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

Joint CAAT-Europe / Joint CAAT-Europe / ecopaecopa

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

Transparency (Reporting, Art. 54), Transparency (Reporting, Art. 54),


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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

Retrospective assessment (Art 39) Retrospective assessment (Art 39)


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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.

Animal welfare expectationsAnimal welfare expectations


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• 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 Concluding remarks


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• Thej

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

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