Role ofEC4 in the Harmonisation ofClinical
Chemistry in the EuropeanUnion
GTB SANDERS, RTP JA SEN andMTPARVIAINEN
Authors:
Professor Gerard TB Sanders
PastPresident ofEC4;AcademicMedical Center (AMC),Department ofClinical Chemistry, P.O. Box
22660, 1100DDAmsterdam, the Netherlands.
Dr. Rob TP lansen, PhD
President ofEC4; Chairman EC4Warking Group on Harmonisation ofQuality Systems andAccredi–
tation; StAnnaHospital, Department ofClinicalChemistry, P.O. Box90, 5600ABGeldrop, theNether–
lands.
Dr. Markku TParviainen, PhD
Member ofEC4 Board; Technology CentreTeknia Ltd,
P.
O.Box 1750, FIN-70211 Kuopio, Finland.
Introduction
In this article the position and activities of EC4,
the European Communities Confederation ofCli–
nical Chemistry will be explained.
The confederationwas formally institutedApril
27, 1993 in Nice (France). Before that date infor–
mal contacts between the clinical chemistry socie–
ties in the EU existed since the seventies.Already
then visions about the practice of clinical chemis–
try in the different EU countries were exchanged.
Common aspects concerning the national contents
ofour profession, professional post-graduate train–
ing, quality assurance systems and other issues
were addressed. It was hoped to obtain a specific
directive for clinical chemistry at the European
Commission in Brussels, but this exenion failed
and finally was stopped.
What did not end, and even was strongly rein–
forced, was theworkonharmonisation ofour pro–
fession, especially after the official foundation of
EC4.
1
EC4 is the organisation of societies of clinical
chemistry in the European Union (EU). Thus the
EC4-board consists of representatives of the na–
tional European Union societies of clinical che–
mistry. All these societies are members of the In–
ternational Federation of Clinical Chemistry
(IFCC) and its European regional branch, the Fe–
deration of European Societies of Clinical Che–
mistry (FESCC).
Klinisk Kemi
i
Norden 4. 1999
Within FESCC the clinical chemistry societies
within the EU have realised themselves that due
to the different treaties a special situation exists
for professionals and the way they perform their
services. For our discipline it means the clinical
chemists are subject to the different directives and
other regulations which may influence the practi–
ce of clinical chemistry.
The structure of EC4 based onmembership of
EC4 by societies, means that individual professi–
onals cannot bemembers. Only via their national
IFCC-related societies the contact with EC4 ex–
ists.
Goals
Themain goal ofEC4 is harmonisation ofclinical
chemistry in theEuropeanUnion in particular and
Europe in general.
l
t is the aim ofEC4 to improve
the quality of all aspects that comprise clinical
chemistry in the EU, and this of course can be
accomplishedbest and foremost by raising the level
of the quality of the individual professionals. By
doing so we wish to influence clinical chemistry
in a positive way and to bring the practice of
clinical chemistry more on one Iine. For that the
EU has ehosen the mechanism of harmonisation.
Thiswe consicter not to be the same as unification,
since EC4 wishes to respect the way clinical
chemistry is performed and has developed itself
within the national health care systems. By doing
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