Rapporti verbatim tad-dibattiti

It-Tlieta, 18 ta' Jannar 2011 - Strasburgu

14. Inizjattiva Ewropea dwar il-marda ta' Alzheimer u dimenzji oħrajn - Inalaturi għall-ażma (dibattitu)

  El Presidente. − El punto siguiente es el, debo decir, extraño debate conjunto sobre

- el informe de Marisa Matias, en nombre de la Comisión de Medio Ambiente, Salud Pública y Seguridad Alimentaria, sobre una iniciativa europea acerca de la enfermedad de Alzheimer y otras demencias (2010/2084(INI)) (A7-0366/2010), y,

- la pregunta oral a la Comisión sobre los inhaladores para el asma, de Erminia Mazzoni, en nombre de la Comisión de Peticiones (O-0182/2010 – B7-0666/2010).

  Marisa Matias, relatora. − Senhor Presidente, eu gostaria de começar por dar um exemplo que me parece claro da urgência desta iniciativa. Começámos o trabalho no Parlamento há seis meses, exactamente há seis meses, entre o período de início da elaboração do relatório e o período de voto. Durante estes seis meses, mais de 700 000 pessoas na Europa desenvolveram Alzheimer ou qualquer outro tipo de demência. Este número por si só mostra o quão relevante e urgente é intervir neste domínio. E é por isso que, em boa hora, vem a Comunicação da Comissão.

As pessoas que sofrem de Alzheimer e de outras demências na Europa têm que ser tratadas todas por igual. São mais de 7 milhões de pessoas com Alzheimer, são quase 10 milhões de pessoas que sofrem no total de doenças demenciais.

Se falássemos de números, falaríamos da dimensão de um país médio. Nós não podemos discriminar uma doença como não podemos discriminar um país. Temos que tratá-los a todos por igual. E é por isso mesmo que é preciso e urgente intervir em várias áreas. Na área da investigação, nós sabemos que esta doença duplica a cada vinte anos em termos de números.

Nós sabemos que se a faixa etária for com mais de 65 anos, o número de duplicação é a cada quatro anos, e é por isso mesmo que nós temos que investir nas causas e descobrir as causas porque não temos outra forma de intervir sobre um problema se não o conhecermos bem. E para isso mais investigação, mais cooperação e mais dados epidemiológicos.

Precisamos também de conhecer melhor como intervir em matéria de prevenção e em matéria de controlar os factores de risco. Precisamos de um diagnóstico precoce, precisamos de cuidados especializados, de treinar os cuidadores. Precisamos de dar apoio às famílias, de não estigmatizar os doentes, de lhes dar direitos, de lhes dar dignidade. Precisamos que todos os países tenham planos de acção nacionais para depois termos uma cooperação à escala europeia. Precisamos de combater as desigualdades entre Estados-Membros e dentro dos Estados-Membros. Não podemos admitir que haja doentes de primeira e de segunda. Têm de ser todos iguais, independentemente do sexo, da idade, do local de residência ou outro qualquer critério.

É por isso, Senhor Presidente, que é muito, muito importante que possamos ter a maior cobertura possível dos serviços de saúde. E não podemos evitar falar destas urgências apenas porque estamos em crise e falamos sempre dos custos da doença. Os custos sociais e económicos resultantes de não tratar deste problema são muito maiores, são muito mais elevados do que se o enfrentarmos. E é por isso que temos que enfrentar este problema e investir, investir nas pessoas, investir, como disse, na prevenção e dar apoio às famílias e aos cuidadores que tantas vezes são esquecidos.

Nós sabemos que para cada pessoa que sofra de Alzheimer são precisas três pessoas para cuidar dela. Uma pessoa que sofra de Alzheimer não pode passar uma hora sem acompanhamento. Isto tem que nos servir de lição. Não podemos continuar sem articulação, sem cooperação e sem uma cooperação que seja solidária entre os Estados-Membros para responder a este problema.

E é por isso que eu gostaria de dizer o seguinte: falando em cooperação, todos sabemos e todas sabemos que nenhum deste trabalho pode ser feito isoladamente e também aqui dentro do Parlamento o trabalho foi feito em cooperação com todas as relatoras-sombra de todos os grupos parlamentares, com o apoio das três mulheres que me ajudaram na Comissão do Ambiente, no meu grupo parlamentar, na minha delegação.

E é por isso que quero agradecer muito a todas essas mulheres, e se calhar não é por acaso que foram só mulheres que trabalharam neste relatório, é porque as mulheres são as mais afectadas, são elas que tratam dos relatórios Alzheimer e são elas que também tratam dos doentes de Alzheimer, incluindo os homens. E por isso quero que se preste também atenção às formas de discriminação que estão escondidas sob a forma de não haver tratamento nem resposta para estas matérias.

E termino dizendo que gostaria de questionar directamente o Sr. Comissário para lhe perguntar que propostas incluídas neste relatório está a Comissão disposta a aceitar e quando estará disposta a aceitar e dar seguimento a tamanha urgência como é esta que vivemos actualmente.

  Erminia Mazzoni, Autore. − Signor Presidente, onorevoli colleghi, devo dire che condivido anch'io le perplessità sulla logica dell'abbinamento di questa interrogazione con la precedente relazione, ma l'importante per me è che oggi quest'Aula si occupi dell'argomento che è contenuto nell'interrogazione da me presentata a nome della commissione per le petizioni.

Questa interrogazione solleva un caso di denegata giustizia nei confronti di una piccola impresa europea per l'inerzia purtroppo consumata dalla Commissione dal 1997 ad oggi, così come ha sostenuto anche la commissione giuridica che è stata interpellata per un parere dalla commissione che io presiedo.

La vicenda riguarda un apparecchio medico, nello specifico un inalatore per asmatici, brevettato nel 1990 e immesso regolarmente sul mercato. Questo prodotto rientra nella disciplina dettata dalla direttiva 93/42/CEE, la quale prevede che la conformità alle prescrizioni sia oggetto di autocertificazione da parte del produttore e affida poi alle autorità nazionali un potere di controllo sulla regolarità, attraverso attività di monitoraggio e di controllo a campione.

Il prodotto, diffuso con successo sul mercato per sei anni, quindi fino al 1996, in assenza di specifiche contestazioni e di rilievi che non sono mai stati documentati nel corso di oltre quindici anni, viene sottoposto a controllo da parte dell'Autorità governativa dell'Alta Baviera che chiede alla commissione del Magdeburgo di rivedere l'autorizzazione rilasciata a questa società.

Nel dicembre dello stesso anno, la commissione, il ministro della Salute della Sassonia-Anhalt procede a questa attività di controllo e conclude la procedura dichiarando la perfetta conformità del prodotto alle prescrizioni normative, sollevando tra l'altro, al termine di questa procedura, un dubbio sulla fondatezza della richiesta formulata dall'Autorità governativa dell'Alta Baviera e invitando la stessa, nel caso dovessero permanere dubbi, ad avviare la procedura di salvaguardia prevista dalla direttiva citata.

Nel corso dell'anno successivo si susseguono una serie di attività non documentate, delle quali abbiamo notizia solo de relato, e si arriva poi nel 1997, improvvisamente, senza nessuna comunicazione fatta al produttore, a un provvedimento da parte del ministro della Salute federale di ritiro del prodotto dal mercato.

La procedura viene avviata alla fine del 1997 dal ministero – la procedura ai sensi dell'articolo 8 della direttiva citata – ma va a finire su un binario morto, perché non si hanno notizie, non viene avviata la fase delle consultazioni con il produttore. Nel silenzio generale il produttore, nel 2003, ritenendo di poter attribuire a questo silenzio un significato di evidente negazione di quei rilievi non chiariti formulati dalle autorità tedesche, reimmette sul mercato il prodotto a metà del 2003.

Purtroppo nel 2005, sempre senza una comunicazione, le autorità tedesche emettono un nuovo provvedimento di ritiro dal mercato di questo prodotto. Da precisare che non risulta ancora oggi, nonostante le reiterate richieste, alcun elemento che porti a chiarire il perché di questo ritiro del prodotto.

Quindi: mancata comunicazione, mancato accertamento, negazione di qualunque possibilità di legittimo contraddittorio per il produttore e conseguenze gravi di carattere economico per lo stesso, perché da oltre quindici anni è in attesa di una risposta e il suo prodotto non può circolare sul mercato.

