EMEA / IFAH–Europe Info Day « Balancing the benefits and risks of Veterinary Medicinal Products »

2 Update on Pharmacovigilance Perspective of the veterinary practitioner

3 FVE is a Federation of 42 veterinary organisations in 37 European countries Through its members, FVE represents approximately veterinarians

4 FVE’s objective Representing the Veterinary Profession at the European level in order to: Promote veterinary medicine Support veterinarians in delivering their services and their responsibilities towards our societies

5 Animals Owners / Keepers Society v Science Knowledge / Skills Ethics / Attitude Objective Independent Impartial

6 benefits / risk of vmps cost / benefits of monitoring system

7 VMPs are very important tools in the prevention and control of animal diseases Veterinary practitioners would like to have broad range of products for all species and indications (incl MUMS) that are reliable i.e. have a good and predictable efficacy and safety

8 Veterinarians believe that current product safety and efficacy evaluations required for obtaining a marketing authorisation and batch tests are solid

9 Veterinary practitioners see the need for continuous monitoring of vmps under field conditions ! To have a better understanding of the product To be re-assured that a product is efficacious and safe To be alerted in case something goes wrong or

10 Adverse effects are unwanted, especially in case they were not foreseen they are serious and / or long-lasting where groups of animals are involved where the owner is worried

11 Reasons for veterinary practitioners to report (suspected) product failure Ethical and legal obligation Prevention of future cases (general interest) For compensation of damage (per case)

12 Veterinarians are more motivated to report adverse effects, when they see an added value: –when they encounter something new –when it is considered a serious case –when it does not cause too much extra work – preferably on-line reporting –when they get feedback on the report –when the owner of the animal complains

13 Balancing risk / benefits of vmps Normal authorisation procedure By CA for immunologicals in the event of serious epizootic diseases Post marketing surveillance / Pharmacovigilance By veterinary practitioner case by case

14 Balancing the monitoring system Veterinary practitioners wish to have limited administrative procedures (simple as possible) get feedback on indivisual cases get feedback on the system / trends (make it visible) avoid disproportionate concerns about possible adverse reactions

15 How far do we want to go? What are the priorities? What is proportionate? –In relation to the effect as such –In relation to other Community animal health and welfare policies

16 Recommendation: a more intelligent use of the expertise available through the veterinary practitioners

17 “ Hominum Animaliumque Saluti” Thank you for your attention!

18 For Further information: Tel (+ 32)