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Alternative methods contemporary and future situation in the Czech Republic

Alternative methods contemporary and future situation in the Czech Republic. Dagmar Jírová,M.D., Ph.D. Department of Toxicology National Institute of Public Health Praha, CR. Protection of Animals Used for Experimental Purposes legislation in the CR.

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Alternative methods contemporary and future situation in the Czech Republic

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  1. Alternative methods contemporary and future situationin the Czech Republic Dagmar Jírová,M.D., Ph.D. Department of Toxicology National Institute of Public Health Praha, CR

  2. Protection of Animals Used for Experimental Purposeslegislation in the CR Directive 86/609/EEC,on protection of animals used for experimental purposes is implemented in Act No.246/1992 Sb. , on the protection of animals against cruelty Decree No. 207 / 2004 / Coll., on protection, breeding and use of animals for experimental purposes

  3. Act No.246/1992 Sb. ,on the protection of animals against cruelty Regulating : • definition of cruelty, possible purposes / procedures to kill animals • protection of animals during transport • protection of farm animals • protection of domestic animals / breeding of special interest • protection of wildlife species of animals • protection of animals used for experimental purposes : article 15 - 18 • competent authorities responsible for protection of animals : Ministry of Agriculture, Central Commission for Animal Welfare (consultant body to the Minister), State Veterinary Administration, Municipal Authorities

  4. Act No.246/1992 Sb. ,article 15 - 18animals used for experimental purposes • Possible purposesto conduct experiments on animals, including : - ban on testing of cosmetics and their ingredients, ..... weapons - ban on use of abandoned animals , .... animals of endangered species - priority to use animals bred for experimental purposes Experiment can only be performed, if proved that no alternative methods are available ;unavoidable pain and distress should be minimized. • Obligation to prepareproject of the experiment, it has to be approved by Animal Wefare Commission of the respective Ministry • Requirements on qualification of personnelconducting experiments • Ruleson breeding, care, accomodation and transport of experimental animals, on accreditationof breeders, suppliers and users, on animal welfare committees of these facilities, reports on number and species used.

  5. Decree No. 207 / 2004 Coll.,on protection, breeding and use of animals for experimental purposes 25 mandatory items to be addressed in project of the experiment, including reasoning for unavoidability of the experiment, absence of alternatives, justification of species selection, number of animals, possible anesthesia, qualification of personnel, laboratory eqiupment ..... Requirements on application for accreditation of the facility. Requirements on qualification of personnel conducting experiments : obligatory examination in elementary anatomy and physiology of laboratory animals, genetics, pharmacology, toxicological methods including alternatives. Requirements applied on facilities intended for breeding, accomodation, care, transport and use of animals - zoohygiene : space, temperature, humidity, ventilation, illumination .... - transport conditions, veterinary care and examinations, labelling and registry of animals, inspections, reporting (12 Annexes related to individual species, templates for reporting ....).

  6. Animal Testing in the CR : 2009 Information Bulletine of Ministry of Agriculture No.4 / 2010 http://eagri.cz State (Veterinary) administration of animal experiments / Central Commission for Animal Welfare 2009

  7. Animal Testing in the CR : 2009 Information Bulletine of Ministry of Agriculture No.4 / 2010 http://eagri.cz

  8. Alternative methods in the CRintroduced originaly for In-market testing of cosmetics In 1970sas a screening tool for localtoxicity evaluation of consumer products / cosmetics and medical devices Reasons :scientific + ethical, economical + methodological National Reference Center for Cosmetics and National Reference Laboratory for Experimental Immunotoxicology at NIPH Unit for Toxicology In vitro at Department of Toxicology at NIPH • authorized by Ministry of Health for in-market testing of cosmetics, employ alternatives on routine basis for safety and efficacy testing • apply validated and valid alternatives for local toxicity testing and safety evaluation of chemicals and consumer products intended for skin/ mucosa contact (toys, children products, MD, chemical preparations, others...) • testing facility for control authorities, manufacturers, NGOs , individuals... • accredited according to ISO 17025, GLP principles respected

