Paper short abstract:

Since recently, clinical trials of cancer immunotherapy drugs are conducted in Cuba at the level of primary healthcare. We analyze the role of primary healthcare actors in the innovation process, with the attempt to show how it is linked to both public health policies and export strategy.

Paper long abstract:

The State-owned Cuban biopharmaceutical industry is experimenting cancer immunotherapy drugs in clinical trials for about 20 years. Yet this industry is facing difficulties to meet the global regulations for exporting its medicines, mainly due to the economic hardships in the island. Thus, some Cuban biotechnology centers have deployed a "double strategy" of clinical trials, one following global regulations thanks to foreign investments, while the other is adapted to the Cuban public health context. The latter aims to demonstrate the effect of cancer immunotherapy on the "real population of patients" in terms of transforming advanced cancer into "chronic diseases". This public health approach of clinical trials is based on the integration of primary healthcare centers as clinical sites, in which family doctors and nurses are trained in clinical research and oncology. Building on an ethnography of the trajectory of cancer immunotherapy in Cuba, we will argue that translational research is embedded in the public health system and its underlying ideology. The current development of these drugs relies on evidence-based research implying family healthcare professionals. Specific challenges are posed regarding the articulation of various levels of knowledge production - i.e. biotechnology centers, monitoring institutions, hospital oncology services, and primary healthcare institutions. Other stakes are related to the Cuban drugs agency policies affecting these practices. This paper will contribute to the analysis of social, economic, geopolitical, and ideological dimensions of pharmaceutical innovation, and shed light on the role of new actors - i.e. primary healthcare professionals - in this process.