Gemma Marfany, PhD Associate professor of Genetics, on behalf of the Vicerectorat de Recerca, Universitat de Barcelona

Animal experimentation and the principles of the 3Rs (Replacement, Reduction and Refinement)

European Directive and implementation in European Universities

Policy on the Use of Animals in Research

•  Animals may only be used in research programmes where their use is shown to be essential.

•  Scientists actively seek alternative methods and techniques that will enable them to further their research without animals

•  Where alternatives cannot be found, only the smallest number of purpose-bred animals are used

•  Scientists and staff at Imperial work hard to ensure that animals are kept and cared for using the highest standards of husbandry, thereby causing least pain or distress.

Animal experiments are only conducted under certain conditions:

•  There must be no other way of achieving the research or

pedagogical objectives.

•  The importance of the test for society as a whole must be evident.

•  The specialist Animal Experiments Committee (Dierexperimentencommissie (DEC)) must have determined that the importance of the animal test balances out the use of and resulting distress experienced by the laboratory animals.

•  When conducted, animal tests are conducted responsibly, meaning that every attempt is made to replace, reduce and refine (i.e. the 3 R’s).

Current and future policy on laboratory animals at Utrecht University and UMC Utrecht aims to promote the development, application and acceptance of methods to replace, reduce or refine the use of laboratory animals. Despite advances in the 3 R’s, it is unrealistic to believe that biomedical research will completely obviate the need for laboratory animals in the short term.

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Plastination models from ethically sourced animals

And promote the use of virtual learning (videos, 3D animations…) Search other animal models, particularly for education

Gemma Marfany, PhD Professor of Genetics, on behalf of Vicerectorat de Recerca, Universitat de Barcelona

Implementation of the 3Rs/alternative methods at the UB

ADHERENCE TO THE EU LEGAL FRAMEWORK

LEGAL FRAMEWORK

EUROPEAN PARLIAMENT SPANISH GOVERNMENT CATALAN GOVERNMENT

•  BEFORE Directive 86/609/CEE on the protection of animals for research and other scientific finalities.

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•  NOW Directive 2010/63/UE concerning the protection of animals used for scientific research.

•  BEFORE Royal Decree 223/1988.

•  Royal Decree 1201/2005 on the protection of animals used for research and other scientific finalities.

----------------------------------------------------------- - •  NOW Royal Decree 53/2013, which

established the basic normative for the protection of animals used for experimental research and other scientific finalities, including education and training.

• Law 5/1995, on the protection of animals used for research and other scientific finalities. • Decree 214/1997, whereby the use of animals in research and other scientific finalities is regulated. ---------------------------------------------------------------------------- Still pending

PREMISES PERSONNEL PROCEDURES LEGISLATION

PROJECT involving RESEARCH in ANIMAL MODELS

PROJECT

APPROVAL (maximum of 5 years)

-  Project Proposal -  Report of the CEEA (Bioethics Comittee of the University of Barcelona) - Copy of the Project Application with the relevant data concerning animal use and procedures

COMISSION OF ANIMAL USE IN RESEARCH (CEA)

OF THE GENERALITAT

COMPETENT GOVERNMENT UNIT

GENERALITAT OF CATALONIA

Positive Evaluation

(Timeframe: 40 working days)

Negative Evaluation

DENIAL

After the new EU Directive for the use of animals in Research Premises, husbandry at the UB

Inspection every 3 years Authorization by the EC laws every 10 years

Larger premises, enriched habitats, humanitary treatment

After the new EU Directive for the use of animals in Research Premises, husbandry at the UB

Personnel categories and training: A- Animal care and euthanasia B- Handling experimental procedures (with specific training courses) C- Devising experimental procedures (with approved bioethical procedures) D1- Healthcare and wellbeing D2- Veterinary personnel

PERSONNEL

TRAINING COURSES: the 3Rs (and ongoing project…)

REDUCTION: The number of animals is strictly controlled in experimental protocols, and also in teaching. REFINEMENT: The protocols intend not to produce unnecessary pain REPLACEMENT: WHAT QUESTION ARE YOU TRYING TO ANSWER? Choose the right model to obtain the right answer.

Wild Type Morphants

TRAINING COURSE: the 3Rs

Whenever possible in teaching, the animal model to observe has shifted to Drosophila or zebrafish (to study embryogenesis and perform experimental protocols) reducing animals, avoiding problems with students with bioethical issues. The practical courses are less expensive and easier to conduct Digital videos are also used. Moodle activities for evaluation of the knowledge acquired in the practical courses has also been implemented. A special course on alternatives to the experimentation in animals, with a complete guide of Institutions and organizations devoted to the search of alternatives, videos, etc... (Mª P. Vinardell Martínez-Hidalgo, PhD).

REDUCTION:

TRAINING COURSE: the 3Rs

The research in toxicology has made already a swift move onto the use of cultured cells and other models for assays. Many researchers from basic research have moved onto DIFFERENT ANIMAL MODELS, which are cheaper as well, either vertebrates (zebrafish) or invertebrates (Drosophila, C.elegans, Amphioxus, cephalochordates...), or directly onto HUMANS, as a subject of research. Other researchers, which are working on more appliccable models (gene and cell therapy, are starting to use DIFFERENTIATED HUMAN iPSCS (induced pluripotent stem cells, differentiated to generate specialized cells or tissues and organ-like models. In this respect, we have in BCN a large institute with public funding dedicated to Regenerative Medicine, who collaborates with the universities and other research institutions.

REPLACEMENT:

For instance, collaborative research between Scientitsts from several centres: UB, IBUB, IBEC, CRM, IDIBAPS, IRB …

TRAINING COURSE: the 3Rs

Yet, some research can only be performed using animal models: particularly in neuroscience, physiology, biochemistry... A compromise is possible if we treat every organism with respect for life, and using ethical procedures. We should add a fourth R: RESPONSABILITY (from the PI of the project, the designer of experiments, the scientists actually performing them, and of the rest of society as the beholders and recipients of our research.

We believe that science and bioethics work together hand by hand for a better world.

THANKS for your attention!