Overview of rules on animal experiments in Denmark and on the Faculty of Health Sciences, University of Copenhagen

Transkript

1 Annex PJ Overview of rules on animal experiments in Denmark and on the Faculty of Health Sciences, University of Copenhagen Abbreviations: KU=University of Copenhagen SUND= The Faculty of Health Sciences at KU EMED=Department of Experimental Medicine at SUND Department of Experimental Medicine (EMED) is responsible for housing the animals used for experiments at SUND. EMED s website indicates the Danish regulation concerning animal experiments on the following e-address: According to the front-page of the above site, the following executive orders and bodies concern animal experiments: (English translation does not have official status.) Bekendtgørelse af dyreværnsloven. 1343, 04/12/2007 Proclamation of the Danish Animal Welfare Act. 1343, 04/12/2007 The Dyreværnsloven (Animal Welfare Act or: Animal Protection Act) no. 386 of 6 June 1991 provides a general protection of all animals from suffering, pain, fear, harm or significant nuisance. Bekendtgørelse af lov om dyreforsøg. 1306, Proclamation of law on animal experimentation 1306, The Lov om Dyreforsøg (Act on Animal Experiments ), as to Consolidation Act no. 726 of 9 September 1993 provides restrictions on animal experiments if the animal has a vertebra. The Act thus protects the animal from pain, suffering etc. Bekendtgørelse om forsøgsdyrs pasning og opstaldning og om anvendelse af udryddelsestruede og vildtlevende dyr til forsøg mv. 997, Executive order regarding care and husbandry for experimental animals and the use of threatened species and wild animals for experiments etc. 997, Bekendtgørelse om kvalifikationskrav til personer, der beskæftiger sig med forsøgsdyr 1016, 12/12/2001. Order regarding requirements for qualifications for persons working with experimental animals 1016, 12/12/2001. Lov om kloning og genmodificering af dyr m.v. 550, 24/06/2005 Law on cloning and genetic modification of animals. 550, 24/06/2005

2 Bekendtgørelse om fremskaffelse af dyr til forsøg. 332, 18/05/1990 Order on the procurement of animals for experimentation. 332, 18/05/1990 Bekendtgørelse om føring af journal over dyreforsøg samt kloning og genmodificering af hvirveldyr. 1273, 12/12/2005 Order on record keeping for animal experiments and cloning and genetic modification of vertebrate animals. 1273, 12/12/2005 Rådet for Dyreforsøg (The Animal Ethics Council) / Dyreforsøgstilsynet (The Animal Experiments Inspectorate.) Applications for animal experiments must be submitted to The Animal Experiments Inspectorate The Animal Welfare Division, the Ministry of Justice, is the responsible authority as regards regulation concerning animal experiments (Head of Division: Rikke Freil Laulund.) The Division s areas of responsibility: Animal Welfare, Act on Dogs, Act on the use of animals for experimental purposes, The Animal Ethics Council, The Council on the Keeping of Exotic Animals, The Animal Welfare Council. In addition the following two Acts may be of relevance: Dyreopdrætslov ( Animal Breeding Act ) no. 401 of 10 June 1997 This Act regulates the general breeding of animals in order to protect animals from pain, fear, harm etc. Lov om udførsel og indførsel af levende dyr m.v. ( Act on import and export of live animals etc. ) no. 61 of 23 March 1993 This Act authorises the Minister of Foods to provide regulations on import or export of live animals, which may harm the Danish Nature. The Bekendtgørelse af lov om dyreforsøg. 1306, (Proclamation of law on animal experimentation 1306, ) EMED provides, on its website, the following translation of the Proclamation of law on animal protection (the executive order on Act on animal experiments): 1 Bekendtgørelse af lov om dyreforsøg. 1306,

