Az ülések szó szerinti jegyzőkönyve

2023. január 17., Kedd - Strasbourg

8. A légúti fertőzések számának megemelkedése és gyógyszerhiány Európában (vita)

  Predsedajúci. – Ďalším bodom programu je vyhlásenie Rady a Komisie k téme Nárast respiračných infekcií a nedostatok liekov v Európe (2023/2510(RSP)).

  Jessika Roswall, President-in-Office of the Council. – Mr President, honourable Members, Commissioner, I’m pleased to represent the Council in this debate.

Many Member States are currently facing an increase in respiratory infections due to the combined circulation of three viruses: the RS virus, influenza and the coronavirus. The current COVID—19 situation is considerably calmer compared to the past two years, partly due to the high level of vaccination coverage achieved in Europe.

However, this winter season brings new challenges. Respiratory infections have occurred earlier and in higher numbers than expected. More children are affected than usual. The seasonal flu epidemic has also begun earlier this year and cases continue to increase. The COVID crisis, as well as the Russian war of aggression against Ukraine are also having negative consequences on global supply chains and the pharmaceutical industry’s overall production capacities. Consequently, health systems across Europe, particularly hospitals and emergency departments, find themselves under pressure once again to meet the rising number of patients with respiratory diseases and the rising demands for medicines to treat these, such as antibiotics, antivirals and anti—inflammatories. I can assure you that the Swedish Presidency is monitoring the situation very carefully and will continue to do so.

The Presidency is also committed to promote action deemed necessary both at European and national level to enable sufficient supply of medicines across all Member States. We should work towards devising long—term sustainable solutions to the structural causes of these shortages.

The Presidency welcomes the upcoming Commission proposal on the revision of the pharmaceutical legislation, which aims to enhance the security supply of medicines and address the issue of shortages.

Thank you very much for your attention.

  Stella Kyriakides, Member of the Commission. – Mr President, honourable Members, first of all let me start by wishing everyone a Happy New Year and to say how important I think that we have this topic today on the agenda of the European Parliament because of the surge that we are witnessing in Europe in respiratory infections and of course the shortage of medicines.

We are now three years after the COVID—19 pandemic and of course the COVID virus is still circulating within Europe. And I wanted to share with you that we are closely monitoring the situation in China, and of course in the United States, where a new Omicron subvariant has appeared. And with the circulation of COVID and the impact of other respiratory viruses, we are facing a very challenging situation.

The lockdown measures that have been in place because of COVID for almost three years have made people understandably less exposed to respiratory viruses. And when we say this, it actually means that children that were born since the pandemic may have never encountered the influenza virus, for example. Member States have already reported high transmission rates in all population groups, but also that the season for the respiratory viruses has started earlier than usual. And this is putting huge pressure on already pressed health systems and workers. It may be triggering further staff shortages due to sick leave. And of course we can also possibly see stress—related anxiety and burnout as we saw in healthcare staff during the pandemic. I’m saying this because maintaining an adequate ratio between the staff and the patients in ICUs and paediatric wards is critical for patient safety and quality of care. Also, vaccination against respiratory viruses remains our best tool, our shield to protect citizens.

In areas with high circulation of respiratory viruses, healthcare facilities should consider making face masks a requirement for healthcare workers and visitors in healthcare facilities. So in the coming months, reinforcing our healthcare systems is a priority and also strengthening our healthcare force workforce.

Now, alongside this, we are also witnessing a shortage of medicines in some Member States, and particularly antibiotics and paediatric analgesics. As this is a global issue we are in close contact with our international counterparts, while also supporting Member States and industry. The systems and processes which we established during the pandemic and through the extended mandate – which was supported by this Parliament – of the European Medicines Agency, are helping us to better manage the situation.

We have already had discussions with industry and the main root causes which have been identified are the sharp increase in demand because of more respiratory infections, along with insufficient production capacity. As these products are authorised at national level, the Member States’ competent authorities are already putting mitigation measures in place. And, together with the European Medicines Agency, we are doing our very best to support but also to coordinate Member States and industry facing this challenge. We are doing this by deploying all the flexibility that the regulatory framework allows us to use in seeking ways with our industrial partners to rapidly increase production and to prevent and mitigate shortages. And if needed, HERA can step in and coordinate on behalf of the Member States the joint procurement of medical countermeasures, as we did during COVID, and also organised matchmaking events between industry actors in order to help increase production.

Honourable Members, I have often said from this podium that patients in the EU and across the EU, no matter where they live, must always have access to the medicines they need at affordable prices. And this is why, as has been mentioned before, we have the ambition to achieve this with a new pharmaceutical strategy for Europe. We will be proposing both non—legislative and legislative measures for better access and greater security of supplies for medicines in the EU. The proposal to revise the pharmaceutical legislation is a programme for March, and will be including stronger obligations for supply, earlier notifications of shortages and withdrawals, and enhanced transparency of stocks. Other non-legislative measures are being taken to keep the medicine supplies for the EU citizens and patients going.

So our objective remains to secure access to medicines for all patients in need and to avoid disruption of medicines in the EU. I look forward to hearing your interventions on this very important topic today.

  Nathalie Colin-Oesterlé, au nom du groupe PPE. – Monsieur le Président, pour lutter contre les pénuries de médicaments, notre continent doit avant tout redevenir attractif avec une politique industrielle ambitieuse, incitative et compétitive face à la Chine et aux États-Unis.

Grippe, bronchiolite, Covid-19: dès qu’une épidémie apparaît, de nombreux patients sont confrontés aux pénuries de médicaments. Ce phénomène n’est pas nouveau; en Europe, les pénuries de médicaments ont été multipliées par 20 en 20 ans. Les causes sont multiples: augmentation de la demande et compression des prix, manque de diversification des sources d’approvisionnement et délocalisations massives de la production de substances actives, puisque 80 à 85 % des principes actifs utilisés pour produire des médicaments en Europe sont importés de Chine et d’Inde et que 45 % des médicaments commercialisés en Europe sont produits hors Union européenne. Nous sommes aujourd’hui ultra dépendants de pays qui peuvent décider de limiter leurs exportations, que ce soit pour privilégier leurs populations – c’est le cas en Chine actuellement avec le paracétamol – ou en cas de conflits géopolitiques. Cette situation n’est pas tenable.

Dans mon rapport sur les pénuries de médicaments adopté dans cet hémicycle en septembre 2020, une très large majorité des recommandations ont été formulées: relocalisation de l’intégralité de la chaîne de fabrication du médicament, de la substance active au conditionnement et à la distribution, avec des incitations fiscales et financières et en autorisant les aides d’État pour inciter les industriels à produire en Europe, création d’une réserve européenne de médicaments essentiels, surveillance européenne des stocks tant au niveau des industriels que de chaque État membre et, pour les médicaments qui ne présentent plus de rentabilité, la création d’établissements européens pharmaceutiques à but non lucratif en capacité de produire ces médicaments souvent anciens, mais qui demeurent essentiels pour la santé publique.

Alors oui, depuis 2020, l’Union européenne a renforcé son arsenal législatif pour mieux répondre à l’urgence des crises sanitaires. Il est temps désormais de privilégier le made in Europe pour retrouver une souveraineté sanitaire.

  Tiemo Wölken, im Namen der S&D-Fraktion. – Herr Präsident, sehr geehrte Frau Kommissarin, liebe Vertreter des Rates! Die Corona-Pandemie beschäftigt uns tatsächlich seit drei Jahren. Wir konnten als Europäische Union nach anfänglichen Schwierigkeiten das Schlimmste abwenden, und aufgrund der Maßnahmen zur Bekämpfung der Corona-Pandemie sind auch andere saisonale Krankheiten, wie das insbesondere für Säuglinge sehr gefährliche RS-Virus, und andere Viren – auch Grippeviren – zurückgegangen.

