License application procedure for an animal experiment

Only researchers who have the relevant training and are employed by an institution that is licensed to carry out animal tests may apply to conduct an animal experiment. However, even if a researcher considers an animal experiment to be necessary, there is a long way to go before the experiment can actually start.

When is a license required?

At Wageningen University & Research, all studies involving animals are assessed by the Animal Welfare Authority (Instantie voor Dierenwelzijn, IvD) to check whether the intended research falls within the Experiments on Animals Act (Wet op dieren, Wod) and is therefore an animal test or not. Even if the research is not considered an animal experiment within the definition of the law, if necessary, IvD advises the researcher on optimal conduct of the study. We have an IvD for Wageningen University and one for Wageningen Research.

How is an animal testing license applied for?

To be able to carry out an animal experiment, the researcher first needs to apply for a project license. The application must include a detailed description of the research project, in which the researcher makes it clear why an animal experiment must be used and not an alternative approach. The applicant is legally obliged to describe why an approach that does not use animal testing is not possible, and why it is not possible to carry out the experiment with fewer animals or with less suffering for the animals.

The licence application is assessed in various steps. These steps address issues such as legal requirements, ethical considerations, the scientific value of the animal experiments, and technical aspects.

Is the animal test acceptable under Dutch law?

The European directive on animal research was drawn up to protect test animals in Europe. This directive has been incorporated into Dutch law as follows:

Wet op de dierproeven (Wod; Experiments on Animals Act): The purpose of this Act is to protect test animals. The Act applies the ‘no, unless’ principle, which means that no animal experiments may be carried out unless there are no suitable alternative methods for the research project. The Act was amended in 2014, resulting in regulations that are, in some areas, stricter than the European directive. For example, animals that are killed for research with no prior handling also fall under the protection of the Act.
Dierproevenbesluit (Animal Experiments Order): This describes the conditions that companies, institutions and researchers must meet in order to conduct animal experiments. Examples are housing requirements for test animals and training requirements for people who work with test animals.
Dierproevenregeling (Animal Experiments Regulations): These regulations go into more detail than the Experiments on Animals Act and the Animal Experiments Order, for example by naming specific requirements that the licensee, researcher and test animal breeder must meet.

Does the research aim outweigh possible animal suffering?

Animals have an intrinsic value, separate from their usefulness to humans. This is laid down in the Wet dieren (2013; Animals Act) and the Wod. A researcher must therefore also provide valid ethical arguments for why the animal experiment is necessary in the license application.

Is the experiment scientifically justified?

The scientific value of the animal test must be maximised and the number of animals and level of animal suffering minimised. To assess the scientific value, a review is made of the experimental design, for example the risk of mistakes being made and the correct number of test animals.

It is important not to use more test animals than are needed, but enough animals must be used to enable reliable research results to be obtained.

Will the experiment be conducted in the best way possible?

Do the researchers and other staff members have the required expertise and skills, are the housing and care facilities appropriate, and are suitable procedures used?

The license application procedure is shown in the figure at the bottom.

Who is involved in the licence application procedure?

Various bodies and committees are involved in the licence application procedure for animal testing. The main parties are the Animal Welfare Body (Instantie voor Dierenwelzijn, IvD), the Animal Tests Committee (Dierexperimentencommissie; DEC) and the Central Animal Testing Committee (Centrale Commissie Dierproeven; CCD).

Every licence holder is required by law to appoint an Animal Welfare Body (IvD). This body is responsible for advising on animal welfare and on replacement, reduction and refinement (the three Rs), for registering animal experiments and for coordinating a project proposal prior to application for a project licence. The IvD assesses whether the proposed research can be carried out appropriately in the research facility. Attention is also paid to the expertise and skills of the researchers and other staff members, the housing provided for the animals, and the availability of suitable test procedures. Once a project licence has been awarded, the IvD then assesses whether specific experiments meet the conditions of the licence.

In accordance with the Wod, the members of the IvD must meet certain criteria. For example, the IvD must include at least one research scientist and an expert in animal testing – an ‘Article 13f3a officer’.

Depending on the location of the study and under which project licence it falls, the experiment is assessed by either the IvD of Wageningen University or the IvD of Wageningen Research.

The Institutional Animal Care and Use Committee is an independent committee that evaluates the ethical aspects of applications for a licence to conduct animal tests. The main question that the DEC asks is, ‘Does the purpose of the animal experiment outweigh the suffering of the animals in question?’

To answer this question, the DEC again considers the 3Rs:

Replacement: are there alternatives to the animal experiments?
Refining: can the pain or discomfort be prevented, for example using pain relief?
Reduction: is it possible to reduce the number of test animals? The fewer animals that are used the better, but too few animals can mean that the research results are invalid and that the research has been carried out for nothing.

Under the Wod, the DEC must meet certain requirements in terms of expertise and independence. The DEC must also be recognised by the CCD.

The Central Authority for Scientific Procedures on Animals (CCD) is the body that provides licences for animal testing. The CCD is an
independent executive body (zelfstandig bestuursorgaan, or ZBO). The CCD always seeks advice from a DEC. Regardless of whether the DEC’s view is positive or negative, the CCD will often ask additional questions of the researchers. It then makes its own assessment, with the DEC’s recommendation carrying significant weight. In the past the CCD also published the Non-technical Summary (NTS) for the project, which was a brief description of the project, written for a general audience. These summaries are now published on an EU website: ALURES NTS Database.

The Netherlands Food and Consumer Product Safety Authority (NVWA) monitors and enforces regulations relating to animal testing in the Netherlands on behalf of the Dutch government. The NVWA conducts inspections at institutions where animal testing is carried out and checks that the necessary licences have been obtained and that the animal experiments are carried out in accordance with these licences. It also checks that animal housing and care and the administration concerning animal experiments are in accordance with regulations.

Institutions report the number and purpose of their animal experiments to the NVWA each year, and the NWVA publishes these figures in an annual report (‘Zo doende’).