Explanatory Memorandum to COM(2022)474 - Strengthening prevention through early detection: A new EU approach on cancer screening - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)474 - Strengthening prevention through early detection: A new EU approach on cancer screening. |
|---|---|
| source | COM(2022)474  |
| date | 20-09-2022 |
1. CONTEXT OF THE PROPOSAL
Reasons for and objectives of the proposal
The current Council Recommendation 2003/878/EC sets out recommendations for cancer screening. It encourages Member States to implement population-based, quality-assured screening programmes. It has been instrumental in improving cancer screening and ensuring that the vast majority of people in the target age ranges have access to organised screening.
The 2017 implementation report 1 on the Council Recommendation and the European Guide on Quality Improvement in Comprehensive Cancer Control 2 pointed to several ongoing challenges and needs, most importantly that the current Recommendation is not based on the latest evidence. Since 2003, new screening tests and protocols have been validated and introduced in the Member States, and new evidence supports the extension of screening recommendations to other cancers than covered by Recommendation 2003/878/EC. The European Guide on Quality Improvement in Comprehensive Cancer Control, and the Joint action on innovative partnerships for action against cancer 3 launched in 2019 identify prostate, lung, and gastric cancers as potentially suitable for inclusion in future recommendations.
This proposal for a new Council Recommendation replacing Recommendation 2003/878/EC has the following objectives:
–Supporting cancer screening through the whole pathway of cancer care as part of a new Union approach to cancer prevention under Europe’s Beating Cancer Plan.
–Supporting the development of the new EU-supported Cancer Screening Scheme to ensure that 90% of the EU population who qualify for breast, cervical and colorectal cancer screenings are offered screening by 2025;
–Regular systematic monitoring of screening programmes including disparities via the European cancer information system and the Cancer Inequalities Registry;
–Sharing data on cancer screening, including through the planned European Health Data Space 4 ;
–Updating the breast, cervical and colorectal cancer screening recommendations;
–Extending breast cancer screening from women aged 50 to 69 to include women between 45 and 74 years of age and to consider specific diagnostic measures for women with particularly dense breasts;
–Prioritising cervical cancer screening by testing for human papilloma virus (HPV) for women aged 30-65 instead of pap smear screening between the ages of 20-30 and supporting its eradication through the uptake of vaccination against HPV below 15 years of age;
–Using faecal immunochemical testing for colorectal cancer screening instead of faecal occult blood screening as the preferred triage test for referring individuals aged 50-74 for follow-up colonoscopy ;
–Extending cancer screening programmes to lung and prostate cancer as well as to gastric cancer in those countries or regions with the highest gastric cancer incidence and death rates;
–Taking into account the latest scientific knowledge and innovative technologies, and considering the introduction of novel cancer screening programmes based on minimally invasive methods, for instance liquid biopsies, exhaled breath gas, and other methods.
Consistency with existing policy provisions in the policy area
This proposal for a new Council Recommendation is a key element of the new EU-supported Cancer Screening Scheme. The scheme is one of the flagship initiatives of the Europe’s Beating Cancer Plan 5 , a key pillar of the European Health Union announced in the 2020 State of the Union address by President Ursula von der Leyen.
The new cancer screening scheme has two main objectives. First, to increase by 2025 the screening rates for breast, colorectal and cervical cancer in the Union, by building on the most recent evidence and methods, and facilitating more targeted and less invasive screenings together with a quality-assured and secured follow-up. Second, the scheme aims to extend organised screening to prostate, lung and gastric cancer (the latter under certain conditions), based on the assessment of validated new screening tests, and on consideration of more general health system parameters, including risk-benefit ratio and cost-effectiveness.
The new EU-supported Cancer Screening Scheme seeks to make the most from digitalisation and health data via the European cancer imaging initiative and the planned European Health Data Space, which aims to develop new diagnostic technologies and to enable cancer patients to securely access and share their health data in an integrated format in the electronic health records between healthcare providers and across borders in the Union.
