Inside regulatory bureaucracy: When Europe hits home in pharmaceuticals and chemicals
| DOI | 10.1177/0952076715616999 |
| Date | 01 January 2017 |
| Published date | 01 January 2017 |
| Author | Eva Ruffing |
| Subject Matter | Articles |
Public Policy and Administration
2017, Vol. 32(1) 3–23
Inside regulatory
! The Author(s) 2015
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DOI: 10.1177/0952076715616999
Europe hits home
ppa.sagepub.com
in pharmaceuticals
and chemicals
Eva Ruffing
University of Hannover, Germany
Abstract
Research on the impact of European integration focuses on the external relations of
national agencies. This has neglected the impact that Europeanization has on the internal
operations of agencies and the way in which coordination is practiced. This article
researches the impact of European integration on national agencies with regard to
three dimensions: their recruitment schemes, their internal organization, and their exter-
nal coordination arrangements. The paper presents a 20-year historical review of highly
Europeanised agencies – the German pharmaceutical and chemical regulators. This allows
us to explore whether different roles in the policy process mediate the effects of
Europeanisation. As a result, the article shows that Europeanisation has impacted com-
prehensively on the recruitment schemes, organizational structure, and coordination
arrangements of the two agencies. Both agencies have gained highly qualified personnel
for their tasks related to European decision-making and have reorganized their structure
to adapt to the requirements of this decision-making.
Keywords
Administrative organisation and structures, chemicals regulation, public agencies,
policy coordination, Europeanisation, pharmaceuticals regulation
Introduction
How Europe hits home (Bo¨rzel and Risse, 2000), and in particular, how it hits the
national administrations, is a rising topic in current research. While the question of
whether we are witnessing the emergence of a European administrative space was
Corresponding author:
Eva Ruffing, University of Hannover, Hannover, Germany.
Email: e.ruffing@ipw.uni-hannover.de
4
Public Policy and Administration 32(1)
originally the most prominent research topic (e.g. Goetz, 2000; Olsen, 2003), later
research focused on the autonomy and control of Europeanised agencies (Egeberg
and Trondal, 2009; Maggetti, 2014; Ruffing, 2015; Yesilkagit, 2011). However, the
effects of Europeanisation might permeate national administrations in a much
more comprehensive manner and affect their internal operations and their coord-
ination processes with external actors. We therefore have to look “inside bureau-
cracy” (Downs, 1967). Research on these questions currently concentrates mostly
on national ministries (e.g. Mastenbroek and Princen, 2010; Meyer-Sahling and
Van Stolk, 2015; Zubek and Staronova, 2012), leaving aside the effects of
Europeanisation on national agencies. This is surprising as the involvement of
agencies in European decision-making processes is a consistent finding of current
research (e.g. Busuioc, 2015; Littoz-Monnet, 2014; Mathieu, 2015).
This involvement means that agencies are experiencing a role shift since they
now have to negotiate with sister agencies from other member states in joint
decision-making processes. It also means that their task structure is changing
towards one of preparatory work for European decision-making (Ruffing, 2015).
These processes will arguably not remain without consequences for the internal and
external operations of national agencies. As early as 1997, Maor and Stevens found
that language skills were becoming more important for British ministries’ staff
recruitment (Maor and Stevens, 1997). However, how this has changed functional
requirements influence recruitment schemes in Europeanised agencies has remained
largely unstudied up to now. Furthermore, for national ministries, several authors
have found that the process of European integration induces them to change their
organisational structure, particularly because of the new coordination require-
ments that go hand in hand with European decision-making (Hustedt, 2013;
Schout, 1999). In contrast, research on the coordination structures of agencies
focuses mostly on the European level, neglecting the fact that internal as well as
external coordination structures with other national administrative actors might
also be transformed when agencies gain new roles and tasks. Against this back-
ground, the current article researches how Europeanisation hits national agencies,
focusing on three dimensions: It asks whether the ongoing process of European
integration influences the recruitment schemes of national agencies, induces
changes in their organisational structure, and affects their coordination processes
with other national administrative actors. The theoretical argument of the article
thereby is that although national agencies cannot ignore the pressure placed
on them by Europeanisation, this pressure is mediated by existing adminis-
trative structures and legacies, meaning that we cannot expect any kind of
change. Instead agencies fall back on time-tested solutions to meet the new
requirements.
