Protectionanimals pp3 PDF
Protectionanimals pp3 PDF
Protectionanimals pp3 PDF
Foreword
The aim of this position paper of the European Medical
Research Councils (EMRC), the Standing Committee
for Medical Sciences at the European Science Foundation
(ESF), is to provide continuing input into developments
resulting from the new European Directive 2010/63/EU
of the European Parliament and of the Council on
the protection of animals used for scientific purposes
(fulltext adopted at http://eur-lex.europa.eu/LexUriServ/
LexUriServ.do?uri=OJ:L:2010:276:0033:0079:En:PDF).
The second ESF-EMRC position paper, published
in March 2009, was a key factor in raising awareness of
the implications of the revised Directive amongst scientists,
research funders, corporate research organisations
and patient groups, and informing the process of revising
the Directive.
This new paper is aimed at the same audience.
It summarises the current status of the Directive and looks
forward to the next crucially important stage during which
the Directive will be transposed into law and then fully
implemented in the Member States.
This paper builds on previous work of the ESF1,2,3
Cover
Sprague Dawley Variety of White Laboratory Rat
Visuals Unlimited/Corbis
Professor
Liselotte Hjgaard
EMRC Chair
Professor
Marja Makarow
ESF Chief Executive
1. E
SF Science Policy Briefing (SPB) no9 Use of Animals in Research,
September 2000 & ESF SPB no15 Use of Animals in Research,
August 2001 (2nd Edition)
2. E
SF-EMRC Position on the Proposed Revision of the Directive on the
Protection of Animals Used for Experimental and Other Scientific Purposes
(86/609/EEC), September 2008
3. E
SF-EMRC Position on the Proposal for a Directive on the Protection
of Animals used for Scientific Purposes, March 2009 (2nd Edition)
List of Abbreviations
AW: Animal Welfare Body
EC: European Commission
EU: European Union
GM: Genetically Modified
NHPs: Non-Human Primates
Position on the Directive on the Protection of Animals used for Scientific Purposes (2010/63/EU) | February 2011
Opportunities
The new Directive offers a new opportunity for harmonisation between European countries of regulatory
outcomes of research involving animals. It should also
make pan-EU research easier to fund, since funders will be
assured of minimum welfare and ethical standards, and
the authorisation of a given project will have equivalent
status in different EU states. If the Directive is properly
implemented, no animal research should be exported
from one EU state to another due to differences in the level
of restrictions. However, each member state is still free to
set its own regulatory processes, and it is important for
the scientific community to minimise the administrative
burden of these.
2. Key Elements
of the New Directive
The new Directive is considerably longer and more prescriptive than the 1986 Directive. It specifies much more
explicitly what is allowed and what is not. The revised
Directive contains provisions on a number of key areas.
Here are some of them:
Scope: Clearly defined animals and stages covered,
with special provisions in certain instances, such as
endangered species, non-human primates (NHPs),
dogs and cats, stray and feral, or wild-caught animals.
Cephalopods are the only invertebrates included.
Purposes and procedures: Clearly defined permissible
purposes, with requirements over procedures, such as
the application of 3Rs (see below), selection of methods, stipulation of severity, methods of killing, limits
to re-use, etc.
Establishments: Definitions of breeder, supplier and user,
together with general requirements for authorisation,
equipment, staffing, record-keeping, care and accommodation, authorised personnel and animal welfare
bodies.
Personnel: Requirements are based on education, training, supervision and competence, together with some
system of national authorisation.
Projects: Research projects involving animals now require
evaluation and authorisation of the proposed project
inevitably through a licensing process. Additional
requirements include non-technical summaries, and
in some cases retrospective assessment.
