WRITTEN QUESTION E-1413/99

by Heidi Hautala (Verts/ALE) to the Commission

(1 September 1999)

Subject: Veterinary treatment of horses

There is increasing concern amongst veterinarians and horse owners at the loss of a number of important medicines used for the treatment of horses, thereby compromising both the health and welfare of these animals. The reason is the obligation on pharmaceutical companies to establish, at great cost, maximum residue limits (MRLs) for all drugs used to treat food-producing animals.

The cost is not justified for products used for minor species for which there is little commercial return. The EU classifies the horse as a food-producing animal, even though less than 15 % enter the human food chain. One possible solution is to reclassify the horse as a companion animal. Will the Commission confirm that such a move is being considered and, also, that other solutions are being discussed?

Answer given by Mr Byrne on behalf of the Commission

(15 November 1999)

The availability of medicinal products for food producing animals is a complex problem. The problem has an animal welfare aspect since necessary treatments cannot be applied due to a prohibition on the use of certain drugs, and also a consumer health protection aspect. It reflects a conflict between the agricultural needs, the required investments of the pharmaceutical industry and the public perception of the problem as a whole. The problem also has an important international aspect, as a significant proportion of the horsemeat consumed in the Community is of foreign origin.

In accordance with the EC Treaty, equidae (donkeys, horses and their crossbreeds) are agricultural animals. Council Directive 64/0433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat(1) applies to horsemeat. Reclassification of equidae as companion animals would deprive a substantial number of citizens of their traditional food.

While in the Community horses are bred primarily for uses other than food production, slaughter of horses is common at a certain stage of their lives and is not excluded by Community law. No Member State forbids the slaughter of horses and trade in horses for slaughter for food. Taking account of the age a horse may reach, the frequent change of owner and nationality and the different purposes for which a horse may be used during its career, the enforcement of a general distinction between horses as companion animals and food producing animals would be difficult.

The protection of the health of European consumers is ensured by Council Regulation (EEC) 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits maximum residue limits (MRLs) of veterinary medicinal products in foodstuffs of animal origin(2). Substances for which MRLs cannot be established (because these products or their metabolites are toxic in any concentration) have already lost their marketing authorisation for food producing animals. Those for which provisional MRLs have been established will disappear from the market by 1 January 2000, if the industry fails to establish the definitive MRL.

However, the loss of certain substances does not mean that there are no therapeutic alternatives. Some of the substances without MRL may be replaced by other substances for which MRLs are established, and which are effective for the identical clinical indication. However, some of these alternatives may be substantially higher in price or more difficult in their application.

The current state of play is that the European agency for the evaluation of medicinal products (EMEA) established a list of those medicinal products that are indispensable and would be irreplaceably lost for the treatment of food-producing animals as from 1 January 2000. The Commission has informed the Parliament(3) that fewer than 15 substances fall into this category.

However, the off-label use of medicaments, for example of those developed for human medicine, is of equal importance and is common in today's sophisticated horse medication. Such treatment, however, requires the removal of the animal from the food chain.

Council Directive 81/0851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products(4) has made provisions to avoid shortfalls in supply of medicaments. In Article 4 of that Directive the exceptional conditions are laid down for the use of medicinal products which integrate substances in a composition not authorized for food producing animals in given Member State. This so-called cascade eventually requires that the included substances have an authorisation in another veterinary medicinal product for food producting animals in the Member State concerned. A waiting period of 7 to 28 days must be observed, depending on the product derived from this animal.

However, today's horse medicine is highly sophisticated, well comparable with small animal practive and in parts with human medicine. It is not uncommon that horse practitioners use medicaments developed for treatment of human or pet animals. For substances included in such medicaments MRLs may never be established, and there are each day new medicaments on the market. This off-label, i.e. outside the intended indication, use of medicaments in horses requires the removal of the animal from the food chain.

With regard to the complex nature of the problems related to availability of medicinal products for food producing animals, easy and quick solutions cannot be found. A concerted action of the Commission together with the authorities in the Member States and the pharmaceutical industry agriculture and fisheries is needed to ensure effective medicinal treatment of minor species.

However, taking account of the aforementioned particularities of equidae, the Commission informed the Agricultural Council of 14 June 1999 about its intention to present as soon as possible appropriate proposals. These proposals, based on Article 152 (ex-Article 129) of the EC Treaty will address the possibility to administer non-MRL substances to equidae under certain controlled conditions ensuring the observation of the required withdrawal periods.

(1) OJ 121, 29.7.1964.

(2) OJ L 224, 18.8.1990.

(3) Committee on the environment, public health and consumer protection, 1-2 September 1999.

(4) OJ L 317, 6.11.1981.