“Make haste slowly when phasing out testing on animals”

The resolution has created lots of worries among Swedish and international researchers. It is perceived as being vague, at the same time as including a requirement for an ambitious time-plan, with mileposts for the phase-out. The resolution is not binding, and no deadline is given for when the phase-out should be completed.

Differing definitions of laboratory animals complicate matters

We must also remember that the European definition of a laboratory animal differs markedly from the one used in Sweden. In Sweden, a “laboratory animal” is an animal used in areas such as scientific research, teaching, or the manufacture of pharmaceuticals. This means, for example, that research that studies the behaviour of animals is also defined as “testing on animals” in Sweden. In the EU, in order for research to be classified as “testing on animals” requires causing the animals some kind of suffering. Animals used purely for behaviour studies, for example, are therefore not classified as “laboratory animals” according to the EU’s definition.

Phasing out the type of testing on animals that the EU is referring to, and replacing them with secure and validated animal-free methods, is a goal that we all want to achieve – including the researchers that carry out tests on animals.

Secure and validated alternatives are needed

Even today, there are various methods that can replace testing on animals, and when such alternatives are available they should be used. However, we are currently lacking both comprehensive alternative methods, and also knowledge about the consequences of entirely replacing all types of testing on animals. For example, without experimenting on animals, it is impossible to fully find out how a complex organism – such as a human or an animal – reacts to a substance or to a pharmaceutical. Both animals and humans need pharmaceuticals that are well tested.

As things stand today, research in medicine, natural sciences and veterinary medicine would stop if we could not use testing on animals. A phase-out therefore requires new methods to be researched and validated. How long it will be before testing on animals can be entirely replaced is very difficult to say.

The Swedish Research Council has the Government’s mandate to distribute 13 million SEK each year to research into ‘3R’ (Replace, Reduce, Refine), which aims to develop alternative methods to testing on animals. The mandate also includes distributing up to 2 million SEK to ‘validation projects’. Validation is an important stage in the process of replacing testing on animals, as we must make sure that all methods are reliable, and produce robust results. If we are really to achieve a phase-put within the foreseeable future, society needs to invest more resources in this type of research.

Consequence analysis of the phase-out is needed

To enable testing on animals to be phased out, we also need changes to laws and regulations. The requirements for a pharmaceutical to be approved for use in Sweden state that it has to be shown to have the intended effect, and, not least, that it is not harmful. To do this, tests have to be carried out, known as ‘pre-clinical studies’ and ‘clinical studies’. A clinical study is a study where the pharmaceutical is tested on humans. A pre-clinical study is, in this case, a study on animals, as this is currently the only way of studying processes where different organs and organ systems work together and communicate with each other in a living organism. A topical example is the rapid development of a vaccine against COVID-19. If the vaccines had not first been tested on animals, the pharmaceutical companies would not have received a permit to test them on humans. And without tests on humans, the vaccines would not have received a permit for use.

The Swedish Research Council agrees that we need goals, plans and processes to enable testing on animals that may cause suffering to the animal to be phased out. However, this work requires in-depth consequence analysis and clear mandates, as well as considerable resources for research aimed at finding methods that can replace testing on animals. Without these, the phase-out risks being done at the expense of the health and well-being of humans and animals.

Madeleine Durbeej-Hjalt, Secretary General, Scientific Council for Medicine and Health

The Swedish Research Council’s expert group on laboratory animal science