The “Compassionate Exemption” In Spain: Not Asking for Compassion

Authors: Francisco Miguel Bombillar Sáenz


The Royal Decree 1015/2009, June 19th 2009 (RDDMSE) aims to facilitate the access to drugs –the drug in question should be subject to a marketing authorisation application or must be undergoing clinical trials– before approval, in Spain, in patients with a chronical or severely debilitating disease or one considered life threatening and who cannot be treated satisfactorily by an authorised product (compassionate use); as well as the access to drugs approved in countries other than Spain, when they do not comply with the definition of compassionate use of investigational drugs (foreign drugs use) and, finally, the access to drugs in conditions other than those stated in the authorised data sheet (off-label use). Traditionally, in Spain, the first and third cases were known as “compassionate use” –an unfortunate name, as it is not compassion that is sought–, being legally regulated in the same way.