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 {SEC(2005)1746}
Date: 2005-12-22
Institutions: European Commission
Subjects: antibiotic, biology, infectious disease, medicine, pharmaceutical product, public health, report

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.12.2005 
COM(2005)684 final 

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 

{SEC(2005)1746} 

EN 

   EN 

 
 
 
  
 
 
 
 
TABLE OF CONTENTS 

REPORT FROM THE COMMISSION TO THE COUNCIL ON 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 .......................................................................................... 1 

1. 

2. 

3. 

4. 

INTRODUCTION........................................................................................................ 3 

SUMMARY OF MAIN ACTIONS AT MEMBER STATE LEVEL ......................... 3 

SUMMARY OF MAIN ACTIONS AT COMMUNITY LEVEL............................... 5 

CONCLUSIONS.......................................................................................................... 6 

EN 

2 

   EN 

 
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 

(Text with EEA relevance) 

1. 

INTRODUCTION 

in  human  medicine  (2002/77/EC)  (hereinafter  referred 

In  November  2001  the  Council  adopted  a  Recommendation  on  the  prudent  use  of 
antimicrobial  agents 
to  as 
Recommendation).  This  Recommendation  asks  Member  States  and  EEA  countries  to  put  in 
place  specific  strategies  on  prudent  use  of  antimicrobial  agents  aiming  to  contain 
antimicrobial  resistance.  These  strategies  have  to  comprise  measures  in  relation  to 
surveillance  of  antimicrobial  resistance,  surveillance  of  antimicrobial  use,  control  and 
preventive measures, education and training, and research. The Recommendation invites the 
Commission  to  facilitate  mutual  information,  consultation,  coordination,  action  and  to  keep 
matters covered under review and to submit reports on basis of Member States’ reports 

Member  States  and  EEA  countries  were  asked  to  report  to  the  Commission  on  the 
implementation  of  the  Recommendation  within  2  years  of  its  adoption.  All  Member  States, 
Iceland, Norway, and Bulgaria have reported to the Commission. This report summarizes the 
main actions taken at Member State and Community level. It also highlights in conclusion the 
areas  of  the  Recommendation  needing  further  attention.  This  report  is  supported  by  a 
Commission Staff Working Paper providing a more detailed technical analysis. 

This  Recommendation  has  its  main  focus  on  the  importance  of  using  antimicrobial  agents 
prudently in human medicine to contain primarily the emergence of antimicrobial resistance. 

2. 

SUMMARY OF MAIN ACTIONS AT MEMBER STATE LEVEL 

The Recommendation asks Member States to put in place specific strategies on prudent use of 
antimicrobial agents aiming to contain antimicrobial resistance. Sixteen Member States have a 
national  strategy  in  place  and  ten  countries  are  developing  such  a  strategy.  These  strategies 
should pursue the following main objectives: 

(a) 

to establish or strengthen surveillance systems on antimicrobial resistance and 
use of antimicrobial agents. 

Almost all countries have national systems for surveillance of antimicrobial use and 
antibiotic  consumption.  Fourteen  countries  reported  to  have  the  ownership  of 
antimicrobial  resistance  data  clearly  defined.  However,  several  obstacles  for 
surveillance  of  resistance  and  use  were  reported:  primarily  the  lack  of  a  sustained 
financial  basis,  unclear  legal  status  and  regulation  of  privacy  issues.  Sixteen 
countries  have  published  a  national  report  on  antimicrobial  resistance.  In  a 
significant number of old Member States and EEA countries a formal collaboration 

EN 

3 

   EN 

 
 
with  veterinary  surveillance  is  established,  but  in  none  of  the  new  Member  States 
such a link is reported. 

The majority of Member States co-ordinate actions to improve prescribing practices. 
The  scope  and  target  groups  vary.  In  eight  countries  no  co-ordinated  actions  were 
reported  at  all.  Although  many  countries  provide  some  kind  of  feed-back  to 
prescribers,  this  seems  to  consist  of  more  general  information  and  no  country 
provides continuous feed-back on the prescribing practices of prescribers. 

(b) 

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

Selling of antimicrobial agents without a prescription is considered a relevant source 
of  inappropriate  antimicrobial  use  in  at  least  seven  countries,  although  no  country 
was  able  to  estimate  the  current  proportion  of  all  antimicrobial  agent  sold  without 
prescriptions.  Sixteen  countries  have  measures  in  place  to  enforce  regulations  for 
prescription-only use of systemic antimicrobial agents. Such measures are provided 
by the Community pharmaceutical legislation on medicinal products for human use 
(Directive 2001/83/EC as amended by Directive 2004/27/EC).  

