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Processo : 2012/2621(RSP)
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Textos apresentados :

O-000101/2012 (B7-0118/2012)

Debates :

PV 13/06/2012 - 19
CRE 13/06/2012 - 19

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Debates
Quarta-feira, 13 de Junho de 2012 - Estrasburgo Edição revista

19. Implantes mamários defeituosos fabricados com gel de silicone pela empresa francesa PIP (debate)
Vídeo das intervenções
PV
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  Presidente. − L'ordine del giorno reca la discussione sull'interrogazione con richiesta di risposta orale alla Commissione sulle protesi mammarie difettose in gel di silicone prodotte dalla società francese PIP di Philippe Juvin e Thomas Ulmer, a nome del gruppo PPE, Linda McAvan e Gilles Pargneaux, a nome del gruppo S&D, Corinne Lepage e Antonyia Parvanova, a nome del gruppo ALDE, Margrete Auken e Michèle Rivasi, a nome del gruppo Verts/ALE, Marina Yannakoudakis, a nome del gruppo ECR, Marisa Matias, a nome del gruppo GUE/NGL, e Oreste Rossi, a nome del gruppo EFD (O-000101/2012 – B7-0118/2012).

 
  
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  Sophie Auconie, auteure. − Madame la Présidente, Monsieur le Commissaire, chers collègues, Mesdames et Messieurs, force est de constater que l'affaire des implants PIP n'est pas une simple fraude sanitaire nationale. Nous pouvons malheureusement constater à quel point cette affaire a et aura un impact à l'échelle européenne et internationale.

Quelques chiffres pour illustrer mon propos: les implants PIP ont été commercialisés dans 71 pays à travers le monde, soit environ 400 000 prothèses mammaires. Ce sont environ 40 000 femmes concernées au Royaume-Uni, 30 000 en France et 10 000 en Espagne. La directive sur les dispositifs médicaux fera l'objet d'une révision à l'automne 2012. Nous devons, en tant que législateur, tirer les leçons de cette fraude et renforcer notre système de surveillance et de matériovigilance pour les dispositifs médicaux.

Je m'associe aux propositions de mes collègues Thomas Ulmer et Philippe Juvin, les rapporteurs de la résolution pour le PPE, qui s'excusent de ne pouvoir être là ce soir. J'appelle la Commission européenne à prendre en compte les recommandations suivantes. Nous devons renforcer et harmoniser les obligations d'inspection au niveau communautaire. Il est urgent de mettre en place des contrôles réguliers, inopinés, annuels, à tous les stades de la vie d'un dispositif médical. Il faut harmoniser les conditions d'habilitation des organismes notifiés et renforcer la traçabilité, la transparence et le suivi des dispositifs médicaux mis sur le marché européen.

Enfin, je souhaite attirer votre attention sur un point fondamental: la nécessité de trouver un équilibre entre la protection de nos patients européens et le soutien à l'innovation et à la recherche. Nous devons allier sécurité, transparence, cohérence et flexibilité. La première des démarches cohérentes est de ne pas traiter les dispositifs médicaux comme des médicaments. Il y a entre les deux trois différences fondamentales: une différence de nature, une différence de durée de commercialisation et une différence en termes de flux sur les marchés.

Dès lors, on le voit bien, la mise en place d'une AMM sur le marché pour les dispositifs médicaux les plus à risque n'entraînerait que des lourdeurs administratives, des coûts supplémentaires, une augmentation des délais de mise sur le marché et, surtout, serait un frein à l'innovation. C'est quelque chose qu'il faut mesurer suivant les cas.

 
  
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  Linda McAvan, author. − Madam President, I agree with nearly everything that is in the resolution before us this evening. I am looking forward to hearing Commissioner Dalli tell us how the revision of the Medical Devices Directive will take on board the lessons we can learn from the PIP scandal which, as Ms Auconie has said, has affected so many women in the European Union and beyond.

But I want to talk tonight about something a little wider than our resolution. It is about my amendment on advertising. We do not allow prescription medicines to be advertised in the European Union, yet we do allow magazines – women’s magazines mainly – to publish adverts like this: pages and pages of glossy, full colour adverts urging women to get breast implants. Two countries have already banned this kind of advertising – France and Belgium – but in the rest of Europe this is pretty normal stuff. I wonder, Commissioner, whether you could tell us if anything can be done about it at European level.

