European Parliament resolution on the proposal for a Council recommendation on the prudent use of antimicrobial agents in human medicine (COM(2001) 333 - C5-0411/2001 - 2001/2164(COS))
Date: 2001-10-23
Institutions: European Parliament
Subjects: antibiotic, epidemiology, health control, infectious disease, information network, medical research, microorganism, public health, transmission network

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7. Use of antimicrobial agents in human medicine (procedure without debate)

A5-0318/2001

European Parliament resolution on the proposal for a Council recommendation on the prudent use
of antimicrobial agents in human medicine (COM(2001) 333 & C5-0411/2001 & 2001/2164(COS))

The European Parliament,

(cid:16) having regard to the proposal for a Council recommendation (COM(2001) 333 (cid:16) C5-0411/2001),

(cid:16) having regard to Rule 152(4) of the EC Treaty,

(cid:16) having regard to Rule 47(1) of its Rules of Procedure,

(cid:16) having regard to the report of the Committee on the Environment, Public Health and Consumer Policy

(A5-0318/2001),

1.

2.

Calls on the Commission and the Council to take account of the following modifications:

Instructs its President to forward this resolution to the Council and Commission.

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MODIFICATIONS
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Modification 1
Recital 1

infections. For the purposes of

the growth of micro-organisms

(1) The use of antimicrobial agents has greatly contributed to
improvements in health. Such ‘antimicrobial agents’ have been
introduced for decades to treat communicable diseases and pre-
vent
this Recommendation,
antimicrobial agent means substance produced either syntheti-
cally or naturally by bacteria, fungae or plants, used to kill or
inhibit
including bacteria,
viruses and fungae, and of parasites,
in particular protozoa,
exhibiting the phenomenon of resistance. However, their use
has also resulted in certain selected microbes previously sensi-
tive to these agents developing resistance, so-called ‘antimicro-
bial resistance’. This leads to increased danger, to prolonged
suffering of the individual, and to enhanced costs for health
care and society. Therefore concerted action is necessary at
Community level to contain this problem by encouraging the
prudent use of antimicrobial agents in human medicine and
better hygiene and infection control;

infections. For the purposes of

(1) The use of antimicrobial agents has greatly contributed to
improvements in health. Such ‘antimicrobial agents’ have been
introduced for decades to treat communicable diseases and pre-
vent
this Recommendation,
antimicrobial agent means substance produced either syntheti-
cally or naturally by bacteria, fungae or plants, used to kill or
the growth of micro-organisms including bacteria,
inhibit
viruses and fungae, and of parasites,
in particular protozoa,
exhibiting the phenomenon of resistance. However, their use
has also resulted in certain selected microbes previously sensi-
tive to these agents developing resistance, so-called ‘antimicro-
bial resistance’. This leads to increased danger, to prolonged
suffering of the individual, and to enhanced costs for health
care and society. Therefore concerted action is necessary at
Community level to contain this problem by encouraging the
prudent use of antimicrobial agents in human medicine and
better hygiene and infection control. Such action cannot be
taken in isolation from measures to combat resistance to
antibiotics in veterinary medicine, animal feedingstuffs and
crop growing (including GM crops).

Modification 2
Recital 2

(2) The Council of
the European Union on 8 June 1999
adopted a Resolution on antibiotic resistance ‘A strategy against
the microbial threat’. The Resolution highlights that antimicro-

(2) The Council of
the European Union on 8 June 1999
adopted a Resolution on antibiotic resistance ‘A strategy against
the microbial threat’. The Resolution highlights the fact that

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bial resistance increases morbidity and mortality due to com-
municable diseases leading not only to a diminution of quality
of life but also to additional health and medical care costs, and
that actions need to be taken at Community level;

Tuesday 23 October 2001

MODIFICATIONS
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antimicrobial resistance increases morbidity and mortality due
to communicable diseases leading not only to a diminution of
quality of life but also to additional health and medical care
costs, and that action needs to be taken at Community level to
reduce the use of antimicrobial agents in veterinary as well
as human medicine, and to ban any use of antimicrobial
agents for non-therapeutic purposes, and the use of antibiotic
resistance genes in GMOs, which may be disseminated in the
environment;

Modification 3

Recital 6

(6)
Surveillance on prescription and consumption of anti-
microbial agents should form an essential component for an
overall surveillance strategy to address the problem of anti-
microbial resistance;

(6)
Surveillance of the prescription and consumption of anti-
microbial agents in all fields should form an essential com-
ponent for an overall surveillance strategy to address the prob-
lem of antimicrobial resistance;

Modification 4

Recital 7

(7) An important step to avoid or even reverse further
increases in resistant micro-organisms would be to reduce
unnecessary and inappropriate use of antimicrobial agents.
General principles and methods for the prudent use of these
agents in humans must be identified, and defined and imple-
mented;

(7) An important step to avoid or even reverse further
increases in resistant micro-organisms would be to reduce
unnecessary and inappropriate use of antimicrobial agents.
General principles and methods for the prudent use of these
agents in humans, animals and plants must be identified, and
defined and implemented;

