Brussels, 13 May 2003
While animal welfare groups question the proposed introduction of new chemicals legislation that will increase the need for animal tests, the European Commission is keen to illustrate that it is actively seeking alternatives to such tests. The results of one such alternative, which is claimed could save the lives of 200,000 rabbits every year, was presented in Brussels on 12 May.
Highlighting the dilemma faced by the scientific community and legislators, EU Research Commissioner Philippe Busquin outlined the Commission's desire to avoid animal suffering and waste of life, but at the same time to ensure human safety. Now that a ban on cosmetics testing has been passed by the European Parliament and the Commission's proposals regarding stricter rules on chemicals testing have been outlined, the need for such alternatives has become more acute. The Commission has thus far invested around 65 million euro into such research.
A new set of tests developed through an EU funded project is one such viable alternative. The six tests, developed by a consortium involving national control laboratories, test developers and companies, present a new method of detecting potential fever-causing agents (pyrogens) in drugs using human blood cells instead of rabbits. The new methods monitor the response of human leukocytes, which release inflammatory mediators in response to pyrogenic contamination. Such tests are needed for all drugs that are injected, and tests are not performed only once, but for every batch of the drug in question.
'In comparison with animal testing, these tests are less expensive; they offer quantifiable and more efficient results,' said Mr Busquin. 'The study has shown that they fulfil the necessary conditions as substitutes for animal experimentation.'
The tests are currently being validated by the Commission's European centre for the validation of alternative methods (ECVAM), located at the Joint Research Centre (JRC) in Ispra, Italy, and after approval by Member States' regulators on a case by case basis, they are expected to replace the rabbit test. The tests are already being used in over 200 laboratories across the world. 'This is the largest successful validation study ever,' declared Thomas Hartung, head of ECVAM.
Dr Hartung claimed that alternative testing methods should not only be developed in order to replace animals. 'The alternatives can outperform in vivo tests and they have a lower cost,' said Dr Hartung. 'Today the state of the art in technology is not represented in animal testing,' he added.
The search for alternatives is therefore receiving increasing support from the scientific community. 'We have seen a dramatic change in attitude. Ten years ago this was a niche product followed by a few mad crazy scientists who thought animals were more important than humans. But the alternatives have proved themselves,' said Dr Hartung. The new methods have further potential applications, including the testing of baby food, cellular therapies, medical devices and pollution control in the workplace.
Asked whether he thought this is the beginning of the end for animal testing, Dr Hartung said that it is a question of belief, but that he does not expect such a huge step within his lifetime. 'In the future we will have technology that we can't imagine now [...] but it will be much more challenging in some areas,' said Dr Hartung. He cited the example of monitoring changes over the lifetime of a cell, which is 'very difficult to do in a test tube'.
But huge progress is expected in the field. 'The political will is there and the results are there,' said Mr Busquin.
For further information on ECVAM, please consult the following web address:
http://ecvam.jrc.it/index.htm
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