Regulação da medicina nuclear no Brasil – O setor de radiofármacos

Partner Henrique Rocha and associate Luiza Brumati wrote an article to Revista de Direito Público da Economia, called “Regulation of Nuclear Medicine in Brazil – The Radiopharmaceutical Mark”. The regulation of radiopharmaceuticals has significant particularities in relation to the regulation of other drugs, particularly due to its radioactive element. This article seeks to analyze the main aspects of radiopharmaceutical regulation in Brazil, including the end of the Union's monopoly in its production, the possibility for private participation, the main institutional actors in the sector and the role each of them plays. The year 2021 and the beginning of 2022 were especially important in the sector, being marked by the publication of essential instruments and norms for its development, among which are the Constitutional Amendment 118; and the Law 14.222/2021, which creates the National Security Authority Nuclear (“ANSN”). It is concluded that the current regulatory framework allows, based on its regulamention, to induce the development of the radiopharmaceutical market to expand the population's access to the benefits of nuclear medicine, without neglecting the necessary safety in the radiopharmaceutical production chain.