Damaris Silveira
University of Brasilia, Brazil
Title: Sharing regulatory data as tools for strengthening health systems in the region of the Americas
Biography
Biography: Damaris Silveira
Abstract
Backgrounds: Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the building process of an open government is still fragile and fragmented on Health Regulatory Agencies (HRA) even on Regional Reference Authorities (RRA). Purpose: This paper assesses the transparency status of RRA, focusing on some medicine life-cycle documents (Medicine Dossier, Clinical Trial Report, and Inspection report), as tools for strengthening health systems. Methods: Through a qualitative and descriptive evaluation of regulatory transparency on RRA, it was portrayed in two different branches: information public disclosure and inter-agency data and work sharing. Results: The risk benefits of information public disclosure were assessed considering the involvement and roles of multi-stakeholders (healthcare professionals, regulators, industry, community, and academics) bearing in mind the protection of commercially and personally confidential data. Inter-agency data and work sharing were inserted in the context of harmonization and co-operation projects that focus on regulatory convergence. Conclusions: Technical and practical engagements are proposed to improve and strengthen health systems in the region of the Americas through establishment of an openness directive over pharmaceutical regulatory environment. To successfully address these challenges is crucial that regional leadershipssteer and support collaborative regional alliances toward the development and establishment of a trustful regulatory environment as well as a sustainable public health system in the Latin America and the Caribbean, using as reference international successful initiatives besides taking into account domestic characteristics and experiences of each single country.