European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes *

Transcription

1 Europen Trety Series - No. 123 Europen Convention for the Protection of Verterte Animls used for Experimentl nd Other Scientific Purposes * Strsourg, 18.III.1986 Premle The memer Sttes of the Council of Europe, signtory hereto, Reclling tht the im of the Council of Europe is to chieve greter unity etween its memers nd tht it wishes to co-operte with other Sttes in the protection of live nimls used for experimentl nd other scientific purposes; Recognising tht mn hs morl oligtion to respect ll nimls nd to hve due considertion for their cpcity for suffering nd memory; Accepting nevertheless tht mn in his quest for knowledge, helth nd sfety hs need to use nimls where there is resonle expecttion tht the result will e to extend knowledge or e to the overll enefit of mn or niml, just s he uses them for food, clothing nd s ests of urden; Resolved to limit the use of nimls for experimentl nd other scientific purposes, with the im of replcing such use wherever prcticl, in prticulr y seeking lterntive mesures nd encourging the use of these lterntive mesures; Desirous to dopt common provisions in order to protect nimls used in those procedures which my possily cuse pin, suffering, distress or lsting hrm nd to ensure tht where unvoidle they shll e kept to minimum, Hve greed s follows: Prt I Generl principles Article 1 1 This Convention pplies to ny niml used or intended for use in ny experimentl or other scientific procedure where tht procedure my cuse pin, suffering, distress or lsting hrm. It does not pply to ny non-experimentl griculturl or clinicl veterinry prctice. (*) Text mended ccording to the provisions of the Protocol (ETS No. 170) s of its entry into force on 2 Decemer The Trety of Lison mending the Trety on Europen Union nd the Trety estlishing the Europen Community entered into force on 1 Decemer As consequence, s from tht dte, ny reference to the Europen Communities shll e red s the Europen Union.

2 2 In this Convention: c "niml", unless otherwise qulified, mens ny live non-humn verterte, including free-living nd/or reproducing lrvl forms, ut excluding other foetl or emryonic forms; "intended for use" mens red or kept for the purpose of sle, disposl or use in ny experimentl or other scientific procedure; "procedure" mens ny experimentl or other scientific use of n niml which my cuse it pin, suffering, distress or lsting hrm, including ny course of ction intended to, or lile to, result in the irth of n niml in ny such conditions, ut excluding the lest pinful methods ccepted in modern prctice (tht is "humne" methods) of killing or mrking n niml. A procedure strts when n niml is first prepred for use nd ends when no further oservtions re mde for tht procedure; the elimintion of pin, suffering, distress or lsting hrm y the successful use of nesthesi or nlgesi or other methods does not plce the use of n niml outside the scope of this definition; d e f g h i j "competent person" mens ny person who is considered y Prty to e competent in its territory to perform the relevnt function descried in this Convention; "responsile uthority" mens, in the territory of given Prty, ny uthority, ody or person designted for the relevnt purpose; "estlishment" mens ny stle or moile fcility, ny uilding, group of uildings or other premises, including plce which is not wholly enclosed or covered; "reeding estlishment" mens ny estlishment where nimls re red with view to their use in procedures; "supplying estlishment" mens ny estlishment, other thn reeding estlishment, from which nimls re supplied with view to their use in procedures; "user estlishment" mens ny estlishment where nimls re used in procedures; "humne method of killing" mens the killing of n niml with minimum of physicl nd mentl suffering pproprite to the species. Article 2 A procedure my e performed for one or more of the following purposes only nd suject to the restrictions lid down in this Convention: i voidnce or prevention of disese, ill-helth or other normlity, or their effects, in mn, verterte or inverterte nimls or plnts, including the production nd the qulity, efficcy nd sfety testing of drugs, sustnces or products; ii dignosis or tretment of disese, ill-helth or other normlity, or their effects, in mn, verterte or inverterte nimls or plnts; c detection, ssessment, regultion or modifiction of physiologicl conditions in mn, verterte nd inverterte nimls or plnts; protection of the environment; 2

