One of the primary functions of law is to ensure that the legal
structure governing all social relations is predictable, coherent,
consistent and applicable. Taken together, these characteristics of
law are referred to as legal certainty. In traditional approaches
to legal certainty, law is regarded as a hierarchical system of
rules characterized 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 at both 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 the author uses multilevel regulation as a term
to characterize a regulatory space in which the process of rule
making, rule enforcement and rule adjudication (the regulatory
lifecycle) is dispersed across more than one administrative or
territorial level and amongst several different actors, both public
and private. The author draws 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 non-hierarchical and they may be independent of each
other. The lack of central ordering of the regulatory lifecycle
within this regulatory space is the most important feature of such
a space. The implications of multilevel regulation for the notion
of legal certainty have attracted limited attention from scholars
and the demand for legal certainty in regulatory practice is still
a puzzle. The book explores the idea of legal certainty in terms of
the perceptions and expectations of regulatees in the context of
medical products - specifically, pharmaceuticals and medical
devices, which can be differentiated as two regulatory spaces and
therefore form two case studies. As an exploratory project, the
book necessarily explores new territory in terms of investigating
legal certainty first in terms of regulatee perceptions and
expectations and second, because it studies it in the context of
multilevel regulation.
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