Regulations and institutional attributions for the evaluation of modified mosquitoes for the control of arboviruses in Brazil

Abstract

Introduction: New biotechnologies have grown rapidly with recent techniques for manipulating living beings. When combined with public health policies, these biotechnologies result in wide-scale interventions when creating, producing and disseminating new hybrid beings. A recent field of application of these biotechnologies lies in combating the epidemics of arboviruses caused by the Aedes aegyptimosquitoes. Objective:To analyze the regulatory trajectories of two new biotechnologies for the control of arboviruses transmitted by A. aegypti: the transgenic A. aegyptiand the A. aegyptiinfected with the bacteria Wolbachia. Method: A qualitative analysis of publicly accessible documents made available by official organizations, in particular the Brazilian Health Regulatory Agency – ANVISA, the National Technical Commission for Biosafety – CTNBio and the Court of Justice of Distrito Federal, was carried out; in addition, an analysis of the legislation associated with these documents was performed. Results:  Documents describe the different regulatory trajectories and the attempt to standardize the two biotechnologies in the country and present the gaps and controversies that involve the regulatory processes of these new artifacts. Conclusions:The difficulties presented to provide definitive registration for these new technologies have generated processes that last to the present day, highlighting gaps in the norms in terms of framework, definition of institutional competencies and path for the regulatory process. The importance of establishing a      regulatory process for these technologies becomes evident by the scale of their implementation, by their accelerated pace of development, by the difficulty of reverting their implementation after release in the environment and by the need to guarantee participation and public debate.