Process of asessment Resistance

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Process of asessment Resistance Powered By Docstoc
and the fight against

      Vincent Houdry
        DG SANCO C3
      Health Threats Unit
Intersectoral mechanism

 SANCO: health, food, feed, animals,
 ENV: biocides, agriculture, residues
 ENTR: pharmaceutical products, biocides
 RTD: basic research, new antibiotics and
 ECDC, EMEA, EFSA, JRC, non food
 scientific committees, community
 reference laboratory for AMR…
 Zoonoses Monitoring directive (2003)
 Decisions (2007) on Salmonella,
 Campylobacter, MRSA
 RASFF: Rapid Alert System on Food
 and Feed
 Prohibition of the use of antibiotics
 as feed additives (2003)
   Community reference
    laboratory on AMR
Directive on the monitoring of
zoonoses and zoonotic agents
Monitoring of antimicrobial
Ensure quality of antimicrobial
susceptibility testing and harmonise
procedures and methodologies
DG Environment
 Biocidal products directive (1998)
   Revision of all active substances regarding
   safe use for human health and environment
   (before 2010)
 SCENIHR: scientific opinion to assess
 AMR effects of biocides
   Cross resistance to antibiotics as a new
   criteria in evaluation of biocidal products?
DG Research
 5th FP 1999-2002: 20M€/year
 6th FP 2003-2006: 40M€/year
   Translational research: Grace and Mosar
   Animal health: alternatives to antibiotics and
   transmission of AMR
 7th FP 2007-2013: First call
   AMR in human health
   Biocides and AMR in food and animal
Food as a vehicle for antimicrobial
resistance: EFSA Q 2007 089
Antimicrobial resistance of
decontaminants substances (poultry
Data on AMR in zoonotics agents
(salmonella, campylobacter) in animals
and food of animal origin (Zoonoses
Guideline to applicants to obtain more
useful prescribing information
SPC: info on prudent use, prevalence of
Veterinary unit:
  Guidance on preauthorisation requirements
  for authorisation of antimicrobials – potential
  to select for resistance
  Considerations on use of Fluoroquinolones
  for food producing species (cephalosporins,
  macrolides, lincosamines, streptogramins)
3 meetings of NFP for AMR
Country visits on AMR
Working groups:
 Clostridium difficile, MRSA
First EU Antibiotic day
DG SANCO Human Health

EU Network for surveillance and control
of communicable diseases
 (Decision 2119/98/EC)
      Antimicrobial Resistance
      Nosocomial Infections
      Surveillance of specific pathogens
 EU Public Health Programme 2003-2008

EUCAST: developing common methodology, case
definitions and data to be collected for the
surveillance on AMR

ESAC: monitoring the level of consumption of
antibiotics in the EU.

EARSS: surveillance of AMR in the EU
 EU Public Health Programme 2003-2008

IPSE: development of guidelines and
educational tools to better and effectively
manage the risk of HCAI and AMR -
Surveillance of AMR in intensive care units
strategies for the appropriate use of antibiotics
in hospitals
BURDEN: information (morbidity, mortality
and economic impact) on the burden of
disease and resistance across Europe
E-Bug: development of educational
programmes on antibiotics in schools
EU Public Health Programme 2008-2013

Work plan 2008 "Improve citizen's
health security"
  Promotion of risk assessment
  thematic networks for exchange and
  collaboration on critical issues (AMR)
Community Strategy against AMR
Council recommendation on the prudent
use of antimicrobial agents in human
medicine: 2001
  Intersectoral mechanism
  Strategies towards the prudent use
    Surveillance Systems on usage of ATB and AMR
    Control and preventive measures
    Promote education and training of HCW and Inform
    the general public

First implementation report: 2005
Commission staff working document
First implementation report
 Appropriate Intersectoral Mechanism
 Development of Strategies and action plans
 Lack of data at lower level; feedback to
 Collaboration human/animal health
 Ban OTC/Self medication
 Prescription guidelines + monitoring impact
 Hygiene and infection standards in health care
 Enlarge surveillance activities to antivirals and
 antiparasitic agents
 Campaigns toward the general public
Planned Actions in Human Health

 Second implementation report on
 the Council recommendation on the
 prudent use of antimicrobial agents
 in human medicine (2009)
Planned EU Actions in Human Health
 Patient safety proposal

   Commission Communication on
   Patient Safety
   Council Recommendation on
     patient safety and quality of health
     the prevention and control of
     healthcare associated infections
         Recommendation on HCAI
Healthcare-associated infections (HCAIs) affect an estimated 4.1 million
patients and cause an estimated 37,000 deaths in the EU every year.

HCAIs lead to increase in length of stay, illness, mortality and costs.

Infections caused by these pathogens are often difficult to treat due to
antimicrobial resistance (Council Recommendation 2002/77/EC).

Organisational and behavioural changes are needed to make an impact.

Studies and impact assessments show that intervening is cost-effective !

However, a strong political commitment is needed !!!


    EU initiative for a proposal for a Council Recommendation
Content of recommendation on the prevention
    and control of HCAIs – national level
    At the national level:
    1.   National strategy for prevention and control of HCAIs
    2.   National dedicated multidisciplinary Committee for
         implementation of national strategy
    3.   Senior management of healthcare institutions bear
         responsibility for quality of care

    Recommended objectives of national strategy:
    1.   Implement control and preventive measures.
    2.   Organise infection prevention and control programmes.
    3.   Establish or strengthen active surveillance systems on HCAIs.
    4.   Foster education, training, research and information exchange.
Content of recommendations on the prevention
       and control of HCAIs – EU level
     Facilitate mutual information, consultation, cooperation and
     Develop scientific guidance (ECDC).
     Consider with Member States how to publicly report data on
     Strategies for reduction of exposure of healthcare staff to
     HCAIs (= safety at work).
     Funding research.
     Cooperation with WHO and others.
     Revise/update recommendations.
     Submit regular implementation reports to the Council, on the
     basis of Member States’ reports on their follow-up to the
     Council Recommendation.
EU action plan to fight TB
 Framework action plan published
 next week
 Next step
  Who does what ?
AMR on the political agenda

 Council conclusions on AMR
 New antibiotics
           Thank you for your attention!

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Description: Process of asessment Resistance