Licences and legislation

The Project Authorisation Board has informed us that from now on, project licence applications (applications for licences to do animal experiments) will be made in an internet portal. One can still prepare the application in a Word form, but it will then have to be copied to the portal. Logging into the portal requires strong identification with bank ID or mobile ID.

Instructions of use and link to the portal can be found in the Finnish web page of Regional State Administrative Agency / Project Authorisation board: https://avi.fi/asioi/yritys-tai-yhteiso/luvat-ilmoitukset-ja-hakemukset/elaimet/koe-elaimet-luvat-ja-valvonta

General information on applying for project licence is available also in English: https://avi.fi/en/services/businesses/licences-notices-and-applications/animals/laboratory-animals . However, the portal link is, at least for the moment, only in the Finnish language website.

The project licence should be applied for by submitting a form available at the Animal experiment board website. The form is updated regularly and the researchers are asked to obtain the latest version of the form from the website. ELLA’s website also includes instructions on project licence procedures as well as other information on animal experiments.

ELLA accepts the licences written only in Finnish or in Swedish.

The licence application is sent by e-mail for a pre-inspection to OULUC(Hanna-Marja Voipio or Sakari Laaksonen). This ensures that it is possible to perform the experiment in OULAC and that the application has all the necessary information.

When the application is ready, it should be sent as an e-mail attachment to the address ella(at)avi.fi.

The licence is granted for a fee and only for three years at a time, in some cases for even five years. It is possible to make amendments or additions to the experiment through an application for changes to a licence.

The prices for the licences are available on ELLA website. The licence process takes approximately one to two months.

Amendments to the licence

If changes must be made to the project plan, this may be applied for with an ELLA application for change form.

The application for change can be used to apply for changes related to the research procedure in question, such as increasing the number of animals, adding a new animal species, continuing the experiment for longer or further procedures.

A fee is charged for the licence for change, the notification of change is free of charge.

Project licence is always needed when the pain or distress to the animal is equivalent or higher than the pain caused by an ordinary injection. Sometimes it can be difficult to define if the study needs a project licence or if it is enough to apply for an internal licence. OULAC personnel will help in such cases and you can always ask help from ELLA. Remember that the researcher is always responsible for the validity of her/his own licences.

A project licence is needed

• The animal is experiencing pain, suffering, distress or lasting harm equivalent to the feeling caused by the introduction of a needle in accordance with good veterinary practice
• Producing a new gene modified animal strain
• Procedures performed on an animal under anaesthesia are also considered an animal experiment, even if the animal does not wake up from the anaesthesia after the procedure.

An internal licence can be applied

• When there is no pain, suffering, distress or lasting harm to the animal
• Breeding and maintaining a GM strain that does not have welfare problems
• Crossing two existing GM strains when neither strain has welfare problems

An animal experiment may be performed in an establishment that has an authorisation issued by the Regional State Administrative Agency. The operator and the animal experiment establishment must be mentioned in the project application.

OULAC at the University of Oulu have this licence and it is possible to perform animal experiments in these establishments.

OULAC has a licence for the use of gene-manipulated class 1 mice and rats issued by the Board for Gene Technology.

Establishments that do not have a licence for laboratory animal activity can perform non-animal experiments, such as collecting tissue from euthanised animals. Due to factors such as allergy risks, it is always recommendable to handle euthanised animals either in a laboratory animal facility or an appropriate laboratory.

The pain, suffering, distress and lasting harm caused to the animals in the procedure shall be assessed in the project application.

There are four severity categories

• Non-recovery
• Mild
• Moderate
• Severe.

Non-recovery means a procedure, in which the animal is anesthetised and euthanized after the procedure under the same anaesthesia.

The annex VIII in the directive as well as the EU working group give some examples for the classification.

ELLA evaluates the severity class of each project; this can differ from that given by the applicant. ELLA will decide if the retrospective assessment shall be done also of a project which is not in the category severe.

Severity classification after the experiment

Pain, suffering and distress caused to each individual animal, shall be classified after the animal has euthanized. This classification can differ from the original assessment. For the classification, it is necessary to follow up the welfare of the animal during all the procedures. In LabAnimals Pro, there is a statistics part, where the researcher can do the final severity classification for each animal used in her/his project.

Retrospective assessment

Retrospective assessment is carried out for the severe projects as well as the projects where non-human primates have been used.

The assessment will be carried out by the Regional state administrative agency for southern Finland and it is based on the information given by the principal researcher.

Book keeping and statistics

Responsibility of the licence holder is to take care that the use and classification of the animals in each project is given in LabAnimals Pro. OULAC will collect this information together and forward it to authorities.

The act on the protection of animals used for scientific or educational purposes applies to the use of live cephalopods or vertebrates for scientific or education purposes. The act also applies to the independently feeding larval forms and foetal forms of mammals as from the last third of their normal development.

In projects, animals bred for scientific or educational purposes (purpose-bred animals) shall be used

Farm animals, like pigs and sheep can be purchased from farms and they do not need to be purpose bred

Pet animals can be used only in clinical studies

Wild animals can be used only exceptionally

European union and the national authorities annually collect statistics of the use on animals