Experiencia de importacao de equipamentos para pesquisa no ELSA-Brasil

Abstract

OBJECTIVE:Policies that promote research in health were established in the last decade, developing the Brazilian scientifi c production. This development has not been accompanied by an improvement in the legal-institutional framework, thus hindering the development of research projects, including equipment importation activities. The present study aimed to analyze the equipment importation process for the Brazilian Longitudinal Study for Adult Health (ELSA-Brasil). METHODS:A case study was performed with data collected from internal ELSA-Brasil documents in fi ve Investigation Centers and their respective supporting foundations. The following importation documents were analyzed: pulse wave velocity, bioimaging and retinography. Additionally, non-structured interviews with researchers and key informers were conducted in the foundations. Data were treated and organized into three stages: administrativeoperational, exchange rate, and fi scal. Lengths of duration of these stages were calculated comparatively among centers. RESULTS:The need to standardize equipment in a multicenter study required a joint action of implementing institutions and foundations. Of all pieces of equipment analyzed, the fi rst stage was administrative-operational, with a varying duration (minimum of eight, maximum of 101, and mean of 55 days) which was longer when legal opinions were included. The second stage was the exchange rate, which was longer than the former and did not pose any obstacles to the process (minimum of 11, maximum of 381, and mean of 196 days). The third stage was fi scal, which was the longest one (minimum of 43, maximum of 388, and mean of 215.5 days), due to the release of equipment without registration into the country. There were other factors that posed obstacles: inexperience of investigation centers and institutions in networking; inadequacy of the national legislation on scientifi c research particularities; and the lack of specialized professionals in scientifi c project management. CONCLUSIONS:The results show the slowness of the equipment importation process in Brazil, especially due to legal, bureaucratic and managerial obstacles.

SECTEM: sistema baseado na web de especificação e comparação técnica de equipamentos médicos registrados na Agência Nacional de Vigilância Sanitária

“…As principais razões desta ocorrência são a complexidade das tecnologias, dificuldades das políticas hospitalares e fornecedores para promover treinamentos técnicos, pouca flexibilidade da Lei Geral de Licitações Públicas n° 8. 666/1993666/ (RAMIREZ, 2005ALMEIDA et al, 2013).…”

“…A especificação do equipamento, de forma clara e objetiva, conforme as normas da ANVISA e demais parâmetros legais, é condição inafastável para que a compra seja efetivada. Frise-se que as abordagens técnicas se estendem ao MS a fim de que este possa assegurar o empenho financeiro na conta do projeto, para assegurar o pagamento dos equipamentos (MS, 2007;ALMEIDA et al, 2013).…”