If you look at the websites of these same companies, they have these frequently asked questions about breast surgery on them. It tells you how much you will pay, and how to get a loan to have the surgery. It does give you some facts about the surgery, but nowhere does it say that 30 % of women will have to have a new implant within 10 years, and that nearly all implants have to be replaced at least every 10 to 15 years. In other words, if you go at the age of 32, which is the average age for having a breast implant, for the rest of your life you will have to another implant and then another implant, and so on. I looked at three reputable companies. Not one website mentioned this fact – not one. I do not think that is good enough.

When people have major surgery it is a risk to their health and I do not think there is enough information out there. We need informed patients. Commissioner, I do not know what your competence is, but as we have laws on advertising prescription medicines, I consider it about time we regulated this industry, which is encouraging people to take risks. Many women who have been surveyed were not aware that this meant repeat operation after repeat operation.

(Applause)

 
  
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  Margrete Auken, stiller. − Fru formand! Jeg tror, at det er vigtigt, at vi i denne situation får sagt, at vi skal have en meget, meget bedre autorisation, end vi har haft frem til nu. Det ved vi alle sammen godt. Jeg vil godt understrege, hvad der især skal frem nu, nemlig at der skal være transparens, der skal være åbenhed, der skal være adgang for, at også helt uafhængige forskere og læger osv. kan komme ind og kontrollere forsøgsdata. Det vil sige, at det ved forsøg med mennesker skal være umuligt for industrien at skjule resultaterne. Det skal være sådan, at man på et hvilket som helst tidspunkt i forløbet vil kunne komme ind og se: Har der været skadelige effekter her? Er det faktisk en forbedring, vi står med? Eller er der ikke nogen forbedring? Plyndrer vi samfundet ved at komme med nye devices, altså nye ting, som faktisk fungerede glimrende med det gamle, vi havde?

Det er efter min mening helt afgørende, at vi får den transparens, og jeg håber meget, at kommissær Dalli vil støtte, at det nu bliver patienten, at det bliver menneskene, at det bliver borgerne, der er i centrum, og ikke industrien.

Dernæst håber jeg, at vi får indført, at hvis der er fusk med resultaterne (det har vi set inden for medicinalindustrien) hvis der er fusk med resultaterne (nu snakker jeg ikke om brystimplantaterne, det var jo ulovligt, det der blev lavet, men der kan være meget andet fusk), så skal det behandles som kriminalitet, og ikke bare som noget, man kan klare med bøder.

Det sidste, jeg gerne vil sige til mine kolleger og også til Kommissionen, er, at hvis industrien overhovedet opdager, at der er udsigt til at få rigtig, ægte, sand transparens og adgang til de ubehandlede data, så vil den sætte et fuldstændigt formidabelt skyts af lobbyisme ind imod os. Vi vil blive udsat for alle mulige beskyldninger om, hvordan vi ødelægger deres muligheder, vi forringer patienternes chancer, vi ødelægger konkurrencemulighederne, vi ødelægger forsknings- og fornyelsesmulighederne. Da håber jeg altså meget, at vi er i stand til at modstå det pres, vi bliver udsat for alle sammen, så vi faktisk kan få lavet noget, som vi kan være bekendt, og som vi kan komme med til amerikanerne (hvis ikke vi skal have deres system) og sige: Vores er bedre endnu!

 
  
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  Marina Yannakoudakis, author. − Madam President, six months after the PIP breast implant scandal hit the headlines, the European Parliament is finally getting round to addressing this appalling case of medical malpractice.

It is staggering to comprehend how PIP, once the world’s third largest supplier of breast implants, could disregard the law for almost ten years.

It is important we learn from public health incidents such as this. However, it is also vital that we examine all the facts before drawing conclusions on how a system might need to change to prevent such malpractice happening again.

In addition, we must stress that the PIP scandal does not illustrate a failure of the current compliance system. This was a criminal offence that involved manufacturers placing a substandard product on the market.

Although the committee resolution contains plenty of positive measures that will improve the regulatory framework for medical devices, the text also includes demands for a pre-market authorisation. This duplicates existing laws and standards and is needlessly disproportionate in my view.

Paragraph 22, for example, tabled by the Greens, calls for toxicology assessments on all medical devices. Do we really think that by nitpicking over the toxicity of everything, from elastic bandages to pacemakers, people will stop breaking the law?

