COMMISSION STAFF WORKING DOCUMENT STAKEHOLDER CONSULTATION - SYNOPSIS REPORT Accompanying the document Proposal for a Council Recommendation on strengthening prevention through early detection: A new EU approach on cancer screening replacing Council Recommendation 2003/878/EC
Date: 2022-09-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: cancer, disease prevention, health care, health risk, medical diagnosis

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 20.9.2022  SWD(2022) 296 final  COMMISSION STAFF WORKING DOCUMENT  STAKEHOLDER CONSULTATION - SYNOPSIS REPORT      Accompanying the document Proposal for a Council Recommendation on strengthening prevention through early detection: A new EU approach on cancer screening replacing Council Recommendation 2003/878/EC {COM(2022) 474 final}  
 
 
1.  Introduction 

This  report  presents  the  outcomes  of  a  number  of  consultations,  which  were  conducted  to 
support the development of a Commission proposal on cancer screening, including namely: 

(1) The Scientific Opinion on Cancer Screening in the European Union1, developed by the 
Group of Chief Scientific Advisors (GCSA), which builds upon the Evidence Review 
Report  (ERR,  SAPEA  2022),  additional  literature,  and  expert  and  stakeholder 
consultation. 

(2) Feedback received from 87 contributors in response to a Call for Evidence on the ‘Have 
your say’ platform from 25 January until 22 February 20222, by which the Commission 
invited  stakeholders  to  share  their  experiences,  expectations,  evidence  and  other 
relevant  input  to  prepare  the  Council  Recommendation.  The  responders  included  40 
non-governmental organisations, 20 company and business organisations/associations, 
18  citizen/consumer  organisations  and  individual  citizens/consumers,  6  public 
authorities, and 3 academic and research institutions. Contributions were received from 
16 EU Member States, and three other countries (Switzerland, United Kingdom, United 
States). 

(3) Inputs from EU/EEA Member States’ representatives of health and research ministries 
participating  in  the  Steering  Group  on  Health  Promotion,  Disease  Prevention  and 
Management  of  Non-Communicable  Diseases  (SGPP)  Sub-group  on  Cancer  in  four 
meetings organised in the period March-May 2022.  

(4) Inputs  from  stakeholders  provided  in  a  public  webinar,  titled  “Cancer  Screening  – 
Update of Council recommendation on cancer screening”, organised by the Commission 
on 28 March 2022 with 81 participants), and inputs of 2069 stakeholders who responded 
to  a  public  online  consultation  on  the  Europe’s  Beating  Cancer  Plan  (February-May 
2020).  The  responders  represented  all  Member  States;  two  thirds  were  individual 
stakeholders and one third were representatives of stakeholder organisations, including 
research (35%), patient associations (25%) and care professional associations (10%). 

Results  of  the  consultations  are  clustered  along  three  questions,  which  also  guided  the 
development of the Scientific Opinion of the GCSA: 

(1) How  can  screening  programmes  targeting  breast,  cervical  and  colorectal  cancers  be 

improved throughout the EU?  

(2) What is the scientific basis for extending screening to other cancers, e.g. lung, prostate 

and gastric cancers, and for ensuring their feasibility throughout the EU?  

(3) What are the main scientific elements to consider, and best practices to promote, for 

optimising risk-based cancer screening and early diagnosis throughout the EU? 

2.  Improving breast, cervical and colorectal cancer screening programmes 

2.1 Scientific Opinion 

The GCSA Scientific Opinion recommends that the existing screening programmes for breast, 
cervical and colorectal cancer integrate up-to-date scientific knowledge, are coordinated across 
the whole cancer pathway, and center around citizens. The report includes the following specific 

1  European  Commission,  Directorate-General  for  Research  and  Innovation,  Group  of  Chief  Scientific  Advisors, Scientific 
opinion on cancer screening in the European Union, 2022, https://data.europa.eu/doi/10.2777/14480 
2 Call for Evidence for an initiative Ares(2022) 583417-25/01/2022, https://ec.europa.eu/info/law/better-regulation/have-your-
say/initiatives/13155-Cancer-Screening-Recommendation-update_en 

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recommendations: 

 

Improve the participation of citizens in cancer screening programmes by making access 
easy (e.g. through self-sampling or home-based testing), by offering decision support 
aids and through shared decision-making between citizens and clinicians.  

