The 'Compassionate Exemption' in Spain: Not Asking for Compassion
25 Pages Posted: 24 Jul 2010 Last revised: 29 Sep 2010
Abstract
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.
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.
Keywords: Availability of drugs in specific situations, Compassionate use, Foreign drugs, Off-label, Clinical trials, Authorisation, Temporary authorisation, Telematic application, Spanish Medicines Agency, Patient. Risk, Pharmacovigilance
JEL Classification: H51, I11, I12, I18, K32
Suggested Citation: Suggested Citation