Care should always be taken not to use a sledgehammer to crack a nut and I caution against knee-jerking responses that could fundamentally alter a regulatory system that has been protecting patients for more than 20 years.

My group has therefore tabled an amendment and several requests for split and separate votes, in the hope that we can iron out these inconsistencies.

 
  
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  Marisa Matias, Autora. − Senhora Presidente, Senhor Comissário, é verdade que já passaram seis meses desde que houve este escândalo com o PIP e o mais inacreditável é que, durante 10 anos, uma empresa privada possa ter conseguido operar no mercado e ter introduzido implantes de silicone que deveriam ser destinados à construção e ao fabrico de colchões e foram utilizados em mulheres em 71 países.

Isto afetou umas largas centenas de milhares de mulheres, como já foi referido, estima-se que cerca de 500 mil. Ora, estamos a falar de estimativas porque houve falhas, e houve falhas sérias neste processo, sabemos que o que se passou com esta empresa é um caso criminoso, é uma fraude, é um caso de tribunal, mas também sabemos que há aqui uma fraude que deve ser controlada pelos tribunais e os tribunais tratarão dela, mas há uma falha legal, há um vazio legal e desse devemos tratar nós, nós temos responsabilidades nesta matéria.

Durante 10 anos, nós não conseguimos identificar aquilo que os criminosos conseguiram identificar e, portanto, houve um vazio em termos de controlo, em termos de rastreabilidade, em termos dos arquivos, em termos dos registos, tudo falhou, mas estes senhores desta empresa conseguiram pôr em prática aquilo que nós não conseguimos controlar e é, por isso, que neste processo não há apenas só a questão da falta de informação, que é muito importante, de facto, a falta de informação em todas as questões relativas com os implantes mamários, mas também a humilhação de milhares de mulheres e a humilhação, em particular, daquelas mulheres que tiveram que submeter-se a testes para saber se tinham colocado ou não implantes corretos.

Estamos a falar de uma questão de saúde pública e nós não podemos ser laxistas em matéria de saúde pública, nós controlamos tanta coisa desnecessária, controlamos até a autenticidade das peças de substituição nos automóveis, ainda há pouco tempo aprovámos uma diretiva sobre isto. Temos que controlar aquilo que é fundamental para a vida das pessoas, a revisão da diretiva dos dispositivos médicos é uma boa notícia, era melhor notícia que não tivéssemos que fazê-lo, mas agora, já que vamos fazê-lo, que apliquemos com condições, com rastreabilidade, transparência, controlo, sanções, porque infelizmente as sanções, mesmo a serem aplicadas, não serão aplicadas às mulheres que sofreram deste problema e os Estados devem assumir total responsabilidade.

 
  
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  Oreste Rossi, Autore. − Signora Presidente, onorevoli colleghi, la discussione e la votazione della risoluzione cadono in un momento particolarmente favorevole in quanto, se approvata, la risoluzione potrà dare utili indicazioni sulla revisione del medical device.

Il caso delle protesi mammarie ha dimostrato le carenze dell'attuale sistema di certificazione della conformità ai requisiti essenziali in materia sanitaria e di sicurezza. Ritengo che le proposte di revisione avanzate dalla Commissione europea e dal Commissario Dalli vadano giustamente nel senso di pretendere maggiori controlli nelle aziende produttrici dei dispositivi medici e maggior severità nel rilascio delle autorizzazioni da parte di organismi preposti. Sono anche d'accordo sul fatto che non si debbano inserire eccessivi oneri burocratici che impediscono per anni l'utilizzo di prodotti innovativi. Credo sia importante garantire a livello europeo controlli severi, efficienti e rapidi.

Relativamente alle migliaia di donne che si sono sottoposte all'inserimento di protesi mammarie, bisogna renderle consapevoli dei possibili rischi a cui andranno incontro, dando loro la possibilità di sottoporsi a screening e consulenza medica per verificare eventuali danneggiamenti e prevenire le rotture dei dispositivi. È importante costituire un registro da cui sia possibile risalire a coloro che si sono sottoposti a innesti di dispositivi medici particolari in modo che, qualora vi sia necessità e dare informazioni su eventuali controlli, modifiche o sostituzioni, sia possibile farlo in tempi certi.

