COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Action plan against the rising threats from Antimicrobial Resistance
Date: 2011-11-15
Institutions: European Commission
Subjects: animal disease, antibiotic, drug surveillance, health control, infectious disease, medical research, public awareness campaign, veterinary drug

EUROPEAN COMMISSION 

Brussels, 15.11.2011 
COM(2011) 748 final 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

Action plan against the rising threats from Antimicrobial Resistance  

 
 
 
 
  
 
1. 

INTRODUCTION 

1.1. 

The rising risk of antimicrobial resistance (AMR) 

Since  the  introduction  of  penicillin  in  the  1940s  antimicrobial  medicines,  such  as 
antibiotics, have become essential for the treatment of many microbial infections in 
humans  and  animals.  In  addition  to  the  treatment  of  infectious  diseases  (e.g. 
pneumonia, tuberculosis, malaria, HIV/AIDS) and hospital-acquired infections (e.g. 
methicilin  resistant  Staphylococcus  aureus  (MRSA),  antimicrobials  are  vital  for 
reducing the risk of complications in relation to complex medical interventions, such 
as  hip  replacements,  organ  transplants,  cancer  chemotherapy  and  the  care  of 
premature babies. In addition, antimicrobials are used in veterinary medicine and for 
non-therapeutic  purposes  (e.g.  disinfectants,  preservatives,  and  food  and  feed 
additives).  

Seventy  years  later,  these  applications  are  now  seriously  jeopardized  by  the 
emergence and spread of microbes that are resistant to affordable and effective first-
choice,  or  "first-line"  medicines,  rendering  the  drugs  concerned  ineffective  for  the 
treatment of the infection. This resistance is a natural biological phenomenon but is 
amplified by a variety of factors. The inappropriate use of therapeutic antimicrobials 
in  human  and  veterinary  medicine,  the  use  of  antimicrobials  for  non-therapeutic 
purposes as well as the pollution of the environment by antimicrobials is accelerating 
the emergence and spread of resistant microorganisms. The consequences are severe: 

• 

• 

A  subset  of  drug-resistant  bacteria  is  responsible  for  about  25,000  human 
deaths  annually.  In  addition  to  avoidable  death,  this  also  translates  into  extra 
healthcare  costs  and  productivity  losses  of  at  least  EUR  1.5  billion1.  In 
healthcare settings, AMR notably represents a threat of particular concern, i.e. 
infections  acquired  from  exposure  in  a  hospital  or  a  healthcare  service  unit. 
Approximately  4  million  patients  are  estimated  to  acquire  a  healthcare-
associated infection in the EU every year.  

Common  bacteria  causing  e.g.  diarrhoea  or  respiratory  infections  in  several 
animal  species  have  become  more  resistant  to  commonly  used  veterinary 
antimicrobials  causing  increased  suffering  and  mortality  in  animals,  and 
consequently, production losses and extra costs as well as occupational hazards 
to animal keepers. 

The  development  of  resistance,  the  pressure  to  reduce  the  use  of  antimicrobials  as 
well as the weak market incentives and increasing difficulty and cost to develop new 
effective antibiotics have discouraged investment in this area with the consequence 
that only a few new antibiotics are currently under development. 

Increasing  global  trade  and  travel  favours  the  spread  of  antimicrobial  resistance 
between  countries  and  continents.  Therefore,  antimicrobial  resistance  is  a  global 
public health concern.  

1 

ECDC/EMEA JOINT TECHNICAL REPORT The bacterial challenge: time to react. Available from: 
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500008770.pdf 

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1.2. 

Ongoing efforts are not sufficient 

The problem of AMR is known since many years now and has been recognized both 
by the Council and the European Parliament: 

• 

• 

The Council adopted on 10th June 2008 Conclusions on AMR calling upon the 
Commission,  in  accordance  with  the  "health  in  all  policies"  approach,  to 
promote  cooperation  between  the  Commission,  Agencies  and  the  Member 
States  against  AMR,  and  on  1st  December  2009  Conclusions  on  innovative 
incentives  for  effective  antibiotics  calling  upon  the  Commission  to  develop  a 
comprehensive  action  plan  concerning  incentives  to  develop  new  effective 
antibiotics including ways to secure their rational use.  

