WRITTEN QUESTION E-2148/98

by Ursula Schleicher (PPE) and Horst Schnellhardt (PPE) to the Commission

(13 July 1998)

Subject: Availability of veterinary medicinal products - crisis regarding treatment

In the Federal Republic of Germany increasing numbers of vets and their professional associations are complaining about the declining available range of veterinary medicinal products. As a result the veterinary care of certain groups of animals is being placed at risk and has become impossible in some cases. There are clearly also similar problems with homeopathic medicinal products, in particular for animals providing foodstuffs.

1. a) How does the Commission assess this development?

b) What does the Commission consider to be the cause of this trend?

c) Is it aware of similar complaints from other Member States?

d) What action does the Commission intend to take to alleviate the situation?

2. Can the Commission provide information on the criteria for assessing homeopathic medicinal products for animals providing foodstuffs in relation to approval or certification validity by the European Agency for the evaluation of medicinal products?

Answer given by Mr Bangemann on behalf of the Commission

(30 September 1998)

1. The Commission is aware of the fact that the number of veterinary medicinal products available in the Community for animals intended for food production is decreasing.

The reasons for this are firstly that the pharmaceutical industry does not apply for marketing authorisations or maximum residue limits (MRLs) for minor species and minor uses. It claims that there is not sufficient revenue in these products to justify the necessary investments in studies. This applies especially to studies designed to prove that residues of pharmacologically active substances are not harmful to human health, and to develop methods of analysis necessary to monitor the residues in foods (required by Council Regulation (EEC) 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary mexicinal products in foodstuffs of animal origin(1)). Another reason is that for some substances maximum residue limits cannot be established since their residues have proven to be hazardous to the consumer at any limit.

The Commission is considering various options to facilitate the authorisation of veterinary medicinal products in certain circumstances, which take the principles of consumer protection into account.

2. A homeopathic veterinary medicine intended for use in animals the flesh or products of which are intended for human consumption has to be authorised for marketing according to the requirements of Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products(2) and Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products(3). One of the conditions that has to be fulfilled before a marketing authorisation for a veterinary medicinal product can be granted is that the residues in foodstuffs of any pharmacological active substance contained therein has been positively evaluated. This evaluation has to be performed according to Council Regulation (EEC) 2377/90.

(1) OJ L 224, 18.8.1990.

(2) OJ L 317, 6.11.1981.

(3) OJ L 297, 13.10.1992.