A bill reported by Brazilian Congressman Hiran Gonçalves (PP-RR) establishes, among other provisions, a period of 72 hours for the National Agency of Health Surveillance – ANVISA (the Brazilian FDA) to authorize the immediate importation and distribution of materials, medicines, equipment, and inputs related to health care that had already been both registered by foreign health authorities[1] and authorized for internal distribution abroad (PL 864/2020, which amends Law no. 13,979/2020).
It should be emphasized that Law no. 13,979/2020 (responsible for setting forth on measures to address the public health emergency resulting from COVID-19), pursuant to Section 3, VIII, items “a” and “b”, and paragraph 5, II, affords the Ministry of Health the power to grant “exceptional and temporary authorization to import products subject to health surveillance without ANVISA’s approval, provided that they are: a) registered by a foreign health authority; and b) foreseen by a Ministry of Health act”.
Therefore, aiming at expediting and affording legal security to this procedure, it is proposed through PL 864/2020 that Section 3, VIII should not be restricted just to importation, but it should also cover the distribution of these products in Brazil, as well as that the generic term “products” should be replaced by “any materials, medicines, equipment, and inputs related to health care”, affording the legal text greater clarity and accuracy. Furthermore, PL 864/2020 establishes as a condition for the importation of such products/materials that the referred foreign health agencies have not only released them for exportation but also approved them for internal distribution (that is, those products have been released for their citizens).
Finally, the bill determines that, in place of the Ministry of Health, ANVISA will be responsible for granting such exceptional and temporary authorization for the importation and distribution of the aforementioned products, in a 72 (seventy-two) hours term counted from the submission of each request to the agency.
Considering that ANVISA normally takes about 120 to 365 days to grant marketing approvals (depending on the type of input/medicine/device), if passed, PL 864/2020 could be an important measure in the midst of the current efforts to tackle COVID-19, allowing rapid access of the population to a series of medications, tests, examinations, respiratory devices and other products and equipment designed to combat the virus.
It is important to highlight that, along with this draft law, many other measures are being taken by the national authorities to reduce the harmful effects of the pandemic throughout the country. ANVISA itself, for example, which is part of the Emergency Operations Center (EOC) in the fight against COVID-19, established by the Ministry of Health, has been performing an extremely important role within this context, promoting various measures to expand the options for prevention and treatment of the disease, in addition to avoiding shortages of products.[2]
[1] By foreign health authority, it should be considered at least one of the following: 1) Food and Drug Administration (FDA – USA), 2) European Medicines Agency (EMA – EU), 3) Pharmaceuticals and Medical Devices Agency (PMDA – Japan) or 4) National Medical Products Administration (NMPA – China).
[2] Ref.: portal.anvisa.gov.br/coronavirus . < accessed on April 02, 2020 >
Article published on Lexology.