Istituzione delle procedure dell'Unione per l'autorizzazione e la sorveglianza dei medicinali per uso umano, definizione delle norme che disciplinano l'Agenzia europea per i medicinali, modifica dei regolamenti (CE) n. 1394/2007 e (UE) n. 536/2014 e abrogazione dei regolamenti (CE) n. 726/2004, (CE) n. 141/2000 e (CE) n. 1901/2006

Presentato da Alessandra Moretti, Brando Benifei, Patrizia Toia, Pina Picierno, Elisabetta Gualmini, Camilla Laureti, Paolo De Castro, Achille Variati, Pietro Bartolo, Beatrice Covassi, Giuliano Pisapia, Mercedes Bresso, Irene Tinagli, Daniela Rondinelli, Kathleen Van Brempt, Sara Cerdas, Marc Angel, Alfred Sant, Dimitrios Papadimoulis, Pierre Larrouturou, Pascal Durand, Emmanuel Maurel, Robert Hajšel, Sylvie Guillaume, Alex Agius Saliba, Tsvetelina Penkova, Konstantinos Arvanitis, Isabel Carvalhais, Eugenia Rodríguez Palop, Matjaž Nemec, Milan Brglez, Rosa D'Amato, Mario Furore, Dino Giarrusso, Maria Angela Danzì, Laura Ferrara, Tiziana Beghin, Piernicola Pedicini, Fabio Massimo Castaldo, Giuseppe Ferrandino, Massimiliano Smeriglio, Andrea Cozzolino, Marc Botenga, Nicola Danti, Sirpa Pietikäinen, Antoni Comín i Oliveres, Sabrina Pignedoli, Christophe Clergeau, Franco Roberti, Lina Gálvez Muñoz

Aggiunto: Article40a Article 40a Establishment and role of the European Medicines Facility 1.⁠ ⁠The European Medicines Facility ( ‘EMF’) is hereby established. 2.⁠ ⁠The main missions and responsibilities of the EMF shall be: (a) setting out a long-term vision of health priorities in the public interest at a Union level in the form of a strategic roadmap with a number of specific purpose-led R&D projects; in the elaboration of the strategic roadmap, the EMF shall engage in transparent consultation with relevant stakeholders, including scientific communities, Union public health authorities, patient and consumer organisations as well as the relevant agencies established at Union level; (b) establishing, as a priority, a portfolio of priority pharmaceutical R&D projects addressing at least the following therapeutic areas: (i) the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level; (ii) the development of medicinal products for high unmet medical needs as referred to in Article 70(1) of this Regulation and unmet medical needs as referred to in Article 83 of [revised Directive 2001/83/EC], in particular for conditions not sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therapies; (iii) the development of medicinal products for which the private sector charges excessive prices and for which alternatives or generic alternatives are non-existent or unaffordable.

Testo come pubblicato dal PE, in inglese. PE760.539