Proposal for a Council Recommendation on cancer screening
Date: 2003-05-05
Institutions: European Commission
Subjects: cancer, disease prevention, public health

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 5.5.2003
COM(2003) 230 final

2003/0093 (CNS)

Proposal for a

COUNCIL RECOMMENDATION

on cancer screening

(presented by the Commission)

EXPLANATORY MEMORANDUM

EXECUTIVE SUMMARY

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1

Approximately  one  European  in  four,  nearly  one  million  per  annum,  will  die  of
cancer.  This  cost  of  this  is  enormous,  both  in  human  terms  for  cancer  patients  and
their families and in terms of the resources consumed by the diagnosis, treatment and
care of this disease. Combating cancer has, therefore, been a long-standing European
priority through the Europe against Cancer programme established in 1985.

This innovative programme comprised three key elements: the partnership approach,
bringing together all the national actors involved in all areas of cancer prevention in
the campaign against cancer; the European Code  against cancer,  which suggests 10
rules for a healthy lifestyle; and the long-term vision of lowering the cancer-specific
mortality of the European population by 15 % for the year 2000. Major progress has
been  made  toward  this  target:  between  1987  and  2000,  annual  cancer-specific
mortality  in  Europe  fell  by  10%,  equating  to  around  92,000  lives  saved1.  But
differences  remain  between  Member  States  in  the  death  toll  due  to  cancer  in  each
country . This underpins the expectation that further reductions would be possible by
applying best practice uniformly in all Member States.

Public health aims to prevent disease at population. While primary prevention aims
to  reduce  the  incidence  of  cancer  by  avoiding  exposure  to  any  kind  of  carcinogen,
secondary  prevention  aims  to  reduce  mortality  by  the  early  detection  of  cancer
through screening of the population at risk of developing the disease. Well-managed
population screening should be more effective than individual screening on demand,
which  also  needs  to  have  a  science-based,  cost-effective  approach,  built  on  best
practice. It follows that early detection of cancer by screening is one of the strategic
areas  of  cancer  prevention.  For  breast  cancer,  for  example,  it  is  estimated  that  the
lives  of  about  25,000  women  could  be  saved  if  best  practice  in  screening  were
available  throughout  the  European  Union.  However,  organised  cancer  screening
should only be offered to healthy people if the screening has been proved to decrease
disease-specific mortality or the occurrence of advanced disease, if the benefits and
risks are well known, and if the cost-effectiveness of the screening is acceptable.

The purpose of this proposal is, therefore, against a background of uncertainty on the
benefits of population-based cancer screening, to make recommendations on a sound
scientific  basis,  as  summarised  in  the  conclusions  of  the  Advisory  Committee  on
Cancer  Prevention,  which  confirms  the  proved  forms  of  screening  that  should
therefore be taken up by the Member States. The proposal recommends:

mammography screening for breast cancer in women aged 50-69;

faecal occult blood screening for colorectal cancer in men and women aged 50-74;

and  pap  smear  screening  for  cervical  abnormalities,  starting  between  the  ages  of
20 and 30;

Boyle P., d'Onofrio A., Maisonneuve P., Severi G., Robertson C. and Veronesi U.: Measuring progress
against  cancer  in  Europe  -  Has  the  15%  decline  targeted  for  2000  come  about?  Annals  of  Oncology
2003 in press.

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5.

Other tests may also be recommended once research shows that they meet the criteria
for organised cancer screening. Decisions on the implementation of cancer screening
programmes must be made as part of a general priority-setting exercise on the use of
healthcare  resources,  and  with  due  respect  for  the  responsibility  of  the  Member
States for the organisation and delivery of health services and medical care.

GENERAL INTRODUCTION

The European dimension of cancer

6.

7.

8.

Today  cancer  is  a  disease  which  still  kills  about  one  European  in  four.  Some
1,594,379  new  cases  were  recorded  in  the  fifteen  Member  States  in  1997.  The
situation  in  the  new  Member  States  is  expected  to  be  very  similar  to  the  present
situation  in  the  European  Union.  Detailed  statistical  information  on  the  Member
States is set out at the end of this explanatory memorandum.

In  1997  the  most  frequent  cancers  in  the  European  Union  were  colorectal,  breast,
lung, prostate, bladder, and stomach cancer, which made up 59 % of all new cancer
cases.  In  the  same  year  the  cancers  responsible  for  the  most  deaths  were  lung,
colorectal,  breast,  stomach,  prostate  cancer  and  pancreas  cancer,  which  made  up
57 % of all cancer deaths.

These figures, as high as they might appear, only represent a small proportion of the
human  and  social  dimension  of  the  suffering  caused  to  cancer  patients  and  their
families,  as  well  as  the  financial  and  economic  dimension  of  the  health  resources
absorbed  for  the  diagnosis,  treatment  and  care  of  this  disease.  These  figures  also
explain why Europe is engaged in the global battle against this disease.

3

History of European cooperation under Europe against Cancer in the field of screening

9.

2

3

4

5

6

In  its  Resolution  of  7  July  1986,2  the  Council  expressed  its  political  will  to
implement a European programme of action against cancer. Among the priorities it
identified for attention was the need for the exchange of information and experience,
particularly  with  regard  to  the  preventive  and  early  diagnosis  programmes  of  the
Member  States.  This  initiative  was  taken  up  and  enhanced  from  June  1988  by  the
three consecutive European action plans to fight cancer, the "Europe against Cancer"
(EAC)  programmes.3,4,5,6  All  of  these  EAC  programmes  have  included  secondary
prevention,  i.e.  systematic  population-based  screening  for  specific  sites  of  cancer
where such interventions had been judged to be effective. Acknowledging that some
Member  States  were  already  considering  national  screening  programmes,  in  areas
such as breast cancer and cervical cancer, a plan was developed to enable each of the
Member States to propose pilot-screening projects within its borders. This has led to
the  current  screening  networks,  the  European  Breast  Cancer  Network  (EBCN)  and
the European Cervical Cancer Screening Network (ECCSN).

