unimelb-nlp/MultiEup-v2 huggingface dataset:
Debate: Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Catherine Amalric
Political group: Renew
Language: FR

Monsieur le Président, Monsieur le Commissaire, chers collègues, la proposition de révision des législations sur les dispositifs médicaux et les dispositifs médicaux in vitro a été publiée le 26 septembre 2012, suite au drame sanitaire des prothèses mammaires PIP, qui parle – oh combien! – au praticien hospitalier que j'étais alors.  Dix ans plus tard, la mise en œuvre de cette législation est toujours en discussion. Nous devons malheureusement admettre que l'application de ces règlements est loin d'être résolue. De par le trop faible nombre d'organismes notifiés, chargés de la certification notamment, mais aussi de par le manque d'anticipation et la carence aussi en personnel spécialisé. Depuis plusieurs mois, tous les acteurs de cette évaluation en font le constat et alertent les autorités compétentes, les industriels, les organismes notifiés. Répondre par des solutions pragmatiques et acceptables par tous s'impose, bien sûr.  Si nous sommes forcés d'adapter une nouvelle fois la réglementation pour éviter les ruptures d'approvisionnement potentiellement dangereuses pour les patients, cette adaptation doit être conçue de manière tout à fait provisoire, car il n'est pas question de remettre en question ce règlement nécessairement ambitieux parce qu'absolument nécessaire à la sécurité des patients européens, notamment pour les dispositifs de haute criticité. Parce que la sécurité des patients ne peut être en soi une variable d'ajustement, les normes sanitaires sont absolument essentielles dans nos législations européennes.
Debate: Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Marc Tarabella
Political group: NI
Country: Austria
Language: FR

Monsieur le Président, Monsieur le Commissaire, chers collègues, les dispositifs médicaux jouent un rôle sanitaire essentiel en offrant des solutions innovantes pour le diagnostic, la prévention et le traitement des maladies. Il existe plus de 500 000 types de dispositifs médicaux sur le marché européen, tels que des lentilles de contact, des prothèses ou des implants qui occupent une place importante dans le quotidien de dizaines de millions d'Européens.  Au vu de leur importance pour la santé, il est impératif d'éviter la pénurie, face aux difficultés rencontrées par les fabricants et organismes notifiés, mais sans négliger la nécessité d'assurer la traçabilité et la qualité des dispositifs. De plus, EUDAMED la base de données sur les dispositifs médicaux mis sur le marché de l'Union européenne doit être déployée plus rapidement, car elle permet aux citoyens d'avoir accès à des informations sur les dispositifs commercialisés, de se renseigner sur les incidents déclarés ainsi que sur l'avancée des études cliniques. La disponibilité des dispositifs médicaux sûrs pour les patients européens doit être une priorité. triste.
Debate: Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Tomislav Sokol
Political group: PPE
Country: Italy
Language: HR

Poštovani predsjedavajući, povjereniče, kolegice i kolege, tijekom donošenja zakonodavstva o medicinskim proizvodima i  Naime, sukladno ovom zakonodavstvu, svi medicinski IVD uređaji proizvedeni u Europi moraju biti ponovno certificirani putem prijavljenih tijela, a Brexit je dodatno zakomplicirao stvar jer su se mnoga prijavljena tijela nalazila u Velikoj Britaniji. Rezultat toga je da zamišljeni sustav sada ne funkcionira u praksi. U nekoliko navrata smo imali zato odgodu primjene određenih odredbi u navedenim zakonodavstvima. U 2022. godini smo imali 36 prijavljenih tijela koja su trebala certificirati oko 23 000 medicinskih uređaja i pritom izdati isto toliko certifikata. Stoga je rok za certifikaciju prebačen na 2027., a za neke uređaje čak i na 2028. Potrebna nam je, stoga, sustavna revizija zakonodavstva medicinskim proizvodima i
Debate: Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Maria Grapini
Political group: S-D
Country: Portugal
Language: RO

