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Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance

In: European Journal of Health Law
Authors:
Annagrazia Altavilla Espace Éthique Méditerranéen/PACA-Corse, Assistance Publique Hôpitaux de Marseille/Aix-Marseille Université Marseille France TEDDYChair
TEDDY (European Network of Excellence for Paediatric Research) Pavia Italy

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Viviana Giannuzzi Fondazione per la Ricerca Farmacologica Gianni Benzi onlus Bari Italy
TEDDY (European Network of Excellence for Paediatric Research) Pavia Italy

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Mariangela Lupo TEDDY (European Network of Excellence for Paediatric Research) Pavia Italy

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Donato Bonifazi TEDDY (European Network of Excellence for Paediatric Research) Pavia Italy
Consorzio per Valutazioni Biologiche e Farmacologiche Bari Italy Coordinator, European Paediatric Translational Research Infrastructure (EPTRI)

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Adriana Ceci Fondazione per la Ricerca Farmacologica Gianni Benzi onlus Bari Italy
TEDDY (European Network of Excellence for Paediatric Research) Pavia Italy

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Abstract

The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster paediatric research addressing unsolved and uncovered issues within a ‘translational approach’ has appeared. This article, after having clarified the concept of translational research in the perspective of the establishment of a European paediatric research infrastructure (RI), will identify and point out ethical, legal and regulatory issues particularly relevant in a children’s rights perspective. It concludes asking for the setting up of an adequate model of governance within a future RI, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children.

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