3 d e f scientific reserch; eduction nd trining; forensic inquiries. Article 3 Ech Prty undertkes to tke ll the necessry steps to give effect to the provisions of this Convention nd to ensure n effective system of control nd supervision s soon s possile nd in ny cse within period of five yers from the dte of entry into force of the present Convention in respect of tht Prty. Article 4 No provision in this Convention shll ffect the lierty of the Prties to dopt stricter mesures for the protection of nimls used in procedures or for the control nd restriction of the use of nimls in procedures. Prt II Generl cre nd ccommodtion Article 5 1 Any niml used or intended for use in procedure shll e provided with ccommodtion, n environment, t lest minimum degree of freedom of movement, food, wter nd cre, pproprite to its helth nd well-eing. Any restriction on the extent to which n niml cn stisfy its physiologicl nd ethologicl needs shll e limited s fr s prcticle. In the implementtion of this provision, regrd should e pid to the guidelines for ccommodtion nd cre of nimls set out in Appendix A to this Convention. 2 The environmentl conditions in which nimls re red, kept or used shll e checked dily. 3 The well-eing nd stte of helth of nimls shll e oserved sufficiently closely nd frequently to prevent pin or voidle suffering, distress or lsting hrm. 4 Ech Prty shll determine rrngements to ensure tht ny defect or suffering discovered is corrected s quickly s possile. Prt III Conduct of procedure Article 6 1 A procedure shll not e performed for ny of the purposes referred to in Article 2, if nother scientificlly stisfctory method, not entiling the use of n niml, is resonly nd prcticly ville. 2 Ech Prty should encourge scientific reserch into the development of methods which could provide the sme informtion s tht otined in procedures. Article 7 When procedure hs to e performed, the choice of species shll e crefully considered nd, where required, e explined to the responsile uthority; in choice etween procedures, those should e selected which use the minimum numer of nimls, cuse the lest pin, suffering, distress or lsting hrm nd which re most likely to provide stisfctory results. 3

4 Article 8 A procedure shll e performed under generl or locl nesthesi or nlgesi or y other methods designed to eliminte s fr s prcticle pin, suffering, distress or lsting hrm pplied throughout the procedure unless: the pin cused y the procedure is less thn the impirment of the niml's well-eing cused y the use of nesthesi or nlgesi, or the use of nesthesi or nlgesi is incomptile with the im of the procedure. In such cses, pproprite legisltive nd/or dministrtive mesures shll e tken to ensure tht no such procedure is crried out unnecessrily. Article 9 1 Where it is plnned to suject n niml to procedure in which it will or my experience severe pin which is likely to endure, tht procedure must e specificlly declred nd justified to, or specificlly uthorised y, the responsile uthority. 2 Approprite legisltive nd/or dministrtive mesures shll e tken to ensure tht no such procedure is crried out unnecessrily. Such mesures shll include: either specific uthoristion y the responsile uthority; or specific declrtion of such procedure to the responsile uthority nd judicil or dministrtive ction y tht uthority if it is not stisfied tht the procedure is of sufficient importnce for meeting the essentil needs of mn or niml, including the solution of scientific prolems. Article 10 During procedure, n niml used shll remin suject to the provisions of Article 5 except where those provisions re incomptile with the ojective of the procedure. Article 11 1 At the end of the procedure it shll e decided whether the niml shll e kept live or killed y humne method. An niml shll not e kept live if, even though it hs een restored to norml helth in ll other respects, it is likely to remin in lsting pin or distress. 2 The decision referred to in prgrph 1 of this rticle shll e tken y competent person, in prticulr veterinrin, or the person who, in ccordnce with Article 13, is responsile for, or hs performed, the procedure. 3 Where, t the end of the procedure: n niml is to e kept live, it shll receive the cre pproprite to its stte of helth, e plced under the supervision of veterinrin or other competent person nd kept under conditions conforming to the requirements of Article 5. The conditions lid down in this su-prgrph my, however, e wived where, in the opinion of veterinrin, the niml would not suffer s consequence of such exemption; n niml is not to e kept live or cnnot enefit from the provisions of Article 5 for its well-eing, it shll e killed y humne method s soon s possile. 4