Position on the Directive on the Protection of Animals used for Scientific Purposes (2010/63/EU) | February 2011
Animal Welfare:
Scientific Considerations
Severity classification
Position on the Directive on the Protection of Animals used for Scientific Purposes (2010/63/EU) | February 2011
Position on the Directive on the Protection of Animals used for Scientific Purposes (2010/63/EU) | February 2011
Inspections
Administrative cost
The Directive says that Member States must carry out regular inspections of people and establishments. However,
there appears to be a conflict between this requirement
and the minimum requirement to carry them out on
at least one third of users. In any case, the frequency of
inspection must be adapted on the basis of a risk analysis for each establishment. Various factors are specified,
including types and numbers of animals, types and numbers of projects, and previous compliance. Wide variation
across the EU in the arrangements for inspections would
be problematic.
Retrospective reviews
It will be important to avoid situations whereby retrospective review is used as a means of blocking the
licensing of new projects.
Training
Position on the Directive on the Protection of Animals used for Scientific Purposes (2010/63/EU) | February 2011
3. Strategic Action
by EU Organisations and
EU Scientists
Europe
At the national level, EU scientists must avoid complacency: if Member States do not implement the spirit of the
Directive, supporting effective and responsible research
in animals, everything that has been achieved to date
could be lost. Scientists must be watchful and make sure
they and their representative bodies are fully engaged and
consulted in the process of implementation. ESF-EMRC
member organisations will be key players in this process
and we will provide them with support if necessary but
4. Conclusion
We are now entering a critical period for the future of
animal research in Europe. Scientists must be vigilant
that their governments now enact legislation that is in
keeping with the more positive spirit of the Directive.
That legislation should continue to allow the responsible
use of animals in research for maximum scientific, medical and veterinary benefit carried out in conditions that
optimise animal welfare. Scientists must therefore be
ready to participate in the translation of the Directive in
national legislation. In addition, they should try to participate as experts in the different committees involved
and provide the EC with valuable scientific results on the
development and limits of alternative methods, the upper
and lower thresholds and the impact of the Directive on
animal welfare and science.
In the future, ESF-EMRC will remain actively involved
throughout the transposition of the Directive. We will of
course provide support to scientists as well as our member
organisations at a national level but we will also remain
at the disposal of the EC and of those Member States that
request our input.
Position on the Directive on the Protection of Animals used for Scientific Purposes (2010/63/EU) | February 2011
Ranko Stojkovic,
Rudjer Boskovic Institute, Zagreb (HR)
Max Planck Society
Stefan Treue,
German Primate Center, Gttingen (DE)
Ewa Szczepanska-Sadowska,
Warsaw Medical University and Committee
on Physiological Sciences, Polish Academy
of Sciences, Warsaw (PL)
Giovanni Vesce,
School of Veterinary Medicine, University
of Napoli Federico II, Naples (IT)
Italy
National Research Council, Giovanni Pacini
Lithuania
Lithuanian State Science and Studies
Foundation, Zita Kucinskiene
Luxembourg
National Research Fund, Carsten Carlberg
The Netherlands
Royal Netherlands Academy of Arts and
Sciences/Netherlands Organisation for
Scientific Research, Marcel Levi
Norway
The Research Council of Norway,
StigSlrdahl
Poland
Polish Academy of Sciences,
AnnaCzlonkowska
Portugal
Foundation for Science and Technology,
Isabel Palmeirim
Romania
National University Research Council,
Simona-Maria Ruta
Slovak Republic
Slovak Academy of Sciences,
RichardImrich
Slovenia
Slovenian Academy of Sciences and Arts,
Uros Skaleri
Spain
Council for Scientific Research,
IsabelVarela-Nieto
Ministry of Science and Innovation,
MiguelAngel Piris Pinilla
Sweden
Swedish Research Council, Mats Ulfendahl
Switzerland
Swiss National Science Foundation,
Stephane Clarke-Hosek
Turkey
The Scientific and Technological Research
Council of Turkey, Haluk Topaloglu
United Kingdom
Medical Research Council, Mark Palmer
Observer
Wellcome Trust, Nancy Lee
ESF-EMRC Office
Stephane Berghmans,
Head of Unit, Medical Sciences
Position on the Directive on the Protection of Animals used for Scientific Purposes (2010/63/EU) | February 2011