IJC International Journal of Cancer

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1 IJC International Journal of Cancer Status of implementation and organization of cancer in The European Union Member States Summary results from the second European report Partha Basu 1, Antonio Ponti 2, Ahti Anttila 3, Guglielmo Ronco 2, Carlo Senore 2, Diama Bhadra Vale 4, Nereo Segnan 2, Mariano Tomatis 2, Isabelle Soerjomataram 5, Maja Primic Zakelj 6, Joakim Dillner 7, Klara Miriam Elfstr om 8, Stefan L onnberg 9 and Rengaswamy Sankaranarayanan 1 1 Group, International Agency for Research on Cancer, Lyon, France 2 CPO Piemonte and University Hospital Citta della Salute e della Scienza, Turin, Italy 3 Mass Registry/Finnish Cancer Registry, Helsinki, Finland 4 Departamento de Tocoginecologia, Divis~ao de Oncologia, Universidade Estadual de Campinas, Brazil 5 Section of Cancer Surveillance, International Agency for Research on Cancer, Lyon, France 6 Institute of Oncology Ljubljana, Ljubljana, Slovenia 7 Swedish Cervical Registry, Stockholm, Sweden 8 Regionalt cancercentrum Stockholm-Gotland, Stockholm, Sweden 9 Cancer Registry of Norway, Oslo, Norway; Finnish Cancer Registry, Helsinki, Finland The second report on the implementation status of cancer in European Union (EU) was published in The report described the implementation status, protocols and organization (updated till 2016) and invitation coverage (for index year 2013) of breast, cervical and colorectal cancer in the EU. Experts in monitoring (N 5 80) from the EU Member States having access to requisite information in their respective countries provided data on breast, cervical and colorectal cancer through online questionnaires. Data was collected for performed in the framework of publicly mandated s only. Filled in questionnaires were received from 26 Member States for all three sites and from one Member State for breast cancer only. Substantial improvement in implementation using populationbased approach was documented. Among the age-eligible women, 94.7% were residents of Member States implementing or planning population-based breast cancer in 2016, compared to 91.6% in The corresponding figures for cervical cancer were 72.3 and 51.3% in 2016 and 2007, respectively. Most significant improvement was documented for colorectal cancer with roll-out ongoing or completed in 17 Member States in 2016, compared to only five in So the access to population-based increased to 72.4% of the age-eligible populations in 2016 as opposed to only 42.6% in The invitation coverage was highly variable, ranging from % for breast cancer, % for cervical cancer and % for colorectal cancer in the target populations. In spite of the considerable progress, much work remains to be done to achieve optimal effectiveness. Continued monitoring, regular feedbacks and periodic reporting are needed to ensure the desired impacts of the s. Background The estimated burden of cancer in the 28 Member States of the European Union (EU) in 2012 was 1.43 million new cases and 0.71 million deaths among men and 1.2 million new cases and 0.55 million deaths among women. 1 Cancers of breast, cervix and colorectum together were responsible for 0.26 million deaths. 1 There is established evidence that implementation of organized through a population- Key words: cancer, breast cancer, cervical cancer, colorectal cancer, European Union Abbreviations: CPO: Centro di Riferimento per l Epidemiologia e la Prevenzione Oncologica; EPAAC: European Partnership for Action Against Cancer; EU: European Union; IARC: International Agency for Research on Cancer; PBCR: population-based cancer registries; UK: United Kingdom; WHO: World Health Organization Additional Supporting Information may be found in the online version of this article. Grant sponsor: European Union Public Health Programme (Scientific and technical support to the European Partnership for Action against Cancer and follow-up of the implementation of the Council Recommendation on Cancer ) DOI: /ijc History: Received 28 June 2017; Accepted 30 Aug 2017; Online 23 Sep 2017 Correspondence to: Partha Basu, Group, Early Detection and Prevention Section, International Agency for Research on Cancer (WHO), 150 cours Albert Thomas, Lyon Cedex 08, France, Tel.: ; Fax: , BasuP@iarc.fr Int. J. Cancer: 142, (2018) VC 2017 UICC

2 Basu et al. 45 What s new? In 2003 the European Union (EU) Council urged member states to devote greater attention to breast, cervical, and colorectal cancer. The second report on progress in this regard was published in The present manuscript details implementation status, protocol, and organization of programs and invitation coverage of target populations in member states. The data show that within a decade, the proportion of eligible EU populations having access to breast, cervical, and colorectal cancer increased by 5.8, 11.9 and 33.6 percent respectively. Future Council recommendations may need to consider the incorporation of alternative strategies. based can significantly reduce mortality from these cancers. 2,3 The EU Council in a series of recommendations published in 2003, urged the Member States to introduce or scale up breast, cervical and colorectal cancer through systematic population-based approach with quality assurance at all levels. 4 The first report on the implementation of the Council recommendations prepared by the International Agency for Research on Cancer (IARC) concluded that the number of individuals having access to population-based in the year 2007 was much lower than the desired level and substantial opportunistic was ongoing in the Member States, targeting nearly 100 million men and women. 5 The second report on the implementation of Council recommendations on cancer was published in 2017 to update and expand the scope of the first report. 