Conceptualising Multilevel Regulation in the EU: A Legal Translation of Multilevel Governance?

TLDR

Regulation in the European context requires a new conceptual framework. The paper develops multilevel regulation as a theoretical concept and evaluates whether it is a legal translation of multilevel governance. The authors frame multilevel governance within regulatory spaces and conduct an exploratory study of the regulatory space of marketing authorisation of medical devices. The study shows that regulatory processes are no longer solely in the hands of a single governmental actor, underscoring the need to consider interventions beyond the state to address regulatory effectiveness issues.

Abstract

Abstract How should we conceive of regulation in the European context? This paper attempts to answer this by developing multilevel regulation as a theoretical concept. The basic aim of the paper is to explore the difference and convergence between regulation and governance and develop multilevel governance and multilevel regulation as two individual heuristic concepts. We suggest that it is useful to frame multilevel governance in the context of regulatory spaces. As an example, we undertake an exploratory investigation of multilevelness of the regulatory space of marketing authorisation of medical devices. This allows us to help focus on certain aspects of the regulatory process by acknowledging that it is no longer located in the hand of a single (governmental) actor and highlighting the necessity of considering interventions beyond the state in addressing regulatory effectiveness problems that may crop up in this context. Ultimately, we assess whether multilevel regulation is a legal translation of the concept of multilevel governance.