  Ensure that best practices and quality standards are developed and applied in screening, 
along  with  staff  training  and  continuous  monitoring  and  evaluation  for  quality 
assurance.  

  Extend breast cancer screening for women below the age of 50 with mammography or 
digital breast tomosynthesis, and for women with dense breasts with magnetic resonance 
imaging (MRI).  

  For cervical cancer, prioritise screening by testing for human papilloma virus (HPV) 
and  support  its  eradication  through  the  uptake  of  vaccination  against  HPV  below  15 
years of age.  

  For colorectal cancer, use fecal immunochemical testing (FIT) as the preferred triage 

test for referring individuals for follow-up colonoscopy. 

2.2 Response on Call for evidence 

Almost  two  thirds  of  the  responses  were  suggestions  to  improve  the  current  screening 
programmes; these were both overarching suggestions or specific for certain types of cancer 
screening. 

Overarching suggestions: 

Improve participation 

Improve (digital) communication and awareness campaigns. 
Improve equity within screening programmes.  

 
 
  Address barriers to cancer screening faced by people with disabilities. 
  Pay  attention  to  the  realities  of  trans,  non-binary  and  intersex  citizens  in  access  to 

screening, treatment, and prevention appropriate to their bodies. 
Improve cancer health literacy and awareness through national campaigns.  

 
  Enhance shared decision making. 
  Work together with patient organisations. 

Improve coordination 

  Establish a coordinated action or network of agencies across Member States to prioritise 
access and allocate adequate funds to cancer screening in their national cancer plans. 

  Create a European policy agenda on early detection and diagnosis of all cancers. 
  Establish  a  comprehensive  EU-wide  monitoring  framework,  linked  to  the  Cancer 
Inequalities Registry, to support assessment against predetermined performance indicators. 
  Consider differences in implementation when comparing national screening programmes, 
such as conscious deviation from EU guidelines as to targeted patient populations, scope 
and methodology, as well as their results. 

Improve quality 

  Set a minimum standard and promote harmonised screening programmes across the EU, in 

line with European guidelines with quality assurance, where available.  
Invest in staff, technologies, and diagnostic capacity. 

 

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  Train  more  healthcare  professionals,  and  ensure  that  healthcare  professionals  are 

incentivised to meet quality standards. 

  Establish at least one national cancer registry per Member State. 
  Support pilot projects that generate evidence. 
  Develop, validate and evaluate new screening programmes.  
  Monitor adherence and effectiveness of screening programmes at EU level. 

Specific suggestions: 

  Breast cancer: promote targeted screening; inform women about their breast tissue density; 
promote  earlier  access  than  45  years;  use  alternative  screening  tests  (ultrasound,  MRI, 
CEM, DBT). 

  Cervical  cancer:  implement  a  more  common  training  programme  and  certification;  use 
alternative screening tests (self-testing, mRNA-based HPV testing, liquid-based cytology). 
  Colorectal  cancer:  better  align  diagnosis,  treatment,  and  aftercare;  build  an  electronic 
platform  for  reporting,  acquisition  and  storage  of  images  and  films;  build  capacity  to 
manage  colonoscopies  and  colorectal  cancer  surgeries;  use  alternative  screening  tests 
(blood-based screening tests, adenoma detection rate, FIT test).  

The suggestions listed were mostly made by company and business organisations when it comes 
to specific tests, and also by NGOs when it comes to other screening aspects. 

2.3 Feedback from EU/EEA Member States’ representatives 

Overarching suggestions: 

  Take  a  stepwise  approach:  1.  fully  implement  the  2003  Council  Recommendation  (for 
Member States that have not done this yet); 2. improve the quality and implementation of 
current cancer screening programmes; 3. expand to other types of cancer screening. 

