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Procédure : 2012/0192(COD)
Cycle de vie en séance
Cycle relatif au document : A7-0208/2013

Textes déposés :

A7-0208/2013

Débats :

PV 02/04/2014 - 15
CRE 02/04/2014 - 15

Votes :

PV 02/04/2014 - 18.18
Explications de votes

Textes adoptés :

P7_TA(2014)0273

Compte rendu in extenso des débats
Mercredi 2 avril 2014 - Bruxelles Edition révisée

15. Essais cliniques de médicaments à usage humain (débat)
Vidéo des interventions
PV
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  Presidente. - L'ordine del giorno reca la relazione di Glenis Willmott, a nome della commissione per l'ambiente, la sanità pubblica e la sicurezza alimentare, sulla proposta di regolamento del Parlamento europeo e del Consiglio concernente la sperimentazione clinica di medicinali per uso umano, e che abroga la direttiva 2001/20/CE (COM(2012)0369 – C7-0194/2012 – 2012/0192(COD)) (A7-0208/2013).

 
  
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  Glenis Willmott, rapporteur. - Mr President, first of all thank you to all the shadow rapporteurs for their excellent support and cooperation. Together we have been able to negotiate a great deal for Parliament. I also want to thank the Lithuanian Presidency for the huge amount of work it did to deliver a compromise in time, and to the Commission for coming forward with a good proposal and being so helpful in our discussions.

I want to start with why I first got involved with this legislation. Three years ago I went to a childhood brain tumour centre in Nottingham. There I met children and teenagers suffering from rare cancers, including a young man called Sam White. They told me that too often no treatment existed for their conditions, they had to use drugs that had not been tested in children or, for some, a clinical trial might be their only hope of survival.

For rare diseases often there are not enough patients in one country to make a clinical trial viable, which makes working together across Europe essential. At the moment it is just too difficult and expensive. This new regulation, harmonising rules across the EU, creating a single application portal and a clear system for cooperation between Member States, would radically change that.

Sadly, Sam White passed away last September but his work goes on. He was a great inspiration and I hope that what we have managed to achieve will help to improve life for others and treatment for others in Sam’s situation, and push up survival rates for childhood cancers and rare diseases.

But we have to make sure that all trials contribute towards better medicine. Currently only half of clinical trials are published and positive results are more likely to be published than negative results. This can give a biased picture about the safety and efficacy of medicines and can lead to unnecessary or even dangerous trials being repeated. So the transparency measures this law will put in place are a huge step forward.

All trials – positive, negative or inconclusive – will need to upload a summary of results to a publicly accessible database one year after completion and, once marketing authorisation is applied for, the full clinical study reports will be uploaded. We also have a clear statement that these reports should not be seen as commercially confidential and I hope that will support the EMA in their quest to publish the data they already hold.

We should all be proud that the EU will now be leading the way globally in clinical trial transparency, which is good for patient safety, good for scientific progress and good for public trust in medicines. But we have to ensure that clinical trials take place here in Europe. They provide opportunities for new treatments, as well as supporting thousands of skilled research jobs. We know that since 2007 clinical trials carried out in the EU have dropped by 25%. I hope this regulation will reverse that trend. By facilitating cross-border trials we can cut unnecessary bureaucracy; with clear and forcible timelines we provide certainty to companies and academics; and by introducing the concept of low-intervention trials we make simple, less risky trials much less burdensome to conduct.

But at the heart of the legislation is patient protection. We have made it clear that ethics committees will always be involved in assessing clinical trials and have the power to stop them going ahead. We also have a comprehensive text on protecting vulnerable populations and ensuring that patients are fully informed before participating in a trial. Of course, we are voting on a compromise and there are areas where I would have liked to have gone further. I would have liked even more patient involvement and shorter approval times but I understand that Member States had strong views on these issues and overall I think we have reached an excellent compromise.

Once again, thank you to everyone who has helped us get to this stage and I hope the whole Parliament can give the regulation their support today.

 
  
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  Tonio Borg, Member of the Commission. - Mr President, let me start by thanking the rapporteur, Mrs Willmott, as well as the shadow rapporteurs, for their hard work and excellent cooperation throughout the evolution of this important proposal. I agree with the rapporteur that I would have preferred a more ambitious conclusion, particularly with regard to time frames, but I think that what we have, considering that politics is the art of the possible, is a good compromise.

