13-12-2004 3R Socio-political challenges

Anim.Al.See project

1

Socio-political challenges of the 3Rs

Dr. Helma Hermans

Executive Secretary IVTIP

13-12-2004 3R Socio-political challenges

Anim.Al.See project

2

• 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

Anim.Al.See project

3

• 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

Anim.Al.See project

4

• 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

13-12-2004 3R Socio-political challenges

Anim.Al.See project

5

• 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

13-12-2004 3R Socio-political challenges

Anim.Al.See project

6

• 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)

13-12-2004 3R Socio-political challenges

Anim.Al.See project

7

• 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

13-12-2004 3R Socio-political challenges

Anim.Al.See project

8

• 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)

13-12-2004 3R Socio-political challenges

Anim.Al.See project

9

• 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

13-12-2004 3R Socio-political challenges

Anim.Al.See project

10

• 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)

13-12-2004 3R Socio-political challenges

Anim.Al.See project

11

• 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!)

13-12-2004 3R Socio-political challenges

Anim.Al.See project

12

• 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

13-12-2004 3R Socio-political challenges

Anim.Al.See project

13

• 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

13-12-2004 3R Socio-political challenges

Anim.Al.See project

14

• 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

13-12-2004 3R Socio-political challenges

Anim.Al.See project

15

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