6 The second report described the status of implementation and level of organization of the population-based in the Member States and also estimated selected performance indicators included in various European guidelines for quality assurance in cancer In the present manuscript, we describe the implementation status, protocol, organization of the programs and the invitation coverage of the target population for breast, colorectal and cervical cancers in the Member States. In addition, in order to assess the progress made within the last decade, we also compared the current status of s (2016) to the status at the last reporting period (2007). Methods The preparation of the second report on implementation of the Council recommendations on cancer was coordinated by IARC, Centro di Riferimento per l Epidemiologia e la Prevenzione Oncologica (CPO), Piemonte, Italy and the Finnish Cancer Society, Mass Registry, Finland. The experts in monitoring and evaluation having access to the relevant information in their respective countries were selected from the 28 Member States to provide data on the breast, cervical and colorectal cancer s. The data-providers were requested to ensure that the responsible national authorities supported the sharing of data. The implementation data was collected for performed in the framework of publicly mandated s only. Each data-provider was requested to fill in the online questionnaires (provided as a supplement) designed to capture the information on policy, organization, implementation status, and further assessment protocols, financing and practices related to quality assurance. Three sets of questionnaires were sent, each specific for the three cancer sites assessed in this report. Data-providers could update information till July 31, The draft report based on the analyzed questionnaires was shared with the data-providers from all the Member States and the report was finalized after incorporating their feedbacks. To ensure comparability between the first and the second reports, the questionnaires followed the same definitions used in the first report. Minimum degree of public health system responsibility, organization and supervision was essential for activities taking place in the context of a as opposed to a non-. To qualify as a, a documented public policy defining at least the eligible population, the intervals and the tests was also considered essential. The s were considered to be population-based if the eligible target population in an area served by the were identified and invited to each round of. We excluded the opportunistic performed outside of any. The cervical cancer s that invited only those not screened opportunistically were also included, provided they had identified individually the entire target population. 8 In a population-based, the rollout was considered completed when 90% or more of the eligible target population had been invited at least once and all elements of the process were fully functional. The target populations for breast and colorectal cancer were estimated in the target age groups recommended by the Council (50 69 years for breast cancer and years for colorectal cancer respectively). The Council did not specify the age range for cervical cancer but recommended that the age of initiation should be between years. The year age-group was selected to estimate the target population for cervical cancer as all the s adopted this age as the minimum common target.

3 46 Cancer in European Union The target population was segregated by the type and the implementation status to estimate the total number of individuals having access to population-based. Invitation coverage was calculated as the proportion of subjects in the target age range who were invited for in the index year, over the annual population. The annual population is defined as the target population divided by the interval, assuming that the invitations are issued uniformly during the interval. Given that this assumption is not always true, it should be noted that the measurement of the invitation coverage over a single year might be inaccurate. This is reflected by the reported invitation coverage exceeding 100% in some of the Member States. The annual population is defined as the target population by age and gender divided by the interval. Population estimates were obtained from the EUROSTAT projection for the year Findings Participation of the member states The data-providers from 26 out of the 28 Member States filled in the questionnaires for all the three sites. The dataproviders from Bulgaria filled in the breast cancer questionnaire only and no filled in questionnaires were received from Greece. However, the required information was obtained from them through s. Neither of these two Member States had population-based cancer s for breast, cervical or colorectal cancer. The current manuscript reflects the status of the s as of July Breast cancer The implementation status, protocols, organization and coverage Compared to the first report (describing the implementation status in the Year 2007), a significant increase in the number of the Member States offering population-based breast cancer s (25 vs. 22) and completing roll out (21 vs. 11) was observed (Table 1 and Fig. 1). Romania had a small-scale pilot project ongoing in 2016, so majority of the target population was subjected to non-population-based. Bulgaria completed a pilot project ( Stop and Get Screened ) in 2014 to provide breast, cervical and colorectal cancer using a population-based approach, though there was no scaling up. We estimated that out of the 67.5 million female populations living in the EU aged years, 63.9 million (95%) resided in the 25 Member States that already implemented or were piloting population-based breast cancer s (Table 1 and Supporting Information Table 1). The invitation coverage of the population-based cancer s claiming to issue individual invitations through the registries varied widely from 0.0 to 111% across the Member States (Table 