Report from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions - Implementation of the Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC)
Date: 2008-12-22
Institutions: European Commission
Subjects: cancer, disease prevention, public health, report

EN 

EN 

   EN 

 
COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.12.2008 
COM(2008) 882 final 

REPORT FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN 
PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND 
THE COMMITTEE OF THE REGIONS 

Implementation of  
the Council Recommendation of 2 December 2003 on cancer screening  
(2003/878/EC) 

EN 

   EN 

 
 
  
1. 

PREFACE 

1.1. 

Introduction 

On  2  December  2003  the  Health  Ministers  of  the  European  Union  unanimously 
adopted  a  Recommendation  on  cancer  screening1.  The  Recommendation  on  cancer 
screening of the Council of the European Union acknowledges both the significance 
of the burden of cancer in the European population and the evidence for effectiveness 
of breast, cervical and colorectal cancer screening in reducing the burden of disease. 

The  Council  Recommendation  spells  out  fundamental  principles  of  best  practice  in 
early  detection  of  cancer  and  invites  Member  States  to  take  common  action  to 
implement national cancer screening programmes with a population-based approach 
and  with  appropriate  quality  assurance  at  all  levels,  taking  into  account  European 
Quality Assurance Guidelines for Cancer Screening, where they exist. Updated and 
expanded  EU  guidelines  for  breast2  and  cervical3  cancer  screening  have  recently 
been published by the Commission; comprehensive European guidelines for quality 
assurance of colorectal cancer screening are currently in preparation. 

The  development  of  new  guidelines  on  cancer  screening  as  a  means  to  foster  good 
health  in  an  ageing  Europe,  has  also  been  highlighted  in  the  EU  Health  Strategy4. 
Implementation  of  the  Recommendation  has  also  been  supported  by  the  European 
Parliament through resolutions adopted in 20035, 20066 and 20087.  

invites 

The  Recommendation 
the 
implementation of cancer screening programmes, to consider the extent to which the 
proposed  measures  are  working  effectively,  and  to  consider  the  need  for  further 
action. This is the first such report. 

the  European  Commission 

to  report  on 

1.2. 

Basis of the report 

In preparing this report, the Commission invited Member States to reply to a written 
survey  in  the  second  half  of  2007.  22  of  the  27  Member  States  (82%)  returned  the 
questionnaire as of May 2008 (Austria, Belgium, Cyprus, Czech Republic, Estonia, 
France,  Germany,  Greece,  Hungary,  Italy,  Latvia,  Lithuania,  Luxembourg,  Malta, 
Netherlands,  Poland,  Portugal,  Slovak  Republic,  Slovenia,  Spain,  Sweden,  United 
Kingdom). 

1 
2 

3 

4 
5 

6 

7 

Council Recommendation of 2 December 2003 on Cancer Screening (2003/878/EC): OJ L327/34-38. 
EU guidelines for quality assurance in breast cancer screening and diagnosis – 4th edition: Luxembourg: 
Office  for  Official  Publications  of  the  European  Communities;  ISBN:  92–79–01258–4,  catalogue 
number: ND-73–06–954-EN-C © European Communities, 2006. 
EU guidelines for quality assurance in cervical screening – 2nd edition: Luxembourg: Office for Official 
Publications  of  the  European  Communities;  ISBN  978-92-79-07698-5,  catalogue  number:  ND-70-07-
117-EN-C © European Communities, 2008. 
Together for Health: A Strategic Approach for the EU 2008-2013, COM(2007) 630 final of 23.10.2007. 
European  Parliament  resolution  of  05  June  2003  on  breast  cancer  in  the  European  Union 
(P5_TA(2003)0270): OJ C 68 E, 18.3.2004, p. 611. 
European Parliament resolution of 25 October 2006 on breast cancer in the enlarged European Union 
(P6_TA(2006)0449 B6-0528/2006): OJ C 313 E, 20.12.2006, p.273. 
European Parliament resolution of 10 April 2008 on combating cancer in the enlarged European Union 
(P6_TA(2008)0121). 

EN 

2 

   EN 

                                                 
This  survey  was  supplemented  by  information  obtained  in  two  ongoing  European 
projects  supported  by  the  EU  Public  Health  programme  (2003-20088)  dealing  with 
monitoring,  evaluation  and  quality  assurance  of  cancer  screening:  the  European 
Cancer  Network  (ECN);  and  the  European  Network  for  Information  on  Cancer 
(EUNICE). 

