Nun liegen die Vorschläge der EU-Kommission für eine umfassende Überarbeitung der europäischen Arzneimittelvorschriften auch offiziell auf dem Tisch – einen Monat später als erwartet und mit unwesentlichen Änderungen gegenüber den letzten, an die Öffentlichkeit durchgedrungenen Entwürfen. Für die hiesige Pharmaindustrie bleiben besonders die Kommissions-Pläne zu Änderungen am Unterlagenschutz schmerzhaft. Bislang genießt ein Hersteller eines neuen Medikamentes in der Regel zehn Jahre Schutz, bevor Nachahmerprodukte, sogenannte Generika, auf den Markt kommen können. Diese Fristen sollen nach dem Willen der EU-Kommission künftig aufgeweicht werden, um Kosten zu senken, die Verfügbarkeit zu erhöhen und Anreize für die Entwicklung innovativer Arzneimittel zu setzen.
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