Es ist daher nicht verwunderlich, dass mit der Lockerung der Corona-Maßnahmen Infektionskrankheiten jetzt wieder ausbrechen und ihren Weg in die Gesellschaft finden, insbesondere in den Wintermonaten. Aber was wir in den vergangenen Wochen und Monaten gesehen haben neben weiteren Corona-Infektionen, neben der Grippewelle – insbesondere den dramatischen Anstieg von RS-Infektionen –, ist tatsächlich besorgniserregend.

Wir kommen an die Grenze der präventiven und therapeutischen Behandlungsmöglichkeiten, sowohl in den Kinderkliniken als auch bei Erwachsenen. Mitarbeiterinnen und Mitarbeiter, Ärztinnen und Ärzte sind und arbeiten über ihre Belastungsgrenze. Und es gibt, das wurde gerade schon erwähnt, dramatische Medikamentenengpässe. Daher kann ich die Forderungen, die wir hier in diesem Haus, auch auf Vorschlag meiner Fraktion hin, gemacht haben, nur wiederholen: Die europäische Produktion von Schlüsselprodukten in der Arzneimittelindustrie muss gestärkt werden, sie muss hier stattfinden.

Wir brauchen eine widerstandsfähige Gesundheitsindustrie. Wir brauchen eine Versorgung für die Krankenhäuser, für die Arztpraxen, hier aus Europa – nicht zuletzt vor dem Hintergrund, dass China, wie meine Kollegin vor mir das auch schon erwähnt hat, insbesondere Medikamente zurückhält und nicht mehr exportiert. Deswegen müssen wir jetzt aufhören, nur zu sagen, dass wir Maßnahmen brauchen, um die Herstellung hier wieder herzuholen und hier durchzuführen. Wir müssen endlich handeln, und dafür braucht es endlich den Vorschlag der Europäischen Kommission zur Arzneimittelstrategie. Damit hätten wir den Schlüssel in der Hand, als Europa eng zusammenzustehen, wie wir das in der Corona-Pandemie getan haben. Wir sind in Vielfalt geeint, und gemeinsam sind wir immer stärker. Sehr geehrte Frau Kommissarin, wir freuen uns auf Ihren Vorschlag.

  Véronique Trillet-Lenoir, au nom du groupe Renew. – Monsieur le Président, Madame la Commissaire, la triple épidémie de COVID-19, de grippe et de bronchiolite met nos systèmes de santé sous pression et génère des pénuries de médicaments essentiels. Mais cette situation aiguë survient sur un fond chronique de tension d’approvisionnement et nous en connaissons les principales causes: elles trouvent toutes leurs racines dans des anomalies du circuit de développement et de commercialisation du médicament au sein de l’Union.

En effet, à l’issue d’une autorisation de mise sur le marché européen unique, basée sur l’expertise de l’EMA, on assiste 27 fois, et de manière non coordonnée dans chaque État membre, à une nouvelle autorisation nationale, à un dispositif d’évaluation national, à une négociation bilatérale des prix, à un désintérêt profond des industriels pour les médicaments devenus peu rentables et à une gestion nationale des stocks qui met les États membres en compétition les uns avec les autres. Nous devons pouvoir restaurer le cercle vertueux de la souveraineté européenne: évaluation conjointe des médicaments, négociation collective des prix sur la base de coopérations renforcées, mobilisation des agences EMA et ERA. Les outils existent, la crise nous a montré qu’ils fonctionnent. Alors, profitons de l’opportunité de la révision de la législation pharmaceutique pour les renforcer.

  Tilly Metz, au nom du groupe Verts/ALE. – Monsieur le Président, la situation actuelle est alarmante et je comprends la colère des citoyens et citoyennes. D’une part, l’augmentation des virus respiratoires place les services d’urgence européens dans une situation extrêmement précaire et, d’autre part, les citoyennes et citoyens doivent subir des pénuries de médicaments, conséquence directe de la politique de laisser-faire appliquée depuis des années à l’industrie pharmaceutique. Le résultat? Une délocalisation massive de la production de médicaments, des pénuries, des patients qui ne reçoivent pas les soins nécessaires et un manque d’information effarant des pouvoirs publics afin de pouvoir agir.

En laissant la main entièrement au secteur privé, les pouvoirs publics, tant nationaux qu’européens, ont laissé place à la commercialisation systématique de la santé publique. En résulte la situation que nous connaissons aujourd’hui, où la santé des citoyens est mise à risque. J’aimerais donc que la Commission et le Conseil s’expriment sur les mesures qu’ils prévoient, d’abord à court terme, pour soutenir immédiatement les services publics de santé et s’approvisionner en médicaments essentiels, mais aussi, à plus long terme, pour assurer plus de transparence sur les chaînes de production du médicament, afin que les pouvoirs publics puissent agir en amont des pénuries et non juste en réaction. Et enfin, sur la possibilité de créer une entité publique européenne responsable de la production d’un minimum de médicaments essentiels de façon à toujours avoir un filet de sécurité.

  Simona Baldassarre, a nome del gruppo ID. – Signor Presidente, onorevoli colleghi, l'OMS allerta su un'impennata dei casi di infezioni respiratorie mentre in Europa viviamo una preoccupante carenza di antibiotici e di altri farmaci essenziali.

Siamo troppo dipendenti da paesi come Cina e India, che rappresentano addirittura il 66 % del nostro import di principi attivi. La dipendenza da altri paesi in settori strategici come il gas dalla Russia ha già mostrato che alla fine a pagare sono sempre i cittadini.

Bene parlare dunque di questi argomenti perché sono vitali, ma serve tenere chiaro l'obiettivo: renderci quanto più indipendenti nel comparto farmaceutico. Dobbiamo essere pronti. Guardiamo cosa avviene in Cina: 60 000 morti dall'inizio di dicembre, secondo le stime del governo. Un numero che fa paura e che non sappiamo quanto sia attendibile, data la poca trasparenza.

La salute è un bene comune di tutti gli europei. Serve un impegno serio per stimolare e sostenere la produzione di tutta la filiera del farmaco nei nostri paesi, dal principio attivo al prodotto finale. Ne va della salute e della vita di tanti cittadini.

  Joanna Kopcińska, w imieniu grupy ECR. – Panie Przewodniczący! Szanowna Pani Komisarz! Szanowni Państwo! Dostęp do leków jest kwestią bezpieczeństwa pacjentów, a termin „bezpieczeństwo zdrowotne” zawsze otwiera poważną dyskusję na temat wszystkich form właściwej odpowiedzi na jakikolwiek stan zagrożenia zdrowia publicznego.

Bezpieczeństwo zdrowotne Unii Europejskiej jest w ostatnim czasie zagrożone w związku z gwałtownym wzrostem liczby przypadków zakażeń bakteryjnych po zniesieniu przez kraje ograniczeń związanych z pandemią, co doprowadziło w konsekwencji do niedoborów antybiotyków oraz podstawowych leków.

Choć jestem świadoma, że przyczyny, które leżą u podstaw niedoborów leków, są złożone i wieloczynnikowe, gdyż obejmują wyzwania produkcyjne, limity branżowe oraz elementy gospodarcze, to mimo wszystko uważam, że strategia rozwiązania problemu musi przebiegać dwutorowo. Z jednej strony powinno się ograniczyć narażenie producentów na wstrząsy podażowe, a z drugiej zaś strony należy przemyśleć rozwiązania, które skutkować będą usprawnieniem mechanizmów nadzoru rynku i jasnym doprecyzowaniem katalogu problemów oraz precyzyjnymi danymi, których leków brakuje.

