Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-01-18-Speech-2-531-000"
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"en.20110118.20.2-531-000"2
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"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 Mazzoni’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."@en1
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