  9. NRL for experimental ImmunotoxicologyUnit for Toxicology In vitro Department of Toxicology at NIPH Granted for projects of applied researchfocussed on use of alternative methods in vitro for determination of local toxicity ( phototoxicity, skin and eye irritation, skin penetration) of ingredients of consumer products (5x local projects, 2x 6.FP projects) Participation of experts in Peer Review of ESAC-ECVAM , OECD WGs on skin irritation, eye irritation validation studies, ICCVAM skin sensitization ESAC-ECVAMMember (Head of Department ) Local information centerfor alternative methods in the CR, provide training of other laboratories, perform comparative studies Member of Central Commission for Animal Welfarein the CR, evaluation of projects of experiments at Commission of Ministry of Health CZECOPA (ECOPA)founder- registered office / executive center at NIPH No specific budget for alternatives - included in budget of NIPH CZECOPA : membership fees only

  10. Alternative methods performed at NIPHRegulation No.440/2008/EC - OECD TG – ISO - ESAC Skin corrosion:B.40 EpiSkin/ EpiDerm models of epidermis (OECD 430) Skin irritation: B.46EpiSkin, EpiDerm, SkinEthic RHE models of epidermis Phototoxicity: B.41 3T3 NRU test (OECD 432) , 3D skin models Eye irritation :Cytotoxicity test - 3T3 NRR, Organotypic model HET-CAM, 3D cornea models : EpiOcular, HCE SkinEthic Skin absorption / penetration :B.45(OECD 428) ex vivo porcine skin Genotoxicity / Mutagenicity : B.13/14 Reverse mutations in bacteria (Ames test) (OECD 471) B.10 Chromozomal aberations in mammals in vitro (OECD 473) Clastogenicity + aneugenicity. In vitro micronucleus test (OECD 487) Acute toxicity:Cytotoxicity test for starting dose for in vivo test Cytotoxicity test: EN ISO 10993-5 for medical devices, cytotoxicity as screening for local tolerance evaluation of consumer products

  11. Directive 2010/63/EU on protection of animals used for scientific purposestransposition • Transposition foreseen by Ministry of Agriculture, as : - recognized competent authority by „competence law“ for „protection of animals“ in general and responsible for implementation. - has already established instruments to implement directive into the Act No.246/1992 Coll. on protection of animals against cruelty and Decree No.207/2004 Coll. on protection, breeding and use of animals for experimental purposes. • Alternatively,Society for science on laboratory animals suggests transposition as a new law submitted by Ministry of Education : - easier transposition as law dealing only with animals used for scientific purposes - clearly separated law for laboratory animals, free from provisions on farm animals, wildlife species, etc. - majority of experiments are performed within the sector of education, i.e. universities, scientific institutions

  12. Directive 2010/63/EU Existing provisions / instruments – easy to update • Mandatory requirement to apply 3R principles, priority in replacement and use of alternative methods in vitro. • Requirements on the evaluation and authorization of projects involving the use of animals, qualification/competence of personnel. • Requirements on the origin, breeding, marking, care and accomodation and killing of animals, regular inspections. • Requirements on breeders, suppliers and users. • Animal welfare bodies (committees) in facilities of breeders, suppliers and users. • Reporting on experiments (number / species/ purpose).

  13. Directive 2010/63/EU New provisions – new instruments needed • Classification of severity of procedures • Reuse of animals, sharing organs/tissues, rehoming/setting free of animals • Retrospective assessment of projects, non-technical project summaries • „Contribution“ to the development / validation of alternatives (Art.47) by MS not understood as financial, no extra resources identified. • Designation of new competent authorities : • Competent authority (Min.of Agriculture) responsible for Dir. implementation • National Committee at Min.of Agriculture(new) for welfare of animals used for scientific purposes and for evaluation/approval of projects, harmonizing approaches of animal wefare commissions of individual sectors (Ministries) • Contact point to provide advice on regulatory relevance/suitability of alternatives for validation, qualified laboratory to carry out validation study. National Institute of Public Health is suggested.

  14. NRL / Unit for Toxicology in vitro / CZECOPA at NIPH Prague Thank you for your attention

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