Anche l'introduzione di una carta di riconoscimento delle protesi consentirebbe all'utente di essere informato su tutti i potenziali rischi a cui potrebbe andare incontro e a quali controlli sarebbe bene sottoporsi negli anni. È fondamentale, in un'ottica di collaborazione a livello di Unione, che gli Stati membri assumano precisi impegni per eliminare o minimizzare il ripetersi di eventi gravi come quello legato alle protesi al silicone PIP.

 
  
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  John Dalli, Member of the Commission. − Madam President, during the last 20 years, the medical device regulatory system has, overall, provided for safe, reliable and performing devices in Europe and has provided the flexibility needed for the high number of medical devices and the short life-cycle of these products. It has also proven to be a system that is cost-effective and SME-friendly. It has put Europe in the forefront of innovation.

For months before the PIP case, the Commission was reviewing the Medical Devices Directive, because we found that it needed quite a number of improvements. The PIP case is indeed appalling. It is a case of fraud which went undetected due to weaknesses in the post-market phase. Nevertheless, the case has highlighted a number of weaknesses in the regulatory framework.

In order to provide a rapid answer to European patients’ concerns, I have identified, and shared with the European Parliament, a number of actions to be taken immediately, together with the Member States, on the basis of the current legislation. This includes tightening market controls, in order to provide a better guarantee of the safety of medical technology, especially high risk devices. I have therefore written to the Health Ministers of all the Member States to ask for their support, and together we are now putting these actions in place.

For the longer term, the revised medical device legislation that the Commission has been preparing – independently of the PIP case, as I said –will also take on board the experiences of this affair. The Commission intends to adopt its proposal shortly after the summer break.

A number of improvements were already foreseen to reinforce the system. These improvements will contribute to avoiding cases like the PIP implant case. To mention but a few: we want to strengthen the designation, monitoring and functioning of notified bodies and ensure that this is carried out in accordance with the same high standards across the EU; and we want a stronger role to be given to competent authorities, both in pre- and post-market phases.

The system can only be efficient if we make the best use of the limited number of experts available. This is why the Commission foresees a pre-market scrutiny mechanism to be put in place for high-risk devices, and other devices where necessary, but on a case by case basis. This mechanism will allow a committee composed of Member States’ experts to check certain notified bodies’ assessments before the devices can have access to the market.

The advantage of doing so will be twofold. First, it will ensure an equal level of assessment by notified bodies, in particular with regard to clinical evidence. Second, it will allow Member States to be informed of products coming onto the market so that they can ensure targeted controls of these products. This mechanism has the advantage that scarce resources and expertise are used to ensure efficient and proportionate pre-market control and reinforced vigilance and market surveillance. Last but not least, we want to improve the traceability requirements for medical devices, for instance by means of a unique device identification and a single registration system.

Following the PIP case, the Commission performed a ‘stress test’ of the medical device legislation in order to identify additional possible shortcomings of the regulatory framework and address them in the context of the upcoming revision. As a result of the stress test, additional measures will be included in the Commission proposal.

These proposals will concern the audit activities of the Notified Bodies. Particular attention will be paid to the obligatory unannounced visits to the manufacturer, testing of products and rotation of auditors. Information will be given to national authorities with regard to negative outcomes of such audits. Measures should also be put in place to enhance the reporting of incidents by healthcare professionals and patients. Patients’ awareness should also be improved through, for example, implant cards providing appropriate information.

This is where I believe that the transparency of the market should be enhanced, by giving all interested parties the right information not only – as Mrs McAvan has said – about costs and benefits, but also about the duration, durability and consequences of the implants or whatever other device they are using, because this is not only a question of implants and there are other devices in use.

I believe everybody needs to know all the implications of using such devices, because some people really do think that once they go through a procedure, it is a once in a lifetime procedure, which in many instances is not the case. This has to be continuously put in front of our patients, or our consumers, in the way we are suggesting. These cards have to be given to every single patient who undergoes any type of procedure involving such implants. In this way, patient awareness will be greatly improved.

I do believe that the set of measures already foreseen, combined with additional measures deemed necessary in the light of the result of the stress test, will considerably reinforce the system, favour innovation and ensure that only safe and performing medical devices are placed on the European market, for the benefit of European citizens. I have taken note of the points raised by Mrs Auconie and I must say that all her points are, in fact, included in the proposal that we will be presenting, as I said, just after the summer.

