Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Veterinary medicinal products for horses in the European Union - an overview

Dr. Florence Loeffler (Abschlußjahr: 2012)

Language: English

The horse has a particular position within the food-producing animals as it can be classified as "not intended for slaughter for human consumption". However, depending on the classification, legal requirements are imposed on the responsible veterinarian, the animal owner / holder, the pharmaceutical industry or the Member States of the European Union. Thus the most important legislation/guidelines applicable for horses are the Commission Regulation (EC) No 504/2008, the Commission Regulation (EC) No 1950/2006, the Articles 6, 10 and 11 of the Directive 2001/82/EC as amended, as well as the MUMS Guidelines and Guidances. They are essential for the identification and classification status of all equidae ("intended for slaughter for human consumption" or "not intended for slaughter for human consumption"), for the treatment of horses with substances declared as essential for the possibility to treat horses "off-label" according to the cascade, and for the development and research of new veterinary medicinal products. The requirement to identify and classify all horses is bound to the correct management of the equine passport and its record keeping obligations, as well as to the correct treatment of the animal and the dispatch of veterinary medicinal products. Even though these requirements are attendant on a high bureaucratic effort for the veterinarian, they are mandatory to guarantee both animal health and consumer safety. In some countries of the EU, it was requested to classify the horse as companion animal (i.e. not foodproducing animal) and to eliminate the status "intended for slaughter for human consumption". Even so the deletion of this status would prevent the horses from slaughterhouses within the EU, and would reduce the bureaucratic effort as well as facilitate the treatments of horses with medicinal products, major animal welfare problems for the horses as well as problems for the consumer health may be created, similarly as seen in the US where this led to increased export for slaughtering under considerably less controlled conditions.

Also all of the mentioned legal acts/guidelines are essential to maintain the availability of medicinal products for horses. Even though in the past a lot of measures were taken to improve the availability of veterinary medicinal products in equidae, such as off-label use (the cascade), "list of essential substances", incentives for research and development etc., there is an insufficient availability to assure an adequate treatment of the animals. Only a small number of veterinary medicinal products are centrally authorised in the EU (ten pharmaceuticals and eight vaccines), and in some European countries such as Finland and Denmark, the number of veterinary medicinal products seems to be dramatically low. However, as the VMP legislation is currently under review, the availability may be improved in the future. This actual review of the VMP legislation is one chance to improve this situation from a legal point of view. Nevertheless one very important aspect for animal health, animal welfare and consumer safety is the execution of all measures listed in this thesis, and this still lays in the responsibility of each stakeholder owning, caring, treating and controlling horses.

Pages: 52