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European Regulation of Medical Devices and Pharmaceuticals - Regulatee Expectations of Legal Certainty (Paperback, Softcover reprint of the original 1st ed. 2014)
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European Regulation of Medical Devices and Pharmaceuticals - Regulatee Expectations of Legal Certainty (Paperback, Softcover reprint of the original 1st ed. 2014)
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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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