11. political and regulatory aspects of veterinary antibiotics use in europe

DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 1

3ANTIBIOTIC VOLUMES ANDDISTRIBUTION

4RESISTANCEMONITORING

5RESPONSIBLEUSE

Political and Regulatory Aspects of Veterinary Antibiotic use in Europe DIETER SCHILLINGER

1ANIMAL HEALTH ANDFOOD SECURITY/FOOD SAFETY

2THE WAR OF « BUGS vs. DRUGS »


Animal Health and Food Security/Food Safety

• WORLD POPULATION• FOOD SECURITY/FOOD SAFETY• RESIDUES


AH – FOOD SECURITY/FOOD SAFETY

Animal medicines incl. antibiotics have a very important future!

• Saving agricultural resources will be essential for food security

Green et al. (2005) “Farming and the Fate of Wild Nature.” ScienceTilman et al. (2002) “Agricultural sustainability and intensive production practices.” NatureUN-FAO (2002) “World Agriculture: toward 2015/2030”



A very important future?

• “20% of animal production is lostbecause of animal diseases”

Univ. Leuven

• “Without veterinary medicines we would need 89% more cattle in Europe to produce the same amount of meat and milk”



• Data provided by the 27 EU Member States for 2008

• Over 750,000 targeted meat/milk samples - less than 2,000 (0.27%) results were found to be over the legal limits

• The highest proportion of the non-compliant results:

Antimicrobials (46%) Hormones (19%) Other veterinary medicinal products (18%)

• Fact = only 0.12% (46% of 0.27%) of 750,000 samples contained levels of antibiotics above legal limits.

Animals are not “stuffed full of antibiotics”

EFSA report on residues (2010)



Animals need medicines too!

• The need for antimicrobials to treat animal bacterial diseases will remain

- Ethical reasons

- Economical reasons

- Environmental reasons

- Food safety reasons


The war of “bugs vs. drugs”

• HISTORY OF ANTIBIOTIC AND RESISTANCE DEVELOPMENT • EUROBAROMETER• CRITICAL LISTS OF ANTIBIOTICS


THE WAR OF « BUGS vs. DRUGS »

Resistance is inherent to us

Fleming: Nobel Prize lecture - 1945

“If a specific antibiotic is frequently applied, selection of resistant individuals among the target bacteria will normally result”

If a bacterium develops resistance against a specific antibiotic, other antibiotics of the same class with a similar mode of action may also lose their effectiveness (cross resistance).

In 1947 physicians observed the first case of clinical resistance (Staphylococcus aureus/Penicillin).


THE WAR OF “BUGS vs. DRUGS”

• 20% of Europeans said they had taken ABs to treat flu

• 53% of Europeans said ABs kill viruses

• 83% were aware that the unnecessary use of ABs makes them ineffective

Eurobarometer (2010) ECDC Report 2008

Consuming few antibiotics: Dutch (1), Germans, Scandinavians and Baltics- 5% penicillin resistance in Streptococcus pneumonia

Main users: Greece (1), Cyprus, France, Italy and Spain- 25% penicillin resistance in Streptococcus pneumonia


T. ISHIBASHI– 17/01/2008; Brussels

Antibiotic Classification* Also on the critical list of WHO

Tetracyclines*

Sulfonamides*

StreptograminsPolypeptidesQuinolones*

QuinoxalinesPleuromutilinePhenicols

OrthosomycineLincosamidesPenicillins*

NovobiocineIonophoresMacrolides*

Fusidic AcidFosfomycineCephalosporins*

BicyclomycineRifamycineAminoglycosides*

importanthighly important critically important


Antibiotic Volumes

• IFAH-Europe: ANTIBIOTICS & CONTEXT • MEMBER STATE SYSTEMS• EMA PROPOSAL - ESVAC


Decreased antibiotic use in animals? –Yes, sort of!

COLLECTING VOLUME DATA


COLLECTING VOLUME DATA

ESVAC – European Surveillance of Veterinary Antimicrobial Consumption

• Broad agreement on the value of collecting volume data (interpretation of AMR monitoring over time).

