Opportunities for the 3Rs
Implementation of Directive 2010/63/EU
in Finland
by
Kai Pelkonen
PhD, Adjunct Professor in Laboratory Animal Science
Expert Consultant for the Ministry of Agriculture and Forestry of Finland
CAAT-Europe / ecopa Workshop
Berlin 31.1.2011
What changed ?
• NOW: Directive 2010/63/EU: “This Directive establishes
measures for the protection of animals used for scientific or
educational purposes.”
• BEFORE: Directive 86/609/EEC: The aim of this Directive is to
ensure that where animals are used for experimental or other
scientific purposes the provisions laid down by law, regulation
or administrative provisions in the Member States for their
protection are approximated so as to avoid affecting the
establishment and functioning of the common market, in
particular by distortions of competition or barriers to trade.
Finnish legislation development
• Decree on Animal Experiments 334/1971 -> 1076/1985
-> Act 62/2006 (August 1, 2006)
• The present Act is mainly based on 86/609/EEC
• In 2003 a Technical Expert Working Group (TEWG)
worked through a set of questions prepared by DG
Environment (experts from Member States, acceding
countries, industry, science and academia as well as
from animal welfare organisations)
• Many principles from the TEWG conclusions and
promotion of 3Rs were already adopted into the
Finnish Act in 2006
Finnish Act 2006 (very briefly)
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Based on Directive 86/609/EEC and previous Finnish Decree 1985
Covers vertebrates
3R-principle is implemented in project authorisations
Project authorisations by a National committee: 1+16-member
multidisciplinary, authorisations by majority decision, or by its 4
local subcommittees (4 members) by unanimous decision
Right to appeal to Administrative court in negative cases
Establishment authorisations are given by Regional State
Administrative Agencies, which also carry out the inspections
Educational requirements for personnel are based on their duties
In Finland there is an official vocational education system for animal
caretakers and technicians with certifications for different levels
Yearly statistical reports are sent to the Commission
3Rs in New Directive
• Directive 2010/63/EU strengthens adoption of
the 3R principle throughout all use of animals for
scientific (and educational) purposes:
• (A1) To that end, it lays down rules on the
following: (a) the replacement and reduction of
the use of animals in procedures and the
refinement of the breeding, accommodation,
care and use of animals in procedures;
What is new?
• Directive 2010/63/EU contains considerably
more detailed requirements than the “old”
• Some provisions create some new
administrative burden in Finland, e.g. in
– severity classification, publication of project
summaries, retrospective assessment, commission
controls in Member States, national committee
and institutional welfare bodies in each unit
(breeders, suppliers, users)
New subjects and matters (1)
• foetal forms of mammals and cephalopods
• severity classification (left out from the Finnish
Act 2006)
• inspections without prior warning
(”unannounced”)
• publish requirements with regard to education
and training (already given in the Finnish Act)
• requirement for maintaining requisite
competence for the functions
• publish non-technical project summaries of
authorised projects and any updates thereto
New subjects and matters (2)
• retrospective assesments of projects (severe,
primates)
• institutional animal welfare bodies (breeders,
suppliers and users)
• National committee for the protection of animals
used for scientific purposes
• National single point of contact to provide advice
on the regulatory relevance and suitability of
alternative approaches proposed for validation
New subjects and matters (3)
• Detailed rules on the use of primates
• Rules for the permissible use of stray and feral
animals of domestic species
• Possibility to allow animals used or intended to be used
in procedures to be rehomed
• Ban of adoption of stricter national measures for the
protection of animals used for scientific purposes
– In old directive 86/609/EEC: This Directive shall not restrict the right of the
Member States to apply or adopt stricter measures for the protection of
animals used in experiments or for the control and restriction of the use of
animals for experiments.
New subjects and matters (4)
• Harm-benefit analysis in the project
authorisation shall take into account ethical
considerations (already in the Finnish Act)
• Commission controls of the infrastructure and
operation of national inspections in Member
States
Encourage alternatives -> Contribute to the
development of alternatives
• (A 47.1) The Commission and the Member States shall contribute*
to the development and validation of alternative approaches,… and
they shall take such other steps as they consider appropriate to
encourage research in this field.
* contribute = give something, esp. money, in order to help achieve or provide something
• (A 47.2) Member States shall assist the Commission in identifying
and nominating suitable specialised and qualified laboratories to
carry out such validation studies.
• (A 47.5) Member States shall nominate a single point of contact to
provide advice on the regulatory relevance and suitability of
alternative approaches proposed for validation
Encourage -> Contribute
Finland is one founder state of ecopa (signature 10.11.2002)
Fincopa founded 21.09.2003
Finnish Centre for Alternative Methods (FICAM) founded
10.12.2008
• (A 47.4) Member States shall, at national level, ensure the
promotion of alternative approaches and the dissemination of
information thereon.
Referring to the FICAM’s mission:
”FICAM´s role is to be the centre of excellence for alternative
(replacement) methods in Finland, to share information locally and to
implement education and training on alternative methods into the
advanced training courses.”
Step by step…(1)
• (A 47.5) Member States shall nominate a single
point of contact to provide advice on the
regulatory relevance and suitability of alternative
approaches proposed for validation
1. Finland hereby informs the Commission that it has
appointed Ms. Tuula Heinonen, the Director of Finnish
Centre for Alternative Methods, as a contact person
for the PARERE* network (30.11.2010)
* Preliminary Assesment of Regulatory Relevance
Step by step…(2)
• (A 47.3) After consulting the Member States, the Commission shall
set the priorities for those validation studies and allocate the tasks
between the laboratories for carrying out those studies.
• Presently FICAM works on a temporary financing basis, but there is
reason for optimism …
Referring an email comment sent to me: 2. ”I have been at a
technical meeting at ECVAM for the last few days, and this is just a short
note to pass on the fact that both the Commission and an in vitro test
developer were VERY VERY complimentary both about the people and the
level of service they are getting from FICAM as one of the test labs
participating in the pre-validation study we are overseeing.” (Anon)
Step by step…(3)
3. We have Parliamentary election in Finland in April 2011
• Animal welfare has been on agenda of of the Ministry of Agriculture and
Forestry constantly in recent years
• Directive 2010/63/EU has to be implemented during the next
Parliamentary period 2011-15
• There is an initiative to the Ministry to suggest FICAM and its activities to
be taken into the new Government Program, as Directive 2010/63/EU has
to be implemented during its work period in 1.1.2013.
– Replacement and Reduction are also in the present Government program
• There is no reason to expect Replacement and Reduction would not
be in the Government Program 2011-2015
Thank you for your attention!
For more information on the topic, feel free to
contact:
Kai Pelkonen Consulting Ltd.
Tel. +358-500-654343
email kai.pelkonen@kolumbus.fi
Expert consulting in laboratory animal science, its administration and legislation
since 1981.