Asunto T-733/17: Recurso interpuesto el 2 de noviembre de 2017 — GMPO/Comisión
Section | información judicial |
Issuing Organization | Comisión de las Comunidades Europeas |
15.1.2018 ES Diario Oficial de la Unión Europea C 13/26
Lengua de procedimiento: inglés
Demandante: GMP-Orphan (París, Francia) (representantes: M. Demetriou, QC, E. Mackenzie, Barrister, y L. Tsang y J. Mulryne, Solicitors)
Demandada: Comisión Europea
La parte demandante solicita al Tribunal General que:
— Anule el artículo 5 de la Decisión de Ejecución de la Comisión de 5 de septiembre de 2017, por la que se autoriza, al amparo del Reglamento (CE) n.o 726/2004 (1), la comercialización de «Cuprior-trientina», medicamento de uso humano.
— Ordene a la parte demandada que vele por que Cuprior se clasifique como medicamento huérfano y que se actualice en consecuencia el Registro Comunitario de Medicamentos Huérfanos.
— Condene en costas a la parte demandada.
En apoyo de su recurso, la parte demandante invoca cuatro motivos:
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Primer motivo, basado en que el artículo 5 de la Decisión impugnada se fundamentaba en una interpretación errónea de la expresión «beneficio considerable» del artículo 3, apartado 1, letra b), del Reglamento (CE) n.o 141/2000 («Reglamento de Medicamentos Huérfanos»). — El Comité de Medicamentos Huérfanos/Comisión incurrieron en error al no darse cuenta (de conformidad con los objetivos de la normativa farmacéutica armonizada en su conjunto y con la formulación del Reglamento de Medicamentos Huérfanos en concreto) de que una mayor disponibilidad de Cuprior en toda la UE suponía un «beneficio considerable» a efectos de la normativa.
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Segundo motivo, basado en que el Comité de Medicamentos Huérfanos/Comisión incurrieron en error de Derecho o error manifiesto de apreciación al aplicar el artículo 3, apartado 1, letra b), del Reglamento de Medicamentos Huérfanos. — El Comité de Medicamentos Huérfanos/Comisión no se dieron cuenta de que cualquier problema de disponibilidad de trientina en la UE supondría automáticamente que los pacientes no verían satisfechas...
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