Animal experimentation licenses

In Switzerland, each animal experiment must be approved by the Veterinary Authorities. In collaboration with the EPFL Animal Welfare Unit, the study director (in general the PI of the group) describes the intended experiments in a specific form (Form A).

The application is then submitted for review to the Cantonal Veterinary Authorities and the Cantonal Commission for Animal Experimentation.

Licenses are then approved for a limited time (max. 3 years) and may contain conditions and requirements (“charges”). Modifications to an approved license are possible by amendments, which follow a similar approval pathway.

Overview of licensing procedure: from the conception to the expiry date

Description of experiments and Authorities decision
 
 Report of each experiment
 
Annual and final reports of animals used during the calendar year

 

The Study Director (or another scientist from the group) writes the application in the CPG version of Form A and sends it for review to the Animal Welfare Officers ([email protected]). When the revision process is completed, the SD uploads the license into ANIMEX-CH and informs the Animal Welfare Officers (AWOs) that the application is ready to be submitted. The AWOs submit the application further to the Cantonal Veterinary Office (DGAV).
The DGAV reviews the application and may ask questions. In case of questions, the SD sends the draft version of his answers to the AWOs. Once agreed upon, the answers are uploaded in ANIMEX by the SD who then notifies the AWOs that the answers are ready to The AWOs submit the answers to the DGAV.
When deemed satisfactory, the DGAV dispatches the application to the CEA for a further ethical review.
The CEA sends questions via ANIMEX to the SD. The SD sends the draft answers to the AWOs for review. Once agreed upon, the answers are then uploaded in ANIMEX by the SD who then notifies the AWO that the answers are ready to submitted. The AWOs submit the answers to the CEA.
The CEA sends its recommendations to the DGAV.
The DGAV announces its decision by issuing the license (Form B). This form contains the authorized number of animals, the validity of the license, and it may contain conditions and requirements (ex: modifications of the model, interim report to be submitted, visits of experiments/specific procedures, …).

After the Form B is issued, the FSVO may exercise its “veto” during one month (“federal appeal”). Consequently, the experiments accepted by the DGAV can only start after the end of the appeal period.

During the performance of an animal experiment, a written record shall be kept for each animal or group of animals. (Art. 144, AWO). This record should encompass the following points:

  1. Start of experiment (date), species, number, sex, origin, and identification of animals and designation of experimental group:
  2. Experiment-related aspects, such as surgical procedures/interventions and measures on the animals;
  3. Animal welfare-oriented aspects, such as frequency of monitoring animals;
  4. Systematic record of clinical symptoms;
  5. Anesthesia, analgesia and premature discontinuation of experiment;
  6. Category of strain to which each animal was exposed;
  7. Adverse/special events;
  8. Evaluation of experiments and usefulness of results;
  9. End of experiment (date).

The records shall:

  1. Be open to scrutiny based on labelling of cages or identification of animals;
  2. Be available to the enforcement agencies at all times;
  3. Be kept for three years after the license has expired.

To fulfill this legal requirement, you may use for your report this template.

The study director needs to fill reports (Report AC) on animal usage for each authorized license through the ANIMEX web application. A report is submitted for each calendar year (interim report) and at the latest 2 months after the end of the license validity (final report). The Animal Welfare Officers review the reports before submission to the cantonal authorities.

Main points reported in the Report AC:

  • Number of animals used;
  • Retrospective severity degree experienced by the animals;
  • A summary of obtained results:
  • Justification for the unforeseen events (for example: animals found dead, DG3)
  • List of (planned) publications, incl. potential patents.

Deadlines:

For interim report: February 28th to report animals used in the previous calendar year.

For final report: at the maximum two months after the expiry of the license.

Templates:

How to use PyRAT and ANIMEX for your report AC:

Published Data by the Federal Food Safety & Veterinary Office (FSVO)

 After license expiration, the FSVO will publish some of the information reported in the Form A and reports AC:

  • Title of the license and research field (respectively from Sections 05 and 15 of the Form A)
  • Experiment purpose (from Section 16 for the Form A)
  • Animal species (from Section 09 of the Form A)
  • Retrospective severity degree experienced by the animals (from Point 6 of the Reports AC)

The ANIMEX-CH online application is the replacement of e-tierversuche (e-TV), used to manage applications, licenses, reports, GM datasheets (Form D), invalidating phenotype notifications, continuing education and training records, and announcements related to animal experiments.

Conditions and modalities for system use are defined and fixed in the Ordinance on the computer system management of experimental animals (O-SIGEXPA, RS455.61).

The access to the system is limited to persons that are in charge of the redaction of the applications, in general for each research group a study director and deputy study directors are designated.

Access to ANIMEX-CH is subjected to an agreement. Information and user guides are available on the FSVO dedicated website.

If you need access to ANIMEX-CH, please contact [email protected].<!– wp:epfl/people {“scipers”:” 160202″,”columns”:”1″} /–>

[email protected]