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New EU Chemical Legislation

The facts about the REACH programme

[December 2006] - The REACH (Registration, Evaluation and Authorisation of Chemicals) legislation was adopted by the Environment Council on 18 December 2006 and will be entered into force on 1 June 2007.

Over the next 11 years In Europe, the amount of animal testing is set to soar under this new EU legislation. Some 30,000 substances will be tested to evaluate their impact on health and the environment. These substances include those for which no safety data is currently available. Though the evaluation of these substances is essential, the continued misuse of animals to do so is neither ethical nor an effective indicator as to how the substances might affect human health.

The European Community has put in place guidelines to minimise unnecessary testing, through sharing of data, yet estimates of the number of animals involved are in the region of 10 million.

In order to reduce the suffering we urge the European regulatory bodies to recognise and use non-animal alternatives throughout the REACH programme.

For the REACH programme to effectively identify potential health and environmental risks, it has to use reliable methods of testing. However, animal tests cannot be said to be reliable, as these instances show:

REZULIN succeeded in animal tests, and went onto the US market in 1997 for the treatment of diabetes, only to be withdrawn in 2000 following 63 confirmed fatalities.

VIOXX succeeded in animal tests, went onto the market as an anti-arthritis drug, but was withdrawn in September 2004 after extended clinical trials revealed increased risk of heart attack and stroke.

SEREVENT was highly successful after its launch in 1994, but this anti-asthma treatment performed very badly in rats and mice, which could have led to its withdrawal long before reaching the market. Fortunately, researchers decided that the data was not applicable to humans; but how many more quality drugs have been lost for the same reason?

TGN1412 TeGenero was tested successfully on animals, but when tested on humans it caused multiple organ failure. Within minutes of being injected with the drug, the six originally healthy men began to scream in terror, suffering with breathing attacks, convulsions and severe pain. The German manufacturers of the drug state that they did not expect this kind of reaction and that these results do not reflect those gathered from the earlier laboratory (animal) experiments.

A group of experts recently conducted an experiment into the validity of animal research by implementing a systematic review of animal experiments and clinical trials, publishing their findings in the British Medical Journal. The scientists examined 228 animal-based drug analyses, focusing on six representative areas of research, comparing animal research results against human trial results, to assess whether they matched or not. Out of the six cases, only half of them matched, suggesting that the results from animal experiments are not necessarily a reliable source of research. The report highlights that the “Lack of concordance between animal experiments and clinical trials may be due to bias, random error, or the failure of animal models to adequately represent human disease.”

It’s easy to see that not only is animal testing objectionable on ethical grounds, it is also an imperfect method which cannot be relied upon. If the much needed REACH legislation is to be effective it is essential that it uses testing methods that provide valid results.

To voice your views on this matter, please write to your MEP. Include the following points:

  • Tell them you are writing about the REACH programme, and the increase in animal testing that will arise from it.
  • Point out that the purpose of the REACH programme is to provide accurate data, identifying which substances are safe and which unsafe.
  • Emphasise that the use of animals to test substances is both unethical and unreliable in predicting how they impact on human health.
  • Urge your MEP to support moves to recognise alternatives to animal tests, and to lobby for non-animal alternatives to be used throughout the programme.

You can address and send your letter to:

UK Office of the European Parliament, 2 Queen Anne’s Gate, London SW1H 9AA. Alternatively you can send the letter to your MEP’s constituency office. For full contact details, visit www.europarl.org.uk.


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