The End of Public Health Emergency of National Concern in Brazil
On April 22, 2022, the Brazilian Health Ministry edited Ordinance GM/MS No. 913 (“Ordinance”), establishing the end of Public Health Emergency of National Concern (“Espin”), that had been decreed on February 3, 2020, by means of Ordinance No. 188, due to the new Coronavirus pandemic(2019-nCoV).
As a result of the end of Espin, more than 2,000 regulatory standards that had been established on a temporary and exceptional basis and due to Espin will now depend on the issuance of new regulations by competent governmental bodies and agencies, which may revoke the standards or give them a definitive character, such as, among others, (a) the authorization to perform rapid tests for COVID-19 in drugstores (Anvisa Resolution No 377/2020); (b) the authorization and expansion of telemedicine during Espin (Law No. 13,989/2020); (c) the exemption of bidding for the acquisition of goods that are essential to confront the pandemic of COVID-19 by public bodies (Law No. 14,217/2021).
In addition, some other standards, which do not expressly refer to Espin but were issued as a result of the pandemic caused by COVID-19, such as the sale of COVID-19 self-tests in drugstores (Anvisa Resolution No. 595/2022) and the authorization of remote nutritional and physiotherapeutic appointments (Resolution CFN No. 684/2021 and Resolution COFFITO No. 516/2020), may also be reviewed influenced by the end of the national emergency situation, as the pandemic rates of contamination and hospitalization falls.
In order to avoid disruptions in healthcare programs and innovation resulting from the pandemic, the Ordinance established a period of 30 days to adapt any standards and specified that the Ministry of Health shall offer guidance to the federative States regarding the continuity of the National Contingency Plan for Human Infection by the new Coronavirus. In line with these measures, the Ministry of Health reported at a press conference on April 17, 2022 that it has already requested Anvisa to maintain applicable rules to the emergency use of supplies needed to fight COVID-19, priority in the analysis of registration of health supplies and to performance of rapid tests in drugstores.