooke, for her presentation.
I am very happy that you're going to have a seminary dedicated to women health because I believe that this is a very important topic. But today I'd like to ask you a question based on the fact that a number of us here in this committee very recently went to the United States to discuss with the administration and the Department of State and members of Congress and also Food and Drug Administration leadership, NIH leadership, and CDC leadership. And we got the idea that the current administration of United States is going to push for having in the United States the same price for the drugs that we have in Europe. And obviously we know that because we have national health systems, we are able to negotiate the cost of the drugs, so our cost is inferior to the cost in the United States.
But we also met with people representing the drug companies, and the feeling that we had was really bad, that possibly they will sell new innovative drugs only to United States for a number of years, so the administration cannot say that the drugs is less expensive in Europe and the big drug company will have their profit, but here in Europe we will not have some of the innovative drugs that will be developed in the next several years. And I would like to know if what do you think we can do, because you know, all this that we learned over there sounds pretty logical, that you know, the big pharma wants to make profit and the administration doesn't want to pay more than Europe, so it's convenient to big pharma to keep the innovative drugs in United States and not share the same product with Europe. Thanks.
Romana Jerković
Thank you. And finally on behalf of Left, Sebastian Everding, please you have the floor.
Sebastian Everding
Thank you chair, I will continue in German. Auch von meiner Seite aus vielen Dank, dass Sie bei uns sind, dass Sie sich den Fragen stellen. Ich würde den Fokus gerne auf noch ein ganz anderes Thema richten. Ich werde immer wieder von Bürgerinnen und Bürgern gefragt, wie kann es sein, dass Jahr 2026 und immer noch leiden so viele Tiere in Versuchslaboren in ganz Europa?
Und das, wo es nun wirklich so ist, dass Wissenschaftlerinnen und Wissenschaftler geprüfte Methoden entwickelt haben, die zur Verfügung stehen, die komplett einen Verzicht auf Tierversuche ermöglichen. Ich habe mich erst am Wochenende dazu noch mit einem Verein ausgetauscht, der seinen Schwerpunkt auf Laborbeaglen setzt, aber Beagle mögen vielleicht noch die Tiere sein, die die höchsten Sympathiewerte noch bei bei den Menschen auslösen, aber man muss wirklich sagen, es sind mehr als 10 Millionen Tiere für die wissenschaftliche Forschung und und zum auch zu Zwecken von von Arzneimittelüberprüfung. Und das sind eben auch Kaninchen, Ratten und Mäuse. Und auf der anderen Seite, künstliche Intelligenz zieht immer weiter in unser Leben ein, verändert alles, was wir bis jetzt kennen. Zusätzlich gibt es noch In-silico-Modelle, Organ-on-Chip-Technologien und ganz ganz viele andere tierversuchsfreie Methoden.
Ich höre aber auch immer wieder, dass gesagt wird, dass die regulatorischen Prozesse nicht mit dem wirtschaftlichen Fortschritt Schritt halten. Und deswegen meine ganz gezielte Frage an Sie, wie beschleunigt die EMA den Ersatz von Tierversuchen in der Entwicklung von Arzneimitteln? Welche Möglichkeiten sehen Sie da und auch anders gefragt, welche regulatorischen Anforderungen verhindern derzeit noch eine breitere Anwendung von KI, In-silico-Modellen und anderen tierversuchsfreien Methoden? Da schon mal danke für eine Antwort im Voraus.
Thank you.
Romana Jerković
And now, Ms. Cooke, you have five minutes to answer on the questions from the first round, please.
Emer COOKE
So, thank you very much and really some excellent questions. Let me start with the response on the Critical Medicines Act implications and the challenges, I think, that you asked that we see in terms of implementing it. Now, the first thing I would say is that we've already done quite a lot of work in advance. We've already anticipated some of the requirements. So we've already started to look, for example, at the vulnerability assessments and we've launched a pilot now with 19 active substances where we've developed the methodology and we're now looking at how that works in practice.
If I had to talk about one challenge, it would be the sheer numbers that we're talking about here because in the 19 products that we're looking at in terms of vulnerability assessment, so looking to see whether there is dependence on single suppliers, whether there's a need for diversification, whether there are specific risks in the supply chain, we've 19 substances, but that amounts to 3,400 medicines.