Domnule președinte, domnule comisar, stimați colegi, este foarte bine că discutăm astăzi despre securitatea pacienților. E târziu. Sigur, după 12 ani ne gândim să modificăm regulamentele. Prea mult ne conducem după principiul „mai bine mai târziu decât niciodată”. Domnule comisar, în țara mea și în multe alte țări pacienții nu au acces la dispozitive.  Să fii programat peste trei luni pentru o tomografie sau pentru un computer tomograf. Să nu ai acces la o proteză, să nu ai acces, așa cum s-a spus aici, pentru copii, la catetere sau lucruri esențiale. Este absolut uluitor că după atâția ani mor pacienții pentru că nu au acces la dispozitive. Pe de altă parte, există pe piața internă dispozitive care nu au performanță, nu sunt certificate și chiar a dus la deces utilizarea unor dispozitive.  Sistemele sanitare sunt în criză, este clar și sper, domnule comisar, că dacă acum analizăm și modificăm regulamentele, vom putea avea și accesul pacienților, indiferent în ce țară trăiesc, la aceste dispozitive, de care depinde, până la urmă, viața lor. Până la urmă, nimic nu este mai important decât viața oamenilor.
Debate: Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Deirdre Clune
Political group: PPE
Country: France
Language: EN

Mr President, the objectives of the Medical Device Regulation are not being met. It was developed to ensure patient safety, to give confidence to patients and medical practitioners that necessary devices were safe and fit for purpose, which I absolutely support. But there are problems with certification that is resulting in pressure on the sector to ensure availability of these necessary devices. Of course, extending transitional periods are welcome, but this is not a permanent solution. It will not give confidence to the industry to keep innovating and to keep producing. We need structural reforms to the Medical Device Regulation if we are to see any lasting effect. The current regulatory system, marked by its slowness and complexity, demands urgent action for European patients. In the first 100 days of the next Commission, the Commission needs to bring forward a proposal to fix this problem, or we will be left with a situation where Europeans are left without life-saving devices.
Debate: Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Stefania Zambelli
Political group: PPE
Country: Spain
Language: IT

Signor Presidente, signor Commissario, onorevoli colleghi, il tema dei dispositivi medici in Europa è importantissimo e di grande attualità.  Negli ultimi anni stiamo assistendo a una carenza di questi dispositivi: le aziende del settore hanno costi di produzione molto, molto alti e hanno bisogno di tecnologie all'avanguardia. Per questo, purtroppo, sono scoraggiate a produrre questi dispositivi salvavita, anche per quanto riguarda i bambini e i neonati.  Gli altissimi costi e la complessa procedura di certificazione stanno portando a una carenza di dispositivi pediatrici ed è per questo che ci troviamo di fronte a due grandi rischi: da una parte, la carenza di questi dispositivi mette a serio rischio la salute e la sopravvivenza dei cittadini europei che ne hanno bisogno; dall'altra c'è il rischio che i dispositivi medici vengano importati dalla Cina o da paesi terzi, aumentando la nostra dipendenza da Pechino nel campo proprio della salute.
Debate: Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Seán Kelly
Political group: PPE
Country: Greece
Language: EN

Also, as colleagues pointed out, we have to be very careful that we don’t drive companies out of Europe because of overregulation or not giving them the time to do the work they need to do, because innovation takes a lot of time, it isn’t always successful and we have to bear that in mind. But particularly, I think, as has been emphasised particularly by my colleague Deirdre Clune, as soon as the next Commission is up and running, they’ll have to do a complete overhaul of the regulations here, remove the unnecessary bureaucracy, and ensure that innovations can take place and also that patients will get the medical aid they need as quickly as possible. That has to be done and it shouldn’t be beyond our remit.
Debate: Next steps towards greater patient safety by swiftly ensuring the availability of medical devices through a targeted transitional period
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Didier Reynders
Language: EN

At the same time, the Commission launched a targeted evaluation of the two medical device regulations to analyse the structural problems related to their implementation, which will pave the way to identify possible solutions for the medium and long run. And together, we can continue to further promote innovation and safeguard patient safety in the European Union. So thank you very much for your contribution and for the different remarks that I have had the opportunity to listen to today.
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Tom Berendsen
Political group: PPE
Country: Netherlands
Language: NL