On  12th  May  2011  the  European  Parliament  adopted  a  non-legislative 
resolution on antibiotic resistance in which it stresses that AMR has become a 
huge  issue  in  recent  years.  To  cope  with  this  growing  problem  and  the 
consequent treatment failures, the EP calls on the Commission to establish an 
EU-wide plan to combat AMR. 

The Commission has taken a number of important actions:  

• 

• 

• 

• 

• 

• 

In the field of human medicine, the 2001 Community Strategy against AMR2 
called  for  EU  actions  against  AMR  in  the  fields  of  surveillance,  research, 
prevention and international cooperation. This led to the adoption of EU wide 
recommendations and guidelines against AMR.  

In  animal  husbandry,  the  ban  on  the  use  of  antimicrobials  for  growth 
promotion was introduced in 2006. The Commission has developed legislation 
on  the  control  of  Salmonella  at  all  relevant  stages  of  production,  processing 
and  distribution  in  order  to  reduce  the  exposure  of  humans  to  potentially 
resistant Salmonella. 

In  the  field  of  veterinary  medicine,  the  emphasis  has  been  in  monitoring 
zoonotic AMR (i.e. resistance transmissible between animals and humans) and 
on the use of antimicrobials in animals.  

The  authorisation  requirements  of  human  and  veterinary  medicines  and 
other products, such as food enzymes, probiotics and decontamination agents, 
with possible effects on development of AMR have also been the focus areas.  

AMR  is  the  subject  of  research  funded  under  the  Seventh  Framework 
Programme (FP7) and the Innovative Medicines Initiative (IMI). AMR is also 
the  subject  of  a  proposed  Joint  Programming  Initiative  (JPI),  which  aim  to 
coordinate research activities among EU Member States3.  

Scientific opinions on AMR by EU Risk Assessment bodies i.e. the European 
Centre for Disease Prevention and Control (ECDC), the European Food Safety 

2 
3 

COM/2001/0333 final Volume I. 
http://ec.europa.eu/research 

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Authority  (EFSA),  the  European  Medicines  Agency  (EMA),  the  Scientific 
Committee on Emerging and Newly Identified Health Risks (SCENIHR) have 
formed  the  basis  for  policy  planning,  for  example,  development  of  new 
antimicrobials and monitoring AMR and antimicrobial usage. 

Similarly, some action has been undertaken at international level e.g. by the World 
Health Organisation (WHO) and the Codex Alimentarius. 

1.3. 

The need for substantially reinforced action and new determined initiatives 

Although the actions taken so far go in the right direction, they have not succeeded in 
containing  the  rising  threat  from  AMR.  A  substantial  reinforcement  of  current 
measures in place together with a new set of rigorous measures are therefore needed 
in  order  to  reduce  the  pressure  of  using  antimicrobials  and  to  prevent  the  further 
spread of resistance and preserve the ability to combat microbial infections.  

In order to succeed, a holistic approach is needed. AMR is a major European and 
global  societal  problem,  involving  many  different  sectors  e.g.  medicine,  veterinary 
medicine,  animal  husbandry,  agriculture,  environment  and  trade.  It  cannot  be 
successfully  tackled  through  isolated,  sectoral  efforts.  Food  and  direct  contact  with 
animals may serve as a vehicle for the transmission of AMR from animals to humans 
emphasizing the link between human and veterinary medicine in line with the "One 
Health" initiative4. The fact that resistance may spread from country to country when 
people and animals travel or when food, feed and other possible vehicles of AMR are 
traded, stresses the need for coordinated efforts across borders. 

Based on such holistic approach, the new actions put forward in this Action Plan aim 
at:  

1.  Mitigating  the  risk  of  developing  AMR  in  humans  from  the  use  of 
antimicrobials  both  in  humans  and  animals  by  effectively  ensuring  across  the 
EU  their  appropriate  use,  and  promoting  microbiological  diagnosis  as  the 
means to determine, to the extent possible, the need for antimicrobials. 

2. 

Putting  in  place  effective  ways  to  prevent  microbial  infections  and  their 
spread.  

3.  Developing  effective  antimicrobials  or  alternatives  for  treatment  of  human 

and animal infections. 

4. 

5. 

Joining  forces  with  international  partners  to  contain  the  risks  of  spreading 
AMR from international trade and travel and via the environment.  