Let me mention in particular what the rapporteur has just highlighted, as she did throughout the negotiations as well, namely that this regulation will benefit, first and foremost, European patients and all European citizens – not just the European pharmaceutical industry.

Why? Because clinical trials are key to the development of new medicines and to improving, comparing and refining treatments using already authorised medicines. Sometimes these trials can even represent the last hope for patients suffering from rare or serious conditions, as we have just heard from the rapporteur. In addition to benefiting patients, by promoting research and investment, including inward investment from outside the European Union, clinical trials can also make an important contribution to growth and jobs.

The new regulation also aims to address the fact that in recent years clinical trials in the EU have declined by around 25%, while administrative costs and resource needs have doubled and delays have increased by 90%. So there is an urgent need to act, to retain clinical trials in Europe and to increase their numbers for the benefit of patients and industry alike. At the same time, high-level protection of the subjects involved in such trials must be ensured: so swifter trials, but at the same time maintaining patient safety. The text agreed on, which we have before us today, addresses – and I believe can meet – these challenges.

The key features are: firstly a streamlined application procedure via a single entry point, the EU portal, and a single set of documents to be prepared and submitted for the application.

Secondly, a harmonised procedure for the assessment of applications for clinical trials, which will eliminate duplications and unnecessary delays, and – perhaps most importantly of all – the extension of the so-called tacit agreement principle to the whole authorisation process which, without compromising safety, will give sponsors – in particular SMEs and academics – increased legal certainty. So there is a time frame and, if there is no reaction within that time frame, it is presumed that the authorisation is approved.

Thirdly, simplified reporting procedures which will spur sponsors away from submitting broadly identical information separately to various bodies and in different Member States; increased transparency regarding clinical trials and their outcomes, even in cases where something is refused, amended or approved.

Moreover – and this is an important point – clinical trials that are conducted outside the EU but which are referred to in a clinical trial application within the EU – so where the clinical trial takes place outside the EU but the application for an authorisation of medicine takes place within the EU – will have to comply with regulatory requirements at least equivalent to those applicable inside the European Union.

Finally, the Commission will be able to carry out controls, both in the Member States and in third countries, to ensure that the rules on clinical trials are being properly supervised and enforced.

Let me conclude by emphasising once again the importance of this regulation which you will be voting on today. It will foster clinical research in Europe and will increase the hope of finding solutions for the many patients for whom currently there is no effective treatment available.

 
  
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  Philippe Juvin, au nom du groupe PPE. – Monsieur le Président, le règlement sur les essais cliniques peut amener un bouleversement dans la pratique des essais cliniques en Europe, pour plusieurs raisons: d'abord, les procédures seront homogénéisées sur tout le territoire de l'Union, ce qui facilitera grandement l'élaboration et la réalisation des essais cliniques multicentriques européens.

Le deuxième point, c'est que les procédures seront simplifiées, ce qui va faciliter évidemment la vie des promoteurs, en particulier des promoteurs universitaires – M.[nbsp ]Borg a rappelé combien ils étaient nombreux –, qui n'auront plus qu'un seul interlocuteur et non une flopée d'interlocuteurs absolument anonymes la plupart du temps.

Troisièmement, les procédures seront raccourcies. Ces délais plus courts simplifieront aussi la vie des chercheurs universitaires.

Quatrièmement, les résultats seront publiés. Quand je dis les résultats, je veux dire tous les résultats, y compris les résultats négatifs. Cela augmentera la transparence et en fin de compte la confiance des citoyens de l'Union européenne dans les essais cliniques.

Cinquième point enfin, pour la première fois au niveau européen, c'est le risque ajouté par la recherche clinique et non plus le risque absolu qui sera étudié dans le cadre de la formation des dossiers des essais cliniques. Tout cela est fondamental.

Mes chers collègues, la simplification des procédures, leur accélération, la baisse de coûts signifieront probablement pour l'Europe plus de protection pour les patients et plus de chances pour ceux-ci de bénéficier de nouveaux traitements rapidement. Pour nos scientifiques, il s'agira d'une garantie de participer à des essais qui comptent dans le monde de la recherche scientifique tandis que nos industriels du médicament y trouveront un avantage évident.