And trying to evaluate those, those vulnerabilities is a complex, it's a complex matter and it requires resources, good methodology, and continuous improvement. Um, we, we will see once we get the outcome of the first pilot, whether what we will learn from this. I think it's, it's also very important to acknowledge that a lot of work is put on member states to do the assessment activities, but we have a very strong role in, in doing the coordination, in making sure the methodology is right, in trying to explore new ways of doing that methodology, so using digital tools, AI, etc. So I think the, the real challenges is just the numbers here. And we have some new resources, but the member states also need support and we need to make sure that we can continually adapt and, and improve these systems.
Um, I also wanted to talk about, you asked about the successes.
And I'm very proud to say since our extended mandate came into force in 2022, that we've already been able to make a tangible difference in shortages in a number of areas. The first example I would do, well, I think maybe you know we've already set up the Medicines Shortage Steering Group, the Single Point of Contact working party, and we were able to take action during the 2024-2025 winter season to cut antibiotic shortages by 50% relative to the previous year. And that was because of work that the new entities put in place. We've also been able to meet with companies, have frank conversations with them, leading to the commitment to introduce new manufacturing sites in Europe to manage demand. So we've got two or three very positive commitments, one of them is going to be in July of this year.
And then we've also been able to issue recommendations in areas where we know there are challenges, like in the area of anti-D immunoglobulins and radiopharmaceuticals.
So some very concrete successes that we have already. Mr. Andriukaitis, you talked about the need for expert capacity. And I think it's it's very important that we have the experts. We already have a pool of 4,000 experts that we can rely on to help us with our with our assessment work. We will with the the change to the committee structure, we'll be relying on experts even more.
We've just agreed on a best practices for recruiting and managing experts to come to our systems. And these are not just experts from the scientific area but also from the patient and healthcare professional area. So we have the tools in place to make this to make sure that we can use the best expertise. And we're continuing investing in this. Mr. Hauser, we are we do significant work on transparency.
We have published every European public assessment report in full of all the COVID vaccines.
We have also done exceptional transparency on the COVID vaccines as well. Now, legally, we are not required to redact, we are not required, we are not allowed to publish personal data or confidential data. And there are parts of the dossier that contain personal data and confidential data, but there are lots of parts and many parts that are fully made public on our website, and we are committed to the utmost transparency on this. With respect to your suggestion that we were under pressure, I can only say that I think the whole world was under pressure. We were under pressure to try and do the right thing, and I am confident that we have done the right thing for European citizens.
Mr. Marino, I wanted to, I need to say first of all that pricing and reimbursement decisions are outside the scope of the European Medicines Agency, so I cannot comment directly on that.
But I think what I want to talk about here is that we are monitoring the situation very carefully to see whether any geopolitical considerations might have an impact on the availability of medicines for European citizens. Now so far, I told you the number of 104 new active, or 104 recommendations for authorization in 2025, it was 114 in 2024. We're not seeing a decrease at the moment, but it is something we need to keep an eye on. And I'm very pleased that our Commissioner has taken this seriously and is working with stakeholders to see what can be done, or what might need to be done. Then, I'm sorry, I didn't catch your name.
Evering.
Emer COOKE
Evering, yes, thank you very much, and thank you for raising the question of reducing and refining animal testing. This is something that we are very committed to at the European level. And we very much welcome the European Commission's roadmap for phasing out animal testing. I probably would agree with you that it's not as quick as it could be, but it's not because of lack of effort on our side.
And we have published a number of recommendations to help make the transition. We're looking carefully at in silico methods. We've even given a qualification opinion on an in silico method to replace a animal testing. And this is of course the way of the future. But they must be validated to make sure they provide the same protection as the animal testing does.
So there's a lot of work being done, but a lot of work still to be done. So thank you thank you very much for raising this issue.
Romana Jerković
Thank you. Now I will open the floor for the SANT members. Just to let you know that interpretations so interpreters will stay with us until maximum 10 past 12, so please keep in mind. First I will give the floor to Peter Liese, please. One minute please.
Peter Liese
Thank you chair and thank you to Emer Cooke for your presentation but also for your hard work in the recent years. And I fully agree with your main message: to solve the problems we need more European cooperation. For example the Biotech Act to harmonize better the clinical trials is an important step. And more Europe is also in my view the answer to a question where I'm dealing with experts now very intensively: the male contraception.
