unimelb-nlp/MultiEup-v2 huggingface dataset:
Debate: Screening of third country nationals at the external borders - European Criminal Records Information System  - Third Country Nationals - Common procedure for international protection in the Union - Establishing a return border procedure, and amending Regulation  / - Asylum and migration management - Addressing situations of crisis and force majeure - Establishment of 'Eurodac' for the comparison of fingerprints for the effective application of Regulation  No , for identifying an illegally staying third-country national or stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes  - Union Resettlement Framework - Standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection - Standards for the reception of applicants for international protection
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Matjaž Nemec
Country: Greece
Language: SL

Vsi mi se zavedamo, da celoten paket – rešitev pred nami ni popolna, je pa kompromis. A alternative za tak paket ni. V kolikor bi ga danes zavrnili, bo Evropo pahnilo v veliko negotovost. S tem bi dali vetra predvsem populističnim silam. Sprejetje paketa je zato strateška nujnost za Evropsko unijo in je naša skupna odgovornost.  In takoj zatem se bomo morali osredotočiti na implementacijo. Nedvomno bo pri tem prišlo tudi do določenih izzivov in težav, in te bomo morali sproti naslavljati. Druge poti enostavno ni, spoštovani. To od nas pričakujejo tudi evropski državljani in državljanke.  Za konec zato še enkrat poziv vsem kolegom: podprite paket! Ni idealen, ampak alternative ni. Hvala vam, vsem kolegom, za podporo in za sodelovanje. Srečno, Evropa!
Debate: Screening of third country nationals at the external borders - European Criminal Records Information System  - Third Country Nationals - Common procedure for international protection in the Union - Establishing a return border procedure, and amending Regulation  / - Asylum and migration management - Addressing situations of crisis and force majeure - Establishment of 'Eurodac' for the comparison of fingerprints for the effective application of Regulation  No , for identifying an illegally staying third-country national or stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes  - Union Resettlement Framework - Standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection - Standards for the reception of applicants for international protection
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Sophia in 't Veld
Country: Poland
Language: EN

I have concerns and doubt, and I too struggle with the dilemma. But that is why we are in politics. Because having an opinion is easy. Voting for something perfect is not very difficult, but to take responsibility for dilemmas and difficult decisions is our job. The pact definitely contains problematic elements, risks and weaknesses and it is dishonest to deny that. But it is equally dishonest to claim that this pact is the end of the right to asylum, or that, in itself, it will lead to more violence at the borders. The violence today is not the result of the existing law, but of national policies and the absence of enforcement. I can defend the new Reception Conditions Directive without any hesitation, and those standards (which I had the pleasure to negotiate) will apply across the package. And if I had written the pact, it would look very different. But there will not be any fresh proposals on the table or a better negotiation result. It is false to create that impression and our job does not end here. We have an even bigger task in overseeing implementation and enforcement, and the best guarantee for European values is a solid majority of European liberal democrats who stand tall for human rights. So let’s make it happen in June.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Evelyn Regner
Country: Netherlands
Language: EN

The next item is the joint debate on: – the report by Pernille Weiss, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC  ( – the report by Tiemo Wölken, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Pernille Weiss
Country: Poland
Language: EN

With today’s vote, we take a step towards addressing current and future challenges, as well as opportunities of our healthcare ecosystems. Europe is increasingly falling behind other regions in pharmaceutical research and development investments. Novel technology is challenging the existing legislative framework, and the COVID-19 pandemic demonstrated the need for timely and equitable access to medicine, which should have already been obvious to all of us.  Our report on the pharmaceutical directive proposes mandatory measures to increase access to medicines across Europe, while recognising that the availability of medicine is not depending on industry decisions alone.  It proposes a more efficient regulatory framework while preserving quality, safety and efficacy standards and strengthening the protection of our environment. And it proposes a framework for incentives which, like a magnet, attracts products to Europe. This shall ensure that Europeans will always, also in the future, see medicine offered as soon as possible on our markets and developed to meet our needs, namely those needs which are not met today.  In less than a year, Members from all different political groups and parts of Europe came together to form this position in the midst of election season and heightened political polarisation, no less.  I would like to thank all colleagues involved in bringing this file here today, namely my co-rapporteur, MEPs Wölken, for the pharmaceutical package together with me, the shadow rapporteurs across all groups, my EPP Group colleagues who negotiated the regulation, MEP Sokol, and all our colleagues and our indispensable advisers who otherwise contributed with good suggestions and debate. Everything bricks making it possible to make good legislation in a professional and empathetic atmosphere.  I need not remind any colleagues of the widespread doubts regarding the Parliament reaching today’s vote. The true measure of our success lies, of course, not in this legislative milestone, but in the real impact our work will eventually have on patients’ lives.  Still, and very importantly, I look at the Council and hope that they will take note not only of our ambition for a swift adoption of the final legislation, but also our commitment in this House to collaborate, inspire and eventually reach a compromise that benefits the entire health care ecosystem in all corners of Europe.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Henna Virkkunen
Country: Italy
Language: EN