Aggiungo anche che, nel corso dei sei anni di diffusione del prodotto – e su questo ci sono documenti che sono stati forniti anche alla Commissione – nei sei anni di distribuzione del prodotto si sono annotati notevoli risparmi nella spesa pubblica della sanità per il ridotto costo del prodotto e positivi effetti per i malati sofferenti di asma.

Nel 2008, visti vani tutti i tentativi formulati con le altre autorità, il sig. Klein, il produttore, si rivolge alla commissione per le petizioni. La commissione avvia la procedura nel corso di questa legislatura e, considerato il lungo tempo della vicenda contenuta nella petizione, avvia anche una consultazione informale con il Commissario, chiedendo di accelerare i tempi di una risposta, perché la richiesta dell'autore della petizione è una richiesta che va nell'ordine di riconfermare la conformità del prodotto alla normativa europea o, in subordine, quanto meno di avere un provvedimento impugnabile davanti alla Corte che quindi gli consenta di avere giustizia.

Tutto questo non è avvenuto e nel corso della discussione in commissione petizioni la Commissione europea, purtroppo, ha eluso le domande ancora una volta. Ecco perché la commissione ha deciso all'unanimità di arrivare in Aula e di chiedere in Aula alla Commissione risposte chiare, perché questa vicenda, è innegabile, solleva gravi dubbi su una violazione della Carta dei diritti fondamentali e non solo per l'inerzia della Commissione, ma anche, e soprattutto, per l'impossibilità nella quale è posto l'autore della petizione, il sig. Klein, di adire un'autorità giudiziaria.

La vicenda pone evidenti dubbi sulla violazione delle regole del mercato e sulla tutela della piccola impresa, ecco perché insistiamo per avere, qui, delle risposte alle domande formulate nell'interrogazione.

  El Presidente. − Señora Mazzoni, le agradezco, sobre todo, el haber compartido mi perplejidad por el solapamiento de los dos temas, que, naturalmente, no supone, por mi parte, ningún demérito de una pregunta importante y que, además, usted plantea en su condición de presidenta de la Comisión de Peticiones, de la que formo parte y, por lo tanto, tengo el máximo interés en lo que allí se hace.

Será muy difícil, tanto para el Comisario como para los intervinientes, mezclar dos temas de naturaleza tan distinta y, por lo tanto, cabe preguntarse si es razonable plantear el debate tal y como se ha planteado en el orden del día.

  John Dalli, Member of the Commission. − Mr President, honourable Members, first allow me to pay tribute to Parliament, in particular to the rapporteur, Mrs Matias, for your commitment to addressing Alzheimer’s and other dementias.

The Commission fully shares your concern. Dementia means great suffering for millions of Europeans and their families. With a population ageing fast, now is the time for Europe to act.

This is why the Commission put forward a Communication on Alzheimer’s and other dementias in 2009 with action to improve prevention and diagnosis, research and best practice exchange.

I am delighted that Parliament is supporting ongoing work in this context and presenting a comprehensive set of recommendations. This report and its recommendations are very timely at a moment when the Commission is about to launch a joint action with the Member States on Alzheimer’s in April, the so-called ALCOVE (ALzheimer COoperative Valuation in Europe).

I am persuaded that this joint action will deliver on many of the recommendations that you are adopting here today.

The joint action will focus on prevention – an area which Parliament underlines in this report – and also on improving knowledge and data and sharing good practices. It will also address another area where Parliament is calling for action: the rights of people living with dementia. I agree with you that we need fully coordinated research to understand better how to prevent or delay the onset of dementia. This is why the Commission has launched a joint programming initiative on combating neurodegenerative diseases, in particular Alzheimer’s.

For the first time, 23 countries are working together to tackle Alzheimer’s. There are good practices across Europe on diagnosis and treatment for Alzheimer’s and the Commission is fostering exchange of knowledge and good practice.

As recommended by Parliament, I can also confirm that the Innovation Union initiative under the Europe 2020 strategy will take as its first pilot area for the new European innovation partnership the topic of active and healthy ageing.

Action to support people suffering from dementia could be developed in this context. A good example could be the ongoing Parliament initiative on carers. We hope to be able to support further innovative actions in this area which may also address the issues of Alzheimer’s and other dementias.

Finally the Commission looks favourably at a number of other recommendations, including declaring 2014 as European Year of the Brain. Let me assure you that the Commission is committed to doing its share to address dementia.

Let me now address the second topic in this debate: the petition filed by Mr Klein, the inventor and producer of the inhaler ‘Effecto’.

The placing on the market of the device in question was originally refused in Germany in 1997. This decision was not pursued further, either by the Commission, the German authorities, or the manufacturer. The then distributor indicated at the time that it would conduct further studies before placing the product on the market again.

The device was placed back on the market in 2002 under a new name. When the product was again prohibited by the German authorities in 2005, the Commission carefully analysed the case and concluded the procedure by formal letter to the German authorities and the manufacturer in July 2007.

The Commission analysis was that the prohibition by the German authorities was justified because the clinical data provided by the manufacturer was insufficient to demonstrate the safety of the device.

According to the Medical Device Directive, safety has to be demonstrated by the manufacturer in order for him to be allowed to use the CE marking. This meant that the applicable legal provision was Article 18 of the directive which addresses cases where a product is placed on the market with improperly affixed CE marking. In this case, there is no formal Commission decision.

Since, in the Commission’s view, the case is not one to which the safeguard clause procedure applies, it has no reason to request notification of the 2005 prohibition adopted by the German authorities.

The obstacle which the petitioner faces in placing the product on the market is the decision of the German authorities (the 2005 prohibition) and not a decision of the Commission. The petitioner had clear legal avenues which he could pursue at national level, and indeed he has made use of these opportunities. His claims, however, were rejected by the German courts.

I would like to stress that the Commission has, since 2007, invited the petitioner to bring the device into compliance by providing the missing clinical data and has facilitated contacts between him and the German authorities to that end. To the Commission’s knowledge, no action has been taken by the petitioner so far.

  Elena Oana Antonescu, în numele grupului PPE. – Mă voi referi la boala Alzheimer şi alte demenţe. Doresc să o felicit pe doamna raportor Matias pentru munca depusă şi, în calitate de raportor din umbră din partea Grupului PPE pe acest dosar, vreau, de asemenea, să mulţumesc tuturor colegilor care şi-au adus contribuţia. Atenţia de care s-a bucurat acest dosar arată importanţa temei şi, în acelaşi timp, gravitatea fenomenului.

Numărul persoanelor care suferă de demenţă se ridică la 9,9 milioane, bolnavii de Alzheimer reprezentând cea mai mare parte, iar până în anul 2020 ne aşteptăm la o creştere dramatică a numărului, în condiţiile în care boala este încă subdiagnosticată în Uniunea Europeană. Există inegalităţi între statele membre în ceea ce priveşte prevenţia, accesul la tratamente şi îngrijire. Acţiunile sunt fragmentate, reacţiile sunt inegale în ceea ce priveşte cercetarea şi lupta împotriva acestei boli.

Raportul este un pas important în direcţia luptei împotriva acestei boli în Uniunea Europeană şi un pas esenţial pentru introducerea unui nou mod de colaborare între statele membre, prin care să se ia măsuri coordonate pentru combaterea unor probleme care afectează întreaga Europă. Raportul sprijină solidaritatea între state, schimbul de bune practici, pentru a se evita duplicarea efortului şi risipa de resurse. Doresc să subliniez importanţa diagnosticării preventive şi a intervenţiilor timpurii în cazurile incipiente ale bolii şi cred că aceasta este cheia către progresul în lupta împotriva acestei maladii.

De asemenea, doresc să amintesc şi importanţa unei abordări multidisciplinare a cercetărilor în acest domeniu. Compartimentarea între discipline şi slaba conectare între cercetarea primară, clinică, domeniul sănătăţii publice şi cercetarea socială influenţează transferarea descoperirilor ştiinţifice în practica medicală şi în asigurarea îngrijirii. Faptul că toate acestea se fac la nivel naţional accentuează fragmentarea. De aceea, trebuie să punem accentul pe abordarea multidisciplinară şi pe transferul descoperirilor şi cunoştinţelor la nivel comunitar.

  Nessa Childers, on behalf of the S&D Group. – Mr President, nearly 10 million Europeans suffer today from dementia, with Alzheimer’s the most common form. One of those statistics was my own mother who passed away last year. I therefore strongly welcome this European initiative on dementia.

