Local view for "http://purl.org/linkedpolitics/eu/plenary/2007-04-23-Speech-1-122"
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"en.20070423.17.1-122"2
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".
Mr President, honourable Members, you will, on Wednesday, be voting on the regulation on medicinal products for advanced therapies, which has since early 2006 been promoted initially by the Austrian Presidency of the Council and then by its Finnish counterparts, and we have, since the beginning of this year, done everything in our power to bring about agreement without delay. The regulation aims, in the highly-innovative and extremely important area of medicine production, to protect all the patients who need those medical products, and to do so by means of quality standards that are uniform across Europe. The need for high-quality products for everyone in Europe means that it is true to say, as some of you have, that what is on the agenda today is in fact life itself, improved quality of life and the chance of new life. What is also on the agenda, and not least in importance, is the competitiveness of the European biotechnology sector.
In negotiations on the regulation in the Council working party, aimed not least at achieving agreement with your House, it has proved possible, over recent weeks, to make decisive progress, and it is on these negotiations, which take into consideration a very large number of amendments drafted by experts and submitted by the lead committees, that the prospects for a good compromise, and also a rapid agreement between the Council and Parliament, depended, and still do depend; as the negotiations currently stand, agreement is possible on the basis of that which is to be the subject of Wednesday’s vote. The rapporteur has submitted a parcel of amendments, and the Socialist Group in the European Parliament, the Group of the Alliance of Liberals and Democrats for Europe, and the Group of the European United Left have drafted their own sets of them. Both packages draw to the fullest possible extent on the debate in the Committee on the Environment, Public Health and Food Safety and on the amendments drafted by it, and are therefore close to one another, although it is clear that it is the package produced by the shadow rapporteurs of the named groups on which agreement is possible at Council level.
However great our differences in debate, it strikes me as essential that it be stressed that what this is all, primarily, about is the quality and safety of these new and advanced therapeutic products. Clear though it is that ethical considerations have a part to play in these deliberations, there has, ever since the cells and tissues directive was resolved upon, been agreement to the effect that we in Europe see ethics as subject to subsidiarity and hence as something for which the Member States bear responsibility, and it is for this reason that two ethically-motivated amendments proposed by your House’s Committee on Legal Affairs could not be agreed to by the Council working party and would represent a definite obstacle to agreement between the Council and your House. The German Presidency strongly asks you to bear this in mind when the time comes for you to vote.
Application of the subsidiarity principle ensures that national legislation – and I would draw Mrs Breyer’s attention to the example of stem cells – is not touched by the regulation. It is not we who have stated that, but rather the Committee on Legal Affairs of your own House that has made that clear, so that, for example, my own country’s legislation on stem cells is not affected, while, on the other hand, the regulation gives all the others the highest possible degree of certainty.
Certain among you have – and quite rightly – had comments to make on the ethical framework, with warnings as to what might come to pass. I certainly share your misgivings, and I am quite sure that the Member States are taking them into account already; moreover, I know of no doctors in this Europe of ours who would do the things that some of you have so graphically described today. In view of the importance of the document you have to vote on, which touches upon the future of many patients in this Europe of ours, the German Presidency has a great interest in concluding this legislative process as successfully and speedily as possible. We have a great opportunity to show the public how we are, in a very important field, capable of being very purposeful and consistent in working towards adding European value, and our sense of ethical responsibility leaves us no alternative to a rapid and necessary decision that will be a basis for quality products of high value.
We therefore strongly urge you, whatever misgivings some of you may have, to perhaps put these to the backs of your minds in view of the vital and higher objective of getting this regulation in place without delay. For that, we – and in that I include the citizens of Europe and the patients – would owe you the utmost gratitude."@en1
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