Forsøgsdyrenes Dag. Thursday 24 April 2014. Tom Bengtsen. Copyright 2013. Dyreforsøgstilsynet. All rights reserved.

Forsøgsdyrenes Dag Thursday 24 April 2014 Tom Bengtsen Copyright 2013. Dyreforsøgstilsynet. All rights reserved.

Dyreforsøgstilsynet The Animal Experimentation Inspectorate Sekretariatet The secretariat Rådet for Dyreforsøg The animal experimentation board

The Board for Animal Experimentation/ Rådet for dyreforsøg Chair: Byretspræsident Christian Lundblad, Retten i Aalborg Professor, dr. med. Peter Bie, Syddansk Universitet Lektor, dyrlæge Dorte Bratbo Sørensen, Københavns Universitet Overlæge Lars Bo Svendsen, Rigshospitalet Dyrlæge Jens Thing Mortensen Ph.d., Birgitte Holst, Københavns Universitet Gårdejer Karsten Vig Jensen Direktør Bente Lakjer, Landsforeningen Forsøgsdyrenes Værn Lektor, dyrlæge, ph.d. Julie Fjeldborg, Københavns Universitet Dyrlæge Louise Stab Bryndum, Miljøstyrelsen Dyrlæge Ann Persson, Dyrenes Beskyttelse Appointed 2010-2014 appointment period 4 years C course for postgraduate students 2013

Rådet for Dyreforsøg Peter Bie Professor, dr.med Statens Sundhedsvidenskabelige Forskningsråd Lars Bo Svendsen Dr.med. Sundhedsstyrelsen Jens Thing Mortensen Dyrlæge Dansk Industri Bente Lakjer Direktør Louise Stab Bryndum Dyrlæge Christian Lundblad Byretspræsident Forskningsrådet for Teknologi og Produktion De store sygdomsbekæmpende foreninger Det Dyreetiske Råd Dyreværnsforeninger Ann Persson Formand, beskikket dommer Dorte Bratbo Sørensen Dyrlæge, ph.d. Birgitte Holst Læge, ph.d. Karsten Vig Jensen Gårdejer Julie Fjeldborg Dyrlæge, ph.d. Dyrlæge

The Animal Experiments Inspectorate Dyreforsøgstilsynet Head of secretariat: Tom Bengtsen Scientific co-ordinator: Leif Røge Lund Veterinarian: Kirsten Bayer Andersen Office: Betina Pihl Scheef Student: Jakob Nybo Nissen Phone:7227 6900 mail: dyreforsoegstilsynet@fvst.dk www.dyreforsoegstilsynet.dk C course for postgraduate students 2013

What are the duties of the Board/Inspectorate? Review applications Issue permissions (animal experiments and breeding of experimental animals) Publish all licenses on web page (since 2003) Perform inspections of experiments and housing Publish a yearly report (since 1999 on the homepage) C course for postgraduate students 2013

Denmark: Central administration of animal experiments No legal requirement for regional, local, or institutional boards or ethical committees however animal welfare body required from 2013 Danish legislation based on: DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes C course for postgraduate students 2013

Grundforskning Medicinsk produktudvikling Produktkontrol Toksikologisk afprøvning Diagnostik Undervisning Andet Number of experimental animals used in Denmark Antallet af dyr brugt til forsøg i udvalgte år 400.000 350.000 300.000 250.000 200.000 150.000 100.000 300.000 250.000 200.000 150.000 100.000 50.000 0 2011 2012 140.000 120.000 100.000 80.000 60.000 40.000 20.000 0 50.000 0 1970 1980 1990 2000 2008 2010 2011 2012 Antal dyr i 2010 Antal dyr i 2011 Antal dyr i 2012 Titel 9

Regulation for breeding, supplying and reporting of laboratory animals Titel 10

Danish Legislation Lov om dyreforsøg Jfr. lovbekendtgørelse nr. 253 af 8. marts 2013 The Animal Experimentation Act number 253, March 8.th 2013 Bekendtgørelse om dyreforsøg nr. 88 af 31. januar 2013 Ministerial Order number 88 January 31.th 2013