3 Proclamation of law on animal experimentation 1306, Kapitel 1 Chapter 1 Dyreforsøg Animal experiments 1. Anvendelse af hvirveldyr til forsøg, der må formodes at være forbundet med smerte, lidelse, angst eller varigt men for dyrene (dyreforsøg), må kun ske med tilladelse fra Dyreforsøgstilsynet. Stk. 2. Tilladelse til dyreforsøg må kun meddeles til forsøg med følgende formål: 1) forebyggelse af sygdom, dårlig sundhedstilstand eller anden abnormitet og virkningerne heraf hos mennesker, dyr og planter, herunder fremstilling af lægemidler, stoffer og produkter samt afprøvning af deres kvalitet, effektivitet og sikkerhed, 2) diagnosticering og behandling af sygdom, dårlig sundhedstilstand eller anden abnormitet og virkningerne heraf hos mennesker, dyr og planter, 3) vurdering, påvisning, justering eller forandring af fysiologiske tilstande hos mennesker, dyr og planter, 4) beskyttelse af miljøet, 5) forskning, 6) undervisning og uddannelse på universiteter og højere læreanstalter eller ved anden undervisning på tilsvarende niveau og ved undervisning af personer, der skal beskæftige sig med dyreforsøg, eller 7) retsmedicinske undersøgelser. Stk. 3. Der kan ikke meddeles tilladelse til udførelse af dyreforsøg med færdige kosmetiske midler, hvis forsøget udføres for at opfylde kravene til kosmetiske produkters sikkerhed. Stk. 4. Dyreforsøgstilsynet kan afslå at give tilladelse til dyreforsøg, såfremt forsøget ikke skønnes at være til væsentlig gavn. Stk. 5. Dyreforsøgstilsynet kan som et led i behandlingen af en ansøgning om tilladelse til dyreforsøg tillade, at et påtænkt forsøg demonstreres for tilsynet, såfremt det findes dyreværnsmæssigt forsvarligt. Stk. 6. Justitsministeren kan fastsætte regler om, at anvendelse af andre dyr end de i stk. 1 nævnte til forsøg helt eller delvis skal være omfattet af loven eller skal indberettes til Dyreforsøgstilsynet. Stk. 7. Ved kloning og genmodificering af hvirveldyr og ved anvendelse af klonede og genmodificerede hvirveldyr til dyreforsøg, som falder ind under lov om kloning og genmodificering af dyr m.v., finder denne lov anvendelse. 1. The use of vertebrate animals in experiments which are presumed to be associated with pain, suffering, fear or lasting harm in the animals (animal experiments), may only take place with license by the Animal Experiments Inspectorate. 2 Subsection 2. License for animal experiments can only be issued for experiments with the following purposes: 1) Prevention of disease, impaired state of health or other abnormality and the effects thereof in humans, animals or plants, including the production of pharmaceuticals, substances and products and testing of their quality, effectiveness and safety, 2) Diagnosis and treatment of disease, impaired state of health or other abnormality and the effects thereof in humans, animals or plants, 3) Evaluation, detection, adjustment or change of physiological conditions in humans, animals or plants, 4) Protection of the environment 5) Research 6) Teaching and education in universities and institutions of higher education or other teaching at a similar level and teaching of persons who are going to work with animal experiments, or

4 7) Medico-legal investigations Subsection 3. License for animal experiments with ready-made cosmetics, with the purpose of fulfilling the requirements for the safety of cosmetics, cannot be issued. Subsection 4. The Animal Experiments Inspectorate can deny license for an animal experiment, if the experiment is judged to be of no essential benefit. Subsection 5. The Animal Experiments Inspectorate can, as part of the processing of an application, permit that an intended experiment is demonstrated before the Inspectorate, if this is considered humanely acceptable. Subsection 6. The Minister of Justice can lay down rules that the use of other animals than those mentioned in Subsection 1 for experiments entirely or partly must be included in the law or must be reported to the Animal Experiments Inspectorate. Subsection 7. Cloning and genetic modification of vertebrate animals, and the use of cloned and genetically modified vertebrate animals for animal experiments, which are regulated by the law on cloning and genetic modification of animals etc., is included in this law. 1 a. Dyreforsøgstilsynet kan uanset de øvrige bestemmelser i denne lov tillade, at dyr, der anvendes i et forsøg, slippes løs, hvis forsøgets formål kræver det. Tilladelse hertil kan dog kun meddeles, hvis tilsynet finder det godtgjort, at der er gjort alt for at sikre dyrenes velbefindende, og såfremt dyrenes sundhedstilstand tillader det og der ikke er nogen fare for folkesundheden eller miljøet. Stk. 2. Forsøg, der indebærer, at dyr slippes løs, kan ikke tillades i rent undervisnings- eller uddannelsesmæssigt øjemed. 