CLASSIFICATION AND REPORTING OF SEVERITY OF PROCEDURES
The new Directive 2010/63/EU on the protection of animals used for scientific purposes entered into force in Member States on January 1st, 2013. As with the previous Directive 86/609/EEC, this Directive requires that experiments are designed to cause the least pain, suffering, distress or lasting harm to the animals used.
However, there is a new and additional requirement that all procedures are assigned a severity classification in advance of the procedure being performed.
Furthermore, the actual severity experienced by each individual animal must be reported in the Statistical returns.
This actual severity of any previous procedure is a key consideration in determining whether or not an animal can be re-used in further procedures.
The implementation of a severity classification process, both prospectively and retrospectively, is a big challenge in animal studies as it entails legal and ethical implications. On the other hand, it is an important and useful tool for properly evaluating research projects with regards to their prospective severity classification so as to implement the least constraining procedures (refinement), and keep the level of severity of procedures to the lowest possible. The reporting of actual severity will help to refine similar procedures going forward and improve communication with the public by providing a more detailed picture of what animals experience during procedures.
The animal models used in the workshop will be based on commonly used laboratory species and will address the three steps described in the document of the Commission’s Expert Working Group which was endorsed by the National Competent Authorities in 2012: designing the project, monitoring it when it is performed and assessing the outcomes after it has ended.
Consistency of severity classification across Member States is critical for the harmonization of project licensing and reporting. Therefore, the European Commission has encouraged FELASA to perform standardized Workshops on Severity Classification of Procedures that could be held in the Various Member States. The first of these workshops was held at FELASA Congress in Brussels in 2016, and has since then been successfully presented on more than sixty occasions throughout EU.
These Workshops, held by FELASA Trainers, allow great interaction with the audience through the analysis and discussion of “real-life” case studies.
The Workshop is divided in 3 parts:
- Presentation and explaining of the objectives of the Workshop Severity Assessment and reporting
- Workshop itself: 2 parts:
- Group review of selected case studies
- Identifying impact, severity and endpoints
- Members of Animal Welfare Bodies and Ethics Committees
- Laboratory Animal Veterinarians
- Scientists applying for project authorizations
- Researchers coordinating or performing animal experiments
- Laboratory Animal Technicians
- Animal Care staff