European Parliament adopts proposals to amend the legislation for veterinary medicinal products

FOR IMMEDIATE RELEASE

Brussels, Belgium, 17 December 2003: At its plenary session in Strasbourg today, 17 December 2003, the European Parliament adopted its final proposals to amend the current legislation on veterinary medicinal products, so closing its second reading of the review of the legislative package governing human and veterinary medicinal products.

IFAH-Europe welcomes the Parliament’s position on encouraging continued investment in the development of veterinary medicinal products by guaranteeing a ten year data protection period.

Dr. Jean-Louis Delforge, Chairman of IFAH-Europe, commented “The text as envisaged by Parliament encourages innovation.” He explained, “The cost of product development has doubled over the last decade. As animal health markets are small and fragmented, product development represents a major investment risk that can only be accommodated by introducing a harmonised data protection period of 10 years. Indeed, this is essential for the future health of our industry.”

IFAH-Europe appreciates the Parliament's decision to avoid the introduction of any unnecessary bureaucracy linked with the renewal of marketing authorizations.

However, IFAH-Europe is disappointed that the Parliament has missed the opportunity to recognise the different national distribution systems authorised for veterinary medicinal products, which meet the specificities of the various market conditions.

The Parliament’s position will now be considered by the Council. If the Council were to adopt the Parliament’s proposals, final agreement on the package would be reached. However if Parliament’s position were not to be accepted by the Council the package would be the subject of a conciliation procedure.

IFAH-Europe is firmly of the view that the extended period of legal uncertainty resulting from a delay in the adoption of the package beyond EU enlargement on 1 May 2004 would dissuade companies from deciding to invest in necessary development of new veterinary medicinal products. In order to avoid this, IFAH-Europe urges the Council to accept the Parliament’s position at second reading and thus avoid conciliation.

Ends

Notes to Editors:

IFAH-Europe is the representative body of manufacturers of veterinary medicines, vaccines and other animal health products in Europe. It is a major operating division of a broader organisation – the International Federation for Animal Health (IFAH), an international non-profit organisation registered under Belgian law.

For further information on IFAH and IFAH-Europe, please visit http://www.ifahsec.org/

For further press information please contact Rick Clayton, Technical Project Manager

IFAH-Europe
Rue Defacqz, 1
B-1000 Brussels
Tel.: +32 (0)2 543 7504
Fax: +32 (0)2 537 0049
E-mail: clayton.rick@ifahsec.org

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