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The potential impact of animal welfare legislation on new veterinary medicines

Abstract: Animal welfare is deemed to be of high importance in the EU; requirements for animal welfare considerations have been increasing at varying speeds in the different EU member states for several decades. However, it appears that European innovation is slowing. Several different organisations are pushing to apply human standards and endpoints to the care, husbandry and management of animals. This movement is also influencing the use of animals for research and development of human and animal medicines, food and other products. While initially targeting a limited number of industries (eg, cosmetics, chemicals), the interpretation of animal welfare is now seen from a much broader perspective. One notable success has been the implementation of animal welfare as a primary topic in the EU (Article 13 of the Treaty on the Functioning of the European Union (TFEU)) and at constitutional member state level in Germany. Directive 2010/63/EU1 sets criteria for the protection of animals used for scientific purposes. Implemented as a Directive, it gives member states a degree of freedom for national implementation, including going beyond the Directive scope in their national legislation. While some member states fully implement EU Directives, others change the text significantly when transposing these into national legislation. Consequently, the requirements for obtaining an approval for conducting studies in target animals have increased considerably in some member states. Standards are still far from harmonised throughout the EU. This article discusses Directive 2010/63/EU, its national implementation in selected EU countries and potential consequences for the availability of new veterinary medicinal products (VMPs) in Europe.

DATE » 01.03.2016

AUTHORS » Klaus Hellmann, Claudia Schneider, Regina Wolf

PUBLISHED » Regulatory Rapporteur, Vol. 13, No. 4, April 2016