EFSA-EMA Joint Scientific Opinion

Transcription

1 EFSA-EMA Joint Scientific Opinion on the Reduction Of the Need to use Antimicrobials in Foodproducing Animals (RONAFA) Beatriz Guerra Copenhagen, 7 April 2017 FWD/EURL-AR Worshop

2 SCIENTIFIC OPINION EC Mandate to EFSA and EMA for a joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impact on food safety Adopted by EFSA BIOHAZ Panel and EMA CVMP in December 2016 Published on 24 January

3 THE MANDATE Terms of reference, as clarified with EC ToR 2 Assess the impact of such measures on AMR ToR 3 Review measures to reduce the need to use AM ToR 4 Assess the impact of such measures on AMR ToR 1 Review measures to reduce the use of AM ToR 5 Recommend options to reduce antimicrobial use in EU 3

4 PARTIES INVOLVED AHAW Panel Antimicrobials WP BIOHAZ Panel CVMP FEEDAP Panel Joint WG RONAFA Immunologicals WP EU stakeholders providing information (FVE, a.v.e.c., COPA COGECA, EUROCOMMERCE, FOODDRINKEUROPE, UECBV, Member States) 4

5 APPROACH What was done 1. Critical review of measures to reduce use/need of AM Starting point: EC prudent use guidelines Based on scientific literature, official reports, information from MSs, information from experts (hearing experts) and stakeholders (several questionnaires), etc. 5

6 APPROACH What was done 2. Assessment of the impact of measures on AMR in bacteria from food-producing animals and food A difficult task: Delay between implementation and impact Need to have proper monitoring for several years Different measures together: impact due to what? etc. Not possible to quantify impact, only qualitative assessment was done! 6

7 List of recommended options 11 options are recommended for consideration: what can be done advantages and disadvantages No measure alone sufficient to have an impact on AMR! Options to be implemented in an integrated approach, and according to the local circumstances: 11 options. Option 1: Development of national strategies implemented through action plans: One health education monitoring prudent use limiting use CIA animal disease prevention research alternatives 7

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10 Use high targets to reduce overall use Especially FQ, 3-4 gen ceph, colistin Species-/farm-level monitoring in place targets at sector level Benchmarking between farms with plan of interventions 10

11 Vets accountable for prescribing Single prescribing practice per farm, with regular clinical examinations Consideration to conflict of interest Treatment guidelines; mandatory AST for some AMs? Monitoring and benchmarking of vets? 11

12 Phase out preventive use, with some exceptions (to be recorded) Reduce and refine metaphylaxis, specific principles and criteria to be defined Repeated mataphylactic use investigate risk factors, review prevention and control measures, identify alternative measures Rapid and reliable diagnostics, use of AST 12

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14 Positive impact on AH parameters: o organic acids o probiotics o competitive exclusion o synbiotics o passive immunisation o bacteriophages o immunomodulators o zinc oxyde o clay minerals o teat sealants Limited number of studies in EU Rarely assessing efficacy as alternatives to antimicrobials; more often to AGP Few repeated studies on same agent 14

15 Identify new alternatives or increase knowledge on described alternatives Understand mode of action, perform controlled clinical trials Appropriate risk assessments to identify potential new risks for consumers, animals, environment 15

16 Current framework unclear: VMP or food additive? Need to have clearer rules for development of new alternatives 16

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18 All farms to have farm health plan Programme of disease prevention with measurable farm-level outcomes (primary, secondary, tertiary prevention) o Consider also adverse effects on animal welfare Development of improved vaccines Interventions to reduce use of antimicrobials guided by measurement and benchmarking 18

19 High use critical review of farming system: sustainable with reduced use? Revision? Some regulated systems are able to operate with low antimicrobial use, and the farming practices which facilitate this should be further evaluated Organic production? Conclusive evidence cannot be established 19

20 Regular trainings o Undergraduate and postgraduate vets o Farmers: association use-amr and public health, principles to reduce use Education and awareness of AMR to be addressed to all levels of society 20

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22 Monitoring To develop harmonised systems for monitoring antimicrobial use and AMR in humans, food-producing animals and food Ideally at farm/species/production stage levels To follow the situation To observe the impact of measures applied To identify the need for action To benchmark/compare use in farms and animal species 22

23 FOLLOW-UP Outcome indicators New EC joint mandate to ECDC, EFSA and EMA for an opinion on a list of outcome indicators as regards surveillance of AMR and antimicrobial consumption in humans and food-producing animals Deadline 30 September

24 THANK YOU FOR YOUR ATTENTION Scientific opinion: Infographic: 24