Socio-historical understanding of the institutionalization of rare diseases—analysis of Spanish policies in the European context

Abstract

The analysis of scientific policies on rare diseases provides insights into the evolving dynamics in health systems. This study aims to understand the growing importance of societal influence in the development of policy standards, particularly those related to rare diseases. Adopting a socio-historical approach, the research will examine the various processes of institutionalization in rare disease research. The objective is to gain an in-depth understanding of the institutionalization of rare diseases as a socio-biomedical phenomenon. From this perspective, this study will analyze the main actors involved in this process, along with paradigmatic regulatory examples in Europe and Spain. The research will take an interdisciplinary approach, addressing the social, historical and biomedical aspects as a whole, with a focus on key stakeholders. Identifying these stakeholders is of paramount importance to understanding how the health system is currently being transformed by associationism and the influence of these organizations on political forces.