  Build capacity: The EU could support Member States in setting up screening infrastructures 
and programmes, while taking into account the resources needed to increase and improve 
cancer screening as well as the implications for the health workforce capacity throughout 
the entire care pathway, and investing in skill development of healthcare professionals. 
  Take a systemwide approach, i.e. link screening with primary prevention; offer screening 
in close relation with primary care, and ensure continuity of care after a positive screening 
result.  

  Address barriers related to the health system to improve equity and facilitate the exchange 
of expertise and good practices across Member States and consider twinning programmes. 

  Optimise and use validated screening procedures and available tools.  
  Pay more attention to risk-based screening protocols and applying other age ranges in case 

 

 

of familial cancers. 
Increase screening participation rates by engaging citizens in designing and implementing 
information campaigns.  
Improve informed decision-making on participation by paying more attention to citizens’ 
health literacy. 

  Collect and exchange quality data for monitoring and evaluation. This would include the 
development of quality assurance guidelines and a common set of quality indicators/KPIs 
(including targets), and using digital tools to facilitate data sharing.  

Specific suggestions and comments: 

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  Breast cancer: consider a longer interval between screenings (for the sake of feasibility of 
population-wide screening); consider an earlier start-age for familial cases; provide more 
clarity  on the definition of ‘particularly dense’ breasts;  consider the implications  for the 
capacity needed for MRI screening; and take into account the chance of allergic reactions 
to intravenous contrast agents in case of considering MRI. 

  Cervical cancer: a discrepancy was noted between the evidence and the proposed  draft of 
the  Council  Recommendation  in  the  start-age  for  HPV  screening  and  personalising  the 
screening according to vaccination status. Furthermore, the proposed start-age, stop-age and 
screening interval are the most intensive ones suggested by European guidelines; this may 
hamper de-intensification of screening for vaccinated women and in low-risk women (e.g. 
older women with previous negative HPV tests). 

  Colorectal cancer: consider qualitative and quantitative protocols as triage methods; specify 
the  use  and  evaluation  of  the  FIT  test;  clarify  the  role  of  colonoscopy  in  the  screening 
process;  tackle  alignment  problems  between  primary  and  secondary  care  in  relation  to 
colonoscopies; and consider the option of an endoscopic approach. It was also suggested 
that  Member  States  conduct  systematic  evidence-based  decision  analyses,  taking  into 
account the benefit-harm balance, cost-effectiveness and other relevant factors, to finetune 
their screening approach. 

2.4. Feedback from stakeholder groups 

The public consultation on the Europe’s Beating Cancer Plan resulted in 419 responders (out 
of 2069) who prioritised improving the participation in breast, cervical and colorectal cancer 
screening  above  other  actions  in  the  area  of  screening.  The  following  factors  were  most 
frequently mentioned by responders to influence their decision to take part in a cancer screening 
programme:  safety  and  quality  of  equipment  (31%),  information  about  the  usefulness  of 
screening and early diagnosis (21%), expertise and skills of healthcare workers (17%), and costs 
(12%).  

In the more recent stakeholder meeting on cancer screening, stakeholders made some specific 
suggestions: 

  Address the main issues facing LGBTI people in the context of cancer: 1. focus on the body 
parts that people have, not on the sex marked in their identity documents; and 2. address 
discrimination. 
Include HPV vaccination for both girls and boys under 15 years of age. 

 

3.  Scientific basis for and feasibility of extending screening to other cancers 

3.1 Scientific Opinion 

The  Scientific  Opinion  recommends  to  extend  population  screening  to  cancers  for  which 
scientific evidence demonstrates a good harm-benefit ratio, cost-efficiency, advantages of early 
detection, and feasibility throughout the EU, while regularly reviewing the scientific evidence 
for screening of other cancers. The report includes the following specific recommendations: 
  Extend  population  screening  to  lung  cancer  using  low  dose  computed  tomography  for 

current and ex-smokers. 

  Extend population screening to prostate cancer by Prostate Specific Antigen (PSA)-based 

screening with additional MRI scanning as follow-up test.  

  For gastric cancer, population based screen-and-treat programmes for Helicobacter pylori 
are only recommended in regions with intermediate to high gastric cancer incidence.  

