EUROPEAN COMMISSION
RESEARCH DIRECTORATE-GENERAL
Directorate B.II - Life Sciences II
Generic activities, infrastructures
ETHICS, LAW AND ANIMAL EXPERIMENTATON – NOVEMBER 9TH 2000
SUMMARY OF THE WORKSHOP DISCUSSIONS
INTRODUCTION
The Quality of Life Programme – Generic RTD Activities organised a workshop on
Ethics, Law and Animal Experimentation, which took place in Brussels on 9 November
2000. (See Annex : List of participants)
The main objective of the workshop was to foster pan-European discussions about ethics
and animal experimentation issues and to promote bioethics research in specific areas
where data, research and discussion tools are insufficient.
Furthermore, the workshop intended to explore ethical assessment of research involving
animals.
The focus of the discussion of the workshop was to specifically pinpoint areas of research
and topics where specific work is required in order to further the protection of animals
used for research purposes. This document summarises the areas of research and topics
proposed during the discussion.
This list of areas of research and topics of activities will be published by DG Research on
the Internet together with other documents concerning future calls for proposals in the
area of Bioethics under the Quality of Life Programme. (http://www.cordis.lu/life).
Specific headings should be promoted in the Sixth Framework Programme, in the
appropriate areas.
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E-mail: Laurence.Cordier@cec.eu.int
AREAS OF RESEARCH /TOPICS FOR RELATED ACTIVITIES
1.
The 3 Rs (replacement, reduction and refinement) and Ethical review:
There was a consensus that particular efforts are needed to implement the 3Rs to full
extent in the process of the ethical review. Furthermore, the consideration of the 3R, as a
principle which aims to ensure that science is humane, should be a requirement for all
"groups" concerned with licensing / approving animal experiments: funding
organisations, research establishments review bodies, government advisory bodies etc.
The implementation of the 3Rs concept in research should be studied according to the
specific areas of sciences: ethical implementations could be very different according to
disciplines, fields of study etc.
Despite all efforts on various levels to apply the 3Rs in the evaluation process there is
broad agreement that serious problems exist to do so for a number of reasons. There was
a discussion on how to turn the 3rs model into an effective tool for ethical evaluation of
research involving animals.
Example of possible improvements:
 The improvement in the composition of the groups: knowledge on available
alternatives, statisticians in order to make sure that the number of animals to be used is
that the minimum number of animals is to be used to get valid results.
 Refined standard requirements for research proposals/applications so that these can
provide a sound basis for the work of the committees with regard to the 3Rs, e.g. the
obligatory use of internationally accepted pain scales, the proof of literature/database
research on 3Rs etc.
 Tool to avoid redundant testing, e.g. a database or registry containing information on
test on animals performed by research institutions world-wide.
2.
Ethical review and “Cost/benefit Analysis”
There is a real need to include in the evaluation of the proposals a discussion on the aims
(the expected scientific goals) of the research involving animals in order to perform a true
cost/benefit analysis (balance analysis). It was felt that now the ethical evaluation
concentrates on the implementation of the 3Rs. It is essential to seek a balance between
the needs of the different actors involved in an experimental practice.
It was suggested that work should be done in order to introduce a complete cost/benefit
analysis, for example research into:
 The extent by which cost/benefit analysis can be carried out for basic research (just in
sake of knowledge).
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 Tools to perform the cost/benefit analysis in specific areas such as legally demanded
testing (where the potential benefits are normally not part of the evaluation process) or
basic research (where the potential benefits of the results to further human health are
not clear) must be fully explored.
 Possible limits for the cost and minimum standards for the benefit
– Factors to take into account in the cost/benefit analysis that include not only the
experiment itself but also the context of such experiment: supply/origin of
animals, housing, production of surplus animals.
– A classification tool of animal experimentation and tests, which can help to
assess the cost and set a starting point for the 3Rs.
3.
Organisation of ethical review of animal experimentation
Any guidelines would be based on agreements on the aims of the ethical reviewing.
However, both the practice and experience of animal ethics committees in Europe vary
enormously. There was a clear understanding about:
 A need to share experiences in the organisation and operation of ethical review a need
to draft guidelines for the establishment, composition and the operation of such ethics
committees.
 A need to explore the links between the public at large and these animal ethics
committees.
 A need for special guidelines for the evaluation of different types of animal
experimentation and testing, such as
– Chemical testing, regulatory testing,
– The case of the question of transgenic animals which is more than a matter of
assessing animal welfare. This type of ethical evaluation has to take into account
the special nature of such an application of biotechnology for the animal.
 Comparison of criteria for the cost/benefit assessment of animal experimentation as
applied by research foundations and other research funding bodies in the different
Member States.
4.
Education of scientists
The awareness of the structure of contemporary science, and in particular biology, would
help in finding the appropriate strategy to deal with the role of tools (animals) in the
advancement of science:
 The training of young scientists on animal welfare issues at the beginning of their
career. This training should be organised systematically before they actually start
working with animals. They need to take their full responsibilities at the time of the
design of their experiments, by balancing benefits against costs and taking into
account the 3Rs, in particular alternatives to the use of animals.
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 Already established scientists could be educated to the bioethical issue of animal
experimentation: this would shorten the time and amplify the results with respect to
initiatives addressed to a younger generation.
 Knowing better the scientists and their values.
5.
Basic research and research relating to basic principles
This issue requires a debate between researchers of different discipline. For instance,
philosophers should work in research laboratories, and biologists should be involved in
philosophical studies, in order to cross the boundaries and to develop a common
language.
 Research on the interspecies justice.
 Research on issues that are currently being debated among bioethicists dealing ethical
implications of using animals for human purposes (e.g.: the intrinsic value of animals,
animal integrity, the teleonomic value of animals, animal suffering issues – biological,
ethological and philosophical issues).
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Annex: List of Participants

