Drawing upon one of the themes of the TOPRA Symposium,
Continuous Regulatory Evolution, the risks posed by avian influenza
and blue tongue disease in ruminants has forced an urgent re-think
about how to respond to animal disease threats in the EU.
“Prevention is better than cure” stated Dr. Klaus Depner, involved
in animal disease control within DG SanCo, while describing how
the community animal health policy has evolved in response to lessons
learnt from the Foot and Mouth outbreaks, the avian influenza threat,
and swine fever outbreaks.
“The Commission is now proposing the broader use of vaccination
of animals for both emergency and preventive control” he reported,
together with more policy flexibility based on risk assessment.
“For Bluetongue, DG SanCo is recommending mass vaccination of susceptible
ruminants such as sheep and goats”, and he noted that as it is
a vector borne disease, culling of infected animals will not work
on its own.
“During peace-time we are sleeping; then in crises we are forced
to take urgent measures; we need to be better prepared for such
disease emergencies.” Declared Dr. Depner.
In addition to hearing from the Commission various high level
officials from within the European institutions also told delegates
about new thinking on existing issues and a few that are emerging.
Patrick Dehaumont, head of the French National Agency for Veterinary
Medicinal Products, gave a keynote address on challenges identified
by the Heads of Medicines Agencies Strategy document. Martin Terberger,
Head of Unit F2 on pharmaceuticals within the European Commission,
gave an update on the progress of the COM proposal for a new Regulation
on maximum residue limits.
David Mackay, Head of the veterinary and inspections unit at the
EMEA, reported on the role being played by the EMEA and CVMP in
the Community Animal Health Policy and the EMEA’s approach to responding
to urgent disease threats, for example by the emergency authorisation
of vaccines.
Offering an industry viewpoint, Declan O’brien, Managing Director
of IFAH-Europe, noted “Projects within the European Technology
Platform for Global Animal Health are trying to identify what needs
to be done during peacetime, by identifying the potential future
disease threats and related therapeutic gaps, so the EU can be
better prepared.”
The revised Annex 1 to Directive 2001/82 as amended was critically
appraised by Raymond Harding of Cyton Biosciences. Then the arbitration
and referrals procedure, seen as a main driver to forced harmonisation,
was reviewed from 2 perspectives by Esther Werner, chair of the
Committee for mutual recognition and decentralised procedures and
Melanie Leivers, from the EMEA.
Turning the area of safety issues, Martin Terberger discussed
the co-decision procedure and Rick Clayton, Technical Director
of IFAH-Europe offered a more candid external view. He explained
the timelines of the procedure and examined some of the critical
amendments proposed by the European Parliament, and how these were
managed.
The second safety issue involves the question of environmental
risk assessments, particularly for generic products. The current
legal interpretation of the Veterinary Directive was presented
by Kornelia Grein, Head of Sector for Safety within the veterinary
unit of the EMEA.
Concluding the TOPRA Veterinary Symposium, two important initiatives
for improving the regulatory environment for veterinary medicinal
products were explored. The first initiative is a joint project
between IFAH-Europe and the CMDv to look at ways of rationalising
the packaging and labelling requirements. The topic was introduced
by Veena Singh, Pfizer Animal Health, who described the main proposals
that had been developed by IFAH-Europe and the background for them.
Christophe Debruyne, Federal Agency for medicines and health in
Belgium, complemented this by detailing the main areas where member
states found agreement, and the main contentious areas of the proposals.
Melanie Leivers, EMEA, also gave an update on the on-going review
of the variations Regulations.
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