Resolution of the Council and the Representatives of the Governments of the Member States, meeting
within  the  Council,  of  7  July  1986,  on  a  programme  of  action  of  the  European  Communities  against
Cancer. OJ C 184, 23.7.1986. p.19.
Decision of the Council and of representatives of the Governments of the Member States, meeting with
the  Council  of  21  June  1988  adopting  a  1988  to  1989  plan  of  action  for  an  information  and  public
awareness  campaign  in  the  context  of  the  ‘Europe  against  cancer’  programme  (88/351/EEC).
OJ L 160, 28.6.1988 p. 52.
Decision the Council and the Representatives of the Governments of the Member States, meeting within
the Council, on 17 May 1990, adopting a 1990 to 1994 action plan in the context of the "Europe against
Cancer" programme. OJ L 137, 30.5.1990. p.31.
Decision  No  646/96/EC  of  the  European  Parliament  and  the  Council  of  29  March  1996,  adopting  an
action  plan  to  combat  cancer  within  the  framework  for  action  in  the  field  of  public  health
(1996 to 2000). OJ L 95, 16.4.1996. p.9.
Decision  No  521/2001/EC  of  the  European  Parliament  and  of  the  Council  of  26  February  2001,
extending certain programmes of Community action in the field of public health adopted by Decisions
No 645/96/EC, No 646/96/EC, No 647/96/EC, No 102/97/EC, No 1400/97/EC and No 1296/1999/EC
and amending those Decisions. OJ L 79 of 17.3.2001, p.1.

4

                                                
European guidelines on quality assurance in mammography and the recommendations
for cancer screening of the Advisory Committee on Cancer Prevention

10.

In  parallel  to  the  Networks’  aim  of  developing  and  publishing  consensus  on  best
screening  practice  as  a  series  of  European  guidelines,  the  Advisory  Committee  on
Cancer  Prevention7  has  reviewed  the  global  scientific  evidence  and  the  experience
gathered  from  the  screening  networks  under  Europe  against  Cancer.  In  1999  the
for  Cancer  Screening.8,9  These
Committee  adopted 
recommendations establish a set of general principles for best practice in screening,
on  which  the  recommendations  in  this  document  are  based.  The  Committee’s
recommendations  on  specific  screening  tests  are  reflected  in  the  Annex  to  the
proposed Recommendation.

the  Recommendations 

Europe against cancer

11.

As  mentioned  above,  the  fight  against  cancer  follows  several  strands  of  action:
identifying  the  causes  of  cancer,  eliminating  or  reducing  exposure  to  known  risk
factors for cancer, early detection of  cancer through screening,  and better treatment
of and care for cancer.

The success is measurable

12.

13.

Since  the  European  Council  had  asked  for  a  co-ordinated  European  action  against
cancer  at  the  Milan  Summit  of  1985,  new  ground  was  broken.  Since  then,  the
European Community has acted in new areas such as disease prevention, information
to  the  public,  health  education  (especially  in  schools)  and  the  training  of  health
personnel. But the innovative character of the  ”Europe against cancer”  programme,
which followed from this initiative, was not just a  question  of the  areas  covered.  It
also concerned the chosen strategy, which had three key elements.

First,  the  partnership  approach,  which  enabled  the  programme  to  bring  together  all
the national actors involved in the campaign against cancer, and to group them into
European committees and working parties, both scientific and non-scientific. Second,
the  European  Code  against  cancer,  which  suggests  10  rules  for  a  healthy  lifestyle.
Third,  the  importance  of  maintaining  a  long-term  vision,  linked  to  the  objective  of
the  programme  which  is  to  lower  the  cancer-specific  mortality  of  the  European
population by 15 % for the year 2000.

7

8

9

Commission  Decision  96/469/EC  of  30  July  1996,  establishing  an  Advisory  Committee  for  Cancer
Prevention. OJ L 192, 2.8.96, p.31.
Recommendations on cancer screening in the European Union, prepared by the Advisory Committee on
Cancer Prevention after the Conference on Screening and Early Detection of Cancer, Vienna 18th – 19th
November 1999. Unpublished. Available on request from the General Directorate Health and Consumer
Protection, Directorate Public Health, Unit Cancer, Drugs, and Pollution-related Diseases.
Position paper, Recommendations on cancer screening in the European Union, Advisory Committee on
Cancer Prevention, Lynge E. corresponding author: Eur J Cancer 2000, 36, p.1473-1478.

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14.

This  strategy  has  been  both  innovative  and  fertile.  Looking  back,  as  a  recent
epidemiological  analysis  reveals1,  the  strategy  and  actions  pursued  under  the  three
consecutive  Europe  against  Cancer  programmes  have  contributed  to  a  reduction  of
cancer-specific  mortality by  10  % between 1987  and 2000,  which  equates  to  about
92,000 European's lives saved. This is despite the considerable increase in smoking
among European women, which led to an unforeseen 5 % increase in tobacco-related
cancer mortality for women over this period of time.

Cancer screening for breast, cervical and colorectal cancer is effective

15.

16.