Reinforcing research to develop the scientific basis and innovative means to 
combat AMR. 

4 

http://www.one-health.eu 

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2. 

KEY ACTIONS FOR A SUCCESSFUL FIGHT AGAINST AMR 

2.1. 

Appropriate use of antimicrobials 

The appropriate use of antimicrobials is essential for reducing and preventing AMR 
and  is  the  cornerstone  of  EU  policy  against  AMR,  both  in  human  and  veterinary 
medicines. Antimicrobials should only be used if necessary and in accordance with 
best practices.  

Prudent use of antimicrobials in human medicine  

AMR is directly linked to the way in which patients and prescribers use antimicrobial 
agents.  The  inappropriate  use  of  these  agents  (e.g.  taking  antimicrobials  for  wrong 
reasons  or  incorrectly)  is  driving  the  emergence  and  selection  of  drug  resistant 
microbes. Promoting the appropriate or prudent use of antimicrobials from the doctor 
and the pharmacist to the patient is the determinant in reversing the increasing rates 
of AMR.  

The  2002  Council  Recommendation  on  the  prudent  use  of  antimicrobial  agents  in 
human medicine5 lays out specific actions to be implemented by Member States and 
the Union  with a  view to containing AMR (e.g. setting  up of surveillance systems, 
implementation of control measures such as access to antibiotic through prescription 
only,  promotion  of  education  and  training  programmes  etc.).  Whereas  reports 
published by the Commission in 2005 and 2010 have highlighted important progress 
in the implementation of this Recommendation, there are still numerous areas where 
only limited improvement has been attained. 

Action n° 1: Strengthen the promotion of the appropriate use of antimicrobials in 
all Member States.  

– 

In  cooperation  with  ECDC,  the  Commission  will  aim  at  ensuring  that  all 
the  2002  Council  Recommendation  on  the  prudent  use  of  antimicrobial 
agents  in  human  medicines  are  effectively  implemented  by  the  Member 
States with a particular emphasis on: 

○ 

○ 

○ 

○ 

Improving the sustainability of national surveillance systems on AMR 
and access to surveillance data at local and regional levels. 

Improving 
prescription only requirements for antimicrobial agents. 

implementation  by  all  Member  States  of 

the 

the 

Improving  the  implementation  of  control  measures  against  AMR  in 
nursing homes and long-term care facilities. 

Development of education and training for healthcare workers on all 
aspects of AMR.  

○ 

Better  assessment  and  monitoring  at  national 

level  of 

the 

5 

Council  Recommendation  (2002/77/EC)  of  15  November  2001  on  the  prudent  use  of  antimicrobial 
agents in human medicine, OJ L 34, 5.2.2002, p. 13-16. 

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5 

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implementation and efficiency of the national strategies and  control 
measures. 

– 

The Commission will publish by 2015 at the latest a new report identifying 
progress made and shortfalls in promoting prudent use of antimicrobials at 
national  and EU  level and  assess whether the existing EU framework for 
the promotion of prudent use of antimicrobials should be revised. 

Prudent use of antimicrobials in veterinary medicine 

The  sub-optimal  use  of  therapeutic  antimicrobials  for  animals,  in  particular  under-
dosage, can enhance the development of AMR. Efforts to ensure that the medicines 
are administered to the animals only at the correct therapeutic level are undertaken in 
the enforcement of the current rules on veterinary medicines and medicated feed but 
also in the margins of the ongoing revision of these legal acts. 

In  the  veterinary  sector  cooperation  has  been  established  between  the  stakeholders 
(animal  health  industry,  veterinarians  and  farmers)  to  promote  prudent  use.  In 
addition  guidelines  from  international  organisations,  veterinary  associations  as  well 
as  by  Member  States  on  the  use  of  antimicrobials  have  been  developed.  Some 
Member  States  have  also  put  in  place  various  measures,  legislative  and  others,  to 
promote  appropriate  use.  However,  between  Member  States  significant  differences 
exist in the sales of antimicrobials that cannot be explained by the animal husbandry 
practices. Moreover, there is an increasing concern on the use of antimicrobials in the 
veterinary sector that are critical for humans. 