We should be very concerned that only half of cases are estimated to have been diagnosed. We should be very concerned that twice as many women as men suffer from dementia, and we should be very concerned that with an ageing European population the number of sufferers will double in the next 20 years.

Given that a five-year delay in the onset of Alzheimer’s means 50% less prevalence rates, I welcome the focus on prevention and early detection by the Commission. I welcome the focus on better research in Europe, especially as we know that 85% of research today is without EU coordination. I also welcome the focus on the sharing of best practices and the rights of sufferers and their families.

I, and my fellow Social Democrat MEPs, focused on the social aspects of dementia in our amendments and we urge the following:

We call for a strong focus on the specific needs of women, who account for twice the number of sufferers and a disproportionate number of carers, in the areas of medical and social research, health, employment and social policies.

We renew our call on the Commission to legislate for mental-health-at-work policies, as part of their health and safety at work responsibility to incorporate persons with mental disorders into the labour market in the best way possible.

We recommend an examination of the use of living wills across European borders, which are so badly needed.

Finally we also highlight the importance, in all awareness and education campaigns, of the ability to recognise the symptoms of dementia.

To conclude, I should like to congratulate the rapporteur Maria Matias, and thank her and my fellow shadow rapporteurs for their work on this report.

  Frédérique Ries, au nom du groupe ALDE. – Monsieur le Président, la lutte contre la maladie d'Alzheimer est devenue une priorité européenne ces dernières années et il était temps. J'ajoute que je me réjouis de toutes les initiatives qui viennent d'être annoncées par le commissaire Dalli.

Cette forme de vieillissement cérébral est en pleine explosion en Europe et dans le monde: plus de sept millions de personnes touchées et dix millions si l'on veut bien considérer les autres types de maladies neurodégénératives. On peut certes – et on doit – se féliciter du financement européen actuel de trente-quatre projets de recherche mais il faudra faire mieux, beaucoup mieux même, et notamment en termes de coordination des recherches sur Alzheimer dans le huitième programme-cadre de recherche et cela dès 2014. C'est clairement spécifié au point 21 de notre résolution.

Il est également essentiel de privilégier une approche multidisciplinaire qui englobe le diagnostic, la prévention, le traitement et l'accompagnement des patients et de leur famille; cela fait l'objet des points 2 et 20, qui sont très importants. À ce sujet d'ailleurs, une étude récente, qui vient d'être publiée en France, révèle les coûts socio-économiques considérables induits par cette maladie: plus de mille euros par mois pour la prise en charge médicale et la surveillance des malades seulement, et cela sans calculer l'immense dévouement des proches, des familles qui consacrent, au quotidien, plus de six heures à l'éveil et à l'encadrement du patient.

Aider ces patients, c'est aussi ne pas se tromper de diagnostic. Le monde scientifique nous l'indique: il s'agit aujourd'hui de modifier les critères internationaux car, en appliquant à la lettre des critères souvent obsolètes, on inclut trop de patients qui ont d'autres formes de démence.

Au niveau européen – et j'en viens ici au point 64 de notre résolution –, il est essentiel que notre Parlement réponde enfin à l'appel des chercheurs. Il faut plus de volontaires lors des études cliniques si l'on espère trouver un jour – et c'est une obligation – un traitement curatif. La révision toute prochaine de cette directive "essais cliniques" est donc l'occasion rêvée d'y répondre concrètement et d'apporter de l'espoir aux familles.

  Gerald Häfner, im Namen der Verts/ALE-Fraktion. – Herr Präsident! Wer immer das veranlasst hat, diese Debatten zu mischen, hat dem Parlament keinen guten Dienst erwiesen und noch weniger unseren Themen!

Überall in Europa steigen die Arzneimittel- und die Krankenversicherungskosten und überall denken wir darüber nach, wie wir sie senken können. Es heißt, durch den medizinischen Fortschritt würden die Heilmittel immer teurer. In diesem Fall, den wir jetzt verhandeln, ist es anders. Wir haben 30 Millionen Asthmatiker in Europa, und wir haben einen kleinen Hersteller, der ein Instrument entwickelt hat, durch das die Inhalation, die für Asthmatiker manchmal lebensnotwendig und therapeutisch extrem wichtig ist, besser, schneller, effizienter und vor allem kostengünstiger erfolgen kann. Seit 14 Jahren wird diesem Hersteller der Marktzutritt verwehrt. Seit 1996 hat er sich an die Kommission gewandt, seit 2006 beschäftigt sich der Petitionsausschuss damit. Es ist die Aufgabe der Kommission, lieber Herr Kommissar Dalli, dem Recht zur Durchsetzung zu verhelfen und aufseiten der Bürger zu stehen. In diesem Fall ist es nicht so, sondern die Kommission verweigert eine klare Entscheidung, eine Entscheidung, die dem Petenten weiterhilft.

Ich möchte Sie ganz persönlich ansprechen, Herr Dalli, denn Sie erinnern sich: Wir haben Sie in den Petitionsausschuss eingeladen, um mit Ihnen zu diskutieren. Sie haben uns mitgeteilt, Sie hätten dafür keine Zeit, Sie hätten aber Zeit für ein persönliches Gespräch. Wir sind zu Ihnen gekommen und haben persönlich mit Ihnen gesprochen. Sie haben mir persönlich versprochen, Sie würden sich um den Fall kümmern und sehr schnell für eine Lösung sorgen. Ich habe bis heute nichts gehört. Ich habe Ihnen nochmals einen Brief geschrieben, aber keine Antwort erhalten. Sie haben versucht, auch die nächste Debatte zu verhindern. Das ist nicht, wie die Kommission agieren sollte!

Ich möchte sehr deutlich sagen: Das Europäische Parlament erwartet – und wir werden über diese Entschließung morgen gemeinsam abstimmen –, dass die Kommission aufseiten des Rechts und der Bürger steht. Wir erwarten, dass Sie einen Schutz für solche kleinen Hersteller garantieren gegenüber denen, die den Marktzugang verwehren wollen. Es geht um viel Geld, es geht aber insbesondere auch um die Gesundheit der Menschen. Wir kennen die Problematik. Wir verstehen Ihr Handeln nicht, Herr Dalli. Wir kennen alle Ihre Argumente. Ich habe bergeweise Akten durchgesehen, aber kein klares Argument gefunden, das Ihre Position stärkt. Es geht um ein Medizinprodukt. Es ist 30 000 Mal angewendet worden, millionenfach haben Menschen inhaliert, mit besten Ergebnissen. Wir haben Briefe von Krankenkassen, die darum bitten, dass wir den Marktzugang ermöglichen, damit dort Kosten gespart werden. Ich erwarte, dass die Kommission endlich ihre Aufgabe erfüllt und hier zu einer positiven Entscheidung kommt.

(Der Redner ist damit einverstanden, eine Frage nach dem Verfahren der „blauen Karte“ zu beantworten (Artikel 149 Absatz 8 GO).)

  William (The Earl of) Dartmouth (EFD). - Mr President, I would like to ask Mr Häfner if he would agree that the Commissioner’s comments on the matter of Broncho-Air that we heard earlier have been thoroughly evasive and unhelpful to the company in particular and to asthma suffers in general?

  Gerald Häfner (Verts/ALE). - Wenn Sie mir eine knappe, aber persönliche Antwort erlauben, so ist mein Eindruck, dass der Kommissar noch nicht die Gelegenheit wahrgenommen hat, sich persönlich einen eigenen und neuen Eindruck von der Sache zu verschaffen. Das aber wäre genau die Chance nach den langen Jahren, in denen es verschleppt worden ist, dass Sie, Herr Kommissar Dalli – und ich würde vorschlagen, durch andere Beamte Ihres Hauses als diejenigen, die bisher für die Verschleppung verantwortlich waren – einen neuen Blick auf die Sache werfen und zu einem neuen Urteil kommen. Ich würde das gerne mit Ihnen diskutieren, noch lieber wäre mir, Sie würden sich mit dem Petenten zusammensetzen und für eine Lösung sorgen.

Ich bin völlig Ihrer Meinung, geschätzter Herr Kollege!

  Marina Yannakoudakis, on behalf of the ECR Group. – Mr President, 750 000 people in the UK suffer from dementia; over 50% of these will have Alzheimer’s. The effects are common but everyone’s experience is different. There is no cure for this condition which often holds hostage both patient and carer regardless of age. But what can be done in the EU? Legislation is clearly secondary in what primarily needs local support.

