ANIMAL RESEARCH ACT ……. 20 YEARS ON

1. ANIMAL RESEARCHACT ……. 20 YEARS ON

2. thejourney begins…..

3. 1978 - Australian Veterinary Assoc receives brief from NSW government * Separate legislation * Comprehensive review of existing legislation * Ontario legislation as model * Extensive consultation 1983- AVA submits proposal to government 1985- Animal Research Act passed

4. Animal Research Act 1885 An Act to protect the welfare of animals used in connection with animal research. Guiding principle– to create legislation which takes into account the rights of opposing groups to hold and express differing views and which attempts to address and recognise issues on which opinions differ in such a way as to bring a degree of acceptance from all concerned. Enforced self-regulation Public participation in the decision-making process

5. Key Elements ….. • Focus on ‘duty of care’ • Central role for ACEC • approve and monitor all animal use • power to direct appropriate treatment • External membership of ACEC • ARRP overview of activities • animal welfare organsations • reports to Minister/Parliament • Linked to Code of Practice • Separate legislation /enforced self-regulation

6. AVA Proposal Background: • Recognise need to use animals for scientific purposes but to do so is a privilege. • Recognise community concerns • International recognition of ethical responsibilities • Dual needs - scientific & social • Legislation to define minimum standards • Responsibility of institutions and investigators

7. AVA Proposal….. The proper management of animals used for scientific purposes is essential for their welfare and the validity of research data.

8. Issues considered in development of legislation -NSW Submission SSCAW • Changing community attitudes • Importance of human/animal bond • Moral standing of animals ? • relevant differences ? • setting limits and on what grounds? • Australian COP - already contained essential elements of legislation • Public perception of science • Public participation > undue controls

9. Legislative framework …. 1. Providing a balance between accountability for both the decision to use animals for scientific purposes and the conduct of those activities and the value of freedom of scientific enquiry. 2. Judgements need to reflect a balanced view especially where lack of community consensus.

10. The Animal Research Act …. • Style and purpose of Act reflects changing community attitudes • Mechanisms to ensure responsibility & accountability • Goal to extend legislation to promote 3Rs • External monitor of institutional activities • Public particpation at both levels of accountability • Code of Practice - principles to guide conduct

11. Role of ACEC • Major social benefit by bringing together people of differing views • Serve to amplify awareness of scientists • Improved review - focus on animal concerns • Seek reconciliation of human needs and animal interests • Pivotal role for lay/non-scientific members • Knowledge basis for judgement also essential • Acknowledged critics of process

12. Institutionalcommitteeswill be effective by bringing considered, collective judgement to the decision to use animals for research and by the close supervision they can bring to the conduct of such research … they must be informed of issues, aware of community and scientific sensitivities and committed to the resolution of conflicts.

13. Senate Select Committee on Animal Welfare Report on Animal Experimentation 1989 • Supported separate legislation based on duty of care and respect for animals • Supported model of enforced self-regulation • Supported primacy of responsibility of investigators • Noted benefits of accreditation vs licensing • Cautioned the need to balance between self-regulation by institution and government controls.

14. Ethics committees are the lynch pin in the system of responsibilty and accountability. It is the collective wisdom of a committee, with each member bringing his or her own expertise to bear on the matter together with other members, that enables a collective judgement to be made.

15. Foundations of Legislation • Duty of care core value • Primacy of responsibility of investigator • Pivotal role for institutional ACEC • Participation of wider community • Institutions < > government

16. 1986 - Animal Research Review Panel Appointed - Code of Practice - Accreditation process 1989 - Act amended LD 50 & Draize tests 1990 - Regulations proclaimed 1991 - Act introduced 1992 - Site Visit program

17. Code of Practice • Incorporation of a code of practice into a legislative framework based on principles of good conduct rather than prescription of practices most effective way of promoting good practice and the 3Rs • Guidelines should clearly lay down general principles and criteria by which practices and procedures can be judged.

18. Aims to • emphasise responsibilities, • ensure animal welfare is always an essential factor, • ensure animal use is valid, • minimise numbers • limit pain and distress • promote replacement. 1990

20. Australian Code of Practice #Self regulatory system Responsibility & Accountability #Ethical issues Framework for Review #Good Scientific Practice < > Animal Welfare # Principles of Practice Evidenced-based

21. Accreditation…. In keeping with the notion of promotion of good practice - it incorporates peer review and mandates critical and informed review and appraisal. To be effective the agency responsible must have sufficient knowledge to evaluate practices and procedures and be able to reflect in its judgement a balanced community view. Assessment by a panel of persons , including community representatives, should achieve this.

22. Scope of activities today • 103 accredited institutions • 24 licensed animal suppliers • 75 accredited schools • 2,315, 328 animals (2004) • monitored by AECs and ARRP

23. Outcomes ….. • Robust processes • AECs • ARRP • Public involvement • Accountability • Identify animal welfare benefits • 3Rs • High standards of care

24. ARRP Annual Reports • Produced annually since 1987 • Documents administrative arrangements • Panel Membership , meetings, attendance, site visits, subcommittee activities • Issues arising from site inspections and other ARRP activities and remedial actions • Statistics on animal use (since 1992) • Policies and guidelines • Initiatives to achieve 3Rs

25. Replacement • Use of models, videos, interactive programs, abattoir specimens in teaching • Extensive use of in vitro systems before progress or animal studies • In vitro production of monoclonal antibodies • Development of in vitro methods to replace animals • Habitat assessment prior to trapping

26. Reduction • Statistical assessment • Trials follow GLP or GCP - data quality • Review of breeding protocols - overbreeding • New analysis methods -dec. tissue sample • Sharing tissues • Wildlife studies - number of ways to dec samples reported • Collaborative projects eg antibody production

27. Refinement • Use of chicken eggs to produce PABs • Setting early endpoints • Group housing / companions • Environmental enrichment • Education programs • Pain management esp. analgesics, monitoring • Baited hair tube traps/pitfalls modified • Alternative methods for identification

28. Strategic Plan -Goals • The principles, processes and responsibilities of the Code are actively embraced • All use of animals consistent with the Code & Act • Procedures regularly reviewed and refined to minimise numbers and reduce impact • Pain & distress promptly recognised & relieved • High standards of housing and care • Access to information about animal use

29. Support for AEC Process • Site inspection reports - detail, analysis, supportive evidence • Development of Policies (17) and Guidelines (21) • Meetings for AEC members • Meetings - special issues • Model Protocol Form • Animal Ethics Infolink

30. International Developments • Ethical principles • Criteria to assess animal welfare outcomes • Evidence-based guidelines to inform process • Harmonisation of guidelines

31. Commitment to and engagement with process by all involved • Acceptance of diversity of views • Good communication • Focus on core issues • On-going review and promotion of animal welfare standards • Education and evidence-based practice underpinactions

32. Ongoing Challenges • Identifying barriers to participation & developing strategies to respond • Development, implementation and promotion of the 3Rs • Effective pain management • Housing and care - species needs • Supporting evidence-based practice

33. Responsibility.... • Individual • Institution • Relationships • Individual < > AE Committee • Individual < > Institution • Institution < > Community

34. Acknowledgments • Members of Animal Ethics Committees • Members of ARRP • Researchers , Teachers • Animal Technicians • Animal Welfare Unit

35. thejourney continues