Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Revision of Council Directive 90/167/EEC – current and future legal situation regarding medicated feed in the European Union as compared to the United States of America and Canada ***

Dr. Julia Katharina Mack (Abschlußjahr: 2016)

Summary
Language: English
In animal husbandries housing large numbers of animals, the use of medicated feed is a common treatment option in many countries. Medicated feed consists of a compound feed as a carrier and one (or more) veterinary medicinal product(s). The resulting ready-to-use feed can be offered to large groups of animals to be treated simultaneously.
The European Union (EU) regulates this type of medication in Council Directive 90/167/EEC which came into force in 1990. The directive had to be implemented into national law in every EU member state. Since the directive was never substantially amended and the national implementations were highly divergent, the EU recently decided to replace the directive by a regulation that will then be immediately binding in all member states at once. The proposal for this new regulation is currently on its way.
The present thesis aims at comparing the regulatory framework in the EU with the regulatory approach in other countries, i.e. in the United States of America (USA) and Canada, and at uncovering differences as well as similarities.
In general, the three regions or countries developed rather different ways to deal with the regulatory topic “medicated feed”. While in the EU every member state found its own interpretation, the USA regulated medicated feed on federal basis, whereas in Canada there is federal law that can be complemented by provincial legislation. These facts make a detailed comparison rather complex.
Overall, the EU appears to have the strictest legislation including mandatory approval and regular risk-based inspections of manufacturing sites, compulsory veterinary prescription of medicated feed, and a complete ban of antimicrobial usage for growth promotion purposes. The Canadian legislation, on the other hand, appears to be the most lenient, with neither pre-production approval of medicated feed manufacturers nor regular inspections aside from those carried out within the frame of some national inspection programmes which do not mandatorily include all medicated feed manufacturers. Most medicated feeds are available over-the-counter as long as they comply with some pre-set requirements; the use of medicated feed for growth promotion is common and not planned to be banned anytime in the near future. The USA’s current medicated feed regulation is somewhere in between the Canadian and the EU’s approach in so far as they have a rather strict course of action regarding the implementation of Good Manufacturing Practices and the approval and inspection of (certain types of) medicated feed manufacturers, but the veterinary oversight over medicated feed is lacking, which is planned to be changed by the beginning of 2017.
By repealing Directive 90/167/EEC and passing a new regulation similar to the current proposal the EU will tighten its regulatory framework in most member states (though it will be mitigated in some of them) and retain its position as region with the strictest medicated feed legislation amongst those compared within this thesis, an approach that appears to be highly important regarding the potential threat of antimicrobial resistance which could be fostered by a lax legislation for medicated feed containing antimicrobials.
Pages: 105