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13-12-2004 3R Socio-political challenges
Anim.Al.See project
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Socio-political challenges of the 3Rs
Dr. Helma Hermans
Executive Secretary IVTIP
13-12-2004 3R Socio-political challenges
Anim.Al.See project
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• Socio-political realities (project) (1):
• The rationale urging a review of the 3Rs
includes:
– Stalemate debate between proponents/opponents
animal use
– Recognition that animals have intrinsic value
– Science no longer authoritative, not sole engine of
progress
– Increasingly holistic view
13-12-2004 3R Socio-political challenges
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• Socio-political realities (2):– More and deeper social and political conflicts
– How to pursue economic prosperity, knowledge andhealth?
– Animal experiments more socially relevant (resultsneeded) AND socially contested (doubts on efficacy,efficiency, irrelevant purpose, science no panacea)
Considerations led to conclusion: there is a need formore inclusive and encompassing approach to 3Rs –how to realize?
13-12-2004 3R Socio-political challenges
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• Key for Realization
• consider all 3R’s at once and their interactions
• consider 3Rs as a guiding principle that
structures ethical perspective on animal
experiments
– Narrow interpretation: 3Rs is a common moral
standard
– Broad interpretation: 3Rs is starting point of debate
on ethical and political issues in animal
experimentation
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• Recommendations (1) – the
context
• Promote awareness of changing social and
cultural context – science is not sole authority
• Recognize and balance that there are multiple
and plural normatives (scientific, legal,
economic, political, cultural, ethical)
• Promote value of risk assessment and scientific
knowledge in general
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• Recommendations (2) –
• Promote 3Rs instead of replacement alternatives only
• Promote broad versus narrow interpretation of 3Rs
• Adopt inclusive approach to 3Rs: more than scientificconsiderations; welfare during lifetime; broader than justsingular experiment
• Draft practical and ethical guidelines what to do in 3Rconflict situations
• Disseminate and promote updated 3R principles(particularly in new and candidate member states)
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• Recommendations (3)• Put reduction and refinement strategies on political
agenda (public interest, legislators)
• Create economic incentive to develop/implement 3Rs
(tax deduction, fixed % research, budget the number of
animals per user, issue animal-use audits)
• Implement code of ethics
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• Missing: where are we in the innovationcycle? (1)
Draw parallel between 3Rs and societal awareness on pollutionand implementing environmental policies
– Awareness society: 1960-1980/90, now common in West, catching upelsewhere
– First legislation: 1980-1990
– Results: cleaner environment, new technologies, new SMEs, ingrainedin society
– Worldwide: 2004, Kyoto protocol: worldwide recognition, creationnorms, will be trade in emission options, new legislation also createsnew commercial opportunities (lower costs, trade-offs, better publicrelations image), clear idea of the ‘villains’ (non-signatories)
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• Where are we in the innovation cycle? (2)
• How about awareness and implementing policies in 3R’s??
– Awareness society: 1960-1980/90, increasing, not yet common in West, stillrealm interest groups and experts in the field, absent elsewhere
– First legislation: 1980-1990; significant in 2003 (EU ban on cosmetic testing), isboosting interest; threat REACH, further significant interest booster
– Results: fewer experimental animals (not enough reduced); often betterexperimental results, new technologies and tests, new SMEs, not yet ingrainedin society (perception, ethics, relevance)
– Worldwide: EU ahead, USA catching up, far from worldwide recognition,creation norms in infancy, economic value only evident in compound discoveryand development processes, new legislation also creates new commercialopportunities (lower costs, faster discoveries, better public relations image), nochampions yet
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• Where are we in the innovation cycle? (3)
Conclusions
• Adoption of the concept is taking place, but a bit slower thancompared to environmental innovations
• Legislative push has not been detrimental
• Image 3Rs needs improvement (not just ethical issue, but makesgood science, good business sense, good legislative sense)
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• Missing: Industrial realities (1)
• Industry is driver of innovation (in vitro tests, HTS,genomics/proteomics), spill over to in vitro toxicology
• Industry at receiving end of legislation (cosmetic testing ban,REACH)
• Industry increasingly aware 3Rs (more than academic institutions?)
• Industry needs new thinking on risk assessment (use of differentsets of data?, different way of thinking?, decisions based on in vitrostudies?
• Decisive factors: better product, improved competitiveness, lowercosts, better image (share holders!)
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• Industrial realities – a case story (2)• Company X, large pharmaceutical company, worldwide
• Since 2 years corporate policy on 3Rs = essential!!
• Other essentials:
– Clear administrative procedures
– Commitment to 3Rs
– Availability resources
– Knowledge management
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• Industrial realities – a case story (3)
• Added in corporate policy 2R’s to existing 3R’s:
– R of Respect for animals
– R of Recognition of important role animal experiments
• Impact:
– Substantial reduction of number of animals used (>50%)
– Weeded out obsolete procedures
– Raise awareness 5Rs among all employees
– Best results when 3Rs are integrated into existing platforms,when integrated into everyday operations
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• Industrial realities – other industrialcase stories (4)
• Best implementation when:– Support from management/corporate policy
– Dedicated ethics/3R officers
– Dedicated resources
– Continuous awareness building (internally and externally)
– Continuous review internal procedures
– Pride in new technologies/own achievements
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Conclusions:
– 3Rs is following a ‘normal’ acceptance pattern (but a bit slowerthan i.e. environment. Cause: not direct impact on life?
– Maturity not yet reached – 3Rs not yet accepted as ‘normal’socio-economic and political behavior, thus work to do onawareness
– Realistic legislative push will help (as with environment)
– Positive encouragement will help (get rid of stigmatization andpolarization on side of all parties, award ‘good behavior’)
– Anim.Al.See project shows need for broader scope andintegration, reflects move towards maturity