 
  
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  Elisabetta Gardini, a nome del gruppo PPE. – Signora Presidente, onorevoli colleghi, ringrazio il Commissario che ha detto cose importanti e condivisibilissime. Io trovo che sia davvero, come ha detto lui, sconvolgente il fatto che abbiamo vissuto, ognuno nel proprio paese, con i numeri e le cifre che abbiamo sentito prima dalla collega Auconie.

Tuttavia, è altrettanto evidente che questo scandalo ha davvero evidenziato la necessità di un'attenta valutazione della legislazione europea attualmente in vigore sui dispositivi medici. Purtroppo, questa frode ha messo in evidenza le lacune di cui abbiamo parlato fin qui in Aula, e che ha così bene rappresentato il Commissario, per cui non mi vorrei soffermare nel breve tempo che ho a disposizione su questo aspetto.

Credo che sia bene mettere in campo tutto il necessario perché noi possiamo avere il meglio da offrire ai nostri cittadini. Io credo che questo scandalo che ci ha insegnato tante cose potrebbe anche essere uno spunto per fare un ulteriore passo in avanti e mi ricollego a quanto detto dalla collega prima. La comunicazione che viene fatta per i pazienti è davvero scadente, viene sempre e soltanto sottolineato l'aspetto positivo, si dice che esiste una sorta di giovinezza eterna, di bellezza promessa, mentre non esistono protesi che siano assolutamente prive di rischi. Io credo che questa consapevolezza, soprattutto quando si parla di pura chirurgia estetica, debba essere veramente comunicata alle persone e in particolare alle ragazze, perché sappiamo che ci sono giovanissime che si avvicinano a questo tipo di interventi. Quindi – vedo che lei assente con convinzione – mi raccomando, lavoriamo perché veramente i tempi sono stretti, dovremmo averlo già fatto ieri.

 
  
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  Gilles Pargneaux, au nom du groupe S&D. – Madame la Présidente, Monsieur le Commissaire, nous avons connu le scandale du Mediator, il y a quelque temps. Nous avons maintenant le scandale des implants mammaires, qui met malheureusement en évidence – comme vous l'avez dit, Monsieur le Commissaire – les dysfonctionnements de la sécurité sanitaire européenne.

Ce scandale des implants mammaires, c'est quatorze années d'escroquerie – de 1996 à 2010 – impunies. Ce sont 500 000 prothèses portées dans le monde. C'est 8 000 retraits d'implants, 48 cas de cancer avérés. C'est enfin 3 500 plaintes déposées. Ces chiffres effraient, choquent. Comment, malgré les avertissements de l'Agence du médicament américaine FDA, Monsieur le Commissaire, et les nombreuses plaintes et condamnations pour rupture de prothèses déposées en Grande-Bretagne et en France notamment, comment les agences nationales et européennes ont-elles pu passer à côté d'une telle escroquerie?

Ce drame nous a immédiatement amenés à réfléchir à une amélioration du système européen du contrôle des dispositifs médicaux tel que vous nous l'avez expliqué à l'instant. Nous devons, Monsieur le Commissaire, aujourd'hui bâtir un système capable d'éviter le scandale, mais c'est un nouveau système qu'il faut bâtir. Il est annoncé pour l'automne, vous nous avez parlé de cette nouvelle législation. En tant que corédacteur de cette résolution, j'en suis bien évidemment satisfait.

Mais, Monsieur le Commissaire, vous semblez vouloir prendre en compte une grande partie de nos préoccupations telles qu'édictées par cette résolution. Alors pourquoi faire une exception, inacceptable pour bon nombre de parlementaires ici présents? Pourquoi ne pas vouloir la création d'une autorisation de mise sur le marché pour les dispositifs médicaux de la classe 3, les plus à risque? Monsieur le Commissaire Dalli, pouvez-vous m'expliquer votre position?

 
  
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  Izaskun Bilbao Barandica, en nombre del Grupo ALDE. – Señora Presidenta, deseo que la reforma de la legislación europea sobre el control de dispositivos médicos e implantes sea tan completa como las propuestas que se plantean en esta Resolución.

Hemos aprendido muchas lecciones con la crisis de los implantes PIP y buena parte de las soluciones están sobre la mesa. Es obligatorio el intercambio de datos, el establecimiento de sistemas de alerta para notificar en toda Europa cualquier incidencia, la mejora de los tests mecánicos y clínicos sobre las prótesis y la transparencia y mejora de la información que reciben los pacientes.