Modification 5

Recital 11

(11) There is also a relationship between the occurrence of
antimicrobial resistant pathogens in humans and their occur-
rence in animals and the environment. This Recommendation
does not preclude further initiatives in other areas;

(11) There is also a relationship between the occurrence of
antimicrobial resistant pathogens in humans and their occur-
rence in animals and the environment. This Recommendation
requires further initiatives in other areas, in particular to com-
bat antimicrobial resistance in veterinary medicine, animal
feedingstuffs and crop growing (including GMOs);

Modification 6

Recital 11a (new)

(11a) The strategy against microbial resistance needs to be
a global one and should cover not only human medicine but
also veterinary medicine, animal production and plant protec-
tion;

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Modification 7
Chapter I, paragraph 1, subparagraph 1

(1) gather reliable, comparable data by means of a laboratory
based system of the susceptibility of pathogens to anti-
microbial agents. The data should be amenable to time
trend analysis and early warnings and to monitor spread
of resistance at national, regional and community level;

(1) gather reliable data, comparable at Community level, by
means of a laboratory based system on the susceptibility in
vitro of pathogens to antimicrobial agents and their clini-
cal implications. The data should be amenable to time
trend analysis and early warnings and to monitoring the
spread of resistance at national, regional and community
level;

Modification 8
Chapter I, paragraph 1, subparagraph 2

(2) collect data on prescription and consumption of anti-
microbial agents on national, regional, hospital and com-
munity level, involving prescribers, pharmacists and other
parties collecting such data, in order to be able to poten-
tially link prescription and consumption of antimicrobial
agents to the development of pathogens resistant to those
agents.

(2) collect data on prescription and consumption of anti-
microbial agents in all their forms and in all fields at
national, regional, hospital and community level, involving
prescribers, pharmacists and other parties collecting such
data, in order to be able to potentially link prescription
and consumption of antimicrobial agents to the devel-
opment of pathogens resistant to those agents.

Modification 9
Chapter I, paragraph 2, subparagraph 1, indent 2

(cid:16) Setting rules for the use of other antimicrobial agents that
are not subject to requirements for prescription-only use
and an assessment of the need for changes;

(cid:16) Setting rules for the use of other antimicrobial agents,
to
including those for local use,
requirements for prescription-only use and an assessment
of the need for changes;

that are not subject

Modification 10
Chapter I, paragraph 2, subparagraph 1, indent 3

(cid:16) Establishment of clinical and microbiological criteria for

rapid on-the-spot diagnosis of infections, and

(cid:16) Establishment of clinical and microbiological criteria and
the evaluation of tests for rapid on-the-spot diagnosis of
bacterial or viral infections, and of tests for sensitivity to
antimicrobial agents, and

Modification 11
Chapter I, paragraph 2, subparagraph 1, indent 4

(cid:16) Optimising choice of drug, dosage and duration for the

treatment and prevention of infections.

(cid:16) Optimising the choice of drug, dosage and duration for the
treatment and prevention of infections, on the basis of
microbiological and clinical criteria and the patient’s per-
sonal data and medical history (individualised treat-
ment).

Modification 12
Chapter I, paragraph 2, subparagraph 1, indent 4a (new)

& Comparative and critical assessment of the effectiveness
of antimicrobial agents used for preventive purposes;

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Modification 13
Chapter I, paragraph 2, subparagraph 3

(3) Encouraging national

immunisation programmes to pro-

gressively eliminate vaccine preventable diseases,

(3) Encouraging national

immunisation programmes to pro-
gressively eliminate vaccine preventable diseases, after a
continuous assessment of the vaccines concerned and the
immunisation programmes under consideration,

Modification 14
Chapter I, paragraph 3, subparagraph 1

(1)

teaching principles and guidelines on the appropriate use
of antimicrobial agents by incorporation into undergrad-
uate and postgraduate training and in regular continuous
training for physicians, dentists, pharmacists and nurses
and others in the medical profession, using effective good
practice methods with continuous feedback;

(1)

teaching principles and guidelines on the appropriate use
of antimicrobial agents by incorporation into undergrad-
uate and postgraduate training and in regular continuous
training, independent of the drugs industry, for physi-
cians, dentists, pharmacists and nurses and others in the
medical profession, using effective good practice methods
with continuous feedback;

Modification 15
Chapter I, paragraph 3, subparagraph 3

(3)

training on immunisation programmes and their role in
preventing infections, thereby reducing outbreaks of dis-
eases and thus the demand for antimicrobial agents.

(3)

in-service and updated training on immunisation pro-
their role, their effectiveness and their rel-
grammes,
evance in preventing infections,
thereby reducing out-
breaks of diseases and thus the demand for antimicrobial
agents.