2). National/regional policies for breast cancer existed in 24 out of the 25 Member States having populationbased s, though the policies were mandated by law in only 11 of them (Table 2). A target age wider than the Council recommended age of 50 to 69 years was adopted by Austria, Czech Republic, France, Greece, Hungary, Italy (some regions), the Netherlands, Portugal and Sweden. Only Estonia and Hungary stopped the invitations at 64 years. The interval was 2 years in all countries except Malta and the United Kingdom (UK) where threeyearly was practiced. Mammography was the primary test in all the 25 Member States and digital mammography completely replaced screen film mammography in 16 of them (Table 2). All the 24 Member States having a breast cancer policy had a dedicated team responsible for the policy implementation except Lithuania. The population-based s were public-funded, though only partially in Belgium and Portugal. The tests were provided free of charge in all. The women had to pay for the diagnostic tests in Belgium, Cyprus and France. registries to collect individual data existed in all the population-based s except Croatia and Lithuania. In Cyprus individual data was collected only in the Nicosia district where the records were maintained by the compulsory health insurance system. The registries were linked with the population-based cancer registries (PBCR) in all Member States except in Austria, Czech Republic, Poland and Portugal. Performance reports were regularly published by 16 Member States only. Cervical cancer The implementation status, protocols, organization and coverage Total 22 Member States were implementing, piloting or planning the population-based cervical cancer s in 2016 compared to only 17 Member States in 2007 (Table 1 and Fig. 2). The roll out of the s was complete in nine Member States. A pilot population-based with a mandate for nationwide scale up was ongoing in Malta. Germany adopted in 2013 the legal framework to initiate a population-based by Slovak Republic also initiated the planning for a population-based. Out of the million women residing in the EU aged years in 2016, 77.0 million (72.0%) were in the 22 countries implementing, piloting or planning population-based s (Table 1 and Supporting Information Table 2). All the 22 Member States with population-based s had documented policies on cervical cancer, though such policies were mandated by law only in six of them (Table 3). Czech Republic was the only country to screen the women below 20 years of age. The pilot in Malta targeted a narrow age range of years. Only Denmark, Ireland and the UK (England and Wales) reported to have replaced conventional cytology with liquidbased cytology completely. HPV detection was reported to be offered as a stand-alone test, at least in some regions in Denmark, Finland, France, Italy, Portugal and

4 Table 1. Implementation status and the estimated target population by implementation status for breast, cervical and colorectal cancer in the Eurepean Union - comparison between the second report (2016) and the first report (2007; *Rollout was complete in the s of Austria, Italy and Sweden targeting certain regions only) Breast cancer (target age years) Cervical cancer (target age years) Colorectal cancer (target age years) Number of Member States in 2016 Rollout completed Population-based Non-population based or Rollout ongoing Piloting no TOTAL Rollout completed Population-based Non-population based or Rollout ongoing Piloting no TOTAL Rollout completed Population-based Non-population based Rollout ongoing Piloting or no TOTAL * Number of Member States in Estimated target populations in M (87.7%) 2.1 M (3.1%) 2.6 M (3.8%) M (5.3%) 67.5 M (100%) 34.7 M (32.5%) 24.1 M (22.7%) 0.02 M (0.0%) 18.2 M (17.1%) 29.5 M (27.7%) M (100%) 43.3 M (28.4%) 36.4 M (24.0%) 3.7 M (2.4%) 26.9 M (17.6%) 42.1 M (27.6%) M (100%) Estimated target populations in M (41.1%) 26.1 M (43.9%) 1.0 M (1.7%) 2.9 M (4.9%) 5M (8.4%) 59.4 M (100%) 24.1 M (22.7%) 21.9 M (20.6%) 5.3 M (5.0%) 3.2 M (3.0%) 51.7 M (48.7%) (100%) 0 (0%) 46.1 M (34.0%) 2.8 M (2.0%) 9.0 M (6.6%) 78.0 M (57.4%) M (100%) Abbreviations: M: Million.

5 48 Cancer in European Union Figure 1. The type and the implementation status of the breast cancer s in the Member States of European Union (2016). Sweden; and combined with cytology (co-testing) in Malta, Portugal and Romania. The interval was 3 or 5 years for the population-based cytology s (except Czech Republic and Germany that continued with yearly ) and 5 years for the HPV based s. Sweden was planning to introduce the HPV detection tests in 2017 to screen year old women three-yearly and the year old women seven-yearly. The women aged years would continue to be screened by three-yearly cytology in the country. The invitation coverage in the Member States having population-based s ranged from 7.3 to 102.1% (Table 3). All the Member States having population-based cervical cancer s, except Lithuania had a team responsible for implementation (no information from Croatia). All the s were publicly funded and the tests were provided free of charge. However, women had to pay for a follow-up assessment in Finland, France and Sweden that would be reimbursed after testing. registries existed in all the population-based s except in Lithuania. The registries in Croatia and Romania collected only aggregated data. The linkage between the registries and the PBCR was absent in Croatia, Czech Republic and Poland. Systematic audit of the cervical cancer cases was conducted by Denmark, Finland, Ireland, the Netherlands, Romania, Slovenia, Sweden and the UK. Only Finland, Slovenia, Sweden and the UK reported the inclusion of systematically selected comparison groups (controls) during an audit of the cancer cases. All the Member States except Croatia, Estonia, France, Hungary, Ireland, Malta and Romania published the performance reports on regular basis.

