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Čtvrtek, 1. června 2023 - Brusel Revidované vydání

3. Koordinovaná činnost řešící antimikrobiální rezistenci (rozprava)
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  President. – The next item is the debate on the oral question to the Commission on coordinated action to address antimicrobial resistance by Pernille Weiss and Tiemo Wölken on behalf of the PPE and S&D groups (O-000027/2023 – B9-0022/2023).

 
  
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  Tiemo Wölken, Verfasser. – Frau Präsidentin, liebe Kolleginnen und Kollegen, sehr geehrte Frau Kommissarin, liebe Stella, schön, dass wir uns hier heute sehen zu einem wirklich sehr, sehr wichtigen Thema: Antimikrobielle Resistenzen.

Es ist eines der unterschätztesten Gesundheitsthemen. Schon seit 2017 gibt es ja einen Aktionsplan der Europäischen Kommission, und passiert ist relativ wenig. Deswegen ist es gut und notwendig, dass wir jetzt wieder über das Thema reden. Ich möchte mich zunächst bei der Kommission dafür bedanken, dass sie ihre Empfehlungen an die Mitgliedstaaten herausgegeben hat. Ich hoffe, dass die Mitgliedstaaten diese Empfehlungen dann auch annehmen werden.

Wir als Europäisches Parlament stehen sehr geschlossen hinter dem Vorschlag, und ich möchte mich bei allen Kolleginnen und Kollegen bedanken, die mit uns zusammen diese Anfrage zur mündlichen Beantwortung eingereicht haben. Es sind ja nicht nur wir, das ist auch die EVP, das ist Renew, das sind die Grünen, das sind die Linken – also wirklich eine ganz, ganz breite, geschlossene Mehrheit.

Ich finde, wir erwähnen wichtige Punkte: Das Konzept „Eine Gesundheit“ zu stärken, das dafür sorgt, dass wir Gesundheit als Gesamtpaket denken – von der Umwelt aus über die menschliche Gesundheit, aber auch die Tiergesundheit –, das ist von zentraler Bedeutung. Wir müssen den Antibiotikaeinsatz weiter reduzieren, sowohl in der menschlichen Verschreibung als auch in der Tiergesundheit – da, wo es geht, damit wir diese lebensrettenden Medikamente weiter behalten und sie nicht noch weiter ihre Schutzwirkung verlieren.

Wichtig ist auch, dass wir die Umweltmaßnahmen sehr viel stärker beobachten. Wir unterstreichen in unserer Entschließung auch noch einmal, dass wir insbesondere auch darauf achten müssen, dass wir Wasser untersuchen, um zu testen, ob es eine neue Antibiotikaresistenz gibt. Wir wollen, dass Menschen mehr Schnelldiagnosetests benutzen, bevor Antibiotika verschrieben werden. Und wir wollen insbesondere auch nochmal das Gesundheitspersonal schulen, da, wo noch Verbesserungsbedarf ist.

Aber wir dürfen auch nicht die Augen davor verschließen, dass wir mit den bisherigen Antibiotika in eine Sackgasse laufen. Deswegen müssen wir auch alternative Behandlungsmethoden in den Fokus nehmen und vor allen Dingen dafür sorgen, dass Antibiotikaforschung wieder in der Europäischen Union passiert. Insofern, Frau Kommissarin, vielen Dank, dass Sie sich heute die Zeit nehmen und mit uns diskutieren. Ich glaube, es wird eine sehr spannende und eine sehr wichtige Debatte.

 
  
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  Stella Kyriakides, Member of the Commission. – Madam President, honourable Members, first of all, I want to thank you for the ongoing support of all our work on fighting AMR and for putting this question here today, which I think is extremely important.

Many of us have been calling antimicrobial resistance the silent pandemic, and we are all aware that we can no longer say that it is silent. The pandemic has further highlighted the challenges we are facing with antimicrobial resistance, and we know that over 35 000 EU citizens every year lose their lives from antibiotic-resistant infections. And this is a number that is rising, because bacterial resistance is also rising, so we need to give it the highest priority.