 
  
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  Antonyia Parvanova, rapporteur for the opinion of the Committee on the Internal Market and Consumer Protection. - Mr President, let me first warmly congratulate Glenis on all her work and for having successfully led the great team work on the Parliament side, achieving a result which I think we can be proud of.

On behalf of the Committee on the Internal Market and Consumer Protection (IMCO) and as the shadow rapporteur for the ALDE Group, let me stress that, despite some remaining reluctance on the side of the Member States, this piece of legislation is a clear signal to European patients, researchers, academics, doctors and industry that the EU is addressing the future of research and development, being the most relevant level at which to act. Safety, transparency and attractiveness have been the key principles defended by my political group and I am glad to see that these priorities are well reflected in the final agreement.

We need to attract research in Europe for patients to benefit swiftly from innovation. We need a functional and effective legal framework at EU level to maintain the competitiveness of our industry and create jobs, and we need transparency and evidence-based decision-making when it comes to public health policies and priorities. We achieved all these demands through the negotiating process with the Council and the Commission.

Once more may I thank Glenis warmly for this wonderful agreement. Parliament has been decisive in making the difference for patients and for independent and transparent research. I therefore welcome very much the conclusion of this agreement and the regulation to be implemented in the future, which my group will fully support during the vote tonight.

 
  
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  Gilles Pargneaux, au nom du groupe . - Monsieur le Président, chers collègues, je remercie Glennis Willmott pour le travail qu'elle a accompli en tant que rapporteure, parce qu'il était urgent de proposer un certain nombre de solutions permettant, par exemple, d'éviter la diminution du nombre des demandes d'autorisation d'essais cliniques qui a atteint 25[nbsp ]% entre 2007 et 2011 en Europe.

Nous avions également constaté que les coûts administratifs et les délais applicables en Europe étaient devenus complètement dissuasifs. Depuis ces dernières années, on a assisté, malheureusement, à une délocalisation de la recherche dans les pays émergents, où la supervision des essais cliniques est plus souple. Les associations de patients, les laboratoires pharmaceutiques et les chercheurs reprochaient à la législation actuelle d'imposer un cadre réglementaire trop lourd en matière de formalités administratives.

Saluons les réelles améliorations du texte: tout d'abord, la garantie de transparence du déroulement et des résultats des essais cliniques, ensuite le renforcement du rôle des comités éthiques dans l'approbation des essais, mais aussi la bonne information des patients ainsi que l'augmentation des mesures de protection pour les personnes vulnérables et enfin la protection des données personnelles. Voilà des améliorations qui font honneur au Parlement européen et aux institutions européennes concernant ces essais cliniques à usage humain.

 
  
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  Margrete Auken, for Verts/ALE-Gruppen. – Hr. formand! Vi har opnået et godt resultat efter fire års arbejde og til tider ganske bistre forhandlinger. Først og fremmest tak til Glenis for et seriøst og inkluderende arbejde. Tillad mig at samle mig om det, jeg er allermest begejstret for, nemlig at vi har fået knæsat reel åbenhed i medicinalindustrien og dermed forhåbentlig fremover kan forebygge ikke bare uetiske forsøg men også indimellem alt for store skader på vores sundhedsbudgetter, hvor det simpelthen har været for dyrt mange gange, at vi ikke har haft kontrol med den medicin, der er kommet. Jeg behøver blot at nævne Tamiflu som et gruopvækkende eksempel.

Jeg vil ikke gå ind på, hvordan den åbenhed fungerer. Det har Glenis beskrevet udmærket i sit indlæg. Jeg vil blot sige: Kampen er ikke forbi! I lækkede dokumenter fra TTIP-forhandlingerne er det kommet frem, at Big Pharma, den amerikanske industri, udtrykkeligt har nævnt, at de vil have denne lov trukket tilbage. De vil gerne være fri for al den åbenhed; de mener, at forenklinger altid vil komme den store industri til gode. Det er der også en risiko for, medmindre vi alle sammen holder os klar til at kæmpe for patienterne, for borgerne, for sundhedsbudgetterne og for den progressive industri, der gerne vil opføre sig ordentligt og har brug for stramme regler og skrap kontrol. Tak, hr. formand.