Population  statistics  were  obtained  from  the  European  Statistical  System,  or  from 
national  sources  if  more  recent  data  was  available.  Preliminary  findings  were  also 
discussed  with  health  ministers  at  the  informal  health  council  under  the  Slovenian 
Presidency in April 2008, following which several Member States provided further 
information. This has enabled reporting on programme implementation status for 27 
of  the  27  Member  States.  The  detailed  findings  collated  and  analysed  by  the 
European Cancer Network have also been published separately (ECN Report9).  

1.3. 

The relative burden of cancer as part of the overall burden of disease 

After  circulatory  disease,  cancer  is  the  second  most  common  cause  of  death  in  the 
European  Union  in  2006,  accounting  for  two  out  of  ten  deaths  in  women,  which 
amounts  to  a  total  number  of  554,000  women,  and  three  out  of  ten  deaths  in  men, 
which  amounts  to  698,000  men  (Figure  1a).  Due  to  the  ageing  population  this 
number is expected to rise further every year, if no preventive action is taken by the 
EC and the Member States. 

Figure 1a. Total number of deaths in the EU in 2006 and proportions of two major 
causes of death

Women 
N = 2,407,298 

Cancer 
23% 

Men 
N = 2,406,699 

Cancer 
29% 

Other 
32% 

Other 
33% 

Circulatory 
disease 
45% 

Circulatory 
disease 
38% 

Source: EUROSTAT 2006 

As  regards  cancer  cases,  every  year,  3.2  million  Europeans  are  diagnosed  with 
cancer, most of whom are suffering from breast, colorectal or lung cancers. But the 

8 

9 

Decision  No  1786/2002/EC  of  the  European  Parliament  and  of  the  Council  of  23  September  2002 
adopting a programme of Community action in the field of public health (2003-2008): OJ L271/1-11 of 
09.10.2002. 
First  report  on  the  implementation  of  the  Council  Recommendation  on  Cancer  Screening  by  the 
European  Cancer  Network  and  the  European  Network  for  Information  on  Cancer:  Luxembourg 
(http://ec.europa.eu/health/ph_determinants/genetics/documents/cancer_screening.pdf). 

EN 

3 

   EN 

 
 
                                                 
burden of cancer is far from being equally distributed across the European Union (for 
details see 1.5 below)10. 

As illustrated by national differences in cancer mortality, there is considerable scope 
to  reduce  deaths  from  cancer  across  the  Community  by  sharing  information  and 
exchange  of  best  practice  in  cancer  prevention  and  control  on  an  EU  level.  EU 
cooperation  can  thus  provide  significant  added  value,  as  developed  under  "Europe 
against Cancer" since 1987 for the area of screening for cancer in particular. 

1.4. 

Specific burden of breast, cervical and colorectal cancer 

Breast, cervical and colorectal cancer are a major cause of suffering and death in the 
Member  States  of  the  European  Union10.  According  to  estimates  of  incidence  and 
mortality  by  the  International  Agency  for  Research  on  Cancer  (IARC),  there  were 
331,000 new cases and 90,000 deaths due to breast cancer, and 36,500 new cases and 
15,000 deaths due to cervical cancer11 among women in the EU in 2006. At the same 
time  new  cases  of  colorectal  cancer  were  estimated  at  140,000  in  women  and 
170,000 in men. Colorectal cancer deaths were estimated at 68,000 for women and 
78,000 for men in the EU. Together, these cancers account for almost one out of two 
(47%) new cases and one out of three (32%) cancer deaths in women in the EU. In 
men, colorectal cancer currently accounts for one out of eight (13%) new cases and 
one out of nine (11%) cancer deaths (Figures 1b and 1c). 

 Figure 1b. Total number of cancer cases in the EU in 2006 and proportion of breast, 
cervical and colorectal cancer9,10 

Women 
N = 1,087,200 

Colon and rectum
13% 

Men 
N = 1,307,800 

Colon and rectum 
13% 

Other 
54% 

Other 
87% 

Breast 
30% 

Cervix 
3% 

10 

11 

Ferlay  J,  Autier  P,  Boniol  M,  Heanue  M,  Colombet  M,  Boyle  P  (2007)  Estimates  of  the  cancer 
incidence and mortality in Europe in 2006. Ann Oncol 18: 581-592. 
IARC mortality estimates for cervical cancer include a proportion of deaths attributed to "unspecified 
uterine cancer". 

EN 

4 

   EN 

 
 
                                                 
Figure 1c. Total number of cancer deaths in the EU in 2006 and proportion of deaths 
due to breast, cervical and colorectal cancer. Percentages for women do not add up 
due to rounding9,10 

Women 
N = 536,700 

Colon and rectum
13% 

Men 
N = 690,100 

Colon and rectum
11% 

Other 
68% 

Other
89% 

Breast
17% 

Cervix
3% 

1.5. 