1 a. Regardless of the other provisions in this law, the Animal Experiments Inspectorate can permit that animals that are used in an experiment are released if the purpose of the experiment necessitates this. Permission for this may only be given if the Inspectorate finds it substantiated that every possible measure has been taken to safeguard animal welfare, and that the state of health of the animals allows this, and there is no danger to public health or the environment. Subsection 2. Experiments which involve the release of animals, cannot be permitted for the sole purpose of teaching or education. 2. Tilladelse til dyreforsøg kan kun gives til navngivne personer, der efter deres uddannelse og beskæftigelse må antages at kunne sikre, at forsøgene udføres på forsvarlig måde. 3 Stk. 2. Dyreforsøgstilsynet kan tillade, at ansvaret for den del af dyreforsøgsaktiviteten, som vedrører staldes og forsøgslokalers indretning og drift og dyrenes pasning, påhviler institutionen eller virksomheden eller en der ansat eller antaget person, der har den fornødne faglige uddannelse. Også ansvaret for journalføringen kan tillades henlagt til andre end tilladelsens indehaver. Justitsministeren kan fastsætte nærmere regler herom. 2. License for animal experiments can only be issued to named persons, who according to their education and occupation may be presumed to be able to ensure that the experiments are done properly. Subsection 2. The Animal Experiments Inspectorate may permit that the responsibility for that part of the experimental activity which concerns the design and operation of animal rooms and experimental rooms and husbandry of animals, rests with the institution or company or a person employed or hired, with the necessary professional education. The responsibility for record-keeping can also be permitted to be delegated to others than the holder of the permit. The Minister of Justice can lay down further rules about this. 3. Tilladelse gives til nærmere angivne typer af forsøg og arter af dyr. Antallet af dyr, der må anvendes til forsøg, angives i tilladelsen. Tilladelse kan dog meddeles uden sådanne begrænsninger, når særlige forhold taler herfor.

5 Stk. 2. Der kan fastsættes vilkår for tilladelsen, herunder om forsøgenes udførelse, dyrenes anvendelse, opstaldning og pasning og forsøgslokalernes indretning. Stk. 3. Det skal fremgå af tilladelsen, i hvilken institution eller virksomhed forsøgene må foretages, og hvem der har ansvaret for forsøgenes udførelse, staldes og forsøgslokalers indretning og drift, dyrenes pasning og journalføringen. 3. The permit is issued for definite types of experiments and species of animals. The number of animals that may be used for the experiment is stated in the permit. A permit may be issued without such limitations, if special conditions favour this. Subsection 2. Conditions may be attached to the permit, including the performance of the experiments, the use of the animals, housing, husbandry and the design of the experimental rooms. Subsection 3. The permit must specify the institution or company in which the experiments may be performed, and who is responsible for the performance of the experiments, the design and operation of animal rooms and experimental rooms and husbandry of animals, and responsibility for record-keeping. 3 a. Justitsministeren kan fastsætte regler om tilladelse til dyreforsøg med henblik på opfyldelse eller anvendelse af Det Europæiske Fællesskabs retsakter om forhold omfattet af denne lov. 3 a. The Minister of Justice can lay down rules about license for animal experiments to fulfill or apply the legal acts of the European Community regarding matters included in this law. Kapitel 2 Chapter 2 Regler for dyreforsøg Rules for animal experiments 4 4. Tilladelsens indehaver må kun lade forsøgene udføre af andre, såfremt disse har den fornødne faglige uddannelse og arbejder under ledelse og tilsyn af tilladelsens indehaver. 4. The holder of the permit may only allow others to perform the experiments, if they have the necessary professional training and work under the management and supervision of the holder of the permit. 