 
  
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  Milan Cabrnoch, za skupinu ECR. – Vážený pane předsedající, jsem rád, že zde dnes můžeme uzavřít jednu z klíčových zdravotnických legislativ posledních let. Děkuji všem kolegům za spolupráci a vítám, že jsme s Radou nalezli shodu na finálním znění nařízení.

Ambiciózní návrh Parlamentu na další zkrácení doby pro posouzení žádostí není členskými státy plně vyslyšen. Avšak šedesát dnů je uspokojivý výsledek a můžeme doufat, že tato lhůta nebude vždy využívána do posledního dne. Kdyby byla překročena, je tu pojistka v podobě tichého souhlasu.

Spolu s jednotnou žádostí o provádění klinického hodnocení pro všechny participující státy se zjednoduší celý proces a do Evropy se tak má šanci vrátit medicínský výzkum. Veřejnost jistě ocení úsilí, jaké jsme v legislativě věnovali transparentnosti celého procesu, a naučí se pracovat s poskytnutými informacemi. Stejně tak toto přímo použitelné nařízení dopřeje farmaceutickým společnostem žádanou právní jistotu a předvídatelnost rozhodování státních orgánů.

 
  
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  Alda Sousa, em nome do Grupo GUE/NGL. – Queria em primeiro lugar cumprimentar a Colega Glenis Willmott e os outros relatores-sombra porque creio que a colaboração sobre este dossiê foi extremamente profícua e foi muito franca e honesta e levou a uma conclusão que me parece um dossiê muito interessante e que merece, evidentemente, a nossa aprovação.

Senhor Comissário Borg, eu gostava de lhe fazer uma pergunta, um comentário, e eu não sei, só consigo exprimir-me na minha própria língua, em português costuma dizer-se que, enfim, o Senhor teve alguma lata em dizer algumas das coisas que disse aqui, porque disse que os doentes europeus, os doentes e os sujeitos passaram a ser beneficiados com este processo mais do que a indústria farmacêutica.

Pois, é verdade, mas isso deve-se ao trabalho do Parlamento Europeu. A proposta inicial da Comissão, a proposta que veio do seu gabinete, era uma proposta que parecia escrita pela indústria farmacêutica e foi este Parlamento e foram estes relatores que conseguiram reverter essa proposta, garantir o papel dos comités de ética, garantir a transparência e garantir, também, a segurança e os direitos dos indivíduos que vão participar nos estudos acima de tudo e, portanto, não é de competitividade que se trata é de competência.

 
  
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  Claudio Morganti, a nome del gruppo EFD. – Signor Presidente, onorevoli colleghi, purtroppo ci sono ancora molte malattie per cui non esiste una cura efficace, e quindi ben vengano nuove ricerche e sperimentazioni.

Al centro di tutto non dobbiamo dimenticarci che ci sono i malati, le persone che soffrono, le quali spesso hanno purtroppo solo una speranza, ovvero i nuovi metodi e i farmaci che possono funzionare. Questa è ad esempio la speranza che hanno decine di famiglie che in Italia vorrebbero potersi curare con il metodo Stamina o con altri metodi ideati dal professor Vannoni.

Io non sono un medico, non sono uno scienziato, non sono un ricercatore, ma sono una persona che ha conosciuto molte di queste persone. Ho ascoltato le loro testimonianze e mi sono fatto un'idea chiara: per loro questa è al momento l'unica possibilità e l'unica speranza di vita che hanno. Trovo vergognoso che ci possano essere dei medici e dei professori che bocciano a priori questo metodo perché non è basato su dimostrazioni scientifiche.

Gli esperti dei comitati dovrebbero forse prima incontrare i pazienti e le loro famiglie e poi tirare eventuali conclusioni, non il contrario come è avvenuto fino ad ora.

 
  
  

VORSITZ: RAINER WIELAND
Vizepräsident

 
  
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  Peter Liese (PPE). - Herr Präsident, Herr Kommissar, liebe Kolleginnen und Kollegen! Heute können wir wirklich stolz sein. Das, was wir hier gemeinsam erreicht haben, ist ein ganz konkreter Fortschritt für die Patienten in der Europäischen Union. Viele Forscher, viele Ärzte und damit auch viele Patienten haben jahrelang darauf gewartet, dass wir die bürokratischen Hürden bei grenzüberschreitenden klinischen Prüfungen in der Europäischen Union reduzieren, weil nur so eine gute Forschung möglich ist. Das gilt insbesondere für Institutionen, die von der pharmazeutischen Industrie unabhängig sind, in meinem Land z.[nbsp ]B. für die deutsche Krebshilfe, die Spendengelder einsetzt, und die sagen, dass sie die Spendengelder nicht für Bürokratie ausgeben wollen, sondern wirklich für Forschung, die den Patienten hilft.