You know, we have the fact that the burden of contraception is mainly with women, with serious side effects. Many men would like to use male contraception if it would be available, but it is not, even though scientists and companies are working on it. And they told me they don't want national approval. They want European approval because that brings them the business case for the biggest market in the world. And we had an event in November with all the experts and your people.
And I would just ask you to repeat what has been said there. It's somehow a chicken and the egg problem. The scientists, the companies say, "We don't have guidelines from the EMA." But the EMA says, "You know, our door is open, they should come to us and present the projects, and then we can develop informed guidelines." So you cannot do guidelines without having the knowledge.
So can you just repeat this invitation? I think they need to show up now, and I don't know why they don't, because your door is open since November. Second point, shortly: urban wastewater.
We in EPP, we have a big concern that the burden in particular for generics is too big under the current legislation. We just approved here in this committee the Critical Medicine Act. So we want to bring production back to Europe, in particular with generics on critical medicine, but couldn't the urban wastewater regulation be counterproductive when we look at this target? Thank you.
Romana Jerković
Thank you. And now I give the floor to Nico Casares Gonzalez, please.
Nicolás González Casares
Thank you, Chair, and thank you, Mrs. Cooke. This is your last time as EMA director in this committee. And let me say to you honestly, thank you, thank you for your great work during these years. You arrived in very hard times. I want to support how the agency dealt with pandemic decisions.
You can see here today that we have some vaccine denials, therefore science denials. This is not the Europe we want to build. I hope wherever you go now, you keep defending science. But finally, let me say thank you to you and to your team for this very hard work that you have done in the last and recent years.
I go now to switch to Spanish and go to speak about ATMPs. Y quisiera centrarme en ello porque es un ámbito de excelencia científica europea y su traducción en medicamentos autorizados sigue sin ir de la mano. Desde 2008, más de un centenar de ATMPs han llegado a los pacientes a través del régimen de exención hospitalaria. Sin embargo, muy pocos de ellos han llegado a tener una autorización de comercialización válida para toda la UE. La ciencia existe, lo que falta es el puente para escalarla y llevarla del laboratorio al paciente.
Y ahora que el paquete de farmacéutico ya ha sido acordado y que el proyecto piloto de la EMA para desarrolladores académicos de las ATMPs lleva ya varios años en marcha, quisiera formular dos preguntas breves.
En primer lugar, con nuevas herramientas como los espacios controlados de prueba regulatorios, los regulatory sandboxes, y el mandato para elaborar un informe sobre un marco más ligero para los ATMPs menos complejos desarrollados al amparo de la excepción hospitalaria, ¿cómo piensa la EMA priorizar sus recursos destinados a los ATMPs y qué ocurrirá con el Comité de Terapias Avanzadas en el marco de la reestructuración interna de la agencia? Y en segundo lugar, el proyecto piloto de la agencia para desarrolladores académicos solo presta apoyo a cinco productos simultáneamente y los resultados tardarán todavía años en conocerse. ¿Está considerando la agencia convertir esta iniciativa en una estructura permanente con reducciones específicas de tasas y un acceso más temprano al programa PRIME? ¿Cuáles son los principales obstáculos que con mayor frecuencia señalan los desarrolladores académicos? Muchas gracias, thank you so much.
Speaker 44
Thank you, and now I give the floor to Oliver Schink, please, you have the floor.
Oliver Schenk
Ja, vielen Dank und auch ein herzliches Willkommen von mir an Frau Cooke und die EMA. Ich springe gedanklich zurück zu unserem vorherigen Tagesordnungspunkt der Medical Device Regulation. Die EMA wird in diesem Zusammenhang auch ausdrücklich eine neue Aufgabe bekommen, insbesondere bei Breakthrough- und Orphan-Produkten.
Mich interessiert, wie Sie die EMA für diese Aufgabe vorbereitet sehen, wie die EMA an diese Aufgabe herangehen wird. Und der zweite Punkt in dem Zusammenhang ist, aus meiner Sicht muss diese neue Regulierung, die wir auf den Weg bringen, nicht nur die Sicherheit der Patientinnen und Patienten garantieren, sondern auch die Versorgung. Wir müssen auch Innovation antreiben. Und das ist auch etwas, was ich bei der EMA wahrgenommen habe, dass es dort ja auch nicht nur darum geht, Arzneimittel zuzulassen und die Sicherheit herzustellen, sicherlich als Hauptaufgabe, aber auch Innovation mit anzureizen, auch sagen dafür zu sorgen, dass Innovationen in die Versorgung kommen. Und vielleicht können Sie uns noch ein paar Hinweise mit auf den Weg geben, wie man das auch mit Blick auf die MDR am besten organisieren kann.
