Role of Hospital Exemption in Europe: position paper from the Spanish Advanced Therapy Network (TERAV)
Fermín Sánchez‐Guijo, C. Avendaño, Lina Badimón, Juan A. Bueren, Josep M. Canals, Joaquim Delgadillo, Julio Delgado, Cristina Eguizábal, María Eugenia Fernández‐Santos, Damián García‐Olmo, Gloria González‐Aseguinolaza, Manel Juan, Francisco Martı́n, Rosario Mata, Núria Montserrat, Antonio Pérez‐Martínez, José Antonio Pérez‐Simón, Felipe Prósper, Álvaro Urbano-Ispizúa, A. Zapata, Anna Sureda, José M. Moraleda
Abstract
The Hospital Exemption rule is considered a valuable European legislative initiative that guarantees patient access to novel therapies based on the use of advanced therapy medicinal products (ATMPs) in the Member States. On the occasion of the update of the European General Pharmaceutical Legislation, the Spanish Network of Advanced Therapies (TERAV, formerly TerCel), which has played a recognized leadership in Europe in the development of both academic and pharmaceutically commercialized ATMPs [ 1 ], would like to make the following position statement: