About the role of the National Welfare/Ethics Committee with regard to the 3R s

Transcription

1 About the role of the National Welfare/Ethics Committee with regard to the 3R s Experiences while acting under the regulations effective in Hungary Susan Somfai-Relle MD

2 COUNCIL DIRECTIVE 86/609/EEC / 1986 Article Member States should encourage development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals involve fewer animals, entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. monitor trends in experimental methods..

3 HUNGARIAN XXVIII Act of Parlament on the protection and welfare of animals, 1998; and 243/1998. (XII. 31.) Governmental Regulation on Animal experiments Animal experiments may be carried out exclusively in registered establishments on the basis of a single or a general licence.. ORGANIZATION: Ministry of Rural Development Animal Protection Advisory Panel Scientific Ethical Committee on Animal Experimentation appointed but voluntary bord (without financial support) Food Chain Control Supervision and Agricultural Administration

4 Ministry of Rural Development Animal Protection Advisory Panel (21 members) Scientific Ethical Committee on Animal Experimentation (9members) Gives proposal for the decisions on the Applications Food Chain Control Supervision and Agricultural Administration supervises the facilities and the authorized experimental procedures Research Institution

5 HUNGARIAN XXVIII Act of Parliament on the protection and welfare of animals, 1998 and 243/1998. (XII. 31.) Governmental Regulation on Animal experiments REPLACE No animal experiments may be authorized and performed in those cases where such other, scientifically correct methods are known that can be carried out without the use of animals. REFINE the appropriateness of the up to date methodology to reduce the number of animals, their pain, suffering, distress or lasting damage as far as possible The availability the personnel and material conditions for the experiment. REDUCE To avoid unnecessary repetitions of animal experiments the applicant has to endeavour to learn about the results of those experiments that have been carried out already in the given topic.

6 At the research institutiuon Management, Study director, and Local Ethical Committee are responsible that the facility complies with the low Submit the Application for Allowance

7 Local Ethical Committee s approval is based on (among others) Purpose and aim of the experiment, data concerning scientific grounding; species and number of the animals planned to contribute; the general care and accommodation of animals; fate of animals at the end of the experiment; methods to avoid distress and unnecessary pain and suffering; educational background of the study director, study supervisor and participants 3R s were not mentioned

8 Application for Allowance Scientific Ethical Committee on Animal Experimentation 9 members representing: The Academy of Sciences, Universities: Medical, Veterinary and Biological Faculties, Chemical and Pharmaceutical Industry, Animal Protection Societies

9 National Welfare/Ethics Committee Experiences: The Local Ethical Committee proved to be a particular first screen. Significant reductions in the number of animals used for acute toxicity testing and pharmaceutical control (OECD and Ph. Eu. regulations) Tissue and organ culture systems are increasingly used with increasing frequency for primary screening and mechanistic studies. Applications not providing sufficient scientific grounding were returned and completed.

10 National Welfare/Ethics Committee Problems The Ethical Committee is an advisory board. Supervising is in other hands. No contact, no feedback. 4 meetings per year slow Round applications/year Not all scientific fields could be represented among the expert members Various size of content: projects vs. experiments No financial basis for - computerization - to cover costs of the time the experts spent - secretary services

11 This is history by now. Most things will change from 1 st January 2013 on. Happy New Year!