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The future of antibiotics use in Europe

Moderator: Dr Sophie Randoux

• The antibiotic hype and the consequences for pig production in Europe. Dr. D. Schillinger

• Limiting the use of antibiotics in the Pig industry: the Danish experience. Dr M. Andreasen

• PCVD control in 2012: how to design the best PCV2 vaccination programme? Dr R. Aerts

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The Antibiotic-Hype and the Consequences for Pig

Production in Europe

4th MERIAL Swine Forum Berlin – May 30th to June 1st, 2012

Dr. Dieter Schillinger – Animal Health Consultancy

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EFSA – Report for 2010 on the results from the monitoring of vet medicinal product

residues in live and animal products

418,081 targeted samples were reported under

Council Directive 96/23/EC:

• 61% were analysed for veterinary drugs and


• 0,33% non-compliant

• For antibacterials, 0.23% samples non-compliant

• Highest frequencies on non-compliant for antibacterials

were found in honey (2.9%) and rabbit meat (0.62%)

• No notable variations in the frequency of non-compliant

samples over the years

D.Schillinger – 4th Merial Forum 4

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“Increasing Transmission of Antibiotic Resistance from Animals to Humans“

Frank M. Aarestrup & Niels Frimodt-Moller; Dänemark,

Mai 2011

• The importance of the animal reservoir for

emergence of AMR in bacteria in humans is difficult

to estimate.

• It still is the human usage of antibiotics which

contributes most to resistance observed in humans.

• But the contribution from animals is large and larger

than estimated just a few years ago.

• This indicates the need to implement restriction on

antimicrobial usage for both humans and animals

D.Schillinger – 4th Merial Forum 5

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One Health – The view of EFPIA European Federation of Pharmaceutical Industries and Associations

• Widespread over-prescription and misuse of antibiotics triggered resistance - need of new drugs

• Treatments must be affordable – few financial incentives to stimulate research

• New business model – intensifying appropriate use rather than overuse (maximising sales)

• Antimicrobials are not very profitable – treatment period only a few days

• Risk of resistance may reduce the lifecycle

• Innovation – tax credits for research, prize or award for a successfully developed drug, extension of exclusive patent rights

D.Schillinger – 4th Merial Forum 6

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European Surveillance of Veterinary Antimicrobial Consumption

• 2005-2009 Trends in the sales of vet antimicrobial agents in nine European countries (published September 2011)

• www.ema.eu/docs/en_GB/document_library/Report/2011/09/WC500112309.pdf

• Czech Republic, Denmark, Finland, France, the Netherlands, Norway, Sweden, Switzerland, UK

• PCU = Population Correction Unit, a proxy for the animal biomass at risk of being treated

D.Schillinger – 4th Merial Forum 7


•Tier- und Humanmedizin, über verschiedene Zeitphasen und im Ländervergleich,

•Grundlage für gezielte F&E-Aktivitäten.

Commission requests the EMA to

• Develop a harmonised approach for collection and reporting of data on antimicrobial veterinary medicinal


• Collect the data from MSs and manage the data base

• Draft an annual report with the data from MSs

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Trends in the sales of veterinary antimicrobial agents in nine European


D.Schillinger – 4th Merial Forum 8

EMA/238630/2011 Reporting period: 2005-2009

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Trends in the sales of veterinary antimicrobial agents in nine European


D.Schillinger – 4th Merial Forum 9

Temporal trends in the sales, expressed in mg per population correction (mg/PCU), of veterinary antimicrobial agents in European countries. Note the differences in the scales.

EMA/238630/2011 Reporting period: 2005-2009

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Critically important antimicrobials in vet and human medicine

• 3rd and 4th generation Cephalosporins

• Quinolones (incl. Fluoroquinolones)

• Macrolides

• Penicillins

• Aminoglycosides

• …… Joint FAO/OIE/WHO Expert Meeting on Critically Important

Antimicrobials (Rome, November 2007)

D.Schillinger – 4th Merial Forum 10

The Dilemma: For a number of antimicrobial classes there is an overlap of the OIE and the WHO list!

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AMR – Policy positions of key stakeholders (1)

11/2009 – European Commission staff working paper o Loss of efficacy of antimicrobials ‘a largely unresolved issue in

public health’

o 25,000 patients dying annually; € 1.5 billion costs; 4 Mio patients

06/2010 – Heads of Medicines Agencies (HMA) o ‘Strategic plan on antimicrobial issues’

o Most important task in vet medicine: maintaining efficacy of

antimicrobials and minimizing strategy

o Responsible use – the focus of any action minimizing AMR

o All antimicrobials classed as prescription-only medicines

o Surveys of antimicrobial consumption and resistance (human +

vet medicine)