Examples:  

• 

3rd  and  4th  generation  cephalosporins  are  antibiotics  that  have  been  classified 
by the WHO as critically important antibiotics for humans. EMA indicated in a 
reflection paper in 20086 that for almost all of the indications for the systemic 
use  of  these  medicines  in  the  treatment  of  food  producing  animals,  equal  or 
better alternatives are available. In a 2011 opinion, EFSA7 "considered that a 
highly  effective  control  option  for  certain  types  of  AMR  would  be  to  stop  all 
uses of cephalosporins/systemically active 3rd/4th generation cephalosporins, or 
to restrict their use (use only allowed under specific circumstances)." 

•  MRSA  is  a  major  cause  of  resistant  hospital  infections.  In  a  2008  baseline 
survey  coordinated  by  EFSA,  it  has  been  demonstrated  that  pigs  are  a  major 
reservoir  of  a  new  emerging  type  of  MRSA.  A  joint  ECDC/EFSA/EMA 
scientific  report  published  in  20098  concludes  that  "the  extensive  use  of 

6 

7 

8 

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/ 
WC500004307.pdf 
Scientific  Opinion  on  the  public  health  risks  of  bacterial  strains  producing  extended-spectrum  β-
lactamases  and/or  AmpC  β-lactamases 
in  food  and  food-producing  animals.  EFSA  Journal 
2011;9(8):2322. [95 pp.]. Available online: www.efsa.europa.eu/efsajournal 
Joint  scientific  report  of  ECDC,  EFSA  and  EMEA  on  meticillin  resistant  Staphylococcus  aureus 
(MRSA)  in  livestock,  companion  animals  and  foods.  EFSA-Q-2009-00612  (EFSA  Scientific  Report 
(2009) 
from: 
Available 
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/10/WC500004306.pdf 

EMEA/CVMP/SAGAM/62464/2009. 

1-10) 

301, 

and 

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antimicrobials for prevention of disease appears to be an important risk factor for the 
spread of MRSA".  

Action n° 2: Strengthen the regulatory framework on veterinary medicines and on 
medicated feed via the review package foreseen for 2013, in particular: 

– 

– 

– 

– 

To ensure appropriate warnings and guidance on the labels of veterinary 
antimicrobials. 

To consider restrictions on the regular or the off-label use of certain new 
or critically important antimicrobials for humans in the veterinary sector.  

To  consider  amending  the  rules  for  the  advertisement  of  veterinary 
antimicrobials. 

To  revisit  the  authorisation  requirements  in  order  to  sufficiently  address 
the risks and benefits of antimicrobial medicines. 

Action n° 3: Introduce recommendations for prudent use in veterinary medicine, 
including  follow-up  reports,  using  the  same  approach  as  2002  Council 
Recommendation on prudent use of antimicrobial agents in human medicine. 

2.2. 

Prevent microbial infections and their spread 

Infection prevention and control in healthcare settings 

The  burden  caused  by  infections  occurring  in  healthcare  settings  –  so  called 
'healthcare associated infections' – is high within the EU and is closely related to the 
issue  of  AMR.  The  latter  has  emerged  in  virtually  all  healthcare-associated 
pathogens,  and  the  majority  of  novel  resistance  factors  first  surface  in  healthcare 
facilities. Considering the scientific evidence indicating that approximately 20-30% 
of all healthcare associated infections can be prevented by intensive prevention and 
control programmes, the 2009 Council Recommendation on patient safety, including 
includes 
the  prevention  and  control  of  health  care  associated 
recommendations  to  step  up  the  prevention  and  control  of  infections  in  healthcare 
settings.  

infections9 

9 

Council Recommendation (2009/C 151/01) of 9 June 2009 on patient safety, including the prevention 
and control of healthcare associated infections, OJ C 151, 3.7.2009, p. 1–6. 

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Action n° 4: Strengthen infection prevention and control in healthcare settings 

– 

Conduct and publish by 2012 a report identifying the progress made by the 
Member  States  and  gaps 
the  2009  Council 
Recommendations  on  patient  safety,  including  prevention  and  control  of 
health  care  associated  infections,  with  a  special  emphasis  on  verifying 
whether:  

implementing 

in 

○ 

○ 

○ 

guidance on infection prevention and control is developed, 

surveillance of healthcare associated infections is strengthened and 

proper education and training of healthcare workers is organised. 

