The medicines legislation has recently been reviewed by the European Commission with the resultant changes having come fully into force in November 2005.
FUTURE CHALLENGES
The
medicines legislation has recently been reviewed by the European Commission
with the resultant changes having come fully into force in November 2005.
Although there is no fundamental change to the basic system, many elements have
been re-enforced or newly introduced, with the aim to improve pharmacovigilance
and to meet the higher expectations of EU citizens. Such expectations also lie
in establishing mechanisms for direct reporting of adverse experiences by
consumers, and related initiatives have been started at the level of some
Member States and through dialogue at EU level. Another important challenge
results from the EU enlargement in 2004 and 2007, involving Central and Eastern
European countries. Steps have already been taken since 1999 to integrate the
new countries in drug regulation and pharmacovigilance activities through an initiative
known as the Pan-European Regulatory Forum (PERF). In this context, it is
particularly impor-tant to have in place agreed standards for the conduct of
pharmacovigilance for all the parties involved. The PhVWP is currently
developing such standards for regulators through an initiative known as good
phar-macovigilance practice (GVP). Particular efforts are also being put into
further development of the elec-tronic information network through the
EudraVigilance project.
One
important limitation of all current pharmacovig-ilance systems is the
difficulty in measuring the effects of the actions taken. It will be
particularly important for EU competent authorities to address this using the
available electronic epidemiological databases. Expec-tations of consumers in
respect of drug safety have increased considerably in recent years (EMEA/CHMP
Working Group with Patient Organisations, 2005) and are likely to continue to
do so. To meet these expecta-tions, processes will need to become even more
trans-parent and to be demonstrably effective. Communica-tion tools also need
to be improved, and it will be impor-tant that both competent authorities and
pharmaceutical companies ensure full compliance with their pharma-covigilance
obligations.
CONCLUSIONS
The
system of pharmacovigilance established in the EU aims to promote the safe use
of medicines in clinical use thereby protecting public health. During the
1990s, existing pharmacovigilance systems in Member States have been brought
together to form an EU-wide system that currently, after the EU Enlargement in
2004, covers a population of more than 450 million people. The main challenges
of the future include further EU enlarge-ment and the increasing expectations
of consumers. To meet these challenges, and to efficiently add further value in
the protection of public health, the system is continuing to evolve,
particularly in response to scien-tific progress and technological
developments. Optimal use of the best evidence and expertise for decisions will
be essential to conduct proactive pharmacovigilance for medicines in any phase
of their product life.
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