Implementation plan for the Council Directive 86/609/EEC, on the protection of animals used for experimental and other scientific purposes and Council Decision 90/67/EEC up an Advisory Committee on the protection of animals used for experimental and other scientific purposes IMPLEMENTATION PLAN FOR THE COUNCIL DIRECTIVE 86/609/EEC 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 AND COUNCIL DECISION 90/67/EEC SETTING UP AN ADVISORY COMMITTEE ON THE PROTECTION OF ANIMALS USED FOR EXPERIMENTAL AND OTHER SCIENTIFIC PURPOSES I. Responsible Ministry (division of responsibilities) Responsible Ministry: Ministry of the Environment of the Czech Republic (further here under as ME) Co-operating Ministry: Ministry of Agriculture of the Czech Republic (further here under as MA) Expert responsible: Mr. Karel Bláha, Head of the Department of Environmental Risks of ME II. Main objectives of the Directive The main objectives of the Directive are as follows: to establish conditions for use of animals for experimental purposes, to provide for reporting on experiments to competent authority, to provide for use of alternative methods that do not require use of animals. III. Plan for meeting the requirements of the Directive A. Main requirements of the Directive Approximation of legal and administrative regulations of Member States on animal protection applied for experimental and other scientific purposes in order to prevent doubling in experiments and trade barriers, which could affect the function of the common market. The concrete requirements are as follows: 1. protection of experimental animals, 2. unification of the market especially that of medicines, 3. classification of facilities into breeding, using, and supplying ones, 4. informing and education. B. Plan for implementation of the requirements The Directive requirements are fully transposed into the Act No. 246/1992 Code, on protection of animals against cruelty and the Regulation No. 311/1997 Code, on breeding and use of test animals. The Central Commission for Animal Welfare of the Ministry of Agriculture is the appropriate institution for. G1 1 Implementation plan for the Council Directive 86/609/EEC, on the protection of animals used for experimental and other scientific purposes and Council Decision 90/67/EEC up an Advisory Committee on the protection of animals used for experimental and other scientific purposes IV. Requirements to the date of accession To carry out registration of breeding, supplying, and using facilities, to work out projects on experiments, and to meet qualification requirements for personnel. V. Current state The Directive requirements are in full transposed into the Act No. 246/1992 Code, on protection of animals against cruelty and the Regulation No. 311/1997 Code, on breeding and use of test animals. Implementation of the legislation has been completed recently. It is not assumed the regulations will be in need for amendments in near future. The Central Commission for Animal Welfare of the Ministry of Agriculture and are the appropriate institutions for the legislation implementation. VI. Identification of problem areas, proposed measures The troublesome areas are as follows: - granting accreditation for using facilities, - issuing certificates for breeding and supplying facilities, - carrying out of qualification courses: VII. Identification of stakeholders and their involvement in the approximation process The Directive implementation concerns every breeding and supplying facility, which deal with test animals, and laboratories and test facilities, where the animals are used. From the point of supervision the Directive concerns the Ministry of Agriculture of the Czech Republic, the State Veterinary Service of the Czech Republic, the Central Commission for Animal Welfare of the Ministry of Agriculture, and local authorities. VIII. Institutional, material and personnel needs a) Institutional and material needs Requirement Institutions involved Necessary changes Current Optimum state state Approving, permitting, CCAW /MA CCAW /MA More personnel making registration, solving appeals G1 2 Implementation plan for the Council Directive 86/609/EEC, on the protection of animals used for experimental and other scientific purposes and Council Decision 90/67/EEC up an Advisory Committee on the protection of animals used for experimental and other scientific purposes b) Needs for additional personnel in state institutions Description Approving, permitting, making registration, solving appeals IX. Institution State at the beginning of 1999 / optimum state CCAW /MA ½/2½ Personnel Personnel needs reinforceme in 2001 - 2003 nt in 1999 and 2000 1999 2000 2001 2002 2003 2004 2005 1 1 Costs and financial resources For the sake of the implementation of the appropriate legislation is completed in full neither additional costs for state budget nor private sector are assumed. X. Economic impacts There are none assumed. XI. Project identification None G1 3