Infection prevention and control in farm animals 

Improved  animal  health  and  biosecurity  measures  as  well  as  promotion  of  Good 
Farming  Practices  avoid  infections  and  therefore  contribute  to  the  reduction  of  the 
use antimicrobials in animals including aquaculture ("prevention is better than cure") 
and  consequently  of  the  development  of  AMR  in  animal  pathogens  and  zoonotic 
agents.  

In  addition  to  the  ongoing  Salmonella  control  programs  in  poultry,  cost/benefit 
analyses  are  currently  carried  out  on  the  control  of  Salmonella  in  pigs,  the  second 
source of human salmonellosis, in view of setting a target for (potentially resistant) 
infections. 

Action  n°  5:  Introduction  of  the  new  Animal  Health  Law,  which  will  focus  on 
prevention  of  diseases,  reducing  the  use  of  antibiotics  and  replacing  current 
Animal Health provisions based on disease control.  

2.3. 

Develop new effective antimicrobials or alternatives for treatment  

Development of new human antimicrobials 

A report published in 2009, "The bacterial challenge: time to react"10, highlights the 
gap between the increasing problems related to multi-resistant bacteria in the EU and 
the  pressing  need  for  developing  new  antimicrobials  to  meet  medical  needs.  This 
study  calls  for  a  European  strategy  to  address  this  gap.  This  call  was  further 
strengthened  by  the  1st  of  December  2009  Council  Conclusions  on  incentives  for 
effective antibiotics mentioned in paragraph 1.2 above.  

Numerous  research  projects  that  aim  to  support  antimicrobial  development  are 
funded  within  FP711,  including  support  to  clinical  trials  on  off-patent  antibiotics. 
Nevertheless, there is currently and since many years a lack of industrial investment 
in  the  development  of  new  antibiotics  and  only  a  few  products  that  could  combat 

10 

11 

ECDC/EMEA JOINT TECHNICAL REPORT The bacterial challenge: time to react. Available from: 
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500008770.pdf 
http://ec.europa.eu/research/health/infectious-diseases/antimicrobial-drug-resistance/index_en.html 

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resistant strains are in the late-stage of development. In the absence of new effective 
antimicrobials  there  is  a  risk  that  resistance  will  further  develop  and  certain 
infections will no longer be able to be treated effectively. 

There  are  several  reasons  for  the  lack  of  industrial  investment  in  new  antibiotics. 
Developing  new,  effective  and  safe  antibiotics  is  more  and  more  scientifically 
difficult  and  costly.  Restrictions  on  the  use  of  antibiotics  deter  investment.  Pricing 
structure  does  not  reward  utility.  The  majority  of  antibiotics  are  administered  for 
short periods. Generics take an increasing share of the antibiotic market. There is an 
urgent  need  for  increased  research  and  development  and  a  new  business  model  for 
antibiotics. 

Action  n°  6:  To  promote,  in  a  staged  approach,  unprecedented  collaborative 
research and development efforts to bring new antibiotics to patients by: 

– 

– 

Launching  rapidly  with  EFPIA12,  within  the  IMI-Joint  Undertaking,  a 
programme  for  research  on  new  antibiotics  aimed  at  improving  the 
efficiency  of  research  and  development  of  new  antibiotics  through 
unprecedented open sharing of knowledge. 

Establishing  an  overarching  framework  agreement  with  the  industry, 
defining  objectives,  commitments,  priorities,  principles  and  modes  of 
action  for  public-private  collaboration  in  a  longer  term  perspective. 
Mobilising  adequate  resources,  within  IMI  in  particular  (and  its  possible 
successor),  FP7  and  in  the  longer  term  the  forthcoming  research  and 
innovation  programme  2014-2020  (Horizon  2020),  in  order  to  support 
research and development work, based on criteria and modalities adapted 
to  the  specific  needs  and  challenges  of  antibiotic  development.  Use  the 
flexibility 
to  give  rapid 
authorisation  to  new  antibiotics  and  work  with  stakeholders  and  the 
Member  States'  authorities  towards  the  establishment  of  adequate  market 
and pricing conditions for new antibiotics.  

the  current  pharmaceutical 

legislation 

in 

– 

Ensure  conditions  for  and  implement  fast  track  procedures  for  the 
marketing authorisation of new antimicrobials. 

This action will be complemented by the reinforced action to ensure prudent use as 
well as international collaboration aimed at combating transfer of resistance. 

