Council Recommendation of 2 December 2003 on cancer screening
Date: 2003-12-02
Institutions: Council of the European Union
Subjects: cancer, disease prevention, public health

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Official Journal of the European Union

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COUNCIL RECOMMENDATION

of 2 December 2003

on cancer screening

(2003/878/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 152(4), second subparagraph,
thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Whereas:

Article 152 of
the Treaty provides that Community
to complement national policies and be
action is
directed towards improving public health, preventing
human illness and diseases, and obviating sources of
danger to human health. Such action shall cover the
fight against the major health scourges, by promoting
research into their causes, their transmission and their
prevention, as well as health information and education.
Community action in the field of public health shall fully
respect the responsibilities of the Member States for the
organisation and delivery of health services and medical
care.

Further development of cancer screening programmes
should be implemented in accordance with national law
and national and regional responsibilities for the organi-
sation and delivery of health services and medical care.

Cancer is a major disease and cause of death throughout
including the future Member States. An esti-
Europe,
mated number of 1 580 096 new cancer
cases,
excluding non-melanoma skin cancer, occurred in the
European Union in 1998. Of these, 1,4 % were cervical
cancers, 13 % breast cancers, 14 % colorectal cancers
and 9 % prostate cancers. Cervical and breast cancer
constituted 3 % and 29 %, respectively, of new cancers
in women. Prostate cancer constituted 17 % of new
cancers in men.

(1)

(2)

(3)

(4)

Principles for screening as a tool for the prevention of
chronic non-communicable diseases were published by
the World Health Organisation in 1968 and by the
Council of Europe in 1994. These two documents form,
together with the current best practice in each of the
cancer screening fields, the basis for the present recom-
mendations.

(10)

(5)

(6)

(7)

(8)

(9)

Additionally, these recommendations are based on the
‘Recommendations on cancer screening’ of the Advisory
Committee on Cancer Prevention together with the
experience gathered under the different actions sustained
under the Europe against Cancer programme where
European collaboration has helped, for example, high
quality cancer screening programmes to provide efficient
European guidelines of best practice and to protect the
population from poor quality screening.

Important factors which have to be assessed before a
population-wide
upon
include, inter alia, the frequency and interval of the appli-
cation of the screening test as well as other national or
regional epidemiological specificities.

implementation

decided

is

Screening allows detection of cancers at an early stage of
invasiveness or possibly even before they become inva-
sive. Some lesions can then be treated more effectively
and the patients can expect to be cured. The main indi-
cator for the effectiveness of screening is a decrease in
disease-specific mortality. As in the case of cervical
cancer, cancer precursors are detected, a reduction in
cervical cancer
incidence can be considered a very
helpful indicator.

Evidence exists concerning the efficacy of screening for
breast cancer and colorectal cancer, derived from rando-
mised trials, and for cervical cancer, derived from obser-
vational studies.

Screening is, however, the testing for diseases of people
for which no symptoms have been detected. In addition
to its beneficial effect on the disease-specific mortality,
screening can also have negative side effects for the
screened population. Healthcare providers should be
aware of all the potential benefits and risks of screening
for a given cancer site before embarking on new popula-
tion-based cancer screening programmes. Furthermore,
for the informed public of today, these benefits and risks
need to be presented in a way that allows individual citi-
zens
screening
programmes for themselves.

to decide on participation in the

legal,

social, medical,

Ethical,
and
economic aspects have to be considered before decisions
can be made on the implementation of cancer screening
programmes.

organisational

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(11) Due account should be taken of specific needs of
persons who may be at higher cancer risk for particular
reasons (e.g. biological, genetic,
lifestyle and environ-
mental, including occupational).

(21) Adequate human and financial resources should be avail-
able in order to assure the appropriate organisation and
quality control in all the Member States.

(12)

The public health benefits and cost efficiency of a
screening programme are achieved if the programme is
implemented systematically, covering the whole target
population and following best-practice guidelines.

