Concesión de licencias obligatorias para la gestión de crisis y modificación del Reglamento (CE) n.º 816/2006

Presentada por Helmut Scholz, Bernd Lange

(28) Eliminado: It is imperative that Añadido: Notwithstanding the flexibilities included in the TRIPS Agreement, products manufactured under a Union compulsory licence Eliminado: reach only Añadido: should be predominantly destined for the supply of the internal market. The Union compulsory licence should therefore Eliminado: impose clear conditions upon the licensee Añadido: define clear conditions for the licensee as well as the rights-holder as regards the activities authorised under the licence, Eliminado: 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 Añadido: which do not exceed those agreed under TRIPS. Directive 2004/48/EC of the European Parliament and of the Eliminado: Council9 . In order to facilitate monitoring of the distribution of Añadido: Council9should not impede the legitimate production and supply of pharmaceutical products manufactured under a Eliminado: 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. Añadido: compulsory licence as provided by law. 9 Directive 2004/48/EC of the European Parliament and of the Council of …

Texto tal como lo publica el PE, en inglés. PE760.448