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Symposium
"Legislation on drug and vaccine use"
Current and futures
perspectives on the regulation of anticoccidial drugs
and vaccines.
Prof. Dr. João Palermo
Neto
Applied Pharmacology and Toxicology, Scholl of Veterinary
Medicine,
University of São Paulo, São Paulo, Brazil.
Coccidiosis
is one of the most relevant diseases concerning economic
losses it causes on livestock production. The world
losses attributable to avian coccidiosis were estimated
in 1,5 billion dollar per year. In Brazil, a 30 million
dollar damage per year was assigned to this disease.
Many of those figures are based on grants spent with
anticoccidials. In this respect, what about the future
of anticoccidial drugs in EU?
According
to the Regulation (EC) no 1831/2003 of the European
Parliament and of the Council on additives for use in
animal nutrition, coccidiostats and histomonostats are
feed additives (articles 5 & 6). Thus, their placement
on the market and use within the Community and in other
countries that export to EU must follow the conditions
laid down in this Regulation. Regulation articles 10
& 11 state “... with a view on the phasing
out of the use of coccidiostats and histomonostats as
feed additives by 31 December 2012, the Commission shall
submit to the European Parliament and to the Council
before 1 January 2008 a report on the use of these substances
as feed additives and available alternatives, accompanied,
where appropriate, by legislative proposals”.
As far as it is of our concern, no decisions have been
taken on the coccidiostats yet. They require prescriptions
in Sweden and it seems they are pushing for the rest
of Europe to go down this route. However, taking into
account the economic importance of coccidiosis, the
most likely outcome by 2012 will be the transition of
anticoccidials to a new veterinary product status; perhaps
they will be classified by medicine legislation when
reviewed. Anyway, the impact on both pharmaceutical
companies and livestock production should be small as
the requirements for feed additives of this type are
now very similar to the medicines. It should not be
forgotten, however, that vaccines against coccidiosis
are becoming more and more sophisticated and also more
consistent. For instance, it was recently observed that
interleukins, such as INF-y, IL-2 and IL-15, strengthened
the antigenic effects of recombinant DNA vaccines. Thus,
although anticoccidial use might be kept in Europe for
the control of coccidiosis, the establishment of vaccines
in this scenario should increase, becoming more relevant
worldwide.
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