Alternatives to antibiotics in the veterinary therapeutic arsenal: issues and challenges
Agence Nationale du Médicament Vétérinaire, Fougères, France
The current plans of action to fight antibiotic resistance emphasize the significance of developing new therapeutic approaches. Numerous initiatives have explored alternative or complementary treatments to reduce the use of so-called "conventional" antimicrobial agents in livestock production. They include vaccines, antibodies, bacteriophages, peptides, probiotics, and medicinal plant extracts. From a regulatory perspective, many of these substances are considered “frontier” substances that may, depending on the “presentation” or the “function”, fall within legislative jurisdictions encompassing veterinary medicines, biocides, or animal feeds.
Antibiotics have been approved as medicines and can be used for the treatment or prevention of infectious diseases. A substance proposed as a substitute for such treatment should be considered a veterinary drug (therapeutic claim). This category is strictly regulated; development therein requires studies of animal, human, and environmental safety and efficacy studies for the targeted pathology, the development of an industrial-scale manufacturing process, and a quality control system. Commercialization is subject to prior obtaining administrative authorization and permits. Production and wholesale and retail distributions are reserved for suitably staffed business entities that have secured the rights to do so.
Other products may be administered to animals but are subjected to specific regulations.
Biocides: intended to destroy, repel, or render harmful organisms inoffensive, prevent their action or otherwise fight them by chemical or biological means (e.g., disinfectants for veterinary hygiene).
Animal feeds: products formulated to some degree, with or without containing additives. They may be intended for specific nutritional purposes; in which case they are called dietary feeds.
Currently, veterinary medicines regulation is an issue because no specific regulatory framework exists for the evaluation of so-called “alternative” products. The focus of current European thought on this matter aims to develop specific guidelines defining requirements for quality, safety (including the resistance risk) and efficacy to establish the risk/benefit balance of these products. These requirements will have to be sufficiently flexible to encourage the development of new medicines while guaranteeing their safe and efficient use for humans, animals, or the environment, and thereby achieving the overall goal of reducing exposure to antimicrobial agents.