Structural Trends and State Capacities in Regenerative Medicine in Brazil: Science, Innovation, Regulation, Governance and Social Inclusion

Abstract

Regenerative medicine has transformed conventional practises in medicine. It focuses on the repair and regeneration of cells, tissue, and genes. Regenerative medicine has led to new forms of regulation of biological inputs and required the upgrading of some state capacities at the public, private, national and supranational levels, as well as the inclusion of new social sectors in the governance of the area. However, there are still many matters of concern on diminishing risks and uncertainties that have not been completely resolved either globally or nationally. The aims of the present study are to analyse the specific manner in which innovation and regulation in regenerative medicine have developed in Brazil; which state capacities are facilitated or hindered and how different social groups participate in the sector. At the methodological level, the research consists of a bibliographical and documentary study that mainly uses secondary data to develop a qualitative analysis of information and a quantitative analysis of statistics. In addition, interviews were conducted with associated social actors, including representatives from patient organisations, on which content analysis of narratives was performed. Public policies present lacunae in the regulation of clinical trials, the inclusion of private capital, and the promotion of local patents, as well as a lack of coordination between public agencies. A set of state dynamic capacities have been developed gradually in Brazil over the last ten years, but mission-oriented public policy has been almost inexistent, state aims are unfocused, and the legitimation of state action is still under development.