5. Forsøgene skal udføres og opstaldning ske i dertil egnede lokaler. 5. The experiments must be performed and animals must be housed in suitable rooms. 6. Ved ethvert forsøg skal valget af dyreart omhyggeligt vurderes og på forlangende begrundes over for Dyreforsøgstilsynet. Ved valg mellem forskellige fremgangsmåder skal den vælges, der medfører brug af færrest dyr, forvolder mindst smerte, lidelse eller varigt men, og som mest sandsynligt fører til tilfredsstillende resultater. Stk. 2. Dyr må ikke anvendes til forsøg, hvortil anvendelse af celle-, vævs- eller organkulturer eller andre metoder må antages at være lige så velegnede. 6. In any experiment the choice of animal species must be carefully considered and upon request explained to the Animal Experiments Inspectorate. In the choice between different methods the one using the lowest number of animals, causing the least pain, suffering or lasting harm, and most likely to lead to satisfactory results should be chosen. Subsection 2. Animals must not be used for experiments where the use of cell, tissue, or organ cultures or other methods are presumed to be equally effective. 7. Dyreforsøg må kun udføres, når dyret er lokalt eller universelt bedøvet. Stk. 2. Skønnes bedøvelse at være mere belastende for dyret end selve forsøget, kan den undlades. Stk. 3. Hvis bedøvelse ikke er mulig, eller er bedøvelse uforenelig med forsøget, skal der anvendes smertestillende midler eller anden lindrende foranstaltning med henblik på, at smerte, lidelse, angst eller varigt men begrænses mest muligt. Dyret må ikke opleve stærk smerte, anden intens lidelse eller intens angst. Hvis tilstanden af stærk smerte, anden intens lidelse eller intens angst må antages at bestå ved bedøvelsens eller den lindrende behandlings ophør, skal dyret aflives. Stk. 4. Hvis forsøgets formål er demonstrationer ved undervisning, skal der ved forsøg, der må antages at kunne være forbundet med smerte, altid anvendes universelt bedøvede dyr, og disse skal altid aflives inden

6 bedøvelsens ophør. 7. Animal experiments may only be performed when the animal is locally or generally anaesthetized. Subsection 2. If anaesthesia is considered to cause more strain on the animal than the experiment itself, it may be omitted. Subsection 3. If anaesthesia is not possible, or if anaesthesia is incompatible with the experiment, pain relieving remedies or other alleviating measures must be used to ensure that pain, suffering, fear or lasting harm is limited to the greatest extent. The animal must not experience strong pain, other intense suffering or intense fear. If a condition of strong pain, other intense suffering or intense fear must be assumed to exist at the discontinuation of anaesthesia or alleviating treatment, the animal must be killed. Subsection4. If the purpose of the experiment is demonstration for teaching, general anaesthesia must 5 always be used for experiments that are assumed to be associated with pain, and these animals must always be killed while still in anesthesia. 8. (Ophævet) 8. (Revoked) 9. Der skal efter regler fastsat af justitsministeren føres journal over forsøgene og afgives indberetning herom til Dyreforsøgstilsynet. Pligten hertil påhviler tilladelsens indehaver, medmindre anden beslutning er truffet efter 2, stk. 2. Det kan i reglerne bestemmes, at journal skal føres på edb. Stk. 2. Den, der foretager dyreforsøg, skal endvidere efter tilsynets anmodning give nærmere oplysninger om forsøgene. 9. A record of experiments must be kept according to rules laid down by the Ministry of Justice and a report of the experiments must be submitted to the Animal Experiments Inspectorate. The duty rests with the holder of the permit, unless a different decision has been made according to 2, subsection 2. The rules may state that the record is kept electronically. Subsection 2. Furthermore, the person who performs animal experiments must upon request from the Inspectorate submit more detailed information about the experiments. Kapitel 3 Chapter 3 Dyreforsøgstilsynet The Animal Experiments Inspectorate 10. Dyreforsøgstilsynet ledes af Rådet for Dyreforsøg, der består af