We need to take action that needs to be both ambitious and also urgent. We have proposed the reform of our pharmaceutical legislation and this came with a Council Recommendation on AMR to strengthen our response. And through the recommendation, we have asked Member States to ensure the prudent use of antimicrobials and that unused and expired antimicrobials are disposed of in a very safe way.

We have put forward measurable EU national targets on antimicrobial consumption and resistance to be achieved by 2030. More prudent use measures are proposed in the legislation. For example, we have adequate pack size, we have plans and reporting of resistance to microbes, we have prescription status. So there is a great deal we need to do. And I want to say here that what we are trying to achieve can only be achieved if we have a toolbox of measures that is in place in order to fight AMR.

On the veterinary side, the legislation on veterinary medicinal products and medicated feed will help to meet our farm to fork strategy targets of halving overall EU sales of antimicrobials used for farmed animals and agriculture by 2030. The recommendation invites Member States to implement infection prevention and control measures so that we curb the spread of antimicrobial resistant pathogens. And it calls particularly for stronger measures in healthcare settings and long-term care facilities. This is building on what we have learned during the pandemic of the situation that we saw in long-term care facilities and in healthcare settings.

With EU funding support, Member States are encouraged to take measures to improve the health and the welfare of food-producing animals in order to decrease the spread of infectious diseases. And if we manage to do this, we will reduce the use of antimicrobials. However, reducing the use of antimicrobials has an impact on sales volumes and on the return of investment for marketing authorisation holders. And this is responsible for the current market failure and the lack of new antimicrobials.

Let me just share with you that the last antimicrobials that came onto the market, the novel ones, were in the 1980s, so we clearly need to do something urgently to bring innovation in, to bring new antimicrobials into the market. And this is why we’re using push incentives by research and innovation funding and pull incentives to reward successful development and secure access to effective antimicrobials.

And that is why we have proposed what is possibly a world pioneering measure: the transferable data exclusivity vouchers to develop new antimicrobials. To be clear, these will be granted under extremely strict conditions to minimise the cost to health systems and to ensure a fair return on investments to developers, often small SMEs.

We have also presented procurement mechanisms for access to new and existing antimicrobials, and this would guarantee revenue for marketing authorisation holders regardless of sales volumes. Other medical countermeasures such as alternative treatments, diagnostic tests and vaccines targeting antimicrobial resistance pathogens are also covered here.

At the global level, the proposed recommendation looks to the Member States and the Commission to support concrete actions on AMR in the pandemic agreement currently being negotiated at the G7 and G20. I would also want to say, in addition, on bacteriophages, which has often been discussed, the revised pharmaceutical legislation would make it possible to establish an adapted, tailor-made framework to take the specificities of these medicinal products into account. And really, as we have often said, we need a One Health approach to tackle AMR, and that is a priority for the EU’s global health strategy. And that’s why we have encouraged, at EU level, the Member States to exchange and cooperate via the AMR One Health network.

So I have really gone through a list of the measures that we are taking, the actions that we are putting into place to tackle AMR. But I want to close by saying that I believe that we all come from a common point and that is that we urgently need to address antimicrobial resistance. We cannot afford not to act. We need to have ambitious actions and we need to ensure that we combine bringing new, innovative antimicrobials onto the market, but at the same time having awareness of prudent use and of what we need to do to strengthen our health systems. So I look forward to hearing your views and look forward to working with you on this important topic.

 
  
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  Tomislav Sokol, u ime kluba PPE. – Poštovana predsjedavajuća, povjerenice, kolegice i kolege, bakterije otporne na antibiotike svake godine uzrokuju više od 670 tisuća infekcija, od čega umire otprilike 35 tisuća ljudi u Europskoj uniji. Antimikrobna otpornost problem je koji ni jedna država članica ne može sama riješiti te je zajednički europski odgovor nužan, kao što smo već danas čuli.

Ovdje treba posebno naglasiti važnost razmjene podataka kako bismo u stvarnom vremenu imali informacije o antimikrobnoj otpornosti i potrošnji antimikrobnih sredstava na svim razinama. Zbog toga je ključno da što prije dovršimo pregovore i uspostavimo europski prostor za zdravstvene podatke.