Kończę. Choć na efekt przywracania bezpieczeństwa lekowego przyjdzie jeszcze poczekać, to już dziś musimy myśleć o reorganizacji europejskiego środowiska produkcji leków.

  Kateřina Konečná, za skupinu The Left. – Pane předsedající, vážená paní komisařko, vážení kolegové, problém je samotný systém a všechny jeho úpravy, které zde děláme, jsou prostě pouze kosmetické a neřeší jej. Za současného legislativního stavu existuje řada opatření, kterými lze nedostatky léků alespoň zmírnit.

Dovolte mi připomenout, že Komise již před lety přišla s novou farmaceutickou strategií pro Evropu, ve které akcentovala potřebu vrátit část farmaceutické výroby zpět do EU. Nicméně ona ani členské státy již neuvedly, kdo to má zaplatit. A tak se roky nic neděje. Je potřeba se bavit také o obecném ukotvení léků a léčiv v právu Evropské unie. Dnes jsou léky brány jako obyčejné zboží, jako cukr, sůl, mouka, tudíž podléhají pravidlům společného trhu a principu nabídky a poptávky. A to se prostě musí změnit! Musíme vyřadit léky ze svobody volného pohybu zboží a více pohyb regulovat. Koneckonců navrhovala jsem to již v roce 2018.

V některých členských státech dnes s hrůzou zjistili, že dokonce neexistují centrální registry, které by člověku umožnily podívat se, ve kterých konkrétních lékárnách lék mají dostupný a ve kterých ne. Systém, který by to umožnil, jsem já i mí kolegové – někteří z nich tady sedí – navrhovali u nového mandátu EMA. Opět to bylo odmítnuto s tím, že takový registr by přinesl přílišnou administrativní zátěž.

Dále je pak potřeba zmínit absolutně nevyhovující, až tragickou úpravu patentového práva Evropské unie, které je nastaveno tak, že se vyrábí jen to, z čeho je nejvyšší marže. O té se zde zase pravice nechce vůbec bavit. Tak se v tom prostě plácáme a máme a budeme mít nedostatky léků, dokud ten systém nezměníme. Je to na nás, kolegové, ty návrhy tady jsou, je jen na nás, abychom měli odvahu je přijmout.

  Laura Ferrara (NI). – Signor Presidente, onorevoli colleghi, in Italia si registra la carenza temporanea di oltre 3 000 farmaci e gli altri Stati membri hanno problemi analoghi. Le cause non riguardano solo l'aumento della domanda per le ondate di Covid-19, per virus influenzali e infezioni respiratorie, vi sono infatti criticità produttive legate a costi energetici più elevati, a materie prime più costose e a difficoltà nella catena di approvvigionamento.

Diversi paesi europei continuano ad avere un problema di dipendenza dall'estero per l'accesso a prodotti farmaceutici e dispositivi sanitari. Vi è una concentrazione della produzione negli Stati terzi, con Cina e India in testa. È quindi prioritario accelerare la realizzazione degli obiettivi della strategia farmaceutica europea per aiutare il comparto ad accrescere la produzione e l'autonomia nell'Unione.

Nell'immediato si intervenga con misure coordinate a livello unionale per il reperimento, lo scambio e la distribuzione di medicinali necessari per ciascuno Stato membro, assicurando stoccaggi strategici e contrastando ogni speculazione per garantire determinate cure farmaceutiche.

Non lasciare indietro nessuno. Servono risposte unitarie ed europee.

  Bartosz Arłukowicz (PPE). – Panie Przewodniczący! Pani Komisarz! Rak udowadnia nam od wielu lat i każdego dnia udowadnia dalej, że bez wspólnej walki z rakiem, europejskiej walki z rakiem, światowej walki z rakiem jesteśmy bez szans. Udowodniła to pandemia, w czasie której zmarły setki tysięcy ludzi. Udowodniła to, że bez wspólnego działania nie jesteśmy w stanie uratować życia ludzi. I to jest ten moment, w którym musimy się zdecydować na to, o czym rozmawialiśmy w ramach Specjalnej komisji do spraw walki z rakiem. To jest ten moment, w którym Europa musi powiedzieć „dość” i Europa musi rozpocząć wspólne negocjacje cenowe dla leków dla Europejczyków, wspólne zakupy leków. W Europie musimy stworzyć system tworzenia zapasów leków krytycznie potrzebnych, żeby nie było sytuacji takiej, że nadchodzą kolejne fale wirusa, a ludzie biegają bezradnie od apteki do apteki po całej Europie i nie mogą kupić leków. Politycy są od tego, żeby ratować zdrowie i życie ludzi.

Europa potrafi budować drogi, szkoły, mosty. Europa musi stawić czoło walce z chorobami i walce o leki dla ludzi. Często słyszę, że zdrowie jest w rękach państw członkowskich. To wszystko prawda. Ale można się temu biernie przyglądać albo się na to nie zgadzać. Jeśli przepisy przeszkadzają ratować ludzi, to trzeba zmienić przepisy, żeby ratować ludzi. Musimy zacząć kupować wspólnie leki i musimy tworzyć europejskie zapasy leków krytycznie potrzebnych. Inaczej ludzie będą umierali, a my nie będziemy się mogli temu przyglądać biernie. Apeluję o to, pani komisarz. Rozmawialiśmy o tym wielokrotnie.

  Sara Cerdas (S&D). – Senhor Presidente, Senhora Comissária, Senhora Presidente do Conselho, Caros Colegas, precisamos de respostas para a escassez de medicamentos e a União Europeia tem capacidade de as concretizar. Precisamos que a Agência Europeia de Medicamentos seja capaz de identificar os fármacos em falta, mas também os pontos de produção e abastecimento onde há falhas. Precisamos de transparência das empresas no que diz respeito ao stock de produtos e à retirada dos mesmos do mercado, e também de avançar para a compra conjunta de medicamentos essenciais, tal como aconteceu para as vacinas contra a COVID-19. E também precisamos que esta nova estratégia farmacêutica para a Europa contribua para que a União Europeia seja autónoma e sustentável no que concerne à produção de fármacos.

O acesso a medicamentos não pode flutuar em consequência de guerras, da inflação ou outras disrupções. Milhões de vidas dependem destes fármacos e, por isso, também dependem daquilo que fazemos aqui no Parlamento Europeu, na União Europeia.

É esta a nossa obrigação, e só unidos conseguiremos estar à altura do desafio.

  Nicolae Ştefănuță (Renew). – Domnule președinte, doamnă Kyriakides, este 2023 și parcă ne întoarcem de unde am plecat.

Cazurile de gripe și de viroze respiratorii au explodat peste tot în Europa. Din farmacii și din spitale lipsesc medicamente de bază. Oare nu am învățat nimic din lunile grele de pandemie ?

În România, în plin sezon rece, lipsesc medicamente precum antibiotice, antivirale, antiinflamatorii. Asta în timp ce cresc numărul de cazuri, nu doar de gripe, ci și de gripă împreună cu COVID.

Spitalele sunt aproape la limită, complete. La Constanța, secția de Pediatrie a Spitalului de Boli Infecțioase nu mai are niciun pat liber în acest moment. Cum reușim să fim mereu nepregătiți când este sezonul infecțiilor respiratorii ? Nu mai putem glumi cu sănătatea oamenilor. Este vorba de integritatea și de bunul nume al Uniunii Europene. La mine în țară situația este clară. Oamenii cer medicamente și spitale decente. Vrem rezerve. Vrem ca Europa să fie solidară. Europa trebuie să ne ajute acum.

