A regulação do setor farmacêutico no âmbito da administração pública: uma análise da produção normativa da CMED

Abstract

Over the course of two decades, many normative acts were published by CMED with the aim of fulfilling the main task established in Law No. 10,742/03, which established the Chamber, which deals with the definition of regulatory standards to be applied to the pharmaceutical sector and the promotion of assistance. pharmaceutical sector to the population through mechanisms that stimulate the supply of medicines and competition in the sector. Thus, given the long period of validity of the legal diploma and CMED's unprecedented initiative in promoting the review of Resolution No. 2/2004, this being the most significant normative act produced by the Chamber for approving the criteria for defining maximum prices allowed for the commercialization of new medicines and new presentations in our country, academic interest in the normative production of CMED was awakened. Thus, with the aim of contributing to the production of scientific knowledge in the field of regulation and normative production within the scope of public administration, especially that produced by CMED, this empirical research sought to understand and answer the following research question: considering the published Resolutions by the Council of Ministers of the Medicines Market Regulation Chamber, what were the most representative changes in their respective contents in relation to the Resolutions prior to Law No. 10,742/03 establishing CMED? As theoretical bases for the investigation, the teachings of the author Zenon Bankowski were used, therefore, through theory and understanding the relationship between the morality of duty and the morality of aspiration, it was possible to better understand the regulatory process and normative production of the Chamber of Medicines Regulation (CMED) linked to ANVISA. Furthermore, empirical research based on the rules of inference developed by Lee Epstein and Gary King was used methodologically. Finally, it was concluded that CMED has an important social function in promoting greater access for the population to medicines and that the rules contained in Law No. 10,742/03, observed by the body, are, in fact, necessary to prevent errors of regulation that occurred in the past are not repeated again. Furthermore, it was found that CMED does in fact have a large normative production compared to previous legislation from the Chamber of Medicines (CAMED), information, empirical data absent in the texts researched relating to the pharmaceutical sector.