Ahead of the vote on the Commission's proposal on the Directive on the protection of animals used for experimental purposes it is necessary that interested broad public knows how the issue is evolving in the Committees of the European Parliament. 

As the draftswoman of the opinion of the ENVI to the lead Committee for agriculture and rural development I made the following statement:  

It is my firm belief that the opinion on the proposal of the Directive on the protection of animals used for experimental purposes which I drafted for the Committee for Environment, Public Health and Food Safety was a balanced one. While supporting the Commission's proposal I added some stronger animal welfare and wild-life conservation amendments.

Main points were strengthening of the "3R's" principle (replacement, reduction, refinement of the animal tests), better inspection (EU and member states) on infringements and communication of those to the public, stricter rules on non-human primate use (the phasing-out of wild-caught animals), ban on great apes use, and strict rules to allow tests causing "prolonged severe suffering".

The industry and research community were lobbying intensively against several crucial parts of the Commission's proposal on the grounds of following thesis: Industry is trying hard to reduce, refine or replace animal experiments. No legislative incentives are therefore necessary. Yet, “should you not allow that the experiments continue without (too much) interference from outside – people/children will be dying”. A conservative member of the environment committee accused me of being responsible for "killing the research and therefore children..."

This is absurd. I fully acknowledge the efforts made by the industry and by the research community since 1986. Yet, we know from other areas that the European legislator’s involvement has been “the” accelerator in the efforts for replacement of experiments with non-animal alternatives. Targets are working. We have seen how implementation of cosmetics' directive has ensured the validation and implementation of replacements for a range of tests, and as result, how it has cut animal use.

The difference is, indeed, in the way of thinking. If we agree to move a few inches and to look at our common aim (human health) from a different angle we might achieve more objectives sooner. We might think of combining currently irreplaceable animal experiments with a range of multidisciplinary, sophisticated techniques that allow the safe and accurate examination of potential effects of medicines on humans.

Two examples:

1. Advances in modern scanning techniques are enabling no-invasive neuroimaging of the human brain, providing unprecedented understanding of mental illness, neurodegenerative diseases, vision, hearing, speech, pain, and more. This provides data of direct relevance to patients, who can be asked to describe how they feel. In 2008, at a meeting in the EP a comparison of data from scanning studies of human patients and electrodes implanted in the heads of monkeys was presented. The same level of data was obtained – and the first was of direct relevance to people.

2. By the time the monkeys are being used for experiments, thousands of smaller animals would already have died to test the same product. Cannot the current rule of testing medicines on a second animal, apart from rodent, be questioned? Yet, before UK test drug TGN1412 had been given to human volunteers and caused terrible, almost fatal, and permanent side effects, it was tested in laboratory monkeys in doses 500 times higher, without side effects. Now many agree that this disaster could have been avoided by using advanced technology of microdosing.

If the EU is serious about replacing animal tests with advanced technology, it is vital that the animal tests are ended earlier in the programme – to be replaced by methods based upon human data, such as microdosing. Industry and regulators, and much of the academia, are resistant to change, but it remains the reality that even the primates are an inaccurate predictor of human responses.

Also we know that not all research in the medicines is devoted to incurable diseases, such as Alzheimer’s, Parkinson’s, AIDS, etc. Looking through slightly different angle at the entire range of animal testing for scientific purposes would help us to differentiate between necessary and not so necessary drugs or still necessary animal experiments and already replaceable ones. 

*****