  Jutta Paulus (Verts/ALE). – Herr Präsident, Frau Kommissarin, meine Damen und Herren! Nach zwei Corona-Jahren, in denen das Tragen von Masken und Ausgangsbeschränkungen viele Infektionen verhindert haben, erleben wir nun einen massiven Anstieg von Atemwegserkrankungen, und die Gesundheitssysteme der Mitgliedstaaten sind schon wieder auf eine schwere Probe gestellt.

Jetzt höre ich ganz oft, daran sei die Maskenpflicht schuld, die das Immunsystem der Bürgerinnen und Bürger geschwächt habe. Das ist ein Fehlschluss: Das Immunsystem ist kein Muskel, den man trainieren muss, und das sage ich nicht einfach so, sondern das ist die Aussage von Epidemiologen und Immunologinnen weltweit. Überdies sind viele Säuglinge und Kleinkinder betroffen, die ja nie eine Maske getragen haben.

Tatsächlich mehren sich aber die Indizien und auch die Studien dafür, dass Corona-Infektionen das Immunsystem nachhaltig beeinträchtigen. Es gibt eine Vielzahl von Studien weltweit dazu und es werden täglich mehr. Deswegen frage ich die Kommission: Wann werden Sie endlich ein Programm auf den Weg bringen, das die Langzeitfolgen von Corona-Infektionen – sowohl Long Covid als auch Immunschäden – untersucht und die Forschung zu möglichen Therapien fördert?

  Sylvia Limmer (ID). – Herr Präsident! Tja, Pandemien sind eben praktisch, wenn es darum geht, sich Kompetenzen anzueignen, die Ihnen eigentlich nicht zustehen.

Dabei haben die Bürger gerade eine Odyssee hinter sich, auch befeuert aus Brüssel: mit Lockdowns ihrer Grundrechte beraubt, Staubmasken, von denen es noch 2021 von der EU-Gesundheitsbehörde ECDC hieß, sie hätten keinen Mehrwert – befohlen wurden sie trotzdem –, und eine Impfung, die bestenfalls, so die Pfizer-Vertreterin Frau Small im Corona-Sonderausschuss, Infektionen nicht verhindert.

Nun also eine Atemwegs- und RSV-Welle bei Kindern, eine Infektion, die ein Großteil der Kinder schon immer durchgemacht hat. Ich erinnere hier auch an die Welle der Saison von 2018/2019, in der man ebenfalls von einer Überlastung der Kliniken gesprochen hat. Was ist heute also anders? Zum Beispiel medizinisches Personal, das sich nicht mit experimentellen Impfstoffen zwangsimpfen lassen wollte und jetzt einfach mal weg ist. Oder die Geimpften, die oft dauerkrank sind. Oder woher kommt der von Ihnen genannte Anstieg der Erkrankungen, Frau Kommissarin?

Ja, es fehlen zum Teil über 300 überlebenswichtige Medikamente wie Krebstherapeutika, weil die Produktion in Billigländer ausgelagert wurde – übrigens nicht erst seit gestern. Aber Hauptsache, die Corona-Task-Force einer EU-Kommission hat die letzten Jahre Milliarden Steuergelder dafür ausgegeben, dass mRNA-Impfungen zu 100 Prozent innerhalb der EU hergestellt werden können. Denn das und nur das war das Kriterium für eine Entscheidung, welche Impfstoffe zugelassen und eingekauft werden. Sie lösen keine Probleme, Sie sind Teil des Problems.

  Cristian Terheş (ECR). – Mr President, dear colleagues. Is the European Commission part of the solution or part of the problem when it comes to shortage of medication in Europe?

This is the question that we must that we must ask now when the European Commission is asking for more power on handling medical crisis. Handling the COVID pandemic, prove that the European Commission is not the solution, but the cause of many problems on dealing with health crisis. While the focus of the Commission was to purchase astronomical quantities of alleged anti-COVID vaccines, people could not find antivirals or antibiotics in the European pharmacies.

Now we have a flu season and we debate again about shortage of different medicines, most notably antibiotics. This debate is the proof that the European Commission is not the solution, but the cause of many problems all across Europe.

The best thing the European Commission can do is to prevent the formation of medical monopolies and cartels and let the national states act in the best interests of their citizens.

  João Pimenta Lopes (The Left). – Senhor Presidente, aumentam os casos de infeções respiratórias e as complicações a elas associadas de morbilidade, e mesmo mortalidade, e da capacidade de resposta dos serviços de saúde.

Importa abordar as causas desta questão sem descurar, contudo, a dimensão social e a coincidência do agravamento das condições de vida das pessoas, para que as políticas da União Europeia contribuem, do empobrecimento generalizado, inibidor de melhores cuidados alimentares, da melhoria das condições de habitação ou da garantia do seu aquecimento.

A este problema associa-se, cada vez mais, a frequente situação de falta de medicamentos de natureza diversa, situação que não é alheia ao que são opções motivadas não pelo interesse das populações e saúde pública, mas pelos interesses das empresas farmacêuticas e seus lucros, em particular das multinacionais, para quem as instituições da União Europeia tudo facilitam.

Qualquer que seja a análise, a solução que é necessária, se queremos de facto responder a estes problemas, passa impreterivelmente por uma resposta pública, investindo e reforçando os serviços públicos nacionais de saúde, capacitando cada país produtiva e tecnicamente, e libertando patentes com vista a responder às suas necessidades quanto a medicamentos no quadro da sua soberania.

  Κώστας Παπαδάκης (NI). – Κύριε Πρόεδρε, αλήθεια, πώς γίνεται στην Ελλάδα των 30 μεγάλων φαρμακοβιομηχανιών να υπάρχουν εκρηκτικές ελλείψεις σε στοιχειώδη αναλγητικά φάρμακα, σε εισπνεόμενα, ακόμα και σε σκευάσματα για εξειδικευμένες θεραπείες; Γιατί υπάρχουν ανάλογες ελλείψεις και σε άλλες χώρες της Ευρωπαϊκής Ένωσης; Μα γιατί το φάρμακο είναι εμπόρευμα. Γιατί αυτή είναι η κανονικότητα των νόμων της καπιταλιστικής αγοράς και της ανταγωνιστικότητας, που επιβάλλουν παράλληλες εξαγωγές στις πλάτες του λαού. Κυβερνήσεις, Ευρωπαϊκή Ένωση και τα κόμματα που υπηρετούν τα συμφέροντα των ομίλων, όπως στην Ελλάδα η Νέα Δημοκρατία, ο ΣΥΡΙΖΑ και το ΠΑΣΟΚ, εκβιάζουν με ένα στόμα τον λαό με το δίλημμα «ή αύξηση τιμών ή ελλείψεις». Το ίδιο έργο είδαμε και στην πανδημία με τα εμβόλια και τους ανταγωνισμούς ομίλων, όπου και οι τελευταίες εξελίξεις επιβεβαιώνουν ότι το «διαφθορείο» της Ευρωπαϊκής Ένωσης είναι χωμένο μέχρι τον λαιμό. Ο λαός έχει τη δύναμη να επιβάλει το να πληρώσει το κεφάλαιο. Να απαγορευτούν οι παράλληλες εξαγωγές, για καθολική δωρεάν φαρμακευτική κάλυψη του λαού και για μια άλλη οικονομία με κριτήριο τις λαϊκές ανάγκες και όχι τα κέρδη των ομίλων.

  Stelios Kympouropoulos (PPE). – Mr President, Minister, Commissioner Kyriakides, colleagues, COVID-19 has made the last couple of years quite challenging for our health systems. However, we are now facing even greater challenges so we need an EU coordinated approach to overcome them. While the COVID-19 cases are rising in China, hospitals across the Member States are being overwhelmed by an early surge in respiratory infections but their hospital beds are full. As a result, persons with less urgent illnesses may face long waits, and kids who need cancer treatment or surgery may be sent home to wait.

