Local view for "http://purl.org/linkedpolitics/eu/plenary/2007-04-23-Speech-1-097"
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". Mr President, honourable Members, I am very glad that we are able today to talk about the regulation on medicinal products for advanced therapies, which has been long awaited, and is of enormous importance to innumerable sick people in Europe, to many of whom these new therapies offer hope of new and life-saving treatment. I am not talking here about the common cold, but about such conditions as cancer, Parkinson’s disease, AIDS, and other dreadful scourges. So far, no single legal framework has been put in place, with the consequence that many patients are not in a position to benefit from the treatments that are available, or they end up being prescribed medications that are not safe. By means of this regulation, we are preparing the way for easier and safer access to the ones that will save their lives. Let me say once more – and I do so in all seriousness – that today presents us with a unique political opportunity to adopt a regulation for which sick people in Europe, and the European medicines industry, have been waiting for a long time. It is because this is an opportunity that we cannot allow ourselves to miss that I ask all the Members of the European Parliament to endorse the compromise package submitted by Mrs Roth-Behrendt, Mrs Ries and Mr Adamo on behalf of their groups, and to reject other motions. If this regulation is adopted, it will promote innovation, make our research and industry more competitive, and, above all, help to save lives and deliver people from grave suffering; all these things you can bring to pass by endorsing this package. The proposal is also of great importance for Europe as a centre for research. With things as they stand at present, European researchers and manufacturers – who are often small and medium-sized enterprises – can neither grow nor hold their own in international competition. Let me now say something about the legislative process. While it is self-evidently a matter for your House as to how the procedure is handled, I would, however, ask you to bear with me as I appeal to you to come to a decision and to refrain from dragging the process out any longer, in view of the need to create unambiguous conditions for these innovative therapies, for which people have been waiting for so long, and it is for that reason that I am all the more pleased that three groups have put forward a comprehensive compromise package that will make a speedy agreement of that sort possible. I am able to say, on behalf of the Commission, that we are able to endorse this package as a whole without any changes needing to be made, and I believe that the Council Presidency, too – although we have yet to hear it say so – is persuaded that the Council will be able to adopt the package as it stands. I am perfectly well aware that we are dealing here with a particularly tricky topic, and we must be especially sensitive when considering ethical issues as important as this one, and so let me once again make it clear that our sole intention, with this regulation, is to ensure that patients get safe and effective medicines. There is no other objective in mind. The fact is that the regulation does not actually lay down whether or not medicines are ethically acceptable, and in this respect, we are abiding strictly by the subsidiarity principle, for ethical matters are reserved to the Member States, and we, in the European Union, cannot end up in a situation in which one of them can impose its ethical convictions on another; that is not on. The only thing that is workable is that we leave the ethical issues to the Member States, for that is what we have always done. There is nothing new about it; that is a policy that has been clearly established for many years, and there are many examples of it. It follows, then, that the proposal neither compels the licensing of ethically problematic technologies at national level nor prohibits them from being used throughout Europe; the proposal goes no further than respecting decisions taken at national level. The important principle that donations of organs and tissue must be voluntary and unpaid applies as a matter of course, and is already enshrined in other legal acts. Reiterating it in this proposal would therefore be superfluous. What we should do, whatever happens, is lay down common safety standards for such products. I do not think there is any argument by which we might justify acceptance of a standard of protection that varied from one Member State to another, which – among other things – would result only in patients and their various diseases travelling the length and breadth of Europe. Despite the amendments proposed by the Committee on Legal Affairs, then, we should not remove ethically problematic products – those derived from embryonic stem cells, for example – from the scope of the regulation."@en1
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