Dalje: posebno je važno stvoriti europski pravni okvir koji će jače poticati istraživanje i inovacije, budući da neuspjeh u razvoju i proizvodnji djelotvornih novih antibiotika pogoršava posljedice antimikrobne otpornosti. U tom smislu, smatram da prijedlog Komisije o reformi farmaceutskog zakonodavstva ide u dobrom smjeru, ali naravno, poboljšanja su uvijek moguća. Osim toga, bitno je na razini država članica osigurati odgovarajuće infrastrukturne i ljudske resurse za sprečavanje i kontrolu infekcija te za programe za poboljšanje usluga vodoopskrbe, odvodnje i higijene.

Na kraju, moramo dodatno uložiti u razboritu uporabu antimikrobnih sredstava, provedbu smjernica EU-a i osmišljavanje mjera za zdravstvene djelatnike, kako bi se zajamčilo da se pridržavaju smjernica o liječenju uobičajenih infekcija.

 
  
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  Heléne Fritzon, för S&D-gruppen. – Fru talman! Kommissionär! Jag vill börja med att tacka mina kollegor för det goda arbetet med resolutionen.

Antimikrobiell resistens är en ödesfråga för EU och världen. Ska vi lyckas motverka den måste vi samarbeta internationellt, och därför är det så viktigt att vi på EU-nivå tar kampen mot antibiotikaresistensen. Vi måste se till att budskapen från den här resolutionen också återspeglas i revideringen av EU:s läkemedelslagstiftning. Och vi behöver göra ännu mer.

En avgörande fråga är hur vi ska få fram ny antibiotika. Om vi blickar mot mitt hemland – Sverige – ser jag att det är möjligt. I Sverige har vi fått tillgång till flera nya läkemedel tidigare än andra länder i Europa, bland annat genom den ersättningsmodell för vissa antibiotika som ju liknar det voucher-system som kommissionen har föreslagit.

Jag ser fram emot att utveckla detta förslag i revideringen av läkemedelslagstiftningen. Det är dags för EU att på allvar kliva fram.

 
  
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  Billy Kelleher, on behalf of the Renew Group. – Madam President, I welcome the urgency with which this issue is now being dealt with, and I welcome the fact that it was part and parcel of the pharmaceutical strategy in terms of combating antimicrobial resistance and the ‘one health’ approach.

As referenced, it is a silent killer: 35 000 people approximately die every year in the European Union. That number is rising. There are 700 000 infections across Europe every year. So it's putting additional pressure on our health systems right across Europe as well, so we do have to address it very, very quickly. Overprescribing, Commissioner, is a clear issue that has to be addressed. We are becoming very dependent on antibiotics as the first line of defence in terms of dealing with illnesses and sickness. And certainly that is an area that we have to address.

The issue of innovation and research – I welcome the push pull factor that you referenced, but we do really have to ramp up the research and innovation into new antibiotics and into antimicrobial resistance as well, to support companies in the areas of research, so that we can bring forward new medicines that will be able to address the issue of antimicrobial resistance. So I commend this and hope that it will be pushed forward as quickly as possible.

 
  
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  Tilly Metz, au nom du groupe Verts/ALE. – Madame la Présidente, chère Commissaire, chers collègues, je suis heureuse que le Parlement européen prenne une nouvelle fois position pour demander aux États membres d’être cohérents dans leur action contre l’antibiorésistance.

On parle de pandémie silencieuse, mais les conséquences sont criantes. Plus de 35 000 personnes meurent chaque année dans l’Union à cause d’une bactérie résistante aux antibiotiques, et cela ne fera qu’augmenter, dépassant le nombre de patients décédant du cancer. Sans parler des coûts sociétaux qui dépasseront ceux de la crise financière de 2008.

Le message central de cette résolution est qu’il est grand temps d’agir, et ce en amont. Nous savons que l’usage actuel abusif des antibiotiques pour la santé humaine et animale ne contribue en fait qu’à amplifier l’antibiorésistance, de même que le rejet des produits pharmaceutiques et agricoles dans l’environnement. Alors changeons nos pratiques et appliquons l’approche «One health» afin d’être cohérents. J’appelle aussi les États membres à mettre à disposition les ressources nécessaires pour mettre en place les plans nationaux de lutte contre l’antibiorésistance.