As part of the pharmaceutical strategy, we need to address the rising admissions and the extreme shortage of medication in a holistic way and, of course, without compromising the health of other persons. Dear Commissioner, we need to know what measures the Commission will take in the short and the long term to ensure immediate access to all pharmaceutical products.

  Ivars Ijabs (Renew). – Prezidenta kungs! Komisāres kundze! Medikamentu trūkums Eiropā ir kļuvis hronisks, un mēs esam pieņēmuši ne vienu vien politikas dokumentu, bet no tās saukšanas tikai “halva, halva” mutē saldāks nekļūst. Es šeit gribētu uzsvērt divas lietas. Pirmkārt, ir vajadzīgs vienkāršāks, modernāks zāļu regulējums, jo šobrīd panākt medikamentu atbilstību Eiropas Farmācijas likuma saistībām un procedūrām ir ļoti, ļoti sarežģīti, un regulatīvā sistēma nav pietiekami digitalizēta. Ir jāpārskata Eiropas normatīvi, vienkāršojot un modernizējot tās procedūras. Tas uzlabos zāļu dzīves cikla pārvaldību, un digitālā infrastruktūra un digitālie rīki veicinās piegādes drošību. Sadarbība starp regulatoriem veicinās elastīgas piegāžu ķēdes. Otrām kārtām, mums ir labāk jāsaprot sakarības starp zāļu cenām, uzņēmumu peļņu un zāļu pieejamību. 27 dalībvalstu dažādo cenu veidošanās, maksāšanas, iepirkuma politiku džungļos var ļoti, ļoti retais tikt skaidrībā. Tāpēc valstu veselības zāļu dienestiem ir jānāk kopā, savstarpēji jāinformē un jāmācās, kā tikt pie labākiem rezultātiem, un tas tad arī ļautu panākt gan cilvēkiem pieejamākas cenas, gan arī piegāžu ķēžu drošību. Paldies!

  Michèle Rivasi (Verts/ALE). – Monsieur le Président, Madame la Commissaire, nous faisons face à l’heure actuelle en Europe, à une pénurie de médicaments. La situation est très préoccupante et, encore une fois, cela montre un peu les limites d’un système de production à flux tendu et fondé sur le profit. En France, les infections saisonnières sont reparties à la hausse, le Doliprane, l’Efferalgan, le paracétamol, et l’antibiotique amoxicilline sont venus s’ajouter à la liste des 277 médicaments en rupture de stock. En Irlande, 212 médicaments sont indisponibles, dont au moins onze figurant sur la liste des médicaments critiques de l’OMS.

Alors, on nous dit quoi? On nous dit que c’est à cause du nombre de malades trop élevé, à cause des prix des médicaments trop bas. Ou enfin, ce n’est pas cette fois un problème de substances actives, mais de façonnage, avec un manque d’approvisionnement en papier et en carton. Mais enfin, de qui se moque-t-on? Cela fait plus de dix ans que l’on tire la sonnette d’alarme et que la liste des pénuries s’allonge tous les ans. Si les labos ont négligé la production de certains médicaments pas assez rentables, il faut changer de fournisseur, il faut organiser une filière alternative.

Nous avons eu au Parlement un rapport de ma collègue Colin-Oesterlé où on avait proposé une alternative, c’est-à-dire un espèce d’établissement public-privé qui fabrique justement des médicaments qui ne sont pas intéressants pour le Big Pharma et qui peut produire justement des médicaments dont on a besoin. Il est donc urgent qu’on se bouge et qu’on fasse des propositions concrètes.

  Virginie Joron (ID). – Monsieur le Président, Madame la Commissaire, la pénurie de médicaments en France est devenue ahurissante et je suis furieuse, furieuse, d’apprendre qu’Elhana, six ans, est morte aux urgences à Montauban. Son père a confié à la presse qu’en 2023, perdre un enfant pour un antibiotique, ce n’est pas acceptable. En effet, ce n’est pas acceptable. Que font les Big pharma qui passent leur temps à délocaliser, à spéculer? Et maintenant, il faudrait défiscaliser pour obtenir du paracétamol? C’est vrai qu’ils ont trouvé un bon filon: négociation par SMS de milliards de doses de vaccins COVID.

En France, en 2023, on n’a plus d’hôpitaux, plus de soignants, plus de médicaments. C’est ça le bilan de 30 ans de Maastricht, avec la complicité de nos gouvernements, qui courent après les conseils de McKinsey. Comment expliquer que depuis des mois, les pharmaciens ont du mal à se procurer des médicaments de base comme les antibiotiques ou le paracétamol pédiatrique? Pour la Commission européenne, l’Europe va s’en occuper comme avec l’achat de millions de doses de vaccins COVID que plus personne ne veut.

Furieuse de voir qu’en même temps on est obligé de jeter des milliers de vaccins COVID périmés. Il y a urgence. Aucun parent ne peut accepter cette pénurie. Des comptes seront à rendre.

  Πέτρος Κόκκαλης (The Left). – Κύριε Πρόεδρε, κυρία Επίτροπε, η πανδημία απέδειξε ότι το αόρατο χέρι της αγοράς, το μικρό κράτος και η χρόνια αποεπένδυση από την κοινωνία και τη δημόσια υγεία είναι —αν όχι η αιτία της κρίσης της δημόσιας υγείας— ανεπαρκή για την αντιμετώπισή της. Απέδειξε ότι οι δημοκρατικές κυβερνήσεις μπορούν και οφείλουν να λάβουν ριζοσπαστικά μέτρα για την προστασία της δημόσιας υγείας και ανέδειξε την ανάγκη για μια κοινή ευρωπαϊκή πολιτική δημόσιας υγείας. Τρία χρόνια μετά, αντίθετα, παρατηρούμε ακόμα μεγαλύτερες ελλείψεις σε πρώτες ύλες και συνεπώς σε σκευάσματα, φαινόμενα απορρύθμισης στην αγορά του φαρμάκου και σοβαρά πλήγματα στα συστήματα δημόσιας υγείας με μαζικές παραιτήσεις προσωπικού και έλλειψη πόρων.

Σήμερα, λοιπόν, χρειαζόμαστε έναν πραγματικά ευρωπαϊκό σχεδιασμό στον τομέα της υγείας με βάση την προσέγγιση «Μία υγεία» στο πνεύμα της Ευρωπαϊκής Πράσινης Συμφωνίας, με πρώτο μέλημα την υποχρέωση της προστασίας των πολιτών από φαινόμενα αισχροκέρδειας σε καιρούς κρίσης, πολέμων, αλλά κυρίως της κλιματικής κατάρρευσης και της επερχόμενης εξάπλωσης των πανδημιών. Η Ελλάδα είναι χώρα αναφοράς στην τιμή του φαρμάκου. Το φαινόμενο της εξαγωγής σκευασμάτων προτού καλυφθεί η εγχώρια αγορά είναι αντικοινωνική πρακτική και οφείλει να απαγορευθεί. Η οικονομική στέρηση του ευρωπαϊκού Νότου δεν μπορεί να οδηγεί σε στέρηση φαρμάκων από τους πολίτες του Νότου —και ειδικά από τα παιδιά— σε μια ενωμένη Ευρώπη της αλληλεγγύης.

  Maria Angela Danzì (NI). – Signor Presidente, signora Commissaria, onorevoli colleghi, la grave carenza di farmaci di uso comune è un problema serio che non può più essere rimandato.

Dall'esperienza del Covid non sembra che abbiamo mutuato delle scelte da effettuare ed effettuare al più presto. Dal 1989 l'allora Comunità europea indicava la necessità che l'Europa intervenisse nelle politiche di controllo dei prezzi. Per il Movimento 5 Stelle l'Unione europea deve diventare garante della ricerca, della produzione e della creazione di scorte strategiche.

