The use of antibiotics in German animal husbandry is to be significantly reduced. To this end, the competent surveillance authorities of the federal states (Länder) will be endowed with more stringent powers of inspection than before, the exchange between the authorities will be improved, a new nationwide database will create maximum transparency, animal keepers will in future have to document the use of antibiotics on their farms in greater detail and it will be made more difficult to use certain active substances. The Federal Cabinet adopted an amendment of the German Medicinal Products Act (AMG) to this effect.
The far-reaching reform of the AMG incorporates various suggestions and ideas put forward by the Länder. The Act is expected to take effect in the spring of 2013 following the conclusion of the parliamentary process.
A strategy to minimise the use of antibiotics constitutes the centrepiece of the amending act. It will enable the surveillance authorities to assess the frequency of antibiotic treatment on a farm and to compare it with other farms. On this basis, the animal keepers can be required to carry out necessary checks and to take necessary measures, also in cooperation with the veterinarian and the surveillance authority. The aim is to limit the use of antibiotics to the minimum that is actually required for the therapy.
The Länder will be able to establish a nationwide official database in order to record and process the data on therapeutic frequency.
The most important new features at a glance
• Both the authorities and the animal keepers will in future be able to cross-check the therapeutic frequency on a farm with the data collected nationwide on therapeutic frequency. The comparison with nationwide figures will clearly demonstrate the urgency of reducing the use of antibiotics on individual farms.
• The competent authority will be endowed with a number of powers if the farm should exceed the national figures and if it should fail on its own initiative to minimise the use of antibiotics effectively. Thus, the authority may order concrete action on the ground in order to curb the use of antibiotics, i.e. impose detailed requirements for the keeping of animals.
• The way will be paved for recording and processing, in a centralised manner, the data to be reported to the authority on therapeutic frequency in a single official database.
• An inspection requirement will be introduced for livestock farmers who keep certain food-producing animals for commercial purposes. They will be obliged, in consultation with the veterinarian, to review the therapeutic frequency and, if this should be higher than the figure that has been determined nationwide for the type of farm, minimise the use. They may also be required to take steps to enhance hygiene, health care or the husbandry conditions if this has a positive impact on the use of antibiotics.
• Upon request by the Länder surveillance authorities, veterinarians and animal keepers will be required to transmit a summary of all data regarding the sale and administration of antibiotics. This will simplify and speed up the controls required for monitoring.
• The legal conditions will be established for restricting the off-label use of antibiotics; these are also of great importance in human medicine.
• An authorisation will be created to mandatorily prescribe the drawing up of a so-called "antibiogram", i.e. of a laboratory test on the efficacy of an antibiotic when changing the antibiotic, for instance, or if an off-label use may be required.
• A further authorisation shall stipulate that the instructions for use that are specified in the package insert upon the approval of certain antibiotics are made compulsory for the veterinarian. This is, for example, important for antibiotics intended for oral administration.
• The exchange of information between authorities will be significantly improved: It will be made compulsory for authorities that monitor establishments, for instance with regard to animal welfare and food hygiene, to pass on, upon request, to the bodies responsible for the monitoring of veterinary drugs any data and findings that suggest there has been an infringement of the medicinal regulations.
Wednesday September 19, 2012/ Federal Ministry of Food, Agriculture and Consumer Protection/ Germany.