Incorporation and use of medicines in the Brazilian Unified National Health System: changes and risks of new Ministry of Health legislation

Abstract

In the last 15 years, Brazil has experienced a progressive institutionalization of health technology assessment (HTA), especially within the public system. The Brazilian National Policy on Health Technology Management assigns to the HTA the role of generating scientific evidence to support decisionmaking entities regarding the incorporation and monitoring of the use of technologies in the health system, in addition to guiding health professionals and users 1 .However, the process of using HTA in decisions related to health technologies within the Brazilian Unified National Health System (SUS) had a slow implementation and only became fully effective with the Department of Science, and Technology (DECIT) and the Science, Technology, Innovation and Strategic Health Supplies Secretariat (SCTIE), in 2000 and 2003, respectively. The emphasis that was once aimed at selecting the essential medicines for the SUS -as part of the National Medicines Policy agenda -gradually started losing ground in favor of HTA and incorporation. In January 2006, the Brazilian Ministry of Health created the Technology Incorporation Commission (CITEC), for technical counseling on the analysis of new technologies 2 .Another important milestone in this institutionalization process was the creation of the National Committee for Health Technologies Incorporation (CONITEC), via the publication of Law n. 12,401 of April 2011 3 .CONITEC advises the Brazilian Ministry of Health in decisions regarding the incorporation, exclusion, or alteration of medicines, products, and procedures in SUS 1 . Its creation strengthened the relationship between HTA and the development of a policy based on scientific evidence regarding the efficacy, safety, accuracy, and effectiveness of health technologies, as well as the development of economic studies aimed at the efficient application of resources and at the economic and financial impact of their introduction and use. The regulatory frameworks that guide the incorporation process defined flows, criteria, and deadlines for the evaluation and incorporation of technologies, promoting an expansion of society participation, via consultations, public hearings, surveys, dissemination of reports, and patient involvement to inform the decision process.However, the political and non-technical conduct regarding the incorporation outcomes of such policies exposes difficulties 4 . There are still problems in CONITEC analysis and judgment processes, such as heterogeneity of the reports, some of which are quite simplified and without clearly arranged justifications for the recommendations; lack of standardization of analytical methods; and non-compliance with requirements contained in the internal regulations on the type and quality of evidence This article is published in Open Access under the Creative Commons Attribution license, which allows use, distribution, and reproduction in any medium, without restrictions, as long as the original work is correctly cited.