Europe must strengthen our economic and security capabilities across all critical sectors. One of these critical areas is the pharmaceutical industry. It’s one of our most important industrial sectors. It employs directly more than 840 000 people in Europe and invests over EUR 40 billion annually in research and development. These figures are significant, but the pace of growth and investments in comparison to regions such as Asia and the United States are significantly higher. It means that incentives for pharmaceutical and development research and new innovations in Europe must be increased. Otherwise, there is a risk of new investments increasingly flowing to other parts of the world.  It’s important to ensure the availability of critical medicines in all situations in Europe, and therefore ITRE Committee sees that in this legislation it’s particularly important to focus on our competitiveness, security of supply and the promotion of research and development and new innovations in this sector.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Tomislav Sokol
Political group: PPE
Country: Italy
Language: HR

Moramo preokrenuti ovaj trend i vratiti inovacije u Europu te stvoriti okruženje koje privlači, a ne stvara prepreke za proizvođače novih lijekova. Pristup pacijenata lijekovima u EU-u i sigurnost opskrbe također su sve veći razlozi za zabrinutost. Zbog svega navedenog potrebna je dubinska reforma trenutnog zakonodavstva koje se posljednji put ozbiljnije mijenjalo prije 20 godina.  Glavni je cilj reforme osigurati da svi pacijenti u EU-u imaju jednak i brži pristup učinkovitim lijekovima, bez obzira na to gdje žive. Zato smo skratili vrijeme potrebno za izdavanje odobrenja za lijekove od strane Europske agencije za lijekove. Također, omogućujemo da se lijekovi pacijentima mogu isporučiti u svakom trenutku, bez obzira na to gdje žive u Uniji. Novi lijek sada će se morati staviti na tržište svih država članica koje to zatraže.  Svakako treba spomenuti borbu protiv antimikrobne otpornosti budući da farmaceutske tvrtke dodatno potičemo na razvoj novih antibiotika, kombinacijom različitih mjera koje uključuju vaučere, ali i javne subvencije. U uredbi na kojoj sam radio posljednjih mjeseci, također smo donijeli i odredbe za olakšavanje istraživanja razvoja odobravanja lijekova za rijetke bolesti, područje u kojem su istraživanja najpotrebnija, a ulaganja najrizičnija. To je posebno važno za 95 posto pacijenata s rijetkom bolesti za koje danas ne postoji lijek, što apsolutno trebamo promijeniti.  Isto tako, istaknuo bih da proširujemo područje primjene takozvanog izuzeća Bolar, kojim će se omogućiti da generički lijekovi dolaze na europsko tržište znatno ranije nego do sada, što je za naše građane izuzetno važno. Mjerama za poticanje ranog ulaska na tržište generičkih lijekova jačamo tržišno natjecanje, pacijentima omogućujemo lakši pristup, a zdravstvenim sustavima smanjujemo troškove.  Dame i gospodo, ovom reformom jačamo europsku industriju, olakšavamo pristup inovativnim lijekovima, ali i generičkim lijekovima te omogućujemo da svi pacijenti imaju jednak status i da nitko nije građani drugog reda. Iz tih razloga molim vas da podržite ovu reformu.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Nicolás González Casares
Political group: S-D
Country: Netherlands
Language: ES

El texto final favorece la innovación y el acceso, incentiva la inversión en el tratamiento de enfermedades como las enfermedades raras y el desarrollo de nuevos antimicrobianos, y, desde luego, lleva a mejorar y proteger la investigación clínica que nuestros médicos y nuestros investigadores hacen en los hospitales, gracias, por ejemplo, a la exención hospitalaria en terapias avanzadas, tan singular en mi país. Y exige transparencia, también respecto a los fondos públicos que reciben las compañías farmacéuticas.  En un debate marcado por una fuerte presión externa, quiero hacer una reflexión. Se ha repetido un mensaje incorrecto: no existe la necesidad de elegir entre mejorar la innovación farmacéutica en Europa o hacer que los medicamentos sean más accesibles y asequibles. Esta dicotomía no existe si aplicamos las políticas adecuadas. El presupuesto sanitario es limitado. Por eso nos oponemos con firmeza a que el dinero de nuestros pacientes financie innovación fuera de Europa.  Los socialistas vamos a seguir poniendo soluciones para respaldar la investigación e la innovación farmacéuticas punteras en Europa y, al mismo tiempo, seguiremos luchando contra desigualdades inaceptables. El código postal no debe determinar qué fármacos o qué tratamientos reciben las personas, o incluso los que no reciben.  Creo que este acuerdo, lo que vamos a votar hoy, es un buen principio, pero tengamos claro este no es el fin. Debemos seguir siendo ambiciosos. Tenemos que proteger el interés general de la salud por encima del interés de los operadores económicos. Que quede claro que ese seguirá siendo el objetivo del Grupo S&D en este debate.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Catherine Amalric
Political group: Renew
Language: FR

