Time for Change? The Why, What and How of Promoting Innovation to Tackle Rare Diseases – Is It Time to Update the EU’s Orphan Regulation? And if so, What Should be Changed?

Time for Change? The Why, What and How of Promoting Innovation to Tackle Rare Diseases – Is It Time to Update the EU’s Orphan Regulation? And if so, What Should be Changed?

Since developments are global in the healthcare arena, more should be done to align EU and other big markets’ regulatory practices for rare disease patients. Notwithstanding efforts and cooperation between the US and EU aimed to harmonize their strategic plans in the field of orphan drugs, regulator...

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Bibliographic Details
Main Authors: Denis Horgan, Barbara Moss, Stefania Boccia, Maurizio Genuardi, Maciej Gajewski, Gabriele Capurso, Pierre Fenaux, Beatrice Gulbis, Mariangela Pellegrini, Maria del Mar Mañú Pereira, Victoria Gutiérrez Valle, Iñaki  Gutiérrez Ibarluzea, Alastair Kent, Ivana Cattaneo, Beata Jagielska, Ivica Belina, Birute Tumiene, Adrian Ward, Marisa Papaluca
Format: Article
Language:English
Published: Karger Publishers 2020-07-01
Series:Biomedicine Hub
Subjects:
rare disease
regulatory
member states
orphan regulation
european commission
patients
personalised healthcare
incentives
challenges
access
biosimilars
unmet need
reimbursement
diagnostics
biomarkers
inequality
treatment
data
ultra-rare disease
empowerment
patient
citizens
Online Access:https://www.karger.com/Article/FullText/509272

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https://www.karger.com/Article/FullText/509272

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