Dr David BENNETT, European Federation of Biotechnology, Task Group on Public
Perceptions of Biotechnology and Working Party on Education, Netherlands

Prof Franco CELADA, University of Genova - CBA, Centro Biotecnologia
(Advanced Biotechnology Centre), Italy

Prof. Dr Tjard DE COCK BUNING, University of Utrecht, Veterinary Faculty, Dpt.
of Lab Animal Issues, Netherlands

Ms Elisabeth HAMMER, Bundesministerium für Bildung - Wissenschaft und Kultur
, Germany

Dv Birgitte JANSEN, Europäische Akademie fuer Umwelt und Wirtschaft e.V,
Research Center Biotechnology, Germany

Dr Maggy JENNINGS, RSPCA, Research animals Dept., UK

Mrs Sara KNIJFF, Ministry of Agriculture, Nature Management and Fisheries,
Netherlands

Mr. Dipl.-Biol. Roman KOLAR, Deutscher Tierschutzbund, Akademie für
Tierschutz, Dept. of Alternatives to Animal Experiments, Germany

Prof. Emilio MORDINI, Psychoanalytic Institute for Social Research, Italy

Mrs Riitta SALMI, Juliana von Wendt foundation, Finland

Mr. Frans STAFLEU, Utrecht University, Centre for Bioethics & Health Law,
Netherlands

Mrs Michelle THEW, ECEAE, European Coalition to End Animal Experiments

Mr. TRAMPER Ronno, Utrecht University, Centre for Bioethics & Health Law,
Netherlands

Mr Asier URRUELA-MORA, Inter-University Chair of Law and Human Genome,
Spain

Prof. L.F.M VAN ZUTPHEN, Utrecht University, Veterinary Faculty, Dept. Lab.
Animal science, Netherlands

Prof. Etienne VERMEERSCH, University Ghent (Ethics), Belgium

Mr David WILKINS Eurogroup for Animal Welfare

Dr Mariaflavia ZUCCO Consiglio Nazionale delle Ricerche, Istituto di Tecnologie
Biomediche, Italy
Participants from the European Commission:
Life Science Programme:
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
Mr Peter KIND, Director

Mr Manuel HALLEN, Head of Unit

Ms Laurence CORDIER

Mr Maurizio SALVI

Ms Lieve VAN WOENSEL
Environment Programme:

Mr Graham WILLMOTT
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