European perspectives on the fight against

antibiotic resistance

Isabel de la Mata,

Principal Advisor with special interest in Public Health, DG SANCO

European institutional frame in public health

Art 152 of the Treaty: legal basis for EU action in public health

Aim:

Ensure a high level of human health protection (e.g.

prevention & protection against health threats with a

particular EU concern when threats are crossing

borders).

Health protection requirements form a constituent

part of the Community’s other Policies.

Antimicrobial Resistance – EU concern

AMR ignores frontiers; it is a cross-border issue;

AMR is a particular TOPIC example of Health in all policies: challenges to almost all public authorities beyond human health (prudent use among humans education, health prevention and infection control) or animal and food: enterprises (medicines sales –among humans and animals- and market profit), agriculture (animal raised for food and technologies), environment

(biocides), research (which priorities)...

European institutional frame: article 152

How to contribute to these achievements (regarding health threats):

• Community shall encourage cooperation between MS and Community actions shall complement national policies

• Members States shall, in liaison with the Commission, coordinate among themselves their policies.

• The Commission may take any useful initiative to promote such coordination.

Shared competencies domain

• The Council shall adopt incentive measures and recommendations

▲ Clear exclusion of harmonisation of national laws

▲ Full respect of national sovereignty in healthcare organisation

▲ Principles of subsidiary and proportionality

Antimicrobial resistance – legal basis

Decision 2119/98/EC of the Council and the Parliament establishing Community network for surveillance and control of communicable diseases

2000/96/EC: Commission Decision on the communicable diseases to be progressively covered by this Community network: Integration of

nosocomial infections

antimicrobial resistance

in addition to specific pathogens

European building policy process in public health

EU Health Strategy: puts in place an overarching, strategic framework for work on health at the EU level, and sets the direction of travel for the coming years.

The EU Public Health Programme: the European Commission’s main instrument for implementing the EU health strategy. among others to improve citizens' health security (by protecting against health threats, and promoting safety);

Implementation through Annual Work Plan:

Call for project proposals, Operating grants FOR NGOs or specialised networks, Call for conference proposals, Joint actions by the Community and MS etc..

Antimicrobial resistance – EU strategy

EU Health Strategy: puts in place an overarching, strategic framework for work on health at the EU level, and sets the direction of travel for the coming years.

2001: Commission Communication on a Community strategy against antimicrobial resistance covering

o Surveillance, Monitoring and Data collection on antimicrobial resistance including zoonoses and on consumption of antimicrobial agents

o Prevention of communicable diseases, infection control, prudent use of antimicrobial agents

o Research (vaccines, new classes of treatment agents, rapid diagnostic tests, strategies to reduce the spread of infections)

o International cooperation: WHO, Codex alimentarius, OIE...

Antimicrobial resistance Overview of past and under development activities

Policy

Policy support / implementation

AMR Past activities - Policy (1)

2002: Council Recommendation on the prudent use of antimicrobial agents in human medicine (2002/77/EC).

Recommends Members States

• to ensure strategies towards prudent use

• to have in place an intersectoral mechanism

• to cooperate with EC and other MS for developing assessment indicators and information exchange on research

AMR Past activities - Policy (2)

Council Recommendation 2002/77/EC

• Strategies should pursue the following objectives:

Establish/strengthen surveillance systems on antimicrobial resistance and the use of antimicrobial agents.

Implement control and preventive measures to support the prudent use of antimicrobial agents and limit the spread of communicable diseases.

Promote education and training of health professionals.

Inform the general public of the importance of prudent use of antimicrobial agents.

AMR Past activities - Policy (3)

Council Recommendation 2002/77/EC

• Intersectoral mechanism

for the coordinated implementation of the above strategies, as well as for the purposes of information exchange with the Commission and other MS.

AMR Past activities - Policy (4)

2005: Report from the Commission to the Council on the basis of Member States’ reports on the implementation of the Council Recommendation (2002/77/EC) on the prudent use of antimicrobial agents in human medicine.

Conclusions:

improved surveillance of antibiotic use and resistance

closer cooperation between different professionals

Member States have taken good steps forward in putting measures in place against AMR.

infection control

reducing self-medication of antibiotics

educating citizens on the proper use of antimicrobial treatments

AMR Past/Current activities - Policy (5)

Importance of interaction between all actors involved in the intersectoral mechanism at MS level and reflecting in a coherent way the multisectoral approach at EU level:

Intra-SANCO technical group involving Directorates C (Public Health), D (Animal Health) and E (Food Safety)

Intra Commission: DG SANCO, DG ENTR, DG ENV, DG AGRI, DG RTD

Intra EU: ECDC, EMEA, EFSA, National Focal Points in Member States, Community Reference Laboratory for AMR