6 Table 2. Information on the policy, protocol, organizational characteristics and invitation coverage of breast cancer s in the European Union (updated till July 2016; excluded Bulgaria, Greece and Slovak Republic due to non population based s) initiation, policy & protocol Programme implementation & financing registry, data collection & reporting Member States having population based s Year of initiation policy is documented as law or official recommendation Target age (years) interval (years) Percentage of mammograms performed with digital equipment a team is responsible for policy implementation the is publicly funded health insurance is a source of funding tests are provided free of charge diagnostic tests are provided free of charge registries & whether they are national or regional/local data is collected as individual data sceening data is linked with cancer registries there is quality control of data collection performance reports are published Invitation coverage in years age group (annual population) 1 Austria 2014 OR % National 2 0.0% Belgium Law % Partially Regional 99.7% Croatia 2006 No policy Unknown NA NA NA u 104.8% Cyprus 2003 OR % 4 National & regional 39.6% Czech Republic 2002 OR % National 0.0% Denmark 2008 Law % National & regional 82.3% Estonia 2003 OR % National 69.2% Finland 1987 OR % National 91.6% France 2004 OR % National & regional 102.7% Germany 2005 Law % National & regional 90.8% Hungary 2001 Law % National & regional 78.5% Ireland 2000 OR % National 110.5% Italy 1990 Law (age:45 49); 2 (age:50 74) 80% National & regional 70.6% Latvia 2009 Law % National 98.4% Lithuania 2005 Law % NA NA ^u 0.0% Luxembourg 1992 OR % National 107.5% Malta 2009 OR % National 78.8% Netherlands 1989 Law % National & regional 96.7% Poland 2006 Law % Regional 101.8% Portugal 1990 OR % Partially National & regional 55.4% Romania 2015 OR % Regional Unknown 0.2% Slovenia 2008 Law % National 20.9% Spain 1990 Law % Regional 84.7% Sweden 1986 OR % Regional 93.3% United Kingdom OR % National & reginal 111.0% Abbreviations: : yes; : no; NA: not applicable; OR: official recommendation. 1 Index year for invitation coverage was 2013 for all except Austria (2014), Estonia (2014), Finland (2012), France (2012), Germany (2012) and Lithuania (2014). 2 Austria is planning to establish the linkage between and cancer registries in In Belgium the population based started in 2001 in the Flemish region and in 2002 in the Wallonia and Brussels regions. 4 In Cyprus The diagnostic test charges are waived for the beneficiaries of state health insurance (covering nearly 73% of the permanent residents). 5 In Italy the target age is years only in Piemonte and Emilia Romagna. In other regions the target-age is years. 6 In Portugal the target age is years in Algarve, years in Azores and years in other regions. 7 In Spain the target age is years in some regions. 8 In Wales the started in 1989.

7 50 Cancer in European Union Figure 2. The type and the implementation status of the cervical cancer s in the Member States of European Union (2016). Colorectal cancer The implementation status, protocols, organization and coverage As of 2016, the population-based colorectal cancer s were being rolled out (ongoing, or completed) in 17 Member States, of which seven Member States completed nationwide roll out (Table 1 and Fig. 3). This was a significant improvement over the situation in 2007 when only 5 Member States were rolling out the and none had completed roll out. The population-based s targeted only certain regions in Austria (Burgenland region), Portugal (Alentejo and Center regions) and Sweden (Stockholm region). In addition, Germany and Luxembourg were planning to start population-based s nationwide. Germany adopted the legal framework to initiate the population-based by Estonia initiated a population-based pilot in 2016 among a 60-yearold age cohort with an intended target to cover the year age group in the scaled up. We estimated that out of the 152 million women and men aged years in the EU, 110 million (72%) were targeted by in those 23 Member States implementing, piloting or planning population-based colorectal cancer s. This number is almost double the number (57.9 million) targeted by the population-based s in 2007 (Table 1 and Supporting Information Table 3). The invitation coverage in the Member States having populationbased s ranged from 1.5 to 100.5% (Table 4). Documented policies for colorectal cancer existed in all the 23 Member States implementing, piloting or planning population-based s, though the policy was mandated by law in only eight of them (Table 4). The recommended target age of years was adopted by the

