European Commission - DG Environment Directive 2010/63/EU on the protection of animals used for scientific purposes “Opportunities and challenges” Berlin, Susanna Louhimies CAAT-Europe / ecopa – Workshop ‘Opportunities for the 3Rs’

European Commission - DG Environment Directive 2010/63/EU ‘Opportunities and challenges’  The revised Directive - Main differences - The principle of the Three Rs with two examples - Alternative approaches  Opportunities  Challenges and responses  Conclusions

European Commission - DG Environment The objectives of the revision  Significant increase in animal welfare  Level playing field for industry and academia  Active promotion and implementation of the principle of the Three Rs

European Commission - DG Environment ElementDir 86/609/EEC Dir 2010/63/EU ScopeVert. Ceph’s, imm.forms, edu&training, basic research Compliance with the Three RsYes Project evaluationNoYes Project authorisation(Yes/No)Yes Housing and care standardsguidelinesbinding standards Main differences between the current & the new Dir

European Commission - DG Environment ElementDir 86/609/EEC Dir 2010/63/EU Project follow-up(Yes)Yes - Retrospective assessmentNoYes Non-technical summariesNoYes Severity classificationNoYes EnforcementPeriodic Min.targets Main differences between the current & the new Dir

European Commission - DG Environment Main differences and the Three Rs  Explicitly spells out the principle of the Three Rs: Replacement, Reduction and Refinement (e.g. Recitals 10-13; Articles 4, 13)  Ensuring that Refinement is not limited to scientific procedures but also relevant in relation to care, accommodation and breeding of animals  The development, validation and use of alternative approaches more firmly anchored

European Commission - DG Environment Systematic Project (ethical) evaluation (Art 38) The aims and objectives of the project Application of the Three Rs – Annex VI Severity classification of the procedures – Annex VIII Harm-benefit analysis of the project to assess the contents for: and to determine the need for a retrospective assessment resulting in more humane treatment of animals and improved science.

European Commission - DG Environment Systematic Project (ethical) evaluation 1. Relevance and justification of the following: (a) use of animals including their origin, estimated numbers, species and life stages; (b) procedures. 2. Application of methods to replace, reduce and refine the use of animals in procedures. 3. The planned use of anaesthesia, analgesia and other pain relieving methods. the application of the Three Rs as per Annex VI (1/3)

European Commission - DG Environment Systematic Project (ethical) evaluation 4. Reduction, avoidance and alleviation of any form of animal suffering, from birth to death where appropriate. 5. Use of humane end-points. 6. Experimental or observational strategy and statistical design to minimise animal numbers, pain, suffering, distress and environmental impact where appropriate. 7. Reuse of animals and the accumulative effect thereof on the animals. the application of the Three Rs as per Annex VI (2/3)

European Commission - DG Environment Systematic Project (ethical) evaluation 8. The proposed severity classification of procedures. 9. Avoidance of unjustified duplication of procedures where appropriate. 10. Housing, husbandry and care conditions for the animals. 11. Methods of killing. 12. Competence of persons involved in the project. the application of the Three Rs as per Annex VI (3/3)

European Commission - DG Environment Systematic Project (ethical) evaluation The aims and objectives of the project Application of the Three Rs – Annex VI Severity classification of the procedures – Annex VIII Harm-benefit analysis of the project to assess the contents for: and to determine the need for a retrospective assessment resulting in more humane treatment of animals and improved science.

European Commission - DG Environment Animal Welfare Body (Art 26)  advising the staff on welfare of animals  advising the staff on the application of the Three Rs and especially the developments on their application  establishing/reviewing internal operational processes  following the development and outcome of projects,  advising on re-homing schemes To bring the Three Rs alive and foster the climate of care by

European Commission - DG Environment Alternative approaches EU reference laboratory for the validation of alternative approaches Member States to assist by identifying and nominating suitable laboratories for validation studies Member States to appoint a single point of contact for assessment of regulatory relevance of a method Member States to promote alternatives at national level The Commission to promote at international level

European Commission - DG Environment Key dates Entry into force on 10 November 2010 Transposition to be completed by 10 November 2012 The Directive taking full effect by 1 Jan 2013

European Commission - DG Environment Opportunities Increase animal welfare through a systematic implementation of the Three Rs Improve science Reduce ‘waste’ Cut down red tape – follow best practice Increase public confidence through improved enforcement and transparency Alternatives: cut down costs, create new business opportunities…

European Commission - DG Environment Challenges Uniform understanding and interpretation Available resources (both with administrations as well as with breeders/suppliers/users) Existing infrastructures Change in mindset (top down) Rolling out of the concept of climate of care Transposition or a copy/paste exercise Time…

European Commission - DG Environment  Set up the infrastructure and designate the appropriate competent authorities (Art 59) for Project evaluation Project authorisation Retrospective assessment Inspections Granting of specific exemptions  Establish a National Animal Welfare Committee (Art 49) Responding to the challenge - the role of Member States

European Commission - DG Environment  Streamlined processes, clear responsibilities, avoidance of duplication of tasks – identification of the optimum set-up (national, regional, local)  Make users, breeders and suppliers take ownership of the Three Rs – control the establishment of AWBs  Contribution into the development, validation and regulatory acceptance of alternative methods  Dissemination and promotion of alternative approaches Responding to the challenge - the role of Member States

European Commission - DG Environment  Transposition and implementation action plan together with the Member States  Stakeholder expert discussions to arrive at a common understanding of specific terms used in the text (such as ‘debilitating clinical condition’, ‘prolonged suffering’)  Legal interpretation (e.g. use of animals in the army) Responding to the challenge - the role of the Commission

European Commission - DG Environment Answering the challenge - the Commission’s role  Establishment of the format and contents for statistical reporting  Establishment of the EU reference laboratory  Development of guidance on education and training requirements for personnel  Feasibility studies on NHPs  Thematic reviews

European Commission - DG Environment Conclusions The revised Directive is based on the latest scientific knowledge, extensive expert and stakeholder consultation, and a thorough impact assessment. The outcome of the lengthy negotiations represents a good compromise which strikes the right balance. The principle of the Three Rs is embedded in the text and brought alive through a number of specific provisions.

European Commission - DG Environment Conclusions With the new Directive EU has the most advanced legislation in the world providing a flexible framework for the current and future research to flourish whilst taking fully into account the welfare requirements of the animals The timely and intelligent transposition is a challenge requiring reflection and effort from all. There is a true opportunity to breath life into the Three Rs – what is your response to the challenge?

European Commission - DG Environment The text of the revised Directive Thank you for your attention !