Diversity of cancer rates in the EU2710 

Incidence and mortality rates of these cancers vary widely across the EU, reflecting a 
major health burden in various Member States. 
According  to  IARC  estimates  the  highest  incidence  rate  of  breast  cancer  is  137.812 
for Belgium, with a mortality rate of 33.5, while the highest mortality rate is 34.5 for 
Denmark,  with  an  incidence  rate  of  122.6.  The  lowest  estimated  incidence  rate  for 
breast  cancer  is  61.2  for  Romania  with  a  mortality  rate  of  23.9  and  the  lowest 
mortality rate is 19.2 for Spain with an incidence rate of 93.6. 

The  burden  of  disease  is  particularly  unevenly  distributed  in  the  case  of  cervical 
cancer.  For  cervical  cancer  IARC  estimates  the  highest  incidence  rate  as  24.5  for 
Romania with the highest mortality rate of 17.0. The lowest incidence rate is 4.9 for 
Finland  and  at  the  same  time  Finland  enjoys  the  lowest  mortality  rate  of  1.6.  The 
proportion of cancer cases and deaths attributed to this cancer is markedly elevated in 
all but one of the Member States which acceded to the EU in 2004 and 2007. 

For  colorectal  cancer  the  highest  incidence  rate  is  106.0  for  Hungary,  which  in 
addition suffers from the highest mortality rate of 54.4. The lowest incidence rate for 
colorectal  cancer  is  31.0  for  Greece,  which  at  the  same  time  enjoys  the  lowest 
mortality rate of 15.5.  

2. 

RESULTS 

2.1. 

Overview of results 

The  maps  below  show  the  current  coverage  of  population-based  screening 
programmes across the EU.  

12 

Reflecting standard practice, incidence and mortality rates given in this Report are per 100,000 of the 
population. 

EN 

5 

   EN 

 
 
                                                 
Distribution of Breast Cancer Screening Programmes Based on Mammography 
in the EU in 2007 

Population-based, Nationwide

Rollout complete 

Rollout ongoing 

Piloting 

Planning 

Non-Population-based, Nationwide

Population-based and 
Non-Population-based 

No programme 

Figure 2. Breast screening programmes in the European Union in 2007, by programme type 
(population-based; non-population-based; no programme) and country implementation status 
(population-based:  nationwide  or  regional,  rollout  complete  or  ongoing,  piloting  and/or 
planning;  non-population-based:  nationwide  or  regional).  Programmes  shown  use  screening 
test (mammography) recommended by the Council of the European Union in 20031. 
Source: ECN9 

EN 

6 

   EN 

 
Distribution of Cervical Screening Programmes based on Cervical Cytology 
in the EU in 2007 

Population-based, Nationwide

Rollout complete 

Rollout ongoing 

Piloting 

Planning 

Population-based, Regional

Rollout complete 

Rollout ongoing 

Piloting 

Non-Population-based, Nationwide

Non-Population-based, Regional

Population-based and 
Non-Population-based 

No programme 

Figure  3.  Cervical  cancer  screening  programmes  in  the  European  Union  in  2007,  by 
programme  type  (population-based;  non-population-based;  no  programme)  and  country 
implementation  status  (population-based:  nationwide  or  regional,  rollout  complete  or 
ongoing,  piloting  and/or  planning;  non-population-based:  nationwide  or 
regional). 
Programmes  shown  use  screening  test  (PAP  smear)  recommended  by  the  Council  of  the 
European Union in 20031. 
Source: ECN9 

EN 

7 

   EN 

 
Distribution of Colorectal Cancer Screening Programmes based on the 
Faecal occult Blood Test in the EU in 2007 

Population-based, Nationwide

Rollout ongoing 

Piloting 

Planning 

Population-based, Regional 

Piloting 

Planning 

Non-Population-based, Nationwide

Population-based and 
Non-Population-based 

No programme 

Figure 4. Colorectal cancer screening programmes based on FOBT (faecal occult blood test) 
in the European Union in 2007, by programme type (population-based; non-population-based; 
no programme) and country implementation status (population-based: nationwide or regional, 
rollout  complete  or  ongoing,  piloting  and/or  planning;  non-population-based:  nationwide  or 
regional).  Programmes  shown  use  screening  test  recommended  by  the  Council  of  the 
European Union in 20031. 
Source: ECN9 

EN 

8 

   EN 

As  the three  maps above indicate,  although  much progress has been made, more is 
still required: 

•  For breast cancer, only 22 Member States are running or establishing population-

based screening programmes; 

•  For cervical cancer, only 15 Member States; 

•  For colorectal cancer, only 12 Member States. 