Since  the  beginning  of  Europe  against  Cancer,  clinical  trials  of  specific  screening
methods have been shown to be effective for three different cancers: breast cancer,
colorectal  cancer  and  cervical  cancer.  For  example,  each  year  breast  cancer  is
diagnosed  in  about  220,000  European  women  and  kills  around  75,000.  Estimates
suggest,  however,  that  the  lives  of  about  25,000  women  could  be  saved  if  best
practice of screening were available to all women in the European Union.

In  1999,  at  the  request  of  the  Commission,  the  Advisory  Committee  on  Cancer
Prevention  prepared  recommendations  on  cancer  screening  in  the  European  Union.
The  Committee  reviewed  the  scientific  literature  and  analysed  the  experience  from
the  different  screening  networks  established  under  the  Europe  against  Cancer
programme.  The  Committee  also  organised  an  international  symposium  on  cancer
screening,  in  order  to  be  able  to  take  into  account  the  latest  progress  on  cancer
screening and to discuss the draft  recommendations with the international scientific
community.  Based  on  the  most  up-to-date  science,  these  recommendations
established a set of general principles for best practice in cancer screening and made
specific  recommendations  for  the  implementation  of  mammography  screening  for
breast  cancer,  pap  smear  screening  for  cervical  cancer,  and  faecal  occult  blood
testing for colorectal cancer. A recommendation on screening with the PSA-test for
prostate cancer could not be made at that time,  as  this  depends  on the outcomes of
large  international  studies  in  the  USA  as  well  as  in  Europe,  which  are  expected  to
become available in 2008.

Translating scientific advice into Community legislation

17.

Public health aims to prevent disease at population level and thus reduce the burden
of disease for individuals and for society as a whole. While primary prevention (such
as  through  tobacco  control  legislation)  aims  to  reduce  the  incidence  of  cancer  by
avoiding exposure to carcinogens, secondary prevention aims to reduce mortality by
the  early  detection  of  cancer  through  screening  of  the  population  at  risk  from
carcinogens.  Well-managed  population  screening  should  be  more  effective  than
individual  screening  on  demand,  and  is  therefore  a  key  instrument  of  prevention
which  also  needs  to  have  a  science-based,  cost-effective  approach,  built  on  best
practice.

6

18.

19.

20.

21.

The  Europe  against  Cancer  programme  has  enabled  best  practice  approaches  in
individual Member States to be identified and shared and then tested in the European
screening networks. They should now be implemented in other Member States. The
new public health programme will help to continue the experimental approach of the
screening networks for updating best practice in established screening areas, as well
as developing best practice in new screening areas. These networks will contribute to
the new public health programme objectives concerning both health information and
health determinants.

The  Commission  proposal  for  a  Council  recommendation  on  cancer  screening  is
based  mainly  on  the  recommendations  of  the  advisory  committee  on  cancer
prevention.  To  ensure  that  the  proposal  is  up  to  date  external  scientists  were
extensively consulted in 2002.

Based  on  Article  152  of  the  Treaty  establishing  the  European  Community,  this
Commission proposal recommends the implementation of best practice principles in
cancer  screening  in  all  Member  States,  preferably  through  following  European
guidelines. It also aims to define the role of the Community in this important area of
disease prevention. The specific screening methods concerned (listed in the annex to
the Recommendation) have proved to be effective in reducing the cancer death toll in
randomised  controlled  clinical  trials.  The  Recommendation  advocates  mass  cancer
screening  by  clearly  established  scientific  methods  in  quality-controlled  screening
programmes.  Such  an  approach  also  addresses  health  inequalities  and  the  need  for
take-up  amongst  those  most  vulnerable  and  least  likely  to  actively  manage  their
health. It does not cover individual screening on demand.

The proposal does not exclude other screening tests currently under development and
evaluation,  nor  does  it  criticise  actions  that  individuals  may  wish  to  take  for
themselves. Such innovations,  which  also  have to be tested in  clinical trials, would
nevertheless benefit from being clinically evaluated in the framework of an organised
screening programme.

The benchmark: European guidelines on quality assurance in cancer screening

22.

European  guidelines provide a  detailed  description  of  all  necessary  implementation
measures  to  maximise  effectiveness  and  minimise  possible  adverse  effects  of  any
given screening method. They are based on a European scientific consensus arrived
at from the  partnership  approach of  the Europe  against  Cancer  programme  through
the  screening  networks.  The  European  guidelines  for  quality  assurance  in
mammography  developed  since  1992  are  a  good  example  of  the  best  practice
approach  in  the  early  detection  of  breast  cancer.  These  European  guidelines  have
been produced by the European screening networks with the support of the Europe
against Cancer programme. The third edition appeared in July 2001. Public interest
in  clear  messages  on  screening  has  been  shown  by  the  success  of  these
mammography guidelines, which are among the top ten best selling publications of
the Office for Official Publications of the European Communities.

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24.

25.

26.

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This  experience  demonstrates  that  it  would  be  useful  to  have  specific  European
guidelines  for  each  of  the  priority  areas  to  define  specific  conditions  for  organised
screening programmes. Work has begun in the European network on cervical cancer
screening  to  follow  up  the  example  of  the  mammography  network  in  drafting
comprehensive European guidelines on quality assurance. Discussions are underway
to explore the possibility of a similar approach which builds on the former European
colorectal cancer-screening network.

