EPRUMA – Part of Responsible Use Declan O’ Brien on behalf of EPRUMA TAIEX, Istanbul, April 19th, 2011

Why EPRUMA? The motivation behind launching EPRUMA was to build stakeholder agreement on what constitutes “Responsible Use” of veterinary medicines We have very good agreement & collaboration across European stakeholders: COPA-COGECA (farmers & co-operatives), EISA (European Initiative for Sustainable Development in Agriculture), FECAVA (small animal vets), FEFAC (feed manufacturers), FESASS (animal-health farmer organisations), FVE (veterinary surgeons) & IFAH-Europe (animal health industry), PGEU (pharmacists) All pre-farm gate stakeholders support EPRUMA We actively welcome new members

EPRUMA partners:

Objectives of EPRUMA Promote animal health & welfare as well as human health through the “Responsible Use” of veterinary medicines an essential component of public health Develop “best practice” frameworks concerning the use of veterinary medicines Communicate with & involve all parties concerned with the “Responsible Use” of veterinary medicines 4

“Responsible Use” of Veterinary Medicines Bio-security: preventative measures aimed at keeping diseases out of groups of animals or to limit the spread of disease within an animal population Good housing Appropriate nutrition Regular monitoring of health and welfare Herd health plans: tailored to record specific actions for individual farms Vaccination Diagnosis and treatment under veterinary care Use medicines according to instructions 5

Policy Context Medicated Feed legislation being reviewed Veterinary Directive being reviewed Commission ‘Staff Working Paper’ consultation CVMP consultation Heads of Medicines Agencies consultation EU/US dialogue Innovation being promoted – Europe 2020

Communication Activities Website launched during Vet Week in June, 2010 Antimicrobial framework translated into Czech, Dutch, English, French, German, Hungarian, Italian, Polish, Romanian, Turkish & Spanish! EPRUMA present at relevant conferences – e.g. Vet Week, Congress of European Farmers Plan to present to veterinary students across Universities Plan to include in Continuous Professional Development courses for practicing veterinarians Leaflet & ‘roll up’ developed & Poster being developed 7

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Vet Week, June, 2010 9

Additional Antimicrobial Initiatives EPRUMA welcomes the EMA initiative on collecting volume information across the EU Important information that has not been available to date Ongoing reports from EFSA provide additional valuable information Need to also present Clinical breakpoint data EU/US Dialogue ongoing Animal Health Law & “One Health” 10

Implementation in the Field Met with Commissioner Dalli in September, 2010 Need to communicate Provide information to those who make the decisions especially veterinarians Continuous Professional Development as route 11

Industry Recommendations - 1 We should use all existing & new classes strategically – possibly in rotation & guided by diagnostics - to minimise resistance development to all classes We can protect the efficacy of existing & new antibiotics via ongoing diagnostics – use to inform future antimicrobial choices We promote the idea of significantly restricting the ‘cascade’ as a means of combating resistance – cascade by ‘exceptional exception’ but critical to have the cascade

Industry Recommendations - 2 We propose extended data protection for new molecules to ensure innovation continues With a combination of diagnostics, restrictions on off label use, appropriate use of new molecules & classes coupled with extended data protection, concerns of most stakeholders have been addressed

Conclusions EPRUMA has established very constructive collaboration across stakeholders EPRUMA has been very active in promoting “Responsible Use” Our activities complement European policy & legislation We need support to communicate “Responsible Use” and to really make a difference on the ground Strategic use of all classes supported by diagnostics can protect long term efficacy Restrict use of ‘cascade’ but critical to have it Stimulate innovation EPRUMA is a critical part of an overall policy to protect the long term efficacy of antimicrobials 14