Most  countries  have  nationally  accepted  guidelines  on  appropriate  use  of 
antimicrobials  for  surgical  prophylaxis,  otitis  media,  sinusitis,  tonsillopharyngitis, 
community acquired pneumonia, urinary tract infections and meningitis. The impact 
of these guidelines on prescribing practices is only monitored in a few countries.  

Twenty-two countries have a national programme for hospital hygiene and infection 
control in place, and in eighteen it is mandatory for each hospital to have an infection 
control  committee.  Only  about  half  of  the  countries  have  legal  requirements  or 
recommendations about the number of infection control nurses per hospital bed, and 
have  an  accreditation  procedure  for  hospitals  and/or  nursing  homes.  Only  fourteen 
countries require infection control to be a part of the hospital accreditation procedure, 
and  even  less  with  respect  to  nursing  homes  accreditation  procedure.  Eighteen 
countries  have  national  guidelines  for  the  control  of  multi-resistant  pathogens, 
however,  this  mostly  includes  only  methicillin-resistant  Staphylococcus  aureus 
(MRSA). 

(c) 

to  promote  education  and  training  of  health  professionals  on  the  problem  of 
antimicrobial resistance and to inform the general public about the importance 
of prudent use of antimicrobial agents. 

Not  in  all  countries  health-professional-undergraduates  receive  education  on 
appropriate  use  of  antimicrobials.  However,  they  receive  continuing  education  on 
selected  issues  later  in  their  career.  In  all  countries  education  is  provided  by  non-
sponsored  continuing  education,  and  in  almost  all  of  them  also  through  sponsoring 
by the pharmaceutical industry. 

All  but  six  countries  have  performed  a  campaign  in  some  format  in  the  past  five 
years  to  raise  awareness  on  topics  related  to  antimicrobial  resistance.  Campaigns 
addressed more often health professionals than the general public. 

EN 

4 

   EN 

 
To  co-ordinate  the  implementation  of  the  above  strategies  as  well  as  for  the  purpose  of 
information exchange and co-ordination with the Commission and other Member States, the 
Council  recommended  that  each  Member  State  should  have  in  place  rapidly  an  appropriate 
intersectoral mechanism. Twenty Member States, two EEA countries, and Bulgaria reported 
to  have  an  intersectoral  mechanism  in  place  and  five  countries  are  about  to  create  it.  One 
Member  State  did  not  report  to  create  such  a  mechanism.  There  are  major  differences  in 
responsibilities/objectives  of  these  intersectoral  mechanisms  and  considerable  variation  in 
legal status and in composition. 

3. 

SUMMARY OF MAIN ACTIONS AT COMMUNITY LEVEL 

Antimicrobial resistance is a key priority and the Commission is undertaking and promoting a 
wide  range  of  activities  at  Community  level,  in  particular  through  its  public  health  and 
research programmes. The Commission has acted on the specific invitations by the Council: 

•  The Commission has kept the structures and Committees of the Community network1 up to 
date  of  the  progress  in  the  area  of  antimicrobial  resistance  and  has  sought  its  advice  in 
developing  a  ‘template  for  reporting’  that  the  Member  States  have  used  to  report  on  the 
implementation of the Council Recommendation. Members of the Committees have been 
crucial in coordinating the response of the Member States. 

•  Considering that there are differences in the information provided by Summary of Product 
Characteristics (SPC) for already authorised medicinal products for human use containing 
same  antibacterial  active  substance(s),  National  competent  regulatory  authorities  in 
consultation  with  European  Medicines  Agency  (EMEA)  are  currently  undertaking 
initiatives  to  evaluate,  update  and  harmonise  as  appropriate  the  information  provided  in 
SPC.  Furthermore  the  criteria  on  which  application  for  marketing  authorisation  for  new 
antibacterial medicinal products for human use are evaluated have been further developed 
and  updated  to  take  fully  into  account  the  principle  of  containment  of  antimicrobial 
resistance.  

•  Following  the  Council’s  invitation,  the  Commission  has  called  in  its  workplan  2003  for 
projects  proposing,  where  appropriate,  common  methodology  and  case  definitions.  The 
Commission concluded a grant agreement with the European Committee on Antimicrobial 
Susceptibility Testing (EUCAST). EUCAST has agreed with all stakeholders on a model 
for harmonising breakpoints for new antibiotics in Europe, and to define epidemiological 
breakpoints  for  the  measurement  of  antimicrobial  resistance  development.  It  is  liaising 
with  European  regulatory  authorities  and  with  projects  within  the  field  of  antimicrobial 
resistance  to  deliver  a  platform  for  pan-European  education  in  matters  of  antimicrobial 
susceptibility testing, definition of breakpoints and standardized reference methods. 