en formand, der skal opfylde betingelserne for at kunne beskikkes som dommer, og 10 andre medlemmer. Stk. 2. Justitsministeren udpeger rådets formand og de øvrige medlemmer. Èt medlem udpeges efter udtalelse fra Statens Sundhedsvidenskabelige Forskningsråd 2), ét medlem efter udtalelse fra Statens Jordbrugs- og Veterinærvidenskabelige Forskningsråd 3), ét medlem efter udtalelse fra Sundhedsstyrelsen, ét medlem efter udtalelse fra Dansk Industri, ét medlem efter udtalelse fra de store sygdomsbekæmpende foreninger, ét medlem efter udtalelse fra Det Dyreetiske Råd og fire medlemmer efter udtalelse fra dyrebeskyttelsesforeninger. Stk. 3. Justitsministeren skal ved sammensætningen af rådet så vidt muligt sikre, at der blandt rådets medlemmer er personer med indsigt i de faglige discipliner, der har særlig betydning for de opgaver, som er tillagt Dyreforsøgstilsynet. Stk. 4. Rådets medlemmer beskikkes for 4 år ad gangen. Stk. 5. Justitsministeren kan fastsætte en forretningsorden for rådet. Det kan heri bestemmes, at visse afgørelser kan træffes af et udsnit af rådsmedlemmerne, af formanden eller af sekretariatet. Stk. 6. De medlemmer af Rådet for Dyreforsøg, der ikke udfører hvervet som led i deres tjenstlige arbejde, ydes vederlæggelse og godtgørelse for befordring i lighed med ikke-statsansatte, der modtager særskilt vederlæggelse. Udgiften hertil afholdes af staten. 10. The Animal Experiments Inspectorate is headed by the Council for Animal Experimentation which consists of a chairman who must fulfill the requirements for being appointed as judge, and 10 other

7 6 members. Subsection 2. The Minister of Justice appoints the chairman and other members of the Council. One member is appointed according to statement by the Danish Medical Research Council 2), one member according to statement by the Danish Agricultural and Veterinary Research Council3)one member according to statement by The Danish National Board of Health, one member according to statement by the Confederation of Danish Industry, one member according to statement by the large patient organizations, one member according to statement by the Danish Council of Animal Ethics, and four members according to statement by animal protection societies. Subsection 3. The Minister of Justice must in the composition of the Council ensure as far as possible, that the Council members include persons with knowledge of the technical disciplines which have special importance for the responsibilities which rest with the Animal Experiments Inspectorate. Subsection 4. The Council members are appointed for 4 years at a time. Subsection 5. The Minister of Justice can lay down rules of procedure for the Council. The rules may allow that certain decisions can be made by a subsection of the Council members, by the chairman, or by the secretariat. Subsection 6. Members of the Council for Animal Experimentation, who do not serve in the Council as part of their professional position, are awarded compensation and allowance for travelling expenses similarly to non-state employees who receive separate compensation. The expense is borne by the Danish State. 11. Rådet og personer, som rådet har bemyndiget hertil, har til enhver tid uden retskendelse mod behørig legitimation adgang til forsøgslokaler og andre lokaler, hvor forsøgsdyr anbringes, med henblik på at tilvejebringe oplysninger til brug for tilsynet. Der kan i forbindelse med tilsynet foretages demonstration af det tilladte forsøg. Stk. 2. Den, der leder forsøgene, og personer, der er beskæftiget med forsøgene eller med dyrenes pasning, skal yde tilsynsmyndigheden vejledning og hjælp under tilsyn efter stk The Council and persons whom the Council has so authorized, may at any time without legal warrant upon presentation of proper identification enter experimental rooms and other rooms where experimental animals are kept, with the purpose of obtaining information for the use of the Council. In connection with the inspection, demonstrations of the permitted experiment may be carried out. Subsection 2. The person who conducts the experiments, and persons who work on the experiments or with the care of the animals, must offer the inspection authority assistance and help during inspections according to Subsection Rådet kan give påbud om forsøgenes udførelse, dyrenes anvendelse, opstaldning og pasning og forsøgslokalernes indretning. Rådet kan endvidere påbyde, at forsøg ikke må udføres, medmindre repræsentanter for rådet er til stede. 