Mr President, ladies and gentlemen, in examining the legislation before us, we need to consider whether more EU involvement is needed when it comes to approving innovative medicinal products, or whether the mutual recognition procedure is the best approach. In other words, do we want a more integrated internal market for medicinal products with a view to giving patients throughout Europe swifter access to new, safe and effective medicines, or is the idea that extremely complicated authorisation procedures should continue to keep new medicines out of patients' hands for as long as possible? I would like to argue in favour of the wider registration of medical products with new active substances. This has advantages not only for patients, but also for companies, because they can market medicines more quickly than up to now and thus enhance their competitiveness. The support proposed for SMEs should compensate for the drawbacks of the centralised authorisation procedure, which do hit them. As I see it, legislation should focus on patients and their needs. That means that safety and the effectiveness of medical products must play a key role in the authorisation procedure. The procedure must be transparent. Patients, doctors and companies alike must therefore have access to any information not covered by business secrecy protection. In future, comprehensive information on progress with the authorisation procedure, on clinical tests carried out and on side effects and the prices of medical products will be downloadable at any time from a public database. In this connection, I regret that the Commission's information project on asthma, diabetes and AIDS did not receive the support of a majority of the committee. The Commission proposal was certainly ambiguous and gave rise to fears that advertising for prescription medicines was to be permitted. However, the committee's decision meant that an opportunity to improve patient information has been lost. I feel sure that this ought to be put right over the next few years. Pharmacovigilance, that is to say monitoring and reporting of side effects, is important to the safety of a medical product. The obligation to report side effects and submit periodic reports to the authorisation authority ensures continuous comprehensive assessment of any given medical product. There is a very effective safety net in the field of pharmacovigilance. This makes it easier to ascertain side effects and makes it possible to act quickly in the event of a crisis. For these reasons it will be possible to dispense with the procedure for relicensing products every five years. Another key aspect of reform is the plan to prepare the boards and committees of the European Agency for the Evaluation of Medicinal Products for their future remits and for the enlargement of the EU. The structure of the EAEMP is intended to reflect that of the EU Food Safety Authority, with an open application procedure for the Management Board and the Executive Director. Anyone wishing to become a member of one of the agency's boards or committees should have a high degree of scientific expertise and must declare any relevant interests. In addition to the existing scientific committees, there will in future be a committee for herbal medicinal products with the same status. This will make voluntary central authorisation for herbal medicines possible, giving patients throughout Europe the option of using tried and tested herbal medicines. In addition to health protection, which is important for patients, there is also the issue of competitiveness and innovation in Europe's pharmaceutical industry. The harmonisation of data exclusivity is certainly a step towards increased competitiveness. Under the present arrangements, data exclusivity in Europe ranges from six to ten years, and this is in urgent need of harmonisation. The 10-year-rule gives a signal to pharmaceutical companies to intensify research and market truly innovative products. However, it also gives a signal to generic drug manufacturers to use the Bolar provisions. As I see it, the Commission proposal is a successful attempt to strike a balance between the justifiable desire of pharmaceutical companies to protect their data and the need of public health systems to improve access to cost-effective generic drugs. All in all, the legislation before us will make an important contribution to improving health protection in Europe, which will be of lasting benefit to patients. (Applause)

Political group: PSE