However, firstly by bringing this topic to this Chamber, we can bring it to the forefront, open discussion and increase public awareness. Leading from this, Member States can decide on its prioritisation and sharing of best practice. Secondly, awareness can lead to a greater understanding of the symptoms and, consequently, early diagnosis. There are drugs on the market that can assist here and, if taken at the correct time, can slow down the process. The important point is this: sufferers are helped, families have information and support and, ultimately, the patients are helped to retain their dignity through this difficult illness.

  William (The Earl of) Dartmouth, on behalf of the EFD Group. – Mr President, apparently a small German company, BronchoAir of Munich, has produced an inhaler which can actually improve the life of asthma sufferers who rely on such devices to breathe. This product has been shut out of the market for over 14 years, and the Commissioner’s account of why this has been was very different from the that of the Chair of the Committee on Petitions who opened the debate. The Committee on Legal Affairs has stated, and I quote: ‘the company has been the victim of a flagrant denial of justice’ on the part of the Commission.

Why does the Commission favour the big pharmaceutical companies and their lobbyists? In this case the UK Independence Party, which I have the honour to represent, strongly supports the immediate setting up of an inquiry into the Commission’s handling of this matter.

  Diane Dodds (NI). - Mr President, as has already been stated in this Chamber today, in the United Kingdom almost three-quarters of a million people currently suffer from some form of dementia. Sixteen thousand of those live in my constituency in Northern Ireland.

Alzheimer’s is a cruel disease. It strips sufferers of their personality, it takes away their independence and robs them eventually of their relationship with family and friends. It is a devastating disease which places huge burdens on families and carers, who are often isolated and in poor health because of the burdens they face. As has already been mentioned in this House, many of those who care are women.

In the United Kingdom by 2050 the number of those with dementia is estimated to soar to approximately 1.7 million. The estimated cost of health and social care by 2018 will be GBP 27 billion. These are staggering figures, which make research absolutely vital and the careful targeting of resources in medical and social care an absolute imperative. I also believe that we should recognise the contribution of the voluntary and community sector in this.

Commissioner, you have made much of healthy and active ageing and I am proud to highlight the work of the Mullen Mews scheme in Belfast, which has driven off international competition to win awards for its social inclusion and improvement of the lives of those who live with dementia and their families and carers.

  Peter Jahr (PPE). - Herr Präsident, Herr Kommissar Dalli! Ich finde es auch sehr ärgerlich, dass wir jetzt ständig zwischen zwei Themen wechseln müssen. Ich hätte mir gewünscht, dass wir zumindest die Themen nacheinander behandeln.

Also ich spreche wieder zu der Petition von Herrn Klein. Ich freue mich, dass wir Gelegenheit haben, darüber zu sprechen, denn der Petitionsausschuss beschäftigt sich schon seit geraumer Zeit mit dieser Petition. Was ist passiert? Da gab es einen innovativen Unternehmer, der eine Inhalierhilfe für Asthmatiker entwickelte. Das war gut für die Patienten, weil verträglicher. Das war gut für die Krankenkassen, weil preiswerter. Richtigerweise wurde der Unternehmer auch ausgezeichnet. Doch dann der Schock: Das Inhalierhilfsmittel wurde von deutschen Behörden verboten, und deshalb wurde bei der Europäischen Kommission ein Schutzklauselverfahren eröffnet.

Ohne noch einmal auf alle Details einzugehen, bin ich davon überzeugt, dass bei dem ersten Verbot der Inhalierhilfe aus dem Jahr 1996 nicht alles rechtmäßig abgelaufen ist. Die Kommission wäre dazu verpflichtet gewesen, das Schutzklauselverfahren mit einem Ergebnis zu beenden, um den Betroffenen den Klageweg zu eröffnen. Im Ergebnis ist Herr Klein – und an dieser Stelle zitiere ich die Stellungnahme unseres eigenen Rechtsausschusses – ein Opfer einer eklatanten Rechtsverweigerung geworden. Herr Kommissar, hier geht es mir nicht um Schuldzuweisungen. Wichtig ist mir, dass eine zeitnahe Lösung gefunden wird, um dieses Problem nun endlich zu beheben. Ich bitte Sie einfach: Respektieren Sie auch das einstimmige Votum unseres Petitionsausschusses. Ich hoffe und setze im Interesse der Petenten, aber auch im Interesse der Patienten in der Europäischen Union auf Ihre Zusammenarbeit und Mithilfe.

  Daciana Octavia Sârbu (S&D). - În zilele noastre există încă multe incertitudini şi necunoscute despre boala Alzheimer şi, din păcate, situaţia continuă să se înrăutăţească, odată cu îmbătrânirea populaţiei în Europa. Avem nevoie, în mod evident, de cercetare şi mai multe studii în ce priveşte cauzele şi tratamentul demenţei, dar, la fel ca şi în cazul bolilor netransmisibile, există dovezi că nişte măsuri simple în alegerea modului de viaţă pot preveni multe afecţiuni. De aceea, în amendamentele depuse, am cerut să fie acordată mai multă importanţă cercetării efectelor pe care le are nutriţia în apariţia bolii Alzheimer.

Mulţi dintre noi cunoaştem, cu siguranţă, măcar o persoană afectată de această boală sau altă formă de demenţă şi ştim că, de fapt, costurile personale sunt mult mai mari decât cele sociale sau financiare. Mult răspânditele şi devastatoarele efecte ale demenţei, la un număr atât de mare de persoane, ne îngrijorează pe toţi. Ca rezultat, avem un raport foarte cuprinzător, care conţine toate problemele cheie şi ne dorim o reacţie pozitivă din partea Comisiei, dar şi a statelor membre.

  Antonyia Parvanova (ALDE). - Mr President, I too regret that we are joining one debate to another one: it is like having a joint debate on shipping and fishing because both of them happen in the marine environment. However, I would like to congratulate the rapporteur, Marisa Matias, and it is indeed of the utmost importance that the European Union should address, in a concrete manner, the challenge of Alzheimer’s disease as one of its health priorities.

The current medical and social burden of this disease represents a serious threat to the sustainability of our healthcare and social systems. Several other chronic diseases will significantly increase in the coming years and it is crucial that we should also address them in a comprehensive way with an appropriate preparedness plan. I sincerely hope that the Commission will take the lead in building on the European initiative on Alzheimer’s disease, and will support Member States in addressing the public health challenges of our ageing population. I particularly welcome the focus on a multidisciplinary approach.

Finally, I would like to stress the need to focus on research, and on targeted investment in this field, with one priority in mind: not to serve business interests but to deliver concrete public health outcomes for patients and citizens.

With regard to the oral questions, I think we are witnessing here a method of lobbying aimed at increasing pressure on the German authorities and contesting EU safety requirements and regulations. It does not matter whether the companies concerned are big or small: the only question of importance for us is the safety of patients.

  Satu Hassi (Verts/ALE). - Arvoisa puhemies, hyvät kollegat, suuret kiitokset esittelijä Marisa Matiassille erinomaisesta työstä Alzheimer-mietinnön yhteydessä. Alzheimerin tauti ja dementiat ovat yhteiskunnalle valtavan iso asia. Inhimillisen hinnan lisäksi rahallinen hinta on valtava. Arvioidaan, että Alzheimerin taudin hoito maksaa vuodessa yli sata miljardia euroa. Se on enemmän kuin komission arvioima hinta sille, mitä maksaisi, jos tiukentaisimme kasvihuonekaasupäästövähennystavoitettamme 30 prosenttiin. Alzheimer-potilaiden määrän arvioidaan kaksinkertaistuvan 20 vuoden välein.

Haluankin korostaa ennaltaehkäisyn ensisijaisuutta ja varhaista diagnoosia. Erityisesti toivon lisää tutkimusta siitä, mikä on hermoston kehitystä haittaavien kemikaalien vaikutus Alzheimeriin ja muiden hermostorappeutumatautien riskiin. Varovaisuusperiaatteen nojalla näiden kemikaalien käyttöä torjunta-aineina puutarhoissamme ja pelloilla tulee joka tapauksessa vähentää.