Modification 16
Chapter I, paragraph 3, subparagraph 3a (new)

(3a) monitoring the information, promotions and advertis-
ing channelled to the medical profession by the drugs
industry and ensuring observance of good prescribing
practice;

Modification 17
Chapter I, paragraph 4, subparagraph 3a (new)

(3a) prohibiting any advertising addressed to the general

public promoting antibiotics;

Modification 18
Chapter I, paragraph 4, subparagraph 3b (new)

(3b)

encouraging home treatment wherever feasible;

Modification 19
Chapter I, paragraph 4, subparagraph 3c (new)

(3c)

encouraging clinical and laboratory practice and
methods to reduce the duration of hospital care without
jeopardising the outcome of the treatment;

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Modification 20
Chapter II

II.
cooperate with the Commission in the development of
indicators for monitoring prescribing practices of antimicrobial
agents on the basis of the evidence-based principles and guide-
lines on good practice for the management of communicable
diseases within two years of the adoption of this Recommen-
dation, and evaluate these indicators once developed with
regard to potential improvements of prescribing practices and
feedback to prescribers;

II.
cooperate with the Commission in the development of
indicators for monitoring prescribing practices of antimicrobial
agents on the basis of the in vitro and clinical evidence-based
principles and guidelines on good practice for the management
of communicable diseases within two years of the adoption of
this Recommendation, and evaluate these indicators once
developed with regard to potential improvements of prescrib-
ing practices and feedback to prescribers;

Modification 21
Chapter III

III.
establish and implement control systems on good prac-
tice of marketing of antimicrobial agents to ensure compliance
with the evidence-based principles and guidelines on good
practice for the management of communicable diseases within
two years of the adoption of this Recommendation;

III.
establish and implement control systems on good prac-
tice for marketing antimicrobial agents to ensure compliance
with the in vitro and clinical evidence-based principles and
guidelines on good practice for the management of communi-
cable diseases within two years of the adoption of this Recom-
mendation;

Modification 22
Chapter IV

IV.
initiate with other Member States and the Commission
activities aimed at harmonising and updating the product
information (SPC) for antibacterial medicinal products particu-
larly related to indications, dose and dose regimen and preva-
lence of acquired resistance;

IV.
initiate with other Member States and the Commission
activities aimed at harmonising and updating the product
information (SPC) for antibacterial medicinal products which
have been subject to clinical and epidemiological studies and
studies based solely on in vitro microbiological arguments,
to indications, dose and dose
with particular
regimen;

reference

Modification 23
Chapter Va (new)

Va.
adopt, in the Council, framework legislation to confine
the use of antimicrobial agents to therapeutic purposes alone,
in all fields, and to prohibit the use of antibiotic resistance
genes in GMOs which may be disseminated in the environ-
ment;

Modification 24
Paragraph 5

5.
to keep matters covered by this Recommendation under
review, with a view to its revision and updating, and submit an
annual report to the Council on the basis of Member States’
annual reports;

5.
to keep under review and coordinate matters covered by
this Recommendation, with a view to its revision and updating,
and submit an annual report to the Council on the basis of
Member States’ annual reports;

Modification 25
Paragraph 6a (new)

6a.
to propose without delay a global Community legis-
lative framework for action against antimicrobial resistance,
seeking to confine the use of antimicrobial agents to thera-

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peutic purposes alone, in all fields, and to prohibit the use of
antibiotic resistance genes in GMOs, which may be dissemi-
nated in the environment;

Modification 26
Paragraph 6b (new)

to strengthen the

6b.
cooperation between the
close
Member States, the applicant countries and other parties con-
cerned at international level in order to deal more effectively
at international and intercontinental level with the spread of
disease and antimicrobial resistance arising from the increase
in international trade and travel;

Modification 27
Paragraph 6c (new)

to promote a global strategy in all the relevant sectors:

6c.
public health, veterinary medicine and plant health.

8. Undertakings for collective investment in transferable securities (UCITS) ***II

A5-0324/2001

1.
European Parliament legislative resolution on the Council common position for adopting a Euro-
pean Parliament and Council directive amending Council Directive 85/611/EEC on the coor-
dination of laws, regulations and administrative provisions relating to undertakings for collective
investment in transferable securities (UCITS), with regard to investments of UCITS (7551/1/2001
& C5-0296/2001 & 1998/0243(COD))

(Codecision procedure: second reading)

The European Parliament,

(cid:16) having regard to the Council common position (7551/1/2001 (cid:16) C5-0296/2001),

(cid:16) having regard to its position at first reading (1) on the Commission proposal to Parliament and the

Council (COM(1998) 449) (2),

(cid:16) having regard to the amended Commission proposal (COM(2000) 329) (3),

(cid:16) having regard to Article 251(2) of the EC Treaty,

(cid:16) having regard to Rule 80 of its Rules of Procedure,

(cid:16) having regard to the recommendation for second reading of the Committee on Economic and Mon-

etary Affairs (A5-0324/2001),

1.

2.

Amends the common position as follows;

Instructs its President to forward its position to the Council and Commission.

(1) OJ C 339, 29.11.2000, p. 220.
(2) OJ C 280, 9.9.1998, p. 6.
(3) OJ C 311 E, 31.10.2000, p. 302.