1. 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

2. 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.

3. 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

4. Finnish Act 2006 (very briefly) 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

5. 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;

6. 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)

7. 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

8. 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

9. 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.

10. 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

11. 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

12. 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.”

13. 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

14. 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)

15. 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

16. Thank you for your attention!

17. For more information on the topic, feel free to contact: Kai Pelkonen Consulting Ltd. Tel. +358-500-654343 email kai.pelkonen@kolumbus.fikai.pelkonen@kolumbus.fi Expert consulting in laboratory animal science, its administration and legislation since 1981.