Development of veterinary antimicrobials  

The development of antimicrobials for potential use in animals has been hampered, 
particularly in view of the uncertainty as to whether new antimicrobials or even new 
indications for such active substances would be given a marketing authorisation for 
the veterinary sector.  

12 

European Federation of Pharmaceutical Industries and Associations. 

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Development of diagnostic tools in human and veterinary medicine 

Diagnostic tools that include tests for quick and accurate identification of pathogenic 
micro-organisms and/or for determining their sensitivity to antimicrobials play a key 
role  in  the  fight  against  microbial  infections.  Research  on  the  development  of  such 
tools  as  well  as  their  implementation  in  health  care  is  funded  under  FP7  and 
additional  efforts  are  expected  to  be  funded  under  the  forthcoming  research  and 
innovation programme 2014-2020 (Horizon 2020).  

Development of vaccines and other preventive measures 

Vaccines and other preventive measures could have an important impact on reducing 
the  spread  of  infections  and,  thus,  the  need  for  treatment.  Therefore,  research  and 
innovation in this field should be supported. 

Action  n°  7:  Promote  efforts  to  analyse  the  need  for  new  antibiotics  into 
veterinary medicine 

– 

– 

Establishing  request  for  scientific  advice  to  clarify  in  particular  whether 
the development of new veterinary antimicrobials would reduce AMR. 

Evaluation of the need and possible introduction of incentives that trigger 
development  in  veterinary  medicines  to  increase  the  likelihood  that 
innovations reach the market  within the review of the rules on veterinary 
medicines foreseen in 2013. 

2.4. 

Joining  forces  with  international  partners  to  contain  the  risks  of  spreading 
AMR from international trade and travel and via the environment 

In view of the global nature of AMR, the EU has already worked actively in several 
international  fora,  which  aim  to  expand  global  awareness  and  joint  measures.  The 
Commission  will  continue  to  support  this  work,  e.g.  to  encourage  other  WHO 
regions to take into account the approach of the WHO's European region, to ensure 
continuous  consistency  with  work  of  the  WHO  Advisory  Group  on  Integrated 
Surveillance of Antimicrobial Resistance, to further contribute to the development of 
Health Codes by the World Organisation for Animal Health (OIE), to play an active 
role  in  the  Codex  Alimentarius,  and  to  continue  to  encourage  trading  partners  to 
consider their own measures against AMR.  

In addition, the EU aims at developing bilateral cooperation against AMR. The EU 
started  a  bilateral  cooperation  with  the  USA  on  AMR  as  a  request  of  the  EU-US 
summit 2009. In 2011 the EU-US Transatlantic taskforce (TATFAR) has identified 
17 key recommendations for strengthened cooperation in 3 key areas: 1) Appropriate 
therapeutic use of antimicrobials in human and veterinary medicines, 2) Prevention 
of  drug-resistant  infections  and  3)  Strategies  for  improving  the  pipeline  of  new 
antibiotics.  The  TAFTAR  recommendations  for  concrete  future  collaboration  on 
these key areas are consistent with the priorities in this action plan.  

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Action  n°  8:  Develop  and/or  strengthen  multilateral  and  bilateral  commitments 
for the prevention and control of AMR in all sectors. 

Multilateral cooperation 

– 

– 

– 

Cooperate with WHO EURO in implementing the new Regional Strategies 
against  AMR  and  Multi  Drug  Resistant  tuberculosis  across  the  WHO 
EURO Region. 

Contribute  to  further  development  of  the  Health  Codes  of  the  OIE  and 
promote 
internationals 
implementation  of  Codex  Alimentarius 
standards on AMR. 

the 

Initiate  cooperation  on  reduction  of  the  environmental  pollution  by 
antimicrobial medicines particularly from production facilities. 

Bilateral cooperation 

– 

Strive  to  maintain  and  deepen  transatlantic  cooperation  against  AMR 
through active participation in the TATFAR and the implementation of its 
recommendations.  Set  out  and  apply  in  a  staged  approach  a  plan  to 
implement the 17 recommendations of TATFAR. 

3. 

OTHER HORIZONTAL ACTIONS 

In  addition  to  above  key  actions,  some  other  measures  should  be  taken,  including 
monitoring, research, communication and education/training. 