In 2000 and 2001, the validity of the evidence of the older studies on the efficacy of
mammography screening was questioned by two publications.10,11 Following a lively
global debate among the experts, two international conferences reviewed old as well
as more recent evidence12 on the efficacy of mammography screening. The first was
organised  in  March  2002  by  the  International  Agency  for  Research  on  Cancer  of
WHO  (WHO/IARC)  in  Lyons.  The  second,  the  Global  Summit  on  Mammography
Screening, was organised by the European Institute of Oncology (EIO) in Milan, in
June  2002,  and  was  supported  by  the  European  Commission.  Both  conferences
concluded  that  mammography  screening  is  effective  if  organised  and  embedded  as
recommended,  among  others,  by  the  European  Guidelines  on  Quality  Assurance  in
mammography screening.13,14

Screening  for  cancer  and  the  establishment  of  best  practice15  still  vary  between
Member  States.  To  a  certain  degree  this  contributes  to  the  differences  in  cancer-
specific mortality for breast, cervical and colorectal cancer between Member  States
(see  tables  below).  The  introduction  of  high  quality  mammography  screening  for
breast cancer in Sweden and Finland has reduced breast cancer-specific mortality by
about  one  third.  On  this  basis,  it  became  clear  that  the  availability  of  such  high-
quality screening in all Member States could save the lives of about 25,000 women
with  breast  cancer  (provided  that  compliance  of  women  is  as  high  as  in  Sweden  -
over 90%).

This proposed Council recommendation aims to close the gap between differences in
screening among the Member States to achieve a similar reduction of cancer-specific
mortality in all Member States by establishing general principles of best practice for
cancer screening as recommended by the Advisory Committee on Cancer Prevention.
The  intention  is  to  bring  about  a  similar  high  level  of  health  protection  for  those
cancers where early detection is possible and efficient for all European citizens.

Goetzsche  PC  and  Olsen  O.  Is  screening  for  breast  cancer  with  mammography  justifiable?
Lancet 2000; 355: 129-134.
Olsen  O,  Goetzsche  PC.  Cochrane  review  on  screening  for  breast  cancer  with  mammography.
Lancet 2001; 358: 1340-1342.
Nystroem L, Anderson I, Bjurstam N, Frisell J, Nordenskjoeld B and Rutqvist LE. Long-term effects of
mammography  screening:  updates  overview  of  the  Swedish  randomised  trials.  Lancet  2002;
359: 909-919.
IARC Handbooks of Cancer Prevention, Volume 7: Breast Cancer Screening. International Agency for
Research on Cancer, World Health Organisation, IARC Press 2002, ISBN 92 832 3007 8.
Global Summit on Mammographic Screening: Statement  from the  Chair.  Published  on  the  Internet  at
http://www.ieo.it/inglese/didattica/state_1.htm
Communication  from  the  Commission  to  the  Council,  the  European  Parliament,  the  Economic  and
Social  Committee  and  the  Committee  on  the  Regions  on  the  health  strategy  of  the  European
Community (COM(2000) 285 final) of 16 May 2000.

8

                                                
SCREENING SPECIFIC BACKGROUND

27.

28.

29.

30.

31.

32.

Screening aims to detect cancers at an early stage of invasiveness or even before they
become invasive. Some lesions can then be treated more effectively and patients can
expect to be cured. A key indicator for the effectiveness of screening is a decrease in
disease-specific mortality or a decrease in the occurrence of advanced disease.

Screening means testing healthy people for diseases which have not yet given rise to
symptoms.  Although  it  can  have  beneficial  effects  and  improve  survival  rates,
screening can also have negative side-effects for the screened population, including
psycho-social effects (such as anxiety), unnecessary medical interventions in the case
of false positive results, and delays in timely detection of disease in the case of false
negative diagnosis.

Healthcare  providers  should  be  aware  of  all  the  potential  benefits  and  risks  of
screening  for  a  given  cancer  site  before  embarking  on  new  cancer  screening
programmes. Furthermore, for the informed public of today, these benefits and risks
should be presented in a way that allows individual citizens to decide on participation
in the screening programmes for themselves.

Principles  for  screening  as  a  tool  for  the  prevention  of  chronic  non-communicable
diseases  were  published  by  the  World  Health  Organisation  in  196816  and  by  the
Council of Europe in 1994.17 These two documents form, together with  the  current
best  practice  in  each  of  the  cancer  screening  fields,  the  basis  for  the  present
recommendations.

All  data  on  incidence  and  mortality  quoted  are  regularly  updated  and  published  on
the Internet by the European Network of Cancer Registries (ENCR) 18. An estimated
number  of  1,594,379  new  cancer  cases,  excluding  non-melanoma  skin  cancer,
occurred in the European Union in 1997. Of these, 1.4% were cervical cancers, 14%
breast cancers, 14% colorectal cancers and 9% prostate cancers. Cervical and breast
cancer constituted 3% and 29%, respectively, of new cancers in women, and prostate
cancer constituted 17% of new cancers in men.

By  comparison,  the  incidence  for  lung  cancer  in  the  EU  in  1997  amounted  to
197,106  new  cases  for  both  sexes,  and  accounted  for  180,751  deaths.  Of  these,
44,642  were  new  cases  in  women,  and  41,004  women  died  from  lung  cancer.
Unfortunately, the specific incidence for lung cancer in women is rising rapidly and
will, in the near future, reach the same level as the incidence figures for men. This is
the result of women taking up smoking in large numbers. No effective screening test
has  yet  been  developed  for  lung  cancer.  The  Commission  is  thus  fostering  a
combined  approach  of  primary  prevention  by  health  information,  health  promotion
and tobacco regulation policies.