AMR Past/Current activities - Policy (6)

EU Presidencies identify AMR as a priority

Slovenian Presidency: Council Conclusions on AMR adopted by EU Health Ministers in Luxembourg on 10/06/08,initially based on the Council Recommendation 77/2002, broadened the scope beyond human health :

STRESSES the importance of effective surveillance systems from both human health and veterinary sectors for collecting comparable data on AMR and antibiotic use

Call upon the Members States to strengthen surveillance systems and improve data quality on AMR and use of antimicrobial agents from both human health and veterinary sector, and healthcare-associated infections

AMR Past/Current activities - Policy (7)

Slovenian Presidency: Council Conclusions (2)

• CALLS UPON THE COMMISSION to promote mutual

cooperation between all Directorates General & Agencies on

all aspects of AMR, e.g.:

- examine the issue of antimicrobial use in animals raise

for food and agriculture, especially for antimicrobials that are

also used to treat infections in human medicine and

veterinary medicine and consider further control options;

- examine the issue of antimicrobial residues in the

environment and assess the contribution of the use of

biocides

AMR Past/Current activities Policy support/implementation (1)

EU Public Health Programme

Projects funded by the 2003-2008 Public Health Programme:

2003-2006: EARSS - European Antimicrobial Resistance Surveillance System (RIVM, NL)

2004-2007: EUCAST - European Committee on Antimicrobial Susceptibility Testing (ESCMID, DE)

2004-2007: ESAC - European Surveillance of Antimicrobial Consumption (University of Antwerp, BE)

2005-2008: Euro-TB (Institut de la Veille Sanitaire, FR)

2005-2008: IPSE - Improving Patient Safety in Europe (University Lyon, FR)

2006-2009: ABS International - Implementing Antibiotic Strategies for Appropriate Use of Antibiotics in Hospitals in MS of the EU (Roland Gareis Consulting, AT)

2006-2009: EBUG PACK - Development and Dissemination of a School Antibiotic and Hygiene Education Pack and website across Europe (HPA, UK)

2007-2009: Burden of Disease and Resistance in European Nations (University Clinic Freiburg, DE)

AMR Current activities Policy support/implementation (2)

European Centre for Disease Prevention and Control (ECDC): AMR and healthcare-associated infections is one of the seven priority topics/disease area for action

Surveillance (Annual Epidemiological Report)

Development of scientific guidance (e.g. ECDC report on C. difficile)

Interaction with AMR National Focal Points in the Member States + country visits to discuss AMR issues

Advocacy around antimicrobial resistance: annual European Antibiotic Awareness Day (first edition on 18 November 2008)

Possible continuation of (certain parts of) project activities:

In house

Call for tender

The European Commission’s

Research on antimicrobial drug

resistance

26,1

43,7

36,7

28

37,2

28,3

0

5

10

15

20

25

30

35

40

45

50

1 2 3

FP5

FP6

Framework Programme 5

(1999-2002)

Over 20 million € / year

Framework

Programme 6 (2003-

2006)

Over 40 million € / year

1: Reduce / Rationalize the use of antibiotics

2: Reduce the spread of resistant bacteria

Health alliance for prudent prescribing,

yield and use of anti-microbial drugs in the

treatment of respiratory tract infections

Genomics to combat resistance against

antibiotics in community-acquired low

respiratory tract infections in Europe

Changing behaviour of health care

professionals and the general public

towards a more prudent use of anti-

microbial agents

www.happyaudit.org

www.grace-lrti.org

Selected Projects

Denmark

Sweden

Spain

Lithuania

Russia

Argentina

NETWORKS

Netherlands

Belgium

United Kingdom

Poland

Switzerland

Italy

Spain

Overall Objectives

Combating antibiotic resistance of community-acquired LRTI pathogens through

- Networks of excellence of academic research and primary care

practitioners

- Application of human and microbial genomics

To promote prudent use of antibiotics by developing effective tools for changing their prescription and use practices among

- Health care professionals

- Patients in primary care

- General public

To reduce the occurrence of bacterial resistance to antibiotics by

- Reducing antibiotic use for RTI

- Optimizing antibiotic use in suspected bacterial infections

- Improving the diagnostics of RTI in general practice

Selected findings

GRACE (based on 3400 primary care patients with LRTI)

- Antibiotics are prescribed to about 50% of LRTI patients.

- No clinically important differences in outcome for patients despite

extensive variation in antibiotic prescription practices in Europe.

CHAMP

- Local health system, culture and available funding determine the

diversity of public antibiotic awareness campaigns.

- Impact assessment of these campaigns should focus on the changes of

antibiotic prescription practices, clinical outcomes and antibiotic resistance

rates among pathogens.

