1. 4TH MERIAL FORUM
HAVE WE GOT PCVD &
SWINE INFLUENZA UNDER
CONTROL?

2. 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

3. 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

4. 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
contaminants
• 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

5. “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

6. 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

7. ESVAC
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/WC5001123
09.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
Commission requests the EMA to
• Develop a harmonised approach for collection and
reporting of data on antimicrobial veterinary medicinal
products
• Collect the data from MSs and manage the data base
• Draft an annual report with the data from MSs
D.Schillinger – 4th Merial Forum 7

8. Trends in the sales of veterinary
antimicrobial agents in nine European
EMA/238630/2011
Reporting period: 2005-2009
countries
D.Schillinger – 4th Merial Forum 8

9. Trends in the sales of veterinary
antimicrobial agents in nine European
countries
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
D.Schillinger – 4th Merial Forum 9

10. Critically important antimicrobials
in vet and human medicine
The Dilemma: For a number of antimicrobial classes there is an
overlap of the OIE and the WHO list!
• 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

11. 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

12. AMR – Policy positions of key
stakeholders (2)
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

13. AMR – Policy positions of key
stakeholders (3)
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

14. AMR – Policy positions of key
stakeholders (4)
05/2011 and 10/2011 – European Parliament
o More research (new products, alternative production
systems)
o Better monitoring of effects of antibiotics
o Surveillance of AMR
o Reduce use of antimicrobials in livestock and companion
animals
o EU vets retain right to sell medicines
o Emphasis on responsible use, good husbandry practices,
research
o Commission multi-annual action plan against AMR
D.Schillinger – 4th Merial Forum 14

15. AMR – Policy positions of key
stakeholders (5)
11/2011 – European Commission
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
D.Schillinger – 4th Merial Forum 15

16. 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

17. Communication from the Commission to
the European Parliament and the Council
15/11/2011 – ActionPlan 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. Strengthensurveillance 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

18. “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
Conclusions
• A ban on use of cephalosporins in veterinary medicine
• Prohibition on prescribing and dispensing
D.Schillinger – 4th Merial Forum 18

19. 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
BVA
• 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
IFAH
• 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

20. 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

21. www.epruma.eu 21

22. Thank you
D.Schillinger – 4th Merial Forum 22

23. 4TH MERIAL FORUM
HAVE WE GOT PCVD &
SWINE INFLUENZA UNDER
CONTROL?