Horizon 2020
Advancing Safety Science and Health
Research with Modern, Non-Animal Tools
Nina Cohen, PhD
Science Policy Officer
Research & Toxicology Department
About HSI
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One of the world’s largest animal protection organisations
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EU activities
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11+ million members globally
Programmes in Australia, Canada, China, Europe, India, Latin America, New
Zealand, United States & beyond
Shark-finning
Seal products trade
Animal experiments (directive, cosmetics, REACH, biocides, Horizon 2020)
Approach
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Science-driven
Representing views of supporters during policy-making & legislative processes
Replacing Animal Tests » Policy Drivers
DECISION NO. 1982/2006/EC ON FP7
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“Research activities should … reduce
the use of animals with a view
ultimately to replacing animal use.”
REACH – ARTICLE 1.1
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“The purpose of this Regulation is to
ensure a high level of protection of
human health and the environment,
including the promotion of alternative
methods for assessment of hazards of substances, …”
COSMETICS DIRECTIVE – ANIMAL TEST & MARKETING BANS
Replacing Animal Tests » Scientific Drivers
POOR PREDICTORS OF HUMAN SITUATION
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Species differences in genetics, biochemistry, etc. do matter
9 out of 10 animal-tested drugs fail because they’re
not effective in humans or present safety concerns
POOR EFFICIENCY
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Animal tests can take months or years per chemical
Not suitable for testing tens of thousands of chemicals, mixtures, etc.
LIMITED BIOLOGICAL UNDERSTANDING
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Animal tests tell us little about how chemicals cause toxic effects
Horizon 2020 » Commission Proposals
KEY OBJECTIVES
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Tackling societal challenges
Creating industrial leadership
Promoting scientific excellence
SOCIETAL CHALLENGES INCLUDE…
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Alternatives to animals for safety & effectiveness testing
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Greater use of non-animal tools (e.g., “-omics, human cell
systems) in health research to better understand human
disease
“21st Century Toxicology” (Tox21) Approach
“… envisions a not-so-distant future in which virtually all
routine toxicity testing would be conducted in human cells or
cell line in vitro by evaluating cellular responses in a suite of
toxicity pathways using high-throughput tests, that could be
implemented with robotic assistance.”
—US National Research Council
“Animal testing won’t disappear overnight, but the agencies’ work signals the beginning of the end.”
—Dr Elias Zerhouni, Former Director, US National Institutes of Health
“21st Century Toxicology” (Tox21) Approach
Horizon 2020 » HSI Priority #1
EUROPEAN “TOX21” FLAGSHIP RESEARCH INITIATIVE*
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Uncover how chemicals disrupt normal processes in the human body at
the level of genes, proteins & cells (“pathways of toxicity”)
Develop human-relevant cell systems to test for disruptions
Develop computer models to relate cell test results to real world
KEY FEATURES
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“Top-down” strategic focus
Public-private partnership with industry
International collaboration
* AS SUGGESTED BY THE EU FP7 COORDINATION PROJECT AXLR8
Horizon 2020 » HSI Priority #2
BETTER TOOLS FOR HEALTH RESEARCH
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Prioritise research to define human “disease pathways”
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Increase proportion of EU health research funding
dedicated to human biology-based (non-animal) tools
ETHICAL CONSIDERATIONS
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More robust ethical & scientific merit review processes for EU-funded
animal experiments
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Substantiation of claims regarding human-relevance of animal models
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Retrospective assessment of all EU-funded vertebrate experiments
expected to cause more than “moderate” suffering, regardless of species
Horizon 2020 » Next Steps
TIMETABLE & MILESTONES
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4 May – Draft report sent for translation
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15 May – ‘Human Toxome Project’ event hosted by Vittorio Prodi
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30-31 May – Consideration of draft report
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7 June – Deadline for tabling amendments
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11 July – 1st consideration of amendments
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24 September – 2nd consideration of amendments
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8-9 October – ITRE committee vote
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amendments
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EUROPEAN UNION
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