WRITTEN QUESTION E-1508/02

by Mihail Papayannakis (GUE/NGL) to the Commission

(29 May 2002)

Subject: Veterinary medicinal products in the EU

Licences for the distribution and supply of proprietary veterinary medicinal products are increasingly being issued by the European Agency for the Evaluation of Medicines, while the separate national bodies for issuing such licences are gradually being restricted to a supervisory role.

While this facilitates the functioning of the single internal market, other problems are arising:

- because of the cost, small firms operating in this area producing traditional medicinal products cannot support their case to the European Agency for the Evaluation of Medicines;

- small traditional ruminants in many countries, chiefly in southern Europe, together with equidae, do not have any proper kind of scientific treatment available to them (nor, of course, are checks carried out on residues) since producers are either unwilling or unable to carry out the relevant studies (on waiting times etc.). Thus veterinarians give these animals treatment based on traditional methods and there is no guarantee of food safety for products derived from them.

In view of the above, could the Commission say:

1. whether it is true that there has been a dramatic decrease in the range of proprietary veterinary medicinal products in the EU?

2. whether there is in fact a problem concerning medicinal products for small ruminants and equidae?

Answer given by Mr Liikanen on behalf of the Commission

(4 July 2002)

The Commission is fully aware of the issue of availability of veterinary medicinal products (VMPs) especially to treat horses and other species like small ruminants as well as for certain indications (minor uses). The Commission however does not agree that there is a dramatic decrease in the range of VMPs in the Union.

The current evaluation system for approval and surveillance of VMPs is based on quality, efficacy and safety criteria under an umbrella of the protection of human and animal health and the environment, laid down in Community law(1).

The European Agency for the Evaluation of Medicines (EMEA) is the body, which gives opinions on applications concerning specific types of VMPs, such as products produced using certain biotechnological procedures(2). However, numerous VMPs are authorised nationally by two or more Member States following the Mutual Recognition Procedure. The majority of products are thus still authorised by the competent authorities in Member States.

A precondition for granting a marketing authorisation for VMPs for food producing animals is the establishment of maximum residue limits (MRLs) according to Council Regulation (EEC) No2377/90(3). Some substances for which MRLs could not be established (because these products or their metabolites are toxic in any concentration) have already lost their marketing authorisations for food producing animal species. Substances with no MRLs are not allowed to be used in VMPs since 1 January 2000.

However, the loss of these substances does not mean that there are no therapeutic alternatives. Some of the substances without MRL have been replaced by other substances for which MRLs are established, and which are effective for the same clinical condition.

To improve the availability of medicines for certain species, the Committee for Veterinary Medicinal Products (CVMP) recently recommended the extension of the existing MRLs for substances used in major species to be used to set MRLs for other food-producing species (through extrapolation).

Additionally, Council Directive 2001/82/EC(4) provides provisions to avoid shortfalls in supply of medicines. In Article 10 of this Directive exceptional conditions are laid down for the use of VMPs in pet and food producing animals. According to the so-called cascade, veterinarians are enabled to use VMPs authorised for another food producing species or for another indication in the same species.

As already mentioned in the Communication from the Commission to the Council and the Parliament on the Availability of veterinary medicinal products(5), the Commission decided to propose amendments to Directive 2001/82/EC in the framework of the current revision of the pharmaceutical legislation(6) also aiming in improving availability of VMPs. These proposals consist mainly in facilitating the cascade provisions and making their use compulsory for Member States. The extension of the administrative protection of scientific data provided for by the applicant for a marketing authorisation should bring further incentives to the veterinary pharmaceutical industry especially for minor species. Regarding horses in particular it is proposed to allow the use of a substance without MRL, under the only condition that the concerned animal is excluded from the nutritional chain.

A surveillance system establishing measures to monitor certain substances and residues thereof in live animals and animal products in accordance with Council Directive 96/23/EC(7) also ensures the safety of products originating from small ruminants (sheep, goats) and horses.

(1) Parliament and Council Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products, OJ L 311, 28.11.2001.

(2) 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.

(3) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits (MRLs) of veterinary medicinal products in foodstuffs of animal origin, OJ L 224, 18.8.1990.

(4) Directive 2001/82/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, OJ L 311, 28.11.2001.

(5) COM(2000) 806 final.

(6) OJ C 75 E, 26.3.2002.

(7) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC, OJ L 125, 23.5.1996.