WRITTEN QUESTION E-0098/98 by Sirkka-Liisa Anttila (ELDR) to the Commission (30 January 1998)

Subject: Licensing of veterinary medicines for sale should take account not only of food hygiene but also of animal protection and welfare

The EU is reforming its system of licensing veterinary medicines for sale. There is thus a risk that the medical objectives of animal protection and welfare will be neglected in the name of consumer protection. This is completely at odds with animal protection and all aspects of animal welfare, which society feels to be more important. Medical ethics is opposed to any prohibition on relieving the pain and suffering of animals.

A rational balance must be struck between the use of medicaments and the supervision of residues. One possible solution would be as follows:

1. No restrictions on medicaments permitted for the treatment of pets and 'non-food' animals i.e. including medicines classified as for human use. The veterinary surgeon's own training and professional competence would guarantee the best and safest use in the animal's interest.

2. Treatment of farm animals used for other reasons than food production (horses) to be permitted using medicines approved for animal use on medical grounds, provided that a record is kept of the treatment given to each animal and its location, and that animals are identifiably marked in accordance with the EU directives. Where such animals are sent for slaughter, a waiting period should be set, and the meat rejected if the animal is slaughtered within the waiting period.

3. Treatment of farm animals kept for the production of meat, milk, eggs or other foodstuffs to be permitted only with medicaments approved for their own species. Approval would be granted not only on food hygiene grounds, but would also have to take into account medical factors and the maintenance and promotion of animal welfare. Monitoring is facilitated by the provisions on the marking and certification of animals.

How does the Commission propose to take into account factors relating to animals' veterinary protection and welfare in its reform of the issuing of sales licences for veterinary medicines?

Answer given by Mr Bangemann on behalf of the Commission (6 March 1998)

A fundamental reform of the marketing authorisation system for veterinary medicinal products has been completed through the entering into force of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European agency for the evaluation of medicinal products ((OJ L 214, 24.8.1993. )) on 1 January 1995. Following the expiry of the time limits for the implementation of Council Directive No 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products1 on 1 January 1995 and 1 January 1998 the procedures for obtaining marketing authorisations for medicinal products in the Community changed significantly. No further fundamental reform has been envisaged for the near future.

However a certain flexibility is already enshrined in the existing provisions established in order to protect consumers and animals. For example Article 4 of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products ((OJ L 317, 6.11.1981, as amended by Council Directives 90/676/EEC - OJ L 373, 31.12.1990 and 93/40/EEC. )) already provides that where no authorised product for a condition exists, the Member States may exceptionally, in particular to avoid causing unacceptable suffering to the animal concerned, permit the administration of another product by a veterinarian. The medicinal product has to be administered under his direct personal responsibility to one animal or to a small number of animals or a particular holding. The product used has either to be authorised in the Member State for another species or another condition, or, if the first two possibilities do not apply, for use in human beings. If there is no authorised product available, extemporaneously a veterinary medicinal product may be prepared by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. For food-producing animals an extended withdrawal time has to be observed to ensure that food obtained from treated animals does not contain residues harmful to the consumer.