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 *dash C5-0411/2001 *dash 2001/2164(COS))
The European Parliament,
:dash having regard to the proposal for a Council recommendation (COM(2001) 333 :dash C5-0411/2001),:dash having regard to Rule 152(4) of the EC Treaty,
:dash having regard to Rule 47(1) of its Rules of Procedure,
:dash having regard to the report of the Committee on the Environment, Public Health and Consumer Policy
(A5-0318/2001),
1. Calls on the Commission and the Council to take account of the following modifications:
2. Instructs its President to forward this resolution to the Council and Commission.
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Modification 1
Recital 1
(1) The use of antimicrobial agents has greatly contributed to
improvements in health. Such ‘antimicrobial agents’ have beenintroduced for decades to treat communicable diseases and pre-vent infections. For the purposes of this Recommendation,
antimicrobial agent means substance produced either syntheti-
cally or naturally by bacteria, fungae or plants, used to kill orinhibit the growth of micro-organisms including bacteria,viruses and fungae, and of parasites, in particular protozoa,exhibiting the phenomenon of resistance. However, their usehas 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 prolongedsuffering of the individual, and to enhanced costs for healthcare and society. Therefore concerted action is necessary atCommunity level to contain this problem by encouraging theprudent use of antimicrobial agents in human medicine andbetter hygiene and infection control;(1) The use of antimicrobial agents has greatly contributed to
improvements in health. Such ‘antimicrobial agents’ have beenintroduced for decades to treat communicable diseases and pre-vent infections. For the purposes of this Recommendation,
antimicrobial agent means substance produced either syntheti-
cally or naturally by bacteria, fungae or plants, used to kill orinhibit the growth of micro-organisms including bacteria,viruses and fungae, and of parasites, in particular protozoa,exhibiting the phenomenon of resistance. However, their usehas 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 prolongedsuffering of the individual, and to enhanced costs for healthcare and society. Therefore concerted action is necessary atCommunity level to contain this problem by encouraging theprudent use of antimicrobial agents in human medicine andbetter hygiene and infection control. Such action cannot be
taken in isolation from measures to combat resistance toantibiotics in veterinary medicine, animal feedingstuffs andcrop 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 againstthe 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 againstthe microbial threat’. The Resolution highlights the fact thatC 112 E/106 EN 9.5.2002 Official Journal of the European Communities
Tuesday 23 October 2001
bial resistance increases morbidity and mortality due to com-
municable diseases leading not only to a diminution of qualityof life but also to additional health and medical care costs, and
thatactions need to be taken at Community level;antimicrobial resistance increases morbidity and mortality due
to communicable diseases leading not only to a diminution ofquality 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 wellas human medicine, and to ban any use of antimicrobialagents for non-therapeutic purposes, and the use of antibioticresistance genes in GMOs, which may be disseminated in theenvironment ;
Modification 3
Recital 6
(6) Surveillance onprescription and consumption of anti-
microbial agents should form an essential component for anoverall 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 reduceunnecessary and inappropriate use of antimicrobial agents.General principles and methods for the prudent use of theseagents 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 reduceunnecessary and inappropriate use of antimicrobial agents.General principles and methods for the prudent use of theseagents 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 Recommendationdoes 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 Recommendationrequires further initiatives in other areas , in particular to com-
bat antimicrobial resistance in veterinary medicine, animalfeedingstuffs 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 butalso veterinary medicine, animal production and plant protec-tion;9.5.2002 EN C 112 E/107 Official Journal of the European Communities
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Modification 7
Chapter I, paragraph1, subparagraph1
(1) gather reliable, comparable databy means of a laboratory
based system ofthe susceptibility of pathogens to anti-
microbial agents. The data should be amenable to timetrend 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 onthe 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 communitylevel;
Modification 8
Chapter I, paragraph1, subparagraph2
(2) collect data on prescription and consumption of anti-
microbial agents onnational, regional, hospital and com-
munity level, involving prescribers, pharmacists and otherparties collecting such data, in order to be able to poten-tially link prescription and consumption of antimicrobialagents to the development of pathogens resistant to thoseagents.(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, involvingprescribers, pharmacists and other parties collecting suchdata, in order to be able to potentially link prescriptionand consumption of antimicrobial agents to the devel-opment of pathogens resistant to those agents.
