Límites legales al uso “off label” de medicamentos en derecho español y derecho comunitario

The Spanish Association of Health Law celebrated its annual Congress in Madrid on 17 October 2013. Among the various working sessions, one was dedicated to the legal regime under which medicines may be used “off label” in Spain.

In recent times, in Spain, various regions have adopted formal or informal measures leading to “off label” use of some products as part of protocols aiming to control pharmaceutical expenditure. In his presentation, Jordi Faus stressed how important it is to secure that medicines are not used “off label” on a general basis as a tool to cut costs at hospitals.

In this respect, Jordi Faus recalled that the general rule, under Law 29/2006 on Medicines, is that drugs should be used under the conditions laid down in their approved Summary of Product Characteristics and that “off label” should only be an option for individual patients when a given situation cannot be treated with an approved product.

Jodi Faus also mentioned that doctors treating patients “off label” should secure that the patient had consented to the treatment after having received all adequate information.