Necesitamos un sistema de sanciones que afecte a los proveedores que venden mercancía peligrosa y a los profesionales de toda la cadena comercial y sanitaria que no colaboran con este esfuerzo de transparencia, seguimiento y control. Son exigencias éticas y científicas, como es de justicia arbitrar compensaciones para las víctimas de este episodio.

Hay también cosas nada cómodas para decir en voz alta y añadir aquí en una semana en la que la voracidad financiera sigue devorando nuestro empeño por salvar el proyecto europeo, que tanto aporta al bienestar de la ciudadanía con asuntos como el que debatimos ahora. Recordemos que la llamativa diferencia de precio entre los productos fabricados por PIP y los que ofertaba la competencia no animó a extremar el control. Sin embargo, el precio fue la base del éxito del PIP en el mercado de las prótesis y esto tuvo una repercusión en las pacientes, en las mujeres.

Estoy segura de que con estos controles las organizaciones médicas europeas pondrán los medios para que esto no vuelva a ocurrir jamás, pero corresponde a la Comisión implantar de manera urgente un sistema de seguimiento y control, y responsabilidades, y a este Parlamento controlar el contenido del cumplimiento de esta Resolución.

Esperemos por eso, Comisario, que cumpla con su palabra.

 
  
 

Procedura "catch the eye"

 
  
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  Mairead McGuinness (PPE). - Madam President, this is a very important debate, but while we are talking about this particular scandal, we have to recognise that the European medical devices industry has been very innovative and has helped patients a great deal.

So I welcome the balanced approach of the Commission in relation to improving our regulatory system. I am against paragraph 7 because it will overdo things and take away the possibility of the industry being innovative. What we are trying to strike here is a balance between what is good for patients and improving the quality of life of those who need medical devices.

Could I just say on a slightly different theme, picking up on the point made by Ms McAvan, that we have had a debate on female genital mutilation and we are now having a debate on breast implants. Sometimes these are used by very young girls who chose this process and who, as Ms McAvan pointed out, do not understand the consequences of it. While the debates are not linked, it is interesting that, on this occasion, we are having them both tonight.

My main point is, however, that with regard to the progress made for people who have had hip implants or knee implants, and whose quality of life has been improved by the European medical devices industry, we need to allow this to flourish and grow. We need to better regulate the notified bodies, as has been suggested, and not stifle innovation.

The separate issue of breast implants calls for another debate, about society and pressure on young women. Perhaps we can have that another time.

 
  
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  Evelyn Regner (S&D). - Frau Präsidentin! Herr Kommissar, ich möchte den Rahmen dieser Aussprache dafür nutzen, um auf eine Verordnung hinzuweisen, die derzeit überarbeitet wird, genauer gesagt steht sie kurz vor dem Abschluss. Aber dieser Anlassfall der defekten Brustimplantate zeigt uns, dass diese Verordnung noch weiter überarbeitet werden muss. Ich spreche von Brüssel I, der Verordnung über die gerichtliche Zuständigkeit und die Anerkennung und Vollstreckung von Entscheidungen in Zivil- und Handelssachen. In Österreich gibt es mindestens 60 Opfer der defekten Brustimplantate, die vergeblich versucht haben, über ihre Verbraucherorganisation in Wien eine Klage einzubringen. Es ist ihnen aufgrund einer Lücke in der Zuständigkeitsverordnung nicht gelungen.

Wir könnten nun die Situation dieser Opfer und vieler anderer verbessern, wenn auch Verbraucherorganisationen, die die Opfer vertreten, den günstigeren Verbrauchergerichtsstand nützen könnten. Hier haben wir mit den defekten Brustimplantaten einen weiteren Anlassfall, der zeigt, dass die exklusiven Gerichtsstände, wie der Verbrauchergerichtsstand, ebenfalls einer Überarbeitung bedürfen.

 
  
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  María Irigoyen Pérez (S&D). - Señora Presidenta, hablamos de un escándalo, un escándalo por el uso de las prótesis PIP, que usaban silicona industrial.

