animalwelfare
centredidactiquebiotech

Severity degree 3 experiments

Animal welfare legislation in Switzerland is one of the strictest worldwide. Animal experiments may only be conducted if no alternatives are available.

1. Fewer than 3.5% of all animal experiments involve severe constraints

The pharmaceutical industry, researchers, laboratory animal specialists, the federal authorities, animal welfare groups and politicians have been championing the application of the3Rs for more than 30 years. The consistent promotion of the 3Rs has played a significant part in helping to lower the number of laboratory animals used from around 2 million in 1983 to fewer than 575,000 animals in 2019 and steadily reduce the constraint on the animals. Fewer than 3.5% of all animal experiments were classified under severity degree 3 in 2019. The pharma industry is committed to systematically continuing its ongoing efforts to reduce animal experiments to the absolute minimum.

2. Research bans have negative consequences for patients

Even though severely stressful animal experiments in the category of severity degree 3 account for only a small proportion of research with animals, a ban on these experiments would have far-reaching negative consequences. It would not only jeopardizeSwitzerland’s position as a research hub, but would also make it impossible to develop new and more effective therapies for serious diseases such as cancer, rheumatoid arthritis or multiple sclerosis. Particularly animal models used for research into new therapeutic approaches for such serious diseases often fall under the category of severity degree 3. A research ban would therefore not only impact researchers in universities and the pharmaceutical industry, but above all also patients who depend on more effective therapies.

3. Strict legislation protects the dignity of animals

Switzerland has one of the strictest animal welfare laws worldwide. Animal experiments may only be conducted if there are no recognized alternatives. Moreover, in the mandatory ethical trade-off between the benefits to be expected from the research and the constraint on the animals, the scales must tip in favour of the benefits; otherwise, an experiment may not be carried out. The well-being and the dignity of the animal are thus protected by the law. Most questions can be answered with experiments involving mice or rats. In 2019, these species accounted for about 80% of all laboratory animals in Switzerland (see chart on the next page). Sheep, pigs, poultry, fish, dogs or non-human primates are used for a small proportion of experiments depending on the question concerned. Studies with non-human primates are only approved if the findings cannot be obtained using alternative methods without animals or in experiments with other animal species.

4. Four severity grades

In Switzerland, animal experiments are classified into four categories of stress or constraint. Severity grade 0 means the animals are not exposed to any stress. Observation studies are an example of this. Forty percent of laboratory animals in Switzerland are used in severity grade 0 experiments. Severity grade 1 corresponds to mild stress (e.g. blood sampling) and severity grade 2 to moderate stress (e.g. surgical procedure under anaesthesia). Highly stressful animal experiments (severity grade 3) are only used for research into serious diseases (for example, multiple sclerosis or Parkinson’s). In Switzerland, fewer than 3.5% of all animal experiments were classified as severity grade 3 in 2019. In these studies, almost 95% of the animals were mice or rats.

5. Assignment of severity grade

A severity grade is always assigned before the start of the experiment (prospective classification). The researchers here must give the highest possible stress that could occur during an experiment. But what is crucial for the actual stress to which the animals are exposed is not the prospective classification, but how the animals react to a procedure. After the experiment, therefore, the studies are evaluated and each animal is assigned to the severity grade that it actually experienced in the experiment (retrospective classification).

If an animal dies during an experiment, the experiment is automatically classed as severity grade 3. This also applies if an animal dies a natural death in an experiment classed as severity grade 0. Since this possibility always exists, a ban on severity 3 experiments would be equivalent to a ban on all animal experiments and thus a de facto research ban.

6. Withdrawal criteria defined

The law also demands that suitable withdrawal criteria already be defined when the application for approval of the animal experiment is submitted. These withdrawal criteria can be easily modified so that new findings immediately feed into the ongoing studies. In this way, excessive constraints on the animals can be avoided. In the autumn of 2018, the Federal Food Safety and Veterinary Office (FSVO) published new guidelines for the prospective assignment of severity grade to an animal experiment. In these guidelines, for example, the severity grade for experiments in brain research (neurodegeneration as in Parkinson’s) was raised from 2 to 3.