SPEECH/01/542
Mr David BYRNE
European Commissioner for Health and Consumer Protection
"The EU strategy on antimicrobial
resistance in humans"
European Conference on Antibiotic Use in Europe
Brussels, 15 November 2001
Minister Aelvoet,
Mr. Chairman,
Members of the Organising Committee,
Ladies and Gentlemen.
I am very pleased to welcome the Belgium Presidency, the European Agency for
the Evaluation of Medicinal Products, and the European Society of Clinical
Microbiology and Infectious Diseases, to our conference today. It is very reassuring
to see such an impressive array of partners ready to join with the Commission in
launching this important initiative. To kick off a new project on surveillance of the
use of antimicrobial agents in humans within the Community.
Antimicrobial agents have greatly contributed to improvements in health. Antibiotics
have been introduced for decades to prevent infections and treat infectious
diseases. In the last century they revolutionised the treatment of disease, and
played a major role in extending the quality and duration of human life. However, in
addition to their benefits, their increased use and misuse in medicine and
agriculture have given rise to some problems. This has resulted in antimicrobial
resistance to certain micro-organisms, leading to prolonged suffering of the
individual and enhanced costs for health care and society.
Antimicrobial resistance has been of increasing importance for the Commission
over recent years and will be a public health key issue for the future. Particularly as
we begin to elaborate strategies to prepare for events like pandemics.
In June the Commission adopted a Communication on a Community strategy
against antimicrobial resistance. The formulation of a proposal for a Council
Recommendation on the prudent use of antimicrobial agents in human therapy
takes pride of place in that strategy. I am confident that at today’s Health Council
meeting the Member States will adopt such a Recommendation on the basis of our
proposal.
The Community strategy calls for actions to preserve the effectiveness of
antimicrobial agents by restricting their use to treatment and prevention of infectious
diseases. This is in line with the basic message of “The Copenhagen
Recommendations” emanating from the first European Union Conference on “The
Microbial Threat” in 1998. It is also in line with national and international guidelines
and action plans published since then, such as the WHO “Global strategy for
containment of antimicrobial resistance”.
At an EU conference under the auspices of the Swedish presidency in June,
experts and government representatives of the Member States discussed the
implementation of the Copenhagen recommendations. It also served to identify
major gaps regarding national systems capacity to fight antimicrobial resistance,
such as
- inappropriate implementation of guidelines on proper antimicrobial usage,
- missing links between information systems on antimicrobial resistance and
antimicrobial usage,
- missing evaluation of data collated as a basis for health policy, and
- missing feedback to individual prescribers of antimicrobials to improve
prescribing practices.
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It was concluded that co-operation at Community level for coordinated actions
would be an important step to improve national efforts and add real European value.
Antimicrobial resistance is a multi-facetted problem. However, there is a clear
relation between the quantities of antimicrobial agents used and the prevalence of
drug-resistant microbes. This problem can no longer be overcome by continuously
developing new drugs, as the time needed may one day become too short.
We cannot run the risk of someday finding ourselves one last resort drug away from
failure, largely due to overuse. And if we are to avoid this scenario, an immediate
reduction of unnecessary and inappropriate use of antimicrobials is essential.
The Commission has addressed the containment of antimicrobial resistance
through various individual measures based on the provisions of Article 152 of the
Treaty establishing the European Community.
The main goals of the Community strategy, based on advice by the Scientific
Steering Committee to the Commission, include:
- Minimising morbidity and mortality due to antimicrobial resistant infections,
- Preserving the effectiveness of antimicrobial agents for prevention and treatment
of infectious diseases, and
- Containing antimicrobial resistance by prudent use of antimicrobial agents.
As antimicrobial resistance is a multi-factorial problem, a multi-sectoral effort is
needed to control it. The Community’s health strategy comprises actions in all the
relevant sectors: Public health, veterinary and phytosanitary sectors. A
comprehensive action plan has been developed targeting three priority areas
including
- the Surveillance of antimicrobial resistance,
- the Surveillance of the use of antimicrobial agents,
- the Containment of antimicrobial resistance by reducing the needs for
antimicrobials,
- preparing for the future by research & product development, and
- international co-operation.
With regard to surveillance of antimicrobial resistance in humans, the European
Parliament and the Council decided to set up a Community Network for the
Epidemiological Surveillance and Control of Communicable Diseases which entered
into force in January 1999. This Network is formed by the European Commission
and by the competent authorities and structures in Member States and EEA/EFTA
countries (Norway, Iceland and Liechtenstein). Antimicrobial resistance is one of its
priorities.