Hablamos de riesgos, los riesgos que han corrido los usuarios, las pacientes, muchas mujeres jóvenes que acuden ahí y que no saben cómo son estas prótesis que les están colocando sin información alguna. Vemos que hay muchas lagunas legislativas, muchas; por tanto, hay que ir más allá. Además de control, vigilancia y protección, por supuesto, es necesaria más información porque el escándalo de estos implantes que afectan a más de 30 000 mujeres europeas nos enseña que hay que sancionar a los proveedores que introducen estos productos incompatibles con la salud, porque, señor Comisario, las pacientes que usan estas prótesis tienen derecho a estar informadas y, también, al mismo tiempo, a no correr ningún riesgo, porque hoy en día aquellas personas que se ponen prótesis y las utilizan, no solamente lo hacen por razones de salud, sino en beneficio de ellas mismas.

 
  
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  Marc Tarabella (S&D). - Madame la Présidente, Monsieur le Commissaire, on peut s'interroger sur l'inertie apparente des pouvoirs publics dans ce dossier. Dans un tel cas de figure, les victimes sont en droit d'attendre une vraie prise de responsabilité et qu'on leur propose de vraies solutions.

Il est vrai que les actions du comité de suivi mises en place par les autorités sanitaires sont loin d'être exemptes de tout reproche.

Je constate également que la question des dépassements d'honoraires pratiqués par les chirurgiens chargés de retirer les prothèses défectueuses n'a toujours pas été réellement abordée, ce qui n'est pas non plus acceptable. Gilles Pargneaux a rappelé les chiffres alarmants de cette action criminelle de la société PIP en termes de victimes.

Faisant suite à la question que je vous ai posée le 13 janvier, vous me répondiez que l'inclusion dans la législation sur les dispositifs médicaux des produits injectés ou implantés destinés exclusivement à des fins esthétiques faisait partie des options notamment proposées par la Commission dans une consultation publique qu'elle avait lancée dès 2008.

J'aurais voulu savoir avec précision, Monsieur le Commissaire, dans ce contexte de projet de révision de la législation sur les dispositifs médicaux, si vous vouliez – si vous aviez l'intention de le faire – étendre le champ d'application de cette législation aux produits esthétiques en question.

Dans quel délai peut-on s'attendre à avoir cette législation?

 
  
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  Karin Kadenbach (S&D). - Frau Präsidentin, Herr Kommissar! Ich möchte da anschließen. Wir sprechen heute über Medizinprodukte, und ich glaube, wir brauchen hier strengste Zulassungskriterien, wir brauchen strengste Kontrolle, und wir brauchen eine weitestgehende Information.

Aber ich bin auch davon überzeugt, dass nur der geringste Teil der Brustimplantate wirklich als medizinische Produkte im Sinne von medizinischer Therapie oder Behandlung Verwendung findet und dass ein ganz großer Teil in der Schönheitschirurgie eingesetzt wird. Wir sprechen hier von einem Markt, der ungefähr 700 Millionen Euro ausmacht. Meine Frage heute geht dahin – und da möchte ich bei Linda McAvan anschließen –, wie weit wir es auch als Gesundheitsverantwortliche verantworten können, dass in der Zwischenzeit ein Großteil der Europäer, in erster Linie Frauen, von sich ein so gestörtes Selbstbild haben, dass sie glauben, über derartige Implantate erst wirklich Frau zu sein.

Wenn wir uns anschauen, dass in Europa ca. 22 % der Jugendlichen, in erster Linie Frauen, unter Essstörungen leiden, dass die Werbung und das Bild, das uns in der Werbung, in den Medien von einem jungen Menschen, von einer vollwertigen Frau, von einem vollwertigen Mann, vermittelt wird, ein Bild ist, das es zu korrigieren gilt, wenn der Ausfluss darin besteht, dass ein Großteil dieser Menschen glaubt, ihr Selbstwertgefühl nur mit Hilfe von chirurgischen Eingriffen wieder herstellen zu können, dann müssten wir uns hier im Sinne einer guten Gesundheitsprävention auch über Werbebeschränkungen den Kopf zerbrechen.

 
  
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  Nicole Sinclaire (NI). - Madam President, this issue stems from the failure of the French authorities to regulate its manufacturing industry. Typically, ‘France has a take it or leave it’ approach to regulations that it expects other countries to adopt.

In June 2000, US medical regulators posted a warning letter on the internet about problems at a breast-implant maker in southern France. The French authorities did not pay this much attention. The French health authorities acknowledged as much in a 175-page report published on 1 February this year.

Radical change is needed in Europe to ensure proper surveillance of medical devices. France has shown itself incapable of regulating itself and should have external checks.

Many thousands of women have suffered, and are continuing to suffer, because of French negligence. France should be made to compensate all women affected by this negligence.