“Het is oorlog maar niemand die het ziet”: dat gold ook lang voor alles wat zich op de zeebodem afspeelt. Maar de waarschuwingen voor Russische spionage- en sabotageplannen in de Noordzee en de concrete voorbeelden van sabotage zijn talrijk. De baas van de Nederlandse MIVD, generaal Jan Swillens, drukte ons al met de neus op de feiten: de Russen hebben niet één schip, maar een heel programma dat erop gericht is om met name de onderwaterinfrastructuur in kaart te brengen, zodat ze daar eventueel verstorend kunnen optreden. Het belang van onderzeese kabels en leidingen is enorm: 97 % van de wereldwijde communicatie loopt via onderzeese internetkabels, 40 % van onze elektriciteit moet in 2030 van zee komen, en de leiding uit Noorwegen levert meer dan 25 % van het gas dat we in Europa gebruiken. Heel goed dus dat de Europese Commissie met verdere plannen komt om onze onderzeese infrastructuur te beschermen. Maar dit is natuurlijk niet genoeg. Stapjes die we met 27 landen kunnen zetten, gaan te langzaam. Er is nu actie nodig. Dat kunnen en moeten we niet allemaal tegelijk met elkaar willen doen. Daarom pleit het CDA voor een Europese kopgroep voor het beschermen van de onderwaterinfrastructuur, samen met de NAVO. Samenwerking tussen landen als Nederland, België, Noorwegen, het Verenigd Koninkrijk en Frankrijk. De eerste stappen zijn hiervoor gezet, maar het gaat nog te langzaam. We hebben snel fysieke beveiliging, cyberbeveiliging, internationale samenwerking en alternatieve kabels nodig. We hebben de verantwoordelijkheid om onze kritieke infrastructuur, onze burgers, onze economie te beschermen. Het is oorlog op de zeebodem en iedereen zou het moeten zien.
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Beatrice Covassi
Political group: S-D
Language: IT

Ma non solo: anche l'energia scorre sott'acqua. I cavi, che già collegano Stati membri e zone insulari, saranno sempre più importanti per un'Europa rinnovabile e interconnessa. Penso all'enorme potenziale dell'energia eolica offshore, così come l'obiettivo di un Mediterraneo dove l'energia colleghi sponde ancora troppo lontane.  Parliamo di infrastrutture altamente critiche che, in un contesto geopolitico instabile, hanno una funzione strategica e quindi devono essere protette da possibili attacchi. È di questi giorni la notizia preoccupante di danneggiamenti nel Mar Rosso a cavi essenziali per la connessione tra Europa e Asia: questo in una zona dove i combattenti Houthi hanno già colpito navi con droni e missili. Inoltre, ci sono i danni causati da eventi naturali o incidentali: penso alle reti da traino o alle ancore trascinate su fondali marini. È quindi importante un approccio integrato che abbracci la sicurezza, la qualità delle infrastrutture, la loro sostenibilità ambientale e le tecnologie per il loro dispiegamento, manutenzione e protezione. Ci sono grandi vascelli speciali posacavi di ultima generazione. Oggi abbiamo droni subacquei autonomi in grado di monitorare e proteggere queste infrastrutture.  È urgente una prospettiva europea. Bene quindi lo scambio di informazioni, le mappature, le valutazioni comuni dei rischi, la predisposizione di progetti strategici, come ha ricordato il Commissario. Ma non basta: occorre fin da ora lavorare alla diffusione di soluzioni innovative per contrastare le minacce e aumentare la resilienza dei cavi. Per questo servono fondi, a partire dal Fondo europeo per la difesa, il Meccanismo per collegare l'Europa e Orizzonte Europa.  Colleghi, la sicurezza e il futuro del progetto europeo passano anche dai fondali marini. Anche per questo io credo che sia davvero tempo di un Blue Deal europeo!
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Bart Groothuis
Political group: Renew
Country: Portugal
Language: EN