8 Table 3. Information on the policy, protocol, organizational characteristics and invitation coverage of cervical cancer s in the European Union (updated till July 2016; excluded Austria, Bulgaria, Cyprus, Greece, Luxembourg and Spain due to non population based s) Member States having population based s Year of initiation initiation, policy & protocol Programme implementation & financing registry, data collection & reporting policy is documented as law or official recommendation Target age (years) interval (years) tests used a team is responsible for policy implementation the is publicly funded health insurance is a source of funding tests are provided free of charge diagnostic tests are provided free of charge registries & whether they are national or regional/local data is collected as individual data sceening data is linked with cancer registries there is quality control of data collection cancer cases are audited performance reports are published Invitation coverage in years age group (annual population) 1 Belgium OR CC Regional 33.8% Croatia 2012 OR CC Unknown National & regional Czech Republic 2008 OR CC National Denmark 2006 OR (HPV test: 60 64) 3 (Cyto) 5 (HPV test) LBC or HPV National & regional 67.1% Estonia 2006 OR CC National 77.1% Finland 1963 OR CC or HPV National 97.9% France 1991 OR (HPV test: 30 64) 3 (Cyto) 5 (HPV test) CC or HPV National & regional 7.3% Germany Law CC Hungary 2003 Law CC National 15.2% Ireland 2008 OR (age:25 44); 5 (age:45 60) LBC National Italy 1989 Law (HPV test: 30 64) 3 (Cyto) 5 (HPV test) CC or HPV National & regional 65.1% Latvia 2009 OR CC National 92.7% Lithuania 2004 Law CC NA NA 75.5% Malta 2015 OR CC and HPV National Netherlands 1970 Law CC National & regional 96.7% Poland 2006 Law (Cyto & HPV test: 30 59) 3 CC National % 7 Portugal 1990 OR CC and HPV Regional 18.6% 7 Romania 2012 OR CC and HPV Regional 65% 7 Slovak Republic 2008 OR Yrly x 2; then 3 yrly CC Slovenia 2003 OR Yrly x 2; then 3 yrly CC National Sweden 1967 OR (age:23 50); 5 (age:51 60) CC or HPV National & regional 79.9% United Kingdom 1988 OR (age:25 49); 5 (age:50 64) LBC National & regional 102.1% Abbreviations: : yes; : no; NA: not applicable; OR: official recommendation; CC: conventional cytology; LBC: liquid based cytology; HPV: human papillomavirus test. 1 Index year for invitation coverage was 2013 in all except Belgium, Estonia, Latvia and Lithuania where the index year was In Belgium only the Flemish region has a. 3 In Finland, the test can be either cytology or HPV. Some municipalities target women below 30 years. 4 In Germany the Cancer and Registry Act, 2013 created the legal framework to turn the current opportunistic s for cervical cancer into organised, population based. The Act regulates data linkage between s and cancer registries (epidemiological/clinical). 5 Malta is implementing a pilot targeting a narrow age group. 6 Poland has a system of identifying the false negatives in their registry called Information System for Monitoring of Prevention (SIMP). It relies on the ICD 10 codes reported to the National Health Fund by the healthcare providers. 7 Invitation coverage reported for all ages. 8 The target age in Azores region of Portugal is years.

9 52 Cancer in European Union Figure 3. The type and the implementation status of the colorectal cancer s in the Member States of European Union (2016). population-based s in Belgium (Wallonian-Brussels region), Croatia, Denmark, France, Germany, Lithuania, Portugal (Alentejo Region), Slovenia and the UK (Scotland only). The target age was narrower in Belgium (Flemish region), Cyprus, Estonia, Finland, Hungary, Ireland, Italy, Luxembourg, Malta, the Netherlands, Poland, Portugal (Centro region), Spain, Sweden and the UK (England, Wales and Northern Ireland), while it was wider in Austria (Burgenland) and Czech Republic. The different tests used in the s across the different Member States are shown in the Figure 4. The interval for s based on the faecal occult blood testing (either guaiac-based or immunochemical) was 2 years in all the countries, except Austria having yearly. Within the population-based s, colonoscopy was reported to be offered once in a lifetime in Poland, as was the case for sigmoidoscopy in Italy (Piedmont) and England. Within the non-population-based s, with colonoscopy was reported to be offered at 10-year interval in Austria, Czech Republic and Germany and at 5-year interval in Greece. Each Member State having population-based had a dedicated team to implement the. The tests were administered free of charges in all except Croatia, where the test expenses were reimbursed through the health insurance. The diagnostic investigations for the screen-positive individuals were free in all the countries except Finland, France, The Netherlands and Sweden. The registries to collect the individual data existed in all the population-based s except in

