Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-039"

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". Mr President, honourable Members, indeed, the debate has confirmed the broad consensus on the Variations Regulation, and so I shall not discuss it further. We should now bring this into force as it stands and make sure that we do so as effectively as possible. I think that, beyond this, what are more important overall are the other issues that have been raised here. We shall find solutions that make it possible for all parties to continue their business, precisely in the spirit of what Mrs Roth-Behrendt said: we must apply a little creativity, use our brains and give it some thought, but the safety requirements apply in full to all: there can be no exceptions! I believe I have answered your questions and also given you a foretaste of the coming lively debate. The proposals will be presented in a few weeks’ time, and all I can say in this regard is that we shall meet again in this Chamber and we shall have to discuss this matter further. Allow me to make a couple of very fundamental points. It is not my job, of course, to explain technical rules to you, but to tell you why we do certain things and why we do not do certain things. There is a conflict in our societies between the requirements of the health care bureaucracy, on the one hand, and those of patients on the other. This is absolutely clear. The proposals that will be occupying our attention in future lie at the centre of this conflict area. The health bureaucracies in the Member States are not interested in informed patients. Informed patients mean more work, more effort. Those who should be there for them are forced to give them information, answering questions such as: why am I being given this medicine, why am I not being given that medicine? Why should I be given this treatment and why am I not being given that treatment? They are entitled to know this as human beings. An unwavering principle for me is the following. In a democratic society, it should not be the case that those wishing to provide information must justify themselves, but that those not wishing to provide information do not have to. It is the health care bureaucrats in the Member States who must explain why they do not want to see informed patients. I do not have to explain why I do want to see informed patients. To be perfectly clear, there will be a heated, lively, controversial debate here, and it is my hope and wish that the European Parliament will support the Commission and me in this debate. After all, this issue is quite fundamental, and concerns not only public health but also social policy. It is a question of what the freedom of citizens in health care, too, means to us. On the second issue, with regard to counterfeiting, I agree with all those who have said that this is a criminal matter. Counterfeiting in the illegal distribution chain is a matter for the police. Illegal is illegal – we cannot do much more than that. I do think, however, that the proposals we can make will ultimately make it virtually impossible to introduce counterfeit medicines into the legal distribution chain. That is what we can do. Mrs Roth-Behrendt is absolutely right. In my opinion, it really is an impertinence to suppose that, in reality, this is about placing obstacles in the way of any forms of distribution of pharmaceutical products for competitive reasons. I could not care less about that. Parallel trade is a legal activity within the European Union. This has been confirmed unequivocally by the European Court of Justice. I am absolutely not thinking of getting my hands on parallel trade, but one thing I would say is that all parties involved in the distribution of medicinal products must be subject to the same strict safety requirements. I fail to see why someone should be exempted from safety requirements just because they buy cheaply in one Member State a medicinal product that is sold for a higher price in another Member State, bring it back into the more expensive country, and resell it for a high price there. I do not understand this. Those of you with some knowledge of food law will have already been asking themselves, as I did, why it is most strictly forbidden in Europe to open a pack of spaghetti on the way from the manufacturer to the consumer – this is indeed most strictly forbidden – yet it is permitted to open on the way from the manufacturer to the consumer medicinal products which, when taken wrongly, can result in death. It is worth reflecting on why this astounding disparity exists, why it is forbidden in the case of spaghetti, for example, but permitted in the case of vital medicinal products. I find this difficult to understand."@en1
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