Federal procurement of unlicensed medicines in Brazil; findings and implications

ABSTRACT

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 64 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.

KEYWORDS:

• Brazil
• drug approval
• federal government
• procurement
• unlicensed medicines

Box 1. Purchases of unlicensed medicines, according to category. Brazil, 2004–2013.

Table

Acknowledgments

The authors gratefully thank Antonio Carlos Bezerra (Anvisa), Maria Eugênia Vieira Martins (Anvisa), and Paulo Marques (Oswaldo Cruz Foundation) for support in data collection and analysis.

Declaration of interest

André Luís Almeida dos Reis is employed by ANVISA. However, the comments made in the paper may not necessarily reflect the thoughts of ANVISA. Cristiane Roberta dos Santos Teodoro, Mariana de Carvalho Barbosa Ramos, and Claudia Garcia Serpa Osorio-de-Castro do not have any disclosures apart from the funding grant mentioned earlier. The other authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

The work was funded in part by the Brazilian Research and Development Council (CNPq), Grant Number 303342/2013-7.