HAPPY AUDIT (based on 30.000 primary care patients with RTI)

- Antibiotics are prescribed to about 30% of RTI patients.

- Narrow-spectrum antibiotics are favoured in Scandinavia, whereas broad

spectrum antibiotics in Eastern European countries.

2007-2008: Over 40 million € for research

on antimicrobial drug resistance, with

emphasis on novel targets for drugs

against Gram-negative bacteria and

molecular epidemiology of antibiotic

resistant pathogens Anti-microbial drug resistance (2009)

(topics open for proposal submission until 03-12-2008)

- Global collaborative research on the prevention of

antibiotic resistance. € 12m.

- Impact of specific antibiotic therapies on the

prevalence of resistant bacteria in the human host. € 6

m.

- Clinical evaluation of point-of-care diagnostic tests for

microbial detection and identification, antibiotic

susceptibility determination and biomarkers. € 6 m.

AMR future activities Policy (1)

2009: 2nd Report from the Commission to the Council on the basis of Member States’ reports on the implementation of the Council Recommendation (2002/77/EC) on the prudent use of antimicrobial agents in human medicine.

First semester 2008: a questionnaire was prepared with input from ECDC and external experts.

August 2008: the questionnaire was piloted with a few Member States

Sept – Oct 2008: the questionnaire is being filled out by Member States

Q4 2008 – Q1 2009: analysis of the responses

2009: preparation of the report and transmission to Council

AMR future activities Policy (2)

2008 - 2009: Commission Communication and proposal for a Council Recommendation on patient safety and quality of health services, including the prevention and control of healthcare-associated infections.

Nov 2008: planned adoption by College of Commissioners

Dec 2008: planned transmission to the Council of the proposal for a Council Recommendation

June 2009: planned adoption of the proposal for a Council Recommendation at the Council of EU Health Ministers

AMR future activities Policy (3)

Forthcoming EU Presidencies also identify AMR as a priority

Czech Presidency (Jan-June 09):

Focus on antibiotic use in hospitals (workshop April 2009)

Swedish Presidency (July-Dec 09):

Focus on R&D for new antibiotics (conference Sept 2009)

AMR future activities Policy support/implementation (1)

European Centre for Disease Prevention and Control (ECDC) in its missions in the field of

Surveillance and Monitoring

Scientific studies/opinions

Communication

Member States support

Collaboration with other Agencies (EMEA, EFSA)

AMR future activities Policy support/implementation (2)

EU Health Programme 2008-2013:

2009 Work plan: in progress … ; can be expected to take into account the Council Conclusions adopted during Slovenian Presidency.

2010 Work plan: will take stock of 2nd implementation report on Council Recommendation 2002/77/EC and adopted (?) Council Recommendation on patient safety and quality of health services, including the prevention and control of healthcare-associated infections.

AMR future activities and activities Policy support/implementation (3)

Zoonotic (foodborne) antimicrobial resistance

Strengthen interactions and cooperation between EU actors reflecting the multisectoral aspect of AMR in zoonotic agents (according ti 2008 Council Conclusions):

Establishment of an Intra-SANCO task force: e.g. coordination with animal health policy, zoonose (e.g. Salmonella) control programmes

EMEA in particular its Committee for Veterinary Medicinal Products

ECDC

EFSA (risk assessment and zoonoses monitoring)

Community Reference Laboratory on AMR

AMR future activities Policy support/implementation (4)

Zoonotic (foodborne) antimicrobial resistance

Harmonisation of monitoring in animals and food with EUCAST methodology

Discussion on monitoring of veterinary use of antimicrobials

Burden of disease:

AMR caused by veterinary <-> human medicinal use

Specific zoonotic AMR e.g. fluoroquinolone resistant campylobacter infections

Specific focus in 2009 under preparation

EUROBAROMETER: opinion enquiry among 27 MS Citizens about their perception and use of antibiotics for which French experience will be much appreciated.

AMR future activities

Policy support/implementation (5)

AMR present activities preparing the future for both Policy and its support & implementation

The present event due to the French Presidency and devoted

to public awareness campaigns on the Prudent use of

Antibiotics is an outstanding opportunity.

• Round table planned to bring together lessons learnt and express strategic priorities will be of pivotal importance to help the Commission in identifying further work

• Agenda mainly focused on evaluation of different kinds of impact of AB use, on quality indicators, … will be worthwhile for refining our objectives and update our Community strategies.

• Thank you for your attention and for your involvement and worthwhile contribution in the fight of AMR, in your community, in Europe

Commission Public Health website: http://ec.europa.eu/health/index_en.htm

EU Health Portal: http://ec.europa.eu/health-eu