Pursuing legal certainty in multilevel regulation : a sociolegal study of medical device and pharmaceutical regulation in Europe

Abstract

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. All these characteristics of law taken together are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchic system of rules characterised by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created both at the international and regional level are directly applicable to national legal systems. Also norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project I use multilevel regulation as a term to characterise a regulatory space in which the process of rule making, rule enforcement and rule adjudication (regulatory life cycle) is dispersed across more than one administrative or territorial level amongst several different actors, both public and private. I draw on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is nonhierarchical. Lack of central ordering of the regulatory life cycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for legal certainty have attracted limited attention from scholars. The demand for legal certainty in regulatory practice is still a puzzle. I explore the idea of legal certainty in terms of perception and expectations of regulatees in the context of medical products. By medical products I mean pharmaceuticals and medical devices which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, this thesis is necessarily stepping into new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies this in the context of multilevel regulation.