Health regulation and technological development: Innovative strategies for accessing medicines in the SUS

Abstract

Regulatory science involves articulating knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. The interfaces between systemic and sectoral health and technological development policies were studied ba-sed on documentary analysis, especially from the National Pharmaceutical Policy (PNAF), with impacts on health regulation and stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the na-tionalized production of ARV “Efavirenz”, which was the subject of a compulsory license in 2007, and the establishment of Partnerships for Produc-tive Development (PDP), contributed to defining innovative regulatory frameworks and practices, emphasizing the Regulatory Technical Committe-es (CTR) for monitoring the internalization of te-chnologies and health registration of the resulting products. The permeation capacity of the princi-ples and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies on expanding access to medicines in the SUS with impacts on regulations were identified.