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  There  is  currently  no  scientific  ground  for  population  based  endoscopic  screening  for 

esophageal cancer, and ultrasound and CA125 screening for ovarian cancer. 

3.2 Responses on Call for Evidence 

The majority of responders expressed their support to extend screening to other cancers. There 
were some calls for caution from four NGO’s and one academic or research institution, asking 
to carefully consider cost-effectiveness and the not (yet) established risk-benefit ratio of new 
screening  programme(s)  for  citizens/patients,  also  considering  unintended  harms.  One  NGO 
specifically referred to prostate and lung cancer as examples where the risk-benefit ratio was 
not yet established. Apart from these few cautious reflections, no respondents clearly opposed 
expansion of cancer screening to specific forms of cancer. 

A third of the contributions provided scientific support for extending cancer screening: 
  The  majority  referred  to  or  provided  evidence  for  extending  to  lung  or  prostate  cancer 
screening.  The  positive  results  of  several  studies  with  low  dose  CT  (LDCT)  scans  as  a 
screening test for lung cancer were mentioned 15 times.  

  Targeted screening and risk-based approaches were mentioned as approaches for prostate 
cancer screening, but  also new  cancer  screening  tests  such as MRI, biomarking test and 
PSA home-testing. 

  Evidence for extending cancer screening to liver cancer, oral cavity cancer and skin cancer 

was also provided.  

Almost  all  recommendations  were  mentioned  by  company  and  business  organisations  and 
NGO’s, except the recommendations regarding skin cancer which were also from academic or 
research institutions. 

3.3 Feedback from EU Member States’ representatives 

Overarching suggestions: 

  Take  account  of  feasibility  and  cost-effectiveness,  in  addition  to  scientific  evidence  on 
efficacy, when deciding on new screening programmes. Consider the criteria developed by 
Wilson & Jungner3 and recent criteria emerging from this work to decide on new screening 
programmes. 

  Take  account  of  the  substantial  false-positive  rates,  and  how  these  could  be  reduced,  in 

deciding on screening and the approach. 

  Approach the implementation of new screening programmes stepwise: include a planning 
phase;  develop  EU  screening  guidelines  (and  include  quality  assurance);  develop  the 
programme(s); conduct national pilots to identify the optimal strategy, selection criteria and 
screening intervals; conduct health services research alongside the implementation phase. 
Clarify the timelines needed for such a stepwise approach. 

  Pay more attention to risk-based variants of screening. 
  Monitor the benefits and harms, and specify which data are needed. 

Specific suggestions and comments: 

Lung cancer screening: 

  Take account of the health economic perspective in considering the frequency of screening. 
  Link  screening  with  smoking  cessation  support  (irrespective  of  screening  result),  when 
screening smokers; and with health education in schools, training institutes, universities. 

3 Wilson, James Maxwell Glover, Jungner, Gunnar & World Health Organization. (1968). Principles and practice of 
screening for disease / J. M. G. Wilson, G. Jungner. World Health Organization. https://apps.who.int/iris/handle/10665/37650 
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  Reconsider to be specific on the age range (not backed up with evidence). 

Prostate cancer screening: 

  Take an earlier start-age in familial cases. 
  Discrepancy noted between evidence and recommendations of the GCSA in using the word 
‘extend’  in  the  screening  protocols  for  risk-adapted  screening  strategy  (in  the 
recommendation to have a baseline PSA at the age of 40-45). 

  Define a follow-up pathway for each result of the PSA test. 
  Evidence is not conclusive that PSA screening reduces mortality.  

3.4.  Feedback from stakeholder groups 

The public consultation on the Europe’s Beating Cancer Plan in 2020 showed broad support 
(84% of the 2069 responders) for extending cancer screening to other types of cancer, where 
screening can be effective. Priorities for extending to other cancer types varied: ovarian cancer 
(mentioned by 28%), prostate cancer (22%), lung cancer (8%), gastric cancer (4%), other types 
of cancer (37%) and not specified (1%). 

In  the  more  recent  stakeholder  meeting  on  cancer  screening,  stakeholders  made  a  specific 
suggestion on prostate cancer screening:  

  PSA is reliable as initial test when properly used with risk calculators/ stratification and the 

use of mpMRI.  

