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Law allows states to buy vaccine without regulatory approval

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Vincent

The Brazilian legislation for combat against the pandemic provides the possibility of a certain vaccine to be purchased and distributed without the need of prior authorization by the National Health Surveillance Agency (Anvisa). Such provision would allow states and municipalities to organize immunization programs regardless of potential actions against them by the federal government.

Article 3rd of Law 13,979, passed last February, authorizes in exceptional conditions, and temporarily, "the importation and distribution of any materials, medicines, equipment and inputs for health subject to health surveillance without Anvisa registration when considered essential to aid in the combat against the pandemic."

The only mentioned requirement is that the items be registered in at least one of the four international agencies listed in the text: the US Food and Drug Administration, the European Medicines Agency, the Pharmaceuticals and Medical Devices Agency of Japan and the National Medical Products Administration of China.

This provision was used by local governments, for example, to import and distribute ventilators and tests for covid-19 during the pandemic. The same article clears authorities to take other measures, including mandatory vaccination, object of controversy.

Yet the provision is valid only while there is a state of public calamity, established by a decree that for now expires on December 31. There are moves in Brasília for extending the decree, but at the moment the chances of that occurring are considered low.

Governors are quite worried about the possibility of President Jair Bolsonaro using his...

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