Vielen Dank.
András Tivadar Kulja
Thank you, Chair. Director, it is a pleasure to have you here today in our committee. And this morning, the committee took an important step with the vote on the Critical Medicines Act. We're also working on the Biotech Act, which has the potential to define Europe's life science strategy for years to come.
During our recent SANT meeting to DC and Pittsburgh, which was mentioned by Professor Marino, one message came across very clearly. Innovation succeeds where regulation, at least in this particular sector, is predictable, investment is encouraged, and scientific excellence is rapidly transformed into patient benefit. To find a treatment is not enough to have great universities or great scientists. We also need the right ecosystem and an investment environment that enables innovation to move quickly from laboratory to patient. Europe undoubtedly has the science.
The question is whether we also have the right ecosystem here. Therefore, I would like to ask you a more general question. From your perspective, how can the EMA, together with the Biotech Act, help to create a regulatory environment that is faster, more predictable, and more attractive for innovation while continuing to protect patients through robust scientific assessment? And another question, that how do you see, what are the predictable effects right now of the most favored nation regulation in the US? How will this affect Europe?
Romana Jerković
Thank you. Now Ms. Cooke, the floor is yours to respond on this short please, if it can be short.
Emer COOKE
Okay, yeah, thank you very much. Yeah, I'll try and be as short as possible. Yes, on the male contraceptives, I think the message is clear, our door is open. We did participate in the meeting in November, we expressed the fact that our door was open and so far nobody's knocked on it. So I think the question now is to get people knocking on the door and that will help us provide the guidance that might create, that might help this progress.
On the urban wastewater, it's always a balance. We have new rules now in the strengthening environmental risk assessments in the new pharmaceutical legislation. But I have to say in my experience now dealing with shortages since the new mandate in 2022, we see the generic supply chains are particularly vulnerable and they find it difficult to introduce additional measures because the cost bases are so low.
So it's always a balance and we have to find that balance. Mr. Kesaros, thank you very much. I think you're very, thank you also for your support for ATMPs. I think it's a very important area for Europe, it's a very important area for innovation. Maybe just to point to the fact that we have the first successful outcome of the pilot procedure for ATMPs with a gene therapy product for Wiskott-Aldrich syndrome, I think.
So it's something that we will definitely continue, but I think the main, you know, using Prime, using some of the new tools in the Biotech Act will be very important. This idea of clusters of excellence, I think, are going to be very supportive.
And maybe, and this also answers some of the other questions as well. One of the things that we're doing now is trying to reach innovators. Rather than waiting for them to come to us, we're trying to reach them by going to biotech hubs, tech transfer offices, so that they're aware and they know what the challenge, they're aware of their regulatory ecosystem and they're aware of what the challenges are. And if I can speak to one challenge that we see almost all the time with smaller operators, academic institutions, is the need to invest in good manufacturing practices and consistency of manufacture. And that awareness is often not there.
Then maybe Mr. Schrenk to talk a little bit about how we're preparing for the medical devices regulations. First of all, this is an area where we've already got some activities under the framework of our extended mandate. We already have expert panels set up to do performance evaluation and clinical evaluation. These will now be extended in the context of the medical device, and we'll also get additional coordination rules for some of the roles for some of the committees. Maybe if I can speak about three areas where I think are really looking at supporting innovation.
These are the pilots that we're doing on breakthrough devices, on orphan devices, and also on pediatric devices. And we're already doing these as pilots, and they will then be reinforced in the context of the of the legislation. So we've already put in place our resources to manage the expert panels. We're looking at what we need more to do in the context of the additional coordination tasks that we're doing. We're well aware of the challenges, but I think we're really on track.
So thank you very much for your support.
Romana Jerković
Thank you, Ms. Cooke. And now I will give the floor to our representatives to EMA Management Board, Mr. Cristian Bușoi and Ms. Garuolienė. Let's start with you, Mr. Bușoi. You have three minutes, please. You have the floor.