1. og 2. punktum finder anvendelse, uanset hvilke vilkår der er givet for tilladelsen. 12. The Council can issue injunctions about the performance of the experiments, the use, housing and care of the animals, and the design of the experimental rooms. Additionally, the Council can order that experiments must not be performed unless representatives of the Council are present. Sentence 1 and 2 apply regardless of the conditions of the permit Dyreforsøgstilsynets afgørelser efter loven eller efter regler fastsat i medfør af loven kan ikke indbringes for anden administrativ myndighed. 13. The decisions of the Animal Experiments Inspectorate according to the law or rules given in pursuance of the law cannot be brought before another administrative authority. 14. Tilsynet afgiver en årlig beretning om sin virksomhed. Justitsministeren offentliggør beretningen.

8 14. The Inspectorate writes a yearly report about its activities. The Ministry of Justice publishes the report. 15. For tilladelser til dyreforsøg efter 1 betales kr. For hvert af de følgende påbegyndte år betales 500 kr. Stk. 2. Beløbene efter stk. 1 tillægges udpantningsret. Stk. 3. Justitsministeren kan fastsætte nærmere regler om tilladelser efter denne lov, herunder om betaling af gebyr. 15. Permits according to subsection 1 are payable by kr. For each consecutive year or fraction thereof the payment is 500 kr. Subsection 2. The right of distress applies to the fees of subsection 1. Subsection 3. The Minister of Justice can issue more detailed rules about permits of this law, including payment of fee. Kapitel 4 Chapter 4 Straf og tilbagekaldelse af tilladelser m.v. Penalty and revocation of permits etc. 16. Medmindre højere straf er forskyldt efter anden lovgivning straffes med bøde eller fængsel indtil 4 måneder den, der 1) overtræder 1, stk. 1, 4-5, 7-8, 9, stk. 2, eller 11, stk. 2, 2) tilsidesætter vilkår for en tilladelse, eller 3) tilsidesætter et påbud efter 12. Stk. 2. I forskrifter, der udfærdiges i medfør af loven, kan der fastsættes straf af bøder for overtrædelse af bestemmelserne i forskrifterne. Stk. 3. For overtrædelser, der begås af aktieselskaber, andelsselskaber, anpartsselskaber eller lignende, kan der pålægges selskabet som sådant bødeansvar. Er overtrædelsen begået af staten, en kommune eller et kommunalt fællesskab, jf. 60 i lov om kommunernes styrelse, kan der pålægges staten, kommunen eller det kommunale fællesskab bødeansvar. 16. Unless a more severe penalty is due according to other legislation, the person who 1) violates 1, subsection 1, 4-5, 7-8, 9, subsection 2, or 11, subsection 2, 2) disregards conditions for a permit, or 3) disregards an injunction according to 12 is penalized by fine or prison up to 4 months. Subsection 2. In rules created in relation to this law, penalty of fine for violation of the provisions in the 8 rules may be established. Subsection 3. In the case of violations committed by corporations, co-operative societies etc., the company as such can be subject to fine. If the violation has been committed by the State, a municipality, or a municipal cooperation, cf 60 in the law regarding municipality government, the State, the municipality, or the municipal cooperation can be subject to fine. 17. Dyreforsøgstilsynet kan tilbagekalde en tilladelse, såfremt der er sket grov eller gentagen overtrædelse af de regler eller vilkår, der gælder for forsøgsvirksomhed og dyrenes behandling, eller er sket tilsvarende tilsidesættelse af påbud. 17. The Animal Experiments Inspectorate can revoke a permit in case of serious or repeated infraction of the rules or conditions which apply to experimental activities and the treatment of the animals, or in case of a similar disregard of an injunction. 18. Justitsministeren kan efter indhentet udtalelse fra Dyreforsøgstilsynet fastsætte regler om: 1) fremskaffelse af dyr til forsøg, herunder om forbud mod forsøg på herreløse hunde og katte samt

