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From law to labs: EU's tide change for animal experiments
At the beginning of 2015 the European Commission was handed a European Citizens' Initiative (ECI) petition with more than 1.15 million certified signatures asking for a paradigm shift in the way research is conducted.
The ‘Stop Vivisection’ petition called for the Commission to go beyond its new directive proposals (directive 2010/63/EU) on the protection of animals used in science given “clear ethical objections” and scientific limitations of animal models - and instead make a new proposal that “does away” with animal experimentation and “makes compulsory” the use of data directly relevant for humans in biomedical and toxicological research.
The call follows a precedent seen already in the cosmetics sector.
The EU outlawed animal testing for new cosmetics and their ingredients back in 2009. In 2013 this was extended to include non-EU products, effectively placing a complete ban on the sale of cosmetics developed through animal testing.
Yet the Commission has been reluctant to respond with such dramatic measures across all industries.
The total number of animals used for experimental and other scientific purposes in 2011 was just below 11.5 million. This was a reduction of over half a million animals used in the EU compared to that reported in 2008.
Rodents and rabbits represent more than 80% of the animals used, with mice the most commonly used animal accounting for 61% alone, followed by rats at 14%.
No great apes have been used in EU since 1999.
Commission vice-president for jobs, growth, investment and competitiveness said the Stop Vivisection initiative came “at a time of transition – thanks to major technological advances, Europe is reducing the use of animal testing.
“However, a complete ban on animal research in the EU would be premature and it would risk chasing out biomedical research from Europe".
Instead the Commission said it would try to enable faster progress in the uptake and use of alternatives approaches based on cell and tissue cultures and computer modelling.
And it’s put its money where its mouth is with this aim.
Funding conditions for the Commission’s Horizon 2020 incentivise non-animal techniques.
The Horizon 2020 programme for 2014-2015 contained four topics addressing predictive safety testing, of which at least two (health and food safety) require “non-animal approaches”.
This strategy centres on a continuation of the 3Rs principle - Replacement, Reduction and Refinement – a concept that had been around since the late 50s.
Key EU organisation the European Food Safety Authority (EFSA) says it is “committed” to the 3Rs.
But speaking with NutraIngredients recently, one member of EFSA’s panel on Dietetic Products, Nutrition and Allergies (NDA) said animal models were still being used widely in the dossiers it received.
He said genotoxicity and mechanism models were two areas where alternatives were being increasingly used. For example for genotoxicity tests, in vitro would only be followed by in vivo tests if a problem had been flagged.
However, he said alternative testing models would have to be verified by EFSA to be accepted as part of a dossier.
And with firms already investing huge amounts of money and resources in health claim and novel food applications, it may be the case that companies are unlikely to want to take the risk of submitting an emerging model as proof of their mechanism or ingredient safety.
Dr Jacqueline Whyte, senior scientific officer at publicly funded organisation Science Europe, said there was a changing culture around animal testing and an intensification of debates that had been on the table for a long time.
“It’s an important question: are we doing the right research and are we doing it in the right way?”
The Stop Vivisection petition had “really stirred a lot of good discussion” and Science Europe was planning further work and workshops on this issue.
“There’s definitely an opportunity to further share new lessons on this, signpost and explore opportunities.”
Yet she said more work was needed on developing the alternatives – and cost remained a key challenge for expensive options like the use of human primary cells.
She said a survey from the Commission’s Joint Research Centre (JRC) – prompted by the Stop Vivisection petition – was a good way to spread the word on new techniques already being used.
“At conferences it’s very clear – there’s lots of discussions on this – both industry and academia are already using other models like computers and
Big funding, big responsibility
Science Europe and its members funding and performing research support the 3Rs concept.
“And they [the funders] definitely question and are increasingly aligning on questioning the use of animals in the research that they fund and this is ongoing work.”
Science Europe members channel €25 billion of public money into research – and Whyte said this was a responsibility to tax payers they took “very seriously”.