Danish Legislation Ministerial Order number 88, january 31.th 2013 replace: Ministerial Number 332, 1990 (Fremskaffelse af dyr til forsøg) Ministerial Number 1016, 2001 (Kvalifikationskrav til personer der udfører dyreforsøg) Ministerial Number 1273, 2005 (Journalføring) Ministerial Number 1320, 2009 (Tilladelsesordninger efter dyreforsøgsloven) Ministerial Number 997, 2010 (opstaldningsbekendtgørelsen) Titel 12

European Legislation European convention for the protection of vertebrate animals used for experimental and other scientific purposes. No. 123, 18. marts 1986 www.coe.int http://www.coe.int/t/e/legal_affairs/legal_cooperation/biological_safety,_use_of_animals/laboratory_animals/ Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes Council Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes Europa.eu http://europa.eu/scadplus/leg/en/lvb/l28104.htm

Danish Animal Experimentation Act 9 Der skal føres journal og afgives indberetning til dyreforsøgstilsynet. An up-to-date local report as well as an annual report to the board is mandatory

Purpose breeding Animals belonging to the species listed in Annex I, may only be used in procedures where those animals have been bred for use in procedures Mouse (Mus musculus) Rat (Rattus norvegicus) Guinea pig (Cavia porcellus) Syrian (golden) hamster (Mesocricetus auratus) Chinese hamster (Cricetulus griseus) Mongolian gerbil (Meriones unguiculatus) Rabbit (Oryctolagus cuniculus) Dog (Canis familiaris) Cat (Felis catus) All species of non-human primates Frog (Xenopus (laevis, tropicalis), Rana (temporaria, pipiens)) Zebra fish (Danio rerio) ICMM Slide 15

Breeders and suppliers All who breeds and supplies purpose breed animals for scientific procedures must be licensed by Dyreforsøgstilsynet This includes breeders of genetically modified animals, professional breeders and breeding by individual researchers Breeders of others species breeding animals primarily for use in scientific procedures must also be licensed by Dyreforsøgstilsynet All licensed breeders must apply to regulation concerning housing and keeping of laboratory animals. This also applies to the education of caretakers and other staff ICMM Slide 16

Animals used for scientific procedures All acquisition of purpose breed laboratory animals must be from licensed breeders or suppliers This applies for animals acquired from both Denmark and abroad A local rapport of all animals used in procedures must be kept The number and purpose of animals used in procedures must be reported every year for statistics Dyreforsøgstilsynet every year publish the statistics for animals used in procedures in Denmark ICMM Slide 17

Animal records All breeders and suppliers must keep records of at least the following: 1) the number and the species of animals bred, acquired, supplied, used in procedures, set-free or rehomed, 2) the origin of the animals, including whether they are bred for use in procedures, 3) the dates on which the animals are acquired, supplied, released or rehomed, 4) from whom the animals are acquired, 5) the name and address of the recipient of animals, and 6) the number and species of animals which died or were killed in each establishment. For animals that have died, the cause of death shall, when known, be noted ICMM Slide 18

Animals not used in scientific procedures Animals bought but not uses in procedures shall not be registered or reported for statistics But all genetically modified animals not used in in scientific procedures, but used for taking out organs must according to local Danish regulation be reported annually to Dyreforsøgstilsynet and the statistics are published by Dyreforsøgstilsynet The keeping of genetically modified and altered animals expressing a harmful phenotype is defined as an experiment and requires a license even if the purpose is only taking out organs ICMM Slide 19

EU statistical regulation Genetically altered animals are reported either a) when used for the creation of a new line; b) when used for the maintenance of an established line with an intended and exhibited harmful phenotype; or c) when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line) Dyreforsøgstilsynet is working on implementing this especially a) ICMM Slide 20