Cette Europe du médicament, nous la construisons équitable, avec la coopération volontaire entre les États membres, notamment sur le prix des médicaments, l’extension des achats conjoints pour nombre de traitements, y compris contre les maladies rares, et aussi l’impossibilité d’interdire ou de restreindre l’accès aux médicaments contraceptifs et abortifs en Europe. Nous la construisons sécurisée, avec des évaluations exigeantes, avec l’engagement de toutes les parties prenantes dans la lutte contre les pénuries, avec les exemptions hospitalières pour la préparation des thérapies innovantes, au plus près des patients. Nous la construisons innovante, ensemble: grands centres de recherche, start-ups, «bioclusters», R&D, unités de production, innovation de rupture, numérique, IA. Nous la construisons incitative et simplifiée, avec une stabilité juridique pour les investisseurs en Europe et une flexibilité réglementaire pour s’adapter aux 20 ans à venir. Nous la construisons durable, avec une meilleure gestion des risques environnementaux et des équilibres biologiques, avec aussi la transition vers un conditionnement pour dispenser la juste quantité prescrite. Notre travail sur ce paquet législatif fait avancer l’union de la santé que les Européennes et les Européens attendent, une ambition que nous portons.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Tilly Metz
Political group: Verts/ALE
Country: France
Language: FR

En parvenant à ce compromis, nous avons réussi à améliorer l’accessibilité des médicaments, à assurer la transparence des investissements publics dans la recherche et le développement pharmaceutique. Nous avons aussi réussi à lutter contre les pénuries de médicaments, à limiter l’impact négatif sur l’environnement de la production des médicaments, et à envoyer aussi un signal important pour que HERA devienne finalement une agence indépendante de l’Union européenne. Pour accélérer notre lutte contre la résistance aux antimicrobiens, nous avons réussi à renforcer l’approche «Une seule santé», tout en maintenant l’attractivité pour le développement et l’innovation en Europe. J’encourage donc tout le monde à soutenir la position du Parlement européen. Ensemble, nous pouvons construire une politique pharmaceutique basée sur des idéaux d’équité, de transparence, de durabilité et centrée sur le patient.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Kateřina Konečná
Political group: The Left
Country: Greece
Language: CS

K věcem, které považuji za velkou chybu, patří přenosné vouchery, které vytváří prostor pro finanční spekulace, a především možnost pro členské státy zavést výhradně elektronický příbalový leták k lékům. Myslím, že tato možnost velmi poškodí starší generaci a je i potenciálně zdravotně nebezpečná. Přeji budoucím poslancům, ať návrh ještě vylepší, je co vylepšovat a zachovají vše dobré, co jsme do něj dostali.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Francesca Donato
Political group: NI
Country: France
Language: IT

Signora Presidente, onorevoli colleghi, la normativa oggi al voto mira a sostenere la competitività del settore farmaceutico europeo nei confronti dei concorrenti esterni. Da tempo le grandi aziende farmaceutiche chiedono una semplificazione ed accelerazione delle procedure di approvazione dei nuovi farmaci da parte dell'EMA e con questa normativa vengono accontentate.  Ma la preoccupazione principale del legislatore in tema di sanità dovrebbe essere sempre e soprattutto la protezione della salute degli individui, possibile solo tramite l'uso di farmaci adeguatamente sperimentati e controllati prima della loro autorizzazione. Purtroppo la fretta nel rilasciare una licenza spesso porta ad accettare rischi e pericoli per la salute umana che vengono pagati dai consumatori dei prodotti autorizzati in via di emergenza, come abbiamo visto in questi anni. Non possiamo permettere che il pungolo della concorrenza o lo spauracchio dell'emergenza ci spingano a giocare alla roulette con la salute e la vita dei cittadini europei.  Apprezzo molto gli emendamenti della commissione ENVI e l'attenzione del relatore verso una maggiore trasparenza, ma per me la proposta rimane nel complesso non accettabile.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Peter Liese
Political group: PPE
Country: Spain
Language: DE

