Discrimination and Reasonable Accommodation: Insights for a (non) Zero Sum Game

Authors: Giovanni Comandé, Luca Nocco


The RDDMSE seeks to eliminate formal steps and speed up procedures, strengthening, in turn, guarantees of safety in these special applications, without neglecting the information and transparency that should prevail in this area. Among the innovations stated in the RDDMSE, we must highlight the fact that the access to drugs that are in research or unauthorised in Spain can be managed telematically for each patient, as well as through a temporary authorisation issued by the AEMPS (the Spanish Medicines Agency), in coordination with other European agencies, for a group of patients. In relation with the off-label use, this Decree eliminates the need to obtain an individual authorisation from the AEMPS, focusing liability on doctors.