Non possiamo dipendere dalle scelte delle Big Pharma. Rafforziamo le funzioni di EMA sul fronte del controllo dei prezzi, della programmazione e della definizione di chiari standard a cui le aziende farmaceutiche si devono attenere prevedendo misure penalizzanti e premiali.

Creiamo un organismo di diritto pubblico partecipato dagli Stati centrali, da tutti i nostri Stati, una centrale di committenza che faccia degli accordi quadro per garantire un sistema di distribuzione dei farmaci che deve essere e deve rimanere ovunque unanimemente un servizio di interesse generale.

  Seán Kelly (PPE). – A Uachtaráin, over the past three years, the European Union has overcome extraordinary obstacles in our fight against COVID-19. Unfortunately, this winter has again been exceptionally challenging for our hospitals.

We are witnessing public health systems across the EU become overwhelmed and exhausted as a result of the recent surge of COVID-19, flu and RSV patients. Earlier this month, Ireland reached record levels of overcrowding, and it is clear that we are at crisis point.

Consequently, the surge of respiratory infections has had an effect on our medical supplies. It is vital that we take action and that our supply of medical products are assessed to ensure access to medicines for all patients in need. I also highlight the importance of coordination at European level. What we have learned over the past years is that a public health problem affects the functioning of all European sectors.

It is time for swift and immediate action.

  Milan Brglez (S&D). – Gospod predsednik! Razlogi za pomanjkanje zdravil v Evropski uniji so zmanjšana predvidljivost sezonskih bolezni po pandemiji, motnje v oskrbovalnih verigah, pomanjkanje delovne sile, umikanje zdravil s strani farmacevtske industrije, kjer ni dovolj velikih dobičkov, še zlasti z manjših trgov. Zaradi tega se državljani soočajo s pomanjkanjem več sto zdravil, pri čemer je posebej nedopustno, da to pomanjkanje najbolj prizadene otroke, zlasti tiste z redkimi boleznimi. Možni takojšnji ukrepi na tem področju so podpora proizvodnji na ravni Evropske unije, skupna javna naročila, zmanjšanje administrativnih ovir pri čezmejnem prenosu ter seveda državne zaloge ključnih zdravil. Vse te ustrezne rešitve so že vsebovane v evropski strategiji za zdravila, ki pa jo je potrebno dosledno upoštevati pri reviziji splošne zakonodaje EU o zdravilih. Strateška avtonomija in družbena odpornost bosta zgolj prazni obljubi, če odločevalci ne bomo uspeli zagotoviti zdravja našim državljankam in državljanom, še zlasti pa najmlajših.

  Andreas Glück (Renew). – Herr Präsident, Frau Kommissarin, werte Kolleginnen und Kollegen! Es wird Sie wundern, wenn ich das sage: Wir brauchen nicht überall ein bisschen Europa, aber wir brauchen ein starkes Europa an den richtigen Stellen. Und die richtigen Stellen sind genau dort, wo es um die Versorgung mit lebensnotwendigen Dingen geht, zum Beispiel mit Medikamenten, oder wo es um die strategische Ausrichtung von Dingen geht. Und wir brauchen uns nicht zu wundern, denn in der Vergangenheit haben wir die Frage der Versorgungssicherheit überhaupt gar nicht gestellt. Jeder hat immer nur beim billigsten Anbieter eingekauft.

Aber, meine sehr geehrten Damen und Herren, wir sind der größte Binnenmarkt der Welt. Alle haben es kapiert, aber nicht wir selber. Wenn jeder Mitgliedstaat einfach nur immer beim Billigsten einkauft, brauchen wir uns nicht wundern, wenn es weltweit gerade mal noch zwei oder drei Produktionsfirmen für bestimmte Medikamente gibt.

Wir müssen uns weiterentwickeln, wir brauchen ein Konzept zur gemeinsamen Beschaffung, wir brauchen eine Diversifizierung von Lieferketten, wir brauchen auch mehr Produktion in Europa, wir brauchen einen gemeinsamen Einkauf.

And as I said in the beginning, we don’t need a little bit of Europe everywhere, but we need a very strong Europe when it comes to the important stuff, and this is like one of the very important points here: we need a little less Member State and a little more Europe.

  Nicolaus Fest (ID). – Herr Präsident, Frau Kommissarin, verehrte Kollegen! Nun haben wir also einen massiven Anstieg von Atemwegserkrankungen und gleichzeitig einen Mangel an Medikamenten. Ein Kollege fragte vorhin, ob die EU-Kommission eigentlich nichts aus der Pandemie gelernt habe. Und die Antwort lautet nein.

Die EU-Kommission hat tatsächlich nichts gelernt. Man muss sagen: leider wie immer. Immer verspricht die EU-Kommission, dass nur sie die großen, die EU-weiten Probleme lösen könne. Aber wenn es dann eben zu solchen Problemen kommt, zeigt sich wieder und wieder: Die EU-Kommission ist unvorbereitet, sie ist unorganisiert und leider auch oftmals ahnungslos. Das war so bei COVID und der kopflosen Organisation von Impfungen. Das ist so beim Ukraine-Krieg, das ist so bei der Inflation, und das ist natürlich auch so bei der Energiekrise.

Jetzt sind wir also bei Atemwegserkrankungen. Es gehörte immer zu den großen Versprechungen der EU, dass sie das Wohl der Bürger befördert, nicht nur den Wohlstand. Nun sehen wir: In immer weiteren Bereichen tut sie nichts für das Wohl der Bürger, sondern unterminiert den Wohlstand und nun auch die körperliche Gesundheit.

Frau Kommissarin, wenn die EU-Kommission nicht irgendwann mal anfängt, ihre Versprechen zu erfüllen, dann muss man sich fragen: Warum gehört man eigentlich diesem Laden noch an?

  Sunčana Glavak (PPE). – Poštovani predsjedavajući i poštovana povjerenice, kolegice i kolege, neovisnost o trećim zemljama oko nabavke lijekova, rekla bih da moramo sagledati kao prvorazredno sigurnosno pitanje. Hrvatska, zemlja iz koje dolazim, u posljednjim tjednima bilježi, jednako tako kao što smo i ranije čuli, skok oboljelih pa je u prvim tjednima u siječnju prijavljeno oko 3000 slučajeva gripe, no sustav se zaista zasad dobro nosi s time i nema nestašice lijekova. Međutim, u ovom trenutku imamo trostruku pandemiju, možemo reći: gripu, respiratorne bolesti i, naravno, još uvijek prisutan COVID.

Fenomen nestašice lijekova nije nov, ali naravno, pogoršao se uslijed pandemije COVID-a 19 i, naravno, rata u Ukrajini. Situacija je bila vrlo loša i tijekom godina u svim zemljama i utjecala je na sve vrste lijekova. Glavni razlog, naravno, jest globalizacija proizvodnje lijekova u kojoj su različite faze proizvodnje podijeljene na više lokacija diljem svijeta, a kao što znamo, Kina i Indija proizvode između 60 i 80 posto svjetskih aktivnih farmaceutskih sastojaka.

Ova koncentracija tržišta, naravno, dolazi s rizicima kojima moramo hitno početi upravljati imajući na umu buduću perspektivu. Već smo dosada, završit ću, u više navrata u ovom parlamentu pozivali na osnivanje europske ljekarne i sustava redistribucije lijekova u slučaju nestašica i potrebna nam je konkretna legislativa.

  Alessandra Moretti (S&D). – Signor Presidente, signora Commissaria, onorevoli colleghi, credo sia molto importante discutere oggi di questo quadro complicato, che vede da un lato l'insorgenza di diversi ceppi di malattie respiratorie ed influenzali che si accodano al Covid e, in contemporanea, la carenza di alcuni tipi di medicinali che per alcuni paesi inizia a diventare preoccupante.