•  As  regards  to  the  nature  and  type  of  data  to  be  collected  for  the  surveillance  of 
susceptibility  of  human  pathogens  and  use  of  antibiotics  the  Commission  has  co-funded 
two  large  networks  that  have  managed  to  agree  and  implement  standardized  data 
collection: 

1 

Decision  2119/98/EC  of  the  European  Parliament  and  the  Council  setting  up  a  network  for  the 
epidemiological surveillance and control of communicable diseases in the Community, O.J. No L 268, 
3.10.1998. 

EN 

5 

   EN 

 
                                                 
•  The  European  Antimicrobial  Resistance  Surveillance  System  (EARSS)  is  a 
network  of  national  surveillance  systems  that  currently  collects  resistance  data 
according  to  a  common  protocol  from  about  800  laboratories  from  28  countries. 
The  main  function  of  EARSS  is  to  monitor  variations  in  resistance  of  indicator 
pathogens  of  main  public  health  relevance  for  targeting  interventions  and 
assessing effectiveness of national intervention programmes. All this information 
is  stored  in  a  standardised  database  available  freely  on-line  on  the  EARSS  web 
site: www.earss.rivm.nl. 

•  The European Surveillance on Antimicrobial Consumption (ESAC) implemented 
a  prospective  data  collection  system,  based  on  a  validated  register  of  available 
antibiotic  products  according  to  an  international  classification.  Standardised 
national data are assembled in a European database for international comparison 
of  antibiotic  use  in  relation  to  antibiotic  resistance  patterns,  socio-economic 
determinants  and  general  health  indicators.  Aggregated  results  of  the  ESAC 
project are available on the public ESAC website (http://www.esac.ua.ac.be) and 
the database is accessible for health authorities, scientists and a wider public. 

•  In  addition,  the  Commission  has  co-funded  a  “Selfmedication  and  Antimicrobial 
Resistance  (SAR)”  project  to  assess  the  problem  of  self-medication  with  antibiotics  in 
Europe.  Results  show  that  self-medication  with  antibiotics  is  indeed  a  problem  all  over 
Europe  and  that  there  are  quite  a  number  of  countries  where  a  substantial  proportion  of 
antibiotics  are  sold  without  prescription,  commonly  referred  to  as  “Over-The-Counter 
(OTC)” antibiotics. 

•  Through  its  Sixth  Framework  programme  for  Research  and  Technological  Development, 
the Commission supports a broad range of research projects of major relevance to prudent 
use of antimicrobials in human medicine. 

•  The Commission has set up the ‘Working group on the prudent use of antimicrobial agents 
in  human  medicine’  to  keep  relevant  matters  under  review  and  has  been  consulting  this 
working  group  in  collating  the  Member  States’  reports  and  in  developing  a  proposal  on 
containing healthcare-associated infections. 

•  Special  attention  has  been  devoted  over  the  past  years  to  applicant  countries  and  all  of 
these  countries  are  actively  participating  in  the  antimicrobial  resistance  surveillance 
networks. 

•  The  Commission  and  the  WHO  have  signed  a  Memorandum  of  Understanding 
reconfirming their common interest in public health. Antimicrobial resistance is among the 
agreed priorities and close co-operation with WHO has been ensured for all antimicrobial 
resistance  related  networks.  The  Commission  is  developing  a  programme  with  WHO  on 
strengthening  pharmaceutical  policies,  including  rational  use  of  drugs  and  particularly 
supporting national programmes to contain antimicrobial resistance through the expansion 
of projects that link surveillance data to rational prescribing programmes. 

4. 

CONCLUSIONS 

Most  Member  States  have  taken  a  variety  of  actions  as  requested  by  the  Recommendation. 
However, there remain numerous areas of the Recommendation where only limited action has 

EN 

6 

   EN 

 
been  undertaken.  It  is  important  that  all  the  provisions  in  the  Recommendation  are  being 
adhered to, in particular: 

•  A quick development and efficient implementation of National Strategies and National 

Action plans should be a priority. 

