Política e requisitos regulatórios para biossegurança e bioproteção laboratorial no Brasil

Abstract

The subject “Laboratory Biosafety and Biosecurity” is becoming more and more strategic. Considering its broad scope and relevance to animal, human and environmental health, the WHO released the document “Guidance on implementing regulatory requirements for biosafety and biosecurity in biomedical laboratories - a stepwise approach” with recommendation about the regulation of this issue worldwide. The purpose of this essay is to evaluate the national scenario in face of this recent issued recommendations. It was showed that our institutions achieved relevant progress, such as the identification of this issue as strategic for CREDEN and the release of the “National Plan for Security of the Critical Infrastructure”. Nevertheless, some critical gaps remain, such as: lack of a model to support instruction, research, technological development and innovation; lack of a wide and updated legal framework adequate to this complex subject; lack of a “National Training Plan” on Laboratory Biosafety and Biosecurity; lack of a “National Network for High Containment Laboratories”; lack of a strategic plan that includes the definition of the national desirable infrastructure in terms of number and biosafety level of laboratories; lack of procedures for high-containment laboratory certification; need to coordinate collaboration programs at national and international levels. It is also necessary identifying roles and responsibilities of the governmental bodies involved with this issue, as well as mechanisms to continuously provide the high financial resources needed to carry out the mitigation actions to address the gaps identified.