Directive 2010/63/EU

Date and location:

31.01. – 02.02. 2011, Berlin, Germany, NOVOTEL Berlin-Mitte

Goals of the workshop:

To bring together key stakeholders from various EU member states to reach common ground for steps to be taken with regard to the implementation of individual articles of the new directive with an impact on 3Rs research, validation, funding and dissemination.

Background:

After years of negotiation the new EU Directive on the protection of animals used for scientific purposes 2010/63/EU has just entered into force. Member States have to implement this piece of legislation within two years time. The new Directive entails a variety of requirements connected to the 3Rs and in vitro research, such as:

• Enlarged scope of the Directive: now also covers animals bred specifically so that their organs or tissues may be used for scientific purposes
• Member States to nominate a Competent Authority/ies interalia for laboratory animal welfare, national ethics committees and a single point of contact to provide regulatory advice on the 3Rs
• Commission and Member States shall contribute to the development, validation and dissemination of 3Rs methods
• EU Commission shall establish a Union Reference Laboratory at the Joint Research Centre
• Member States need to nominate laboratories suitable to participate in validation studies
• Member States shall ensure the promotion and dissemination of information at a national level, EU Commission at international level
• Regular reporting on animal use, implementation and reviews of the Directive regarding advancements in the development of 3Rs methods and regarding progress in laboratory animal science, e.g. assessment of pain and distress
• Regular adaptation to 3Rs progress by adaptation of annexes of the Directive
• Member States are encouraged to establish programmes for the sharing of organs and tissues of killed animals
• Member States can provide specific funds for the development and validation of 3Rs methods/strategies

The implementation of these requirements poses therefore a unique opportunity to give incentives for the 3Rs in the EU Member States and within the European Commission. It is important that the legal and administrative steps taken by the Member States and by the Commission reflect this opportunity and prove to be effective. Ideally, Member States, or stakeholders active in Member States, develop a common view on what type of action is needed and how to divide tasks. National governments need to be aware of the views and desires of stakeholders in order to proceed on a both rational and agreed route.