Currently, four projects related to the Community network are specifically
addressing antimicrobial resistance:
- the European Antimicrobial Resistance Surveillance System, known as
E.A.R.S.S.
- Enter-Net - the International Surveillance network for the enteric infections
salmonella and VTEC 0157,
- EURO-TB - a Surveillance system on tuberculosis in Europe, and
- HELICS - an EU network on nosocomial infections.
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It is generally accepted that there is an association between the quantities of
antimicrobial agents used and the increase in resistant infectious agents over time.
Regarding antimicrobials’ use in human medicine, most Member States have been
collecting data on their consumption. However, these data are scattered,
heterogeneous and in most Member States, not publicly available. Therefore, the
Commission has decided to support a project on developing a European
surveillance on antimicrobial consumption, which will be subject to discussion at this
conference. And I would like to express my confidence that this kick-off meeting will
reach decisive results for a successful outcome of that project.
What about other key areas of Community action?
With regards to the containment of antimicrobial resistance by reducing the needs
for antimicrobials, three priorities have been identified:
- Improving prevention of infections and control of communicable diseases,
- Ensuring prudent use of antimicrobial agents in all areas, and
- Improving market authorisation and user information.
To improve prevention and control of communicable diseases in humans, the
Community is supporting surveillance networks on vaccine preventable diseases
and pilot projects on vaccine coverage and vaccination schedules in the Member
States. Respective research activities are ongoing in the fifth Framework
Programme.
A new proactive food policy is foreseen as a priority in the White Paper on Food
Safety, including reduction programmes on zoonotic agents to be implemented by
Member States. An improved co-operation of Commission services with regard to
zoonoses will develop when surveillance on these diseases will be progressively
integrated into the Community network on communicable diseases. This is foreseen
in the Commission proposal for revised legislation on monitoring and control of
zoonoses, which is currently discussed with Member States in the Council. This
proposal includes also a requirement for mandatory monitoring of antimicrobial
resistance in zoonotic agents derived from animals.
I would like to come back the Recommendation on the prudent use of antimicrobial
agents in human therapy, which I mentioned earlier. That Recommendation will just
be one step within the comprehensive set of actions needed to fight antimicrobial
resistance. But it will be an important step.
It recommends Member States to establish a multi-sectoral national mechanism for
implementing specific strategies.
Key areas of those strategies will be:
- Enforcing the principle: Antibacterial agents by prescription only;
- Surveillance on resistant pathogens and consumption of antimicrobial agents for
co-ordinated intervention policies;
- Prevention of infections by immunisation programmes and infection control
standards in order to reduce the needs for antimicrobial treatment;
- Research on rapid diagnostics and susceptibility testing;
- Awareness raising and information to the general public;
- Monitoring on prescribing practices of antimicrobial agents, and
- Control systems on good practice of marketing of antimicrobials.
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A Community strategy to contain AMR would be incomplete without the two areas,
which will be addressed in detail during this conference by our colleagues from the
EMEA and indeed by Philippe Busquin, my colleague who is Commissioner for
Research.
To develop principles and guidelines of best practice on the prudent use of
antimicrobial agents at Community level, we will need links to EMEA activities on
the improvement of market authorisation and user information.
A major pillar for the Community strategy to contain antimicrobial resistance is
research & product development, particularly with regard to developing new
antimicrobial agents, alternative treatments and vaccines, and rapid and reliable
diagnostic and susceptibility tests.
Antimicrobial resistance, like communicable diseases, does not respect borders.
International co-operation is indispensable from the start to reach sustainable
results in the fight against the microbial threat. The Commission will therefore
continue and extend co-operation with candidate and third countries, and
strengthen co-operation, co-ordination and partnership at international level via
international organisations and action plans.
Cooperation with WHO at working level has been of mutual benefit to define key
actions for a strategy on the containment of antimicrobial resistance in Europe and
world wide. At my recent visit at the Centers for Disease Control in Atlanta we
considered the improvement of mutual information on strategies for the prudent use
of antimicrobials most useful.
Ladies and Gentleman,
Recent health threats by anthrax attacks did not only dramatically highlight the need
for coordinating preparedness planning at Community level. It also indicated the
need for co-ordinated Community action with regard to information and
communication to avoid inappropriate private stockpiling and preventive
consumption of antimicrobial agents.
The problem of antimicrobial resistance needs to be addressed in a continuous
process of actions. Strengthening co-ordination of efforts within the Community will
be a major step. I am convinced that we are moving in the right direction and that
with your support we can make a real contribution to improving health in Europe.
Thank you for your attention.
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