Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-16-Speech-2-279"
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". Mr President, I would like to reply to at least those Members who asked questions and who are still present.
The compromise gives a limited exemption which should be applied in a harmonised manner. It states, however, that Member States may grant exemption from this requirement according to criteria established in accordance with the procedure referred to in Article 89(2). So it will limit it, and this can be done on the basis of this compromise.
Mr Nicholson mentioned internal affairs. That issue was raised in the Council and many Member States strongly contested that position. They say that even though the medicines may not circulate on the internal market, meat, as a food product, circulates. So there is an impact across the national borders. That has been the position of many Member States and for reasons of internal market coherence they contested the possibility of having a permanent derogation in this area.
Unfortunately Mrs de Keyser has gone, because I would have liked to reply in even more depth to her comment. Discussions regarding the pharmaceuticals industry are always problematic. We have public objectives which are accepted across the board: we need to have better health that is what medicines are for. But if there are no innovative new medicines we will not be able to tackle illness in the way we should. There have been some success stories in the last 20 years for example, illnesses which were extremely difficult to handle without heavy treatment in closed institutions can now be treated with medicines. But this cannot be done without innovation. Twenty or thirty years ago people with mental illnesses were placed in institutions. Today they can live freely, which means better quality of life and also lower costs. So we need to pursue innovation.
Let us take the example of Alzheimer's Disease. If we do not find any new, innovative medicines the cost will be enormous. We must support innovation. Somebody referred to the situation in America where exclusivity periods are shorter. Compare the costs for a moment. Because we in Europe cover the costs from public budgets we want to have a say in pricing levels. The longer protection period gives some compensation for innovation, due to the lower prices.
I commissioned a study in 2000 to assess the state of the European pharmaceuticals market. It showed that in Europe there are countries where, after the expiry of a patent or data protection, there is no change in the price level of generics. They remain at the same price level. So there are high prices when they are put under a patent and under data exclusivity and no change after that. This proposal will certainly create a real European market for generics. When the rules are the same and they are harmonised, I am sure the generic industry will profit from this opportunity. We need to invest in innovative medicines in order to be able to tackle difficult diseases but, at the same time, we need to push prices of generics down to reduce the costs. That is the balance we want to achieve. I am personally convinced that in that area this House has been working on very good balance.
Finally, I want to thank this House for a
good debate. It has been very committed in its work throughout this period. I must also say that not all the issues have been solved here, but we all have worked very hard and very well to find a compromise which is good for public health and innovation.
Firstly, Mrs Corbey's written question on Doha. If I rephrase your question it will be easier to give a reply. I want to be very precise here. Authorisation is needed for medicines only in the EU market, so this legislation concerns medicines which are authorised for the Community market. Mrs Corbey asks whether I declare that data protection does not hinder and here I rephrase it the production of the medicines in the EU to be authorised in the developing countries.
If I rephrase it like this, then my reply is 'yes'. It means that this legislation concerns the authorisation to market products in the EU. If TRIPS and patents mean that products produced in one country can be exported to a developing country, this has no impact, because this protection only concerns authorisation to market: it is not linked to manufacturing. We are not regulating manufacturing via this regulation, we are regulating authorisation to market. There is one small exception: Bolar provision, because there is always some production as regards generics.
I fully share the concerns of Mrs Corbey, Mr Whitehead and many others that we must respect Doha. Doha takes a strict position on the patent. It does not take a position on data protection. Data protection is not linked to market authorisation outside the EU. Products outside the EU will be authorised for placing on the market by the authorities of those third countries, according to their legislation. I hope that this has clarified the situation. This does not hinder in any way the implementation of Doha.
Secondly, as far as commitment is concerned, what I have said here before has been accepted by the whole college of Commissioners: it will be our first priority in early 2004, which is in two weeks' time. I will do my best also to help my colleagues prepare, because not all the proposals fall under my direct responsibility. I will, however, take this issue up once this has been voted.
Mrs Jackson raised the issue of the new Member States and asked how many of them have asked for a transition period. So far none have asked, but for good reason: we cannot start to negotiate on transition periods before the legal act has been adopted. Then we will be able to start negotiations. My position which my colleagues support is positively open. We understand the transition period is a problem here.
Mr Liese raised the issue of paediatric medicines. I feel a little uncomfortable here because I personally told this House that a proposal would soon be forthcoming. As I said before, the Commission decided that this proposal should go through an extended, in-depth assessment, which has delayed the procedure. On the one hand, this is good for better regulation but, on the other hand, it has caused a delay. We will do that early in 2004. I will take personal responsibility here because it is my proposal.
Mr Liese also raised the question of direct consumer advertising. He mentioned a case in Bratislava. If you have been surfing the Internet or looking at your e-mail, you will have seen a lot of aggressive advertising which pops up on your screen and which you cannot do anything about. That is an explosive problem which we must deal with, but I am sure we can come back to that in the future.
I turn now to the points made by Mrs Doyle, Mr Whitehead, Mr Parish and Mr Nicholson on veterinary medicine. I know they feel very strongly about this issue. Mrs Doyle has talked about it in committee and elsewhere and I understand her problem. When we say that we can accept an amendment in principle, it would of course be more precise to say that the amendment should be subject to modification, because normally, permanent derogation will never go through in the Member States' institutions. Permanent derogations are exceptional."@en1
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