5 4 No niml which hs een used in procedure entiling severe or enduring pin or suffering, irrespective of whether nesthesi or nlgesi ws employed, shll e used in further procedure unless it hs returned to good helth nd well-eing nd either: the further procedure is one in which the niml is suject throughout to generl nesthesi which is to e mintined until the niml is killed; or the further procedure will involve minor interventions only. Article 12 Notwithstnding the other provisions of this Convention, where it is necessry for the legitimte purposes of the procedure, the responsile uthority my llow the niml concerned to e set free provided tht it is stisfied tht the mximum prcticle cre hs een tken to sfegurd the niml's well-eing. Procedures tht involve setting the niml free shll not e permitted solely for eductionl or trining purposes. Prt IV Authoristion Article 13 A procedure for the purposes referred to in Article 2 my e crried out y persons uthorised, or under the direct responsiility of person uthorised, or if the experimentl or other scientific project concerned is uthorised in ccordnce with the provisions of ntionl legisltion. Authoristion shll e grnted only to persons deemed to e competent y the responsile uthority. Prt V Breeding or supplying estlishments Article 14 Breeding nd supplying estlishments shll e registered with the responsile uthority suject to the grnt of n exemption under Article 21 or Article 22. Such registered estlishments shll comply with the requirements of Article 5. Article 15 The registrtion provided for in Article 14 shll specifiy the person in chrge of the estlishment, who shll e competent to dminister or rrnge for suitle cre for nimls of the species red or kept in the estlishment. Article 16 1 Arrngements shll e mde t registered reeding estlishments to record, in respect of the nimls red there, the numer nd species of such nimls leving, the dtes they leve nd the nme nd ddress of the recipient. 2 Arrngements shll e mde t registered supplying estlishments to record the numer nd species of such nimls entering nd leving, the dtes of these movements, from whom the nimls concerned were cquired nd the nme nd ddress of the recipient. 3 The responsile uthority shll prescrie the records which re to e kept nd mde ville to it y the person in chrge of the estlishments mentioned in prgrphs 1 nd 2 of this rticle. Such records shll e kept for minimum of three yers from the dte of the lst entry. 5

6 Article 17 1 Ech dog nd ct in n estlishment shll e individully nd permnently mrked in the lest pinful mnner possile efore it is wened. 2 Where n unmrked dog or ct is tken into n estlishment for the first time fter it hs een wened, it shll e mrked s soon s possile. 3 Where dog or ct is trnsferred from one estlishment to nother efore it is wened nd it is not prcticl to mrk it eforehnd, full documentry record, specifying in prticulr its mother, shll e kept until it cn e mrked. 4 Prticulrs of the identity nd origin of ech dog or ct shll e entered in the records of the estlishment. Prt VI User estlishments Article 18 User estlishments shll e registered with or otherwise pproved y the responsile uthority nd shll comply with the conditions lid down in Article 5. Article 19 Provisions shll e mde t user estlishments for instlltions nd equipment pproprite for the species of nimls used nd the performnce of the procedures conducted there. The design, construction nd functioning of such instlltions nd equipment shll e such s to ensure tht the procedures re performed s effectively s possile, with the oject of otining consistent results with the minimum numer of nimls nd the minimum degree of pin, suffering, distress or lsting hrm. Article 20 In user estlishments: c d the person or persons who re dministrtively responsile for the cre of the nimls nd the functioning of the equipment shll e identified; sufficient trined stff shll e provided; dequte rrngements shll e mde for the provision of veterinry dvice nd tretment; veterinrin or other competent person should e chrged with dvisory duties in reltion to the well-eing of the nimls. Article 21 1 Animls of the species listed elow which re for use in procedures shll e cquired directly from or originte from registered reeding estlishments, unless generl or specil exemption hs een otined under rrngements to e determined y the Prty: Mouse Rt Guine Pig Golden hmster Mus musculus Rttus norvegicus Cvi porcellus Mesocricetus urtus 6

7 Rit Dog Ct Quil Oryctolgus cuniculus Cnis fmiliris Felis ctus Coturnix coturnix 2 Ech Prty undertkes to extend the provisions of prgrph 1 of this rticle to other species, in prticulr of the order of primtes, s soon s there is resonle prospect of sufficient supply of purpose-red nimls of the species concerned. 3 Strying nimls of domesticted species shll not e used in procedures. A generl exemption mde under the conditions of prgrph 1 of this rticle my not extend to stry dogs nd cts. Article 22 In user estlishments, only nimls supplied from registered reeding or supplying estlishments shll e used, unless generl or specil exemption hs een otined under rrngements to e determined y the Prty. Article 23 Procedures my, where uthorised y the responsile uthority, e conducted outside user estlishments. Article 24 Arrngements shll e mde t user estlishments to mintin records nd mke them ville s required y the responsile uthority. In prticulr, these records shll e sufficient to meet the requirements of Article 27 nd, in ddition, show the numer nd species of ll nimls cquired, from whom they were cquired nd their dte of rrivl. Prt VII Eduction nd trining Article 25 1 Procedures crried out for the purpose of eduction, trining or further trining for professions or other occuptions, including the cre of nimls eing used or intended for use in procedures, must e notified to the responsile uthority nd shll e crried out y or under the supervision of competent person, who will e resposile for ensuring tht the procedures comply with ntionl legisltion under the terms of this Convention. 2 Procedures within the scope of eduction, trining, or further trining for purposes other thn those referred to in prgrph 1 ove shll not e permitted. 3 Procedures referred to in prgrph 1 of this rticle shll e restricted to those solutely necessry for the purpose of the eduction or trining concerned nd e permitted only if their ojective cnnot e chieved y comprly effective udio-visul or ny other suitle methods. Article 26 Persons who crry out procedures, or tke prt in procedures, or tke cre of nimls used in procedures, including supervision, shll hve hd pproprite eduction nd trining. 7