Contents
The Mission on Cancer 6 under the Horizon Europe framework programme for research and innovation (2021-2027) is a major component of the Union’s investment in cancer research and innovation. Several of the planned actions 7 , namely on optimised and improved access to existing screening programmes, developing new methods and technologies for screening and early detection, and developing early predictors/tests will directly support the new EU-supported Cancer Screening Scheme and create an important link between Research and Innovation (R&I) and cancer policies.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
Legal basis
The Treaty on the Functioning of the European Union, and in particular Article 168(6) provides that the Council, on a proposal from the Commission, may adopt recommendations for the purposes set out in that article. This includes the possibility to adopt a recommendation on cancer screening, which complements national policies and contributes to preventing cancer, which is a major health issue in the Union.
Subsidiarity (for non-exclusive competence)
The updated Council Recommendation aims to establish general principles for cancer screening as recommended by the Group of Chief Scientific Advisors and to set out the best practices for cancer screening in the Union.
A Union recommendation based on guiding principles and a joint analysis of the underlying evidence provides added value for Member States, which will not have to embark on individual assessments and can use this as a basis for their national cancer screening policies, while the form of a Council Recommendation allows Member States to adapt their approach to their national needs.
Proportionality
This proposal offers recommendations for evidence-based, patient-centred cancer screening through a systematic population-based approach and, when appropriate, through risk-stratified 8 cancer screenings, supported by European guidelines, with quality assurance at all appropriate levels, in line with the guidelines developed under the European Commission Initiative on Breast Cancer, which have been recently updated 9 . The proposal is suitable for achieving the intended objective and does not go beyond what is necessary and proportionate, as the recommendations help Member States to upgrade their cancer screening programmes leaving ample room for Member States to adapt their approach to national needs and resources.
Choice of the instrument
The Council Recommendation 2003/878/EC on cancer screening is almost 20 years old, and needs to be updated by another Council Recommendation to take into account the increased knowledge about effective cancer screening, while leaving thebasic principles for cancer screening unchanged.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
Ex-post evaluations/fitness checks of existing legislation
Stakeholder consultations
Stakeholders were consulted on the call for evidence 10 in relation to the update of the Council Recommendation on cancer screening, which was published for feedback from 25 January to 22 February 2022. A total of 87 genuine responses were received, with the majority of replies coming from non-governmental organisations, company/business organisations, consumer organisations/consumers, public authorities, and academic/research institutions. The stakeholders’ replies included the need to improve and extend current cancer screening programmes and use of innovative and new technologies, as well as the need for quality assurance and coordination of the screening programmes.
In addition, several meetings of relevant thematic groups of the Cancer Plan’s stakeholder contact group and three meetings specifically dedicated to the proposal with the cancer sub-group of the Steering Group on Health Promotion and Disease Prevention and Management of Non-Communicable Diseases took place. Member State experts advised to take into account feasibility, cost-effectiveness and scientific evidence when deciding on new screening programmes and favoured a stepwise approach for the implementation of the new screening programmes.
The opinions, suggestions and recommendations of stakeholders were analysed and taken into account as much as possible. Some of the issues raised were rather detailed and technical and should rather be taken into account during the implementation phase. The outcomes of these consultations and how they were taken into account is described in detail in the synopsis report.
The public had already been consulted in the context of the public consultation on Europe’s Beating Cancer Plan 11 . Therefore, no additional public consultation was undertaken.
Collection and use of expertise
The Group of Chief Scientific Advisors published its scientific opinion on cancer screening in the European Union 12 on 2 March 2022. The aim of the opinion was to examine how the Commission can contribute to improving cancer screening across the Union and to inform the Commission’s 2022 proposal to update the 2003 Council Recommendation on cancer screening.
The Group’s opinion makes three main recommendations:
ensure that existing screening programmes for cervical, colorectal, and breast cancer integrate state-of-the-art scientific knowledge, are coordinated within the whole pathway of cancer management and are centred on the citizens.
extend population-screening programmes to cancers for which scientific evidence demonstrates a good harm-benefit ratio, cost-efficiency, advantages of early detection, and feasibility throughout the Union, whilst regularly reviewing scientific evidence for screening of other cancers.
take advantage of rapidly developing technological possibilities and scientific knowledge to optimise early diagnosis and risk-based cancer screening.
Impact assessments
An impact assessment was not considered necessary as the Commission acted upon the opinion of the Group of Chief Scientific Advisors. The form of a Council Recommendation is a non-binding measure and leaves ample room for Member States to adapt their approach to national needs.
4. BUDGETARY IMPLICATIONS
None