3.1.  Monitoring and surveillance  

3.1.1. 

Surveillance of AMR and antimicrobial consumption in human medicine 

EU  surveillance  systems  have  been  developed  to  monitor  AMR  (European 
the  consumption  of 
Antimicrobial  Resistance  Surveillance  Network)  and 
antimicrobials (European Surveillance of Antimicrobial Consumption, ESAC). These 
systems  provide  key  information  and  data  supporting  the  prevention  and  control  of 
AMR. In addition, while young children are the main recipients of antibiotics in the 
EU,  there  is  currently  only  very  limited  surveillance  data  on  antimicrobial 
consumption and antibiotic resistance for children in Europe.  

Action  n°  9:  Strengthen  surveillance  systems  on  AMR  and  antimicrobial 
consumption in human medicine 

– 

– 

– 

With the support of the ECDC, assess ways to improve access to data on 
AMR at all levels (regional, local and hospitals). 

Ensure  the  efficient  transfer  of  the  ESAC  project  to  ECDC  to  secure  the 
sustainability of the project. 

With  the  support  of  the  ECDC,  support  and  monitor  the  successful 

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development  of  the  new  EU  funded  surveillance  project  ARPEC  – 
Antibiotic Resistance and Prescribing in European Children.  

3.1.2. 

Surveillance of AMR and antimicrobial consumption in animals 

AMR  monitoring  is  mandatory  for  most  important  zoonotic  bacteria  in  food 
producing  animals.  These  bacteria  (e.g.  Salmonella,  E.  coli)  may  infect  humans 
directly or through the consumption of food and jeopardize  antimicrobial treatment 
in humans. Based on recent EFSA recommendations, the Commission will propose 
updating  of  the  monitoring  requirements.  Data  on  usage  of  antimicrobials  both  in 
humans  and  in  animals  is  needed  for  risk  profiling,  risk  assessment  and  research 
purposes  as  well  as  for  setting  risk  management  goals  and  evaluating  their 
effectiveness.  

Harmonisation  of  resistance  monitoring  for  human,  animal,  environment  and  food 
bacteria  favours  the  comparability  of  the  monitoring  results  and  consequently 
provides  better  input  for  the  risk  assessment  and  risk  management  activities.  In 
addition, the access to data and information on AMR and use of antimicrobials must 
be enabled and improved for decision makers, professionals and the public. 

Action  n°  10:  Strengthen  surveillance  systems  on  AMR  and  antimicrobial 
consumption in animal medicine 

– 

– 

– 

– 

Inclusion of a legal basis for the monitoring of AMR in animal pathogens 
in its forthcoming proposal for a new Animal Health Law. 

Promotion  and  extension  of  the  European  Surveillance  of  Veterinary 
Antimicrobial  Consumption  (ESVAC)  with  the  collaboration  of  EMA  to 
obtain  harmonised  data  on  the  usage  per  animal  species  and  production 
categories as well as for different indications from all Member States.  

Review of the monitoring of AMR in zoonotic bacteria and/or indicators. 

With  the  support  of  the  relevant  EU  agencies,  establish  harmonisation 
between human and veterinary surveillance to allow comparison of data. 

3.2. 

Additional Research and Innovation 

Scientific  research  and  innovation  serves  as  a  basis  for  science-based  policy  and 
legal  measures  to  combat  AMR  and  can  provide  new  tools  for  diagnosis  and 
treatment. Diagnostic tools that include tests for quick and accurate identification of 
pathogenic micro-organisms and/or for determining their sensitivity to antimicrobials 
play  a  key  role  in  the  fight  against  microbial  infections.  Vaccines  and  other 
preventive  measures  could  have  an  important  impact  on  reducing  the  spread  of 
infections  and,  thus,  the  need  for  treatment.  Therefore,  research  and  innovation  in 
these fields should be supported. 

The FP7 funds a multitude of collaborative research projects aimed at improving the 
understanding of resistance mechanisms, as well as projects that stimulate academia 

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and  small  and  medium  sized enterprises to  work  together towards novel innovative 
solutions for diagnostic tests and to combat the spread of AMR. 

Action n° 11: Reinforce and co-ordinate research efforts, in particular 

– 

– 

– 

– 

– 

Promote further research aiming at better understanding of antimicrobial 
resistance and pathogenic-host interactions.  