16

17

18

Wilson  JMG,  Jungner  G.  Principles  and  practice  of  screening  for  disease.  Public  Health  Papers  34.
Geneva: World Health Organisation, 1968.
Council  of  Europe:  Committee  of  Ministers.  On  screening  as  a  tool  of  preventive  medicine.
Recommendation no. R (94) 11. Strasbourg: Council of Europe, 1994.
http://www.iarc.fr.  International  Agency  for  Research  on  Cancer.  Cancer  Incidence  Data  Bases.
EUCAN 1997. (retrieved 16 January 2003).

9

                                                
PRINCIPLES

33.

34.

35.

Screening is an effective method of controlling cancer. Whenever possible, primary
cancer  prevention  should  be  given  first  priority.  When  cancer  screening  is
undertaken,  it  should  be  offered  only  in  organised  programmes  with  quality
assurance  at  all  levels,  and  good  information  about  benefits  and  risks.  The
population/public health benefits of a screening programme will only be achieved if
compliance  and  coverage  are  high.  When  organised  screening  is  offered,  high
therefore  be  sought.  Screening  on  demand  cannot  be
compliance  should 
recommended  as  a  basis  for  public  health  practice  since  it  will  not  deliver  the
maximum benefits and may have the negative side-effects referred to above.

The need for the proper evaluation of the health outcomes and costs of all screening
procedures  through  randomised  controlled  trials,  including  new  cancer  screening
tests, before being implemented in routine health care must be emphasised. It is also
essential that an independent body evaluate the results of the screening trials.19 Once
the  effectiveness  of  a  new  screening  test  has  been  demonstrated,  evaluation  of
modified  tests  (e.g.  alternative  tests  for  faecal  occult  blood  or  interpretation  of
cervical  specimens)  may  be  possible  using  surrogate  endpoints,  providing  that  the
predictive value of this (intermediate/surrogate) endpoint is sufficiently established.
The  evaluation  and  monitoring  of  a  screening  method  may  make  use  of  IST  tools  as
developed  under  the  Community  research  programmes,  such  as,  e.g.,  soft  copy  digital
screening in mammography.

Centralised data systems, including a computerised list of all persons to be targeted
by  the  screening  programme,  and  data  on  all  screening  tests,  assessment  and  final
diagnoses  are  needed  to  run  organised  screening  programmes.  Organised  screening
also involves scientific analysis of the outcome of the screening and rapid reporting
of these results to the programme providers and the health authorities. This analysis
is facilitated if the screening database is linked to cancer registry data. It follows that
cancer  registry  data  in  the  continuous  monitoring  and  comparing  of  incidence,
mortality and survival should be as complete, accurate and up-to-date as possible. All
procedures  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

36.

High-quality screening is  possible  only  if  the  personnel  at  all  levels  are  adequately
trained for their tasks. Performance indicators should be monitored regularly.

19

Evaluation  and  monitoring  of  screening  programmes,  edited  by:  Sankila  R,  Démaret  E,  Hakama  M,
Lynge E, Schouten LJ, Parkin DM for the European Network of Cancer Registries (ENCR), European
Commission,  Office 
the  European  Communities,  2001,
ISBN 92-894-0253-9.

for  Official  Publications  of 

10

                                                
37.

38.

In  addition  to  ethical,  legal,  social,  medical,  organisational  and  economic  aspects,
scientific  analysis  and  reporting  for  quality  assurance  have  to  be  considered  before
decisions can be made on the implementation of cancer screening. Resources, human
as well as financial, must be available in order to assure the appropriate organisation
and quality control. Actions have to be taken to ensure that different socio-economic
groups  have  equal  access  to  screening.  The  implementation  of  a  cancer-screening
programme is therefore a decision to be made nationally or regionally, depending on
the disease burden and the health care resources.

Cancer is a major disease and cause of death throughout Europe. Collaboration on a
European level should help high-quality  cancer screening  programmes  to provide a
service which is efficient and in accordance with best practice guidelines and protect
the population from poor-quality screening.

CONCLUSIONS

39.

– 

– 

– 

40.

41.

20

21

22

Organised  cancer  screening  should  be  offered  to  healthy  people  if  the  screening  is
proved  to  decrease  disease-specific  mortality  and/or  decrease  the  occurrence  of
advanced  disease,  if  the  benefits  and  risks  are  well  known,  and  if  the  cost-
effectiveness of the screening is acceptable. At present the following screening tests
meet such requirements:

pap smear screening for cervical abnormalities starting at the latest by the age of 30
and definitely not before the age of 20,9,20

mammography screening for breast cancer in women aged 50-699 in accordance with
European guidelines on quality assurance in mammography,21

faecal occult blood screening for colorectal cancer in men and women age 50-74.9,22

Decisions on implementation of cancer screening programmes must be made as part
of a general priority-setting exercise on the use of healthcare resources.

Other cancer screening test are not yet recommended for EU-wide population-based
cancer  screening,  although  they  already  may  be  used  in  individual  screening  on
demand.  Such  tests  may  provide  individual  benefits  but  at  the  same  time  may  also
lead  to adverse effects  for individuals (e.g.  unfounded anxiety)  and the public  (e.g.
additional financial burden). Recommendations  for  such  tests  cannot  be  made  until
they  have  shown  to  have  benefits  such  as  reducing  disease-specific  mortality  or
improving survival.

Cervical Cancer Screening in the European Union, special issue of European Journal of Cancer; Guest
Editors: A. Linos, E. Riza, M. van Ballegooijen, EJC 2000 36/17 pp. 2175-2275.
European guidelines for quality  assurance in  mammography screening, 3rd Edition. Eds: N.  Perry,  M.
Broeders,  C.  de  Wolf,  S.  Toernberg.  European  Commission,  Office  for  Official  Publications  of  the
European Communities, Luxembourg 2001, ISBN 92-894-1145-7.
Scholefield  J  H  and  Moss  S.M.,  Faecal  occult  blood  screening  for  colorectal  cancer,  J  Med  Screen
2002 9:54-55.