  Miroslav Ouzký (ECR). - Budu hovořit také k Alzheimerově chorobě. Víme, že je to zpráva, která nemá vlastní legislativní dopad a ani není příliš konfliktní. Doufám, že nerozdělí toto plénum. Víme ale, že se jedná o velmi závažné zdravotní postižení s velmi závažnými ekonomickými dopady a tím pádem i velmi závažný sociální problém. Ten velmi souvisí se stárnutím evropské populace a jeho nárůst začíná v Evropě připomínat jakousi neurologickou epidemii. Co můžeme udělat v této věci? Můžeme zdůraznit prevenci, která šetří prostředky a zlepšuje zdravotní stav, můžeme zlepšit dietní návyky evropské populace, můžeme sjednotit naši vědeckou základnu v Evropě a koordinovat práci jednotlivých členských států, můžeme podporovat občanská sdružení a sdružení rodinných příslušníků a můžeme napomoci vytváření specializovaných center v Evropě.

  Philippe Juvin (PPE). - Monsieur le Président, chers collègues, il y a tant à dire sur la maladie d'Alzheimer.

Permettez-moi de centrer mon propos sur deux aspects: le premier est la question du maintien à domicile des patients gravement atteints. Pour des raisons médicales, nous savons qu'il convient de ne pas bouleverser les patients dans leur environnement. Un bouleversement de l'environnement peut aggraver la maladie et ses symptômes et rendre les choses beaucoup plus difficiles.

Une de nos priorités doit être absolument de permettre aux patients de rester le plus longtemps possible dans leur environnement habituel. Pour ce faire, il faut aider les familles et aider ceux dans les familles qui aident les patients. Bref, il ne faut pas laisser les familles seules. C'est un premier point.

Le deuxième point concerne la recherche. Pourquoi? Parce que, au fond, l'espoir en matière de maladie d'Alzheimer est de trouver un médicament et, pour trouver ce médicament, il faut une recherche efficace. J'entends ici et là dire qu'il faut plus de moyens pour la recherche. Sans doute! Mais avant tout, avant de parler de moyens, il faut parler de l'utilisation de ces moyens.

Jusqu'ici, la recherche a été trop fragmentée, saupoudrée. Aucune priorité n'a été définie. Les gens ne travaillent pas ensemble et ne parlent pas entre eux. Il faut que demain le biologiste cellulaire parle avec le physiologiste, avec le radiologue, avec le neurologue. Il faut mieux faire travailler les gens ensemble. J'appelle donc la Commission à donner tout son poids au programme commun de recherche qui avait été lancé pendant la Présidence française.

Enfin, je veux conclure en disant aux patients et à leur famille que les choses avancent. Qu'ils aient confiance, ils ne sont pas seuls, ils ne sont plus seuls!

IN THE CHAIR: Edward McMILLAN-SCOTT
Vice-President

  Glenis Willmott (S&D). - Mr President, I would like to thank the rapporteur and the shadow rapporteurs for their good work on this report.

Whilst this report on Alzheimer’s is very important, we know that the power for implementing policy lies mainly with the Member States. But the ageing population is one of the most pressing challenges for the future and we know that dementia is one of the main causes of disability and dependence among the elderly.

Currently the main responsibility of care tends to lie with the spouse or child of the dementia patient, which can be extremely hard work and emotionally gruelling. This is why our amendments that call on the Commission to consider the opportunities for creating jobs from a better care sector in the EU 2020 Strategy are so important. It is also important that we focus not only on providing research funding into new drugs to treat diseases, but also to look at simple preventative measures that everybody can take such as a change in diet and lifestyle. Nutrition is increasingly being shown to be an important factor in the development of Alzheimer’s and other dementias and we need to dedicate some of our resources into investigating this further.

The cost of dementias in the EU was EUR 130 billion in 2005 and it affected 19 million people – that is sufferers and carers. So it makes sense, both morally and economically, to ensure that we put more funds into work into this terrible disease.

  Jorgo Chatzimarkakis (ALDE). - Herr Präsident! Die Mitteilung und der Bericht sind sehr gut. Deswegen mein Dank an Kommissar Dalli und Kollegin Matias.

Alzheimer ist eine Plage unserer Zeit, und unser großes Problem ist: Wir wissen einfach zu wenig über Alzheimer. Deswegen geht es hier um Forschung, Forschung, Forschung! Wir müssen unsere Kräfte bündeln. Ich begrüße daher die Initiative der Kommission, eine Innovationspartnerschaft zum Thema gesundes Altern, zu schaffen und Alzheimer passt genau da hinein.

Die US-Regierung hat vor vielen Jahren einmal den Kampf gegen Krebs zu einem Leuchtturmprojekt ausgerufen. Sie haben den Krebs nicht bekämpft, aber sehr viele Medikamente, sehr viele Therapien sind daraus entstanden. So etwas brauchen wir heute, und deswegen begrüße ich es, dass wir uns auf Alzheimer konzentrieren. Wir müssen wissen: Wie können wir präventiv vorgehen? Was können wir in Zukunft gegen Alzheimer tun? Deswegen geht es bei dem Gießkannenprinzip der europäischen Forschungspolitik so nicht weiter. Wir brauchen eine Konzentration! Alzheimer könnte eines unserer großen Themen werden, um das wir uns kümmern!

  Frieda Brepoels (Verts/ALE). - Voorzitter, als vicevoorzitter van de Alzheimer Alliantie in het Europees Parlement verwelkom ik van harte het verslag van mevrouw Matias. Het bevat de belangrijkste zaken die prioritair moeten worden aangepakt. Ik wil in dit kort tijdsbestek twee punten aanstippen.

Ten eerste het belang van preventie en vroegtijdige diagnose. Bewustwordingscampagnes over de eerste symptomen zijn essentieel, opdat patiënten en hun verzorgers zo snel mogelijk gebruik kunnen maken van de behandeling en steun die momenteel al beschikbaar zijn. Maar daarnaast kan het belang van een gemeenschappelijke programmering van onderzoeksmiddelen niet genoeg worden benadrukt. Veel collega's hebben het al gezegd: 85% van de publieke investeringen in onderzoek gebeurt vandaag de dag zonder enige Europese coördinatie en dit leidt onvermijdelijk tot versnippering en dubbel werk. Dus een gezamenlijke strategische onderzoeksagenda kan zorgen voor een meer efficiënte besteding van de middelen en kan een beter inzicht verschaffen in de oorzaken, behandelingsmogelijkheden en de sociale impact van ziekten als Alzheimer.

  Miroslav Mikolášik (PPE). - Oznámenie Komisie o európskej iniciatíve o Azheimerovej chorobe a iných druhoch demencií zlepšuje doterajšie rozdrobené opatrenia a jestvujúce rozdiely, pokiaľ ide o prístup k liečbe, a vedie nás k zlepšeniu zdravotných a sociálnych podmienok stále väčšieho počtu takých pacientov aj vzhľadom na ich zvyšujúci sa podiel v starnúcej Európe.

Smernica sa venuje aj zdravotníckym pracovníkom v tejto oblasti a zabezpečuje odborné vzdelávanie, čo som veľmi rád, a podporu rodinných príslušníkov. Problémy máme už teraz, veď každý rok pribudne až 1,4 milióna prípadov nejakého typu demencie a včasná diagnostika, prevencia a ďalšie súvisiace otázky, ako je dôstojnosť takého pacienta, by nás mali teda viesť k energickej činnosti.

Sú tu aj ovplyvnené osoby, obzvlášť rodinní príslušníci, ktorí sú vystavení veľkej spoločenskej stigmatizácii. Ide o to, aby spoločnosť dokázala pomôcť aj finančne oceniť tých, ktorí sa v domácich podmienkach o dementného pacienta starajú.

  Justas Vincas Paleckis (S&D). - Sveikinu pranešėjus, kurie gerai padirbėjo. Tenka pripažinti, kad Europos Sąjungai senstant Alzheimeris ir kitos demencijos formos plinta pavojingu greičiu. Neretai šių ligų simptomai nėra teisingai nustatomi arba susigriebiama per vėlai ir ligoniai nesulaukia tinkamo gydymo. Teisingas kvietimas demencijas paskelbti viena iš prioritetinių sveikatos apsaugos sričių. Tik kuo plačiau skleisdami informaciją, didindami visuomenės supratimą apie ligą, jos simptomus, ankstyvius diagnozės būdus, galėtume susidoroti su kylančia demencijos banga. Deja, daugumoje naujųjų Europos Sąjungos šalių, jų tarpe ir Lietuvoje, demencijos ligonių priežiūra paprastai ypač nepatenkinama. Didžiausias krūvis dažniausiai tenka ligonių artimiesiems, šeimos nariams. Valstybės turėtų įvertinti jų darbą: ligonį slaugantiems artimiesiems pagal galimybes fiksuoti darbo stažą, suteikti socialines garantijas.