(13)

The cost-effectiveness of cancer screening depends on
factors such as epidemiology, and healthcare
several
organisation and delivery.

(14)

(15)

Systematic implementation requires an organisation with
a call/recall system and with quality assurance at all
levels, and an effective and appropriate diagnostic, treat-
ment and after-care service following evidence-based
guidelines.

Centralised data systems, including a list of all categories
of persons to be targeted by the screening programme
and data on all screening tests, assessment and final diag-
noses,
screening
programmes.

organised

needed

run

are

to

(16) All procedures for collecting, storing, transmitting and
analysing data in the medical registers involved must be
in full compliance with the level of protection referred
to in Directive 95/46/EC of the European Parliament and
of the Council of 24 October 1995 on the protection of
individuals with regard to the processing of personal
data and on the free movement of such data (1), as well
as in full compliance with the relevant provisions of
Member States on the management and processing of
health data in accordance with Article 8 of the Directive.

(17) Quality screening includes analysis of the process and
outcome of the screening and rapid reporting of these
results to the population and screening providers.

(22) Action should be taken to ensure equal access

to
screening taking due account of the possible need to
target particular socioeconomic groups.

(23)

It is an ethical, legal and social prerequisite that cancer
screening should only be offered to fully informed
people with no symptoms if the screening is proved to
decrease disease-specific mortality,
if the benefits and
risks are well known, and if the cost-effectiveness of the
screening is acceptable.

(24)

The screening methods which presently meet these strict
prerequisites are listed in the Annex.

(25) No screening test other than those listed in the Annex is
scientifically justified to be offered to people with no
symptoms in an organised population-based programme
before it has been shown in randomised controlled trials
to decrease disease-specific mortality in particular.

(26)

The screening tests listed in the Annex can only be
offered on a population basis in organised screening
programmes with quality assurance at all levels, if good
information about benefits and risks, adequate resources
for screening, follow-up with complementary diagnostic
procedures and, if necessary, treatment of those with a
positive screening test are available.

(27)

The introduction of the recommended screening tests in
the Annex, which have demonstrated their efficacy,
should be seriously considered, the decision being based
on available professional expertise and priority-setting
for healthcare resources in each Member State.

(18)

This analysis is facilitated if the screening database can
be linked to cancer registries and mortality databases.

(28) Once there is evidence that a new screening test is effec-
tive, evaluation of modified tests may be possible using
other epidemiologically validated surrogate endpoints if
the predictive value of these endpoints is established.

(19) Adequate training of personnel is a prerequisite for high

quality screening.

(29)

(20)

Specific performance indicators have been established
for cancer screening tests. These should be monitored
regularly.

(1) OJ L 281, 23.11.1995, p. 31.

Screening methodologies are subject to ongoing develop-
ment. The application of recommended screening meth-
odologies should therefore be accompanied by simulta-
neous assessments of the quality, applicability and cost-
effectiveness of new methods if available epidemiological
data justify this. In fact, the ongoing work may lead to
new methods, which could ultimately replace or comple-
ment the tests listed in the Annex or be applicable to
other types of cancer,

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HEREBY RECOMMENDS THAT MEMBER STATES:

3. Monitoring

1. Implementation of cancer screening programmes

(a) offer

evidence-based

through a
cancer
systematic population-based approach with quality
assurance at all appropriate levels. The tests which
should be considered in this context are listed in the
Annex;

screening

(b) implement screening programmes in accordance with
European guidelines on best practice where they exist
and facilitate the further development of best practice
for high quality cancer screening programmes on a
national and, where appropriate, regional level;

(a) regularly monitor the process and outcome of organised
screening and report these results quickly to the public
and the personnel providing the screening;

(b) adhere to the standards defined by the European
Network of Cancer Registries in establishing and main-
taining the screening databases in full accordance with
relevant legislation on personal data protection;

(c) monitor the screening programmes at adequate inter-

vals.