•  The  status,  organisational  structure,  composition,  funding  and  understanding  of  the 
responsibilities of the ‘intersectoral mechanism’ reveal major differences. Actions should 
be taken to ensure that each Member State has in place an appropriate intersectoral 
mechanism with appropriate mandate and means to coordinate the implementation of 
the  strategies  foreseen  in  the  Recommendation.  The  functioning  of  the  different 
intersectoral mechanisms could usefully be evaluated. 

•  Much  has  been  done  on  surveillance  of  antibiotic  resistance  in  indicator  bacteria  and  on 
surveillance of antibiotic use at national and EU level, fostered by initiatives and EU-wide 
projects  with  Community  funding.  However,  data  can  often  not  be  broken  down  to  a 
lower level (hospitals, single diseases) where it is needed for local policies. 

•  Also feed-back on prescribing practices should be improved. This should be a point for 

attention for the ‘intersectoral mechanisms’.  

•  Collaboration between human health and animal health sector on antibiotic resistance 
and  antibiotic  use  should  be  fostered  in  all  countries  where  this  has  not  been  established 
yet. 

•  The  Commission  funded  SAR-project  identified  that  in  seven  countries,  systemic 
antibacterial  medicinal  products  are  still  obtained  without  a  prescription  and  that  self-
medication  with  antibiotics  should  be  tackled  appropriately  in  many  Member  States  in 
particular through education of the general public about the risks of self-medication. All 
countries  should  have  clear  measures  in  place  to  enforce  prescription-only  use  of 
systemic antimicrobials or antibiotics. 

•  All  countries  should  have  nationally  accepted  guidelines  in  place  recommending 
appropriate  antibiotic  treatment,  at  least  for  the  most  common  human  infections.  The 
impact of these guidelines on prescribing practices should be assessed regularly.  

•  It is highly recommended that each hospital/nursing home ensures appropriate infection 
control.  Institutions  should  have  its  own  infection  control  system/committee  in  place  or 
ensure  that  relevant  tasks  are  undertaken  by  other  appropriate  existing  bodies.  Countries 
should consider making infection control part of an accreditation or other quality control 
procedure for hospitals and possibly nursing homes. 

•  EU-wide exchange of best practice of all relevant issues should be promoted. Examples 
of  good  practice  concerning  antimicrobial  resistance,  vaccination  campaigns  and 
hygiene/infection control should be discussed and exchanged between Member States.  

•  Recital 1 of the Recommendation defines ‘antimicrobial agents’ indicating that the scope 
of resistance monitoring should include bacteria, viruses, fungi, and parasites, in particular 
protozoa.  The  focus  of  most  surveillance  activities  undertaken  until  now,  has  been  on 

EN 

7 

   EN 

 
antibacterial  resistance  and  should  be  enlarged  to  include  data  on  antivirals  and 
antiparasitic agents. 

•  As laid down in the Regulation establishing the Centre for disease prevention and control 
(ECDC)2,  in  particular  in  Articles  5  and  11,  the  ECDC  will  have  an  important  role  to 
operate European surveillance also in the area of antimicrobial resistance. The ECDC 
should be able to assist the Commission in the future preparation of implementation reports 
and of recommendation proposals. 

•  This  report  aimed  to  summarise  main  findings  from  the  Member  States’  reports  and 
highlighting  those  provisions  in  the  Recommendation  that  may  need  particular  attention. 
The information contained in the Member State reports provide more detail and may be of 
interest  to  health  professionals,  international  institutions  such  as  WHO,  and  the  general 
public. Providing public access to the Member State reports should be encouraged by 
the Member States. 

•  One additional concern is the global dimension of the antimicrobial resistance problem. 
Given  the  migration  and  trade  flows  from  outside  Europe  and  the  exposure  to  resistant 
microbial  strains  from  other  continents,  action  can  not  be  limited  to  the  EU  level  and 
attention  is  necessary  for  links  with  EU  external  actions  such  as  strengthening 
pharmaceutical policies and health systems in developing countries. 

This Recommendation focussed on the importance of using antimicrobial agents prudently in 
human  medicine  to  contain  primarily  the  emergence  of  antimicrobial  resistance.  Not  only 
emergence, but also spread is an important driver of the problem of resistance. Therefore the 
Commission  is  currently  preparing  an  appropriate  initiative  in  the  area  of  infection 
control.  

2 

Regulation  (EC)  No  851/2004  of  the  European  Parliament  and  of  the  Council  of  21  April  2004 
establishing a European Centre for disease prevention and control. OJ L142/1, 30.04.2004. 

EN 

8 

   EN