Mr President, Commissioner, this evening we are examining the review package of legislation on medicinal products for human use and veterinary medicinal products. This review represents two years of work, indeed more than two years of joint work, of research, questions and negotiations: two years which will, I hope, be crowned with success at tomorrow’s vote. I should like to extend very sincere thanks to my fellow Members of the European Parliament, across all of the groups, with whom I have held countless meetings, and in particular my fellow rapporteur, Mrs Müller. I should like to thank her for collaborating so effectively. I have listened to the requests made by fellow Members. I have put forward their arguments to the Council. I have involved them every step of the way, so that everyone could share in today’s result. I should also like to thank the Commission, in particular Commissioner Liikanen and his outstanding team. I have had first-hand experience of their dedication and have appreciated the quality of our exchanges. I should also like to thank the Council for being willing to adopt a constructive approach on these dossiers so as to reach an agreement at second reading. These expressions of gratitude will, however, count for nothing if Members of this Parliament do not act responsibly tomorrow and adopt the compromise that has been negotiated, rather than vote in favour of other amendments which, I believe, are more of a reflection of individual interests than the common good. Yes, we have a compromise and a compromise is never satisfactory on all counts. But consider the strides forward that we have made in protecting public and animal health! The objective of striking a balance, which was so difficult to attain at the outset, has been achieved. Attempts were made to pit the various different partners against each other, and in particular to put the health system and innovation on opposing sides. In fact, analysis has shown that generic medicines on the one hand and innovations by pharmaceutical laboratories on the other are not contradictory. These two products are not incompatible, but complementary. Generics do not develop without innovation and innovation is stimulated by the availability of generic medicines. Protecting patient health means being able to counteract the emergence of new diseases, to confront old scourges when they reappear and to provide more effective treatment. Protecting patient health means giving scientific research the necessary resources to discover either new molecules or new therapeutic applications for existing medicines. Innovations come at a price. Let us not forget that safeguarding our health requires significant financial investment. Data protection is therefore essential to guarantee medical advances, the European medical advances of which we are proud. The result of our compromise, known as 8+2+1, is what I would like to see adopted in tomorrow’s sitting. Research and development are at the root of health protection, which would not be complete without the availability of generic medicines. Generics are very important for our European health systems and for patients. I therefore welcome the approach adopted by these directives. The term ‘generic medicines’ has been introduced for the first time. It is also proposed to start using the Bolar system in the Union, a proposal that our amendments have, by the way, served to improve. This provision will enable all generics to be made available more quickly. My fellow Members and the Council also accepted my ‘eurogenerics’ proposal, which will prevent any hold-up in the development of these products, in particular in the candidate countries. The review of pharmaceutical legislation does not seek solely to strike an optimum balance between generics and innovation. Many other aspects that are just as important have been studied. I am thinking in particular of the definitions of medicinal product, generic medicinal product and biosimilars. These have been the subject of heated debate. Personally, I have always advocated an approach based on product safety. Having definitions that are too broad would be counterproductive for both manufacturers and patients. A satisfactory balance has been struck in this respect, as is illustrated by the provision on borderline products. I know that this point raises further questions. Simply deleting this so-called ‘borderline products’ clause would not have resolved anything and would require each manufacturer to seek judicial clarification from the courts, which would involve hiring lawyers and waiting months and months for a judgment. Drawing up a list of exemptions did not appear to be the right solution, either. Such a list would never have been exhaustive. We already have legislation on cosmetics, food supplements and medical devices, to name but a few examples. This is legally valid and our task here is not to call it into question, but to resolve a very real problem. Here I have a request to make of the Commission and I would actually like it to give an undertaking in this regard, so as to increase the legal security of those active in the field. There is no doubt that it would be helpful if the competent Commission services were to convene a meeting as soon as possible of all of the stakeholders that I have mentioned previously. I believe that this would be particularly important to set their minds at rest. On the basis of this meeting and in the light of rulings already handed down by the Court of Justice of the European Communities, a joint and official interpretative statement could then be published. I sincerely hope that this proposal is acted on, in the same way that I expect the Commission to clarify its position on the Doha Declaration. I know that this too is an essential point for a good number of my fellow Members. The issuing of an authorisation for a medicinal product for human or veterinary use does not, however, signal the end of checks on its efficacy and safety. Strengthening pharmacovigilance has therefore been one of our priorities. This has made it necessary to modify the existing provisions: firstly, to make it possible for inspections to be carried out unannounced at the manufacturing source and secondly, to shorten the deadlines for mandatory submission of the periodic reports and to set up a system for the rapid exchange of data collected by all of the partners so as to ensure that the pharmacovigilance systems are applied consistently across the Member States. We have also stressed that pharmacovigilance should be independent and requested that the management of funds earmarked for this purpose remain under the direct supervision of the competent authorities. My fellow Members and I also wished to take into account the environmental aspect of medicinal products. This point was, moreover, raised with the Executive Director of the EMEA in London, who confirmed that this was a valid approach. However, under no circumstances should this constitute grounds for a marketing authorisation to be refused. We all know, for example, that the products used in chemotherapy may cause harmful chemicals to be discharged into the environment, but we would not consider banning their authorisation. This would not make any sense. The idea here is to assess better the environmental risk and, for all therapeutic classes, to take effective measures to reduce its impact. This is a very important issue for this Parliament. I also wanted, with the support of my fellow Members, to return to the issue of information. It is our responsibility to address the problems that arise. It would have been easy to ignore the subject, but we have not done so. We are therefore asking the European Commission to table a clear paper setting out what exists in this field, to analyse the potential benefits and risks of making information available to patients, to reflect on the responsibility of the information provider and to table proposals. Nevertheless, I do have a number of regrets where these reports are concerned. The most significant concerns the scope of application of the directive and the Council’s refusal to make the centralised procedure obligatory immediately for all new active substances. Here, Parliament has been too European for the Council. The compromise does, however, include some significant pathologies in the scope of application and a review clause in four years’ time will enable us to strengthen this provision and increase equal access to health for every European citizen. I would congratulate my fellow rapporteur, Mrs Müller, who negotiated this. Where the EMEA and the composition of its scientific committees are concerned, common sense should prevail. It would seem to me to be inconsistent and even very dangerous if the professionals appointed to sit on these committees did not have a similar level of expertise. It is the criterion of competence and not nationality that will guarantee the quality and effectiveness of the scientific evaluation. We will be very vigilant on this point. On homeopathic medicinal products, Parliament wanted to go further than the proposed compromise. I am very aware of this, but advances have been made in the field of mutual recognition. This provision will secure the development of this category of medicines. We should look at what is being proposed and not just at what has not been agreed in the negotiations. It is important to put things in perspective, as it shows that homeopathic medicinal products have not been neglected, just as veterinary medicinal products have not been sacrificed. All of the provisions that I have mentioned so far also apply to all veterinary medicinal products. These directives do not seek, as I have had occasion to hear, to hamper social security systems or to give one sector an advantage over any other. On the contrary, they guarantee the development of a high level of health protection. They facilitate access to products for all patients and encourage scientific research by supporting essential growth in generic medicines. Neither do they divide the fifteen current Member States or the enlargement countries. I hope that tomorrow’s vote is favourable, so that our three institutions are successful in improving human and animal health. I am confident: we have an undertaking from the majority of the political groups. I dare not imagine that it will not be respected.

Political group: PPE-DE