The tools of globalization: ways of regulating and the structure of the international regime for pharmaceuticals

Abstract

ABSTRACTThis article investigates the relationship between regulatory globalization and neoliberal standard-setting arrangements building on industry capacities and responsibilities. Focusing on international pharmacovigilance, it recounts the history of the World Health Organization programme for the international drug monitoring, to shed light and explain the concomitant rise of the International Conference on Harmonization and of its standards. It shows that the neoliberalization of a regime or installation of a regulatory standard-setting arrangement responsibilizing the industry is inseparable from the emergence of an altogether different way of regulating pharmaceuticals (including a different definition of the problem of pharmaceuticals safety, of the organizations in charge of this problem and of the kinds of expertise and information used to make decisions about it). This happens incrementally, through gradual changes and hybridization of the existing regime, much more than all-out replacement of the regime. The rise of a market-oriented regulatory arrangement can therefore not be reduced to the influence of a neoliberal scheme, but is on the contrary linked to the ways in which a tool gains legitimacy as a way of tackling a global issue.