 
  
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  Joanna Kopcińska, w imieniu grupy ECR. – Pani Przewodnicząca! Szanowna Pani Komisarz! Niewłaściwe stosowanie środków przeciwdrobnoustrojowych doprowadziło na przestrzeni czasu do narastającego problemu oporności na środki przeciwdrobnoustrojowe do tego stopnia, że zagrożenie to zostało uznane za jedno z dziesięciu największych globalnych wyzwań dla zdrowia publicznego. Dlatego kiedy w zeszłym roku adresowałam interpelacje do Komisji odnośnie do kryteriów wyznaczania środków przeciwdrobnoustrojowych, w otrzymanej odpowiedzi przewijało się pojęcie solidarnych i wspólnych wysiłków ekspertów z zakresu medycyny, weterynarii, z organów krajowych, agencji unijnych i środowisk akademickich, tak aby sprostać temu zagrożeniu dla zdrowia publicznego.

Dzisiaj podobnie jest z głosowaną rezolucją, która diagnozuje problem AMR właśnie jako wspólne wysiłki. I choć dobór niektórych środków może budzić kontrowersje, to niemniej jednak dla mnie, jako osoby związanej przede wszystkim z polityką zdrowia publicznego, właściwe jest przyjęcie takiej metodologii prac, która przed 2050 r. przyczyni się do zmniejszenia liczby ofiar śmiertelnych. W przeciwnym razie śmierć poniesie ponad 10 milionów osób rocznie, a to więcej niż przewidywana liczba łącznych zgonów z powodu nowotworów i cukrzycy.

 
  
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  Kateřina Konečná, za skupinu The Left. – Paní předsedající, asi všichni uznáváme nutnost bojovat s antimikrobiální rezistencí a moc děkuji za tu rezoluci, kterou tady dnes máme. I nový farmaceutický balíček je ústy Komise prezentován tak, že má pomoci s touto tikající bombou. Bohužel dopadlo to jako vždycky. S řešením antimikrobiální rezistence v novém balíčku se prostě nemohu ztotožnit. Asi největším zlem je samozřejmě navržená pobídka, která by odměnila vývojáře nových antibiotik takzvaným prodejním poukazem, tedy voucherem, který by umožnil speciální neomezenou roční ochrannou exkluzivitu pro lék dle výběru dané společnosti. Jako by to nestačilo, tak s těmito vouchery bude dál následně možno také obchodovat. To je přece ale naprosto skandální!

Komise zde nejenom, že reálně neřeší problém antimikrobiální rezistence, ale navíc ještě vytváří sekundární spekulační trh s léky. Co se asi tak stane? Na které léky myslíte, že dané společnosti vouchery uplatní? No samozřejmě na ty nejdražší a nejvíce poptávané léky ze svého portfolia, aby na úkor například pacientů se vzácným onemocněním a našich veřejných systémů zdravotního pojištění maximalizovali své zisky. S tím se já ani má skupina prostě nemůžeme a nehodláme smířit.

 
  
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  Peter Liese (PPE). – Frau Präsidentin! Liebe Kolleginnen und Kollegen, es ist wirklich dramatisch. Vor einigen Jahren starben 30 000 Menschen jährlich in der EU an Antibiotikaresistenzen. Jetzt sind wir schon bei 35 000 und es wird jedes Jahr schlimmer. Deswegen müssen wir endlich aufhören mit dem Schwarzer-Peter-Spiel.

Viele meiner Berufskollegen – Humanmediziner – sagen, in der Tiermedizin muss gehandelt werden. Die Tiermediziner sagen, in der Humanmedizin muss gehandelt werden. Die Grünen sagen, wir brauchen strengere Kontrollen. Liberale und wir Christdemokraten sagen zu Recht, wir brauchen Innovation, wir brauchen auch die Vouchers.

Meine Meinung ist: Wir brauchen dies alles. Wir müssen aufhören, die Vorschläge zu kritisieren und zu sagen, man müsste es irgendwie anders machen. Alle Vorschläge, die auf dem Tisch liegen, müssen umgesetzt werden. Und wer wie Kateřina Konečná rummäkelt an dem Voucher, der soll einen besseren Vorschlag machen. Es ist vorbei mit dem Schwarzer-Peter-Spiel, wir müssen dieses Problem endlich anpacken!