Frau Präsidentin, liebe Kolleginnen und Kollegen! Wenn wir diese beiden Texte gleich annehmen, dann machen wir einen sehr wichtigen Schritt, um Patientinnen und Patienten zu helfen, denen wir bisher nicht helfen können. Deswegen herzlichen Dank an alle, die zu diesem Ergebnis beigetragen haben – insbesondere an die Mitarbeiter. An einer Stelle glaube ich, dass der Ausschuss einen Fehler gemacht hat: Ich glaube, wir sollten uns im Europäischen Parlament an geltendes Recht halten, und es ist durch den Europäischen Gerichtshof und durch ein Protokoll zum Vertrag festgelegt, dass die Frage der Abtreibung eine nationale Kompetenz ist und dass das nicht europäisch geregelt werden kann. Deswegen empfehle ich, gegen den Änderungsantrag 85 zu stimmen. Aber ansonsten haben wir wirklich einen guten Text. Für mich ist ganz besonders wichtig, die Antibiotikaresistenzen zu bekämpfen. Wir brauchen einen sorgfältigeren Umgang mit Antibiotika, aber wir brauchen auch Innovation, und ich bin dankbar, dass sich nach anfänglichem Widerstand am Ende eine breite Mehrheit auch für das Gutscheinsystem ausgesprochen hat. Wenn ich über Innovation rede, dann bin ich sehr dankbar, dass wir auch Innovation in die Gesetzgebung aufgenommen haben. Bisher bekam jeder, egal, was er für ein Medikament herstellt, acht Jahre Marktexklusivität, acht Jahre Schutz. Jetzt senken wir das auf siebeneinhalb Jahre ab. Und ich glaube, wir brauchen nicht den 27. Blutdrucksenker oder den 38. Blutfettsenker – wir brauchen wirkliche Innovationen. Und die Unternehmen, die Dinge angehen, die bisher nicht angegangen worden sind, die Patienten helfen, denen wir bisher nicht helfen können, die bekommen mehr Unterlagenschutz. Durch mehr Innovation helfen wir diesen Patienten – und das ist der wichtigste Punkt.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Heléne Fritzon
Political group: S-D
Country: Austria
Language: SV

Fru talman! Kommissionen! De senaste decennierna har stora delar av välfärdssamhället privatiserats och avreglerats och det har lett till sämre välfärd och ökade klyftor. Det blev extra tydligt under pandemin. Bristen på mediciner och importstopp visade att läkemedelsmarknaden inte fungerade när vi så väl behövde den, inte minst för våra äldre och svårt sjuka. Samhället måste fungera i vardagen, men också i kris och i värsta fall i krig.  Och därför vill jag att vi gör upp med detta läkemedelsmisslyckande. Med denna nya läkemedelslag i EU ska alla ha tillgång till läkemedel oavsett var man bor. Beredskap och lagerhållning ska öka så att vi aldrig får brist på viktiga mediciner. Och vi ska återupprätta värdigheten och tryggheten för alla. En ny riktning för mitt Sverige och för Europa är möjlig när vi återtar den demokratiska kontrollen. Detta är Socialdemokraternas riktning för både mitt Sverige och för mitt Europa.
Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Frédérique Ries
Political group: Renew
Country: France
Language: FR

Madame la Présidente, Monsieur le Commissaire, huit mois maintenant de négociations, une centaine de réunions, des procédures au pas de charge, pour revisiter cette importante législation pharmaceutique. C’est un véritable marathon législatif qu’il faut tenter de résumer en une minute ici. À l’impossible, nul n’est tenu, et nos rapporteurs ont déjà dit l’essentiel.  Il s’agit en gros d’affronter la menace silencieuse de la résistance antimicrobienne et les pénuries endémiques de médicaments, de revitaliser un écosystème tourné vers l’innovation, vers la durabilité, et puis de faire jouer cette solidarité européenne, la plus-value de notre Union. Ce qui me permet de conclure cette législature, comme je l’ai commencée, avec madame Kyriakides, sur les maladies rares: 70 000 patients en Belgique et 300 millions d’Européens vivent avec une de ces maladies délaissées et réclament un plan d’action européen. Je m’en fais le relais auprès de madame la commissaire, depuis le début de ce mandat, sans succès. Ma question est simple: soutiendra-t-elle l’instauration de ce plan, que nous inscrivons dans le règlement qui sera voté ce soir? Est-ce que ce plan d’action européen pour les maladies rares fera partie de son héritage?  Je conclus avec une remarque à monsieur Casarès, qui n’est plus là, malheureusement. Il n’a pas arrêté de parler de législation socialiste. Je sais que c’est la campagne, mais cette législation, elle est orientée, elle est centrée, elle se doit de viser les patients et uniquement les patients. Il ne s’agit pas ici d’y apposer une couleur.