Atualizado: 12 de Dez de 2019
In more than 28 years working with health and food companies I have being insisting to say our legal system works.
As matter of fact, most of the time my clients -specially the foreigns - they don't trust the Brazilian food and drug law systemand they feel very much frustrated by it. They usually say that our system "is not fair and transparent and it is far to be accessible".
I frequently answer, if you are unsatisfied now you have no idea how it was before the creation of our Agency, Anvisa.
In my opinion, if problems arises frequently in you regulatory affairs strategies most of them comes from the lack of understanding of how the food and drug law system works in Brazil. Yes, to approve a product in Brazilcould be considered for many companies as time-consuming and a expensive process.However, it does not mean that the regulatory system in Brazil is not working.
My perception is, there is a lack of understandingof the system by several players involved, specially the companies.There are plenty of tools in our legal system that allow the company force the regulators to observe the time and rules fixed. These tools could help you to speed up your process approval.
Firstly, the time to approve a productis clear in the law as well as the consequences if it is not observed by the regulators. Besides, we have a very modern constitution (the same that is now enforcing the protection of the Brazilian people against corruptors) that enforces the regulators observe strictly what the law says. One of them, is the principle of transparence as well as the risk control. But we have much more than these principles, we also have the "legal principle" (that every administrative act must come from the law) as well as several "administrative principles" that impose to the regulators bad consequences if the law is not observed by them.
It is so true that, today a judge(president of the federal Court in Brasilia) issued an injunctionagainst the president of Anvisa to accomplish with the regulation otherwise he can thread to go to the jail (in the case of Global Gestão em Saúde x Anvisa - TRF 1a Região). It proves that the companies need to know what are their rights. In the other words, they need to have a broadly understanding of how the Brazilian food and drug law system works, and not only how to deal with Anvisa.
As a prestigious Brazilian federal judge said once (during the first Forum of the Creation of Anvisa organized by Abpvs), it is not enough to dressan office as an agency, but rather to had builded the body and soul of a regulatory agency that is made by the Brazilian legal system. And who can put it in practice are all users of the regulatory service exercising their rights.