Wir schaffen es – herzlichen Glückwunsch an Glenis Willmott und alle anderen –, mehr Transparenz zu schaffen. Negative Ergebnisse von klinischen Prüfungen dürfen nicht länger unter den Tisch gekehrt werden. Wir haben es gleichzeitig geschafft, die strengen ethischen Standards, die wir bisher hatten, in der bestehenden Richtlinie zu erhalten. Hier haben wir die Kommission korrigiert, und ich bedanke mich insbesondere bei Kommissar Borg, dass er das begleitet hat: Der ursprüngliche Vorschlag kam ja gar nicht von ihm. Also gibt es da auch eine positive Rolle für den amtierenden Kommissar.

Vielen Dank an alle, die geholfen haben, die Ratspräsidentschaft, die Berichterstatterin, die Schattenberichterstatter. Ich glaube, das ist ein gutes Ergebnis, und ich hoffe auf eine deutliche Mehrheit gleich bei der Abstimmung.

 
  
 

Catch-the-eye-Verfahren

 
  
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  Christa Klaß (PPE). - Herr Präsident! Klinische Studien sind unverzichtbar für die medizinische Forschung und für die Entwicklung neuer und besserer Medikamente und Behandlungsmethoden. Mit den Studien können vor allen Dingen Nebenwirkungen von Arzneimitteln festgestellt werden, bevor diese auf den Markt kommen.

Klinische Studien sind aber auch ein ganz sensibles Thema. Es geht um wichtige ethische Fragen, um Transparenz und um Schutz von Risikogruppen: Minderjährige, Menschen mit geistiger Behinderung, Schwangere.

Ein europäischer Ansatz zur Regulierung der klinischen Studien ist absolut notwendig. Die Studien werden in den meisten Fällen in zwei oder in mehreren Mitgliedstaaten durchgeführt. Die jetzige Richtlinie weist Lücken auf und wurde auch nicht in allen Mitgliedstaaten gleichermaßen umgesetzt. Harmonisierung ist also notwendig. Mit dieser Verordnung gelingt es uns, den Verwaltungsaufwand zu senken. Der Kompromiss berücksichtigt die Bedürfnisse aller Beteiligten. Ohne die Zustimmung der Ethik-Kommission kann nun keine klinische Prüfung mehr stattfinden. Die Klärung der Rolle der Ethik-Kommission ist eine wichtige Änderung im Kommissionsentwurf.

Ich bedanke mich bei der Berichterstatterin und bei den Schattenberichterstattern für eine gute Arbeit und hoffe, dass wir morgen eine gute Abstimmung haben werden.

 
  
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  António Fernando Correia de Campos (S&D). - Eu queria dizer que lamento que não tenham sido aprovadas disposições que permitissem ensaios clínicos comparativos que em muito contribuiriam para avaliar o valor terapêutico dos novos medicamentos mas, apesar de tudo, houve inovações importantes. O processo de autorização harmonizado entre Estados-Membros, que permite poupar burocracia, o estabelecimento de um portal único que centraliza toda a informação entre os promotores de ensaios clínicos e as autoridades competentes nacionais, a diferenciação entre ensaios clínicos com diferentes níveis de risco e o papel das comissões de ética e a transparência dos resultados dos ensaios clínicos, que obrigam, em determinadas condições, à divulgação do relatório do estudo clínico.

Creio que, no âmbito do presente regulamento, o Parlamento melhorou consideravelmente esta proposta da Comissão. Gostaria, por isso, de congratular a minha colega relatora Glenis Willmott.

 
  
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  Ruža Tomašić (ECR). - Gospodine predsjedniče, podržavam prijedlog uredbe, iako ima određenih nedostataka. Posebno korisnim smatram mogućnost podnošenja zahtjeva preko jedinstvene točke, odnosno internetskog portala, jer predstavlja dobar primjer korištenja naprednih tehnologija kako bi se prevladale administrativne prepreke i ograničenja.