10 Table 4. Information on the policy, protocol, organizational characteristics and invitation coverage of colorectal cancer s in the European Union (updated till July 2016; excluded Bulgaria, Greece, Latvia, Romania and Slovak Republic due to non population based s) Member States having population based s Year of initiation initiation, policy & protocol Programme implementation & financing registry, data collection & reporting policy is documented as law or official recommendation Target age (years) interval (years) a team is responsible for policy implementation the is publicly funded health insurance is a source of funding tests are provided free of charge diagnostic tests are provided free of charge registries & whether they are national or regional/local data is collected as individual data sceening data is linked with cancer registries there is quality control of data collection performance reports are published Invitation coverage in year age group (annual population) 1 Austria (Burgenland) OR National & regional Belgium OR (Wal Bru); (Flemish) 2 (FIT); 10 (TC) Regional 81.4% Croatia 2008 OR National & regional 100.5% Cyprus 2013 OR National Czech Republic OR (FIT; 50 54); 2 (FIT; 551) National Denmark 2014 Law National & regional Estonia OR National Finland 2004 OR National 10.5% France 2002 OR National & regional 99.1% Germany Law (gfobt: 50 54); 2 (gfobt: 551); 10 (TC: 551) Hungary 2007 Law National 1.5% Ireland 2012 OR National % Italy OR National & regional 52.4% Lithuania Law NA NA Luxembourg OR Malta 2013 OR National 28.5% Netherlands 2014 Law National & regional 20.3% Poland 2012 Law National & regional 12.5% Portugal 2009 OR Regional 1.6% Slovenia 2009 Law National 80.0% Spain 2000 Law Regional 11.3% Sweden OR Regional 8.5% United Kingdom OR (Scotland 50 74) 2 National 58.7% Legends: : yes; : no; NA: not applicable; OR: Official recommendation. 1 Index year for invitation coverage was 2013 for all except Belgium (2014), Finland (2014), France (2012), Malta (2014) Netherlands (2014), Portugal (2014) and Slovenia ( ). 2 In Austria a population based is implemented only in the state of Burgenland, since In the rest of the country is opportunistic. gfobt is offered every year and the interval for colonoscopy is 10 years. 3 The population based in Wallonia-Brussels (Belgium) started in 2009, and in the Flemish region (Belgium); 4 In Croatia the cost of tests is reimbursed through insurance. 5 The population based in the Czech Republic started in The invitations are sent only to the individuals up to 70 years of age. 6 In Estonia the population based pilot started in 2016 among a 60 years old age cohort, with an intended target group of years. 7 In Germany a population-based is planned to start in TC is recommended twice for men and women older than 55 years. The Cancer and Registry Act, 2013 created the legal framework to turn the current opportunistic s for colorectal cancer into population based with setting up of registries. 8 In Ireland, linkage between data and cancer registry and the first performance reports are in preparation as the program was launched few years back. 9 In Italy, started in 1982 in Florence, and between 2000 and 2004 in other regions. 10 In Lithuania, the population based started in 2009 in two districts, and became nationwide in In Luxembourg a population based is planned to start in In Sweden, only Stockholm Gotland region has introduced. 13 Year of initiation: England 2006, Northern Ireland 2010, Scotland 2007, Wales 2008.

11 54 Cancer in European Union Figure 4. The tests used for the colorectal cancer s in the Member States of the European Union (2016). Lithuania. The linkage with the PBCR was not yet functional in Austria, Croatia, Cyprus, Czech Republic, Ireland, Italy and Sweden. The performance reports were published regularly by all except Hungary and Ireland. Discussion From the findings of the current report it is obvious that within less than a decade since the publication of the first report, a large number of Member States have implemented or are in the process of implementing the population-based s in compliance with the Council recommendations. The progress made in the implementation of colorectal cancer in particular, is quite remarkable. Compared to 2007, the number of men and women in the EU having access to population-based colorectal in 2016 has almost doubled (57.9 million vs million). Majority of the service s for colorectal cancer introduced during these years were introduced directly as population-based ones, while this happened only partly for breast cancer. Cervical cancer was introduced much earlier and started as an opportunistic testing in most Member States except in Finland, Sweden and Denmark (partly). Many of the countries with an opportunistic cervical cancer are yet to switch to a population-based s completely. This shows that converting an opportunistic testing to a population-based organized is much more challenging than launching the as a population-based one from the beginning. Though the protocols for breast cancer were almost similar across the Member States, a lot of heterogeneities existed in the cervical and colorectal cancer protocols. To some extent this was due to the variability in introduction of the new tests following the recommendations of the European Guidelines for Quality

