A avaliação da transparência ativa do processo regulatório de medicamentos na ANVISA

Resumo

Purpose – Evaluate whether through active transparency and confrontation with other agencies, Anvisa provides the citizen with information on the regulatory process of medicines, visibly and allowing your deductible. Design/Methodology – It consists of the application of an instrument for assessing active transparency on the Anvisa website, and comparing Anvisa’s active transparency with three other equivalent regulatory agencies in the Americas on the basis of three conditions: compliance with the law on access to information, usability and navigability of the website, and the availability of information in accordance with the principles of transparency and open data. Findings – Anvisa's general active transparency index ranked third in comparison with the other agencies, 61 points on a scale ranging from 0 to 100 points. Public Opinion on Drug Evaluation (PPAM Anvisa) has similar information to other agencies, but features opportunities for its improvement. Research limitations – Future studies can be conducted in order to improve the proposed assessment instrument and extrapolate its use in other types of regulatory processes. Practical implications – This study offers a methodological proposal for the evaluation of active transparency, considering the dimensions of visibility and inferability for transparency. Social implications – In conjunction with the other instruments for improving the regulatory quality of the agency, the study offers a tool for assessing active transparency, permitting users access and understanding of the Agency's regulatory process. Originality – This is the first study that proposes a methodology to assess the active transparency of the regulatory process for medicines within the scope of Anvisa.

Ficha do documento

Tipo

Dissertação

Ano

2020

Instituição

Fundação Getulio Vargas

Fonte

Repositório da FGV

Idioma

Português

Acesso

Não informado

Identificador

oai:repositorio.fgv.br:10438/29885

Temas

Administração PúblicaGovernança

Palavras-chave

Administração públicaDireito à informaçãoAgências reguladoras de atividades privadasVigilância SanitáriaAgência Nacional de Vigilância Sanitária (Brasil)Agência reguladoraPolíticas de acesso à informaçãoTransparência ativaTransparência na regulação sanitáriaAvaliação da transparência ativaPublic administrationRegulatory agencyPolicies for access to informationActive transparencyTransparency in health regulationAssessment of active transparencyTransparência na administração pública