Novas regras e velhos desafios na regulação da propaganda de medicamentos New rules and old challenges in the regulation of drug advertising

Este estudo teve como objetivo analisar o processo de regulamentação da propaganda de medicamentos pela Agência Nacional de Vigilância Sanitária (Anvisa) ocorrido em 2008 e identificar os seus resultados quanto ao modelo regulador nessa área de atuação. Foram analisadas as mudanças ocorridas em 2008, com a publicação da RDC nº 96/2008, a partir de três fontes de dados. A primeira foi a análise comparativa com a normativa anterior, a RDC nº 102/2000. Em seguida, as mudanças foram relacionadas a dois documentos técnicos, de escopos diferentes: os Critérios Éticos para a Promoção de Medicamentos da Organização Mundial de Saúde, de alcance mundial; e a Contribuição ao Debate e Proposições à Consulta Pública 84/2005, de âmbito nacional, da Anvisa, relativa à propaganda de medicamentos no Brasil. A análise de onze mudanças de conteúdo na ordenação legal estabelecida pela RDC nº 96/2008 aponta para uma maior proximidade com os Critérios Éticos para a Promoção de Medicamentos da Organização Mundial de Saúde, mas um claro distanciamento de proposições para a alteração do modelo regulador atualmente estabelecido. Concluiu-se que a adoção de medidas que alterem o modelo regulador nesse campo de atuação, o da regulação da propaganda de medicamentos, requer mudanças mais substanciais no modelo de gestão e da ação regulatória da Anvisa, especialmente quanto ao seu papel de regulação social.<br>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

Social inequalities in lawsuits for drugs

The aim of this study was to characterize the lawsuits requesting drugs considering the economic profile of their petitioners. All lawsuits (1378) accepted against Goiânia, GO from 2003 to 2007 were analyzed. Petitioners' demographic characteristics, reported diseases, requested drugs, origin of healthcare service, and lawsuit agent were described. Complainants' addresses were georeferenced and distributed into 4 regional groups classified in accordance with the population's average income. Dwellers of wealthier regions filed court actions requesting drugs more frequently, with an average rate of 1.7 lawsuits/1000 inhabitants versus 0.55/1000 in the poorer region. Lawsuit costs were 4-fold higher in wealthier regions compared with the poorest region. Chronic diseases were involved in most lawsuits, where acute and low complexity diseases predominated among complainants living in poorer regions. Thus, social differences were reflected in the granting of health rights