4.  Scientific elements of risk-based cancer screening and early diagnosis 

4.1 Scientific Opinion 

The Scientific Opinion recommends to take advantage of the rapidly developing technological 
possibilities  and  scientific  knowledge  to  optimise  risk-based  cancer  screening  and  early 
diagnosis throughout the EU. Specific recommendation are to: 
  Develop  a  system  of  “living  guidelines”  that  can  be  rapidly  modified  and  updated  in 

response to new scientific findings. 

  Further develop and implement risk-stratified screening to improve the harm-benefit ratio 

of screening programmes.  

  Ensure preparedness for the introduction of new screening methods, for less invasive and 
blood-based  screening  where  large-scale  clinical  trials  are  expected  to  yield  results  for 
multiple cancer screenings in the coming years.  

  Support the establishment of biobanks appropriate for biomarker-based cancer screening 

research.  

  Support the harmonisation of protocols and quality assurance within and between countries. 

4.2 Responses to Call for Evidence 

A  quarter  of  the  responders  made  recommendations  for  new  screening  technologies  or 
approaches:  

  Digital innovation  

o  New  imaging  in  breast  cancer  (ultrasound,  MRI,  molecular  breast  imaging,  contrast-

enhanced mammography); 

o  New non-invasive methods and technologies for prostate cancer screening, also using 

AI-based computational medicine and network analysis; 

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o  Exploitation  of  technical  innovations  (integrated  diagnostics)  for  prostate  cancer 

screening. 

 

Innovative technologies 
o  (High performing) multi-cancer screening test or early detection test; 
o  Liquid biopsies (minimally invasive blood/urine tests to detect cancer cells); 
o  Genomic testing/Predictive genetic testing (biomarkers). 

 

Innovation in the screening programme design 
o  Risk  stratification/risk-based  screening/targeted  or  personalised  screening  in  general, 

and specifically for breast and prostate cancer. 

o  Social  innovation  in  programme  design,  i.e.  considering  possible  behavioural 

determinants for cancer screening. 

Almost all input was from public authorities, company and business organisations and NGO’s. 
Also  here  some  calls  for  caution  were  made,  among  others  pointing  to  the  importance  of 
avoiding overdiagnosis and of focusing on high-performing tests only, also to avoid reductions 
in participation rates over time. 

4.3  Feedback from EU Member States’ representatives 

The  recommendation  to  develop  a  system  of  “living  guidelines”  was  supported.  It  was 
emphasised that countries should take into account the feasibility, organisational impact and 
acceptability of such a system. It was also suggested to set up a systematic monitor to assess 
the quality and impact of (new) cancer screening programmes, and link this with existing cancer 
monitoring systems, such as cancer registries. 

4.4  Feedback from stakeholder groups 

Respondents to the public consultation on the Europe’s Beating Cancer Plan in 2020 reported 
that the following elements were areas where screening could be improved: by standard setting, 
risk categorisation, quality assurance, encouragement of best practices, targeted interventions, 
monitoring, and research. 

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5.  Discussion 

5.1 Improving breast, cervical and colorectal cancer screening programmes 

Many recommendations of the GCSA and suggestions from public contributors to the Call for 
Evidence and Member States’ representatives are about improving the participation of citizens 
in  cancer  screening  programmes.  Consensus  exist  that  this  could  be  achieved  by  better 
informing citizens (e.g. improving awareness campaigns, improving (digital) communication 
about  risks  and  benefits,  implementing  decision  tools),  but  also  by  facilitating  access  to 
screening  by  implementing  self-  and  home-testing,  and  alternative  testing  such  as  MRI  and 
fecal immunochemical test (FIT). 

The GCSA, public contributors and EU Member States’ representatives are also unanimous in 
their recommendation to put more effort in quality improvement and assurance, for example by 
developing and implementing a minimum set of standards and promoting harmonised screening 
programmes throughout the EU, in line with European guidelines with quality assurance, where 
available.  and by continuously educating healthcare professionals and training staff operating 
on equipment. All sources also emphasise the importance of building more screening capacity 
and  training  healthcare  professionals,  including  those  who  are  not  directly  involved  in 
screening, to ensure continuity of care through the cancer pathway.  

