The 3Rs principles in the revised
Directive 2010/63 – industry
position
Karin Blumer, Novartis & Magda Chlebus, EFPIA
Ecopa/CAAT Europe , 31 January 2011
Drug development in the 21st century
Symptomatic
“Yesterday”
Causal/disease-modifying
Today/tomorrow
increasing understanding of disease biology
Shifting the scale of animal use...
Research
„Testing“
„The past“: Animals mainly used in pre-clinical safety and efficacy
testing
...from testing to research
„Testing“
Research
Today’s reality: 60-80% of research animals used in discovery of
disease mechanisms and druggable targets
Biomedical research reality
• 60 - 80%of all animals are used in discovery research
– There are only limited alternatives available
– Reduction and refinement are feasible but no full replacement
– Tx-animals are essential to better understand genetic/epigenetic
mechanisms and to discover disease pathways
• Testing encompasses the remaining use 20 to 40%.
– There are legion opportunities for replacement, reduction and
refinement
– Industry has an overarching commitment to the 3R’s in this field
of further developing the drug for use in humans and animals.
• Innovation implies uncharted territory – biomedical research
will continue to be based on the use of animals for as long as
there are unknown or novel biological processes
Review of Dir 86/609 was necessary
Industry objectives during the legal review:
• Secure balance between research reality and needs
and animal welfare
• Implement measures that would have a real welfare
impact
• Avoid unnecessary bureaucracy that would not translate
into animal welfare benefits
• Base policy decisions upon sound science
Good welfare = Good science
• Directive 86/609 and science provide good
incentives for continuously enhancing welfare
• 3Rs principles are the guiding principle – however,
use of alternatives where they existed is not new
• Authorizations and ethical review were
recommended
• Limitations for use of certain species, including
primates was there
Where is new direct welfare benefit?
Provisions with direct impact on daily practice:
• Harmonization of standards across the EU
• Mandatory project (ethical) review and authorizations
• Professional qualifications and continued professional
education
• Animal Welfare Bodies in establishments
• Regular and unannounced inspections
• Harmonised system of severity classification
• Retrospective review of projects
Pharmaceutical industry position
• Many of the new provisions are already part of company
practice
• Industry supports as rapid and harmonized transposition
as possible
• A number of grey areas leave room for uneven
implementation
• Avoiding unnecessary red tape is key to defend
competitiveness of EU establishments
• All three Rs should be equally important - refinement
and reduction should not be neglected
Opportunity to reduce red tape
The directive offers possibility to reduce red tape
• It sets outputs, not processes
• The processes do not need to be bureaucratic but
efficient
• Efficiency should not be measured in number of studies
delayed or blocked by administrative procedures, but
how these translate into better welfare/lesser negative
impact
The Directive needs to be explained
• Some areas reflect the compromises made - use
political language – legal guidance/exemplification,
needed, e.g.:
– Long lasting pain that cannot be ameliorated?
• As many interpretations as readers, also translation
problems, e.g. :
–
–
–
–
Debilitating conditions
Duplication/replication
Procedure/project
Reuse/continued use
• The network of competent authorities will be key for
guidance, experience and good practice sharing
Transparency measures
• Are important from the CSR point of view
• Offer important communication opportunity
• But should not be diverted from their initial objective –
providing more information to lay public about use of
animals and role of alternatives in research
• Communication should also be part of authorities
obligations
Pharma 3Rs survey 2010: current practice
• Industry strives to exceed what is required by law for
scientific, ethical, legislative and reputational reasons
• 3Rs is a consequence of scientific and technological
progress and research rationalization
• Structures to enhance global coordination, share good
practices and disseminate 3Rs topics, incl. reporting to
top management
• Same 3Rs approach to all species. Where speciesspecific approaches exist, these mainly concern NHPs
• High standard requirements vis-à-vis contractors
• All companies support more good practice sharing
within and across sectors
Conclusions
• A number of new measures will have a tangible
benefits, most importantly the EU-wide harmonization
• Replace and Reduction should not be
neglected/undermined
• Red tape should not be the objective but positive
welfare impact
• We need to keep the momentum - constant dialogue
between all stakeholders – to identify and resolve
problems as soon as they arise
• Industry strives to be a transparent, open partner for
discussion in the years ahead
Thank you for your attention 