Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-01-18-Speech-2-501-000"
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"en.20110118.20.2-501-000"2
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"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.
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.
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."@en1
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