12 Basu et al. 55 Assurance for cervical and colorectal published in 2008 and 2010, respectively. 8,10 Narrower target age was adopted by many member states due to the limited resources with a view to gradually expand with improvement in resource availability. The practices of initiating too early or too frequently have become less common, which is expected to reduce the harms and save the resources with minimal or no loss in the effectiveness. The second report documented the heterogeneity in the approaches of the Member States to organize quality assured services in the context of the population-based cancer s and this was reflected in the wide variations in the invitation coverage. The s should adopt the following best practices for effective organization of services 12 : Defined policies either as legislations (preferred) or official regulations providing the with the mandate, authority and financial resources Autonomous team(s) responsible for organization, implementation, quality assurance and evaluation Appropriate financing to ensure free of charge and second level assessment Robust information systems in the form of registries with linkage to cancer registries and cause of death registers Systematic audit of the history of each cancer case (both in screened and unscreened population) identified by the cancer registries with appropriate comparison group. Periodic evaluation of performance and publication of the performance reports There is still scope for substantial quality improvement of cancer in the EU Member States, specially in the coverage. It is crucial that in the process of switching from a non-population-based to a population-based the Member States pay due attention to the above evidence-based recommendations. The experience of the cancer networks established under the European Partnership Action Against Cancer (EPAAC) demonstrated that piloting prior to nationwide rollout could provide the policymakers with information essential for effective implementation Furthermore, as described in the European quality assurance guidelines, a long term translational is essential to successfully plan, pilot and rollout population-based s across an entire country. The time frame depends, to a large extent, on the professional and organizational capacity, which must be developed to successfully perform, monitor and evaluate the high quality services. Efforts are needed to ensure the consistency and the enhanced quality of data collected for the future reports. The registries linked to the PBCRs need to be the integral parts of the population-based s to enable evaluation of the impact. They should collect individual information on, diagnostic work-up and treatment activities ongoing in the opportunistic settings as well. 16 The data on cancer activities should preferably be linked with the European Health Interview Survey (EUROSTAT-EHIS) and National Health Interview Surveys to obtain more precise information on the attendance and the intervals. 17 Actions need to be initiated to exploit the potential of stage distribution information as an intermediate indicator of effectiveness and this would require the PBCRs to collect stage information according to the widely accepted stage classification schemes. The Annex of the Council recommendations needs updating. The Council should also consider if the criteria for cancer concerning the legal frameworks, governance and quality assurance structures could be made more stringent, taking into account the sub-optimal achievements of some of the Member States in >10 years after the Council recommendations were announced. Financial constraints may be a barrier to implement population-based by some Member States. They should consider the alternative tests and the algorithms recommended by the World Health Organization (WHO) for the resource-limited settings. 18,19 The next version of the Council recommendations needs to consider and incorporate these alternative strategies. Acknowledgements We are thankful to John F. Ryan, Stefan Schreck, Antonio Montserrat, and Paolo Guglielmetti at the European Commission for their support and guidance. We are thankful to the following scientific reviewers to the project Lutz Altenhofen, Germany; Rosemary Ancelle-Park, France; Nieves Ascunce Elizaga, Spain; Harry J. de Koning, The Netherlands; Elsebeth Lynge, Denmark; Ondrej Majek, Czech Republic; Florian Nicula, Romania; Julietta Patnick, United Kingdom; Jaroslaw Regula, Poland; Sven T ornberg, Sweden; Marco Zappa, Italy We are thankful to the following data providers to the project Natasa Antoljak, Croatia; Ahti Anttila, Finland; Marc Arbyn, Belgium; Claire Armstrong, Northern Ireland; Nieves Ascunce Elizaga, Spain; Frank Assogba, France; Roger Black, Scotland; Luc Bleyen, Belgium; Josep M. Borras, Spain; Andras Budai, Hungary; Karen Budewig, Germany; J.B. Burrion, Belgium; Michel Candeur, Belgium; Helen Clayton, United Kingdom; Carol Colquhoun, United Kingdom; Miriam Dalmas, Malta; Isabel De Brabander, Belgium; Harry de Koning, The Netherlands; Claire Dillenbourg, Luxembourg; Joakim Dillner, Sweden; Plamen Dimitrov, Bulgaria; Lajos D obr~ossy, Hungary; Nicolas Duport, France; Klara Miriam Elfstr om, Sweden; Mara Epermane, Latvia; Josep A. Espinas, Spain; Valerie Fabri, Belgium; Elisabeth Fasching, Austria; Patricia Fitzpatrick, Ireland; Jacques Fracheboud, The