Alignment between sanitary regulation and drug policies in Brazil
DOI:
https://doi.org/10.3395/2317-269x.00233Keywords:
National Health Surveillance Agency, Legislation, Drug, National Drug Policy, National Policy of Pharmaceutical AssistanceAbstract
Objectives: Assess the production of Anvisa´s regulations regarding medications and check your alignment to the National Drug Policy and the National Policy of Pharmaceutical Assistance. Methods: This is a descriptive study, the type of data collection, based on quantitative research method and also using elements of documentary research. We used the resolutions of Anvisa published in the period 1999-2012. These resolutions were divided into “normative” and “non-normative” and grouped into twelve themes. For the resolutions related to the theme drugs were defined categories, according to the main subject regulated. At the end, we analyzed the correlation between these resolutions and the directives established by National Drug Policy and strategic priorities of the National Policy of Pharmaceutical Assistance, characterizing the alignment between the regulatory process and public policy. Results: Were identified 2367 resolutions, whereas 43% are “normative”. The remaining (57%) were not considered in the analysis. The main theme regulated by Anvisa was drugs (37%), followed by food (22%) and sanitizing (7%). All resolutions normative related to drugs are aligned to at least one directive of the National Drug Policy and one strategic priority of the National Policy of Pharmaceutical Assistance. Conclusions: The main conclusion of the research, which has an unpublished character, is the fact that the regulatory action of Anvisa related to drugs is aligned to the main steering instruments of Brazilian federal government in this sector. Thus, it can be stated that the Agency has contributed to the implementation of the policies studied, providing important subsidies for the maintenance of safety, efficacy and quality of medicines and pharmaceutical services available to the population.Downloads
Downloads
Published
Issue
Section
License
Copyright (c) 2015 Health Surveillance under Debate: Society, Science & Technology (Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnología) – “Visa em Debate”
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
