Use of animals for scientific or educational purposes principles in Finland Eila Kaliste Project Authorisation Board (ELLA) Chief presenting officer Regional Administrative Agency for Southern Finland (ESAVI) Senior officer 2017
EU regulates via national legislation European and National EU directive 2010/63/EU According to European Convention (Council of Europe, ETS Nro 123, 1986) According to international OIE:n (Terrestrial Animal Health Code, Chapter 7.8) guiding Commission implementing Decision for annual statistics and reporting Commission Recommendation 2007/526/EY compliments the provisions of directive for accommodation and care of animals In Finland the provisions of directive: Act(497/2013) and Decree(564/2013) on the protection of animals used for scientific or educational purposes Why regulated? Protection of animals to ensure and promote animal welfare Good living environment Operation authorisation and supervision Procedures in projects Project authorisation Competent and skilled personnel Guiding for eduction and training Control of competence Promotion of 3R principles Replacement - korvaaminen Reduction vähentäminen Refinement parantaminen Promotion of transparency Non-technical summaries of projects in net Statistical data and reporting
When the regulation must be applied? 1) Use of living animal 2) Scientific or educational purpose Living animal vertebrate or cephalopod Also foetal forms of mammals from the last third of their development Also independently feeding larval forms When used for scientific or educational purpose Including animals bred for scientific or educational purposes Operation authorization, competent personnel, appropriate environment etc rules 3) procedures will be done Procedure = All kind of animal use, which causes harm equivalent to or more than an introduction of needle Also creation of gm line Also maintenance of gm line, if the genetic modification causes harm for animals equivalent to or more than introduction of needle Exceptions: Euthanasia according to decree, customary breeding and care practices, marking of animals for identification, clinical veterinary practices, veterinary clinical trials
EU MMM Commission National committees PARERE Network Project Authorisation Board ELLA TOKES Council Promotes 3R methods OPERATOR User Breeder - Supplier Responsible persons Operation licence ESAVI & ISAVI ANIMAL WELFARE BODY Takes care of the welfare of animals Cooperation ESTABLISHMENT 1 EST 2 EST 3 Project licences Project 1 Project 2 Project 1 Project 2 Project 3 Project 1 Inspections 4
Project Authorisation Board (ELLA) Project licences and amendments Authorities Ministry of Agriculture and Forestry- MMM General steering and control & EU cooperation Regional State Administrative Agencies of Southern and Eastern Finland ESAVI ja ISAVI: steering of operators (ESAVI acting also on behalf of ISAVI 2017-2018) Operation authorisations & control of the compliance with act and project licences ESAVI Presentation of projects applications for ELLA Minor amendments of project licences (time, animal numbers) Publication of summaries & retrospective assessment Statistics and reporting of animal use Competence authorisation for designers of projects and procedures, when the animal courses were not done in Finland Committees and operators TOKES committee Council on the protection of animals used for scientific and educational purposes Follow up activities, especially promotion of 3R-methods, Cooperation with EU member committees Operators Research or education activies including animal use, for example university May include several establishments (= units where animals are bred or used) Persons responsible: responsible for the activities, responsible for the establishment, designated veterinarian, responsible for implementing the project Animal welfare group follows activities and advises personnel
Operators, establishments and responsible persons Operator = institute or company doing research including animal use Establishment = animal unit Facilities, where animals are maintained and/or used in projects (experiments) One operator may have one or several establishments For example university = operator Animal units A ja B = establishments of the university Persons responsible: Responsible for the activity Requirements laid down for the activity are fulfilled Personnel is competent Designated veterinarian Veterinary care Responsible for the establishment Housing environment, care and use of animals according to law and licence Advice the personnel Ensures that people working with animals are competent Responsible for the project implementation Projects done according to project licence and law Animal Welfare Group follows and advices Promotion of 3R methods
Requirements for activities & 3R principles Operation licence for operator: Ensures appropriate activities Procedures must be done in establishment Project licence for scientist: Ensures that 3R principles are implented The benefit expected is in ethically justified proportion considering the harm to the animals: harm-benefit assessment Competence of persons Appropriate education and experience to work with living animals 3R principles must be followed Replacement korvaaminen Living animals are not used, if alternative method exists Reduction vähentäminen Number of the animals used is determined with statistical methods Refinement parantaminen: Procedures are done with best practices Better housing environment and care routins are developed continuously
Only competent persons may work with living animals Competency is needed A. Persons carrying out procedures on animals Species-spesific & procedure-spesific B. Persons designing procedures and projects Suitable academic degree + courses for animal experimentation C. Persons taking care of animals D. Persons killing animals Shall be supervised until the competency is demonstrated. Continuous training required Operator (named person) ensures and evaluates the competency Adequate knowledge and skills depending on the duties Legislation, ethics and 3Rs Species spesific needs, husbandry and care Genetics, biology, anatomy, behaviour Welfare, enrichment Health management and hygiene Design, species-specific procedures Pain, anaesthesia, analgesia, humane end points, euthanasia Person previously qualified as competent to perform animal experiments retains qualified to design projects and carry out procedures
