Press release - March 30th, 2009

EU directive lags woefully behind the science

With a crucial vote about to take place on Tuesday 31st March, by the Agriculture Committee (AGRI) of the European Parliament, Antidote Europe has made a final concerted attempt to salvage what it can from the amended version of directive 86/609, relating to animal experiments.

Antidote Europe has sent the following message to all members of the European Parliament, urging them to include a clause in the revised version of the 86/609 directive, to facilitate the adoption of any scientifically sound, non animal method, based on the "weight of evidence" principle. Such a clause would significantly increase the scope and application of non animal methods in practice.

Media contacts : Claude Reiss (33 (0)4 76 36 35 87) ; André Ménache (33 (0)4 68 80 53 32)

Dear Member of the European Parliament,

We would like to bring the following points to your attention, prior to the AGRI committee vote on March 31st, 2009, and prior to the plenary vote in May 2009 on the revision of EU Directive 86/609/EEC.

Re: application of directive 86/609/EEC, of REACH regulation 1907/2006 and of existing EU regulations and directives, mentioning the 3Rs.

Although the stated aim of Directive 86/609/EEC is the protection of animals used for experimental and other scientific purposes, its ultimate purpose is the preservation of human health. The fundamental principle of the 3Rs (refinement, reduction, replacement) is the dominant theme to be found throughout Directive 86/609/EEC. However, the 3Rs concept is now an anachronism and unable to keep pace either with scientific progress or scientific excellence. Indeed, the past director of the European Centre for the Validation of Alternative Methods (ECVAM), Professor Thomas Hartung, was quoted in the journal Nature as saying that the animal tests that have been used for decades to assess human toxic risk are "simply bad science" (1). Many of these same animal tests will continue to be conducted in the revised 86/609 directive, under the smokescreen of the 3Rs.

In addition, the European Commission (EC) has imposed barriers to the acceptance of sound scientific methods, instead of facilitating the submission of such methods to its own relevant authority, ECVAM. The EC's incoherent approach is especially regrettable with respect to the REACH regulation 1907/2006, where the regulatory poisoning of millions of animals will be favoured over modern toxicological methods - such as toxicogenomics - the significance and urgency of which the EC fails to comprehend (2). Given the many undisputed advantages of toxicogenomics over animal tests, including relevance to the human species, speed and cost, it is reassuring to know that this technology was voted into the REACH regulation by the European Parliament three years ago, but it is bizarre that it is not being applied.

Validation via weight of evidence approaches

According to a former head of ECVAM, it is "not always necessary, or even possible, to conduct a practical laboratory study to establish the validity of tests or testing strategies. A weight-of-evidence approach aims to use already available information in a structured, systematic, independent and transparent assessment" (3).

For example, article 1.2 of Annex XI of the REACH regulation 1907/2006 allows for the submission of non animal methods, based on a "weight of evidence" approach:
"There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by the Commission or the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous property.
Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:
- further testing on vertebrate animals for that property shall be omitted".

It is essential that the revised version of Directive 86/609/EEC include a clause similar to the one above in REACH, so as to allow modern scientific methods to be implemented with a minimum of delay, for the preservation of human health.

Antidote Europe is a non-profit association created by scientists and researchers working towards biomedical research methods that represent sound science.

We would be happy to provide any additional information. Please do not hesitate to contact us.

Sincerely,

Claude Reiss PhD
President

André Ménache MRCVS
CEO

References:
(1) Nature 438, 144-146 (10 November 2005)
(2) http://www.antidote-europe.org/plainte_gb.htm
(3) Balls M, Combes R. ALTEX 2006; 23 Suppl: 332-5. Validation via Weight-of-Evidence Approaches.