Procedures on Live Animals Emily Mcivor Policy Director, Research - PowerPoint PPT Presentation

Meeting the Objective: Full Replacement of Procedures on Live Animals Emily Mcivor Policy Director, Research & Toxicology Department Humane Society International emcivor@hsi.org | hsi.org

About HSI and our affiliates Our global regulatory science team is actively engaged with: • OECD Test Guidelines, Chemicals & AOP development programs • EU Competent Authorities for REACH and Classification and Labelling • European Chemicals Agency Member State Committee, Endocrine Disruptors Expert Group, etc. USEPA Pesticide Program Workgroup on 21 st Century Toxicology • • USTR Trade and Environment Policy Committee & TTIP negotiations Chinese Environmental Mutagen Society 21 st Century Toxicology Group • • NTP Scientific Advisory Committee on Alternative Toxicological Methods • European Union Reference Laboratory for Alternatives (EURL-ECVAM) • European Partnership for Alternative Approaches to Animal Testing • International Cooperation on Cosmetics Regulation & national laws • International Conference on Harmonization (via ICAPPP) • Human Toxicology Project Consortium • … and many others

Replacement of animals used to test products/drugs • Significant progress in development and validation of animal replacement , reduction & refinement (‘3R’) methods • Role of EU policy mandates as drivers • 1986 Animal Experiments Directive drove the establishment of ECVAM validation center 2003 Cosmetics Directive 7 th Amendment • established phased-in restrictions on animal testing & sales, prompting >300 million € in public/private investments in non-animal health effects tests • 2006 ‘REACH’ chemicals regulation lists ‘promotion of alternative methods for assessment of hazards’ as one of three main objectives

Need for replacement technologies in biomedical research? • Growing frustration with late-stage failure of pharmaceuticals — • Animal models of disease: questionable predictors of efficacy in humans • Costly, time-consuming, may prevent beneficial compounds reaching the market • Rely on an outdated paradigm • Welfare costs to high for limited success?

W elfare cost v expected outcome: “Severe” (i) use of metabolic cages involving severe restriction of movement over a prolonged period; (j) inescapable electric shock (e.g. to produce learned helplessness); (k) complete isolation for prolonged periods of social species e.g. dogs and non-human primates; (l) immobilisation stress to induce gastric ulcers or cardiac failure in rats; (m) forced swim or exercise tests with exhaustion as the end-point.

“F inal goal of full replacement of procedures on live animals” • Regulatory data requirements need frequent updating to keep pace with scientific progress • Use all tools available (Directive 2010/63 etc.) to push biomedical animal replacement innovation • Create EU “Reduction Plan” to kick -start disease model/efficacy paradigm shift • Truly EU-wide effort, international impact • Animal welfare is an EU value, and full replacement an admirable goal • HSI objective: Establish processes for cross- agency consensus: review, innovate, implement.

Thank you for your attention

Revision of EU REACH testing annexes VII-X 1. Uptake of all applicable OECD 3R guideline methods, as well as other scientifically-supported alternative testing strategies 2. Move away from redundant in vivo testing • Multiple exposure routes (oral + dermal/inhalation) • Multiple species (rodent + rabbit) 3. Encourage ‘thoughtful toxicology’ • Examine 2 or more endpoints within a single test • Adopt more efficient & informative study designs • Waiving in vivo studies based on in vitro data 4. With sufficient lead-time for implementation by global industry ahead of 2018 registration deadline