91999E2613

WRITTEN QUESTION E-2613/99

by Horst Schnellhardt (PPE-DE) to the Commission

(12 January 2000)

Subject: Pharmaceuticals for veterinary medicine

In the legislative procedure for the adoption of a European Parliament and Council regulation on pharmaceuticals for rare illnesses, the text now available represents a satisfactory result for all parties concerned. As far as human medicine is concerned, the regulation creates a framework which will considerably facilitate the fight against rare diseases. The EU has closed a gap with the USA and Japan which were able to adopt similar legislation at a much earlier date.

In my opinion, however, similar conditions need to be created in other areas of pharmaceutical science; in particular in veterinary medicine. A number of veterinary

pharmaceutical products have, I believe, disappeared from the market in recent years. As a result, specific preventive or therapeutic use is now possible only under certain conditions. This situation has arisen for purely economic reasons. In my opinion, the development of the veterinary pharmaceutical market in Europe is critical and it can be compared with the situation of orphan drugs in human medicine.

1. Does the Commission share this assessment of the veterinary pharmaceutical market?

2. Does the Commission intend to take any legislative initiative? What action may be expected?

3. What are the Commission's reasons for not taking any legislative initiatives?

Answer given by Mr Liikanen on behalf of the Commission

(22 February 2000)

The Commission recognizes that there are certain similarities between the problems of availability of medicines in both human and veterinary markets and in many ways the lack of availability of veterinary medicines to treat minor species mirrors the availability of human medicines to treat patients with rare diseases. In both these parts of the markets, research, development and marketing of the necessary medicinal products is hampered by the absence of potential profits and hence by the unwillingness of the pharmaceutical industry to invest.

In the particular case of veterinary medicines, the problem is aggravated by the existence of different target animal species for which additional scientific data must be generated. Additionally, in the case of food producing animals, the evaluation of residue data requires significant supplementary investment from industry. Currently no incentives are available.

The Commission is currently working on a proposal to amend Council Regulation (EEC) 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(1) and 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), in order to solve the problem of the existing lack of veterinary medicines for minor species and for certain indications (minor uses). This proposal will be sent as soon as possible to the Council and the Parliament.

Additional legislation regarding the particular case of horses foresees an appropriate mechanism 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 and that a general withdrawal period of six months is observed.

Finally, in the context of a general evaluation of the veterinary medicines approval system, the Commission has recently contracted a third party to perform the evaluation of the entire system of authorisation and supervision of medicinal products in the Community. Based on this evaluation, a proposal for a new system will be submitted to the Council and Parliament in 2001.

(1) OJ L 224, 18.8.1990.

(2) OJ L 317, 6.11.1981.