Promote  further  research  on  the  development  of  diagnostic  tools,  vaccins 
and other preventive measures. 

Support  the  launch  of  a  Joint  Programming  Initiative13  aimed  at 
coordinating national research activities related to AMR. 

Support  an  analysis  of  the  reasons  for  high  usage  of  antimicrobials  in 
countries with the highest occurrence of AMR in the human sector. 

Contribute to a global mapping of drug resistance. 

3.3. 

Communication, education and training 

With  more  than  50%  of  EU  citizens  still  believing  that  antibiotics  are  effective 
against viruses, awareness and understanding of the public in general and healthcare, 
veterinary  and  other  professionals  on  AMR  and  the  importance  of  appropriate  use 
need  to  be  enhanced  through  education  campaigns  throughout  the  EU  and  by 
making  AMR  a  more  integral  part  of  education  programs  for  health  and  veterinary 
professional  groups.  The  "European  Antibiotics  Awareness  Day"  (EAAD)  –  an 
annual  European  public  health  initiative  taking  place  on  18  November  to  raise 
awareness about the threat to public health of antibiotic resistance and about prudent 
antibiotic  use  –  provides  a  unique  platform  to  support  the  dissemination  of 
information and key messages on this issue. With more than 35 Member States and 
international partners having developed campaigns and events in 2011 as part of the 
EAAD, this initiative should be maintained and strengthened.  

This communication effort should be supported by effectiveness research to improve 
and maximise the impact of these campaigns on practitioners and the general public.  

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Action n° 12: Survey and comparative effectiveness research 

Building  up  on  the  findings  of  the  2010  AMR  Eurobarometer  survey,  the 
Commission will by no later than 2015 conduct a new EU wide survey: 

– 

– 

– 

Assessing  the  impact  of  the  national  and  EU  awareness  campaigns  on 
AMR including the development of indicators. 

Monitoring the evolution of the behaviour of the general public with regard 
to AMR and the appropriate use of antimicrobials. 

support  improving  the  effectiveness  and  the  impact  of  these  campaigns 
among others through the identification of target groups and most efficient 
communication practices and the exchange of best practices. 

4. 

EX-POST EVALUATION  

In  order  to  evaluate  and  assess  the  trends,  the  impact  and  effectiveness  of  the 
measures  taken  and  the  goals  achieved  by  the  implementation  of  the  5-year  action 
plan to fight against AMR, the Commission shall monitor the use of antibiotics and 
antimicrobial  resistance,  and,  where  appropriate,  shall  ask  follow  up  reports  on  the 
implementation and actions taken at national level. 

5. 

CONCLUSIONS 

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: 

• 

• 

• 

• 

• 

• 

Action n° 1: Strengthen the promotion of the appropriate use of antimicrobials 
in all Member States.  

Action n° 2: Strengthen the regulatory framework on veterinary medicines and 
on medicated feed. 

Action  n°  3:  Introduce  recommendations  for  prudent  use  in  veterinary 
medicine, including follow-up reports. 

Action n° 4: Strengthen infection prevention and control in healthcare settings. 

Action  n°  5:  Introduce  of  a  legal  tool  to  enhance  prevention  and  control  of 
infections in animals in the new Animal Health Law. 

Action  n°  6:  Promote,  in  a  staged  approach,  unprecedented  collaborative 
research and development efforts to bring new antimicrobials to patients. 

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• 

• 

• 

• 

• 

• 

Action  n°  7:  Promote  efforts  to  analyse  the  need  for  new  antibiotics  into 
veterinary medicine. 

Action n° 8: Develop and/or strengthen multilateral and bilateral commitments 
for the prevention and control of AMR in all sectors. 

Action  n°  9:  Strengthen  surveillance  systems  on  AMR  and  antimicrobial 
consumption in human medicine. 

Action  n°  10:  Strengthen  surveillance  systems  on  AMR  and  antimicrobial 
consumption in animal medicine. 

Action n° 11: Reinforce and co-ordinate research efforts. 

Action n° 12: Survey and comparative effectiveness research. 

Several Member States have been pro-active in carrying out actions related to those 
considered  at  EU  level.  These  actions  at  national  level  and  the  experience  gained 
from it should be the basis of the practical development and implementation of this 
Action Plan. 

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