WRITTEN QUESTION E-2620/99

by Robert Sturdy (PPE-DE) to the Commission

(12 January 2000)

Subject: Approval system for veterinary medicines

The Commission is certainly aware that there is a current lack of availability of veterinary medicines across the EU.

As I understand it, there are two principal reasons for this:

1. the inability of the Committee for Veterinary Medicinal Products (CVMP) to establish maximum residue limits for a number of active substances used in medicinal products, and

2. the failure of the sponsoring companies to provide sufficient safety and residue data to enable the Committee to complete its work.

Without the availability of such veterinary medicines, farmers are faced with two choices B either that they accept the unnecessary and considerable economic burden imposed on them by their ailing livestock, something they should not have to and/or may not be able to do, or that they give their livestock untested remedies which would have an incalculable effect on the health and safety of both animals and humans.

An efficient veterinary medicines approval system should determine the safety of new medicines. Furthermore, the same level of transparency in residue monitoring programmes must be applied across all Member States. Currently the UK is the only Member State to publish the results of its approval process.

What is the Commission doing to ensure that the veterinary medicines approval system currently in place is efficient?

Answer given by Mr Liikanen on behalf of the Commission

(10 February 2000)

The Commission is certainly aware of the problem of availability of veterinary medicinal products on the market. The current evaluation system for approval and surveillance of veterinary medicinal products is based on quality, efficacy and safety criteria under an umbrella of the protection of human and animal health and the environment. After the grant of a marketing authorisation, veterinary medicines must continue to meet safety and efficacy requirements and offer an acceptable balance between their benefits and risks during the life of the products. To fulfil these objectives, the implementation of several legal provisions and Commission initiatives contribute to an assurance that the veterinary medicines approval system is efficient.

The establishment of a surveillance system for veterinary medicinal products on the market, according to the framework foreseen in Chapter VIa (Pharmacovigilance) 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(1), provides for the collection and evaluation of pharmacovigilance data that can be traced to the use of veterinary medicinal products thereby contributing to the appropriate use of products to satisfy clinical needs.

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 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(2), contributes to ensuring the safe use of medicines in food producing animals.

Mechanisms ensure that animals may be treated with off label use medicines under certain conditions in order to protect the animal and the consumer. Article 4 of Council Directive 81/851/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 vet under specific conditions. 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. In the particular case of horses, an appropriate mechanism provides for the separation of equidae intended for slaughter for human consumption which are subject to the medication rules for food producing animals, and those equidae which are specifically marked either to definitively exclude them from the food chain or to allow their slaughter under the condition that any such treatment is recorded in the special section of a horse passport, in accordance with recently adopted Community legislation and that a general withdrawal period of six months is observed.

In order to address the problems of availability of veterinary medicines, the Commission is currently working on a proposal to amend Council Regulation 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin(3) and Council Directive 81/851/EEC. This will be sent at the earliest possible moment to the Council and the Parliament.

Finally, in more general terms, as regards the evaluation of the veterinary medicines approval system, the Commission has recently contracted out an audit of the entire system of authorisation and supervision of medicinal products in the Community to an independent consultant. Based on the results of this evaluation, the Commission will submit a proposal for a new system to the Council and Parliament in 2001.

(1) OJ L 317, 6.11.1981, as amended by Council Directives 90/676/EEC, OJ L 373, 31.12.1990, and 93/40/EEC, OJ L 214, 24.8.1993.

(2) OJ L 125, 23.5.1996.

(3) OJ L 224, 18.8.1990.