Procedure vs Project Procedure May be a single act A single injection May be multiple acts with one defined purpose Anesthesia + surgical implantation of a blood pressure transducer + following a suitable recovery period + administration of test substance + follow up the blood pressure + euthanasia of animals All separate steps are needed to meet the single scientific purpose Project Procedures are done only in projects Project must be authorised project licence (previously licence for animal experiment)) In the same project: several subprojects and procedures may include Other animal use For example tissue sampling after euthanasia Must be reported to operator: Ensures that activities are appropriate Reports to ESAVI
Applying a project licence http://www.laaninhallitus.fi/lh/etela/hankkeet/ellapro/home.nsf/pages/indexeng Project Authorisation Board (ELLA) evaluates and authorises projects: new projects and changes to project Decision within 40 working days (after all necessary information is received) Licence period in general 3 years, max 5 years short continuing period or minor increase in the number of animals: ESAVI may authorise Non-technical project summary published in internet Evaluation of projects: Prospective severity classification of procedures Check for 3R methods & harm-benefit assessment licence ELLA may require retrospective assessment Always if project includes severe procedures May be required for moderate procedures if special reasons
Applying a project licence http://www.laaninhallitus.fi/lh/etela/hankkeet/ellapro/home.nsf/pages/indexfin Important things to clarify Why necessary reasoning of project and expected benefits 3R methods implemented: replacement, reduction, refinement Refinement (parantaminen) appropriate experimental techniques and good living environment humane end points Harm caused to animals = severity assessment and classification Justification of licence authorisation: 3R methods applied in maximum Harm-benefit assessment: if ethically justified -> licence granted Benefits expected as result, harm caused to animals, project s likelihood of success (can the expected benefits be reached, are reliable results possible)
Project licence responsibilities of scientists Project licence holder overall responsibility of the project Designated person responsible Must be named in the application (changes must be informed to operator and ESAVI) Project is done according to the project licence and regulations Persons doing procedures are competent If needed, actions taken to correct shortcomings and records of that Continuous monitoring and recording the welfare of individual animals during procedure => actual severity classification after procedure Records for retrospective assessment to ESAVI if required Records for annual statistics Medication given to animals in research purposes is recorded according to decree 26
Re-use of animals The animal is used in another procedure to meet a new defined purpose, the procedure could also be done for a naive animal Only if The actual severity of the previous procedures was mild or moderate The general state of health and well-being has been fully restored The further procedure is classified as mild, moderate or nonrecovery It is in accordance with veterinary advice
Severity assessment and classification Before the project: applicant s estimation in the application ELLA gives a prospective assessments for procedures Factual severity assessed for each animal in the end of procedure Criteria for classification given by decree During the project Animal welfare must be monitored and recorded during the procedures severity assessment and recording in the end of procedure: take into account all steps of the procedure & harm caused by genotype Guidance: http://ec.europa.eu/environment/chemicals/lab_animals/interpretation_en.htm
Severity classification of procedures Decree 564/2013 Annex 3 (Directive Annex VIII) Non recovery Procedures performed entirely under general anasthesia from which animals shall not recover consciousness Mild Likely to experience short-term mild pain, suffering or distress Procedures with no significant impairment of well-being or general condition For example pharmacokinetics, non invasive imaging (MRI) with appropriate sedation, ear or tail biopsies, IM-SC-IP-IG-IV administration, short term (<24h) restrain in metabolic cages, breeding of GM-animals without clinically detectable adverse phenotype
Severity classification of procedures Moderate Likely to experience short-term moderate or long-lasting mild pain, suffering or distress Procedures that likely cause moderate impairment of well-being or general condition For example surgery under general anaesthesia and appropriate analgesia (thoracotomy, laparotomy, organ transplants, implantation of catheters/telemetry transmitters), withdrawal of food >48h in adult rats, acute dose-range finding studies and chronic toxicity tests without lethal end-points
Severity classification of procedures Severe Likely to experience severe or long-lasting moderate pain, suffering or distress Procedures that likely cause severe impairment of well-being or general condition For example toxicity testing with death as end-point, tumours resulting in cachexia, surgery with severe/persistent moderate harm, multiple organ failure, genetical disorders with severe impairment of general condition (Huntington s disease, muscular dystrophy) Not allowed: Procedures which involve severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated
Retrospective assessment of project Must be made by ESAVI if ELLA requires in the licence projects with severe procedures projects with moderate procedures if special reasons Projects with non-human primates Data to ESAVI within 3 months after the end of project ESAVI makes the final assessment and updates non-technical summary in internet Info goes also to ELLA to help it for evaluation of future projects
Retrospective assessment Project information submitted to ESAVI: 1. Whether project objectives were achieved 2. Harm caused for animals numbers and species used actual severity of procedures 3. All elements that may enhance implementation of replacement, reduction and refinement In the end of licence with project plan: information about which procedures/issues specifically must be reported
Annual statistics: new reporting table Animals used in procedures: Species Number Severity classification Genotype Purpose And many other things! Operator sums up and sends to ESAVI before 31.3. Animals not used in procedures Species Numbers Used or not used in gm production or maintenance (all animals are reported, including wild types and standard strains)
Board for Gene Technology and animal unit control also : GMOs and GMMOs 1. GENE MODIFIED ANIMALS Researcher: Risk assessment of the use of GM-strains (normally class 1) GM-notification to animal unit, which keeps records of strains 2. GENE MODIFIED MICRO-ORGANISM Researcher: Risk assesment of micro-organism -> Board for Gene Technology Risk assessment when used in animal unit Info of risk assesment to animal unit Working instructions to animal unit