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 Berlin.

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 Humane Society International-EU Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January 2011

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? 3Rs – dynamic / never static Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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 Implementing the 3Rs Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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’ Project evaluation Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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 Inspections (Article 34) Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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 Transparency (Reporting, Art. 54), Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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 National Committees (Article 49) Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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)? Information (Art. 47) Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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 Retrospective assessment (Art 39) Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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? Personnel and animal welfare body Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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 Developing new 3Rs techniques and methods (Art.47/48, Annex VII) Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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 Developing new 3Rs techniques and methods (Art.47/48, Annex VII) Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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. Animal welfare expectations Animal welfare expectations Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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 Concluding remarks Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 st January

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