his paper presents our published research that compares Early Access Programs (EAPs) in four European countries (France, Italy, Spain, UK) and focuses on EAPs in Italy. The study conducted a literature review and interviews with experts. Key findings include variations in program structures and funding sources. France has the most comprehensive EAPs, while Italy has multiple programs, including the 648 List, the 5% Fund, and Compassionate Use. The analysis reveals inequalities in access and suggests harmonizing EAPs based on the French model for improved data collection and clear distinctions from off-label use programs.
Early access programs for medicines: comparative analysis among France, Italy, Spain, and UK and focus on the Italian case
Tarantola, Alice;Otto, Monica Hildegard;Armeni, Patrizio;Costa, Francesco;Malandrini, Francesco;Jommi, Claudio
2023
Abstract
his paper presents our published research that compares Early Access Programs (EAPs) in four European countries (France, Italy, Spain, UK) and focuses on EAPs in Italy. The study conducted a literature review and interviews with experts. Key findings include variations in program structures and funding sources. France has the most comprehensive EAPs, while Italy has multiple programs, including the 648 List, the 5% Fund, and Compassionate Use. The analysis reveals inequalities in access and suggests harmonizing EAPs based on the French model for improved data collection and clear distinctions from off-label use programs.
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