Are there legal-sanitary bases for the distribution of direct-to-consumer genetic tests in Brazil?

Abstract

The objective of this essay is to analyze the legal-sanitary grounds in Brazil for the direct commercialization of genetic tests to the public. It points to the growing commercialization of genetic tests that determine not only individual ancestry but also possible genetic diseases that can affect the individual. It is also questioned whether the shipment of genetic material to genetic databases formed from these deregulated tests entails a breach of legal and infra-legal norms. For this, the normative arc on the subject and related legislation of the National Health Surveillance Agency - Anvisa are analyzed, concluding that there is a normative lapse for the commercialization of genetic tests in Brazil.