Focus Hospital Exemption on developing innovative and safe treatments for patients

The Alliance for Advanced Therapies (AAT) appreciates and supports the Hospital Exemption (HE) as a means to offer individual patients a treatment with a customized, innovative and safe product, particularly when a disease occurs so rarely that the regular development and validation of the required therapy is not feasible. However, AAT would like to emphasize that the inconsistent implementation of the HE in the Member States and routine preparations of treatments under an exemption impede the development of new safe and effective treatments. Therefore, AAT believes that a harmonized and transparent European approach is crucial to bring more innovative, effective and safe therapies to all European patients. It is in the best interest of patients to limit HEs to nonroutine preparations of treatments based on Article 28 of European Regulation 1394/2007 under all applicable safety and quality rules. Furthermore, HEs should no longer be allowed when a fully validated, centrally approved Advanced Therapy Medicinal Product is available. At this moment, there is no Europe-wide legal certainty on this point.