Federal procurement of unlicensed medicines in Brazil: findings and implications

Background: There are safety concerns with using unlicensed medicines across countries including Brazil. Consequently, this needs to be evaluated and concerns address if pertinent. Aim: Investigate such purchases by the Brazilian Federal Government from 2004 to 2013. Methods: Procurement data from a public-access databank that contains procurement information of the Brazilian Federal Government. Each procured item was cross-referenced to its active drug approval status in the Brazilian National Register (DOU). Exploratory analysis and trend measures were performed for the variables for mapping and characterizing the purchases of non-market approved drugs. Results: 614 (0.14%) purchases in ten years corresponding to 65 unlicensed medicines – some of which had orphan drug status – and 48 different active substances; with a growing trend in recent years. Medicines in 51% of purchases were procured before obtaining marketing approval – with eventual refusals occurring in 17.8% and cancellation due to lack of efficacy and/or safety concerns in 1.1%. Health litigation accounted for 81.9% of purchases and growing in recent years. Conclusions: Overall a low rate of unlicensed medicine use. However, there are concerns given the current regulations in Brazil and the recent increase in the use of unlicensed medicines with increased litigation.