Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-09-06-Speech-2-342"
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"en.20050906.36.2-342"2
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".
Mr President, ladies and gentlemen, it gives me great pleasure to be able to present to you this evening the Commission’s proposal for a regulation on medicinal products for paediatric use. This is a very important proposal, which will improve child health in Europe and spare many families the suffering which the premature death of a child brings.
Over 50% of the medicinal products used on children in the European Union today are neither tested on children nor authorised for paediatric use. This means that we cannot always be sure that these medicines are effective or safe. As I understand it, none of us is prepared to take that risk any more. The Commission’s proposal tackles this aspect of public health head-on. It will provide an incentive for high-quality research and bring about the development and authorisation of paediatric medicinal products that will be of
high quality, extremely safe and extremely effective. The proposal not only addresses this important aspect of public health, but also aims to stimulate innovation and competition and contribute towards growth and employment in the European Union.
I should like to extend my thanks and congratulations to Mrs Grossetête, the rapporteur for the Committee on the Environment, Public Health and Food Safety, for her work and the effort she put in to complete this report. She has made a truly outstanding job of it. I also wish to thank Mrs Toia for drafting the opinion of the Committee on Industry, Research and Energy, and all the members of both committees for their support for the proposal.
I should like to proceed directly to the specific point that I know has been the subject of extremely intensive debate in Parliament. I am talking about the Commission’s proposal for a fixed six-month extension of the Supplementary Protection Certificate for the products concerned here. This is one of the most fundamental provisions of our proposal, without which it is of little value.
Let me start by explaining why we have given preference to a fixed over a variable extension of the Supplementary Protection Certificate. A fixed extension is simple to use and can be foreseen exactly. It creates only a small administrative burden, and is compatible with existing patent law. In contrast, a variable extension of the Supplementary Protection Certificate would contravene the principles of patent law and, moreover, would not be conducive to innovation. A provision to this effect would be highly impracticable, as it would require a precise economic analysis for each medicinal product.
I also doubt whether a variable solution, being based on sales figures, would be fair. One thing that should be borne in mind in this regard is that sales success is not an indication of the innovativeness of a medicinal product; nor of the outlay on research. I should like to make it clear that the Commission is very determined about this, and I do not believe that the Commission sees any prospect of compromise in this regard.
Secondly, I should like to explain the Commission’s reasons for proposing a six-month extension of the Supplementary Protection Certificate. Based on our impact assessment, which was very thorough, we believe that this period strikes a balance between the aims of the proposal on the one hand, and the costs and benefits to public health, industry and public health service finances on the other. The Commission can support in principle the amendment advocating a review of the regulation on medicinal products for paediatric use, in order to enable a proper assessment of its impact, particularly the financial impact of bonuses and incentives. We must ensure that any review carried out also takes into account the desired benefits to public health of this regulation. Finally, the financial impact of the regulation should not be assessed until such time as sufficient data are available.
Understandably, I have not been able to discuss every single amendment, but the Commission’s position on all of the amendments has been communicated to Parliament’s services. The proposal for a regulation on medicinal products for paediatric use is important from the points of view of child health, innovation and competitiveness. I have no doubt that today’s debate will show that we are on the right track here. By way of conclusion, I should like to emphasise most strongly that the issue here is the health and welfare of children for whom no help was previously available. This is far more important than the interests of any pharmaceutical-industry lobby group."@en1
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