D.Schillinger – 4th Merial Forum 11

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10/2010 – Chief Veterinary Officers (CVOs) o ‘Conclusions on Antimicrobial Resistance’

o Strict enforcement of existing regulatory framework

o Minimise the use of antimicrobials as preventative treatments

o Alternative methods (vaccination, biosecurity, management)

o Discourage cascade

07/2011 – CMVP (Committee for Medicinal Products for Veterinary Use)

o ‘Strategy on antimicrobials 2011-2015’

o Confirmed the importance of effective antimicrobial treatment for

relevant indications in all species to alleviate pain and suffering

o Fluoroquinolones and 3rd & 4th generation cephalosporins should

be classed as second line antimicrobials

D.Schillinger – 4th Merial Forum 12

AMR – Policy positions of key stakeholders (2)

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09/2011 – European Food Safety Authority (EFSA) o ‘Scientific opinion on the public health risks of bacterial strains

producing ESBLs and/or AmpC ß-lactamases in food-producing animals’

o Recommendation: discontinuing or restricting all use of 3rd and 4th generation of cephalosporins in all food-producing animals

o Resistance in cattle and pigs ‘very low to low’

09/2011 – TATFAR (Transatlantic Taskforce on Antimicrobial Resistance)

o Urgent antimicrobial resistance issues focused on appropriate therapeutic use of antimicrobial drugs in the medical and veterinary communities

o Strategies for improving the pipeline of new antimicrobial drugs

o 17 recommendations for future EU-US cooperation to ensure that antimicrobials remain effective

D.Schillinger – 4th Merial Forum 13

AMR – Policy positions of key stakeholders (3)

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05/2011 and 10/2011 – European Parliament

o More research (new products, alternative production


o Better monitoring of effects of antibiotics

o Surveillance of AMR

o Reduce use of antimicrobials in livestock and companion


o EU vets retain right to sell medicines

o Emphasis on responsible use, good husbandry practices,


o Commission multi-annual action plan against AMR

D.Schillinger – 4th Merial Forum 14

AMR – Policy positions of key stakeholders (4)

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11/2011 – European Commission

D.Schillinger – 4th Merial Forum 15

Conclusion: The increasing resistance to antimicrobial drugs represents one of the major emerging threats to human health. To address this, a holistic approach is stressed in line with the ‘One Health’ initiative. The Commission proposes to put in place a 5-year Action Plan to fight against AMR based on 12 key actions

AMR – Policy positions of key stakeholders (5)

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Communication from the Commission to

the European Parliament and the Council

15/11/2011 – Action Plan against the rising threats from AMR

1. Strengthening the promotion of the appropriate use of antimicrobials in all Member States

2. Strengthening the regulatory framework on veterinary

medicines and on medicated feed

3. Introduce recommendations for prudent use in veterinary

medicine, including follow-up reports

4. Strengthening infection prevention and control in healthcare settings

5. Introduce a legal tool to enhance prevention and control

of infections in animals in the new Animal Health Law

6. Promote, in a staged approach, unprecedented collaborative

research and development efforts to bring new antimicrobials to

patients D.Schillinger – 4th Merial Forum 16

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15/11/2011 – Action Plan against the rising threats from AMR

7. Promote efforts to analyse the need for new antibiotics

into veterinary medicine

8. Develop and/or strengthen multilateral and bilateral commitments for

the prevention and control of AMR in all sectors

9. Strengthen surveillance systems on AMR and antimicrobial consumption in human medicine

10. Strengthen surveillance systems on AMR and

antimicrobial consumption in animal medicine

11. Reinforce and co-ordinate research efforts

12. Survey and comparative effectiveness research

D.Schillinger – 4th Merial Forum 17

Communication from the Commission to

the European Parliament and the Council

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“Combating Antimicrobial Resistance – Time for Joint Action“

Copenhagen, March 2012

3 Major Themes

1. Decreasing general usage

2. Decreasing use of critically important antimicrobials

3. Monitoring and surveillance


• A ban on use of cephalosporins in veterinary medicine

• Prohibition on prescribing and dispensing

D.Schillinger – 4th Merial Forum 18

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Spotlight on Antimicrobial Resistance for World Veterinary Day –

28/04/2012 OIE

• The global demand for proteins – healthy animals

• Antibiotics are not ordinary products – specialists

• Promoting the prudent use in all animals is a priority

• Veterinarians around the world must prevent misuse


• The BVA’s 8-point plan for responsible use in veterinary practice

• Vet must accept constraints on the use of certain classes of AM

• Antimicrobials are a vital tool in our armoury to combat animal diseases

• One Health


• Antibiotics need to be used responsibly, with care and discrimination

• Innovation and R&D to find new classes and innovative ways to fight new diseases

D.Schillinger – 4th Merial Forum 19

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IFAH-Europe Activities and Recommendations

• The strategic and responsible use of all antimicrobial products

• Prescriptions of antimicrobial products should be made on the basis of the results of resistance testing

• The use of the ‘Cascade’ system should only be under exceptional circumstances

• Eliminating ‘off-label’ use other than according to the Cascade

• Efforts to maintain the availability of new and existing classes, products and formulations

• Support for the CVOs efforts to improve the collection of data on antimicrobial usage at farm level

• Target Pathogen Monitoring Programme

D.Schillinger – 4th Merial Forum 20

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www.epruma.eu 21

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Thank you

D.Schillinger – 4th Merial Forum 22

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