Mr President, Commissioner, ladies and gentlemen, revising Community legislation on medicinal products, with the aim of providing improved levels of care, is a good thing and we welcome this new process of harmonisation of veterinary and human medicinal products. Health policy in Europe should not, however, be limited to the text on which we are about to vote, and should have been the subject of a more thorough deliberation. We must once again look at medicine in a context of public health that serves our citizens, as, although medicinal products exist, they must still be accessible to all men and women, and we regret the fact that we have not had a debate on social protection. For public health policy to take precedence over industrial policy, the Agency for medicinal products must be part of the Directorate General for Health and Consumer Protection once more, rather than the Directorate General for Enterprise. We are also disappointed by other aspects of the Commission proposal. The first I shall mention is that of patient information. We live in a society of high-speed communication and the Internet enables those, who wish or are able to, to access a great deal of information. Although the quality of this information is not always satisfactory, the solution proposed by the Commission to resolve this problem is not the right answer. Giving the pharmaceutical companies the option of communicating information on their products will not make it possible to eradicate erroneous information, but will authorise advertising on prescription-only medicines. This formula, which is permitted in the United States and in New Zealand, has shown its limits. During the last decade, spending by the United States on direct advertising has risen from USD 55 million, reaching USD 2.5 billion in 2000. Out of the total increase related to medicinal products, 47% was spent on advertising 50 medicinal products. There is no doubt that this is a commercial strategy and is not out of a concern for information. This is not what we want for European citizens. What we need is independent information provided by independent sources, which do not harm the relationship between patients and doctors and which do not lead to the excessive consumption of medicinal products. The proposals on the transparency of data provided by the Agency are heading in this direction. We could certainly have gone a little further. In demanding information, patients are also demanding safety and it is doubtful that the withdrawal of the five-yearly renewal will help to achieve this. Let us wait for the new proposals in the area of pharmacovigilance to prove their worth and let us maintain the option of carrying out a genuine scientific evaluation of a medicinal product, five years after it has been placed on the market, in the case of a new medicine. This evaluation could also provide an opportunity to weigh up the therapeutic value of the medicinal product. Lastly, I will say that although patients need effective medicinal products, some, unfortunately, need treatment urgently and hope to have access to new treatments, which, although they have not yet provided all possible safety guarantees, are a last resort for these patients. We must listen to them and provide a response to their appeal. This report highlights some considerable challenges. They will have an effect on the policy regarding medicinal products, but also on health policies.

Political group: PSE