Hello Gisela,

The failure of the European Union to replace animal use in scientific procedures

Directive 2010/63/EU on the protection of animals used for scientific purposes is an updated version of Directive 86/609/EEC, whose chief aim is to reduce the numbers of animals used for experiments by requiring that animal experiments should not be performed when an alternative method exists, and by encouraging the development and validation of alternative methods to replace animals. The latter served as the basis for the European Commission to set up ECVAM, the European Centre for the Validation of Alternative Methods, in 1991.

Neither of these Directives has succeeded in achieving meaningful reduction in the numbers of animals used for experiments. Indeed, in some areas, there has been a marked increase in animal use. This is particularly significant and of great concern with respect to the numbers of animals used and killed in the breeding of genetically modified lines.

The use of the term “alternative methods” has led to much confusion and has misled the public. In particular, there is no legal definition of what constitutes an “alternative method” and in the absence of a legal precedent, the meaning of the term will continue to mislead and confuse the public. This is of particular concern with respect to replacement methods (versus the reduction of animal numbers or the refinement of animal procedures). 

The European Centre for the Validation of Alternative Methods (ECVAM) is not adequately able to fulfil its role to encourage the development and validation of alternative methods to replace animal methods, for several reasons. It is understaffed and under funded. Perhaps worst of all, is that it was given a scientific mission that is impossible to achieve. ECVAM’s terms of reference are based on historical animal data that have never been formally validated, against which it must compare modern, evidence-based non-animal test methods. The absurdity of the situation is made obvious when attempting to compare historical animal data against results obtained using human material, much like trying to compare apples and oranges. 

In the 23 years since its inception, ECVAM has validated fewer than 40 alternative test methods, which translates into fewer than two validated test methods per year. In addition, the vast majority (around 80%) of these “alternatives” still use animals or animal tissues. These facts translate into a betrayal of public trust and a lack of transparency.

Directive 2010/63/EU is out of step with modern scientific knowledge. The result has been the unnecessary use and killing of millions of animals in the EU every year. There is also an indirect negative impact on human health and the environment because of an unscientific reliance on a methodology that is not evidence based (animal tests) and that is not capable of providing safety data relevant to the human species.