Alternatives to Animal Testing

Transcription

1 Alternatives to Animal Testing ILSI Europe's 2017 Annual Symposium March 2017 Dr. Katrin Schütte DG Environment, European Commission

2 Contents 1) 1) Directive 2010/63/EU From legislation to application 2) 2) Scientific Conference: Non-animal Approaches the Way Forward 3) 3) The European Partnership for Alternative Approaches to Animal Testing (EPAA)

3 Directive 2010/63/EU Significant increase in animal welfare Level playing field for industry and academia Active promotion and implementation of the principle of the Three Rs as a legal obligation

4 Environment Biologicals Pesticides DIRECTIVE 2010/63/EU Agriculture Pharmaceuticals Biocides RTD Framework programs Horizon 2020 [Cosmetics] REACH Chemicals Food safety

5 Acknowledging that Animals, including non-human primates, are still needed today for research and testing The ultimate goal is to replace the use of animals Animals have intrinsic value in themselves which must be respected The principle of the Three Rs is the key to more humane and better science

6 REPLACEMENT REDUCTION REFINEMENT

7 Three Rs and the Directive I. Application of existing Three Rs approaches central in project planning, evaluation, during the course of the project and after II. Development, validation and promotion of new alternatives / Three Rs approaches New tools for the development, validation and uptake of alternative approaches to progress towards the ultimate goal of full replacement

8 Formal establishment of EURL ECVAM Legal basis embedded in the Directive (Art. 48) Extended scope covering now also basic and applied research New resources for the validation (EU-NETVAL) (Art. 47) PARERE established to ensure regulatory relevance (Art. 47)

9 New tools and obligations under 2010/63/EU Three Rs a legal obligation - full replacement set as the ultimate goal Systematic project evaluation and authorisation New roles and functions (e.g. Animal Welfare Body, Designated Veterinarian, National Committee) Binding housing and care standards Increased transparency and better enforcement New structures for the validation and regulatory acceptance of alternatives

10 Legal framework Transposition completed Conformity check ongoing

11 Compliance - Legislative process Implementation - tools and guidance Application, enforcement, reporting Experience and review Operational structures National legislation

12 Named responsible persons Animal Welfare Body Designated veterinarian Project leaders, animal technologists animal care takers CAs for project evaluation and RA Inspectors National Committees and MS National Contact Points Education, training and competence Legislation, codes of practice, guidance Efficient COMMUNICATION

13 Testing to satisfy regulatory purposes under the Directive issues identified Who is responsible for compliance with obligations under both the Directive and sector legislation (e.g. REACH, food or feed safety regulation)? How to make the information on (new) alternative approaches reach the right person at the right time?

14 Responsibilities under 2010/63 Draw the attention of users to their legal obligation to apply alternatives as soon as these become available Include a standard phrasing in the project authorisation decisions for projects that involve testing carried out to satisfy regulatory requirements

15 Need to communicate & collaborate!

16 More information at: Member State authorities for Directive 2010/63/EU National Contact Points as per Article 59 of the Directive: Novo Nordisk Photographs istockphoto

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18 Why this conference? European Citizens' Initiative STOP VIVISECTION! (2015) had requested with 1.17 million signatures to end all animal testing and to annul DIR 2010/63/EC COM response on 3 June 2015 was negative about their key request but positive to their request to engage in a scientific dialogue with stakeholders scientific stakeholder conference Dec 6& (Action 4 in written response)

19 Participants 23 different countries 320 people attended in person (of which 80% scientists) 200 participants on-line Academia and research institutes Chemical, pharma and cosmetics industry Contract testing laboratories Governmental agencies (ECVAM/ECHA/EMA/EDQM/EPA/NIH-NICEATM, ) Publishers Research funding organisations Patient groups to citizens groups Many NGOs active on animal welfare.

20 Talks & panel discussions in 6 moderated sessions

21 Animal Testing Today Biomedical research: strengths & limitations of Alternatives Regulatory testing: strengths & limitations of Alternatives Knowledge sharing on Alternatives & Commission funding Responsible Research The Future: the way forward

22 Exhibition & posters on alternatives SEURAT/EU-TOX NC3Rs DG ENV JRC/EURL ECVAM EPAA

23 Happy participants

24 What next? Conference materials (Programme, report, videos, presentations, posters, participant list) will be available on DG ENV animals website in March JRC Action 1- report published Bookshop-Site/en_GB/-/EUR/ViewPublication- Start?PublicationKey=LBNA28234 Aim to follow up on recommendations in context of on-going activities as well as the EU Pilot Project

25 The European Partnership for Alternative Approaches to Animal Testing of interest also for ILSI member companies?

26 1. WHAT IS EPAA? STATUS Partnership between European Commission & Industry stakeholders. PURPOSE To facilitate development, acceptance and validation of alternative approaches. MILESTONES Created in Renewed for the 2 nd time in SCOPE Operates across 7 industry sectors. Covers Regulatory testing.

27 1. EPAA VISION & MISSION Vision The vision of EPAA is the replacement, reduction and refinement (3Rs) of animal use for meeting regulatory requirements through better and more predictive science. Mission - Promote development and acceptance of alternative methods - Enhance international collaboration & mutual recognition of alternatives - Foster knowledge sharing on 3Rs among the partners - Facilitate dialogue between stakeholders contributing to animal welfare

28 1. EPAA Membership 5 Commission Directorate Generals (DG) 7 European trade federations for 7 industry sectors 35 Companies Companies & SMEs European Commission DG Industry DG Environment DG Joint Research Center European Industry Federations DG Research DG Health & Food Safety

29 1. EPAA Remit 7 industry sectors committed to support alternative methods for regulatory safety testing and/or quality & potency testing: - Animal Health - Chemicals - Cosmetics - Crop Protection - Fragrances - Pharmaceuticals (incl. vaccines) - Soaps & Detergents - Food and Feed?

30 1. EPAA Ongoing Projects list - Harmonization of 3Rs in Biologicals - Exposure predictions (ADME) - Human rabies vaccines (potency test replacement) - Clostridial vaccines (validation of alternative to inprocess control tests) - Advancing 3Rs in Regulatory Toxicology: Carcinogenicity - Acute toxicity testing - Skin sensitisation optimised strategies - Skin sensitisation difficult substances

31 Thank you for your attention!