Concessione di licenze obbligatorie per la gestione delle crisi e modifica del regolamento (CE) n. 816/2006

Presentato da Helmut Scholz, Bernd Lange

(28) Rimosso: It is imperative that Aggiunto: Notwithstanding the flexibilities included in the TRIPS Agreement, products manufactured under a Union compulsory licence Rimosso: reach only Aggiunto: should be predominantly destined for the supply of the internal market. The Union compulsory licence should therefore Rimosso: impose clear conditions upon the licensee Aggiunto: define clear conditions for the licensee as well as the rights-holder as regards the activities authorised under the licence, Rimosso: including the territorial reach of those activities. The rights-holder should be able to challenge actions and uses of the rights concerned by the Union compulsory licence that do not comply with the conditions of the licence, as infringement of its intellectual property rights in accordance with Aggiunto: which do not exceed those agreed under TRIPS. Directive 2004/48/EC of the European Parliament and of the Rimosso: Council9 . In order to facilitate monitoring of the distribution of Aggiunto: Council9should not impede the legitimate production and supply of pharmaceutical products manufactured under a Rimosso: Union compulsory licence, including controls by customs authorities, the licensee should ensure that such products have special characteristics that make them easily identifiable and distinguishable from the products marketed by the rights-holder. Aggiunto: compulsory licence as provided by law. 9 Directive 2004/48/EC of the European Parliament and of the Council of …

Testo come pubblicato dal PE, in inglese. PE760.448