And last week, the European Commission put forward a good plan – finally, I must say – to help protect our subsea infrastructure. Thank you! But I ask you to focus only on the things that the EU does best, and leave the rest to NATO or individual Member States. First, make sure that Russian and Chinese companies are excluded from commercial projects connecting Europe with internet cables. I ask for binding rules so that they can be enforced by the European Commission. Secondly, actively increase the connectivity of our continent with the rest of the world so sabotage will be less effective and consumer prices will be lower. Thirdly, create joint European subsea capabilities. Start by setting a standard for a European repair ship, for example, and build it. Set a standard for coast guard vessels; jointly build them; set the standards and do it. Buy them; set up a joint programme around it for joint information sharing, joint response, joint mitigation. Plant a flag by building concrete capabilities.  I’ve seen plenty of strategy. Now let’s see the execution because with the current threat, execution is the strategy.
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Ciarán Cuffe
Political group: Verts/ALE
Country: Ireland
Language: EN

In 2022, the Russian Ministry of Defence proposed exercises over vital cables off the Irish coast. While this proposal was rescinded, it highlighted a key vulnerability. If our defence forces are to effectively defend the state against new hybrid threats, their budget must be upgraded. This will help plug the gaping holes in our ability to identify who or what traverses our sea and sky. We must work with our neighbours in the future to ensure that this infrastructure, which is critical for Ireland and the European Union, is protected. I welcome the Commission’s recommendations that we should regularly assess and improve the security and resilience of existing and new submarine cables infrastructure. And I believe that Ireland should participate in the PESCO Critical Maritime Infrastructure Protection project, in continued alignment with the state’s neutrality position. Bad actors still populate the international stage and, as long as they do, Ireland has a duty to ensure it can defend while also working peacefully to oppose them.
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Angel Dzhambazki
Political group: ECR
Country: Germany
Language: BG

Време е европейските държави да прогледнат и да разберат, че колегата от Холандия е прав. Европейският континент отдавна загуби времето, в което можеше да живее спокойно, мирно и безотговорно. Европейския континент живее в условията на война. Той е нападнат и това нападение не е само в полетата на Донбас, това нападение може да бъде и по въздух, и по вода, и под вода. И затова е крайно време да се осъзнае този факт и европейските правителства да се изправят лице в лице със заплахата, която стои срещу нас.  А за решаването, за отговарянето на тази заплаха трябва да се осъзнаят няколко простички факта. Времето на приказки, на компромиси, на безкрайни обещания отдавна е приключило. Трябва да бъде мобилизирана европейската икономика. Трябва да бъде възстановена европейската отбранителна способност. Трябва да престанат европейските държави да разчитат за своята защита само и единствено на основния стълб на Северноатлантическия договор, а именно Съединените американски щати.  Сегашната ситуация с европейските отбранителни арсенали показва това – изчерпани арсенали, неподготвени персонали, липса на мотив, на желание за служба в тези структури. Така че директивите са хубаво нещо. Само че те са началото. С директиви няма да опазим тези кабели, ще ги опазим, както казах, със съвместна работа, и то в Северноатлантическия договор. Това е инструментът, който може да защити тази инфраструктура.
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Gunnar Beck
Political group: ID
Country: Germany
Language: DE

Sprechen wir aber von wirklicher Sabotage: Nach den Nord-Stream-Sabotageakten ordneten einige Staaten sogenannte Ermittlungen an. Schweden fand nichts. Die dänische Ermittlung endete mit dem Befund, es handele sich eindeutig um Sabotage, aber das – man höre – sei keine Straftat. Deutsche Behörden fanden bislang nur Hinweise auf pro-ukrainische Amateurtaucher, die den gewaltigen Sprengsatz platziert haben sollen. Kein Experte hält solch eine Einzelaktion für möglich. Gleich nach dem Anschlag dankte der Pentagon-nahe polnische Außenminister Sikorski den USA für den Sabotageanschlag. Seitdem legte der Journalist Seymour Hersh detaillierte Recherchen vor, die Sikorskis Äußerungen untermauern. Vielleicht sollten Sie hier erst einmal über den Schutz wirklich kritischer Infrastruktur nachdenken. Stattdessen zünden Sie Nebelkerzen.
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Clare Daly
Political group: The Left
Country: France
Language: EN