8 Prt VIII Sttisticl informtion Article 27 1 Ech Prty shll collect sttisticl informtion on the use of nimls in procedures nd this informtion shll where lwful e mde ville to the pulic. 2 Informtion shll e collected in respect of: c d the numers nd kinds of nimls used in procedures; the numers of nimls in selected ctegories used in procedures directly concerned with medicine nd in eduction nd trining; the numers of nimls in selected ctegories used in procedures for the protection of mn nd the environment; the numers of nimls in selected ctegories used in procedures required y lw. Article 28 1 Suject to requirements of ntionl legisltion relting to secrecy nd confidentility, ech Prty shll communicte every yer to the Secretry Generl of the Council of Europe informtion in respect of the items mentioned in prgrph 2 of Article 27, presented in the form set out in Appendix B to this Convention. 2 The Secretry Generl of the Council of Europe shll pulish the sttisticl informtion received from the Prties in respect of the items mentioned in prgrph 2 of Article Ech Prty is invited to communicte to the Secretry Generl of the Council of Europe the ddress of its ntionl uthority from which informtion out more comprehensive ntionl sttistics my e otined on request. Such ddresses will e contined in the pulictions of sttistics mde y the Secretry Generl of the Council of Europe. Prt IX Recognition of procedures crried out in the territory of nother Prty Article 29 1 In order to void unnecessry repetition of procedures required y lw on helth nd sfety, ech Prty shll, where prcticle, recognise the results of procedures crried out in the territory of nother Prty. 2 To tht end the Prties undertke, where prcticle nd lwful, to render ech other mutul ssistnce, in prticulr y furnishing informtion on their legisltion nd dministrtive prctice relting to the requirements for procedures to e crried out in support of sumissions for registrtion of products, s well s fctul informtion on procedures crried out in their territory nd on uthoristion or ny other dministrtive prticulrs pertining to these procedures. 8

9 Prt X Multilterl consulttions Article 30 (1) 1 The Prties shll, within five yers from the entry into force of this Convention nd every five yers therefter, or more frequently if mjority of the Prties should so request, hold multilterl consulttions within the Council of Europe to exmine the ppliction of this Convention, nd the dvisility of revising it or extending ny of its provisions 2 These consulttions shll tke plce t meetings convened y the Secretry Generl of the Council of Europe. The Prties shll communicte the nme of their representtive to the Secretry Generl of the Council of Europe t lest two months efore ech meeting. 3 Suject to the provisions of this Convention, the Prties shll drw up the rules of procedure for the consulttions. Prt XI Amendments (2) Article 31 (3) 1 Any mendment to Appendices A nd B, proposed y Prty or y the Committee of Ministers of the Council of Europe shll e communicted to the Secretry Generl of the Council of Europe nd forwrded y him to the memer Sttes of the Council of Europe, to the Europen Community nd to ny non-memer Stte which hs cceded to, or hs een invited to ccede to the Convention in ccordnce with the provisions of Article Any mendments proposed in ccordnce with the provisions of the preceding prgrph shll e exmined, not less thn six months fter the dte of forwrding y the Secretry Generl, t multilterl consulttion where it my e dopted y two-thirds mjority of the Prties. The text dopted shll e forwrded to the Prties. 3 Twelve months fter its doption t multilterl consulttion, ny mendment shll enter into force unless one third of the Prties hve notified ojections. Prt XII Finl cluses (4) Article 32 (5) This Convention shll e open for signture y the memer Sttes of the Council of Europe nd y the Europen Communities. It is suject to rtifiction, cceptnce or pprovl. Instruments of rtifiction, cceptnce or pprovl shll e deposited with the Secretry Generl of the Council of Europe. Article 33 (5) 1 This Convention shll enter into force on the first dy of the month following the expirtion of period of six months fter the dte on which four memer Sttes of the Council of Europe hve expressed their consent to e ound y the Convention in ccordnce with the provisions of Article 32. (1) (1) Text mended ccording to the provisions of the Protocol (ETS No. 170). (2) Prt dded ccording to the provisions of the Protocol (ETS No. 170). (3) Text dded ccording to the provisions of the Protocol (ETS No. 170). (4) Prt renumered ccording to the provisions of the Protocol (ETS No. 170) (5) Article renumered ccording to the provisions of the Protocol (ETS No. 170) 9

