Regulatory justifications: regulating European medicines to maximise market potential

Abstract

ABSTRACTThe justification for regulating is generally considered to rely on benefitting interested groups. Whereas the traditional view is that regulators act as impartial arbiters balancing competing public and private interests, modern accounts consider regulation to be dominated by single interests, such as those of industry. This article challenges these theories by arguing that regulators are substantively (not just procedurally) motivated to justify their actions according to the goals set for them by the bodies that empower them. In consequence, regulators understand their goals as market-based objectives, prompting them to focus on maximising market potential. This is demonstrated in the context of regulating medicines in Europe, through the European Patent Organisation, the CJEU, and the European Medicines Agency. The analysis identifies that regulating to achieve market benefits is a better predictor of regulatory behaviour, but this behaviour frustrates goal-achievement (relating to effective and affordable medicines) and only incidentally enables benefits to accrue to specific groups.