Briga o sudionicima kliničkog ispitivanja i njihova zaštita u svakom nam trenutku moraju biti od posebne važnosti pa se mogu samo složiti s duhom ovoga prijedloga. No, smatram kako briga o bolesnim građanima i budućim pacijentima kojima određeni lijek koji se testira može donijeti olakšanje ili izlječenje u određenoj mjeri ipak treba ograničiti prava sudionika u testiranju.

Stoga ne mogu podržati prijedlog u onom dijelu u kojemu dozvoljava povlačenje informiranog pristanka sudionika u svakom trenutku i bez obrazloženja, te odgovornosti za prouzročenu štetu. Smatram da bi se ovakvom praksom potencijalno ugrozio veliki broj kliničkih ispitivanja koja ne samo da puno koštaju, već mogu rezultirati ogromnim koristima za kvalitetu života naših građana.

 
  
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  Maria do Céu Patrão Neves (PPE). - Eu queria começar por agradecer ao relator deste relatório e também aos relatores-sombra pelo magnífico trabalho que fizeram. De facto, o trabalho deste Parlamento melhorou muito significativamente aquilo que era a proposta inicial. Sobre as vantagens da proposta da Comissão no que diz respeito à celeridade dos processos, à poupança de custos e, de uma forma geral, ao estabelecimento de condições que promovem a investigação científica, sobre estas questões já foi dito suficiente. Aquilo que importa aqui reforçar também é que havia uma negligência de requisitos éticos que a diretiva de 2001 tinha colocado no papel de uma forma muito veemente e que nós tínhamos perdido com a proposta da Comissão.

Penso que o equilíbrio foi restabelecido pelo trabalho do Parlamento e queria deixar aqui um reparo para o facto de, no futuro, não só agora mas no futuro, ser sempre importante progredirmos na investigação científica, mas não esquecermos aquilo que são as salvaguardas éticas que protegem também os participantes na investigação.

 
  
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  Biljana Borzan (S&D). - Gospodine predsjedavajući, novi lijekovi i metode liječenja spašavaju živote. No da bi pacijenti dobili spasonosni novi lijek, on mora proći procedure kliničkog ispitivanja koje su ovisno o zemlji članici različito komplicirane i duge. Između ostalog, ta neusklađenost dovela je do 25 postotnog smanjenja broja kliničkih ispitivanja u Europskoj uniji u razdoblju od 2007. - 2011. Posljedice toga osjećaju naši pacijenti, zdravstveni sustavi i sektor istraživanja i inovacija.

Upravo zato potrebno je uskladiti i pojednostavniti pravila na europskoj razini te smanjiti količinu birokracije. Pritom je nužno zadržati razinu zaštite ispitanika čije zdravlje i život moraju biti ispred eventualnog napretka znanosti. To je crta koja se ne smije prijeći. Podaci prikupljeni tijekom kliničkih ispitivanja moraju biti transparentno objavljeni, pogotovo u slučaju neuspjeha testiranja. Tako se sredstva za istraživanje neće ponovno trošiti na lijekove i metode koji su dokazano neučinkoviti. Zaključno podržavam ovu direktivu i čestitam izvjestiteljici Willmott na obavljenom poslu.

 
  
 

(Ende des Catch-the-eye-Verfahrens)

 
  
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  Tonio Borg, Member of the Commission. - Mr President, I would like to thank all those who have participated in this debate. Let me once again thank the rapporteur and the shadow rapporteurs for their strong commitment and intensive work on this important regulation, which will foster clinical research in Europe while ensuring a high level of protection.

Of course, if a proposal is good and is made even better by Parliament, this does not mean that we had a bad proposal in the first place – it is just that this is the democratic process whereby a good proposal is made better. I will not wash my hands of the criticism that has been made against the Commission by saying that I was not around when the proposal was made, because I have to defend the Commission and also my predecessors. But let us take the ethics committees, for instance. It is true that in the original proposal, because this is a regulation, the Commission did not want to impose any particular structure of ethics committees on all the Member States, because different Member States have different traditions. But when some MEPs and government ministers spoke to me on this issue, I immediately helped improve the text by referring to ethics, because I told all those who came to speak to me that I would be the last Commissioner to remove ethics from the proposal.

