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 Causal/disease-modifying Today/tomorrow“Yesterday” increasing understanding of disease biology

Shifting the scale of animal use... „Testing“ Research „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 %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 species- specific 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