Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-16-Speech-2-278"
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"en.20031216.6.2-278"2
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"Mr President, all the same I would like to respond to some objections made by my fellow Members. First of all, I am disappointed to see behind me that Mrs Jackson left a long time ago. I would have liked to tell her what I am going to do and I will also give her an answer in writing tomorrow morning.
We have concerns regarding the enlargement countries. These formed part of the discussions that we had with the Council and the Commission so that, quite rightly, the difficulties that some enlargement countries, but not all, could face with the application of this pharmaceutical legislation were taken into consideration. We know, furthermore, that the Commission has made a commitment to propose derogations for some enlargement countries as soon as this legislative package is adopted.
Above all, however, I would also have liked to tell Mrs Jackson that, this morning, I received a letter from one of our observers from the Czech Republic who declared that he fully supported protecting data for eight years, plus two, plus one, feeling that this was an acceptable compromise between protecting data for six years and the proposal to protect it for ten years plus one. He is completely aware that it is important to protect patent rights whilst allowing generic medicines to enter the internal market. This is a letter which I will make available to my fellow Members. It is not the only one that we have received in this area.
Furthermore, I would also like to reply to the British and Irish Members on the issue of veterinary medicinal products. When I hear my fellow Member, Mrs Doyle, say that we have proceeded much too quickly, I really do find this rather appalling, being aware of the discussions that we have been having for months with the Commission and the Council; hours of discussions to quite rightly find a good compromise. When it is an issue of animal safety, I believe that we cannot prevaricate on this issue either. When it is an issue of animals raised for food production, you will understand that the concept of safety is essential in this case. It is essential for us and it is essential for the Council. We also had a large number of discussions about this too.
The British Members declared that there ought to be separate legislation, but that is what we have! I would like you to look at the texts. We have two directives and today we are discussing two directives. One regards medicinal products for human use and the other regards veterinary medicinal products. There are simply a number of provisions regarding the directive on medicinal products for human use that are the same as the provisions for the directive on veterinary medicinal products. I would, therefore, like you to look closely at these texts, before speaking, in order to avoid this type of mistake.
When you refer to something that is specific to Britain and Ireland – and I hope that it is not because of this specific characteristic that you are going to take the risk of not adopting this compromise – I would like to remind you that Article 67 of the common position rightly provides for derogations, medicine by medicine. You, therefore, already have the answer in the text. All the same, I would like there to be a little more honesty in this type of discussion. When you tell us that horses are not in fact part of the diet in the United Kingdom, then you really should not forget, and you know this all too well, that when these horses are no longer of use in the United Kingdom, then they are exported to other Member States to end up on our butchers’ stalls. This is why there should be much more safety regarding the prescription of veterinary medicinal products.
There are still many things to be said but I would like to finally conclude by stressing that we ended up with compromises that were especially difficult to reach and that the Italian Presidency made the necessary effort to consider a number of requests that it did not intend to take into consideration at the start, and it would be particularly serious to be responsible for not adopting these compromises.
Like my fellow Member Mrs Müller, I appeal to your sense of responsibility: do not allow yourselves to adopt amendments that are not part of the compromises. You would call these compromises into question. That means to say that there would certainly be conciliation, Mrs Doyle, but it is not absolutely certain that we would obtain the results that we amassed today. I therefore ask you to adopt these compromises tomorrow and, above all, not to risk, or be responsible for, allowing what we have achieved through weeks of work to run aground."@en1
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