11

                                                
42.

Potentially  promising  screening  tests  currently  being  evaluated  in  randomised
controlled trials, include:

-

-

-

-

43.

-

-

-

-

44.

prostate-specific antigen (PSA) testing for prostate cancer,9,23

mammography screening for women aged 40-49 for breast cancer,9

immunological Faecal Occult Blood Testing (FOBT) for colorectal cancer,9,22

flexible colonoscopy for colorectal cancer.9

Once the effectiveness of a new screening test has been demonstrated, evaluation of
modified testing methods may be possible using intermediate/surrogate endpoints, if
the  positive  predictive  value  of  such  endpoints  is  sufficiently  established.  Some
examples of screening methods which fall into this category are listed below:

any novel alternative tests for faecal occult blood,

liquid-based cervical cytology,

testing for high risk human papilloma virus (HPV) infection,

other novel methods for the preparation or interpretation of cervical specimens.

Any screening test which has been demonstrated to be effective should be offered on
a population basis only in organised screening programmes, with quality assurance at
all levels and full information about the benefits and risks.

23

Koning HJ de, Auvinen A, Berenguer Sanchez A, Calais da Silva F, Ciatto S, Denis L, Gohagan J.K.,
Hakama M, Hugosson J, Kranse R, Nelen V, Prorok PC, Schröder FH; Large-scale randomised prostate
cancer screening trials: programme performances in the European Randomised Screening  for Prostate
Cancer trial and Prostate, Lung, Colorectal and Ovary cancer trial. (submitted) Int. J Cancer 2002 .

12

                                                
Statistical Annex to the Explanatory Memorandum

Cancer in the European Union 1997 (All Sites and all ages)

Cancer site

No. of Cancer Cases Cancer Cases per 100,000

No. of Cancer Deaths Cancer Deaths per 100,000

Oral cavity and pharynx
 Oesophagus
 Stomach
 Colon/Rectum
 Liver
 Pancreas
 Larynx
 Lung
 Melanoma of skin
 Breast
 Cervix uteri
 Corpus uteri
 Ovary etc.
 Prostate
 Testis
 Bladder
 Kidney etc.
 Brain, nervous system
 Thyroid
 Non-Hodgkin lymphoma
 Hodgkin's disease
 Multiple myeloma
 Leukaemia
 All sites but skin

52682
24736
74604
221042
30892
40611
24000
197106
36224
220836
22838
38270
34335
145065
9661
75033
46617
27277
15441
51509
9199
20791
42435
1594379

12.63
5.42
15.02
45.16
6.44
8.30
5.63
42.71
8.54
51.67
5.45
8.55
7.81
28.14
2.46
15.23
10.27
6.56
3.80
11.42
2.32
4.28
9.37
345.09

19835
22793
56429
111013
33743
44957
10600
180751
8673
74984
10446
8934
23295
55658
695
30653
22306
21093
3144
25418
2474
14185
29120
925387

4.62
4.88
11.00
21.50
6.82
8.99
2.35
38.08
1.91
16.06
2.26
1.72
4.90
9.78
0.17
5.67
4.57
4.90
0.62
5.22
0.55
2.77
5.92
187.88

Incidence and mortality figures for breast, cervical and colorectal cancer in all Member States.

Breast Cancer 1997 (All Ages)

Member State

No. of Cancer Cases

Cancer Cases per 100,000

No. of Cancer Deaths Cancer Deaths per 100,000

European Union
 Austria
 Belgium
 Denmark
 Finland
 France
 Germany
 Greece
 Ireland
 Italy
 Luxembourg
 The Netherlands
 Portugal
 Spain
 Sweden
 United Kingdom

220836
4605
7092
3535
3171
36738
50551
4450
1622
34629
242
10524
4272
15906
5821
37678

74984
1651
2562
1421
788
10831
18374
1512
634
11339
78
3574
1561
5766
1494
13399

29.12
28.81
37.28
40.59
23.22
27.89
30.48
21.62
35.38
27.01
27.12
36.96
24.91
22.67
22.88
33.64

97.25
90.14
116.03
113.24
102.32
109.56
94.71
70.64
96.34
93.37
99.67
120.76
73.84
69.98
107.28
108.25

13

Cervical Cancer 1997 (All Ages)

Member State

No. of Cancer Cases

Cancer Cases per 100,000

No. of Cancer Deaths Cancer Deaths per 100,000

European Union
 Austria
 Belgium
 Denmark
 Finland
 France
 Germany
 Greece
 Ireland
 Italy
 Luxembourg
 The Netherlands
 Portugal
 Spain
 Sweden
 United Kingdom

22838
529
612
438
159
3813
6167
493
171
3183
10
733
952
1665
537
3376

Colon/Rectum Cancer 1997 (All Ages)

Member State

No. of Cancer
Cases

European Union
 Austria
 Belgium
 Denmark
 Finland
 France
 Germany
 Greece
 Ireland
 Italy
 Luxembourg
 The Netherlands
 Portugal
 Spain
 Sweden
 United Kingdom

221042
5022
6204
3486
2075
32956
56040
3416
1847
35185
244
8966
5549
20688
5046
34318

10.48
11.18
10.31
14.62
5.06
11.58
12.14
8.13
10.10
9.06
4.24
8.31
17.34
7.72
10.78
10.17