  Gay Mitchell (PPE). - Mr President, I just want to make the point that we are talking about Alzheimer’s disease and old people, yet I have experience in my constituency with the case of a 48-year-old man who had to be looked after by his elderly widowed father because the young man had Alzheimer’s. I will not abuse the opportunity to speak but I thank you for it, and I want to say that I support innovation in relation to ageing. This is mainly an ageing-related issue, but not simply an ageing-related issue.

  Wolfgang Kreissl-Dörfler (S&D). - Herr Präsident, Herr Kommissar, verehrte Kolleginnen und Kollegen! Ich werde zu der Petition sprechen. Seit Frühjahr 2007 bin ich mit dem Fall beschäftigt. Im Herbst 2007 habe ich eine Anfrage an die Kommission gestellt. Die Antwort war mehr als unbefriedigend.

Ich habe viele Gespräche mit dem Bundesgesundheitsministerium und mit anderen Behörden geführt. Alles war immer sehr vage und weich. Und Ihrer Antwort, Herr Dalli, dem, was Sie vorgelesen haben, entnehme ich, dass Sie gar keine Lust haben, sich näher mit diesem Fall zu beschäftigen. Es geschah nicht in Ihrer Amtszeit, aber Sie gehören einem Kollektivgremium an, und ich fordere Sie auch im Namen des Rechtsausschusses und des Petitionsausschusses auf, uns alle Unterlagen zur Verfügung zu stellen, auf deren Grundlagen Sie entschieden haben. Und ich möchte wissen, wenn man sich das Gerät ansieht, warum denn – man kann es wissen! – bestimmte Firmen kein Interesse haben, dass ein anderes Produkt auf den Markt kommt. Denn mit diesem Plastikteil den Inhalator zu installieren ist relativ preiswert, aber im Verkauf insgesamt liegen die Margen drin.

Wenn man sich einmal ansieht, wie Pharmalobbyismus funktioniert, wenn man sich einmal genau betrachtet, wer welche Interessen im finanziellen Bereich hat, kleine Firmen herauszuhalten, dann wird vieles unter Umständen sehr deutlich.

Ich fordere Sie auf, heute hier einmal klar Stellung zu beziehen, ob Sie uns die Unterlagen zur Verfügung stellen und ob Sie bereit sind, sich mit uns im Petitionsausschuss und im Rechtsausschuss einmal ordentlich auseinanderzusetzen und das nicht einfach wegzuschieben. Denn die Bürgerinnen und Bürger, auch die, die vielleicht nicht so reich und so groß sind, haben auch ein Recht darauf, dass sie ordentlich behandelt werden.

  Elżbieta Katarzyna Łukacijewska (PPE). - Panie Przewodniczący! Wraz ze starzeniem się populacji Unii Europejskiej rośnie odsetek osób cierpiących na choroby wieku podeszłego. Dane statystyczne pokazują, że co piąta osoba powyżej 80 roku życia cierpi na chorobę Alzheimera. Nie wszyscy wiedzą, że jest to choroba nieuleczalna, ale dzięki odpowiedniej profilaktyce i wczesnej diagnozie można opóźnić jej skutki. Według światowego raportu na temat Alzheimera z 2009 roku 28% osób cierpiących na demencję zamieszkuje Europę, która pod tym względem zajmuje drugie miejsce na świecie po Azji. W Polsce, kraju który reprezentuję, na chorobę Alzheimera cierpi około 250 tys. osób, a specjaliści szacują, że do 2040 roku liczba ta się potroi. Jak widać dane te są niepokojące.

Demencja niesie za sobą zarówno skutki społeczne, jak i gospodarcze oraz dotyka nie tylko samego chorego, ale także jego najbliższych. Dlatego cieszę się, że dzisiaj poruszamy ten ważny problem. Tylko współpraca, prowadzenie wysoko specjalistycznych badań oraz prowadzenie szerokiej kampanii informacyjnej pozwolą na szybszą diagnozę i lepszą profilaktykę.

  Vilija Blinkevičiūtė (S&D). - Pritariu iniciatyvoje dėl Alzheimerio ligos siūlomiems konkretiems veiksmams, jog būtina užtikrinti ankstyvą diagnozę ir gyvenimo kokybę, skatinti valstybių narių bendradarbiavimą keičiantis geriausia patirtimi bei klinikiniais tyrimais ir gerbti šia sunkia liga sergančių žmonių teises. Kadangi Europos Sąjunga šiuo metu neturi pakankamai tikslių statistinių duomenų apie Alzheimerio ligos paplitimą, būtina atlikti tyrimus, kurie būtų grindžiami griežtais bendrais rodikliais. Be to, reikia investuoti į mokslinius tyrimus ir veiksmingas priežiūros sistemų programas. Ypač daug dėmesio reikia skirti sveikatos priežiūros specialistams, paslaugų teikėjams bei mokymui ir paramai šeimoms, kurie kasdien susiduria su Alzheimerio ligos atvejais. Noriu pabrėžti, kad kovojant su šia sunkia liga labai svarbu daug dėmesio skirti prevencijai ir stengtis kuo anksčiau nustatyti diagnozę. Todėl reikia parengti prevencinę strategiją dėl Alzheimerio ligos, kuri būtų susijusi su sveikesnės gyvensenos skatinimu, žmonių informavimu apie šią ligą bei medicinos praktikos keitimusi.

  Pat the Cope Gallagher (ALDE). - A Uachtaráin, ba mhaith liom mo bhuíochas a ghabháil leat as ucht an deis labhairt mar gheall ar ghalar Alzheimer.

Alzheimer’s is a disease that is the most common cause of dementia, affecting 44 000 people in Ireland and nearly ten million people across Europe. It is a progressive disease, which means that over time more parts of the brain will become damaged and as this occurs the symptoms become worse.

Unfortunately, due to the ageing population in Europe, more and more people are likely to be affected by this disease in the future. Therefore better coordination between EU Member States, in terms of research into the causes of dementia and best practice in terms of a care system, is essential. The burden of care is often placed on the shoulders of close family members and in Ireland 50 000 people care for people with dementia on a daily basis.

In conclusion, I would like to pay special tribute to those carers and to the Alzheimer’s society of Ireland who provide incredible support to people affected by dementia.

  Margrete Auken (Verts/ALE). - Hr. formand! Jeg henvender mig til kommissær Dalli. Her ser De den plastikdims, det drejer sig om. Det er den store multinationale medicinalindustri, der i den tyske sag har sagt, at plastikdimsen og medicinen hører sammen. Her ser De medicinen. Den skal have den store test! Plastikdimsen svarer til, at man bruger en kanyle. Men det er klart, at medicinalindustrien tjener styrtende med penge på, at de to produkter altid skal sælges sammen. Samfundet, derimod, sparer en masse penge ved at man kan genbruge og genbruge og genbruge. Jeg mener, at det er en ren skandale, at Kommissionen bliver ved med at henholde sig til, at dette simple produkt skal underkastes samme store testprocedure – som om det nødvendigvis hørte med i det samme testsystem – som medicinen. Ikke fuldstændig det samme som medicinen selv, det ved jeg godt, men stadigvæk som en anordning, der hører til der. Det er simpelthen så forfærdeligt, at vi ikke har fået et klart svar på denne sag! Der er så mange mennesker, inklusive mange samfund og sygeforsikringer, der lider under, at denne simple plastikting ikke er blevet godkendt for længst. Den har aldrig skabt andre problemer end økon… (Formanden tog ordet fra taleren)

  Paolo Bartolozzi (PPE). - Signor Presidente, onorevoli colleghi, le malattie neurodegenerative, e tra queste appunto l'Alzheimer, rappresentano una priorità sanitaria per l'Unione europea.

La malattia in questione ha pesanti risvolti, non solo sanitari, per chi la subisce. Elevati sono infatti i costi che devono essere sostenuti per le cure dirette e per quelle informali. Il morbo di Alzheimer, infatti, non riguarda solo le persone che ne sono colpite, ma coinvolge anche tutti coloro che si occupano dei malati stessi.