In future there needs to be more communication with the surgeons, the clinics and the patients. These companies must be checked and the findings should be open to inspection by health professionals.

 
  
 

(Fine della procedura "catch the eye")

 
  
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  John Dalli, Member of the Commission. − Madam President, I would like to thank all Members for their comments on this very important issue.

We all agree that patient health comes first and foremost in our policy deliberations. This is exactly what we are doing too when we insist that we must continue to have a flexible system that delivers innovation as fast as possible to our patients, because that is also a function of patient health.

Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.

So when I was asked by Mr Pargneaux why I would not be pushing for pre-marketing authorisation, this is why: because I do not believe we need it. We do not need to go the way of pre-market authorisation. We have a system in Europe that has worked in the past. We are enforcing this system so it works even better. We are ensuring the competence of all the bodies that are involved in the authorisation process and this is the package that we will be proposing to this Parliament and to Council just after the summer. This, Mr Tarabella, is what the outcome is, and what my position is on this issue.

We have been deliberating, we have been studying and we have been stress-testing what we have done because of the PIP case, and we will be coming forward with a formal, concrete proposal in a few months time, around September.

When we talk about authorisation, what we are saying here is: let us continue to keep the flexibility that we have in Europe; let us enforce and make sure that whoever is involved in the process is competent to do so; let us make the competent authorities in the Member States more involved in what is happening in their own countries within this process, and then let us have a Europe-wide expert group that will ensure the consistency, all across Europe, of a standard level of authorisation.

The PIP case is not about authorisation. The PIP case has nothing to do with authorisation. The PIP case is a fraud which could have happened under the most robust authorisation process you could possibly have.

The PIP case is an indication of the weaknesses we have in our processes: not necessarily in the legislation itself, though the legislation will be strengthened as well, but more in the way it was being implemented in market controls after authorisation.

As some of you have said, competent authorities in Member States simply let the medical devices that were in use in their countries not be subject to any kind of controls, and this is what is wrong.

It was unbelievable to hear – and I am an accountant by profession, so for me it was even worse – that all audits held by the notifying bodies on companies were all pre-notified two months in advance! It is unbelievable that this could happen!

This was all due to their interpretation that this was what was required in our legal process – which is not the case. In fact, in the letter I have written to the Ministers, I have told them that this is not the case, that non-notified audits are provided for in our legislation today, and they should also be making sure that this is happening with marketing controls today. We do not need to wait two years until this legislative process that we will be launching very soon is finished.

We are pushing for transparency; transparency not only in the information that is given to everybody who might be deciding on making any type of procedure, but transparency also in the vigilance aspect so that all incidents that happen within the medical devices sector have to be reported back. A database will be set up to put all this information together so that we can really take the necessary actions.

The traceability of medical devices, which we are also proposing and will be proposing, as was mentioned here again today – and I am pleased that it was because this is also a very important aspect – and especially of risky medical devices would also be part of the proposal.

Therefore, we are keeping our word on this. We will be coming back in September with a robust proposal that will drastically improve our safety issues – and without going overboard, without overreacting to an incident and trying to find a way of transmitting the sense that we are doing something by really doing something where it is not indicated that it needs to be done.

The problem of the PIP fraud was not authorisation. It lay in market controls, and this is where we need to really put our foot down and really ensure that we introduce a robust market control procedure.

 
  
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  Presidente. − Comunico di aver ricevuto una proposta di risoluzione(1) conformemente all'articolo 115, paragrafo 1, del regolamento.

La discussione è chiusa.

La votazione si svolgerà giovedì 14 giugno 2012.

Dichiarazioni scritte (articolo 149)

 
  
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  Véronique Mathieu (PPE), par écrit. – La vente par la société française PIP d'implants mammaires en gel de silicone défectueux est proprement scandaleuse. Il est inconcevable qu'une telle situation ait pu perdurer pendant plusieurs années, que 400 000 implants mammaires aient été vendus dans le monde entier, et cela sans que la chaîne de contrôle et de surveillance ne réagisse. A l'avenir des tests de sécurité plus stricts doivent empêcher qu'un tel drame puisse se reproduire, et que des milliers de femmes se retrouvent dans des situations délicates compromettant leur santé. La coopération européenne et l'échange d'informations à ce titre doivent être renforcés.

 
  

(1)Vedasi processo verbale.

Aviso legal - Política de privacidade