Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
DOI:
https://doi.org/10.22239/2317-269X.01075Keywords:
Advanced Therapies, Stem Cells, Regulation, Marketing Authorization, ConstitutionAbstract
In view of the provisions of the Constitution of 1988, of the Federative Republic of Brazil, article 199, paragraph 4, which prohibits any form of marketing of organs, tissues and human substances for transplants, research and treatment, the possibility of commercialization and marketing authorization of human origin products in Brazil has been questioned. With the advent of advanced therapies, legal uncertainty on the subject has reached regulatory issues and permeated scientific and investments concerns over the sector. Such perception based the detailed analysis on the matter by Anvisa´s Federal Attorney’s Office, which was expressed on the Legal Opinion n. 12/2016/PF-Anvisa/PGF/AGU and exposed in this article. Outline, in this article, the main aspects concerning the legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil, based on the Legal Opinion n° 12/2016/PF-Anvisa/PGF/AGU. Assessment of the Legal Opinion content and extraction from the document of its main issues. The document concluded for the possibility of a marketing authorization of the advanced therapy medicinal products, considering the principle of human dignity and fundamental rights to life and health, and conditioned it to the elaboration of a strict
regulatory framework.
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