Si rende perciò necessaria una risposta europea al problema, una coordinazione globale tra gli Stati membri, una sinergia di azioni concertate che riguardano soprattutto l'ambito scientifico e di ricerca e che si faccia carico del potenziamento della prevenzione e la diagnosi per il perfezionamento delle cure disponibili, anche innovative, nonché della diffusione delle informazioni fra gli Stati sui risultati raggiunti all'interno degli stessi, incrementando nei cittadini il livello di conoscenza della malattia.

  John Dalli, Member of the Commission. − Mr President, honourable Members, I again thank Parliament and the Members who have taken the floor for their engagement with the important cause of Alzheimer’s and other forms of dementia.

The Commission welcomes Parliament’s report and its recommendations. Let me take this opportunity to stress that the Commission is fully committed to doing its share to address Alzheimer’s and other forms of dementia. These conditions are unfortunately part of the ageing process for many European citizens.

I believe it is our collective responsibility to work together to minimise their burden and to invest in innovation to prevent, diagnose, treat and manage these conditions.

I look forward to supporting Member States in their efforts to work closely with Parliament in addressing Alzheimer’s disease and other forms of dementia.

On the ‘Effecto’ Klein petition, I must state first of all – referring to Mrs Manzoni’s statement that the Commission’s job is to stand by the citizens – that I can assure you my job is to stand by the patient. It is very important for me, as Commissioner responsible for health, not to compromise on patient safety, not to take any shortcuts and short-circuit the processes and procedures that we have in place to ensure that any device to be used in any medical way is properly tested and its safety assured.

The issue here is not how to deliver a medicine with a piece of plastic, as has been said. The issue is that we need clinical evidence that the product is safe and to do this the petitioner, in this case Mr Klein, was requested to conduct clinical studies on 24 patients. That is the extent of the clinical tests that were requested.

Why is there a resistance to providing these clinical tests? What is causing this resistance? This is something that I am asking myself. We need to know, for example, is this product universal in application, is it to be used with one specific medicine, is it to be used with different types of medicines? If it is, do these medicines require different dosages? Is there an adjustment system in the device to adjust the dosage? As a layman, if I had to use a device like this, these are the questions that I would ask myself. This is the kind of thing the authorities have been asking themselves. They have been asking for proof that this device would be safe in the hands of patients at large.

There is, as I said, a proper safety assurance procedure, and I will be not short-circuiting that. It has been said that I promised to look into the case. I promised to look into the case, and I did look into the case. I have had a lot of details about the case. Naturally, these are details that I had to learn from others who have been here in the Commission since 1987. When Mr Klein asked for a meeting with me or my cabinet, I immediately agreed. My ‘chef de cabinet’ informed him that we were prepared to have a meeting to explain it. He sent an e-mail back setting a lot of conditions, amongst which he stated that as a basis for this meeting, the EU Commission should completely take over the expenses. This included the flights and overnight stays in Brussels for him and his staff, and I could not accommodate this.

  Marisa Matias, relatora. − Senhor Presidente, Senhor Comissário, caros Colegas, eu quero começar por agradecer todas as palavras que aqui foram deixadas em relação ao relatório que o Parlamento apresenta em matéria de Alzheimer e de outras doenças demenciais. Sabemos todos que a situação que vivemos é substancialmente dramática e que está ainda muito sub-diagnosticada e isso foi aqui referido.

E quero apenas referir uma questão que foi transversal a todas as intervenções, mas provavelmente não tão sublinhada, que é a questão da dignidade dos pacientes, dos seus direitos e não apenas dos pacientes, mas também dos seus familiares e daqueles que cuidam deles, sejam cuidadores formais ou informais e dos profissionais que estão associados a este tipo de doenças.

Eu fico contente, francamente contente, com as palavras do Sr. Comissário quando diz que partilha das mesmas preocupações que o Parlamento Europeu. E que a Comissão Europeia vê de forma muito positiva todas as recomendações do relatório que o Parlamento apresenta e que vai fazer tudo o que estiver ao seu alcance para pô-las em prática.

Nós sabemos que cada dia que passa é mais tarde que o anterior nesta matéria dada a urgência daquilo que temos em mãos. E portanto nós sabemos também que amanhã o Parlamento se vai pronunciar sobre esta matéria. Aguardaremos o resultado da votação, mas sabemos, Senhor Comissário, que os cidadãos europeus esperam de nós muito mais do que solidariedade e conforto moral. Esperam de nós acções concretas e adequadas e espero bem, Senhor Comissário, que então ponha em prática e que a Comissão, que tem a iniciativa que infelizmente este Parlamento não tem, ponha em prática toda essa prioridade que diz dar a este domínio e que a transforme em iniciativa legislativa para que os cidadãos e os seus familiares vejam respeitados os seus direitos e sejam tratados com igualdade e com a dignidade que merecem.

  President. − The debate is closed.

The vote will take place tomorrow (Wednesday, 19 January 2011).

Written statements (Rule 149)

  Liam Aylward (ALDE), i scríbhinn. – Meastar go bhfuil 9.9 milliún duine san Eoraip atá ag fulaingt de bharr galar méarmheathlúcháin, cosúil le galar Alzheimer. Le daonra na hEorpa ag dul in aois, measann Eurostat go mbeidh dhá oiread an méid daoine le galar méarmheathlúcháin orthu sa bhliain 2050 agus mar a bhí i 1995. Thairis sin, ós rud é gur ar bhaill clainne a thiteann ualach an chúraim, meastar go mbíonn tionchar ag an ngalar ar thriúr ball clainne an othair. Chuige seo, ní mór a chinntiú go nglacfar beart ar leibhéal an AE chun cabhrú leis na Ballstáit cúnamh cuí a thabhairt d’othair agus dá muintir.

Aontaím go hiomlán go mba chóir tús áite i mbeartas sláinte an AE a thabhairt don néaltrú. Ní foláir aitheantas mar is cóir a thabhairt d’eagraíochtaí othar agus cúramóirí agus ní mór go mbeadh na heagraíochtaí céanna bainteach le feachtais eolais agus le hullmhúchán clár taighde. Tugann an AE méid suntasach airgid – EUR 159 milliún – do 34 clár taighde ar ghalair mhéarmheathlúcháin ach, ós rud é go bhfuil méadú ollmhór ag teacht ar na galair sin, ní mór go leathnófar ar thionscadail taighde faoin 8ú Chreatchlár chun taighde ar theiripí iompraíochta, cognaíocha agus teiripí gan drugaí a ghlacadh san áireamh.

  Vasilica Viorica Dăncilă (S&D), în scris. – Datele cu privire la prevalenţa bolii Alzheimer şi alte demenţe sunt disponibile în ţările Uniunii Europene şi au fost colectate de Alzheimer Europe. Boala Alzheimer a fost şi este cauza principală a demenţei în toate ţările. Ea reprezintă 74,5% din cazurile de demenţă din America de Nord, 61,4% din Europa şi 46,5 din Asia. Cu toate acestea, în Uniunea Europeană există cazuri de boală Alzheimer nediagnosticată, conform ultimelor date epidemiologice disponibile, numai jumătate din persoanele care suferă de această boală sunt identificate în prezent. În acest context, consider că Statele Membre trebuie să dezvolte politici şi planuri de acțiune pe termen lung pentru a eficientiza accesarea fondurilor de cercetare în domeniul demenței și a bolii Alzheimer, incluzând și cercetări în domeniul prevenției, la un nivel proporțional cu impactul economic al acestora asupra societății şi care să anticipeze și să prevină tendințele sociale și demografice și să-și concentreze atenția pe sprijinul oferit familiilor pacienților care îi îngrijesc, oferind astfel protecție socială persoanelor vulnerabile suferinde de demență.

  Elisabetta Gardini (PPE), per iscritto. – Attraverso la risoluzione presentata rinnoviamo il nostro impegno nella lotta contro una grave patologia che continua a colpire un anziano su 5 di età superiore agli 85 anni. Ritengo che un'efficace azione coordinata su scala europea sia necessaria per compiere ulteriori passi avanti nella ricerca e nella raccolta di dati epidemiologici relativi a questa malattia. Un coordinamento adeguato tra gli Stati membri può contribuire alla condivisione di migliori prassi nella cura dei pazienti e a rendere i cittadini maggiormente consapevoli dell'importanza della prevenzione e di un intervento precoce. E’ fondamentale investire e cooperare in questo campo non solo per ridurre i costi sociali di queste malattie ma anche e soprattutto per garantire ai pazienti colpiti la speranza di un proseguimento di vita sempre più dignitoso. A questo proposito vorrei ricordare che le demenze, ovviamente, non riguardano solo le persone che ne sono affette, ma anche chi le circonda, come i famigliari e gli operatori sanitari. E’in tal senso auspicabile che la strategia europea punti a garantire un sostegno più valido e pratico a chi deve affrontare il compito quotidiano dell'assistenza, colmando le lacune esistenti in materia di formazione professionale e adottando delle campagne di sensibilizzazione sul significato della convivenza con l'Alzheimer.