To answer the three research questions, two agencies were chosen that are highly
involved in European decision-making, and their development over the last
20 years was traced. Analytical leverage is therefore gained particularly from vari-
ance over time. These two agencies are the German Pharmaceuticals Regulator
Ruffing
5
(Bundesinstitut fu¨r Arzneimittel und Medizinprodukte; BfArM) and the German
Chemicals Regulator (Bundesanstalt fu¨r Arbeitsschutz und Arbeitssicherheit;
BAuA), which are typical risk regulators. Although these agencies are quite
comparable, there is also variance between the two cases: While the BfArM trad-
itionally plays a strong role in policy-making and implementation, the role of the
BAuA has changed substantially over time. While there was a clear emphasis on
policy implementation in the past, there is now a strong emphasis on policy-
making. This allows us to at least tentatively explore whether different roles in
the policy process mediate the effects of Europeanisation on an agency’s internal
and external operations. As a result, this article shows that Europeanisation has
impacted comprehensively on the recruitment schemes, organisational structure,
and coordination arrangements of the two agencies. Both agencies have gained
highly qualified personnel for their tasks related to European decision-making
and reorganised their structures to adapt to the requirements of this decision-
making. In particular, the BAuA has also changed its coordination arrangements
with other German agencies, an adaptation that became necessary with the
so-called REACH regulation (1907/2006/EC).
When Europe hits national agencies
The ever-stronger involvement of national administrative actors in European
decision-making processes is one of the many phenomena often discussed
under the heading of ‘Europeanisation’ (Mathieu, 2015; Olsen, 2002; Page and
Wouters, 1995). This meaning of Europeanisation is the independent variable of
this study – and its value increases when national agencies become more engaged
in European decision-making, for example in European agencies which are
habitually built upon a network of national agencies. Whereas European agen-
cies often have an institutionalised role in the policy-making process, yet only
very limited competences in policy implementation (Heidbreder, 2014) the
European agencies in the pharmaceutical and chemical fields have far-reaching
competences in policy-making and policy implementation (Littoz-Monnet, 2014;
Ossege, 2015). The assumption is that a shift of policy-making competences from
the national to the European level should increase an agency’s role in policy-
making, meaning that the agency should develop from an entity not seen as an
individual actor to a proactive entity with its own agenda that demands a for-
mative role in the policy process (Do¨hler, 2007). A shift of implementation
competences to the European level, in contrast, could – at least to some
extent – relieve national agencies of their implementation duties as implementa-
tion usually lies within the realm of national agencies to a great extent. This role
shift – which may vary in its extent from policy domain to policy domain – will
most likely go hand in hand with altered functional requirements and encourages
the assumption that Europeanisation will also affect the internal operations of
agencies.
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Public Policy and Administration 32(1)
Staff
Empirical research on the consequences of European integration for the staff of
national bureaucracies often focuses on the time civil servants devote to ‘European’
tasks (e.g. Lægreid et al., 2004; Mastenbroek and Princen, 2010; Meyer-Sahling
and Van Stolk, 2015). In one of the first studies to research the impact of
Europeanisation on recruitment schemes, Maor and Stevens (1997) also found
that language skills were gaining importance in highly Europeanised ministries in
the United Kingdom. Furthermore, experience in the EU administration played at
least a moderate role in recruitment. In a more recent study, Mastenbroek and
Princen (2010) found that EU experience is an asset for applicants in Europeanised
Dutch ministries. However, although Murdoch et al. (2014) have demonstrated
that merit recruitment is gaining ground on the European level, one of the most
classic topics of administrative recruitment research has been being ignored in
studies on Europeanised national agencies, i.e. the educational background of
administrative staff (Aberbach et al., 1981; Rose, 1981).
Coming from a functionalist perspective, the...
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