 
  
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  Sara Cerdas (S&D). – Senhora Presidente, Senhora Comissária, Caros Colegas, há três grandes fatores responsáveis pelo aumento da esperança média de vida nos últimos 100 anos: o acesso à água potável e saneamento básico, a vacinação e os antibióticos. No entanto, nos últimos anos a resistência aos antimicrobianos aumentou por diversas razões já aqui mencionadas. Aliás, prevê-se que em 2050 venha a ter tantas repercussões económicas como teve a crise de 2008.

Precisamos, assim, de mudar. E é imoral também que, perante este problema, 8 % dos antibióticos para consumo humano ocorram sem prescrição e que 73 % de todos os antibióticos sejam utilizados em animais criados para consumo alimentar. Este é mais um grave problema à escala mundial e nenhum Estado-Membro conseguirá lidar com ele individualmente.

Precisamos, assim, de mais coordenação e cooperação entre os Estados—Membros e a Comissão Europeia, de planos de ação nacionais focados e consequentes, e de inovação científica para novos métodos terapêuticos e também de diagnóstico.

Os microrganismos não conhecem fronteiras e a saúde global está em risco. Assim, precisamos de atuar urgentemente.

 
  
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  Véronique Trillet-Lenoir (Renew). – Madame la Présidente, vous avez raison, Madame la Commissaire, contrairement à ce qu’on entend, la résistance aux antimicrobiens n’est pas une pandémie silencieuse. 35 000 morts par an dans l’Union et chaque jour dans nos hôpitaux, des patients infectés par des bactéries multi-résistantes. Ce fléau illustre douloureusement le concept de «One Health» et il impose une réponse ambitieuse à tous les échelons de la gouvernance:

au niveau des États membres, sensibilisation des citoyens et formation des professionnels; au niveau européen, incitation à la recherche et au développement via les PIEC et grâce à HERA; au niveau international, dans le cadre du futur accord de l’OMS sur les pandémies.

Nous adressons ici un message uni à la Commission et au Conseil. Il faut des mesures législatives fortes. Le Parlement européen dispose avec la révision de la stratégie pharmaceutique d’un outil approprié dont il saura se servir.

 
  
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  João Pimenta Lopes (The Left). – Senhora Presidente, o aumento das resistências antimicrobianas e o uso generalizado de antibióticos são reconhecidos problemas de saúde pública que exigem ação e decisão política.

Importa rejeitar a instrumentalização desta questão por aqueles, como as multinacionais farmacêuticas, que privilegiam o lucro sobre o direito à saúde. Como rejeitar abordagens de responsabilização do indivíduo que mascaram o impacto da opção política da falta de investimento nos serviços públicos de saúde, no agravamento desta situação, dificultando quer a prevenção, quer a adequada gestão da resistência antimicrobiana.

Importa intervir também na alteração dos modos de produção agropecuária, combatendo a produção intensiva que emprega elevadas cargas de antibióticos ou práticas genómicas na produção de sementes geneticamente modificadas, e cujos marcadores contribuem para a resistência antimicrobiana.

Um verdadeiro combate a este problema exige mudança de políticas que promovam o investimento em serviços de saúde públicos de qualidade, promovendo uma maior prudência e vigilância e mais investigação pública neste domínio para o desenvolvimento de novas alternativas e de novos agentes antimicrobianos.

 
  
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  Deirdre Clune (PPE). – Madam President, AMR – antimicrobial resistance – is one of the biggest threats to public health today. The medicines that we use so widely and are so available, and that have had such an impact on our healthcare from minor to major illness, are becoming less effective as the bacteria that antibiotics are tackling are becoming increasingly resistant.

We need more innovation and new developments in this area and the World Health Organisation has been critical of the lack of worldwide action in developing new medicines. So it’s significant and important, Commissioner, that the pharmaceutical legislation addresses this issue and aims to increase further development of antibiotics. But more and better medicines are not the only answer: they are part of a solution. We need a range of actions taking into account human health and welfare, animal health and production, and food and food safety.

Today, we are all aware of the effects that a worldwide pandemic can have on our health, our societies, our economies. We did not see COVID coming, but we can see AMR coming and we need action now, urgently.

