Joint CAAT-Europe / Joint CAAT-Europe / ecopa ecopa Workshop Workshop Implementation of the new EU Implementation of the new EU Directive on the protection of Directive on the protection of animals used for scientific animals used for scientific purposes purposes ‘Opportunities for the ‘Opportunities for the 3Rs’ 3Rs’ Emily McIvor Emily McIvor Senior Advisor, Research and Toxicology Senior Advisor, Research and Toxicology HSI-Europe HSI-Europe 31.01.11. Berlin. 31.01.11. Berlin.
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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. - PowerPoint PPT Presentation
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WorkshopWorkshopImplementation of the new EU Directive on Implementation of the new EU Directive on
the protection of animals used for scientific the protection of animals used for scientific
purposespurposes
‘Opportunities for the 3Rs’‘Opportunities for the 3Rs’Emily McIvorEmily McIvor
Senior Advisor, Research and ToxicologySenior Advisor, Research and Toxicology
HSI-EuropeHSI-Europe
31.01.11. Berlin.31.01.11. 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-EUHumane Society International-EU
Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31Joint CAAT-Europe / ecopa Workshop, NOVOTEL Berlin-Mitte. 31 stst January 2011 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 3Rs – dynamic / never static
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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 Implementing the 3Rs
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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 Project evaluation
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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) Inspections (Article 34)
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• 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
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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) National Committees (Article 49)
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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) Information (Art. 47)
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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
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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 Personnel and animal welfare body
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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 Developing new 3Rs techniques and methods (Art.47/48, Annex VII)and methods (Art.47/48, Annex VII)
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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 Developing new 3Rs techniques and methods (Art.47/48, Annex VII) and methods (Art.47/48, Annex VII)
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• 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.