Modification 9
Chapter I, paragraph2, subparagraph1, indent 2
:dash Setting rules for the use of other antimicrobial agents that
are not subject to requirements for prescription-only useand an assessment of the need for changes;:dash Setting rules for the use of other antimicrobial agents,
including those for local use, that are not subject to
requirements for prescription-only use and an assessmentof the need for changes;
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Chapter I, paragraph2, subparagraph1, indent 3
:dash Establishment of clinical and microbiological criteria for
rapid on-the-spot diagnosis of infections, and:dash 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, paragraph2, subparagraph1, indent 4
:dash Optimising choice of drug, dosage and duration for the
treatment and prevention of infections.:dash Optimising thechoice 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, paragraph2, subparagraph1, indent 4a (new)
/dash Comparative and critical assessment of the effectiveness
of antimicrobial agents used for preventive purposes;C 112 E/108 EN 9.5.2002 Official Journal of the European Communities
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Modification 13
Chapter I, paragraph2, subparagraph3
(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 theimmunisation programmes under consideration ,
Modification 14
Chapter I, paragraph3, subparagraph1
(1) teaching principles and guidelines on the appropriate use
of antimicrobial agents by incorporation into undergrad-uate and postgraduate training and in regular continuoustraining 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 continuoustraining, independent of the drugs industry, for physi-
cians, dentists, pharmacists and nurses and others in the
medical profession, using effective good practice methodswith continuous feedback;
Modification 15
Chapter I, paragraph3, subparagraph3
(3) training on immunisation programmes andtheir 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-
grammes, their role , their effectiveness and their rel-
evance in preventing infections, thereby reducing out-
breaks of diseases and thus the demand for antimicrobialagents.
Modification 16
Chapter I, paragraph3, subparagraph3a (new)
(3a) monitoring the information, promotions and advertis-
ing channelled to the medical profession by the drugsindustry and ensuring observance of good prescribingpractice;
Modification 17
Chapter I, paragraph4, subparagraph3a (new)
(3a) prohibiting any advertising addressed to the general
public promoting antibiotics;
Modification 18
Chapter I, paragraph4, subparagraph3b (new)
(3b) encouraging home treatment wherever feasible;
Modification 19
Chapter I, paragraph4, subparagraph3c (new)
(3c) encouraging clinical and laboratory practice and
methods to reduce the duration of hospital care withoutjeopardising the outcome of the treatment;9.5.2002 EN C 112 E/109 Official Journal of the European Communities
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Modification 20
Chapter II
II. cooperate with the Commission in the development of
indicators for monitoring prescribing practices of antimicrobialagents on the basis of the evidence-based principles and guide-lines on good practice for the management of communicablediseases within two years of the adoption of this Recommen-dation, and evaluate these indicators once developed withregard to potential improvements of prescribing practices andfeedback to prescribers;II. cooperate with the Commission in the development of
indicators for monitoring prescribing practices of antimicrobialagents on the basis of the in vitro and clinical evidence-based
principles and guidelines on good practice for the managementof communicable diseases within two years of the adoption ofthis Recommendation, and evaluate these indicators oncedeveloped 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-
ticeofmarketing ofantimicrobial agents to ensure compliance
with the evidence-based principles and guidelines on goodpractice for the management of communicable diseases withintwo years of the adoption of this Recommendation;III. establish and implement control systems on good prac-
ticeformarketing 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 andstudies based solely on in vitro microbiological arguments,with particular reference to indications, dose and dose
regimen;
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
Paragraph5
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 ofMember States’ annual reports;
Modification 25
Paragraph6a (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-C 112 E/110 EN 9.5.2002 Official Journal of the European Communities
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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
Paragraph6b(new)
6b. to strengthen the close cooperation between the
Member States, the applicant countries and other parties con-cerned at international level in order to deal more effectivelyat international and intercontinental level with the spread ofdisease and antimicrobial resistance arising from the increasein international trade and travel;
Modification 27
Paragraph6c (new)
6c. to promote a global strategy in all the relevant sectors:
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 collectiveinvestment in transferable securities (UCITS), with regard to investments of UCITS (7551/1/2001
*dash C5-0296/2001 *dash 1998/0243(COD))
(Codecision procedure: second reading)
The European Parliament,
:dash having regard to the Council common position (7551/1/2001 :dash C5-0296/2001),
:dash having regard to its position at first reading (
1) on the Commission proposal to Parliament and the
Council (COM(1998) 449) (2),
:dash having regard to the amended Commission proposal (COM(2000) 329) (3),
:dash having regard to Article 251(2) of the EC Treaty,
:dash having regard to Rule 80 of its Rules of Procedure,
:dash having regard to the recommendation for second reading of the Committee on Economic and Mon-
etary Affairs (A5-0324/2001),
1. Amends the common position as follows;
2. 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. 302.9.5.2002 EN C 112 E/111 Official Journal of the European Communities
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