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Physis: Revista de Saúde Coletiva
On-line version ISSN 1809-4481
LUCENA, Regina Célia Borges. New rules and old challenges in the regulation of drug advertising. Physis [online]. 2012, vol.22, n.2, pp.701-712. ISSN 1809-4481. http://dx.doi.org/10.1590/S0103-73312012000200016.
This study aimed to analyze the process of regulation of drug advertising by ANVISA (National Health Surveillance Agency) in 2008 and to identify its results on the regulatory model in this area. We analyzed the changes in 2008 with the publication of RDC No. 96/2008, based on three data sources. The first was a comparative analysis with the previous rules, the RDC No. 102/2000. Then, the changes were related to two technical papers in different scopes: the Ethical Criteria for Drug Promotion of the World Health Organization, with global reach; and the Contribution to the Debate and Proposals for Public Consultation 84/2005, nationwide , issued by ANVISA, on drug advertising in Brazil. The analysis of 11 content changes in the legal order established by RDC No. 96/2008 points to a closer relationship with the Ethical Criteria for Promotion of Medicines of the World Health Organization, but a clear separation of proposals for changing the regulatory model currently established. It was concluded that the adoption of measures amending the regulatory model in this field, the regulation of drug advertising, requires more substantial changes in the management model and the regulatory action of ANVISA, especially regarding the role of social regulation.
Keywords : drug advertizing; health surveillance; regulation.