The fact that, because of the legislative process, improvements are made does not mean that the Commission proposal was drafted by the pharmaceutical industry. I would find it very strange if that were so because, as I would remind Members, the original Commission proposal also had obligatory patient involvement in the assessment of applications. That would have been the first time that the pharmaceutical industry had required obligatory patient involvement. That was the original proposal, which was then removed, I believe, in the trilogue by the Council representing the Member States.

I would also remind this assembly that in its original proposal the Commission proposed national indemnification mechanisms free of charge for academic sponsors. Unfortunately, as we said, politics is the art of the possible, and because of compromise we had to withdraw that particular proposal. I am just saying this to defend the original Commission proposal which, I am pleased to note, has improved in the final text. I am very pleased to be present for the formal endorsement of a first-reading agreement on this important proposal which, I believe, will make it easier for clinical trials to take place in Europe and not outside Europe. This will also be to the benefit of research, which means to the benefit of European patients.

 
  
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  Statement by the Commission on the procedure of adoption of implementing acts Report: Glenis Willmott (A7-0208/2013)

The Commission underlines that it is contrary to the letter and to the spirit of Regulation 182/2011 (OJ L 55 of 28.2.2011, p. 13) to invoke Article 5(4), subparagraph 2, point b) in a systematic manner. Recourse to this provision must respond to a specific need to depart from the rule of principle which is that the Commission may adopt a draft implementing act when no opinion is delivered. Given that it is an exception to the general rule established by Article 5(4) recourse to subparagraph 2, point b), cannot be simply seen as a ‘discretionary power’ of the Legislator, but must be interpreted in a restrictive manner and thus must be justified.

 
  
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  Glenis Willmott, rapporteur. - Mr President, I would like to thank all the speakers who have contributed. Our prime concern, as Commissioner Borg said, is the patient; it has got to be the patient. This regulation answers many questions. We have less bureaucracy, with a single portal and cross-border trials, for which you only need make one application instead of several. That will make everything much easier and much quicker, while keeping patients’ safety at the heart of things. This will also see new and better medicines being brought forward, and that is what is important in this regulation. We have also got increased transparency, and all the clinical trial reports and data will be published, even for unsuccessful trials. That is really important. It is good for science, it is good for patients’ safety and it is good for public trust.

I want to say a little bit about the support that we have had from everybody. I cannot remember dealing with any legislation in this Parliament where we have had so much cooperation and goodwill. We have had the support of the rapporteurs, who have worked very closely together, and the support of the Commission and the Council. Let us also mention the secretariat of the Committee on the Environment, Public Health and Food Safety, who did a fantastic job too. We have achieved a really good deal. We have worked with a strong spirit of cooperation and understanding. I wish that all legislation could be dealt with in that way.

 
  
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  Der Präsident. - Die Aussprache ist geschlossen.

Die Abstimmung findet heute, 2.[nbsp ]April 2014, um 18.00[nbsp ]Uhr statt.

Schriftliche Erklärungen (Artikel 149 GO)

 
  
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  Vasilica Viorica Dăncilă (S&D) , în scris. Directiva 2001/20/CE a avut drept scop simplificarea și armonizarea normelor administrative privind trialurile clinice din Uniunea Europeană. Cu toate acestea, experiența arată că o abordare armonizată privind reglementarea trialurilor clinice a fost realizată doar parțial. Pentru a include un număr suficient de pacienți pentru astfel de trialuri, ar putea fi necesară implicarea tuturor statelor membre. Noile proceduri de autorizare a trialurilor clinice ar trebui să încurajeze includerea a cât mai multe state membre.

Prin urmare, consider că, pentru a simplifica procedurile de prezentare a cererilor, depunerea multiplă a informațiilor în mare parte identice ar trebui evitată și înlocuită de prezentarea unui singur dosar de cerere prin intermediul unui portal unic către toate statele membre în cauză. Portalul ar trebui să reducă birocrația inutilă, astfel încât nu doar sponsorii și cercetătorii academici care realizează cercetări multinaționale, ci și autoritățile publice să poată beneficia de utilizarea sa.