Alcune delle soluzioni sono state proposte da tempo dal Parlamento europeo che ha approvato la relazione sulla carenza dei medicinali, l'individuazione dei farmaci ritenuti strategici, un'iniziativa europea coordinata per l'approvvigionamento dei farmaci, il rafforzamento delle condizionalità legate ai finanziamenti pubblici alla ricerca e sviluppo, per fare solo alcuni esempi.

Credo però che una delle priorità sia oggi quella di spingere sempre di più con gli acquisti congiunti e il ruolo di coordinamento dell'Unione europea, che hanno funzionato bene per i vaccini e che potrebbero servire anche per affrontare le carenze di queste ultime settimane e sono fondamentali. Sarebbe un gravissimo errore se l'Europa non facesse tesoro di quanto accaduto durante la pandemia, ispirandosi alle migliori pratiche e ai successi che abbiamo ottenuto durante quel periodo così complicato.

  Ondřej Knotek (Renew). – Pane předsedající, paní komisařko, potřebujeme, aby byla Evropa soběstačná ve vývoji a výrobě léčiv a aktivních látek. Zaostáváme za Amerikou i Asií a jsme na těchto lokalitách závislí. Proto je nezbytné, aby výroba a vývoj léků pro Evropu probíhaly především v Evropě. Připravte, prosím, odpovídající programy, které nasměrují finanční prostředky k tomu, abychom posílili farmaceutické kapacity právě v Evropě. A to prosím s jedním, mimo jiné konkrétním úkolem – vyvinout nová antibiotika pro Evropu. Uvědomme si, že nedostatek léčiv či nízká účinnost antibiotik mohou mít pro obyvatelstvo fatální následky. Proto jsou investice do vývoje a výroby léčiv právě v Evropě tou nejdůležitější prioritou. Kromě lepší dostupnosti léčiv nám samozřejmě přinesou i dostatek kvalifikovaných pracovních míst.

  Nicolás González Casares (S&D). – Señor presidente, señora comisaria, una vez más en Europa nos encontramos en la situación de no poder ofrecerles a los pacientes las medicinas que necesitan.

Faltan analgésicos, antibióticos... Es cierto que la situación en China y la necesidad de este país de usar más medicamentos en la grave crisis de COVID-19 que está sufriendo hacen que haya una disrupción a nivel europeo. Somos capaces de monitorizar mejor que antes de la pandemia esta situación de desabastecimiento, gracias también a la reforma que hemos hecho de la Agencia Europea de Medicamentos, que nos da más herramientas, a pesar de las intenciones de la Comisión y del Consejo de limitar el alcance de esa reforma y dotarnos aún más de sistemas de monitorización. Pero sabemos que fallan y sabemos que fallan porque también hay un mercado europeo que no está funcionando adecuadamente.

Necesitamos revisar de una vez por todas la legislación farmacéutica para que podamos diseñar una profunda reestructuración de ese mercado. Estamos sin medicinas. Es un problema crónico que se repite, y seguimos esperando soluciones.

Este Parlamento ha hecho ya nada menos que dos resoluciones. Por lo tanto, tenemos que avanzar, comisaria. No podemos esperar más tiempo, porque además generamos mayores resistencias a antibióticos cuando estos faltan.

  István Ujhelyi (S&D). – Elnök Úr! Tegnap itt a plenáris ülésen szép szavakat hallgattunk meg az uniós egységes piac harmincéves születésnapjáról, ami valóban fontos, de minthogyha az egészségügyi szolgáltatások és termékek területén ez még nem érte volna utol az európai polgárokat. Én ma reggel azzal kellett kezdjek, hogy egy vércukormérő szenzort vadásztam, kerestem három gyógyszertárban is, ami Németországban alanyi jogon jár a cukorbetegeknek, Magyarországon nem is kapható egy sem belőle, itt is nehezen. Egy tizenéves fiúnak minden hónapban innen viszem haza. Ez normális?

Normális az, hogy nincsen az Európai Unióban olyan minimális egészségügyi szolgáltatás, amely minden európai polgárnak, éljen bárhol, ugyanúgy jár? Éppen ezért szükség van az európai egészségügyi unióra, szükség van benne egy egészségügyi minimumra, végre kell végre hajtani azt a bizonyos stressztesztet, amely minden ország egészségügyi szolgáltatási ellátását, beleértve a gyógyszerpiacot és beleértve az orvosi szolgáltatásokat is feltérképezi. És tudjuk, hogy mivel állunk szemben, mert szüksége van az Európai Unió minden polgárának egy egyforma, minimális, jó egészségügyi ellátásra. Ne divat legyen néha például pandémia esetén beszélni az egészségügyről európai szinten, hanem pandémia előtt is és utána is ugyanolyan aktívan foglalkozzunk vele.

Vystúpenia podľa postupu prihlásenia sa o slovo zdvihnutím ruky

  Deirdre Clune (PPE). – Mr President, as we can see, rising RSV, and cases of flu and corona have created enormous pressures on our health systems across Europe. And they’ve also highlighted a gap in terms of supply of essential medicines. The number of out—of—stock medicines in Ireland has risen to over 200 this week, and this is also in line with a pan-European shortage of critical elements that require a pan-European response.

We need to evaluate our methods of procurement, purchasing, storage and distribution of these key medicines, and we need to move towards increasing domestic production in Europe to reduce our dependency on imports.

Member States, led by the Commission, need to discuss common procurement, as we did during the pandemic. The people of Europe benefited from the common purchase of vaccines and they want to see this type of approach as well. As one speaker has said, we need to see more Europe in this area, a European approach now, to benefit all of our citizens.

  Tomislav Sokol (PPE). – Poštovani predsjedavajući, dok se Europa bori s visokim stopama inflacije, energetskom krizom i poremećajima u lancima opskrbe hranom, zdravstveni sustavi država članica pod sve većim su opterećenjem zbog porasta respiratornih infekcija. Uz to, nestašica lijekova dodatno pogoršava stanje u zdravstvu.

Osim što nedostaje djelatne tvari paracetamola posebno zabrinjavaju informacije da pacijenti sve teže dolaze do antibiotika, ali i, primjerice, lijekova koji se koriste za liječenje raka dojke. U takvim okolnostima važno je više nego ikad insistirati na stvaranju europske zdravstvene unije koja će moći zajedničkom politikom odgovoriti na izazove nestašica. Europska unija mora puno više financijski pomoći državama članicama u borbi protiv nedostatka zdravstvenih radnika. Osim toga, ciljanom industrijskom politikom moramo u Europu vratiti proizvodnju ključnih lijekova poput antibiotika, čiji nedostatak predstavlja sve veći problem jer je njihova proizvodnja danas naprosto neprofitabilna.

Ukratko, nužni su puno jači poticaji i potpore za proizvodnju lijekova u EU nego što ih imamo sada. Zaštita zdravlja europskih građana ne smije ovisiti o trećim državama kao što je danas slučaj.

(Ukončenie vystúpení podľa postupu prihlásenia sa o slovo zdvihnutím ruky)

  Stella Kyriakides, Member of the Commission. – Mr President, honourable Members of Parliament, first of all, thank you for this very important and constructive discussion.

Now I will start with what honourable Member of Parliament Sokol spoke about, and he spoke about needing a European response. And I have already said in my opening remarks – and I will be repeating it in my closing remarks – that yes, we do have a European response and that European response will be the pharmaceutical strategy we will be presenting at the end in March and that I hope we will have the opportunity to discuss within the European Parliament and the Council and that it will lead to the solution of many of the issues that we all recognise, not now because of the pandemic, but for a number of years it has to do with access to medicines and affordability across our Member States.

