Abstract
BackgroundThis scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for effective pharmacovigilance.MethodsSixty-three terms pertaining to pharmacovigilance in Brazil and ANVISA, global institutions, pharmaceutical industry, and civil society were searched in thirteen relevant databases on November 17-18, 2013. Using a pharmacogovernance framework we analyzed ANVISA's pharmacogovernance: the manner in which governing structures, policy instruments, and institutional authority are managed to promote societal interests for patient safety due to medication use. The integration of transnational policy ideas for regulatory governance into pharmacogovernance in Brazil was also investigated.ResultsBrazil's policy, laws, and regulations support ANVISA's authority to ensure access to safe medicines and health products however ANVISA's broad mandate and gaps in pharmacogovernance account for regional disparities in monitoring and assessing drug safety. Gaps in pharmacogovernance include: equity and inclusiveness; stakeholder coordination; effectiveness and efficiency; responsiveness; and intelligence and information.ConclusionsPharmacogovernance that addresses 1) regional resource disparities, 2) federal and state lack of coordination of pharmacovigilance regulations, 3) asymmetric representation in the pharmaceutical regulatory agenda and which 4) disaggregates regulatory authority over health and commercial sectors would strengthen pharmacovigilance in Brazil.Electronic supplementary materialThe online version of this article (doi:10.1186/s40545-016-0053-y) contains supplementary material, which is available to authorized users.
Highlights
Pursuant to Article 196 of the Brazilian Constitution, all Brazilians have the right to health [1,2,3]
Creating opportunities for corruption to emerge [5,6,7]; Creating institutional conflicts of interest, whereby regulators are dually responsible for protecting patient safety and industry competitiveness [8,9,10]; De-incentivizing adoption of legislation and norms for pharmacovigilance; and De-incentivizing detection of adverse drug reactions (ADR) [5,6,7]
We investigated whether governance by the Agência Nacional de Vigilância Sanitária (ANVISA) and support from the international community are sufficient to ensure postmarket drug safety across Brazil
Summary
Pursuant to Article 196 of the Brazilian Constitution, all Brazilians have the right to health [1,2,3]. Weak pharmacogovernance entails a lack of oversight and accountability that may negatively affect pharmacovigilance by: Creating opportunities for corruption to emerge [5,6,7]; Creating institutional conflicts of interest, whereby regulators are dually responsible for protecting patient safety and industry competitiveness [8,9,10]; De-incentivizing adoption of legislation and norms for pharmacovigilance; and De-incentivizing detection of adverse drug reactions (ADR) [5,6,7] This scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The disseminated policy ideas influenced state pharmacovigilance initiatives in Brazil [14] (Fig. 1)
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