Coordination of screening programmes at national level or EU level was recommended by the 
GCSA and the public responders on the Call for Evidence, either to facilitate access and allocate 
adequate funds to cancer screening in national cancer plans or to ensure optimal communication 
and integration of screening in the whole cancer pathway. Sources also agree that adherence, 
efficacy and cost-effectiveness of the screening programmes should be monitored at EU level. 

Extending  breast  cancer  screening  to  women  younger  than  50  and  an  additional  national 
vaccination  programme  against  HPV  for  cervical  cancer  are  specific  recommendations 
supported by all consulted sources.  

5.2 Scientific basis for and feasibility of extending screening to other cancers 

All  sources  supported  the  extension  of  population  screening  to  cancers  for  which  there  is 
scientific  evidence  of  a  good  harm-benefit  ratio,  cost-effectiveness,  advantages  of  early 
detection, and feasibility throughout the EU. It was also emphasised that the substantial false-
positive rates of new screenings need to be reduced. 

Screening  for  lung  cancer  before  symptoms  appear  can  result  in  earlier  diagnosis,  reduced 
mortality, and reduced expenditure. The GCSA, the public contributors to the Call for Evidence 
and EU countries’ representatives all favour lung cancer screening using low dose computed 
tomography  for  current  and  ex-smokers.  Screening  for  lung  cancer  is  recommended  by  all 
respondents to be combined with smoking cessation support. 

Many sources are also in favour of extending to PSA-based prostate cancer screening, combined 
with MRI scanning as a follow-up test and follow-up path. Targeted screening and risk-based 
approaches  are  mentioned,  but  further  research  is  needed  on  the  cost-effectiveness,  harm-
benefit ratio and an earlier start-age in familial cases of prostate cancer screening. 

According  to  the  Scientific  Opinion  of  the  GCSA,  population-based  screen-and-treat 
programmes for Helicobacter pylori are only recommended for gastric cancer in regions with 
intermediate to high gastric cancer incidence. Population-based screening for H. pylori was not 
supported by all EU countries, and only minimally supported by public contributors. 

5.3 Scientific elements of risk-based cancer screening and early diagnosis 

Both the GCSA and the public contributors to the Call for Evidence are aware of the rapidly 
developing technological possibilities and scientific knowledge to optimise risk-based cancer 
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screening and early detection. Some of these technologies can be used to optimise the selection 
criteria and the frequency of screening. Digital innovations, such as AI and machine learning, 
can improve risk models for cancer detection. Several new screening methods, in particular less 
invasive  and  blood-based  (multiple)  cancer  screening  methods  (liquid  biopsies,  genomic 
testing,  early  detection  tests,  biomarkers  etc.),  are  also  promising,  but  are  not  yet  ready  for 
implementation. 

6.  How feedback was taken into account 

The opinions, suggestions and recommendation of the consulted sources on a new EU Cancer 
Screening Scheme were taken into account. 

With regard to improving the current screening programmes, the Commission recognises the 
great importance of improving the participation of citizens in cancer screening and of putting 
more  effort  in  quality  improvement  and  assurance,  building  more  screening  capacity  and 
training  healthcare  professionals.  The  Commission  also  emphasises  that  these  screening 
programmes should be coordinated, and monitored and evaluated systematically. 

Regarding  extending  screening  to  other  cancers,  the  Commission  plans  are  in  line  with  the 
recommendation to extend population screening to cancers for which there is scientific evidence 
of a good harm-benefit ratio, cost-effectiveness, advantages of early detection, and feasibility 
throughout the EU taking a step-wise approach.  

To  optimise  risk-based  cancer  screening  and  early  diagnosis  the  Commission  considers  the 
importance  of  innovative  screening  technologies  and  the  need  for  a  system  of  “living 
guidelines” that can be rapidly updated in response to new scientific findings. 

The consultation also revealed a variety of more detailed technical suggestions, which will be 
taken  into  consideration  during  the  implementation  phase  of  the  new  EU  Cancer  Screening 
Scheme. 

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