And something happens regularly: 25% of cables are ruptured every single year by maritime activity, negligence and natural impacts. And nobody even notices because the traffic is simply rerouted. A report commissioned for the Security and Defence Committee – months after the Russian invasion of Ukraine – stated that there were no verified reports indicating deliberate attacks on the cable network by any actor, and that the large-scale scenario of complete lack of connectivity suggests a substantial risk of threat inflation. So is it not the case that this is just another part of the relentless drive to launder public money into the defence industry, this time underground? And what good would that do, considering the only actual explosion on the ground took place in a NATO heartland and nobody saw anything?
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Seán Kelly
Political group: PPE
Country: Greece
Language: EN

Approximately 75% of cables in the Northern Hemisphere pass through or are in close proximity to Irish waters. These cables play a crucial role in facilitating 97% – yes, 97% – of worldwide communications, encompassing financial transactions, business activities and everyday internet connectivity. No wonder Russian submarines have been observed more and more off our coast. It’s time for an Irish approach, but also a common EU approach. Ireland is also seen, unfortunately, as a soft touch for the transit of illegal drugs, as shown by the seizure of EUR 33 million of crystal meth in a warehouse not far from where I live, in my constituency, which came from Mexico and was eventually bound for Australia. If that doesn’t tell a message, what does?
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Nils Torvalds
Political group: Renew
Country: Romania
Language: SV

Herr talman! Herr kommissionär! Om vi kastar en blick på Europas karta, över Nordeuropas karta, ser vi en intressant sak som egentligen uppstod efter det att Ryssland inledde sitt krig mot ... ( Vi kunde se när det kinesiska fartyget släpade ett ankare efter sig och Baltic Connector gick av. Med den enkla teknologin kan vi förstöra alla förbindelser mellan Finland och Estland och Finland och Sverige, vilket försätter Finland i en oerhört utsatt position. Av den enkla orsaken är det av yttersta vikt att vi kan beskydda de här förbindelselederna. Det är också viktigt att i det här sammanhanget konstatera att nu, när Sverige har blivit medlem av Nato, är våra förutsättningar att bevaka Östersjön och våra kablar och våra förbindelseleder betydligt bättre än de var tidigare. Men det kommer att förutsätta att Europeiska unionen faktiskt tar det här på allvar.
Debate: Commission recommendation on secure and resilient submarine cables
Date: THURSDAY, 29 FEBRUARY 2024
Speaker: Cláudia Monteiro de Aguiar
Political group: PPE
Country: Austria
Language: PT

Senhor Presidente, Senhor Comissário, congratulo a Comissão por esta iniciativa que garante a resiliência e a segurança dos cabos submarinos. Para muitas regiões da União, como as ultraperiféricas e, em particular, a Madeira, de onde venho, os cabos submarinos são a quarta acessibilidade essencial ao desenvolvimento destas.  Senhor Comissário, lanço-lhe aqui o apelo para que, na elaboração dos projetos de interesse comum europeus para os cabos submarinos, as regiões ultraperiféricas sejam verdadeiramente reconhecidas. Não apenas pelos seus constrangimentos, mas pelo valor geoestratégico do seu posicionamento e dos seus projetos. A Madeira apresentou recentemente um projeto estratégico que permitirá não só ligar as três regiões ultraperiféricas, ou seja, a Madeira, os Açores e Canárias, mas igualmente potenciar a capacidade da atual rede que as fornece, ligando estas duas regiões portuguesas ao continente africano e ao Brasil através da rede já existente em Canárias. Esta aposta, ou a aposta neste tipo de investimentos, é altamente benéfica para estas regiões ultraperiféricas, pois permitem os acessos a dados sobre métricas ambientais, projetos científicos, deteção da atividade marítima, mas estou certa que a União reforçará os seus interesses em matéria de acessibilidade transatlântica e com o continente africano. Termino, Senhor Presidente, estes projetos permitem, de facto, reforçar a resiliência e segurança deste setor, mas permitem simultaneamente o desenvolvimento estratégico, económico e social das regiões envolvidas.