Netherlands; Andrew Gamble, United Kingdom; Alexander Gollmer Gesundheit Osterreich, Austria; Mat Goossens, Belgium; Clare Hall, United Kingdom; Annemie Haelens, Belgium; Françoise Hamers, France; Karin Heckters, Luxembourg; Sarah Hoeck, Belgium, Rugile Ivanauskiene, Lithuania; Urska Ivanus, Slovenia; Beata Janik, Poland; Nataļja Jankovska, Latvia; Katja Jarm, Slovenia; Dorte Johansen, Denmark; Vanessa K a ab-sanyal, Germany; Fofo Kaliva, Greece; Michal Kaminski, Poland; Eliane Kellen, Belgium; Beata Kinel, Poland; Stala Kioupi, Cyprus; Tatjana Kofol Bric, Slovenia; Attila Kovacs, Hungary; Theopisti Kyprianou, Cyprus; Radoslav Latinovic, United Kingdom; Marcis Leja, Latvia; Jolanta Lissowska, Poland; Anne Mackie, United Kingdom; Ondrej Majek, Czech Republic; Daniela

13 56 Cancer in European Union Malek, Germany; Paola Mantellini, Italy; Kenneth Mc Innes, United Kingdom; Nuno Augusto Alberto de Miranda, Portugal; Vaida Momkuviene, Lithuania; Dinka Nakić, Croatia; Ondrej Ngo, Czech Republic; Florian Nicula, Romania; Dominika Novak Mlakar, Slovenia; Andrze Nowakowski, Poland; Pavlos Pavlou, Cyprus; Elena Perez Sanz, Spain; Davor Plazanin, Croatia; Maja Primic-Zakelj, Slovenia; Sarah Pringles, Belgium; Joseph Psaila, Malta; Alexandra Ramssl-Sauer, Austria; Dace Rezeberga, Latvia; Janet Rimmer, United Kingdom; Vitor Rodrigues, Portugal; Agnès Rogel, France; Guglielmo Ronco, Italy; Merete Rønmos Houmann, Denmark; Tytti Sarkeala, Finland; Astrid Scharpantgen, Luxembourg; Ana Lucija Skrjanec, Slovenia; Stanislav Spanik, Slovak Republic; Greig Stanners, United Kingdom; Barbara Stomper, Germany; Andrea Supe Parun, Croatia; Esther Toes- Zoutendijk, The Netherlands; Sven T ornberg, Sweden; Maria Tsantidou, Greece; Zdravka Valerianova, Bulgaria; Heleen M.E. van Agt, The Netherlands; Piret Veerus, Estonia; Suzanne Wright, United Kingdom; Stephanie Xuereb, Malta; Jozica Maučec Zakotnik, National Institute of Public Health, Slovenia; Viačeslavas Zaksas, Lithuania; Marco Zappa, Italy; Raquel Zubizarreta Alberdi, Spain; Georg Ziniel, Austria; Manuel Zorzi, Italy Authors Contributions All the authors contributed equally in conducting the study, analysis and interpretation of data, planning and preparation of the manuscript. All authors reviewed and approved the final draft of the manuscript. References 1. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in Eur J Cancer 2013;49: Schuz J, Espina C, Villain P, et al. European code against Cancer 4th Edition: 12 ways to reduce your cancer risk. Cancer Epidemiol 2015;39:S Armaroli P, Villain P, Suonio E, et al. European Code against Cancer, 4th Edition: Cancer. Cancer Epidemiol 2015;39:S European Commission. Council Recommendation of 2 December 2003 on cancer (2003/ 878/EC). Official Journal of the European Union, von Karsa L, Anttila A, Ronco G, et al. Cancer in the European Union. Report on the implementation of the Council Recommendation on cancer. First report. Brussels: European Commission; Ponti A, Anttila A, Ronco G, et al. Cancer in the European Union. Report on the implementation of Council Recommendation on Cancer. Brussels: European Commission; European Commission. New EU Guidelines on Breast Cancer and Diagnosis. European Commission Press Release Database, Available at: MEMO _en.htm. (Accessed on 17 June 2017) 8. Arbyn M, Anttila A, Jordan J, et al. European Guidelines for Quality Assurance in Cervical Cancer, 2nd edn. Luxembourg: Office for Official Publications of the European Communities, Anttila A, Arbyn A, de Vuyst H, et al. European Guidelines for Quality Assurance in Cervical Cancer, 2nd edn. supplements. Luxembourg: European Union, Segnan N, Patnick J, von Karsa L. European Guidelines for Quality Assurance in Colorectal Cancer and Diagnosis. Luxembourg: European Union, EUROSTAT. Eurostat Regional Yearbook Luxembourg: European Union, Lynge E, Tornberg S, von KL, et al. Determinants of successful implementation of population-based cancer s. Eur J Cancer 2012; 48: Martin-Moreno JM, Albreht T, Krnel SR. Boosting Innovation and Cooperation in European Cancer Control: key Findings from the European Partnership for Action against Cancer. Ljubljana: National Institute of Public Health of the Republic of Slovenia, Peris M, Espinas JA, Munoz L, et al. Lessons learnt from a population-based pilot for colorectal cancer in Catalonia (Spain). J Med Screen 2007;14: UK Colorectal Cancer Pilot Group. Results of the first round of a demonstration pilot of for colorectal cancer in the United Kingdom. BMJ 2004;329: Anttila A, Lonnberg S, Ponti A, et al. Towards better implementation of cancer in Europe through improved monitoring and evaluation and greater engagement of cancer registries. Eur J Cancer 2015;51: EUROSTAT. European Health Interview Surveys (EHIS), Available at: europa eu/ eurostat/web/microdata/european-healthinterview-survey. (Accessed on 17 June 2017) 18. WHO. WHO Position Paper on Mammography. Geneva: World Health Organization, WHO. Comprehensive Cervical Cancer Control - a Guide to Essential Practice. Secoond edition. Geneva: World Health Organization, 2014.