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The Commission activities on AMR (focus on zoonotic issues) R.M. Peran i Sala European Commission, DG SANCO London, 15.09.2011
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Page 1: The Commission activities on AMR - European Medicines Agency · European Commission, DG SANCO London, 15.09.2011. London, 15-09-2011 2 1. DG SANCO and AMR • High priority status

The Commission activities on AMR

(focus on zoonotic issues)

R.M. Peran i SalaEuropean Commission, DG SANCO

London, 15.09.2011

Page 2: The Commission activities on AMR - European Medicines Agency · European Commission, DG SANCO London, 15.09.2011. London, 15-09-2011 2 1. DG SANCO and AMR • High priority status

London, 15-09-2011 2

1. DG SANCO and AMR

• High priority status given on AMR in DG SANCO

• EU Commission DG SANCO coordination

- public health and welfare- food safety- pharmaceuticals- biocides- research- international cooperation

Page 3: The Commission activities on AMR - European Medicines Agency · European Commission, DG SANCO London, 15.09.2011. London, 15-09-2011 2 1. DG SANCO and AMR • High priority status

London, 15-09-2011 3

2. The 90’s• Consciousness of AMR caused by antibiotics• Opinion of the former Scientific Steering

Committee on AMR (1999)“actions needs to be taken promptly to reduce the overall use of antibiotics”

Prudent use of antimicrobialsPrevention of infection and containment of resistant organismsNew modalities of prevention and treatment for infectionsMonitoring of effects of interventions

Page 4: The Commission activities on AMR - European Medicines Agency · European Commission, DG SANCO London, 15.09.2011. London, 15-09-2011 2 1. DG SANCO and AMR • High priority status

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The public health issue of AMR

H

R Strep. pneumoniae

R Haem. influenzae

R Pseudomonas aeruginosaR Acinetobacter baumannii

Food

Ani

mal

sH

uman

sH

uman

s

R Salm.R Camp.

R E. coli

R E. coli

MRSA

RS. aureus

RS. aureus

R E. coli

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London, 15-09-2011 5

3. Overview of recent COM activities

• Staff working paper on AMR 2009, follow-up• Monitoring – EFSA, ECDC, EMA• Scientific opinions• International activities

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London, 15-09-2011 6

3.1 Staff working paper on AMR• Published 18.11.2009• Overview of undertaken EU activities related to AMR• Initiated a holistic reflection and discussion on AMR,

identification of possible areas for further actions • Contributions from DG

Enterprise EnvironmentResearchSANCO (public health, animal health, food

safety, international issues)• Public consultation 2010

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London, 15-09-2011 7

3.2 Monitoring

• EU ProvisionsMandatory monitoring zoonotic agentsDirective 2003/99/EC Detailed provisions for harmonised implementation:

Salmonella in pigs and poultryBaseline surveys:

- Campylobacter in broilers- MRSA in breeding pigs

Nomination EU-Reference Laboratory for AMR

Page 8: The Commission activities on AMR - European Medicines Agency · European Commission, DG SANCO London, 15.09.2011. London, 15-09-2011 2 1. DG SANCO and AMR • High priority status

London, 15-09-2011 8

3.2 Monitoring (cont)• EFSA

Recommendations Salmonella and Campylobacter; E.coli and EnterococciESBL

Summary and analysis of MS data and base line surveys

• ECDCResistance in human isolates (EARSS)Use of antimicrobials in human medicine (ESAC)

• EMAUse of antimicrobials in animals (ESVAC)

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3.3 Scientific opinions

Several scientific reports published by EMA, EFSA, SCENIHR: – fluoroquinolones– 3rd and 4th generation cephalosporinases– use of macrolides, lincosamides and

streptogramins in animals – MRSA– food-borne AMR – Biocides– ESBL

Page 10: The Commission activities on AMR - European Medicines Agency · European Commission, DG SANCO London, 15.09.2011. London, 15-09-2011 2 1. DG SANCO and AMR • High priority status

London, 15-09-2011 10

3.3 Scientific opinions (cont)

Joint EFSA, EMA, ECDC, SCENIHR opinion on AMR focused on zoonotic infections:

Worldwide increase in recent yearsStrengthening surveillance activitiesDevelopment of new antimicrobials and encouragement of new strategies to combat the spread of AMRHigh concern on certain antibiotics use in treatment of Salmonella and CampylobacterUse of antibiotics considered main factor in development of AMRGlobal approach needed

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3.4 International activities

• CODEX Alimentarius Guidelines for risk analysis of foodborne antimicrobial resistance(CAC/GL 77-2011)

• TATFAR = transatlantic task force on AMREstablished by EU-US summit in 2009Aim to identify areas for further cooperation and to suggest them to the summit 2011

• OIE• WHO

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The EU-US Summit Declaration called for the establishment of “…a transatlantic task force on urgent antimicrobial resistanceissues focused on appropriate therapeutic use of antimicrobialdrugs in the medical and veterinary communities, prevention of both healthcare- and community-associated drug-resistantinfections, and strategies for improving the pipeline of newantimicrobial drugs, which could be better addressed byintensified cooperation between us”.

EU-US Summit Declaration – Washington, 3 November 2009

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TATFAR Objectives

• Increase the mutual understanding of US and EU activities and programmes relating to antimicrobial issues

• Deepen the transatlantic dialogue• Provide opportunities to learn from each other• Promote information exchange, coordination and

co-operation between the US and the EU.

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3 key areas of collaboration

• appropriate therapeutic use of antimicrobials in the medical and veterinary communities

• prevention of drug resistant infections• strategies to improve the pipeline of new

antimicrobials

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4. SANCO strategy on AMREP resolution on AMR• Adopted in May 12th 2011• Calls on the Commission to develop a broad multi-

annual action plan on AMR • Calls on the Commission also e.g. to ensure the data

collection on the use of antimicrobials in animals, to update the monitoring of AMR and to improve controls on the use of veterinary antimicrobials

Council Conclusions on AMR

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4. SANCO strategy on AMR (cont)• A communication from the Commission on AMR• A 5-year strategy to be presented on European

Antibiotic Awareness Day 18 November 2011• Based on Council Conclusions and Recommendations

activities following the staff working paper 2009• Including concrete actions• A holistic approach: public health, food safety,

consumer safety, environment, animal health and welfare as well as non-therapeutic use of antimicrobials

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Human medicine

Veterinary medicine

Food safety

Other e.g. biocides

Monitoring

Risk assessment

Risk management

Innovation & research

International link


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