9 indfangede vilde dyr, 2) forsøgsdyrs pasning og opstaldning, 3) forsøgs udførelse, 4) kvalifikationskrav til de personer, som udfører forsøg eller passer dyr til sådanne formål, 5) forsøg i undervisnings- og uddannelsesøjemed, og om 6) institutioner eller virksomheder, som anvender, opdrætter eller leverer dyr til forsøg. Stk. 2. Justitsministeren kan endvidere efter indhentet udtalelse fra Dyreforsøgstilsynet fastsætte regler om Dyreforsøgstilsynets tilsynsvirksomhed og om forbud mod forsøg, der skønnes overflødige på grund af andre forsøg her i landet eller i udlandet. 18. The Minister of Justice can, following a statement by the Animal Experiments Inspectorate, lay down rules for : 1) the procurement of animals for experiments, including the prohibition of experiments with stray dogs and cats and captured wild animals, 2) the care and housing of experimental animals, 3) the performance of experiments, 4) demands for qualifications for persons performing animal experiments or caring for animals for such purposes, 5) experiments for the purposes of teaching and training, and for 6) institutions or companies who use, breed or supply experimental animals. Subsection 2. Furthermore, the Minister of Justice can, following a statement by the Animal Experiments Inspectorate, lay down rules for the inspection activity by the Animal Experiments Inspectorate and about prohibition of experiments which are regarded superfluous because of other experiments in this country or abroad. 19. Retten til aktindsigt efter lov om offentlighed i forvaltningen omfatter ikke adgang til at blive gjort bekendt med identiteten, herunder navne, adresser og telefonnumre, på de personer, der udfører forsøg eller passer dyr til sådanne formål The right to access to documents of the law on transparency in public administration does not include the right to be informed of the identity including names, addresses, and phone numbers, of the persons who perform experiments or care for animals for such purposes. Kapitel 5 Chapter 5 Ikrafttræden og overgangsregler m.v. Entry into force, transitional measures etc. 20. Loven træder i kraft den 1. oktober The law comes into force on 1 September (transitional measures, not translated) Animal Welfare Committee at the Department of Experimental Medicine EMED has established the Animal Welfare Committee, about which the following is stated on EMED s website:

10 The head of the Department appoints the Animal Welfare Committee, also referred to as "the committee," to oversee and evaluate the Department's animal program, procedures, and facilities to ensure that they are consistent with current legislation and the Department's policies. Members of the Committee The Head of the Department The Department's veterinarians (one of whom functions as Secretary for the Committee) A member who is a scientist and user of the Department, and who functions as contact person for researchers, who experience a conflict between their interests and the policies and decisions of the Department, which are intended to improve animal welfare, and their interests. An animal technician from the Department A member not employed by the Department Area of Responsibility The committee is responsible for oversight and evaluation of the animal care and use program and its components. Its functions include inspection of facilities; evaluation of programs and animalactivity areas; review of proposed uses of animals in research, testing, or education (i.e., protocols); and establishment of a mechanism for receipt and review of concerns involving the care and use of animals at the institution. Committee members are bound to secrecy concerning actual persons and cases. Meetings The committee meets at least once every 3 months. Records of committee meetings and of results of deliberations are maintained. Duties The committee should review the animal-care program and inspect the animal facilities and activity areas with a frequency less than 6 months. After review and inspection, a written report is made. The fixed meeting agenda includes Status of the animal-care program Inspections of units Welfare problems in ongoing experiments New licences received and possible welfare problems related to these