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 21st Century Toxicology
• USTR Trade and Environment Policy Committee & TTIP negotiations
• Chinese Environmental Mutagen Society 21st 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 7th 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• Rely on an outdated paradigm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?

Welfare 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.

“Final goal of full replacement of procedures

• n 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