 
  
 

Catch-the-eye procedure

 
  
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  Maria Grapini (S&D). – Doamnă președintă, mă bucur că discutăm acest subiect, pentru că eu cred că nimic nu este mai important decât sănătatea oamenilor și este foarte bine să punem accent pe cercetare și inovare, pentru că da, sigur, avem nevoie de noi antibiotice, de noi medicamente care să poată să pună capăt acestor cazuri. S-a spus aici: 35 de mii de decese pentru infecții microbiene. Problema pe care eu vreau să o ridic, doamnă comisar, este ca rezultatul cercetării să ajungă în toate statele membre.

Da, sănătatea este de competență națională, dar eu cred că libera circulație a cetățenilor face să fie nevoie să avem o politică de sănătate și să dăm rezultatul cercetării. Până la urmă, alocați niște bugete tuturor statelor membre și sper să nu se întâmple ca și cu Pfizer, să livrăm bani acolo pentru cercetare și să avem rezultate negative. Eu sper într-o politică de sănătate echitabilă pentru toți cetățenii, care trebuie să poată să-și cumpere aceste medicamente sau să li se asigure gratuit, în funcție de boala pe care o au.

 
  
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  Juozas Olekas (S&D). – Gerbiamas Pirmininke, gerbiama komisijos nare. Iš tikrųjų antimikrobinis atsparumas – tai dar viena pandemija, kuri žudo mūsų žmones. Trisdešimt penki tūkstančiai mirštančių žmonių yra didelė visų netektis. Viena iš priežasčių yra per daug platus antimikrobinių preparatų naudojimas, ypatingai antibiotikų, jų prieinamumas. Tiek gydant žmones, tiek veterinarijoje. Todėl manau, kad pateiktas dokumentas yra labai svarbus. Mums reikia bendresnių metodologijų, mums reikia vienodesnių gydymo schemų, mums reikia didesnio koordinavimo tarp šalių narių ir komisijų ir taip pat reikia mokslo naujovių įdiegimo. Todėl sveikinu pateiktą DEKO dokumentą ir kviečiu jį palaikyti, nes manau, kad įgyvendinus jo nuostatas, mes turėsime geresnę informaciją tiek medikų tarpe, tiek mūsų piliečių bendruomenėje, ir galėsime sureguliuoti antibiotikų naudojimą ir sumažinti antimikrobinį atsparumą ir mirtis nuo šios pandemijos.

 
  
 

(End of catch-the-eye procedure)

 
  
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  Stella Kyriakides, Member of the Commission. – Madam President, dear Members, first of all, I want to thank you for the very fruitful exchange that we had today. A great deal has already been said, and I must say that I think that it’s one of the times that we agree on where we need to go. I think that we also need to agree on the fact that there can be no quick solutions to deal with a huge public health issue like antimicrobial resistance. It’s there and what we need to do is find solutions that are going to be effective, and to be able to be effective through the One Health approach.

It was mentioned that we need to have a methodology to reduce the number of deaths from AMR, and that is exactly what the Commission has proposed. Through the proposals in the pharmaceutical reform and the recommendation to the Member States what we are doing is proposing a way forward for us all to work together to bring down the number of deaths with AMR.

The transferable exclusivity vouchers were used and I am aware that this is a rather innovative approach, but we need to have an ambitious way of dealing with this problem. When we were looking at this in the proposal, I just want to assure you that the way these vouchers will be used will be under very strict conditions only for very novel antimicrobials and for a very specific number and term. So we are looking for ways to inspire innovation and bring new antimicrobials into the market.

And lastly I want to just spend the last 20 seconds of the time I have to stress the importance of public awareness. And this is where each and every person in this room, each Member of the European Parliament who has the contact with citizens, can help us spread the message of this silent pandemic on AMR. We need to raise public awareness. EU citizens need to understand what is at stake so that they monitor and have more prudent use of antimicrobials.

Thank you so much. I look forward to working with you, and I count on your support on the coming negotiations on the pharmaceutical package.

 
  
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  President. – The debate is closed. I have received one motion for a resolution to wind up the debate.

The vote will be held today.

(The sitting was suspended at 10.57)

 
  
  

VORSITZ: EVELYN REGNER
Vizepräsidentin

 
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