The  current  annual  volume  of  screening  examinations  in  the  EU  is  considerable; 
however,  this  volume is  less  than  one-half  of  the  minimum  annual  number  of 
examinations  that  would  be  expected  if  the screening  tests  specified  in  the  Council 
Recommendation  on  cancer  screening  were  available 
to  all  EU  citizens 
of appropriate age (approximately 125 million examinations per year). Furthermore, 
less  than  one-half  of  the  current  volume  of  examinations  (41%)  is  performed  in 
population-based  programmes  which  provide  the  organisational  framework  for 
implementing  comprehensive  quality  assurance  as  required  by  the  Council 
Recommendation. 

2.2. 

Implementation of the Council Recommendation by the Member States 

2.2.1. 

Implementation of cancer screening programmes 

Section  one  of  the  Council  Recommendation  comprises  a  set  of  safeguards, 
technical,  ethical  and  legal  standards  to  be  followed  when  implementing  screening 
programmes in the Member States. It covers a set of eight recommendations ensuring 
a  strict  evidence  base  for  implementing  screening  programmes,  the  recognition  of 
EU guidelines on best practice, the observation of ethical standards in informing on 
benefits and risks and to be able to adequately follow-up any screen-detected lesion, 
and  last  but  not  least  the  necessary  level  of  data  protection.  Most  of  these  eight 
recommendations,  dealing  specifically  with  establishing  screening  programmes,  are 
reported to be followed by at least two out of three of the Member States (67%). 

2.2.2.  Registration and management of screening data 

Section  two  comprises  a  set  of  four  recommendations  ensuring  the  proper 
functioning  of  any  quality  assured  screening  programme  requesting  an  electronic 
call/recall  system  and  the  collection,  management  and  evaluation  of  all  data  from 
screening tests. 

These points are reported to be followed by a very large proportion of the responding 
Member States. Eighteen out of 22 (82%) use centralized data systems and call/recall 
systems for  running programmes and for inviting all targeted  persons, respectively. 
Twenty  out  of  22  (91%)  Member  States  report  that  data  is  collected,  managed  and 
evaluated  not  just  on  screening  results,  but  also  on  assessment  of  persons  with 
positive screening results and on diagnosis. The same high conformity is reported for 
data  handling  in  full  accordance  with  European  data  protection  legislation, 
particularly  as  it  applies  to  personal  health  data,  prior  to  implementing  cancer 
screening programmes. 

2.2.3.  Monitoring 

Section  three  comprises  three  recommendations  aiming  to  establish  the  necessary 
basis for quality insurance by regular monitoring of screening programmes. 

Although a majority of the Member States indicate that they comply with two of the 
three  specific  items  in  this  section  dealing  with  monitoring  screening  programmes, 

EN 

9 

   EN 

compliance was substantially lower than for most items in all other sections (except 
section six). 

With  regard  to  item  3  (a)  in  the  Council  Recommendation,  only  55%  of  the 
responding  Member  States  report  that  the  process  and  outcome  of  organised 
screening  is  monitored  regularly  by  an  independent  peer  review  and  59%  indicate 
that the results are reported quickly to the general public and to screening staff. The 
lower proportions of responding Member States performing such monitoring reflect 
the  limited  applicability  of  the  respective  questions  in  the  EU  survey  to  Member 
States  in  which  population-based  cancer  screening  programmes  have  not  been 
initiated. The comparatively very low proportion of Member States which report that 
national  cancer  registries  monitor  screening  programmes  (45%)  will  have  to  be 
further explored. 

2.2.4.  Training 

Section  four  contains  one  recommendation  highlighting  the  importance  of  training 
for all health professionals involved in screening programmes. 

Very  high  compliance  is  reported  for  section  four  of  the  Council  Recommendation 
dealing with training. Twenty out of 22 Member States (91%) report that screening 
programme personnel is adequately trained at all levels to ensure that they are able to 
deliver high quality screening. 

2.2.5.  Compliance 

Section  five  comprises  two  recommendations  seeking  high  compliance  for  the 
population  including  special  action  to  insure  equal  access  for  particular  vulnerable 
social economic population groups. 

A  high  proportion  of  the  Member  States  indicate  that  they  adhere  to  these 
recommendations. Twenty out of 22 Member States (91%) report that a high level of 
compliance  is  sought  from  the  eligible  population  when  organised  screening  is 
offered. Eighteen out of 22 Member States (82%) report that action is taken to ensure 
equal access to screening, taking due account of the possible need to target particular 
socio-economic groups. 

