Role of Hospital Exemption in Europe: position paper from the Spanish Advanced Therapy Network (TERAV)

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, would like to make the following position statement.