Piovesan Márcia Franke, Labra Maria Eliana
Agência Nacional de Saúde Suplementar, Ministério da Saúde, Av. Augusto Severo 84, Rio de Janeiro, RJ 20021-040, Brazil.
Cad Saude Publica. 2007 Jun;23(6):1373-82. doi: 10.1590/s0102-311x2007000600012.
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 decision-making 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.
本文探讨了1999年促成巴西国家卫生监督局（ANVISA）成立的决策过程。作者首先论述了该局前身——卫生监督秘书处的历史，以及对其进行现代化改造的必要性，以便使其监管产品的质量符合国内外需求。从新制度主义的理论视角出发，本文接着分析了围绕调整卫生监督以符合此类要求的新规则的提议替代方案展开辩论的社会和政治背景，尤其着重于新政策的制定、决策领域以及该部门中具有特定利益的行为主体。该研究借鉴了大量的文献和媒体资料，还采访了关键行为主体。文章得出结论，ANVISA成立的一个决定性因素是有利的国内政治环境，这种环境促成了各种力量的积极关联，从而（在极短的时间内，即1998 - 1999年）使得巴西首个社会政策领域的监管机构得以成立。