10 2 In respect of Signtory which susequently expresses its consent to e ound y it, the Convention shll enter into force on the first dy of the month following the expirtion of period of six months fter the dte of the deposit of the instrument of rtifiction, cceptnce or pprovl. Article 34 (1) 1 After the entry into force of this Convention, the Committee of Ministers of the Council of Europe my invite ny Stte not memer of the Council to ccede to this Convention, y decision tken y the mjority provided for in Article 20.d of the Sttute of the Council of Europe nd y the unnimous vote of the representtives of the Contrcting Sttes entitled to sit on the Committee. 2 In respect of ny cceding Stte, the Convention shll enter into force on the first dy of the month following the expirtion of period of six months fter the dte of deposit of the instrument of ccession with the Secretry Generl of the Council of Europe. Article 35 (1) 1 Any Signtory my, t the time of signture or when depositing its instrument of rtifiction, cceptnce, pprovl or ccession, mke one or more reservtions. No reservtions my, however, e mde in respect of Articles 1 to 14 or Articles 18 to Any Prty which hs mde reservtion under the preceding prgrph my wholly or prtly withdrw it y mens of notifiction ddressed to the Secretry Generl of the Council of Europe. The withdrwl shll tke effect on the dte of receipt of such notifiction y the Secretry Generl. 3 A Prty which hs mde reservtion in respect of provision of this Convention my not clim the ppliction of tht provision y ny other Prty; it my, however, if its reservtion is prtil or conditionl, clim the ppliction of tht provision insofr s it hs itself ccepted it. Article 36 (1) 1 Any Signtory my, t the time of signture or when depositing its instrument of rtifiction, cceptnce, pprovl or ccession, specify the territory or territories to which this Convention shll pply. 2 Any Prty my t ny lter dte, y declrtion ddressed to the Secretry Generl of the Council of Europe, extend the ppliction of this Convention to ny other territory specified in the declrtion. In respect of such territory, the Convention shll enter into force on the first dy of the month following the expirtion of period of six months fter the dte of receipt of such declrtion y the Secretry Generl. 3 Any declrtion mde under the two preceding prgrphs my, in respect of ny territory specified in such declrtion, e withdrwn y notifiction ddressed to the Secretry Generl. The withdrwl shll ecome effective on the first dy of the month following the expirtion of period of six months fter the dte of receipt of such notifiction y the Secretry Generl. Article 37 (1) 1 Any Prty my t ny time denounce this Convention y mens of notifiction ddressed to the Secretry Generl of the Council of Europe. (1) Article renumered ccording to the provisions of the Protocol (ETS No. 170). 10

11 2 Such denuncition shll ecome effective on the first dy of the month following the expirtion of period of six months fter the dte of receipt of the notifiction y the Secretry Generl. Article 38 (1) The Secretry Generl of the Council of Europe shll notify the memer Sttes of the Council of Europe, the Europen Communities nd ny Stte which hs cceded to this Convention of: ny signture; the deposit of ny instrument of rtifiction, cceptnce, pprovl or ccession; c ny dte of entry into force of this Convention in ccordnce with Articles 33, 34 nd 36; (2) d ny other ct, notifiction or communiction relting to this Convention; In witness whereof the undersigned, eing duly uthorised thereto, hve signed this Convention. Done t Strsourg, this 18th dy of Mrch 1986, in English nd French, oth texts eing eqully uthentic, in single copy which shll e deposited in the rchives of the Council of Europe. The Secretry Generl of the Council of Europe shll trnsmit certified copies to ech memer Stte of the Council of Europe, to the Europen Communities nd to ny Stte invited to ccede to this Convention. (1) Article renumered ccording to the provisions of the Protocol (ETS No. 170). (2) Text mended ccording to the provisions of the Protocol (ETS No. 170). 11