Institutional change and political decision- making in the creation of the Brazilian National Health Surveillance Agency Mudança institucional e processo de decisão política: a criação da Agência Nacional de Vigilância Sanitária

This article examines the decision-making process that led to the creation of the Brazilian National Health Surveillance Agency (ANVISA) in 1999. The authors begin by discussing the history of the Agency’s predecessor, the Health Surveillance Secretariat, and the need for its modernization to adjust the quality of the products under its control to domestic and international demands. From the theoretical perspective of neo-institutionalism, the article goes on to analyze the social and political context surrounding the debate on the proposed alternatives to adjust Health Surveillance to new rules in line with such requirements, focusing especially on the formulation of the new policy, the decisionmaking arena, and the actors with specific interests in the sector. The research drew on extensive documentary and media material, plus interviews with key actors. The article concludes that a determinant factor for the creation of ANVISA was the favorable domestic political context, fostering a positive correlation of forces that (in an extremely short timeframe, 1998-1999) allowed the creation of the first regulatory agency in the social policies area in Brazil. Health Surveillance; National Health Surveillance Agency; Public Policies Introduction The aim of this article is to analyze the political/ institutional context that gave rise to the Brazilian National Health Surveillance Agency (Agência Nacional de Vigiância Sanitária – ANVISA) in the 1990s, especially 1998 and 1999, when the final decisions were made and the respective legislation was enacted. A brief history of the Federal level of Health Surveillance in Brazil shows that it was inevitably characterized by technical and political gaps and impediments, which constrained its action over time and refueled the claims of its purported inoperability. Blatant problems resulted from its inaction at many stages in this historical process, reverberating in the mass media and causing public outcry, with no responses that might have tended to set rules for the power game, i.e., policy institutionalization and a corresponding search for solutions. Against this backdrop, the point of departure for our research was the following question: what were the factors or events that influenced the decision to solve such a longstanding problem, in the form of a public policy drafted and approved in such an usually short timeframe? The analysis focuses on the creation of ANVISA 1, based on a neo-institutionalist approach, emphasizing the way by which a given institutional configuration shapes the interactions between stakeholders and influences the ARTIGO ARTICLE Piovesan MF, Labra ME 1374 Cad. Saúde Pública, Rio de Janeiro, 23(6):1373-1382, jun, 2007 public policy results. By shaping the stakeholders’ strategies and goals, mediating their relations of conflict and cooperation, and leading the decision-making processes along given pathways, the institutional rules provide the structure for political situations, allowing choices or inducing constraints at different moments in the decisionmaking process. By focusing on institutions as both a product and conditioning factor for political conflicts and choices, while constraining and shaping the stakeholders’ strategies and behaviors, it is possible to understand the central issues in political life: choice and constraint 2,3,4. Social actors involved in the political power struggle create institutions, and understanding them requires analyzing the incentives, opportunities, and constraints that emerge for the various actors in this dispute 2,3. The historical analysis of these processes is one of the central points in the neo-institutionalist approach, whose hard core is found in institutions with standardized relations, in which interactions between rules, stakeholders, interests, strategies, and power are identified and integrated in a given context, allowing to capture the complexity of real political situations 4,5,6. Drawing on primary sources, we sought to specifically unveil the interactions of conflict and cooperation between the actors, their strategies for influencing decisions, and the rules of the game conditioning the alternatives for action by the Executive and Legislative Branches. We have divided our presentation into three parts: (1) a brief background on Health Surveillance at the Federal level in Brazil from the 19th century to 1999; (2) aspects pertaining to the former Health Surveillance Secretariat from 1990 to 1998; and (3) the political decision to create ANVISA in the 1998-1999 political context. We conclude with key observations on how this institution was created and its enormous relevance for the protection of the Brazilian population’s