 
  
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  Franz Obermayr (NI), schriftlich. Um neue Medikamente gegen Krankheiten zu entwickeln, werden bei klinischen Studien Arzneimittel an Menschen verabreicht und getestet. Die Patienten werden beobachtet und die Daten ausgewertet. Es ist wichtig, dass der Prüfplan zuvor einer Ethik-Kommission vorgelegt wird, damit sowohl Ärzte, aber auch Patientenvertreter und nichtmedizinische Fachleute, wie z.[nbsp ]B. Rechtsanwälte oder Philosophen, die Durchführung der Studie bewerten! Ein weiterer zentraler Aspekt ist die Transparenz. Alle Pharmakonzerne sollen künftig die Studienergebnisse in einer öffentlich verfügbaren Datenbank ablegen – egal wie das Ergebnis ausgefallen ist! Die Ergebnisse müssen zudem in einer laienverständlichen Zusammenfassung vorliegen. Problematisch ist allerdings die stillschweigende Genehmigung nach Ablauf einer gewissen Frist. Diese sollte im Sinne der Patientensicherheit gestrichen werden!

 
  
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  Bogusław Sonik (PPE), na piśmie. Z zadowoleniem przyjąłem sprawozdanie pani poseł Willmott wprowadzające ułatwienia dla prowadzenia badań leków na terenie Unii Europejskiej oraz przepisy, które zwiększą przejrzystość tych badań. Uproszczenie procedur pozwoli na sprawniejsze przeprowadzanie badań w Europie i zapobiegnie przenoszeniu się ich do krajów trzecich. Zwiększy to nie tylko konkurencyjność i innowacyjność gospodarki europejskiej, ale również zapewni najwyższe standardy etyczne przeprowadzania badań leków. Powstanie wspólnej europejskiej platformy elektronicznej, na której publikowane będą informacje o przeprowadzonych badaniach znacznie przyspieszy proces szukania nowych leków. Naukowcy nie będą zmuszeni do testowania po raz kolejny specyfików raz sprawdzonych i uznanych za nieskuteczne, gdyż w systemie znajdą informacje o wynikach pracy innych badaczy. Nowe przepisy dotyczące badań klinicznych produktów leczniczych stosowanych u ludzi powinny znaleźć szerokie poparcie nie tylko wśród specjalistów, lekarzy i farmaceutów, ale wśród całej społeczności europejskiej.

 
  
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  Claudiu Ciprian Tănăsescu (S&D), în scris. – Creșterea transparenței în jurul studiilor ne va ajuta să înțelegem mai bine bolile și să creștem șansele identificării unor tratamente mai bune într-un timp mult mai scurt. Se pare că deja avem exemple în această direcție și sper să avem în viitorul imediat din ce în ce mai multe companii farmaceutice care să fie deschise către o mai bună comunicare cu colegii și cu publicul larg. Accesul la aceste informații va crește șansele descoperirii de medicamente pentru bolile rare sau pentru acele boli infecțioase care nu primesc suficientă atenție din partea companiilor.

Nu există niciun dubiu asupra necesității dezvoltării de noi vaccinuri, de noi medicamente care să ne ajute în lupta cu bolile infecțioase. O astfel de cooperare între companiile farmaceutice ar permite într-adevăr dezvoltarea de medicamente pe baza nevoilor de sănătate și nu doar pe baza intereselor economice. În multe cazuri avem nevoie de medicamente accesibile și care să fie mai bine tolerate de către pacienți. Publicarea atât a studiilor clinice de succes, dar și a celor nereușite este esențială pentru o valorificare a resurselor limitate ale companiilor și statelor membre, mai ales într-o perioadă de constrângere financiară.

 
  
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  Jarosław Leszek Wałęsa (PPE), in writing. Regarding the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, I would agree that the current system is flawed. The European Union has always been progressive in the field of medicine and it would appear that the 2001 Directive has begun to hinder the medical field. As stated in the report: ‘Between 2007-2011, the number of trials carried out in the EU dropped by 25[nbsp ]%, with many trials moving to emerging markets. Not only does this have dire economic consequences, but it hinders the advance of medicine to the detriment of patientsʼ. The current Directive is hindered by its legal framework in that it suffers from being implemented differently from one Member State to the next. There must be consistency, which will be helpful for those working on rare diseases and will provide a better situation for those working across multiple borders. Another important change will be the reduction in current bureaucracy. Above all the health and safety of our citizens is very important. This new directive has the protections in place that the 2001 version did not.

 
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