Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-09-06-Speech-2-343"
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".
Mr President, Commissioner, ladies and gentlemen, I have been waiting for this moment for a long time, because our Parliament has been calling for this specific European regulation on paediatric medicinal products for many years.
What is Europe good for? This regulation can show our fellow citizens just how useful it is. This matter, which affects everyone, can only be regulated at Community level. No Member State on its own can support the research policy with regard to the pharmaceutical industry. Your vote will be decisive. If we say ‘yes’ to a fixed incentive of six months, our children will soon benefit, thanks to the European Union, from appropriate, safe medicinal products.
Commissioner, you explained it very well: it seems inconceivable that, today, our children cannot get treatment adapted to their needs. It is, however, a reality. In 2005, a large number of the medicinal products administered to children were not specifically developed for paediatric use. In many cases, the products used for the very young are the same as those prescribed to adults, the only difference being that the doses are smaller. However, children do not have the same metabolism as adults. Children therefore need specifically adapted pharmaceutical forms, not only so that they are better tolerated, but also so that they are safer and more effective. That is the aim of this regulation and I would like to thank all of my fellow Members who have participated in the work.
My report presents some considerable advances, which have the approval of a large number of Members. They aim in particular to improve the readability of the actions of the Paediatric Committee, which will be set up within the European Agency for the Evaluation of Medicinal Products, to avoid additional clinical trials being performed on children when they are not necessary, to promote the transparency of the instruments, to reduce administrative delays, to strengthen pharmacovigilance, to introduce an obligation to perform paediatric research for any new medicinal product intended for adults, without this system delaying the placing on the market of innovative medicinal products, to call on the Paediatric Committee to draw up an inventory of therapeutic needs of children, and finally, to create a European research fund intended to finance research on medicines which are not patent-protected but which could be of great benefit to children.
However, the main point in this text is still that connected with the incentive. I have put a great deal of work into this issue. I have listened carefully and, having debated it with you all, I think that the proposal for a fixed incentive, namely a six-month extension of the supplementary protection certificate, is the best possible solution. This period is the fairest and most pragmatic that we could come up with. I definitely say six months, not five months. The US has set up a recognised system with a period of six months. Why should Europe not do the same?
I must admit that I do not really understand the amendment proposed by Mr Maaten. Mr Maaten, we are always asking the European Parliament to look for better solutions by means of benchmarking. Indeed, the United States have a good system in this regard; since they have had this regulation, around 100 paediatric medicinal products have become available to American children. Why should we be unable to provide the same support for pharmaceutical research in Europe? I have the impression that we are forever haggling, and I find it regrettable, because what is at stake here is public health for children. I think it is a shame, Mr Maaten, that we could not agree on this period of six months.
Research is, by definition, risky and if the European Union wants, as you all hope, to develop this strategic sector, we cannot create a watered-down system or institute vague measures. Some of my fellow Members have drawn up a proposal based on proportional rewards. However, this system imposes too many restrictions. I have asked my fellow Members some important questions, questions relating to public health. I am still waiting for the responses of those who advocate this proportionality. Moreover, while waiting for information that never comes from the authors of these amendments, I have been wondering about the reasons for this long silence. It is a question of saving children’s lives and not of balancing the books. Proportionality, however, balances the ‘lives saved’ column against the ‘sales volume’ column.
Under the proportional system, three months plus three months, or four plus four, the second part would be granted depending on whether or not a particular sales volume or turnover had been achieved. In my view, the danger of this system is this: we would be moving from a health-based system to a market-based system. Why? There is no Europe-wide price for medicinal products. Each Member State sets its own price and, as we know, they vary considerably. With the turnover-based system, laboratories will get out their calculators and choose a country depending on the prices set and not depending on health needs. Moreover, who will be able to verify the sales figures? Some Members have suggested using an independent audit, but without specifying what procedures should apply. They have not assessed the costs, or the additional delays that this bureaucratic procedure would bring, or the possible remedies in case of dispute. The European Agency for the Evaluation of Medicinal Products itself has told us that this system is unrealistic, because it does not have the resources. What, then, is the benefit of this proposal?
Ladies and gentlemen, the proportional system is not good, and it is not applicable. The system I am proposing is also not based on the medicine itself but on studies conducted under the authority of the Paediatric Committee. I would ask you to take a close look at this condition.
With regard to the impact of this measure on the public health budgets of our countries, a study presented to the Council concludes that, with a fixed six-month period, the increase in health spending would be infinitesimal, between 0.7 and 1%. Finally, I wanted to include in the amendments a review clause for the incentive. In six years’ time, the Commission will have to assess the situation, indicating the precise conditions under which the six-month extension has been granted, with what costs and what benefits. With this text, we have the opportunity to move from words to actions. We must stop always being philosophical and be more pragmatic instead. Let us make no mistake. If we do not set up a stable framework to promote research in Europe, it will favour the industry in the US and Asia. This would therefore be a real absurdity in terms of politics, science and health."@en1
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