In light of the ongoing Public Health Emergency of National Importance (or, “ESPIN,” the Portuguese acronym) due to the spread of the novel coronavirus (COVID-19)—as declared by the Ministry of Health through Act 188/GM/MS—the Ministries of Health and Environment enacted Act 155/2020 (“Act”). This Act aims to simplify the procedure for shipping samples of genetic heritage abroad for purposes of research and technological development, provided that it relates to the pandemic.
According to the new regulation, shipping is permitted without prior registration with SisGen (electronic self-declaratory system), but it is dependent upon the signing of an agreement for material transfer, in the format previously approved by the Genetic Heritage Management Council (or, “CGEn,” the Portuguese acronym).
Under the Act, registration with SisGen is also not necessary for the publication of results of the research—whether final or partial—in scientific media or means of communication. Those results, however, cannot be used to request intellectual property rights before undergoing the registration process and other procedures provided for by Law 13,123/2015 (“Brazilian Biodiversity Law”).
The research, technological development or shipping of samples associated with the current epidemiological situation must be registered with SisGen within one year after the end of the ESPIN. The same term applies to the notification of finished product derived from those activities, under penalty of fine and other administrative penalties set out in the Brazilian Biodiversity Law and Federal Decree 8,772/2016.
For more information, please contact our Environmental team.
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And for any legal questions related to this pandemic, please contact the authors of this article or Mayer Brown’s COVID-19 Core Response Team at FW-SIG-COVID-19-Core-Response-Team@mayerbrown.com.