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FRAME Chairman issues stark warning

Michael at ZEBETChairman of Trustees of FRAME, Prof Michael Balls issued a stark warning during a speech at a conference in Germany. He said that European legislation is driving laboratory work backwards in terms of animal use.


Authors William Russell and Rex Burch set out the Three Rs system in their book The Principles of Humane Experimental Technique in 1959. It said that, wherever possible, animal tests should be replaced with valid alternatives; if animals had to be used their numbers should be reduced to an unavoidable minimum and their treatment refined to ensure them the least possible pain and distress.


But Prof Balls said none of the Three Rs was being fully applied in spite of being suggested so long ago. He said: “Refinement seems to have been used as a convenient way of ensuring that animal experimentation is seen as respectable and can be allowed to continue, while the fundamental ethical questions are avoided.


“The effort put into a dedicated search for Replacement alternatives has been woefully inadequate. The significance of the high fidelity fallacy - the idea that animals that are most like humans are likely to give the most reliable results in experiments - has not been recognised.


“Europe is going backwards, at great cost to the opportunities offered by the Three Rs. The science is being driven by the politics, even to the point of corrupting the validation process. There is a danger that, rather than having to be independently shown to be reliable and relevant for their stated purposes, replacement alternative tests will be accepted because they are ‘suitable’ – that is, politically convenient. “


He cited the proposed new European REACH legislation (Registration, Evaluation and Authorisation of Chemicals) as one example. The proposal to tests thousands of chemical substances manufactured or imported into the EU in quantities of 1 tonne per year or more has been estimated to need millions of laboratory animals to meet requirements.


He called the plan “totally unworkable, proposed by ill-informed, ambitious civil servants, taken up by ill-informed, ambitious politicians, and then by ill-informed, ambitious governments.”


He called the new 7th Amendment to the Cosmetics Directive “a ruse of no value, seemingly designed to convince politicians and a gullible public that something is being done.”


And blasted a further piece of proposed legislation – the draft proposals to replace Directive
86/609/EEC – “surely one of the worst pieces of draft legislation ever published, which even foresees circumstances in which Member States could permit experiments on Great Apes.”


He called for several changes to bring about more humane science. “Genuine commitment to the Three Rs is needed, leading to identifiable results. Reduction should be achieved without further delay, through better experimental design and statistical analysis.


“Refinement, however welcome, should not be seen as an end in itself.  Replacement is overwhelmingly the most important R . Much greater resources should be invested in the dedicated search for replacement alternatives.”


Prof Balls was speaking at a conference in Berlin, Germany to celebrate the 20th anniversary of ZEBET (Centre for Documentation and Evaluation of Alternatives to Animal Experiments) at the German Federal Institute for Risk Assessment (BfR) and the 50th anniversary of the 3Rs Principle.


Archived Jan 8 2010