1/2/2020
The Brazilian health surveillance agency Anvisa on December 2 published a notice (notice No. 16/2019) calling the public to give suggestions on how to improve and make Anvisa’s rules simpler and less bureaucratic.
The time for suggestions is 90 days and will end on February 29, 2020.
Until then, taxpayers are allowed to make suggestions on how to simplify rules and even suggestions to extinguish certain rules.
An event to launch this public consultation was hosted by Anvisa on November 25 and aimed to stimulate discussions on the subject. Roundtable discussions took place with the participation of Anvisa’s director Antônio Barra, who stressed the importance of Anvisa’s actions in simplifying sanitary rules in a business environment involving 22.7% of Brazil’s GDP.
Director Antônio Barra mentioned as an example a study conducted by Anvisa to check to what extent a revision to the rule requiring reporting of economic information on health products upon the application to renew registration reduced the company’s administrative costs. The study showed a reduction of administrative costs from BRL 1.2 million to BRL 450 thousand.
The head of the office for ports, airports, borders and bonded areas (local acronym GGPAF), Marcus Aurélio Miranda, also on the roundtable, informed that revision of rules imposing requirements for product importation has also reduced import costs by 76.15%, which means a total reduction of BRL 2.8 billion.
According to the data published by Anvisa, since its creation in 1999 until November 2019, Anvisa has published over 1,700 normative rulings imposing rules and obligations on companies and the society, 900 of which are still in force.
Anvisa now seeks to improve its rules by giving the regulated industry opportunity to speak. The purpose here is to devise strategies that make rules clearer and map information which may help such simplification process, including by eliminating redundant rules and revising rules which are over a decade old.
Simplifying Brazil’s sanitary regulation may help reduce administrative costs that increase company’s overall costs in complying with sanitary obligations. Nonetheless, director Antônio Barra explains that simplifying rules – and reducing regulatory obligations – does not mean underestimating regulation.
Discussions on the importance of a simplification culture for regulation, taking into account the reality of digital transformation, will improve social welfare and the business environment, with the ultimate aim of promoting foreign trade growth.