4. Training

(c) ensure that

the people participating in a screening
programme are fully informed about the benefits and
risks;

adequately train personnel at all levels to ensure that they
are able to deliver high quality screening.

(d) ensure that adequate complementary diagnostic proce-
dures, treatment, psychological support and after-care
following evidence-based guidelines of
those with a
positive screening test are provided for;

(e) make available human and financial resources in order
to assure appropriate organisation and quality control;

(f) assess and take decisions on the implementation of a
cancer screening programme nationally or regionally
depending on the disease burden and the healthcare
resources available, the side effects and cost effects of
cancer screening, and experience from scientific trials
and pilot projects;

(g) set up a systematic call/recall system and quality assur-
ance at all appropriate levels, together with an effective
and appropriate diagnostic and treatment and after-care
service following evidence-based guidelines;

(h) ensure that due regard is paid to data protection legisla-
tion, particularly as it applies to personal health data,
prior to implementing cancer screening programmes.

2. Registration and management of screening data

(a) make available centralised data systems needed to run

organised screening programmes;

(b) ensure by appropriate means that all persons targeted
by the screening programme are invited, by means of a
call/recall system, to take part in the programme;

5. Compliance

(a) seek a high level of compliance, based on fully informed

consent, when organised screening is offered;

(b) take action to ensure equal access to screening taking
due account of the possible need to target particular
socioeconomic groups.

6. Introduction of novel screening tests taking into account

international research results

(a) implement new cancer screening tests in routine health-
care only after they have been evaluated in randomised
controlled trials;

(b) run trials,

in addition to those on screening-specific
parameters and mortality, on subsequent
treatment
procedures, clinical outcome, side effects, morbidity and
quality of life;

(c) assess level of evidence concerning effects of new
methods by pooling of trial results from representative
settings;

(d) consider the introduction into routine healthcare of
potentially promising new screening tests, which are
currently being evaluated in randomised controlled
trials, once the evidence is conclusive and other relevant
aspects, such as cost-effectiveness in the different health-
care systems, have been taken into account;

(c) collect, manage and evaluate data on all screening tests,

assessment and final diagnoses;

(d) collect, manage and evaluate the data in full accordance
with relevant legislation on personal data protection.

(e) consider the introduction into routine healthcare of
potentially promising new modifications of established
screening tests, once the effectiveness of the modifica-
tion has been successfully evaluated, possibly using
other epidemiologically validated surrogate endpoints.

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7. Implementation report and follow-up

report to the Commission on the implementation of this
Recommendation within three years of its adoption and
subsequently at the request of the Commission with a view
to contributing to the follow-up of this Recommendation at
Community level.

HEREBY INVITES THE COMMISSION:

2. To encourage cooperation between Member States

in
research and exchange of best practices as regards cancer
screening with a view to developing and evaluating new
screening methods or improving existing ones.

3. To support European research on cancer screening including
the development of new guidelines and the updating of
existing guidelines for cancer screening.

1. To report on the implementation of cancer

screening
programmes, on the basis of the information provided by
Member States, not later than the end of the fourth year
after the date of adoption of
to
consider the extent to which the proposed measures are
working effectively, and to consider the need for further
action.

this Recommendation,

Done at Brussels, 2 December 2003.

For the Council

The President

R. MARONI

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ANNEX

SCREENING TESTS WHICH FULFIL THE REQUIREMENTS OF THE RECOMMENDATION (*):

— pap smear screening for cervical cancer precursors starting not before the age of 20 and not later than the age of

30;

— mammography screening for breast cancer in women aged 50 to 69 in accordance with European guidelines on

quality assurance in mammography;

— faecal occult blood screening for colorectal cancer in men and women aged 50 to 74.

(*) The indicated age ranges are to be understood as maximum ranges; subject to national epidemiological evidence and prioritisation,

smaller age ranges may be appropriate.