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Brazil makes vaccine acquisition rules flexible

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Brazil’s President Jair Bolsonaro has enacted a provisional presidential decree making flexible the rules for the acquisition of supplies and vaccines—including those still in their development phase and before registration or emergency use authorization from the national sanitary regulator Anvisa. The government’s goal is to speed up the process of vaccine acquisition.

Rules are effective immediately, but they must be subsequently approved by Congress.

The text defines the National Operationalization Plan for the Vaccine Against COVID-19 as “a strategic tool” for the vaccination of the entire population, also mandating that health agents explain to patients or their legal representatives that the product has no definitive registration with Anvisa, as well as its risks and benefits.

Both public and health establishments will have to register the data on the use of vaccines against COVID-19 on a daily basis and individually, including side effects, onto a database to be made available by the Health Ministry, as stipulated by the presidential decree.

Under the decree, Anvisa may grant exceptional and temporary authorization to import and distribute any vaccine against COVID-19—as well materials, medication, equipment, and supplies in the medical field, subject to sanitary rules—with no registration with Anvisa, provided these products are registered at least at one foreign sanitary agency and have their distribution authorized in their country.

Foreign agencies selected by Anvisa include Food and Drug Administration – FDA (US); European Medicines Agency – EMA (European Union); Pharmaceuticals and Medical Devices Agency – PMDA (Japan); National Medical Products Administration – NMPA (China), and Medicines and Healthcare Products Regulatory Agency – MHRA (UK).

No vaccine has been registered by Anvisa. Vaccine producers and their partners in Brazil have met with the authority and discussed the documents required for filing a request for the emergency use of a vaccine.

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