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Emily McIvor Senior Advisor, Research and Toxicology HSI-Europe 31.01.11. Berlin.

Joint CAAT-Europe / ecopa Workshop Implementation of the new EU Directive on the protection of animals used for scientific purposes ‘Opportunities for the 3Rs’. Emily McIvor Senior Advisor, Research and Toxicology HSI-Europe 31.01.11. Berlin. Humane Society International-EU.

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Emily McIvor Senior Advisor, Research and Toxicology HSI-Europe 31.01.11. Berlin.

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  1. Joint CAAT-Europe / ecopa WorkshopImplementation of the new EU Directive on the protection of animals used for scientific purposes‘Opportunities for the 3Rs’ Emily McIvor Senior Advisor, Research and Toxicology HSI-Europe 31.01.11. Berlin.

  2. Humane Society International-EU • Among the largest animal protection societies in the world • 11+ million members globally • Offices in Australia, Canada, China, UK, India, Latin America, USA • Spheres of activity • Public & corporate policy, education, direct care (outside the EU) • EU Activities • Cat and dog fur ban / ban on trade in seal products • Environmental impacts of animal agriculture • Animal experiments and testing, eg.: • Product testing (cosmetics, pesticides, biocides, REACH) • Revision of Directive 86/609 • Promotion of alternatives to animal testing and research • Approach • Science-driven advocacy and lobbying • Representing the views of supporters during policy-making and legislative processes Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011

  3. 3Rs – dynamic / never static • Implement all existing 3Rs methods, techniques and welfare standards; • Develop new methods and higher standards. Directive 10/63 provides for both but there are numerous diverse challenges, eg: Development of alternative methods: public and private funding; commitment; capacity; vision; communication. Implementation of existing methods: processes; structures; knowledge; commitment; accountability. So . . . how do we take every opportunity offered by the Directive to maximum advantage? Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  4. Implementing the 3Rs Project evaluation and authorisation Inspections Transparency Retrospective assessment Education and training Animal welfare committees ‘Single point of contact’ National function of ‘promoting’ 3Rs Databases/communication Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  5. Project evaluation Articles 37 and 38 / Annex VI: Opportunities • ‘Member States shall ensure . . . is submitted’ • ‘information on elements set out in Annex VI’ • ‘an assessment of the compliance of the project with the requirement of replacement, reduction and refinement’ • publication of some non-technical summaries • ‘The project evaluation process shall be transparent’ Challenges • ‘degree of detail appropriate for the type of project’ • ‘harm-benefit analysis’ Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  6. Inspections (Article 34) Opportunities: • ‘ . . . regular inspections of all breeders, suppliers and users, including their establishments, to verify compliance with the requirements of this Directive.’ • ‘An appropriate proportion of the inspections shall be carried out without prior warning.’ • EU ‘controls’ and increasing interest at EU level Challenges: • ‘adapt the frequency’ • ‘appropriate proportion’ • lack of transparency Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  7. Transparency (Reporting, Art. 54), • By 10 November 2018 (+every 5yrs) to the Commission information on implementation, in particular Articles 10(1) breeding; 26 (animal welfare body); 28 (breeding NHPs; 34 (inspections); 38 (project evaluation); 39 (retrospective assessment); 43 (non-technical summaries); 46 (duplication). • Annual statistical reporting including NHPs and severity • Annual information to Commission on killing methods exemptions Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  8. National Committees (Article 49) Opportunities • MS: ‘committee for the protection of animals used for scientific purposes’ • Advise the CA and animal-welfare bodies on ‘acquisition, breeding, accommodation, care and use of animals in procedures . . . Sharing best practice’ • Exchange information on operation of animal welfare bodies and project evalutation . . . Share best practice within the Union’ • Relationship with animal welfare bodies Challenges • Lack of transparency; lack of required stakeholder input Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  9. Information (Art. 47) Opportunities • MSs shall, at a national level, ensure the promotion of alternative approaches and the dissemination of information’ • Nominate a single point of contact to provide advice on the regulatory relevance etc. of alternative approaches proposed for validation • (from Annex VII) dialogue through the Union Reference Laboratory • Relationship with national committee? Stakeholders? Aniamal welfare bodies? The public (transparency)? Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  10. Retrospective assessment (Art 39) Centrepiece of 3Rs use and development opportunities: • Were the objectives achieved? • Was the harm/severity as predicted • Lessons for future 3Rs application • Identify the failing animal models and techniques • Potential to save money and coordinate research Challenges: • New to many – how to gain knowledge and create processes? • Too few projects might be retrospectively assessed • Lack of transparency Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  11. Personnel and animal welfare body Opportunities • Art. 27 requires that the animal welfare body advises staff on application of the 3Rs, keeping staff informed about technical progress • Establish and review internal operational processes • Follow the development and outcome of projects • Records made available to the CA upon request • Link with national committees Challenges • Lack of transparency • How is ‘compliance’ demonstrated? Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  12. Developing new 3Rs techniques and methods (Art.47/48, Annex VII) Opportunity: • EU and MS contribution • Not confined to regulatory testing • Integration with use of existing methods and regulatory functions • Potential for coordination with animal welfare bodies and national committees • Coordination with MS ‘single point of contact’ • Strategic (Union Reference Laboratory to ‘set priorities’ in consultation with MSs) • Stakeholder involvement Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  13. Developing new 3Rs techniques and methods (Art.47/48, Annex VII) Challenges • Developing structures that work (EU and MS) • Funding – setting priorities while spending is being cut • Integrating ‘development’ contributions into regulatory processes (eg. Retrospective assessent and project evaluation) • First steps to developing strategies to replace failing animal models – identifying problems • Sharing best practice – how does it work in practice? • Making the networks of communication work Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  14. Animal welfare expectations • At EU level, the EU-RL should provide for the transition from ‘alternatives’ meaning only alternative test methods to the new broader definition • Even low-cost options such as websites and communication have big impacts • Identifying challenges; workshops, publications etc. • At MS level, use the requirements (single point of contact/dissemination etc.) to create a real presence for development of alternatives and integrate into all structures. • EU and national centres for alternative methods remain realistic policy objectives. Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  15. Concluding remarks • With out robust enforcement, we have only words on paper • Activities that take place outside MS or public scrutiny are prone to go wrong Priorities for meeting challenges: • Robust enforcement, underpinned by transparency, accountability, dialogue, stakeholder involvement • New funding solutions (fees / industry collaboration?) • International dimension: EU animal welfare action plan Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

  16. Heading • Thej Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31st January 2011 . .

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