• The data should be collected in a reliable, efficient, consistent and verifiable manner yet providing for confidentiality.

• The cumulative data should be presented in a format that makes it scientifically useful for researchers, risk assessors and stakeholders yet balances the level of detail with the resources necessary to obtain it.

• Data collection together with context data (animal production, food production, disease prevalence, other external factors that my influence antimicrobial usage).

• Risk managers should consult with stakeholders in interpretation of the data.


Antimicrobial Resistance (AMR) Monitoring

• EU - JOINT OPINION ON AMR/ZOONOTIC INFECTION• STAFF WORKING PAPER OF THE COMMISSION• CONSEQUENCES FOR VETERINARY MEDICINE


RESISTANCE MONITORING

AMR challenge today

• Salmonella resistance to Fluoroquinolones & Cephalosporins

• Campylobacter resistance to Fluoroquinolones & Macrolides

• MRSA (Methicillin Resistant Staphylococcus aureus) presence in swine

• ESBL (Extended Spectrum Beta-Lactamase) in Gram negative bacteria (most commonly E. coli and Klebsiella pneumoniae)

• Direct transfer from animals to humans via zoonotic pathogens

• In-direct transfer of resistance genes from animal bacteria non-pathogenic for humans to human pathogenic species



Commission – staff working paper on AMR (2009)

• Purpose: serve as a basis for discussion and further reflections

• AMR is an unresolved issue in public health

• Each year 25,000 patients die in the EU/costs of 1.5bn €

• Decreasing pace of introduction of new classes of AM

• EARSS (European Antimicrobial Resistance Surveillance System) in human medicine

• Harmonised monitoring for MRSA on intensively reared animals; AMR of Campy in poultry; AMR in commensals and ESBL

• Applicants are requested to address the issue of AMR and proposemeasures to limit its development

• Recommendations and tools to improve responsible use



Possible consequences

• Prohibition/limitations of veterinary use of certain critically important antimicrobials for human medicines

• Change of dispensing rights of veterinary medicines from veterinarians to pharmacies

• Harmonisation of risk assessment methodologies

• Mandatory collection of usage at species level

• Resistance as a pharmacovigilance adverse event

• Prohibition of the advertising of veterinary antimicrobials

• Legal enforcement of responsible veterinary use of antibiotics


• WHAT NEEDS TO BE DONE • EPRUMA• CONCLUSIONS


RESPONSIBLE USE

How to address AMR in humans by vet medicine?

• Reducing the use of antibiotics in vet medicine?

Difficult: 80% of animal medicines are related to infectious diseases (less than 10% in human medicine)

• New antimicrobial classes/pathogen-specific (narrow-spectrum/disease-focused) antibiotics

• Alternative means (e.g. probiotics, bacteriophages, efflux pump inhibitors, biofilm disrupters, virulence factors,)

• New vaccines; state-of-the-art on-site diagnostics

• Responsible use of antibiotics


RESPONSIBLE USE

“Best-practice framework for the use of antimicrobials in food-producing animals in the EU” – www.epruma.eu

• COPA/COGECA (farmers and co-operatives),

• EISA (European Initiative for Sustainable Development in Agriculture),

• FEFAC (feed manufacturers),

• FESASS (animal-health farmer organizations),

• FVE (veterinary surgeons)

• IFAH-Europe (animal health industry)


CONCLUSIONS

Conclusions

• We face a food supply challenge

• Animals need medicine too – we cannot eliminate diseases

• Innovation needs to be encouraged

• Susceptibility surveillance needs to be harmonized andvolume collection needs to be rolled out

• Responsible use must be promoted

“The right antibiotic applied correctly”

“As little as possible, but as much as necessary”


THANK YOU

A happy end?

11. political and regulatory aspects of veterinary antibiotics use in europe

Education

food security food safety

drugs resistance

food production

penicillin resistance

salmonella resistance

context data animal

specific antibiotic

data collection