Putting Pharmaceutical Regulation to the Test: From Historical Description to a Social Science for Public Health

Abstract

This book examines how innovative pharmaceuticals have been regulated in the US and the European Union (EU) since 1980 — a period which we refer to as the ‘neo-liberal era’. Regarding the EU, our principal focus is on the period since 1995 because that is when a supranational EU regulatory agency and system became fully established with specific responsibilities for regulating innovative pharmaceuticals. Like many other writers, we refer to the post-1980 era in the US and western Europe as ‘neo-liberal’ because it was, and remains, a period in which the political project of minimizing state intervention, subjecting the state to competitive tests of ‘the market’, and elevating individual consumer choice above the state as a form of collective decision-making, all came to the fore. This has involved the ‘liberalization’ of markets, that is, relaxation of government regulations and controls believed to hamper business activity and the socio-economic signals of consumer demand (Fisher 2009).