2.2.6. 

Introduction of novel screening tests 

Section six comprises a set of five recommendations how to deal with and implement 
new  screening  methods  for  two  distinct  situations:  Novel  screening  tests  and 
variations or improvements of the recommended screening tests listed in the annex of 
the Council Recommendation on cancer screening. 

Approximately  11  out  of  the  22  Member  States  (50%)  report  adherence  to  the 
respective  items  in  section  six  of  the  Council  Recommendation  dealing  with 
introduction  of  novel  screening  tests  taking  into  account  international  research 
results.  

3. 

CONCLUSIONS 

Four  years  after  the  Council  of  Ministers  of  the  European  Union  adopted  a 
Recommendation  on  Cancer  Screening,  most  Member  States  have  acted  on  the 
Recommendation and intend to undertake further action where implementation is not 
yet complete. Thus, the formulation of joint priorities and principles of health policy 
at  the  European  level  has  been  followed  up  by  actions  at  the  level  of  the  Member 
States to implement the shared policies and priorities. 

EN 

10 

   EN 

Nevertheless, and despite these substantial efforts, overall the EU is still only around 
half-way  towards  implementing  the  Recommendation.  Slightly  less  than  half  the 
population  who  should  be  covered  by  screening  according  to  the  Recommendation 
actually  are;  and  less  than  half  of  those  examinations  are  performed  as  part  of 
screening programmes meeting the stipulations of the Recommendation. 

This  illustrates  the  need  for  greater  efforts  within  Member  States,  supported  by 
collaboration between Member States and professional, organisational and scientific 
support  for  Member  States  seeking  to  implement  or  improve  population-based 
screening programmes. Substantial added value may be expected from such support 
and  from  additional  efforts  to  improve  and  maintain  high  quality  of  screening 
programmes. 

Work  continues  to  help  support  the  implementation  of  the  Recommendation.  For 
example, development and piloting of EU-wide accreditation/certification schemes13 
for  screening  services  based  on  EU  guidelines  for  quality  assurance  of  cancer 
screening would enable programmes to focus efforts on achieving the EU standards. 
This, in turn, would enable Member States to reap the potential of population-based 
screening to lower the burden of cancer in the population. 

Even though the current volume of activities is still far from the level which can be 
expected  in  the  future,  the  current  expenditure  in  human  and  financial  resources  is 
already  considerable.  A  sustained  effort  is  therefore  necessary  at  Community  level 
and within Member States in identifying appropriate and effective measures to assure 
the  quality,  effectiveness  and  cost-effectiveness  of  current  and  future  screening 
into  account  scientific  developments.  Regular,  systematic 
taking 
activities, 
investigation,  monitoring, 
reporting  on 
and  EU-wide 
implementation of cancer screening programmes will continue to support exchange 
of  information  on  successful  developments  and  to  identify  weak  points  requiring 
improvement. 

evaluation 

status 

Cancer  continues  to  represent  one  of  the  greatest  burdens  of  ill-health  within  the 
European Union. The Recommendation on cancer screening represents a shared EU-
wide commitment to taking practical steps to minimise that burden in practice, to the 
benefit of individual citizens and their families as well as to society as a whole. As 
this  Report  shows,  putting  in  place  these  screening  measures  is  a  challenging  task, 
and more work is needed to fully implement the Recommendation.  

This  effort  only  addresses  one  aspect  of  action  against  cancer.  Actions  to  better 
monitor  and  prevent  cancer  at  Community  and  Member  States'  level  can  help  to 
reduce the number of cases arising at all; application of best-practice treatment can 
help to ensure better outcomes for people with cancer, as can European cooperation 
on  cancer  research  for  the  future.  The  Commission  will  also  consider  whether  and 
what  further  support  can  be  provided  to  Member  States  to  address  other  specific 
issues related to cancer challenges for the future. 

In  2009  the  Commission  intends  to  launch  a  partnership  for  action  against  cancer. 
This partnership intends to put in place EU-wide commitments on concrete action to 
prevent  and  control cancer  and  thus  contribute  to  reducing  inequalities  in  tackling 
cancer.  It  will  aim  to  support  the  Member  States  by  providing  a  framework  for 

13 

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the  requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of  products  and 
repealing Regulation (EEC) No 339/93: OJ L218/30-47 of 13.08.2008. 

EN 

11 

   EN 

                                                 
identifying and sharing information, capacity and expertise in cancer prevention and 
control,  and  by  engaging  relevant  stakeholders  across  the  European  Union  in  a 
collective effort to reduce the burden of ill health that cancer represents.  

EN 

12 

   EN