  Louis Grech (S&D), in writing. – To date, the EU still does not have an adequate response to Alzheimer’s, neither has it concluded a single policy on its prevention. Moreover, it is worrying that countries like Malta still do not offer any refund for medication needed by patients suffering from the disease. Notwithstanding that the Commission cannot interfere with the organisation of national health insurance schemes, the Commission should step up its efforts to put pressure on Member States to guarantee that any person suffering from Alzheimer’s is getting the necessary treatment. I call on the Commission to truly make the fight against dementia a European priority and conclude the below-mentioned proposals within a reasonable time frame: (1) promote cardiovascular health and invest in a healthier workforce; (2) promote initiatives that ensure social and intellectual engagement of the elderly; (3) encourage Member States to implement systematic routine screening which allows for early diagnosis of the disease, as well as providing easy access to medication and treatment once the disease has set in; (4) ensure that regular epidemiological studies at a European level are carried out; (5) prompt Member States to make better use of Assistive Technology (AT).

  Jim Higgins (PPE), in writing. – I welcome this report as an important step forward in the battle against dementia. At present one in 20 people over the age of 65 and one in five over 80 suffer from dementia. It is estimated that more than 8 million Europeans aged between 30 and 99 suffer from neurodegenerative diseases, and scientists anticipate that this number could double every 20 years. Alzheimer’s disease represents 50% of these cases. Nearly ten million Europeans suffer today from dementia, with Alzheimer’s the most common form. There are 44 000 people in Ireland with dementia. There are over 50 000 carers for dementia suffers and an estimated 100 000 people are directly affected by dementia. Given that a five-year delay on the onset of Alzheimer’s means 50% less prevalence rates, I welcome the focus on prevention and early detection by the European Commission. I welcome the focus on better research in Europe, especially as we know 85% of research today is without EU coordination. For any European strategy in this area to work, it is crucial that the various countries give priority to drawing up national action plans. A European strategy must also seek to safeguard the existence of services that guarantee maximum possible coverage and equal conditions and treatment for all patients.

  Anneli Jäätteenmäki (ALDE), kirjallinen. – Herra Puheenjohtaja! Muistisairaudet ovat yleinen ongelma Euroopassa. Arviolta noin 10 miljoonaa eurooppalaista kärsii tälläkin hetkellä muistisairauksista. Valtaosalla heistä on Alzheimerin tauti. Monet tekijät vaikuttavat ihmisten kykyyn muistaa asioita ja oppia uutta. Muun muassa stressi, masennus, suru, runsas alkoholin käyttö, huono ravitsemustila ja lääkkeet ovat esimerkkejä näistä tekijöistä. Muistisairauksien ehkäisyyn on kiinnitettävä enemmän huomiota jo nuoruudesta alkaen. Liikunta, henkinen aktiivisuus, terveelliset ravintovalinnat ja päihteiden välttäminen suojaavat muistisairauksilta. Hoitamalla muistisairauksien vaaratekijöitä hoidamme samalla sydän- ja aivoverisuonitautien vaaratekijöitä. Herra Puheenjohtaja! Muistisairauksien vastaisessa työssä on jatkossa korostettava enemmän tiedottamisen ja kansalaisjärjestöjen merkitystä. Järjestöt tekevät erittäin arvokasta työtä. Niitä on tuettava enemmän, jotta muistisairauksista kärsivät saisivat paremmin apua. Lisäksi hoitopaikkoihin ja niiden laatuun on jatkossa kiinnitettävä enemmän huomiota. Tarjolla olevat hoitopaikat eivät valitettavasti vastaa tällä hetkellä kysyntää. Esimerkiksi Suomessa pulaa on etenkin vertaistuesta ja sopivista päivä- ja pitkäaikaishoitopaikoista. Lopuksi haluaisin kiinnittää huomion muistisairauksien hoitoon erikoistuneen ammattihenkilöstön tukemiseen, oikeanlaiseen koulutukseen ja osaamisen kehittämiseen. Kiitos!

  Sirpa Pietikäinen (PPE), kirjallinen. – Arvoisa puhemies, hyvät kollegat, haluaisin kiittää Marisa Matiasta ansiokkaasta valiokunta-aloitteisesta mietinnöstä Alzheimerin tautia ja muita dementioita koskevasta eurooppalaisesta aloitteesta. Joka viides eurooppalainen sairastuu muistisairauteen. Muistisairaudet luovat jatkuvasti enemmän painetta ikääntyvän väestön kanssa kamppaileville terveydenhuoltojärjestelmille, mutta myös sairastuneille ja heidän omaisilleen uuden tilanteen edessä. Muistisairauksien synnystä ei ole olemassa yksimielisyyttä, mutta varhaista puuttumista taudin etenemiseen pidetään ensiarvoisena. Mietinnön myötä muistisairaudet nostetaan etusijalle EU:n terveystavoitteissa. Äänestystulos antaa oikeansuuntaisen viestin siitä, että muistisairauksien tutkimus ja hoito edellyttävät yhteistyötä koko Euroopan tasolla. Vaikka muistisairauksista kärsivät eniten ikääntyvät ihmiset, diagnosoinnin kehittyessä niiden ensioireita havaitaan yhä useammin myös työtätekevän väestön keskuudessa. Eurooppalaisen yhteistyön tiivistämiseksi tarvitaan myös kansallisia muistiohjelmia, joita muutamissa jäsenvaltioissa on jo käynnistetty. Kansallisilla muistiohjelmilla on merkittävä rooli tiedon ja parhaiden käytänteiden levittämisessä sekä päällekkäisten toimintojen vähentämisessä.

  Richard Seeber (PPE), schriftlich. – 10 Millionen Menschen in Europa leiden an Demenz, die Hälfte davon sind Alzheimerpatienten. Durch die zunehmende Lebenserwartung steigen diese Zahlen weiter an. Der Initiativbericht geht mit seiner Forderung nach einem wirkungsvolleren Ansatz für die Behandlung von Demenz und insbesondere Alzheimer in eine richtige Richtung. Ein besonderes Augenmerk sollte dabei auf die Prävention gerichtet werden. Frühdiagnose, kostenlose Untersuchungen für Risikogruppen und insbesondere bessere Information der Bevölkerung sind dafür von zentraler Bedeutung, da Alzheimer in der EU meistens zu spät erkannt wird. Die weitere Verbreitung von Demenz erfordert eine europäische Strategie, die möglichst flächendeckende Strukturen anbietet, durch die den Patienten gleicher Zugang zu Informationen und Behandlungsmöglichkeiten gegeben wird. Dabei darf auch die Unterstützung für Angehörige und Betreuungspersonen nicht vergessen werden. Breit angelegte epidemiologische und klinische Studien sowie eine verbesserte Demenz- und Alzheimerforschung sind des Weiteren ein wichtiger Faktor bei der Bekämpfung von Demenzerkrankungen.

  Olga Sehnalová (S&D), písemně. – Demence a zejména Alzheimerova choroba jsou nejen závažným medicínským, ale i eticky a společensky nesmírně citlivým problémem, jehož význam bude v souvislosti se stárnutím evropské populace dále stoupat. V předloženém dokumentu je velmi správně věnována pozornost různým aspektům tohoto onemocnění, zejména podpoře časné diagnostiky, výzkumu i zlepšení samotné péče o pacienty. Za neméně důležitou však považuji i oblast podpory rodin osob postižených demencí, za zásadní pak důraz na nediskriminační dostupnost kvalitních zdravotních a sociálních služeb. V této souvislosti spatřuji rozhodující úlohu samospráv, ať již místních či regionálních i neziskových organizací, které mohou operativně reagovat na nárůst potřeby těchto služeb. Evropská iniciativa pro Alzheimerovu chorobu a jiné formy demence je velmi důležitá i pro nastartování seriózní a otevřené společenské diskuze o tomto onemocnění v nejširším slova smyslu. Proto tuto iniciativu rozhodně vítám a podporuji.