10446
302
321
226
78
1674
2943
219
88
1297
2
264
349
742
242
1699

4.13
5.52
4.60
6.63
2.12
4.25
4.95
3.13
4.88
3.14
0.97
2.77
5.69
3.15
3.68
4.46

Cancer Cases per 100,000

No. of Cancer Deaths

Cancer Deaths per 100,000

45.16
49.60
46.08
52.21
33.35
43.32
50.78
24.49
52.75
44.16
48.66
50.34
46.47
42.16
39.77
44.95

111013
2586
3198
2150
984
16134
29767
1620
971
16126
133
4274
2706
10639
2395
17330

21.50
24.12
22.46
30.69
15.01
19.70
25.84
11.14
26.78
19.21
25.29
22.89
21.78
20.16
17.33
21.62

14

2003/0093 (CNS)

Proposal for a

COUNCIL RECOMMENDATION

on cancer screening

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,24

Having regard to the opinion of the European Parliament,25

Whereas:

(1)

(2)

Article 152 of the Treaty provides that Community  action is to  complement national
policies  and  be  directed  towards  improving  public  health,  preventing  human  illness
and diseases, and obviating sources of danger to human health.

Principles  for  screening  as  a  tool  for  the  prevention  of  chronic  non-communicable
diseases  were  published  by  the  World  Health  Organisation  in  196826  and  by  the
Council  of  Europe  in  199427.  These  two  documents  form,  together  with  the  current
best  practice  in  each  of  the  cancer  screening  fields,  the  basis  for  the  present
recommendations.

24

25

26

27

OJ C […], […], p. […].
OJ C […], […], p. […].
Wilson  JMG,  Jungner  G.  Principles  and  practice  of  screening  for  disease.  Public  Health  Papers  34.
Geneva: World Health Organisation, 1968.
Council  of  Europe:  Committee  of  Ministers.  On  screening  as  a  tool  of  preventive  medicine.
Recommendation no. R (94) 11. Strasbourg: Council of Europe, 1994.

15

                                                
(3)

(4)

(5)

(6)

28

29

30

31

32

33

34

Additionally,  these  recommendations  are  based on the “Recommendations  on  cancer
screening”  of  the  Advisory  Committee  on  Cancer  Prevention28,29  together  with  the
experience  gathered  under  the  different  actions  sustained  under  the  Europe  against
Cancer  programme30,31,32,33,34  where  European  collaboration  has  helped,  e.g.,  high-
quality cancer screening programmes to provide efficient European guidelines of best
practice and to protect the population from poor-quality screening.

Screening allows detection of cancers at an early stage of invasiveness or even before
they  become  invasive.  Some  lesions  can  then  be  treated  more  effectively  and  the
patients can expect to be cured. The key indicator for the effectiveness of screening is
a decrease in disease-specific mortality or in the occurrence of advanced disease.

Evidence  exists  concerning  the  effectiveness  of  screening  for  breast  cancer  and
colorectal  cancer,  derived  from  randomised  trials,  and  for  cervical  cancer,  derived
from observational studies.

Screening  is,  however,  the  testing  of  healthy  people  for  diseases,  of  which  no
symptoms  have  been  detected.  In  addition  to  its  beneficial  effect  on  the  disease-
specific mortality or occurrence of advanced disease, 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 population-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  citizens  to  decide  on  participation  in  the  screening  programmes  for
themselves.

Recommendations on cancer screening in the European Union, prepared by the Advisory Committee on
Cancer Prevention after the Conference on Screening and Early Detection of Cancer, Vienna 18th – 19th
November 1999. Unpublished. Available on request from the General Directorate Health and Consumer
Protection, Directorate Public Health, Unit Cancer, Drugs, and Pollution-related Diseases.
Position paper, Recommendations on cancer screening in the European Union, Advisory Committee on
Cancer Prevention, Lynge E. corresponding author: Eur J Cancer 2000, 36, p.1473-1478.
Resolution of the Council and the Representatives of the Governments of the Member States, meeting
within  the  Council,  of  7  July  1986,  on  a  programme  of  action  of  the  European  Communities  against
Cancer. OJ C 184, 23.7.1986. p.19.
Decision of the Council and of representatives of the Governments of the Member States, meeting with
the  Council  of  21  June  1988  adopting  a  1988  to  1989  plan  of  action  for  an  information  and  public
awareness  campaign  in  the  context  of  the  ‘Europe  against  cancer’  programme  (88/351/EEC).
OJ L 160, 28.6.1988 p. 52.
Decision the Council and the Representatives of the Governments of the Member States, meeting within
the Council, on 17 May 1990, adopting a 1990 to 1994 action plan in the context of the "Europe against
Cancer" programme. OJ L 137, 30.5.1990. p.31.
Decision  No  646/96/EC  of  the  European  Parliament  and  the  Council  of  29  March  1996,  adopting  an
action  plan  to  combat  cancer  within  the  framework  for  action  in  the  field  of  public  health
(1996 to 2000). OJ L 95, 16.4.1996. p.9.
Decision  No  521/2001/EC  of  the  European  Parliament  and  of  the  Council  of  26  February  2001,
extending certain programmes of Community action in the field of public health adopted by Decisions
No 645/96/EC, No 646/96/EC, No 647/96/EC, No 102/97/EC, No 1400/97/EC and No 1296/1999/EC
and amending those Decisions. OJ L 79 of 17.3.2001, p.1.

16

                                                
(7)

(8)

(9)

Cancer is a major disease  and cause  of death throughout Europe including the  future
member  States.  An  estimated  number  of  1 594 379  new  cancer  cases,  excluding  non-
melanoma skin cancer, occurred in the European Union in 1997. Of these, 1.4% were
cervical cancers, 14% 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.

