EURO DURG
European Drug Utilization Research Group Resolution of the European
Drug Utilization Research Group on Confidentiality of Personal
Health Data (5 July 1996)
The European Drug Utilization Research Group (EURO DURG) considering
* The Directive 95/46/EC of 24 October 1995 on the protection
of individuals with regard to the processing of personal data
and on the free movement of such data
* The need to conduct research to protect the public health and
to ensure the efficient use of medicines in the healthcare systems
of Member States
* The need to access personal health data in order to conduct
an appropriate spectrum of research with fully addresses the clinical,
social and economic circumstances of patients urges European Union
Member States to take into account the importance to the public
health of drug utillzation and pharmacoepidemiology research when
implementing the Directive 95/45/EC into national legislation.
In particular Member States are urged to recognize that drug utilization
and pharmacoepidemiology research is an activity "of substantial
public interest" and to ensure that an exemption to the prohibition
in paragraph 1 of Article 8 of the Directive, as provided for
in paragraph 4 of article 8, is included in national implementation
of the Directive. In the absence of such an exemption EURO DURG
believes that public health research in the European Union will
be inappropriately restricted with adverse consequences on the
public health.
Drug utilization research is an important branch of public research.
It performs several functions, including
* the monitoring of medicines safety after marketing
* ensuring and improving quality in drug therapy by the doctor
and pharmacist
* monitoring and control of medicament costs in welfare state-financed
health systems
EURO DURG defines drug utilization and pharmacoepidemlology research
as research on the quantitative and qualitative aspects of drug
use, the determinants and the effects on patients specifically
and the population in General. Drug utilization research is an
interdisciplinary research area which employs the methodology
of epidemiology, pharmacology, health services research, empirical
social research and cultural anthropology.
Drug utilization research investigates medicines usages in the
population, the prescription habits of doctors, the market strategies
of pharmaceutical companies and the effects of political interventions
in the use of medicines.
Drug utilization research relies on access to documents, paper
and electronic, containing personal health data such as diagnoses
and prescriptions. Primary surveys of medicines usage are comparatively
expensive and time consuming. The use of documents from welfare
state-financed health systems is an important and efficient source
of data to be used to protect the public health.
EURO DURG recognizes both the importance of protecting the privacy
of personal health data and the importance of protecting and improving
the public health by means of appropriate research. EURO DURG
will seek, by means of Working Party on Confidentiality, to work
with other European and national organisations to draw up a Code
of Practice relating to the use of personal health data in health
research in order to protect the privacy of individuals while
supporting continuing improvements in public health arising from
high quality research.
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