Cristian Bușoi
Thank you very much. It is a real honor to be here as one of the two European Parliament representatives of the EMA Management Board. First of all, I would like also to express my sincere appreciation and congratulations to Mrs. Emer Cooke for her excellent work and achievements in challenging times.
I remember well the day when as EMA contact person, the position that Mr. Sokol is having now, I presented her candidature in coordination with the coordinator at the time, Mr. Liese, in ENVI Committee. It was online meeting because it was during COVID and the challenges were very hard. But you did it very well and once again congratulations. Also a lot of appreciation to the management, to the rest of the management of European Medicines Agency and all the hardworking people in this important European institution for what they achieved during all these years. 2025 was a year with complex global health challenges, but EMA reinforced its international partnerships, promoted harmonization of scientific guidelines, and advanced coordinated approaches to emerging priorities, including artificial intelligence and global health preparedness.
As a former rapporteur of ENVI Committee for EMA fees, but also opinion rapporteur for other relevant legislation, one of my priority was to watch the correct and timely implementation of the legislation.
And here in 2025, European Medicine Agency advanced very well with, of course, the full implementation of the clinical trials regulation, successful implementation, but also with the fee regulation, the health technology assessment regulation, which entry into force in January 2025, and the preparation for what will be the implementation of the new EU pharmaceutical legislation, which is an unique opportunity to simplify, modernize, and better integrate the medicines regulatory framework. Finally, something that is very important for many of the members of the SANT committee, but also of the public who's looking at us, is the medicine shortages. And in 2025, European Medicine Agency further strengthened its role as a central coordinator for shortages management by enhancing monitoring and coordination mechanisms, improving preparedness, and reinforcing the long-term resilience of medicine supply chain. 2025 was also the 30th anniversary of European Medicine Agency itself. And of course, this was an opportunity to reflect on three decades of scientific excellence, regulatory leadership, and public service.
And sure, things could be better, but what was achieved until now was excellent. And once again, congratulations to all that contributed to this. Thank you so much.
Romana Jerković
Thank you. And now, Ms. Garoli, you have the floor. Sorry, you have the floor. Sorry.
Jolanta Garuolienė
Thank you, Madam Chair. Thank you very much for opportunity to participate in today's discussions. First of all, I would like to warmly thank Director Emer Cooke for presenting annual report and for her leadership of the agency. I would like to express my sincere appreciation to the EMA staff, for the members of scientific committees and for experts of the national competent authorities. The achievements presented today are the results of collective effort across European medicine regulatory network.
I would like to highlight some areas I consider particularly important.
Medicine shortages continue to affect patients and healthcare systems across Europe. Achievements creating European shortages monitoring platform and critical medicines list and stronger cooperation within European regulatory network are important achievements and the sheer ambition should increase to be more move from managing shortages to preventing them. The better use of European health data and real world evidence and initiatives such as Darwin EU demonstrate the enormous potential of European health data to support regulatory decision making throughout life cycle of medicines. We should continue working forward to truly European evidence ecosystem that benefits from data, expertise and participation of all member states. The new EU HTA regulation has strengthened collaboration and information exchange between EMA and HTA bodies, supporting more timely and efficient joint clinical assessment.
Closer cooperation between regulatory and HTA authorities should improve the quality of evidence and support faster and more equitable patient access to effective health technologies across Europe. EMA's work on maximum residue limits demonstrates that one health approach is already an integral part of medicines regulation.
Building on this experience, I believe that One Health will become an increasingly visible strategic priority, linking human and animal health, food safety, and antimicrobial resistance. Once again, I would like to thank Director Emer Cooke and the EMA staff for their commitment and excellent work in strengthening a resilient, equitable, and sustainable European medicines regulatory system that serves patients and society. Thank you.
Romana Jerković
Thank you. Thank you all for presenting EMA's work today. These topics are crucial to health and safety of our patients, and sharing this knowledge help us continue to provide safe, high-quality care. So thank you for your commitment and for all your work. Dear colleagues, at the end of today's meeting, I would just say that our next meeting will take place after the summer break, September 2nd, during which we will welcome the President of the European Parliament, Roberta Metsola, at 3:00 PM.
So I'm looking forward to see you all there. Thank you. Have a nice day.
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