The good news first: this new directive is definitely a step forward. This was intentioned, since the old directive is from 1986 and was hopelessly outdated, especially with a view to the development of alternative methods and the coming up of transgenic animals. Additionally, there are new insights into the capability for suffering in animals, that had to be taken into account. What is different now? To Swiss readers, a lot of things will appear familiar.
For the first time, animals bred for experimental purposes are included – as well as mammalian fetuses in the last trimester of development.
A grading of severity and an upper limit of distress that can be inflicted on animals.
An elaborate prospective analysis containing the goals of the planned research project, the applicability of 3R methods as well as the assumed degree of severity shall make a harm-benefit analysis. In addition, it is decided whether the project requires a retrospective analysis as well. This is possible with projects that are considered critical with respect to animal welfare. It evaluates whether the goal of the project was achieved and the actual severity degree that the animals were subjected to. An authorization is limited to a maximum of 5 years. Inspections have to take place at least once a year, partly unannounced. The prospective evaluation can be simplified and abbreviated within member states, except if the project involves primates or experiments at the highest degree of severity.
Binding minimum standards for housing and care of laboratory animals are introduced; after a very general catalogue there are additional species-specific rules. An “enrichment strategy” has to be implemented and is checked regularly. Animals are to be controlled for their well-being at least once a day; and isolation of social animals has to be an absolute exception. If it is unavoidable, visual, auditory, or tactile contact has to be possible. Young primates must not be separated from their mothers before they are at least 6-12 months old (depending on the species).
Each institution has to have an animal welfare body, who is responsible for implementation and instruction of personnel in the matters of 3R and who keeps him-/herself informed on the relevant developments in this field.
Improved transparency through more frequent reporting and local inspections should serve to recognize a lack of implemention of the directive. The European Commission can request the respective documents from the member states for audition.
In principle, the use of apes for research purposes in the EU is banned; are they to be used, the EU Commission and a qualified majority of other member states have to approve.
An important feature for us is the consensus in the directive saying that in the European Union
a) the ultimate goal is the replacement of laboratory animals
b) this is to be achieved by development and implementation of alternative methods
c) 3R methods are the key to a better science
Even animal welfare activists voice the opinion that with this directive, Europe is going to have the most progressive ruling on laboratory animal welfare in the world.
But of course, there is always a “but”:
Article 4 is devoted to alternative methods, but it is phrased in a very vague and general way. 3R methods are to be applied “whenever possible” whatever that means.
In spite of a ban on primates exceptions are made in the next paragraphs, and these exceptions cover in principle all areas of research. The Directive is speaking of permitted experiments on non-human primates, if they are to adress “debilitating diseases”of humans. This is defined in the same directive as: „A debilitating clinical condition for the purposes of this Directive means a reduction in a person’s normal physical or psychological ability to function“.
For the discussion of an exact definition of this term, as well as determining the meaning of key terms like “severe” and “distress” an expert panel will meet. Until these terms are not folled with concrete meaning, an implementation of this directive will not be possible.
A first time feature of this Directive is the fact that member states are not allowed to exceed its standards after it is implemented. This is highly unusual, since the point of a directive is the establishment of binding minimum standards. Normally, a member state can implement stricter ruling. In this case, this is not permitted. The question is whether this is legally feasible. The concern is of course that this directive may again become an obstacle to animal welfare in the long run, if member states are not capable of reacting in a flexible manner to unexpected developments or improvements in animal welfare.
Nevertheless, this new directive creates a lot of promising possibilities, and it is up to the member states to implement it properly:
- By creating a central data bank in which the pro- and retrospective evaluations are accessible- this can help to prevent multiple experiments
- With programmes which allow to share tissues of animal killed for experimental purposes between member states and reduce animal numbers
- With the creation of 3R centers, similar to the Centre for Documentation and Evaluation of Alternatives to Animal Experiments in Berlin, which function as advisors for regulatory authoriteis and researchers
- And (finally) a focussed financing of alternative methods
Animalfree Research is going to follow these efforts closely and support local authorities whenever possible. In spite of certain deficiencies, this directive is a unique opportunity to reach the ultimate goal: complete replacement of animal experiments!
