The Brazilian Supreme Court affirmed the constitutionality of the Biosafety Law

by | Aug 21, 2023 | Client Alert, Patent

The Brazilian Supreme Federal Court concludes today, 08/21/2023, the virtual session of the trial for Case of Direct Unconstitutionality (ADI) 3526. By a majority vote, including the recently appointed Justice Cristiano Zanin, the Court decided on the constitutionality of Law 11.105/2005, following the dissenting vote of Justice Gilmar Mendes.

The division of competencies among different entities of the federation – Union, States, Federal District, and Municipalities – to legislate on environmental matters was extensively discussed, addressing the principle of predominance of interest and recognizing its fundamental role in the jurisprudence of the court. It was acknowledged that “safety standards and monitoring mechanisms for activities related to genetically modified organisms require consistent treatment throughout the national territory. In other words, there is an unequivocal predominance of the Union’s interest.”

Regarding the merits, the understanding that the National Biosafety Technical Commission (CTNBio) is the competent authority to analyze and define criteria and requirements for environmental impact studies, in perfect alignment with the provisions of Article 225 of the Federal Constitution, was validated.

The Brazilian Supreme Court upheld the entire regulatory framework that supported research, development, and commercialization of essential products for food security (such as soybean and corn seeds), as well as for health – in the case of gene therapies and vaccines that utilize recombinant RNA technology.


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