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.

This requires an organisation with a call-recall system and with quality assurance at all
levels, and an effective and appropriate diagnostic and treatment service.

(10) 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
diagnoses, are needed to run organised screening programmes.

(11) All  procedures  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.

(12) Quality screening includes  analysis  of  the  process  and  outcome  of the screening  and

rapid reporting of these results to the population and screening providers.

(13)

This analysis is facilitated if the screening database is linked to cancer registry data.

(14) Adequate training of personnel is a prerequisite for high quality screening.

(15)

(16)

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

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

(17) Adequate  human  and  financial  resources  should  be  available  in  order  to  assure  the

appropriate organisation and quality control.

(18) Different  socio-economic  groups  often  do  not  have  equal  access  to  screening.

Therefore, action should be taken to ensure equal access.

(19)

It  is  an  ethical,  legal  and  social  prerequisite  that  cancer  screening  should  only  be
offered to fully-informed healthy people if the screening is proved to decrease disease-
specific  mortality  or  the  incidence  of  advanced  disease,  if  the  benefits  and  risks  are
well known, and if the cost-effectiveness of the screening is acceptable.

(20)

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

17

(21) No screening test other than those listed  in the Annex  is  scientifically  justified  to  be
offered  to  healthy  people  in  an  organised  population  based  programme  before  it  has
been  shown  in  randomised  controlled  trials  to  decrease  disease-specific  mortality  or
the occurrence of advanced disease.

(22)

The  screening tests listed  in the  Annex  can  only  be  offered  on  a  population  basis  in
organised  screening  programme  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 is available.

(23)

The introduction of the recommended screening tests , which have demonstrated their
effectiveness,  should  be  seriously  considered,  the  decision  being  based  on  available
professional expertise and priority setting for healthcare resources;

(24) Once the  effectiveness of  a  new  screening  test  has  been  demonstrated,  evaluation  of
modified tests may be possible using other endpoints, if the predictive value of these
endpoints is established,

HEREBY RECOMMENDS THAT MEMBER STATES:

1.

Implementation of cancer screening programmes

(a)

(b)

(c)

(d)

offer  evidence-based  cancer  screening  through  a  systematic  population-based
approach with quality assurance at all levels. The cancer screening tests listed
in the Annex fulfil these requirements;

implement screening programmes  in  accordance  with  European  guidelines on
best practice and should facilitate the further development of best practice for
high-quality cancer screening programmes on a national level;

ensure that the people participating  in  a  screening  program  be  fully  informed
about the benefits and risks before interventions;

ensure  that  adequate  complementary  diagnostic  procedures  and  treatment  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)

(g)

take  decisions  on  the  implementation  of  a  cancer-screening  programme
nationally  or  regionally  depending  on  the  disease  burden  and  the  healthcare
resources available;

set up a systematic invitation and follow-up system and quality assurance at all
levels,  together  with  an  effective  and  appropriate  diagnostic  and  treatment
service;

2.

Registration and management of screening data

(a) make  available  centralised  data  systems  needed  to  run  organised  screening

programmes;

18

(b)

(c)

(d)

set  up  a  computerised  list  of  all  categories  of  persons  to  be  targeted  by  the
screening programme;

collect, manage  and  evaluate data on all screening tests, assessment  and  final
diagnoses;

collect,  manage  and  evaluate  the  data  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 in the
procedures  collecting,  storing,  transmitting  and  analyzing  data  in  the  medical
registers involved;

3.

Monitoring

(a)

(b)

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

adhere to the standards defined by the European Network of Cancer Registries
in establishing and maintaining the screening databases 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 in the procedures  collecting,  storing, transmitting  and
analyzing data in the medical registers involved;

(c)

regularly  monitor  performance  indicators  at  a  predefined  and  adequate
frequency;

4.

Training

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

5.

Compliance

(a)

(b)

seek  a  high  level  of  compliance,  based  on  fully-informed  consent,  when
organised screening is offered;

take action to ensure that different socio-economic groups have equal access to
screening;

6.

Introduction of novel screening tests

(a)

(b)

evaluate new cancer screening tests in randomised controlled trials before their
implementation in routine healthcare;

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;

19

(c)

(d)

decide on 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;

decide on the introduction into routine healthcare of potentially promising new
modifications  of  established  screening  tests,  once  the  effectiveness  of  the
modification  has  been  successfully  evaluated,  possibly  using  surrogate
endpoints.

7.

Implementation report and follow-up

-

report  to  the  Commission  on  the  implementation  of  this  Recommendation
within  two  years  of  its  adoption  and  subsequently  at  the  request  of  the
Commission  with  a  view 
this
to  contributing 
Recommendation at Community level;

the  follow-up  of 

to 

HEREBY INVITES THE COMMISSION:

1.

2.

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 third year after
the  date  of  adoption  of  this  recommendation,  to  consider  the  extent  to  which  the
proposed  measures  are  working  effectively,  and  to  consider  the  need  for  further
action.

To  encourage  cooperation  between  MS  and  exchange  of  best  practices  as  regards
cancer  screening  with  a  view  to  developing  new  screening  methods  or  improve
existing ones.

Done at Brussels, […]

For the Council
The President

20

ANNEX

RECOMMENDED SCREENING TESTS:

– 

– 

– 

pap smear screening for cervical abnormalities starting at the latest by the age
of 30 and definitely not before the age of 20;

mammography screening for breast cancer in women aged 50-69 in accordance
with European guidelines on quality assurance in mammography;

faecal  occult  blood  screening  for  colorectal  cancer  in  men  and  women  age
50-74.

21