Now, since the pandemic we have all managed to work together, and I think that we also need to recognise that the work that we have done together in the pandemic, which I will not say has not resulted in any significant change, but I think that it is work that we can justifiably in many areas feel that we can take pride in, and it was work of the European Commission, of the Council and of the European Parliament, and a great deal of what has been achieved was achieved because of the constructive discussions we had with this Parliament. And because of our Serious Cross-border Health Threats Regulation, which, as you know, is in place now, we do now have the measures we need to respond. We have now integrated approaches to respiratory viruses. We have more robust sequencing and diagnostic capacities in Member States and we are supporting them with this, and we are reinforcing our healthcare workforce in many areas in this respect.

We are still facing a pandemic, and I never said that this was over. But we are better now in the Member States to identify, to assess and to respond to respiratory viruses than we were pre-pandemic.

Now, a great deal has been said by the honourable members of the European Parliament. I will stand by some of the words said by MEP Cerdas and MEP Wölken, who spoke about standing together, and I believe that this is what we need to be doing in the areas of health.

MEP Ştefănuță spoke about seeing an increase in respiratory viruses and that we are backsliding. I just wanted to mention here that I have been in touch with health ministers from very early on and I would say as early on as in the summer and autumn months, saying that in autumn and winter we would be expecting a surge possibly in respiratory viruses, so we have been working with Member States on the level of preparedness as a Commission from very early on.

In the comments that we heard today there was a comment which also spoke of the cancer plan. And here I feel that the cancer plan and the strategy on cancer is really such an important initiative that we can all be proud of as Council and as Parliament. A great deal has been achieved in the last three years with cancer. We presented new screening guidelines recently, and believe me, I never watch passively any issue which is related to citizens’ health, not for any day.

It was has also been said by MEP Limmer that we are part of the problem. I just want to say here that the European vaccine strategy I think is one of the biggest successes that we had in dealing with the pandemic, because every single European citizen had access to vaccines in every Member State at the same time. Now whether citizens decided to use those vaccines or not is different, because that’s very much a personal choice. But we did have vaccines available for all citizens. And vaccines do, as science says, prevent serious disease and hospitalisation and the issues of long COVID. And from the very beginning we have always followed very clearly scientific advice when giving recommendations to Member States.

Now what are we doing in the case of the drug shortages in the European market? The root cause of shortages of medicines is both very complex and is also multifactorial, and it can range from the vulnerabilities from the pharmaceutical value chain, the manufacturing challenges, the unanticipated increases in demand, and these are detailed in the Commission study that we did on shortages. I heard MEP Metz and Rivasi and Kympouropoulos all ask what we are doing about this. And the European Medicines Agency has been working very closely – I’m very sorry, President, I’m going to take a little bit longer, but there were many questions – have been working very closely with the Member States and industry in order to understand the root causes of medicine shortages, in order to monitor shortages and develop a stronger assessment, I would say, of the demands and the needs.

And specifically, for example, the industry has reported the root causes of amoxicillin shortages, and these are due to production capacity issues following a reduction of the production volume during COVID, then an unexpected increase in respiratory infections, particularly in children. And this is not an issue just affecting Member States: it is a global issue. So what are we doing about it? We have strengthened the mandate, working with the European Medicines Agency as part of our proposals for the European Health Union. The European Medicines Agency has been working from day one of this issue with all the national competent authorities, with industry, with all the stakeholders in order to resolve this.

We hold very regular exchanges between the EMA and the national competent authorities with a single—contact working party. There are then discussions ongoing with industry in order to identify the problems and to see what correction measures can be taken. And this is really the crucial point. We need to understand that we need to have mitigation measures, including a close engagement with the marketing authorisation holders, including engaging with other manufacturers to determine if we have other production capacity. We are strongly encouraging all the national regulatory authorities to consider and use the regulatory flexibilities available, for example, to allow the exceptional supply of certain medicines or presentations which may be not authorised in one Member State but may be authorised in others, and the EU has the opportunity to grant full or partial exemption to certain labelling or packaging requirements. So a great deal has been going on, also working at national level to advise to avoid hoarding.

Now on the issues to do with the open strategic autonomy approach in order to decrease dependency, which is extremely important, I think it was MEP Colin-Oesterlé who opened up with this, we’re working on a very important project here of common European interest to increase production in Europe and the resilience of the European industry post-COVID. But this, of course, is ongoing. But let me be clear that the ongoing shortages we are seeing now are not linked to a shortage of active pharmaceutical ingredients. They are all linked to the huge upsurge of cases of COVID we have in China.

In terms of stockpiles, at this stage, the EU does not have an intention to increase stockpiles of medicines on the basis of the current set of circumstances, because where there is insufficient market manufacturing capacity, stockpiling would not be resolving these issues.

Now, on pricing, pricing and reimbursement does remain the responsibility of Member States, but the EU does have a role to play, and the pharmaceutical strategy and reform will facilitate the earlier entry of generic, will improve transparency and will support the cooperation between the national authorities so as to exchange, for example, best practices on pricing, on reimbursement and procurement policies.

So I will end here by saying that I hope to be able to put forward this proposal in March. We are very aware of the pressure that health systems are under because of the increase of the respiratory viruses and because COVID is still ongoing. And we have been working since the very first days with Member States and all our agencies to see how we can support, but I have also really highlighted this to Member States from very early on, that this was the situation, the challenge that we would be facing in the autumn and winter months.

Thank you once again and thank you for the opportunity to be here.

  Jessika Roswall, President-in-Office of the Council. – Mr President, honourable Members, Commissioner, let me assure you that the action is being taken by the Member States at national level as required.

As you all are aware of, EU Member States are responsible for the organisation and delivery of their health-care policies and services. The Presidency, however, is ready to discuss possible coordinated actions and exchange of good practices.

The shortage of medicines in the EU is a recurrent issue. Therefore, in addition to resolve the current situation, we also have to consider long—term sustainable solutions to the structural causes of these shortages, as I said in my first statement.

In this sense, I also would like to recall the important step forward that was taken by the co—legislation in 2022 with a revised and enhanced mandate of the European Medicines Agency (EMA). The EMA is now responsible for monitoring medicines shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during a crisis.

Mr President, the Swedish Presidency will continue to monitor closely the situation and also in close contact, of course, with the Commission to consider any additional supportive measures that could be needed at the European level, both in the short and in the long term.

We count on the Parliament to be a part of these efforts. Thank you very much once again for a very interesting debate.

  President. – That concludes the debate.

Written statements (Rule 171)

  Josianne Cutajar (S&D), in writing. – As we recovered from the COVID-19 pandemic and prepared for the future, the European Commission committed to delivering a strong European Health Union, where medical supplies are available, affordable and innovative. Today, when we see respiratory infection viruses circulating with increasing transmission rates, we are still unprepared. We face a shortage of antibiotics and of medical devices caused also by Brexit, a shortage in raw materials, logistical issues, particularly transportation, and a lack of economic incentives to produce them within the EU. Hospitals in Europe are again overrun with patients, including small children. It is both frightening and unacceptable that we do not have enough capacity to cure the sick and vulnerable. Small children, our elderly and all those in need, should not be deprived of adequate, timely and affordable medicine and treatment. The lack of antibiotics and of life-sustaining medical devices are clear signs we need to reinforce our support for the innovation promised and for the entry on the market of medical devices. The health and lives of European citizens depend on infection prevention and control measures, on securing the supply of essential medicines and on our willingness to facilitate the Union’s strategic pharmaceutical production.

(The sitting was suspended at 14:40)

VORSITZ: RAINER WIELAND
Vizepräsident