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.