A instituição regulatória setorial e os arranjos contratuais em alianças para pesquisa clínica de medicamentos experimentais no Brasil

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Sanches, Ji Yoon Lee
Bataglia, Walter
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Zilber, Moisés Ari
Zylbersztajn, Decio
Administração de Empresas
In the pharmaceutical industry, investments in R&D on new drugs are determinant of competitiveness and it is going through a continuous process of research internationalization, especially over emerging countries. Due to cost strategy, know-how and efficiency reasons, pharmaceutical companies have set alliances with CRO`s - Clinical Research Organizations, which are companies specializing in clinical trials management (study of new drugs conducted in humans) in an outsourcing movement, to perform management activities and monitoring of trials. In this context, Brazil, on one hand, is growing in the segment of clinical trials in virtue of its many attractive factors for the development of research such as population quantity and heterogeneity, market size and quality in research. On the other hand, particularities of the Brazilian sectoral regulation to clinical trials define it as an ineffective and lengthy system, discouraging investments. Given this situation, this study aimed to investigate the relationship between sectoral regulation and contractual arrangements in such alliances among industries and CRO’s, that is, verify how contractually agents behave in these alliances considering the format of sectoral regulation. Therefore, the study adopted an exploratory qualitative methodology, given the lack of previous similar studies for this industry, under the strategy of multiple case study. Two pharmaceutical companies and two CRO’s have been studied as well as heard the perception of other actors from the segment, such as associative entities and government ethical approval body. Data were collected by semi structured interviews and public documents as available legislation. Thematic categorical analysis was used by categories defined a priori, and then a cross-analysis of the data was applied. The results show the relationship between the characteristics of the sectoral regulation and the design of contractual arrangements, inducing to reflection that the inefficiency of the regulatory system requires the adoption of compensatory mechanisms to the institutional failures in transactions. They revealed in that sense the inadequacy of the institutional system in guarantee of transactions, leading to the need for expansion of the theory from the perspective of New Institutional Economics and Transaction Costs Economics. A bureaucratic, inefficient, lengthy and unstable regulation compounds the uncertainty of the transactions and stimulates the adoption of contractual and extra contractual coordination mechanisms between the parties. Understanding how contracts can be arranged and coordinated in accordance to the institutional environment characteristics is important as it influences the different decisions, actions and result for organizations, justifying hence its relevance for the strategic study.
sistema institucional , regulação setorial , aliança estratégica , contratos , arranjos contratuais , mecanismos contratuais de coordenação , mecanismos complementares de coordenação
SANCHES , Ji Yoon Lee. A instituição regulatória setorial e os arranjos contratuais em alianças para pesquisa clínica de medicamentos experimentais no Brasil. 2016. 128 f. Dissertação (Administração de Empresas) - Universidade Presbiteriana Mackenzie, São Paulo.